MitraClip for High-Risk Patients with Significant Mitral Insufficiency: Shall We Unreservedly Recommend It?
04 April 2017
24 July 2017
18 September 2017 (online)
Background MitraClip (Abbott Inc.) is propagated as a palliative option for high-risk patients with mitral insufficiency considered not qualifying for surgical repair. A proportion of patients requires consecutive surgery because of technical failure or inappropriate clinical improvement. Furthermore, surgical reconstruction is impossible in almost all patients after MitraClip implantation. Consequently, these patients receive replacement although primary repair may have been possible. The outcome of those patients compared with patients receiving primary mitral valve replacement (MVR) or mitral valve repair (MVP) was analyzed.
Methods A total of 23 patients were retrospectively analyzed after MVR following MitraClip. Overall, 46 patients with corresponding demographic data and risk profile receiving primary MVR (23 patients) or MVP (23 patients) were retrieved for matched pair analysis.
Results Mean age was 70 years in all groups, log European system for cardiac operative risk evaluation (EuroSCORE) was 22.47% ± 16.30 in MVR after MitraClip (MC), 22.34% ± 16.23 in MVP, and 22.33% ± 16.14 in MVR group. Preoperative left ventricular ejection fraction (LVEF) was 44%, and postoperative LVEF was 48% in all groups. The 30-day mortality was 21.7% in the MitraClip group whereas it was 4.3% in the MVR and 13.0% in the MVP group. The 1-year survival was 56.5% in the MitraClip group while it was 95.6% in the MVR group and 82.6% in the MVP group (Wilcoxon test: p = 0.007; chi-square test: p = 0.001 MitraClip vs. MVR; p = 0.054 MitraClip vs. MVP).
Conclusions Patients requiring surgical MVR after the previous MitraClip fared worse than matched cohorts receiving primary MVR or MVP. Indication for MitraClip should, therefore, be made very cautiously given the excellent results gained with primary surgery.
This article was presented at the 46th Annual Meeting of the German Society for Thoracic and Cardiovascular Surgery; February 12, 2017; Congress Center Leipzig, Walton Lillehei.
- 1 Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet 2006; 368 (9540): 1005-1011
- 2 Iung B, Baron G, Butchart EG. , et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J 2003; 24 (13) 1231-1243
- 3 Klein AL, Burstow DJ, Tajik AJ. , et al. Age-related prevalence of valvular regurgitation in normal subjects: a comprehensive color flow examination of 118 volunteers. J Am Soc Echocardiogr 1990; 3 (01) 54-63
- 4 Olson LJ, Subramanian R, Ackermann DM, Orszulak TA, Edwards WD. Surgical pathology of the mitral valve: a study of 712 cases spanning 21 years. Mayo Clin Proc 1987; 62 (01) 22-34
- 5 Bursi F, Enriquez-Sarano M, Jacobsen SJ, Roger VL. Mitral regurgitation after myocardial infarction: a review. Am J Med 2006; 119 (02) 103-112
- 6 Chi NH, Yu HY, Chang CI, Lin FY, Wang SS. Clinical surgical experience of congenital submitral left ventricular aneurysm. Thorac Cardiovasc Surg 2004; 52 (02) 115-116
- 7 Shah J, Jain T, Shah S, Mawri S, Ananthasubramaniam K. Rare case of unileaflet mitral valve. J Cardiovasc Ultrasound 2016; 24 (02) 168-169
- 8 Séguéla PE, Houyel L, Acar P. Congenital malformations of the mitral valve. Arch Cardiovasc Dis 2011; 104 (8-9): 465-479
- 9 Enriquez-Sarano M, Sundt III TM. Early surgery is recommended for mitral regurgitation. Circulation 2010; 121 (06) 804-811 , discussion 812
- 10 Vahanian A, Alfieri O, Andreotti F. , et al; Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 2012; 33 (19) 2451-2496
- 11 Gillam LD, Schwartz A. Primum non nocere: the case for watchful waiting in asymptomatic “severe” degenerative mitral regurgitation. Circulation 2010; 121 (06) 813-821 , discussion 821
- 12 Adams DH, Rosenhek R, Falk V. Degenerative mitral valve regurgitation: best practice revolution. Eur Heart J 2010; 31 (16) 1958-1966
- 13 Nickenig G, Mohr FW, Kelm M. , et al. Konsensus der Deutschen Gesellschaft für Kardiologie – Herz- und Kreislaufforschung und der Deutschen Gesellschaft für Thorax- Herz- und Gefäßchirurgie zur Behandlung der Mitralklappeninsuffizienz. Kardiologe 2013; 7: 76-90 . DOI: 10.1007/s12181-013-0488-1
- 14 Beckmann A, Funkat AK, Lewandowski J. , et al. German Heart Surgery Report 2015: The Annual Updated Registry of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg 2016; 64 (06) 462-474
- 15 Boekstegers P, Hausleiter J, Baldus S. , et al. Interventionelle Behandlung der Mitralklappeninsuffizienz mit dem MitraClip®-Verfahren. Empfehlungen des ArbeitskreisesInterventionelle Mitralklappentherapie der Arbeitsgemeinschaft Interventionelle Kardiologie (AGIK) der Deutschen Gesellschaft für Kardiologie und der Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte e. V. (ALKK). Kardiologe 2013; 7: 91-104
- 16 Bail DH, Doebler K. The MitraClip System: a systematic review of indications, procedural requirements, and guidelines. Thorac Cardiovasc Surg 2014; 62 (01) 18-25
- 17 Calafiore AM, Al Abdullah M, Iaco AL. , et al. Mitral valve replacement after MitraClip therapy. J Card Surg 2015; 30 (05) 414-418
- 18 Monsefi N, Zierer A, Khalil M. , et al. Mitral valve surgery in 6 patients after failed MitraClip therapy. Tex Heart Inst J 2014; 41 (06) 609-612
- 19 Cockburn J, Fragkou P, Hildick-Smith D. Development of mitral stenosis after single MitraClip insertion for severe mitral regurgitation. Catheter Cardiovasc Interv 2014; 83 (02) 297-302
- 20 Reis K, Köster G. Minimalinvasive Herzklappeninterventionen: G-BA beschließt Mindeststandards für Krankenhäuser. Available at: https://www.g-ba.de/institution/presse/pressemitteilungen/568/ . Accessed March 14, 2017
- 21 D'Agostino Jr RB. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med 1998; 17 (19) 2265-2281
- 22 Saito S, Baraki H, Fleischer B, Kutschka I. Mitral valve replacement after failed MitraClip™ therapy: report of two cases. J Artif Organs 2015; 18 (02) 177-180
- 23 Takahashi H, Rauch H, Karck M, Fritz M. Surgical conversion early after failed percutaneous repair with the MitraClip system. Eur J Cardiothorac Surg 2012; 42 (06) 1053
- 24 Chanda B, Venn GE. Mitral valve replacement following a failed MitraClip procedure. Eur J Cardiothorac Surg 2012; 42 (04) 739-740
- 25 Pope NH, Lim S, Ailawadi G. Late calcific mitral stenosis after MitraClip procedure in a dialysis-dependent patient. Ann Thorac Surg 2013; 95 (05) e113-e114
- 26 Conradi L, Treede H, Franzen O. , et al. Impact of MitraClip™ therapy on secondary mitral valve surgery in patients at high surgical risk. Eur J Cardiothorac Surg 2011; 40 (06) 1521-1526
- 27 Wendeborn J, Donndorf P, Westphal B, Steinhoff G. Surgical double valve replacement after transcatheter aortic valve implantation and interventional mitral valve repair. Interact Cardiovasc Thorac Surg 2013; 17 (05) 909-911
- 28 Geidel S, Schmoeckel M. Impact of failed mitral clipping on subsequent mitral valve operations. Ann Thorac Surg 2014; 97 (01) 56-63
- 29 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 interventions registry. Eur Heart J 2016; 37 (08) 703-712
- 30 Alozie A, Westphal B, Kische S. , et al. Surgical revision after percutaneous mitral valve repair by edge-to-edge device: when the strategy fails in the highest risk surgical population. Eur J Cardiothorac Surg 2014; 46 (01) 55-60