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Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study

Kar, Saibal; von Bardeleben, Ralph Stephan; Rottbauer, Wolfgang; Mahoney, Paul; Price, Matthew J; Grasso, Carmelo; Williams, Mathew; Lurz, Philipp; Ahmed, Mustafa; Hausleiter, Jörg; Chehab, Bassem; Zamorano, Jose L; Asch, Federico M; Maisano, Francesco
BACKGROUND:The third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system was introduced to assist in leaflet grasping with the longer clip arms of MitraClip XTR and to improve ease of use with the modified delivery catheter. OBJECTIVES/OBJECTIVE:The EXPAND study evaluated contemporary real-world outcomes in subjects with mitral regurgitation (MR) treated with the third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system. METHODS:EXPAND is a prospective, multicenter, international, single-arm study that enrolled patients with primary MR and secondary MR at 57 centers. Follow-up was conducted through 12 months. Echocardiograms were analyzed by an echocardiographic core laboratories. Study outcomes included: MR severity, functional capacity measured by New York Heart Association functional class, quality of life measured by Kansas City Cardiomyopathy Questionnaire, heart failure hospitalizations, all-cause mortality. RESULTS:1,041 patients were enrolled from April 2018 through March 2019, of which 50.5% had primary or mixed etiology. Implant success was 98.9%; 1.5 ± 0.6 clips were implanted per subject. Significant MR reduction from baseline (≥MR 3+: 56.0%) to 30 days (≤MR 1+:88.8%) was maintained through 1 year (MR ≤1+: 89.2%). A total of 84.5% and 93.0% of subjects in primary MR and secondary MR, respectively, had ≤1+ MR at 1 year. Significant improvements were observed in clinical outcomes (New York Heart Association functional class I/II in 80.3%, +21.6 improvement in Kansas City Cardiomyopathy Questionnaire score) at 1 year. All-cause mortality and heart failure hospitalizations at 1 year were 14.9% and 18.9%, respectively, which was significantly lower than previous studies. CONCLUSIONS:The study demonstrates treatment with the third-generation system resulted in substantial reduction of MR in a contemporary real-world practice, compared with the results of earlier EVEREST and COAPT trials.(The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices [EXPAND]; NCT03502811).
PMID: 36922046
ISSN: 1876-7605
CID: 5448922

Transesophageal Echocardiographic Screening for Structural Heart Interventions

Ro, Richard; Bamira, Daniel; Bernard, Samuel; Vainrib, Alan; Ibrahim, Homam; Staniloae, Cezar; Williams, Mathew R; Saric, Muhamed
PURPOSE OF REVIEW/OBJECTIVE:Percutaneous structural interventions have provided patients with an effective therapeutic option, and its growth has been aided by echocardiography. We describe the vital role that transesophageal echocardiography (TEE) plays in screening patients prior to their procedure. RECENT FINDINGS/RESULTS:A multimodality imaging approach is employed by the valve team, but TEE plays a unique role in diagnosis and planning. Utilization of all TEE views and features such as biplane, 3D imaging, and multiplanar reconstruction ensures accurate assessment of the structural lesion of interest. The role of TEE remains essential in the planning of structural interventions, and these studies should be performed in a systematic and comprehensive manner.
PMID: 36680732
ISSN: 1534-3170
CID: 5405192

Transcatheter edge-to-edge repair for secondary mitral regurgitation with third-generation devices in heart failure patients - results from the Global EXPAND Post-Market study

Orban, Mathias; Rottbauer, Wolfgang; Williams, Mathew; Mahoney, Paul; von Bardeleben, Ralph Stephan; Price, Matthew J; Grasso, Carmelo; Lurz, Philipp; Zamorano, Jose L; Asch, Federico M; Maisano, Francesco; Kar, Saibal; Hausleiter, Jörg
AIMS/OBJECTIVE:Mitral valve transcatheter edge-to-edge repair is a guideline-recommended treatment option for patients with secondary mitral regurgitation (SMR). The purpose of this analysis was to report contemporary real-world outcomes in SMR patients treated with third-generation MitraClip systems. METHODS AND RESULTS/RESULTS:EXPAND is a prospective, multicentre, international, single-arm study with 1041 patients treated for mitral regurgitation (MR) with MitraClip NTR/XTR, with 30-day and 1-year follow-up. All echocardiograms were analysed by an independent echocardiographic core lab. Study outcomes included procedural outcomes, durability of MR reduction, and major adverse events including all-cause mortality and heart failure hospitalizations (HFH). A subgroup of 413 symptomatic patients (age 74.7 ± 10.1 years, 58% male) with severe SMR were included. MR reduction to MR ≤ 1+ and MR ≤ 2+ was achieved in 93.0% and 98.5% of patients, respectively, which was sustained at 1-year follow-up. All-cause mortality was 17.7% at 1-year- follow-up, and the combined endpoint of all-cause mortality or first HFH occurred in 34% of patients. This combined endpoint was significantly less frequently observed in MR ≤ 1+ patients (Kaplan-Maier estimates: 29.7% vs. 69.6% for MR ≤ 1+ vs. MR  ≥ 2 +; p < 0.0001). New York Heart Association (NYHA) functional class improved significantly from baseline (NYHA ≤ II: 17%) to 1-year follow-up (NYHA ≤ II: 78%) (p < 0.0001). While MR reduction was comparable between NTR-only vs. XTR-only treated patients, less XTR clips were required for achieving MR reduction. CONCLUSIONS:Under real-world conditions, optimal sustained MR reduction to MR ≤ 1+ was achieved in a high percentage of patients with third-generation MitraClip, which translated into symptomatic improvement and low event rates. These results appear to be comparable with recent randomized clinical trials.
PMID: 36597850
ISSN: 1879-0844
CID: 5418992

CRT-700.03 TAVR in Intermediate-Risk Patients: 5-Year Outcomes From the SURTAVI Continued Access Study [Meeting Abstract]

Mahoney, P; Newton, J; Gada, H; Mumtaz, M; Williams, M; Waksman, R; Bafi, A; Fail, P; Netherland, D; Davis, T; Batra, S; Chhim, R; Verdoliva, S; Reardon, M J
Background: The Surgical Replacement and Transcatheter Aortic Valve Implantation Continued Access Study (SURTAVI CAS) evaluated the safety and effectiveness of transcatheter aortic valve replacement (TAVR) in patients with severe symptomatic aortic stenosis (AS) at intermediate surgical risk. Long-term follow-up data after TAVR are limited, and the objective of this analysis is to report 5-year outcomes for these patients.
Method(s): SURTAVI CAS was designed as a single-arm prospective, multicenter, non-randomized phase of the primary SURTAVI randomized controlled trial. Patients enrolled in CAS were selected based on detailed inclusion and exclusion criteria and assigned to TAVR with either the CoreValve or Evolut R device (Medtronic, Mpls, MN). The primary endpoint was the composite of all-cause mortality or disabling stroke at 2 years. Prespecified secondary endpoints were also defined, and echocardiographic assessment of hemodynamics and measurements of health status and quality of life were included. Echocardiograms were assessed by a central core laboratory. Patients were followed through 5 years.
Result(s): A total of 275 patients underwent an attempted TAVR at 44 investigational sites in the U.S. Mean age was 79.0+/-6.1 years, and 46.2% were male. At baseline, most patients were in New York Heart Association class II (54.5%) or III (42.9%), and the mean Society of Thoracic Surgeons predicted risk of mortality score was 4.1+/-1.5%. Study compliance through five years was 88.6% for follow-up visits. At 5-year follow-up, the rate of all-cause mortality or disabling stroke was 29.9% (all-cause mortality, 29.2%; disabling stroke, 3.4%). The rate of reintervention was 1.1%, and the new permanent pacemaker implantation rate was 27.6%. There were no cases of clinical valve thrombosis, and 3 cases of valve endocarditis (1.2%). The 5-year mean gradient was 9.16 mmHg and 5-year mean effective orifice area was 2.06 cm2. Most patients had no or trace aortic regurgitation (87.9%) and no or trace paravalvular leak (89.4%). At 5-year follow-up, the average increase in Kansas City Cardiomyopathy Questionnaire overall summary score from baseline was 16.6 +/- 24.8, p<0.001.
Conclusion(s): For patients with severe symptomatic AS at intermediate surgical risk treated with TAVR, 5-year data from SURTAVI CAS shows favorable clinical outcomes, with excellent valve hemodynamics, low reintervention rates, and no clinical valve thrombosis. These data demonstrate the long-term safety and effectiveness of TAVR in this risk population.
ISSN: 1876-7605
CID: 5509672

Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery: Design and Rationale of the REPAIR MR Trial

McCarthy, Patrick M; Whisenant, Brian; Asgar, Anita W; Ailawadi, Gorav; Hermiller, James; Williams, Mathew; Morse, Andrew; Rinaldi, Michael; Grayburn, Paul; Thomas, James D; Martin, Randolph; Asch, Federico M; Shu, Yu; Sundareswaran, Kartik; Moat, Neil; Kar, Saibal
Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge-to-edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device. However, in the United States, MitraClip is approved for use only in primary patients with MR who are at high or prohibitive risk for mitral valve surgery. The REPAIR MR (Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery) trial is designed to compare early and late outcomes associated with transcatheter edge-to-edge repair with the MitraClip and surgical repair of primary MR in older or moderate surgical risk patients. Methods and Results The REPAIR MR trial is a prospective, randomized, parallel-controlled, open-label multicenter, noninferiority trial for the treatment of severe primary MR (verified by an independent echocardiographic core laboratory). Patients with severe MR and indications for surgery because of symptoms (New York Heart Association class II-IV), or without symptoms with left ventricular ejection fraction ≤60%, pulmonary artery systolic pressure >50 mm Hg, or left ventricular end-systolic diameter ≥40 mm are eligible for the trial provided they meet the moderate surgical risk criteria as follows: (1) ≥75 years of age, or (2) if <75 years of age, then the subject has a Society of Thoracic Surgeons Predicted Risk Of Mortality score of ≥2% for mitral repair (or Society of Thoracic Surgeons replacement score of ≥4%), or the presence of a comorbidity that may introduce a surgery-specific risk. The local surgeon must determine that the mitral valve can be surgically repaired. Additionally, an independent eligibility committee will confirm that the MR can be reduced to mild or less with both the MitraClip and surgical mitral valve repair with a high degree of certainty. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive the MitraClip device or to undergo surgical mitral valve repair (control group). There are 2 co-primary end points for the trial, both of which will be evaluated at 2 years. Each subject will be followed for 10 years after enrollment. The study has received approval from both the Food and Drug Administration and the Centers for Medicare and Medicaid Services, and enrolled its first subject in July 2020. Conclusions The REPAIR MR trial will determine the safety and effectiveness of transcatheter edge-to-edge repair with the MitraClip in patients with primary MR who are at moderate surgical risk and are candidates for surgical MV repair. The trial will generate contemporary comparative clinical evidence for the MitraClip device and surgical MV repair. Registration; NCT04198870.
PMID: 36752231
ISSN: 2047-9980
CID: 5420822

Minimally Invasive versus Full Sternotomy for Isolated Aortic Valve Replacement in Low-risk Patients

Russo, Mark J; Thourani, Vinod H; Cohen, David J; Malaisrie, S Chris; Szeto, Wilson Y; George, Isaac; Kodali, Susheel K; Makkar, Raj; Lu, Michael; Williams, Mathew; Nguyen, Tom; Aldea, Gabriel; Genereux, Philippe; Fang, H Kenith; Alu, Maria C; Rogers, Erin; Okoh, Alexis; Herrmann, Howard C; Kapadia, Samir; Webb, John G; Smith, Craig R; Leon, Martin B; Mack, Michael J
BACKGROUND:Surgical aortic valve replacement can be performed either through a minimally invasive (MI) or full sternotomy (FS) approach. The present study compared outcomes of MI versus FS for isolated surgery among patients enrolled in the PARTNER 3 low-risk trial. METHODS:Patients with severe, symptomatic aortic stenosis at low surgical risk with anatomy suitable for transfemoral access were eligible for PARTNER 3 enrollment. The primary outcome was the composite endpoint of death, stroke, or rehospitalization (valve-, procedure-, or heart-failure-related) at 1 year. Secondary outcomes included the individual components of the primary endpoint as well as patient-reported health status at 30 days and 1 year. RESULTS:In the PARTNER 3 study, 358 patients underwent isolated surgery at 68 centers through an MI (n=107) or FS (n=251) approach (8 patients were converted from MI to FS). Mean age and Society of Thoracic Surgeons score were similar between groups. The Kaplan-Meier estimate of the primary outcome was similar in the MI versus FS groups (16.9% versus 14.9%; hazard ratio [95% CI]: 1.15 [0.66 - 2.03]; P=0.618). There were no significant differences in the 1-year rates of all-cause death (2.8% versus 2.8%), all stroke (1.9% versus 3.6%), or rehospitalization (13.3% versus 10.6%, P > 0.05 for all). Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire score at 30 days or 1 year was comparable in both groups. CONCLUSIONS:For patients at low risk for isolated surgery, MI and FS approaches were associated with similar in-hospital and 1-year outcomes.
PMID: 34958771
ISSN: 1552-6259
CID: 5108042

When Fixing Hinders, Why We Should Sometimes Fight the Urge to Fix [Editorial]

Ibrahim, Homam; Williams, Mathew R
PMID: 36538581
ISSN: 1941-7632
CID: 5394642

Bacterial endocarditis with AACEK (HACEK) organisms [Case Report]

Kuohn, Lindsey R; Ro, Richard; Bamira, Daniel; Vainrib, Alan; Freedberg, Robin; Galloway, Aubrey; Williams, Mathew R; Saric, Muhamed
INTRODUCTION/BACKGROUND:Gram-negative organisms of the AACEK group, formerly known as HACEK, rarely cause endocarditis. CASE SERIES/METHODS:We present three cases of bacterial endocarditis, involving native and prosthetic valves, caused by AACEK organisms. In two patients, Cardiobacterium hominis was the responsible organism, and in a third, Aggregatibacter aphrophilus was implicated. A dental source of infection was identified in two patients, and in all three patients, the presentation of endocarditis was subacute. DISCUSSION/CONCLUSIONS:This case series highlights the indolent nature of infection with the AACEK organisms. It also demonstrates the crucial role of multimodality imaging, especially transesophageal echocardiography, in the diagnosis of AACEk endocarditis of both native and prosthetic valves, and in delineating the extent of abscess in those with prosthetic valve infection.
PMID: 36198094
ISSN: 1540-8175
CID: 5356642

Mitral Valve-in-Ring Leaflet Thrombosis: A Multimodality Imaging Primer [Case Report]

Hayes, Dena E; Bamira, Daniel; Vainrib, Alan F; Staniloae, Cezar; Jilaihawi, Hasan; Williams, Mathew; Saric, Muhamed
PMID: 36172479
ISSN: 2468-6441
CID: 5334432

Amyloid deposition in an explanted bioprosthetic aortic valve: case report and review of the literature [Case Report]

Weerasekare, Jonika M; Zhou, Fang; Skolnick, Adam H; Jilaihawi, Hasan; Williams, Mathew R; Dasari, Surendra; McPhail, Ellen D; Theis, Jason D; Dao, Linda N; Bois, John P; Maleszewski, Joseph J; Bois, Melanie C
Herein we present a case of an 80-year-old gentleman who presented with exertional dyspnea status post aortic valve replacement with #23 Trifecta pericardial St. Jude aortic bioprosthetic valve (BV) 12 years prior. He subsequently underwent valve re-replacement due cusp calcification. Histologically, the surgically explanted BV revealed Congophilic deposits with birefringence under cross-polarized light. Extensive work-up identified no systemic source of amyloid in this patient. Liquid chromatography-tandem mass spectrometry-based (LC-MS/MS) proteomics showed the amyloid was composed of human-origin amyloid signature proteins (apolipoprotein A4, apolipoprotein E, serum amyloid P) and human-origin mu heavy chains. Background bovine collagen was also present. Transmission electron microscopy (TEM) showed collections of 7.5-10 nm nonbranching fibrils, consistent with amyloid. Using these techniques, we classified the amyloid as Mu heavy chain, deposition of which is highly unusual in BV. Finally, we provide a review of the literature regarding isolated amyloid deposition in BV.
PMID: 36038051
ISSN: 1879-1336
CID: 5332042