The Centers for Medicare and Medicaid Services has required minimum procedural volumes as a condition of reimbursement for TAVR. CMS is reviewing this policy. In this analysis of data from 2015 ...through 2017, mortality at 30 days was higher among patients treated at hospitals or by operators with a lower volume of TAVR procedures.
The STS-ACC TVT Registry (Society of Thoracic Surgeons–American College of Cardiology Transcatheter Valve Therapy Registry) from 2011 to 2019 has collected data on 276,316 patients undergoing ...transcatheter aortic valve replacement (TAVR) at sites in all U.S. states. Volumes have increased every year, exceeding surgical aortic valve replacement in 2019 (72,991 vs. 57,626), and it is now performed in all U.S. states. TAVR now extends from extreme- to low-risk patients. This is the first presentation on 8,395 low-risk patients treated in 2019. In 2019, for the entire cohort, femoral access increased to 95.3%, hospital stay was 2 days, and 90.3% were discharged home. Since 2011, the 30-day mortality rate has decreased (7.2% to 2.5%), stroke has started to decrease (2.75% to 2.3%), but pacemaker need is unchanged (10.9% to 10.8%). Alive with acceptable patient-reported outcomes is achieved in 8 of 10 patients at 1 year. The Registry is a national resource to improve care and analyze TAVR’s evolution. Real-world outcomes, site performance, and the impact of coronavirus disease 2019 will be subsequently studied. (STS/ACC Transcatheter Valve Therapy Registry TVT Registry; NCT01737528)
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•The STS-ACC TVT Registry documents the growth of TAVR in the United States.•Low-risk patients and valve-in-valve procedures are rapidly growing subsets of TAVR procedures.•The Registry will continue to gather data on the demographics and outcomes of TAVR procedures and allow assessment of the impact of the COVID-19 on patients and health systems involved in this procedure.
Data from The Society of Thoracic Surgeons Adult Cardiac Surgery Database were analyzed to identify trends in patient characteristics and outcomes of mitral valve operations in North America.
All ...patients with isolated primary mitral valve operations with or without tricuspid valve repair, surgical atrial fibrillation ablation, or atrial septal defect closure performed July 2011 to September 2016 were identified. A subgroup analysis assessed patients with degenerative leaflet prolapse (DLP).
Isolated primary mitral valve operations were performed on 87,214 patients at 1,125 centers, increasing by 24% between 2011 (n = 14,442) and 2016 (n = 17,907). The most common etiology was DLP (60.7%); 4.3% had functional mitral regurgitation. Preoperatively, 47.3% of patients had an ejection fraction less than 60% and 34.2% had atrial fibrillation. Overall mitral valve repair rate was 65.6%, declining from 67.1% (2011) to 63.2% (2016; p < 0.0001). Repair rates were related to etiology (DLP, 82.5%; rheumatic, 17.5%). Of the 29,970 mitral valve replacements, 16.2% were preceded by an attempted repair. Repair techniques included prosthetic annuloplasty (94.3%), leaflet resection (46.5%), and artificial cord implantation (22.7%). Bioprosthetic valves were implanted with increasing frequency (2011, 65.4%; 2016, 75.8%; p < 0.0001). Less-invasive operations were performed in 23.0% and concomitant tricuspid valve repair in 15.7%. Unadjusted operative mortality was 3.7% (replacements) and 1.1% (repairs).
Patients undergoing primary isolated mitral valve operations commonly have ventricular dysfunction, atrial fibrillation, and heart failure. Although contemporary outcomes are excellent, earlier guideline-directed referral and increased frequency and quality of repair may further improve results of mitral valve operations.
IMPORTANCE: Introducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials. OBJECTIVE: To update the previous report of ...30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States. DESIGN, SETTING, AND PARTICIPANTS: Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30, 2013, and the end of the follow-up period was June 30, 2014. EXPOSURE: Transcatheter aortic valve replacement. MAIN OUTCOMES AND MEASURES: One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling. RESULTS: The median age of patients was 84 years and 52% were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1%. Following the TAVR procedure, 59.8% were discharged to home and the 30-day mortality was 7.0% (95% CI, 6.5%-7.4%) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4% (n = 2074) of survivors were rehospitalized once and 12.5% (n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7% (95% CI, 22.8%-24.5%) (n = 2450 deaths), the stroke rate was 4.1% (95% CI, 3.7%-4.5%) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0% (25.1%-26.8%) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio HR for ≥95 vs <75 years, 1.61 95% CI, 1.24-2.09; HR for 85-94 years vs <75 years, 1.35 95% CI, 1.18-1.55; and HR for 75-84 years vs <75 years, 1.23 95% CI, 1.08-1.41), male sex (HR, 1.21; 95% CI, 1.12-1.31), end-stage renal disease (HR, 1.66; 95% CI, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95% CI, 1.25-1.55), nontransfemoral access (HR, 1.37; 95% CI, 1.27-1.48), STS PROM score greater than 15% vs less than 8% (HR, 1.82; 95% CI, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95% CI, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95% CI, 1.15-1.71). CONCLUSIONS AND RELEVANCE: Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7%, the stroke rate was 4.1%, and the rate of the composite outcome of death and stroke was 26.0%. These findings should be helpful in discussions with patients undergoing TAVR.
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.
Abstract Background The STS/ACC Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration (FDA) approved transcatheter valve devices performed in the United ...States and is mandated as a condition of reimbursement by a Centers for Medicaid and Medicare Services (CMS) Objectives This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. Methods Data for all patients receiving commercially approved devices from 2012 through December 31, 2015 are entered in the TVT Registry. Results The 54,782 TAVR patients demonstrated decreases in expected risk of 30-day operative mortality (STS PROM) 7% to 6% and TAVR PROM (TVT PROM) 4% to 3% (both p<.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9% and one-year mortality decreased from 25.8% to 21.6. However, 30-day post procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent TMC in 2015 were similar to 2013-14 patients with hospital mortality of 2% with mitral regurgitation reduced to gradient ≤ 2 in 87% of patients (p<.0001). The 349 patients who underwent MViV and MViR procedures were high risk with, an STS PROM for MVR of 11%. The observed hospital mortality was 7.2% and 30-day post procedure was 8.5%. Summary The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies. Condensed Abstract The STS/ACC TVT Registry captures all Food and Drug Administration (FDA) approved transcatheter valve devices preformed in the United States and is mandated as a condition for reimbursement by the Centers for Medicare Services. TAVR patients’ expected risks of mortality and actual in-hospital mortality decreased. Transcatheter mitral clip procedures had a low mortality with reduced in mitral regurgitation to grade ≤ 2 in 87%. Mitral valve in valve or valve in ring patients were high risk for mortality, but actual hospital mortality was lower. The TVT Registry is an innovative registry that monitors quality, safety and trends of these evolving technologies
IMPORTANCE: Reducing postprocedural stroke is important to improve the safety of transcatheter aortic valve replacement (TAVR). OBJECTIVE: This study evaluated the trends of stroke occurring within ...30 days after the procedure during the first 5 years TAVR was used in the United States, the association of stroke with 30-day mortality, and the association of medical therapy with 30-day stroke risk. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study including 101 430 patients who were treated with femoral and nonfemoral TAVR at 521 US hospitals in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry from November 9, 2011, through May 31, 2017. Thirty-day follow-up ended June 30, 2017. EXPOSURES: TAVR. MAIN OUTCOMES AND MEASURES: The rates of 30-day transient ischemic attack and stroke were assessed. Association of stroke with 30-day mortality and association of antithrombotic medical therapies with postdischarge 30-day stroke were assessed with a Cox proportional hazards model and propensity-score matching, respectively. RESULTS: Among 101 430 patients included in the study (median age, 83 years interquartile range {IQR}, 76-87 years; 47 797 women 47.1%; and 85 147 patients 83.9% treated via femoral access), 30-day postprocedure follow-up data was assessed in all patients. At day 30, there were 2290 patients (2.3%) with a stroke of any kind (95% CI, 2.2%-2.4%), and 373 patients (0.4%) with transient ischemic attacks (95% CI, 0.3%-0.4%) . During the study period, 30-day stroke rates were stable without an increasing or decreasing trend in all patients (P for trend = .22) and in the large femoral access subgroup (P trend = .47). Among cases of stroke within 30 days, 1119 strokes (48.9%) occurred within the first day and 1567 (68.4%) within 3 days following TAVR. The occurrence of stroke was associated with a significant increase in 30-day mortality: 383 patients (16.7%) of 2290 who had a stroke vs 3662 patients (3.7%) of 99 140 who did not have a stroke died (P < .001; risk-adjusted hazard ratio HR, 6.1 95% CI, 5.4-6.8; P < .001). After propensity-score matching, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.55%) or were not (0.52%) treated with dual antiplatelet therapy at hospital discharge (HR, 1.04; 95% CI, 0.74-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.71%) or were not (0.69%) treated with dual antiplatelet therapy (HR, 1.02; 95% CI, 0.54-1.95). Similarly, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.57%) or were not (0.55) treated with oral anticoagulant therapy at hospital discharge (HR, 1.03; 95% CI, 0.73-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.75%) or were not (0.82%) treated with an oral anticoagulant (HR, 0.93; 95% CI, 0.47-1.83). CONCLUSIONS AND RELEVANCE: Between 2011 and 2017, the rate of 30-day stroke following transcatheter aortic valve replacement in a US registry population remained stable.
Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral ...embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited.
We performed an observational study using data from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights.
Our analytic sample included 123 186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing no procedures with an EPD in the last quarter of 2019. In our primary analysis using the instrumental variable model, there was no association between EPD use and in-hospital stroke (adjusted relative risk, 0.90 95% CI, 0.68-1.13; absolute risk difference, -0.15% 95% CI, -0.49 to 0.20). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted odds ratio, 0.82 95% CI, 0.69-0.97; absolute risk difference, -0.28% 95% CI, -0.52 to -0.03). Results were generally consistent across the secondary end points, as well as subgroup analyses.
In this nationally representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary instrumental variable analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale randomized, controlled trials to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR.
Abstract Background Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). ...Objectives The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. Methods Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. Results Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. Conclusions In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.
Abstract Background Peripheral vascular intervention (PVI) is an effective treatment option for patients with peripheral artery disease (PAD). In 2008, Medicare modified reimbursement rates to ...encourage more efficient outpatient use of PVI in the United States. Objectives The purpose of this study was to evaluate trends in the use and clinical settings of PVI and the effect of changes in reimbursement. Methods Using a 5% national sample of Medicare fee-for-service beneficiaries from 2006 to 2011, we examined age- and sex-adjusted rates of PVI by year, type of procedure, clinical setting, and physician specialty. Results A total of 39,339 Medicare beneficiaries underwent revascularization for PAD between 2006 and 2011. The annual rate of PVI increased slightly from 401.4 to 419.6 per 100,000 Medicare beneficiaries (p = 0.17), but the clinical setting shifted. The rate of PVI declined in inpatient settings from 209.7 to 151.6 (p < 0.001), whereas the rate expanded in outpatient hospitals (184.7 to 228.5; p = 0.01) and office-based clinics (6.0 to 37.8; p = 0.008). The use of atherectomy increased 2-fold in outpatient hospital settings and 50-fold in office-based clinics during the study period. Mean costs of inpatient procedures were similar across all types of PVI, whereas mean costs of atherectomy procedures in outpatient and office-based clinics exceeded those of stenting and angioplasty procedures. Conclusions From 2006 to 2011, overall rates of PVI increased minimally. However, after changes in reimbursement, PVI and atherectomy in outpatient facilities and office-based clinics increased dramatically, neutralizing cost savings to Medicare and highlighting the possible unintended consequences of coverage decisions.
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