Transcatheter Valve Therapy Research Articles

Use of Direct Oral Anticoagulant and Outcomes in Patients With Atrial Fibrillation after Transcatheter Aortic Valve Replacement: Insights From the STS/ACC TVT Registry

BackgroundClinical evidence on the safety and effectiveness of using direct oral anticoagulants (DOACs) in patients with atrial fibrillation after transcatheter aortic valve replacement (TAVR) remains limited. The aim of this study was to investigate the trends and outcomes of using DOACs in patients with TAVR and atrial fibrillation.Methods and ResultsData from the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry was used to identify patients who underwent successful TAVR with preexisting or incident atrial fibrillation who were discharged on oral anticoagulation between January 2013 and May 2018. Patients with a mechanical valve, valve‐in‐valve procedure, or prior stroke within a year were excluded. The adjusted primary outcome was 1‐year stroke events. The adjusted secondary outcomes included bleeding, intracranial hemorrhage, and death. A total of 21 131 patients were included in the study (13 004 TAVR patients were discharged on a vitamin K antagonist and 8127 were discharged on DOACs.) The use of DOACs increased 5.5‐fold from 2013 to 2018. The 1‐year incidence of stroke was comparable between DOAC‐treated patients and vitamin K antagonist‐treated patients (2.51% versus 2.37%; hazard ratio [HR], 1.00; 95% CI, 0.81–1.23) whereas DOAC‐treated patients had lower 1‐year incidence of any bleeding (11.9% versus 15.0%; HR, 0.81; 95% CI, 0.75–0.89), intracranial hemorrhage (0.33% versus 0.59%; HR, 0.54; 95% CI, 0.33–0.87), and death (15.8% versus 18.2%; HR, 0.92; 95% CI, 0.85–1.00).ConclusionsIn patients with TAVR and atrial fibrillation, DOAC use, when compared with vitamin K antagonists, was associated with comparable stroke risk and significantly lower risks of bleeding, intracranial hemorrhage, and death at 1 year.

Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017.

Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted (P<0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex. No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

Patient-reported vs. physician-estimated symptoms before and after transcatheter aortic valve replacement.

In contrast to patient-reported health status measures (such as the Kansas City Cardiomyopathy Questionnaire), the New York Heart Association class is based on a physician's assessment of heart failure symptoms and functional limitations on behalf of the patient. We sought to determine the concordance and predictors of physician under- and overestimation of symptoms prior to and after transcatheter aortic valve replacement (TAVR). The analytic cohort included 172667 patients within the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry who underwent transfemoral TAVR. At baseline, physicians underestimated patients' symptoms in 47.4%, correctly assessed symptoms in 26.6%, and overestimated symptoms in 26.0%. At 30days after TAVR, these proportions were 22.8%, 50.3%, and 26.9%, respectively. Using nominal logistic regression with random intercepts to account for within-hospital clustering, we found that physicians were more likely to incorrectly estimate patients' symptoms when patients were older, women, had a prior stroke, had severe lung disease, had atrial fibrillation, or were more obese. There was marked variability in the rates of underestimation, correct estimation, and overestimation across the 641 sites. Among patients undergoing treatment for severe aortic stenosis, physicians estimate patients' symptoms and functional status poorly both prior to and after TAVR, with different patterns. These findings emphasize the need to collect patient-reported health status to more reliably assess the benefits of TAVR in routine clinical practice.

Transcatheter Mitral Valve Therapy in the United States: A Report from the STS/ACC TVT Registry

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763).

The Call to Perfection: A High Bar for Sutureless and Rapid Deployment Aortic Valves

The emergence of transcatheter aortic valve replacement (TAVR) has shaped a dramatic paradigm shift in the treatment of aortic stenosis. According to The Society of Thoracic Surgeons–American College of Cardiology Transcatheter Valve Therapy Registry,1 the volume of TAVRs now exceeds that of surgical AVR (SAVR). TAVR is increasingly applied to younger, lower-surgical-risk patients, with the resultant outcomes improving over time.

Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke Among Patients at Low Surgical Risk

There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis. TAVR for bicuspid vs tricuspid aortic stenosis. Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

Redo‐transcatheter aortic valve replacement with the supra‐annular, self‐expandable Evolut platform: Insights from the Transcatheter valve Therapy Registry

AbstractObjectivesTo assess the safety profile of redo‐TAVR procedures from patients in the transcatheter valve therapy (TVT) Registry.BackgroundThe use of transcatheter aortic valves (TAV) to treat previously implanted failing TAVS (TAV‐in‐TAV) has been an increasingly important topic as indications for TAVR move to younger and lower‐risk patients, but data on the safety and efficacy of redo‐TAVR is limited.MethodsPatients undergoing redo‐TAVR procedures using the Evolut R, Evolut PRO or Evolut PRO+ valve in the TVT Registry between April 2015 and March 2020 were included. In‐hospital, 30‐day and 1‐year outcomes were analyzed.ResultsRedo‐TAVR was performed in 292 patients (213 patients received the Evolut R valve and 79 received the Evolut PRO or PRO+ valve). Device success was achieved in 94.5%. In‐hospital mortality was 2.1%, stroke occurred in 2.7%, and 77.2% of patients were discharged home. There were no cases of coronary compression/obstruction or myocardial infarction that occurred in index hospitalization. Mean gradient at 30‐days was 11.9 ± 6.9 mmHg, and 73.1% had none/trace total aortic regurgitation.ConclusionsResults from the TVT Registry demonstrate good short‐term outcomes after redo‐TAVR with the supra‐annular, self‐expandable Evolut platform. Long‐term follow‐up is necessary to further expand understanding this complex scenario.

Transcatheter Aortic Valve Replacement With Self-Expandable Supra-Annular Valves for Degenerated Surgical Bioprostheses: Insights From Transcatheter Valve Therapy Registry.

BackgroundTranscatheter aortic valve replacement with supra‐annular transcatheter heart valves has been adopted in patients with degenerated surgical aortic valves. The next generation self‐expanding Evolut PRO valve has not been evaluated in patients with surgical valve failure.Methods and ResultsPatients undergoing transcatheter aortic valve replacement in degenerated surgical aortic valve procedures using the Evolut R or Evolut PRO transcatheter heart valves in the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry between April 2015 and June 2019 were evaluated. Transcatheter valve performance was evaluated by clinical site echocardiography. In‐hospital, 30‐day, and 1‐year clinical outcomes were based on the Society of Thoracic Surgeons‐American College of Cardiology‐Transcatheter Valve Therapy registry definitions. Transcatheter aortic valve replacement in degenerated surgical aortic valve was performed in 5897 patients (5061 [85.8%] patients received the Evolut R valve and 836 [14.2%] received the Evolut PRO valve). Thirty‐day transcatheter heart valves hemodynamic performance was excellent in both groups (mean gradient: Evolut PRO: 13.8±7.5 mm Hg; Evolut R: 14.5±8.1 mm Hg), while paravalvular regurgitation was significantly different between valve types (P=0.02). Clinical events were low at 30 days (Evolut PRO: for the all‐cause mortality, 2.8%, any stroke was 1.8%, new pacemaker implantation, 3.0%: Evolut R:all‐cause mortality, 2.5%, any stroke was 2.2%, new pacemaker implantation, 5.3%) and 1 year (Evolut PRO: all‐cause mortality, 9.2%; any stroke, 3.1%; Evolut R: all‐cause mortality, 9.8%; any stroke, 2.9%).ConclusionsTranscatheter aortic valve replacement in degenerated surgical aortic valve with self‐expandable supra‐annular transcatheter heart valves is associated with excellent clinical outcomes and valve hemodynamics. Additional reductions in residual paravalvular regurgitation were obtained with the next generation Evolut PRO.

Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve: A Propensity-Matched Analysis From the United States.

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Aortic valve reintervention in patients with failing transcatheter aortic bioprostheses: A statewide experience

BackgroundDespite the rapid adoption of transcatheter aortic valve replacement since its approval, the frequency and outcomes of aortic valve reintervention after transcatheter aortic valve replacement are poorly understood. MethodsValve reinterventions, either surgical transcatheter aortic valve explantation or repeat transcatheter aortic valve replacement, between 2012 and 2019 were queried using the Society of Thoracic Surgeons Database and the Transcatheter Valve Therapy Registry through the Michigan Statewide quality collaborative. The reintervention frequency and clinical outcomes including observed-to-expected mortality ratio using Society of Thoracic Surgeons Predicted Risk of Mortality were reviewed. ResultsAmong 9694 transcatheter aortic valve replacement recipients, a total of 87 patients (0.90%) received a reintervention, consisting of 34 transcatheter aortic valve explants and 53 repeat transcatheter aortic valve replacement procedures. The transcatheter aortic valve explant group demonstrated a higher Society of Thoracic Surgeons Predicted Risk of Mortality. Reintervention cases increased from 0 in 2012 and 2013 to 26 in 2019. The proportion of transcatheter aortic valve explants among all reinterventions increased and was 65% in 2019. Self-expandable devices had a higher reintervention rate than balloon-expandable devices secondary to a higher transcatheter aortic valve explant frequency (0.58% [23/3957] vs 0.19% [11/5737]; P = .001), whereas repeat transcatheter aortic valve replacement rates were similar (0.61% [24/3957] vs 0.51% [29/5737]; P = .51). Among patients with transcatheter aortic valve explants, contraindications to repeat transcatheter aortic valve replacement included unfavorable anatomy (75%), need for other cardiac surgery (29%), other structural issues by transcatheter aortic valve device (18%), and endocarditis (12%). For transcatheter aortic valve explant and repeat transcatheter aortic valve replacement, the 30-day mortality was 15% and 2% (P = .032) and the observed-to-expected mortality ratio was 1.8 and 0.3 (P = .018), respectively. ConclusionsAortic valve reintervention remains rare but is increasing. The clinical impact of surgical device explantation was substantial, and the proportion of transcatheter aortic valve explants was significantly higher in patients with a self-expandable device.

Composite Metric for Benchmarking Site Performance in Transcatheter Aortic Valve Replacement: Results From the STS/ACC TVT Registry.

Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine whether there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure. We performed a retrospective cohort study using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites with risk-adjusted outcomes significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected. The development cohort consisted of 52 561 patients who underwent TAVR between January 1, 2015, and December 31, 2017. Based on associations with 1-year risk-adjusted mortality and health status, we identified 4 periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe perivalvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) sites, performance as expected was observed in 242/301 sites (80%), and worse than expected performance was observed in 34/301 (11%) sites. Thirty-day mortality; stroke; major, life-threatening, or disabling bleeding; and moderate or severe perivalvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model. There are substantial variations in the quality of TAVR care received in the United States and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.

Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality.

The use of valve-in-valve–transcatheter aortic valve replacement (VIV-TAVR) in degenerated aortic bioprosthesis has been increasing, but the Food and Drug Administration approval is limited to high-risk patients. We analyzed the real-world experience of SAPIEN 3 VIV-TAVR, especially in lower-risk patients, based on the Society of Thoracic Surgeons (STS) score. All transfemoral VIV-TAVR with the SAPIEN 3 and Ultra valves between June 2015 and January 2020 were identified using the STS/American College of Cardiology Transcatheter Valve Therapies Registry. Patients were grouped based on STS score (low score: <4%, intermediate score: 4%≤ and≤8%, high score: >8%). Propensity-matched (1:3) analysis was conducted to compare to patients undergoing native TAVR. Of 145 917 SAPIEN 3 TAVR patients, 4460 (3%) underwent transfemoral VIV-TAVR with available baseline STS data in 4276 patients. Average age was 73.9±11.2, 66.4% were male, and the mean STS score was 6.9±6.0%. Overall 30-day mortality was 2.4% (observed to expected ratio, 0.33), and 1-year mortality was 10.8%. 30-day mortality and observed to expected ratio were 0.9% and 0.32 in low-score, 2.2% and 0.38 in the intermediate-score, and 4.3% and 0.31 in the high-score group. Based on propensity-matched analysis, 30-day mortality was similar and 1-year mortality was lower in VIV compared to native TAVR among all risk groups. When the groups were analyzed based on the Heart Team risk stratification using high-risk and non–high risk, the findings remained consistent. In this real-world study, VIV-TAVR had excellent 30-day and 1-year outcomes, especially in lower-risk patients. These findings may suggest the feasibility and expansion of VIV-TAVR in lower-risk patients. However, long-term follow-up continues to be crucial.

Surgical Explantation of Transcatheter Aortic Valve Bioprostheses: A Statewide Experience.

Despite the rapid adoption of transcatheter aortic valve replacement (TAVR) since its initial approval in 2011, the frequency and outcomes of surgical explantation of TAVR devices (TAVR-explant) is poorly understood. Patients undergoing TAVR-explant between January 2012 and June 2020 at 33 hospitals in Michigan were identified in the Society of Thoracic Surgeons Database and linked to index TAVR data from the Transcatheter Valve Therapy Registry through a statewide quality collaborative. The primary outcome was operative mortality. Indications for TAVR-explant, contraindications to redo TAVR, operative data, and outcomes were collected from Society of Thoracic Surgeons and Transcatheter Valve Therapy databases. Baseline Society of Thoracic Surgeons Predicted Risk of Mortality was compared between index TAVR and TAVR-explant. Twenty-four surgeons at 12 hospitals performed TAVR-explants in 46 patients (median age, 73). The frequency of TAVR-explant was 0.4%, and the number of explants increased annually. Median time to TAVR-explant was 139 days and among known device types explanted, most were self-expanding valves (29/41, 71%). Common indications for TAVR-explant were procedure-related failure (35%), paravalvular leak (28%), and need for other cardiac surgery (26%). Contraindications to redo TAVR included need for other cardiac surgery (28%), unsuitable noncoronary anatomy (13%), coronary obstruction (11%), and endocarditis (11%). Overall, 65% (30/46) of patients underwent concomitant procedures, including aortic repair/replacement in 33% (n=15), mitral surgery in 22% (n=10), and coronary artery bypass grafting in 16% (n=7). The median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.2% at index TAVR and 9.3% at TAVR-explant (P=0.001). Operative mortality was 20% (9/46) and 76% (35/46) of patients had in-hospital complications. Of patients alive at discharge, 37% (17/37) were discharged home and overall 3-month survival was 73±14%. TAVR-explant is rare but increasing, and its clinical impact is substantial. As the utilization of TAVR expands into younger and lower-risk patients, providers should consider the potential for future TAVR-explant during selection of an initial valve strategy.

Incidence, Predictors, and Outcomes of Acute Kidney Injury in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology National Cardiovascular Data Registry-Transcatheter Valve Therapy Registry.

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Variation in Antithrombotic Therapy and Clinical Outcomes in Patients With Preexisting Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Optimal antithrombotic management of patients with preexisting atrial fibrillation undergoing transcatheter aortic valve replacement is challenging given the need to balance the risk of bleeding and thromboembolism. We aimed to examine variation in care and association of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality in patients undergoing transcatheter aortic valve replacement with concomitant atrial fibrillation in the United States. Patients who underwent transcatheter aortic valve replacement with preexisting atrial fibrillation from November 2011 through September 2015 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry linked to the Medicare database were examined according to receipt of oral anticoagulants (OACs) or antiplatelet therapies (APTs) or a combination of these (OAC+APT) at discharge. To assess the associations of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality, we utilized inverse probability weighting for antithrombotic therapies and multivariable regression modeling to adjust for patient- and hospital-level variables. In the 11 382 patients included in our study, 5833 (51.2%) were discharged on OAC+APT, 4786 (42.0%) on APT alone, and 763 (6.7%) on OAC alone. There was significant variability in discharge medication patterns, including 42% of patients discharged without OAC therapy. In adjusted analyses, the risk for all-cause mortality and stroke was not significantly different when comparing the 3 different antithrombotic strategies. Risk of bleeding was higher with OAC+APT compared with APT alone (hazard ratio, 1.16 [95% CI, 1.05–1.27]) and similar compared with OAC alone (hazard ratio, 1.17 [95% CI, 0.93–1.47]). There was significant variability in discharge medication patterns across US sites in patients with atrial fibrillation undergoing transcatheter aortic valve replacement, including significant underuse of OAC in this high-risk cohort. The use of OAC+APT (versus OAC alone or APT alone) was not associated with a lower risk of stroke or mortality but was associated with increased risk of bleeding complications at 1 year compared with APT alone.

Transcatheter aortic valve replacement: An alternative for severe aortic stenosis.

Transcatheter aortic valve replacement (TAVR) is considered a lower-risk procedure for patients with severe aortic valve stenosis. Several FDA-approved trials performed in the United States support TAVR to be beneficial over surgical aortic valve replacement in certain patient populations. An optimal TAVR program consists of a multidisciplinary team that selects candidates for the procedure based on shared decision-making and the patient's anatomy and risk factors, and follows the patients through the Transcatheter Valve Therapy National Registry.

Effect of Operator Experience on Transcatheter Mitral Valve Repair Outcomes

Transcatheter mitral valve repair with MitraClip is a novel, intricate therapy for mitral regurgitation that improves survival and quality of life. Similar to other medical procedures, there is a relationship between procedural experience and clinical outcomes. MitraClip results and the efficiency and safety of the procedure all improved with increasing experience at both the institutional and operator level in two large studies from the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry. Patient selection was also found to have a significant role in procedure success. The old adage of “See one, do one, teach one” does not necessarily apply to complex interventions, such as MitraClip, given that the learning curve does not appear to plateau even as operators approach a 150-case experience.

Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results From the Transcatheter Valve Therapy Registry.

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.

Evaluating Out-of-Hospital 30-Day Mortality After Transfemoral Transcatheter Aortic Valve Replacement

This study sought to better understand out-of-hospital 30-day mortality following transfemoral transcatheter aortic valve replacement (TAVR) and identify factors associated with poor outcomes. Despite improvements in outcomes with TAVR for severe aortic stenosis, out-of-hospital 30-day mortality has not been evaluated. This study examined patients in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry undergoing TAVR for severe aortic stenosis from January 2015 to March 2018. Primary and secondary endpoints were 30-day out-of-hospital all-cause mortality and out-of-hospital cardiovascular mortality, respectively. Logistic regression models were used to assess association between pre-specified factors and endpoints. A total of 106,749 patients underwent TAVR and were eligible for analysis. Transfemoral TAVR was performed in 92.3% of patients. A total of 2,137 (2.2%) transfemoral patients died within 30days of the procedure, and 623 (29%) patients of these patients experienced out-of-hospital 30-day mortality. Cardiovascular and pulmonary etiologies accounted for the majority of observed mortality. Multivariable regression analysis identified older age, gender, lower body surface area, lower left ventricular ejection fraction, lower hemoglobin, atrial fibrillation or flutter, severe lung disease, home oxygen use, lack of moderate-to-severe aortic insufficiency, urgent TAVR, lower Kansas City Cardiomyopathy Questionnaire score, longer hospital length of stay, and in-hospital complications as being independently associated with the primary endpoint. New onset or pre-existent atrial fibrillation or flutter was also independently associated with 30-day out-of-hospital cardiovascular mortality in the transfemoral population. We identified 30-day all-cause mortality rate for TAVR of 2.2%. Approximately one-third of patients experienced out-of-hospital mortality at 30days. Several factors were identified as being independently associated with30-day out-of-hospital all-cause and cardiovascular mortality. Further work is needed to understand how besttoimprove out-of-hospital mortality following TAVR.

Temporal trends and outcomes in utilisation of transcatheter and surgical aortic valve therapies in aortic valve stenosis patients with heart failure.

Heart failure (HF) is a common comorbidity in patients undergoing surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). We sought to access the temporal trends and outcomes of TAVR or SAVR in HF patients. The NIS database from 2011-2014 was queried for patients that underwent TAVR or SAVR and were subsequently diagnosed with HF. Temporal trends in the utilisation of TAVR or SAVR in HF patients were analysed. Among 27982 patients who were diagnosed with HF of whom 17681 (63.2%) had heart failure with reduced ejection fraction (HFrEF) while 10301 (36.8%) had heart failure with preserved ejection fraction (HFpEF), 9049 (32.3%) underwent TAVR and 16933 (76.7%) underwent SAVR. Patients with HFrEF and HFpEF had higher utilisation of TAVR compared with SAVR over the course of the study period (P trend<.001). TAVR was associated with lower mortality [2.8% in 2012 and 1.8% in 2014 (P .013)] compared with SAVR. Similarly, multiple logistic regression showed a statistically significant lower in-hospital mortality in the TAVR group compared with SAVR (aOR 0.634; CI 0.504, 0.798, P<.001). For patients with severe aortic valve stenosis and heart failure who undergo aortic valve intervention, TAVR is associated with less odds of in-hospital mortality compared with SAVR.