Asian Hospital & Healthcare Management - Issue 20

Issue 20

2009

ÂŁ12 â‚Ź18 $25 Rs.300

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Advance Care Planning A new intervention

Technology and Patient Safety Capturing the power of technology

Healthcare IT Spending

Effects of a changing global economy

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A s ia n H o s p i ta l & H ea lt hcare M a nage ment

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Foreword

Healthcare Reforms in India The right steps

If national and global targets of healthcare are to be achieved, large-scale reforms are the right way forward.

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o say that healthcare reforms are the biggest challenge facing Indian healthcare would be an understatement.

The enormity of this roadblock can be judged by the fact that there has hardly been any change in the way the state provides healthcare since independence.

True, things have changed dramatically with the entry of the private sector. But access to basic healthcare amenities is still considered to be a luxury in many parts of the country. As a result, a country that has registered staggering economic growth is struggling to fulfil the most basic healthcare needs. The government’s spending on healthcare continues to be one of the lowest in the world.

The monetary stakes are not high and this is reflected in the condition of government-funded healthcare.

According to the report Global Infrastructure: Trend Monitor Indian Healthcare Edition by KPMG, a research firm, Indian healthcare is expected to double in value between 2009 and 2012. This will be driven by rising income levels and changing demographics and illness profiles. Realising this potential will involve huge investments in the healthcare infrastructure. And given the healthcare system in place, wherein the respective state governments control healthcare spending, chances of disparities not arising are bleak. A state like Bihar, for example, is not likely to do as well as Maharashtra or Andhra Pradesh.

The government has been showing interest in the Public Private Partnership (PPP) model to further its cause.

But so far this seems to have had limited success with most of the activity happening in areas like emergency ambulance services. Citing this, the KPMG report goes on to state that “One of the major challenges remains the need to develop scalable and sustainable healthcare delivery models to deal with India’s diversity and changing socio-economic population profiles.”

Not surprisingly, the push for better infrastructure is coming from the private sector. Of late, leading private healthcare providers have shown interest in smaller cities and towns. The economic benefits of operating in smaller cities being a major incentive, this will help the private sector tap into a virtually captive market that is eager for high-quality services. Non-profit organisations have been there for long time now and have been providing basic care for virtually no cost.

What then can the government do about this trend?

At the least, it could help with putting in place the infrastructure and quality standards for these providers to get a foothold. Secondly, it could promote the non-profit organisations by giving them economic incentives. A third move, however improbable it may sound, would be to compete with the private and non-profit organisations.

Competition spurs innovation with the patient being its ultimate beneficiary. This would also mean that the government would play a much important role in the provision of care that just being a facilitator.

If national and global targets of healthcare are to be achieved, large-scale reforms are the right first step. The potential is there to be exploited. And by all means it is more about when India will take the right steps than whether it will at all.

This issue of Asian Hospital & Healthcare Management presents insights from industry experts on what all needs to be put into place for the potential to be realised.

Akhil Tandulwadikar Editor

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Contents Healthcare in India

MILES TO GO

HEALTHCARE MANAGEMENT

SURGICAL SPECIALITY

06 Quality of Healthcare Value of accreditation

Stephen Large, Papworth Hospital, UK

36 Surgery for Acute Heart Failure

Karen H Timmons, Joint Commission International, USA

DIAGNOSTICS

08 Advance Care Planning A new intervention

50 Three-dimensional Transesophageal Echocardiography Early experiences

Fiona Randall, Royal Bournemouth and Christchurch Hospitals Foundation Trust, UK

Nina Wunderlich, Cardio Vascular Center Frankfurt, Germany Neil Wilson, John Radcliffe Hospital, Oxford, UK

12 The Lean Way Improving healthcare performance

Jennifer Franke, University of Heidelberg, Germany Horst Sievert, CardioVascular Center Frankfurt, Germany

CaseStudy

David Howard, The Manufacturing Institute, UK

56 Molecular Diagnostics and Personalised Medicine Present and future

16 Urgent Carew The shift in emphasis

Eddie Blair, Integrated Medicines Ltd, UK

Rick Stern, David Carson and Henry Clay Primary Care Foundation, UK

TECHNOLOGY, EQUIPMENT & DEVICES

29 Primary Healthcare in India An ideal approach Geeta S Pardeshi, Dr. Shankarrao Chavan Government Medical College, India

60 Evolving Healthcare Technology Changing processes

MEDICAL SCIENCES

Rajiv Varyani, Frost & Sullivan Healthcare, Singapore

32 Circulating Nucleic Acids in Plasma & Serum A non-invasive approach Peter B Gahan, King’s College London, UK

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Healthcare in India Miles to go

Ranjit Shahani, Novartis, India

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Indian Healthcare Reforms A much needed prescription

Navin Chandra Nigam Satyam Computers Services Ltd., India

FACILITIES & OPERATIONS MANAGEMENT 62 Technology and Patient Safety Capturing the power of technology Shobha Phansalkar and David W Bates Brigham and Women’s Hospital and Harvard Medical School, USA

INFORMATION TECHNOLOGY 65 SOA for Healthcare Promises and pitfalls Dennis B Smith and Grace A Lewis Carnegie Mellon University, USA

70 Hospital of Tomorrow Technology leads the way in Asia CaseStudy

Gerard Anthony Dass, Nortel Asia, Australia

72 Clinical Transformation Future of health IT at Marshfield Clinic Robert A Carlson, Marshfield Clinic, USA

76 Healthcare IT Spending Effects of a changing global economy Rajiv Varyani, Frost & Sullivan, Singapore

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Advisory Board

John R Adler Professor Neurosurgery and Director Radiosurgery and Stereotactic Surgery Stanford University School of Medicine, USA

editorial Team Sana Syed

Sandy Lutz Director Health Research Institute PricewaterhouseCoopers, USA

Art Director M A Hannan Senior Designer Ayodhya Pendem

Pradeep Chowbey Chairman Minimal Access, Metabolic and Bariatric Surgery Centre, Sir Ganga Ram Hospital, India

Harald Becher Professor Cardiac Ultrasound Oxford University, UK

John R Hawkins Director Information and Technology Services Abu Dhabi Health Service Company (SEHA), UAE Malcom J Underwood Chief Division of Cardiothoracic Surgery Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong

Gabe Rijpma Health and Social Services Industry Director Public Sector Group Microsoft Asia Pacific, Singapore Basri JJ Abdullah Professor Department of Biomedical Imaging Faculty of Medicine University of Malaya, Malaysia

Sales Associates Savita Devi Murali Manohar Sherley Jones Mark Twain

Compliance Swetha Kalal A N Rani CRM Yahiya Sultan Sindhura Abburi Subscriptions incharge Vijay Kumar Gaddam IT Team Ifthakhar Mohammed Azeemuddin Mohammed Sankar Kodali Thirupathi Botla Chief Executive Officer Vijay Chintamaneni Managing Director Ashok Nair

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Editors Akhil Tandulwadikar Prasanthi Potluri

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Healthcare Management

Quality of Healthcare Value of accreditation Accreditation is recognised as a framework to integrate a quality management system while reducing risk, and requires a systematic assessment of hospitals against explicit standards.

Karen H Timmons President and CEO Joint Commission International USA

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very day, people entrust their health or that of a loved one to healthcare organisations. Whether it is in a hospital or at another type of facility, there is a basic expectation of safe quality care.

Additionally, patients and their loved ones expect and deserve that the care received meets expectations. External validation of an organisation’s commitment to quality through international accreditation is becoming an increasingly popular choice among leading Asian hospitals.

As more hospitals compete to deliver new and better healthcare services to attract more patients, healthcare leaders must ask themselves, “What assurance of quality and safety do our patients and other stakeholders need about our organisation?

Are quality and safety needs currently being met as well as they could be?”

A new approach

Increasingly, organisations are seeking— and patients are demanding—a proven method for an objective, external quality assessment of healthcare organisations, which includes providing safe quality care, competent and skilled clinical staff and a safe environment. To accomplish these aims and demonstrate a commitment to quality, healthcare organisations are seeking accreditation.

Few would dispute that doctors, nurses and other healthcare practitioners sincerely strive to deliver high quality care, and in fact have an ethical duty to do so.

However, the systems and environments that such dedicated staff work in every day are frequently not designed to allow them to deliver error-free or patient-safe care every time. The needs and expectations of care for the international or foreign patient may differ from those of Asian patients because

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of different social, cultural or religious factors.

Accreditation is recognised as a framework to integrate a quality management system while reducing risk, and requires a systematic assessment of hospitals against explicit standards. International accreditation programmes, such as Joint Commission International’s, can go a long way towards helping Asian hospitals not only to improve their systems of care but also meet the needs of their often more diverse population of patients.

Value of accreditation

A recently published study shows how stakeholders such as patients, government authorities, healthcare workers and external auditors all perceived significant improvement in the overall performance of a healthcare organisation within 15 months of implementing consensus standards. In organisations that have achieved accreditation, patients experienced a culture of continuous quality improvement within which their rights are identified and respected, the assessment and treatment processes are efficient, and care is coordinated. Moreover, patients are educated to participate in the care process and better care for themselves following discharge, staff are qualified and have information to do their jobs well, infections are monitored and controlled, and care is provided in facilities that provide a safe and supportive environment. Changi General Hospital, a 797-bed public hospital in Singapore that achieved Joint Commission International (JCI) accreditation in 2005, found decreases in needlestick injury rates and hospitalacquired infection rates and lowered their medico-legal and insurance costs as a result of the accreditation journey.

Healthcare Management

Interviews with chief executive officers, medical directors and directors of nursing show that leaders at accredited hospitals consider accreditation important for public image, political reasons and retention of existing staff. Leaders further perceive accreditation as a useful marketing tool to recruit new staff and to attract top-performing physicians and nurses to their organisations.

One case study is Singapore General Hospital, a 1,400-bed acute tertiary care public hospital. The oldest and largest hospital in Singapore, it has long been a healthcare institution admired and trusted by the public for its quality care.

Although it is a public hospital, Singapore General also attracts patients from outside Singapore because of its reputation for its standard of care in various medical and surgical specialties. The hospital chose to pursue JCI accreditation to affirm its belief, as well as the public’s, that it is an excellent organisation that delivers care with a patient-centric focus. “We have experienced many benefits through our preparations for JCI accreditation. One of the key findings is the teamwork and commitment shown by our staff when we achieved a common vision… This has been an awesome discovery that has further strengthened our organisation.”

Improving safety

A 2007 study in the Journal of Healthcare Management found a strong association between accreditation and the implementation of patient safety systems. The study concluded that accreditation is a predictor of healthcare organisations engaging in actions to improve safety.

Bangkok Hospital Medical Centre (BHMC) is a medical campus consisting of four hospitals and a broad range of specialised clinics. When the hospital, led

by CEO Dr. Chatree Duangnet, began to pursue international accreditation with JCI, it knew that preparation would be necessary to ensure that its systems and processes were functioning well and conforming to JCI standards. It instituted

Tracer Rounds, based upon JCI’s Tracer Methodology approach toward evaluation of standards compliance during onsite accreditation surveys. This approach requires the hospital to actually follow the care experiences of patients and follow the organisation’s systems and processes of care by tracing them through the organisation.

For BHMC, environmental rounds have also evolved into a series of interconnecting pieces that must be in place to avoid any gaps in oversight. Top level planning from all sectors is vital for a safe environment including the involvement of the CEO, CMO, COO, CNO and

customer satisfaction is through the emphasis on collaboration with patients and their families. Healthcare organisations must work to establish trust and open communication with patients and to understand and protect each patient’s cultural, psychosocial and spiritual values.

JCI’s patient and family rights standards focus on improving patient outcomes by involving patients and their families in care decisions and processes in ways that match cultural expectations. At the same time, many organisations have found significant improvements in their patient satisfaction rates and fewer complaints from patients.

Virginia Maripolsky, Assistant CEO for Nursing Affairs, Bangkok Hospital Medical Centre, shared the following comments as their hospital was preparing to achieve Disease-Specific Certification for four diseases following their successful JCI accreditation in 2007: “Our Customer Satisfaction Index scores are usually quite high, however there was a significant and remarkable jump in the scores of the departments affiliated with the disease-specific pathways. No one would have predicted this so soon and no one expected it. But the results told the story. Pursuing Disease-Specific Certification not only promotes high quality care and improves patient outcomes, but it also enhances patient satisfaction. We are living proof!” hospital directors from the leadership team. None of the individual rounds, tracers or surveys can stand alone to provide and maintain a safe environment. Rather, all the information and data gathered from a variety of rounds is collectively tracked, reviewed and analysed in the Total Quality Center (TQC) to project the full picture of safety at Bangkok Hospital Medical Center.

Promoting patient satisfaction

While all JCI standards contribute to improved patient care, one important way that accreditation promotes

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Competitive advantage

Conclusion

Achieving JCI’s Gold Seal of accreditation is a symbol to the community that the organisation embraces quality and will continue to do so.

What accreditation does is equally important—by focusing on the systems that meet patient needs, organisations create a healthcare experience that meets their patient’s expectations for safe, quality care, and in the process, enhances their customer satisfaction.

References are available at http://www.asianhhm.com/magazine

Karen H Timmons is the President and Chief Executive Officer of Joint Commission Resources, Inc. (JCR) and Joint Commission International (JCI). Timmons also spearheaded the establishment of the Joint Commission International Center for Patient Safety, and is a past board member and Treasurer for the International Society of Quality Assurance (ISQua).

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Advance Care Planning A new intervention

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dvance Care Planning (ACP) is no more, and no less, than a patient planning in advance for anticipated future loss of capacity to make healthcare decisions, with the assistance of their healthcare providers.

Loss of capacity to decide whether to consent to or refuse treatment options offered, or to decide other healthcare matters such as place of care, is common in illnesses such as dementia, in delirium from whatever cause and in the last days of life. When the patient lacks capacity to make such decisions, they must be made by others on the patient’s behalf.

In many countries responsibility for decision making then lies with the healthcare team. In others, relatives of the patient may consent to or refuse treatment on

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behalf of the patient, either as a matter of course or via a special prior appointment by the patient. Regardless of who must make decisions on behalf of a patient who now lacks capacity, knowledge of the patient’s wishes, feelings, beliefs and values whilst capacity was retained is invaluable in deciding on behalf of the patient.

In the UK, ACP has been defined as, ‘a voluntary process of discussion about future care between an individual and their care providers, irrespective of discipline. If an individual wishes, their family and friends may be included.’

ACP should properly be seen as a healthcare intervention, as it is basically a healthcare professional encouraging and assisting a patient to consider and express wishes, feelings, beliefs and values

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about future treatment and care in the event of future loss of capacity to make the relevant decisions.

An ACP discussion may result in an advance care plan, which may also be called an advance statement, but only if the patient wants this plan / statement made or recorded in the healthcare file.

In the UK, if such a plan / statement has been recorded the law (the Mental Capacity Act) directs that it must be taken into account in decisions once the patient has lost capacity.

The difference between ACP and care planning more generally is that the objective of ACP is improving / directing future decision making if / when capacity is lost, and any plan or statement formulated from the discussion will not be used unless capacity is lost.

Healthcare Management

Cultural and political influences promoting the ACP intervention

In some countries, notably including the USA and the UK, there has been recent enthusiasm for ACP. Two reasons are particularly influential; first is the acknowledged difficulty of making decisions on behalf of patients who lack capacity, especially decisions about treatment which is not a cure but which has potential to prolong or sustain life; the second is increasing cultural and political importance attached to patient ‘choice’ in terms of treatment and location of care.

So ACP has been both professionally and politically encouraged as a healthcare intervention, despite a paucity of evidence regarding the balance of benefit to harm and risk for individual patients, and for the overall majority of patients if its implementation is to be widespread in a national health service.

Professional guidance

Since the nature, purpose and correct clinical practice regarding ACP are often misunderstood, two sets of professional guidance were recently launched in the UK. The first was written as part of the UK End of Life Care Programme, is aimed at health and social care staff, and was revised in 2008. The second was produced after review of all the available evidence on ACP by a well constituted group comprising healthcare professionals from relevant specialties and disciplines, plus patient and carer representatives from relevant charities with a disease / health focus. This guidance is clearly evidence-based and was published by the Royal College of Physicians of London. The two documents are consistent with each other, and give the following guidance to healthcare professionals.

When should ACP be instigated by professionals?

ACP is definitely completely voluntary for patients, who must be permitted to decline to contemplate loss of capacity and future illness scenarios, or to close

Advance Care Planning is a healthcare intervention in which the patient plans in advance in making ones healthcare decisions for which we do not know the overall balance of benefit to harm and risk.

Fiona Randall Consultant Palliative Medicine Royal Bournemouth and Christchurch Hospitals Foundation Trust, UK

down the discussion at any time. ACP should not be instigated simply as part of routine record keeping or care, but instead should be instigated only if and when the professional makes a clinical judgement that the likely benefits of the ACP discussion for the patient outweigh the possible harms and risks.

ACP should not be initiated with a patient as a result of outside pressures, such as from the family, or organisational pressures (which would include political and managerial influences on healthcare services).

The evidence indicated that instigation of ACP is not appropriate just after diagnosis of a terminal illness, or at acute admission to hospital, or just after nursing home admission. At these times it may simply cause distress.

The time and setting should be appropriate for a private ACP discussion; evidence indicated that ideally the patient should be in a stable condition and not in hospital, so primary care might be the best context in this respect.

What information will the patient require in the discussion?

To establish preferences regarding future treatment options in the event of loss of capacity, patients will need essentially the same information as they would be need to give consent to the treatment, in order to be sufficiently informed to express true preferences. Regarding care options including place of care, they need information about what would be available, and about the effect that location of care might have on treatment options available.

Regarding potentially life-prolonging or life-sustaining treatment, for example artificial hydration and nutrition, antibiotics and mechanically-assisted ventilation, patients will need to know the likely effects of receiving and of not receiving the treatment. To establish preferences they will need to understand what each treatment can and cannot achieve and the effect of each treatment on the course of the illness. Not only is this quite a large amount of information, but it is also potentially very distressing as it will often be about ‘ways of dying’ from incurable illness.

What knowledge and skills will the professional need?

Whilst good communication skills are obviously important, the necessary knowledge base to give the patient adequate information is essential. The guidance states that the professional requires ‘full knowledge of the patient’s medical condition, treatment options and social situation’, and it notes that the most appropriate professional might be a specialist—either nurse or doctor.

So there are significant resource consequences of professional time.

What is recorded?

The patient may wish to write an advance statement / advance care plan.

Alternatively, the professional may make a record of the outcome of the ACP discussion in the notes, but what is recorded must be explicitly sanctioned

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Healthcare Management

by the patient. The advance statement / plan might record whether the patient would or would not want particular treatments in particular circumstances, or preferences regarding place of care and death. It might also record beliefs and values, for example attitudes towards death and life-prolonging measures generally, and the importance to the patient of the welfare of close family members especially spouses.

The statement / plan is confidential, and can be shared with other healthcare providers (and family members) only if the patient agrees. However, the more that patient restricts such sharing, the less likely it is that the statement / plan will be available when needed for decision making.

What are the potential benefits to patients?

The advance statement / plan provides information about the patient’s wishes, feelings, beliefs and values so that they are better understood by those who must make decisions on the patient’s behalf when the latter lacks decision-making capacity. In some countries (such as the UK), the basis for such decisions is the ‘best interests’ standard, which means what is considered best for the patient when the benefits, harms and risks of treatment and care options are considered together with whatever is known of the patient’s wishes, feelings, beliefs and values. In other countries, the basis is the ‘substitute judgement’ standard, which means the decision which it is believed the patient would have made in the circumstances had he / she been able to do so. Whichever standard is used, the record of the outcome of the ACP discussion enables the patient’s own preferences to be more accurately known and taken into account.

In addition, the process of the ACP discussion may itself be beneficial to patients, increasing their understanding of the illness and enabling them to have some control over its course—to the extent that this is possible—by expressing

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preferences regarding future treatment and care. Where patients wish to involve family members in the ACP discussion, they may achieve greater mutual understanding about the illness and treatment possibilities, and about the patient’s preferred location for care and death and the family’s ability and willingness to support that preference.

What are the potential harms and risks to patients?

Patients may be emotionally traumatised by confronting information about future illness scenarios, much of it unpleasant and pertaining to ‘ways of dying’.

Moreover, whilst likely and possible scenarios will be discussed, many of them will never arise so it can be argued that this emotional trauma is avoidable,

The ‘unknowns’ ACP is a healthcare intervention for which we do not know the overall balance of benefit to harm and risk for individual patients and for populations served by a healthcare system.

Advocating its widespread implementation is therefore ethically questionable and indeed difficult to justify.

unnecessary and unjustifiable. There is a real risk that pressure will be put on patients to engage in ACP because of organisational / professional / political pressures. Any such pressure is a risk to the voluntary nature of ACP and increases the likelihood of emotional trauma.

Conflict between patient and family may occur as they may disagree about future treatment and particularly location of care and death, since the family may have entirely legitimate interests in the latter if they are expected to provide practical care.

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Patients are known to change their minds! There is a real risk that changes in a patients’ preferences for future treatment/care will not be recorded, and such failure to update the advance statement/ care plan will then result in erroneous representation of the patient’s preferences when a decision is later necessary.

In such a case the advance statement/care plan is arguably worse than useless!

Encouraging patients to record their preferences in ACP can easily give rise to unrealistic expectations regarding what can actually be achieved in terms of treatment and location of care and death. For example, it is so often just not possible to ensure that patients die in the place of their previously expressed choice!

What are the effects on services and other patients?

It is acknowledged in the UK professional guidance that there is generally a paucity of evidence (especially high quality evidence), on ACP. Since much of the evidence is from the USA caution should be used in applying that evidence to other healthcare systems and cultures.

We do not know the ‘professional time’ resource consequences of ACP discussions—a single discussion is unlikely to be sufficient and very knowledgeable and skilled professionals are required. Nor do we know the resource consequences of complying with patients’ preferences especially in relation to place of care and death. So we do not know the ‘opportunity costs’ for other patients if ACP is implemented in resource-limited publicly funded healthcare systems. Such systems generally allocate resources on the basis of patient need and not merely patient choice, as the former is seen to be a more just principle. Implementation of ACP has real potential to lead to unjust resource allocation by prioritising patient choice over need.

References are available at http://www.asianhhm.com/magazine

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Organisational change and sustained improvement can be achieved using the same principles of strong leadership and lean deployment that have transformed major producers worldwide.

David Howard Performance Improvement Practitioner The Manufacturing Institute, UK

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ean can provide better care, better quality at low costs and that is why many healthcare managers are using the principles, systems and systems of Lean to stretch limited resources, improve the quality of patient care and safety, eliminate errors, reduce waste, cut delays and reduce the length of patient stays.

Sustainable Lean

A Lean healthcare review should start by identifying all of the process inputs from start to finish - working out where value is being added and where it’s not.

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Healthcare Management

The Lean Way Improving healthcare performance

Leading cultural change

This is similar to a medical diagnostic process where the symptoms are identified to understand the current condition and issues. Next step is to work with the relevant team to develop solutions for eliminating all the non-value added steps within the process. In a healthcare setting, it’s totally focussed on putting patients first.

There are huge advantages of using Lean in healthcare because it determines a new culture and system of checks and improvements—providing a sustainable methodology to continuously improve services.

To succeed in the long term, healthcare organisations must be willing to rethink how they do things and commitment from management and executive teams is crucial. A system to create these Lean leaders is essential, as is the need to encourage participation by all staff and give all employees the necessary skills.

The Lean pillar of respect is fundamental to success and that means listening to people, involving them and empowering them to make the lean changes from the bottom up. This is particularly powerful in a healthcare setting where by truly engaging with staff it is possible to unleash the power of hundreds of people to bring about big changes. But unless senior management demonstrates total commitment and gives others the freedom, power and authority

to improve their department or function, the momentum will slide.

Lean will only work properly if it is driven from within and so it is vital to equip staff with the knowledge and skills to drive change. It is particularly important to prepare a tier of staff at all levels and within all disciplines to lead and champion Lean—to promote a culture of continuous improvement and mobilise and involve everybody.

Best practice

The Manufacturing Institute’s lean healthcare team—comprising lean leaders with many years of experience in industry–has been achieving powerful results in partnership with UK hospitals.

Among them are: West Middlesex University Hospital Trust has applied lean thinking to its HR

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Healthcare Management

department—tackling universal issues of sickness and absence rates and recruitment lead time. Process flow mapping, root cause analysis and visual management techniques are some of the strategies that have been used to shrink recruitment lead times from up to 9 months to a standardised 53 days. A new sickness and absence management process has reduced the rate from 3.9 per cent to 3 per cent and has the potential to make significant financial savings.

Said Nina Singh, Director, Workforce Development for West Middlesex, “Making changes in practice is one thing but making sustainable improvements is altogether a more difficult challenge. Our work with the Manufacturing Institute has been invaluable in understanding how to achieve long term change and how to continuously improve standard practice.”

At Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust Pharmacy Lean is helping the team to realise performance benefits from the

installation of an automated dispensing system. Work began with value stream mapping that highlighted a robust future state system for installation of the automated dispensing system and beyond— bringing smooth single piece flow to the dispensing process and halving the time required to prepare prescriptions.

Lean methodologies have also been applied to capacity planning to ensure full utilisation of facilities and to improved workplace organisation using visual management and 5S techniques.

New key performance indicators have also been introduced to measure automation reliability, workload levels and stock control of medicines.

Lean Pharmacy projects have also brought benefits to the Royal Devon and Exeter NHS Foundation Trust, where inventory levels have been cut, and process flow has been improved through a new Lean layout—cutting an average 70 minutes from the process of preparing prescriptions.

Lean principles are also improving standards and efficiencies in medical diagnostics. The Manufacturing Institute has been working with staff in radiology departments, endoscopy suites and specimen labs to consider how they can develop work processes and maximise their contribution to patient care. One example is the Royal Devon and Exeter ultrasound department, where opportunities were identified for better utilisation of this important asset. Constructive problem solving and process redesign was employed to increase throughput.

This improved the quality of interaction between patient and doctor while bringing down individual consultation time from 24 to 15 minutes and eliminating the need for extra evening and weekend sessions.

Stockport NHS Foundation Trust has integrated lean methodologies into its long-term business improvement model. With support from The Manufacturing Institute, it set up the

Five key steps to Lean 1. Specify value in the eyes of the customer Patients expect to receiv.e the best care and service that can be provided, free of defects. This means identifying best practice in every step of the patient journey, both information and physical flow, and then rigorously applying gold standard work. This could mean always labelling samples at the bedside, applying care bundles rigorously, or eliminating opportunity for transcription errors by using IT effectively.

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there has to be unused capacity. This is actually more economic because the hidden waste in dealing with the errors, cancelled appointments, initiative lists, missed targets and lost activity is eliminated. This means turning the traditional accounting view on its head, and counting the true cost of broken flow.

2. Identify the value stream It is useful to start at the end of the process and follow the activity right back to the beginning. This is because the process of discharge often holds up the whole healthcare system, whether this is blocked beds, or follow up appointment processes.

4. …so the customer can pull When a service is capable, adequate and available, with good flow, it is possible to move to a system that is pulled by patient demand, rather than pushed onto the patient. The possibilities of this are fantastic! No need for outpatient appointments and waiting list procedures, just turn up at a convenient time. Wards call the emergency department to ask for a patient to fill an empty bed—right patient, right service, right time.

3. Make value flow…

No manufacturer would ever run every asset in the value chain at 100 per cent. Customers would never contract to use all the capacity of every supplier, as they know this would guarantee failure the moment there is a small change in demand. But hospitals often run their wards at 100 per cent occupancy. To enable patients to flow safely,

5. Continuously improve in pursuit of perfection Visual management is essential to show what has been achieved and how to improve. This ensures patients can easily see what has been done to make their service better.

The Lean organisation will challenge every team to have a daily review, and write on the wall what the staff will do to make tomorrow even better than today.

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Healthcare Management

Issues identified through the Value Stream Mapping were tackled through Rapid Improvement Events, including: • Reduction in the overall lead time from referral to discharge • Time taken for call centre to confirm outpatient appointments • Medical records and storage capacity • Capacity within radiology balancing existing and future demand • Creation of additional emergency treatment capacity • Specifications for commissioning of future services.

The early benefits of this work include: • 33 per cent increase in throughput in radiology • 64 per cent reduced time to prepare

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Stockport Improvement Programme (SIP) —committing at the highest level to a powerful programme of change.

As such, it firstly worked with The Manufacturing Institute at an executive level on its lean leadership development, then appointed and trained fifteen ‘Stockport Improvement Champions’ who undertook The Manufacturing Institute’s intensive Accelerated Route to Lean Healthcare 10-day training course in preparation for supporting a series of projects.

Lean implementation began with value stream mapping within two key departments of orthopaedics and emergency medicine. By analysing the patient journey both inside and outside the hospital—from PCT referral through all the complex steps to discharge —a complete and detailed picture of the process and the waste within that process emerged. Supported by The Manufacturing Institute, the SIP team was able to create an ideal future state map to eliminate all the non value added steps.

intravenous drugs • 33 per cent increased capacity in treatment room areas • Outpatient appointments confirmations reduced from 23.5 days to 12 days • 43 per cent increase in optical scanning • 99.9 per cent availability of case notes Commenting on the Lean changes, Teresa Hopley, Senior Personnel Manager, Stockport NHS Foundation Trust said, “The Manufacturing Institute showed us how the principles that have transformed manufacturing industry can revolutionise healthcare by eliminating waste, increasing efficiency and delivering improved quality and patient care.”

David Howard is successfully mapping Lean techniques, systems and principles in healthcare. Working in partnership with several National Health Service Trusts, he is leading organisational change and sustained improvement to improve the quality of patient care and achieve better cost performance.

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Healthcare Management

Urgent Care The shift in emphasis The UK National Health Service has seen a shift in emphasis in managing urgent care, from preventing emergency admissions to better management of care outside hospital.

Benchmark out of hours services and improving the management of urgent care in general practice are the two recent initiatives in this shift.

Rick Stern Director David Carson Director Henry Clay Director Primary Care Foundation UK

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he National Health Service (NHS) in England has benefited from an unprecedented growth in funding over the last ten years. It is now bracing itself for an end to consistent growth in budgets of 8-9 per cent a year as the full effect of the global financial crisis begins to bite. Increasingly, managers and policy makers will be looking for improvements in care fuelled by greater productivity rather than more funding, or for opportunities to improve patient care in ways that also reduce overall costs to the healthcare system.

As a reliance on national targets is relaxed, it is becoming more possible to focus on areas that have tended to be overlooked. Media attention has focussed on key targets involving 24 or 48 hour access in general practice, the speed of ambulances to emergency calls, and reducing waits at A&E departments.

While all of these targets are important in their own right, they have distracted attention away from all other important aspects of the system. The Primary Care Foundation, an independent organisation committed to developing best practice in primary and urgent care, were commissioned by the Department of Health in England to look at two important areas of the NHS—the management of urgent care in general practice and the performance of out of hours medical services—and the results suggest that a greater focus on these and other areas could do more to improve the quality and safety of patient care and offer better value for money.

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What do we mean by urgent care and how is it managed?

Urgent and emergency care is being used to describe all unplanned care; a need for a rapid response to an immediate health problem rather than a developing complaint that can be managed in a planned way. Within unplanned care, emergencies cover care for conditions that are, or could be, immediately life threatening. Urgent care is more difficult to define and is likely to be differently understood by the patient rather than the clinician. In the end, the Department of Health has avoided a technical definition and prefers to give priority to the patient’s perspective, so whatever that patient thinks is urgent, is presumed to be so until they have been properly assessed by a clinician.

The patient is also faced by a confusing array of choices in accessing care when they have an urgent health problem. The table below shows that after considering self care, they can contact a range of services that vary depending on developments within their local healthcare system.

They can contact, their GP surgery, or potentially a series of community based nursing or therapy services, which may now be based at a new Walk In Centre, if it is out of normal practice hours they can call their ‘GP out of hours service’, they can dial 999 to call an ambulance, or go direct to a hospital Accident & Emergency (A&E) Service. Recent studies have shown that while patients understand the role of their GP surgery and of A&E, everything else is far from

A whole system perspective: An urgent & emergency care pathway

There has been increasing attention given to developing ‘urgent and emergency care networks’ to ensure that all the different agencies co-operate together and ensure that patients do not slip between the different care systems. Our focus, at the Primary Care Foundation, has been to ensure that we have a better understanding of each part of the chain of urgent care.

Below we describe our work looking at two key parts of this whole system.

Improving the management of urgent care in general practice

An estimated 300 million primary care consultations take place in some 9,000 practices throughout England each year.

Practices vary considerably in their size, staff mix and way of operating. The cities, towns, villages and populations they serve

Developing the principle for urgent cases presenting to general practice

vary too. In a diverse and complex system for providing primary care, it is clear that one size does not fit all.

Urgent care in general practice is important from a number of perspectives. It matters to patients, who may be harmed or distressed if diagnosis and treatment is delayed. It matters to the NHS as a whole, because urgent care arrangements which have not kept pace with other operational changes within the NHS place pressure on the rest of the system, driving people towards A&E and avoidable hospital admissions. It matters to general practices, where workloads can become unmanageable if urgent care is not handled well. It also affects the reputation of the service – unhappy patients tell their family, friends and colleagues about their experience.

In April 2009, a report funded by the Department of Health ‘Urgent care: a practical guide to transforming same-day care in general practice’ was distributed to all practices in England.

It describes our work with practices across five very different communities,

including a survey of how 150 practices currently manage same day urgent care, as well as supporting eight practices to make rapid improvements. It focused on three simple questions concerning care for patients who contact their practice with an urgent need: • Will they get through?

• Will they be identified?

• Will they be seen rapidly?

The report asked practices to apply the principles we outline to their own practice and system (see table below).

The decisions on what solution to put in place must rest with the practice and its team rather than imposed centrally.

Our findings highlighted a number of potential barriers to accessing services. This included difficulties in booking appointments on the telephone, with over a third of practices within the study having insufficient lines or reception staff to manage calls at peak times. We also found a large variation in the number of appointments available over a working week, suggesting that many practices simply did not have enough capacity to meet demand. In other

CaseStudy

clear. This has led to new ideas to pilot a national 111 number for urgent care, to sit alongside the 999 number for genuine emergencies.

Which implies Secondary principles Minimal delay reacting to a patient that presents

Urgent is defined by patient until assessed Fundamental principle The system must be safe for the patient

Must deal with patients wherever they present Must avoid long queues (for initial phone call assessment or face to face) Receptionists have adequate training / process to indentify potentially urgent cases Potentially urgent cases should be assessed by a clinician as early as is practical Must have adequate receptionsts for calls and face to face

Plans and capacity to respond as needed

Must have ‘duty clinicain’ or other arrangement for early assessment Must have capacity and plans to react if patient needs to be seen

In cases of doubt, then err on the side of safety

Build ‘safety netting’ (advising callers what to do if the condition worsens / does not improve) into the process In case of doubt ensure that the patient is assessed or seen sooner rather than later

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Healthcare Management

practices, it was less an issue of the overall number of appointments, but rather trying to ensure a better match between when people were seeking appointments and scheduling appointments. The clearest example of this is that while there is between 20-30 per cent more demand in almost every practice for appointments on a Monday morning, few practices schedule extra appointments at this time. Simple changes to the way patients access care and the practice manages its appointments can have a big impact on whether patients are seen rapidly when they have an urgent need.

It also highlighted the importance of non-clinical reception staff in spotting potentially urgent cases. While there was a high level of consistency in identifying and responding to potentially life threatening cases, there was greater variability in other cases that were potentially urgent, so that patients might wait longer than necessary for an appointment with a clinician. In a similar way, request for a home visit were often left until the end of the morning, even though they are more likely to require an urgent response. We found one example of a number of small practices working together to employ a doctor who would pick up all urgent home visits as soon as possible, following an initial call from the practices to check if an urgent response was needed.

This prompt response to urgent requests for home visits led to a 30 per cent reduction in emergency hospital admissions, freeing up resources for the practices to use in better ways.

The report highlights five key areas that all general practices should address: 1. Address urgent needs of a patient, whether they choose to access the service by phone or in person.

2. Match capacity to demand—both in responding to patients initial call and recognising the different demand patterns for same day and advance appointments.

3. Ensure that the full range of cases that might need urgent attention will

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reliably be recognised by staff when the patient rings or presents in person and that the process is understood 4. Set deadlines for assessment and intervention and measure performance against these, paying particular attention to the needs of those requesting home visits where the chances are that the case may be more acute or complex 5. Review and audit the processes to refine the way that they operate An example of how one innovative practice developed their service will help to illustrate these issues.

The Birchwood practice, a mediumsized rural practice in Norfolk, is a pioneer in urgent care and has developed a comprehensive urgent care service. GP Paul Everden led a national project to give ‘appropriate care at point of need’ (ACAPON). Its aim is to take away barriers to care.

The practice has established a genuinely integrated team, working across primary care, based on clear patient pathways. It includes an experienced GP, a nurse practitioner, emergency care practitioner and a healthcare assistant.

The aim is to assess patients as early as possible and to make sure that they are seen by the right person, best able to provide timely care.

When a patient presents with an immediate need a message goes to a team leader who makes an immediate telephone assessment. The patient is directed to the most appropriate clinician, who makes a full assessment, rapidly discusses what to

General Practice

Self Care Patient

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Community Services

Out of Hours Service

do with the wider team and implements an agreed pathway.

The results have been impressive. Lives have been saved that might well have been lost; there is better use of other services such as ambulances and paramedics; patients are being treated quicker and with better results. This has led to 16 per cent fewer hospital admissions than other local practices, saving money across the system. It offers a good example of how general practice can change the way it manages urgent care.

Driving up standards through a national benchmark in out of hours care

The national out of hours benchmark is a new initiative to drive up the quality of care and improve value for money across England. The first round of the benchmark was completed in March 2009 by the Primary Care Foundation and involved 63 different services measured on a wide range of performance indicators, ranging from cost, to quality, outcomes, productivity and patient experience. The benchmark is rigorous being based on a sample data extract typically of several thousand cases, supplemented by web based questionnaires, as well as a specially commissioned patient experience survey.

All of this ensures that we are genuinely comparing ‘like with like’.

Although the benchmark, initiated by the Department of Health, has been up and running for less than a year, more than half the PCTs across England have made separate decisions to buy into this

Ambulance Services

Accident & Emergencey services

Medical or Surgical Assessment in Hospital

CaseStudy service for three years. Commissioners understand that this type of information is the currency for world class commissioning of urgent care. There is already evidence that the benchmark is a powerful catalyst for action and there are good examples of how it has led to changes in the way services are delivered and significant improvements in patient care.

The benchmark marks a new approach, driven by data extracts supplied by out of hours providers for four separate weeks over a six month period. This is supplemented by web based questionnaires for both commissioners and providers. Reports were sent to each commissioner and service provider identifying their performance, but providers currently retain their anonymity. We also ran a series of half-day workshops with both commissioners and providers to help them understand the different measures and how they can be used to improve performance locally. We have now further refined the benchmark, with a second round underway, with reports due on

up to 100 services in September 2009.

This includes a number of improvements suggested by users as well as results from the first patient experience survey.

The first round of the benchmark has identified striking difference across services. These include: • Wide variations in cost per head (from £3.69 to £12.76 per head) and cost per case (from £31.41 to £119.91) • Extremely wide variations in the way providers identify callers as ‘urgent on receipt’ ranging from 1.3 per cent to 60.3 per cent • Substantial differences in the balance between offering telephone advice (21.2 per cent to 67.4 per cent), seeing patients at a base (19 per cent to 69.2 per cent), or carrying out home visits (3.3 per cent to 23.6 per cent) • Striking differences in productivity of clinicians at peak times ranging from 0.91 to 4.60 cases per hour • Large differences in the percentage of cases referred towards hospital (a key indicator of the effectiveness of an out

of hours service), although we have asked providers to focus on the way clinicians records this informational outcome on their systems.

It is now clear that the benchmark is encouraging greater consistency so that like for like comparisons can be made in all areas. As membership increases, the strength and credibility of the benchmark is enhanced. It has also provided a more positive story in the media in a sector that only tends to attract media attention following a catastrophic service failure.

In the end, the value of a benchmark is to drive improvements in care. One example helps to illustrate the potential for driving change, in this case, by understanding why their productivity was low, leading to improvements in both quality of care and value for money.

Urgent Care 24, providing out of hours services to about 600,000 people in the North-West of England, were involved in an early pilot were broadly pleased with the overall pattern of performance, but were concerned by their comparatively

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low level of productivity. This led them to dig deeper in this area. They carried out a further review of productivity by each clinician (doctors and nurses) and found an even greater variation across the wide range of clinicians covering shifts in their out of hours service. They then fed back this information to all clinicians and met with all clinical staff to discuss the results and reflect on what this might mean for an individual’s practice.

They also looked at other aspects of clinical behaviour. They found out that some GPs were logging onto the system late for shifts, others in remote Centres were not picking up telephone advice calls and were often inactive, while their colleagues undertaking triage at the main base were over-stretched. By addressing these and other issues they were able to improve performance, patient care and promote a culture of fairness for all staff.

The overall result was that productivity at peak times more than doubled, clinicians were happier that workload was more evenly spread and patient care improved. Their Clinical Director commented that “by making clinicians more productive—supporting them as necessary, sorting out the problems that they face and addressing one or two poor performers—it has improved care for patients because clinicians can focus on the job that they are there to do”.

but underneath this is an even greater variation between individual clinicians.

Understanding this variation, feeding it back to clinicians and reducing unnecessary variation is a key route to improving quality of care at the same time as reducing costs • The UK has relied heavily on a few key central targets which have tended to distract attention away from other potential improvements. In primary care we have focussed exclusively on 24 hour and 48 hours targets to see a doctor or a nurse, rather than potentially more important focus on seeing urgent patients much more rapidly • There is an understandable desire to try and develop a set of metrics across the whole of the urgent and emergency care system, but it is proving difficult to identify suitable measures and even harder to monitor them effectively and consistently. It may be better to start in a less ambitious way, by finding an effective way of monitoring performance in each part of the system, as described in the out of hours benchmark, before then trying to join them up • Politicians tend to push policy makers towards simple solutions in systems that are too complex to respond to a ‘quick

Rick Stern was previously a Chief Executive of a Primary Care Trust, responsible for commissioning NHS services for a community on the South Coast of England. He is also leads the NHS Alliance Urgent Care Network and is part of the Department of Health’s governing board for urgent and emergency care.

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What are the lessons from these new initiatives in the NHS for improving urgent care?

There are a number of key learning points for the NHS which may also apply to other healthcare systems.

• General practice has a crucial role to play in managing urgent care, but up until recently, little was known about their role and it has tended to be overlooked • The crucial factor driving the quality of care and the nearly all cost in the NHS is clinical decision making.

We have begun to understand some of the variations across organisations

fix’. The reality is that rather than seeking to improve urgent care by tackling the way patients are admitted at the front of about 300 hospitals across England, there are probably better solutions to be found by improving the management of urgent care across 9,000 general practices. A series of small, sustainable improvements are likely to have a greater impact to the system as a whole • A key challenge is integrating urgent care within local care systems.

Increasingly patients have more choices for accessing care, including Walk-In Centres, Out of Hours Care, Urgent Care Centres and now ‘Darzi’ Centres (named after the Health Minister, Lord Darzi), but they are far from clear where to go when they need rapid help.

Introducing a new national three digit number (such as 111) for urgent care may offer a new way in, but will only help if the services available locally are properly joined up • There is a strong case to be made to trust patients to make sensible decisions about how to access care and how urgently they need to be seen, rather than trying to educate them into using a complex and confusing service in the ‘right’ way.

David Carson was a GP in Scotland before working in an Inner London Health Authority leading primary care policy and performance. He is also author of a key report, known as the Carson Report, for the Department of Health in 2000 that defined the way ahead and set the standard for unscheduled care in the healthcare community in the UK. Henry Clay has spent over 15 years as a consultant to organisations in both the private and public sector. He has worked with many Out of Hours providers and has a particular expertise in benchmarking their performance.

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Healthcare Management

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Healthcare in India

MILES TO GO India is the leading supplier of generics to the world and yet in India healthcare for all is a chimera. Research-oriented Indian pharmaceutical companies spend less than 10 per cent of their sales on research. Innovation plays a key role in mitigating unmet medical needs. Future success in the healthcare arena will increasingly depend on collaborations and partnerships between all stakeholders.

Ranjit Shahani Vice Chairman & Managing Director Novartis, India

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ndia is the leading supplier of generics drugs to the world and yet in India healthcare for all is a chimera. 65 per cent of our population has little or no access to any kind of quality healthcare. Government spending on healthcare is abysmally low particularly when one looks at countries at a similar level of development as we are. This seems particularly ironical given the stature that India enjoys as the leading supplier of generics drugs to the world.

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The advent of the patent law in 2005 provides an opportunity for pharmaceutical companies that are researchoriented. It is now more common to read of companies like Dr Reddy’s and Glenmark Pharmaceuticals out-licensing some of their molecules to global companies who have the wherewithal to take these forward. Pharmaceutical research is a high risk business where the failures come more often than success and the resources required are huge.

Indian companies, even those that

are research-based, spend less than 6 per cent of their sales on R&D compared to the 18-20 per cent spent by global companies. While it is a good beginning, more collaborative working can reduce cost and speed up entry of new medicines for unmet medical needs.

Status of healthcare in India

Let us take a look at where we as a nation stood in terms of healthcare a few years ago. As per estimates shown in the World Health Report 2001, the life expectancy at birth was 53 years for men and 51.7 years for women. While these figures by themselves speak, it is important to note that the Report goes on to state that the percentage of life expectancy years lost as result of the disease burden and effectiveness of healthcare systems was 12.7 years for men and 17.5 years for women in India. Since then while some progress has been made it also clearly brings into perspective the need for a comprehensive approach to healthcare where infrastructure allows for access to quality healthcare right up to the last mile.

Opportunity for Indian pharma

The Indian pharmaceutical industry can contribute to mitigate this situation. It is estimated that currently it takes between eight and ten years to bring a compound from an idea to a usable medicine and this entire process could involve a total spend of up to US$ 1-1.7 billion covering research, development and testing costs. Clinical development time has actually doubled since 1982 and this only serves to make a bad situation worse where a US$ 100 billion worth of drugs will be going off patent over the next 2-3 years.

Pharmaceutical companies across the world have a challenge and are striv-

ing to meet the increasing expectations of all their stakeholders and to meet the unmet medical needs of today and tomorrow within acceptable costs.

There is a school of thought in India which propagates the view that domestic production of generic medicines will be encouraged by preventing more medicines from gaining patent protection, and this in turn will serve to increase access to medicines. Nothing can be further from the truth. The truth is that generics alone are not the solution to access. Access to medicines is more about making medicines available and less about costs. It is ironical that in a country like India aerated drinks are available in the most remote corners of the country but a medicine as simple as paracetamol is not. While affordability can be taken care of through several ways including innovative models such as tiered pricing, public-private partnerships and patient assistance programmes, access can primarily be taken care of by improving healthcare infrastructure in the country. Our country risks access to future medicines with long term negative impact on public health by ignoring the benefits of innovation.

It must also be remembered that generic medicines are not enough to meet the growing need for new medicines to counter issues such as drug resistance or to fight new diseases or even to treat specialised populations and to offer patients both new and better alternatives.

World class intellectual property rights in India—A necessity

The pharmaceutical industry in India has a strong manufacturing base with the country having the largest number of US FDA approved plants outside the

US. The recent development of the US FDA setting up local offices in India shows that Indian manufacturing in the pharmaceutical field has come of age. There is every reason to believe that the same can happen in pharmaceutical research where all of global pharma will be vying to either set up its own research units in the country or will be looking to collaborate with national pharmaceutical companies so as to leverage the strengths of both.

It is no longer a luxury to yearn to have world-class intellectual property rights in our country but rather a necessity. The much written about section 3(d) of the Indian patent law will only serve to deter innovators from looking beyond the obvious at areas that could benefit public health. It is proven that the invention of the wheel forever changed the way transport took place anywhere in the world. History shows that subsequent improvements in transportation were really incremental innovations.

Incremental innovation or innovation in sequential steps is the way in which medical progress takes place. It must be recognised that breakthrough innovations are few and far between not just in the pharmaceutical field but in all fields. Forcing drug discovery back to the drawing board each time a new medicine is needed to meet a hitherto unmet need will only serve to ensure that overall costs will be astronomical and that drug delivery is interminably delayed. It will do India no good if we as a nation fail to recognise that incremental innovation actually provides exceptional value for patients and society. If we look at the medicines available on the market today, we will find that more than 70 per cent of these were developed through incremental

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Incremental innovation distinct from ‘evergreening’

There have been efforts in several quarters to liken incremental innovation to ‘evergreening’. The two are completely distinct and must be recognised as such.

Evergreening is an attempt to extend the life of a patent by making tiny changes to a drug just before the expiry of its patent. These changes do not represent any medical advances and in fact many a time do not actually bring about any additional therapeutic value to the patient. Incremental innovation on the other hand results in the conversion of a compound in to a better medicine while providing clinical efficacy and exceptional benefits for both patients and society at large.

It is important to note that it is the patient who is the ultimate beneficiary of pharmaceutical research and development. We as a country appear to be mortgaging the future for the current.

India is today known for its vast intellectual capital and is recognised as a knowledge economy with expertise in process chemistry and strong IT skills.

The opportunity, therefore, is there for the asking but this can only be leveraged once government removes the artificial barriers it has created for the pharma-

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ceutical industry through section 3(d) and throws open the research space to the best minds in the pharmaceutical industry.

Exploring partnerships to leverage research

I am of the firm belief that future success in the healthcare arena will increasingly depend on collaborations and partnerships between all stakeholders including national and global pharmaceutical companies as the struggle to deal with patent expiries and rising research and development costs comes to a head. India is in the enviable position of having a large English-speaking scientific pool and this provides it a great opportunity to become a hub for future drug discovery programmes. While the concerns with regard to world-class intellectual property rights exist and enforcement of these is an issue, I strongly believe that putting in place an environment that is conducive to innovation and research will be for the ultimate good of the pharmaceutical industry in India and the people of this country.

Looking in to the crystal ball Miles to go for healthcare in India?

What then does the future hold for healthcare in India? It would be nice to be able to take a peek in to a crystal ball to be able to foretell the future.

Life expectancy is expected to increase further but much of this will be centred on urban India where the focus of qual-

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innovation on either a base compound or an existing medicine.

While these advances on the surface may seem minimal, in reality these provide outstanding value and without these so called building-block improvements, medical science in general and healthcare in particular would not have advanced to where it is today. Allowing patents for incremental innovations will play a crucial role in improving domestic public health in India and also help bring new and better medicines to the patients here.

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ity healthcare currently lies. I do believe though that partnerships and collaborations between various stakeholders will be the norm for the pharmaceutical industry not just in India but around the world and this will be for the overall good of public health. Whether this will translate in to taking healthcare to the heart of rural India only time will tell.

The World Health Report 2001 does see an India where there will be some measure of success in dealing with diseases such as polio, yaws, leprosy, kala azar, t’ilaria and blindness by 2020. The one area where the prognosis continues to remain uncertain is that of HIV / AIDS. The rate of maternal mortality in India is estimated to reach world standards by 2020. Will all of this happen? While I am a diehard optimist about the overall growth of the Indian economy, I am slightly less optimistic about the country achieving its healthcare targets. India needs to aggressively pursue a policy of increased expenditure on healthcare to reach these goals. India also needs to quickly put in place a world-class intellectual property rights regime where patent rights are respected both in letter and spirit and where data protection is accorded top priority.

India will move on as she must but as Robert Frost wrote a long time ago, “The woods are lovely, dark and deep, but I have promises to keep and miles to go before I sleep, and miles to go before I sleep.”

Ranjit Shahani is a Mechanical Engineer from IIT Kanpur and MBA from JBIMS, Bombay. He started his career with ICI in India in their businesses of Fibres & Speciality chemicals. He is a thought leader in the Pharmaceutical Industry and has been actively involved in lobbying for a strong Product Patent law in the country and Data Protection and liberalization of the price control mechanism for Pharmaceuticals.

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Indian Healthcare Reforms

A much needed prescription The first major change in Indian healthcare system started way back in 1946 by the recommendation of ‘Bhore Committee’.

Since then it has been a journey of various swings in ups and downs.

The challenges are enormous and remedies are limited. India, with huge population base, needs reforms in areas of technology, resource availability, public-private partnership as top priority, to redefine progression in healthcare system.

Navin Chandra Nigam Lead Consultant Healthcare Satyam Computers Services Ltd., India

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s one of the largest industries, Indian Healthcare takes care of over a billion people. India accommodates 20 per cent of the world’s young population below 24 years which is a vibrant, achiever and economy builder in many developed countries. Yet the Indian healthcare industry is a sleeping giant on its home turf, it needs to be awakened to unleash its real power which has potential to become the world’s best medical tourism destination and a stateof-the-art healthcare provider. It has what is needed to deliver unprecedented levels of healthcare. But this potential yet to be unearthed.

India’s healthcare expenditure is around 6 per cent of its GDP (US$ 13 per capita) which in comparison to developed countries is way behind in terms of absolute numbers. The abysmal state of availability of qualified resources and healthcare infrastructure can be judged by current data which shows doctor and nurse patient ratio is 0.6 and .08 per 1000 people respectively while bed ratio is 1.5 per 1000 people. A comparison with the world ratio where averages are 1.2 doctors and 2.6 nurses and 4 beds per 1000 people shows a need for improvement. There are more than 15000 hospitals of which two-thirds are public owned. Of 1.1 Million hospital beds available, 40 per cent are privately owned. The private sector accounts for

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approximately 80 per cent of healthcare expenditure. Of the remaining 20 per cent; more than three-fourth is funded by respective state governments. Today, the Indian Healthcare sector is valued at approximately US$ 34 billion.

Currently, the Indian population is growing at the rate of nearly 2 per cent every year. It will be the most populous country in the world by 2035. The year 2025 will see around 190 million people with 60 years of age. One can imagine the burden on healthcare expenditure of a growing economy. For an example increased life expectancies and alarming incidences of chronic health conditions adds pressure to overall healthcare system where chronic conditions account for approximately 75 per cent of total healthcare expenditures.

The rising concern of a changed life style due to working conditions, abnormal food habits in young population and growing elderly population are forcing for an immediate focussed approach with appropriate investment in healthcare before it becomes chronic. For example, there is a need to add approximately 25, 000 beds annually for another 10 years and invest annual budget of 50 million per year for next 20 years. More than 70 per cent of the population resides in rural India where accessibility to healthcare is almost negligible and illiteracy prevents health education to reach to

the consumer which can be vital for preventive health.

So what is needed to create an affordable, qualitative, accessible healthcare environment available to all that competes with world-class medical destinations? The answer lies in a collaborative approach of merging technology, innovative approach in national health policy, guidelines, infrastructure and a vision to create a healthy society. The government initiatives for healthcare are much appreciated, for example creating a framework for IT infrastructure for health in collaboration the private healthcare, establishment of the National Knowledge Commission (NKC), liberalisation of insurance sector, elimination of certain diseases—yet the desired results need to be realised. The Ministry of Health, Department of Family Welfare, Department of Communication and Information Technology, state government and the ISRO are those who have played significant roles in the development of healthcare strategies in India.

The recent announcement of rural health initiatives is an encouraging step from newly formed government. The time is right for India to learn from the best practices available across the world to customise, adopt and implement for its own betterment before it fails to deliver fundamental public right of good health.

Infrastructure and Resources

The availability of critical resources

to deliver medical care needs serious inputs. The inadequate numbers of public health facilities are struggling to deliver basic healthcare. According to PricewaterhouseCoopers, India needs 74,150 community health centres per million populations but currently has less than half that number. In addition, at least 11 Indian states do not have laboratories for testing drugs, and more than half of existing laboratories are not properly equipped or staffed.

The quality of healthcare professionals is also a concern. One part of Indian healthcare system delivers world-class competitive healthcare through private channels and another part as rural healthcare struggles with dearth of qualified professionals. The reluctance from qualified professionals to work in rural areas due to minimal basic infrastructure (water, electricity and road) forces them to choose the urban based private healthcare facilities. This opens up space for unqualified health professionals to deliver healthcare in rural areas which further adds to the woes of healthcare delivery.

This calls for an aligned strategy and an immediate need for investment to create the basic infrastructure to reach out to common public. The primary healthcare centres need to be equipped with basic diagnostic facilities and availability of medical practitioner across the country. The government should derive innovative incentive schemes for medical professionals to attract them to work

Health standard adoption Formulisation of national care delivery guidelines and healthcare standards in line with international standards can be the first step toward affordable international healthcare establishment.

Adoption of proven health standards like HL7, HIPAA, SNOMED, ICD-10, X12, JCI accreditation can bring significant changes in healthcare delivery system by cutting cost and fruitful results in long term. The adoption of some of the health standards have been seen in recent past while others are gearing up. Nationally defined guidelines with clear cut reporting of patient centric data captured in each of the healthcare delivery centres— rural and urban, primary to tertiary—will help greater depth of analysis for future trends and requirements at the districts,

in rural set-up. The community centres (Nursing facilities, day care) in larger towns should be facilitated to cater to general public for health related issues which does not need sophisticate medical intervention. Also, these can be utilised as gate-keepers to tertiary care hospitals to maintain the optimum utilisation of tertiary public healthcare centres without overburdening them.

Healthcare IT Implementation

Healthcare is one of the key areas which can benefit by the use of IT. The ministry of communication department has initiated Information Technology Infrastructure for Healthcare (ITIH).

In 2003, the Department published a “Framework for Information Technology Infrastructure for Health in India.” This framework is centred on the philosophy that “information is determinant of health”. Despite initial progress, the promising initiative fell short of implementation. The gap between policy formulation and implementation needs to be bridged with stringent processes, procedures, tight timelines and deterministic objectives. The IT investment in healthcare industry is still seen as an expenditure rather than investment for future where results are long term. This myth has to be broken. The pre-analysed business processes rightly coupled with IT investment strategies can save millions of dollars in long term and provide quality healthcare.

state and national level. The meaningful information collected from several sources can help the decision makers to be on the forefront and analyse the future trends in healthcare.

The adoption of clinical guidelines, treatment protocols and national policies can drive the unified healthcare to global standards. Quality standards should be implemented in all the care delivery organisations and collected data should be closely monitored on performance, clinical outcomes, patient satisfaction and peer reviews. It is also important to introduce mandatory continuing medical education programme to cope up with fast changing healthcare practices. Collectively, efforts will bring a disciplinary approach across the system and push the healthcare professionals to hone their skills in line with competitive world.

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Medical tourism exploration

Medical tourism is one of the major external drivers of growth of the Indian healthcare sector which is vouched to become an industry itself and has a potential to contribute US$ 5 billion to Indian economy. Indian medical tourism was estimated at US$ 350 million in 2006 and has the potential to grow into a US$ 2 billion industry by 2012.

The private healthcare sector caters to this niche segment and renders world-class affordable healthcare to patients using state-of-the-art technologies at a fee which is 10-15 times lower than anywhere in the world. The Confederation of Indian Industry and McKinsey together estimated the Indian medical tourism sector to be US$ 350 million annually. More than 180,000 tourists are treated every year at Indian facilities and the number is growing at 25-30 per cent per year. As a result, the government is encouraging a variety of incentives aimed at boosting this sector.

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Apart from the allopathic medical system, the Indian traditional proven healthcare system ‘Ayurveda’ has come of age and is becoming very popular in western countries. A subtle approach to chronic diseases, healthy living and wellness management with no side effects is attracting a number of patients from all over the world. A variety in treatment and multiple options has given a boost to alternative medicine which delivers services and treatment covering whole gamut of illness to wellness. It is attracting around 20,000 patients annually and is set to receive 100,000 by 2010.

Medical insurance

Indian healthcare is mostly out-of-pocket payment based (98.4 per cent) which keeps the poor out of accessibility network or forces them to sell their belongings to avail the best medical services. Once in the hospital, patient either needs to pay upfront or immediately at the end of the treatment. This many a times leaves no choice but to stay away from highly priced private hospitals and rely on unqualified professionals. While insurance has been vital to bring positive changes since its first launch in 1996-97, yet only 11 per cent of the population has some form of health insurance till recently. Private health insurance has played a major role in reviving the health industry after the globalisation, yet it covers a little more than 1 per cent of the total population.

State level insurance schemes have been launched and gained well-deserved popularity among economically deprived class.

Karnataka government initiative ‘Yashwini’ and Andhra Pradesh ‘Arogyashree’—a perfect example of Public—Private partnership—has been a marvellous example of micro-insurance too. It has benefited

A uthor

There is a need to adopt e-health strategy which can primarily store the patient database - accessible beyond boundaries.

The available clinical information database can be utilized to help the patients and clinicians to access the patient centric information and past history at the time of critical decision making, emergency and natural calamity. Further, the central patient database can help in systematic health economics reporting and in decision making for continuous improvement.

The last decade has seen lot of mobility in Indian population and it is nearly impossible to keep the medical records all the time at all the places. Digitised form of record capturing at all delivery levels should be the first step to collect information from all sources and further align all the healthcare providers using national IT guidelines creating clinical data repository either at the state or central level. India does not need to reinvent the wheel as there are many worldwide initiatives to learn from, adopt and customise healthcare IT practices for our own benefits.

ISSUe - 20 2009

millions of people at a minimal annual cost (Rs 30 - 60) who were earlier deprived of world-class healthcare due to non-availability of insurance.

A national level approach on microinsurance can change the way healthcare is delivered to rural population. A collaborative approach among government, private hospitals and insurance bodies can create a significant difference to make the basic level of healthcare facilities accessible to rural population at the minimum annual premium. Insurance companies need to open up new channels to reach out to rural population in collaboration with public and private hospitals. The government should support the rural healthcare by establishing more number of PHCs, telemedicine centers, diagnostic facilities and secondary care hospitals which can be utilised at the optimum level.

Baseline

The national health policy 2002 was derived keeping the well-being of all the sections of society. Due to limited financial and operational resources, the implementation has been delayed, though many issues are addressed. The need of the hour is to create a self-reliant healthcare environment with a clear roadmap and aggressive timelines. The implementation of health policy is not the responsibility of centre and state government alone but health provider—public and private—should also own the responsibility to deliver for the benefit of the society. Reforms in healthcare policy are long due as need are changed. A collaborative approach with government, private healthcare providers, NGOs, insurance companies has become essential to keep the help Indians stay fit and contribute to the society for a long time.

Navin Chandra Nigam currently works as a lead healthcare consultant in Satyam Computers. His expertise lies in providing healthcare solutions to customer. Over 12 years global healthcare experience including NHS, Victoria Health and Canada Infoway, he is member of HIMSS and equipped with international healthcare certifications.

Healthcare Management

Primary Healthcare in India An ideal approach

Primary healthcare in India needs to be revamped and is in urgent need of reforms.

Geeta S Pardeshi Lecturer Department of PSM Dr. Shankarrao Chavan Government Medical College India Geeta S Pardeshi is currently working as a lecturer in the department of PSM at Government Medical College, Akola, Maharashtra, India.

She has also worked at Government Medical Colleges at Pune, Kolhapur, Yavatmal and Akola in Maharashtra.

What is the difference between Primary care and Primary healthcare?

Health services in India are provided through a three-tier setup namely primary, secondary and tertiary. Primary care is the healthcare provided at the primary level of care, which is the first level of contact of the community with the health system.

Cases which are more complex and need specialised care are referred to the secondary (District hospital) and tertiary level (Regional and national hospitals).

Primary healthcare is an approach defined as ‘essential healthcare made universally accessible to individuals and acceptable to them through their full participation and at a cost the community and country can afford.’

Primary care, which incorporates these characteristics is primary healthcare and forms a foundation of effective health services.

What are the principles of primary healthcare? What services are provided under primary healthcare?

The principles of primary healthcare are equitable distribution, community participation, inter-sectoral coordination and appropriate technology. In addition to this, team approach, decentralisation, effective referral system are also important elements of this approach.

The services under primary healthcare are to be made accessible and available to people as per the principles of universality.

It also asserts the role and responsibilities of the state and recognises that health is a multi-factorial entity and there is a need of multi-sectoral approach to health.

This approach emphasises complete and organised community participation and ultimate self reliance of individuals and community towards their own health.

Primary healthcare views health as an integral part of socioeconomic development of a country. It calls for an integration of preventive, promotive, curative and rehabilitative health services. Traditionally, it is expected that primary healthcare should include at least education concerning prevailing health problems and methods to prevent and control them, promotion of food supply

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Healthcare Management

and proper nutrition, adequate supply of water and basic sanitation, maternal and child health including family planning, immunisation against major infections, prevention and control of locally endemic diseases and provision of essential drugs. Current reforms look beyond this basic package towards lifestyle disorders and deal with health of everyone in the community.

There are specific population norms for these health centres.

A sub-centre is the most peripheral and first contact between the community and primary heath care system. Each sub-centre is manned by a female and a male multipurpose worker. Primary health centre is manned by a medical doctor, supported by14 paramedical staff. It acts as a referral unit for 6 sub-centre s and has 4 to 6 beds for patients. Community Health Centre is manned by four medical specialists viz.

Surgeon, Physician, Paediatrician and gynaecologist supported by 21 paramedical and other staff. It has 30 indoor beds with operation theatre, X-ray facility, labour room and laboratory. It serves as a referral centre for 4 PHCs. As on March 2007 there were 1, 45, 272 subcentres; 22,370 PHCs and 4045 CHCs in the country.

ture is made out of pocket at the point of service delivery it increases health inequities as the rich can afford to pay and the poor cannot. In India nearly 75 per cent of the health expenditure is such out of pocket expenditure.

Lack of accessibility and poor quality of services also adds to such inequities.

The target of equitable distribution / universal coverage is yet to be achieved.

Universal coverage of health services is necessary foundation for health equity. It is necessary but not sufficient to achieve health equity.

Universal access to health services should be complemented by social health protection through targeted interventions for vulnerable groups and mobilising for health equity through public awareness and policy debates thereby creating space for social movements.

Is the objective of reducing the health inequalities in introducing primary How is primary healthcare provided in healthcare in India being met?

India?

Overall, many health indicators for our India was a signatory to the Alma Ata country have shown an improvement declaration and the health system in over the years, but the gains have been the country has been built up along the unequally distributed. Glaring inequaliprimary healthcare approach. India has ties are seen between different states, a well-defined infrastructural setup for communities, between different strata provision of Primary healthcare in rural in societies within the urban areas. areas.

It is important to understand that A network of government-owned and the roots of health inequities lie in social operated Sub-centres, Primary Health conditions outside the direct control of Centres and Community Health Centres health systems and hence need to be is designed to provide primary healthcare tackled through inter-sectoral coordiin the county. nation and cross-government action.

Health inequities stem from social stratification and Population norms for different centres inequalities such Population as income, social Norms status, neighbourCentre Plain Area Hilly/Tribal/ Achievements hoods where people Difficult live, employment Area conditions, personal Sub-Centre 5,000 3,000 5,111 factors etc.

Primary Health Centre 30,000 20,000 33,191 In addition when a major chunk of Community Health 1,20,000 80,000 1.83 lakhs Centre healthcare expendi-

How does the primary healthcare system help with overcrowding at the hospitals?

It is clear that if the quality of care at the first level of contact is not satisfactory, people will bypass this level and seek care from higher levels of care.

This leads to overcrowding at hospitals thereby affecting the quality of is services adversely. This affects the overall health service provision.

Primary healthcare approach, if implemented in its true spirit, improves the performance of primary care. The comprehensive and integral nature of services prevents and controls many illnesses thereby reducing the burden of illness. Early diagnosis and appropriate treatment of ailments ensures that the patient does not land up in complications. Good quality of services encourages the community to seek treatment at the primary level itself. Thus only patients referred from the primary level or those with complex health problems needing specialised care will seek treatment from the hospitals and higher levels. This will prevent overcrowding at the hospitals.

What are the main goals of Primary Healthcare in India?

Primary healthcare was accepted as the best approach to achieve the goal of ‘Health For All’ in the Conference of the World Health Organisation held at Alma Ata in 1978. ‘Health For All’ is defined as an attainment of a level of health that will enable individuals to lead a socially and economically productive life. The fundamental focus of this approach is on universality, comprehensiveness and equity in health.

Table 1

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Healthcare Management

In addition, provision of primary healthcare in urban areas will also limit the burden of cases at the hospitals.

Is the available healthcare infrastructure meeting the healthcare needs of the people?

The health infrastructure in India is based on the primary healthcare approach.

Over the past years there has been a significant reduction in crude birth rate, crude death rate, infant mortality rate and an increase in life expectancy. But these rates are nowhere near the values achieved by the developed countries and regional inequalities remain.

The country has an extensive network of health centres. Yet the geographical and quantitative availability of primary healthcare facilities is far less than the guidelines laid down by the government.

Studies have shown that only 20 per cent of those seeking outpatient services and 45 per cent of those seeking indoor treatment avail public services.

Primary healthcare in India is in need of urgent reforms to meet the needs of the people.

Is primary healthcare as much a pressing priority now as it was before?

Primary healthcare is as much of a pressing priority now as it was before. Social, demographic and epidemiological transitions along with globalisation, urbanisation and an ageing population pose challenges of a magnitude not anticipated earlier. Primary healthcare is an ideal approach to deal with this complex situation of great magnitude.

In addition, in this scenario many persons are likely to present with comorbidities which underlines the importance of dealing with the person as a whole which is possible with this approach.

As societies modernise, there will be a rise in expectations regarding health and healthcare. A people-centred approach like primary healthcare is likely to satisfy such expectations of a knowledgeable society.

Is primary healthcare in India facing a shortage of human resources?

There is a shortage of manpower at the centres providing primary healthcare. Overall there is a shortage of all cadre of workers. There is a 7.8 per cent shortfall of the total requirement of doctors at PHCs and more than 50 per cent shortage of the posts of male MPW at sub-centres and specialists at community health centres.

In the present circumstances, medical personnel in general do not want to relocate to rural and remote areas.

Attempts have been made to bridge this gap but have met with limited success.

Appointments on contract basis, posting interns and graduates and postgraduates after there degrees in rural areas have been tried. However, concrete steps need to be taken to tackle this problem.

It has also been observed that focussing only on priority diseases through vertical programmes leads to fragmentation of health services and short term gains while the holistic and personcentred approach in primary healthcare provides long term gains. Primary healthcare in urban areas is the need of the hour. Apart from urbanisation, the enormous social and economic stratification within the urban areas leads to extreme marginalisation in the form of slums and street dwellers.

What are the issues and challenges of primary Healthcare in India? How can primary healthcare be improved in India?

Primary healthcare in India needs to be revamped and is in urgent need of reforms.

The misconception of primary healthcare amongst policy makers and field workers is that it is cheap, low technology, non professional care for the rural poor and deals with few priority diseases. It is important to understand that primary healthcare requires adequate resources and investment. It gives much better value for money than other alternatives. Currently the public health expenditure on health is only 0.9 per cent and needs to be increased with major inputs for primary healthcare services.

The community-level health workers can only complement the team at the health centres and cannot be an

alternative for them. It is important to focus on the team approach; a team of trained, motivated workers who are able to establish ongoing relations with the community to ensure continuity of care, a team which has the capacity to provide integrated services in response to the community needs.

Primary healthcare is not the antithesis of hospital care nor can this care be isolated care provided through isolated centres. Currently the referral system is ineffective and the health centres hardly coordinate with other departments and organisations. Ideally, primary healthcare should serve as an entry point for the individuals, which ensures continuity of care by coordinating a comprehensive response at all levels of care. The problems of manpower shortage and universal coverage are major challenges.

Community participation and intersectoral coordination are aspects which will require special efforts. Effective leadership and administrative skills are required to implement these principles on field which appear simple on paper.

Public private partnerships in provision of primary healthcare are interesting avenues which should be tapped.

Non governmental organisations and corporate sector should show interest in contribution to primary healthcare.

With the trends of increasing urbanisation, planning and provision of primary healthcare services in urban areas can no longer be neglected.

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Medical Sciences

Circulating Nucleic Acids in Plasma & Serum A non-invasive approach CNAPS offers a noninvasive approach to a wide range of clinical disorders that will allow the basic information necessary not only for use in predictive medicine but also for direct use in acute medicine.

Peter B Gahan Emeritus Professor Anatomy & Human Sciences Department King’s College London, UK

A

lthough DNA was first demonstrated in human blood from healthy donors, pregnant women and clinical patients in 1948, the structure of DNA was still to be determined as was the elucidation of its role as the basis of the gene [Table 1].

Consequently, no interest was shown in the presence of DNA in the circulatory system until high DNA levels were demonstrated in the blood of patients with systemic lupus erythematosus.

Similar observations were also made in acute medicine, diabetes, oncology and fetal medicine [Table 2, 4, 5].

Nucleic acid and nuclease content

Both DNA (1.8 - 35 ng mL-1) and RNA (2.5ng mL-1) are found in and plasma and serum from healthy donors.

These levels rise in patients with various cancers, trauma, myocardial infarction and stroke with values of over 3,000ng DNA being recorded on occasions. The amount of DNA and RNA present in the plasma and serum will depend upon the health status of the individual and the level of nucleases present in blood.

The average blood plasma concentration of DNAase I is 3.2 - 18.4ng mL-1 whilst the average serum RNAase value is 104 units mL -1. Hence the relatively low levels of circulating DNA in healthy individuals may indeed be partially due to peripheral blood DNAase activity, although DNA from cancer patients

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may be resistant to DNAase and the DNAase levels may have just been low.

Similarly, high RNA levels may also be due to RNA resistance to RNAase digestion especially when high RNAase and RNA levels are present together.

The RNA may be protected with a glycolipid due to its apoptotic origin.

Furthermore, an RNA fraction is associated with the released DNA-complex from healthy cells which appears to be protected from digestion by RNAase (see below).

Nucleic acid sources

There are six possible sources of blood DNA, namely (i) breakdown of bacteria and blood cells; (ii) viruses, (iii) leucocyte surface DNA, (iv) necrosis, (v) apoptosis and (vi) spontaneous release of a newly synthesised DNA / RNA-lipoprotein complex from healthy cells.

DNA

Only small amounts of DNA are yielded by the first three possibilities with just nasopharyngeal carcinoma Barr virus and human papilloma virus carcinoma DNAs having been identified and the breakdown of bacteria and bloods cells yielding only low levels of DNA. Necrosis is clearly an option for the origin of Circulating Nucleic Acids in Plasma & Serum (CNAPS). However, when the double stranded CNAPS DNA is separated by gel electrophoresis, the fragments tend to form a ladder rather

Medical Sciences

RNA in the bloodstream is due to the availability and type of the RNAs and RNAses present (see above).

However, a newly synthesised RNA is released spontaneously from cells together with the DNA-lipoprotein complex. In consequence, RNA is primarily released by apoptosis and through the DNA/RNA-lipoprotein complex.

Some RNA may also be derived by necrosis e.g. some m-RNAs.

Some developments in understanding DNA and its cellular roles Date

Authors

Discovery

1869

Miescher

isolation of DNA (nuclein)

1929

Levene

building blocks of DNA identified

1944

Avery et al.

DNA as genetic material

1948

Mandel & Metais

circulating nucleic acids in blood

1949

Chayen

cytoplasmic DNA localisation

1953

Watson & Crick

DNA structure

1953

Wilkins et al.

DNA structure

1957

Sinsheimer

DNA-gene concept

1959

Gartler

DNA uptake by mammalian cells

1962

Gahan

DNA mobility

1962

Stroun

DNA mobility

1965

Gahan & Chayen

messenger DNA

1972

Stroun & Anker

released nucleic acids

1977

Stroun et al.

circulating nucleic acids

1977

Leon et al.

blood DNA levels up in cancer

1989

Stroun et al.

cancer derived blood DNA

1999

Kopreski et al.

malignant melanoma serum mRNA

Applications of CNAPS in diagnosis, prognosis and the monitoring of treatments

Table 1

than a smear. The ladder fragments are mainly 180 - 1,000 bp in size and so are likely to be formed by apoptosis. DNA released by necrosis is incompletely and non-specifically digested and so smears on electrophoretic separation due to its fragment sizes of about 10,000bp; this is not a major source of CNAPS. Apoptosis is confirmed as a major DNA source especially since nucleosomes are present in the blood e.g. of cancer patients. Naked DNA fragments are also found in serum, possibly due to apoptosis.

Therefore, the two major sources of CNAPS are apoptosis and the spontaneously released DNA/RNA-lipoprotein complex. The DNA is newly synthesised and is released from the cell in the form of a complex together with newly-synthesised lipoprotein and RNA. This complex is released homeostatically from the healthy, but not dead or

dying, cells whether human or other mammalian cells or avian or amphibian. The DNA is double-stranded and about 2,000 bp in size. Importantly, after leaving the cell, the complex readily enters other cells where it expresses a biological activity that appears to be cell-type specific (Table 3).

RNA

RNA is only recently of importance through its exploitation in clinical diagnosis and prognosis. The stability of

CNAPS in diagnosis, prognosis and the monitoring of treatments has been applied in a wide variety of clinical disorders and situations from the emergency and accident ward to foetal medicine. The general approach to clinical application involves the taking of blood samples from which are separated plasma, serum and leucocytes. DNA / RNA are removed from plasma / serum and the surface DNA from leucocytes.

The DNA / RNA are then subjected to quantitative real-time PCR and RT-PCR prior to analysis by gel electrophoresis and mass spectrometry. Relating the markers so derived to the clinical condition permits the possibility of early diagnosis, and prognosis as well as the possibility of monitoring the treatment prescribed.

Acute Medicine

a) Trauma: Circulating DNA levels increased in patients presenting with injury, the concentration relating to the severity of the injury with up to a

Presence of DNA and RNA in blood from patients with various disorders Year

Authors

Marker disorder

1966

Tan et al.

DNA SLE

2003

Rainer et al.

DNA stroke

2003

Lam et al.

DNA trauma

2003

Chang et al.

DNA myocardial infarction

2004

Laktionov et al.

RNA trauma Table 2

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Medical Sciences

Cellular changes induced by the uptake of CNAPS by cells 1. Initiation of cancer 2. Alteration of myocardiocyte contraction rates 3. Production of antibodies 4. Initiation of DNA synthesis 5. Blockage of DNA synthesis Table 3

100-fold increase occurring in patients developing organ failure, multiple organ disfunction syndrome, acute lung injury and those who will die when compared to patients with uncomplicated injury.

Since the DNA normally has a short halflife in circulation and given the elevated DNA levels in the first few hours after patient admission with potential organ failure, the maintenance of the high DNA levels could be used to anticipate that organ failure. b) Stroke: Circulating DNA levels are elevated after a stroke, the amount being related to the extent of brain damage and it may be possible to use these DNA levels as indicators of short and long-term changes as well as post-stroke mortality. c) Acute Myocardial Infarction (AMI): AMI patients have elevated circulating DNA levels when compared to controls including both AT-rich and GC-rich fragments of DNA. This has yet to be transformed into an early diagnostic approach. d) Organ Transplants: Preliminary studies on rejection monitoring with CNAPS by exploiting donor-DNA fractions showed a good correlation in the case of pancreas-kidney rejection and elevated donor-DNA levels.

Diabetes

a)Diabetic Retinopathy (DR): Comparison of diabetic patients without DR, with DR and healthy subjects showed diabetic patients as a whole to have about 2.5 times the rhodopsin mRNA than the control subjects. Diabetic control

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patients levels were about 60 per cent higher than those of healthy individuals whilst the background retinopathy and pre-proliferative retinopathy patients showed increasing rhodopsin mRNA levels with increasing severity of the retinopathy. Diabetic patients without clinical features of retinopathy also showed significantly higher levels of rhodopsin mRNA so indicating that retinal damage could have already occurred. In this case, rhodopsin mRNA levels in peripheral blood could offer an early detection of DR. Additional early predictive markers include increased retinal specific mRNA, RPE65 levels and reduced retinoschisin mRNA levels. b) Diabetic Nephropathy (DN): DN patients have a higher mean amount of circulating nephrin mRNA when compared with a control healthy cohort possibly due to a loss of nephrin mRNA from glomerular epithelial cells which correlates well with pathological assays.

Prenatal Medicine

ble to distinguish the parental origin of the DNA. Furthermore, hypermethylated DNA was derived from the maternal blood cells, whilst the hypomethylated form was derived from the placenta and hence of foetal origin. Although the hypomethylated form was normally cleared from the blood in pregnant women, it increased by about six-fold in the case of pre-eclampsia. Higher levels of ß-globulin and SRY genes were also present in pregnant mothers who went on to develop pre-eclampsia and intrauterine growth retardation.

When the foetus-specific circulating mRNA for corticotrophin-releasing hormone increased ten-fold, the levels relate to the severity of pre-eclampsia (Table 4).

Foetal DNA can also be used for foetal blood group genotyping with the Rh status of the foetus being determined successfully. There are strong indications for the successful identification of other blood types including Rhc, RhE. Other approaches include the possibility to determine Mendelian inherited disorders especially through the

Although fetal DNA accounts only for 3-6 per cent of the total maternal CNAPS, its identiPossible CNAPS markers in foetal medicine fication and isolation is facilitated by the majority of the Pre-eclampsia fetal DNA fragments being Chim et al. hypomethylated DNA

2005 primarily >300 bp whereas the maternal DNA fragments are Swaminathan/ SRY gene

2005 Butt >300 bp.

Successful sex determinaWong et al.

ACTH

2005 tion has been performed on ß-thalassaemia fetal DNA in maternal blood

2008 Papasavva et al. δ-globulin SNPs using either paternal derived fragments of the Y chromoLi et al. foetal DNA

2005 some or paternal X-chromoFoetal sex some derived fragments of

2008 Vecchione et al. amelogenin gene the amelogenin gene and multicopy DAZ sequence Vecchione et al. multicopy DAZ

2008 (Table 4).

Down’s Syndrome Working with the maspin Lo et al.

PLAC4 gene

2008 gene sequences, it was shown that if regions of the DNA Vainer et al.

DNA

2008 from the father were methylRh status ated, but unmethylated from Finning et al.

DH exons 4,5,10

2004 the mother then is was possi-

Table 4

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Medical Sciences

fragments involved and a particular type of cancer (see Table 5). Nucleosomes form one source of DNA released into the blood stream but are not considered to be suitable for cancer diagnosis due to elevation of nucleosome levels in patients with benign diseases. Nevertheless, circulating nucleosomes can be informative for monitoring cytotoxic therapy with strongly decreasing levels being mainly found in patients with remission of disease whereas constantly high or increasing values are associated with progressive disease during chemo- and radiotherapy.

Some CNAPS markers in oncology Lung Cancer

Cell-surface DNA Hypermethylated p16 (INK4A), APC, DAPK

Colo-rectal Cancer

K-ras mutations General DNA level elevated Hypermethylated APC

Breast Cancer

Hypermethylated APC, RASSFIA, DAPK

Oesophageal Cancer v

Hypermethylated APC

Prostate Cancer

CpG dinucleotides methylated in GSPT1

Lung, Colorectal, Prostate, Liver, Ovary, Breast, Oesophageal Cancers

Loss of heterozygosity for 3p24 and 8p21 Elevated microsatellite DNA Telomere transcriptase m-RNA elevated

Liver Cancer

Hypermethylated RASSFIA Table 5

from the maternal blood using an allelespecific based real-time PCR method and using eleven paternally inherited SNPs with a high degree of heterozygosity from the ß-globulin gene for the diagnosis of ß-thalassemia.

Oncology

Initially, circulating DNA was used as (a) an early marker for cancer seen as an increased amount circulating and (b) in monitoring treatment when the DNA levels returned to normal levels upon successful treatment. However, there was no specific correlation between the DNA

A uthor

paternally-inherited alleles as can be seen through the diagnosis of Huntington’s disease, achondroplasia and mytonic dystrophy. Less easily detected are the aneuploid disorders due to the smaller increases in fetal DNA. However, modest results have been achieved with foetal chromosome 21 status by measuring either the relative concentrations of foetal-specific epigenetic markers on chromosome 21 to those on one or more reference chromosomes or placental-specific mRNA species transcribed from a chromosome involved in an aneuploidy, e.g. the PLAC4 gene on chromosome 21 for Down syndrome using the RNA-SNP (single-inherited nucleotide polymorphisms) allelic ratio method, which has a high sensitivity of 90 per cent and a high specificity of 96.5 per cent.

Pre-natal detection of ß-thalassemia is also feasible using fetal DNA isolated

A range of markers have been proposed for the identification of a particular cancer, though there is frequent conflict in the literature as to the effectiveness of particular probes. However, recently, hypermethylated CpG in the promotor region of tumour suppressor genes has been suggested to trigger local gene silencing. Aberrant methylation of the p26 tumour suppressor gene was the first to be detected in liver, breast and lung cancer. Other frequently methylated tumour suppressor genes (Table 5) have been used with varying success.

CNAPS

Although a relatively recent addition to methodologies available for early diagnosis, prognosis and treatment monitoring, CNAPS offers a non-invasive approach to a wide range of clinical disorders that will allow the basic information necessary not only for use in predictive medicine but also for direct use in acute medicine.

Peter Gahan is Emeritus Professor of Cell Biology at King’s College London where he continues to teach. He is a director of the European Association for Predictive , Preventive and Personalised Medicine and researches the biology of the DNA/RNA lipo-protein complex found in CNAPS and its possible role in cancer.

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Medical Sciences

Surgery for Acute

heart failure

Stage A: asymptomatic patients at risk of developing heart failure (with hypertension, coronary artery disease for example), ACC / AHA time line classification of heart failure

Stage B : those who are asymptomatic but have ventricular changes of heart failure (hypertrophy or ventricular impairment), Stage C: those with a current or past history of heart failure in association with structural changes and Stage D: those with refractory heart failure.

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Table 1

Surgical speciality

As we consider the surgical approach to heart failure, it is helpful to distil physiological themes that support pharmacologic treatment such as reduction of after-load to the heart or increased force of contraction.

Stephen Large Consultant Cardio-Thoracic Surgeon Papworth Hospital and Associate Lecturer, Department of Medicine, Cambridge University, UK

W

hen the heart starts to fail, healthcare costs start to rise.

The cheapest option is to do nothing as heart failure is lethal. Heart failure is common and becomes more so with age. Indeed it is the most common diagnostic related group in the UK at hospital discharge and is the primary or secondary diagnosis in about 1 per cent of the population consuming a similar proportion of the country’s GDP every year. So, how to recognise this monster?

The 2005 ACC / AHA guideline update for the diagnosis and management of chronic heart failure in the adult gives a definition for heart failure as: “a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood”.

It is a progressive disorder and to capture this ACC / AHA has proposed a new approach to the classification of heart failure set out in Table 1.

Although progressive the clinical picture for heart failure is unpredictable.

It is difficult to characterise and especially so in its early stages. This probably follows its recognition as a “..largely a clinical diagnosis that is based on a careful history and physical examination”. When symptoms present they are predominantly made up of fatigue, breathlessness and limited

exercise tolerance. Fluid accumulation is apparent on the right side as dependent oedema and on the left as interstitial lung oedema. The condition is fickle and patients describe a variety of symptoms.

Thus sequential clinical assessment finds patients moving up and down the NYHA (New York Heart Association set out in Table 2).

Series of drug trials have firmly established the current pharmacological management of heart failure. These are summarised in the ACC / AHA guidelines with awarded levels of evidence. As we consider the surgical approach to heart failure, it is helpful to distil physiological themes that support pharmacologic treatment such as reduction of after-load to the heart or increased force of contraction. Let us express these in the following relationships: The first Cardiac output (CO) = perfusion pressure (arterial BP – venous P) peripheral resistance(Ω) This first relationship demonstrates that inadequate CO can be improved either by increasing perfusion pressure (reducing venous pressure by diuresis, haemofiltration or veno-dilatation) or reducing peripheral resistance (using arteriolar dilators or strategies to uncouple the augmented angiotensin-renin axis that New York Heart Association classification of heart failure NYHA I symptoms that appear only at levels of exertion that would limit normal individuals.

NYHA II symptoms on ordinary exertion and NYHA III symptoms on less than ordinary exercise NYHA IV symptoms of heart failure at rest.

characterises heart failure).

The second Cardiac output (CO) = stroke volume (SV) x heart rate (HR) The second indicates that an increase in stroke volume or a raised heart rate (to an upper limit dictated by adequate diastolic filling of the ventricle or both), will improve the lot of the heart failure patient.

The third Ejection fraction = (end diastolic volume – end systolic volume) x 100 per cent end diastolic volume This third relationship is often used to describe ventricular function but it must be used with caution. It is a derived value and risks misinforming the clinician.

The fourth Intra-ventricular pressure (P) = 2 x ventricular wall tension (T) Ventricular radius (R) or T=PxR

2 Where ventricular wall tension (T) is directly related to oxygen consumption and ventricular work. This is La Place’s law and its evolution was in the surface tension of a bubble. It is not clear how it relates to the working ventricle but probably has its influence during diastole.

Starling’s law relating stretch of the ventricle to power generated by subsequent contraction (to a finite limit of stretch) predicts systolic function.

Armed with these four relationships this paper attempts to bring some clarity to the apparent hotch-potch of surgical solutions for the failing heart. An attempt will be made to offer levels of evidence for each operative approach (for definitions of evidence levels see Appendix).

A Surgical approach to heart failure: Cardiac output improvement is the aim of all therapeutic approaches for heart failure. Can a surgical approach affect cardiac output? It would appear so though either of two approaches: 1. either by removing the primary ventricular insult, so permitting recovery or

Table 2

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Possible causes of heart failure Impaired filling

before the ventricle: i) extra cardiac obstruction: eg: pericardial constriction or venous obstruction ii) intra-cardiac obstruction of inflow. eg: mitral valve stenosis or obstructing atrial tumour

Impaired filling

of the ventricle: i) hypertrophy. eg: congenital (genetic eg: HOCM ) acquired (pressure loading in hypertension ) ii) infiltration. eg: fibrosis, acute and chronic inlamatory (myocarditis), giant cell, sarcoidosis, amyloidosis

Impaired ejection

of the ventricle: i) of the wall: iron overload or chronic alcohol or glycogen excess), ventricular aneurysm formation, dilating cardio-myopathy, ischaemia with hibernation, ischaemia with scarring, loss of ventricular interdependence (bundle branch block, pacing), outflow tract obstruction (dynamic: septal hypertrophy, systolic anterior mitral valve leaflet movement. Fixed: subvalvar aortic stenosis) ii) Miscellaneous: sustained excessive work load without obstruction: a-v fistulae, super athelete, high output shock

Impaired ejection

after the ventricle: i) valvular aortic stenosis, regurgitation ii) aortic coarctation (congenital or acquired) iii) hypertension Table 3

2. By amelioration of the damaged ventricle with improvement of cardiac output (so called ‘reverse remodelling’ or ‘ventricular restoration surgery’).

Where possible it is preferable to pursue option 1 to identify the cause and remove it rather than accept attempts to surgically reverse remodel the failing ventricle. With this in mind an attempt to identify the possible cause of heart failure in Table 3.

An obstructed or pressure loaded chamber seems to primarily remodel through hypertrophy of its wall. On the other hand, volume overload (eg: valvular regurgitation) leads to ventricular dilatation. An enlarging ventricle moves from a cone shape towards a spherical shape with consequent (secondary) mitral regurgitation. The increasing ventricular radius also leads to increased wall tension

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(4th relationship above) and increased oxygen demand. As the remodelling process continues it appears that the hypertrophied, pressure loaded ventricle dilates and the enlarged, volume loaded ventricle develops hypertrophy.

Ventricular remodelling is malign and must be reversed, or at least halted if the patient’s symptoms and prognosis are to be improved.

Surgical approaches should have the aim of reverse remodelling or restoring the ventricle to normality. If this is unachievable then the compromise is to force a trend towards a more normal heart.

Such normality must be recognised in 3 dimensions: 1. Morphological (both at the gross anatomic and microscopic levels) 2. Physiological in terms of: • contractility: overall and as coordinated

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inter and intra-ventricular contraction with normalisation of contractile reserve.

• electrical (normalisation of ecg and myocardial excitability) • biochemical: normalisation of: º high energy phosphate production, storage and oxygen use º enhanced natriuretic peptide secretion º elevated renin-angiotensin levels º catecholamine levels º endothelin levels º markers of inflammation 3. Prognostic returning the patient’s expectation of survival towards that of peers without heart failure.

The operations

The operations or interventions will be described in a standardised fashion according to whether: 1. the primary insult can be identified and removed or 2. the aim is to attempt to surgically reverse remodel the ventricle.

The outline of the procedure, efficacy, safety and level of evidence will be offered.

1. Removing the primary insult:

In ideal circumstances the primary ventricular insult or remodelling force is identified and removed. For example, removing the pressure loading of the left ventricle by Aortic Valve Replacement (AVR) in aortic valve stenosis. Following this operation hypertrophy may regress and morphology normalise. Physiology improves too as does prognosis. Similarly, mitral valve repair for regurgitation corrects the volume over-loaded left ventricle and dilatation may recede.

Removing toxins such as iron in haemochromatosis and alcohol (supplemented with thiamine) in alcoholic cardio-myopathy has led to reverse remodelling of dilated and failing ventricles. Surgical strategies to control rate or rhythm in persistent atrial fibrillation may lead to reverse remodelling of the dilated heart in tachycardio-myopathy. These surgical approaches will not be discussed further

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MRI image of a poorly functioning left ventricle in association with coronary artery disease and A. Hibernating myocardium and B Scar

A

1

2

1

2

3

4

3

4

Figure 1A

A. Triple vessel disease and poor ventricular function but preserved wall thickness and no evidence of scar where 1 shows diastole and 2 systole and windows 3 and 4 evidence of wall thinning with fibrous tissue, but showing neither (Hibernation)

Figure 1B

B. Triple vessel disease and poor ventricular function. Frame 1 shows diastole, 2 systole and 3 and 4 evidence of loss of wall thickness (white arrows) and the presence of the white image suggesting scar formation in the lateral free wall (white arrows in images 3 & 4). History of extensive myocardial infarction in the circumflex territory

Survival of patients with no mismatched segmental flow and function compared to those with mismatches

Figure 2

as they are well described elsewhere. Save to say that the new offered sequential classification of heart failure by ACC / AHA indicates that all cardiac surgical procedures can be regarded as ‘heart failure surgery’ in their attempts to prevent,

B

ameliorate or correct the condition. This paper would not be complete without some further attention given to the hibernating ventricle, a consequence of ischaemia.

Revascularisation: Myocardial ischaemia

is probably the most important cause of heart failure and is associated with a substantial mortality. However, ischaemic ventricular dysfunction may be reversible. A temporary reduction in function in response to an ischaemic insult has been termed stunning if acute and hibernating if protracted. Hibernation and stunning are characterised by reduced systolic and diastolic function, stunning improving with inotrope and hibernation with restoration of blood flow.

Ramtoola’s description of hibernation in the late 1980s indicated a reduction in myocardial function that paralleled fall in myocardial blood supply and the restoration of function following correction of ischamia may take some time, on occasion, months.

Identification of hibernation is probably best achieved with labelled (F deoxyglucose uptake) positron emission metabolic tomographic studies (PET).

It can be demonstrated by dobuatmine stressed echo with its characteristic bi-phasic response to increasing levels

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of hibernation compared to those without (Figure 2).

The arterial waveform with IABP counter-pulsation mm Hg 120

Increased Conronary Artery Perfusion

C D

Level of evidence: B level or recommendation IIa

F

100 B E

80 A

Reduced Myocardial O2 Demand Figure 3

1) Intervention to improve cardiac output by reducing ventricular afterload:

Operations to reverse remodel the failing heart 1) Intervention to improve cardiac output by reducing ventricular after-load

i) Intra-aortic balloon pumping (IABP)

ii) Resection of obstructed left ventricular outflow in hypertrophic cardiomyopathy (HOCM)

2) Surgical procedures to improve cardiac output by reducing left ventricular size (‘La Place surgery’)

i) The Myo-splint

ii) The CorCap® or Acorn device

iii) The Batista operation

iv) Left ventricular aneurysmectomy

v) Mitral valve repair for 2ary regurgitation

3) Surgical strategies to re-power the failing heart

i) mechanical

a) Cardiac resynchronisation therapy (CRT)

b) ventricular assist devices (LVAS, RVAS, BIVAS and total artificial heart)

ii) biological

a) Dynamic cardiac myo-plasty

b) Heart transplantation

c) Cell transplantation

d) Gene therapy

e) Up-regulation of natural pathways Table 4

of inotrope. There is an initial improvement in contractility followed by a fall off in function as dobutamine levels reach values of 25—40μg / Kg / min.

Magnetic Resonance Imaging (MRI) is showing promise too by unmasking scar and viable muscle (Figure 1).

Outline of revascularisation for hibernation

This procedure requires the demonstra-

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tion of hibernation as set out above. The patient then undergoes coronary artery bypass grafting, with the expectation of improvement in objective signs of heart function, heart failure symptoms and survival. Improvement of course maybe prompt or delayed by a number of days.

Safety & Efficacy: Survival appears to be better after coronary artery bypass grafting in patients with evidence

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Ventricular reverse remodelling surgery: All too often the primary remodelling process is not identifiable (eg: idiopathic dilating cardiomyopathy) or if it is, it is not amenable to correction (identified genetic lesion e.g. HOCM). An attempt is made to summarise these operations in Table 4.

Intra Aortic Balloon Pumping: Kantrowitz introduced the intra-aortic balloon pump (IABP) 4 decades ago. The principle involves inflation of an intra-arterial balloon in early diastole augmenting coronary perfusion (D in figure 3) followed by pre-systolic (late diastolic) collapse which results in a lower after load or effective lower systemic resistance for the left ventricle (E) and so less work done by the heart.

Outline of procedure: A 35cc or 40 cc Helium intra-aortic balloon is inserted into the femoral artery and passed, retrograde, into the thoracic aorta. Sensing of heart rate through ECG or arterial pressure monitoring allows the IABP to inflated on the dicrotic notch of the systemic arterial wave form (onset of diastole) and be collapsed at the latest point possible in diastole.

Efficacy & Safety: IABPs are in common use and are regarded as important in the initial management of patients with acute coronary syndromes and those with heart failure. It is a percutaneous device and restricts the patient to an intensive care bed.

Evidence: Level of evidence B, ACC / AHA recommendation level I

Resection of left ventricular outflow tract: Patients with Hypertrophic Cardiomyopathy (HCM) may be troubled by Left Ventricular Outflow Tract

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colleagues reported benefit in a canine model with improvement in ejection fraction, ventricular volumes and wall stress. There are reports of clinical work in 20015 concluding that careful patient selection with maintained medical therapy is crucial for successful treatment. This has fallen out of clinical practice.

Impact of Myo-splint® buttons on ventricular radius

r

R

Where R > r Figure 4

The Myo-splint®

Figure 5

Obstruction (LVOTO). Relief of this obstruction leads to improvement of cardiac output and prognosis. This is of course not an example of reverse remodelling surgery but ameliorative surgery as the driving force for ventricular remodelling is genetic.

Outline of procedure: Direct de-bulking of a LVOTO can be undertaken by open heart surgery or alcohol injection of the first septal artery.

Efficacy & Safety: Echocardiographic evidence suggests that both direct surgical resection and alcohol injection are effective at relieving LVOTO in HCM. However, of the two approaches surgery appears to be more effective. Ommen and colleagues 4 through retrospective review demonstrated that surgical resection of LVOTO restored survival to that

of individuals unaffected by HCM. Level of evidence: B Recommendation: IIa

2) Surgical strategies to reduce left ventricular size (La Place surgery):

The myo-splint: Ventricular diameter is reduced by a series of trans ventricular buttons placed across the short axis of the ventricle. This tends to produce a figure of eight cross section to the ventricle producing a reduction of internal radius (Figure 4).

Outline of procedure: The aim of this operation is to reduce wall stress using the La Place principle and so improve ventricular function. Targeted patients are those with heart failure resistance or intolerance of medical therapy.

Efficacy & Safety: McCarthy and

Evidence: Level C ACC / AHA recommendation: IIb.

The Acorn CorCap device: Pfeffer and Braunwald described progressive ventricular dysfunction leading to congestive cardiac failure after myocardial infarction.

Five years later Kass’s group 6 concluded that dynamic myoplasty (see below) was probably nothing more than a sympathetic cardiac constraint limiting further dilatation of a damaged heart. Probably from these observations came the CorCap, a polypropylene mesh designed to be placed about the ventricles at open operation.

Outline of the procedure: There is evidence from animal models that passive constraint improves left ventricular geometry and myocardial stresses after myocardial infarction. The aim is to constrain the failing and dilating left ventricle in patients with NYHA class III or less. Clearly no immediate benefit is offered by this cardiac device and requires an operation with all the hazards of surgery in those with compromised heart function.

Efficacy & safety: A randomised study including 300 heart failure patients was reported to the AHA in 2004. Those receiving a CorCap device appeared to fare better than those without. There was a significant reduction in left ventricular end-diastolic and end-systolic volumes with an improvement in quality of life.

This, unfortunately did not translate into a reduction in mortality or hospital readmissions for heart failure.

Evidence: Level B and AHA/ACC recommendation level IIb.

Partial left ventricular resection: In contrast to scar resections of damaged left ventricles (see below) this procedure requires the prescribed removal of muscle between

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dom from death or transplant listing of 56 per cent. This compares poorly with the results of heart transplantation. There are few if any centres undertaking this surgery now.

The CorCap®

Level of evidence: Level B and AHA / ACC recommendation III.

Figure 6

Cumulative survivals after resection of ventricular scar (Dor et al.)

100 90

Cumulative Survival

80 70 60 50 40 30 20

Diskontic

10

Akinetic

0

0

6

12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 Months

anterior and posterior papillary muscles in dilating, failing left ventricle. This procedure was developed in Brazil almost two decades ago by Batista. Its intention was to offer a surgical solution for patients with heart failure symptoms in the context of dilating cardiomyopathy and specifically Chaga’s disease.

Outline of procedure: The aim is to normalise cardiac volume/mass ratio, so reducing LV volume, LV wall stress and improving systolic function. This surgery is usually carried out on cardio-pulmonary bypass but has been reported to having been completed off bypass. The surgeon is

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Figure 7

guided by the arithmetic relationship between circumference and diameter (where circumference = π. Diameter and π = 3.142). Each 3cms of circumference resected by the surgeon is equivalent to a 1cm reduction of ventricular diameter. This is often combined with mitral surgery.

Efficacy & Safety: Reports have demonstrated a reduction in LV end diastolic and systolic volumes, an improvement in ejection fraction, cardiac index and stroke volume. Unfortunately death is a frequent complication. Dowling and colleagues 8 reported a 12 month free-

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Left ventricular aneurysmectomy (ventricular scar resection): The aim of left ventricular aneurysmectomy is to reduce an enlarged ventricular volume and to reverse the forces driving further ventricular remodelling (where dilating force is increased wall tension through enlarging ventricular diameter: equation 4 above). As with the Batista procedure, a dyskinetic segment of ventricle is removed reducing ventricular diameter and so reducing ventricular wall tension. However the segment removed here is scar and not ventricular muscle.

Initially simple excision of post myocardial infarction scar followed by ventricular plication was undertaken. This produced distortion of ventricular geometry led Jatene to recommend an encircling stitch about the aneurysm neck, and Cooley and Dor independently to recommend a patch to the remaining defect. The aim was to restore a more ’normal’ ventricular geometry Outline of procedure: Patients with left ventricular scar and no evidence of hibernating myocardium and who have symptoms of heart failure, angina or ventricular arrhythmias are candidates for this surgery.

On cardio-pulmonary bypass the scar is opened. If scarred or aneurysmal the septum is plicated from within the left cavity. The ’neck’ or edge of the scar is then identified and an encircling stitch placed about it. This is tied, reducing the enlarged ventricular cavity. The remaining defect is then patched with synthetic material. The exteriorised scar edges are finally closed over the repair. Cryotherapy may be applied to the myocardial edge of this repair in an attempt to abolish ventricular arrhythmias should they be present.

Efficacy & Safety: Dor and colleagues reported 9 their experience of resections of

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End diastolic ventricular volumes before, early after and late (12 months) after left ventricular aneurysmectomy with linear closure, septal remodelling or endo-ventricular patch plasty (endoVP) Technique

EDV (mls) pre

early post

late post

linear

189 ± 25

143 ± 291

165 ± 24

septal

199 ± 36

150 ± 27

170 ± 26

endoVP

251 ± 64

174 ± 32

187 ±27 Table 5

Level of evidence: Evidence level C and AHA/ACC recommendation IIb.

Survival after mitral repair in heart failure Bolling et al 1.0

C. Surgical strategies to re-power the failing heart i. mechanical support:

0.9 0.8

Survival

0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0

that survival was much the same as that following heart transplantation. This is perhaps a little bit optimistic as recent reports suggest no difference in outcomes for MR patient who have had or not had mitral surgery. Recent work suggests reasonable results from co-aption of papillary muscle with attention being directed towards the dilating ventricle which is probably the primary cause of this form of mitral regurgitation.

0

12

24

’akinetic’ (without movement) and dyskinetic (paradoxical movement) ventricular scar resections with followed up over 9 years (Figure 7). Survival of those with akinetic scar was worse than heart transplantation at 5 years. Worryingly, further work by Marchenko and colleagues (Table 5) describes a trend of re-dilatation of the left ventricle with time. This appeared to complicate all 3 surgical different approaches to aneurismal scar resection. The STITCH trial has recently ben reported at American College of Cardiology in Orlando (2009). Although results are not yet in print there appears to be no benefit in survival, quality of life or hospital stay to date.

Level of evidence: B and AHA / ACC recommendation III.

Mitral repair for secondary mitral regurgitation: It seems counter-intuitive to repair the secondarily regurgitant mitral valve (MR) in the face of poor left vetricular

Months

36

48

60 Figure 8

function. It would seem that this action shuts off retrograde flow, effectively raising the after-load to the failing heart, so worsening failure.

Outline of procedure: However MR with poor left ventricular function is associated with a dilated annulus and a tendency for the leaflets to be splinted open by their chordal attachments, as the ventricle dilates and becomes more sphericle.

These mechanisms are added to in the case of ischaemia by papillary rupture, ischemia or fibrosis.

Efficacy & Safety: Bolling and colleagues 10 reported a series of patients with severe MR, ejection fractions of 8 per cent – 15 per cent and NHYA status of III – IV in whom mitral valve repair was performed.

Heart failure symptoms reduced significantly, ejection fraction increased and both LV diastolic and systolic volumes fell with a reduction in ‘sphericity’ of the heart. Survival of these patients is shown in Figure 9. The authors suggested

a. CRT (cardiac resynchronisation therapy): Bi-ventricular pacing is considered when there is evidence of a lack of synchronous inter-ventricular contraction eg: bundle branch block.

Outline of procedure: Pacing leads are positioned directly within the right ventriclar cavity and onto the left ventricle through the coronary venous system.

Simultaneous stimulation re-introduces co-ordination of Right (RV) and Left Ventricular (LV) contraction. This therapy is directed towards patients who have had heart failure for at least 6 weeks and who are in NYHA class III or IV despite standard pharmacological therapy and who have a reduced LV ejection fraction (≤ 35 per cent) and a QRS on ECG of > 120msecs.

Efficacy & Safety: CRT has been shown to result in reduced inter-ventricular mechanical delay, an increased LV ejection fraction, reduce mortality and improved NYHA class. In addition improvement of symptoms and quality of life have been reported Level of evidence: Level of evidence A and ACC/AHA recommendation I.

b. Ventricular Assist Devices (VAD): The intention here is to off load the failing heart. This is achieved by the unloading of blood from the ventricle and its delivery into the arterial tree (pulmonary for right ventricular assist or RVAD and

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A display of various ventricular assist devices

2

1

3

5

4

1 and 2. temporary percutaneous continuous flow trans aortic valve VAD : Implella 3. Diagram illustrating pulsatile BiVAD Thoratec devices. 4. Total artificial heart (pulsatile: Abiocor) 5. Chest X ray illustrating Heartmate I as a pulsatile LVAD with ICD in place Figure 9

Destination therapy (chronic VAD) compared to maximum medical therapy: REMATCH study

Percent Survival

systemic for left or LVAD) by a ventricular parallel pump. Both left and right ventricles may be supported simultaneously with BiVADs. Total excision of a failing heart is occasionally undertaken followed by replacement with an artificial heart (Cardiowest, Abiocor) made up of a mechanical replacement for both of the heart’s ventricles. Ventricular assist devices may be continuous in flow or pulsatile and there is currently little to discriminate between them, save to say that pulsatile pumps are larger. Pumps may be placed within the body or lie outside being connected to the heart by pipes that cross the skin (para-coporeal). There is a risk of deposition of blood elements onto the inner lining of pumps or their connecting tubes. This pseudo-intima may be responsible for the generation of “cross-match antibodies” that are sometimes found with VADs. They may also act as a source of systemic emboli, a particular problem of mechanical heart pumps.

Outline of procedure: Generally a potential VAD candidate presents with severe, refractory heart failure with deterioration despite intensive medical therapy.

VADs are selected and may be temporary or long–term. Some are designed for per cutaneous insertion into the systemic arterial tree lying across the aortic valve (Impella). More usually VADs are inserted through a sternotomy under general anaesthetic. It is possible to place some devices without the use of cardio-pulmonary bypass (eg: Levitronix).

Patients are often mortally ill with multisystem dysfunction. Bleeding, control of vascular resistance and multi-organ failure are early problems and soon replaced by risks of infection and thrombo-embolism.

Individuals are bridged to transplantation safely by the VAD. Interestingly more and more patients (often those with a short but aggressive history of failure or myocarditis) have been found to recover so much so that the VAD can be removed and heart transplantation avoided (bridge to recovery).

There is interest in the role of perma-

Months Post Enrollment Figure 10

nent mechanical support for heart failure, usually in patients in-eligible for transplantation. Such chronic support is grimly termed ’destination therapy’. REMATCH was a land-mark CRT exploring the efficacy of destination therapy. Survival with a VAD was significantly better than maximum medical therapy at both 1 and 2 years (Figure 10).

Efficacy & Safety: Mechanical support is carried out in very sick patients and has a substantial attendant mortality of 25 per cent or so for LVAD and 40 per cent for BiVAD. Infection is common but appears to be less so for small, electrical implant-

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able devices with lengthily sub-cutaneous, tunnelled, trans-cutaneous cables. There is no totally implantable VAD currently because of problems with energy delivery.

As a result power cables must cross the skin for all devices. Thrombo-embolic events are common despite anticoagulation and are most common early after placement. Haemolysis is often seen and is more likely with BiVAD with renal support. Right-sided failure is often seen with LVADs and is usually an early postoperative event. Equally daunting to these profound complications is the cost of devices. Recent work suggests that this

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may be as high as £50,000 for each quality adjusted life year gained. It is probably fair to say that there is still no perfect device available to deliver a satisfactory long-term outcome.

Dynamic cardiac myo-plasty Latissimus Dorsi muscle wrapped about failing heart

Level of evidence: Level B AHA/ACC recommendation I

Failing heart

ii. Biological:

Evidence: Level of evidence B and AHA/ACC recommendation IIb.

b. Heart transplantation: The replacement of the failing human heart by a ’normal donor heart’ appears a little extreme. But since its introduction by Barnard in South Africa in 1967 it is

Latissimus Dorsi pacing lead

Figure 11

Survival of patient with cardiac myoplasty (DCMP) and chronic heart failure (Reference patients)

100% 80% Actuaarial Survival

a. Dynamic cardiac myo-plasty: The intention here is to re-power the failing heart using autologous skeletal muscle.

Outline of procedure: Skeletal muscle (Latissimus Dorsi muscle) is mobilised on its neuro-vascular pedicle and brought into the chest through a small thoracotomy (Figure 11) and wrapped about the heart to deliver increased muscle bulk to add power to ventricular contraction, improving systolic function. It is continuously paced in order to transform fast twitch muscle to slow twitch (Salmons and Streeter) and secondly to synchronise the skeletal wrap contraction with cardiac contraction. The patient group targeted are those in heart failure but who do not have NYHA IV, mitral regurgitation, atrial fibrillation, pulmonary wedge pressure > 25mmHg, ejection fraction <12 per cent, multi-vessel coronary artery disease and peak oxygen consumption <10 mls/ Kg/min. as poor surgical outcomes have been reported in these groups.

Efficacy & Safety: Despite promising animal work improvement in systolic function in patients has been inconsistent.

However some improvement in load independent measures (Kass) of diastole have been described. This procedure is rarely undertaken now. Figure 11 contrasts the survival of 68 skeletal myoplasty patients to a matched group of 58 patients with chronic heart failure.

(41)

60%

(10)

(21)

(16)

(26)

40% DCMP Patients (N=68) Referance Patients (N=58)

20% 0% 0

6

12

18

24

Months Figure 12

regarded as the best that can be done for patients with severe, refractory heart failure (AHA/ACC stage D). Heart transplant activity is dictated by donor heart availability and can be seen to be in decline World-wide since a peak of just under 4,500 procedures in 1994.

The insertion of several hundred grams of foreign protein by transplanting a human heart excites a rejection response.

As a result the patient is dependent upon life-long immune suppression.

Outline of procedure: The recipient is selected to avoid significant secondary complications that may arise through

immuno-suppression. Therefore patients with a recent history of malignancy or persistent acute or chronic infection are excluded. There is evidence that the donor hearts manage poorly in the face of moderate pulmonary vascular hypertension. A right heart study defines the size of the trans-pumonary pressure gradient (TPPG = mean pulmonary artery pressure—mean pulmonary wedge pressure).

Patients are required to have a TPPG of 14mm Hg. or less. Rarely are patients selected with significant co-morbidity and consequently heart plus other solid organ transplantation is unusual.

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Level of evidence: Level B and AHA / ACC recommendation I.

Changes in heart transplant activity and donor age South America North America Europe Australia / Ocean Asia Africa

4500 4000 3500 3000 2500 2000 1500 1000

2000

1998

1996

1994

1992

1990

1988

1986

1984

0

1982

500

Figure 13

Actuarial survival after heart transplantation (ISHLT registry 2005) 100

Survival (%)

80 60 40 20 0

0

1

2

3

4

5

6

7

8

The donor organ is reviewed by the donor team and its function assessed by pulmonary artery catheter or echo-cardiography. If satisfactory it is subjected to cold diastolic arrest and excised before being transported to the recipient hospital in cold saline.

Donor to recipient matching is made by blood group (according to the rules of transfusion) and body size (either height or weight). The recipient heart is removed and replaced by suturing at mid left and right atrial and mid pulmonary and aortic arterial levels on Cardio-Pulmonary Bypass (CPB). The new heart is usually capable of supporting the recipient after 30 minutes of reperfusion.

Efficacy & Safety: Survival with the diagnosis of severe refractory heart

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9 10 11 12 13 14 15 16 17 18 19 Years Figure 14

failure is appalling. The REMATCH study demonstrated 28 per cent one year survival falling to eight per cent at two years in medically managed patients with severe refractory heart failure. The ISHLT registry (Figure13) of survival after heart transplantation compares well to this natural history with an overall half-life after heart transplantation of 11 years.

Additionally, many studies have demonstrated quality of life of heart transplant recipients to be good.

However there are persisting concerns with personal appearance and sexual dysfunction. Surprisingly there have been no prospective randomised trials exploring the position of heart transplantation in the management of patients with class D heart failure.

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c. Cellular transplantation: The concept of re-powering the failing ventricle by cellular transplantation has attracted a great deal of attention. It requires that the new cells will: • be retained within the tissue into which they have been injected.

• engage as part of the cardiac syncytium.

• differentiate into myoblasts.

• lead to an improvement of contraction.

• improve the outcome for the recipient.

Outline of procedure: Stem cells, be they the pleuri-potent cells of bone marrow, adipose tissue, skeletal muscle or embryo are injected into the myocardium where they are expected to grow. This injection is either via the coronary arterial system or directly into the myocardium.

Efficacy & Safety: Results in the laboratory have been encouraging with a suggestion of improvement in heart function. Skeletal myoblasts have been harvested from the quadriceps muscle in a series of patients with a region of poor ventricular function and who were expecting coronary artery bypass surgery. Autologous skeletal myoblasts were isolated and expanded in numbers by cell culture. Using this approach in a recent prospective, blinded randomised clinical trial (MAGIC study) patients received transport medium, low concentration or high concentration suspension of autologous skeletal myoblasts as a series of injections into the area of poor ventricular function. This trial failed at interim analysis and has been suspended. A further 60 patients, five days after trans-mural myocardial infarction received autologous bone marrow cells at the time of angioplasty. There was a suggestion of small but significant improvement in ventricular function.

Level of evidence: Level B – C and ACC / AHA recommendation IIb

d. gene therapy: It is very early days in this arena. The aim appears to be

Surgical speciality

better known for its abuse by athletes, has been reported to increase the likelihood of recovery in patients being bridged to transplantation by VAD. More excitingly, however, is the recent identification of the human cardiac myoblast. Recent clinical reports have demonstrated both cellular hypertrophy and new myocyte production within the myocardium stressed by aortic stenosis (Figure 14) Level of evidence: Unknown

The myocardium of a patient with aortic stenosis showing evidence of myoblasts (vital staining: blue) and mitotic activity marked by white arrow.

Right panel an enlargement of white boxed area in left

Concluding remarks

Figure 15

Appendix A. Level of evidence: a. Data are derived from multiple randomised clinical trials or meta-analysis. b. Data are derived from a single randomised trial or non randomised studies. c. Only consensus opinion of experts, case studies, or standard of care.

B. Levels of recommendations (ACC / AHA) Class 1: Conditions for which there is evidence and / or general agreement that a given procedure / therapy is beneficial, useful, and / or effective Class II: Conditions for which there is conflicting evidence and / or a divergence of opinion about the usefulness / efficacy of a procedure / therapy.

IIa: Weight of evidence / opinion is in favour of usefulness / efficacy

IIb: Usefulness / efficacy is less well established by evidence / opinion Class III: Condition for which there is evidence and / or general agreement that a procedure / therapy is not useful / effective and in some cases may be harmful.

Level of evidence: Unknown

e. Up-regulation of natural pathways: Promotion of intrinsic pathways that

would result in improved power production by the heart is of current interest.

For example, Clenbutarol, an anabolic steroid with β agonist properties, perhaps

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up-regulation of biochemical pathways by gene delivery.

Outline of procedure: There is some animal work to suggest that up-regulation of SERCA (Sarco/Endoplasmic Reticulum Ca2+-ATPase) through adenovirus vecta may increase the likelihood of recovery of ventricular function with mechanical ventricular support.

Interventions for heart failure are proliferating as interest in this patient-group heightens. It is true to say that all heart surgery can be regarded as Heart Failure Surgery in the light of the new, sequential classification of heart failure by the ACC and AHA. Direct surgical approaches to reverse remodel the dilated and failing left ventricle appear to be less successful at restoring normality than if the primary ventricular remodelling insult can be identified and removed. Where such approaches are not possible due to an advanced state of heart failure the results of heart transplantation remain impressive, now 40 years after its introduction. Despite concerns over donor heart supply for transplantation the future in this area is encouraging following the recent identification of a possible internal recovery system through the human cardiac myoblast. Perhaps it is not too romantic to imagine a future time when temporary mechanical support allows for a failing heart to be re-powered by upregulated autologous-myocyte production; cells bourn into the syncytium and able to contract?

References are available at http://www.asianhhm.com/magazine

Stephen Large is full-time cardiac surgeon in Cambridge Universityâ&#x20AC;&#x2122;s Papworth Hospital. His interests have focussed on various aspects of the failing heart. Apart from this his professional interests lie in medical education and hospital management. He did his MBA from the Open University. Stephenâ&#x20AC;&#x2122;s research interests have generated some 220 papers to date. He enjoys drawing, walking and ski-ing!

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Diagnostics

Three-dimensional Transesophageal Echocardiography Early experiences Imaging, especially echocardiography, plays a key role in structural, congenital and valvular heart disease interventions; not only for the evaluation of the disease and selection of eligible patients, but also for guidance of the procedures and in follow-up examinations.

Live 3D echocardiography has recently added new dimensions by providing new views which help to get a better idea of the 3D character of the defect.

Nina Wunderlich Director Department of Cardiology CardioVascular Center Frankfurt, Germany Neil Wilson Director Department of Paediatric Cardiology John Radcliffe Hospital, Oxford, UK Jennifer Franke Fellow Department of Cardiology University of Heidelberg, Germany Horst Sievert Director Department of Cardiology CardioVascular Center Frankfurt, Germany

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M

inimally invasive catheterbased treatment of structural, congenital and valvular heart disease is a rapidly growing field.

Imaging plays a key role in the guidance of these procedures. As a result there has been considerable advancement in image guidance technology.

Echocardiography fulfils the needs by providing real-time imaging, thus reducing the dose of ionizing radiation.

It is cost-effective, widely used and most interventionalists are very familiar with this imaging format.

In the past, percutaneous interventions were guided by 2D Transesophageal Echocardiography (TEE) in addition to fluoroscopy in most catheter laboratories. 2D TEE, however, has limitations due to merely two spatial dimensions.

In most cases it is possible to get an idea of the 3D character of the structures, but not in one single view.

Recently, a new generation of TEE probes with a novel matrix array technique was introduced that allowed threedimensional visualisation of cardiac structures in real time thus overcoming some of the major limitations of 2D TEE. The pathomorphology of defects, surrounding structures, catheters and devices can be visualised quickly and

Diagnostics

accurately while presenting the 3D character in one single view.

Our first experiences with this new technique in the guidance of percutaneous cardiac interventions using a matrix array 3D TEE probe (X7-2t, Philips Medical Systems) connected to a 3Dcapable echocardiographic system (iE33, Philips Medical Systems) are discussed below.

Clinical applications Closure of Patent Foramen Ovale (PFO)

Percutaneous PFO closure was first performed by Bridges et al. in 1992.

Transcatheter closure of PFO has become a routine procedure for patients suffering from cryptogenic stroke with low complication and recurrence rates.

Multiplanar 2D TEE is widely used as an imaging technique for guidance of procedures in most centres worldwide.

However, it has limitationsâ&#x20AC;&#x201D;wires, catheters and devices cannot be fully imaged in relation to the surrounding structures.

With 2D TEE, scanning of several views is necessary to mentally reconstruct the 3D anatomy. 3D TEE provides threedimensional spatial orientation in one view allowing monitoring of the entire procedure with excellent imaging quality.

3D perspectives enable monitoring of all steps of the interventionâ&#x20AC;&#x201D;from the passage of the guide wire and delivery catheter through the PFO to the final assessment before device release.

The following figures illustrate that guiding of a PFO closure procedure with 3D TEE is feasible.

Figure 1a demonstrates the passage of the guidewire through the PFO track.

The wire stretches the PFO tunnel and the tenting of the channel within the interatrial septum is clearly visualised.

Figure 1b shows the sizing balloon in the left atrium. We perform balloon sizing of all defects because the size of the PFO is unpredictable in TEE. After balloon sizing the specific introducer sheath is advanced. In Figure 1c, crossing the PFO with the delivery sheath is shown. Figure 1d shows an Amplatzer

occluder with both atrial discs deployed.

Before device release the correct and secure position of the occluder has to be ascertained. One single 3D perspective shows the correct device position, which is a major advantage of real-time 3D TEE. After placing the device in the right position, it can be released as demonstrated in Figure 1e which gives an en-face view from the left atrial side.

Figure 2 shows a complication. The patient had a large atrial septum aneurysm. First a 25-mm Amplatzer PFO occluder was implanted. Figure 2a shows a 2D TEE image of the entire occluder being slipped into the PFO tunnel.

Figure 2b shows the same situation with an en-face 3D view of the left side of the atrial septum where both atrial discs can easily be identified on the left atrial side. This occluder was retrieved and replaced by a 30-mm Amplatzer PFO occluder. On this occasion, the septum secundum is embraced adequately by both discs. This is shown in Figure 2c with 2D TEE imaging. Figure 2d shows the same with 3D TEE imaging where a single disc can be visualised on the left atrial side. Conventional 2D TEE (Figure 2a, c) enables the assessment of

appropriate device position but requires scanning of several image planes. In contrast, 3D TEE offers exact visualisation of the device position and its relations to the interatrial septum in one single view.

Closure of Atrial Septal Defects (ASD)

Since the first transcatheter closure of an ASD by King and Mills in 1976, device closure of ASD has become an alternative to surgical closure. Normally, 2D TEE is used in combination with fluoroscopy to monitor the interventional procedure, but due to the limitations of 2D TEE it is difficult to obtain optimal visualisation of the complex anatomy of ASDs. The dynamic variations of the defects are insufficiently appreciated by 2D TEE. 3D TEE provides en-face views of the interatrial septum and therefore can clearly identify the morphology of the defect as well as its relation to surrounding structures, which cannot be achieved with any other available imaging technology.

The following examples demonstrate that 3D TEE guidance of ASD closure procedures is feasible and helpful. Figure 3a shows a 3D TEE stop-frame image of the ASD displaying an en-face view from the left atrium. This view allows an

Monitoring of PFO closure (PFO Patent Forament Ovale LA Left Atrium IAS Interaitrial Septum RA Right Atrium) Figure 1

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Monitoring of a complication in a PFO closure procedure RA Right Atrium LA Left Atrium Figure 2

assessment of the complete circumference of the ASD. The size, shape and rim of the defect can be judged in this single view. The exchange wire is passing through the ASD. Figure 3b shows the positioning of the delivery sheath. Figure 3c shows the delivered left atrial disc and the pull-back towards the interatrial septum. It is also possible to close multiple defects in one procedure. In Figure 4,

an example of a patient with two defects is shown. Preferably, the smaller defect is closed first followed by the second, the larger defect. In Figure 4a, we see two Amplatzer occluders; the smaller one is positioned in a more caudal located defect. This occluder is sandwiched by the larger Amplatzer occluder located in the more cranial defect which covers the larger ASD. 3D TEE shows in one image that both occluders are positioned correctly in relation to each other and to the interatrial septum.

Figure 4b illustrates the final result in an en-face view from the left atrial side.

Mitral valve procedures

Monitoring of a mitral valvuloplasty (LA Left atrium LV left ventrucle)

Figure 3

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3D TEE provides en-face views of the mitral valve from the left atrial and left ventricular aspects.

This allows a detailed assessment of the mitral valve anatomy. Ring size, precise valve morphology and pathomorphology of leaflets such as prolapse can be visualised clearly which is extremely help-

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ful in assessing the mitral valve before and during interventional and surgical procedures. Eligible patients for specific mitral valve procedures can be identified more accurately and the likelihood of procedural success is more predictable.

Since its introduction by Inoue et al. in 1984, percutaneous mitral comissurotomy (PMC) has been successfully and safely performed in large series of patients at numerous centres.

Our experience shows that it is feasible to monitor balloon mitral valvuloplasty with 3D TEE. By receiving a three-dimensional impression of the valve, less favourable anatomy such as valve calcification, severe subvalvular disease, echocardiographic score, can be assessed accurately. The procedure described was performed in a 42-year old patient with history of rheumatic fever.

Figure 5a shows the valve anatomy with typically thickened leaflets. There was no severe calcification and no subvalvular disease. In Figure 5b, the thickened leaflets and the narrowed mitral valve area is clearly visualised in an en-face view from the left atrium. The Inoue balloon is positioned in the left atrium before passing the mitral valve. Figure 5c demonstrates the correct position of the inflated Inoue balloon in the stenotic mitral valve.

For patients who suffer from mitral valve regurgitation, a percutaneous nonsurgical repair with the MitraClipÂŽ can be an option. Results from studies so far show that the MitraClipÂŽ can provide successful reduction of mitral regurgitation. Furthermore, the studies have shown that with resumption of proper valve function improved left ventricular remodelling significantly during 12month follow-up.

Evalve has developed catheter-based technology, which, by apposing the edges of a regurgitant mitral valve, results in edge-to edge repair .The MitraClipÂŽ grasps affected parts of the anterior and posterior leaflet similar to the Alfieri surgical procedure. The challenge of

Diagnostics

Multiple ASD closure

(RA Right atrium) Figure 4

the technique is to position the Clip perpendicularly to the coaptation line of the mitral leaflets in the area of the affected parts of the leaflets. The intention is not to favour one side of the created two mitral orifices. Figure 6a shows the procedural outcome from the left atrial side. The leaflets are grasped in the middle (A2 and P2 parts) of the anterior and posterior leaflet and the two created mitral orifices have a similar size which is a good result. In Figure 6b, the Clip can be identified from the left ventricular side. Patient mitral regurgitation declined from grade IV to grade II after the procedure.

Paravalvular mitral leak closure

Valve replacement surgery is the second commonest cardiothoracic operation after coronary artery bypass grafting. A potential sequel to surgery is the development of a paravalvular leak due to incomplete apposition of the sewing ring to the native tissue. This may be a consequence of suture dehiscence. Detection has increased as a result of improved techniques, particularly transesophageal echocardiography. Percutaneous transcatheter closure techniques have also been applied to paravalvular leaks. A routine TEE may document the presence and severity of regurgitation but is often not sufficient to assess the accurate location of the defect, the exact size and shape of the defect, course of the leak and hence, less chances of successful percutaneous repair. The irregular three-dimensional structure of these defects has to be taken into account and this cannot be imaged entirely by 2D TEE. Thus, guidance of paravalvular

leak closure is very challenging even for experienced echocardiographers and interventionalists. If the defect itself cannot be adequately visualised echocardiographically, percutaneous closure is less likely to be successful.

3D TEE is able to provide an en-face view of the mitral valve which allows complete and adequate assessment of the three-dimensional character of paravalvular leaks. This information is crucial particularly for the determination of the technique and choice of device size and shape. The following 3D TEE images of a paravalvular closure procedure emphasise these facts.

Figure 7 shows the example of a 51year old woman who had a mechanical mitral valve replacement (SJM 29 mm) because of severe mitral regurgitation after a bout of endocarditis. A few months later she developed severe mitral regurgitation due to a paravalvular leak.

Figure 7a shows a very clear image of the size and the oval shape of an anterior-medial located paravalvular leak.

A 14/5 mm Amplatzer-Vascular-Plug III occluder (AVPIII) was implanted.

This device is especially designed for paravalvular leak closure and has an oval shape. Figure 7b demonstrates that the device can be identified very easily, and

the 3D image shows the exact positioning of the device perpendicular to the defect. This could not be seen with 2D TEE. The final position of the device where the occluder is now properly aligned to the defect can be seen in Figure 7c. This example underlines the enormous potential benefit 3D TEE can provide with a better outcome for the patient.

Percutaneous Aortic valve replacement

Degenerative aortic valve disease is the most common valvular heart disease and its prevalence increases with age.

The morbidity and mortality of surgical aortic valve replacement is increased in elderly patients with multiple high-risk comorbidity.

Percutaneous aortic valve replacement has become an alternative therapeutic option to surgical valve replacement in selected elderly patients with an unacceptably high risk of surgery. Early improvement in left ventricular ejection fraction and mitral regurgitation following pecutaneous aortic valve implantation has been reported. Recently, it has been shown that echocardiography is important in case selection, guiding valve placement and in detecting complications during and after the procedure.

Figure 8 shows an example of an 82-year old woman with a severe symptomatic aortic stenosis. Figure 8a shows the aortic valve in a short axis 2D TEE view and Figure 8b the corresponding 3D TEE image, giving a spatial impression of the aortic valve and its surrounding structures. Figure 8c show

Monitoring of a miral valvu repair procedure with the MitraClip device (LA Left atrium LV left ventrucle)

Figure 5

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appendage would, therefore, seem to be a logical approach to minimise the risk of thrombus formation and subsequent embolisation. Surgical attempts at left atrial appendage closure have drawn interest towards percutaneous interventional techniques and led to the development of devices specifically for this purpose.

The earliest device, the percutaneous Left Atrial Appendage Occluder (PLAATO) [36] is no longer available. The Watchman Monitoring of Left Atrial Appendage paravavular leak System and most recently, closure the Amplatzer cardiac plug (LA Left atrium) (ACPIII) are currently in Figure 6 clinical use. the partially deployed valve in 2D TEE To determine eligible patients for and Figure 8d the completely deliberthe procedure and for device selection ated valve in 3D TEE imaging. measurements of the LAA orifice and It provides a clear three-dimensional the LAA length are of major importance. view of the aortic valve, the LVOT and Using 2D TEE, several views have to its surrounding structures. The relation be scanned to get an idea of the size of the anterior leaflet of the mitral valve and shape of the LAA orifice. 3D TEE to the LVOT can be imaged particularly enables us to get an en-face view of the well. This is of major importance for the LAA orifice which allows us to clearly final positioning of the self-expandable identify the correct dimensions in one CoreValveÂŽ prosthesis to ensure that the movement of the anterior mitral leaflet is not constrained.

As the technical aspects and clinical understanding of this technique continue to evolve, echocardiography and especially 3D TEE will have a crucial role in the future development of the treatment of aortic valve disease.

view. Figure 9 demonstrates the guidance of a LAA occlusion procedure with a Watchman device in a patient with permanent atrial fibrillation. Figure 9a shows the LAA which is examined for thrombi before the procedure. Figure 9b provides an en-face view of the LAA orifice and the left upper pulmonary vein which is a unique view only available with 3D TEE. Figure 9c shows the guidewire being advanced into the LAA and Figure 9d shows the placing of the delivery sheath in the LAA. Figure 9e shows the final position of the Watchman device. Fixation barbs around the mid-perimeter engage the occluder to the wall of the LAA. The major advantage of 3D TEE in this procedure is providing the en-face view of the LAA entrance, which gives a clear impression of the orifice of the LAA where the occluder is finally positioned.

Conclusion

Real-time 3D TEE is a novel technique to guide cardiac interventions.

We have learned from our early experience that this new technique adds previously unavailable anatomical information of cardiac structures and defects. Information on the pathomor-

Left Atrial Appendage closure (LAA)

The left atrial appendage is the most common source of cardiac thrombus formation in patients with atrial fibrillation. More than 90 per cent of all cardiac thrombi in patients with nonrheumatic atrial fibrillation forming in the left atrium originate in the left atrial appendage. Occluding the left atrial

Monitoring of percutaneous aortic valve implantation (CorelValve prosthesis) LA left atrium LV left ventriole Ao asc Aorta ascendens MV Mitral valve

Figure 7

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Diagnostics

Monitoring of LAA closure

(LAA left atrial appendage LA left atrium LUPV left upper pulmonary vein) Figure 8

phology and the relation of defects to surrounding structures can be provided quickly and accurately. High quality real-time 3D TEE imaging with good spatial and temporal resolution has great potential for guiding interventional procedures.

This may likely lead to safer and shorter procedures with higher technical success, a diminished amount of radiation exposure and therefore lead to better outcomes for the patients, which has to be proven in further clinical studies.

Nina Wunderlich is the director of non-invasive Cardiology at the CardioVascular Center Frankfurt, Sankt Katharinen. Dr. Wunderlich received her medical degree at the University of Frankfurt, Germany and completed a fellowship in cardiology. She has been involved in a number of clinical trials, and has authored peer reviewed medical publications and book chapters.

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Neil Wilson is the director of the department of paediatric cardiology at John Radcliffe Hospital, Oxford, United Kingdom and he is also a Pediatric Cardiologist practicing in the UK.

Jennifer Franke is a fellow in cardiology at the University Hospital of Heidelberg, Germany. She graduated from the University Frankfurt, Germany and performed her doctorate thesis on Carotid interventions at the CardioVascular Center Frankfurt. She has coordinated over 20 clinical trials and has been the scientific secretary of the International Course on Carotid Angioplasty (ICCA).

Horst Sievert is the director of the CardioVascular Center Frankfurt, Sankt Katharinen, and the Department of Internal Medicine, Cardiology and Vascular Medicine of the Sankt Katharinen Hospital in Frankfurt, Germany. He is also an Associate Professor of Internal Medicine / Cardiology at the University of Frankfurt. Dr. Sievert received his medical degree at the University Frankfurt, Germany.

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Molecular Diagnostics and Personalised Medicine Present and future Rationally developed therapies used diligently in the healthcare marketplace can undoubtedly benefit society, and the role of good quality predictive and diagnostic molecular tests is unambiguously a great advance for pharmaceutical medicine.

Eddie Blair Managing Director Integrated Medicines Ltd, UK

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A

cceptance of the personalised medicines paradigm is strictly dependent on this approach clearly benefiting patients with minimal effects on the actual delivery of healthcare. The use of molecular diagnostics to predict how an individual will respond to particular medicine, in terms of safety or effectiveness, offers considerable benefits over the current practices of prescribing and monitoring patient responses.

What’s the present situation?

With the increasing number of ‘blockbuster’ drugs, i.e., those individual entities that reach global sales of more than US$ 1billion per annum, being marketed and prescribed, it has become apparent that many of these drugs only benefit part of the intended patient cohort, with estimates suggesting that overall effectiveness ranges from 80 per cent to as low as 20 per cent depending on the disease area addressed. These observations about the relative effectiveness of medicines, equally fuelled by concerns about safety of medicines, the rising costs of supplying medicines and other macroeconomic factors affecting healthcare budgets, are leading to new models of how medicines are prescribed. Such new models of prescribing increasingly involve health technology assessments, undertaken by agencies modelled on the UK National Institute of Clinical Excellence (NICE) and now prevalent across Europe and the US, two of the largest geographic pharmaceutical markets.

Amongst the many activities of these agencies, there lies a role in the

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decision-making around reimbursement for medicines, and indeed the level and timing of reimbursement. The timing of reimbursement in particular is interesting and begins to touch on the potential role of molecular diagnostics in how medicines are supplied to appropriate patients. For example, two years ago, UK NICE ruled that the UK National Health Service (NHS) should only pay for a ubiquitin proteasome inhibitor, bortezomib (Velcade) when it had been proven effective, as measured by the response of a single validated biomarker, Serum M Protein (SMP). There is now open discussion that this model of ‘proven efficacy preceding reimbursement’ as the preferred model for regulators, payers and healthcare providers in all major pharmaceutical markets. What this model then does is to remove the perceptual barrier that protected the block-buster mentality and heralds the opportunity for segmentbuster and niche-buster medicines i.e. medicines based on higher response rates with minimised side-effects (Figure 1).

The segment-buster opportunity extends the healthcare tool-kit to include companion diagnostics and monitoring tests. Such tests will tend to use traditional diagnostic technologies based on protein and/ or small molecule detection, although the increasing use of molecular diagnostics in nearer-patients settings may extend the tool-kit somewhat. The niche-buster model is predicate upon the careful definition of the responder population during drug development and then the careful identification of individual responders in the market place; it is this

Diagnostics

Migration from blockbuster treatments to high-value targeted treatments

that are most likely to respond to specific medicines, either as individual entities (cetuximab) or as part of a specific drug class (EGFR kinase inhibitors). Case study examples of these types of tests —predictive tests of safety or effectiveness—are discussed in Boxes 2 and 3, by way of illustrating the real value that these tests offer.

What’s the future situation?

(SAE = Severe Adverse Event; CDx = Companion Diagnostic; PGx = Pharmacogenetics)

predictive role that is a key benefit of molecular diagnostics in the personalised medicine offering.

Predictive tests—see Box 1 to understand the differences between prognostic

and predictive tests—are now available for guiding the metabolic potential of individuals and the often-linked propensity to suffer serious adverse events, as well as tests that robustly identify those

The role of molecular diagnostics in the future delivery of healthcare is not as simple as guiding the right treatment to the right patient at the right dose and at the right time, but also impacts on health economics by delivery benefit at the right price. As a general consequence, the prediction of response and the early treatment of disease is likely to have a more favourable outcome on the health to individuals. This, however, has two long term effects: firstly, individuals may be on therapies for considerably longer

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Predictive vs Prognostic Tests The Genomics Health Oncotype Dx test commands a substantial and fully reimburseable price of about US$ 3,500 because it identifies patients likely to suffer a relapse and / or metastasis of primary breast cancer. It is known to have a very high prognostic value in determining the likelihood of an individual to experience a particular outcome, i.e., recurrence-free survival.

The various tests that indicate the likelihood of an individual responding to trastizumab (Herceptin) or to imatinib (Gleevec) are known as predictive tests because the do predict with reasonable confidence whether

the particular form of breast cancer resent is likely to be sensitive to treatment. As many of these tests use relatively simple technologies to conduct the predictive diagnosis, they do not command a high reimbursable price, despite offering high value information.

It is possible for predictive test to also have prognostic value and vice versa, but it is the primary application of the test that determines its real value and positioning.

In addition, such tests may also be used for response monitoring but generally their pricing means that alternate platforms will be used for this purpose.

Box 1

treatment periods and, secondly, individuals are likely to stay functionally well for much longer. In terms of health economics, costs may well switch from expensive primary, secondary and / or tertiary care provision, such as hospital beds, mechanical interventions etc. to the costs of providing long-term treatments to many more symptomatically well indi-

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viduals. In fact, the scenario above is one that many healthcare systems as moving to; they are supplanting symptom-based reactive medicine with objective testingbased predictive medicine. Thus it is clear that molecular diagnostics tests as guides to prescribing tailored (or personalised) medicines have an impact way beyond the current scenarios described in Figure

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1. Indeed, the use of molecular testing to offer better medicines at earlier times with more favourable outcomes may well have longer term effects on societies as a whole.

Many healthcare commentators, particularly those with a predilection for the problems of the pharmaceutical industry, can get very preoccupied by issues such as dry development pipelines, inexorably increasing costs for medicines R&D and the difficulties in getting medicines approved and reimbursed at an economically fair rate. However, the real challenges for the future of healthcare are readily summed up by two words—‘aging populations’. In almost all countries globally, life expectancy is increasing—driven in part by basics such as clean water, better sanitation and plentiful food supplies—with effective medicines playing a considerable role; at the same time the quality of life is not increasing. Indeed, in India, dietary

Diagnostics

1

Kras-based efficacy prediction

It has been known to molecular oncologists for many years that the signalling cascade, initiated by occupancy of the epidermal growth factor receptors (EGFRs), continued downstream via the ras transducer molecular to result in the nuclear activation of gene expression and DNA replication. This cascade is managed by series of on-off switches – actually mediated by the opposing processes of phosphorylation and de-phosphorylation—which ensure that signal transduction operates in a controlled and environmentally-responsive way. Equally, molecular oncologists have known for many years that the ras family of proteins can be altered by gene mutations such that they remain in a permanently activated form resulting in permanent downstream activation that manifests itself as the unregulated growth of cancers cells.

Thus when exciting new EFGR-modulating products, such as panitumumab (Vectibix) and cetuximab (Erbitux), reached the marketplace, it was reasonable to expect that individuals with activating mutations in ras might respond less well. This sadly has indeed proven to be the case. Individuals expressing a normal Kras molecule, on the basis of Kras genotyping, show substantial benefit, in terms of improved survival (overall and ‘progression-free’) whilst those with ‘activating’ mutations in the Kras gene show no benefit from cetuximab treatment. Kras mutation tests, offered by several vendors, are now featured on drug labels in the EU and are likely to be approved for full reimbursement by UK NICE, such is the predictive value of these molecular diagnostic tests.

Box 2

2

Abacavir hyper-sensitivity safety prediction

The nucleoside-based reverse transcriptase inhibitor, abacavir (Ziagen), became an important component of multi-drug HIV therapies following clinical development in the mid- to late1990’s. However, its role at the vanguard of successful HIV management was compromised by a rare but potentially fatal hypersensitivity reaction in AIDS patients. Following a genomewide genetic association study by several independent groups, it was found that mutations at a major histocompatability locus, i.e., a part of the genome that expressed regulators of immune response and tolerance, appeared to be retrospectively

associated with the majority of hyper-sensitivity reactions.

Prospective studies confirmed the association of this singlenucleotide polymorphism (SNP) locus, called HLA-B*5701, with hypersensitivity and established a clinical utility for the test. The test, offered by a number of clinical lab organizations, now appears in the label of all abacavir-containing drug formulations, and since its introduction there have been no reported SAEs associated with abacavir hypersensitivity. In essence, this predictive test has rescued a whole diseasemanagement strategy for HIV/ AIDS. Box 3

In conclusion…

Rationally developed therapies used

diligently in the healthcare marketplace can undoubtedly benefit society, and the role of good quality predictive and diagnostic molecular tests is unambiguously a great advance for pharmaceutical medicine. The increased use of predictive tests will surpass the benefits already seen by traditional companion diagnostics to the point that earlier interventions will herald the rise of predictive medicines.

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changes are causing a huge rise in the levels of Type 2 Diabetes (T2D) and in China the affordability of cigarettes is seeding respiratory problems, particularly Chronic Obstructive Pulmonary Disease (COPD). In Western populations, the management of previously lethal disease conditions, including some, but not all, cancers, is allowing all members of societies to live longer; however, the rise of degenerative disease, particularly associated with the Central Nervous System (CNS), is substantially reducing the quality of life in later years for many individuals. Thus some care must be taken in assessing benefit over perhaps inappropriately short time frames.

However, disease will not become a thing of the past; disease will remain and will be manifest in different forms from that observed and so well-managed today.

It is clear that in ensuring a healthier future, we should be careful about what we ask for and be careful about what we deliver.

References are available at http://www.asianhhm.com/magazine

Eddie Blair is a MD of Integrated Medicines Ltd, enabling personalised medicines by combining diagnostic-type testing with new and existing medicines. He is non-executive director of IDS Holdings plc and a visiting scholar to the Cambridge University-MIT Masters Programme. He also lectures on personalised medicines and offers occasional bespoke courses based on his best-selling books. He has published more than 40 primary papers on the subject and is named inventor on a dozen patents.

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Technology, Equipment & Devices

Evolving Healthcare Technology Changing processes As and when technology changes and new products come into the markets, a situation is created wherein newer types of services are to be brought into picture. This change also leads to newer business models that are to be implemented by the market players.

Rajiv Varyani Program Manager Frost & Sullivan Healthcare Asia Pacific, Singapore

C

ontinuous rise in population, substantial economic transformation in low income countries, rapid urbanisation and consequent changes in lifestyle are few of the many changes happening around. In parallel to these developments, rapid technology evolution isnâ&#x20AC;&#x2122;t stopping either. New innovations in in-vitro diagnostics like microarrays and lab-on-a-chip has brought a revolution in the field of diagnostics. Furthermore, preventive as well as personal care devices and home therapy devices are emerging and showing a very high growth rate and opportunities in entire spectrum of the market. Intelligent devices i.e. robotic devices for surgery and diagnosis are showing a potential to reshape the modern face of the healthcare sector. Tissue generated devices and site-specific drug delivery devices are being developed for more sophisticated healthcare delivery.

Table 1 illustrates the major technology happenings in APAC today.

As and when technology changes and new products come into the markets, a situation is created wherein newer types of services are to be brought into picture.

This change also leads to newer business models that are to be implemented by the market players. Apart from this new sets of competitors emerge and the need for exploring newer geographies also comes into place. Eventually these developments lead to changes or upgrades in the entire value chain or delivery. The bottom line is when there is technology available there is a reactive effectâ&#x20AC;&#x201D;direct or indirectâ&#x20AC;&#x201D;on various industry participants.

How are the various industry participants affected?

At the supplier side, the need arises to address rising costs of consolidating newer technologies, concentrate on large volumes of sales and set up plans for lowering the cost of manufacturing (e.g basic medicines / vaccines). As a result, contract manufacturing and other viable techniques come into picture. There have been tremendous changes in supply chain and logistics resulting in emergence of regional distribution centres to match raising volumes. At government level there are various newer regulations for medical devices coming into place, which Technology Developments in Medical Device Sector Top - 10 Medical device-based platforms for the next decade 1

Infection control devices / Wound care

2

Home / Self therapy devices

3

Total disc replacement

4

Robotic devices

5

Advanced In Vitro Diagnistics

6

Virtual reality

7

Intelligent / Automated devices

8

Electrical stimulation

9

Site specific drug delivery

10

Tissue generation devices Source: Frost & Sullivan

Table 1

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Technology, Equipment & Devices

Future Trends From

To

Fragmented

Business Model

Integrated & Automated

Invasive

Diagnosisi & Treatment

Less invasive, Preventative Image Based

Provider Centric

Focus

Patient Centric

Centralised - Hospital

Monitor

De-Centralsed - Shift to Community

One size fits all

Approach

Personalised Medicine

Therapuatics / Diagnistics / Devices

Tools

“Theranostics”

Treating sickness

Objective

Preventing sickness - “Wellness” Figure 1

Source: Frost & Sullivan

in-turn affects the business model at all the levels. Need for changes in geography of operation have emerged and newer alliances, mergers & acquisitions have become need of the hour. Newer techniques have also changed the research and development process of medical devices.

High-end medical device technology has lead to reduction of errors in diagnosis, thereby, improving the care delivery altogether. In other words, early diagnosis and targeted treatment regimes has saved countless lives. Wireless technology in devices has enabled ambulatory care delivery. Medical grade power system and 802.11 wireless allows for room-toroom movement without shutting down changed treatment process. Addressing vast demographics has been made possible by the growth of telemedicine. Again thanks to medical devices like portable ECG monitors equipped with ECG software and multi-parameter monitoring systems. Last but not the least, medical research and academic teaching techniques have also dramatically improved because of advent of technologies.

At the consumer level, introduction of devices i.e. virtual patient monitoring tools / home monitoring there is a whole lot of a concentration on preventive care.

Thereby over a period of time a preventive care mindset is forming within patient groups. It will not be long when various disease management programs would be

in place, wherein patients would have signed up and undergoing therapy. For example, diabetics will be able to monitor their blood glucose by self-monitoring devices and in turn keep their sugar levels in check. The result is change in treatment of the disease which has been brought due to such technology coming in place.

Modern healthcare system is on the horizon and experiencing a paradigm shift. Figure 1 captures the evolution in a nutshell.

Evaluating the impact of new innovation can be complicated. Because of the size of the health sector and its diversity (thousands of procedures, products, and interventions) and the fact that innovation in the healthcare sector occurs continuously also renders any direct measurement impractical. For example, a single technology or disease may show cost savings based on the costs and benefits of the new technology if it replaces a more expensive technology and provides health improvements, while an analysis of healthcare system-wide costs may show cost increases if the new technology results in greater utilisation than the old. Thereby while it is not possible to directly measure the impact of new medical technology on healthcare, the impacts of various changes interrelate and are inevitable.

References are available at http://www.asianhhm.com/magazine

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Technology and Patient Safety

Capturing the power of technology While healthcare is beneficial in the aggregate, it may also result in harm.

Information technology may be used in a variety of ways to improve the safety and efficiency of healthcare.

Shobha Phansalkar Instructor Medicine David W Bates Professor and Chief Division of General Medicine and Primary Care, Brigham and Women’s Hospital and Harvard Medical School USA

H

ealthcare Information Technology (HIT) forms a pivotal component of the American healthcare reform bill being proposed by the Obama administration.

HIT is being looked upon as a solution that can improve the quality of healthcare and patient safety, while at the same time reducing the costs associated with medical mistakes and the inefficiencies of a largely frag¬mented healthcare delivery system in the US. Many other nations have already made similar investments, especially in electronic health records in the outpatient setting, though hospital systems lag behind in most nations.

Some Asian countries already have widespread implementation of HIT in at least some sectors of their systems—notably Singapore, Hong Kong, South Korea and Taiwan—and others are also embarking on this path.

In the past decade, the field of HIT has experienced significant growth, but even more can be expected in the coming years. A multitude of technologies and solutions have paved their way to the patient’s bedside and in outpatient settings, with the promise of making care safer and more efficient. A few

innovative solutions remain key to leveraging the power of technology to improve patient safety.

Computerised Physician Order Entry (CPOE)

CPOE systems allow providers to electronically enter orders for therapeutic interventions such as medications, laboratory tests, and radiology orders.

CPOE systems are widely recognized as the single most powerful HIT intervention for improving medication safety.

Medication errors are the largest cause of hospital adverse events. Use of CPOE systems has reduced the serious medication error rate by 55 per cent and the overall medication error rate by 81 per cent in the inpatient setting. The Leapfrog Group-a coalition of the largest employers in the United States, estimates that by averting Adverse Drug Events (ADEs), CPOE systems could potentially lead to savings of US$ 2 billion every year in the US alone.

Despite studies that highlight the economic and the quality of care benefits, penetration of CPOE technology has been very slow in the US and in other nations. Adoption has largely been

To lower healthcare cost, cut medical errors and improve care, we’ll computerize the nation’s health record in five years, saving billions of dollars in healthcare costs and countless lives.

US President Barack Obama, 24 January 2009

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impeded by the high cost and complexity of these systems. Implementation of CPOE systems is not just a technological intervention; it has significant implications on the cultural and behavioural aspects of how medicine is practiced.

Adaptation for countries in which it has not previously been used has been especially tricky, in part because customisation is needed nearly everywhere. It is only recently that qualitative evaluations have revealed the impact of CPOE systems on behavioural changes such as perceived loss of autonomy and the shifting of power among clinical disciplines. With respect to the complexity, the domain of informatics is still struggling to define the core functionality needed in a CPOE system. This has lead to great variability in the definition of a CPOE system and limitations related to its evaluation.

As a minimum, CPOE systems allow physicians to enter orders electronically.

This produces legible orders that possibly contain all of the information needed to correctly dispense a medication thus reducing potential medication errors and decreasing pharmacy call-backs. However, the full benefit of CPOE systems can be realised only when they are integrated with other components of clinical information systems such as, pharmacy, radiology, laboratory and billing systems, and they are linked with Clinical Decision Support (CDS). The integration allows seamless flow of information from ordering applications into the relevant clinical application with minimal manual intervention. Providing CDS at the point–of-order entry is perhaps even more critical to realising benefit.

Standardising the definition of a CPOE system and addressing issues related to core functionality will help understand the value that these systems can provide. Rapid adoption can be enabled by a better understanding of the institutional strategies and resource consumption required for successful implementation in a variety of healthcare settings.

Computerised CDS

This innovation includes a wide variety of decision support capabilities that can be incorporated in an electronic medical record (EMR) both in the inpatient and outpatient setting. CDS can facilitate a variety of clinical functions, such as notification about critical test results, computerised ADE monitoring, etc.

Automated CDS systems vary depending on the level of sophistication, the nature of the CDS provided viz. interruptive or informational, the modality of the CDS viz. whether it is an alert or a reminder, and whether the information is provided in a synchronous

The full benefit of CPOE systems can be realised only when they are integrated with other components of clinical information systems such as, pharmacy, radiology, laboratory and billing systems, and they are linked with clinical decision support (CDS).

or asynchronous manner. Synchronous alerts are generated during the process of ordering while asynchronous alerting consists of delivering the information to the prescribing physicians as an email or another form of communication following the ordering process.

Depending on the level of sophistication, CPOE systems can provide basic or advanced decision support. Basic CDS includes the ability to provide default values for drug doses, routes, and frequencies. Advanced CDS provides the ability to perform a range of drug interaction checking, such as drug-allergy and drug-drug interactions. Medication decision support forms a large part of the CDS used in CPOE systems.

Kuperman, et al. provide a framework for defining the categories of basic and advanced decision-support. While a lot of focus in the literature has been paid to the content of CDS, little is known about the human factors aspect of generating alerts. Additionally, the dangers of over alerting and consequent ‘alert fatigue’ are now well- known but our knowledge of how best to fine tune alerts remains limited. Lack of standardisation hinders the implementation of a basic set of CDS rules that should be present in all EMR and CPOE systems. The National Health Service (NHS) in the UK has adopted an approach of clinical governance to provide more uniform CDS. The US is slowly adopting this approach of overseeing the certification and the availability of basic CDS across EMRs. These changes herald an era where HIT interventions will meet an international standard both to facilitate content sharing as well as to improve patient safety.

Bar-code technology

Bar-coding medications provides a safeguard to assure that the “five rights” of medication administration - right patient, right medication, right dose, right time, and right route of administration, are adequately confirmed. In case either of these constraints is not met the system visually alerts the nurse about the error.

Use of bar-coding technology forces a substantial modification on the workflow of nurses and pharmacists. While adequate training can ease the learning curve associated with correctly using the technical components, organisational culture needs to be addressed to successfully incorporate bar-code technology in the clinical workflow. Successful implementation of bar-coding at the bedside requires both technical and socio-technical investments. The technical capabilities needed are uncomplicated and include a wireless network infrastructure, mobile computing cart and a bar-code scanner.

The socio-technical capabilities needed are complex and include modification

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of organisational culture to improve communication, understanding human factors, and providing administrative and technical support. Without careful consideration of the workflow dangerous work-arounds could be developed which would undermine the utility of this technology.

While adequate training can ease the learning curve associated with correctly using the technical components, organisational culture needs to be addressed to successfully incorporate bar-code technology in the clinical workflow.

Smart pumps

Developing International standards on safety in health IT

A lot of work has gone into building HIT standards that can allow interoperable sharing of information across EMRs. Despite these efforts interoperability remains elusive. In the United States, the development of Regional Health Information Organisations (RHIOs) has been the approach that has been selected for facilitating the sharing of clinical information. The hope is that these regional organisations will grow into a network of national health

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information networks (NHIN) and ultimately these may be extensible globally.

In other nations, for example the United Kingdom and Singapore, much more central approaches have been taken. The central approach raises concerns about privacy and also has limitations in terms of semantic interoperability since it may be difficult to exchange data meaningfully unless all entities adopt the same data definitions. From a technological standpoint we need to define and adopt terminologies that allow us to communicate semantically equivalent concepts across institutions. This in turn would enable us to achieve the next step, which is the adoption of a standard set of CDS rules that can be globally implemented.

In order to make global implementation possible we need international buy-in to create a certification process and definition of a set of minimum functionalities

A uthors

These computerised pumps promote medication safety by alerting clinicians regarding programming errors when administering intravenous (IV) infusion medications. Infusion pumps can alert clinicians about a range of dangerous errors. Examples of advanced alerting capabilities incorporated in ‘smart’ pumps include, generating alerts when limits for total dose and minimum infusion time are exceeded, or the ability to calculate Body Surface Area (BSA) doses, especially for chemotherapy infusions, etc.

This is a fairly new technology that was introduced in 2001 and as compared to other HIT interventions has enjoyed a high rate of implementation. A 2009 American Society of Health-System Pharmacists (ASHP) medication safety survey revealed that while only 25 per cent of hospitals had bar-code technology almost 60 per cent had implemented smart infusion pumps. The high adoption rate is facilitated by the fact that hospitals receive incentives based on best practice measures and quality improvement by use of this technology.

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that an EHR system should meet. Core CDS needed in CIS may differ little from country to country and developing standard sets could make implementation of CIS more cost effective.

Development of international health information networks would be especially beneficial from a public health informatics perspective. The recent H1N1 influenza threat brings to light our difficulties in sharing information to assess global public health threats.

Development of large scale, real-time surveillance systems could enable event detection and monitoring of critical public health indicators. An epidemic such as the Severe Acute Respiratory Syndrome (SARS) outbreak in 2003 could be better managed by leveraging an international data sharing network.

Understanding the incentives that could drive global participation and arriving on commonly agreed terminologies and standards will facilitate meaningful information exchange.

The time is ripe for HIT to bring about a change in the way medicine is practiced globally. Understanding the multi-faceted nature of HIT interventions can help us be better prepared for accepting the organisational changes that they can bring about. The next era of HIT should focus on defining the governance models to facilitate long term global EHR adoption.

References are available at http://www.asianhhm.com/magazine

Shobha Phansalkar is a clinical informaticist at Partners Healthcare and an Instructor in Medicine at Brigham and Women’s Hospital and Harvard Medical School. Her research interests are in the design, implementation and evaluation of clinical information systems. Key research topics include medication decision support, patient safety, and electronic prescribing.

David W Bates is Chief, Division of General Medicine, Brigham and Women’s Hospital and Medical Director of Clinical and Quality Analysis for Partner’s Healthcare Systems. He is a Professor of Medicine at Harvard Medical School and Professor of Health Policy and Management at the Harvard School of Public Health.

Information Technology

SOA for Healthcare Promises and pitfalls To realise the benefits of Service-Oriented Architecture (SOA) adoption, including costefficiency, adaptability, leverage of legacy systems, and the business agility required to meet new healthcare needs, healthcare organisations must adopt a realistic strategy, establish effective SOA governance processes, perform contextual evaluations of technologies, and recognise that SOA requires a different mind-set.

Dennis B Smith Lead System of Systems Practice Initiative Grace A Lewis Lead System of Systems Engineering Team Software Engineering Institute Carnegie Mellon University, USA

F

or some time, national governments and the healthcare industry have pursued the development of effective health information systems. Just recently in the US, the Obama administration pledged, “…the immediate investments necessary to ensure that within five years, all of America’s medical records are computerised” [Obama, 2009]. However, so far the widespread adoption of health information systems has been elusive.

This slow pace can be attributed to a number of factors, including a historic lack of funding, challenges in achieving regulatory compliance, fragmentation in the healthcare industry, strongly hierarchical decision-making within organisations, extensive needs for security and difficulty in reaching consensus on shared data.

Constraining factors like these point out that the healthcare industry has a number of unique business needs, such as a unique set of business processes and data, a heavy regulatory environment and different sets of stakeholders with often conflicting needs and goals. However, the industry also confronts a set of IT problems common to many industries, such as defining and modelling essential business information and business rules; storing and accessing information in support of business processes; and assuring the security, performance, availability and usability of IT systems. One promising systems development and implementation approach, Service Oriented Architecture (SOA), can enable business agility, leverage of legacy investments, adaptability and cost-efficiency all of which support the goal of developing effective health information systems.

Basic SOA concepts

SOA is a way of designing, developing, deploying and managing systems, in which reusable business functionality is made available in the form of services, and the services can be reused by a number of different applications. This reuse is enabled by a SOA infrastructure that supports discovery, composition and invocation of services through a set of common protocols and standards [Lewis, 2008b].

A service-oriented system has three major components: services, service consumers and SOA infrastructure.

• Services are reusable components that represent business tasks, such as patient lookup, medical test order, insurance lookup, or patient history lookup.

Services can be globally distributed across organisations and can support a number of business processes • Service Consumers use the functionality provided by the services. Some examples of service consumers are end-user applications, portals, and internal and external systems • A SOA Infrastructure connects service consumers to services through an agreed upon communication model. It often contains elements to support service discovery, security, data transformation, and other operations.

Figure 1 illustrates the relationship between these major types of components.

Avoiding the traps of common misconceptions

Currently SOA is the best option available for achieving the interoperability, agility and reuse goals that are common to many healthcare organisations. However, in some cases expectations have far exceeded

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High-level representation of a service-oriented system Patient Portal

Insurance Company System

Research and Public Health System

Outpatient System

Inpatient System

Service Consumer X

Service Consumers

SOA Infrastructure Infrastructure Get Patient Info

Get Physician Info

Get Test Info

Create Lab Test Order

Service Y Service Interfaces

Patient Record System

Physician Record System

Laboratory System

System X

Service Implementaion Figure 1

the reality. This section outlines several common misconceptions, as well as advice on how to avoid falling into common traps [Lewis, 2007a].

SOA provides the complete architecture for a system

SOA is an approach to systems development and not a complete well-crafted architecture. In addition SOA cannot be bought off the shelf. For example, if an organisation acquires an Enterprise Service Bus (ESB) or any other middleware product, the organisation has simply acquired an SOA infrastructure. A set of engineering decisions need to be made to realise the concrete remaining elements and interactions that make up the complete architecture of the system, in such a way that meets the qualities that stakeholders expect of the system.

All legacy systems can automatically be integrated into a SOA environment

Migrating legacy systems to SOA environments is neither automatic nor easy.

The organisation needs to conduct an upfront and hands-on analysis of technical feasibility and cost-benefit for each individual system to answer questions, such as: • Is it technically feasible to expose capabilities of the legacy system as services?

• How much would it cost?

• Is this cost plus the cost of maintaining the legacy system greater than the cost of replacing it with a new one?

• What changes will have to be made to the legacy system?

• How much will these changes affect current legacy system users and other production systems?

The use of standards guarantees interoperability

True interoperability can only be achieved with agreement at both the syntactic and semantic levels. Interoperability exists at the syntactic level where there is agreement on the representation of data, such as test order codes represented as 5-digit numbers or patient temperature represented as a number with two decimal places. Semantic interoperability requires agreement on the meaning of the exchanged data. An example, an instrument reports temperature in Fahrenheit. The receiving system receives a number with two decimal places, which is syntactically correct. However, the system assumes that the temperature is in Celsius and interprets it as such,

potentially leading to a situation for a patient that could be severe and even life threatening.

The most common approach to SOA implementation is that of Web services, which relies on widespread, stable standards that include HTTP, SOAP, XML and WSDL. Unfortunately, this fact has contributed to the misconception that standards guarantee interoperability. While there is standardisation at the basic levels to support syntactic interoperability, in Web Services there are over 250 standards to support other qualities such as system security and availability and many of them are unstable, immature, incomplete and even conflicting. Web Services do not guarantee semantic interoperability; there has to be a careful selection of appropriate standards, as well as tools, to support other levels of interoperability [Lewis, 2008a].

SOA is all about technology

It is tempting to assume that specific types of technologies or tools will provide the answer to a healthcare organisation’s IT problems. However, SOA adoption also entails changes to the organisation’s IT governance model—the set of rules and regulations under which an IT department operates, and the mechanisms to ensure compliance with those rules and regulations. SOA implementations need to address system life cycle issues, such as processes and rules for • service requirements and definition • service development, composition and testing • service evolution and change management It also needs to identify and enforce other mechanisms, such as service registry

Pillars of SOA adoption Strategic alignment Successful SOA Adoption Strategic Alignment

SOA Governance

Technology Evaluation

Change of Mindset

SOA Principles Figure 2

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Advertorial

Information Technology

mental development and deployment of components of the service-oriented system

Service-Oriented systems require a different development approach Traditional systems development

Service-oriented systems development

Tight coupling between system components Loose coupling between service consumers and services Semantics shared explicitly at design time

Semantics shared without much communication between service consumers and service providers

Known set of users and usage patterns

Potentially unknown service users and usage patterns

System components owned by the same organisation

Systems components potentially owned by multiple organisations Table 1

management, definition and collection of metrics, runtime monitoring mechanisms, enterprise-wide policies, and service-level agreements between service consumers and service providers.

• effective SOA governance • contextual evaluation of relevant technologies • recognition that SOA adoption requires a change of mindset

Developing applications based on services is easy

Strategic alignment

A complete service-oriented system is composed of services, service consumers and an SOA infrastructure. In an organisation with a well-managed registry that contains highly reusable services, building applications is relatively easy. However, there may not have been much thought put into the definition of services or service requirements or the possibility that services can be owned by different organisations.

For application development to be easy, service providers need to design services that meet the right Quality of Service (QoS) requirements in areas such as security, performance, usability and availability.

Service providers also need to anticipate potential consumers and usage patterns.

If they build services that nobody uses, they are simply wasting time and money.

Service consumers need to have the right tools available, to easily find services at the appropriate level of granularity for their needs, and hopefully not have to deal with major data and process mismatched between the services used.

Pillars for successful SOA-based systems development

Successful SOA adoption requires attention to four pillars as illustrated in Figure 2.

[Lewis, 2007b]. These pillars are: • strategic alignment with business goals

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Strategic alignment means that a successful SOA strategy needs to be aligned with business goals. Different business needs can require different SOA strategies. For example, a business goal of increasing information available to patients may lead to developing intuitive portals or creating services related to patient information. On the other hand, a business goal of integrating with new healthcare partners may lead to activities for back-office integration, interoperability between different types of software and hardware, and identification of common business rules.

A successful SOA strategy includes • relationship to critical business goals • alignment with organisational enterprise architecture and current and future IT infrastructure • realistic choices of technologies and infrastructures • plan that supports realistic and incre-

SOA governance

Governance is often considered the main inhibitor of SOA adoption [InfoWorld, 2007]. SOA governance is the set of policies, rules and enforcement mechanisms for developing, using and evolving service-oriented systems, and for analysis of their business value. It includes policies and procedures, roles and responsibilities, design-time governance and runtime governance [Afshar, 2007; Brown, 2006; Marks, 2008].

Design-time governance includes elements such as rules for strategic identification of services, development, and deployment of services; reuse; and legacy system migration. It also enforces consistency in use of standards, SOA infrastructure, and processes. Runtime governance develops and enforces rules to ensure that services are executed only in ways that are legal and that important runtime data is logged. From a life-cycle point-of-view, design-time governance applies to early activities such as planning, architecture, design, and development.

Runtime governance applies to deployment and management of service-oriented systems.

Technology evaluation

Because a SOA implementation may use a number of technologies in novel contexts, it is important to evaluate whether a specific set of technologies is appropriate for the task at hand. One way to determine the fitness of a specific technology for a specific need is to perform a handson contextual evaluation through methods

Healthcare has a good starting point for SOA adoption Health Level 7 (HL7) and Object Management Group (OMG) jointly sponsored The Healthcare Services Specification Project which developed “The Practical Guide for SOA in Healthcare” [HSSP 2008]. It provides guidance on SOA adoption in a healthcare setting by • identifying core SOA principles • developing a business case for SOA • providing guidance on steps for SOA implementation

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Information Technology

such as T-Checks [Lewis, 2005]. The TCheck approach formulates hypotheses about the technology and examines these hypotheses against very specific criteria.

These criteria are defined taking into consideration the expectations placed on the technology by the organisation as well as expected usage patterns. By conducting focussed, extremely simple experiments, it is possible to validating specific technology claims, early in the life cycle and at very low cost.

Conclusions

SOA adoption has the potential of providing real value for healthcare organisations to realise benefits such as cost-efficiency, adaptability, leverage of legacy systems, and the business agility required to meet new healthcare needs. However, the benefits of SOA adoption, although real, are not automatic. Organisations need to align business strategy and SOA strategy, establish effective SOA

Service-oriented systems require a different development approach to deals with characteristics of service-oriented systems.

Some of the contrasts between serviceoriented systems and traditional systems are presented in Table 1.

These differences affect the way software is developed throughout its life cycle and impact requirements, architecture and design, development and system testing activities.

A uthors

Change of Mindset

governance processes, and perform contextual technology evaluation of technologies of choice for their SOA implementations to realise these benefits. Most importantly, organisations need to recognise that SOA adoption requires a change of mindset that needs to be reflected in the full life cycle of service-oriented systems.

References are available at http://www.asianhhm.com/magazine

Dennis Smithâ&#x20AC;&#x2122;s current work focuses on principles, methods and technologies that enhance the effectiveness of complex systems of systems. It has specifically emphasized SOA strategy and adoption as well as the development of an SOA research agenda.

Grace Lewisâ&#x20AC;&#x2122; current work and publications are in service-oriented architecture (SOA), technologies for systems interoperability, software development life cycle activities in systems of systems environments, and establishing a SOA research agenda.

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Hospital of

Tomorrow

Technology leads the way in Asia Hospitals of the 21st century will have state-of-theart communication capabilities which will not only speed us along the path to recovery, but also ensure that our personal health records will remain, as they should do.

Gerard Anthony Dass Healthcare Solution Leader Nortel Asia, Australia

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nnovative technologies are constantly improving the quality of healthcare by ensuring improvements to the speed and reliability of information— critical to saving lives.

IT spending is driven by several factors, the most immediate being the need for organisations to upgrade their healthcare services to meet international standards.

There are two goals here—a more efficient system and better quality patient care. It is efficiency gaining and life saving combined.

It also makes good business sense.

Medical tourism in Thailand now attracts over one million patients per year, with earnings for 2008 forecast at around US$ 1.2 billion. A conservative estimate for the Asia region—primarily Thailand, India, Malaysia and Singapore—suggests combined revenues of over US$ 5 billion by 2010. With all of these countries vying for the prized position as a regional ‘healthcare hub’, the incentive to implement the latest technologies has never been keener.

Most leading international healthcare providers are taking steps to install the latest technologies to help them stake their claim to the lion’s share of this lucrative and expanding market.

The leading players in Thailand’s private healthcare sector, like their

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counterparts across the region, are rushing to implement unified communication systems, ensuring patient information is available upon request, regardless of location. Already, many local medical practitioners rely on a range of wireless communication devices such as mobile PDAs to make bedside care decisions more quickly. These devices also allow them to connect with doctors or specialists in other locations for an immediate consultation, or quickly access information from a facility’s digital files without losing valuable time with the patient.

Doctors can now share medical imaging files with distant colleagues for an immediate second opinion or receive real-time alerts, wherever they are, the moment a patient’s condition worsens or needs their attention.

Hospitals of the 21st century will ensure that our personal health records will remain, as they should do, a matter of patient / doctor confidentiality.

Information Technology

all a patient’s information. This is an excellent example of how technology can improve quality healthcare services and patients’ quality of life by simplifying the complexity for medical providers to access and share information.

With such fingertip access to information, security is an understandable concern. So, what measures have firms implemented to ensure patient confidentiality?

There are solutions that give approved users access via the ‘officeon-a-stick’, a specially-formatted USB key that automates business network

A uthor

There is a strong drive to modernise installing systems that allow medical practitioners to do more, faster and with fewer errors. For example, new technology now allows hospitals to mobilize clinicians and staff, unify multimedia communications and make the most of standardized digital health records— enabling healthcare practitioners to take better care of their patients.

While much of this new technology may seem somewhat futuristic for many of us, there are existing networks that have already revolutionised the practices of the organisations in which they have been installed.

Kyushu University Hospital in Japan upgraded its current IT system to a new medical service infrastructure to enable information to be more efficiently stored, managed, retrieved and shared amongst physicians and medical staff. Next-generation networks provide anywhere, anytime, quick access to

access when inserted and protects information and applications by completely removing them when the USB key is removed. This solution combines hardware, software and services to provide simple, secure network access.

It is comforting to know that the hospitals of the 21 st century will have state-of-the-art communication capabilities which will not only speed us along the path to recovery, but also ensure that our personal health records will remain, as they should do, a matter of patient / doctor confidentiality.

Gerard Anthony Dass is Healthcare Solutions Leader for Nortel Asia. At Nortel, Gerard is responsible for driving sales and customer relationships within the healthcare industry in Asia. Prior to working at Nortel, Gerard was senior technology manager for Cerner Asia where he managed technology projects in Asia. Gerard received a Masters degree in Computer Sciences from Sheffield Hallam University and a PhD in Computer Forensics from the University of Melbourne.

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Clinical Transformation Future of health IT at Marshfield Clinic With a 40+ year history of clinical computing, Marshfield Clinic is rethinking the role and function of Information Systems. New tools and approaches will reshape the way medicine is practiced setting the stage for Marshfield Clinic to be successful in the new, evolving world of healthcare in the US. Robert A Carlson Chief Information Officer Marshfield Clinic, USA

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stablished in 1916, Marshfield Clinic (Figure 1) serves a predominately rural area covering close to 30,000 square miles of central and northern Wisconsin. Over 40 outpatient campuses and a half dozen affiliated hospitals share a common electronic medical record (EHR) serving a patient population of over 1 million individuals.

With 40+ years of clinical computing and over a decade of having the EHR as the legal medical record, the computer is a well established tool in the practice of medicine at Marshfield. Even with this advanced fully implanted EHR, however, Marshfield Clinic is rethinking the role and function of Information Systems.

New tools and approaches will reshape the way medicine is practiced in the evolving world of healthcare in the US. Changing demographics and declining reimbursement are key drivers for this change. The growing number of elderly in the general population will put tremendous pressure on healthcare providers to develop more cost-effective treatment of chronic diseases. Information technology plays an important role in meeting these challenges.

The time when the job of Information Systems was simply taking care of the mainframe in the basement has quickly evolved into a complex department that touches all aspects of medicine. Marshfield Clinic’s Information

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Systems Division now oversees three broad domains at Marshfield: infrastructure, knowledge management and analytics.

Infrastructure

This rapidly growing area covers everything from phone systems to PACS archives. Managing a broadband network that covers 30,000 square miles of rural Wisconsin is no small task. Demands on availability, storage, security and backup are constant pressures. Implementing a completely chartless environment significantly increased the demands and expectations on availability and response time. Any system down of greater than just a few hours quickly escalates into significant workflow problems. It requires 24-hours a day, 7 days a week support structure that can quickly respond to correct any issue that may arise. The reliance on the EHR also requires important new investments to be made to support the critical role of electronic information in patient care. This past spring, the Clinic opened a new secondary data centre in Madison, Wisconsin, and this fall will begin construction on a new primary data centre in Marshfield, both of which are Tier III. Knowledge management

‘Record’ implies documentation of past events. Certainly one of the important

CaseStudy

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functions of the EHR is documentation.

However, with the implementation of tablet computers that can easily be carried into exam rooms, new opportunities are now available. Patient education (Figure 2) with access to current information is now readily available at the point of patient interaction. Decision support is available at the critical time needed.

Checking for drug-drug interactions, allergies and contraindications are important safeguards that provide alerts before mistakes are made. The EHR is now a portal into knowledge sources to support the practice of medicine and informa-

tion for patients. Many of these knowledge sources are third-party products.

Managing updates, links, licenses and alert dialogues within and between these products is an important task. Making information available is important but unless the right information can be quickly and easily identified, it is easy to overwhelm providers and render the information unreachable and therefore useless. Information overload is a growing problem that EHRs must address.

Practice guidelines, reimbursement requirements, coding, PQRI and others bring a level of complexity that require

EHRs to bring relevant information to the forefront and not buried within large databases requiring significant effort to find. Perhaps a more appropriate name for the electronic health record is electronic health assistant.

Related, and equally important, is being aware of the impact on workflow and productivity. Documentation requirements, coding and various other required forms can quickly bring the most productive provider to a grinding halt. Efforts to understanding process flow, roles, information sources, and optimising work flow prior to implementing yet another documentation form requires direct involvement from information systems far beyond the traditional walls of an IS department.

Automating a bad or broken process provides little help.

Analytics

As the amount of digital health information grows, the opportunity to evaluate and mine information for best practices, new disease associations and other information requires yet another important role for the EHR-data input for the data warehouse. The shortcomings of a standard EHR quickly become apparent. Lack of standards, limited coded information, poor consistency and accuracy limit the usefulness of data mining. Promoting standards, codification of information, and striving for accurate and consistent diagnostic criteria provide yet another important opportunity for Information Systems to engage in supporting the practice of medicine. Marshfield Clinic will establish a new Center for Healthcare Intelligence that brings together resources within the data warehouse. Tools used in traditional business analytics applied to medical information will provide new insight into better ways to provide healthcare more effectively and efficiently.

Three years ago, Marshfield Clinic decided to commercialise its in house developed EHR. Forged in the fires of an active group practice of medicine, this EHR, called CattailsMD, was created

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Promoting standards, codification of information, and striving for accurate and consistent diagnostic criteria provide yet another important opportunity for Information Systems to engage in supporting the practice of medicine.

A uthor

to the emergency department and subsequent hospitalisation. The need to intervene and prevent events that require more expensive interaction requires a change in the way health systems interact. The new model will be more like an air traffic control tower monitoring health trajectories. Moving from a reactive acute care model to a more proactive one will require significant reworking of existing practice patterns. Asia, with its rich history of holistic medicine, may find such change much less of a leap and be able to incorporate these new tools and approaches with greater speed and success.

CaseStudy

in an environment where the daily challenges of medical practice were always at the forefront. This relationship continues today and as Marshfield Clinic looks to the immediate future, its experience and resources within information systems will play an important role in reshaping medical practice. To meet these challenges, those involved in information technology will need to engage and embrace areas beyond the traditional walls of information systems.

Traditionally, medical practice in the US can be likened to a repair shop.

Things break and you go in to get it fixed.

This often results in expensive hospitalisations that could have been avoided if the risks could have been identified earlier.

Detecting weight gain in a patient with known congestive heart failure while the patient is still home could have provided an opportunity to adjust medication and avoid the more complicated, expensive care provided when the patient presents

Robert A Carlson is a graduate of the University of Wisconsin Medical School and is a Diplomate of The American Board of Pathology in anatomic and clinical pathology. He has been with Marshfield Clinic since 1987 and is currently Director of Applied Sciences and Chief Information Officer.

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Healthcare

IT Spending Effects of a changing global economy

W

ith the economy caught-up in recession, many Care Delivery Organisations (CDOs) these days are in cutâ&#x20AC;&#x201D;down mode. Although the healthcare industry till now has not suffered directly from the current economic slowdown, future revenue and funding curtailments will definitely cause a shift in the spending patterns in the domain of Healthcare Information Technology (HIT). Furthermore, likely reduction in

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Information Technology

A prolonged or deeper economic slowdown will inevitably be met by further reductions in IT capital and operating budgets, so, even those health IT initiatives that have a demonstrated ROI could become difficult to fund. The IT services and solution providers have to prepare themselves and develop some quick strategies to respond to the changed client behaviour and market conditions in healthcare expected in 2009 and 2010.

secondary revenue sources like clinical trials will lead to reduction in capital in the healthcare delivery organisations.

Although countries such as Australia and Singapore, where the healthcare is primarily publicly funded, will be considerably sheltered from the worst of the economic turmoil, overall the healthcare providers’ spending may face internal pressures to divert funds away from IT departments and toward care delivery. But looking on the brighter side—given how deep-rooted IT has become in today’s healthcare set-up and how little of IT budgets are discretionary— only new, large-scale projects with long-term paybacks are expected to be in risk.

Rajiv Varyani

Program Manager Frost & Sullivan Healthcare Asia Pacific Singapore

Who is going to buy what?

The overall HIT market for Asia Pacific region in 2008 was around US$ 4.7 billion, which is expected to rise by around 3-4 per cent this year. Despite the rapid growth in IT spending enjoyed by healthcare providers during the past three years, it is expected to undergo a remarkable change in spending patterns especially varying among the types of buyers.

The Government and publicly funded hospitals are expected to keep healthcare funding stable during the present economic phase.

The shared services model would gain popularity as it is a universally accepted cost controlling technique.

The IT budgets in these hospitals

would have to compete with other budgets such as operational, care delivery etc. IT budgets are expected to rise in organisations where IT has become an indispensable part and elsewhere they are expected to remain flat.

Private hospitals and other related CDOs are most sensitive to such cash and credit flow fluctuations. A freeze in spending, halt on all large and new initiatives, facility expansions and acquisitions would be expected as a result of such developments. But, once the cash flow becomes more visible, it is likely that systems and solutions with a short term return to investment would be approved over large longterm projects.

Promising

Not so promising

• Application Support • Outsourcing of Services (Revenue Cycle Management,Medical Coding etc.)

• Large Enterprise Resource Planning Systems and solutions requiring lengthy implementation duration

• Custom Application Development

• Other Clinical Information Systems

• Virtualisation

• Data centers

• Standardisation Initiatives (ICD10, SNOMED etc.)

• Hardware requiring huge capital investments

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On demand service offerings

CIOâ&#x20AC;&#x2122;s expected response to financial crisis

More oversight on charity / uncompensated care More aggressive negotiation with payers Increases in changes Selective layoffs due to utilization reductions Delaying health IT initiatives or lengthening timeframes for completion Delaying equipment purchases Delaying facility faulty upgrade investment or lengthening timeframes for completion Reductions in specific departments budgets Across the board cuts Source: Frost & Sullivan

0% 10% 20% 30% 40% 50% 60% 70% 80% Figure 1

As far as other smaller healthcare delivery set-ups such as physician practices, clinics and nursing homes are concerned, IT spending in this sector is anticipated to remain low with flat growth expectations.

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Certain leading HIT organisations conducted a survey with the CIOs of leading healthcare institutions to establish this change in spending trends. The analysis is as depicted in figure 1.

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Considering that the economic downturn could affect the entire region, not all the solutions of IT product and service offerings will be uniformly affected.

While some categories remain successful and perform above par, others may not perform well. The strong offerings display quick RoI, short term value and visibility in terms of quick problem solving capabilities. The weak technology areas display trends such as long term RoI, complexity, huge investment and underrated services. Overall the healthcare providers will heavily scrutinise any investment happening in this space. The listing below provides details of solutions that show promise and are expected to mark the industry in 2009.

Need for a revised strategy

It is expected that such a trend of low

Information Technology

ProductShowcase

market movement would run through 2010. Asia Pacific market is considered next in line after the US market in terms of growth and prospects and holds wider opportunities for healthcare IT and related services. Irrespective of varied growth rates, projected vendors are expected to be wary of the market dynamics and thereby generate revenue.

The key aspects that need to be definitely considered and are likely to influence sales are: • New offerings that have long term deployment cycles are expected to face long sales cycle or outright refusal.

The initiatives that are likely to gain approval would either be derived from a previously demonstrated benefit or will address some mandatory compliance parameter • The solutions offering a better time-tovalue benefit will be preferred over long term return on investment project • Sales cycles during these challenging times are expected to increase drastically, maybe to/by 1 to 2 years. The projects that are able to justify a very short return on investment are most likely to sell. These aspects should be kept in mind for all customer communications and sales pitches

• Proposing innovative solution delivery and maintenance models that would enable sincere cost cutting to prospective clients. Offshore development centres, near-shore development centres etc. are to name a few such models.

Moving forward

A prolonged or deeper economic slowdown will inevitably be met by further reductions in IT capital and operating budgets, so, even those health IT initiatives that have a demonstrated ROI could become difficult to fund. Summing up the various factors contributing to the market dynamics are as depicted below: Drivers

• Constant Government funding and Medical Insurance subscriptions • Healthcare delivery has not taken any direct hit i.e. patients are getting to CDO’s and data generation from HIS, EMR’s is non-stop • Definite need for compliance to universal standards i.e. HL7, HIPAA, ICD etc.

• Proven improvements in clinical aspects of CDO through IT enablement

• Need for efficient back office functioning like human resources, material management for cost reductions • Ageing population which needs continuous care demand IT in healthcare • Constant growth in Medical Tourism.

Restraints

• Many healthcare IT projects take long time to complete and there is no immediate ROI • Access to capital is expected to reduce – donations from private and charitable institutions are likely to lessen • Tighter and more expensive credit facilities today make investment further difficult.

• Bad debts are anticipated to increase Overall, the IT services and solution providers have to prepare themselves and develop some quick strategies to respond to the changed client behaviour and market conditions in healthcare expected in 2009 and 2010.

References are available at http://www.asianhhm.com/magazine

DRIVEN BY CUSTOMERS’ INSIGHTS, SATISTFACTION AND EXPECTATIONS Based in Bangalore, Hospaccx India has over 300 customers spread all over Southern and Western India. With just about 5 years in the industry Hospaccx has also built a large network of business associates in other zonal and regional markets. Hospaccx has made its presence felt in all segments of the healthcare industry ranging from diagnostic centres to large hospitals. The company is rooted in a strong professional value system. Some of the products highlighted here are hospital cubicle curtains, the IV stands and design of a hospital ward layout. Hospaccx India is driven by “Customer Insights, Satisfaction and Expectations.

Hospaccx India specialises in offering the latest high quality hospital equipment. The products of Hospaccx are specifically designed according to customer requirements. Hospaccx not only provides the strongest and most durable products, it also makes sure the customers’ requests for maintenance are taken care of without any further cost.

Hospaccx India derives support from customer feedback and referrals which contribute to 90 percent of its sales.

# 6, Chaithanya Complex, Site # 1, 17th Cross, Sir M.V. Nagar, T.C. Palya Main Road, Bangalore, India Mob: 098452-08778/ 099028-61413 E-mail: manish_rastogii@rediffmail.com Website: www.hospaccxindia.com

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Products&Services

Classifieds

Company

Page No.

Diagnostics Hitachi Medical Systems (S) Pte Ltd...................................... IBC2 Magna-Tek Enterprises.............................................................57 NDS Surgical Imaging..............................................................58 Orbitz Exhibitions Pvt. Ltd...................................................55, 61 Healthcare Management Acuity Information Systems Private Limited..........................OBC3 Ahlstrom Corporation...............................................................25 Binary Spectrum .....................................................................10 Orbitz Exhibitions Pvt. Ltd...................................................55, 61 Xeralife ...................................................................................11 Information Technology Acuity Information Systems Private Limited..........................OBC3 Binary Spectrum .....................................................................10 Elekta Limited .......................................................................IFC1 Sains ......................................................................................75 SEED Healthcare Solutions Pvt. Ltd..........................................69

Magna-Tek Enterprises, #97, S.V.C Industrial Estate, Balanagar, Hyderabad - 37, AP, India.

Ph: +91-40-65501094, 66668036 Fax: +91-40-66668037 Email: magnatek-ent@usa.net, magnatek@gmail.com Web: www.magnatekenterprises.com

Surgical Speciality NDS Surgical Imaging..............................................................58 Technology, Equipment & Devices Hitachi Medical Systems (S) Pte Ltd...................................... IBC2 Magna-Tek Enterprises.............................................................57 NDS Surgical Imaging..............................................................58 Philips.....................................................................................05

SuppliersGuide

Magnatek manufactures world class C arm compatible OT table for Neurosurgery, Cardio thoracic, Pediatric, Orthopedics, Urology, Obesity and Fluoroscopy tables for Angiography / ERCP. Specialized features available like extra low height, table top slide, zero auto leveling, dual override control and wide range of specialized attachments to make surgeries more convenient, precise and time saving. Magnatek manufactures Bariatric table called Obesomatic which can take a load capacity of 350 Kgs., a specialized automatic table for Bariatric procedures. Our clientele includes prestigious hospitals like Apollo group, Columbia Asia, Care & Manipal hospitals and several prestigious medical colleges. â&#x20AC;&#x153;We also have imported operation theatre lights, pendants, anaesthesia work stations & dialysis chairsâ&#x20AC;?

Medical Sciences Elekta Limited .......................................................................IFC1

Company

Page No.

Acuity Information Systems Private Limited..........................OBC3 www.acutysoft.com Ahlstrom Corporation...............................................................25 www.ahlstrom.com Binary Spectrum .....................................................................21 www.binaryspectrum.com Elekta Limited .......................................................................IFC1 www.elekta.com Hitachi Medical Systems (S) Pte Ltd . ................................... IBC2 www.hitachi-medical.com.sg Magna-Tek Enterprises.............................................................57 www.magnatekenterprises.com NDS Surgical Imaging .............................................................58 www.ndssi.com

Rx Professions Clinical Research Academy is offering Long-term and short-term courses in Clinical Research, Data Management, Trials, SAS, Pharmacovigilance, etc in affiliation with Drexel Medical University and SOCRA, USA.

Orbitz Exhibitions Pvt. Ltd...................................................55, 61 www.meditec-clinika.com Philips ....................................................................................05 www.philips.com Sains ......................................................................................75 www.sains.com.my SEED Healthcare Solutions Pvt. Ltd..........................................69 www.seedhealthcare.com Xeralife ...................................................................................11 www.xeralife.com

#1106, 11th Floor, Babukhan Estate, Basheerbagh, Hyderabad-01, India Phone: 91 40-40118186 / 32428185 Cell: 91- 9866608038 / 9392659959 Email: rx.clinical.research@gmail.com Web: www.rxprofessions.com

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To receive more information on products & services advertised in this issue, please fill up the "Info Request Form" provided with the magazine and fax it, or fill it online at www.asianhhm.com by clicking "Request Client Info" link.

1.IFC: Inside Front Cover 2.IBC: Inside Back Cover 3.OBC: Outside Back Cover

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