Canadian Journal of Cardiology 30 (2014) 1506e1507
Editorial
Starting Small But Aiming High: Important Lessons in Establishing a Successful TAVR Program Tamim M. Nazif, MD, and Martin B. Leon, MD Columbia University Medical Center and The Cardiovascular Research Foundation, New York, New York, USA
See article by Chevalier et al., pages 1576-1582 in this issue. Transcatheter aortic valve replacement (TAVR) was first performed by Alain Cribier in 20021 and culminated a decade later in definitive randomized clinical trials, notably the Placement of AoRTic TraNscathetER Valves (PARTNER) trial, that proved the safety and efficacy of TAVR in high-risk and inoperable patients.2,3 This rigourous clinical research effort justified explosive growth in the clinical use of TAVR, and it is now estimated that more than 120,000 patients have been treated in > 750 centres worldwide. Because of the rapidity of TAVR growth, a major challenge of the second decade of the TAVR experience will be the continued safe and rational dispersion of this new technology beyond the realm of high-volume, expert sites. The establishment of new TAVR centres has been relatively slow and judicious in Canada and the United States, particularly compared with some European countries. This is due to a variety of cultural, regulatory, and economic issues. Among these are persistent concerns regarding a TAVR “learning curve” and the effect of lower-volume centres and surgeons on outcomes and cost.4 Because TAVR is a complex procedure primarily performed in elderly patients with significant comorbidities and the highest risk for complications, it is not surprising that several studies have demonstrated the effects of a “learning curve.”5,6 Experience has been shown to affect overall outcomes and specific procedural elements, such as vascular access. Several measures have been instituted to address these concerns, including requirements for formal training courses and proctoring for initial cases. Multisociety consensus statements have addressed the requirements for new valve programs and are largely volume-based for surgeons and institutions.7-9 These documents also recognize the importance of a minimum yearly case volume in program maintenance and the preservation of satisfactory outcomes. These Received for publication September 5, 2014. Accepted October 2, 2014. Corresponding author: Dr Martin B. Leon, Columbia University Medical Center, New York-Presbyterian Hospital, 161 Fort Washington Ave, 6th Floor, New York, NY 10032. Tel.: þ1-212-305-7060; fax: þ1-212-3423660. E-mail: [email protected] See page 1507 for disclosure information.
requirements have further been linked to reimbursement in the United States. Despite these rigourous training and certification efforts, concern remains regarding the safe dispersion of TAVR to lower-volume centres. In their article in this issue of the Canadian Journal of Cardiology, Chevalier and colleagues seek to address this concern.10 The authors present the 30-day results of the first 30 TAVR procedures performed by their nascent program at the Hôpital du Sacre-Coeur de Montreal. The procedures were performed in 2013 and 2014 with the balloon-expandable Edwards SAPIEN XT transcatheter heart valve, delivered using transfemoral arterial access. All patients were deemed highrisk or inoperable by a heart team, consisting of a cardiologist and a cardiothoracic surgeon. It is worth noting that, although the patients were elderly (average age, 84.6 years), the Society of Thoracic Surgeons (STS) score of 7.0 3.5% is somewhat less than would be expected for this risk stratum. This is likely because of the high proportion of patients with increased risk due to anatomic features (eg, porcelain aorta) that are not accounted for in the STS score, a characteristic previously associated with favourable TAVR outcomes.11 Nevertheless, the results of these first 30 procedures are quite impressive. Using Valve Academic Research Consortium-2 definitions, the authors report 100% device and procedure success with no need for second valve implantation or emergency surgery.12 There was no 30-day mortality and only 1 occurrence each of disabling stroke, major bleeding, and major vascular complication. The hemodynamic results were also excellent with no moderate or severe paravalvular regurgitation and a single case of severe patient prosthesis mismatch in a valvein-valve procedure. The favourable procedural outcomes were also reflected in a short overall length of stay with more than half of the patients discharged within 48 hours of the procedure. That the authors were able to achieve these excellent shortterm results in their initial experience likely reflects the combined effect of several factors, which deserve comment. First, although the heart team itself was new, the operators had extensive training at high-volume centres. The primary interventional cardiologist and cardiothoracic surgeon both completed dedicated fellowship training in TAVR, and the imaging specialists had specific expertise in TAVR. Second, the described patient screening process and clinical practices
http://dx.doi.org/10.1016/j.cjca.2014.10.001 0828-282X/Ó 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
Nazif and Leon Establishing a Successful TAVR Program
clearly demonstrate “transmitted learning” from the existing literature and the cumulative experience of the TAVR community over the past decade. Examples of clinical and procedural “best clinical practices” are found throughout the report. In the screening process, all patients were evaluated by the multidisciplinary heart team in a dedicated TAVR clinic. Rigourous multimodality imaging was performed, including routine computed tomography angiography for comprehensive evaluation of the iliofemoral arterial access and 3-dimensional assessment of the aortic valve annulus with the goal of systematic 10%-20% prosthesis area oversizing. The procedures themselves were performed with general anaesthesia and transesophageal echocardiographic guidance. Transfemoral arterial access was optimized with ultrasound-guided arterial puncture, suture-mediated preclosure, and a crossover balloon occlusion technique to facilitate hemostasis.13 Care after the procedure focused on early mobilization with routine extubation in the operating room and removal of invasive catheters on the first day. It seems likely that the cumulative effect of these best clinical practices contributed to the favourable outcomes reported. Value in health care is defined as outcomes achieved relative to expenditure.14 It is worth noting that in addition to excellent outcomes, the authors of the current study were able to achieve early discharge (< 48 hours) in most cases. Length of hospital stay and procedure-related complications have previously been shown to be major determinants of the cost effectiveness of transfemoral TAVR relative to surgical valve replacement.15 Although comprehensive cost data are not available, the short length of stay and infrequent complications in this study suggest a favourable shift of the value equation. In summary, the article by Chevalier and colleagues issues a bold challengedthat the learning curve for TAVR can indeed be truncated and that new, relatively low-volume programs can achieve excellent outcomes and high value. It remains to be seen whether other new programs are able to accept this challenge and to succeed through lessons collectively learned, specifically the importance of rigourous training, the multidisciplinary heart team, careful patient screening, and best clinical practices.
1507
2. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-607. 3. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aorticvalve replacement in high-risk patients. N Engl J Med 2011;364:2187-98. 4. Feldman AM, Disesa VJ. Transcatheter aortic valve replacement: Flattening the cost curve. JAMA 2014;312:25-6. 5. Nuis RJ, van Mieghem NM, van der Boon RM. Effect of experience on results of transcatheter aortic valve implantation using a Medtronic CoreValve System. Am J Cardiol 2011;107:1824-9. 6. Gurvitch R, Tay EL, Wijesinghe N, et al. Transcatheter aortic valve implantation: lessons from the learning curve of the first 270 high-risk patients. Catheter Cardiovasc Interv 2011;78:977-84. 7. Webb J, Rodes-Cabau J, Fremes S, et al. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol 2012;28:520-8. 8. Holmes DR Jr, Mack MJ, Kaul S, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol 2012;59:1200-54. 9. Tommaso CL, Bolman RM 3rd, Feldman T, et al. Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: operator and institutional requirements for transcatheter valve repair and replacement, part 1: transcatheter aortic valve replacement. J Am Coll Cardiol 2012;59:2028-42. 10. Chevalier F, Poulin F, Lamarche Y, et al. Excellent outcomes for transcatheter aortic valve replacement within one year of opening a low-volume center and consideration of requirements. Can J Cardiol 2014;30:1576-82. 11. Makkar RR, Jilaihawi H, Mack M, et al. Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons. J Am Coll Cardiol 2014;63:901-11. 12. Kappetein AP, Head SJ, Genereux P, et al. Updated standardized end point definitions for transcatheter aortic valve implantation: the valve academic research consortium-2 consensus document. J Am Coll Cardiol 2012;60:1438-54.
Disclosures Martin Leon has received reimbursement for travel expenses to investigator meetings from Edwards LifeSciences. Tamim Nazif has received reimbursement for travel expenses and consulting fees from Edwards LifeSciences.
13. Genereux P, Kodali S, Leon MB, et al. Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation. JACC Cardiovasc Interv 2011;4:861-7.
References
15. Reynolds MR, Magnuson EA, Lei Y, et al. Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of Aortic Transcatheter Valves) trial (Cohort A). J Am Coll Cardiol 2012;60:2683-92.
1. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002;106:3006-8.
14. Porter ME. What is value in health care? N Engl J Med 2010;363: 2477-81.
Editorial
Starting Small But Aiming High: Important Lessons in Establishing a Successful TAVR Program Tamim M. Nazif, MD, and Martin B. Leon, MD Columbia University Medical Center and The Cardiovascular Research Foundation, New York, New York, USA
See article by Chevalier et al., pages 1576-1582 in this issue. Transcatheter aortic valve replacement (TAVR) was first performed by Alain Cribier in 20021 and culminated a decade later in definitive randomized clinical trials, notably the Placement of AoRTic TraNscathetER Valves (PARTNER) trial, that proved the safety and efficacy of TAVR in high-risk and inoperable patients.2,3 This rigourous clinical research effort justified explosive growth in the clinical use of TAVR, and it is now estimated that more than 120,000 patients have been treated in > 750 centres worldwide. Because of the rapidity of TAVR growth, a major challenge of the second decade of the TAVR experience will be the continued safe and rational dispersion of this new technology beyond the realm of high-volume, expert sites. The establishment of new TAVR centres has been relatively slow and judicious in Canada and the United States, particularly compared with some European countries. This is due to a variety of cultural, regulatory, and economic issues. Among these are persistent concerns regarding a TAVR “learning curve” and the effect of lower-volume centres and surgeons on outcomes and cost.4 Because TAVR is a complex procedure primarily performed in elderly patients with significant comorbidities and the highest risk for complications, it is not surprising that several studies have demonstrated the effects of a “learning curve.”5,6 Experience has been shown to affect overall outcomes and specific procedural elements, such as vascular access. Several measures have been instituted to address these concerns, including requirements for formal training courses and proctoring for initial cases. Multisociety consensus statements have addressed the requirements for new valve programs and are largely volume-based for surgeons and institutions.7-9 These documents also recognize the importance of a minimum yearly case volume in program maintenance and the preservation of satisfactory outcomes. These Received for publication September 5, 2014. Accepted October 2, 2014. Corresponding author: Dr Martin B. Leon, Columbia University Medical Center, New York-Presbyterian Hospital, 161 Fort Washington Ave, 6th Floor, New York, NY 10032. Tel.: þ1-212-305-7060; fax: þ1-212-3423660. E-mail: [email protected] See page 1507 for disclosure information.
requirements have further been linked to reimbursement in the United States. Despite these rigourous training and certification efforts, concern remains regarding the safe dispersion of TAVR to lower-volume centres. In their article in this issue of the Canadian Journal of Cardiology, Chevalier and colleagues seek to address this concern.10 The authors present the 30-day results of the first 30 TAVR procedures performed by their nascent program at the Hôpital du Sacre-Coeur de Montreal. The procedures were performed in 2013 and 2014 with the balloon-expandable Edwards SAPIEN XT transcatheter heart valve, delivered using transfemoral arterial access. All patients were deemed highrisk or inoperable by a heart team, consisting of a cardiologist and a cardiothoracic surgeon. It is worth noting that, although the patients were elderly (average age, 84.6 years), the Society of Thoracic Surgeons (STS) score of 7.0 3.5% is somewhat less than would be expected for this risk stratum. This is likely because of the high proportion of patients with increased risk due to anatomic features (eg, porcelain aorta) that are not accounted for in the STS score, a characteristic previously associated with favourable TAVR outcomes.11 Nevertheless, the results of these first 30 procedures are quite impressive. Using Valve Academic Research Consortium-2 definitions, the authors report 100% device and procedure success with no need for second valve implantation or emergency surgery.12 There was no 30-day mortality and only 1 occurrence each of disabling stroke, major bleeding, and major vascular complication. The hemodynamic results were also excellent with no moderate or severe paravalvular regurgitation and a single case of severe patient prosthesis mismatch in a valvein-valve procedure. The favourable procedural outcomes were also reflected in a short overall length of stay with more than half of the patients discharged within 48 hours of the procedure. That the authors were able to achieve these excellent shortterm results in their initial experience likely reflects the combined effect of several factors, which deserve comment. First, although the heart team itself was new, the operators had extensive training at high-volume centres. The primary interventional cardiologist and cardiothoracic surgeon both completed dedicated fellowship training in TAVR, and the imaging specialists had specific expertise in TAVR. Second, the described patient screening process and clinical practices
http://dx.doi.org/10.1016/j.cjca.2014.10.001 0828-282X/Ó 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
Nazif and Leon Establishing a Successful TAVR Program
clearly demonstrate “transmitted learning” from the existing literature and the cumulative experience of the TAVR community over the past decade. Examples of clinical and procedural “best clinical practices” are found throughout the report. In the screening process, all patients were evaluated by the multidisciplinary heart team in a dedicated TAVR clinic. Rigourous multimodality imaging was performed, including routine computed tomography angiography for comprehensive evaluation of the iliofemoral arterial access and 3-dimensional assessment of the aortic valve annulus with the goal of systematic 10%-20% prosthesis area oversizing. The procedures themselves were performed with general anaesthesia and transesophageal echocardiographic guidance. Transfemoral arterial access was optimized with ultrasound-guided arterial puncture, suture-mediated preclosure, and a crossover balloon occlusion technique to facilitate hemostasis.13 Care after the procedure focused on early mobilization with routine extubation in the operating room and removal of invasive catheters on the first day. It seems likely that the cumulative effect of these best clinical practices contributed to the favourable outcomes reported. Value in health care is defined as outcomes achieved relative to expenditure.14 It is worth noting that in addition to excellent outcomes, the authors of the current study were able to achieve early discharge (< 48 hours) in most cases. Length of hospital stay and procedure-related complications have previously been shown to be major determinants of the cost effectiveness of transfemoral TAVR relative to surgical valve replacement.15 Although comprehensive cost data are not available, the short length of stay and infrequent complications in this study suggest a favourable shift of the value equation. In summary, the article by Chevalier and colleagues issues a bold challengedthat the learning curve for TAVR can indeed be truncated and that new, relatively low-volume programs can achieve excellent outcomes and high value. It remains to be seen whether other new programs are able to accept this challenge and to succeed through lessons collectively learned, specifically the importance of rigourous training, the multidisciplinary heart team, careful patient screening, and best clinical practices.
1507
2. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-607. 3. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aorticvalve replacement in high-risk patients. N Engl J Med 2011;364:2187-98. 4. Feldman AM, Disesa VJ. Transcatheter aortic valve replacement: Flattening the cost curve. JAMA 2014;312:25-6. 5. Nuis RJ, van Mieghem NM, van der Boon RM. Effect of experience on results of transcatheter aortic valve implantation using a Medtronic CoreValve System. Am J Cardiol 2011;107:1824-9. 6. Gurvitch R, Tay EL, Wijesinghe N, et al. Transcatheter aortic valve implantation: lessons from the learning curve of the first 270 high-risk patients. Catheter Cardiovasc Interv 2011;78:977-84. 7. Webb J, Rodes-Cabau J, Fremes S, et al. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol 2012;28:520-8. 8. Holmes DR Jr, Mack MJ, Kaul S, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol 2012;59:1200-54. 9. Tommaso CL, Bolman RM 3rd, Feldman T, et al. Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: operator and institutional requirements for transcatheter valve repair and replacement, part 1: transcatheter aortic valve replacement. J Am Coll Cardiol 2012;59:2028-42. 10. Chevalier F, Poulin F, Lamarche Y, et al. Excellent outcomes for transcatheter aortic valve replacement within one year of opening a low-volume center and consideration of requirements. Can J Cardiol 2014;30:1576-82. 11. Makkar RR, Jilaihawi H, Mack M, et al. Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons. J Am Coll Cardiol 2014;63:901-11. 12. Kappetein AP, Head SJ, Genereux P, et al. Updated standardized end point definitions for transcatheter aortic valve implantation: the valve academic research consortium-2 consensus document. J Am Coll Cardiol 2012;60:1438-54.
Disclosures Martin Leon has received reimbursement for travel expenses to investigator meetings from Edwards LifeSciences. Tamim Nazif has received reimbursement for travel expenses and consulting fees from Edwards LifeSciences.
13. Genereux P, Kodali S, Leon MB, et al. Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation. JACC Cardiovasc Interv 2011;4:861-7.
References
15. Reynolds MR, Magnuson EA, Lei Y, et al. Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of Aortic Transcatheter Valves) trial (Cohort A). J Am Coll Cardiol 2012;60:2683-92.
1. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002;106:3006-8.
14. Porter ME. What is value in health care? N Engl J Med 2010;363: 2477-81.
