Recurrent or Persistent Mitral Regurgitation After Transcatheter Edge‐to‐Edge Repair: It Is a Big Deal!
2022; Wiley; Volume: 11; Issue: 20 Linguagem: Inglês
10.1161/jaha.122.027704
ISSN2047-9980
Autores Tópico(s)Infective Endocarditis Diagnosis and Management
ResumoHomeJournal of the American Heart AssociationVol. 11, No. 20Recurrent or Persistent Mitral Regurgitation After Transcatheter Edge‐to‐Edge Repair: It Is a Big Deal! Open AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citations ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toOpen AccessEditorialPDF/EPUBRecurrent or Persistent Mitral Regurgitation After Transcatheter Edge‐to‐Edge Repair: It Is a Big Deal! Firas Zahr and Ranya N. Sweis Firas ZahrFiras Zahr *Correspondence to: Firas Zahr, MD, Knight Cardiovascular Institute, Oregon Health & Science University, 3181 Sam Jackson Park Rd, Portland, OR 97239. Email: E-mail Address: [email protected] https://orcid.org/0000-0001-8448-8880 , Knight Cardiovascular Institute, , Oregon Health & Science University, , Portland, , OR, and Ranya N. SweisRanya N. Sweis , Department of Medicine, , Northwestern University Feinberg School of Medicine, , Chicago, , IL, Originally published17 Oct 2022https://doi.org/10.1161/JAHA.122.027704Journal of the American Heart Association. 2022;11:e027704This article is a commentary on the followingMitral Valve Surgery for Persistent or Recurrent Mitral Regurgitation After Transcatheter Edge‐to‐Edge Repair Is Associated With Improved SurvivalOther version(s) of this articleYou are viewing the most recent version of this article. Previous versions: October 17, 2022: Ahead of Print Once mitral transcatheter edge‐to‐edge repair (MTEER) was approved by the US Food and Drug Administration for commercial use in patients with severe symptomatic primary mitral regurgitation (MR) who are also at prohibitive surgical risk, the Centers for Medicare & Medicaid Services National Coverage Determination was issued in 2014. In 2019, the US Food and Drug Administration expanded the labeled indication to include patients with moderate to severe or severe secondary MR who have heart failure symptoms, though the Centers for Medicare & Medicaid Services National Coverage Determination wasn't issued until early 2021. Since the initial approval, the number of MTEER cases has witnessed significant growth with an almost 10‐fold increase in cases in the first 5 years and the growth appears to be continuing.1 Though this increase is partially related to the expanded indication for MTEER, it is likely even more so, related to the increased use of MTEER in complex anatomy that was not likely fully evaluated in the pivotal trials. Consequently, real life MTEER experience has resulted in a rate of persistent severe MR of ≈5% and recurrent severe MR of 6% to 15% of patients after transcatheter edge‐to‐edge repair (TEER) and it carries poor prognosis.2, 3Medical, surgical, or percutaneous interventions have all been proposed as potential solutions for this problem. Medical treatment is often more challenging after failed MTEER because of potentially functional mitral stenosis, and the resultant pulmonary hypertension. Percutaneous interventions with redo‐MTEER, leaflet laceration, and concomitant transcatheter mitral valve replacement (TMVR), or vascular plugs have all been described with various levels of success. Finally, surgical interventions have been reportedly associated with high mortality close to 10% in a recently published analysis from the Society of Thoracic Surgeons (STS) database.4In this issue of the Journal of the American Heart Association (JAHA), El Shaer et al. present a retrospective observational study of patients who are symptomatic with persistent or recurrent severe MR after MTEER who were ineligible for a redo‐MTEER in a single high volume high expertise center.5 In this review, 142 patients who presented with symptomatic severe MR after TEER were either treated with surgical mitral valve replacement or medical therapy. The primary outcome observed was all‐cause mortality. Among the included patients, 86% of them presented for recurrent mitral regurgitation post‐MTEER of which ≈50% had initial primary MR and ≈34% of them had mixed cause MR; 44 (31.0%) patients underwent mitral surgery. Patients who underwent surgery were younger than those treated medically (74.1±8.9 versus 78.6±10.5 years, P=0.01) but had similar STS Predicted Risk of Operative Mortality of 9.0±4.7 versus 7.9±4.9 in the surgical versus medical therapy groups, respectively (P=0.22). In the surgical group, valve replacement was performed in all patients. Operative mortality was 4.5%. After risk‐adjustment, surgery was associated with significantly lower all‐cause mortality (adjusted hazard ratio, 0.33 [95% CI, 0.12–0.92; P=0.001]) compared with medial therapy.The lessons learned from this single center observational study are valuable but should be cautiously interpreted: (1) Surgery for selected groups of patients with persistent/recurrent MR after MTEER is feasible and mortality can be close to 5% at a high volume, high expertise center. (2) Medical therapy for this cohort carries the expected high mortality during midterm follow‐up. (3) Surgery for persistent/recurrent MR after MTEER often results in mitral valve replacement and most often these patients require concomitant surgery with tricuspid surgery being very common (50%).It has long been accepted and incorporated into the valvular heart disease treatment guidelines that mitral valve repair is preferred to mitral valve replacement as long as successful and durable repair is possible and performance at a primary/comprehensive valve center is feasible.6 The 2020 American College of Cardiology/American Heart Association guidelines incorporated the recommendation for TEER in high and prohibitive risk patients as long as valve anatomy is favorable.7 However, it is worth noting that in a group of patients who were considered high or prohibitive risk for mitral valve surgery by STS Predicted Risk of Operative Mortality were offered MTEER and had recurrence or persistence of severe MR and presented for surgical mitral valve replacement at a high volume high expertise center, they had successful outcomes with a mortality rate of 5% significantly lower than predicted by original index procedure STS Predicted Risk of Operative Mortality or as recently observed in the STS database,4 albeit now with a less optimal replacement result instead of a valve repair. This finding emphasizes that when treating patients with complex anatomy (eg, commissural jets, calcified annuli, mitral annular calcification, or small valves), experienced heart teams are needed to direct the patients to the best treatment pathway including surgical repair when needed. Evolving data of newer technologies such as TMVR (especially transfemoral), new MTEER devices, and chordal replacement can potentially change the transcatheter options for these patients with complex anatomy. Additionally, in this report, there has been significant decrease in the percentage of failed cases per year between 2014 and 2021 indicating the value of learning curve in terms of patient selection, operators experience, and newer generation TEER devices.The application of this discussion to patients with secondary MR remains to be seen as the data presented in this paper only included ≈16% of patients with secondary MR. In this population of patients, surgical mitral valve repair and replacement have not resulted in a decrease in hospitalization or death for patients with secondary MR and have been associated with a significant risk of complications.8 The 2 recent trials that have evaluated the role of MTEER in secondary MR are the MITRA‐FR (Multicenter Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation—France) trial and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. They evaluated outcomes of mitral repair with the TEER device compared with medical therapy in patients with reduced left ventricular ejection fraction, secondary MR, and symptomatic heart failure versus optimal medical therapy alone.9, 10 Much has been written about why these 2 trials arrived at divergent outcomes. However, the 2020 American College of Cardiology/American Heart Association guidelines suggest that mitral TEER may be considered in severe secondary MR based on the COAPT inclusion criteria, which include left ventricular ejection fraction from 20% to 50%, left ventricular end‐systolic dimension ≤70 mm, pulmonary artery systolic pressure ≤70 mm Hg, and persistent symptoms while on optimal medical therapy.7 It remains to be seen how real world performance of MTEER in this patient population impacts long‐term outcomes particularly in patients who have recurrent or persistent severe MR after MTEER.Surgical repair after failed TEER requires proficiency in mitral valve surgery, and optimal results are most likely to necessitate experienced mitral surgeons and perioperative care teams. Concomitant surgery was performed in 100% of cases and involved atrial septal defect closure, atrial fibrillation ablation, tricuspid repair, or coronary bypass surgery. Over 50% of this cohort had greater than moderate TR at the time of their surgery and the majority had concomitant tricuspid surgery indicating the complexity of these patients and the importance of understanding the full etiology of their valvular heart disease, optimizing their medical therapy and including the experienced heart teams in their management at the time of their initial presentation, recommendation for surgery versus TEER, and when/if MTEER fails.Finally, novel technologies will likely be available in the near future that will offer alternative therapies for patients with severe primary or secondary mitral regurgitation especially for patients who are not expected to have good outcome after MTEER. Options would include medical therapy beyond what was studied in COAPT, interventional devices for heart failure, and newer TEER and repair devices. TMVR has also shown excellent MR reduction in early trials for patients with complex mitral valve anatomy and mitral annular calcification. Unfortunately, most of these trials are suffering from high anatomical screen fail rates, small number of patients, and significant long‐term mortality.11 For patients with failed TEER, many devices are under development to evaluate the feasibility of leaflet laceration or TEER device retrieval with simultaneous TMVR. The increased safety of TMVR devices especially the transfemoral systems might be a paradigm shift for some of these patients especially those with complex anatomy and high likelihood of TEER failure or suboptimal TEER results.12, 13 Meanwhile, as demonstrated by this study, surgical mitral valve replacement after failed MTEER remains a good option for a selected groups of patients and can be associated with favorable outcomes when performed at experienced centers. This study again reinforces the value of the knowledgeable multidisciplinary heart team to direct the right patient to the right pathway at the time of their initial MR presentation and subsequently if they fail MTEER.DisclosuresFiras Zahr, MD reports a research and educational grant and consulting for Edwards Lifesciences and Medtronic. Ranya Sweis, MD has no disclosures to report.Footnotes*Correspondence to: Firas Zahr, MD, Knight Cardiovascular Institute, Oregon Health & Science University, 3181 Sam Jackson Park Rd, Portland, OR 97239. Email: [email protected]eduFor Disclosures, see page 3.See Article by Alkhouli et al.References1 Mack M, Carroll JD, Thourani V, Vemulapalli S, Squiers J, Manandhar P, Deeb GM, Batchelor W, Herrmann HC, Cohen DJ, et al. Transcatheter mitral valve therapy in the United States: a report from the STS/ACC TVT registry. Ann Thorac Surg.2022; 113:337–365. doi: 10.1016/j.athoracsur.2021.07.030CrossrefMedlineGoogle Scholar2 Sorajja P, Vemulapalli S, Feldman T, Mack M, Holmes DR, Stebbins A, Kar S, Thourani V, Ailawadi G. Outcomes with transcatheter mitral valve repair in the United States: an STS/ACC TVT registry report. J Am Coll Cardiol.2017; 70:2315–2327. doi: 10.1016/j.jacc.2017.09.015CrossrefMedlineGoogle Scholar3 Sugiura A, Kavsur R, Spieker M, Iliadis C, Goto T, Ozturk C, Weber M, Tabata N, Zimmer S, Sinning JM, et al. Recurrent mitral regurgitation after MitraClip: predictive factors, morphology, and clinical implication. Circ Cardiovasc Interv.2022; 15:e010895.LinkGoogle Scholar4 Chikwe J, O'Gara P, Fremes S, Sundt TM, Habib RH, Gammie J, Gaudino M, Badhwar V, Gillinov M, Acker M, et al. Mitral surgery after transcatheter edge‐to‐edge repair: society of thoracic surgeons database analysis. 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J Am Coll Cardiol. 2017; 70:252–289. doi: 10.1016/j.jacc.2017.03.011CrossrefMedlineGoogle Scholar9 Obadia JF, Messika‐Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, et al. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med.2018; 379:2297–2306. doi: 10.1056/NEJMoa1805374CrossrefMedlineGoogle Scholar10 Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, et al. Transcatheter mitral‐valve repair in patients with heart failure. N Engl J Med.2018; 379:2307–2318. doi: 10.1056/NEJMoa1806640CrossrefMedlineGoogle Scholar11 Muller DWM, Sorajja P, Duncan A, Bethea B, Dahle G, Grayburn P, Babaliaros V, Guerrero M, Thourani VH, Bedogni F, et al. 2‐year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation. 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JACC Cardiovasc Interv.2022; 15:80–89. doi: 10.1016/j.jcin.2021.10.018CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesMitral Valve Surgery for Persistent or Recurrent Mitral Regurgitation After Transcatheter Edge‐to‐Edge Repair Is Associated With Improved SurvivalAhmed El Shaer, et al. Journal of the American Heart Association. 2022;11 October 18, 2022Vol 11, Issue 20 Article InformationMetrics Copyright © 2022 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley BlackwellThis is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.https://doi.org/10.1161/JAHA.122.027704PMID: 36250660 Originally publishedOctober 17, 2022 Keywordstranscatheter mitral edge to edge repairEditorialsmitral valve surgerymitral valve insufficiencyPDF download SubjectsCatheter-Based Coronary and Valvular Interventions
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