Case Study: Steadily Improving TAVR Quality and Efficiency

Case Study: Steadily Improving TAVR Quality and Efficiency

Parkwest Medical Center takes a deep dive into ongoing transcatheter aortic valve replacement (TAVR) program, finding ways to improve care and patient satisfaction while lowering length of stay.

At some point after successfully establishing a TAVR program, hospitals should step back and examine program performance. This scrutiny helps determine whether or not a program is achieving the best clinical outcomes for patients and if it is operating as efficiently as possible. An effective way to do this is to study key data that can highlight opportunities for improvement and point to specific changes that may help the program achieve its goals.

This case study describes the efforts of Parkwest Medical Center, a community hospital in Knoxville, Tenn., to assess and improve the clinical outcomes, patient satisfaction, and efficiency of its TAVR program. These efforts have enabled changes that benefit patients first and foremost, while also ensuring good stewardship of the health system’s investment in TAVR. Forging a Strong Foundation Parkwest’s TAVR program started on solid footing in June 2012, thanks to the work of the original TAVR Team: Thomas Pollard, MD, Nicholas Xenopoulos, MD, and Thomas M. Ayres, MD, and due to the vision of the administrative leadership at both Parkwest Medical Center and Covenant Health. Administrative support of the heart team concept and adoption of new technology has been crucial to the program’s success.

As a result of the commitment to the TAVR program, Ayaz Rahman, MD, a structural heart fellow from Emory University, was added to the heart team in July 2014.

Parkwest has performed over 200 TAVRs since the

beginning of the program through the fall of 2015. For a medium-sized community hospital in a medium-sized market, this volume is a testament to administration for investing in the program and also providing the right infrastructure for the program to be successful.

Cardiothoracic surgeon Thomas Pollard, MD, credits the administration for having vision and playing a key role

ospital administration “could see this H was going to be something that would change the face of certainly aortic surgery if not all of cardiac surgery.”

– Thomas Pollard, MD Cardiothoracic Surgeon Parkwest Medical Center

in the success by ensuring the program had the needed staffing and facilities. “They could see this was going to be something that would change the face of certainly aortic surgery if not all of cardiac surgery.”

Improving Performance Two years into the TAVR program, things were going well. However, the leadership team realized it was time to start thinking about optimization. A decision was made to have the analytics team at Covenant work with Parkwest’s TAVR team to compare their program to other successful TAVR centers. The idea was to examine performance using a few key factors. The program needed to improve at providing excellent care throughout the entire TAVR patient journey but in a way that was also fiscally responsible.

Janice Belbeck, who leads the service line analytics team providing data support and best practice information for the health system’s service lines, and colleague Nancy Brownlow, an analytics team member with responsibility for the cardiac service line, helped the TAVR team identify several areas that might be improved. One of these was length of stay. The data showed similar average stays for TAVR and surgical valve replacement procedures, indicating the TAVR patients were receiving care not tailored to their less-invasive procedures. “These patients were largely being treated like they had open surgery, and they had not,” says Brownlow. A deeper dive into the data showed that ICU length of stay was just as long for patients having TAVR via the transfemoral route as it was for those having TAVR via the more invasive transapical route.

Thus, reducing length of stay became a goal, not just to reduce cost but also, more importantly, to individualize care and improve patient satisfaction and clinical outcomes (for example, by reducing patients’ exposure to infection and changing their care in ways that would help them recover more quickly).

Another goal the team identified was making sure patients were discharged to the most appropriate care setting following TAVR. The data showed that discharge

“ Every month, we do more minimalist TAVRs, which hopefully will allow us to transition to moving out of the hybrid OR and performing TAVR in the cardiac cath lab, fully percutaneously.”

–A yaz Rahman, M.D. Interventional Cardiologist Parkwest Medical Center

patterns at Parkwest were similar for patients having TAVR and those having surgical valve replacement, meaning that perhaps some TAVR patients who were benefitting from less invasive percutaneous intervention could possibly be discharged safely home rather than to skilled nursing. Also, from a reimbursement standpoint, a high percentage of TAVR cases were being negatively affected by the Medicare Post-Acute Care Transfer (PACT) policy. This policy decreases reimbursement for certain procedures, including TAVR, when the patient is discharged to a skilled nursing facility, rehabilitation facility, or home health care following a hospital stay that is shorter than the national average for the associated

DRG (Diagnosis-Related Group). Parkwest’s team members recognized that while they worked to improve discharge practices and reduce length of stay that they also needed to be mindful that TAVR patients could safely be discharged home following a shorter hospital stay.

A third goal for the team focused on more careful documentation throughout patients’ care. The data showed that a low percentage of TAVR cases at Parkwest were falling under the more complex Medicare DRG, that applies to patients with major complications and comorbidities. “This suggested a potential need for more detailed documentation,” says Belbeck. The team felt that more thorough documentation could lead to better care as well as more accurate reimbursement.

Reducing Length of Stay The TAVR team’s efforts to reduce length of stay were helped by the June 2014 FDA approval of the secondgeneration Edwards SAPIEN valve (the SAPIEN XT valve).

“Because this valve could be delivered through a smaller sheath,” Dr. Rahman says, “it became a lot easier to perform a transfemoral procedure.” Instead of entering the femoral artery surgically, as they had been doing, the heart team could access the artery through the skin.

The team began using the transfemoral rather than the transapical approach for most patients. “We became a predominantly transfemoral TAVR program, and we did procedures fully percutaneously,” says Dr. Rahman.

The switch made TAVR less invasive, with less associated morbidity for patients, and allowed a quicker recovery, which meant patients could leave the hospital sooner.

Also underway was the shift to a “minimalist” TAVR approach. This approach involves identifying patients who could have a successful procedure using conscious sedation instead of general anesthesia and noninvasive imaging instead of transesophageal echocardiography during the procedure. The Parkwest TAVR team has begun successfully using the minimalist approach in appropriate patients. With no general anesthesia and no camera in their esophagus, patients can recover sooner from TAVR and should be able to leave the hospital sooner. The heart team’s surgeons, cardiologists, and anesthesiologists decide together which patients are candidates for the minimalist approach — and the team is gradually increasing its use of this approach. Jeff Ollis, MD, one of the team’s anesthesiologists, says it has been a stepwise transition and notes that “monitored anesthesia care” (MAC) is the most accurate description of their current approach. With MAC, says Dr. Ollis, “the

anesthesiologist is still very involved” and can tailor the level of anesthesia to the needs of the patient throughout the procedure. True conscious sedation is at one end of that spectrum, he says, and with it come certain challenges, such as the possibility of the patient moving during the procedure. In the best interest of patients, however, the team works together to anticipate and manage those challenges.

“ Discussion with our doctors led to some rethinking of the way patients were being handled in terms of their discharge planning.”

– Janice Belbeck Senior Consultant, Operational Improvement

Along with these changes to the procedure itself, Parkwest’s TAVR team began working on several changes in patients’ post-procedure care, such as the following:  Extubating the patient as soon as possible.

For patients receiving general anesthesia, the team’s goal is to extubate before the patient leaves the hybrid operating room. If that is not possible, the team follows a newly created protocol to wean the patient from the ventilator within a few hours of arriving in the ICU. These practices help reduce both ICU and overall length of stay. Minimizing the duration of ventilation is also a recommended practice for reducing the risk of ventilator-associated pneumonia.  Reducing or eliminating use of urinary catheters. For patients who have TAVR under conscious sedation, the team’s goal is to eliminate the catheter altogether. For patients under general anesthesia, the team removes it as soon as the patient is awake and recovered from the anesthesia. Earlier removal decreases the potential for infection and also gets the patient up and voiding on their own, which decreases the length of overall hospital stay.

The longer patients stay in bed, the more deconditioned they can become.

 Encouraging early ambulation. The team made it a policy to get patients who had transfemoral TAVR sitting up in a chair six hours following the procedure and even started ambulating patients in the ICU. Now, by the time they leave the ICU, usually having stayed there just one night, most patients are already breathing and voiding on their own and have been moving about, giving them a head start on their recovery and better preparing them for a successful discharge home.

All of these changes, both during and after the procedure, have helped Parkwest significantly decrease length of stay for TAVR patients while improving quality of care. The average stay for the transfemoral approach dropped from 7.5 days to 4 days five months after implementation of the changes began. This reduction met the team’s informal goal and approached the 3.5-day length of stay at Utah’s Intermountain Healthcare, a more experienced TAVR center that Parkwest used as a benchmark.

Jan-Sep 2014

Oct 2014-Feb 2015

Average ICU length of stay

2.2 days

1.5 days

Average overall length of stay, transfemoral approach only

7.5 days

4 days

Improving Discharge Planning For patients who are able, going directly home after TAVR can be ideal because it allows them to return more quickly to their normal activity, sleep, and social routines, which may help them both physically and psychologically in their recovery. To make it possible for Parkwest to safely discharge more of its TAVR patients to home (without home health care), the TAVR team had to reevaluate current practices. Team members took part in education that led to a greater awareness of the need to treat TAVR patients differently than patients having surgical valve replacement. Then they worked to make discharge to home everyone’s goal from the beginning so that patients, family members, and the entire care team all expected and supported it.

Interventional cardiologist Nicholas Xenopoulos, MD, says “the mindset is totally different” now, with a very clear goal that patients should go home if possible. The TAVR team also educated itself about the PACT policy and the negative financial impact of discharging early to skilled nursing, rehabilitation, or home health care in cases where it was not necessary.

At Parkwest, the path to home now starts when a patient is first seen. The TAVR team has developed a much more rigorous preoperative assessment — and if patients need a balloon valvuloplasty as a bridge to TAVR, they begin in light cardiac rehab, if possible, immediately after the balloon procedure. This allows them to become active more quickly and sets them up for later success with TAVR. According to Dr. Rahman, “That kind of methodology has really decreased the number of patients that we have had to send to skilled nursing facilities and rehab. This is good for the patient and is also fiscally more responsible.”

These changes in the team’s mindset and protocols have enabled a dramatic increase in the percentage of TAVR patients who are discharged to home under self/ family care.

Improving Documentation The TAVR team took steps to clarify and standardize documentation throughout the care process, with multiple beneficial effects. For example, they educated physician assistants and nurse practitioners on documenting medical conditions more specifically in discharge summaries (for example, “acute-on-chronic diastolic heart failure” vs. “heart failure, unspecified”) and resolving any discrepancies found in prior documentation.

Better documentation has led to better care, as all members of the team can easily find important information in the patient’s medical record.

For example, the TAVR team can quickly locate documentation of a patient’s comorbidities. This kind of transparency makes it easier to individualize care throughout a patient’s stay and helps reduce the risk of foreseeable complications. Improved documentation also provides referring physicians with a more complete picture of the care their patients received.

The TAVR team’s processes have become a model for the hospital system in terms of how to document accurately and appropriately. As an additional benefit, accurate documentation of the patient’s health status along with proper recording of comorbidities allowed more accurate coding, which can help optimize reimbursement.

“ Keeping track of what we do, and trying to optimize what we do, is key. What we can measure, we can improve.” ~ Nicholas Xenopoulos, MD interventional cardiologist Parkwest Medical Center

Establishing Strict Protocols Protocols at every stage of care have helped the TAVR team improve outcomes and efficiency. When they are first evaluated, all patients get the same workup, no matter which member of the team they see. This consistency extends to the TAVR procedure itself. When the team was transitioning to the fully percutaneous transfemoral approach, they developed strict protocols — a “road map” — for how to access the artery. Perfecting this approach has helped prevent vascular complications and increased the team’s confidence to start performing TAVR under conscious sedation. Working on protocols has brought the team together. Thomas Ayres, MD, another of the team’s interventional cardiologists, says that working closely with the team’s surgeons has made him a better cardiologist. “It’s good to get in a group and talk with not only other cardiologists but cardiac surgeons, because they have a different perspective. We all bring different skills to the table.”

Building a Team Approach Parkwest’s heart team is truly unified. It consists of interventional cardiologists, cardiothoracic surgeons, cardiac anesthesiologists, imaging specialists, OR staff,

cath lab staff, a valve coordinator, and a nurse navigator, all of whom work toward the goal of excellent patient care. Their team approach starts in the valve clinic, where they evaluate patients together and begin planning each procedure. Then, at the valve review session, the whole team reviews every patient’s clinical data, imaging, valve sizing, and delivery route, then signs off as one team. By the day of the procedure, all the homework has been done. This collaboration allows the team to tailor therapy for patients and is now also being applied to procedures other than TAVR. On another level, the analytics team and the TAVR team also work well together. They look at comparative data together and decide where to focus their improvement efforts. “Our role is not just as data gatherers; it’s trying to get the right people in the room … so we can have that dialogue that helps us to accomplish what [clinical improvements] we can,” says Brownlow. At an even higher level, these teams present TAVR program data at system wide service line meetings, which helps foster accountability.

Looking to the Future The analytics team has plans to look at data on readmissions and pacemaker insertions, as well as data from the Transcatheter Valve Therapy (TVT) Registry. The goal, as always, is to look for opportunities to improve care, outcomes, and patient satisfaction. “It’s a constant evolution,” says Brownlow. Echoing that sentiment, Dr. Nicholas Xenopoulos says, “Keeping track of what we do, and trying to optimize what we do, is key. What we can measure, we can improve.”

This method of continually evaluating performance is useful with any new technology. “You make an investment and then you watch over time and you learn from it; you improve your clinical performance, which ultimately, hopefully will improve your financial performance,” says Belbeck. Parkwest’s TAVR team hopes that its experience improving TAVR outcomes and efficiency can smooth the way for adoption of future heart technologies.

Summary Parkwest Medical Center took a successful TAVR program and made it better by analyzing data and finding ways to improve both clinical outcomes and operational efficiency. With the support of the analytics group, the TAVR clinical team made changes that reduced length of stay and allowed more patients to return directly home sooner. The team also improved documentation practices to optimize patient care and collect appropriate reimbursement. Collaboration was the constant that made it all happen. The team looks to continue this approach with TAVR and repeat it for new technology.

TAVR Quality Improvements That Can Decrease Length of Stay

General Differentiate treatment for TAVR vs. surgical valve replacement Differentiate treatment for transfemoral vs. transapical TAVR

Pre-procedure Care Begin discharge planning and setting expectations (i.e., length of stay, home self-care) with the patient and patient’s family prior to TAVR admission.

The TAVR Procedure Use the transfemoral TAVR approach when possible Perform transfemoral TAVR fully percutaneously Perform “minimalist” TAVR in appropriate patients • Conscious sedation • Noninvasive imaging Post-procedure Care Extubate as soon as possible after TAVR • In the operating room or within several hours of ICU transfer Reduce or eliminate use of urinary catheter • With general anesthesia: Remove catheter when patient wakes • With conscious sedation: Eliminate catheter use if possible Encourage early ambulation • Sit in chair when bed rest ends; ambulate soon after

Disclaimer Reimbursement information provided by Edwards Lifesciences is gathered from third-party sources and is presented for informational purposes only.

Edwards makes no representation, warranty or guarantee as to the timeliness, accuracy or completeness of the information and such information is not, and should not be construed as reimbursement, coding or legal advice. Any and all references to reimbursement codes are provided as examples only and are not intended to be a recommendation or advice as to the appropriate code for the a particular patient, diagnosis, product or procedure or a guarantee or promise of coverage or payment, nor does Edwards Lifesciences warranty that codes listed are appropriate in all related clinical scenarios. It is the responsibility of the provider to determine if coverage exists and what requirements are necessary for submitting a proper claim for reimbursement to a health plan or payer, including the appropriate code(s) for products provided or services rendered. Laws, regulations, and payer policies concerning reimbursement are complex and change frequently; service providers are responsible for all decisions relating to coding and reimbursement submissions.

Medicare’s Correct Coding Initiative and commercial payer policies are reviewed and updated several times each year. Accordingly, Edwards strongly recommends consultation with payers, reimbursement specialists and/or legal counsel regarding appropriate product or procedure codes, coverage, and reimbursement matters.

Please Note: The information provided is the experience of this speaker/facility, and Edwards Lifesciences has not independently evaluated these data.

Outcomes are dependent upon a number of facility and surgeon factors which are outside of Edwards’ control. These data should not be considered promises or guarantees by Edwards that the outcomes presenter here will be achieved by any individual facility.

Important Safety Information Edwards SAPIEN XT Transcatheter Heart Valve with the Novaflex+ Delivery System Indications: The Edwards SAPIEN XT transcatheter heart valve is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥ 8% or at a ≥ 15% risk of mortality at 30 days).

Contraindications: The THV and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation/ antiplatelet regimen or who have active bacterial endocarditis or other active infections.

Warnings: Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of pacing lead perforation.

There is an increased risk of stroke in transcatheter aortic valve replacement procedures, as compared to balloon aortic valvuloplasty or other standard treatments. The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. Care should be exercised when sizing the native annulus or surgical valve; implanting a THV that is too small may lead to paravalvular leak, migration or embolization, whereas implanting a THV that is too large may lead to residual gradient (patient-prosthesis mismatch) or annular rupture. Accelerated deterioration of the THV may occur in patients with an altered calcium metabolism. Prior to delivery, the THV must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution. THV leaflets mishandled or damaged during any part of the procedure will require replacement of the THV. Caution should be exercised in implanting a THV in patients with clinically significant coronary artery disease. Patients with pre-existing mitral valve devices should be carefully assessed prior to implantation of the THV to ensure proper THV positioning and deployment. Do not use the THV if the tamper evident seal is broken, the storage solution does not completely cover the THV, the temperature indicator has been activated, the THV is damaged, or the expiration date has elapsed. Do not mishandle the NovaFlex+ delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.g. kinked or stretched), or the expiration date has elapsed. Use of excessive contrast media may lead to renal failure. Measure the patient’s creatinine level prior to the procedure.

Contrast media usage should be monitored. Patient injury could occur if the delivery system is not un-flexed prior to removal. Care should be exercised in patients with hypersensitivities to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/ or polymeric materials. The procedure should be conducted under fluoroscopic guidance. Some fluoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, disfiguring, and long-lasting. THV recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, as determined by their physician. This device has not been tested for use without anticoagulation. Do not add or apply antibiotics to the storage solution, rinse solutions, or to the THV. Precautions: Long-term durability has not been established for the THV. Regular medical follow-up is advised to evaluate THV performance. Glutaraldehyde may cause irritation of the skin,

eyes, nose and throat. Avoid prolonged or repeated exposure to, or breathing of, the solution. Use only with adequate ventilation.

If skin contact occurs, immediately flush the affected area with water; in the event of contact with eyes, seek immediate medical attention. For more information about glutaraldehyde exposure, refer to the Material Safety Data Sheet available from Edwards Lifesciences. To maintain proper valve leaflet coaptation, do not overinflate the deployment balloon. Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and endocarditis. Safety, effectiveness, and durability have not been established for THV in THV procedures.

Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: non-calcified aortic annulus, severe ventricular dysfunction with ejection fraction < 20%, congenital unicuspid or congenital bicuspid aortic valve, mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+), pre-existing prosthetic ring in any position, severe mitral annular calcification (MAC), severe (> 3+) mitral insufficiency, or Gorlin syndrome, blood dyscrasias defined as: leukopenia (WBC < 3000 cells/mL), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mL), or history of bleeding diathesis or coagulopathy, hypertrophic cardiomyopathy with or without obstruction (HOCM), echocardiographic evidence of intracardiac mass, thrombus, or vegetation, a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid™), or clopidogrel (Plavix™), or sensitivity to contrast media, which cannot be adequately premedicated, significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding, or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta, access characteristics that would preclude safe placement of 16F, 18F, or 20F Edwards expandable introducer sheath set, such as severe obstructive calcification, severe tortuosity or diameter less than 6 mm, 6.5 mm, or 7 mm, respectively, bulky calcified aortic valve leaflets in close proximity to coronary ostia, a concomitant paravalvular leak where the surgical bioprosthesis is not securely fixed in the native annulus or is not structurally intact (e.g. wireform frame fracture), and a partially detached leaflet of the surgical bioprosthesis that in the aortic position may obstruct a coronary ostium. The safety and effectiveness have not been established for implanting the THV inside a stented bioprosthetic valve < 21 mm (labeled size) or an unstented bioprosthetic aortic valve. Residual mean gradient may be higher in a “TAV-in-SAV” configuration than that observed following implantation of the THV inside a native aortic annulus using the same size device. Patients with elevated mean gradient post procedure should be carefully followed. It is important that the manufacturer, model and size of the preexisting surgical bioprosthetic aortic valve be determined, so that the appropriate THV can be implanted and a prosthesis-patient mismatch be avoided. Additionally, pre-procedure imaging modalities must be employed to make as accurate a determination of the internal orifice as possible.

Potential Adverse Events: Potential risks associated with the overall procedure including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography: death; stroke/transient ischemic attack, clusters or neurological deficit; paralysis; permanent disability;

respiratory insufficiency or respiratory failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, myocardium or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; embolization including air, calcific valve material or thrombus; infection including septicemia and endocarditis; heart failure; myocardial infarction; renal insufficiency or renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia; retroperitoneal bleed; AV fistula or pseudoaneurysm; reoperation; ischemia or nerve injury; restenosis; pulmonary edema; pleural effusion; bleeding; anemia; abnormal lab values (including electrolyte imbalance); hypertension or hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma; syncope; pain or changes at the access site; exercise intolerance or weakness; inflammation; angina; heart murmur; fever. Additional potential risks associated with the use of the THV, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device migration or malposition requiring intervention; valve deployment in unintended location; valve stenosis; structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis); device degeneration; paravalvular or transvalvular leak; valve regurgitation; hemolysis; device explants; nonstructural dysfunction; mechanical failure of delivery system, and/ or accessories, non-emergent reoperation.

Edwards Expandable Introducer Sheath Set Indications: The Edwards expandable introducer sheath is indicated for the introduction and removal of devices used with the Edwards SAPIEN XT transcatheter heart valve.

Contraindications: This product is contraindicated for tortuous or calcified vessels that would prevent safe entry of the introducer and sheath.

Warnings: The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There is no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. The Edwards expandable introducer sheath set must be used with a compatible 0.035â&#x20AC;? guidewire.

Precautions: Do not use the introducer sheath set if the packaging sterile barriers and any components have been opened or damaged.

The Edwards Expandable Sheath temporarily enlarges to allow the passage of devices; ensure that the vasculature can accommodate the maximum diameter of the expanded sheath. When inserting, manipulating or withdrawing a device through the expandable sheath, always maintain sheath position. When puncturing, suturing or incising the tissue near the sheath, use caution to avoid damage to the sheath.

Potential Adverse Events: Complications associated with standard catheterization and use of angiography include, but are not limited to, injury including perforation or dissection of vessels, thrombosis, and/or plaque dislodgement which may result in emboli formation, distal vessel obstruction, stroke, infection, and/or death.

Edwards SAPIEN XT Transcatheter Heart Valve With The Ascendra+ Delivery System Indications: The Edwards SAPIEN XT transcatheter heart valve is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed,

insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score â&#x2030;Ľ 8% or at a â&#x2030;Ľ 15% risk of mortality at 30 days).

Contraindications: The THV and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation/ antiplatelet regimen or who have active bacterial endocarditis or other active infections.

Warnings: Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of pacing lead perforation.

There is an increased risk of stroke in transcatheter aortic valve replacement procedures, as compared to balloon aortic valvuloplasty or other standard treatments. The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. Care should be exercised when sizing the native annulus or surgical valve; implanting a THV that is too small may lead to paravalvular leak, migration or embolization, whereas implanting a THV that is too large may lead to residual gradient (patient-prosthesis mismatch) or annular rupture. Accelerated deterioration of the THV may occur in patients with an altered calcium metabolism. Prior to delivery, the THV must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution. THV leaflets mishandled or damaged during any part of the procedure will require replacement of the THV. Caution should be exercised in implanting a THV in patients with clinically significant coronary artery disease. Patients with pre-existing mitral valve devices should be carefully assessed prior to implantation of the THV to ensure proper THV positioning and deployment. Patients presenting with combination AV low flow, low gradient should undergo additional evaluation to establish the degree of aortic stenosis. Do not use the THV if the tamper evident seal is broken, the storage solution does not completely cover the THV, the temperature indicator has been activated, the THV is damaged, or the expiration date has elapsed. Do not mishandle the Ascendra+ delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.g. kinked or stretched), or the expiration date has elapsed. Care should be exercised in patients with hypersensitivities to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials. The procedure should be conducted under fluoroscopic guidance.

Some fluoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, disfiguring, and long-lasting. THV recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, as determined by their physician. This device has not been tested for use without anticoagulation. Do not add or apply antibiotics to the storage solution, rinse solutions, or to the THV. Precautions: Long-term durability has not been established for the THV. Regular medical follow-up is advised to evaluate THV performance. Glutaraldehyde may cause irritation of the skin, eyes, nose and throat. Avoid prolonged or repeated exposure to, or breathing of, the solution. Use only with adequate ventilation.

If skin contact occurs, immediately flush the affected area with water; in the event of contact with eyes, seek immediate medical attention. For more information about glutaraldehyde exposure, refer to the Material Safety Data Sheet available from Edwards Lifesciences. To maintain proper valve leaflet coaptation, do not overinflate the deployment balloon. Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and endocarditis. Safety, effectiveness, and durability have not been established for THV in THV procedures.

Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: Non-calcified aortic annulus, severe ventricular dysfunction with ejection fraction < 20%, congenital unicuspid or congenital bicuspid aortic valve, mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+), pre-existing prosthetic ring in any position, severe mitral annular calcification (MAC), severe (> 3+) mitral insufficiency, or Gorlin syndrome, blood dyscrasias defined as: leukopenia (WBC < 3000 cells/mL), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mL), or history of bleeding diathesis or coagulopathy, hypertrophic cardiomyopathy with or without obstruction (HOCM), echocardiographic evidence of intracardiac mass, thrombus, or vegetation, a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid™), or clopidogrel (Plavix™), or sensitivity to contrast media, which cannot be adequately premedicated, excessive calcification of vessel at access site, bulky calcified aortic valve leaflets in close proximity to coronary ostia, a concomitant paravalvular leak where the surgical bioprosthesis is not securely fixed in the native annulus or is not structurally intact (e.g. wireform frame fracture), and a partially detached leaflet of the surgical bioprosthesis that in the aortic position may obstruct a coronary ostium. The safety and effectiveness have not been established for implanting the THV inside a stented bioprosthetic valve < 21 mm (labeled size) or an unstented bioprosthetic aortic valve. Residual mean gradient may be higher in a “TAV-in-SAV” configuration than that observed following implantation of the THV inside a native aortic annulus using the same size device. Patients with elevated mean gradient post procedure should be carefully followed. It is important that the manufacturer, model and size of the preexisting surgical bioprosthetic aortic valve be determined, so that the appropriate THV can be implanted and a prosthesis-patient mismatch be avoided. Additionally, pre-procedure imaging modalities must be employed to make as accurate a determination of the internal orifice as possible.

Potential Adverse Events: Potential risks associated with the overall procedure including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography: death; stroke/transient ischemic attack, clusters or neurological deficit; paralysis; permanent disability; respiratory insufficiency or respiratory failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, myocardium or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; embolization including air, calcific valve material or thrombus; infection including septicemia and endocarditis; heart failure; myocardial infarction; renal insufficiency or renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia; retroperitoneal bleed; AV fistula or pseudoaneurysm; reoperation; ischemia or nerve injury; restenosis; pulmonary edema; pleural effusion; bleeding; anemia; abnormal lab values (including electrolyte imbalance); hypertension or hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma; syncope; pain or changes at the access site; exercise intolerance or weakness; inflammation; angina; heart murmur; fever. Additional potential risks associated with the use of the THV, delivery system, and/or accessories include: cardiac

arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device migration or malposition requiring intervention; valve deployment in unintended location; valve stenosis; structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis); device degeneration; paravalvular or transvalvular leak; valve regurgitation; hemolysis; device explants; nonstructural dysfunction; mechanical failure of delivery system, and/ or accessories; non-emergent reoperation.

Ascendra+ Introducer Sheath Set Indications: The Ascendra+ introducer sheath set is indicated for the introduction and removal of devices used with the Edwards SAPIEN XT transcatheter heart valve.

Contraindications: No known contraindications.

Warnings: The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. Do not mishandle the device or use it if the packaging or any components are not sterile, have been opened or are damaged (e.g. kinked or stretched), or the expiration date has elapsed. Should not be used in patients with left ventricular aneurysm. The Ascendra+ introducer sheath set must be used with a 0.035” guidewire.

Precautions: No known precautions.

Potential Adverse Events: Complications associated with cardiac surgical intervention and use of angiography include, but are not limited to, allergic reaction to anesthesia or to contrast media, injury including myocardial injury, thrombus formation, and plaque dislodgement which may result in myocardial infarction, arrhythmia, stroke, and/or death. Reference the Edwards SAPIEN XT transcatheter heart valve with the Ascendra+ delivery system Instructions for Use for a full list of potential adverse events.

Edwards Crimper Indications: The Edwards crimper is indicated for use in preparing the Edwards SAPIEN XT transcatheter heart valve for implantation.

Contraindications: No known contraindications.

Warnings: The device is designed, intended, and distributed for single use only. Do not resterilize or reuse the device. There are no data to support the sterility, nonpyrogenicity, and functionality of the device after reprocessing. Do not mishandle the device. Do not use the device if the packaging or any components are not sterile, have been opened or are damaged, or the expiration date has elapsed.

Precautions: For special considerations associated with the use of this device prior to THV implantation, refer to the SAPIEN XT transcatheter heart valve Instructions for Use. Potential Adverse Events: No known potential adverse events.

CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, Ascendra, Ascendra+, NovaFlex, NovaFlex+, SAPIEN, SAPIEN XT, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. © 2016 Edwards Lifesciences Corporation. All rights reserved. PP-US-0979 Edwards Lifesciences • One Edwards Way, Irvine, CA 92614 • edwards.com