Transcatheter Valve Therapy Registry Research Articles

Temporal Trends, Outcomes, and Predictors of Next-Day Discharge and Readmission Following Uncomplicated Evolut Transcatheter Aortic Valve Replacement: A Propensity Score-Matched Analysis.

Next-day discharge (NDD) outcomes following uncomplicated self-expanding transcatheter aortic valve replacement have not been studied. Here, we compare readmission rates and clinical outcomes in NDD versus non-NDD transcatheter aortic valve replacement with Evolut. Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry patients (n=29 597) undergoing elective transcatheter aortic valve replacement with self-expanding supra-annular valves (Evolut R, PRO, and PRO+) from July 2019 to June 2021 were stratified by postprocedure length of stay: ≤1 day (NDD) versus >1 day (non-NDD). Propensity score matching was used to compare risk adjusted 30-day readmission rates and 1-year outcomes in NDD versus non-NDD, and multivariable regression to determine predictors of NDD and readmission. Between the first and last calendar quarter, the rate of NDD increased from 45.4% to 62.1% and median length of stay decreased from 2 days to 1. Propensity score matching produced relatively well-matched NDD and non-NDD cohorts (n=10 549 each). After matching, NDD was associated with lower 30-day readmission rates (6.3% versus 8.4%; P<0.001) and 1-year adverse outcomes (death, 7.0% versus 9.3%; life threatening/major bleeding, 1.6% versus 3.4%; new permanent pacemaker implantation/implantable cardioverter-defibrillator, 3.6 versus 11.0%; [all P<0.001]). Predictors of NDD included non-Hispanic ethnicity, preexisting permanent pacemaker implantation/implantable cardioverter-defibrillator, and previous surgical aortic valve replacement. Most patients undergoing uncomplicated self-expanding Evolut transcatheter aortic valve replacement are discharged the next day. This study found that NDD can be predicted from baseline patient characteristics and was associated with favorable 30-day and 1-year outcomes, including low rates of permanent pacemaker implantation and readmission.

Transcarotid versus transfemoral transcatheter aortic valve replacement: A systematic review and meta-analysis

BackgroundIn the 2021 Transcatheter Valve Therapy (TVT) registry, 8.9 % of patients underwent TAVR via access sites other than the femoral artery. Transthoracic approaches may be contraindicated in some patients and may be associated with poorer outcomes. Therefore other alternative access routes are increasingly being performed. We conducted a systematic review of the literature on transcarotid transcatheter aortic valve replacement (TC-TAVR) and meta-analysis comparing outcomes of TC-TAVR and other access routes. MethodsWe comprehensively searched for controlled randomized and non-randomized studies from 4 online databases. We presented data using risk ratios (95 % confidence intervals) and measured heterogeneity using Higgins' I2. ResultsSixteen observational studies on transcarotid TAVR were included in the analysis; 4 studies compared TC-TAVR vs TF-TAVR. The mean age and STS score for patients undergoing TC-TAVR were 80 years and 7.6 respectively. For TF-TAVR patients, mean age and STS score were 81.2 years and 6.5 respectively. There was no difference between patients undergoing TC-TAVR and TF-TAVR in the following 30-day outcomes: MACE [8.4 % vs 6.7 %; OR 1.32 (95 % CI 0.71–2.46 p = 0.38) I2 = 0 %], mortality [5.6 % vs 4.0 %; OR 0.42 (95 % CI 0.60–3.37, P = 0.42) I2 = 0 %] and stroke [0.7 % vs 2.3 %; OR 0.49 (95 % CI 0.09–2.56, P = 0.40) I2 = 0 %]. There was no difference in 30-day major vascular complications [0.7 % vs 3 %; OR 0.55 (95 % CI 0.06–5.29, P = 0.61) I2 = 39 %], major bleeding [0.7 % vs 3.8 %; OR 0.39 (95 % CI 0.09–1.67, P = 0.21) I2 = 0 %], and moderate or severe aortic valve regurgitation [8.6 % vs 9.9 %; OR 0.89 (95 % CI 0.48–1.65, P = 0.72) I2 = 0 %]. ConclusionThere are no significant differences in mortality, stroke MACE and major or life-threatening bleeding or vascular complications when TC-TAVR is compared to TF-TAVR approaches.

Comparison of Transcatheter Edge-to-Edge Mitral Valve Repair for Primary Mitral Regurgitation Outcomes to Hospital Volumes of Surgical Mitral Valve Repair.

Transcatheter edge-to-edge mitral valve (MV) repair (TEER) is an effective treatment for patients with primary mitral regurgitation at prohibitive risk for surgical MV repair (MVr). High-volume MVr centers and high-volume TEER centers have better outcomes than low-volume centers, respectively. However, whether MVr volume predicts TEER outcomes remains unknown. We hypothesized that high-volume MV surgical centers would have superior risk-adjusted outcomes for TEER than low-volume centers. We combined data from the American College of Cardiology/Society of Thoracic Surgeons Transcatheter Valve Therapy registry and the Society of Thoracic Surgeons adult cardiac surgery database. MVr was defined as leaflet resection or artificial chords with or without annuloplasty and was evaluated as a continuous variable and as predefined categories (<25, 25-49, and ≥50 MV repairs/year). A generalized linear mixed model was used to evaluate risk-adjusted in-hospital/30-day mortality, 30-day heart failure readmission, and TEER success (mitral regurgitation ≤2+ and gradient <5 mm Hg). The study comprised 41 834 patients from 500 sites of which 332 (66.4%) were low, 102 (20.4%) intermediate, and 66 (13.2%) high-volume surgical centers (P<0.001). TEER success was 54.6% and was not statistically significantly different across MV surgical site volumes (P=0.4271). TEER mortality at 30 days was 3.5% with no significant difference across MVr volume on unadjusted (P=0.141) or adjusted (P=0.071) analysis of volume as a continuous variable. One-year mortality was 15.0% and was lower for higher MVr volume centers when adjusted for clinical and demographic variables (P=0.027). Heart failure readmission at 1 year was 9.4% and was statistically significantly lower in high-volume centers on both unadjusted (P=0.017) or adjusted (P=0.015) analysis. TEER can be safely performed in centers with low volumes of MV repair. However, 1-year mortality and heart failure readmission are superior at centers with higher MVr volume.

Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States

BackgroundThe fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported. ObjectivesThe aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR). MethodsPatients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes. Results10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve area (2.1 ± 0.7 cm2 vs 1.9 ± 0.6 cm2; P < 0.0001) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001). ConclusionsS3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.

National Variability in Pacemaker Implantation Rate Following TAVR: Insights From the STS/ACC TVT Registry

BackgroundAlthough permanent pacemaker (PPM) implantation is a common complication of transcatheter aortic valve replacement (TAVR), hospital variation and change in PPM implantation rates are ill defined. ObjectivesThe aim of this study was to determine hospital-level variation and temporal trends in the rate of PPM implantation following TAVR. MethodsUsing the American College of Cardiology/Society of Thoracic Surgeons TVT (Transcatheter Valve Therapy) Registry, temporal changes in variation of in-hospital and 30-day PPM implantation were determined among 184,452 TAVR procedures across 653 sites performed from 2016 to 2020. The variation in PPM implantation adjusted for valve type by annualized TAVR volume was determined, and characteristics of sites below, within, and above the 95% boundary were identified. A series of stepwise multivariable hierarchical models were then fit, and the median OR was used to measure variation in pacemaker rates among sites. ResultsFrom 2016 to 2020, the overall rate of PPM implantation was 11.3%, with wide variation across sites (range: 0%-36.4%); rates trended lower over time. Adjusted for annualized volume, there were 34 sites with PPM implantation rates above the 95th percentile CI and 28 with rates below, with wide variation among the remaining sites. After adjusting for patient-level covariates, there was variation among sites in the probability of PPM implantation (median OR: 1.39; 95% CI: 1.35-1.43, P < 0.001); although some of the variation was explained by the addition of valve type, residual variation in PPM implantation rates persisted in additional models incorporating site-level covariates (annualized volume, region, teaching status, hospital beds, etc). ConclusionsAlthough PPM implantation rates have decreased over time, substantial site-level variation remains even after accounting for observed patient characteristics and site-level factors. As there are numerous outlier sites both above and below the 95% confidence limit, dissemination of best practices from high-performing sites to low-performing sites and guideline-based education may be important quality improvement initiatives to reduce rates of this common complication.

Heart failure medical therapy and outcomes in patients undergoing transcatheter mitral valve repair for secondary mitral regurgitation: a TVT Registry analysis across 449 US centers

Abstract Background Guidelines recommend medical therapy optimization prior to transcatheter mitral valve repair (TMVr) in patients with heart failure (HF), left ventricular ejection fraction (LVEF) &amp;lt;50%, and severe secondary mitral regurgitation (SMR). Whether TMVr is being performed on the background of optimal guideline directed medical therapy (GDMT) in clinical practice is unknown. Purpose To assess pre-procedure GDMT (B-blockers, ACEI [angiotensin converting enzyme inhibitor]/ARB [angiotensin receptor blocker], ARNI [angiotensin receptor neprilysin inhibitor], MRA [mineralocorticoid receptor antagonist]) use and association with outcomes in patients with HF and LVEF &amp;lt;50% undergoing TMVr. Methods Patients with LVEF &amp;lt;50% who underwent TMVr for SMR from July 2019 – March 2022 in the Transcatheter Valve Therapy Registry were identified. Patients on inotropes or in shock pre-TMVr were excluded. Cox proportional hazards models were constructed to evaluate adjusted associations between pre-TMVr medical therapy (no, single, double, or triple therapy) and risk of the one-year composite outcome of mortality or HF hospitalization. Sensitivity analyses excluded patients with HF with mildly reduced ejection fraction (HFmrEF) (LVEF &amp;gt;40%) or New York Heart Association (NYHA) class I (asymptomatic) prior to TMVr. Results A total of 4,199 patients across 449 sites were identified. Prior to TMVr, B-blockers (85.1%) were prescribed most frequently, followed by ACEI/ARB (44.4%), MRA (28.6%), and ARNI (19.9%). Triple therapy was prescribed for 19.2% of patients, while 38.2% were on double therapy, 36.0% were on single therapy, and 6.5% were on no medical therapy. Triple therapy use varied from 0 - 61% across sites with an adjusted median odds ratio of 1.48 (95% confidence interval [CI] 1.25-3.88, P&amp;lt;0.001), suggesting a 1.5-fold variation in the likelihood that similar risk patients at 2 random US sites received triple therapy pre-TMVr (Figure 1). In patients with one-year follow-up available (n=2,014, 341 sites), the composite rate of one-year mortality or HF hospitalization was lowest in patients on triple therapy (23.1%) compared with double (24.8%), single (35.7%), and no (41.1%) therapy (P≤0.01). Associations persisted after accounting for clinically relevant covariates, with lower risk in patients on triple therapy (adjusted hazard ratio [aHR] 0.73, 95% CI 0.55-0.97) and double therapy (aHR 0.60, 95% CI 0.50-0.74) prior to TMVr compared with no/single therapy. Results were similar when only patients with symptomatic HFrEF were considered (i.e., those with HFmrEF or NYHA class I pre-TMVr were excluded) (Figure 2). Conclusions Under one-fifth of patients who underwent TMVr for SMR were prescribed comprehensive GDMT, with substantial variation across clinical sites. Compared with no or single therapy, triple and double therapy use prior to TMVr was independently associated with reduced risk of mortality or HF hospitalization one-year after intervention.Figure 1Figure 2

Association Between Polyvascular Disease and Transcatheter Aortic Valve Replacement Outcomes: Insights From the STS/ACC TVT Registry.

Atherosclerotic cardiovascular disease is highly prevalent in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Polyvascular disease (PVD), defined as involvement of ≥2 vascular beds (VBs), that is, coronary, cerebrovascular, or peripheral, portends a poor prognosis in patients with atherosclerotic cardiovascular disease; however, data on the association of PVD with outcomes of patients undergoing TAVR are limited. The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy Registry was analyzed to identify patients who underwent TAVR from November 2011 to March 2022. The exposure of interest was PVD. The primary outcome was all-cause mortality. Secondary outcomes included major vascular complications, major/life-threatening bleeding, myocardial infarction, transient ischemic attack/stroke, and valve- and non-valve-related readmissions. Outcomes were assessed at 30 days and 1 year. Of 443 790 patients who underwent TAVR, PVD was present in 150 823 (34.0%; 111 425 [25.1%] with 2VB-PVD and 39 398 [8.9%] with 3VB-PVD). On multivariable analysis, PVD was associated with increased all-cause mortality at 1 year (hazard ratio, 1.17 [95% CI, 1.14-1.20]). There was an incremental increase in 1-year mortality with an increasing number of VBs involved (no PVD [reference]; 2VB-PVD: hazard ratio, 1.12 [95% CI, 1.09-1.15]: and 3VB-PVD: hazard ratio, 1.31 [95% CI, 1.26-1.36]). Patients with versus without PVD had higher rates of major vascular complications, major/life-threatening bleeding, transient ischemic attack/stroke, and non-valve-related readmissions at 30 days and 1 year. PVD is associated with worse outcomes after TAVR, and the risk is highest in patients with 3VB-PVD.

Procedural Volume and Outcomes of Transfemoral Transcatheter Aortic Valve Replacement: From a Japanese Nationwide Registry

The impact of procedural volume on transcatheter aortic valve replacement (TAVR) outcomes in Japan remains uncertain. Japan has carefully introduced TAVR after the establishment of techniques in Western countries and therefore may not exhibit volume-outcome relations after TAVR. Data on transfemoral TAVR was collected from the Japan Transcatheter Valve Therapy (J-TVT) registry between 2018 and 2020. Hospitals were categorized into quartiles (lowest, lower, high, and highest) based on annual TAVR volume. The primary analysis compared 30-day mortality among different TAVR volume hospitals. A multivariable adjustment analysis was performed to calculate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) of 30-day all-cause mortality with highest-volume hospital as the reference. A total of 2,741 transfemoral TAVR cases from 172 hospitals were included in the analysis. Median hospital TAVR volume was 38 (interquartile range 27 to 60) per year. Unadjusted 30-day mortality was 0.46%, 0.69%, 1.17%, and 1.18% from the lowest to the highest quartile of hospitals, respectively. There was no significant difference in 30-day mortality rates for lowest-volume hospitals (aOR 0.51, 95% CI 0.24 to 1.05, p=0.07), low-volume hospitals (aOR 0.76, 95% CI 0.46 to 1.26, p=0.29), or high-volume hospitals (aOR 1.11, 95% CI 0.74 to 1.67, p=0.60). An analysis from the contemporary national registry in Japan did not find an obvious inverse relation between annual hospital volume and 30-day mortality. Our results suggest that TAVR has now reached a level of procedural maturity, with standardized outcomes observed across hospitals regardless of their annual procedural volume.

Echocardiographic and Clinical Outcomes in Symptomatic Patients With Less Than Severe Aortic Stenosis After Supra-Annular Self-Expanding Transcatheter Aortic Valve Replacement

Optimal timing for aortic valve replacement in symptomatic patients with less than severe aortic stenosis (AS) is not well defined. There is limited information on the benefit of valve replacement in these patients. Symptomatic patients with less than severe AS, defined as a mean aortic gradient ≥20 and <40mm Hg, peak aortic velocity >3 and <4m/s, and aortic valve area >1.0 and <1.5cm2, enrolled in the Society for Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry and who underwent attempted supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) were reviewed. Site-reported valve hemodynamics, clinical events, and quality of life metrics were analyzed at 30days and 1year after the procedure. A total of 1,067 patients with attempted TAVR (mean age 78.4 ± 8.4years; Society for Thoracic Surgery score 4.7 ± 3.4%) were found to have symptoms but less than severe AS. From baseline to postprocedure, mean gradient decreased (29.9 ± 4.9 vs 8.4 ± 4.8mm Hg, p <0.001), and aortic valve area increased (1.2 ± 0.1 vs 2.2 ± 0.7cm2, p <0.001). Clinical events included 30-day and 1-year all-cause mortality (1.5% and 9.6%), stroke (2.2% and 3.3%), and new pacemaker implantation (18.1% and 20.9%). There were statistically significant improvements in the New York Heart Association functional class and Kansas City Cardiomyopathy Questionnaire at 30days and 1year. In conclusion, patients with symptomatic but less than severe AS who underwent supra-annular, self-expanding TAVR experienced improved valve hemodynamics and quality of life measures 1year after the procedure. Randomized studies of TAVR versus a control arm in symptomatic patients with less than severe AS are ongoing.

Transcarotid versus transaxillary access for transcatheter aortic valve replacement with a self-expanding valve: Apropensity-matched analysis.

The Transcatheter Valve Therapy Registry was queried for TAVR procedures using transaxillary and transcarotid access between July 2015 and June 2021. Patients received a self-expanding Evolut R, PRO, or PRO+valve (Medtronic) and had 1-year follow-up. Thirty-day and 1-year outcomes were compared in transcarotid and transaxillary groups after 1:2 propensity score-matching. Multivariable regression models were fitted to identify predictors of key end points. The propensity score-matched cohort included 576 patients receiving transcarotid and 1142 receiving transaxillary access. Median procedure time (99 vs 118 minutes; P<.001) and hospital stay (2 vs 3days; P<.001) were shorter with transcarotid versus transaxillary access. At 30days, patients with transcarotid access had similar mortality (Kaplan-Meier estimates 3.7% vs 4.3%, P=.57) but significantly lower stroke (3.1% vs 5.9%; P=.017) and mortality or stroke (6.0% vs 8.9%; P=.033) compared with patients receiving transaxillary access. Similar differences were observed at 1year. Transaxillary access was associated with increased risk of 30-day stroke (hazard ratio, 2.14; 95% confidence interval, 1.27-3.58) by multivariable regression analysis. Transcarotid versus transaxillary access for TAVR using a self-expanding valve is associated with procedural benefits and significantly lower stroke and mortality or stroke at 30days. In patients with unsuitable femoral anatomy, transcarotid access may be the preferred delivery route for self-expanding valves.

TCT-111 Impact of Race and Sex on Outcomes of Transcatheter Mitral Valve Repair: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry

TCT-111 Impact of Race and Sex on Outcomes of Transcatheter Mitral Valve Repair: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry

Transcatheter Edge-to-Edge Repair in 5,000 Patients With Secondary Mitral Regurgitation: COAPT Post-Approval Study

BackgroundReal-world applicability of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) randomized controlled trial (RCT) has been debated because of careful patient selection and the contrasting results of the MITRA-FR (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients with Severe Secondary Mitral Regurgitation) RCT. ObjectivesThe COAPT-PAS (COAPT Post-Approval Study) was initiated to assess the safety and effectiveness of the MitraClip in patients with secondary mitral regurgitation (SMR). MethodsCOAPT-PAS is a prospective, single-arm, observational study of 5,000 consecutive patients with SMR treated with the MitraClip at 406 U.S. centers participating in the TVT (Transcatheter Valve Therapy) registry from 2019 to 2020. The 1-year outcomes from the COAPT-PAS full cohort and the COAPT-like and MITRA-FR–like subgroups who met RCT inclusion/exclusion criteria are reported. ResultsPatients in the COAPT-PAS had more comorbidities, more severe HF and functional limitations, and less guideline-directed medical therapy than those in the COAPT or MITRA-FR RCTs. Patients in the COAPT-PAS full cohort and the COAPT-like (n = 991) and MITRA-FR–like (n = 917) subgroups achieved a 97.7% MitraClip implant rate, a similar and durable reduction of mitral regurgitation to ≤2+ at 1 year (90.7%, 89.7%, and 86.6%, respectively), a large improvement in quality of life at 1 year (Kansas City Cardiomyopathy Questionnaire +29 COAPT-PAS, +27 COAPT-like, and +33 MITRA-FR–like), faster procedure times, similar or lower clinical event rates compared with the RCTs’ MitraClip arms, and lower clinical event rates than the RCTs’ guideline-directed medical therapy only arms. One-year heart failure hospitalizations was 18.9% in COAPT-PAS, 19.7% in COAPT-like compared with 24.9% in COAPT-RCT, and 28.7% in COAPT-PAS-MITRA-FR–like compared with 47.4% in MITRA-FR-RCT. ConclusionsThis large, contemporary, real-world study reinforces the safety and effectiveness of the MitraClip System in patients with SMR, including those who met the COAPT or MITRA-FR RCT inclusion/exclusion criteria and patients excluded from the RCTs.

Outcomes of repeat transcatheter aortic valve replacement with balloon-expandable valves: a registry study

With increasing numbers of patients undergoing transcatheter aortic valve replacement (TAVR), data on management of failed TAVR, including repeat TAVR procedure, are needed. The aim of this study was to assess the safety and efficacy of redo-TAVR in a national registry. This study included all consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from Nov 9, 2011, to Dec 30, 2022 who underwent TAVR with balloon-expandable valves in failed transcatheter heart valves (redo-TAVR) or native aortic valves (native-TAVR). Procedural, echocardiographic, and clinical outcomes were compared between redo-TAVR and native-TAVR cohorts using propensity score matching. Among 350 591 patients (1320 redo-TAVR; 349 271 native-TAVR), 1320 propensity-matched pairs of patients undergoing redo-TAVR and native-TAVR were analysed (redo-TAVR cohort: mean age 78 years [SD 9]; 559 [42·3%] of 1320 female, 761 [57·7%] male; mean predicted surgical risk of 30-day mortality 8·1%). The rates of procedural complications of redo-TAVR were low (coronary compression or obstruction: four [0·3%] of 1320; intraprocedural death: eight [0·6%] of 1320; conversion to open heart surgery: six [0·5%] of 1319) and similar to native-TAVR. There was no significant difference between redo-TAVR and native-TAVR populations in death at 30 days (4·7% vs 4·0%, p=0·36) or 1 year (17·5% vs 19·0%, p=0·57), and stroke at 30 days (2·0% vs 1·9%, p=0·84) or 1 year (3·2% vs 3·5%, p=0·80). Redo-TAVR reduced aortic valve gradients at 1 year, although they were higher in the redo-TAVR group compared with the native-TAVR group (15 mm Hg vs 12 mm Hg; p<0·0001). Moderate or severe aortic regurgitation rates were similar between redo-TAVR and native-TAVR groups at 1 year (1·8% vs 3·3%, p=0·18). Death or stroke after redo-TAVR were not significantly affected by the timing of redo-TAVR (before or after 1 year of index TAVR), or by index transcatheter valve type (balloon-expandable or non-balloon-expandable). Redo-TAVR with balloon-expandable valves effectively treated dysfunction of the index TAVR procedure with low procedural complication rates, and death and stroke rates similar to those in patients with a similar clinical profile and predicted risk undergoing TAVR for native aortic valve stenosis. Redo-TAVR with balloon-expandable valves might be a reasonable treatment for failed TAVR in selected patients. Edwards Lifesciences.

Heart failure medical therapy prior to mitral transcatheter edge-to-edge repair: the STS/ACC Transcatheter Valve Therapy Registry.

Guideline-directed medical therapy (GDMT) is recommended before mitral valve transcatheter edge-to-edge repair (MTEER) in patients with heart failure (HF) and severe functional mitral regurgitation (FMR). Whether MTEER is being performed on the background of optimal GDMT in clinical practice is unknown. Patients with left ventricular ejection fraction (LVEF) < 50% who underwent MTEER for FMR from 23 July 2019 to 31 March 2022 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were identified. Pre-procedure GDMT utilization was assessed. Cox proportional hazards models were constructed to evaluate associations between pre-MTEER therapy (no/single, double, or triple therapy) and risk of 1-year mortality or HF hospitalization (HFH). Among 4199 patients across 449 sites, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, mineralocorticoid receptor antagonists, and angiotensin receptor-neprilysin inhibitors were used in 85.1%, 44.4%, 28.6%, and 19.9% before MTEER, respectively. Triple therapy was prescribed for 19.2%, double therapy for 38.2%, single therapy for 36.0%, and 6.5% were on no GDMT. Significant centre-level variation in the proportion of patients on pre-intervention triple therapy was observed (0%-61%; adjusted median odds ratio 1.48 [95% confidence interval (CI) 1.25-3.88]; P < .001). In patients eligible for 1-year follow-up (n = 2014; 341 sites), the composite rate of 1-year mortality or HFH was lowest in patients prescribed triple therapy (23.0%) compared with double (24.8%), single (35.7%), and no (41.1%) therapy (P < .01 comparing across groups). Associations persisted after accounting for relevant clinical characteristics, with lower risk in patients prescribed triple therapy [adjusted hazard ratio (aHR) 0.73, 95% CI .55-.97] and double therapy (aHR 0.69, 95% CI .56-.86) before MTEER compared with no/single therapy. Under one-fifth of patients with LVEF <50% who underwent MTEER for FMR in this US nationwide registry were prescribed comprehensive GDMT, with substantial variation across sites. Compared with no/single therapy, triple and double therapy before MTEER were independently associated with reduced risk of mortality or HFH 1 year after intervention.

Mediators of Improvement in TAVR Outcomes Over Time: Insights From the STS-ACC TVT Registry.

Over the past decade, there has been substantial improvement in outcomes after transcatheter aortic valve replacement. Many patient and procedural factors have also changed over that time, making it challenging to untangle the drivers of those improvements. Among patients who underwent transcatheter aortic valve replacement from 2012 to 2018 within the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry, we examined the relative contribution of changes in patient factors, device modifications, improving experience/skill, and advances in periprocedural care to the observed improvement in outcomes after transcatheter aortic valve replacement. Mediator clusters included demographics, noncardiovascular comorbidities, cardiovascular comorbidities, device-related factors, and nondevice-related procedural factors. Using logistic regression, we serially adjusted for the mediator clusters to examine the contribution of each to the observed improvement in outcomes over time. Among 161 196 patients treated with transcatheter aortic valve replacement at 596 sites, outcomes improved steadily from 2012 to 2018, including 30-day mortality (6.7% to 2.4%), 30-day composite adverse events (25.3% to 10.5%), and 1-year mortality (19.9% to 10.1%; all P<0.001). In sequential models, the unadjusted odds ratio for 30-day mortality was 0.82 per year (95% CI, 0.80-0.84), which was progressively attenuated with addition of each covariate cluster. Most of the improvement was explained by device factors and nondevice procedural factors. Results were similar for 30-day composite adverse events, although the observed temporal improvement was not fully explained by measured factors, suggesting improved technical skill as an additional mediator. In contrast to 30-day outcomes, each cluster of patient and procedural factors contributed similarly to the temporal improvement in 1-year mortality, indicating a greater impact of patient factors on longer-term outcomes. While US patients undergoing transcatheter aortic valve replacement have become younger, healthier, and lower risk over time, the most important factors contributing to improvements in short-term outcomes relate to advances in device technology and procedural factors, whereas changing patient characteristics had a greater impact on improvement in 1-year outcomes.

Outcomes of transcatheter aortic valve replacement in patients with cardiogenic shock.

The safety and efficacy of transcatheter aortic valve replacement (TAVR) with contemporary balloon expandable transcatheter valves in patients with cardiogenic shock (CS) remain largely unknown. In this study, the TAVRs performed for CS between June 2015 and September 2022 using SAPIEN 3 and SAPIEN 3 Ultra bioprosthesis from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were analysed. CS was defined as: (i) coding of CS within 24 h on Transcatheter Valve Therapy Registry form; and/or (ii) pre-procedural use of inotropes or mechanical circulatory support devices and/or (iii) cardiac arrest within 24 h prior to TAVR. The control group was comprised of all the other patients undergoing TAVR. Baseline characteristics, all-cause mortality, and major complications at 30-day and 1-year outcomes were reported. Landmark analysis was performed at 30 days post-TAVR. Cox-proportional multivariable analysis was performed to determine the predictors of all-cause mortality at 1 year. A total of 309 505 patients underwent TAVR with balloon-expandable valves during the study period. Of these, 5006 patients presented with CS prior to TAVR (1.6%). The mean Society of Thoracic Surgeons score was 10.76 ± 10.4. The valve was successfully implanted in 97.9% of patients. Technical success according to Valve Academic Research Consortium-3 criteria was 94.5%. In a propensity-matched analysis, CS was associated with higher in-hospital (9.9% vs. 2.7%), 30-day (12.9% vs. 4.9%), and 1-year (29.7% vs. 22.6%) mortality compared to the patients undergoing TAVR without CS. In the landmark analysis after 30 days, the risk of 1-year mortality was similar between the two groups [hazard ratio (HR) 1.07, 95% confidence interval (CI) 0.95-1.21]. Patients who were alive at 1 year noted significant improvements in functional class (Class I/II 89%) and quality of life (ΔKCCQ score +50). In the multivariable analysis, older age (HR 1.02, 95% CI 1.02-1.03), peripheral artery disease (HR 1.25, 95% CI 1.06-1.47), prior implantation of an implantable cardioverter-defibrillator (HR 1.37, 95% CI 1.07-1.77), patients on dialysis (HR 2.07, 95% CI 1.69-2.53), immunocompromised status (HR 1.33, 95% CI 1.05-1.69), New York Heart Association class III/IV symptoms (HR 1.50, 95% CI 1.06-2.12), lower aortic valve mean gradient, lower albumin levels, lower haemoglobin levels, and lower Kansas City Cardiomyopathy Questionnaire scores were independently associated with 1-year mortality. This large observational real-world study demonstrates that the TAVR is a safe and effective treatment for aortic stenosis patients presenting with CS. Patients who survived the first 30 days after TAVR had similar mortality rates to those who were not in CS.

Target Aortic Stenosis: A National Initiative to Improve Quality of Care and Outcomes for Patients With Aortic Stenosis.

Target Aortic Stenosis: A National Initiative to Improve Quality of Care and Outcomes for Patients With Aortic Stenosis.

Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation

There are limited data on the outcomes of transcatheter edge-to-edge mitral valve repair for degenerative mitral regurgitation (MR) in a real-world setting. To evaluate the outcomes of transcatheter mitral valve repair for degenerative MR. Cohort study of consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent nonemergent transcatheter mitral valve repair for degenerative MR in the US from 2014 through 2022. Transcatheter edge-to-edge mitral valve repair with the MitraClip device (Abbott). The primary end point was MR success, defined as moderate or less residual MR and a mean mitral gradient of less than 10 mm Hg. Clinical outcomes were evaluated based on the degree of residual MR (mild or less MR or moderate MR) and mitral valve gradients (≤5 mm Hg or >5 to <10 mm Hg). A total of 19 088 patients with isolated moderate to severe or severe degenerative MR who underwent transcatheter mitral valve repair were analyzed (median age, 82 years; 48% women; median Society of Thoracic Surgeons predicted risk of mortality with surgical mitral valve repair, 4.6%). MR success was achieved in 88.9% of patients. At 30 days, the incidence of death was 2.7%; stroke, 1.2%; and mitral valve reintervention, 0.97%. MR success compared with an unsuccessful procedure was associated with significantly lower mortality (14.0% vs 26.7%; adjusted hazard ratio, 0.49; 95% CI, 0.42-0.56; P < .001) and heart failure readmission (8.4% vs 16.9%; adjusted hazard ratio, 0.47; 95% CI, 0.41-0.54; P < .001) at 1 year. Among patients with MR success, the lowest mortality was observed in patients who had both mild or less residual MR and mean mitral gradients of 5 mm Hg or less compared with those with an unsuccessful procedure (11.4% vs 26.7%; adjusted hazard ratio, 0.40; 95% CI, 0.34-0.47; P < .001). In this registry-based study of patients with degenerative MR undergoing transcatheter mitral valve repair, the procedure was safe and resulted in successful repair in 88.9% of patients. The lowest mortality was observed in patients with mild or less residual MR and low mitral gradients.

Modeling the Association of Volume vs Composite Outcome Thresholds With Outcomes and Access to Transcatheter Aortic Valve Implantation in the US

Professional societies and the Centers for Medicare & Medicaid Services suggest volume thresholds to ensure quality in transcatheter aortic valve implantation (TAVI). To model the association of volume thresholds vs spoke-and-hub implementation of outcome thresholds with TAVI outcomes and geographic access. This cohort study included patients who enrolled in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry. Site volume and outcomes were determined from a baseline cohort of adults undergoing TAVI between July 1, 2017, and June 30, 2020. Within each hospital referral region, TAVI sites were categorized by volume (<50 or ≥50 TAVIs per year) and separately by risk-adjusted outcome on the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy 30-day TAVI composite during the baseline period (July 2017 to June 2020). Outcomes of patients undergoing TAVIs from July 1, 2020, to March 31, 2022, were then modeled as though the patients had been treated at (1) the nearest higher volume (≥50 TAVIs per year) or (2) the best outcome site within the hospital referral region. The primary outcome was the absolute difference in events between the adjusted observed and modeled 30-day composite of death, stroke, major bleeding, stage III acute kidney injury, and paravalvular leak. Data are presented as the number of events reduced under the above scenarios with 95% bayesian credible intervals (CrIs) and median (IQR) driving distance. The overall cohort included 166 248 patients with a mean (SD) age of 79.5 (8.6) years; 74 699 (47.3%) were female and 6657 (4.2%) were Black; 158 025 (95%) were treated in higher-volume sites (≥50 TAVIs) and 75 088 (45%) were treated in best-outcome sites. Modeling a volume threshold, there was no significant reduction in estimated adverse events (-34; 95% CrI, -75 to 8), while the median (IQR) driving time from the existing site to the alternate site was 22 (15-66) minutes. Transitioning care to the best outcome site in a hospital referral region resulted in an estimated 1261 fewer adverse outcomes (95% CrI, 1013-1500), while the median (IQR) driving time from the original site to the best site was 23 (15-41) minutes. Directionally similar findings were observed for Black individuals, Hispanic individuals, and individuals from rural areas. In this study, compared with the current system of care, a modeled outcome-based spoke-and-hub paradigm of TAVI care improved national outcomes to a greater extent than a simulated volume threshold, at the cost of increased driving time. To improve quality while maintaining geographic access, efforts should focus on reducing site variation in outcomes.

Outcomes of Adults with Severe Aortic Stenosis Undergoing Urgent or Emergent vs. Elective Transcatheter Aortic Valve Replacement Within an Integrated Health Care Delivery System

BackgroundTranscatheter aortic valve replacement (TAVR) may be used to urgently or emergently treat severe aortic stenosis, but outcomes for this high-risk population have not been well-characterized. We sought to describe the incidence, clinical characteristics, and outcomes of patients undergoing urgent or emergent vs. elective TAVR. MethodsWe identified all adults who received TAVR for primary aortic stenosis between 2013 and 2019 within an integrated health care delivery system in Northern California. Elective or urgent/emergent procedure status was based on standard Society of Thoracic Surgeons definitions. Data were obtained from electronic health records, the Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry, and state/national reporting databases. Logistic regression and Cox proportional hazard models were performed. ResultsAmong 1564 eligible adults that underwent TAVR, 81 (5.2%) were classified as urgent/emergent. These patients were more likely to have heart failure (63.0% vs. 47.4%), reduced left ventricular ejection fraction (21.0% vs. 11.8%), or a prior aortic valve balloon valvuloplasty (13.6% vs. 5.0%) and experienced higher unadjusted rates of 30-day and 1-year morbidity and mortality. Urgent/emergent TAVR status was independently associated with non-improved quality of life at 30-days (hazard ratio, 4.87; p < 0.01) and acute kidney injury within 1-year post-TAVR (hazard ratio, 2.11; p = 0.01). There was not a significant difference in adjusted 1-year mortality with urgent/emergent TAVR. ConclusionsUrgent/emergent TAVR status was uncommon and associated with high-risk clinical features and higher unadjusted rates of short- and long-term morbidity and mortality. Procedure status may be useful to identify patients less likely to experience significant short term improvement in health-related quality of life post-TAVR.