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Impact of heart failure hospitalizations on clinical outcomes after mitral transcatheter edge-to-edge repair: Results from the EXPAND study

Kessler, Mirjam; Rottbauer, Wolfgang; von Bardeleben, Ralph Stephan; Grasso, Carmelo; Lurz, Philipp; Mahoney, Paul; Price, Matthew; Williams, Mathew; Denti, Paolo; Estevez-Loureiro, Rodrigo; Kar, Saibal; Maisano, Francesco
Aim: This analysis aimed to compare the clinical outcomes associated with heart failure (HF) readmissions and to identify associations with HF hospitalizations (HFH) in patients treated with the MitraClip™ NTR/XTR System in the EXPAND study. Methods and results: The global, real-world EXPAND study enrolled 1041 patients with primary or secondary mitral regurgitation (MR) treated with the MitraClip NTR/XTR System. Echocardiograms were analysed by an independent echocardiographic core laboratory. The study population was stratified into HFH and No-HFH groups based on the occurrence of HFH 1 year post-index procedure. Clinical outcomes including MR severity, New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and all-cause mortality were compared (HFH: n = 181; No-HFH: n = 860). Both groups achieved consistent 1-year MR reduction to ≤1+ (HFH vs. No-HFH: 87.3% vs. 89.5%, p = 0.6) and significant 1-year improvement in KCCQ scores (+16.5 vs. +22.3, p = 0.09) and NYHA functional class. However, more patients in the No-HFH group had 1-year NYHA class ≤II (HFH vs. No-HFH: 67.9% vs. 81.9%, p < 0.01). All-cause mortality at 1 year was 36.8% in the HFH group versus 10.4% in the No-HFH group (p < 0.001). The HFH rate decreased by 63% at 1 year post-M-TEER versus 1 year pre-treatment (relative risk 0.4, p < 0.001). Independent HFH associations were MR ≥2+ at discharge, HFH 1 year prior to treatment, baseline NYHA class ≥III, baseline tricuspid regurgitation ≥2+, and baseline left ventricular ejection fraction ≤40%. Conclusions: This study reports the impact of HFH on clinical outcomes post-treatment in the EXPAND study. Results demonstrate that the occurrence of HFH was associated with worse 1-year survival, and treatment with the MitraClip system substantially reduced HFH and improved patient symptoms and quality of life.
ISSN: 1388-9842
CID: 5661372

Routine Extubation in the Operating Room After Isolated Coronary Artery Bypass

James, Les; Smith, Deane E; Galloway, Aubrey C; Paone, Darien; Allison, Michael; Shrivastava, Shashwat; Vaynblat, Mikhail; Swistel, Daniel G; Loulmet, Didier F; Grossi, Eugene A; Williams, Mathew R; Zias, Elias
BACKGROUND:The benefits of fast-track extubation in the intensive care unit (ICU) after cardiac surgery are well established. Although extubation in the operating room (OR) is safe in carefully selected patients, widespread use of this strategy in cardiac surgery remains unproven. This study was designed to evaluate perioperative outcomes with OR vs ICU extubation in patients undergoing nonemergency, isolated coronary artery bypass grafting (CABG). METHODS:The Society of Thoracic Surgeons (STS) data for all single-center patients who underwent nonemergency isolated CABG over a 6-year interval were analyzed. Perioperative morbidity and mortality with ICU vs OR extubation were compared. RESULTS:Between January 1, 2017 and December 31, 2022, 1397 patients underwent nonemergency, isolated CABG; 891 (63.8%) of these patients were extubated in the ICU, and 506 (36.2%) were extubated in the OR. Propensity matching resulted in 414 pairs. In the propensity-matched cohort, there were no differences between the 2 groups in incidence of reintubation, reoperation for bleeding, total operative time, stroke or transient ischemic attack, renal failure, or 30-day mortality. OR-extubated patients had shorter ICU hours (14 hours vs 20 hours; P < .0001), shorter postoperative hospital length of stay (3 days vs 5 days; P < .0001), a greater likelihood of being discharged directly to home (97.3% vs 89.9%; P < .0001), and a lower 30-day readmission rate (1.7% vs 4.1%; P = .04). CONCLUSIONS:Routine extubation in the OR is a feasible and safe strategy for a broad spectrum of patients after nonemergency CABG, with no increase in perioperative morbidity or mortality. Wider adoption of routine OR extubation for nonemergency CABG is indicated.
PMID: 37806334
ISSN: 1552-6259
CID: 5605312

1-Year Outcomes of Transcatheter Edge-to-Edge Repair in Anatomically Complex Degenerative Mitral Regurgitation Patients

Smith, Robert L; Lim, D Scott; Gillam, Linda D; Zahr, Firas; Chadderdon, Scott; Rassi, Andrew N; Makkar, Raj; Goldman, Scott; Rudolph, Volker; Hermiller, James; Kipperman, Robert M; Dhoble, Abhijeet; Smalling, Richard; Latib, Azeem; Kodali, Susheel K; Lazkani, Mohamad; Choo, Joseph; Lurz, Philipp; O'Neill, William W; Laham, Roger; Rodés-Cabau, Josep; Kar, Saibal; Schofer, Niklas; Whisenant, Brian; Inglessis-Azuaje, Ignacio; Baldus, Stephan; Kapadia, Samir; Szerlip, Molly; Kliger, Chad; Boone, Robert; Webb, John G; Williams, Mathew R; von Bardeleben, Ralph Stephan; Ruf, Tobias Friedrich; Guerrero, Mayra; Eleid, Mackram; McCabe, James M; Davidson, Charles; Hiesinger, William; Kaneko, Tsuyoshi; Shah, Pinak B; Yadav, Pradeep; Koulogiannis, Konstantinos; Marcoff, Leo; Hausleiter, Jörg; ,
BACKGROUND:Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. OBJECTIVES/OBJECTIVE:The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. METHODS:Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. RESULTS:Ninety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). CONCLUSIONS:At 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.
PMID: 37905772
ISSN: 1876-7605
CID: 5612722

Membranous Septum Length Predicts New Conduction Abnormalities in Surgical Aortic Valve Replacement: A Novel Predictor for Permanent Pacemaker Implantation After Surgical Aortic Valve Replacement

Nakashima, Makoto; Jilaihawi, Hasan; He, Yuxin; Williams, David; Pushkar, Illya; Williams, Mathew; Hisamoto, Kazuhiro
INTRODUCTION/BACKGROUND:The membranous septum (MS) length measured by cardiac computed tomography (CT) is useful for the prediction of permanent pacemaker implantation (PPMI) and new left bundle branch block (LBBB) after transcatheter aortic valve replacement. However, its predictive value for patients undergoing surgical aortic valve replacement (SAVR) is unknown. METHODS:A total of 2531 consecutive patients were registered in the institutional Society of Thoracic Surgeons database between July 2017 and June 2020. Patients who underwent non-SAVR procedures, had prior pacemaker/implantable cardioverter defibrillator, prior SAVR, no preprocedural CT assessment, or suboptimal CT imaging were excluded. RESULTS:(odds ratio: 9.165; 95% confidence interval: 1.644-51.080; P = 0.011) and MS length <1.5 mm (odds ratio: 14.449; 95% confidence interval: 1.632-127.954; P = 0.016) were independent predictors for new PPMI/LBBB. CONCLUSIONS:Short MS length on preoperative cardiac CT is a powerful and novel predictor for the risk of new PPMI/LBBB after SAVR. Special care should be taken in patients with short MS length to avoid suture-mediated trauma.
PMID: 38070251
ISSN: 1095-8673
CID: 5589792

1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study

von Bardeleben, Ralph Stephan; Mahoney, Paul; Morse, M Andrew; Price, Matthew J; Denti, Paolo; Maisano, Francesco; Rogers, Jason H; Rinaldi, Michael; De Marco, Federico; Rollefson, William; Chehab, Bassem; Williams, Mathew; Leurent, Guillaume; Asch, Federico M; Rodriguez, Evelio
BACKGROUND:The fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated. OBJECTIVES/OBJECTIVE:The aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system. METHODS:EXPAND G4 is an ongoing prospective, multicenter, international, single-arm study that enrolled subjects with primary and secondary MR. One-year outcomes included MR severity (echocardiographic core laboratory assessed), heart failure hospitalization, all-cause mortality, functional capacity (NYHA functional class), and quality of life (Kansas City Cardiomyopathy Questionnaire). RESULTS:A total of 1,164 subjects underwent M-TEER from 2020 to 2022. At 1 year, there was a durable reduction in MR to mild or less in 92.6% and to none or trace in 44.2% (P < 0.0001 vs baseline). Few subjects had major adverse events through 1 year (<2% for myocardial infarction, surgical reintervention, or single-leaflet device attachment). The 1-year Kaplan-Meier estimates for all-cause mortality and heart failure hospitalization were 12.3% and 16.9%. Significant improvements in functional capacity (NYHA functional class I or II in 82%; P < 0.0001 vs baseline) and quality of life (18.5-point Kansas City Cardiomyopathy Questionnaire overall summary score improvement; P < 0.0001) were observed. CONCLUSIONS:M-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to ≤1+ in more than 90% of patients and concomitant improvements in functional status and quality of life.
PMID: 37877913
ISSN: 1876-7605
CID: 5609762

Very Late Sinus of Valsalva Sequestration After Transcatheter Aortic Valve Implantation in Native Aortic Annuli [Case Report]

Ibrahim, Homam; Chaus, Adib; Staniloae, Cezar; Jilaihawi, Hasan; Vainrib, Alan; Alkhalil, Ahmad; Neuberger, Peter; Saric, Muhammad; Williams, Mathew
Coronary artery obstruction caused by sinus sequestration is well described after transcatheter aortic valve implantation in failed bioprosthetic valves, which usually occurs during or shortly after the transcatheter aortic valve implantation procedure. We report the presentation, management, and outcomes of 2 cases of very late sinus sequestration in native aortic annuli, which has not been described before to our knowledge. (Level of Difficulty: Advanced.).
PMID: 37954954
ISSN: 2666-0849
CID: 5611082

Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients

Madhavan, Mahesh V; Kodali, Susheel K; Thourani, Vinod H; Makkar, Raj; Mack, Michael J; Kapadia, Samir; Webb, John G; Cohen, David J; Herrmann, Howard C; Williams, Mathew; Greason, Kevin; Pibarot, Philippe; Hahn, Rebecca T; Jaber, Wael; Xu, Ke; Alu, Maria; Smith, Craig R; Leon, Martin B
BACKGROUND:Previous studies demonstrated transcatheter aortic valve replacement (TAVR) with an earlier generation balloon-expandable valve to be noninferior to surgical aortic valve replacement (SAVR) for death and disabling stroke in intermediate-risk patients with symptomatic, severe aortic stenosis at 5 years. However, limited long-term data are available with the more contemporary SAPIEN 3 (S3) bioprosthesis. OBJECTIVES:The aim of this study was to compare 5-year risk-adjusted outcomes in intermediate-risk patients undergoing S3 TAVR vs SAVR. METHODS:Propensity score matching was performed to account for baseline differences in intermediate-risk patients undergoing S3 TAVR in the PARTNER 2 (Placement of Aortic Transcatheter Valves) S3 single-arm study and SAVR in the PARTNER 2A randomized clinical trial. The primary composite endpoint consisted of 5-year all-cause death and disabling stroke. RESULTS:A total of 783 matched pairs of intermediate-risk patients with severe aortic stenosis were studied. There were no differences in the primary endpoint between S3 TAVR and SAVR at 5 years (40.2% vs 42.7%; HR: 0.87; 95% CI: 0.74-1.03; P = 0.10). The incidence of mild or greater paravalvular regurgitation was more common after S3 TAVR. There were no differences in structural valve deterioration-related stage 2 and 3 hemodynamic valve deterioration or bioprosthetic valve failure. CONCLUSIONS:In this propensity-matched analysis of intermediate-risk patients, 5-year rates of death and disabling stroke were similar between S3 TAVR and SAVR. Rates of structural valve deterioration-related hemodynamic valve deterioration were similar, but paravalvular regurgitation was more common after S3 TAVR. Longer-term follow-up is needed to further evaluate differences in late adverse clinical events and bioprosthetic valve durability. (PII S3i [PARTNER II Trial: Placement of Aortic Transcatheter Valves II - S3 Intermediate], NCT03222128; PII A (PARTNER II Trial: Placement of Aortic Transcatheter Valves II - XT Intermediate and High Risk], NCT01314313).
PMID: 37407110
ISSN: 1558-3597
CID: 5536862

Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair: 30-Day Results From EXPAND G4

von Bardeleben, Ralph Stephan; Rogers, Jason H; Mahoney, Paul; Price, Matthew J; Denti, Paolo; Maisano, Francesco; Rinaldi, Michael; Rollefson, William A; De Marco, Federico; Chehab, Bassem; Williams, Mathew R; Asch, Federico M; Rodriguez, Evelio
BACKGROUND:The fourth-generation MitraClip G4 System builds on the previous NTR/XTR system with additional wider clip sizes (NTW and XTW), an independent grasping feature, and an improved clip deployment sequence. OBJECTIVES:The primary objective of this study was to assess the safety and performance of the MitraClip G4 System within a contemporary real-world setting. METHODS:EXPAND G4 is a prospective, multicenter, international, single-arm, postapproval study that enrolled patients with primary (degenerative) mitral regurgitation (MR) and secondary (functional) MR at 60 centers. Follow-up of the full cohort has been conducted through 30 days. Echocardiograms were analyzed by an echocardiography core laboratory. Study outcomes included MR severity, functional capacity measured by NYHA functional class, quality of life measured using the Kansas City Cardiomyopathy Questionnaire, major adverse event rates, and all-cause mortality. RESULTS:In EXPAND G4, 1,141 subjects with primary MR and secondary MR were treated from March 2021 to February 2022. Implantation and acute procedural success rates were 98.0% and 96.2%, respectively, with a mean of 1.4 ± 0.6 clips implanted per subject. MR was significantly reduced at 30 days compared with baseline (98% achieved MR ≤ 2+, and 91% achieved MR ≤ 1+; P < 0.0001). Functional capacity and quality of life were substantially improved, with 83% of patients achieving NYHA functional class I or II. Likewise, an 18-point improvement was observed in Kansas City Cardiomyopathy Questionnaire summary scores compared with baseline. The composite major adverse event rate was 2.7%, and the all-cause death rate was 1.3% at 30 days. CONCLUSIONS:This study demonstrates for the first time the effectiveness and safety of MitraClip G4 System at 30 days in a cohort of >1,000 patients with MR in a contemporary, real-world setting.
PMID: 37380228
ISSN: 1876-7605
CID: 5538652

Expanding the Spectrum of TEER Suitability: Evidence From the EXPAND G4 Post Approval Study

Rogers, Jason H; Asch, Federico; Sorajja, Paul; Mahoney, Paul; Price, Matthew J; Maisano, Francesco; Denti, Paolo; Morse, Michael A; Rinaldi, Michael; Bedogni, Francesco; De Marco, Federico; Rollefson, William; Chehab, Bassem; Williams, Mathew R; Leurent, Guillaume; Morikawa, Takao; Asgar, Anita W; Rodriguez, Evelio; von Bardeleben, Ralph Stephan; Kar, Saibal
BACKGROUND:Anatomical and clinical criteria to define mitral transcatheter edge-to-edge repair (TEER) "unsuitability" have been proposed on the basis of a Heart Valve Collaboratory consensus opinion from physician experience with early-generation TEER devices but lacked an evidence-based approach. OBJECTIVES:The aim of this study was to explore the spectrum of TEER suitability using echocardiographic and clinical outcomes from the EXPAND G4 real-world postapproval study. METHODS:EXPAND G4 is a global, prospective, multicenter, single-arm study that enrolled 1,164 subjects with mitral regurgitation (MR) treated with the MitraClip G4 System. Three groups were defined using the Heart Valve Collaboratory TEER unsuitability criteria: 1) risk of stenosis (RoS); 2) risk of inadequate MR reduction (RoIR); and 3) subjects with baseline moderate or less MR (MMR). A TEER-suitable (TS) group was defined by the absence of these characteristics. Endpoints included independent core laboratory-assessed echocardiographic characteristics, procedural outcomes, MR reduction, NYHA functional class, Kansas City Cardiomyopathy Questionnaire score, and major adverse events through 30 days. RESULTS:Subjects in the RoS (n = 56), RoIR (n = 54), MMR (n = 326), and TS (n = 303) groups had high 30-day MR reduction rates (≤1+: RoS 97%, MMR 93%, and TS 91%; ≤2+: RoIR 94%). Thirty-day improvements in functional capacity (NYHA functional class I or II at 30 days vs baseline: RoS 94% vs 29%, RoIR 88% vs 30%, MMR 79% vs 26%, and TS 83% vs 33%) and quality of life (change in Kansas City Cardiomyopathy Questionnaire score: RoS +27 ± 26, RoIR +16 ± 26, MMR +19 ± 26, and TS +19 ± 24) were safely achieved in all groups, with low major adverse events (<3%) and all-cause mortality (RoS 1.8%, RoIR 0%, MMR 1.5%, and TS 1.3%). CONCLUSIONS:Patients previously deemed TEER unsuitable can be safely and effectively treated with the mitral TEER fourth-generation device.
PMID: 37380229
ISSN: 1876-7605
CID: 5538662

Economic Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Low Surgical Risk: Results from the PARTNER 3 Trial

Galper, Benjamin Z; Chinnakondepalli, Khaja M; Wang, Kaijun; Magnuson, Elizabeth A; Lu, Michael; Thourani, Vinod H; Kodali, Susheel; Makkar, Raj; Herrmann, Howard C; Kapadia, Samir; Williams, Mathew; Webb, John; Smith, Craig R; Mack, Michael J; Leon, Martin B; Cohen, David J
BACKGROUND:In patients with severe symptomatic aortic stenosis at low surgical risk, transfemoral transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve has been shown to reduce the composite of death, stroke, or rehospitalization at 2-year follow-up compared with surgical aortic valve replacement (SAVR). Whether TAVR is cost-effective compared with SAVR for low-risk patients remains uncertain. METHODS:Between 2016 and 2017, 1000 low-risk patients with aortic stenosis were randomly assigned to TAVR with the SAPIEN 3 valve or SAVR in the PARTNER 3 trial (Placement of Aortic Transcatheter Valves). Of these patients, 929 underwent valve replacement, were enrolled in the United States, and were included in the economic substudy. Procedural costs were estimated using measured resource use. Other costs were determined by linkage with Medicare claims or by regression models when linkage was not feasible. Health utilities were estimated using the EuroQOL 5-item questionnaire. With the use of a Markov model informed by in-trial data, lifetime cost-effectiveness from the perspective of the US health care system was estimated in terms of cost per quality-adjusted life-year gained. RESULTS:Although procedural costs were nearly $19 000 higher with TAVR, total index hospitalization costs were only $591 more with TAVR compared with SAVR. Follow-up costs were lower with TAVR such that TAVR led to 2-year cost savings of $2030/patient compared with SAVR (95% CI, -$6222 to $1816) and a gain of 0.05 quality-adjusted life-years (95% CI, -0.003 to 0.102). In our base-case analysis, TAVR was projected to be an economically dominant strategy with a 95% probability that the incremental cost-effectiveness ratio for TAVR would be <$50 000/quality-adjusted life-year gained (consistent with high economic value from a US health care perspective). These findings were sensitive to differences in long-term survival, however, such that a modest long-term survival advantage with SAVR would render SAVR cost-effective (although not cost saving) compared with TAVR. CONCLUSIONS:For patients with severe aortic stenosis and low surgical risk similar to those enrolled in the PARTNER 3 trial, transfemoral TAVR with the SAPIEN 3 valve is cost saving compared with SAVR at 2 years and is projected to be economically attractive in the long run as long as there are no substantial differences in late death between the 2 strategies. Long-term follow-up will be critical to ultimately determine the preferred treatment strategy for low-risk patients from both a clinical and economic perspective.
PMID: 37154049
ISSN: 1524-4539
CID: 5507932