Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients

Lim, D. Scott; Smith, Robert L.; Gillam, Linda D.; Zahr, Firas; Chadderdon, Scott; Makkar, Raj; Bardeleben, Ralph Stephan von; Kipperman, Robert; Rassi, Andrew N.; Goldman, Scott; Inglessis‐Azuaje, Ignacio; Yadav, Pradeep K.; Lurz, Philipp; Davidson, Charles J.; Mumtaz, Mubashir; Gada, Hemal; Kar, Saibal; Kodali, Susheel; Laham, Roger J.; Hiesinger, William; Fam, Neil; Keßler, Mirjam; O’Neill, William W.; Whisenant, Brian; Kliger, Chad; Kapadia, Samir; Rudolph, Volker; Choo, Joseph K.; Hermiller, James; Morse, Michael A.; Schofer, Niklas; Gafoor, Sameer; Latib, Azeem; Koulogiannis, Konstantinos; Marcoff, Leo; Hausleiter, Jörg

doi:10.1016/j.jcin.2022.09.005

Cited by 86 publications

(56 citation statements)

References 32 publications

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“…Second, incomplete echocardiographic and clinical follow-up may have confounded the study results, although we accounted for missing data using various statistical techniques. Third, the analysis includes only the results of the MitraClip device, which was the only FDA-approved transcatheter mitral valve repair device during the study period . Fourth, the study does not have a surgical or medically treated group as a comparator to evaluate the outcomes of transcatheter mitral valve repair.…”

Section: Discussionmentioning

confidence: 99%

“…Third, the analysis includes only the results of the MitraClip device, which was the only FDA-approved transcatheter mitral valve repair device during the study period. 28 Fourth, the study does not have a surgical or medically treated group as a comparator to evaluate the outcomes of transcatheter mitral valve repair. Fifth, transcatheter mitral valve repair is approved by the FDA in highrisk patients.…”

Section: Limitationsmentioning

confidence: 99%

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Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation

Makkar

Chikwe

Chakravarty

et al. 2023

JAMA

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ImportanceThere are limited data on the outcomes of transcatheter edge-to-edge mitral valve repair for degenerative mitral regurgitation (MR) in a real-world setting.ObjectiveTo evaluate the outcomes of transcatheter mitral valve repair for degenerative MR.Design, Setting, and ParticipantsCohort study of consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent nonemergent transcatheter mitral valve repair for degenerative MR in the US from 2014 through 2022.ExposureTranscatheter edge-to-edge mitral valve repair with the MitraClip device (Abbott).Main Outcomes and MeasuresThe primary end point was MR success, defined as moderate or less residual MR and a mean mitral gradient of less than 10 mm Hg. Clinical outcomes were evaluated based on the degree of residual MR (mild or less MR or moderate MR) and mitral valve gradients (≤5 mm Hg or &gt;5 to &lt;10 mm Hg).ResultsA total of 19 088 patients with isolated moderate to severe or severe degenerative MR who underwent transcatheter mitral valve repair were analyzed (median age, 82 years; 48% women; median Society of Thoracic Surgeons predicted risk of mortality with surgical mitral valve repair, 4.6%). MR success was achieved in 88.9% of patients. At 30 days, the incidence of death was 2.7%; stroke, 1.2%; and mitral valve reintervention, 0.97%. MR success compared with an unsuccessful procedure was associated with significantly lower mortality (14.0% vs 26.7%; adjusted hazard ratio, 0.49; 95% CI, 0.42-0.56; P &lt; .001) and heart failure readmission (8.4% vs 16.9%; adjusted hazard ratio, 0.47; 95% CI, 0.41-0.54; P &lt; .001) at 1 year. Among patients with MR success, the lowest mortality was observed in patients who had both mild or less residual MR and mean mitral gradients of 5 mm Hg or less compared with those with an unsuccessful procedure (11.4% vs 26.7%; adjusted hazard ratio, 0.40; 95% CI, 0.34-0.47; P &lt; .001).Conclusions and RelevanceIn this registry-based study of patients with degenerative MR undergoing transcatheter mitral valve repair, the procedure was safe and resulted in successful repair in 88.9% of patients. The lowest mortality was observed in patients with mild or less residual MR and low mitral gradients.

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Section: Discussionmentioning

confidence: 99%

Section: Limitationsmentioning

confidence: 99%

Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation

Makkar

Chikwe

Chakravarty

et al. 2023

JAMA

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“…Previous data from CLASP (Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study) and CLASPII have validated the safety and efficacy of the Edwards PASCAL TM transcatheter valve repair system [1]. CLASP IID randomised 180 patients with severe degenerative symptomatic MR not eligible for surgery (mean age 81 years, 67% male, median STS 5.9%) to transcatheter Edge-to-Edge Repair (TEER) with the Pascal device (Edwards Lifesciences) vs. MitraClip (Abbott) device [30]. At 30 days, the Pascal device met criteria for noninferiority with respect to the composite endpoint of CV death, stroke, MI, renal replacement therapy, severe bleeding and reintervention (3.4% vs. 4.8%; P for noninferior-ity\0.05).…”

Section: Stuctural: Mitral and Tricuspid Valve Interventionsmentioning

confidence: 99%

“…In PROGRESSIVE-AF (a 3-year followup of the EARLY-AF trial), 303 patients with newly diagnosed symptomatic paroxysmal AF were randomised to upfront ablation versus AAD [74]. Ablation was associated with a 75% reduction in the primary outcome of progression to persistent AF/flutter/tachycardia requiring cardioversion (1.9% vs. 7.4%; HR 0.25; 95% CI 0.09-0.70), a 49% reduction in any atrial arrhythmia [30 Use of botulinum A to reduce AF was assessed in the NOVA (NeurOtoxin for the PreVention of Post-Operative Atrial Fibrillation) study which randomised 323 patients undergoing cardiac (bypass and/or valve) surgery to epicardial botulinum toxin A (125 units or 250 units) versus placebo [75]. Overall, botulinum 125 units or 250 units versus placebo was not associated with a reduction in the primary outcome of AF[30 s at 30 days (RR 0.80; 95% CI 0.58-1.10 and RR 1.04; 95% CI 0.79-1.37), respectively, although in the patient subgroup[65 years, botulinum 125 units was associated with AF reduction (RR 0.64; 95% CI 0.43-0.94) which may be considered hypothesis-generating and warrant further study.…”

Section: Atrial Fibrillationmentioning

confidence: 99%

Advances in Clinical Cardiology 2022: A Summary of Key Clinical Trials

et al. 2023

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Introduction: Over the course of 2022, numerous key clinical trials with valuable contributions to clinical cardiology were published or presented at major international conferences. This review seeks to summarise these trials and to reflect on their clinical context. Methods: The authors reviewed clinical trials presented at major cardiology conferences during 2022, including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), Transcatheter Cardiovascular Therapeutics (TCT), American Heart Association (AHA), European Heart Rhythm Association (EHRA), Society for Cardiovascular Angiography and Interventions (SCAI), TVT-The Heart Summit (TVT) and Cardiovascular Research Technologies (CRT). Trials with a broad relevance to the cardiology community and those with potential to change current practice were included. Results: A total of 93 key cardiology clinical trials were identified for inclusion. Interventional cardiology data included trials evaluating the use of new generation novel stent technology and new intravascular physiology strategies such as quantitative flow ratio (QFR) to guide revascularisation in stable and unstable coronary artery disease. New trials in acute coronary syndromes and intervention focused on long-term outcomes of optimal medical therapy (OMT), revascularisation in ischaemic dysfunction and left main (LM) intervention. Structural intervention trials included latest data on optimal timing and anticoagulation strategies in transcatheter aortic valve replacement (TAVR), in addition to expanding evidence in mitral and tricuspid valve interventions. Heart failure data included trials with sodium-glucose cotransporter 2 (SGLT2) inhibitors, iron replacement and novel drugs such as omecamtiv. Prevention trials included new data on proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors and polypill strategies. In electrophysiology, new data regarding optimal timing of ablative therapy for atrial fibrillation (AF) in addition to novel screening strategies were evaluated. Conclusion: This article presents a summary of key clinical cardiology trials published and presented during the past year and should be of interest to both practising clinicians and researchers.

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“…Mitral regurgitation (MR) is the most prevalent valvular heart disease in the Western world 1,2 . The prevalence of MR is expected to increase owing to the continuously ageing population and the increase in the prevalence of heart failure 1,2 . Percutaneous therapies have played a progressively larger role in the treatment of MR 3 .…”

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confidence: 99%