Showing papers by "Michael J. Mack published in 2019"
TL;DR: Ten years after percutaneous coronary intervention using first-generation paclitaxel-eluting stents with coronary artery bypass grafting in patients with de-novo three-vessel and left main coronary artery disease, there is no significant difference in all-cause death between PCI and CABG.
367 citations
TL;DR: The present expert consensus scientific panel document has been formulated by a multidisciplinary group of interventional cardiologists, electrophysiologists and cardiac surgeons as an initial attempt to provide a guide for the management of conduction disturbances after TAVR based on the best available data and group expertise.
218 citations
TL;DR: Patients with bic Suspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30- day risk for stroke and randomized trials are needed to adequately assess the efficacy and safety of TAVR.
Abstract: Importance Transcatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy. Objective To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis. Design, Setting, and Participants Registry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018. Exposures TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures Primary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment. Results Of 81 822 consecutive patients with aortic stenosis (2726 bicuspid; 79 096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years [interquartile range {IQR}, 66-81 years]; 39.1%, women; mean [SD] STS-predicted risk of mortality, 4.9% [4.0%] and 5.1% [4.2%], respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio [HR], 1.04, [95% CI, 0.74-1.47]) and 1 year (10.5% vs 12.0%; HR, 0.90 [95% CI, 0.73-1.10]). The 30-day stroke rate was significantly higher for bicuspid vs tricuspid aortic stenosis (2.5% vs 1.6%; HR, 1.57 [95% CI, 1.06-2.33]). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid vs tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5% [95% CI, 0%-0.9%]). There were no significant differences in valve hemodynamics. There were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3% [95% CI, −1.3% to 0.7%]) and 1 year (3.2% vs 2.5%; absolute RD, 0.7% [95% CI, −1.3% to 2.7%]). At 1 year there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, −2.4 [95% CI, −5.1 to 0.3];P = .08). Conclusions and Relevance In this preliminary, registry-based study of propensity-matched patients who had undergone transcatheter aortic valve replacement for aortic stenosis, patients with bicuspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30-day risk for stroke. Because of the potential for selection bias and the absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis.
187 citations
University of Toronto1, University of Maryland, Baltimore2, Icahn School of Medicine at Mount Sinai3, University of São Paulo4, Scott & White Hospital5, New York University6, Albany Medical College7, Montreal Heart Institute8, University of British Columbia9, Liverpool Hospital10, University of Missouri–Kansas City11
TL;DR: In patients with DM and MVD, coronary revascularization with CABG leads to lower all-cause mortality than with PCI-DES in long-term follow-up, and this study concludes that this treatment is superior to percutaneous coronary intervention with drug-eluting stents for patients with diabetes mellitus.
177 citations
TL;DR: The beneficial effect of TMVR compared with GDMT alone was consistent in all echocardiographic subgroups, independent of the severity of LV dysfunction, LV dilatation, pulmonary hypertension, severity of tricuspid regurgitation or individual MR characteristics.
140 citations
TL;DR: In patients with severe aortic stenosis at intermediate surgical risk, treatment with transcatheter aortric valve replacement (TAVR) or surgical aortia replacement (SAVR) resu... as mentioned in this paper.
Abstract: Background: In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) resu...
115 citations
TL;DR: For transcatheter mitral valve repair with the MitraClip, increasing institutional experience was associated with improvements in procedural success, procedure time, and procedural complications.
Abstract: Objectives The aim of this study was to examine the relation between institutional experience and procedural results of transcatheter mitral valve repair. Background Transcatheter mitral valve repair for the treatment of mitral regurgitation (MR) is a complex procedure requiring navigation of the left atrium, left ventricle, and mitral valve apparatus using echocardiographic guidance. Methods MitraClip procedures from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were stratified into tertiles on the basis of site-specific case sequence (1 to 18, 19 to 51, and 52 to 482). In-hospital outcomes of procedural success, procedural time, and procedural complications were examined. To evaluate the learning curve for the procedure, generalized linear mixed models were developed using case sequence number as a continuous variable. Results MitraClip procedures (n = 12,334) performed at 275 sites between November 2013 and September 2017 were analyzed. Optimal procedural success (≤1+ residual MR without mortality or need for cardiac surgery) increased across tertiles of case experience (62.0%, 65.5%, and 72.5%; p Conclusions For transcatheter mitral valve repair with the MitraClip, increasing institutional experience was associated with improvements in procedural success, procedure time, and procedural complications. The impact of institutional experience was larger when considering the goal of achieving optimal MR reduction.
115 citations
TL;DR: At 3-year follow-up, TAVR for bioprosthetic aortic valve failure was associated with favorable survival, sustained improved hemodynamic status, and excellent functional and quality-of-life outcomes.
112 citations
TL;DR: Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling.
Abstract: Background: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering ...
93 citations
TL;DR: Racial minorities are underrepresented among patients undergoing TAVR in the United States, but their adjusted 30-day and 1-year clinical outcomes are comparable with those of white race.
Abstract: Objectives: This study sought to evaluate racial disparities in the performance and outcomes of transcatheter aortic valve replacement (TAVR).Background: Racial disparities in cardiovascula...
90 citations
TL;DR: New LBBB was associated with adverse clinical outcomes at 2 years, including all-cause and cardiovascular mortality, rehospitalization, new pacemaker implantation, and worsened left ventricular systolic function.
Abstract: AIMS Transcatheter aortic valve replacement (TAVR) is now an established therapy for intermediate-risk surgical candidates with symptomatic, severe aortic stenosis. The clinical impact of new-onset left bundle branch block (LBBB) after TAVR remains controversial and has not been studied in intermediate-risk patients. We therefore sought to analyse outcomes associated with new LBBB in a large cohort of intermediate-risk patients treated with TAVR. METHODS AND RESULTS A total of 2043 patients underwent TAVR in the PARTNER II trial and S3 intermediate-risk registry and survived to hospital discharge. Patients were excluded from the current analysis due to baseline conduction disturbances, pre-existing permanent pacemaker (PPM), and new PPM during the index hospitalization. Clinical outcomes at 2 years were compared between patients with and without persistent, new-onset LBBB at hospital discharge, and multivariable analysis was performed to identify predictors of mortality. Among 1179 intermediate-risk patients, new-onset LBBB at discharge occurred in 179 patients (15.2%). Patients with new LBBB were similar to those without except for more frequent diabetes and more frequent treatment with SAPIEN 3 vs. SAPIEN XT. At 2 years, new LBBB was associated with increased rates of all-cause mortality (19.3% vs. 10.8%, P = 0.002), cardiovascular mortality (16.2% vs. 6.5%, P < 0.001), rehospitalization, and new PPM implantation. By multivariable analysis, new LBBB remained an independent predictor of 2-year all-cause [hazard ratio (HR) 1.98, 95% confidence interval (95% CI) 1.33, 2.96; P < 0.001] and cardiovascular (HR 2.66 95% CI 1.67, 4.24; P < 0.001) mortality. New LBBB was also associated with worse left ventricular systolic function at 1 and 2-year follow-up. CONCLUSIONS In a large cohort of intermediate-risk patients from the PARTNER II trial and registry, persistent, new-onset LBBB occurred in 15.2% of patients without baseline conduction disturbances or pacemaker. New LBBB was associated with adverse clinical outcomes at 2 years, including all-cause and cardiovascular mortality, rehospitalization, new pacemaker implantation, and worsened left ventricular systolic function. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov #NCT01314313 and NCT03222128.
TL;DR: Among patients with symptomatic HF and 3+ to 4+ secondary MR receiving maximally-tolerated medical therapy, edge-to-edge TMVr resulted in substantial early and sustained health status improvement compared with medical therapy alone.
TL;DR: In the current era with careful patient selection and periprocedural management, isolated TV surgery can be performed with lower morbidity and mortality than has traditionally been reported with good long-term survival.
TL;DR: For TMVr device proceedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications.
TL;DR: The results suggest that despite considerable progress, efforts to further reduce stroke, acute kidney injury, bleeding, and moderate or severe PVL are likely to yield important clinical benefits and remain key targets for device iteration and procedural improvement.
Abstract: Objectives The aim of this study was to examine the independent association of short-term complications of transcatheter aortic valve replacement (TAVR) with survival and quality of life at 1 year. Background Prior studies have examined the mortality and cost implications of various complications of TAVR. However, many of these complications may primarily affect patients’ quality of life after TAVR, which has not been previously studied. Methods Among patients at intermediate or high surgical risk who underwent TAVR as part of the PARTNER (Placement of Aortic Transcatheter Valve) 2 studies and survived 30 days, the association between complications within the 30 days after TAVR and mortality and quality of life at 1 year was examined. Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire and the Short-Form 12. Complications assessed included major and minor stroke, life-threatening and major bleeding, vascular injury, stage 3 acute kidney injury, new pacemaker implantation, and mild and moderate or severe paravalvular leak (PVL). Multivariable models that included all complications as well as baseline clinical factors were used to examine the independent association of each complication with outcomes. Results Among 3,763 TAVR patients, major stroke and stage 3 acute kidney injury were associated with markedly increased risk for 1-year mortality, with adjusted hazard ratios of 5.4 (95% confidence interval [CI]: 3.1 to 9.5) and 4.9 (95% CI: 2.7 to 8.8), respectively, as well as poorer quality of life among survivors (reductions in 1-year Kansas City Cardiomyopathy Questionnaire overall summary score of 15.1 points [95% CI: 24.8 to 5.3 points] and 14.7 points [95% CI: 25.6 to 3.8 points], respectively). Moderate or severe PVL, life-threatening bleeding, and major bleeding were each associated with a more modest increase in mortality and decrement in quality of life, whereas mild PVL was associated with a small decrease in quality of life. After adjusting for baseline characteristics and other complications, need for a new pacemaker, minor stroke, and vascular injury were not independently associated with poor outcomes. Conclusions Among patients undergoing TAVR, similar events are associated with increased mortality and impaired quality of life at 1 year. These results suggest that despite considerable progress, efforts to further reduce stroke, acute kidney injury, bleeding, and moderate or severe PVL are likely to yield important clinical benefits and remain key targets for device iteration and procedural improvement.
University of Missouri–Kansas City1, Edwards Lifesciences Corporation2, Scott & White Hospital3, Columbia University Medical Center4, Cedars-Sinai Medical Center5, University of Pennsylvania6, Cleveland Clinic7, Emory University8, New York University9, Washington University in St. Louis10, University of British Columbia11
TL;DR: Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery and longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time.
TL;DR: A risk model for in-hospital stroke after TAVR was developed from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry and used to estimate site-specific stroke performance and can serve as a valuable resource for quality improvement, clinical decision making, and patient counseling.
TL;DR: In this paper, the COAPT trial (Cardiovascular outcomes assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) demonstrated that edge-to-edge edge-clip percutaneous therapy was effective for patients with functional mitral regurgitation.
Abstract: Background: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) demonstrated that edge-to-edge...
Valve Corporation1, Houston Methodist Hospital2, Stanford University3, Royal Prince Alfred Hospital4, Alfred Hospital5, Leeds Teaching Hospitals NHS Trust6, University of Sussex7, Cedars-Sinai Medical Center8, Northwestern University9, McGill University Health Centre10, University of California, San Francisco11, Emory University12, Columbia University Medical Center13, Scott & White Hospital14, Mount Sinai Hospital15, St Thomas' Hospital16
TL;DR: Multiphase, and specifically early systolic, assessment of the neo-LVOT may better determine risk of LVOTO with transcatheter mitral valve replacement compared with end-systolic estimates.
Abstract: Objectives This study proposes a physiologic assessment of left ventricular outflow tract obstruction (LVOTO) that accommodates changes in systolic flow and accounts for the dynamic neo–left ventricular outflow tract (LVOT). Background Patients considered for transcatheter mitral valve replacement trials often screen-fail because of the perceived risk of LVOTO. In the Intrepid Global Pilot Study, assumed risk of LVOTO was based on computed tomography estimates of the neo-LVOT area computed at end-systole. However, this may overestimate actual risk. Methods Retrospective analyses were performed for screen-failed patients for potential LVOTO (n = 33) and treated patients (n = 29) with available dynamic computed tomography. A multiphase assessment of the neo-LVOT area was performed and represented as: 1) multiphase average; and 2) early systolic value. Prospective evaluation was performed in 9 patients approved for enrollment with multiphase and early systole methods that would have previously screen-failed with the end-systolic approach. Results Of 166 patients screened for possible inclusion; 32 were screen-failed for nonanatomical reasons. Screen failure for assumed LVOTO risk occurred in 37 of 134 (27.6%) patients. Retrospective analysis indicated a potential enrollment increase of 11 of 33 (33.3%) and 18 of 33 (54.5%) patients using multiphase and early systolic assessment methods. In the prospective cohort, there were no clinical observations of LVOTO 30 days post-procedure, despite assumed risk based on end-systolic estimates. Conclusions Multiphase, and specifically early systolic, assessment of the neo-LVOT may better determine risk of LVOTO with transcatheter mitral valve replacement compared with end-systolic estimates. This novel approach has the potential to significantly increase patient eligibility, with over one-half of patients previously screen-failed now eligible for treatment.
Cornell University1, University of Florida2, University of Catania3, Cleveland Clinic4, University of Toronto5, Mayo Clinic6, Erasmus University Rotterdam7, University of Ulsan8, Baylor University9, Imperial College London10, University of Ottawa11, Columbia University12, University of Sydney13, University of Oxford14
TL;DR: This research highlights the need to understand more fully the role of emotion in the decision-making process and the role that emotion plays in the selection and implementation of treatments.
TL;DR: Early AC after bioprosthetic AVR did not result in adverse clinical events, did not significantly affect aortic valve hemodynamics (aortic valves gradients or area), and was associated with decreased rates of stroke after SAVR (but not after TAVR).
TL;DR: Given the variability in structural heart training, it is urgently recommended the establishment of a standardized curriculum and pathways for surgical trainees to gain proficiency in transcatheter technologies.
Eugene H. Blackstone1, Helena L. Chang2, Jeevanantham Rajeswaran1, Michael K. Parides2 +212 more•Institutions (11)
TL;DR: Statistical modeling using TTM recordings after MVS in patients with (long‐standing) persistent AF suggests that a biatrial maze is associated with lower AF/AFL/AT prevalence, but not a lower load, compared with pulmonary vein isolation.
TL;DR: Reduction in hospitalizations varied by specific patient subgroups, and thus, payors and providers seeking to reduce resource use may consider strategies designed to improve processes of care among patients with increased resource utilization post-TAVR as compared with pre- TAVR.
Albert Einstein College of Medicine1, Icahn School of Medicine at Mount Sinai2, Columbia University3, University of Virginia4, Montreal Heart Institute5, National Institutes of Health6, Scott & White Hospital7, Duke University8, University of Pennsylvania9, University of Alberta10, Mount Sinai Hospital11, Dartmouth–Hitchcock Medical Center12, Brigham and Women's Hospital13, Cleveland Clinic14
TL;DR: AF ablation, multivalve surgery, and NYHA functional class III/IV were associated with an increased risk for permanent pacing and PPM implantation following MVS was associated with a significant increase in 1-year mortality.
TL;DR: TAVR has emerged as an effective treatment option in patients with severe aortic stenosis due to a robust evidence base generated by a series of randomised controlled trials, and TAVR was found to be non-inferior in all studies.
Abstract: Transcatheter aortic valve replacement(TAVR) has emerged as an effective treatment option in patients with severe aortic stenosis, in large part due to a robust evidence base generated by a series of randomised controlled trials (RCTs). During the past decade more than 15 000 patients have been randomised worldwide in nine clinical trials, mostly for regulatory approval in the USA, making it one of the most carefully scrutinised medical devices at the time of introduction into clinical practice. Initial trials were performed in inoperable or extreme risk patients compared to medical therapy and demonstrated superiority. Subsequent RCTs compared TAVR to surgical aortic valve replacement in high and intermediate surgical risk patients and TAVR was found to be non-inferior in all studies. RCTs of low surgical risk patients have completed enrolment and 1 year outcomes will be available in early 2019. The details of the trials, trial results, outcomes and remaining clinical questions are summarised in this article.
TL;DR: Current surgical outcomes of tricuspid regurgitation are reviewed to determine whether surgical outcomes have improved in the modern era.
TL;DR: In conclusion, severe calcific MS is uncommon in patients who underwent TAVI, and its presence is associated with higher long-term mortality whereas moderate MS is not.
Abstract: This study was performed to investigate the prevalence and impact on survival of baseline mitral stenosis (MS) in patients who underwent transcatheter aortic valve implantation (TAVI) due to the presence of severe symptomatic aortic stenosis. This retrospective study included 928 consecutive patients with severe, symptomatic aortic stenosis who underwent TAVI in 2 institutions, from January 2012 to August 2016. Mean follow-up was 40.8 ± 13.9 months. Based on the mean mitral gradient (MMG) at baseline, 3 groups were identified: MMG