Publications by authors named "Michael J Mack"

493 Publications

Impact of stent length and diameter on 10-year mortality in the SYNTAXES trial.

Catheter Cardiovasc Interv 2021 May 5. Epub 2021 May 5.

Department of Cardiology, National University of Ireland, Galway (NUIG), Galway.

Objectives: We investigated the impact of total stent length (TSL) and average nominal stent diameter (ASD) on 10-year mortality after percutaneous coronary intervention (PCI) in the SYNTAXES trial.

Background: TSL and ASD in patients treated with PCI are associated with major adverse cardiovascular events. However, the treatment effect of PCI with extensive and/or small stenting as compared with coronary artery bypass grafting (CABG) for complex coronary artery disease has not been fully evaluated.

Methods: Impacts on mortality of extensive stenting defined as TSL >100 mm and small stenting as ASD <3 mm were analyzed in 893 PCI patients and were compared to 865 CABG patients.

Results: TSL as a continuous variable was significantly associated with 10-year mortality (adjusted hazard ratio [HR], 1.05 [1.01-1.09] per 10 mm increase). PCI patients with extensive stenting had a higher 10 year mortality than CABG patients (adjusted HR, 1.97 [1.41-2.74]) or not- extensive stenting PCI (adjusted HR, 1.94 [1.36-2.77]). Although ASD did not have a significant association with 10 year mortality (adjusted HR, 0.97 [0.85-1.11] per 0.25 mm increase), PCI with small stents was associated with a higher 10 year mortality, compared to CABG (adjusted HR, 1.66 [1.23-2.26]) and PCI performed with large stents (adjusted HR, 1.74 [1.19-2.53]). Patients treated with not-extensive and large stents had similar mortality rates (24.0 versus 23.8%) as those treated with CABG.

Conclusions: Extensive and small stenting were associated with higher 10 year mortality, compared with CABG. When patients have to be treated with extensive or small stenting, revascularization with CABG should be preferred.
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http://dx.doi.org/10.1002/ccd.29721DOI Listing
May 2021

Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research.

J Am Coll Cardiol 2021 Apr 15. Epub 2021 Apr 15.

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York, USA. Electronic address:

Aims: The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Methods And Results: Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs.

Conclusions: Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.
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http://dx.doi.org/10.1016/j.jacc.2021.02.038DOI Listing
April 2021

Effect of Mitral Valve Gradient After MitraClip on Outcomes in Secondary Mitral Regurgitation: Results From the COAPT Trial.

JACC Cardiovasc Interv 2021 Apr;14(8):879-889

Cardiovascular Research Foundation, New York, New York, USA; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: https://twitter.com/GreggWStone.

Objectives: The authors sought to evaluate the association between mean mitral valve gradient (MVG) and clinical outcomes among patients who underwent MitraClip treatment for secondary mitral regurgitation (SMR) in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial.

Background: In the COAPT trial, patients with heart failure (HF) and severe SMR who remained symptomatic despite guideline-directed medical therapy had marked 2-year reductions in mortality and HF hospitalizations after treatment with MitraClip.

Methods: MitraClip-treated patients were divided into quartiles (Q) based on discharge echocardiographic MVG (n = 250). Endpoints including all-cause mortality, HF hospitalization, and health status measures at 2 years were compared between quartiles.

Results: Mean MVG after MitraClip was 2.1 ± 0.4 mm Hg, 3.0 ± 0.2 mm Hg, 4.2 ± 0.5 mm Hg, and 7.2 ± 2.0 mm Hg in Q1 (n = 63), Q2 (n = 61), Q3 (n = 62), and Q4 (n = 64), respectively. There was no difference across quartiles in the 2-year composite endpoint of all-cause mortality or HF hospitalization (43.2%, 49.2%, 40.6%, and 40.9%, respectively; p = 0.80), nor in improvements in New York Heart Association functional class, Kansas City Cardiomyopathy Questionnaire score, or 6-min walk time. Results were similar after adjustment for baseline clinical and echocardiographic characteristics, post-procedure MR grade, and number of clips (all-cause mortality or HF hospitalization Q4 [44.6%] vs. Q1 to Q3 [40.3%]; adjusted hazard ratio: 1.23, 95% confidence interval: 0.60 to 2.51; p = 0.57).

Conclusions: Among HF patients with severe SMR, higher MVGs on discharge did not adversely affect clinical outcomes following MitraClip. These findings suggest that in select patients with HF and SMR otherwise meeting the COAPT inclusion criteria, the benefits of MR reduction may outweigh the effects of mild-to-moderate mitral stenosis after MitraClip.
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http://dx.doi.org/10.1016/j.jcin.2021.01.049DOI Listing
April 2021

Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research.

Eur Heart J 2021 May;42(19):1825-1857

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, NY, USA.

Aims : The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Methods And Results : Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs.

Conclusions : Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.
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http://dx.doi.org/10.1093/eurheartj/ehaa799DOI Listing
May 2021

Left Ventricular Global Longitudinal Strain as a Predictor of Outcomes in Patients with Heart Failure with Secondary Mitral Regurgitation: The COAPT Trial.

J Am Soc Echocardiogr 2021 May 8. Epub 2021 May 8.

MedStar Health Research Institute, Washington, District of Columbia; Georgetown University, Washington, District of Columbia. Electronic address:

Background: Left ventricular (LV) global longitudinal strain (GLS) is a sensitive marker of LV function and may help identify patients with heart failure (HF) and secondary mitral regurgitation who would have a better prognosis and are more likely to benefit from edge-to-edge transcatheter mitral valve repair with the MitraClip. The aim of this study was to assess the prognostic utility of baseline LV GLS during 2-year follow-up of patients with HF with secondary mitral regurgitation enrolled in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation trial.

Methods: Patients with symptomatic HF with moderate to severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT) were randomized to transcatheter mitral valve repair plus GDMT or GDMT alone. Speckle-tracking-derived LV GLS from baseline echocardiograms was obtained in 565 patients and categorized in tertiles. Death and HF hospitalization at 2-year follow-up were the principal outcomes of interest.

Results: Patients with better baseline LV GLS had higher blood pressure, greater LV ejection fraction and stroke volume, lower levels of B-type natriuretic peptide, and smaller LV size. No significant difference in outcomes at 2-year follow-up were noted according to LV GLS. However, the rate of death or HF hospitalization between 10 and 24 months was lower in patients with better LV GLS (P = .03), with no differences before 10 months. There was no interaction between GLS tertile and treatment group with respect to 2-year clinical outcomes.

Conclusions: Baseline LV GLS did not predict death or HF hospitalization throughout 2-year follow-up, but it did predict outcomes after 10 months. The benefit of transcatheter mitral valve repair over GDMT alone was consistent in all subgroups irrespective of baseline LV GLS.
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http://dx.doi.org/10.1016/j.echo.2021.04.003DOI Listing
May 2021

Impact of chronic obstructive pulmonary disease on 10-year mortality after percutaneous coronary intervention and bypass surgery for complex coronary artery disease: insights from the SYNTAX Extended Survival study.

Clin Res Cardiol 2021 Mar 12. Epub 2021 Mar 12.

Department of Cardiology, National University of Ireland, Galway (NUIG), P.O. University Road, Galway, H91 TK33, Ireland.

Aims: To evaluate the impact of chronic obstructive pulmonary disease (COPD) on 10-year all-cause death and the treatment effect of CABG versus PCI on 10-year all-cause death in patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) and COPD.

Methods: Patients were stratified according to COPD status and compared with regard to clinical outcomes. Ten-year all-cause death was examined according to the presence of COPD and the revascularization strategy.

Results: COPD status was available for all randomized 1800 patients, of whom, 154 had COPD (8.6%) at the time of randomization. Regardless of the revascularization strategy, patients with COPD had a higher risk of 10-year all-cause death, compared with those without COPD (43.1% vs. 24.9%; hazard ratio [HR]: 2.03; 95% confidence interval [CI]: 1.56-2.64; p < 0.001). Among patients with COPD, CABG appeared to have a slightly lower risk of 10-year all-cause death compared with PCI (42.3% vs. 43.9%; HR: 0.96; 95% CI: 0.59-1.56, p = 0.858), whereas among those without COPD, CABG had a significantly lower risk of 10-year all-cause death (22.7% vs. 27.1%; HR: 0.81; 95% CI: 0.67-0.99, p = 0.041). There was no significant differential treatment effect of CABG versus PCI on 10-year all-cause death between patients with and without COPD (p  = 0.544).

Conclusions: COPD was associated with a higher risk of 10-year all-cause death after revascularization for complex coronary artery disease. The presence of COPD did not significantly modify the beneficial effect of CABG versus PCI on 10-year all-cause death.

Trial Registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.
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http://dx.doi.org/10.1007/s00392-021-01833-yDOI Listing
March 2021

Atrial Fibrillation and Outcomes After Transcatheter or Surgical Aortic Valve Replacement (from the PARTNER 3 Trial).

Am J Cardiol 2021 Jun 7;148:116-123. Epub 2021 Mar 7.

Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York. Electronic address:

The prognostic impact of preexisting atrial fibrillation or flutter (AF) in low-risk patients with severe aortic stenosis treated with transcatheter (TAVR) or surgical aortic valve replacement (SAVR) remains unknown. In this sub-analysis of the PARTNER 3 trial of patients with severe aortic stenosis at low surgical risk randomized 1:1 to TAVR versus SAVR, clinical outcomes were analyzed at 2 years according to AF status. Among 948 patients included in the analysis (452 [47.7%] in the SAVR vs 496 [52.3%] in the TAVR arm), 168 (17.6%) patients had AF [88/452 (19.5%) and 80/496 (16.1%) treated with SAVR and TAVR, respectively]. At 2 years, patients with AF had higher unadjusted rates of the composite outcome of death, stroke or rehospitalization (21.2% vs 12.9%, p = 0.007) and rehospitalization alone (15.3% vs 9.4%, p = 0.03) but not all cause death (3.8% vs 2.6%, p = 0.45) or stroke (4.8% vs 2.6%, p = 0.12). In adjusted analyses, patients with AF had a higher risk for the composite outcome of death, stroke or rehospitalization (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.20-2.71, p = 0.0046) and rehospitalization alone (HR 1.8, 95% CI 0.12-2.9, p = 0.015), but not death or stroke. There was no interaction between treatment modality and AF on the composite outcome (Pinter = 0.83). In conclusion, preexisting AF in patients with severe AS at low surgical risk was associated with increased risk of the composite outcome of death, stroke or rehospitalization at 2 years, irrespective of treatment modality.
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http://dx.doi.org/10.1016/j.amjcard.2021.02.040DOI Listing
June 2021

Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk.

J Am Coll Cardiol 2021 Mar;77(9):1149-1161

Department of Medicine, Laval University, Quebec, Quebec, Canada.

Background: In low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year.

Objectives: This study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial.

Methods: This study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis.

Results: Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years.

Conclusions: At 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114).
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http://dx.doi.org/10.1016/j.jacc.2020.12.052DOI Listing
March 2021

3-Year Outcomes of Transcatheter Mitral Valve Repair in Patients With Heart Failure.

J Am Coll Cardiol 2021 Mar;77(8):1029-1040

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai and Cardiovascular Research Foundation, New York, New York, USA. Electronic address: https://twitter.com/GreggWStone.

Background: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) resulted in fewer heart failure hospitalizations (HFHs) and lower mortality at 24 months in patients with heart failure (HF) with mitral regurgitation (MR) secondary to left ventricular dysfunction compared with guideline-directed medical therapy (GDMT) alone.

Objectives: This study determined if these benefits persisted to 36 months and if control subjects who were allowed to cross over at 24 months derived similar benefit.

Methods: This study randomized 614 patients with HF with moderate-to-severe or severe secondary MR, who remained symptomatic despite maximally tolerated GDMT, to TMVr plus GDMT versus GDMT alone. The primary effectiveness endpoint was all HFHs through 24-month follow-up. Patients have now been followed for 36 months.

Results: The annualized rates of HFHs per patient-year were 35.5% with TMVr and 68.8% with GDMT alone (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.37 to 0.63; p < 0.001; number needed to treat (NNT) = 3.0; 95% CI: 2.4 to 4.0). Mortality occurred in 42.8% of the device group versus 55.5% of control group (HR: 0.67; 95% CI: 0.52 to 0.85; p = 0.001; NNT = 7.9; 95% CI: 4.6 to 26.1). Patients who underwent TMVr also had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity. Among 58 patients assigned to GDMT alone who crossed over and were treated with TMVr, the subsequent composite rate of mortality or HFH was reduced compared with those who continued on GDMT alone (adjusted HR: 0.43; 95% CI: 0.24 to 0.78; p = 0.006).

Conclusions: Among patients with HF and moderate-to-severe or severe secondary MR who remained symptomatic despite GDMT, TMVr was safe, provided a durable reduction in MR, reduced the rate of HFH, and improved survival, quality of life, and functional capacity compared with GDMT alone through 36 months. Surviving patients who crossed over to device treatment had a prognosis comparable to those originally assigned to transcatheter therapy. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation [COAPT]; NCT01626079).
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http://dx.doi.org/10.1016/j.jacc.2020.12.047DOI Listing
March 2021

Ten-year all-cause mortality according to smoking status in patients with severe coronary artery disease undergoing surgical or percutaneous revascularization.

Eur J Prev Cardiol 2020 Nov 30. Epub 2020 Nov 30.

Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.

Aims: To evaluate the impact of various smoking status on 10-year all-cause mortality and to examine a relative treatment benefit of coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) according to smoking habits.

Methods And Results: The SYNTAX Extended Survival study evaluated vital status up to 10 years in 1800 patients with de novo three-vessel disease and/or left main coronary artery disease randomized to CABG or PCI in the SYNTAX trial. In the present analysis, patients were divided into three groups (current, former, or never smokers), and the primary endpoint of 10-year all-cause mortality was assessed according to smoking status. Smoking status was available in 1793 (99.6%) patients at the time of randomization, of whom 363 were current smokers, 798 were former smokers, and 632 were never smokers. The crude rates of 10-year all-cause mortality were 29.7% in current smokers, 25.3% in former smokers, and 25.9% in never smokers (Log-rank P = 0.343). After adjustment for imbalances in baseline characteristics, current smokers had a significantly higher risk of 10-year all-cause mortality than never smokers [adjusted hazard ratio (aHR): 2.29; 95% confidence interval (CI): 1.60-3.27; P < 0.001], whereas former smokers did not. PCI was associated with a higher risk of all-cause mortality than CABG among current smokers (HR: 1.60; 95% CI: 1.09-2.35; P = 0.017), but it failed to show a significant interaction between revascularization strategies and smoking status (Pinteraction = 0.910).

Conclusion: Current smokers had a higher adjusted risk of 10-year all-cause mortality, whereas former smokers did not. The treatment effect of CABG vs. PCI did not differ significantly according to smoking status.

Clinical Trial Registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972; SYNTAX Extended Survival. ClinicalTrials.gov reference: NCT03417050.
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http://dx.doi.org/10.1093/eurjpc/zwaa089DOI Listing
November 2020

Practical Application of Patient-Reported Health Status Measures for Transcatheter Valve Therapies: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry.

Circ Cardiovasc Qual Outcomes 2021 Mar 18;14(3):e007187. Epub 2021 Feb 18.

Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, Kansas City, MO (V.H., A.O.M., J.A.S., S.V.A.).

Background: Health status assessment is essential for documenting the benefit of transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve repair on patients' symptoms, function, and quality of life. Health status can also be a powerful marker for subsequent clinical outcomes, but its prognostic importance around the time of both TAVR and transcatheter mitral valve repair has not been fully defined.

Methods: Among 73 699 patients who underwent transfemoral TAVR or transcatheter mitral valve repair between 2011 and 2018 (mean age, 81.9±7.0 years, 53% men, 92% TAVR), we constructed sequential models examining the association of health status (as assessed with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Score; KCCQ-OS) at baseline, 30 days, change from baseline to 30 days, and combinations of these assessments with death and heart failure (HF) hospitalization from 30 days to 1 year.

Results: Although higher baseline KCCQ-OS and 30-day KCCQ-OS scores were each associated with lower risk of death and HF hospitalization (in individual models and in a model including both measures), the 30-day KCCQ-OS was most predictive (death: hazard ratio, 0.89 per 5-point increase [95% CI, 0.89-0.90]; HF hospitalization: hazard ratio, 0.91 [95% CI, 0.90-0.91]). The 30-day KCCQ-OS also was most predictive when included in a separate model with change in KCCQ from baseline to 30 days. Similar findings were noted for the outcomes of death and of HF hospitalization, unadjusted and adjusted for patient factors. All interaction terms between procedure type and KCCQ were not significant, suggesting that health status provided similar prognostic information in both procedures.

Conclusions: The patient's assessment of their health status immediately before and 30 days after TAVR and transcatheter mitral valve repair is associated with subsequent risk of death and HF hospitalization, with the 30-day assessment being most strongly associated with outcomes. Our findings support the routine use of KCCQ data as a prognostic tool.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007187DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982132PMC
March 2021

Outcomes of Transcatheter Mitral Valve Repair for Secondary Mitral Regurgitation by Severity of Left Ventricular Dysfunction.

EuroIntervention 2021 Feb 16. Epub 2021 Feb 16.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Background: In the COAPT trial, transcatheter mitral valve repair with MitraClip plus maximally-tolerated guideline-directed medical therapy (GDMT) improved clinical outcomes compared with GDMT alone in symptomatic patients with heart failure (HF) and 3+ or 4+ secondary mitral regurgitation (SMR) due to left ventricular (LV) dysfunction.

Aims: In this COAPT substudy we sought to evaluate 2-year outcomes in HF patients with reduced LV ejection fraction (HFrEF; LVEF £40%) versus preserved LVEF (HFpEF; LVEF >40%) and in those with severe (LVEF £30%) versus moderate (LVEF >30%) LV dysfunction.

Methods: The principal effectiveness outcome was the 2-year rate of death from any cause or HF hospitalizations (HFH). Subgroup analysis with interaction testing performed according to baseline LVEF; 472 patients (82.1%) had HFrEF (mean LVEF 28.0%±6.2%; range 12% to 40%) and 103 (17.9%) had HFpEF (mean LVEF 46.6%±4.9%; range 41% to 65%), while 292 (50.7%) had severely depressed LVEF (LVEF ≤30%; mean LVEF 23.9% ± 3.8%) and 283 (49.3%) had moderately depressed LVEF (LVEF >30%; mean LVEF 39.0% ± 6.8%).

Results: The 2-year rate of death or HFH was 56.7% in patients with HFrEF and 53.4% with HFpEF (HR 1.16, 95%CI 0.86-1.57, p=0.32). MitraClip reduced the 2-year rate of death or HFH in patients with HFrEF (HR 0.50, 95%CI 0.39-0.65) and HFpEF (HR 0.60, 95%CI 0.35-1.05), pint=0.55. MitraClip was consistently effective in reducing the individual endpoints of mortality and HFH, improving MR severity, quality-of-life, and 6-minute walk distance in patients with HFrEF, HFpEF, LVEF <30%, and LVEF >30%.

Conclusions: In the COAPT trial, among patients with HF and 3+ or 4+ SMR who remained symptomatic despite maximally-tolerated GDMT, MitraClip was consistently effective in improving survival and health status in patients with severe and moderate LV dysfunction and preserved LVEF.
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http://dx.doi.org/10.4244/EIJ-D-20-01265DOI Listing
February 2021

Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience.

JACC Cardiovasc Interv 2021 Mar 10;14(5):501-511. Epub 2021 Feb 10.

St. Paul's Hospital, Centre for Heart Valve Innovation, University of British Columbia, Vancouver, British Columbia, Canada.

Objectives: The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes.

Background: Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population.

Methods: Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up.

Results: All patients (mean age 76 ± 3 years, 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score 9.1 ± 2.3%), with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 ± 7.8 mm and mean tricuspid annular plane systolic excursion of 16 ± 2 mm. Technical success was 92%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was ≤2+ in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis.

Conclusions: This first-in-human experience evaluating EVOQUE TTVR demonstrated high technical success, acceptable safety, and significant clinical improvement. Larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes.
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http://dx.doi.org/10.1016/j.jcin.2020.11.045DOI Listing
March 2021

Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation.

J Am Coll Cardiol 2021 Feb;77(6):713-724

Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts, USA.

Background: Whether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain.

Objectives: The goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery.

Methods: Patients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years.

Results: Patients' mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04).

Conclusions: After IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040).
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http://dx.doi.org/10.1016/j.jacc.2020.11.066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7953587PMC
February 2021

Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions.

J Am Coll Cardiol 2021 Feb;77(5):529-540

Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.

Background: The long-term clinical benefit after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with total occlusions (TOs) and complex coronary artery disease has not yet been clarified.

Objectives: The objective of this analysis was to assess 10-year all-cause mortality in patients with TOs undergoing PCI or CABG.

Methods: This is a subanalysis of patients with at least 1 TO in the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which investigated 10-year all-cause mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial, beyond its original 5-year follow-up. Patients with TOs were further stratified according to the status of TO recanalization or revascularization.

Results: Of 1,800 randomized patients to the PCI or CABG arm, 460 patients had at least 1 lesion of TO. In patients with TOs, the status of TO recanalization or revascularization was not associated with 10-year all-cause mortality, irrespective of the assigned treatment (PCI arm: 29.9% vs. 29.4%; adjusted hazard ratio [HR]: 0.992; 95% confidence interval [CI]: 0.474 to 2.075; p = 0.982; and CABG arm: 28.0% vs. 21.4%; adjusted HR: 0.656; 95% CI: 0.281 to 1.533; p = 0.330). When TOs existed in left main and/or left anterior descending artery, the status of TO recanalization or revascularization did not have an impact on the mortality (34.5% vs. 26.9%; adjusted HR: 0.896; 95% CI: 0.314 to 2.555; p = 0.837).

Conclusions: At 10-year follow-up, the status of TO recanalization or revascularization did not affect mortality, irrespective of the assigned treatment and location of TOs. The present study might support contemporary practice among high-volume chronic TO-PCI centers where recanalization is primarily offered to patients for the management of angina refractory to medical therapy when myocardial viability is confirmed. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).
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February 2021

Association of Effective Regurgitation Orifice Area to Left Ventricular End-Diastolic Volume Ratio With Transcatheter Mitral Valve Repair Outcomes: A Secondary Analysis of the COAPT Trial.

JAMA Cardiol 2021 Apr;6(4):427-436

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.

Importance: Transcatheter mitral valve repair (TMVr) plus maximally tolerated guideline-directed medical therapy (GDMT) reduced heart failure (HF) hospitalizations (HFHs) and all-cause mortality (ACM) in symptomatic patients with HF and secondary mitral regurgitation (SMR) compared with GDMT alone in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial but not in a similar trial, Multicenter Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR), possibly because the degree of SMR relative to the left ventricular end-diastolic volume index (LVEDVi) was substantially lower.

Objective: To explore contributions of the degree of SMR using the effective regurgitation orifice area (EROA), regurgitant volume (RV), and LVEDVi to the benefit of TMVr in the COAPT trial.

Design, Setting, And Participants: This post hoc secondary analysis of the COAPT randomized clinical trial performed December 27, 2012, to June 23, 2017, evaluated a subgroup of COAPT patients (group 1) with characteristics consistent with patients enrolled in MITRA-FR (n = 56) (HF with grade 3+ to 4+ SMR, left ventricular ejection fraction of 20%-50%, and New York Heart Association function class II-IV) compared with remaining (group 2) COAPT patients (n = 492) using the end point of ACM or HFH at 24 months, components of the primary end point, and quality of life (QOL) (per the Kansas City Cardiomyopathy Questionnaire overall summary score) and 6-minute walk distance (6MWD). The same end points were evaluated in 6 subgroups of COAPT by combinations of EROA and LVEDVi and of RV relative to LVEDVi.

Interventions: Interventions were TMVr plus GDMT vs GDMT alone.

Results: A total of 548 participants (mean [SD] age, 71.9 [11.2] years; 351 [64%] male) were included. In group 1, no significant difference was found in the composite rate of ACM or HFH between TMVr plus GDMT vs GDMT alone at 24 months (27.8% vs 33.1%, P = .83) compared with a significant difference at 24 months (31.5% vs 50.2%, P < .001) in group 2. However, patients randomized to receive TMVr vs those treated with GDMT alone had significantly greater improvement in QOL at 12 months (mean [SD] Kansas City Cardiomyopathy Questionnaire summary scores: group 1: 18.36 [5.38] vs 0.43 [4.00] points; P = .01; group 2: 16.54 [1.57] vs 5.78 [1.82] points; P < .001). Group 1 TMVr-randomized patients vs those treated with GDMT alone also had significantly greater improvement in 6MWD at 12 months (mean [SD] paired improvement: 39.0 [28.6] vs -48.0 [18.6] m; P = .02). Group 2 TMVr-randomized patients vs those treated with GDMT alone tended to have greater improvement in 6MWD at 12 months, but the difference did not reach statistical significance (mean [SD] paired improvement: 35.0 [7.7] vs 16.0 [9.1] m; P = .11).

Conclusions And Relevance: A small subgroup of COAPT-resembling patients enrolled in MITRA-FR did not achieve improvement in ACM or HFH at 24 months but had a significant benefit on patient-centered outcomes (eg, QOL and 6MWD). Further subgroup analyses with 24-month follow-up suggest that the benefit of TMVr is not fully supported by the proportionate-disproportionate hypothesis.

Trial Registration: ClinicalTrials.gov Identifier: NCT01626079.
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http://dx.doi.org/10.1001/jamacardio.2020.7200DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7859876PMC
April 2021

Ten-year all-cause death following percutaneous or surgical revascularization in patients with prior cerebrovascular disease: insights from the SYNTAX Extended Survival study.

Clin Res Cardiol 2021 Jan 30. Epub 2021 Jan 30.

Department of Cardiology, National University of Ireland Galway, University Road, Galway, H91 TK33, Ireland.

Background: Coronary bypass artery grafting (CABG) has a higher procedural risk of stroke than percutaneous coronary intervention (PCI), but may offer better long-term survival. The optimal revascularization strategy for patients with prior cerebrovascular disease (CEVD) remains unclear.

Methods And Results: The SYNTAXES study assessed the vital status out to 10 year of patients with three-vessel disease and/or left main coronary artery disease enrolled in the SYNTAX trial. The relative efficacy of PCI vs. CABG in terms of 10 year all-cause death was assessed according to prior CEVD. The primary endpoint was 10 year all-cause death. The status of prior CEVD was available in 1791 (99.5%) patients, of whom 253 patients had prior CEVD. Patients with prior CEVD were older and had more comorbidities (medically treated diabetes, insulin-dependent diabetes, metabolic syndrome, peripheral vascular disease, chronic obstructive pulmonary disease, impaired renal function, and congestive heart failure), compared with those without prior CEVD. Prior CEVD was an independent predictor of 10 year all-cause death (adjusted HR: 1.35; 95% CI: 1.04-1.73; p = 0.021). Patients with prior CEVD had a significantly higher risk of 10 year all-cause death (41.1 vs. 24.1%; HR: 1.92; 95% CI: 1.54-2.40; p < 0.001). The risk of 10 year all-cause death was similar between patients receiving PCI or CABG irrespective of the presence of prior CEVD (p = 0.624).

Conclusion: Prior CEVD was associated with a significantly increased risk of 10 year all-cause death which was similar in patients treated with PCI or CABG. These results do not support preferential referral for PCI rather than CABG in patients with prior CEVD.

Trial Registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.
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http://dx.doi.org/10.1007/s00392-020-01802-xDOI Listing
January 2021

Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation.

J Am Coll Cardiol 2021 Feb;77(4):345-356

Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.

Background: Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options.

Objectives: This is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR.

Methods: Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints.

Results: Of the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001).

Conclusions: In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313).
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http://dx.doi.org/10.1016/j.jacc.2020.11.047DOI Listing
February 2021

The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on Transcatheter and Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of Randomized and Propensity-Matched Studies.

Innovations (Phila) 2021 Jan-Feb;16(1):3-16. Epub 2021 Jan 25.

12264 Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, MD, USA.

Objective: There is an increasing amount of evidence supporting use of transcatheter aortic valve replacement (TAVR) for treatment of aortic stenosis in patients at low or intermediate risk for surgical aortic valve replacement (SAVR). TAVR is now approved for use in all patient cohorts. Despite this, there remains debate about the relative efficacy of TAVR compared with SAVR in lower-risk cohorts and various subgroups of patients. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and propensity-matched trials to guide a consensus among expert cardiologists and surgeons.

Methods: Studies comparing TAVR and SAVR in low- and intermediate-risk patients were identified by a thorough search of the major databases. Mortality, stroke, and other perioperative outcomes were assessed at 30 days and 1 year.

Results: Early mortality was lower in TAVR compared to SAVR in RCTs, but not propensity-matched studies in low-risk cohorts (0.66% vs 1.5%; odds ratio [OR] = 0.44, 95% confidence interval [CI] 0.20 to 0.98, = 0%). No difference in mortality between TAVR and SAVR was identified in intermediate-risk patients at early or later time points. Incidence of perioperative stroke in 3 low-risk RCTs was significantly lower in TAVR (0.4%) than SAVR (1.4%; OR = 0.33, 95% CI 0.13 to 0.81, = 0%). There was no difference in stroke for intermediate-risk patients between TAVR and SAVR. The expert panel of cardiologists and cardiac surgeons provided recommendations for TAVR and SAVR in various clinical scenarios.

Conclusions: In RCTs comparing TAVR and SAVR in low-risk patients, early mortality and stroke were lower in TAVR, but did not differ at 1 year. There was no difference in mortality and stroke in intermediate-risk patients. The Multidisciplinary Heart Team must consider individual patient characteristics and preferences when recommending TAVR or SAVR. The decision must consider the long-term management of each patient's aortic valve disease.
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http://dx.doi.org/10.1177/1556984520978316DOI Listing
January 2021

Safe implementation of enhanced recovery after surgery protocol in transfemoral transcatheter aortic valve replacement.

Proc (Bayl Univ Med Cent) 2020 Sep 23;34(1):5-10. Epub 2020 Sep 23.

Cardiovascular Research Department, Baylor Scott and White The Heart Hospital, Plano, Texas.

Enhanced recovery after surgery (ERAS) protocols are gaining wide acceptance. We evaluated ERAS protocol implementation in transfemoral transcatheter aortic valve replacement (TAVR) patients. The ERAS protocol included (1) moderate sedation or general anesthesia with on-table extubation, (2) no pulmonary artery or urinary catheters, (3) arterial line removal within 4 hours, (4) no postoperative narcotics, (5) mobilization at 4 hours and ambulation within 8 hours, and (6) antihypertensive reinstitution without nodal blockers. Patients who received TAVR before and after ERAS implementation were compared (N = 121 and N = 368, respectively). The primary endpoint was total hospital length of stay (LOS). ERAS patients had a lower mean Society of Thoracic Surgeons predicted risk of mortality (6.7% vs 7.5%;  = 0.04). Unadjusted analysis demonstrated that ERAS was associated with significantly decreased mean LOS (2.8 vs 4.0 days,  <  0.001), decreased 30-day mortality (0.8% vs 5.0%;  = 0.003), and increased discharge home (90.2% vs 79.3%,  = 0.002) with no increase in 30-day readmission (11.1% vs 14.0%,  = 0.39). After risk adjustment, ERAS patients had a 1.87-day shorter LOS ( = 0.001) and trended toward increased discharge home (odds ratio 1.76,  = 0.078) without increased readmission (odds ratio 0.74,  = 0.4). An ERAS protocol for TAVR is safe and is associated with shorter LOS without increased readmission.
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http://dx.doi.org/10.1080/08998280.2020.1810198DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785172PMC
September 2020

First in human experience with an epicardial beating heart device for secondary mitral regurgitation.

J Thorac Cardiovasc Surg 2021 Mar 14;161(3):949-958.e4. Epub 2020 Dec 14.

Baylor Scott & White Heart and Vascular Hospital, Plano, Tex.

Objective: We describe a novel, off-pump, epicardial implant that is intended to reshape both the mitral valve annulus and the left ventricle (LV) in those with secondary mitral regurgitation (MR).

Methods: Five patients underwent an epicardial implant with the Mitral Touch device (Mitre Medical Corp, Morgan Hill, Calif), during concomitant off-pump coronary artery bypass for secondary MR. The median age was 71.2 years; 4 patients had severe MR and 1 moderate. Patients were followed for 1 year with transthoracic echocardiography and computed tomography. Safety, cardiac remodeling, and MR were assessed by an independent core laboratory.

Results: One patient died within 30 days from nondevice-related organ failure and the remaining 4 survived through 1-year follow-up. Implant technical success was 100% and took an average of 52 minutes. Paired computed tomography showed mean left ventricular end-systolic volume remodeling at 1 and 12 months of -35% and -31%, respectively. They averaged left atrial end-systolic volume remodeling of -12% and -15% at 1 and 12 months. Right ventricular end-systolic volume changes of -19% and -8% and right atrial end-systolic volume remodeling of -5% and 1%, at the 1- and 12-month time points were noted. Regurgitant volume by transthoracic echocardiography decreased by 46% and 44% and the ejection fraction from 34.6% to 32.1% and 39.5%, at 1 and 12 months, respectively. There were no device-related complications reported to 1 year.

Conclusions: The Epicardial Mitral Touch System for Mitral Regurgitation (ENRAPT-MR) study demonstrates a first-in-man, off-pump, epicardial repair of secondary MR. Procedural safety and geometric correction of the mitral valve apparatus and LV was achieved. Further studies in the United States are underway.
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http://dx.doi.org/10.1016/j.jtcvs.2020.11.169DOI Listing
March 2021

Impact of COPD on Outcomes After MitraClip for Secondary Mitral Regurgitation: The COAPT Trial.

JACC Cardiovasc Interv 2020 12;13(23):2795-2803

Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address:

Objectives: The aim of this study was to examine the relationship between chronic obstructive pulmonary disease (COPD) and outcomes after transcatheter mitral valve repair (TMVr) for severe secondary mitral regurgitation.

Background: TMVr with the MitraClip improves clinical and health-status outcomes in patients with heart failure and severe (3+ to 4+) secondary mitral regurgitation. Whether these benefits are modified by COPD is unknown.

Methods: COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) was an open-label, multicenter, randomized trial of TMVr plus guideline-directed medical therapy (GDMT) versus GDMT alone. Patients on corticosteroids or continuous oxygen were excluded. Multivariable models were used to examine the associations of COPD with mortality, heart failure hospitalization (HFH), and health status and to test whether COPD modified the benefit of TMVr compared with GDMT.

Results: Among 614 patients, 143 (23.2%) had COPD. Among patients treated with TMVr, unadjusted analyses demonstrated increased 2-year mortality in those with COPD (hazard ratio [HR]: 2.08; 95% confidence interval [CI]: 1.33 to 3.26), but this association was attenuated after risk adjustment (adjusted HR: 1.48; 95% CI: 0.87 to 2.52). Although TMVr led to reduced 2-year mortality among patients without COPD (adjusted HR: 0.47; 95% CI: 0.33 to 0.67), for patients with COPD, 2-year all-cause mortality was similar after TMVr versus GDMT alone (adjusted HR: 0.94; 95% CI: 0.54 to 1.65; p = 0.04), findings that reflect offsetting effects on cardiovascular and noncardiovascular mortality. In contrast, TMVr reduced HFH (adjusted HR: 0.48 [95% CI: 0.28 to 0.83] vs. 0.46 [95% CI: 0.34 to 0.63]; p = 0.89) and improved both generic and disease-specific health status to a similar extent compared with GDMT alone in patients with and without COPD (p >0.30 for all scales).

Conclusions: In the COAPT trial, COPD was associated with attenuation of the survival benefit of TMVr versus GDMT compared with patients without COPD. However, the benefits of TMVr on both HFH and health status were similar regardless of COPD. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).
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http://dx.doi.org/10.1016/j.jcin.2020.09.023DOI Listing
December 2020

A system-wide extracorporeal membrane oxygenation quality collaborative improves patient outcomes.

J Thorac Cardiovasc Surg 2020 Oct 27. Epub 2020 Oct 27.

Baylor University Medical Center, Baylor Scott & White Health, Dallas, Tex. Electronic address:

Objective: Extracorporeal membrane oxygenation (ECMO) use in adult patient populations has grown rapidly with wide variation in practices and outcomes. We evaluated the impact on patient outcomes, resource use, and costs of an initiative to coordinate and standardize best practices across ECMO programs within a large integrated health care system.

Methods: The ECMO Collaborative Project brought clinicians and service-line leaders from 4 programs within a single health care system together with operational subject matter experts tasked with developing and implementing standardized guidelines, order sets, and an internal database to support an automated quarterly report card. Patient outcomes, resource use, and financial measures were compared for the 16 months before (January 2017 to April 2018; "precollaborative," n = 185) versus the 14 months after (November 2018 to December 2019, "postcollaborative," n = 243) a 6-month implementation and blanking period. Subset analyses were performed for venoarterial ECMO, venovenous ECMO, and extracorporeal cardiopulmonary resuscitation.

Results: Survival to discharge/transfer increased significantly (in-hospital mortality hazard ratio, 0.75; 95% confidence interval [95% CI], 0.58-0.99) for the postcollaborative versus the precollaborative period (107/185, 57.8% vs 113/243, 46.5%, P = .03), predominantly due to improvement among patients receiving venoarterial ECMO (hazard ratio, 0.61; 95% CI, 0.41-0.91). The percentage of patients successfully weaned from ECMO increased from 58.9% (109/185) to 70% (170/243), P = .02. Complication rates decreased by 40% (incidence rate ratio, 0.60; 95% CI, 0.49-0.72). No significant changes were observed in ECMO duration, intensive care unit or hospital length of stay, or cost-per-case; payment-per-case and contribution-margin-per-case both decreased significantly.

Conclusions: The ECMO Collaborative Project improved survival to discharge/transfer, weaning rates and complications, without additional costs, through coordination and standardization across ECMO programs within a health care system.
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http://dx.doi.org/10.1016/j.jtcvs.2020.10.079DOI Listing
October 2020

Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.

J Am Coll Cardiol 2020 12;76(23):2786-2794

Department of Cardiovascular Surgery, Baylor Health Care System, and Baylor Scott and White-The Heart Hospital-Plano Research Center, Plano, Texas.

The development of technology to treat unmet clinical patient needs in the United States has been an important focus for the U.S. Food and Drug Administration and the 2016 Congressional 21st Century Cures Act. In response, a program of early feasibility studies (EFS) has been developed. One of the important issues has been the outmigration of the development and testing of medical devices from the United States. The EFS committee has developed and implemented processes to address issues to develop strategies for early treatment of these patient groups. Initial implementation of the U.S. Food and Drug Administration EFS program has been successful, but residual significant problems have hindered the opportunity to take full advantage of the program. These include delays in gaining Institutional Review Board approval, timeliness of budget and contractual negotiations, and lack of access to and enrollment of study subjects. This paper reviews improvements that have been made to the U.S. EFS ecosystem and outlines potential approaches to address remaining impediments to program success.
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http://dx.doi.org/10.1016/j.jacc.2020.10.019DOI Listing
December 2020

Pulmonary Hypertension in Transcatheter Mitral Valve Repair for Secondary Mitral Regurgitation: The COAPT Trial.

J Am Coll Cardiol 2020 12;76(22):2595-2606

Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.

Background: Pulmonary hypertension worsens prognosis in patients with heart failure (HF) and secondary mitral regurgitation (SMR).

Objectives: This study sought to determine whether baseline pulmonary hypertension influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF with SMR.

Methods: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, 614 patients with HF with moderate-to-severe or severe SMR were randomized to TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) (n = 302) versus GDMT alone (n = 312). Baseline pulmonary artery systolic pressure (PASP) estimated from echocardiography was categorized as substantially increased (≥50 mm Hg) versus not substantially increased (<50 mm Hg).

Results: Among 528 patients, 184 (82 TMVr, 102 GDMT) had PASP of ≥50 mm Hg (mean: 59.1 ± 8.8 mm Hg) and 344 (171 TMVr, 173 GDMT) had PASP of <50 mm Hg (mean: 36.3 ± 8.1 mm Hg). Patients with PASP of ≥50 mm Hg had higher 2-year rates of death or HF hospitalization (HFH) compared to those with PASP of <50 mm Hg (68.8% vs. 49.1%; adjusted hazard ratio: 1.52; 95% confidence interval: 1.17 to 1.97; p = 0.002). Rates of death or HFH were reduced by TMVr versus GDMT alone, irrespective of baseline PASP (p = 0.45). TMVr reduced PASP from baseline to 30 days to a greater than GDMT alone (adjusted least squares mean: -4.0 vs. -0.9 mm Hg; p = 0.006), a change that was associated with reduced risk of death or HFH between 30 days and 2 years (adjusted hazard ratio: 0.91 per -5 mm Hg PASP; 95% confidence interval: 0.86 to 0.96; p = 0.0009).

Conclusions: Elevated PASP is associated with a worse prognosis in patients with HF with severe SMR. TMVr with the MitraClip reduced 30-day PASP and 2-year rates of death or HFH compared with GDMT alone, irrespective of PASP.
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http://dx.doi.org/10.1016/j.jacc.2020.09.609DOI Listing
December 2020