PR O G RE S S I N C ARDI O V A S CU L A R D I S EA S E S 5 6 (2 0 1 4) 56 3–5 6 4
Available online at www.sciencedirect.com
ScienceDirect www.onlinepcd.com
Editorial
Transcatheter Aortic Valve Replacement: A Transformative Therapy The health care profession is a highly privileged one, in which professionals are able to both witness and actively participate in the delivery of care that transforms patients’ lives, as well as the profession itself. In this light, we have been beholden to the rapid evolution of transcatheter aortic valve replacement (TAVR), a therapy whose influence has stretched far beyond simply being a mechanical solution for treating aortic stenosis (AS). To date, there have been over 100,000 patients who have undergone TAVR worldwide, including over ~ 8000 individuals in the United States (US) since commercial approval in 2011. 1 Moreover, the number of treated patients is expected to grow exponentially due to population aging. In one study, it was estimated that ~ 9000 individuals in the US and ~ 19,000 persons in Europe become eligible for TAVR each year. 2 Through multiple clinical investigations, it is now widely accepted that TAVR is an efficacious therapy for patients with severe symptomatic AS who are either inoperable or at high-surgical risk for open surgical aortic valve replacement (SAVR). While the clinical impact of TAVR is certain, its emergence also has spurned important systematic changes in the care of the cardiovascular (CV) patient. Perhaps the most noteworthy of these effects is the demonstration of the importance of a dedicated, multi-disciplinary heart team that functions in a highly specialized center.3 The shared vision of the heart team is the optimization of clinical outcomes through cohesive and collegial collaboration. Although the heart team approach had been described previously for the revascularization of coronary artery disease, the collaborative model used in TAVR has been so successful that the Center for Medicare Services, as well as industry partners, now mandates such teamwork when considering TAVR. Moreover, the term ‘heart team’ has become a more frequent part of our professional lexicon. The heart team approach used in TAVR also continues to serve as a model for the evaluation and eventual implementation of future advances in TAVR, as well as other catheter-based technologies that are currently under investigation.4 The multi-disciplinary approach of the heart team for TAVR is essential due to the significant complexity of both the patients and the potential therapies. The choice to pursue TAVR can only be made through a comprehensive evaluation
of the cardiac and non-cardiac morbidities, advanced CV imaging studies, and a shared-decision making process that involves careful consideration of the benefits and risks of both percutaneous and surgical options. In this special issue of Progress in Cardiovascular Diseases, we focus on the current and potential future roles of TAVR as part of the therapeutic armamentarium for patients with AS. In this series of articles, which are all written by notable experts in the field, we describe the burden of AS in the patient population and eligible TAVR candidates; clinical methods and tools for their evaluation, including assessments of frailty and surgical risk; clinical data on current TAVR therapy; and the latest catheterbased and surgical therapies. Importantly, this issue also provides unique perspectives from Europe, where the earliest adoption of TAVR occurred, and from cardiac surgery, where the standards of care for operable patients have been established through decades of technical advancements and highly regarded expertise. The success and adoption of any new therapy are heavily influenced by the clinical outcomes, quality-of-care, and its cost-effectiveness. The complexity of managing TAVR patients is notably challenging and costly, due to the elderly age of these individuals and their frequent co-morbidity. Of note, the average age of patients undergoing TAVR under the auspices of clinical trials and following commercial approval in the US is ~ 84 years with a 95% confidence interval of 6 to 8 years.1,5,6 Patients, in whom SAVR was not contemplated previously, are now being evaluated frequently for TAVR. The economic implications of this change are significant, as there are many patients who are evaluated but do not eventually undergo the procedure. As an example, in the Placement of Aortic Transcatheter Valves trial (PARTNER), only 34% of the 3105 patients screened by the executive committee were enrolled, and there were additional patients who underwent testing at the various sites and not presented for enrollment.5,6 In this issue, the current clinical indications and the potential for expanded use of TAVR are discussed in the context of quality-of-care and performance metrics, as well as the economic implications, which are significant for hospitals pursuing TAVR programs and the payers who bear the financial costs to support this therapy. Since the first clinical description of TAVR in 2002, an enormous wealth of investigation into this therapy has been
564
PR O GRE S S I N C ARDI O VAS CU L AR D I S EAS E S 5 6 ( 2 0 14 ) 56 3–5 64
performed.7 A recent literature search performed in the US National Library of Medicine database using the terms “transcatheter” combined with “aortic valve” generated 2449 citations in the previous 10 years, but 2314 of these publications (94%) occurred in the past 5 years alone. 8 This special issue summarizes and frames a detailed understanding of TAVR with the perspectives of highly experienced clinicians and leading investigators. This understanding is important, as there is evidence that some patients may be eligible, yet are not receiving life-saving therapy, and the associated costs of medically-managing symptomatic AS are high. 9,10 The championing of high quality in the care of CV patients is elementary in our profession, and also will help to ensure the success of TAVR and its continued role as a transformative therapy in the lives of many of our patients.
REFERENCES
1. Mack MJ, Brennan JM, Brindis R, et al. Outcomes following trancatheter aortic valve replacement in the United States. JAMA. 2013;310:2069-2077. 2. Osnabrugge RL, Mylotte D, Head SJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013;62:1002-1012. 3. Holmes Jr DR, Rich JB, Zoghbi WA, Mack MJ. The heart team of cardiovascular care. J Am Coll Cardiol. 2013;61:903-907. 4. Cardiovascular outcomes assessment of the mitraclip therapy percutaneous therapy for high surgical risk patients (COAPT).
5.
6.
7.
8. 9.
10.
http://clinicaltrials.gov/ct2/show/NCT01626079. [Accessed on February 14, 2014]. 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;363:1597-1607. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. New Engl J Med. 2011;364:2187-2198. 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;106:3006-3008. http://www.ncbi.nlm.nih.gov/pubmed. [Accessed on February 14, 2014]. Mylotte D, Osnabrugge RL, Windecker S, et al. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013;3:210-219. Clark MA, Arnold SV, Duhay FG, et al. Five-year clinical and economic outcomes among patients with medically managed severe aortic stenosis: results from a a Medicare claims analysis. Circ Cardiovasc Qual Outcomes. 2012;1:697-704.
Paul Sorajja Center for Valve and Structural Heart Disease Minneapolis Heart Institute at Abbott Northwestern Hospital E-mail address: [email protected] 0033-0620/$ - see front matter © 2014 Published by Elsevier Inc.
http://dx.doi.org/10.1016/j.pcad.2014.02.005
Available online at www.sciencedirect.com
ScienceDirect www.onlinepcd.com
Editorial
Transcatheter Aortic Valve Replacement: A Transformative Therapy The health care profession is a highly privileged one, in which professionals are able to both witness and actively participate in the delivery of care that transforms patients’ lives, as well as the profession itself. In this light, we have been beholden to the rapid evolution of transcatheter aortic valve replacement (TAVR), a therapy whose influence has stretched far beyond simply being a mechanical solution for treating aortic stenosis (AS). To date, there have been over 100,000 patients who have undergone TAVR worldwide, including over ~ 8000 individuals in the United States (US) since commercial approval in 2011. 1 Moreover, the number of treated patients is expected to grow exponentially due to population aging. In one study, it was estimated that ~ 9000 individuals in the US and ~ 19,000 persons in Europe become eligible for TAVR each year. 2 Through multiple clinical investigations, it is now widely accepted that TAVR is an efficacious therapy for patients with severe symptomatic AS who are either inoperable or at high-surgical risk for open surgical aortic valve replacement (SAVR). While the clinical impact of TAVR is certain, its emergence also has spurned important systematic changes in the care of the cardiovascular (CV) patient. Perhaps the most noteworthy of these effects is the demonstration of the importance of a dedicated, multi-disciplinary heart team that functions in a highly specialized center.3 The shared vision of the heart team is the optimization of clinical outcomes through cohesive and collegial collaboration. Although the heart team approach had been described previously for the revascularization of coronary artery disease, the collaborative model used in TAVR has been so successful that the Center for Medicare Services, as well as industry partners, now mandates such teamwork when considering TAVR. Moreover, the term ‘heart team’ has become a more frequent part of our professional lexicon. The heart team approach used in TAVR also continues to serve as a model for the evaluation and eventual implementation of future advances in TAVR, as well as other catheter-based technologies that are currently under investigation.4 The multi-disciplinary approach of the heart team for TAVR is essential due to the significant complexity of both the patients and the potential therapies. The choice to pursue TAVR can only be made through a comprehensive evaluation
of the cardiac and non-cardiac morbidities, advanced CV imaging studies, and a shared-decision making process that involves careful consideration of the benefits and risks of both percutaneous and surgical options. In this special issue of Progress in Cardiovascular Diseases, we focus on the current and potential future roles of TAVR as part of the therapeutic armamentarium for patients with AS. In this series of articles, which are all written by notable experts in the field, we describe the burden of AS in the patient population and eligible TAVR candidates; clinical methods and tools for their evaluation, including assessments of frailty and surgical risk; clinical data on current TAVR therapy; and the latest catheterbased and surgical therapies. Importantly, this issue also provides unique perspectives from Europe, where the earliest adoption of TAVR occurred, and from cardiac surgery, where the standards of care for operable patients have been established through decades of technical advancements and highly regarded expertise. The success and adoption of any new therapy are heavily influenced by the clinical outcomes, quality-of-care, and its cost-effectiveness. The complexity of managing TAVR patients is notably challenging and costly, due to the elderly age of these individuals and their frequent co-morbidity. Of note, the average age of patients undergoing TAVR under the auspices of clinical trials and following commercial approval in the US is ~ 84 years with a 95% confidence interval of 6 to 8 years.1,5,6 Patients, in whom SAVR was not contemplated previously, are now being evaluated frequently for TAVR. The economic implications of this change are significant, as there are many patients who are evaluated but do not eventually undergo the procedure. As an example, in the Placement of Aortic Transcatheter Valves trial (PARTNER), only 34% of the 3105 patients screened by the executive committee were enrolled, and there were additional patients who underwent testing at the various sites and not presented for enrollment.5,6 In this issue, the current clinical indications and the potential for expanded use of TAVR are discussed in the context of quality-of-care and performance metrics, as well as the economic implications, which are significant for hospitals pursuing TAVR programs and the payers who bear the financial costs to support this therapy. Since the first clinical description of TAVR in 2002, an enormous wealth of investigation into this therapy has been
564
PR O GRE S S I N C ARDI O VAS CU L AR D I S EAS E S 5 6 ( 2 0 14 ) 56 3–5 64
performed.7 A recent literature search performed in the US National Library of Medicine database using the terms “transcatheter” combined with “aortic valve” generated 2449 citations in the previous 10 years, but 2314 of these publications (94%) occurred in the past 5 years alone. 8 This special issue summarizes and frames a detailed understanding of TAVR with the perspectives of highly experienced clinicians and leading investigators. This understanding is important, as there is evidence that some patients may be eligible, yet are not receiving life-saving therapy, and the associated costs of medically-managing symptomatic AS are high. 9,10 The championing of high quality in the care of CV patients is elementary in our profession, and also will help to ensure the success of TAVR and its continued role as a transformative therapy in the lives of many of our patients.
REFERENCES
1. Mack MJ, Brennan JM, Brindis R, et al. Outcomes following trancatheter aortic valve replacement in the United States. JAMA. 2013;310:2069-2077. 2. Osnabrugge RL, Mylotte D, Head SJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013;62:1002-1012. 3. Holmes Jr DR, Rich JB, Zoghbi WA, Mack MJ. The heart team of cardiovascular care. J Am Coll Cardiol. 2013;61:903-907. 4. Cardiovascular outcomes assessment of the mitraclip therapy percutaneous therapy for high surgical risk patients (COAPT).
5.
6.
7.
8. 9.
10.
http://clinicaltrials.gov/ct2/show/NCT01626079. [Accessed on February 14, 2014]. 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;363:1597-1607. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. New Engl J Med. 2011;364:2187-2198. 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;106:3006-3008. http://www.ncbi.nlm.nih.gov/pubmed. [Accessed on February 14, 2014]. Mylotte D, Osnabrugge RL, Windecker S, et al. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013;3:210-219. Clark MA, Arnold SV, Duhay FG, et al. Five-year clinical and economic outcomes among patients with medically managed severe aortic stenosis: results from a a Medicare claims analysis. Circ Cardiovasc Qual Outcomes. 2012;1:697-704.
Paul Sorajja Center for Valve and Structural Heart Disease Minneapolis Heart Institute at Abbott Northwestern Hospital E-mail address: [email protected] 0033-0620/$ - see front matter © 2014 Published by Elsevier Inc.
http://dx.doi.org/10.1016/j.pcad.2014.02.005
