BACKGROUND: Cardiac conduction disturbances remain the most frequent complication of transcatheter aortic valve replacement (TAVR), but the clinical implications of new left bundle branch block (LBBB) after TAVR remain c...BACKGROUND: Cardiac conduction disturbances remain the most frequent complication of transcatheter aortic valve replacement (TAVR), but the clinical implications of new left bundle branch block (LBBB) after TAVR remain controversial. Here, we aim to assess the impact of new LBBB after TAVR on patient outcomes in a large, real-world registry. METHODS: The study population consisted of patients in the TVT registry (Society of Thoracic Surgery and American College of Cardiology Transcatheter Valve Therapy Registry) who underwent TAVR for aortic stenosis between 2016 and 2022 and were discharged alive from the index hospitalization. Key exclusion criteria included preexisting conduction defects and a permanent pacemaker before TAVR or during the index hospitalization. Clinical outcomes were compared between patients with and without new LBBB using Cox proportional hazards models adjusted for baseline demographic, clinical, and echocardiographic variables. RESULTS: Among 202 533 TAVR recipients, 32 933 (16.3%) developed new LBBB after TAVR. Over the study period, there was a significant decrease in the incidence of new LBBB from 19.9% in the first quarter of 2016 to 14.4% in the third quarter of 2022. Patients with new LBBB after TAVR, compared with those without LBBB, had significantly greater 1-year all-cause mortality (adjusted hazard ratio, 1.19 [95% CI, 1.13-1.25]; <0.001), hospital readmission (adjusted hazard ratio, 1.23 [95% CI, 1.19-1.28]; <0.001), and new pacemaker requirement (adjusted hazard ratio, 3.50 [95% CI, 3.26-3.76]; <0.001). Patients with new LBBB also had lower Kansas City Cardiomyopathy Questionnaire Overall Summary scores (adjusted difference, -1.7 points [95% CI, -2.1 to -1.3]; <0.001) and left ventricular ejection fraction (adjusted difference, -2.8% [95% CI, -3.4% to -2.2%]; <0.001). CONCLUSIONS: New LBBB after TAVR is associated with worse 1-year outcomes, including death, rehospitalization, and permanent pacemaker, as well as worse health status and lower left ventricular ejection fraction. These findings suggest that continued efforts to limit the development of conduction disturbance after TAVR are warranted.
BACKGROUND: Heart failure (HF) remains a significant burden following transcatheter aortic valve replacement, adversely impacting survival and quality of life. Identification of patients who may benefit from closer monit...BACKGROUND: Heart failure (HF) remains a significant burden following transcatheter aortic valve replacement, adversely impacting survival and quality of life. Identification of patients who may benefit from closer monitoring or adjunctive medical therapy to reduce the risk of HF is an unmet need. The objective of this study was to develop and internally validate a clinical prediction model to determine the 1-year risk of HF hospitalization or death after transcatheter aortic valve replacement. METHODS: Using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, we analyzed patients who underwent successful transcatheter aortic valve replacement for aortic stenosis and survived to discharge between 2016 and 2019. Covariates were selected based on expert opinion and prior literature. A hierarchical cumulative odds regression model was used to predict a composite outcome of (1) all-cause death, (2) ≥2 HF readmissions, or (3) 1 HF readmission at 1 year. RESULTS: Among 78 384 patients (median age, 82 years; 45.6% female), 17.4% experienced the composite outcome, including death (10.9%), ≥2 HF readmissions (1.6%), and 1 HF readmission (4.9%). The model demonstrated good discrimination (C statistic, 0.753 derivation and 0.747 validation) and excellent calibration. Among 1-year survivors, performance in predicting HF readmission as an isolated outcome was similar (C statistic, 0.753). A simplified model, including the top 12 variables from the full model, maintained comparable performance (C statistics, 0.74-0.75). CONCLUSIONS: This prediction model effectively stratifies post-transcatheter aortic valve replacement patients by risk of death or HF readmission, supporting its use to guide clinical surveillance and clinical trial enrollment for adjunctive medical therapies aimed at mitigating this risk.
BACKGROUND: Current national performance metrics rank transcatheter aortic valve replacement (TAVR) centers based on risk-adjusted outcomes. This could make operators/centers less inclined to offer TAVR in high-risk case...BACKGROUND: Current national performance metrics rank transcatheter aortic valve replacement (TAVR) centers based on risk-adjusted outcomes. This could make operators/centers less inclined to offer TAVR in high-risk cases. METHODS: We used simulation models based on registry data to explore whether avoiding high-risk TAVR cases would improve the hospitals' comparative risk-adjusted TAVR outcomes. This multicenter, retrospective cohort study included all adults (≥18 years) who underwent TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry in 2021. We evaluated hospital-level, risk-adjusted outcomes, before and after simulating the omission of the top 10% highest-risk patients. The primary outcome was a 30-day composite of death, stroke, VARC major/life-threatening/disabling bleeding, renal failure, or moderate/severe para-valvular leak. The secondary outcome was 30-day death. We used the mean difference±SD in the win ratio and observed/expected ratio for evaluation of the primary and secondary outcomes, respectively. RESULTS: There were 43 907 TAVR cases with available primary outcome data and 56 982 cases with available secondary outcome data. Median age was 79 (73-84) years, 57% were men, and 93% were White race. Our simulation demonstrates that, on average, excluding the top 10% highest-risk patients from centers' case mix would not change their hospital-level, risk-adjusted win ratio (mean difference, 0.002±0.067; =0.60) or observed/expected ratio (mean difference, -0.003±0.633; =0.90). CONCLUSIONS: Hospital-level, risk-adjusted TAVR outcomes did not consistently improve with simulated strategies of avoiding the highest-risk cases. Operators and centers can be reassured that they can continue to offer TAVR to high-risk patients, as clinically indicated, without the sole focus on being penalized via quality measures.
Fischer Q, Urena M, Veiga G
… +11 more, Nombela-Franco L, Muntané-Carol G, Regueiro A, Suc G, de la Torre Hernandez JM, Tirado-Conte G, Romaguera R, Cepas-Guillén P, Côté M, Philippon F, Rodés-Cabau J
Maehara A, Kirtane AJ, Généreux P
… +21 more, Matsumura M, Lewis BE, Shlofmitz RA, Dohad S, Choudary J, Dahle T, Pineda AM, Shunk KA, Popma A, Redfors B, Ali ZA, Krucoff MW, Armstrong EJ, Kandzari DE, Phalakornkule K, Kraemer C, Stiefel KM, Jones DE, Buccola JR, Chambers JW, Stone GW
BACKGROUND: The treatment of calcified coronary lesions requires optimal lesion preparation to achieve a larger minimal stent area (MSA), the strongest predictor of long-term outcomes. The comparative mechanisms of actio...BACKGROUND: The treatment of calcified coronary lesions requires optimal lesion preparation to achieve a larger minimal stent area (MSA), the strongest predictor of long-term outcomes. The comparative mechanisms of action of calcium-modifying therapies have not been well defined. METHODS: In a prospective, multicenter ECLIPSE trial (Evaluation of Treatment Strategies for Severe Calcific Coronary Arteries: Orbital Atherectomy Versus Conventional Angioplasty Technique Before Implantation of Drug-Eluting Stents), 2005 patients with severely calcified lesions were randomized to vessel preparation with orbital atherectomy (OA) versus balloon angioplasty (BA) before drug-eluting stent implantation. The primary end point of the optical coherence tomography (OCT) substudy was the MSA at the site of maximal calcification; MSA across the entire stent was also assessed. RESULTS: Postprocedural OCT images were available in 286 lesions in 276 patients treated with OA and 292 lesions in 279 patients treated with BA. By angiographic core laboratory analysis, 567 (98.1%) of lesions were severely calcified. By postprocedural OCT, the maximal calcium arc, maximal calcium thickness, and total calcium length measured 204° (149°-268°), 0.85 mm (°0.69-1.03°), and 22.0 (16.0-31.0) mm. Compared with BA, calcium modification was greater in the OA group (greater number, total length, and maximal depth of calcium fractures), especially in lesions with thicker calcium. Nonetheless, the MSA at the site of maximal calcification was large in both groups and not different (median [interquartile range], 7.44 [6.03-8.94] mm versus 7.05 [5.78-8.66] mm; =0.08). Similar results were observed for the MSA across the entire stent (5.86 [4.60-7.38] mm versus 5.57 [4.50-6.97] mm; =0.10). Among patients in the OCT substudy, 1-year target-vessel failure rates were low and not different between the groups (7.8% with OA and 6.6% with BA, =0.61). CONCLUSIONS: In lesions that are severely calcified by angiography, the extent of calcification by OCT was highly variable. Despite greater calcium modification after OA, the acute MSA and 1-year target-vessel failure rates were not different between OA and BA. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03108456.
So KC, Walters D, Meemook K
… +15 more, Xu J, Lai A, Chang CC, Ngernsritrakul T, Leelasithorn S, Thaw KM, Murdoch D, Lee CW, Kam KK, Scalia G, Yan BP, Lee AP, Tang GHL, Lam YY, Sung ASH
Haddad RN, Rouau Q, Albenque G
… +11 more, Cohen S, Radojevic J, Valdeolmillos E, Guirgis L, Fournier E, Chevalet V, Belli E, Petit J, Ladouceur M, Batteux C, Hascoët S
BACKGROUND: Self-expandable valves are emerging complements to balloon-expandable valves for transcatheter pulmonary valve replacement in dysfunctional right ventricular outflow tracts, though their safety and efficacy r...BACKGROUND: Self-expandable valves are emerging complements to balloon-expandable valves for transcatheter pulmonary valve replacement in dysfunctional right ventricular outflow tracts, though their safety and efficacy remain underexplored. We aim to compare patient characteristics and outcomes of self-expandable valves and balloon-expandable valves in transcatheter pulmonary valve replacement. METHODS: Baseline and early follow-up data were prospectively analyzed for 145 patients who underwent transcatheter pulmonary valve replacement with Edwards SAPIEN 3 (ES3) balloon-expandable valves or Venus-P self-expandable valves (January 2022-December 2024). An independent adjudication expert analyzed and classified adverse events. RESULTS: Cohort: 58.6% males, median weight of 65 kg, median age of 36.3 years; 64.1% of ES3, 35.9% of Venus-P. Tetralogy of Fallot was present in 55.2%, with native/patched right ventricular outflow tracts in 41.9% of ES3 and 100% of Venus-P cases (<0.001). Severe pulmonary regurgitation was found in 64.5% of ES3 and 100% of Venus-P (<0.001). Median valve diameter was 26 mm (Q1-Q3: 23-29) for ES3 and 36 mm (32-36) for Venus-P (<0.001). All implantations were successful, with no significant difference in procedure or fluoroscopy times between groups. Postoperative median right ventricular outflow tract maximum velocity was 2.2 m/s (1.9-2.6) for ES3 and 1.6 m/s (1.1-1.8) for Venus-P (<0.001). Procedural and vascular-access adverse events occurred in 14 patients (ES3: 9.7%, Venus-P: 9.6%; =0.992), including 8 moderate and 1 major (ES3: 5.4%, Venus-P: 7.7%; =0.582). New-onset ventricular arrhythmias occurred in 14 patients (ES3: 3.2%, Venus-P: 21.1%; <0.001), including 5 classified as moderate adverse events, all in Venus-P (=0.002). All arrhythmias resolved with short-term therapy; no permanent antiarrhythmics or ablations were needed. CONCLUSIONS: Self-expandable valves are effective for transcatheter pulmonary valve replacement but linked to higher transient arrhythmic adverse event rates than balloon-expandable valves in the early postoperative period.
Masiero G, Arturi F, Ceni S
… +56 more, Panza A, Kresoja KP, von Stein J, Fortmeier V, Koell B, Rottbauer W, Kassar M, Goebel B, Denti P, Achouh P, Rassaf T, Barreiro-Perez M, Boekstegers P, Rück A, Zdanyte M, Adamo M, Vincent F, Schlegel P, Rosch S, Wild MG, Besler C, Toggweiler S, Brunner S, Grapsa J, Patterson T, Thiele H, Kister T, Sticchi A, De Carlo M, Voss F, Polzin A, Popolo Rubbio A, Bedogni F, Stolte T, Nestelberger T, Benito-González T, Sánchez-Muñóz E, Konstandin MH, Van Belle E, Metra M, Geisler T, Estévez-Loureiro R, Mahabadi AA, Karam N, Maisano F, Lauten P, Praz F, Kessler M, Kalbacher D, Rudolph V, Iliadis C, Lurz P, Hausleiter J, Stolz L, Tarantini G, EuroTR Investigators
Circ Cardiovasc Interv
· 2026 Jan · PMID 41235431
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BACKGROUND: Right heart catheterization plays a pivotal role in the preprocedural evaluation of patients considered for transcatheter tricuspid valve edge-to-edge repair. This study aimed to explore the potential impact...BACKGROUND: Right heart catheterization plays a pivotal role in the preprocedural evaluation of patients considered for transcatheter tricuspid valve edge-to-edge repair. This study aimed to explore the potential impact of hemodynamic parameters obtained through right heart catheterization on patient-centered outcomes. METHODS: This study represents a subanalysis from the multicenter EuroTR registry (European Registry of Transcatheter Repair for Tricuspid Regurgitation). Patients with invasive hemodynamic data who underwent isolated transcatheter tricuspid valve edge-to-edge repair for significant tricuspid regurgitation were included. Outcomes of interest were a composite of 2-year all-cause death or hospitalization for heart failure (HFH) and a patient-centered composite of 6-month all-cause mortality, HFH, New York Heart Association class IV/worsening New York Heart Association class compared with baseline. Secondary outcome included postprocedural New York Heart Association class improvement. RESULTS: Seven hundred and eleven patients were included in the analysis. Two-year survival free from death and HFH was 63%. Optimal prognostic thresholds identified for death and HFH at 2 years were: mean pulmonary artery pressure≥32 mm Hg, pulmonary capillary wedge pressure (PCWP)≥20 mm Hg, and pulmonary vascular resistance≥5 wood units (WU). The early patient-centered composite outcome occurred in 25% of cases. PCWP≥20 mm Hg was independently associated with an early clinical deterioration (hazard ratio, 2.77 [95% CI, 1.47-5.28]; <0.001) and with 2-year death/HFH (hazard ratio, 1.75 [95% CI, 1.03-3.02]; =0.04). No invasive parameter was associated with residual tricuspid regurgitation ≥3+. New York Heart Association class improved significantly throughout the follow-up (<0.001), although patients with elevated mean pulmonary artery pressure (=0.04) or PCWP (<0.01) experienced less symptomatic benefit. CONCLUSIONS: In patients undergoing transcatheter tricuspid valve edge-to-edge repair, invasive hemodynamics-especially elevated PCWP-are independently associated with early patient-centered outcomes and late adverse clinical events. Despite overall improvement of the functional status and no impact on residual tricuspid regurgitation, patients with higher mean pulmonary artery pressure or PCWP benefit less. These findings support the role of comprehensive right heart catheterization in preprocedural risk stratification. REGISTRATION:URL: https://clinicaltrials.gov; Unique identifier: NCT06307262.
BACKGROUND: Drug-coated balloons (DCBs) are now a Food and Drug Administration-approved treatment option for the management of in-stent restenosis (ISR) based on superior outcomes compared with plain old balloon angiopla...BACKGROUND: Drug-coated balloons (DCBs) are now a Food and Drug Administration-approved treatment option for the management of in-stent restenosis (ISR) based on superior outcomes compared with plain old balloon angioplasty (POBA) alone. However, the efficacy of DCB compared with drug-eluting stent (DES; repeat stenting) for ISR is uncertain, with prior studies showing inferiority of DCB. We aimed to compare the outcomes of DES, DCB, or POBA in patients with coronary ISR. METHODS: We searched PubMed, EMBASE, and clinicaltrials.gov databases (until August 1, 2025) for randomized clinical trials that compared DCB, DES, or POBA alone for ISR. Outcomes included major adverse cardiovascular events, target lesion revascularization, all-cause mortality, cardiovascular mortality, stent thrombosis, late lumen loss, and postprocedure minimum lumen diameter. RESULTS: From 18 randomized clinical trials that randomized 3820 patients with ISR, at mean follow-up of 18 months, compared with POBA, both DCB and DES were associated with reduction in major adverse cardiovascular events (odds ratio, 0.34 [95% CI, 0.24-0.50]; odds ratio, 0.37 [95% CI, 0.25-0.54]) driven by reduction in target lesion revascularization (odds ratio, 0.28 [95% CI, 0.15-0.50]; odds ratio, 0.21 [95% CI, 0.10-0.42]). DCB had a lower postprocedure minimum lumen diameter but lower late lumen loss (mean difference, -0.16 [95% CI, -0.29 to -0.04] mm) compared with DES with no difference in other clinical outcomes. CONCLUSIONS: In patients with ISR, DCB reduced major adverse cardiovascular events/target lesion revascularization compared with POBA. There was no significant difference in clinical outcomes between DCB and DES. REGISTRATION:URL: https://www.crd.york.ac.uk/PROSPERO; Unique identifier: CRD42024598433.