Editorial Transcatheter Aortic Valve Replacement: Does It Work and Can We Afford It? Christopher Cao, MBBS, BSc; Hugh Wolfenden, MBBS; Tristan D. Yan, MBBS, MD, PhD
S
ince the first procedure was performed just over a decade ago, transcatheter aortic valve replacement (TAVR) has emerged as one of the most significant innovations in cardiovascular medicine since the introduction of percutaneous coronary intervention.1 Quantitatively, this has been demonstrated by penetration rates of >35% in countries such as Germany and Switzerland.2 The number of novel devices being developed and the volume of patients being treated continue to expand at exponential rates in both Europe and North America.3,4 Intense enthusiasm from the cardiovascular community and the medical industry has driven several multi-institutional registries and randomized controlled trials to assess the clinical- and costrelated outcomes of TAVR in various patient populations.5–10
Article see p 829
Clinical Outcomes of TAVR Clinical outcomes of TAVR should be considered in relation to the patient risk profile and the comparator. The Placement of AoRTic TraNscathER Valve (PARTNER) B trial reported significantly superior survival outcomes and reduced hospitalizations for ineligible surgical candidates who underwent TAVR, at the cost of higher stroke rates, when compared with medical therapy.11 For high-risk surgical candidates a recent meta-analysis demonstrated similar overall survival and stroke outcomes for patients who underwent TAVR or surgical aortic valve replacement.12 TAVR was more likely to result in the need for a permanent pacemaker insertion, major vascular injury, and moderate or severe aortic regurgitation. However, patients who underwent surgical aortic valve replacement were more likely to experience major bleeding.12 These end points, as well as others such as myocardial infarction and renal failure, have been quantitatively defined by the Valve Academic Research Consortium to facilitate direct comparisons between treatment arms and institutions.13 The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association. From The Systematic Reviews Unit, The Collaborative Research (CORE) Group, Macquarie University, Sydney, New South Wales, Australia (C.C., T.D.Y.); and Department of Cardiothoracic Surgery, Prince of Wales Hospital, Sydney, New South Wales, Australia (H.W.). Correspondence to Christopher Cao, MBBS, BSc, The Systematic Reviews Unit, The Collaborative Research (CORE) Group, Macquarie University, Sydney, New South Wales, Australia. E-mail [email protected] (Circ Cardiovasc Interv. 2014;7:741-743.) © 2014 American Heart Association, Inc. Circ Cardiovasc Interv is available at http://circinterventions.ahajournals.org DOI: 10.1161/CIRCINTERVENTIONS.114.002081
Randomized Controlled Trials To date, 3 randomized controlled trials have been reported on the comparative outcomes of TAVR versus surgical aortic valve replacement.5–7,14,15 Results of the PARTNER A trial demonstrated similar survival and stroke outcomes at 1 and 2 years using the Sapien (Edwards Lifesciences) balloonexpandable device.5,15 More recently, the US CoreValve High Risk Study reported superior overall survival for TAVR at 12 months using the self-expandable CoreValve (Medtronic) device, with similar stroke outcomes.7 The STACCATO trial, which remains to be the only trial not sponsored by medical industry, was prematurely terminated by the Data Safety Monitoring Board due to unexpectedly poor outcomes in the TAVR arm. Despite this, the overall encouraging outcomes from these randomized trials and other observational data have driven the recruitment of lower risk patients for current trials that aim to expand the clinical indication for TAVR. Results from the PARTNER-2 and SURTAVI trials will no doubt provide further valuable clinical evidence for patients who are considered to have intermediate risk for surgery (4%–8% mortality) based on their Society of Thoracic Surgeons scores.
Cost-Effectiveness of TAVR With increasing budget constraints, economic evaluation has become increasingly important in clinical practice guidelines and performance standards, as emphasized by the American Heart Association and the American College of Cardiologists.16 Costrelated reports on TAVR have to date been largely based on economic models that relied heavily on data from the PARTNER trials. A recent systematic review concluded that TAVR may be economically justifiable when compared with medical therapy for ineligible surgical candidates according to reported incremental cost-effectiveness ratios.17 However, for high-risk patients who were eligible for surgery, the evidence was not as strong, and significant variations were identified depending on the specific healthcare system setting, procedural approach, and patient selection process. Perhaps one of the most important determinants of the overall cost, other than the transcatheter valve device itself, was the incidence of periprocedural complications. Several studies reported sensitivity analyses that predicted significant improvements in the cost-effectiveness of TAVR if it could be performed with lower periprocedural morbidity and mortality.18,19
Costs Related to Complications In this issue of Circulation: Cardiovascular Interventions, Arnold et al20 presented multivariable models using detailed data from 406 of 519 (78%) participants from the PARTNER trial to estimate the independent impact of periprocedural complications on in-hospital costs and duration of hospitalization for patients who underwent TAVR. The authors should
Downloaded from http://circinterventions.ahajournals.org/ 741 at University of California--Davis on January 19, 2015
742 Circ Cardiovasc Interv December 2014 be congratulated for identifying this important area of interest and conducting a novel and thorough evaluation of specific periprocedural complications. Using the available data, the authors found that 49% of patients had ≥1 complication during their index hospitalization. Patients who encountered a complication were more likely to be women and belonging to cohort B, but less likely to have had previous coronary artery bypass graft surgery. For these patients, the unadjusted incremental cost was $33 196, with an incremental duration of hospitalization of 6.6 days, significantly higher than those patients who did not have a complication. Specifically, 7 complications were found to be associated with significant increases to hospitalization costs according to a multivariable model that adjusted for demographic and clinical characteristics. These included a repeat TAVR procedure, death, renal failure, major bleeding, surgical conversion, major stroke, and major arrhythmias. Death, renal failure, major bleeding, vascular complications, major arrhythmia, and pacemaker implantation were the complications most predictive of a prolonged length of stay, and an estimated 2.4 days of the overall duration of hospitalization were directly attributable to periprocedural compilations.
Key Findings and Future Directions Findings from this study have answered some questions, but raised others. Periprocedural complications happened frequently in the PARTNER trial, as acknowledged by the authors, and accounted for a quarter of the non-implant– related in-hospital costs. These findings suggest that there is room for improvement in the cost-effectiveness of TAVR, especially when considering the learning curve encountered by some participating institutions within the PARTNER trial.5 As the authors suggested, growing procedural experience and evolving technology may significantly reduce periprocedural morbidity and mortality, and therefore improve cost-effectiveness. In addition, by identifying the most costly complications, results of this study may shift focus toward formulating clinical pathways to minimize these morbidities, either by altering clinical management or by revising patient selection. Additional studies will no doubt focus on these high-yield areas to make TAVR a more affordable treatment modality within healthcare systems. With accumulating data, it may soon be possible to predict patients who are more likely to encounter a particular periprocedural complication based on a range of baseline prognostic factors. From a health administration perspective, this may help facilitate the selection process to offer the TAVR procedure to candidates who are more likely to have cost-effective outcomes. To ensure patient safety and economic sustainability, further robust clinical and cost-related data need to be presented before TAVR is performed outside of its current indications.
Acknowledgments The authors wish to thank Drs Kevin Liou and Faraz Pathan for their contribution to the manuscript.
Disclosures None.
References 1. Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106:3006–3008. 2. Mylotte D, Osnabrugge RL, Windecker S, Lefèvre T, de Jaegere P, Jeger R, Wenaweser P, Maisano F, Moat N, Søndergaard L, Bosmans J, Teles RC, Martucci G, Manoharan G, Garcia E, Van Mieghem NM, Kappetein AP, Serruys PW, Lange R, Piazza N. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013;62:210–219. doi: 10.1016/j.jacc.2013.03.074. 3. Taramasso M, Pozzoli A, Latib A, La Canna G, Colombo A, Maisano F, Alfieri O. New devices for TAVI: technologies and initial clinical experiences. Nat Rev Cardiol. 2014;11:157–167. doi: 10.1038/nrcardio.2013.221. 4. Tchetche D, Van Mieghem NM. New-generation TAVI devices: description and specifications. EuroIntervention. 2014;10(suppl U):U90–U100. doi: 10.4244/EIJV10SUA13. 5. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187–2198. doi: 10.1056/ NEJMoa1103510. 6. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597– 1607. doi: 10.1056/NEJMoa1008232. 7. Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370:1790– 1798. doi: 10.1056/NEJMoa1400590. 8. Oguri A, Yamamoto M, Mouillet G, Gilard M, Laskar M, Eltchaninoff H, Fajadet J, Iung B, Donzeau-Gouge P, Leprince P, Leguerrier A, Prat A, Lievre M, Chevreul K, Dubois-Rande JL, Chopard R, Van Belle E, Otsuka T, Teiger E; FRANCE 2 Registry Investigators. Clinical outcomes and safety of transfemoral aortic valve implantation under general versus local anesthesia: subanalysis of the French Aortic National CoreValve and Edwards 2 registry. Circ Cardiovasc Interv. 2014;7:602–610. doi: 10.1161/CIRCINTERVENTIONS.113.000403. 9. Mohr FW, Holzhey D, Möllmann H, Beckmann A, Veit C, Figulla HR, Cremer J, Kuck KH, Lange R, Zahn R, Sack S, Schuler G, Walther T, Beyersdorf F, Böhm M, Heusch G, Funkat AK, Meinertz T, Neumann T, Papoutsis K, Schneider S, Welz A, Hamm CW; GARY Executive Board. The German Aortic Valve Registry: 1-year results from 13 680 patients with aortic valve disease. Eur J Cardiothorac Surg. 2014;46:808–816. doi: 10.1093/ejcts/ezu290. 10. Barbanti M, Ussia GP, Cannata S, Giarratana A, Sgroi C, Tamburino C. 3-year outcomes of self-expanding Corevalve prosthesis - The Italian Registry. Ann Cardiothorac Surg. 2012;1:182–184. doi: 10.3978/j. issn.2225-319X.2012.06.07. 11. Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aorticvalve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366:1696–1704. doi: 10.1056/NEJMoa1202277. 12. Cao C, Ang SC, Indraratna P, Manganas C, Bannon P, Black D, Tian D, Yan TD. Systematic review and meta-analysis of transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis. Ann Cardiothorac Surg. 2013;2:10–23. doi: 10.3978/j. issn.2225-319X.2012.11.09. 13. Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation:
Downloaded from http://circinterventions.ahajournals.org/ at University of California--Davis on January 19, 2015
Cao et al TAVR: Does It Work and Can We Afford It? 743 the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012;60:1438–1454. doi: 10.1016/j.jacc.2012.09.001. 14. Nielsen HH, Klaaborg KE, Nissen H, Terp K, Mortensen PE, Kjeldsen BJ, Jakobsen CJ, Andersen HR, Egeblad H, Krusell LR, Thuesen L, Hjortdal VE. A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial. EuroIntervention. 2012;8:383–389. doi: 10.4244/EIJV8I3A58. 15. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686–1695. doi: 10.1056/NEJMoa1200384. 16. Anderson JL, Heidenreich PA, Barnett PG, Creager MA, Fonarow GC, Gibbons RJ, Halperin JL, Hlatky MA, Jacobs AK, Mark DB, Masoudi FA, Peterson ED, Shaw LJ; ACC/AHA Task Force on Performance Measures; ACC/AHA Task Force on Practice Guidelines. ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines. Circulation. 2014;129:2329–2345. doi: 10.1161/ CIR.0000000000000042.
17. Indraratna P, Ang SC, Gada H, Yan TD, Manganas C, Bannon P, Cao C. Systematic review of the cost-effectiveness of transcatheter aortic valve implantation. J Thorac Cardiovasc Surg. 2014;148:509–514. doi: 10.1016/j.jtcvs.2013.10.023. 18. Neyt M, Van Brabandt H, Devriese S, Van De Sande S. A cost-utility analysis of transcatheter aortic valve implantation in belgium: Focusing on a well-defined and identifiable population. BMJ Open. 2012;2:e001032. 19. Gada H, Agarwal S, Marwick TH. Perspective on the cost-effectiveness of transapical aortic valve implantation in high-risk patients: Outcomes of a decision-analytic model. Ann Cardiothorac Surg. 2012;1:145–155. doi: 10.3978/j.issn.2225-319X.2012.06.12. 20. Arnold SV, Lei Y, Reynolds MR, Magnuson EA, Suri RM, Tuzcu EM, Petersen JL II, Douglas PS, Svensson LG, Gada H, Thourani VH, Kodali SK, Mack MJ, Leon MB, Cohen DJ; PARTNER Investigators. Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement: results from the placement of aortic transcatheter valve trial. Circ Cardiovasc Interv. 2014;7:829–836. doi: 10.1161/ CIRCINTERVENTIONS.114.001395. Key Words: Editorials ◼ aortic valve stenosis ◼ complications ◼ costs and cost analysis ◼ transcatheter aortic valve implantation ◼ transcatheter aortic valve replacement
Downloaded from http://circinterventions.ahajournals.org/ at University of California--Davis on January 19, 2015
Transcatheter Aortic Valve Replacement: Does It Work and Can We Afford It? Christopher Cao, Hugh Wolfenden and Tristan D. Yan Circ Cardiovasc Interv. 2014;7:741-743 doi: 10.1161/CIRCINTERVENTIONS.114.002081 Circulation: Cardiovascular Interventions is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2014 American Heart Association, Inc. All rights reserved. Print ISSN: 1941-7640. Online ISSN: 1941-7632
The online version of this article, along with updated information and services, is located on the World Wide Web at: http://circinterventions.ahajournals.org/content/7/6/741
Permissions: Requests for permissions to reproduce figures, tables, or portions of articles originally published in Circulation: Cardiovascular Interventions can be obtained via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office. Once the online version of the published article for which permission is being requested is located, click Request Permissions in the middle column of the Web page under Services. Further information about this process is available in the Permissions and Rights Question and Answer document. Reprints: Information about reprints can be found online at: http://www.lww.com/reprints Subscriptions: Information about subscribing to Circulation: Cardiovascular Interventions is online at: http://circinterventions.ahajournals.org//subscriptions/
Downloaded from http://circinterventions.ahajournals.org/ at University of California--Davis on January 19, 2015
S
ince the first procedure was performed just over a decade ago, transcatheter aortic valve replacement (TAVR) has emerged as one of the most significant innovations in cardiovascular medicine since the introduction of percutaneous coronary intervention.1 Quantitatively, this has been demonstrated by penetration rates of >35% in countries such as Germany and Switzerland.2 The number of novel devices being developed and the volume of patients being treated continue to expand at exponential rates in both Europe and North America.3,4 Intense enthusiasm from the cardiovascular community and the medical industry has driven several multi-institutional registries and randomized controlled trials to assess the clinical- and costrelated outcomes of TAVR in various patient populations.5–10
Article see p 829
Clinical Outcomes of TAVR Clinical outcomes of TAVR should be considered in relation to the patient risk profile and the comparator. The Placement of AoRTic TraNscathER Valve (PARTNER) B trial reported significantly superior survival outcomes and reduced hospitalizations for ineligible surgical candidates who underwent TAVR, at the cost of higher stroke rates, when compared with medical therapy.11 For high-risk surgical candidates a recent meta-analysis demonstrated similar overall survival and stroke outcomes for patients who underwent TAVR or surgical aortic valve replacement.12 TAVR was more likely to result in the need for a permanent pacemaker insertion, major vascular injury, and moderate or severe aortic regurgitation. However, patients who underwent surgical aortic valve replacement were more likely to experience major bleeding.12 These end points, as well as others such as myocardial infarction and renal failure, have been quantitatively defined by the Valve Academic Research Consortium to facilitate direct comparisons between treatment arms and institutions.13 The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association. From The Systematic Reviews Unit, The Collaborative Research (CORE) Group, Macquarie University, Sydney, New South Wales, Australia (C.C., T.D.Y.); and Department of Cardiothoracic Surgery, Prince of Wales Hospital, Sydney, New South Wales, Australia (H.W.). Correspondence to Christopher Cao, MBBS, BSc, The Systematic Reviews Unit, The Collaborative Research (CORE) Group, Macquarie University, Sydney, New South Wales, Australia. E-mail [email protected] (Circ Cardiovasc Interv. 2014;7:741-743.) © 2014 American Heart Association, Inc. Circ Cardiovasc Interv is available at http://circinterventions.ahajournals.org DOI: 10.1161/CIRCINTERVENTIONS.114.002081
Randomized Controlled Trials To date, 3 randomized controlled trials have been reported on the comparative outcomes of TAVR versus surgical aortic valve replacement.5–7,14,15 Results of the PARTNER A trial demonstrated similar survival and stroke outcomes at 1 and 2 years using the Sapien (Edwards Lifesciences) balloonexpandable device.5,15 More recently, the US CoreValve High Risk Study reported superior overall survival for TAVR at 12 months using the self-expandable CoreValve (Medtronic) device, with similar stroke outcomes.7 The STACCATO trial, which remains to be the only trial not sponsored by medical industry, was prematurely terminated by the Data Safety Monitoring Board due to unexpectedly poor outcomes in the TAVR arm. Despite this, the overall encouraging outcomes from these randomized trials and other observational data have driven the recruitment of lower risk patients for current trials that aim to expand the clinical indication for TAVR. Results from the PARTNER-2 and SURTAVI trials will no doubt provide further valuable clinical evidence for patients who are considered to have intermediate risk for surgery (4%–8% mortality) based on their Society of Thoracic Surgeons scores.
Cost-Effectiveness of TAVR With increasing budget constraints, economic evaluation has become increasingly important in clinical practice guidelines and performance standards, as emphasized by the American Heart Association and the American College of Cardiologists.16 Costrelated reports on TAVR have to date been largely based on economic models that relied heavily on data from the PARTNER trials. A recent systematic review concluded that TAVR may be economically justifiable when compared with medical therapy for ineligible surgical candidates according to reported incremental cost-effectiveness ratios.17 However, for high-risk patients who were eligible for surgery, the evidence was not as strong, and significant variations were identified depending on the specific healthcare system setting, procedural approach, and patient selection process. Perhaps one of the most important determinants of the overall cost, other than the transcatheter valve device itself, was the incidence of periprocedural complications. Several studies reported sensitivity analyses that predicted significant improvements in the cost-effectiveness of TAVR if it could be performed with lower periprocedural morbidity and mortality.18,19
Costs Related to Complications In this issue of Circulation: Cardiovascular Interventions, Arnold et al20 presented multivariable models using detailed data from 406 of 519 (78%) participants from the PARTNER trial to estimate the independent impact of periprocedural complications on in-hospital costs and duration of hospitalization for patients who underwent TAVR. The authors should
Downloaded from http://circinterventions.ahajournals.org/ 741 at University of California--Davis on January 19, 2015
742 Circ Cardiovasc Interv December 2014 be congratulated for identifying this important area of interest and conducting a novel and thorough evaluation of specific periprocedural complications. Using the available data, the authors found that 49% of patients had ≥1 complication during their index hospitalization. Patients who encountered a complication were more likely to be women and belonging to cohort B, but less likely to have had previous coronary artery bypass graft surgery. For these patients, the unadjusted incremental cost was $33 196, with an incremental duration of hospitalization of 6.6 days, significantly higher than those patients who did not have a complication. Specifically, 7 complications were found to be associated with significant increases to hospitalization costs according to a multivariable model that adjusted for demographic and clinical characteristics. These included a repeat TAVR procedure, death, renal failure, major bleeding, surgical conversion, major stroke, and major arrhythmias. Death, renal failure, major bleeding, vascular complications, major arrhythmia, and pacemaker implantation were the complications most predictive of a prolonged length of stay, and an estimated 2.4 days of the overall duration of hospitalization were directly attributable to periprocedural compilations.
Key Findings and Future Directions Findings from this study have answered some questions, but raised others. Periprocedural complications happened frequently in the PARTNER trial, as acknowledged by the authors, and accounted for a quarter of the non-implant– related in-hospital costs. These findings suggest that there is room for improvement in the cost-effectiveness of TAVR, especially when considering the learning curve encountered by some participating institutions within the PARTNER trial.5 As the authors suggested, growing procedural experience and evolving technology may significantly reduce periprocedural morbidity and mortality, and therefore improve cost-effectiveness. In addition, by identifying the most costly complications, results of this study may shift focus toward formulating clinical pathways to minimize these morbidities, either by altering clinical management or by revising patient selection. Additional studies will no doubt focus on these high-yield areas to make TAVR a more affordable treatment modality within healthcare systems. With accumulating data, it may soon be possible to predict patients who are more likely to encounter a particular periprocedural complication based on a range of baseline prognostic factors. From a health administration perspective, this may help facilitate the selection process to offer the TAVR procedure to candidates who are more likely to have cost-effective outcomes. To ensure patient safety and economic sustainability, further robust clinical and cost-related data need to be presented before TAVR is performed outside of its current indications.
Acknowledgments The authors wish to thank Drs Kevin Liou and Faraz Pathan for their contribution to the manuscript.
Disclosures None.
References 1. Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106:3006–3008. 2. Mylotte D, Osnabrugge RL, Windecker S, Lefèvre T, de Jaegere P, Jeger R, Wenaweser P, Maisano F, Moat N, Søndergaard L, Bosmans J, Teles RC, Martucci G, Manoharan G, Garcia E, Van Mieghem NM, Kappetein AP, Serruys PW, Lange R, Piazza N. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013;62:210–219. doi: 10.1016/j.jacc.2013.03.074. 3. Taramasso M, Pozzoli A, Latib A, La Canna G, Colombo A, Maisano F, Alfieri O. New devices for TAVI: technologies and initial clinical experiences. Nat Rev Cardiol. 2014;11:157–167. doi: 10.1038/nrcardio.2013.221. 4. Tchetche D, Van Mieghem NM. New-generation TAVI devices: description and specifications. EuroIntervention. 2014;10(suppl U):U90–U100. doi: 10.4244/EIJV10SUA13. 5. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187–2198. doi: 10.1056/ NEJMoa1103510. 6. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597– 1607. doi: 10.1056/NEJMoa1008232. 7. Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370:1790– 1798. doi: 10.1056/NEJMoa1400590. 8. Oguri A, Yamamoto M, Mouillet G, Gilard M, Laskar M, Eltchaninoff H, Fajadet J, Iung B, Donzeau-Gouge P, Leprince P, Leguerrier A, Prat A, Lievre M, Chevreul K, Dubois-Rande JL, Chopard R, Van Belle E, Otsuka T, Teiger E; FRANCE 2 Registry Investigators. Clinical outcomes and safety of transfemoral aortic valve implantation under general versus local anesthesia: subanalysis of the French Aortic National CoreValve and Edwards 2 registry. Circ Cardiovasc Interv. 2014;7:602–610. doi: 10.1161/CIRCINTERVENTIONS.113.000403. 9. Mohr FW, Holzhey D, Möllmann H, Beckmann A, Veit C, Figulla HR, Cremer J, Kuck KH, Lange R, Zahn R, Sack S, Schuler G, Walther T, Beyersdorf F, Böhm M, Heusch G, Funkat AK, Meinertz T, Neumann T, Papoutsis K, Schneider S, Welz A, Hamm CW; GARY Executive Board. The German Aortic Valve Registry: 1-year results from 13 680 patients with aortic valve disease. Eur J Cardiothorac Surg. 2014;46:808–816. doi: 10.1093/ejcts/ezu290. 10. Barbanti M, Ussia GP, Cannata S, Giarratana A, Sgroi C, Tamburino C. 3-year outcomes of self-expanding Corevalve prosthesis - The Italian Registry. Ann Cardiothorac Surg. 2012;1:182–184. doi: 10.3978/j. issn.2225-319X.2012.06.07. 11. Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aorticvalve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366:1696–1704. doi: 10.1056/NEJMoa1202277. 12. Cao C, Ang SC, Indraratna P, Manganas C, Bannon P, Black D, Tian D, Yan TD. Systematic review and meta-analysis of transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis. Ann Cardiothorac Surg. 2013;2:10–23. doi: 10.3978/j. issn.2225-319X.2012.11.09. 13. Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation:
Downloaded from http://circinterventions.ahajournals.org/ at University of California--Davis on January 19, 2015
Cao et al TAVR: Does It Work and Can We Afford It? 743 the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012;60:1438–1454. doi: 10.1016/j.jacc.2012.09.001. 14. Nielsen HH, Klaaborg KE, Nissen H, Terp K, Mortensen PE, Kjeldsen BJ, Jakobsen CJ, Andersen HR, Egeblad H, Krusell LR, Thuesen L, Hjortdal VE. A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial. EuroIntervention. 2012;8:383–389. doi: 10.4244/EIJV8I3A58. 15. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686–1695. doi: 10.1056/NEJMoa1200384. 16. Anderson JL, Heidenreich PA, Barnett PG, Creager MA, Fonarow GC, Gibbons RJ, Halperin JL, Hlatky MA, Jacobs AK, Mark DB, Masoudi FA, Peterson ED, Shaw LJ; ACC/AHA Task Force on Performance Measures; ACC/AHA Task Force on Practice Guidelines. ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines. Circulation. 2014;129:2329–2345. doi: 10.1161/ CIR.0000000000000042.
17. Indraratna P, Ang SC, Gada H, Yan TD, Manganas C, Bannon P, Cao C. Systematic review of the cost-effectiveness of transcatheter aortic valve implantation. J Thorac Cardiovasc Surg. 2014;148:509–514. doi: 10.1016/j.jtcvs.2013.10.023. 18. Neyt M, Van Brabandt H, Devriese S, Van De Sande S. A cost-utility analysis of transcatheter aortic valve implantation in belgium: Focusing on a well-defined and identifiable population. BMJ Open. 2012;2:e001032. 19. Gada H, Agarwal S, Marwick TH. Perspective on the cost-effectiveness of transapical aortic valve implantation in high-risk patients: Outcomes of a decision-analytic model. Ann Cardiothorac Surg. 2012;1:145–155. doi: 10.3978/j.issn.2225-319X.2012.06.12. 20. Arnold SV, Lei Y, Reynolds MR, Magnuson EA, Suri RM, Tuzcu EM, Petersen JL II, Douglas PS, Svensson LG, Gada H, Thourani VH, Kodali SK, Mack MJ, Leon MB, Cohen DJ; PARTNER Investigators. Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement: results from the placement of aortic transcatheter valve trial. Circ Cardiovasc Interv. 2014;7:829–836. doi: 10.1161/ CIRCINTERVENTIONS.114.001395. Key Words: Editorials ◼ aortic valve stenosis ◼ complications ◼ costs and cost analysis ◼ transcatheter aortic valve implantation ◼ transcatheter aortic valve replacement
Downloaded from http://circinterventions.ahajournals.org/ at University of California--Davis on January 19, 2015
Transcatheter Aortic Valve Replacement: Does It Work and Can We Afford It? Christopher Cao, Hugh Wolfenden and Tristan D. Yan Circ Cardiovasc Interv. 2014;7:741-743 doi: 10.1161/CIRCINTERVENTIONS.114.002081 Circulation: Cardiovascular Interventions is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2014 American Heart Association, Inc. All rights reserved. Print ISSN: 1941-7640. Online ISSN: 1941-7632
The online version of this article, along with updated information and services, is located on the World Wide Web at: http://circinterventions.ahajournals.org/content/7/6/741
Permissions: Requests for permissions to reproduce figures, tables, or portions of articles originally published in Circulation: Cardiovascular Interventions can be obtained via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office. Once the online version of the published article for which permission is being requested is located, click Request Permissions in the middle column of the Web page under Services. Further information about this process is available in the Permissions and Rights Question and Answer document. Reprints: Information about reprints can be found online at: http://www.lww.com/reprints Subscriptions: Information about subscribing to Circulation: Cardiovascular Interventions is online at: http://circinterventions.ahajournals.org//subscriptions/
Downloaded from http://circinterventions.ahajournals.org/ at University of California--Davis on January 19, 2015
