The April 2013 Digital Edition of General Surgery News by McMahon Group

Convention Issue:

SAGES & ASCRS

April 2013 • Volume 40 • Number 4

GeneralSurgeryNews.com

The Independent Monthly Newspaper for the General Surgeon

Opinion

Can Hospital-Owned Practices Survive in The Long Run?

Study Rekindles Debate Over Bariatric Centers of Excellence No Difference in Outcomes With CoE Designation; Researchers Say Policy May Hinder Access; Others Poke Holes in Study

B y A rthur G ale , MD

B y C hristina F rangou

[Editor’s note: The following article was published in Missouri Medicine, January/ February 2013 issue, page 21.]

octors are becoming hospital employees. Private practice, which has been the dominant way physicians have practiced since the country was founded, may be a thing of the past. Doctors are closing their offices for the simple reason that

Increasing health care costs may give private practice the upper hand.

he debate over bariatric The report, published in the Feb. centers of excellence (CoE) pro- 27 issue of the Journal of the Amerigrams is ramping up once again with can Medical Association, submits that the publication of a study that calls on perioperative complications and reopthe Centers for Medicare erations fell over the last O R F E T N E C & Medicaid decade but not because of IATRIC CE N BAR E L L E Services(CMS) the CMS policy EXC to reconsid(309:792-799). er its policy of “We could restricting covernot attribute age to designatany outcome ed centers.

hospitals give them a hefty signing bonus for the first year or two, and the government and insurance companies reimburse them at higher levels as hospital employees than they can obtain in private practice. Hospitals buy doctors’ practices in order to lock in referral sources for inpatient

see Bariatric page 16

Laparoscopy: The Controversial Beginnings of a Surgical Revolution

see Private Practice page 32

B y V ictoria S tern

REPORT ®

Teflaro (ceftaroline fosamil) for the Treatment of Acute Bacterial Skin and Skin Structure Infections Caused by Designated Susceptible Bacteria See insert at page 8

he emergence of laparoscopy and laparoscopic technologies has represented one of the most essential paradigm shifts in the practice of surgery. Surgical practice has witnessed the introduction of the aseptic technique, general anesthesia and antibiotics, all of which

decreased patients’ pain and the rate of infection during surgery. “There are milestones in the progress of modern surgery that cannot be denied,” said Robert Sewell, MD, a general surgeon at the Master Center for Minimally Invasive Surgery,

INSIDE Tumor Board

Experts Discuss: Is Lap Distal Pancreatectomy ‘Gold Standard’ for Pancreatic Cancer?

In the News

Clinical Review

In the News

Opinion

Molecular Subtyping of Colorectal Cancer Shows Early Promise

Incidence of ARDS Declining in Trauma

Systemic Strategies for Reducing Blood Loss in Surgery

‘Bitter Pill’ Should Be A Wake-Up Call

see Laparoscopic Beginnings page 8

Hospitals Battle Surge in Superbugs Klebsiella Takes the Lead B y K aren B lum

ospital clinicians face several challenges in helping manage antibiotic-resistant, gram-negative superbugs that produce carbapenemases. One of the most worrisome is Klebsiella pneumoniae (KPC). A report in the March issue of Infection Control and Hospital Epidemiology (2013;34:259268) found that the proportion of K. pneumoniae cases resistant to carbapenems increased from 0.1% in 2001 to 4.5% in 2010. “That is huge,” said Robert Rapp, PharmD, professor of pharmacy and surgery emeritus at the University of Kentucky Medical Center in Lexington, one of many pharmacists concerned about KPC. Those concerns were compounded by the Centers for Disease Control and Prevention’s own report on the rising prevalence of carbapenem-resistant enterobacteriaceae (CRE). According to the

see Superbugs page 28

Procedural Breakthrough Innovations in Fully Wristed Vessel Sealers for Robotic Surgery see page 10

New Product

see page 38

GeneralSurgeryNews.com / General Surgery News / April 2013

GSN Editorial

The ‘Sunshine Act’ and You Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

s a feature of the Affordable Care Act (ACA), the Centers for Medicare & Medicaid Services (CMS) announced the final rendition of the Physician Payments Sunshine Act on Feb. 1. This portion of the ACA establishes a legal mandate and mechanism for physicians, group purchasing organizations and teaching hospitals to be reported when an economic benefit—$10 or greater—is provided from applicable manufacturers of pharmaceuticals, biologics and medical devices. These transactions will be collected beginning Aug. 1, 2013 and will be posted on a CMS public website beginning Sept. 30, 2014. Although there is no mandatory reporting by physicians, it would seem prudent that we all must be aware that acceptance of monetary or in-kind items makes us vulnerable for public listing. It is obvious that the busy academic or private practice surgeon may overlook minor gifts, honoraria or consulting fees. Because our information (name, address, license number and specialty) will be posted on a public website, it should at least be listed for correct reasons. Fortunately, the Sunshine

Act allows a 45-day opportunity to resolve any disputes relating to improper reporting to physicians by the offering entity. After this “corrective period,” information becomes publicly available in cyberspace. It is obvious that every surgeon reading this column has been and will be the potential recipient of some monetary or in-kind award of $10 or greater from some company. For many of us, consultation and speaking fees, research grants, meeting support, books, videos etc., exceed the $10 minimum by significant amounts. All of us will need to look periodically at the CMS site and at these dollar values to assure that reporting is both correct and appropriate on this public site after Sept. 30, 2014. This is particularly important for any surgeon who has a financial interest in a pharmaceutical or device manufacturer or group purchasing organization. My message to all is to keep your own records so that any need to justify inaccurate reporting or conflicting information can be corrected. No doubt this will be a burden, and will potentially widen the gap between our manufacturing colleagues and us. I have always been a proponent of open access to drug and device representatives. Because of my experience in academic surgery and resident teaching, I have consistently recommended to pharmaceutical and device companies that “inkind” giving be considered in the form of books, videos and other educational tools. It is still unclear to me even

Joseph J. Pietrafitta, MD Minneapolis, MN General Surgery, Laparoscopy, Colon and Rectal Surgery, Laser Surgery

Senior Medical Adviser Frederick L. Greene, MD

Charlotte, NC General Surgery, Laparoscopy, Surgical Oncology

Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN General Surgery, Laparoscopy, Surgical Oncology, Ultrasound, Endoscopy

Kay Ball, RN, CNOR, FAAN Lewis Center, OH Nursing

Philip S. Barie, MD, MBA New York, NY Critical Care/Trauma, Surgical Infection

L.D. Britt, MD, MPH Norfolk, VA General Surgery, Trauma/Critical Care

David Earle, MD Springfield, MA General Surgery, Laparoscopy

James Forrest Calland, MD Philadelphia, PA General Surgery, Trauma Surgery

Edward Felix, MD Fresno, CA General Surgery, Laparoscopy

Robert J. Fitzgibbons Jr., MD Omaha, NE General Surgery, Laparoscopy, Surgical Oncology

David R. Flum, MD, MPH Seattle, WA General Surgery, Outcomes Research

Michael Goldfarb, MD

Leo A. Gordon, MD Los Angeles, CA General Surgery, Laparoscopy, Surgical Education

Gary Hoffman, MD Los Angeles, CA Colorectal Surgery

Namir Katkhouda, MD Los Angeles, CA Laparoscopy

James O’Neill

Paul Alan Wetter, MD Miami, FL Ob/Gyn, Laparoscopy

Peter K. Kim, MD

Kevin Horty Group Publication Editor (khorty@mcmahonmed.com)

Maureen Sullivan Associate Editor (msullivan@mcmahonmed.com)

Rochester, NY General Surgery, Laparoscopy, Surgical Oncology, Laser Surgery, New Technology

James Prudden

John Maa, MD

Robin B. Weisberg Manager, Editorial Services

Gerald Marks, MD

Associate Copy Chief

Elizabeth Zhong

Wynnewood, PA Colon and Rectal Surgery, Colonoscopy

J. Barry McKernan, MD Marietta, GA Laparoscopy

Joseph B. Petelin, MD Shawnee Mission, KS Laparoscopy

Richard Peterson, MD San Antonio, TX General Surgery, Bariatric Surgery

Long Branch, NJ Laparoscopy, Telemedicine

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after reading the Sunshine Act whether the teaching institution, the trainees or I would be considered the prime recipients. Although surgical residents are frequently targeted by medical companies offering material benefits, it does not appear that trainees will be publically reported. As we go forward, we need to be aware that any relationship, even minor, will be made public and potentially scrutinized. My hope is that this type of government activity will not adversely affect the positive relationship that has existed for decades between surgeons and device makers, but I would be naive to assume this conclusion. I also wonder who or what agencies will keep close scrutiny on this reported information. I do know that when September 2014 rolls around and data become publicly reported, part of our responsibility will be to ask companies if what we receive will be reported and then to keep a careful eye on the CMS website.

Mission Statement It is the mission of General Surgery News to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.

Disclaimer Opinions and statements published in General Surgery News are those of the individual author or speaker and do not necessarily represent the views of the editorial advisory board, editorial staff or reporters.

All U.S. general surgeons, colorectal surgeons, vascular surgeons, surgical oncologists and trauma/critical care surgeons should receive General Surgery News free of charge. If you are changing your address or name, you must notify the AMA at (800) 262-3211 or the AOA (if appropriate) at (800) 621-1773 to continue receiving GSN. You need not be a member; however, they maintain the ultimate source of our mailing addresses. If you are not a general surgeon or other specialist listed above and would like to subscribe, please send a check payable to General Surgery News. Please allow 8-12 weeks for the first issue. Subscription: $70 per year (outside U.S.A., $90). Single copies, $7 (outside U.S.A., $10). Send checks and queries to: Circulation Coordinator, General Surgery News, 545 West 45th Street, 8th Floor, New York, NY 10036. Fax: (212) 664-1242.

INFECTIOUS DISEASE SPECIAL EDITION

Tumor Board

The

GeneralSurgeryNews.com / General Surgery News / April 2013

Tumor Board

Pancreatic Cancer: Is Laparoscopic Distal Pancreatectomy the New ‘Gold Standard’? The Tumor Board This column aims to present readers with challenging cases and/or provide alternative treatment options related to oncology and surgical oncology that are both timely and worthy of discussion. In addition to my commentary, the cases and/or alternative treatment options will be presented to other experts in related fields for “second opinions” regarding evaluation and treatment. This issue focuses on laparoscopy for distal pancreatectomy. I am very honored to have R. Matthew Walsh, MD, chairman of the Department of General Surgery at Cleveland Clinic Foundation in Cleveland, Ohio, participate in this issue by providing an expert “second opinion.” I hope readers enjoy the column and benefit from the timely discussions and multiple opinions presented as they relate to oncologic challenges and alternative—and sometimes controversial—treatments. The focus is on discussion and I hope to hear from readers with their opinions and comments on topics presented in each

column. I also greatly welcome and encourage suggestions or case submissions for future issues. Enjoy! Conrad Simpfendorfer, MD Editor, The Tumor Board Hepato-pancreato-biliary and Transplant Surgeon Cleveland Clinic Weston, Florida

CASE PRESENTATION Case 1

66-year-old woman presents with a mass in the tail of the pancreas, discovered during evaluation for changes in bowel movement. Computed tomography (CT) scan reports a 2.6-cm hypodense lesion in the tail of the pancreas (Figure 1). A follow-up magnetic resonance imaging (MRI) scan reports a 3×2.3-cm heterogeneous mass in the tail of the pancreas. There is no evidence of distant metastasis. An endoscopic ultrasound (EUS) reported a 3.5-cm heterogeneous mass in the distal body of the pancreas. The mass abuts the splenic artery and vein. Fine-needle aspiration (FNA) of the mass reported a cystic neoplasm with papillary architecture. Carcinoembryonic antigen (CA) 19-9 level is greater than 3 U/mL.

Figure 1

Case 2

n 84-year-old man presents with a mass in the tail of the pancreas, discovered during evaluation for abdominal pain. CT scan reports a 5.2-cm complex mass in the tail of the pancreas (Figure 2). The mass is reported to have cystic and solid components. No evidence of distant metastasis is noted. The patient denies any history of pancreatitis. CA 19-9 level is 84 U/mL.

Figure 2

Send questions or comments to: khorty@mcmahonmed.com.

GeneralSurgeryNews.com / General Surgery News / April 2013

Tumor Board

Dr. Simpfendorfer’s Commentary

Case Challenge

How would you treat these two patients?

would advocate treating these patients based on the presumed pathology. The first patient would appear to have an asymptomatic lesion, and the description of the EUS findings is difficult to interpret. The MRI is not presented, and the CT is of poor quality on one image. I am suspicious that the lesion is a serous cystadenoma that can appear incidentally as a “mass lesion” because the size of the cysts may be quite small. The other major diagnostic consideration would be a solid pseudopapillary neoplasm. I would review the imaging and FNA result, including cytology, in more depth before determining the exact approach. The second patient is more concerning for a pancreatic neoplasm. The description of pain is nonspecific, and I would question the patient more closely on the symptoms, which in general can help guide the workup. The presence of a mass component is an indication for resection, and for this patient, I would advise a distal pancreatectomy with splenectomy.

Would you perform open or laparoscopic pancreatectomy?

he operative approach should be guided by disease extent and presumed diagnosis, as well as surgeon experience. It is unclear whether the patient in the first case requires resection, but the patient in the second case should have a distal pancreatectomy with splenectomy, both due to the location of the lesion and presumed carcinoma diagnosis. He is a suitable candidate for a laparoscopic resection provided the surgeon has adequate experience. This patient appears to be quite thin and some of the advantages of a minimally invasive approach may not be realized.

Resection of pancreatic body with automatic suturing device

Is tissue diagnosis necessary before a planned surgery?

he patient in the first case has already undergone FNA, which should be reviewed for the cytologic features. “Papillary architecture” is an uncharacteristic cytologic feature that would need to be reviewed with an experienced pancreatic cytopathologist. The patient presented in the second case has radiographic features of a mass component, which would be an independent indication for resection.

Expert Opinion by R. Matthew Walsh, MD

dvances in instrument technology and surgeon experience have made laparoscopic surgery the standard technique for several abdominal surgical procedures. Minimally invasive surgery for the pancreas has been undertaken with more caution. Recently, laparoscopic distal pancreatectomy (LDP) has gained popularity. Studies comparing open distal pancreatectomy (OPD) and LDP have reported advantages with minimally invasive surgery, including reduced postoperative pain, faster recovery, decreased wound complications, less intraoperative blood loss and fewer postoperative complications.1,2 A meta-analysis comparing LDP with OPD concluded that lower blood loss and reduced hospital length of stay were associated with the laparoscopic approach. LDP also was associated with a lower risk for overall postoperative complications and wound infection.3 A multicenter analysis comparing LDP with OPD for the treatment of adenocarcinoma of the pancreas reported similar short- and long-term oncologic outcomes between the two groups, suggesting that LDP is an acceptable approach for resection of pancreatic ductal carcinoma of the left pancreas.4 Chair, General Surgery Cleveland Clinic Cleveland, OH

• Invasive moderately differentiated adenocarcinoma of the fundus of the gallbladder, 2.7 cm in greatest dimension, infiltrating the entire thickness of the gallbladder wall and involving the surrounding soft tissue • Focal perineural invasion is identified • No definitive evidence of vascular invasion • Cystic duct margin of resection is free of invasive carcinoma • Cystic duct margin of resection is involved by highly dysplastic epithelium • Cholelithiasis

‘Second Opinion’: R. Matthew Walsh

67-year-old man had elective cholecystectomy with intraoperative cholangiogram for an episode of gallstone pancreatitis; during surgery a thickened area was noted at the fundus that resembled impacted stones. The patient denied fever, chills, jaundice or significant weight loss. He had no significant past medical or surgical history. All preoperative labs were normal, as was chest x-ray. Surgery was performed uneventfully and the patient was discharged home the next day. The pathology report returned four days later reported:

• Benign cystic duct lymph node

What would you do?

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References 1. Belli G, Fantni C, D’Agostino A, et al. Laparoscopic and open surgical treatment of left-sided pancreatic lesions: clinical outcomes and cost-effectiveness analysis. Surg Endosc. 2012;26:1830-1836. 2. Kooby D, Kneuertz P, Patel S, et al. Laparoscopic distal pancreatectomy: trends and lessons learned through an 11-year experience. J Am Coll Surg. 2012;215:167-176. 3. Wolfgang C, Venkat R, Edil B, et al. Laparoscopic distal pancreatectomy is associated with significantly less overall morbidity compared to the open technique: a systematic review and meta-analysis. Ann Surg. 2012;255:1048-1059. 4. Kooby D, Hawkins W, Schmidt C, et al. A multicenter analysis of distal pancreatectomy for adenocarcinoma: is laparoscopic resection appropriate? J Am Coll Surg. 2010;210:779-787.

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In the News

GeneralSurgeryNews.com / General Surgery News / April 2013

Molecular Subtyping ‘Symbolic of New Age of Cancer Care’ B y C aroline H elwick San Francisco—Two studies presented at the 2013 American Society of Clinical Oncology Gastrointestinal Cancers Symposium demonstrated a role for molecular classification of tumor cells in the prognosis and treatment of patients with colorectal cancer (CRC). “We have developed a diagnostic, single-sample predictor that allows the

classification of CRC tumors of different intrinsic molecular subtypes,” said Josep Tabernero, MD, PhD, director of Vall d’Hebron Institute of Oncology in Barcelona, Spain, and lead investigator of one of the studies. “These subtypes could be clinically relevant as they differ in their underlying biology and clinical outcomes, and consequently require different treatment strategies.” Molecular classification systems could be most helpful in managing patients

with stage II CRC who have a variable risk for relapse that is hard to predict with current clinical and pathologic methods. The goal of subtyping is not only to identify patients who need aggressive treatment, but also to pair the right patient with the right drug.

Patterns of Gene Expression Dr. Tabernero and his team used gene expression data taken from 188 patients with CRC (stages I-IV) to develop the

classification system, which they subsequently validated in 543 patients with CRC (stages II-III). Three distinct molecular patterns were identified: 21.5% of samples were categorized as subtype A (32 genes), 62% as subtype B (53 genes) and 16.5% as subtype C (102 genes). These subtypes differed according to three biological hallmarks of colorectal tumors: epithelial-to-mesenchymal transition (associated with aggressive tumors); deficiency in mismatch repair genes (associated with genetic alterations); and the rate of cellular proliferation—features that are known to independently affect outcomes, said Dr. Tabernero. “The subtypes were significantly associated with prognosis and significantly correlated with benefit from adjuvant 5-FU-based treatment,” Dr. Tabernero said. Patients with subtype A had a good prognosis, regardless of whether chemotherapy was given: 10-year survival rates were approximately 65% without chemotherapy and 80% with chemotherapy (P=0.183). Patients with subtype B had a pronounced benefit from chemotherapy, with 10-year survival rates of approximately 55% without chemotherapy versus 80% with chemotherapy (P=0.014). Patients with subtype C, in contrast, derived no benefit from adjuvant chemotherapy, with 10-year survival rates of approximately 65% without chemotherapy and 50% with chemotherapy (P=0.542). The five-year overall survival difference between types A and B, versus type C, was statistically significant (P=0.0166). The findings suggest that patients with subtypes A and B would be treated differently: Subtype A patients would probably not require chemotherapy; subtype B patients would receive chemotherapy; and subtype C patients would require a more aggressive and perhaps novel treatment. The study researchers plan to evaluate these subtypes in patients who have received more current regimens, especially oxaliplatin.

Signaling Pathway Deregulation Another study, presented by Joshua M. Uronis, PhD, found that deregulation of oncogenic signaling pathways can be used as a powerful tool in the classification of patients with CRC into molecular subgroups. The researchers, including David Hsu, MD, PhD, of the Duke Institute for Genome Sciences and Policy, Durham, N.C., have developed a preliminary set of biomarkers that are prognostic, predictive of treatment response and applicable to patients who have undergone resection for primary or metastatic tumors.

GeneralSurgeryNews.com / General Surgery News / April 2013

‘The subtypes were significantly associated with prognosis and significantly correlated with benefit from adjuvant 5-FU-based treatment.’ —Josep Tabernero, MD, PhD Dr. Uronis and his colleagues examined microarray data, based on the activity of 19 oncogenic pathways, from 850 patients with primary CRC and generated patterns of pathway deregulation for each patient’s tumor. A molecular profile of CRC was created that identified six molecular subgroups of CRC and showed that patients in each subgroup differed significantly in their risk for CRC recurrence. For example, although recurrence-free survival approached 100% for subgroup 4, it fell to about 40% for subgroup 3 (P=0.0004). The model was then applied to a data set of 133 tumor samples, of which 94 patients presented with metastatic disease and 34 with primary lesions. Again, the subgroups exhibited differences in recurrence-free survival rates (P=0.046), according to Dr. Uronis. Additionally, researchers translated the unique patterns of pathway deregulation into gene expression signatures that were used to measure the probability of pathway activation in a panel of cell lines. With this approach, the model also was predictive of response to various drugs. “We observed that molecular subgroups of CRC demonstrated differential sensitivity to specific targeted agents, such as molecular subgroup of CRC 1, 2 and 3 to inhibition of HER2 by lapatinib, and inhibition of the epidermal growth factor receptor by erlotinib [P<0.05],” Dr. Uronis said. “From this, we gather that we can make basic predictions using pathway signatures.” The study was validated using a murine model of drug sensitivity that used patient-derived CRC explants implanted into mice. This model showed that subgroups with high mammalian target of rapamycin (mTOR) activity were highly sensitive to mTOR inhibitors and those with low mTOR expression were found to be resistant to these drugs. Researchers deduced that the combination of a genomic-based molecular profile of CRC and their preclinical murine model using patient-derived CRC explants can be used to develop a clinically relevant prognostic and predictive biomarker of CRC. “There has been considerable interest in determining whether molecular alterations in primary CRC are more accurate prognostic indicators than a tumor’s pathologic stage, which is what is currently used,” noted William M. Grady, MD, associate professor of medicine and chief

In the News

of the gastroenterology section at the University of Washington Medical Center, Seattle. “[The researchers] have used a unique approach to identify molecular alterations that are predictive of recurrent cancer, not only for non-metastatic disease but also for metastatic disease,” Dr. Grady said of the study by Dr. Uronis. “If these results can be validated, these molecular alteration patterns have the potential to be used as markers to identify which patients should receive aggressive care after surgical resection of both primary and metastatic colorectal cancer and to direct the

specific chemotherapeutic agents they should receive,” he said. “The work by Uronis et al is critical for CRC care advancement, and symbolic of the new age of cancer care in general,” said Jennifer Tseng, MD, chief of surgical oncology and co-clinical director for surgery at Beth Israel Deaconess Medical Center, and associate professor at Harvard Medical School, both in Boston. “For example, we as surgeons can surgically remove tumors to the best of our oncologic ability, and enable our partners, the pathologists, to stage the tumors and help determine the best treatment; however,

currently, there are serious limitations. “At the extremes, there is less controversy,” she continued. “There, there is no question that chemotherapy does not (for stage I) or does (for stage III or IV) help the patient, overall. But the vast majority of patients fall into those shades of gray, stage II especially, where we are weighing potentially toxic chemotherapy risks and benefits versus disease recurrence risks and benefits. This type of study helps point us to personalizing cancer care for the individual tumor, and thus the individual patient,” Dr. Tseng concluded.

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ZĞĨĞƌĞŶĐĞƐ͗ ;ϭͿ ŽŽůĞǇ͕ t͘ ĂŶĚ WĂƌŬĞƌ͕ :͘ ͞hŶĚĞƌƐƚĂŶĚŝŶŐ ƚŚĞ DĞĐŚĂŶŝƐŵƐ ƌĞĂƟŶŐ &ĂůƐĞ WŽƐŝƟǀĞ >ƵŵƉĞĐƚŽŵǇ DĂƌŐŝŶƐ͘͟ American Journal of Surgery ϭϵϬ ;ϮϬϬϱͿ͗ ϲϬϲͲϲϬϴ͘ ;ϮͿ ƌŝƩŽŶ͕ W͘ ͖͘ ^ŽŶŽĚĂ͕ >͘/͖͘ zĂŵĂŵŽƚŽ͕ ͘<͖͘ <ŽŽ͕ ͖͘ ^ŽŚ͕ ͖͘ ĂŶĚ 'ŽƵĚ͕ ͘ ͞ ƌĞĂƐƚ ^ƵƌŐŝĐĂů ^ƉĞĐŝŵĞŶ ZĂĚŝŽŐƌĂƉŚƐ͗ ,Žǁ ZĞůŝĂďůĞ ƌĞ dŚĞǇ͍͟ European Journal of Radiology ϳϵ ;ϮϬϭϭͿ͗ ϮϰϱͲϮϰϵ͘ ;ϯͿ DŽůŝŶĂ͕ D͘ ͖͘ ^ŶĞůů͕ ^͖͘ &ƌĂŶĐĞƐĐŚŝ͕ ͖͘ :ŽƌĚĂ͕ D͖͘ 'ŽŵĞǌ͕ ͖͘ DŽīĂƚ͕ &͘>͖͘ WŽǁĞůů͕ :͖͘ ĂŶĚ ǀŝƐĂƌ͕ ͘ ͞ ƌĞĂƐƚ ^ƉĞĐŝŵĞŶ KƌŝĞŶƚĂƟŽŶ͘͟ Annals of Surgical Oncology ϭϲ ;ϮϬϬϵͿ͗ ϮϴϱͲϮϴϴ͘ ;ϰͿ DĐ ĂŚŝůů͕ >͘ ͖͘ ^ŝŶŐůĞ͕ Z͘D͖͘ ŝĞůůŽ ŽǁůĞƐ͕ ͘:͖͘ &ĞŝŐĞůƐŽŶ͕ ,͘^͖͘ :ĂŵĞƐ͕ d͘ ͖͘ ĂƌŶĞǇ͕ d͖͘ ŶŐĞů͕ :͘D͖͘ ĂŶĚ KŶŝƟůŽ͕ ͘ ͘ ͞sĂƌŝĂďŝůŝƚǇ ŝŶ ZĞĞǆĐŝƐŝŽŶ &ŽůůŽǁŝŶŐ ƌĞĂƐƚ ŽŶƐĞƌǀĂƟŽŶ ^ƵƌŐĞƌǇ͘͟ :ŽƵƌŶĂů ŽĨ ƚŚĞ ŵĞƌŝĐĂŶ DĞĚŝĐĂů ƐƐŽĐŝĂƟŽŶ ϯϬϳ͘ϱ ;ϮϬϭϮͿ͗ ϰϲϳͲϰϳϱ͘ Ξ ϮϬϭϯ sĞĐƚŽƌ ^ƵƌŐŝĐĂů >>

ŶŶŽƵŶĐŝŶŐ ŽƵƌ EĞǁ tĞďƐŝƚĞ ǁǁǁ͘ǀĞĐƚŽƌƐƵƌŐŝĐĂů͘ĐŽŵ

Stitches Laparoscopic Beginnings continued from page 1

in Southlake, Texas. When laparoscopy—a minimally invasive approach to surgery—emerged, patients experienced less pain and potentially fewer complications after surgery. “This event rivaled the others in terms of benefits to patients,” Dr. Sewell said. Over the next several months, General Surgery News will explore the historical landmarks in laparoscopy—from the first-ever procedure attempted on a dog, to today’s experience with single-incision laparoscopy and natural orifice transluminal endoscopic surgery—including interviews with some of the pioneers who helped shape the minimally invasive approach to surgery.

Start of a Transformation On Sept. 23, 1901, Georg Kelling, MD, a surgeon and gastroenterologist, performed a laparoscopy on a live dog in front of an audience at the 73rd Congress of the Naturalist Scientist’s Medical Conference, in Hamburg, Germany. He named the procedure ‘coelioscopy’ (also spelled coelioskopie or koelioscopie). “Kelling was the first to establish modern laparoscopy as a field by synthesizing existing technologies to form the trio of features that still defines the procedure today: an abdominal approach, at least two entry ports and artificial insufflation,” wrote gynecological surgeon Camran Nezhat, MD, FACS, FACOG, in his 2011 book, Nezhat’s History of Endoscopy: A Historical Analysis of Endoscopy’s Ascension since Antiquity’ (Endo Press). Born in Dresden, Germany, on July 7, 1866, Dr. Kelling began his medical education when he was 18 years old, at the Universities of Leipzig and Berlin. In the summer of 1898, he went to the Royal Surgical Clinic in Breslau, where he learned his endoscopic skills from several well-known surgeons. He learned how to perform oral gastrointestinal insufflations—pumping gas into the abdomen to generate enough pressure to create a space between the stomach and small intestine—a skill that would become essential during his first laparoscopic procedure. Dr. Kelling earned a doctorate in 1890, with a specialty in gastric and intestinal disease. Six years later, he opened a practice in Dresden, Germany. Although a surgeon by profession, he became intrigued by the idea of nonsurgical treatments and wanted to address the problem of gastrointestinal bleeding. Hemorrhaging into the abdomen proved fatal for patients, but many never

GeneralSurgeryNews.com / General Surgery News / April 2013

showed the telltale signs, such as the presence of blood in vomit. At that time, the only conclusive way to diagnose or treat the condition was through laparotomy. However, Dr. Kelling believed that trying to address the problem by opening the abdomen could put the patient in greater danger. Dr. Kelling devised a nonsurgical approach to diagnosing and treating intraabdominal bleeding safely. He wrote: “I asked myself, how do the organs react to the introduction of air? To find out, I devised a method of using an endoscope on an unopened abdominal cavity” (Münch Med Wochenschr 1901;48:1480-1483,1535-1538). His instincts proved correct. More recent research shows that making a larger incision impairs an individual’s immunity, said J. Barry McKernan, MD, PhD, the surgeon credited with performing the first laparoscopic cholecystectomy in the United States. By 1901, Dr. Kelling had found a safe way to view the abdomen using insufflation and determined that creating a pressure of 50 mm Hg alleviated bleeding into the abdomen, a technique he called ‘Luft-tamponade’ (air tamponade) (Figure 1). He also recognized the risk for injurFigure 1. Apparatus for creating Luft-tamponade. ing internal organs by incorrectly placing a trocar and found the best Copyright © 1997 by the Society of Laparoendoscopic Surgeons. http://www.ncbi.nlm.nih.gov/pmc/articles/ angle of entry was 45 degrees. During Dr. Kelling’s demon- PMC3015224/figure/F5/ stration of a laparoscopy using a live dog as a subject, he made an incision through which he insert- a dog is as cheerful as it was before [the ed a Nitze-Leiter cystoscope to magni- procedure]” (Münch Med Wochenschr fy and view the inside of the abdomen. 1901;48:1480-1483,1535-1538). The Nitze-Leiter cystoscope, first used Laparoscopy, however, was not Dr. in 1872, created illumination through Kelling’s main interest, and he initially an electrically heated platinum wire did not publish his work on coelioscopy that allowed Dr. Kelling to see the inte- (Zeitschr Biol 1903;44:161-258). rior of the abdomen through telescopic Nine years after Dr. Kelling perlenses. He then created a second inci- formed laparoscopy on dogs, Hans sion, placing a trocar in the abdomen Christian Jacobaeus, MD, a Swedish to insufflate the cavity with air, which internist, performed clinical laparoscopallowed a better visual. This event ic surgery on a human—an electrical marked the first laparoscopic endeav- worker who had been diagnosed with or. The dog survived the procedure. hepatic cirrhosis (Münch Med WochenAfter performing coelioscopy on 20 schr 1910;57:2090-2092). Unlike Dr. dogs, Dr. Kelling deemed the procedure Kelling, Dr. Jacobaeus did not use insufsafe, noting that “after an examination, flation. Although not much is known

‘Operating rooms [literally] exploded and patients died because people didn’t realize oxygen was flammable. Patients also died from air embolism because initially no one realized that too much pressure during insufflation could cause serious complications.’ —Camran Nezhat, MD

In 1970, after Dr. Semm had introduced laparoscopic surgery to the University of Kiel, in Germany, his colleagues made him have a brain scan to check for brain damage. about how Dr. Jacobaeus got involved in laparoscopic surgery, in 1912 he published a monograph describing the 97 laparoscopies he had performed between 1910 and 1912, in Stockholm’s community hospital (Beitr Klin Tuberk 1912;25:185-354). He observed that all of his patients, except one, improved after undergoing the procedure. Despite these events, which physician performed the first laparoscopic procedure in a human remains somewhat ambiguous. Dr. Jacobaeus often is credited with this accomplishment; he was certainly the first to perform a large series of laparoscopic procedures in human patients and the first to broadcast his experience, but Dr. Kelling claimed he had done two such procedures in humans before Dr. Jacobaeus. Having read about Dr. Jacobaeus’ laparoscopic procedures, Dr. Kelling tried to defend his crown and wrote to journal editors with a detailed account of his work in humans (Nezhat C. Endo Press; 2011). By 1923, Dr. Kelling had published a history of his clinical experience over two decades. In the 50 to 60 years that followed the first laparoscopic procedure in humans, early pioneers of laparoscopy experimented with the technique, but it did not make much headway in the general surgery community until the 1970s and 1980s. “The work of Dr. Jacobaeus sparked some interest in laparoscopy around the world. Progress was occurring, but in small pockets and in small measures,” said Dr. Nezhat, president of the Association of the Adjunct Clinical Faculty, Stanford University Medical School, and adjunct clinical professor of surgery and gynecology at Stanford University, in California. Dr. Nezhat pointed to the discovery that carbon dioxide was better than oxygen or air for insufflation. “Operating rooms [literally] exploded and patients died because people didn’t realize oxygen was flammable. Patients also died from air embolism because initially no one realized that too much pressure during insufflation could cause serious complications,” he said. “All of these [issues] took decades to discover and were, unfortunately for the patient,

GeneralSurgeryNews.com / General Surgery News / April 2013

completed a laparoscopic appendectomy. Although Dr. Semm often is credited with being the first physician to perform a laparoscopic appendectomy, a surgeon in The Netherlands, Henk de Kok, MD, performed a laparoscopic appendectomy three years earlier (Arch Chir Neerl 1977;29:195-198). “Dr. de Kok did the Georg Kelling, MD (1866-1945) Hans Christian Jacobaeus, MD Kurt Semm, MD (1927-2003) first laparoscopic appen(1879-1937) dectomy,” Dr. Nezhat said. “And contrary to often only learned by trial and error.” Courtenay Clarke, MD, already had reports, he did not perform a mini lapaAdditionally, the surgery itself was developed a method for laparoscopic rotomy.” Dr. de Kok used a laparoscope difficult for innovators and researchers. extracorporeal knot tying, and had pub- to identify and mobilize the appendix and “Laparoscopy was a ‘one-man band,’” lished and patented his technique—the removed it through a 1-cm incision, Dr. said Dr. Nezhat. “Surgeons had to look extracorporeal knot-pusher—before Dr. Nezhat recalled. In fact, he had done 320 through the eyepiece of the laparoscope Semm (Fertil Steril 1972;23:274). Dr. laparoscopic appendectomies by 1980, [holding it in one hand] and do the pro- Semm may have learned of Dr. Clarke’s but he downplayed his accomplishment cedure with their free hand. That’s why technique during his stay in the United because the medical establishment conthere was minimal progress.” States, and had the idea to adopt it as a tinued to be wary of laparoscopy. It was Dr. Semm who publicized the disposable extracorporeal knot-pusher on Gaining Traction technique, and much of the surgical comthe plane ride home to Germany. A German gynecologist, Kurt Semm, Soon after, Dr. Semm was able to pass ‘Dr. Semm was the father of MD, then appeared on the scene. Born on a knot into the abdomen through a 5 mm March 23, 1927, in Munich, Dr. Semm trocar. “After the loop became routine, I operative gynecology. He attended Ludwig Maximilians Universi- thought to myself that I could do everywas so ahead of everyone ty School of Medicine and received his thing in a different way,” Dr. Semm said degree in 1951, with a specialty in obstet- in the interview (JSLS 1998;2:309-313). else at that time.’ rics and gynecology. He became fasci- Extracorporeal knotting soon became —Barry McKernan, MD nated with laparoscopy and explored the common practice in the Women’s Univertechnique for almost 20 years before per- sity Clinic in Kiel, Germany, and “from forming a laparoscopic appendectomy. there, it went step by step: the intracor- munity in Germany persecuted Dr. Semm However, by the 1960s, laparoscopy poreal knot, the microsuture,” Dr. Semm for his work. Some surgeons asked for had earned a bad reputation in Germany. recalled. him to be suspended from medicine and It was associated with high complication In the Feb. 1, 1980, issue of The Medi- many thought his actions to be unethical. rates, in part because surgeons were burn- cal Tribune, Dr. Semm was asked: “When “People accused him of being crazy,” Dr. ing patients during laparoscopic proce- will the first appendix or gallbladder dis- Nezhat recalled. dures, so the technique was banned there appear into an endoscope?” Eight months At the 2002 meeting of the Society for temporarily. later, on Sept. 13, Dr. Semm successfully Laparoendoscopic Surgeons, where Dr. “I started in 1963 with surgical [pelviscopy], now called laparoscopy, and everybody—the whole world—was against me,” Dr. Semm recalled in an interview with James Daniell, MD, at the 1999 International Society of Gynecological Endocrinology conference in Montreal. The ban was lifted in 1964. By the late 1970s, Dr. Semm was performing a range of laparoscopic procedures, including myomectomy, ovariectomy, tubal ligation and ovarian cyst resection, and had helped to create new technologies such as the electronic insufflator (Figure 2). In an interview with journalist Grzegorz Litynski, Dr. Semm described how he devised a way to suture during laparoscopic surgery. Dr. Semm recalled being on a plane traveling from the United States to Germany, when he thought of a way to create a knot outside the abdomen and transfer it inside. This account Figure 2. Semm’s electronic insufflator. Copyright © 1998 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. may not be completely accurate. Anothhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3015306/figure/F2/ er gynecologist from Buffalo, N.Y., H.

Stitches Semm was being honored, a former student, Liselotte Mettler, MD, relayed several anecdotes describing the disdain he encountered for his work during the 1970s and 1980s. Dr. Mettler, now professor emeritus in the Department of Obstetrics and Gynecology, University Hospitals of Schleswig-Holstein, Kiel, revealed that in 1970, after Dr. Semm had introduced laparoscopic surgery to the University of Kiel, his colleagues made him have a brain scan to check for brain damage. She also recalled that during a slide presentation Dr. Semm was giving on ovarian cysts, an audience member unplugged the projector, saying the surgery was unethical and should not be presented (JSLS 2003;7:185-188). Despite the intense criticism, Dr. Semm pressed onward. After his paper on laparoscopic appendectomy was rejected by the American Journal of Obstetrics and Gynecology because the editors deemed the procedure “unethical,” Dr. Semm found a home for his work in the journal Endoscopy (1983;15:59-64). In the 1980s, Dr. Nezhat was performing complex procedures, including laparoscopic treatments for severe endometriosis (Fertil Steril 1986;45:778-783), and in 1985, German surgeon Erich Muhe, who had seen Dr. Semm’s technique, performed the first laparoscopic cholecystectomy. “If you can treat severe endometriosis [using a] laparoscope, you can do practically anything laparoscopically,” Dr. Nezhat noted. For almost a decade, Dr. Nezhat also had been working to popularize video laparoscopic techniques. Although he encountered resistance, video laparoscopy eventually was recognized as an important paradigm shift in surgery. “It was the video laparoscope that made it possible to operate with two hands, look on the monitor and engage the whole operating room,” Dr. Nezhat said. “That is why these procedures become so advanced after video laparoscopic appendectomies.” In 1988, Dr. Semm traveled to Baltimore to present a video of his laparoscopic appendectomy. When Dr. McKernan heard about this, he also traveled to Baltimore to view it. “Dr. Semm’s procedure was on a horrible 8-mm film, but the second I watched it, I could see it involved basic surgical principles,” he recalled. Intrigued, Dr. McKernan returned home to Marietta, Ga., to work on laparoscopy, and shortly after, he performed the first laparoscopic cholecystectomy in the United States. “Dr. Semm was the father of operative gynecology,” Dr. McKernan said. “He was so ahead of everyone else at that time.” The next column in this series: The First Laparoscopic Cholecystectomy

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Innovations in Fully Wristed Vessel Sealers for Robotic Surgery Anthony Gonzalez, MD Chief of Surgery and Minimally Invasive and Robotic Surgery Baptist Hospital Medical Director, Weight-loss Surgery Program South Miami Hospital Miami, Florida

Craig S. Johnson, MD, FACS, FASCRS Colorectal Surgeon Oklahoma Surgical Hospital Tulsa, Oklahoma

Jorge A. Lagares-Garcia, MD, FACS, FASCRS Chief, Division of Colon and Rectal Surgery Director, Robotic Colorectal Surgery Epicenter Roper Hospital Charleston Colorectal Surgery Roper St. Francis Physicians Charleston, South Carolina

Eduardo Parra-Davila, MD Medical Director Minimally Invasive and Colorectal Surgery and Hernia and Abdominal Wall Reconstruction Florida Hospital Celebration Health Celebration, Florida

Michelle Toder, MD, FACS, FASMBS Medical Director Surgical Weight Loss Program Eastern Maine Medical Center Bangor, Maine

Introduction Minimally invasive laparoscopic surgery offers significant benefits to the patient compared with open techniques1; however, there are still significant disadvantages associated with this approach, including poor instrument control due to rigid instrumentation, limited and unstable 2-dimensional (2-D) visualization, and poor ergonomics.2,3 Over the past decade, robotic assistance has expanded the role of minimally invasive surgery (MIS) for a variety of clinical indications.2,4 Indeed, robot-assisted MIS has several advantages over conventional MIS (ie, nonrobotic laparoscopy), including 3-dimensional (3-D) imaging, tremor filtration, and augmented dexterity because of fully wristed, articulating instruments.1-3 With robotic assistance, surgeons can offer

MIS to more patients, thereby reducing patient trauma, shortening hospital length of stay, and improving outcomes.4-6 Early adoption of robotic technology was seen in both urology (prostatectomy) and gynecology (hysterectomy for benign and malignant conditions), but now awareness of these technical benefits is leading to rapidly increasing use of this technology within general surgery procedures.7 “Robotics has given me a platform for more innovative approaches for MIS because I can use the system for every case,” said Craig S. Johnson, MD, a colorectal surgeon at Oklahoma Surgical Hospital in Tulsa. “When you’re operating at the bedside for laparoscopic and open surgery, physical constraints can be challenging. I see robotics as another progression in the technology

GENERAL SURGERY NEWS • APRIL 2013

that enables us to do things we couldn’t do before. There is a huge improvement in patient satisfaction. With this technology, patients are getting better quicker and our complication rates are lower. Patients don’t experience the trauma of open-belly procedures and there are fewer returns and readmissions.” “Robotics has allowed me to perform operations in MIS that I couldn’t do before,” said Anthony M. Gonzalez, MD, chief of surgery and minimally invasive and robotic surgery, Baptist Hospital; medical director, Weight-loss Surgery Program at South Miami Hospital in Florida. “The technology simplifies difficult operations, allowing more surgeons to adopt minimally invasive techniques,” he said.

The EndoWrist® One™ Vessel Sealer Intuitive Surgical is the recognized leader in robotic-assisted surgery. In February 2012, the company released the EndoWrist® One™ Vessel Sealer for the da Vinci® Si™, an 8-mm, single-use, fully wristed instrument that enables a surgeon-controlled approach to sealing and cutting vessels up to 7 mm in diameter and tissue bundles.8 Historically, the sealing of larger vessels with the da Vinci® Surgical System during colorectal, bariatric, and general surgery procedures has required some tradeoffs regarding surgeon autonomy, articulation, and efficiency.5 Surgeons typically have used a laparoscopic vessel sealer (eg, LigaSure™, Covidien or EnSeal®, Ethicon Endo-Surgery) operated by their bedside assistant during their robotic cases. Traditionally, the laparoscopic instruments are non-articulating and the bedside assistant sees the surgical field through a 2-D surgical monitor. This presents limits in terms of access, efficiency and dexterity, even for skilled assistants. Alternately, surgeons may employ an ultrasonic robotic instrument. The da Vinci Harmonic ACE® (Ethicon Endo-Surgery) instrument offers direct control with 3-D visualization to the surgeon but, unlike other robotic instruments, it is not wristed.9,10 Although surgeons view the Harmonic instrument as broadly usable, it is indicated for smaller vessels than LigaSure and EnSeal devices. There also are some surgeons who may opt to apply clips with the da Vinci Surgical System by using a wristed surgeon-controlled clip applier.6 This provides a wristed instrument

with surgeon control and 3-D visualization; however, if several clips are applied, it can require multiple instrument exchanges. The newly introduced EndoWrist One Vessel Sealer provides da Vinci surgeons with complete control and autonomy during transection steps and critical vessel and tissue sealing. The instrument’s 50 degrees of articulation allows surgeons to gain an optimal angle for approaching and sealing vessels. The single-use instrument is indicated for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit within the instrument’s jaws.8 This new technology helps position robotic surgery for use in an increasing number of procedures within the various subspecialties of general surgery. “With the way the EndoWrist One Vessel Sealer is designed, I can take different angles. It gives me more freedom of motion and I can approach tasks like sealing, differently,” said Eduardo Parra-Davila, MD, medical director, minimally invasive and colorectal surgery, medical director, hernia and abdominal wall reconstruction, Florida Hospital Celebration Health.

Clinical Experience in Colorectal Surgery Working deep in the pelvis to resect malignant tissue while avoiding critical structures, colorectal surgeons encounter many of the same challenges that prevented the widespread adoption of laparoscopic prostatectomy more than a decade ago. “The difficulty I had with laparoscopic pelvic surgery and what really brought me to da Vinci was that it allowed me to perform a better pelvic dissection, especially in patients that had low-lying rectal cancer or even in patients with inflammatory bowel disease where it was difficult laparoscopically to reach the last 5 cm of dissection down in the anal canal,” said Dr. Johnson. In fact, these challenges ultimately led Dr. Johnson to create a truly MIS technique. “Before da Vinci, I would have to do that part of surgery with either a low Pfannenstiel or low midline incision, which had increased morbidity to the patients. Doing it laparoscopically, I felt it was inadequate in terms of distal margins and oncologic dissection.” “Before using da Vinci, I performed 85% to 90% [of pelvic surgeries] with an MIS approach. Now, I would say I perform 99%

Supported by

Table. Capability Profiles of Vessel-Sealing Devices EndoWrist® One™ LigaSure™ V or Vessel Sealer New 5 mm

EnSeal® with Standard Tip

7 mm seal and cut claim

•

>360 mm Hg (3x systolic) burst pressure

•

1-2 mm lateral thermal spread

•

Independent seal and cut functions

•

Wristed (with full pitch and yaw articulation) for optimal access

•

Precision and stability with tremor filtration

•

Dual-hinged jaw (40 opening angle)

•

Real-time system checks and onscreen user feedback

•

From reference 8.

minimally invasively because I don’t have to convert to open when I use the da Vinci,” Dr. Johnson added. Despite these advantages, surgeons were still historically faced with tradeoffs when using advanced vessel-sealing devices in concert with their robotic technique. “I liked having my bedside assistant use advanced vessel-sealing technology in my da Vinci procedures because it was reliable and effective. The drawbacks were that I did not have control and it did not articulate;

sometimes it was difficult to use deep in the pelvis. I would also need a qualified bedside assistant or partner to fire the laparoscopic instrument,” said Dr. Johnson. “The EndoWrist One Vessel Sealer’s best attribute is the control it offers to the surgeon. With this instrument, I don’t have to rely on my assistant or a partner for sealing or cutting.” “At my former hospital, I struggled to find an instrument my assistant could use,” recalled Jorge A. Lagares-Garcia, MD, FACS, FASCRS, chief, Division of Colon and Rectal

Splenic artery (n=13) Mesenteric artery (n=13)

800

Renal artery (n=39)

700 600 500 400

360 mm Hg (3x systolic)

300 200 100 0

EndoWrist® One™ Vessel Sealer

LigaSure™ V

EnSeal® with Standard Tip

Figure 1. Burst pressure of vessel sealers across various arteries. From reference 11.

Surgery, director, Robotic Colorectal Surgery Epicenter, Roper Hospital and Charleston Colorectal Surgery, Roper St. Francis Physicians in Charleston, South Carolina. “I was working with a certified physician assistant who had limited surgical experience. We began using a laparoscopic vessel sealer to seal the inferior mesenteric artery and other major vessels, and it was a frustrating and time-consuming process.” In addition to maintaining surgeon control, Dr. Johnson feels that the instrument is very reliable. Surgeons who have used the instrument report that its sealing performance is comparable to other vessel sealing instruments on the market, thanks in part to its 16-mm sealing surface and consistent, computer-controlled closing pressure. In fact, the sealing strength of the EndoWrist One Vessel Sealer has been investigated in benchtop studies using porcine models, with burst pressure tests performed on a variety of vessel sizes and types.11 These studies have confirmed that seals performed by the EndoWrist One Vessel Sealer can sustain burst pressures well above 3 times systolic blood pressure on vessels up to 7 mm in diameter (Figure 1).11 Dr. Lagares-Garcia cited these attributes as a huge advantage. “I can take any pedicles with the EndoWrist One Vessel Sealer. That peace of mind is vital for the surgeon,” he said. “The device is very intuitive. When it is linked with the da Vinci system, the operation of the vessel sealer is simple: The blue pedal closes and seals and the yellow

pedal cuts. The da Vinci also gives you auditory feedback; it makes a sealing sound as it seals and a cutting sound as it cuts. Everything is clean.” There also are heat concerns to consider during sealing and cutting in MIS procedures. “The Harmonic ACE tends to get hot,” said Dr. Lagares-Garcia. “You have to be careful when you touch a structure. I feel more comfortable with the lower maximum jaw temperature of the EndoWrist One Vessel Sealer.” “Thermal spread of the EndoWrist One Vessel Sealer is the same as LigaSure,” added Dr. Johnson. “The instrument is also much cooler than the Harmonic, and I don’t have to wait for it to cool down. The vessel sealer creates very little smoke. It creates less smoke than LigaSure and much less vapor than Harmonic. Less smoke and vapor translates into less fouling of the scope and better visualization and more efficient surgery.” Dr. Johnson believes the benefits of the EndoWrist One Vessel Sealer go beyond its outstanding sealing performance. The instrument’s fully wristed articulation allows surgeons to approach anatomy at optimal angles for effective sealing performance, but its dual-hinged, thermally isolated jaws (with 40-degree opening angle and unique tip profile) minimize thermal spread (Table).8 “The ability to use the vessel sealer is far superior to the other instruments I used laparoscopically because the surgeon has control of the instrument, and that is a huge advantage. “We chose to adopt the EndoWrist One Vessel Sealer because it was similar technology to what I was using; I had control of the instrument, it articulated, and it was easy to use,” said Dr. Johnson. “Cost was also very important to me and it had to be cost neutral or save money. It was a ‘no brainer’ to get it in our hospital because it was less expensive than the instruments I was using. The functionality was improved because I had control of it, so it was a superior instrument that costs less for my procedures.” “The Vessel Sealer Vision Cart Upgrade has 2 components, one of which will also control the new EndoWrist Stapler when it is released, so right off the bat that is a huge benefit,” said Dr. Lagares-Garcia. “We want the upgrades to the da Vinci Si System to support as many products, cases, and surgeons as possible. On top of the fact that the instrument is easy to use, it also saves time and money.”

GENERAL SURGERY NEWS • APRIL 2013

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

“In general, my rectal cancer approach has improved,” Dr. Lagares-Garcia added. “The device really has increased the spectrum of robotic surgeries that I can do compared with traditional laparoscopic instruments. The visualization with the robot is spectacular. The fact that you have depth of perception as opposed to a 2-D field is phenomenal and, with the EndoWrist One Vessel Sealer, the ability to rotate the wrist and get into a narrow pelvis and perform perfect dissections is incredible.” Dr. Lagares-Garcia also used the instrument recently in a case involving a very young female patient with a rectal prolapse that was recurring after laparoscopic surgery. “My concern was that I was going to get into trouble because in the female pelvis there are a number of vessels you can hit and there’s a lot of pelvic bleeding,” he recalled. “I was also concerned about the fact I was using a brandnew instrument. But I did the entire pelvic dissection in little tiny bites with the EndoWrist One Vessel Sealer, cutting and sealing, and I was able to get all the way down to the anus. Just the ability to rotate right at the pelvic floor when you take the curvature of sacrum left me very impressed.” The autonomy and wristed architecture that the EndoWrist One Vessel Sealer offers to surgeons also decreases the time required for critical steps in a procedure. For “regular colon cases,” Dr. Johnson said the EndoWrist One Vessel Sealer saves anywhere from 15 to 30 minutes per case through reduced instrument exchanges and reliance on surgical assistants. Dr. Lagares-Garcia credits the instrument with reducing OR time on robotic right colectomies—a complex procedure—by as much as 50%. In a study by Lim et al, mean operative time for this procedure was 167.5 minutes,12 and most of that time was spent “taking down the mesentery and sealing the vessels there,” said Dr. ParraDavila. This study took place before the EndoWrist One Vessel Sealer was available. “It’s a very segmentalized procedure,” Dr. Parra-Davila continued. “And in my experience, the EndoWrist One Vessel Sealer speeds up that part of the process because of its reach and versatility. As long as you know where the nerves are, where the ureter is, the instrument enables you to perform that step much quicker.” “The way I look at it as a surgeon is in terms of global costs,” Dr. Johnson explained. “OR time is a consideration; the costs associated with instrumentation are a consideration; and the time you are in the hospital is a consideration. If you can chip away at those various areas, you can make a significant difference in costs. For example, 15 minutes in the OR on 1 case may not

EndoWrist® One™ Vessel Sealer

LigaSure™ V

EnSeal® with Erbe® Generator

Harmonic ACE®

Figure 2. Jaw temperature profile of vessel-sealing devices. From reference 11.

seem like much, but if you do that procedure 200 times per year it adds up. Tools like the da Vinci Si Surgical System and the EndoWrist One Vessel Sealer make a significant contribution in this way.” Colorectal surgeons said the EndoWrist One Vessel Sealer enhances the capabilities of the da Vinci Si Surgical System and enables them to use new approaches for colorectal surgery. For example, Dr. LagaresGarcia credited the instrument with giving him the full confidence and ease of use to perform right colectomy, left colectomy, sigmoid colectomy, and proctectomy with this device, which offers a minimally invasive and reproducible approach. Dr. Johnson, a former user of the Harmonic ACE and LigaSure, now uses the EndoWrist One Vessel Sealer for all of his colorectal surgeries, including abdominoperineal resection, low anterior resection, and rectopexy as well as J-pouch surgery and segmental colon resection. During bowel resections, for example, he said the instrument helps reduce perioperative bleeding. “The EndoWrist One is designed in such a way, with its blunt and squared-off nose, that I can use it around the bowel,” he explained. “That’s what robotic surgery does. It drives better patient outcomes, less time in the hospital, fewer complications, and less postoperative trauma,” said Dr. Johnson. “I spend very little time with patients in postop now compared with colon resections I used to perform with an open incision. These patients were in misery for 2 weeks and there were increased complications—there were a lot of phone calls and visits. Bottom line is that patients spend less time in the hospital and they are happier.”

Bariatric Surgery and Other General Surgery Procedures

Figure 3. EndoWrist® One™ sealing and transecting tissue within the abdomen. Images courtesy of Anthony Gonzalez, MD.

GENERAL SURGERY NEWS • APRIL 2013

In addition to colorectal surgery, general surgeons increasingly are using robotic surgery for procedures ranging from bariatric surgery to hernia repair. The combination of articulation and surgeon control has also proven valuable in early clinical use within these procedures. “I am a true believer in the value of wristed instrumentation,” said Michelle Toder, MD, FACS, FASMBS, medical director, Surgical Weight Loss Program, Eastern Maine Medical Center in Bangor, a Bariatric Center of Excellence. “The EndoWrist One Vessel Sealer is very well designed. I can cauterize and cut with it as well. Unlike with ultrasonic energy, which only cauterizes and essentially vaporizes the tissue, I can seal and cut independently. It also has a very wide cone of articulation, so I can reach into tight spaces and it allows me to reach deeper areas of the abdomen.”

Supported by

to create a spatial opportunity for the right colon with the device that we’ve never been able to create before.” Dr. Gonzalez now uses the EndoWrist One Vessel Sealer for a variety of procedures, including sigmoid colectomy, right colectomy, gastric bypass, and sleeve gastrectomy, as well as procedures to correct hiatal hernias and paraesophageal hernias. “I initially started with the Harmonic ACE because it was the only ultrasonic cutting or sealing instrument available for the robotic platform. However, it was rigid and non-wristed. I switched to the EndoWrist One Vessel Sealer because of the versatility and articulation [Figure 3],” he said.

Conclusion Among general surgeons who perform procedures ranging from colorectal to bariatric, those who have used the EndoWrist One Vessel Sealer believe that it enhances the capabilities of the da Vinci Surgical System by improving efficiency and, in some cases, extending the feasibility of robotic surgery techniques. The improved autonomy and fully articulated instrument have improved efficiency in the OR for many of the surgeons who have used it. “I adopted this technology because I wanted to perform minimally invasive colorectal surgery with the most advanced technology available that would provide better precision and control so that I could perform a more efficient MIS with control of all instruments. Also, I could see better than my bedside assistant and I didn’t want to rely on a bedside assistant looking at a 2-D monitor to seal critical vessels when I can do it myself,” said Dr. Johnson. “The way I look at it is this new technology allows a

da Vinci surgeon to do things they couldn’t do before. That’s what it’s all about.”

References 1. Parini U, Fabozzi M, Contul RB, et al. Laparoscopic gastric bypass performed with the da Vinci Intuitive Robotic System: preliminary experience. Surg Endosc. 2006;20(12):1851-1857. 2. Horgan S, Vanuno D. Robots in laparoscopic surgery. J Laparoendosc Adv Surg Tech. 2001;11(6):415-419. 3. Cadiere GB, Himpens J, Germay O, et al. Feasibility of robotic laparoscopic surgery: 146 cases. World J Surg. 2001;25(11):1467-1477. 4. Yang Y, Wang F, Zhang P, et al. Robot-assisted versus conventional laparoscopic surgery for colorectal disease, focusing on rectal cancer: a meta-analysis. Ann Surg Oncol. 2012;19(12):3727-3736. 5. Baik SH, Kwon HY, Kim JS, et al. Robotic versus laparoscopic low anterior resection of rectal cancer: short-term outcome of a prospective comparative study. Ann Surg Oncol. 2009;16(6):1480-1487. 6. Kim JY, Kim NK, Lee KY, et al. A comparative study of voiding and sexual function after total mesorectal excision with autonomic nerve preservation for rectal cancer: laparoscopic versus robotic surgery. Ann Surg Oncol. 2012;19(8):2485-2493. 7. Intuitive Surgical website. http://phx.corporate-ir. net/External.File?item=UGFyZW50SUQ9MTcwOTQ5 fENoaWxkSUQ9LTF8VHlwZT0z&t=1. Accessed February 22, 2013. 8. Intuitive Surgical website. http://www.intuitivesurgical.com/products/davinci_surgical_system/davinci_ surgical_system_si/. Accessed February 22, 2013. 9. Wilson EB. The evolution of robotic general surgery. Scand J Surg. 2009;98(2):125-129. 10. Kajiwara N, Kakihana M, Kawate N, Ikeda N. Appropriate set-up of the da Vinci Surgical System in relation to the location of anterior and middle mediastinal tumors. Interact Cardiovasc Thorac Surg. 2011;12(2):112-116. 11. Data on file. Intuitive Surgical; 2012. 12. Lim MS, Melich G, Min BS. Robotic single-incision anterior resection for sigmoid colon cancer: access port creation and operative technique. Surg Endosc. 2013;27(3):1021.

Disclosures Dr. Gonzalez reported that he has received research support from Intuitive Surgical, Inc., and has served as a consultant for Ethicon Endo-Surgery, Inc. Dr. Johnson reported that he has served as a consultant for Intuitive Surgical, Inc., and Johnson & Johnson. Dr. Lagares-Garcia reported that he has served as a consultant for and has received honoraria from Intuitive Surgical, Inc. Dr. Parra-Davila reported that he has served as a consultant for Aesculap, Inc., and Ethicon Endo-Surgery. He also has served on the speakers’ bureau for Cook Medical, Inc., Ethicon Endo-Surgery, Inc., and Intuitive Surgical, Inc. Dr. Toder reported that she has received honoraria from and has served as a consultant and member of the speakers’ bureau for Intuitive Surgical, Inc.

Manufacturer Notes The EndoWrist® One™ Vessel Sealer is cleared for commercial distribution in the U.S. for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. For complete Instructions for Use, Indications, Contraindications, Warnings and Precautions, please refer to www.davincisurgerycommunity.com. While clinical studies support the use of the da Vinci® Surgical System as an effective tool for minimally invasive surgery for specific indications, individual results may vary. Data and conclusions presented here should be considered preliminary until published in a peer-reviewed journal. If no statistical analysis has been performed, analysis may confirm that numerical differences are not statistically significant. 876158 rev A 3/13

BB138

“The Harmonic ACE requires a lot of experience on the part of the operator to have good success because it seals and cuts depending on the pressure the operator puts on it,” said Dr. Gonzalez. “If the user is not experienced, they have a tendency to pull too hard, which means it closes too hard and doesn’t allow the vessel to seal completely, and that leads to bleeding. The EndoWrist One Vessel Sealer takes the experience factor out of the equation. It just seals the vessel; it’s that easy to use. It takes variability out of the equation and delivers the same performance consistently.” Histopathologic assessments of seal samples from EndoWrist One Vessel Sealer (compared with similar samples from Liga Sure V and EnSeal PTC) confirmed that when present, thermal spread to the adjacent nerve bundles and small vascular network with the new instrument was “confined within a 1- to 2-mm perimeter.”11 Moreover, thermal-imaging studies showed that the thermo-isolation of the electrode on the EndoWrist One Vessel Sealer allows for a lower maximum jaw temperature (Figure 2).11 Added efficiency comes from the multifunctional capabilities of the EndoWrist One Vessel Sealer. “Other than suturing the hiatus, there isn’t a single instrument exchange during a robotic-assisted paraesophageal hernia repair. I can do the whole operation with the EndoWrist One Vessel Sealer in my right hand,” said Dr. Gonzalez. This superior articulation provided Dr. Toder with outstanding visualization during a difficult case. “The EndoWrist One Vessel Sealer bends more like a snake or a big curve and so it gives you this huge range of motion,” she said. “We were able

GENERAL SURGERY NEWS • APRIL 2013

In the News

GeneralSurgeryNews.com / General Surgery News / April 2013

Incidence of ARDS Declining in Trauma Patients A

ccording to a new study, post-traumatic acute respiratory distress syndrome (ARDS) may be disappearing. Researchers have found the incidence of ARDS in trauma patients significantly decreased between 2001 and 2010. According to lead author Kelly N. Vogt, MD, “The epidemiology of ARDS is changing. What was once an extremely common complication of severe trauma has now, for a multitude of reasons, almost completely disappeared in this population.” Dr. Vogt is a surgical critical fellow from the Division of Trauma and Surgical Critical Care at the University of Southern California (USC), Los Angeles. The work was presented at the 2013 Critical Care Congress of the Society of Critical Care Medicine in San Juan, Puerto Rico. Two different models of post-traumatic ARDS have been described. The early form, due to the degree of injury severity and resuscitation, develops within the first 48 hours. Late-onset ARDS is thought to be related to systemic inflammation and other factors associated with multiple organ failure. Previously noted in as many as 25% of trauma patients, ARDS has been reported less frequently by others. The authors’ aim was to review the USC experience for ARDS incidence, morbidity and mortality

over the period from 2001 to 2010. The researchers employed a standard definition of ARDS and included all trauma patients at least 16 years of age who survived more than 48 hours. Most of them were male, young (average age 40) and almost 75% had suffered blunt trauma. Of the 3,954 patients who met the inclusion criteria, 319 (8%) developed ARDS with rates of 14% in 2001 declining to 1.9% in 2010 (R2=0.76). Those who suffered ARDS were

significantly more often hypotensive on admission and had higher chest abbreviated injury scores (AIS). Although the ARDS group had significantly lower mean injury severity scores (ISS), 56% had an ISS of 25 or higher compared with 32% in the non-ARDS cohort (P<0.01). Regression analysis of risk factors showed that ARDS was associated with an ISS of 25 or higher, chest AIS of no less than 3, mean peak inspiratory pressures (PIP) of no less than 35, red blood

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Of the 3,954 patients who met the inclusion criteria, 319 developed ARDS with rates of 14% in 2001 declining to 1.9% in 2010. Regression analysis of risk factors showed that ARDS was associated with an injury severity score of 25 or higher, chest abbreviated injury scores of no less than 3, mean peak inspiratory pressures of no less than 35, red blood cell and plasma transfusions, and a positive fluid balance of at least 1 L in the initial 48 hours of treatment. Tidal volume index in mL/kg and mean peak inspiratory pressures declined significantly over the years studied.

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Sinatra et al (Pain Study 1) Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g (q6h) + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed. P<0.05 at every time point.

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Indication OFIRMEV is indicated for the management of mild to moderate pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever. Important Safety Information OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. Do not exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. OFIRMEV should be administered only as a 15-minute intravenous infusion.

Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. OFIRMEV is approved for use in patients ≥2 years of age. The antipyretic effects of OFIRMEV may mask fever in patients treated for postsurgical pain. To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc. at 1-877-647-2239 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com. Please see Brief Summary of Prescribing Information on adjacent page or full Prescribing Information at OFIRMEV.com. Reference: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005;102:822-831.

GeneralSurgeryNews.com / General Surgery News / April 2013

The use of lungprotective ventilation strategies and minimizing unnecessary blood transfusion and fluid administration were given as possible reasons for the decline of ARDS.

cell (RBC) and plasma transfusions, and a positive fluid balance of at least 1 L in the initial 48 hours of treatment. Tidal volume index in mL/kg and mean PIP declined significantly over the years studied. During those years, RBC transfusion rates declined, and the use of plasma was variable. Fluid balance in the first 48 hours was fairly stable, ranging from an average of about 600 mL to nearly 1,500 mL. In-hospital mortality for patients who developed ARDS did not change significantly over the study period. It was 30% for those with ARDS versus 9% for those

In the News without ARDS (P<0.01) and was associated with significantly longer durations of mechanical ventilation and longer ICU and hospital lengths of stay. After adjusting for markers of poor outcome, the development of post-traumatic ARDS was significantly associated with mortality (odds ratio, 2.7; 95% confidence interval, 1.8-4.2). “Although this study was not designed to detect the reason why ARDS is declining, several possibilities exist,” said Dr. Vogt. She mentioned the use of lungprotective ventilation strategies and minimizing unnecessary blood transfusion

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and fluid administration as possible reasons for its decline. Regarding the role of some of the newer treatments for ARDS, she said, “We do use airway pressure release ventilation, percussive ventilation and occasionally prone positioning in these patients.” However, given the extremely low incidence of ARDS in their trauma patients now, it would be “difficult to tease out the impact of these strategies on mortality.” Dr. Vogt said that whether ARDS is a cause of death or merely a surrogate marker of serious illness is an important question, and one that remains unanswered.

In the News Bariatric

continued from page 1 improvement to the CMS policy restricting performance of bariatric operations on Medicare patients to CoEs,” wrote lead author Justin B. Dimick, MD, MPH, and his colleagues from the Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor. In 2006, CMS issued a national decision that limited coverage of weight loss surgery to CoEs designated by the American College of Surgeons (ACS) or the American Society for Metabolic and

Bariatric Surgery (ASMBS). At the time, many surgeons protested the decision, arguing that it restricted bariatric surgery to large established practices. In January, John Birkmeyer, MD, a study co-author and the George D. Zuidema Professor of Surgery at the University of Michigan, formally asked the CMS to reconsider the facility certification requirement. As a result, CMS has opened a coverage analysis to review available evidence on the issue. The ASMBS challenged the request, saying the society supports continuation of the COE requirement. The society

GeneralSurgeryNews.com / General Surgery News / April 2013

cited seven studies that “provide strong and compelling evidence” favoring the certification. “Lives have been saved, complications have been prevented, readmissions have been averted, cost has been lowered and access has been broadened,” they wrote in a letter to CMS. In the new study, Dr. Dimick and his colleagues countered many of those arguments. They studied hospital discharge data from 12 states, looking at outcomes for Medicare patients undergoing bariatric surgery between 2004 and 2009. The results were compared

with those for non-Medicare patients over the same period. Unlike prior studies, investigators used a “difference-in-difference” analysis to adjust for temporal trends. They found no differences in safety (measured as riskadjusted complications), serious complications or reoperations after the policy changed (8% vs. 7%, 3.3% vs. 3.6%, 1% vs. 1.1%, respectively). The analysis took into account patient factors, changes in procedure type and preexisting time trends toward improved outcomes. Investigators also found no difference in risk-adjusted complications, serious complications or reoperations for 179 CoE-designated institutions compared with 519 non-CoE institutions over the study period (5.5% vs. 6%, 2.2% vs. 2.5% and 0.83% vs. 0.96%, respectively). Researchers said, in effect, that bariatric outcomes improved over the past decade but these improvements may have resulted from evolving surgical techniques and use of different types of procedures. “This includes transitioning from open to laparoscopic procedures and the increased use of laparoscopic adjustable gastric banding,” they wrote. Use of laparoscopic gastric banding jumped considerably, from 6% to 35% in Medicare patients and from 6% to 24% among non-Medicare patients. The disproportionate increase in gastric banding in Medicare patients suggests that the increased scrutiny of Medicare’s bariatric surgery population “influenced physician decision making,” said the authors. They argued that the CMS policy might unfairly limit patient access to bariatric surgery. A previous study in Texas found patients had a markedly increased travel distance after implementation of the CMS coverage decision (Arch Surg 2009;144:319-325). “Therefore, the CMS policy restricting coverage to CoEs has not been associated with improved outcomes for bariatric surgery, but may have had the unintended consequence of reducing access to care,” said Dr. Dimick and his colleagues. This is the third study to refute the effectiveness of accreditation in bariatric surgery (JAMA; 2010;304:435-442; Arch Surg 2009;144:319-325), whereas seven studies have demonstrated positive effects of the policy. In an accompanying editorial, Caprice C. Greenberg, MD, PhD, associate professor of surgery and director of the Wisconsin Surgical Outcomes Research Program, confirmed that CMS and surgical societies are reexamining the CoE policy in bariatric surgery. She did not argue for or against dropping the CMS’ policy. Instead, she said CMS and surgical societies must find better ways to promote quality surgical care. The current approach to CoE accreditation is expensive, requires extensive

GeneralSurgeryNews.com / General Surgery News / April 2013

In the News

Oncotype DX Colon Cancer Assay Plays Influential Role in Therapy, Cost Prospective Data on Outcomes of Disease Recurrence, Mortality Still Needed B y G eorge O choa

he Oncotype DX Colon Cancer Assay (Genomic Health) alters treatment recommendations and may reduce medical costs and improve patient well-being, according to posters presented at the 2013 American Society for Clinical Oncology Gastrointestinal Cancers Symposium, held in San Francisco. “This test is a useful tool for medical oncologists for risk assessment for their stage II patients beyond [how] the clinicopathologic factors alone can help us,” said Saima Sharif, MD, MS, assistant director of medical affairs for the National Surgical Adjuvant Breast and Bowel Project, and assistant professor of medicine at Temple University School of Medicine in Philadelphia. Dr. Sharif was not involved in the studies presented at the meeting. One of the studies (abstract 453) involved 141 stage II, T3 mismatch repair (MMR)–proficient colon cancer patients from 17 centers in the Mayo Clinic Cancer Research Consortium. In this prospective study, researchers analyzed treatment decisions for these patients and found that the use of the Oncotype DX Colon Cancer Assay changed treatment decisions 45% of the time, with treatment intensity decreasing for 33% of patients and increasing for 11%. Recommendations for chemotherapy fell from 52% pre-assay to 30% post-assay. CENTER OF IATRIC BAR LENCE EXCEL

documentation, site visits and the collection of data that are not being optimally used, she said. “This is an opportune time to examine how the programs can evolve and whether restricting care to CoEs is still the best approach. “Money and effort currently invested by CoE sites could be reallocated to promote a more active approach to quality improvement,” Dr. Greenberg said. The report’s publication was met with criticism from many in the bariatric surgery community. Among the chief criticisms, they say the CoE program incentivized hospitals to improve data collection, focus on processes of care specific to bariatric patients and invest in specialized equipment—all of which improved the quality of bariatric surgery in the United States. “The accreditation does not need to be viewed as restriction of access but as a venue to improve quality of care,” said Jaime Ponce, MD, president of the ASMBS and medical director for bariatric surgery, Hamilton Medical Center, Dalton, Ga., in a statement to General Surgery News. Dr. Ponce believes the study has significant flaws. It’s based on an administrative

In a second study (abstract 391), researchers used the same data to evaluate cost and quality of life. Given the decrease in actual adjuvant chemotherapy recommendations (a 22% decline, from 52% pre-assay to 30% postassay), average total direct medical costs were calculated to decrease by $4,203. The net effect on average patient well-being was a gain of 0.083 quality-adjusted life-years. In a third study (abstract 349), 30 community-based and 20 university-based oncologists were surveyed to assess the agreement among physicians regarding their recurrence risk assessments of patients with stage II colon cancer. Each physician made an assessment in 10 cases using only clinicopathologic factors, and in 10 separate cases using clinicopathologic factors plus the Oncotype DX Colon Cancer Assay recurrence score and MMR tests. Addition of the Oncotype DX Colon Cancer Assay significantly increased agreement among physicians in their recurrence risk assessments, in both university and community settings. “I have used [the Oncotype DX Colon Cancer Assay] for selected cases, particularly those with pT3N0 pathologic stage or when there are conflicting traditional clinicopathologic features that, in some cases, are not supported by a consistently high level of evidence,” said Robin Katie Kelley, MD, assistant professor of medicine at the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, and lead author of the study.

Dr. Kelley noted that the assay could be helpful “in cases with average-risk, stage II colon cancer, without distinct high- or low-risk features.” “[The test] has been analytically validated for its accuracy, and … has clinical validity from two large randomized data sets,” she said. Dr. Sharif said the Oncotype DX Colon Cancer Assay is a reliable assay based on retrospective data available for clinical use; however, it is yet to be evaluated prospectively in a randomized clinical trial to make treatment decisions and to look at outcomes of disease recurrence and death in patients. “It is a useful tool for risk assessment of patients with stage II colon cancer but does not predict benefit from chemotherapy. … Based on each patient’s risk for recurrence, chemotherapy can be offered with the ‘hope,’ but no definitive evidence, that it will improve outcome of disease recurrence or death from cancer,” she said. According to Genomic Health, the Journal of Clinical Oncology has accepted results from the second large clinical validation study of the Oncotype DX Colon Cancer Assay for publication. Dr. Kelley reported receiving research funding from Genomic Health for research on the clinical utility of the Oncotype DX Colon Cancer Assay. Dr. Sharif reported involvement with clinical trials from which samples of tumor tissue were used to develop the assay, but he was not directly involved with its development.

‘The CMS policy restricting coverage to CoEs has not been associated with improved outcomes for bariatric surgery, but may have had the unintended consequence of reducing access to care.’ —Justin B. Dimick, MD, MPH

database; such databases are not overly sensitive or specific for rates of complications, he said. He cited a 2011 study that showed 90-day readmission rates decreased 25% after the national coverage decisions, while reoperation declined 33% (Ann Surg 254:860-865). He stressed that the study shows both Medicare and non-Medicare patients experienced improved outcomes. “The national coverage decision not only helped to improve outcome for Medicare patients but also helped to improve outcome for non-Medicare patients as most payers follow Medicare rulings.” Finally, he said that accreditation is an ongoing process. Hospitals submit data so investigators can study patterns and identify best practices. “Accreditation is needed to get all the measures for quality and the benefits go beyond the data published by Dimick et al.” Most surgeons who spoke with General Surgery News support continuing the CoE program but they noted that the process is flawed.

Ninh T. Nguyen, MD, chief of gastrointestinal surgery at UC Irvine Medical Center and president-elect of the ASMBS, said both the ASMBS and ACS continue to support the accreditation process. They do recognize that the 125-case threshold can be difficult to achieve and the new ASMBS-ACS quality program, the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, will likely have a lower institutional volume requirement based on peerreview literature. He added that “the bariatric surgery community uniformly disagrees” with the request for elimination of the facility requirement. Stacy Brethauer, MD, a bariatric surgeon at Ohio’s Cleveland Clinic, supports the accreditation requirement by CMS. The administrative claims data used in the Dimick study is “suboptimal” for evaluating surgical complications compared with clinical registry data, he said. Moreover, he said, the demise of the accreditation program could bring negative consequences, such as loss of

critical hospital support for resources and loss of ability to track outcomes for quality improvement at a national level. “Without accreditation, we will have no data collection and our ability to navigate the next evolution in quality improvement and outcome reporting will be severely impaired.” Kelvin Higa, MD, program director of minimally invasive and bariatric surgery, Fresno Heart & Surgical Hospital, in California, called the Dimick study “important” and noted that the authors “make a compelling argument against CoE accreditation for Medicare patients.” But, he added, it’s not clear if the study is definitive enough to abandon accreditation. “For those of us who have had to live through the early days of our specialty, when patients were looked at as commodities with no support services by some surgeons and hospitals, we would certainly not like to see history repeat itself.” Dr. Dimick reported serving as a consultant and having an equity interest in ArborMetrix Inc., which provided software and analytics for measuring hospital quality and efficiency but had no role in the study. Dr. Greenberg reported receiving an honorarium from the Michigan Bariatric Quality Collaborative to attend one of its collaboratives and discuss issues related to system performance and safety. Drs. Ponce, Nguyen and Higa have or will serve as president of the ASMBS.

In the News

GeneralSurgeryNews.com / General Surgery News / April 2013

Robotic Gastrectomy Matches Laparoscopic Outcomes in Large Trial B y C hristina F rangou San Francisco—Robotic gastrectomy can match the long-term clinical and oncologic outcomes of laparoscopic surgery in patients with early gastric cancer, a large single-center study has shown. Robotic surgery does not appear, however, to provide superior outcomes, which many experts argue will be necessary to justify the added costs of robotic surgery. At the American Society of Clinical

Oncology’s 2013 Gastrointestinal Cancers Symposium, researchers from Severance Hospital, part of the Yonsei University Hospital System in Seoul, South Korea, presented a retrospective analysis of their large prospectively designed database for gastric cancer. Overall (OS) and relapse-free survival were almost identical for patients who underwent laparoscopic surgery or robotic surgery, in the 862 patients who underwent minimally invasive surgery

for histologically proven gastric adenocarcinoma between July 2005 and December 2009. Five-year survival reached 94% in the robotic group, a nonsignificant half percent higher than among laparoscopic patients. In both groups, disease-free survival hovered around 92%. “Robotic surgery has acceptable longterm oncology outcomes compared with the current laparoscopic procedures and is an effective alternative to laparoscopy,

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which is quite difficult,” said lead author Woo Jin Hyung, MD, PhD, assistant professor of surgery, Yonsei University College of Medicine, also in Seoul. Robotic surgery “may be an easy way for us to perform complex procedures,” he said. He added that studies with more advanced patients and with data on cost-effectiveness and quality of life are needed. The study included 317 patients who underwent robotic surgery, making it the largest reported series of robotic gastric cancer procedures, and 545 patients who underwent laparoscopic surgery. With a median follow-up of 46 months, postoperative recurrences occurred in 5.4% of patients in the robotic group and 3.6% in the laparoscopic arm, which was not statistically significant (P=0.745). The same team of researchers previously reported that patients who received robotic gastrectomy had better shortterm and comparable oncologic outcomes compared with laparoscopic gastrectomy (Arch Surg 2011;146:1086-1092). Donald E. Low, MD, head of thoracic surgery at Seattle’s Virginia Mason Medical Center, commended the study for “outstanding clinical volume,” “breathtaking” surgical outcomes and “unparalleled” oncologic outcomes. Dr. Low noted, however, that the study does not address important questions regarding robotic surgery: How do the functional outcomes compare between the two approaches? How do the costs compare? “I think the conclusion you can take from this is that robotic surgery is equivalent but not better than laparoscopic surgery for major cancer procedures. Robotic gastrectomy currently provides no measurable outcome benefits and is likely, almost assuredly, more expensive.” In the future, costs of robotic surgery are expected to decrease as more robotic systems come to market, although it is currently not known when other systems will be available or how more market competition will affect prices. In this study, patients were billed for the added surcharge of the robotic procedures, although details on costs were not reported. Even without financial specifics, it is assumed the cost associated with robotic gastric cancer surgery would be much higher than for laparoscopic surgery. A previously reported study from a different Korean hospital looked at costs for robotic versus conventional laparoscopic surgery for rectal cancer and found that robotic surgery was associated with increased hospital charges ($14,647 vs. $9,978), greater payments by patients ($11,540 vs. $3,956) and reduced

GeneralSurgeryNews.com / General Surgery News / April 2013

hospital profits ($689 vs. $1,671) (World J Surg 2012;36:2722-2729). Robotic surgery has been shown in other studies to hold some advantages over laparoscopic surgery, including a shorter learning curve for conventionally trained oncologic surgeons; better visualization of structures including lymph nodes and resection margins; and 360-degree range of operator motion, said Jennifer F. Tseng, MD, chief of surgical oncology, Beth Israel Deaconess Medical Center Cancer Center, Boston. “The importance of this abstract is

Daily Chlorhexidine Bathing Reduces HospitalAcquired Infections Daily bathing with washcloths impregnated with the antiseptic agent chlorhexidine reduced acquisition rates of multidrug-resistant organisms (MDROs) and hospital-acquired bloodstream infections, according to a study in The New England Journal of Medicine (2013;368:533-542). The nonblinded study enrolled 7,727 patients in nine units in six hospitals. The units included cardiac surgery, coronary care, medical, surgical ICUs and a bone marrow transplantation unit, among others. During the initial six months, units were randomized to perform daily bathing either with washcloths impregnated with 2% chlorhexidine gluconate or with non-antimicrobial washcloths. During the second six-month period, daily bathing with the alternate product occurred. According to the researchers, the overall rate of MDRO acquisition was 23% lower with chlorhexidine bathing than without; the rate for chlorhexidine was 5.10 cases per 1,000 patient-days compared with 6.60 cases per 1,000 patient-days with non-antimicrobial washcloths (P=0.03). MDROs tracked were methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). The overall rate of VRE acquisition was 25% lower with chlorhexidine than with non-antimicrobial bathing (3.21 vs. 4.28 cases per 1,000 patient-days, P=0.05). The overall rate of MRSA acquisition was 19% lower with chlorhexidine than with non-antimicrobial bathing; the difference was not significant (1.89 vs. 2.32 cases per 1,000 patient-days; P=0.29). The overall rate of hospital-acquired bloodstream infections was 28% lower with chlorhexidine than without (4.78 vs. 6.60 cases per 1,000 patient-days; P=0.007). The rate of primary bloodstream infections was 31% lower for chlorhexidine compared with the control (3.61 vs. 5.24 cases per 1,000 patientdays; P=0.006).

In the News

‘I think the conclusion you can take from this is that robotic surgery is equivalent but not better than laparoscopic surgery for major cancer procedures.’ —Donald E. Low, MD that in the near future, minimally invasive oncologically sound gastric and upper GI [gastrointestinal] surgery, through robotic assistance, may be available to a much wider segment of the population with cancer than is currently the case.” The study consisted predominantly of

patients with early-stage cancers. Around 80% of patients in the cohort had stage I disease, 10.5% were stage II and 6% were stage III. Analysis revealed no significant difference in cancer recurrence or OS between the two procedures for all stages. OS

for stage II patients reached 90% in the robotic arm and 88.2% in the laparoscopic arm (P=0.817); for stage III patients, five-year survival was 65.1% and 70%, respectively (P=0.985). Patients in the robotic arm of the study were younger (54.5 vs. 59.3 years; P<0.001) and were more likely to have a total resection (26.8 vs. 19.7%; P=0.016). In keeping with studies of robotic approaches, the robot was associated with significantly longer operating times (219.0±45.5 vs. 149.0±41.4 minutes; P<0.001).

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To ﬁnd out more, call us on 1.800.437.8181 or visit us online at goremedical.com/hernia. 1. Oelschlager BK, Pellegrini CA, Hunter JG, et al. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. Journal of the American College of Surgery 2011;213(4):461-468. 2. Hazebroek EJ, Leibman S, Smith GS. Erosion of a composite PTFE/ePTFE mesh after hiatal hernia repair. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 2009;19(2):175-177.

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Clinical Review

GeneralSurgeryNews.com / General Surgery News / April 2013

“Can’t You Do Something To Stop This Bleeding?” Systemic Strategies for Reducing Blood Loss In Surgery Pranay Kanake, MD Fellow in Cardiothoracic Anesthesia University of Rochester School of Medicine and Dentistry Rochester, New York

Michael P. Eaton, MD Denham S. Ward Professor and Chair Department of Anesthesiology Executive Director, Perioperative Services University of Rochester School of Medicine and Dentistry Rochester, New York Drs. Kanake and Eaton report no relevant financial conflicts of interest.

urgical procedures account for the transfusion of nearly 15 million units of red blood cells and 1.5 million platelet (PLT) transfusions per year in the United States.1 Although the risk for transmission of viral dis‑ eases with transfusion decreased with the advent of improved screen‑ ing of blood for pathogens, other adverse effects remain. These include transfusion reactions, immunomodulation, acute lung injury, fluid over‑ load, and, in some cases, mortality.2‑4 In the current environment of health care, in which cost containment has become of utmost importance, any intervention that will reduce perioperative bleeding and transfusion should be welcome. This review examines the pharmacologic therapies commonly employed to decrease surgical bleeding and transfusions.

Perioperative bleeding often is exacerbated by abnormalities that develop as a result of surgical trauma, component transfusion, and the activation of inflammatory and fibrinolytic cascades (Figures 1 and 2, pages 21 and 22). Surgical patients often are treated for chronic conditions with anticoagulant medications that further complicate perioperative management.5‑7 Because abnormal bleeding frequently results from derangement of the coagulation system and pharmacologic interventions typically focus on major aspects of this system, it is important to have a basic knowledge of hemostasis. Clinicians also must understand that, although hypercoagulability may be the major hemostatic problem that is addressed in the operating room, patients become hypercoagulable after surgery as a result of surgical stress, and thrombosis is more likely to produce a catastrophic complication such as myocardial infarction or pulmonary embolism. Thus, therapies that decrease bleeding preoperatively should have a relatively short duration of action to avoid exacerbating a prothrombotic state.

Pharmacologic Interventions Pharmacologic interventions to reduce bleeding and transfusion have been studied most often in cardiac and orthopedic surgeries and aim to either prevent or reverse defects associated with coagulopathy ().8 Most prospective studies have focused on the effectiveness of individual drugs given prophylactically, although some, like recombinant factor VIIa (rFVIIa; NovoSeven, Novo Nordisk) are given primarily as rescue treatment when bleeding is excessive. Pharmacotherapy for decreasing bleeding and transfusion may be loosely categorized as antifibrinolytic and procoagulant. Surgeons also use topical agents intraoperatively; however, topical therapy to decrease surgical bleeding is outside the scope of this review.

Antifibrinolytics Antifibrinolytics are the most common class of drugs used to improve hemostasis. These agents may be classified into 2 groups—lysine analogs and serine protease inhibitors.

Lysine Analogs Epsilon aminocaproic acid (EACA;

Amicar, Pfizer) and tranexamic acid (TA; Cyklokapron, Pfizer) are synthetic lysine analogs that inhibit fibrinolysis. EACA and TA competitively bind to lysine-binding sites of plasminogen and plasmin. Blockade of these sites prevents activation of the proenzyme plasminogen to the active fibrinolytic enzyme plasmin. EACA binds to plasmin to a lesser degree at a higher dose, and inhibits plasmin from digesting fibrinogen and fibrin.9 TA is 10 times more potent than EACA and approximately 100 times more expensive in the United States,10 although both drugs are available in generic forms. TA also may improve hemostasis by preventing plasmin-induced PLT activation.11 EACA is approved by the FDA to enhance hemostasis when fibrinolysis contributes to bleeding. TA is approved for the shortterm treatment or prevention of dental bleeding in hemophiliacs. Lysine analogs are water-soluble molecules that distribute readily into extravascular water spaces.11 EACA is largely excreted intact by the kidneys, and approximately 35% undergoes hepatic metabolism to the metabolite adipic acid. Renal clearance of the compound approximates endogenous creatinine clearance. The terminal elimination half-life of EACA is 1 to 2 hours.11 The pharmacokinetics of TA are similar to

those of EACA.5,12‑16 Dosage protocols for lysine analogs for bleeding prophylaxis have not been standardized. Dosing schemes vary widely, particularly for patients undergoing cardiac and orthopedic surgeries, and are not based on pharmacologic principles. Doses for EACA in cardiac surgery may involve the administration of a loading dose of between 75 and 150 mg/kg before cardiopulmonary bypass (CPB), followed by continuous infusion of 10 to 25 mg/kg per hour. Butterworth et al studied the pharmacokinetics of EACA in cardiac surgery with CPB and found that a loading dose of 75 mg/kg followed by maintenance infusion of 25 mg/kg per hour should produce adequate blood levels of the drug throughout surgery.11 In clinical trials of patients undergoing cardiac surgery, loading doses of TA have ranged from 10 to 30 mg/kg followed by infusion of 1 to 16 mg/kg per hour.12‑19 Pharmacokinetic data suggest that the maintenance dose (mg/kg/h) should be close to or the same as the loading dose (in mg/kg) to obtain stable levels during CPB. The plasma level of TA required to inhibit fibrinolysis is unclear. Although many study protocols have used 100 mcg/ mL as the minimal plasma concentration required for complete inhibition of fibrinolysis, more recent data suggest that much lower levels—17.5 mcg/mL in

GeneralSurgeryNews.com / General Surgery News / April 2013

Vessel injury

Clinical Review Intrinsic Pathway

Extrinsic Pathway

Tissue factor

Surface contact pre-kallikrein HMWK XIIa

VIIa/VII Calcium, Phospholipid

XIa

IXa

TF-VIIa complex

VIIIa

Common Pathway

Xa Calcium Phospholipid Va

Prothrombin

Calcium

Thrombin Fibrinogen

Fibrin XIIIa

XIII

Stable crosslinked fibrin

Figure 1. A simplified view of coagulation cascade. HMWK, high-molecular-weight kininogen

Topical Agents

Procoagulant Drugs

Antifibrinolytics

Table. Current Pharmacological Agents Used for Hemostasis During Surgery Plasminogen inhibitors

EACA TA

Serine protease inhibitors

Aprotinin Nafamostat Ecallantide

Desmopressin Recombinant factor VIIa Prothrombin complex concentrate Fibrin sealant Collagen Thrombin Gelatin sponges EACA, TA, Aprotinin

EACA, e-aminocaproic acid; TA, tranexamic acid

adults—are effective, and indicate that a lower dose should be effective. This finding is important given the association between high doses of TA and seizures.20 Efficacy Numerous studies evaluating the effects of EACA and TA have been published across a variety of patient populations. A recent review found nearly 100 such studies of TA alone.21 Although most clinical research on TA and EACA has been conducted in patients undergoing cardiac and orthopedic surgeries, the drugs also have been evaluated in craniofacial, gynecologic, hepatic, urologic, and vascular surgeries. TA and EACA repeatedly have been found to be effective in reducing bleeding and transfusion in adult and pediatric cardiac surgeries. A 2011 Cochrane review included more than 250 studies of TA and EACA, as well as aprotinin (Trasylol, Bayer), including 34 trials of TA and 11 of EACA in cardiac surgery.22 Despite large variability in dosing, both drugs had clinically significant efficacy in reducing

transfusion by about 30%. Trials of TA and EACA in orthopedic surgery have focused primarily on spine surgery and total knee and hip arthroplasty.23 In total joint arthroplasty, TA reduced the risk for transfusion by 53%, and EACA by 36%. Again, disparities in dosing protocols may explain the apparent difference in efficacy more than actual differences in the medication. A 2008 meta-analysis of the use of antifibrinolytic agents in spine surgery found a reduction of about 50% in the risk for transfusion among patients who received TA or EACA,24 although a recent randomized placebo-controlled study in adults undergoing spine surgery found no difference in transfusion associated with use of TA. Two other recent studies did find TA25 and EACA26 to be effective in pediatric spine surgery for scoliosis. Efficacy almost certainly depends on the complexity of the surgery, and the baseline risk for bleeding and transfusion. Dosing regimens that can be predicted to produce subtherapeutic plasma levels also may play a role. Two recent studies have shown marked decreases (66%-75%) in the incidence of transfusion in children undergoing surgery for craniosynostosis.27,28 Another recent study,29 which included open and minimally invasive craniosynostosis repair, did not find TA to be effective; in this trial, all patients were transfused. Multiple studies have shown a decrease in transfusion requirements in liver transplant surgery in patients treated with EACA and TA. Concerns remain about thrombotic complications, particularly thrombosis of the freshly anastomosed hepatic artery. However, the data do not support any increased risk.30 TA also has been studied in trauma patients.31 CRASH-2 (Clinical Randomization of an Antifibrinolytic in Significant Hemorrhage) is a large (>20,000 patients) placebo-controlled trial of the effects of TA on mortality, vascular occlusive events, and transfusions in trauma patients. The results show that the early administration of the drug to these patients reduces their risk for death from hemorrhage with no increase in vascular occlusive events. Use of TA also was associated with a significant reduction in all-cause mortality, likely due to the decrease in bleeding and transfusion and transfusion-associated complications. Fewer data are available for other operations; TA and EACA appear to be effective in cesarean delivery, gynecologic surgery, radical prostatectomy, and tonsillectomy.32‑35 Adverse Effects EACA and TA have not been studied see Blood Loss page 22

Clinical Review

GeneralSurgeryNews.com / General Surgery News / April 2013

Thrombin

FDP

Platelets

undergoing cardiac surgery.44 However, a recent trial comparing ecallantide with TA in high-risk cardiac surgery patients showed TA to be superior in decreasing blood loss and transfusion, with higher 30-day mortality in the patients receiving ecallantide.45

Procoagulant Drugs

Fibrinogen

Fibrin

α-2 Antiplasmin TAFI Plasminogen

PAI-1 EACA, TA

Plasmin

t-PA

Activation Inhibition

Figure 2. The fibrinolytic system.7‑9 EACA, e-aminocaproic acid; FDP, fibrinogen degradation product; TA, tranexamic acid; TAFI, thrombin activatable fibrinolysis inhibitor; t-PA, tissue plasminogen activator

in large, multicenter randomized controlled trials (RCTs) powered to evaluate safety. However, in small studies the drugs appear generally not to promote severe adverse effects.36 Both EACA and TA can cause hypotension when given as rapid IV bolus. EACA can cause rhabdomyolysis, myonecrosis, anion gap acidosis, upper urinary tract thrombosis, and hyperkalemia.14,36 Lysine analogs have not been associated with an increase in incidence of renal dysfunction or of mortality in cardiac surgery.37 Thromboembolic complications, such as reduced early graft patency, stroke, deep vein thrombosis, pulmonary embolus, and myocardial infarction, are theoretically possible. But focused reviews and metaanalyses have not found such association.37 Large retrospective studies have consistently reported an increased risk for seizures with higher doses of TA compared with other antifibrinolytics and placebo.38-40

Serine Protease Inhibitors Aprotinin Serine proteases are ubiquitous enzymes responsible for coordinating a wide variety of physiologic functions. The nonspecific serine protease inhibitor (serpin) aprotinin was in widespread use in cardiac surgery between FDA approval in 1993 and removal from

the market in 2007. It also saw use in other surgical applications such as liver transplantation and orthopedic surgery. Although it was withdrawn from the United States market following a large Canadian trial showing an increase in mortality relative to lysine analog antifibrinolytics,41 the drug remains controversial. Both Canadian and European regulatory agencies recently withdrew their prohibition against the marketing of aprotinin. Aprotinin inhibits several serine proteases, including trypsin, plasmin, plasma kallikrein, and tissue kallikrein. It also inhibits the contact phase activation of coagulation that initiates coagulation and fibrinolysis, and has minor inhibitory effects on the intrinsic pathway coagulation factors. Aprotinin also exerts an indirect preservative effect on PLT function during CPB.36 Aprotinin was extensively studied in cardiac surgery patients and found to significantly decrease blood loss and transfusion in adults and children. Comparison studies with the lysine analogs typically demonstrated superiority of aprotinin, particularly in high-risk patients. Multiple RCTs of aprotinin also demonstrated safety, but beginning in 2006, 3 retrospective studies found an increase in serious adverse events associated with the drug, resulting in an FDA advisory. When the Canadian

prospective RCT showed an increase in mortality in patients treated with aprotinin, the FDA decided to remove the drug from the market. Nafamostat Nafamostat mesilate is a synthetic serpin used in Japan since 1981.42 It is not approved in the United States. Nafamostat inhibits thrombin, factors Xa and XIIa, kallikrein, plasmin, and complement factors (C1r, C1s). Nafamostat also preserves PLT function and attenuates systemic inflammatory response. The drug has been investigated as an anticoagulant in extracorporeal circuits and as a hemostatic agent in cardiac surgery. Several studies conducted in Japan reported a significant reduction in postoperative blood loss in cardiac surgery.43 Large RCTs are needed to define its role in the perioperative period. Ecallantide Ecallantide (Kalbitor, Dyax) is a recombinant human peptide derived from tissue factor pathway inhibitor. The drug is FDA-approved for the treatment of hereditary angioedema. Ecallantide inhibits plasma kallikrein with high affinity, and plasmin with lesser effect. Early clinical data demonstrated that ecallantide decreases blood loss and need for transfusion in patients

Desmopressin Desmopressin acetate (DDAVP, Sanofi-Aventis) is a synthetic vasopressin analog that stimulates the release of factor VIII and von Willebrand factor from the endothelium into the plasma, where they enhance PLT aggregation.15 DDAVP is FDA-approved for treatment of hemophilia A and type I von Willebrand’s disease. The drug is contraindicated in type IIb von Willebrand’s as it will cause thrombocytopenia. The recommended dose of DDAVP is 0.3 mcg/kg, and it should be administered slowly to avoid inducing hypotension. DDAVP also has been used in patients with uremia, cirrhosis, or aspirin-associated bleeding.46,47 The effectiveness of DDAVP for the prevention or treatment of perioperative bleeding in patients without known PLT disorders is not well established. DDAVP has not been consistently shown to reduce perioperative blood loss, and is associated with thrombosis and myocardial infarction in unselected cardiac surgery patients.48 Selected patients with demonstrated PLT defects may be responsive to DDAVP.49 Evidence does not support its prophylactic use in hemostatically normal patients undergoing elective noncardiac surgical procedures. Recombinant Factor VIIa Concentrate rFVIIa is FDA-approved for the management of bleeding related to hemophilia in patients with factor inhibitors. rFVIIa enhances the natural coagulation pathway through the formation of tissue factor–factor VIIa complex at the site of endothelial damage. It binds to the phospholipid membranes of activated PLTs, where it activates factor X independent of the tissue factor pathway. The result is a massive rise in thrombin generation at the surface of the PLTs.50 Because of its short half-life (2.7 hours), rFVIIa must be given as boluses that may be repeated every 2 hours (until bleeding stops) or as a continuous infusion. Recommended doses range from 15 to 90 mcg/kg. Increasing doses are associated with improved effectiveness, but are likely to carry a higher risk for thrombosis, which, along with its high cost, are the major caveats for use of this compound. The off-label use of rFVIIa may be effective in certain settings, such as in cases of intracranial hemorrhage, see Blood Loss page 25

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GeneralSurgeryNews.com / General Surgery News / April 2013

life-threatening bleeding, or as rescue therapy when excessive bleeding does not respond to routine hemostatic therapy.51 rFVIIa does not produce clots on its own. As a result, the drug should be administered only after patients have been transfused with adequate products to replenish clotting factors, including PLTs and fibrinogen. Although the literature is replete with case reports and small retrospective series showing apparently successful treatment of lifethreatening bleeding, large, prospective studies demonstrating the safety and effectiveness of rFVIIa are lacking. Moreover, considerable evidence indicates that off-label use of the drug can cause catastrophic thrombotic complications. The application of rFVIIa for serious hemorrhage should be restricted to situations in which the risk for continued bleeding unresponsive to transfusion therapy clearly outweighs the risk for serious thrombotic complications. Prothrombin Complex Concentrates Prothrombin complex concentrates (PCCs) are pooled factor concentrates of human origin and contain the vitamin K–dependent clotting factors II, VII, IX, and X. Although originally developed and approved for treatment of hemophilia B (factor IX deficiency), PCCs most often are used to reverse the effects of warfarin anticoagulation. Two 4-factor PCCs are approved for use in the United States: Bebulin VH (Baxter) and Profilnine (Grifols). Compared with fresh frozen plasma, these drugs have smaller infusion volumes to reverse warfarin-induced coagulopathy, are more effective, and do not require cross matching. Although PCCs have been used to treat coagulopathic bleeding with some evidence of success, there is insufficient evidence of their safety and effectiveness in conditions other than bleeding resulting from warfarin anticoagulation or known factor deficiencies. Thrombosis and high cost also are major considerations for the use of PCCs.52,53

Conclusions Although some agents may decrease blood loss in appropriate cases, it is important to understand the risks and limitations of each drug before it is given to a patient. It also is important to remember to first rule out surgical bleeding; no drug is a substitute for surgical hemostasis. The majority of these drugs are used perioperatively outside their FDA indications, and may have unknown safety issues. The search for ideal pharmacologic agents to reduce perioperative bleeding continues, and to date no single universal pharmacologic agent is available to solve the problem of excess perioperative bleeding and

transfusion. Although PCCs and rFVIIa may be useful in certain settings, the best data exist for the lysine analog antifibrinolytics. Large safety trials and dose-finding studies for EACA and TA are warranted. TA has emerged as a potential lifesaving drug for trauma patients, and the CRASH-3 study may show similar results for patients with traumatic brain injury.

Clinical Review 35. Chan CC, Chan YY, Tanweer F. System18. Zufferey P, Merquiol F, Laporte S. Do antifibrinolytics reduce allogeneic blood transfusion atic review and meta-analysis of the use of in orthopedic surgery? Anesthesiology. 2006; tranexamic acid in tonsillectomy. Eur Arch 105(5):1034-1046. Otorhinolaryngol. 2012 Sep 21. [Epub ahead of print] 19. Fiechtner BK, Nuttall GA, Johnson ME, et al. Plasma tranexamic acid concentrations during cardiopulmonary bypass. Anesth Analg. 2001; 92(5):1131-1136.

References

20. Koster A, Börgermann J, Zittermann A, Lueth JU, Gillis-Januszewski T, Schirmer U. Moderate dosage of tranexamic acid during cardiac surgery with cardiopulmonary bypass and convulsive seizures: incidence and clinical outcome. Br J Anaesth. 2012 Sep 17. [Epub ahead of print]

1. Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine. First of two parts—blood transfusion. N Engl J Med. 1999;340(6):438-447.

21. Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative metaanalysis. BMJ. 2012;344:e3054.

2. Kuduvalli M, Oo AY, Newall N, et al. Effect of peri-operative red blood cell transfusion on 30-day and 1-year mortality following coronary artery bypass surgery. Eur J Cardiothorac Surg. 2005;27(4):592-598.

22. Henry DA, Carless PA, Moxey AJ, et al. Antifibrinolytic use for minimizing perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2011;19(1):CD001886.

3. Taylor RW, Manganaro L, O’Brien J, Trottier SJ, Parkar N, Veremakis C. Impact of allogenic packed red blood cell transfusion on nosocomial infection rates in the critically ill patient. Crit Care Med. 2002;30(10):2249-2254.

23. Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009;123(5):687-696.

4. Reeves BC, Murphy GJ. Increased mortality, morbidity, and cost associated with red blood cell transfusion after cardiac surgery. Curr Opin Cardiol. 2008;23(6):607-612.

24. Gill JB, Chin Y, Levin A, Feng D. The use of antifibrinolytic agents in spine surgery. A meta-analysis. J Bone Joint Surg Am. 2008;90(11):2399-2407.

5. Hoffman R, Benz EJ, Shattil SS, et al, eds. Hematology: Basic Principles and Practice. 5th ed. Philadelphia, PA: Elsevier Churchill Livingstone; 2008.

25. Yagi M, Hasegawa J, Nagoshi N, et al. Does the intraoperative tranexamic acid decrease operative blood loss during posterior spinal fusion for treatment of adolescent idiopathic scoliosis? Spine. 2012;37(12):E1336-E1342.

6. Kumar V, Abbas AK, Fausto N, Aster J. Robbins and Cotran Pathologic Basis of Disease, Professional Edition. 8th ed. St. Louis, MO: W. B. Saunders; 2010. 7. Candler WL. The human fibrinolytic system. Crit Rev Oncol Hematol. 1996;24(1):27-45. 8. Levy JH, Dutton RP, Hemphill JC 3rd, et al. Multidisciplinary approach to the challenge of hemostasis. Anesth Analg. 2010;110(2): 354-364. 9. Levy JH. Perioperative methods to reduce perioperative bleeding. Transfusion. 2008;48(1 suppl):31s-38s. 10. Porte RJ, Leebeek FW. Pharmacological strategies to decrease transfusion requirement in patients undergoing surgery. Drugs. 2002; 62(15):2193-2211. 11. Butterworth J, James RL, Lin Y, Prielipp RC, Hudspeth AS. Pharmacokinetics of epsilonaminocaproic acid in patients undergoing coronary artery bypass surgery. Anesthesiology. 1999;90(6):1624-1635. 12. Pilbrant A, Schannong M, Vessman J. Pharmacokinetics and bioavailability of tranexamic acid. Eur J Clin Pharmacol. 1981;20(1):65-72.

26. Berenholtz SM, Pham JC, Garrett-Mayer E, et al. Effect of epsilon aminocaproic acid on red-cell transfusion requirements in major spinal surgery. Spine. 2009;34(19):2096-2103. 27. Dadure C, Sauter M, Bringuier S, et al. Intraoperative tranexamic acid reduces blood transfusion in children undergoing craniosynostosis surgery: a randomized double-blind study. Anesthesiology. 2011;114(4):856-861. 28. Goobie SM, Meier PM, Pereira LM, et al. Efficacy of tranexamic acid in pediatric craniosynostosis surgery: a double-blind, placebo-controlled trial. Anesthesiology. 2011;114(4):862-871. 29. Maugans TA, Martin D, Taylor J, Salisbury S, Istaphanous G. Comparative analysis of tranexamic acid use in minimally invasive versus open craniosynostosis procedures. J Craniofac Surg. 2011;22(5):1772-1778. 30. Molenaar IQ, Warnaar N, Groen H, Tenvergert EM, Slooff MJ, Porte RJ. Efficacy and safety of antifibrinolytic drugs in liver transplantation: a systematic review and meta-analysis. Am J Transplant. 2007;7(1):185-194.

31. The CRASH-2 Collaborators. The importance of early treatment with tranexamic acid in 13. Soslau G, Horrow J, Brodsky I. Effect of bleeding trauma patients: an exploratory analtranexamic acid on platelet ADP during extraysis of the CRASH-2 randomized controlled corporeal circulation. Am J Hematol. 1991; trial. Lancet. 2011;377(9771):1096-1101. 38(2):113-119. 14. Verstraete M. Clinical application of inhibitors of fibrinolysis. Drugs. 1985;29(3):236-261. 15. Franck M, Sladen RN. Drugs to prevent and reverse anticoagulation. Anesthesiol Clin North Am. 1999;17(4):799-811. 16. Kang Y, Lewis JH, Navalgund A, et al. Epsilon-aminocaproic acid for treatment of fibrinolysis during liver transplantation. Anesthesiology. 1987;66(6):766-773. 17. Miller RA, May MW, Hendry WF, Whitfield HN, Wickham JE. The prevention of secondary haemorrhage after prostatectomy: the value of antifibrinolytic therapy. Br J Urol. 1980;52(1):26-28.

32. Xu J, Gao W, Ju Y. Tranexamic acid for the prevention of postpartum hemorrhage after cesarean section: a double-blind randomization trial. Arch Gynecol Obstet. 2012 Oct 13. [Epub ahead of print] 33. Celebi N, Celebioglu B, Selcuk M, Canbay O, Karagoz AH, Aypar U. The role of antifibrinolytic agents in gynecologic cancer surgery. Saudi Med J. 2006;27(5):637-641. 34. Crescenti A, Borghi G, Bignami E, et al. Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial. BMJ. 2011;343:d5701.

36. Eaton MP. Antifibrinolytic therapy in surgery for congenital heart disease. Anesth Analg. 2008;106(4):1087–1100. 37. Manjunath G, Fozailoff A, Mitcheson D, Sarnak MJ. Epsilon-aminocaproic acid and renal complications: case report and review of the literature. Clin Nephrol. 2002;58(1):63-67. 38. Keyl C, Uhl R, Beyersdorf F, Stampf S, Lehane C, Wiesenack C, Trenk D. Highdose tranexamic acid is related to increased risk of generalized seizures after aortic valve replacement. Eur J Cardiothorac Surg. 2011;39(5):114-121. 39. Martin K, Knorr J, Breuer T, et al. Seizures after open heart surgery: comparison of e-aminocaproic acid and tranexamic acid. J Cardiothorac Vasc Anesth. 2011;25(1):20-25. 40. Murkins JM, Falter F, Granton J, et al. High dose tranexamic acid is associated with nonischemic clinical seizures in cardiac surgical patients. Anesth Analg. 2011;110(2):350-353. 41. Fergusson DA, Hébert PC, Mazer CD, et al. A comparison of aprotinin and lysine analogs in high-risk cardiac surgery. N Engl J Med. 2008;358(22):2319-2331. 42. Fujii S, Hitomi Y. New synthetic inhibitors of C1r, C1 esterase, thrombin, plasmin, kallikrein and trypsin. Biochim Biophys Acta. 1981;661(2):342-345. 43. Murase M, Usui A, Tomita Y, Maeda M, Koyama T, Abe T. Nafamostat mesilate reduces blood loss during open heart surgery. Circulation. 1993;88 (5 pt 2):432-436. 44. Data on file. DX-88/3, 2008; DX-88/16, 2009, Cubist Clinical Study. Burlington, MA:Dyax Corp. 45. Bokesch PM, Szabo G, Wojdyga R, et al. A phase 2 prospective, randomized, double-blind trial comparing the effects of tranexamic acid with ecallantide on blood loss from high-risk cardiac surgery with cardiopulmonary bypass (CONSERV-2 Trial). J Thorac Cardiovasc Surg. 2012;143(5):1022-1029. 46. Mannucci PM. Treatment of von Willebrand’s disease. N Engl J Med. 2004;351(7):683-694. 47. Mannucci PM. Hemostatic drugs. N Engl J Med. 1998;339(4):245-253. 48. Levi M, Cromheecke ME, de Jonge E, et al. Pharmacological strategies to decrease excessive blood loss in cardiac surgery: a meta-analysis of clinically relevant endpoints. Lancet. 1999;354(9194):1940-1947. 49. Despotis GJ, Levine V, Saleem R, Spitznagel E, Joist JH. Use of point-of-care test in identification of patients who can benefit from desmopressin during cardiac surgery: a randomized controlled trial. Lancet. 1999;354(9173):106-110. 50. Hedner U, Erhardtsen E. Potential role for rFVIIa in transfusion medicine. Transfusion. 2002;42(1):114-124. 51. Mayer SA, Brun NC, Begtrup K, et al. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008;358(20):2127-2137. 52. Ohga S, Nomura A, Takada H, Suga N, Hara T. Successful self-infusion of activated prothrombin complex concentrate for prophylaxis in a child with a factor VIII inhibitor. Am J Hematol. 2007;82(2):145-149. 53. Bruce D, Nokes TJ. Prothrombin complex concentrate (Beriplex P/N) in severe bleeding: experience in a large tertiary hospital. Crit Care. 2008;12(4):R105.

In the News

GeneralSurgeryNews.com / General Surgery News / April 2013

Some Device Makers Try To Pass New Tax Burden on to Hospitals B y G eorge O choa

eginning this year, medical device manufacturers must pay a 2.3% excise tax on their products—and some companies are trying to pass it on to the hospitals and other health care providers who are their customers. The move is drawing opposition from hospitals and group purchasing organizations (GPOs). Adam Robinson, clinical contract

manager at Beth Israel Deaconess Medical Center, Boston, saw a bill from one manufacturer with an extra charge of $8.05—which the hospital determined corresponded to the label “TX” for the excise tax. The extra charge was 2.3% of a $350 cost for two boxes of collodion. He declined to identify the manufacturer in the interest of maintaining good relations with suppliers. “We’re a tax-exempt organization,” Mr. Robinson said in an interview. “We told them we’re not going to

pay it. Later, they sent us a letter saying all taxes are included in the invoice ‘for your convenience.’ They increased the cost without breaking it out.” Pete Allen, senior vice president, Sourcing Operations, at Novation, a GPO in Irving, Texas, said, “We negotiate contracts on behalf of hospitals, and out of approximately 1,200 contracts, only three have tried to pass on the tax. We protested vociferously, and they withdrew those efforts. Now, 100% of contracted suppliers

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have agreed not to pass on the tax.” Novation provided General Surgery News with a list of some non–Novationcontracted suppliers that their members had told them tried to pass the tax on to them. They included Applied Medical Technology, Inc. (AMT); Beekley Corp.; Blue Endo; Cadwell Laboratories, Inc.; Gambro; Hans Rudolph, Inc.; Lenstec, Inc.; STAAR Surgical Co.; Stradis Healthcare, LLC; and Wy’East Medical Corporation. Asked for comment, the companies gave varied responses. In a statement, AMT acknowledged having billed the tax on their invoices, but said that “after reviewing feedback from our customers, AMT has decided to remove the medical device excise tax charge from future invoices.” STAAR Surgical said in a statement that “the company is passing the tax to purchasers similar to all sales taxes.” “We are absorbing the cost of the tax; therefore, we are not passing that cost on to our customers,” Cynthia Dupuis, international customer service manager, Lenstec, St. Petersburg, Fla., said in an email. Bret Buhler, president, Stradis Healthcare, Lawrenceville, Ga., acknowledged billing customers for the tax and commented, “It was a cost we could not afford to absorb.” Kelly Rudolph, president, Hans Rudolph, Shawnee, Kan., said in a statement: “We honor all contracts and agreements with our customers … we do not share our customers’ information with anyone as this is confidential information.” By press time, the other companies listed had not responded to requests for comment. Mr. Allen said that the companies passing on the tax have been mostly “small, independent, owner-owned companies, although there have also been a few larger companies.” Additionally, “it seems like it’s mostly mid-range companies, but it’s hard to be definitive,” said Curtis Rooney, JD, president, Healthcare Supply Chain Association, Washington, D.C., a trade association representing GPOs. According to Mr. Rooney, “excise taxes are prohibited from being deducted, being passed on.” However, in a statement, AMT asserted that the Internal Revenue Service “allows the tax to be passed on.” The IRS did not respond to requests for comment. Opponents of passing on the tax argue that hospitals already are paying their share of the costs associated with the Affordable Care Act (ACA), of which the medical device tax was a part. “When [President] Obama proposed this bill,” said Mr. Allen, “they looked for different funding elements. Pharma agreed to $80 billion to pay for the ACA. The hospital community agreed to $155 billion over 10 years in reduced reimbursements. But

GeneralSurgeryNews.com / General Surgery News / April 2013

â&#x20AC;&#x201A;

â&#x20AC;&#x201A; In the News

FDA Approves New Indication for Avastin With Chemotherapy for Colon Cancer The FDA has approved a new use for Avastin (Genentech; bevacizumab) in combination with fluoropyrimidinebased irinotecan or oxaliplatin chemotherapy for use in patients with metastatic colorectal cancer (mCRC). The new indication will allow people who received Avastin plus an irinotecan- or oxaliplatin-containing chemotherapy as an initial treatment (first-line) for mCRC to continue to receive Avastin plus a different irinotecan- or oxaliplatin-containing chemotherapy after their cancer worsens (second-line treatment). The approval is based on positive results from the Phase III ML18147 study, which showed that people who continued to receive an Avastin-based treatment regimen after their cancer worsened lived longer than people who switched to chemotherapy alone. â&#x20AC;&#x153;The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment,â&#x20AC;? said Hal Barron, MD, chief medical officer and head of global product development at Genentech, in a press release. â&#x20AC;&#x153;These people now have the option to continue with Avastin plus

the medical device community fought the medical device tax completely, and some continue to fight it. Itâ&#x20AC;&#x2122;s $29 billion over 10 years; they got off pretty easy.â&#x20AC;? The medical device industry has felt effects. In preparation for the new tax, one medical device company, UreSil, LLC, in Skokie, Ill., laid off 11% of its workforce, and for a year and a half stopped working on new products, instead focusing on making â&#x20AC;&#x153;existing products cheaper,â&#x20AC;? said UreSilâ&#x20AC;&#x2122;s president, Lev Melinyshyn. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s not good for the patient; new technologies wonâ&#x20AC;&#x2122;t be available as soon.â&#x20AC;? His company decided not to pass on the tax to avoid customer resistance. â&#x20AC;&#x153;We got communications from customers telling us, â&#x20AC;&#x2DC;donâ&#x20AC;&#x2122;t even try to pass it along because we wonâ&#x20AC;&#x2122;t pay it,â&#x20AC;&#x2122;â&#x20AC;? Mr. Melinyshyn said. Chris White, JD, general counsel and senior vice president of AdvaMed, a trade association for the medical device industry in Washington, D.C., said in a statement: â&#x20AC;&#x153;Like all other taxes, the true incidence of the device tax will be determined by market forces and will vary from company to company.â&#x20AC;? He added: â&#x20AC;&#x153;We have consistently said the device tax is bad policy, and thatâ&#x20AC;&#x2122;s why AdvaMed and its member companies continue to fight for its repeal.â&#x20AC;? Mr. Allen, Mr. Buhler, Mr. Melinyshyn, Mr. Robinson, Mr. Rooney, Mr. Rudolph, and Mr. White reported no relevant financial conflicts of interest.

a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone.â&#x20AC;? The ML18147 study was a randomized, open-label, multicenter, multinational trial evaluating the efficacy and safety profile of Avastin plus standard second-line chemotherapy in 820 patients with mCRC whose disease had progressed following Avastin plus standard first-line chemotherapy (irinotecan- or

oxaliplatin-based). The primary end point of the trial was overall survival measured from the time patients were randomized to receive the second-line treatment. Results showed that the risk for death was reduced by 19% in patients who received Avastin in combination with standard chemotherapy in both first- and second-line, compared with those who received chemotherapy alone (hazard ratio, 0.81; P=0.0057). The median overall survival was 11.2 months in the Avastin

group compared with 9.8 months in the chemotherapy-alone group. Adverse effects in the trial were consistent with those seen in previous pivotal trials of Avastin in mCRC. Avastin contains several boxed warnings: In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including gastrointestinal perforation, surgery and wound-healing problems, and severe bleeding. â&#x20AC;&#x201D;Based on a press release

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Superbugs

continued from page 1 report, in the last decade, hospitals have seen a fourfold increase in CRE, with most of the increase attributable to Klebsiella species (MMWR 2013;62:1-6). The fact that these superbugs are making their presence most felt in hospitals is not surprising: In healthy patients, KPC may colonize the intestines without causing disease, but in patients whose immune system is impaired—a common occurrence during a hospital stay—it can turn deadly. KPC can spread through

GeneralSurgeryNews.com / General Surgery News / April 2013

human-to-human contact and has been found to live on equipment such as catheters. In the past, K. pneumoniae typically had been treated with cephalosporins or carbapenems antibiotics, but the bacteria are becoming increasingly resistant. Thus, drugs used to treat the organism, including colistin, polymyxin B and tigecyline are not always effective alone, so they have to be combined. “But there’s no real, solid data on the drugs of choice,” Dr. Rapp noted, and medical staff “are just kind of flying by the seat of their pants.” With no new antibiotics in the pipeline, “we really have a problem,” he stressed. “If

you come down with one of these [superbug infections], your chances of dying are high—probably 40% to 50%,” a figure echoed in the March CDC report. KPC is “definitely something that’s on our radar,” said Claudine El-Beyrouty, PharmD, BCPS, an infectious disease pharmacist at Thomas Jefferson University Hospital in Philadelphia. Although KPC was detected first in New York, in 2000, most hospitals in the Northeast region of the country have encountered it. At Jefferson, several

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patients per quarter carry the organism or show signs of being infected, Dr. ElBeyrouty noted. KPC most often is found among critically ill patients hospitalized for extended stays or in patients who go in and out of the hospital frequently, she said. The hospital manages the infections through a multitiered approach, Dr. ElBeyrouty noted. Infection control personnel track cases; once the organism is detected in a patient, the person is isolated and the chart is flagged. If the patient is discharged and later returns, the flag is reactivated and the person is isolated again. Caregivers treating these patients wear gowns and gloves and employ handwashing techniques. Pharmacists participating in the hospital’s antibiotic stewardship program try to reserve agents like colistin, tigecycline and amikacin specifically for KPC patients.

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One of the most difficult Klebsiella outbreaks to control occurred in 2011, at the National Institutes of Health (NIH) Clinical Center in Bethesda, Md., where the organism infected 19 patients, seven of whom died. That June, a 43-year-old woman with lung disease was transferred to the medical center from a New York hospital. Medical staff knew the patient was colonized with KPC, so they isolated her and wore gowns, gloves and masks while treating her. Three weeks after that patient left the hospital, a cancer patient who had no contact with the infected patient developed KPC. Ten days later, a patient with an immune disease also became infected. NIH epidemiologists and infection control specialists scrutinizing the problem found that the organism had been transmitted from the first patient despite following all infection control protocols. They implemented additional procedures to prevent further transmission, including more invasive testing of ICU patients; using rectal swabs to check for KPC carriers; building a wall to create a specific unit to care for and isolate KPC patients; paying monitors to ensure everyone followed infection control procedures; and

GeneralSurgeryNews.com / General Surgery News / April 2013

In the News

‘If you come down with one of these [superbug infections], your chances of dying are high—probably 40% to 50%.’

cited the emergence of resis- superbugs “a major threat emerging in savior coming from Pharma.” tant Enterobacter and Esche- our hospitals.” Dr. Rapp urged hospitals to take richia species. By releasing That statement is not surprising, the same types of proactive approaches these findings, the agency given the 40% mortality associated with detailed in the Science Translational Medsucceeded in getting a long- some of the superbug infections. More- icine report. —Robert Rapp, PharmD, FCCP standing problem quite a bit over, many of the bacteria have a kind “We have several tools to prevent transof media attention. News of “panresistance” that renders them, in mission and improve patient outcomes, spraying hydrogen peroxide in rooms articles in The Wall Street some cases, unresponsive to most avail- including better infection control practicand on equipment. They reported their Journal, The New York Times and televi- able antimicrobials, which makes even es, strong antimicrobial stewardship proefforts in the journal Science Transla- sion news outlets covered the report in combination treatments problematic, grams and optimization of the pharmational Medicine (2012;4:148ra116). seemingly alarmist terms. Most quot- the CDC researchers reported. cokinetic/pharmacodynamics of our presThe last carrier was identified in ed one health official who termed these “Make no mistake, this is a public ently available agents to enhance the killDecember 2011, but patients still resistant organisms “nightmare bacteria,” health crisis,” Dr. Rapp said. With the ing of these bacteria,” he said. “So we are are swabbed to check for KPC and the CDC’s Arjun Srinivasan, MD, pipeline for new drugs looking dismal certainly not powerless in this fight. But when they arrive and before they got a lot of coverage when he called these right now, “I don’t see much hope for a it’s going to be a long battle.” leave the facility. The pharmacy faced several challenges during that time, said Timothy Jancel, PharmD, BCPS, a clinical pharmacy specialist in infectious diseases at the hospital. The isolation unit was created overnight, he said, so pharmacists had to quickly install a new drug-dispensing unit and decide how emergency medicines would be delivered. They educated staff on handwashing and isolation protocols. Because some isolated patients took their own medicines, pillboxes leaving the unit had to be sterilized. ETHICON INTRODUCES NEW Infectious disease experts worked with with staff to come up with antibiotic regSTRATAFIX™ SPIRAL KNOTLESS TISSUE CONTROL DEVICES imens to treat and monitor KPC, which involved educating a lot of people, Dr. Jancel said. Medications like colistin have “been around for decades, but we never had to use it because we always had other options.” Devising accurate dosing was challenging because labeling requirements were less stringent when colisA comprehensive portfolio for multiple surgical applications. tin was approved, and the pharmacokinetics of the antibiotic still are not well Consistency Security Efﬁciency understood, he added. They had to comMore consistent tension Strength and security of More efﬁcient than bine colistin with gentamicin and tigecycontrol and approximation interrupted suturing without continuous suturing* cline for some patients, and then monitor * 1-4 them for side effects including renal toxduring closure knot-related complications icity, pancreatitis, nausea and vomiting. “We were using drug combinations typically not used on a daily basis,” Dr. Jancel said. Investigational antibiotics were also pursued. Although one agent was acquired and administered to one patient, it was too late: The person died a few days after starting therapy. Dr. Jancel said he has helped thwart other types of antibiotic-resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), but MRSA still had treatment options such as linezolid (Zyvox, Pfizer), trimethoprim/sulfamethoxazole or clindamycin. “With gram-negative bacteria [like KPC], we’re For more information, contact your Ethicon representative or call 1-800-255-2500 getting to the point where we don’t have For complete product details, see Instructions for Use. other options.”

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More From the CDC Report As daunting as Klebsiella is to eradicate in the nation’s hospitals, it isn’t the only superbug that poses a public health threat, the CDC report stressed; the authors also

Compared to traditional sutures. References: 1. Data on ﬁle, Ethicon, Inc. 2. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178. 3. Rodeheaver GT, Pineros-Fernandez A, Salopek LS, et al. Barbed sutures for wound closure: in vivo wound security, tissue compatibility and cosmesis measurements. In: Transactions from the 30th Annual Meeting of the Society for Biomaterials; Mount Laurel, NJ; p. 232. 4. Vakil JJ, O’Reilly MP, Sutter EG, Mears SC, Belkoff SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713 © Ethicon, Inc. 2012 SFX-462-12

Opinion

GeneralSurgeryNews.com / General Surgery News / April 2013

It’s Not How You Look: A Cautionary Tale From the Ward B y S teven K ron , MD “ You look mah-velous! You know, my father used to say to me, ‘Nando, don’t be a schnook. It’s not how you feel—it’s how you look!’” —Billy Crystal

he shaking chills rattled me out of a deep sleep. If only I could raise the temperature in my spaceship. My eyes opened—it was 2 a.m., and I was home in bed, not on a medical mission to Alpha Centauri. I pulled the covers higher, to no avail. By morning I was achy, weak and febrile, and spent the next 24 hours in bed barely able to eat or drink. The next day, my right leg was red and swollen and my doctor, who is almost always

available, was out of town, so it was off to the emergency room. It was my birthday and I was as sick as I have ever felt. As she took my vital signs, the efficient triage nurse got my basic information and chatted. “But you must have forgotten to list your β-blocker. Your blood pressure is 110/60 and pulse 62,” she said. I proudly explained that those numbers were typical for me. I was as healthy as a horse and my only medication is a

baby aspirin. I heard the same comments, more or less, from the emergency physician and nurses as they asculted, thumped, prodded, drew blood and placed an IV catheter. “And,” each said, “you look great—15 years younger.” Despite feeling very ill, I sucked it up. Looking back, I don’t think I made it clear enough that I felt lousy and had taken little by mouth in more than a day. It took a few hours to get admitted to the best room in the house: private, top floor, corner with views of the park. My afternoon nurse and technician introduced themselves, hooked up my catheter to a pump and administered my first dose of antibiotic. My vital signs remained similar to those during triage. And of course, “Doctor, you look so young. If there is anything we can do, just ask.” Everyone was so nice and complimentary. I poked at dinner but couldn’t eat, and managed only a few sips of ginger ale. The night shift arrived and told me how the night would progress and, naturally, how great I looked. It occurred to me that hours had passed since I had gone to the bathroom—many more than usual. It took minutes to get out of bed; everything hurt. I passed a few drops of urine and, feeling dizzy and hot, stumbled back to bed. I glanced at the IV bag: only 300 cc had been infused since I was admitted. But for those few sips, I was NPO for 36 hours. My fluid deficit had to be four or five liters. “Nurse,” I called. “I am dehydrated. I need fluid, lots of fluid—stat!” My nurse said he would call the covering physician and turned to walk out. But I begged, “Take my vital signs,” and to humor me, he did. My blood pressure was 155/87, my pulse was 95 and my temperature read 101.6 F. “So, you have high blood pressure?” “No, no,” I tried to explain. “These numbers are misleading; I’m hyperdynamic.” He quickly received approval by phone to bolus me one liter over a few hours, after which I would receive more as needed. As the saline trickled in and I unhappily contemplated my options, the light bulb went on. I paged the on-call anesthesiologist and, like the cavalry riding over the hill, he soon appeared carrying two liters of Ringers and a blood pump. He closed the door, pulled the curtain and quickly infused the life-giving fluid. As my cerebral perfusion improved, I began to wonder how this issue had been missed and what would have happened had I not self-diagnosed and been aggressively, although unofficially, treated. I imagine that my next vital

GeneralSurgeryNews.com / General Surgery News / April 2013

signs would have been even more abnormal. The staff would have increased my IVs, although not nearly as much, and I would have improved—eventually, but not as fast. Had I more comorbidities, the outcome might not have been quite so good. Of equal interest, I thought I had wonderful care and attention from all the staff. What was missing? An answer arrived three weeks later in the form of a fourpage questionnaire which was similar, if far more detailed, to the one sent following a hotel stay or automobile oil service: Was I treated with respect by nurses, aides and dietary? Check. Was the bathroom clean? Check. Was my pain treated? Check. Was the food hot? Check. Although these aspects of a hospital stay certainly are important, are they critical? Does the quest for perfect customer satisfaction equate to the delivery of excellent medical care? There is evidence out there suggesting that the two do not necessarily correlate but like the No Child Left Behind program in public education, the hospital is teaching to the test. Then, there is nursing time devoted to the electronic medical record—the one we are assured will bring health care to new and unimaginably improved heights. Aggravating the nursing shortage, this represents a further loss of face time with the patient and may result in the nurse missing subtle (or not so subtle) changes in the patient’s condition. Lastly, where were the doctors? My physician returned from vacation and saw me the following morning. He devoted time and effort to my illness and cured me but where was that crew of interns and residents, the hardworking slightly disheveled physicians in training who used to round on us sick folk looking for just such issues as I had? Gone, baby, gone. When I asked him, my doc simply said, “Welcome to the 21st century.” On Dec. 16, the day of my admission, no less an authority than The New York Times gave its imprimatur to the way things are and will be: “There is plenty of evidence,” an editorial in the paper declared, “that well-trained health workers can provide routine service that is every bit as good or better than what patients will receive from a doctor” (italics mine). The piece went on to glorify the abilities of various providers, including patients themselves, as superior to those of MDs. How long before hospitalized patients will have to bring their own bandages, medicines and toilet paper? The 21st century, indeed! I was discharged after two days of IV antibiotics. As my wheelchair went past the front desk, I caught a reflection of my sad and aging face. —Dr. Kron is an anesthesiologist in Southington, Conn.

Opinion

Actively Engaged Patients Have Lower Costs, Better Outcomes Patients with the knowledge, skills and confidence to be actively engaged in their health care are likely to incur lower health care costs than patients without those characteristics, according to a study in Health Affairs. An accompanying literature review found a growing body of evidence that more actively engaged patients also have better health outcomes and health care experiences. In the cost study (2013;32:216-222), the researchers examined data from 33,163 primary care patients enrolled

with Fairview Health Services, a hospital system based in Minneapolis, Minn. Patient activation was measured with a scoring system consisting of 13 items such as “I know how to prevent problems with my health” and “I am confident that I can tell a doctor my concerns, even when he or she does not ask.” The researchers found that patient activation scores from 2010 were a significant predictor of cost of care in the first half of 2011: Patients with the lowest activation level had costs 21% higher than patients

with the highest activation level (P<0.05). The findings held true even after controlling for sociodemographic factors and the severity of health conditions. The literature review (2013;32:207214), identified interventions that have been shown to increase patient activation, such as tailored coaching—a strategy that helps customize support to the individual’s activation level. Efforts to expand patient activation are, the authors said, “a pathway toward improving outcomes.” —George Ochoa

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Opinion Private Practice continued from page 1

and outpatient services. How long can this costly state of affairs last? The government is under tremendous pressure to reduce Medicare costs. Over the past 30 years, health care expenditures have increased from 7% to 16% of the gross national product (GNP). The number of uninsured people has increased from 30 to 50 million (Wikipedia, Health Care in the United States). For a family of four, the cost of health care has increased to $20,000 annually according to a recent report from the Milliman Medical Index (Am Med News, June 4, 2012). And the public is asking if all these expenditures are worthwhile. The health of the U.S. population is no better than the health of citizens of many countries that spend far less on health care than the United States. Hospitals comprise the nation’s largest single health care expenditure at about 30% of the total. Both the government and employers are finding it increasingly difficult to pay for skyrocketing health care costs. And they are finally beginning to scrutinize hospital costs (see “Bitter Pill Should Be a Wake-up Call for Surgeons,” page 34). An article last year in the St. Louis Post-Dispatch ( June 14, 2012) listed the costs of magnetic resonance imaging (MRI) at various hospitals and outpatient imaging centers. There was at least a threefold difference in pricing. A private for-profit

GeneralSurgeryNews.com / General Surgery News / April 2013

hospital was the least expensive. The largest hospital system in the area refused to reveal its prices for MRIs. Competition is supposed to be the hallmark of managed care, under which our current health system operates and which was supposed to reduce health care costs. How can there be competition when there is no price transparency? Why does this marked disparity in hospital pricing exist? MRIs aren’t the only overpriced hospital service. Hospitals strongly urge their employed physicians to refer their patients to hospital imaging centers for other types of x-rays and to high-priced, hospital-owned clinical laboratories and outpatient surgical centers.

Reimbursements Vary

How can there be competition when there is no price transparency? Why does this marked disparity in hospital pricing exist?

The influential governmental nonpartisan Medicare Payment Advisory Commission (MedPAC) has recommended cuts in hospital reimbursement. One major cut would be in primary care services. Currently a mid-level office visit for a hospital-owned doctor is $124.40. The same visit in a private physician’s office is $69.97 or 44.6% less. MedPAC has recommended the elimination of this disparity (Am Med News, March 26, 2012).

GeneralSurgeryNews.com / General Surgery News / April 2013

The ‘experts’ contend that cost savings can be realized when physicians practice as employees in vertically integrated systems like Mayo Clinic, the Cleveland Clinic, Kaiser Permanente and other hospital systems. There are no studies to support this assumption. MedPAC has recommended uniform pricing for identical treatments, regardless of whether they are administered by doctors who own their own practices or doctors who work for hospital-based clinics. It is estimated that this change alone would save Medicare about $1 billion per year. If implemented, it would also severely hamper hospitals’ ability to attract physician employees. How did it come about that the government and insurance companies pay doctors in private practice so little but pay hospital-based doctors so generously? Both the Federal Trade Commission and corporate managed care organizations have encouraged hospitals and health plans to employ physicians. Policymakers hold as an article of faith that conflicts of interest inherent in feefor-service private practice are the root cause of high health care costs. The “experts” contend that cost savings can be realized when physicians practice as employees in vertically integrated systems like Mayo Clinic, the Cleveland Clinic, Kaiser Permanente and other hospital systems. There are no studies to support this assumption. In fact the data, some of which is cited above, support the opposite conclusion. What percent of the GNP does health care have to consume before policymakers start making changes in hospital reimbursement? When will hospitals be held accountable for their lavish spending on massive unnecessary building programs, huge administrative salaries, advertising, and yes, even subsidies to

GSN is now on

Opinion

physicians? And when will the so-called experts in health care admit that multihospital mergers and the ownership of physician practices function as monopolies that raise, not lower, costs? The average physician rushing to sell his or her practice to a hospital doesn’t have time to think about these questions. There are bills to pay, children to send to college, mortgage payments to meet and savings to put away for retirement.

Possibilities for Change But sooner or later, the good times for

hospitals will have to end. The hospitals will of course vigorously oppose any changes in the current system. Congress is not bound to accept the recommendations of MedPAC. Hospitals constitute a very powerful lobby and will use all of their vast resources to maintain the status quo. Economic reality may nevertheless force them to cut back on nonessential expenses. If third-party payers and the government decide to pay physicians owned by hospitals at the same rate that they pay physicians in private practice (as MedPAC recommends), physicians

may find becoming a hospital employee less attractive. And hospitals might be forced to lay off many of their employed physicians. If such a scenario plays out, private practice could make a comeback. —Dr. Gale practices internal medicine in St. Louis and is a contributing editor for Missouri Medicine.

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Opinion

GeneralSurgeryNews.com / General Surgery News / April 2013

‘Bitter Pill’ Should Be a Wake-Up Call for Surgeons B y M itchell R oslin , MD, FACS

hen I was growing up, the names DeBakey, Cooley and Starzl were household names. It was international news when Christian Barnard did the first-ever heart transplant and when Leonard Bailey performed a heart transplant on Baby Fae. Although

quite well educated and interested in health care, I doubt my parents knew who the CEOs of Baylor, Texas Heart, University of Colorado or the University of Pittsburgh were, or any institution in which these esteemed surgeons worked. Neither of my parents was a physician and their knowledge base was representative of well-informed individuals. Every day they watched the news with interest, and our surgical pioneers were a source of pride and were widely revered.

That is why Steven Brill’s article “Bitter Pill: Why Medical Bills Are Killing Us” (Feb. 20) in Time magazine is a must read for every surgeon, and should serve as a rapid wake-up call. Most importantly, it should make us realize the importance of working as a collective entity and make us insist that our societies and lobbying groups represent our real interests. Surgeons should be compensated fairly for each procedure we perform, and we need to reassume the role as the central focus of our health care facilities. Patients travel to and revere those of us who have special skills and perform high-risk procedures. We need to regain control and not allow the respect that the public has for us to decline. We are not interchangeable parts, and we cannot allow hospital administrators to make us a commodity.

We should not tolerate a system in which the facility is overcompensated and the surgeon’s fee is undervalued.

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Opinion

Should Be ‘Bitter Pill’ Call A Wake-Up

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In his front-page article, Mr. Brill details the high collective pay of hospital and health care system CEOs. More importantly, he describes our health system as one in which there are no real rate sheets. Hospitals charge inflated rates to entities that do not have prearranged contracts. Thus, what Medicare or Blue Cross pays for medical services or for surgical procedures is far less than what a patient would pay if he or she wants to pay for his or her own services. Mr. Brill got a lot of things right in his article, but he did not discuss the implications and what has happened to surgeons. Where does the CEO’s money come from? The unfortunate answer is it comes from us. What has happened in the past several decades is that payments have increased for facilities and have been reduced to providers. It is essentially a wealth redistribution plan. The justification for this system is that physicians would not otherwise provide for the poor or those who require government assistance. To make sure the indigent receive care, decision-making power on reimbursement was given to the facility, which would then hire physicians. As a result, an artificial, inefficient market was created. In New York state, Article 28 allows for an inflated facility fee to any center

GeneralSurgeryNews.com / General Surgery News / April 2013

The public understands the years of training and the skill required to be a top surgeon. If they do not, we need to educate them. I believe that they want us to be well compensated and believe we deserve fair rates. with this designation. If a physician sees a patient in his or her own office, the physician is paid a small fraction of the fee, with the bulk of the reimbursement going to the facility. As a result, it is impractical for any physician to see Medicaid or subsidized patients in a private setting. Similarly, Medicare has subtly followed a similar system. The facility payment, or Part B, is much higher than the Part A payment or the physician payment. A cardiac surgeon gets paid $1,900 for coronary artery bypass grafting. In cities such as New York, no one could survive on private practice revenue alone. A Whipple procedure pays even less. And yet the conditions for which these procedures are performed have high-paying diagnosisrelated groups that reimburse the hospital well. Private insurance is beginning to follow a similar model. This means that the majority of money is being paid to the hospital or the health care system, which then redistributes the money. To date, many of us have done well in this model. For disclosure, I am a full-time employee of North Shore-LIJ, a large health system in New York City, and I have been treated well and compensated fairly. That being said, I realize that the bariatric program that I run could not survive without hospital support. This means as surgeons, if things remain the way they are, we are going to lose leverage and have fewer options. Physicians also have manipulated the system for their own self-interest. Surgeons should have the right to set rates and get fair compensation for a procedure. But the idea that patients go to an emergency room and then get seen by a physician who is out of network and then collects a fee beyond what is reasonable is also not right. This practice is unjustly rationalized by the feeling that it compensates for treating the patients for whom we get paid very little. Mr. Brill has paved the road for us to gather public support and change the system before it is too late. The reason CEOs are getting paid is that they control the revenue. It is not hard to improve your bottom line as a nonprofit hospital.

Opinion One popular way is to merge with other hospitals so you reduce the common costs and gain leverage in contract negotiations. As a collective entity, we need to campaign so that we get paid a fair rate for each case. We should not tolerate a system in which the facility is overcompensated and the surgeon’s fee is undervalued for either public or private reimbursement. Nor should we encourage a system in which we are either under- or overpaid. It is not too late, but soon it will be. Currently, every patient knows the name of the surgeon who performs his

or her operation. But they don’t know the CEO of the hospital. Few remember who the anesthesiologist was, but everyone can recall and speak about the surgeon who treated them. Before another day passes, we need to draw attention to these facts. We undergo the most training, take the highest risk and have the most responsibility. An analogy can be made to sports. Fans want to see the players. Coaches and general managers are compensated well, but certainly not close to star players. Also, sports provides an excellent model. Before the formation of the players associations see Bitter Pill page 36

Opinion Bitter Pill

continued from page 35

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and collective bargaining, owners kept the majority of revenue. That formula has really changed and shows the power of organization. Another misconception is that those who perform surgery are overcompensated and that more money should be diverted to keep people healthy. There are many problems with this viewpoint. Can we really make people healthy? Can we force them to exercise, to not smoke, to lose weight and to eat healthier foods? Also, does it take extensive education to be aware of these facts? FILE SLUG No, people should take care of them1ST PROOF LAYOUT APPROVED selves and we should INITIALS AND exist DATE to assist them and fix things when they happen. Again, MAX sign-off returning to sports, I am sure the WashSenior Editor ington Redskins have an excellent trainEditor ing staff that Copy attempts to keep their players healthy.SalesYet, all of our attention was on Dr. James Andrews when star Production quarterback Robert Griffin III reinjured his knee. WhoCreative was ultimately responsible for RGIII’sCOMMENTS: million-dollar knee and whose judgment was questioned? Steve Brill has laid a foundation in his Time article. Now it is our turn. We need to go to our societies and make

clear that we want fair compensation for every case. We do not want bundled fees going to hospitals. We do not want fees artificially raised for the facility and lowered for the provider in either the public or private sector. We do not want large sums going to the hospital and then have the CEO redistribute. Additionally, we have no issue with our rates being transparent. I am certain that our public wants our best and brightest to grow up and be physicians. They want great surgeons who cure cancer, reverse heart disease and allow them to grow old with joints that work. The public understands the years of training and the skill required to be a top surgeon.FINALIfOK they do not, wePROOFneed to edu1 12/10 cate INITIALS them. I believe that they want us AND DATE REV 1 12/17 to be well compensated REV and believe we 2 deserve fair rates. They REVdo3 not underREV 4 stand a system that reimburses vastly REV 5 procedure. different sums for the same 6 Most of all, they do notREV care who the REV 7 hospital CEO is and what system mergREV 8 es with which. We needREV to take these 9 facts to the public and deliver our message before the window closes. —Dr. Roslin is chief of bariatric surgery, Lenox Hill Hospital/North ShoreLIJ, New York City.

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Letter to the Editor

Attention to Postoperative Pain To the Editor: I’m writing in regard to the excellent article, “Chronic Pain Can Be Limited by Anesthesia Choice” by Damian McNamara, which was published in the February 2013 edition of General Surgery News [page 1]. I am a general surgeon who has practiced “preemptive analgesia” for years. I inject 0.5% Marcaine [Hospira, Inc.; bupivacaine and epinephrine injection] intoSTATUS allANDthe layers of the tissue on which HISTORY I’m operating before making my incision. PICKED UP FROM: Studies have shown that this practice APPLIED TO: diminishes the production of substances at the cellular level that contribute to long-term postoperative pain. Before closing the wound, I again inject Marcaine into all the tissue layers. I also use pain pump catheters in all patients who have wounds large enough to contain them. Hopefully, the new drug Exparel [Pacira Pharmaceuticals, Inc.; bupivacaine liposome injectable] may obviate the need for pain pumps. If you ask our hospital’s postoperative nursing staff which doctor’s patients have the least amount of pain, they’ll

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GENER ALSUR GERYN

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The Independent

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Opinion

Surgery Under the Affordable Care Act: Problems and Possible Solutions

, MD B Y H. D AVID R EINES by ow that the decision e Court the U.S. Suprem Affordable guarantees that the is indeed the Care Act (ACA) it is time to law of the land, ly in medstop ranting, especial face reality. I ical journals, and Limbaugh or Rachel don’t listen to Rush believe that ranting Maddow, and I don’t and and deal with helps anyone underst e. This medicin face in the problems we attempt to discuss opinion piece is my with my peers a very complex problem will stimulate I hope in a manner that anding underst and on thoughtful discussi . y complex problem of an overwhelmingl chief justice of the Last spring, the on the deciding vote United States cast acare” “Obam called what some have was idea of a mandate the though (even originating severa Republican idea the Heritage Founda al years ago with despite a poor job tion). The law stands by the Obama of selling the program

see AFFORDABLE

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Chronic Pain Can Be Limited by Anesthesia Choice

otomy Breast Surgery, Thorac at Six Months Patients Better Off al Anesthesia With Local, Region B Y D AMIAN M C N AMARA

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gton state are urgeons in Washin complicatargeting surgical on something tions by focusing in qualioften overlooked things that ty initiatives: the improve to do patients can the weeks their outcomes in come into and days before they the operating room. state have the in s Surgeon called Strong launched a new program first large-scale program for Surgery. The patients, it is ative well-being of to target the preoper rs and patients health care provide educate to d themselves designe can do to better prepare about things patients

inistraMIAMI BEACH—Adm l anestion of local or regiona major thesia before some longoperations can prevent five at term pain for patients rapostope months to six a recent tively, according to

CARE page 33

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Not Beneficial for Enteral Contrast icitis, Study Shows Suspected Append be considered necessary when contrast does not CHICAGO—Enteral patients underdiagnostically benefit s, according to going appendectomie of patients in a study of a majority who had this proWashington state r period. cedure over a two-yea their findings, of As a result the addition of researchers said that IV contrast should enteral contrast to

not aphy (CT) is percomputed tomogr d appendicitis. formed for suspecte s participatPhysicians and hospital l Care and ing in SCOAP (Surgica ent Program), the Outcomes Assessm ative of surgeons voluntary collabor the study, led in Washington that 4 see ENTERAL CONTRAST

meta-analysis. of peo“A large percentage months, ple have pain at six tomy, especially after thoraco and breast cancer surgery l Michae ” cesarean section, said in an H. Andreae, MD, Fall interview at the annual an Americ Meeting of the l AnesRegiona of Society e. thesia and Pain Medicin assoDr. Andreae and his Andreae, MD, idenciate, Doerthe A. blind, randomized tified 23 doublethe literature that controlled trials in regional anesthesia compared local or see POSTOPERATIVE

PAIN page 32

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On the Spot

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e Surgeons’ Loung

The case of refractory

strictures and ulcers after gastric bypass; Answers to two ges Surgeon’s Challen

all tell you they’re mine. I’ve been in practice for more than 37 years, and I continue to be amazed by how little care and attention most surgeons give to their patients’ postoperative pain, especially long-term pain. Richard A. Wiethoff, MD Seymour, Ind.

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GeneralSurgeryNews.com / General Surgery News / April 2013

population-based study has found that nearly three-fourths of women who undergo contralateral prophylactic mastectomy (CPM) following a breast cancer diagnosis do so despite having a very low clinical risk for contralateral disease. The analysis of data in the Surveillance, Epidemiology and End Results program (SEER) showed that less than onefourth of women who underwent CPM had a known mutation in the BRCA1 or BRCA2 gene and/or a strong family history of breast cancer. The Society for Surgical Oncology recommends CPM for patients who meet either criterion. “Yet, many of the women who received CPM did not have any of these indications,” said lead author Sarah Hawley, PhD, associate professor of internal medicine at the University of Michigan Medical School, in Ann Arbor. She presented the findings at the American Society of Clinical Oncology’s 2012 Quality Care Symposium. Women were more heavily influenced by worry about recurrence of breast cancer

than by their true risk for recurrence, she said. Women who said they were “very worried” about recurrence were almost twice as likely to have CPM as those who reported being “somewhat worried” or “not at all” worried. CPM has not been shown to reduce the risk for a recurrence of the original cancer. The procedure reduces the risk for developing a new primary cancer in the unaffected breast, which is of great benefit to women with a high genetic risk for breast cancer but has no known clinical benefit for women without this risk. Despite this, a number of recent reports have shown that more and more women are choosing to undergo CPM. At Memorial Sloan-Kettering Cancer Center, for instance, the rate of undergoing the procedure increased threefold over an eightyear period, from 6.7% in 1997 to 24% in 2005 (J Clin Oncol 2011;29:2158-2164). The reasons for the increase remain unclear. In a study published last year in the Journal of Clinical Oncology, researchers said that women may be influenced by a fear of recurrence, reluctance to undergo repeat biopsies and a desire for breast symmetry (J Clin Oncol 2011;29:2158-2164). see Mastectomy page 38

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GeneralSurgeryNews.com / General Surgery News / April 2013

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In the News Mastectomy

GeneralSurgeryNews.com / General Surgery News / April 2013

5% to 10% of breast cancer cases are relat- ultimately had the surgery. As expected, ed to a genetic mutation, a rate far lower CPM rates were higher among women who underwent mastectomy: 53% conthan the current rate of CPM use. The guidelines of the National ComIn the SEER study, investigators sur- templated having the double mastectomy prehensive Cancer Network (NCCN) veyed 1,446 women diagnosed with breast and 19% eventually had the surgery. FILE SLUG STATUS & HISTORY discourage CPM for most women and cancer who reported to the Detroit PROOF and 1:2/5 Jyoti Patel, MD, an oncologist and Current file: GSN DigitalAd.indd 1ST PROOF LAYOUT APPROVED FINAL OK INITIALSon AND DATE INITIALS AND DATE REV 1: assistant professor of medicine at Northrecommend that it be considered only Los Angeles SEER registries between EDITOR: REV 2: Full name of project Senior editor westernARTUniversity’s Feinberg School of a case-by-case basis for women at high 2005 and 2007. All the women underDIRECTOR: REV 3: Editor Medicine, Chicago, said the findings sugrisk for breast cancer, such as those who went follow-up surveys within four years REV 4: Project no. Copy editor REV 5: carry# a BRCA1Proof or1 BRCA2 mutation, of their original diagnosis. gest that physicians may not be adequateRevision Sales or those with Li-Fraumeni who Of 564 women who underwent mas- ly educating patients about their risk for Layout date/time April 10, 2013 1:46syndrome PM Production File path a higher risk GSN DigitalAd.indd have for contralateral breast tectomies, 107 ultimately had CPM. The recurrent disease. “Many women who overestimate their cancer. According to information com- remaining women had breast-conservrisk for developing breast cancer in the piled by the breast cancer organization, ing surgery. Overall, 35% of women inicontralateral breast undergo unnecessary Susan G. Komen for the Cure, only about tially considered having CPM and 7% Continued from page 36

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At a Glance Three-fourths of women who undergo CPM have a very low clinical risk for contralateral disease. Women were more heavily influenced by worry about recurrence of breast cancer than by their true risk for recurrence Although CPM reduces the risk for developing a new primary cancer in the unaffected breast, it has not been shown to reduce the risk for a recurrence of the original cancer. surgery. This study suggests that we reexamine how we communicate with our patients regarding the decision to undergo prophylactic mastectomy.” Women who met the clinical criteria for CPM were the most likely to undergo the procedure, according to the study. Women who reported that they had tested positive for BRCA1 or BRCA2 gene mutations were about 10 times more likely to undergo CPM than patients without a positive genetic test result (odds ratio [OR], 10.61; 95% confidence interval [CI], 2.51-44.82). Women who had two or more first-degree relatives with breast cancer were about 4.5 times more likely to undergo CPM (OR, 4.40; 95% CI, 1.52-12.71). This study is one of the largest population-based investigations with a significant ethnic and racial sample that takes into account patient attitudes and the strength of family history, Dr. Hawley said.

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Nonsurgical Approaches To Hemorrhoids HARRY SARLES JR., MD Gastroenterologist Digestive Health Associates of Texas Dallas, Texas

emorrhoids are normal vascular structures of the

anal canal. Often, they are the source of a variety of

troublesome symptoms, including bleeding, anal pruritus,

prolapse, and pain due to thrombosis of external hemorrhoids. Patients often mistake other anal or perianal problems for hemorrhoids, such as anal fissures, skin tags, hypertrophied anal papillae, anal cancer, and anal condylomata, as well as other infections. A good medical history and physical examination, including anoscopy or office proctoscopy, should guide the physician to the correct diagnosis; in cases of bleeding, a colonoscopy or sigmoidoscopy in addition to anoscopy is necessary to verify the source of the bleeding. It is the intent of this review to provide surgeons with a general introduction to the nonsurgical management of hemorrhoids.

covers the internal hemorrhoidal cushions (mucosa) and the extremely sensitive squamous epithelium, which extends up into the anus (anoderm). The junction of these 2 epithelial layers is known as the dentate line, and is typically located approximately 3 cm inside the anal verge. This line marks the transition between the columnar epithelial窶田overed internal hemorrhoids and the squamous epithelial窶田overed external hemorrhoidal vessels.4-6

Anatomy Thomson, in his description of hemorrhoidal anatomy, noted a series of 3 cushions in the anal canal, located in the left lateral, right anterior, and right posterior positions. These hemorrhoidal cushions receive their blood supply primarily from the superior and middle hemorrhoidal arteries; the superior, middle, and inferior hemorrhoidal veins provide venous drainage. A sinusoidal pattern of arteriovenous communication is formed within the cushions, which explains why hemorrhoidal bleeding is arterial, rather than venous in nature.1 In addition to the vessels noted above, the hemorrhoidal cushions are also rich in muscular fibers, arising from the internal sphincter and the conjoined longitudinal muscle. These fibers help to anchor the cushions to the underlying muscular layer of the anorectum, and it is the breakdown of these supporting fibers that eventually leads to the changes that can cause hemorrhoidal symptoms.1,2 The cushions play an important role in the maintenance of rectal continence, as they provide 15% to 20% of the resting pressure at the anal verge.3 The epithelial layer of the anorectum is characterized by the relatively insensate columnar epithelium, which

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Pathophysiology There are a number of proposed mechanisms to explain the development of symptomatic hemorrhoids, including abnormal venous dilatation, abnormal distension of the arteriovenous anastomoses, downward displacement or prolapse of the hemorrhoidal tissue, or a breakdown of the connective tissue anchoring the hemorrhoidal cushions. Prolapse of hemorrhoidal tissue is what appears to lead to the development of symptoms. This prolapse allows for mucous deposition on the perianal skin, which causes itching, and leads to tissue friability and bleeding. Other symptoms include swelling of associated external disease and fecal soiling when the prolapsing tissue precludes complete closure of the anal opening.1,7 Internal hemorrhoids are covered by the mucosa; they reside proximal to the dentate line and are generally painless. External hemorrhoids are located distal to the dentate line and are covered by squamous epithelium; patients who experience pain as a result of hemorrhoids often have a thrombosed external hemorrhoid or an anal fissure.

GENERAL SURGERY NEWS 窶｢ APRIL 2013

The causes of symptomatic hemorrhoids are not completely clear, but a number of factors, including a lack of dietary fiber, constipation, straining on defecation, diarrhea, pregnancy, obesity, a sedentary lifestyle, spending excess time on the commode, spinal cord injuries, and family history all have been suggested.8

seems to be better tolerated than the prone, “jack-knife” position.14 A digital rectal examination will identify such things scars, small fissures, and the origins of fistulae. These clinical findings will be important in formulating a comprehensive treatment plan for the symptomatic patient.15

Epidemiology

ENDOSCOPIC EXAMINATION

It is difficult to quantify the incidence of hemorrhoidal disease, in large part because many patients do not seek medical care for their condition; additionally, some attribute almost any anorectal symptom to hemorrhoids. Estimates of the prevalence of hemorrhoidal disease in the United States range from 4.4% to 40%.9 Some research suggests that 75% of the population will experience symptomatic hemorrhoid disease at some point in their lives.10 Although these estimates vary widely, it seems clear that symptomatic hemorrhoids have a significant effect on health and well-being.

Anoscopy is an accurate, efficient, inexpensive way to evaluate the anal canal quickly, with minimal discomfort to the patient. Flexible endoscopy frequently is performed to evaluate patients with symptoms of hemorrhoids, however, it is not as accurate as anoscopy. A prospective study showed that anoscopy revealed 99% of anorectal lesions, whereas endoscopy revealed 78% when performed with straight withdrawal of the endoscope, and 54% with retroflexion.16 The limitations of flexible endoscopy, along with increased cost and inconvenience to the patient, stress the need to consider anoscopy in the evaluation of hemorrhoidal disease.

Grading of Hemorrhoidal Disease Banov et al11 developed a grading system for internal hemorrhoids based on the degree of prolapse. The grade of hemorrhoidal disease has some bearing on the treatment options available to a patient with internal hemorrhoids: • grade I: non-prolapsing internal hemorrhoids • grade II: prolapse of internal hemorrhoids during defecation with spontaneous reduction • grade III: prolapse of internal hemorrhoids during defecation that requires manual reduction • grade IV: prolapse and incarceration of internal hemorrhoids; hemorrhoids cannot be reduced

Diagnosis PATIENT HISTORY As previously stated, patients often attribute any anorectal symptom to hemorrhoidal disease, and although this may partly explain symptoms, it is important for the physician to determine whether there are other issues involved as well.5,12 Internal hemorrhoids are associated with painless bleeding, prolapse, mucus discharge, soiling, and symptoms of pruritus ani; these symptoms rarely cause significant pain. External hemorrhoids usually are asymptomatic, unless they become thrombosed. Pain with defecation is commonly due to the presence of an anal fissure, which is found in up to 20% of patients with hemorrhoids.13 The relationship between symptoms, defecation habits, bleeding, and a description of factors that might relieve or exacerbate a patient’s symptoms are important to consider in the medical history.

PHYSICAL EXAMINATION A visual inspection of the perianal area will allow for the discovery and description of rashes, tags, fissures, fistulae, abscesses, neoplasms, condylomata, some cases of prolapse, and so forth. The left lateral decubitus position is preferred for the examination, as this position

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Treatment CONSERVATIVE MEDICAL TREATMENT There are a number of over-the-counter preparations intended to treat patients with symptomatic hemorrhoids. These compounds contain ingredients such as antiseptics, astringents, topical anesthetics, and corticosteroids. There is not a lot of evidence to support the use of many of these products, and the potential negative effects of the long-term use of topical steroids should be considered.17 Common dietary and behavioral recommendations for patients with hemorrhoids include increasing the intake of dietary fiber, minimizing the amount of time spent on the commode, avoiding straining during defecation, and taking sitz baths several times a day. There is evidence to support these recommendations both for the treatment of symptomatic disease and in limiting the risk for recurrence.18 These measures are a reasonable first-line approach for patients with mild symptoms.

NONSURGICAL TREATMENT Sclerotherapy Sclerotherapy uses the injection of a sclerosant into the submucosa, beneath the hemorrhoid, to create an inflammatory reaction in the soft tissue that affixes the loose hemorrhoidal mucosa back to the underlying musculature. The procedure dates back to the 1800s. Some research shows sclerotherapy to be beneficial in patients with grade I and II hemorrhoids,19 whereas other research shows it to be no more beneficial than bulk laxatives.20 Potential complications of sclerotherapy include pain, urinary retention, abscess, and impotence. Avoidance of these complications depends on precise placement of the injection.21 Rubber Band Ligation Rubber band ligation (RBL) is the most commonly performed nonsurgical procedure used in the treatment of hemorrhoids; it is performed in up to 80% of patients

with hemorrhoids.22,23 Blaisdell first described a ligation technique using a silk suture in 1958,24 with Barron beginning to use rubber bands in 1963.25 Barron treated one column of hemorrhoids per session to minimize pain and post-banding complications. The process causes the banded tissue to necrose and slough, with the resultant inflammatory reaction causing refixation of the mucosa to the underlying tissue, eliminating hemorrhoidal prolapse. This mechanism of action is common among the nonsurgical treatments for hemorrhoids, stressing the importance of hemorrhoidal prolapse in the etiology of symptoms. RBL is a simple, inexpensive procedure, effective for grade I to III hemorrhoids.2 Patients undergoing RBL typically do not require bowel preparation, sedation, narcotics, or a significant recovery period; they are able to return to work immediately.5 One of the disadvantages of earlier RBL procedures was the need for 2 operators to perform the procedure, but this has since been overcome with the development of single-use, disposable devices that do not require an assistant.6,7 RBL leads to reconfiguration and reduction in the size of hemorrhoidal cushions, resulting in symptom resolution. Short-term success rates of up to 99% and longterm success rates of up to 80% have been described; however, there is a large range in the reported incidence of complications. The predominant issue in patients undergoing RBL is significant pain, with the incidence rates ranging from less than 1% to 50%, in some series.6,26 Other reported complications include bleeding, urinary retention, vasovagal reactions, and the very rare complication of sepsis. Based on the literature, the incidence of complications appears to be related to the techniques that are used to perform the banding. Endoscopic RBL has been shown to have excellent results, however, the method is more expensive than the others and requires patient preparation as well as anesthesia.27 Endoscopic RBL also has been reported to be more painful than other banding techniques.28 Other common techniques use an anoscope to gain access to the hemorrhoids. There also is a procedure that allows for a “blind” placement of the band, obviating the need for an anoscope. The literature is confusing when it comes to where the band should be placed, as descriptions vary from “a few millimeters” above the dentate line29 to “at least 2 cm proximal” to the dentate line.30,31 I prefer a technique that involves placing the band at least 2 cm above the dentate line, as this technique has been associated with less pain.6 Controversy exists regarding the number of hemorrhoids to treat during a single session. In the time since Barron’s original work was published,25 most researchers have recommended treating only one column of hemorrhoids per session in order to minimize the rate of complications. Other authors have suggested banding 2 or more columns per session in order to minimize the number of patient visits required; however, complication rates are higher when more bands are placed.32

I recommend banding a single hemorrhoid per session. Endoscopic band placement is effective but is more costly and is associated with higher rates of post-procedural pain compared with in-office band placement.24,33 Personally, I prefer the blind “touch” technique described by Cleator and Cleator.6 This technique allows placement of the band without an anoscope at 2 cm above the dentate line. Using this technique, the researchers demonstrated a 1% complication rate (primarily pain) and successful treatment of up to 99% of patients, with a recurrence rate of 5% at 2 years.5 Infrared Coagulation Neiger first described infrared coagulation (IRC) in 1979.34 The infrared coagulator is placed through an anoscope while infrared light is converted to heat in the hemorrhoidal tissue. The heat produces tissue destruction, protein coagulation, and inflammation, leading to scarring and tissue fixation. During the procedure, 3 to 4 pulses of energy are applied to the mucosa at the apex of the hemorrhoid, and 1 to 2 columns of hemorrhoids are treated at a time. Treatment is repeated every 2 to 4 weeks.24 Advantages of IRC include a relative lack of significant complications. Disadvantages include equipment costs, the need for repeated treatments, higher recurrence rates, and its ineffectiveness in patients with more advanced disease.24,34 Direct Current Electrotherapy Direct current electrotherapy also uses a device that is inserted through an anoscope (Ultroid, Ultroid Technologies, Inc).35 This procedure uses direct current and does not create heat but rather produces sodium hydroxide, creating the submucosal reaction that leads to scarring, which helps to eliminate the hemorrhoidal prolapse.7 Limitations of direct current electrotherapy include the cost of the technology and the amount of time required to treat the involved tissue. The length of the procedure depends on the grade of hemorrhoidal disease and the amount of current that the patient can tolerate, which ranges from 4:45 to 19:45.35 The procedure has been reported to cause significant pain in up to 20% of patients, resulting in termination of therapy; 16% of patients have prolonged post-procedural pain.36 Bipolar Diathermy and “Heater Probe” Coagulation These technologies may be used by way of anoscopy in order to control chronic hemorrhoidal symptoms. Both procedures generate heat, which causes coagulation of the target tissue leading to a fibrotic reaction with fixation of the treated tissue.32 The procedures have similar efficacy for the treatment of bleeding. In one study, the heater probe controlled the bleeding more quickly (76.5 vs 120.5 days) at the expense of more pain.37 The bipolar technology was associated with a higher overall rate of complications (11.9% vs 5.1%), including pain, bleeding, fissure formation, and spasm of the internal sphincter. Another study demonstrated symptomatic mucosal ulceration in 24% of patients treated with bipolar electrocoagulation, significant bleeding in 8%, and prolonged pain in 4%.36

GENERAL SURGERY NEWS • APRIL 2013

Neither technology was able to reliably eliminate prolapsing tissue.29,36,37 Cryosurgery and Lord’s Stretch Procedure These techniques are mentioned for historical reference only, as neither is recommended. Cryosurgery is associated with significant post-procedure pain, along with foul-smelling discharge and prolonged recovery in several series.36 The “Lord’s Stretch,” a forceful dilatation of the anus in order to reduce elevated sphincter pressures was found to result in incontinence in a significant number of patients.38 Some have recommended that the procedure be abandoned.39

SURGICAL TREATMENT OPTIONS This review is intended to discuss nonsurgical options available for the treatment of symptomatic hemorrhoidal disease, and these approaches have been shown to be effective in 80% to 99% of patients. A number of surgical options are available as well, but because of increased cost, pain, disability, recuperation time, risk for complications, and so on, surgical options should be reserved only for nonresponders and for patients with grade IV hemorrhoids or hemorrhoids with both internal and external components.40

Conclusions Symptomatic hemorrhoids are common and patients frequently visit a surgeon for diagnosis and treatment. A number of effective nonsurgical approaches are available for these patients. RBL is the most commonly used office-based hemorrhoidal therapy. Information is presented here to aid the surgeon in the evaluation and definitive treatment of patients with hemorrhoidal disease.

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3. Lestar B, Penninckx F, Kerremans R. The composition of anal basal pressure. An in vivo and in vitro study in man. Int J Colorectal Dis. 1989;4(2):118-122.

15. Beck DE. Evaluation of the anorectum during endoscopic examinations. Tech Gastro Endoscopy. 2004;6:2-5. 16. Kelly SM, Sanowski RA, Foutch PG, Bellapravalu S, Haynes WC. A prospective comparison of anoscopy and fiberendoscopy in detecting anal lesions. J Clin Gastroenterol. 1986;8(6):658-660. 17. Chong PS, Bartolo DC. Hemorrhoids and fissure in ano. Gastroenterol Clin North Am. 2008;37(3):627-644, ix. 18. Moesgaard F, Nielsen ML, Hansen JB, Knudsen JT. High-fiber diet reduces bleeding and pain in patients with hemorrhoids: a double-blind trial of Vi-Siblin. Dis Colon Rectum. 1982;25(5):454-456. 19. Khoury GA, Lake SP, Lewis MC, Lewis AA. A randomized trial to compare single with multiple phenol injection treatment for haemorrhoids. Br J Surg. 1985;72(9):741-742. 20. Senapati A, Nicholls RJ. A randomised trial to compare the results of injection sclerotherapy with a bulk laxative alone in the treatment of bleeding haemorrhoids. Int J Colorectal Dis. 1988;3(2):124-126. 21. Pilkington SA, Bateman AC, Wombwell S, Miller R. Anatomical basis for impotence following haemorrhoid sclerotherapy. Ann R Coll Surg Engl. 2000;82(5):303-306. 22. Kann BR, Whitlow CB. Hemorrhoids: diagnosis and management. Tech Gastro Endoscopy. 2004;6(1):6-11. 23. Corman ML, Veidenheimer MC. The new hemorrhoidectomy. Surg Clin North Am. 1973;53(2):417-422. 24. Blaisdell PC. Prevention of massive hemorrhage secondary to hemorrhoidectomy. Surg Gynecol Obstet. 1958;106(4):485-488. 25. Barron J. Office ligation of internal hemorrhoids. Am J Surg. 1963; 105:563-570. 26. Kumar N, Paulvannan S, Billings PJ. Rubber band ligation of haemorrhoids in the out-patient clinic. Ann R Coll Surg Engl. 2002;84(3):172-174. 27. Jutabha R, Jensen DM, Chavalitdhamrong D. Randomized prospective study of endoscopic rubber band ligation compared with bipolar coagulation for chronically bleeding internal hemorrhoids. Am J Gastroenterol. 2009;104(8):2057-2064. 28. Cazemier M, Felt-Bersma RJ, Cuesta MA, Mulder CJ. Elastic band ligation of hemorrhoids: flexible gastroscope or rigid proctoscope? World J Gastroenterol. 2007;13(4):585-587. 29. Daram SR, Lahr C, Tang SJ. Anorectal bleeding: etiology, evaluation and management (with videos). Gastrointest Endosc. 2012:76(2):406-417. 30. Madoff RD, Fleshman JW, Clinical Practice Committee, American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of hemorrhoids. Gastroenterology. 2004;126(5):1463-1473. 31. Kaidar-Person O, Person B, Wexner S. Hemorrhoidal disease: a comprehensive review. J Am Coll Surg. 2007;204(1):102-117. 32. Lee HH, Spencer RJ, Beart RW Jr. Multiple hemorrhoidal bandings in a single session. Dis Colon Rectum. 1994;37(1):37-41. 33. Cataldo P, Ellis CN, Gregorcyk S, et al. Practice parameters for the management of hemorrhoids (revised). Dis Colon Rectum. 2005;48(2)189-194. 34. Neiger S. Hemorrhoids in everyday practice. Proctology. 1979;2:22-28. 35. Ultroid® Model 3053 Operating & Maintenance Manual. Ultroid Technologies, Inc., Rev 10.5.2010a:17. 36. Yang R, Migikovsky B, Peicher J, Laine L. Randomized, prospective trial of direct current versus bipolar electrocoagulation for bleeding internal hemorrhoids. Gastrointest Endosc. 1993;39(6):766-769.

4. Wexner SD, Jorge JMN. Anatomy and embryology of the anus, rectum, and colon. In: Corman ML, ed. Colon and rectal surgery. 4th ed. Philadelphia, PA: Lippincott-Raven; 1998.

37. Jensen DM, Jutabha R, Machicado GA, et al. Prospective randomized comparative study of bipolar electrocoagulation versus heater probe for treatment of chronically bleeding internal hemorrhoids. Gastrointest Endosc. 1997;46(5):435-443.

5. Guttenplan M, Ganz RA. Hemorrhoids—office management and review for gastroenterologists. Touchgastroentorology.com; December 2011.

38. Lord PH. A new regime for the treatment of haemorrhoids. Proc R Soc Med. 1968;61(9):935-936.

6. Cleator IGM, Cleator MM. Banding hemorrhoids using the O’Regan disposable bander. US Gastroenterology Review. 2005:69-73.

39. The Standards Task Force. Practice parameters for the treatment of hemorrhoids. Dis Colon Rectum. 1990;33(11):992-993.

40. MacRae HM, McLeod RS. Comparison of hemorrhoidal treatments: a meta-analysis. Can J Surg. 1997;40(1):14-17.

Corman ML. Hemorrhoids. In: Corman ML, ed. Colon and rectal surgery. 4th ed. Philadelphia, PA: Lippincott-Raven; 1998:147-205.

8. Loder PB, Kamm MA, Nicholls RJ, Phillips RK. Haemorrhoids: pathology, pathophysiology and aetiology. Br J Surg. 1994;81(7):946-954. 9. Ohning GV, Machicado GA, Jensen DM. Definitive therapy for internal hemorrhoids—new opportunities and options. Rev Gastroenterol Disord. 2009;9(1):16-26. 10. Baker H. Hemorrhoids. In: Longe JL, ed. Gale encyclopedia of medicine. 3rd ed. Detroit: Gale; 2006:1766-1769. 11. Banov L Jr, Knoepp LF Jr, Erdman LH, Alia RT. Management of hemorrhoidal disease. J S C Med Assoc. 1985;81(7):398-401. 12. Halverson A. Hemorrhoids. Clin Colon Rectal Surg. 2007;20(2):77-85. 13. Schubert MC, Sridhar S, Schade RR, Wexner SD. What every gastroenterologist needs to know about common anorectal disorders. World J Gastroenterol. 2009;15(26):3201-3209. 14. Alonso-Coello P, Castillejo MM. Office evaluation and treatment of hemorrhoids. J Fam Pract. 2003;52(5):366-374.

I N D E P E N D E N T LY D E V E L O P E D B Y M C M A H O N P U B L I S H I N G

AUTHOR DISCLOSURE—Dr. Sarles is a member of the advisory board of CRH Medical. DISCLAIMER—This review is designed to be a summary of information and represents the opinions of the author. Although detailed, the review is not exhaustive. Readers are strongly urged to consult any relevant primary literature, the complete prescribing information available in the package insert of each drug, and the appropriate clinical protocols. No liability will be assumed for the use of this review, and the absence of typographical errors is not guaranteed. Copyright © 2013, McMahon Publishing, 545 West 45th Street, 8th Floor, New York, NY 10036. Printed in the USA. All rights reserved, including right of reproduction, in whole or in part, in any form.

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REPORT Optimizing Patient–Ventilator Interaction: Reducing Patient–Ventilator Asynchrony Part 1 of a 2-Part Series Faculty Sanford Levine, MD

echanical ventilation as patient–ventilator asynchrony Adjunct Professor of Surgery (MV) can be a lifesaving (PVA), occurs in up to 80% of Department of Surgery and procedure for patients with mechanically ventilated patients.1 Pennsylvania Muscle Institute various forms of acute respiPVA may increase the duration of University of Pennsylvania ratory failure.1 Ideally, patient ventilation2-4 and may have deleSchool of Medicine and machine share the venterious effects including patient Philadelphia, Pennsylvania tilatory work, and ventiladiscomfort, lower rates of suctor gas delivery is a perfect cessful weaning, 2,4 increased Catherine S. Sassoon, MD match to patient demand. work of breathing (WOB), and Professor of Medicine In practice, however, the increased need for sedation, University of California, Irvine complex patient–ventilator possibly causing higher mortality Division of Pulmonary and interaction is frequently subrates.1,5 Ventilatory interventions Critical Care Medicine optimal and has been charto promote synchrony may lead VA Long Beach Healthcare System acterized as a “tug of war.” to earlier liberation, which, in Long Beach, California This mismatch between mechanically ventilated patients, a patient’s neural inspirais associated with improved clintory time and the ventilator insufflation time, known ical outcomes and future quality of life.6

Supported by

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Conventional ventilatory modes with fixed levels of assist (eg, pressure control, pressure support [PS]) cannot respond to changes in patient demand on a breath-bybreath basis and may contribute to asynchrony.7 Although conventional ventilator support is designed to provide some degree of unloading to the respiratory muscle, MV can have the opposite effect if the patient and the ventilator are at odds over conflicting goals—that is, if the respiratory workload is not being shared by the patient’s spontaneous breathing as well as the ventilator’s set parameters.8,9 Ventilator response to patient effort can be greatly influenced by ventilator variables 8 and if these variables are not in harmony, PVA can occur. There is an established association between PVA and duration of MV, although causality of this association has not been determined.2,4,10 Factors associated with PVA include weak inspiratory effort and presence of intrinsic positive end-expiratory pressure (PEEPi), which together may lead to a common major pattern of PVA known as ineffective triggering. High ventilatory demand coupled with ventilator inspiratory time that is too short may lead to double-triggering, another common PVA.4,11,12 Clinically, deeper levels of sedation are associated with ineffective triggering, which results from low maximal respiratory flow, likely due to respiratory center depression. The association between deeper level of sedation and ineffective triggering needs to remind clinicians to titrate sedation to the lowest level and shortest duration, and to discontinue as soon as possible.1,13 An early preliminary study of 30 ventilated patients with acute respiratory failure in an ICU found a 97% prevalence of PVA and established that mortality was higher in patients with an asynchrony index (AI; percentage of monitored breaths that were asynchronous) of 30% compared with those whose failed efforts threshold was lower.1,14

Prevalence, Etiology, and Common Types Of Asynchrony Asynchrony (generally understood to be characterized clinically significant by ≥10% of asynchronous breaths) is common in mechanically ventilated patients—likely more common than originally thought4,15 —and results from multifactorial etiology. Patient characteristics and ventilatory variables have been evaluated in studies with goals of reducing PVA prevalence and clinical consequences.4 PVA triggers range from abnormal pulmonary mechanics (eg, resistance, elastance, respiratory muscle capacity) or underlying disease states to iatrogenic causes (eg, clinician-adjusted ventilator settings, inaccurate measurement of respiratory mechanics).2,16,17 An array of PVA-precipitating factors may originate with the ventilator: method of inspiratory triggering, inspiratory flow delivery, level and mode of ventilator support, and applied PEEP, which increases end-expiratory lung volume and reduces air-space closure at the end of expiration.18 The

number of ventilator techniques available to clinicians adds complexity to decision making, and patient factors must influence the MV strategy. Three main types of asynchrony patterns are recognized and occur at different phases: the beginning of the breath (the triggering phase, which can be affected by the site of triggering), during the breath (flow delivery phase), or at the end of a breath (cycle or termination asynchrony).16 The type of asynchrony, nature and length of observation, and additional factors such as level of sedation influence determination of prevalence.1 Overall a wide range of prevalence has been reported, with the highest risk reserved for patients with chronic obstructive pulmonary disease (COPD).4,19 In the ICU setting, a PVA prevalence ranging from 24% to 98% has been found.4 The most common asynchrony is ineffective triggering (“missed” triggering or wasted effort), in which the patient’s inspiratory efforts fail to trigger the ventilator. Another common asynchrony is double-triggering (breath stacking), in which ventilator inspiratory time is shorter than the patient’s inspiratory time, thus the patient’s effort triggers a second ventilator cycle.4 In a 1997 weaning center study, patients who experienced apparent difficulty weaning from prolonged MV (ie, a period of weeks) were prone to ineffective triggering; 19 of 174 patients (11%) were found, on initial assessment, to have this asynchrony pattern. 2 Compared with peers in the study cohort, the patients with ineffective triggering events were older and sicker and had a higher prevalence of COPD.19,20 Ineffective triggering is common in the early course of MV, adds to the WOB, and is associated with ventilator parameters including high tidal volume (VT), high peak inspiratory pressure, high PS, and high PEEP.2,4,12,17,19 Ineffective triggering also may result from inappropriate ventilator settings (eg, insensitive trigger setting, gas delivery, delayed triggering, cycling off criterion) or the effect of imposed resistance from the artificial airway.1,3,8 Patient-related factors may cause ineffective triggering by 2 distinct pathophysiologic mechanisms: an inability to overcome the effects of PEEPi (dynamic hyperinflation), or a consequence of reduced respiratory drive associated with deeper sedation levels.1,13 Respiratory muscle weakness can play a role in ineffective triggering.1 Several studies have found that most, but not all, patients with ineffective triggering have COPD.2,19 Patients with COPD have considerable PEEPi and dynamic hyperinflation, a finding that may partly explain the disorder’s association with missed triggers. 2,19,21 Excessive VT or pressure may contribute to missed triggers in this population; air trapping or auto-PEEP (ie, gas trapped in alveoli at end expiration) also leads to missed triggers because the patient must overcome the trapped gas pressure to receive a breath.2,22 Double-triggering results from patient respiratory efforts occurring toward the end of ventilator VT delivery, with

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patient inspiratory effort leading to a second triggered breath and VT delivered before complete exhalation of the initial VT.4,23 This asynchrony can be a consequence of low VT and ventilator inspiratory time that is too short.1,11 Less frequently recognized causes are expiratory asynchrony (ie, mismatch between ending mechanical inspiration and patient expiration, a scenario often seen with pressure support ventilation [PSV]) 9 ; periodic breathing, often in the presence of high PSV settings and characterized by a pattern in which the patient drives down carbon dioxide and apnea ensues, followed by a rise of carbon dioxide that stimulates breathing 8 ; flow asynchrony in volume control ventilation (ie, patient demand for flow exceeds set flow, resulting in an increase in WOB) 9 ; and mode asynchrony, resulting from selecting an inappropriate ventilator mode.12 Studies have helped to clarify the incidence, pathophysiology, and consequences of PVA. In one of the first such studies (Thille et al, 2006), ineffective triggering and double-triggering constituted more than 98% of the asynchrony events, and 85% of the asynchronies were ineffective triggering events.4 In this prospective study of 62 ICU patients who required MV for more than 24 hours (median, 4.5 days), an AI of greater than 10% was found in 24% (n=15); the detection method was visual inspection of flow and airway pressure signals.4 This study helped to establish the association between PVA and longer duration of MV. Patients in the 10% or greater AI group had longer median duration of MV (17 vs 7 days; P=0.04) and a relatively higher risk for tracheostomy than those with AI less than 10% (n=47); mortality was similar between the 2 groups.4 The failed efforts threshold—characterized as AI or ineffective triggering index (ITI) —has clinically important implications. An ITI of 10% or greater is an independent predictor of prolonged MV and shorter ventilator-free survival.3 In a pilot study by de Wit et al, 60 patients were evaluated during the first day of MV (mean, 13 hours after intubation). Patients with an ITI of 10% or greater (n=16) had a longer MV duration (10 vs 4 days; P= 0.0004), worse 28-day ventilator-free survival (14 vs 21 days; P=0.03), and longer hospital stay (21 vs 8 days; P=0.03), and ICU stay (8 vs 4 days; P= 0.01). However, there was no increased mortality compared with patients who had an ITI less than 10%.3 The de Wit study is notable in that the asynchronies were detected earlier in the course of MV (ie, during the first 24 hours; mean, 13 hours) compared with previous studies that evaluated patient populations after at least 24 hours of MV.3 Deeper sedation affects patient–ventilator interaction, perhaps via a mechanism of lower maximal respiratory flow likely due to decreased respiratory drive, and is predictive of ineffective triggering.13 In a pilot study by de Wit et al, ineffective triggering was detected in 17 of 20 medical ICU patients and was the most frequent asynchrony (88% of all asynchronous breaths, 9%±12% of breaths).13 Patients were awake during 11 of 35 observations.13 This association

may not be fully appreciated; in practice, clinicians often administer sedation to facilitate MV or as a first-line asynchrony intervention1,24 despite the association of sedation with poor outcomes including PVA, prolonged MV duration, and mortality.5,25,26 Improved patient–ventilator synchrony may reduce the need for sedation.25,26 Noninvasive methods of detection (ie, visual inspection of flow distortion) that can identify ineffective triggering and double-triggering may partly explain their higher known prevalence relative to other patterns of asynchrony. Airflow spectral analysis has sensitivity and specificity of greater than 80% in detecting AI of greater than 10%.10 However, the number of patient-related factors and ventilation variables influencing asynchrony make the recognition of PVA complex and attendant decision making difficult.1 The ability of clinicians to recognize PVA by visual inspection of flow and ventilator pressure (Paw ) tracings is low and only moderately influenced by clinical expertise; in a recent study, ICU physicians detected less than one-third of PVAs and residents had a 16% detection rate. 27 A working knowledge of the asynchrony-associated factors may help physicians and respiratory therapists to minimize patient–ventilator mismatches (Table).4 Once PVA is detected, clinician responses—whether in the form of protocol adherence, sedation, adjustment of ventilator settings, or initiation of weaning—can influence patient outcomes. For example, patients with COPD frequently receive excessive PS, which at more than 12 cmH2O is associated with higher prevalence of asynchronies27 and tracheostomies to facilitate weaning1; however, in multicenter studies, when patients who were assumed to be difficult to wean were allowed to breathe spontaneously for 2 hours, two-thirds were found to be ready for extubation. 20,28

Clinical Challenges in Ventilation Basic mechanisms of the spontaneous and ventilatorassisted breath have been characterized. During controlled ventilation of a passive patient, the necessary pressure generated by the patient’s respiratory muscles (P mus ) is 0 and the necessary pressure is applied by the ventilator (Paw ).29 In assisted ventilator modes, both ventilator and patient provide the required pressure, which in the patient’s case can be highly variable.29,30 Thus, a change in any of the determinants in this pattern must be met by an opposite change in the other if total pressure applied to the respiratory system is to be maintained. In clinical terms, increasing ventilator PS should increase respiratory muscle unloading (decrease Pmus ), at least theoretically (ie, alleviating WOB by providing optimal PS, which in excess can result in air trapping and missed triggers). 2 However, any change in ventilator setting affects several patient mechanisms: direct effect on neural drive 31; worsening of PEEPi, which in turn raises the inspiratory threshold load of triggering the ventilator12; delayed (expiratory)

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Table. Factors To Consider in Determining How Often Patient–Ventilator Asynchrony Occurs Timing of observations Duration of observations Method of detection • Esophageal pressure • Electrical activity of the diaphragm • Waveform analysis Type of asynchrony Definition of “significant” Patient population Type of mechanical ventilation • Invasive vs noninvasive • Pressure or volume targeted • Ventilation mode (conventional vs newer modes) • Triggering method • Cycling method • Degree of ventilator support Additional factors • Sedation

trigger”).9,34 Flow triggering as a result of inspiratory muscle contraction generally is believed to entail a lower WOB, although the difference may be of little clinical relevance.8 In some cases, a mechanical breath may be triggered in the absence of inspiratory effort (auto-triggering) as a consequence of expiratory leaks, water, or noise in the circuit. This type of PVA usually occurs with low respiratory drive and when dynamic hyperinflation is absent8 and suggests a need for careful adjustment of trigger sensitivity.35 The challenges of reducing unnecessary respiratory muscle workload and improving patient comfort through optimal patient–ventilator interaction are particularly evident in the setting of COPD.19,21 In a classic representation of missed triggers in this setting, triggering may be so delayed that the ventilator cycles are almost completely out of synchronization with the patient, defeating the purpose of assisted ventilatory support.8 Ineffective efforts may occur with high PSV and during mechanical inspiration and expiration. The alteration in expiratory flow pattern associated with patient effort becomes insufficient to trigger a breath, and the inspiratory effort is ineffective.12,35 In one such case, reviewed by Kondili et al, the ventilator frequency was 12 breaths per minute compared with that of the patient, 33 inspiratory efforts min-1.8 In patients with COPD, different levels of PSV may result in ineffective triggering unless external PEEP (PEEPe) is applied; applying PEEPe at values slightly lower than PEEPi in ventilated patients with COPD has been shown to decrease ineffective triggering events and reduce WOB. 36,37 However, PEEPi can vary with each breath 38 and because there is no validated approach for determining the optimal level of PEEPe, it may be reasonable to begin at zero end-expiratory pressure and titrate PEEPe upward in 1- to 2-cmH2O increments until ineffective triggering diminishes.29

Clinician Decisions Affect Synchrony From reference 1.

cycling (DC), a secondary increase in inspiratory flow lasting 0.3 sec or more,32 and during noninvasive ventilation, a higher risk for inspiratory leaks (insufflations) at the patientmask interface and gastric air intake, thereby increasing the risk for PVA.33 Ineffective efforts are dependent on the degree of ventilator support,12 and care must be taken to avoid the complications of both insufficient and excessive support.29 Triggering refers to the mechanism by which a patient’s inspiratory effort produces a ventilator response. This is accomplished either through a decrease in ventilator circuit pressure (“pressure trigger”) or of inspiratory flow (“flow

The most common support modes for the gradual withdrawal of patients from ventilation are PSV and synchronized intermittent mandatory ventilation (SIMV). SIMV allows the patient to breathe spontaneously between ventilator-delivered breaths delivered at a low rate in synchrony with spontaneous effort performed by the patient; a gradual decrease in the rate of mechanical breaths accompanies the weaning procedure.28 Early IMV systems had several limitations, including high airway pressure resulting from breath stacking, a consequence of nonsynchronized inspiration between the patient and ventilator. SIMV requires unassisted inspiration by the patient through an endotracheal tube (ETT), a challenging scenario in a spontaneously breathing person and a serious burden in a person with lung injury.39,40 Because the level of work can remain quite high in this mode, PS is routinely provided during spontaneous breathing to alleviate WOB.12,18

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In contrast to SIMV, there is no mandatory (ventilatory) breath during PSV and patients breathe spontaneously, with each inspiration supported by a mechanically driven flow delivered at a preset amount of pressure. PSV allows for a gradual decrease in the level of assistance.41 Weaning during PSV is accomplished by gradually decreasing the perbreath pressure level until the pressure only compensates for the work imposed by the ETT and ventilator demand valve.28,40 PSV has been shown to provide significant benefit compared with SIMV and T-piece (ETT with no ventilator assistance, a method used to gauge readiness for weaning) ventilator strategies.28 The 3 modalities were compared in a randomized trial with mechanically ventilated patients in 3 ICUs (N=109) who met standard weaning criteria. When all causes for weaning failure were considered, a significantly lower number of weaning failures was found with PSV than with the 2 other modes (23% for PSV, 43% for T-piece, 42% for SIMV; P= 0.05).28 Both weaning duration and total time in ICU were shorter with the PSV group than with the SIMV or T-piece groups pooled together (5.7±3.7 vs 9.3±8.2, P<0.05; 17.5±10.2 vs 27.8±18.3, P<0.01, respectively). 28 The relative probability of a patient being weaned from the ventilator was 2.03 times higher with PSV than with SIMV over the 21-day weaning procedure.28 However, in a study by Esteban et al, two-thirds of patients assigned to either a once-daily trial or intermittent trials of spontaneous breathing through a T-piece circuit were extubated after their first trial, and allowed for faster weaning than PSV.42 Proportional-assist ventilation (PAV) has been shown to promote synchrony by providing pressure that is proportional to instantaneous flow and volume. A major obstacle to its widespread use has been the necessity for regular measurement of key parameters of respiratory system mechanics.30 However, monitoring of respiratory mechanics has not been readily available outside of research settings; measurement can be invasive or subject to misinterpretation. When such data are obtained clinically, they can result in inappropriate ventilator response and asynchrony if adjustment is not made for natural changes in breathing rhythm, respiratory drive, and mechanics.16,43 Recent technological advances have made the measurement of these respiratory mechanics much more accurate and easier to obtain. One such advance is PAV+, clinically validated software that continuously and automatically monitors resistance and elastance in real time and, using these values, adjusts flow and volume gain factors in response to the patient’s measured values.44 PAV+ has the capacity to make many adjustments per second. This allows for easier titration of ventilator support according to the patient’s own respiratory mechanics, thus potentially simplifying respiratory care.45 Because PAV has been shown to promote patient–ventilator synchrony, the ability for clinicians to apply it more readily in practice using

PAV+ technology may aid in helping mechanically ventilated patients to achieve earlier liberation. Although PAV+ is becoming more familiar to clinicians as a synchrony-promoting mode for use in weaning,32,45 PSV is a commonly used ventilatory support mode and is administered frequently in the weaning process.42 In physiologic studies, PSV has been shown to reduce the workload on respiratory muscles.28 PSV supplies a constant level of positive airway pressure during spontaneous inspiratory efforts and compared with earlier modalities, was more comfortable for patients.19,35,36 Although inspiratory time is not directly adjustable with PSV, clinicians can use rise time and expiratory sensitivity to adjust pressure-supported breaths. Compared with PSV, the newer PAV mode (ie, PAV+) is closer to physiologic respiration. It delivers assistance in direct proportion to patient effort, thus decreasing WOB and improving comfort.35,46 The array of ventilator modes can pose challenges for clinicians and outcomes can be influenced by the ventilator strategy selected.28 SIMV would be a poor choice in a patient with COPD; similarly, PSV would not be appropriate for a patient with unstable ventilatory drive. Mode asynchrony appears to be common and widely unrecognized with adaptive pressure modes that combine the attributes of volume- and pressure-regulated ventilatory modes and are characterized by an inspiratory pressure limit that varies from one breath to the next. Examples are “dual-control” modes such as AutoFlow, Pressure Regulated Volume Control (PRVC), Volume Support Ventilation (VSV), Adaptive Support Ventilation, and Volume Control+.47 In a randomized crossover study of ICU patients who required MV, Jaber et al evaluated the effect of increased ventilator demand on VSV—which is responsive to VT—by means of continually adjusting PS to achieve a preset VT. VSV resulted in decreased pressure support provided by the ventilator, which was opposite of the desired response and significantly increased WOB as compared with PSV. Investigators concluded that VSV might result in respiratory distress and asynchrony in clinical settings.48 PVA theoretically may result in inspiratory muscle injury. Inspiratory efforts are associated with diaphragm muscle fiber shortening. With ineffective efforts, inspiratory muscle contractions commonly occur during exhalation when the muscle fibers lengthen. This phenomenon is called eccentric or pliometric contractions, which have been reported to cause skeletal muscle injury.49 In addition to PVA, disuse atrophy and injury of diaphragmatic muscle fibers during controlled MV may also contribute to prolonged ventilator dependence.50 Diaphragm muscle atrophy occurs markedly at the level of slowand fast-twitch diaphragm fibers and does so rapidly—after 18 to 69 hours of diaphragm inactivity and MV, resulting in loss of strength; in specimens from brain-dead organ donors obtained prior to organ harvest (N=14), investigators found decreased cross-sectional areas of slow- and fast-twitch fibers of 57% (P=0.001) and 53% (P=0.01), respectively.51

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Conclusion Recognizing obstacles to patientâ&#x20AC;&#x201C;ventilator synchrony is necessarily complex, as is dealing with these challenges once they are detected. Insufficient ventilatory support or PVA may result in worsening of respiratory mechanics, delayed extubation, and deleterious systemic effects. The

choice of weaning mode remains a major clinical concern. Although PSV has undisputed clinical value, it is associated with relatively higher prevalence of asynchrony than PAV, which when used with PAV+ has been shown to improve PVA and reduce incidence of asynchrony.

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Shehabi Y, Bellomo R, Reade M, et al. Early intensive care sedation predicts long-term mortality in ventilated critically ill patients. Am J Respir Crit Care Med. 2012;186(8):724-731.

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23. Pohlman M, McCallister K, Schweickert W, et al. Excessive tidal volume from breath stacking during lung-protective ventilation for acute lung injury. Crit Care Med. 2008;36(11):3019-3023.

10. Navalesi P. On the imperfect synchrony between patient and ventilator. Critical Care. 2011;15(181):1-2. 11. Tokioka H, Tanaka T, Ishizu T, et al. The effect of breath termination criterion on breathing patterns and the work of breathing during pressure support ventilation. Anesth Analg. 2001;92(1):161-165. 12. Leung P, Jubran A, Tobin MJ. Comparison of assisted ventilator modes on triggering, patient effort, and dyspnea. Am J Respir Crit Care Med. 1997;155(6):1940-1948. 13. de Wit M, Pedram S, Best AM, Epstein SK. Observational study of patient-ventilator asynchrony and relationship to sedation level. J Crit Care. 2009;24(1):74-80. 14. Varon J, Fromm R, Rodart J, Reinoso M. Prevalence of patient ventilator asynchrony in critically ill patients. Chest. 1994;106(2 suppl):141S-144S. 15. Vitacca M, Bianchi L, Zanotti E, et al. Assessment of physiologic variables and subjective comfort under different levels of pressure support ventilation. Chest. 2004;126(3):851-859.

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43. Costa R, Spinazzola G, Cipriani F, et al. A physiologic comparison of proportional assist ventilation with load-adjustable gain factors (PAV+) versus pressure support ventilation (PSV). Intensive Care Med. 2011;37(9):1494-1500.

32. Hosking B, Harris C, Nikoo M, Priestap F, Bosma K. The incidence of patient-ventilator asynchrony during weaning from mechanical ventilation: a comparison of proportional assist ventilation (PAV) to pressure support (PS). Presented at: 2011 International Conference of the American Thoracic Society; May 13-18, 2011; Denver, CO. 33. Crooke PS, Hotchkiss JR, Marini JJ. Linear and nonlinear mathematical models for noninvasive ventilation. Mathematical and Computer Modeling. 2002;35(11):1297-1313. 34. Yang LY, Huang YC, Macintyre NR. Patient-ventilator synchrony during pressure-targeted versus flow-targeted small tidal volume assisted ventilation. J Crit Care. 2007;22(3):252-257. 35. Thille A, Brochard L. Promoting patient-ventilator synchrony. Clin Pulm Med. 2007;14(6):350-359. 36. Nava S, Bruschi C, Rubini F, Palo A, Iotti G, Braschi A. Respiratory response and inspiratory effort during pressure support ventilation in COPD patients. Intensive Care Med. 1995;21(11):871-879. 37. Georgopoulos D, Giannouli E, Patakas D. Effects of extrinsic positive end-expiratory pressure on mechanically ventilated patients with chronic obstructive pulmonary disease and dynamic hyperinflation. Intensive Care Med. 1993;19(4):197-203. 38. Ghamloush M, O’Connor HH, White AC. Patient-ventilator interaction in the long-term acute-care hospital. Respir Care. 2011;56(2):207-213. 39. Karcz M, Vitkus A, Papadakos PJ, Schwaiberger D, Lachmann B. State-of-the-art mechanical ventilation. J Cardiothorac Vasc Anesth. 2012;26(3):486-506. 40. Brochard L, Rua F, Lorino H, Lemaire F, Harf A. Inspiratory pressure support compensates for the additional work of breathing caused by the endotracheal tube. Anesthesiology. 1991;75(5):739-745.

44. Kondili E, Prinianakis G, Alexopoulou C, Vakouti E, Klimathianaki M, Georgopoulos D. Respiratory load compensation during mechanical ventilation—proportional assist ventilation with load-adjustable gain factors versus pressure support. Intensive Care Med. 2006;32(5):692-699. 45. Xirouchaki N, Kondili E, Vaporidi K, et al. Proportional assist ventilation with load-adjustable gain factors in critically ill patients: comparison with pressure support. Intensive Care Med. 2008;34(11):2026-2034. 46. Grasso S, Puntillo F, Mascia L, et al. Compensation for increase in respiratory workload during mechanical ventilation. Pressure-support versus proportional-assist ventilation. Am J Respir Crit Care Med. 2000;161(3 Pt 1):819-826. 47. Branson RD, Chatburn RL. Should adaptive pressure control modes be utilized for virtually all patients receiving mechanical ventilation? Respir Care. 2007;52(4):478-485, discussion 485-488. 48. Jaber S, Delay JM, Matecki S, Sebbane M, Eledjam JJ, Brochard L. Volume-guaranteed pressure-support ventilation facing acute changes in ventilatory demand. Intensive Care Med. 2005;31(9):1181-1188. 49. Hunter KD, Faulkner JA. Pliometric contraction-induced injury of mouse skeletal muscle: effect of initial length. J Appl Physiol. 1997;82(1):278-283. 50. Jaber S, Petrof BJ, Jung B, et al. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011;183(3):364-371. 51. Levine S, Nguyen T, Taylor N, et al. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008;358(13):1327-1335.

Disclosures: Drs. Levine and Sassoon reported no relevant financial disclosures. Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Covidien, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright © 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

SR1218

VE31213

REPORT

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APRIL 2013

REPORT Teflaro® (ceftaroline fosamil) for the Treatment of Acute Bacterial Skin and Skin Structure Infections Caused by Designated Susceptible Bacteria hospital exposure.7 These strains The incidence of Gram-positive skin and skin structure infections of community-associated MRSA Faculty (SSSI) requiring hospitalization (CA-MRSA) are now the most has increased significantly over common cause of SSSI in the Greg Moran, MD, FACEP, FIDSA the past several decades as a U.S., accounting for 59% of these Department of Emergency Medicine and result of changes in virulence proinfections presenting to emerDivision of Infectious Diseases files and antibiotic resistance of gency departments.1,2 CA-MRSA Olive View–UCLA Medical Center 1,2 common causative organisms. strains have not simply replaced Sylmar, California the strains of S. aureus that were Staphylococcus aureus is a leadpreviously most common in skin ing cause of these SSSI.2,3 Methinfections; rather, it appears that icillin-resistant S. aureus (MRSA) they have resulted in an overall increase in the numhas been a common infection in the hospital setting for ber of skin infections in the U.S., many of which result in decades, and currently represents approximately 33% to hospitalization.2,8 55% of all hospital strains and 60% of all isolates iden4-6 tified in critical care units. Since the late 1990s, new Because CA-MRSA is recognized as a common etiology strains of MRSA have emerged in the community among of SSSI, it is recommended that empiric therapy for hospatients who lacked traditional MRSA risk factors such as pitalized patients include activity against this pathogen.9

INDICATION

IMPORTANT SAFETY INFORMATION

• TEFLARO (ceftaroline fosamil) is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Contraindications • TEFLARO is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline.

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 7.