Outcomes With Transcatheter Mitral Valve Repair in the United States: An STS/ACC TVT Registry Report

Journal of the American College of Cardiology

Volumn 70, Issue 19, 2017, Pages 2315-2327

  Sorajja, Paul ^a   Vemulapalli, Sreekanth ^b   Feldman, Ted ^c   Mack, Michael ^d   Holmes, David R ^e   Stebbins, Amanda ^b   Kar, Saibal ^f   Thourani, Vinod ^g   Ailawadi, Gorav ^h  

^a MINNEAPOLIS HEART INSTITUTE FOUNDATION   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c EVANSTON HOSPITAL   (United States)

^d Heart Hospital Baylor Plano   (United States)

^e MAYO CLINIC   (United States)

^f CEDARS SINAI MEDICAL CENTER   (United States)

^g WASHINGTON HOSPITAL CENTER   (United States)

^h UNIVERSITY OF VIRGINIA   (United States)

Author keywords

mitral regurgitation; outcomes; transcatheter

Indexed keywords

AGE DISTRIBUTION; AGED; ARTICLE; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DISEASE REGISTRY; DISEASE SEVERITY; FEMALE; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HOSPITAL MORTALITY; HOSPITAL READMISSION; HUMAN; LUNG DISEASE; MAJOR CLINICAL STUDY; MALE; MITRAL VALVE REGURGITATION; MITRAL VALVE SURGERY; OUTCOME ASSESSMENT; POPULATION RESEARCH; PRIORITY JOURNAL; RENAL REPLACEMENT THERAPY; SAFETY; SEX DIFFERENCE; TRANSCATHETER MITRAL VALVE REPAIR; TREATMENT OUTCOME; TRICUSPID VALVE REGURGITATION; UNITED STATES; VERY ELDERLY; CARDIOLOGY; COHORT ANALYSIS; EPIDEMIOLOGY; FOLLOW UP; GOVERNMENT; MEDICAL SOCIETY; MORTALITY; REGISTER; RESEARCH; THORAX SURGERY; TRANSCATHETER AORTIC VALVE IMPLANTATION; TRENDS;

AGED; AGED, 80 AND OVER; CARDIOLOGY; CENTERS FOR MEDICARE AND MEDICAID SERVICES (U.S.); COHORT STUDIES; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MORTALITY; REGISTRIES; RESEARCH REPORT; SOCIETIES, MEDICAL; THORACIC SURGERY; TRANSCATHETER AORTIC VALVE REPLACEMENT; TREATMENT OUTCOME; UNITED STATES;

EID: 85032726662     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2017.09.015     Document Type: Article

References (32)

1. Freed, L.A., Levy, D., Levine, R.A., et al. Prevalence and clinical outcome of mitral-valve prolapse. N Engl J Med 341 (1999), 1–7.
2. Enriquez-Sarano, M., Tajik, A.J., Schaff, H.V., et al. Echocardiographic prediction of survival after surgical correction of organic mitral regurgitation. Circulation 90 (1994), 830–837.
3. Enriquez-Sarano, M., Avierinos, J.F., Messika-Zeitoun, D., et al. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med 352 (2005), 875–883.
4. Grigioni, F., Tribouilloy, C., Avierinos, J.F., et al. Outcomes in mitral regurgitation due to flail leaflets: a multicenter European study. J Am Coll Cardiol Img 1 (2008), 133–141.
5. Nishimura, R.A., Otto, C.M., Bonow, R.O., et al. 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 63 (2014), e57–e185.
6. Mirabel, M., Iung, B., Baron, G., et al. What are the characteristics of patients with severe, symptomatic mitral regurgitation who are denied surgery?. Eur Heart J 28 (2007), 1358–1365.
7. Goel, S.S., Bajaj, N., Aggarwal, B., et al. Prevalence and outcomes of unoperated patients with severe symptomatic mitral regurgitation and heart failure: comprehensive analysis to determine the potential role of MitraClip for this unmet need. J Am Coll Cardiol 63 (2014), 185–190.
8. Lim, D.S., Reynolds, M.R., Feldman, T., et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol 64 (2014), 182–192.
9. Feldman, T., Kar, S., Elmariah, S., et al. Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST II. J Am Coll Cardiol 66 (2015), 2844–2854.
10. Sorajja, P., Mack, M., Vemulapalli, S., et al. Outcomes of the initial experience with commercial transcatheter mitral valve repair in the United States. J Am Coll Cardiol 67 (2016), 1129–1140.
11. Carroll, J.D., Edwards, F.H., Marinac-Dabic, D., et al. The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies. J Am Coll Cardiol 62 (2013), 1026–1034.
12. American College of Cardiology: Society of Thoracic Surgeons. ACC/STS TVT Registry home page. Available at: https://www.ncdr.com/TVT/Home/Default.aspx. Accessed February 11, 2017.
13. American College of Cardiology: Society of Thoracic Surgeons. ACC/STS TVT Registry: NCDR participants/site manager contact. Available at: https://www.ncdr.com/TVT/Private/Resources/ParticipantDirectory.aspx. Accessed February 11, 2017.
14. Society of Thoracic Surgeons. Online STS risk calculator. Available at: http://riskcalc.sts.org/STSWebRiskCalc273. Accessed February 11, 2017.
15. Holmes, D.R. Jr., Brennan, J.M., Rumsfeld, J.S., et al. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA 313 (2015), 1019–1028.
16. Feldman, T., Wasserman, H.S., Herrmann, H.C., et al. Percutaneous mitral valve repair using the edge-to-edge technique. Six-month results of the EVEREST phase I clinical trial. J Am Coll Cardiol 46 (2005), 2134–2140.
17. Leon, M.B., Piazza, N., Nikolsky, E., et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol 57 (2011), 253–269.
18. Attizzani, G.F., Ohno, Y., Capodanno, D., et al. Extended use of percutaneous edge-to-edge mitral valve repair beyond EVEREST (Endovascular Valve Edge-to-edge repair) criteria. 30-day and 12-month clinical and echocardiographic outcomes from the GRASP (Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation) Registry. J Am Coll Cardiol Intv 8 (2015), 74–82.
19. Nickenig, G., Estevez-Loureiro, R., Franzen, O., et al. Percutaneous mitral valve edge-to-edge repair. In-hospital results and 1-year follow-up of 628 patients of the 2011-2012 pilot European Sentinel Registry. J Am Coll Cardiol 64 (2014), 875–884.
20. Glower, D.D., Kar, S., Trento, A., et al. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol 64 (2014), 172–181.
21. Maisano, F., Franzen, O., Baldus, S., et al. Percutaneous mitral valve interventions in the real world. Early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol 62 (2013), 1052–1061.
22. Lesevic, H., Sonne, C., Braun, D., et al. Acute and midterm outcome after MitraClip therapy in patients with severe mitral regurgitation and left ventricular dysfunction. Am J Cardiol 116 (2015), 749–756.
23. Grasso, C., Dapodanno, D., Scandura, S., et al. One- and twelve-month safety and efficacy outcomes of patients undergoing edge-to-edge percutaneous mitral valve repair (from the GRASP Registry). Am J Cardiol 111 (2013), 1482–1487.
24. Pighi, M., Estevez-Loureirio, R., Maisano, F., et al. Immediate and 12-month outcome of ischemic versus non-ischemic functional mitral regurgitation in patients treated with MitraClip (from the 2011 to 2012 pilot sentinel registry of percutaneous edge-to-edge mitral valve repair of the European Society of Cardiology). Am J Cardiol 119 (2017), 630–637.
25. Puls, M., Lubos, E., Boekstegers, P., et al. One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventional registry. Eur Heart J 37 (2016), 703–712.
26. Tigges, E., Kalbacher, D., Thomas, C., et al. Transcatheter mitral valve repair in surgical high-risk patients: gender-specific acute and long-term outcomes. Biomed Res Intl, 2016, 2016, 3934842.
27. Kapadia, S.R., Leon, M.B., Makkar, R.R., et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomized controlled trial. Lancet 385 (2015), 2485–2491.
28. Webb, J.G., Doshi, D., Mack, M.J., et al. A randomized evaluation of the Sapein XT transcatheter heart valve system in patients with aortic stenosis who are not candidates for surgery. J Am Coll Cardiol Intv 8 (2015), 1797–1806.
29. Arnold, S.V., Afilalo, J., Spertus, J.A., et al. Prediction of poor outcome after transcatheter aortic valve replacement. J Am Coll Cardiol 68 (2016), 1868–1877.
30. Swaans, M.J., Bakker, A.L.M., Alipour, A., et al. Survival of transcatheter mitral valve repair compared with surgical and conservative treatment in high-surgical-risk patients. J Am Coll Cardiol Intv 7 (2014), 875–881.
31. Giannini, C., Fiorelli, F., De Carlo, M., et al. Comparison of percutaneous mitral valve repair versus conservative treatment in severe functional mitral regurgitation. Am J Cardiol 117 (2016), 271–277.
32. Taramasso, M., Denti, P., Buzzatti, N., et al. Mitraclip therapy and surgical mitral repair in patients with moderate to severe left ventricular failure causing functional mitral regurgitation: a single-centre experience. Eur J Cardiothorac Surg 42 (2012), 920–926.