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Open Access 01-05-2021 | Heart Valve Reconstruction | Original Paper

Impact of the introduction of percutaneous edge-to-edge mitral valve reconstruction on clinical practice in Germany compared to surgical valve repair

Authors: Lutz Frankenstein, Klaus Kaier, Hugo A. Katus, Christoph Bode, Tobias Wengenmayer, Constantin von zur Mühlen, Raffi Bekeredjian, Tobias Täger, Manfred Zehender, Hanna Fröhlich, Peter Stachon

Published in: Clinical Research in Cardiology | Issue 5/2021

Abstract

Background

The introduction of percutaneous mitral valve (MV) repair had an effect on clinical practice in comparison with surgical MV repair. Complete nationwide data are useful in examining how the introduction of a new technique influences clinical practice.

Methods

We analyzed procedural numbers, patient characteristics, and in-hospital outcomes for all percutaneous edge-to-edge and surgical MV reconstruction procedures performed in Germany between 2009 and 2015.

Results

12,664 percutaneous edge-to-edge and 22,825 surgical MV reconstructions were recorded. Numbers increased steadily, albeit more rapidly in the percutaneous edge-to-edge group (108–4079 vs. 2923–3603 with surgical MV reconstruction). Patients with percutaneous edge-to-edge MV reconstruction were older (75.6 ± 8.8 vs 61.6 ± 13.4 years, P < 0.001) and at higher operative risk (estimated logistic EuroSCORE 13.2% vs. 4.7%, P < 0.001) compared to those undergoing surgery. However, in-hospital mortality did not differ (2.9% vs. 2.8%; P = 0.395). This was also true for the subset of 2103 patients at intermediate operative risk as defined by a logistic EuroSCORE ≥ 4% and ≤ 9%. Of note, complication rates (except acute kidney injury) were more favorable in patients undergoing percutaneous edge-to-edge reconstruction.

Conclusions

Percutaneous edge-to-edge MV reconstruction has markedly changed clinical practice of MR therapy in Germany. Annual overall procedural numbers more than doubled, with a massive increase in percutaneous edge-to-edge procedures. Our data demonstrate its use mainly in high-risk patients and prove the favorable safety profile of this novel technique, with low in-hospital mortality and complication rates.

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Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M (2006) Burden of valvular heart diseases: a population-based study. Lancet 368(9540):1005–1011. https://doi.org/10.1016/S0140-6736(06)69208-8CrossRefPubMed

Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A (2003) A prospective survey of patients with valvular heart disease in Europe: the Euro heart survey on valvular heart disease. Eur Heart J 24(13):1231–1243 [S0195668X0300201X [pii]]CrossRef

Ling LH, Enriquez-Sarano M, Seward JB, Tajik AJ, Schaff HV, Bailey KR, Frye RL (1996) Clinical outcome of mitral regurgitation due to flail leaflet. N Engl J Med 335(19):1417–1423. https://doi.org/10.1056/NEJM199611073351902CrossRefPubMed

Grigioni F, Tribouilloy C, Avierinos JF, Barbieri A, Ferlito M, Trojette F, Tafanelli L, Branzi A, Szymanski C, Habib G, Modena MG, Enriquez-Sarano M, Investigators M (2008) Outcomes in mitral regurgitation due to flail leaflets a multicenter European study. JACC Cardiovasc Imaging 1(2):133–141. https://doi.org/10.1016/j.jcmg.2007.12.005CrossRefPubMed

Desai MY, Grigioni F, Di Eusanio M, Saccocci M, Taramasso M, Maisano F, Suri RM, Gillinov AM (2017) Outcomes in degenerative mitral regurgitation: current state-of-the art and future directions. Prog Cardiovasc Dis 60(3):370–385. https://doi.org/10.1016/j.pcad.2017.10.005CrossRefPubMed

Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL, Group ESCSD (2017) 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 38(36):2739–2791. https://doi.org/10.1093/eurheartj/ehx391CrossRefPubMed

Goel SS, Bajaj N, Aggarwal B, Gupta S, Poddar KL, Ige M, Bdair H, Anabtawi A, Rahim S, Whitlow PL, Tuzcu EM, Griffin BP, Stewart WJ, Gillinov M, Blackstone EH, Smedira NG, Oliveira GH, Barzilai B, Menon V, Kapadia SR (2014) 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(2):185–186. https://doi.org/10.1016/j.jacc.2013.08.723CrossRefPubMed

Lillehei CW, Gott VL, Dewall RA, Varco RL (1957) Surgical correction of pure mitral insufficiency by annuloplasty under direct vision. J Lancet 77(11):446–449PubMed

Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L, Investigators EI (2011) Percutaneous repair or surgery for mitral regurgitation. N Engl J Med 364(15):1395–1406. https://doi.org/10.1056/NEJMoa1009355CrossRefPubMed

10.

Feldman T, Wasserman HS, Herrmann HC, Gray W, Block PC, Whitlow P, St Goar F, Rodriguez L, Silvestry F, Schwartz A, Sanborn TA, Condado JA, Foster E (2005) 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(11):2134–2140. https://doi.org/10.1016/j.jacc.2005.07.065CrossRefPubMed

11.

Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ, Investigators C (2018) Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med. https://doi.org/10.1056/NEJMoa1806640CrossRefPubMedPubMedCentral

12.

Reinohl J, Kaier K, Reinecke H, Schmoor C, Frankenstein L, Vach W, Cribier A, Beyersdorf F, Bode C, Zehender M (2015) Effect of availability of transcatheter aortic-valve replacement on clinical practice. N Engl J Med 373(25):2438–2447. https://doi.org/10.1056/NEJMoa1500893CrossRefPubMed

13.

Roques F, Michel P, Goldstone AR, Nashef SA (2003) The logistic EuroSCORE. Eur Heart J 24(9):881–882CrossRef

14.

Piazza N, Wenaweser P, van Gameren M, Pilgrim T, Tzikas A, Otten A, Nuis R, Onuma Y, Cheng JM, Kappetein AP, Boersma E, Juni P, de Jaegere P, Windecker S, Serruys PW (2010) Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving system–a Bern-Rotterdam Study. Am Heart J 159(2):323–329. https://doi.org/10.1016/j.ahj.2009.11.026CrossRefPubMed

15.

Braitman LE, Rosenbaum PR (2002) Rare outcomes, common treatments: analytic strategies using propensity scores. Ann Intern Med 137(8):693–695CrossRef

16.

Vansteelandt S, Daniel RM (2014) On regression adjustment for the propensity score. Stat Med 33(23):4053–4072. https://doi.org/10.1002/sim.6207CrossRefPubMed

17.

Maisano F, Franzen O, Baldus S, Schafer U, Hausleiter J, Butter C, Ussia GP, Sievert H, Richardt G, Widder JD, Moccetti T, Schillinger W (2013) 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(12):1052–1061. https://doi.org/10.1016/j.jacc.2013.02.094CrossRefPubMed

18.

Grasso C, Capodanno D, Scandura S, Cannata S, Imme S, Mangiafico S, Pistritto A, Ministeri M, Barbanti M, Caggegi A, Chiaranda M, Dipasqua F, Giaquinta S, Occhipinti M, Ussia G, Tamburino C (2013) 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(10):1482–1487. https://doi.org/10.1016/j.amjcard.2013.01.300CrossRefPubMed

19.

Nickenig G, Estevez-Loureiro R, Franzen O, Tamburino C, Vanderheyden M, Luscher TF, Moat N, Price S, Dall'Ara G, Winter R, Corti R, Grasso C, Snow TM, Jeger R, Blankenberg S, Settergren M, Tiroch K, Balzer J, Petronio AS, Buttner HJ, Ettori F, Sievert H, Fiorino MG, Claeys M, Ussia GP, Baumgartner H, Scandura S, Alamgir F, Keshavarzi F, Colombo A, Maisano F, Ebelt H, Aruta P, Lubos E, Plicht B, Schueler R, Pighi M, Di Mario C, Transcatheter Valve Treatment Sentinel Registry Investigators of the ERPotESoC (2014) 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(9):875–884. https://doi.org/10.1016/j.jacc.2014.06.1166CrossRefPubMed

20.

Puls M, Lubos E, Boekstegers P, von Bardeleben RS, Ouarrak T, Butter C, Zuern CS, Bekeredjian R, Sievert H, Nickenig G, Eggebrecht H, Senges J, Schillinger W (2016) 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 37(8):703–712. https://doi.org/10.1093/eurheartj/ehv627CrossRefPubMed

21.

Sorajja P, Mack M, Vemulapalli S, Holmes DR Jr, Stebbins A, Kar S, Lim DS, Thourani V, McCarthy P, Kapadia S, Grayburn P, Pedersen WA, Ailawadi G (2016) Initial experience with commercial transcatheter mitral valve repair in the United States. J Am Coll Cardiol 67(10):1129–1140. https://doi.org/10.1016/j.jacc.2015.12.054CrossRefPubMed

22.

Yeo KK, Yap J, Yamen E, Muda N, Tay E, Walters DL, Santoso T, Liu X, Jansz P, Yip J, Zambahari R, Passage J, Koh TH, Wang J, Scalia G, Kuntjoro I, Soesanto AM, Muller D (2014) Percutaneous mitral valve repair with the MitraClip: early results from the MitraClip Asia-Pacific Registry (MARS). EuroIntervention 10(5):620–625. https://doi.org/10.4244/EIJV10I5A107CrossRefPubMed

23.

Surder D, Pedrazzini G, Gaemperli O, Biaggi P, Felix C, Rufibach K, der Maur CA, Jeger R, Buser P, Kaufmann BA, Moccetti M, Hurlimann D, Buhler I, Bettex D, Scherman J, Pasotti E, Faletra FF, Zuber M, Moccetti T, Luscher TF, Erne P, Grunenfelder J, Corti R (2013) Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry. Heart 99(14):1034–1040. https://doi.org/10.1136/heartjnl-2012-303105CrossRefPubMed

24.

Munkholm-Larsen S, Wan B, Tian DH, Kearney K, Rahnavardi M, Dixen U, Kober L, Alfieri O, Yan TD (2014) A systematic review on the safety and efficacy of percutaneous edge-to-edge mitral valve repair with the MitraClip system for high surgical risk candidates. Heart 100(6):473–478. https://doi.org/10.1136/heartjnl-2013-304049CrossRefPubMed

25.

Baldus S, Schillinger W, Franzen O, Bekeredjian R, Sievert H, Schofer J, Kuck KH, Konorza T, Mollmann H, Hehrlein C, Ouarrak T, Senges J, Meinertz T, German Transcatheter Mitral Valve Interventions i (2012) MitraClip therapy in daily clinical practice: initial results from the German transcatheter mitral valve interventions (TRAMI) registry. Eur J Heart Fail 14(9):1050–1055. https://doi.org/10.1093/eurjhf/hfs079CrossRefPubMed

26.

Schwencke C, Bijuklic K, Ouarrak T, Lubos E, Schillinger W, Plicht B, Eggebrecht H, Baldus S, Schymik G, Boekstegers P, Hoffmann R, Senges J, Schofer J (2017) Impact of cardiac comorbidities on early and 1-year outcome after percutaneous mitral valve interventions: data from the German transcatheter mitral valve interventions (TRAMI) registry. Clin Res Cardiol 106(4):249–258. https://doi.org/10.1007/s00392-016-1044-3CrossRefPubMed

27.

Packer M, Grayburn PA (2020) New evidence supporting a novel conceptual framework for distinguishing proportionate and disproportionate functional mitral regurgitation. JAMA Cardiol. https://doi.org/10.1001/jamacardio.2019.5971CrossRefPubMedPubMedCentral

28.

Hahn RT (2020) Disproportionate emphasis on proportionate mitral regurgitation—Are there better measures of regurgitant severity? JAMA Cardiol. https://doi.org/10.1001/jamacardio.2019.6235CrossRefPubMed

29.

Gaasch WH, Aurigemma GP, Meyer TE (2020) An appraisal of the association of clinical outcomes with the severity of regurgitant volume relative to end-diastolic volume in patients with secondary mitral regurgitation. JAMA Cardiol. https://doi.org/10.1001/jamacardio.2019.5980CrossRefPubMed

Title: Impact of the introduction of percutaneous edge-to-edge mitral valve reconstruction on clinical practice in Germany compared to surgical valve repair
Authors: Lutz Frankenstein
Klaus Kaier
Hugo A. Katus
Christoph Bode
Tobias Wengenmayer
Constantin von zur Mühlen
Raffi Bekeredjian
Tobias Täger
Manfred Zehender
Hanna Fröhlich
Peter Stachon
Publication date: 01-05-2021
Publisher: Springer Berlin Heidelberg
Keywords: Heart Valve Reconstruction
Heart Valve Reconstruction
Heart Valve Reconstruction
Published in: Clinical Research in Cardiology / Issue 5/2021
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-020-01675-0

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Impact of the introduction of percutaneous edge-to-edge mitral valve reconstruction on clinical practice in Germany compared to surgical valve repair

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Results

Conclusions

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