Showing papers by "Michael J. Mack published in 2020"
Cedars-Sinai Medical Center1, Emory University2, Medical City Dallas Hospital3, Columbia University Medical Center4, Cleveland Clinic5, Laval University6, University of Pennsylvania7, MedStar Washington Hospital Center8, University of Missouri–Kansas City9, Washington University in St. Louis10, Mayo Clinic11, Intermountain Medical Center12, Providence St. Vincent Medical Center13, Rutgers University14, New York University15, Primary Children's Hospital16, Scott & White Hospital17, Stanford University18, Columbia University19, Edwards Lifesciences Corporation20
TL;DR: There was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement among patients with severe, symptomaticAortic stenosis who were at intermediate surgical risk.
Abstract: Background There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve r...
441 citations
TL;DR: In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higherrisk of bleeding than an antiplatelet-based strategy.
Abstract: Background Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear. Methods We randomly assigned...
338 citations
Cedars-Sinai Medical Center1, University of British Columbia2, Scott & White Hospital3, Emory University4, New York University5, Columbia University Medical Center6, Edwards Lifesciences Corporation7, University of Washington8, University of Texas Health Science Center at Houston9, Cornell University10, Brigham and Women's Hospital11, Leiden University12, Cleveland Clinic13, University of Pennsylvania14
TL;DR: Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year, and the impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.
158 citations
Mayo Clinic1, Durham University2, Henry Ford Hospital3, Medical College of Wisconsin4, NorthShore University HealthSystem5, Emory University6, Columbia University Medical Center7, University of Washington Medical Center8, Rutgers University9, Dartmouth–Hitchcock Medical Center10, Brigham and Women's Hospital11, National Institutes of Health12, Baylor University13, Valve Corporation14
TL;DR: Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical rep... as discussed by the authors.
Abstract: Background: Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical rep...
132 citations
Cedars-Sinai Medical Center1, University of Texas Health Science Center at Houston2, Leiden University Medical Center3, Emory University4, New York University5, University of Bern6, Heart and Diabetes Center North Rhine-Westphalia7, French Institute of Health and Medical Research8, University of Colorado Hospital9, Ruhr University Bochum10, University of Washington11, University of Catania12, Rabin Medical Center13, University of Freiburg14, Scott & White Hospital15, Columbia University Medical Center16
TL;DR: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology, and calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality.
110 citations
TL;DR: Transcatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance.
Abstract: Importance Bioprosthetic mitral valves are implanted with increasing frequency but inevitably degenerate, leading to heart failure. Reoperation is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) using balloon-expandable transcatheter valves has emerged as an alternative for high-surgical risk patients. Objective To assess contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) MViV replacement. Design, setting, and participants In this registry-based prospective cohort study of SAPIEN 3 MViV, patients entered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from June 2015 to July 2019 were analyzed. US Centers for Medicare and Medicaid linkage ensured comprehensive collection of death and stroke data. Exposures Mitral valve-in-valve for degenerated bioprosthetic mitral valves. Main outcomes and measures The primary efficacy end point was 1-year mortality. The primary safety end point was procedural technical success as defined by the Mitral Valve Academic Research Consortium criteria. Secondary end points included 30-day mortality, New York Heart Association-defined heart failure, and mitral valve performance. Results A total of 1529 patients (mean [SD] age, 73.3 [11.84] years; 904 women [59.1%]) underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019. The mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 11.1% (8.7%). Procedural technical success was achieved for 1480 of 1529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P = .03). Transcatheter MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure of 87.1% at baseline vs 9.7% at 1 year). The mean (SD) mitral valve gradient at 1 year was 7 (2.89) mm Hg. Conclusions and relevance Transcatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.
106 citations
TL;DR: Using current-generation devices, procedural, postprocedural, and 1-year outcomes were comparable following TAVR for bic Suspid AV versus tricuspid AV disease, and with newer- generation devices, TAVr is a viable treatment option for patients with bicuspids AV disease.
Abstract: Background: Patients with bicuspid aortic valve (AV) stenosis were excluded from the pivotal evaluations of transcatheter AV replacement (TAVR) devices. We sought to evaluate the outcomes of TAVR i...
98 citations
TL;DR: Compared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generationSAPIEN 3 has a rate ofSVD that was not different from SAVS, and the SAPIen-XT TAVR cohort had a significantly higher 5 year incidence rates.
98 citations
TL;DR: SAVR following early failure of TAVR, while rare, is associated with worse-than-expected outcomes as compared with similar patients initially undergoing SAVR.
Abstract: Objectives This study sought to report the largest series of patients receiving a surgical reoperation after transcatheter aortic valve replacement (TAVR) using the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database. Background TAVR has become an effective means of treating aortic stenosis. As TAVR is used in progressively lower-risk cohorts, management of device failure will become increasingly important. Methods The STS Adult Cardiac Surgery Database was queried for patients with a history of prior TAVR undergoing surgical aortic valve replacement from 2011 to 2015. Observed-to-expected (O/E) mortality ratios were determined to facilitate comparison across reoperative indications and timing from index TAVR procedure. Results A total of 123 patients met inclusion criteria (median age 77 years) with an STS Predicted Risk of Mortality of 4%, 4% to 8%, and >8% in 17%, 24%, and 59%, respectively. Median time to reoperation was 2.5 (interquartile range: 0.7 to 13.0) months, and the operative mortality rate was 17.1%. Common indications for reoperation included early TAVR device failures such as paravalvular leak (15%), structural prosthetic deterioration (11%), failed repair (11%), sizing or position issues (11%), and prosthetic valve endocarditis (10%). All pre-operative risk categories were associated with an increased O/E mortality ratio (Predicted Risk of Mortality 8%: O/E 1.2). Conclusions SAVR following early failure of TAVR, while rare, is associated with worse-than-expected outcomes as compared with similar patients initially undergoing SAVR. Continued experience with this developing technology is needed to reduce the incidence of early TAVR failure and further define optimal treatment of failed TAVR prostheses.
73 citations
TL;DR: The PMI rates according to various definitions, their clinically relevant association with all-cause mortality at 10 years, and their impact on composite endpoints at 5 years were investigated in the SYNTAXES (Synergy between PCI with Taxus and Cardiac Surgery Extended Survival) trial.
65 citations
University of Toronto1, Cedars-Sinai Medical Center2, NewYork–Presbyterian Hospital3, Rutgers University4, Cleveland Clinic5, Northwestern University6, University of Missouri–Kansas City7, St. Paul's Hospital8, New York University9, University of Washington10, Scott & White Hospital11, Emory University12, Lankenau Medical Center13, University of Pennsylvania14, Morristown Medical Center15, Edwards Lifesciences Corporation16
TL;DR: In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR, and high Zva and low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis–patient mismatch were not.
Abstract: Background: This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve repl...
TL;DR: Within the COAPT trial, MitraClip improved outcomes in patients with and without ≥Mod TR severity compared with GDMT alone, and among patients with severe secondary MR who also had ≤Mod TR had worse clinical and echocardiographic characteristics and worse clinical outcomes compared to those with ≦Mild TR.
TL;DR: These simple indices are easily attainable, and clinically relevant markers of frailty that may meaningfully stratify patients at risk for mortality after TAVR, and provide incremental value in risk stratification for mortality.
Abstract: Objectives This study sought to evaluate the ability of individual markers of frailty to predict outcomes after transcatheter aortic valve replacement (TAVR) and of their discriminatory value in different age groups. Background Appropriate patient selection for TAVR remains a dilemma, especially among the most elderly and potentially frail. Methods The study evaluated patients ≥65 years of age in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry, linked to Centers for Medicare and Medicaid administrative claims data, receiving elective TAVR from November 2011 to June 2016 (n = 36,242). Indices of frailty included anemia, albumin level, and 5-m walk speed. We performed Cox proportional hazards regression for 30-day and 1-year mortality, adjusting for risk factors known to be predictive of 30-day mortality in the Transcatheter Valve Therapy registry, as well as survival analysis. Results These indices are independently associated with mortality at 30 days and 1 year and provide incremental value in risk stratification for mortality, with low albumin providing the largest value (hazard ratio: 1.52). Those with low albumin and slower walking speed had longer lengths of stay and higher rates of bleeding and readmission (p Conclusions This represents the largest study to date of the role of frailty indices after TAVR, further facilitating robust modeling and adjusting for a large number of confounders. These simple indices are easily attainable, and clinically relevant markers of frailty that may meaningfully stratify patients at risk for mortality after TAVR.
TL;DR: In patients with severe aortic stenosis undergoing TAVR, CKD stage is more likely to stay the same or improve than worsen, and lower baseline and longitudinal post-TAVR eGFR were associated with lower intermediate-term survival.
TL;DR: Female sex was not an independent predictor of mortality at 10 years in patients with complex coronary artery disease in the SYNTAXES study, suggesting that optimal revascularization beyond 5 years according to sex has not been evaluated.
TL;DR: Findings suggest that pHTN is associated with increased mortality and readmission for heart failure in patients undergoing TMVr using the MitraClip system for severe mitral regurgitation.
Abstract: Importance Pulmonary hypertension (pHTN) is associated with increased risk of mortality after mitral valve surgery for mitral regurgitation. However, its association with clinical outcomes in patients undergoing transcatheter mitral valve repair (TMVr) with a commercially available system (MitraClip) is unknown. Objective To assess the association of pHTN with readmissions for heart failure and 1-year all-cause mortality after TMVr. Design, Setting, and Participants This retrospective cohort study analyzed 4071 patients who underwent TMVr with the MitraClip system from November 4, 2013, through March 31, 2017, across 232 US sites in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry. Patients were stratified into the following 4 groups based on invasive mean pulmonary arterial pressure (mPAP): 1103 with no pHTN (mPAP, Interventions Patients were stratified into groups before TMVr, and clinical outcomes were assessed at 1 year after intervention. Main Outcomes and Measures Primary end point was a composite of 1-year mortality and readmissions for heart failure. Secondary end points were 30-day and 1-year mortality and readmissions for heart failure. Linkage to Centers for Medicare & Medicaid Services administrative claims was performed to assess 1-year outcomes in 2381 patients. Results Among the 4071 patients included in the analysis, the median age was 81 years (interquartile range, 73-86 years); 1885 (46.3%) were women and 2186 (53.7%) were men. The composite rate of 1-year mortality and readmissions for heart failure was 33.6% (95% CI, 31.6%-35.7%), which was higher in those with pHTN (27.8% [95% CI, 24.2%-31.5%] in group 1, 32.4% [95% CI, 29.0%-35.8%] in group 2, 36.0% [95% CI, 31.8%-40.2%] in group 3, and 45.2% [95% CI, 39.1%-51.0%] in group 4;P Conclusions and Relevance These findings suggest that pHTN is associated with increased mortality and readmission for heart failure in patients undergoing TMVr using the MitraClip system for severe mitral regurgitation. Further efforts are needed to determine whether earlier intervention before pHTN develops will improve clinical outcomes.
TL;DR: Whereas primary mitral regurgitation is due to a structural or degenerative abnormality of the mitral valve or adjacent structures, secondary or functional MR occurs in the absence of organic MV disease, usually resulting instead from left ventricular dysfunction.
Abstract: Whereas primary mitral regurgitation (MR) is due to a structural or degenerative abnormality of the mitral valve (MV) or adjacent structures, secondary or functional MR occurs in the absence of organic MV disease, usually resulting instead from left ventricular (LV) dysfunction. This dysfunction and the resultant remodeling lead to apical and lateral papillary muscle displacement or deformation of the MV annulus, thereby interfering with leaflet coaptation. The development of secondary MR is associated with a poorer prognosis in patients with heart failure of any cause.
TL;DR: Elevated pulmonary artery systolic pressure is associated with a worse prognosis in patients with HF with severe SMR, and TMVr with the MitraClip reduced 30-day PASP and 2-year rates of death or HFH compared with GDMT alone, irrespective of baseline PASp.
TL;DR: In this paper, the outcomes of MitraClip implantation versus guideline-directed medical therapy (GDMT) in patients with secondary mitral regurgitation (SMR) according to baseline functional status as assessed by the widely used New York Heart Association (NYHA) functional classification.
Abstract: Objectives The aim of this study was to evaluate the outcomes of MitraClip implantation versus guideline-directed medical therapy (GDMT) in patients with secondary mitral regurgitation (SMR) according to baseline functional status as assessed by the widely used New York Heart Association (NYHA) functional classification. Background Patients with heart failure (HF) and impaired functional status at baseline have poor prognosis. Whether the effects of transcatheter repair of secondary SMR in patients with HF are influenced by baseline functional status is unknown. Methods In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, patients with HF with moderate to severe or severe SMR who remained symptomatic despite maximally tolerated GDMT were randomized to MitraClip implantation versus GDMT alone. Outcomes were evaluated according to baseline functional status as assessed using the NYHA functional classification. The primary endpoint of interest was the rate of death or HF-related hospitalization (HFH) at 2 years in time-to-first-event analyses. Results Among 613 randomized patients, 240 were in NYHA functional class II (39.2%), 322 were in NYHA functional class III (52.5%), and 51 were in ambulatory NYHA functional class IV (8.3%). Rates of death or HFH were progressively higher with increasing NYHA functional class. Compared with GDMT alone, MitraClip implantation resulted in lower 2-year rates of death or HFH consistently in patients in NYHA functional class II (39.7% vs. 63.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.37 to 0.77), NYHA functional class III (46.6% vs. 65.5%; HR: 0.60; 95% CI: 0.45 to 0.82), and NYHA functional class IV (66.7% vs. 85.2%; HR: 0.55; 95% CI: 0.28 to 1.10; pinteraction = 0.86). Greater improvements in quality of life at 2 years were observed in patients treated with the MitraClip compared with GDMT irrespective of baseline functional status. Conclusions The NYHA functional classification provides prognostic utility in patients with HF and moderate to severe or severe SMR. In the COAPT trial, the benefits of MitraClip implantation were consistent in patients with better or worse functional status as assessed by NYHA functional class. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079 )
Mount Sinai Hospital1, Westchester Medical Center2, Emory University3, Montefiore Medical Center4, Cedars-Sinai Medical Center5, Brigham and Women's Hospital6, St. Paul's Hospital7, University of Washington8, Columbia University Medical Center9, Cornell University10, Mercy General Hospital11, Scott & White Hospital12, Cleveland Clinic13, Valve Corporation14
TL;DR: S3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes, and quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001).
Abstract: Objectives The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. Background Favorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. Methods From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range: 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. Results The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p Conclusions S3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.
TL;DR: In patients with HF and severe SMR, a short-term change in disease-specific health status was strongly associated with the subsequent long-term risk of death or HF hospitalization, and findings reinforce the prognostic utility of serial KCCQ-OS assessments to identify patients at risk for poor long- term clinical outcomes in this population.
TL;DR: In the COAPT trial, TMVr with the MitraClip improved the 2-year prognosis of patients with HF and moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated GDMT, regardless of prior CRT implantation.
Abstract: Background: In the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure...
TL;DR: The incidence and diagnostic criteria for THV thrombosis are summarized, the pathophysiological mechanisms that may lead to thrombus formation, its natural history, potential clinical implications and treatment for patients are discussed.
Abstract: Transcatheter aortic valve replacement (TAVR) has grown exponentially worldwide in the last decade. Due to the higher bleeding risks associated with oral anticoagulation and in patients undergoing TAVR, antiplatelet therapy is currently considered first-line antithrombotic treatment after TAVR. Recent studies suggest that some patients can develop subclinical transcatheter heart valve (THV) thrombosis after the procedure, whereby thrombus forms on the leaflets that can be a precursor to leaflet dysfunction. Compared with echocardiography, multidetector computed tomography is more sensitive at detecting THV thrombosis. Transcatheter heart valve thrombosis can occur while on dual antiplatelet therapy with aspirin and thienopyridine but significantly less with anticoagulation. This review summarizes the incidence and diagnostic criteria for THV thrombosis and discusses the pathophysiological mechanisms that may lead to thrombus formation, its natural history, potential clinical implications and treatment for these patients.
TL;DR: Baseline assessment of functional capacity by 6MWD was a powerful discriminator of prognosis in patients with HF with SMR and TMVr with the MitraClip provided substantial improvements in clinical outcomes for this population irrespective of baseline functional capacity.
Abstract: Objectives The aim of this study was to determine the prognostic utility of baseline functional status and its impact on the outcomes of transcatheter mitral valve repair (TMVr) in patients with heart failure (HF) with secondary mitral regurgitation (SMR). Background The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial demonstrated that TMVr with the MitraClip in patients with HF with moderate to severe or severe SMR improved health-related quality of life. The clinical utility of a baseline assessment of functional status for evaluating prognosis and identifying candidates likely to derive a robust benefit from TMVr has not been previously studied in patients with HF with SMR. Methods The COAPT study was a multicenter, randomized, controlled, parallel-group, open-label trial of TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone in patients with HF, left ventricular ejection fraction 20% to 50%, and moderate to severe or severe SMR. Baseline functional status was assessed by 6-min walk distance (6MWD). Results Patients with 6MWD less than the median (240 m) were older, were more likely to be female, and had more comorbidities. After multivariate modeling, age (p = 0.005), baseline hemoglobin (p = 0.007), and New York Heart Association functional class III/IV symptoms (p Conclusions Baseline assessment of functional capacity by 6MWD was a powerful discriminator of prognosis in patients with HF with SMR. TMVr with the MitraClip provided substantial improvements in clinical outcomes for this population irrespective of baseline functional capacity.
TL;DR: Strategies for managing patients with severe AS in the COVID-era are presented, including transitions to virtual assessments and consultation, careful pruning and planning of necessary testing, as well as fewer and shorter hospital admissions.
Abstract: The novel coronavirus disease-2019 (COVID-19) pandemic has created uncertainty in the management of patients with severe aortic stenosis. This population experiences high mortality from delays in treatment of valve disease but is largely overlapping with the population of highest mortality from COVID-19. The authors present strategies for managing patients with severe aortic stenosis in the COVID-19 era. The authors suggest transitions to virtual assessments and consultation, careful pruning and planning of necessary testing, and fewer and shorter hospital admissions. These strategies center on minimizing patient exposure to COVID-19 and expenditure of human and health care resources without significant sacrifice to patient outcomes during this public health emergency. Areas of innovation to improve care during this time include increased use of wearable and remote devices to assess patient performance and vital signs, devices for facile cardiac assessment, and widespread use of clinical protocols for expedient discharge with virtual physical therapy and cardiac rehabilitation options.
TL;DR: Although patients on anticoagulants appear to be at lower risk of LT, the available evidence does not allow formulation of recommendations for prophylactical antICOagulation nor routine computed tomography after transcatheter aortic valve replacement.
Abstract: Leaflet thrombosis (LT) has been claimed as a potential cause of hemodynamic dysfunction or bioprosthetic valve degeneration of transcatheter heart valves. Sparse and contrasting evidence exists, however, regarding LT occurrence, prevention and treatment. MEDLINE, ISI Web of Science and SCOPUS databases were searched for studies published up to January 2020. Only studies reporting data on incidence and outcomes associated to the presence/absence of clinical or subclinical LT, detected or confirmed with a multidetector computed tomography exam were included. The study was designed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) requirements. Two reviewers independently screened articles for fulfillment of inclusion criteria. Data were pooled using a random-effect model. The primary end point was the incidence of LT. Secondary outcomes included: stroke and transient ischemic attacks and mean transvalvular gradients at different time-points in patients with and without LT. Of the initial 200 studies, 22 were finally included with a total of 11,567 patients. LT overall incidence was 8% (95% Confidence Interval [CI]: 5% to 13%, I2 = 96.4%). LT incidence in patients receiving only antiplatelets was 13% (95% CI: 7% to 23%, p
TL;DR: Most transferable bases for a modern Indian hospital’s cost advantage would require more flexible American states’ hospital and health professional licensing regulations, greater family participation in inpatient care, and stronger support by hospital executives and clinicians for substantially lowering the cost of care via regionalization of complex surgeries and weekend use of costly operating rooms.
TL;DR: In the COAPT trial, COPD was associated with attenuation of the survival benefit of TMVr versus guideline-directed medical therapy (GDMT) compared with patients without COPD, however, the benefits ofTMVr on both HFH and health status were similar regardless of COPD.
Abstract: 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; pint = 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]; pint = 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 (pint >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 )
TL;DR: Variation in mortality and stroke after patients were randomized to surgical or transcatheter aortic valve replacement in the Placement of Aortic Transcatheter Valves-2A (PARTNER- 2A) randomized trial suggest that in performance-based trials, site variability and its sources should be taken into account in analyzing and interpreting trial results.
TL;DR: Most US individuals 65 years and older live in an HRR with a TAVR center, and more studies are required to evaluate the effect of geographic location of T AVR sites on access to TAVr procedures among individuals with an indication for a TavR within the US population.
Abstract: Importance Geographic access to transcatheter aortic replacement (TAVR) centers varies in the United States as a result of controlled expansion through minimum volume requirements. Objective To describe the current geographic access to TAVR centers in the United States. Design, Setting, and Participants Observational study from June 1, 2015, to June 30, 2017. United States census data were used to describe access to TAVR center. Google Maps and the Society of Thoracic Surgeons American College of Cardiology Transcatheter Valve Therapy Registry were used to describe characteristics of patients undergoing successful TAVR according to proximity to implanting center. The study analyzed 47 527 537 individuals 65 years and older in the United States and 31 098 patients who underwent successful transfemoral TAVR, were linked to fee-for-service Medicare, and had a measurable driving time. Main Outcomes and Measures Median driving distance to a TAVR center. Results Among 40 537 zip codes in the United States, 490 (1.2%) contained a TAVR center, and among 305 hospital referral regions (HRR), 234 (76.7%) contained a TAVR center. Of the 31 749 patients who underwent successful transfemoral TAVR and were linked to fee-for-service Medicare, 31 098 had a measurable driving time. Mean (SD) age was 82.4 (6.9) years, 14 697 patients (47.3%) were women, and 7422 (23.87%) lived in a rural area. This translated to 1 232 568 of 47 527 537 individuals (2.6%) 65 years and older living in a zip code with a TAVR center and 43 789 169 (92.1%) living in an HRR with a TAVR center. Among 31 749 patients who underwent successful transfemoral TAVR and were linked to fee-for-service Medicare, 31 098 had a measurable driving time. All of these patients (100.0%) underwent their procedure in a TAVR center within their HRR, with 1350 (4.3%) undergoing TAVR in a center within their home zip code. Median driving time to implanting TAVR center was 35.0 minutes (IQR, 20.0-70.0 minutes), ranging from 2.0 minutes to 18 hours and 48 minutes. Conclusions and Relevance Most US individuals 65 years and older live in an HRR with a TAVR center. Among patients undergoing successful transfemoral TAVR, median driving time to implanting center was 35.0 minutes. Within the context of the US health care system, where certain advanced procedures and specialized care are centralized, TAVR services have significant penetration. More studies are required to evaluate the effect of geographic location of TAVR sites on access to TAVR procedures among individuals with an indication for a TAVR within the US population.