RESUMEN
BACKGROUND: Compared to high gradient aortic stenosis (AS), patients with low-flow, low-gradient AS have higher mortality after transcatheter aortic valve replacement (TAVR), but distinct outcome predictors in this patient subset are yet to be determined. The present study investigated the prognostic impact of aortic valve calcification (AVC) in patients with low-flow, low-gradient AS undergoing TAVR. METHODS: This retrospective single-center analysis includes all patients undergoing TAVR for severe low-flow, low-gradient AS (nâ¯=â¯526), ie, low EF low gradient AS (LEF-LG AS; nâ¯=â¯290) and paradoxical low-flow, low-gradient AS (PLF-LG AS; nâ¯=â¯236), in whom AVC was quantified from contrast-enhanced multislice computed tomography images. AVCdensity was defined as calcium volume per annulus area. Patients were trichotomized according to sex-specific AVCdensity tertiles in both subgroups. All-cause mortality was assessed by Kaplan-Meier analyses and independent outcome predictors were determined by multivariable analyses. RESULTS: In both subgroups, patients with high AVCdensity had higher mean transvalvular gradients at baseline and higher rates of PVL after TAVR. High AVCdensity was associated with lowest 1- and 3-year mortality after TAVR in the LEF-LG AS but not in the PLF-LG AS group. According to multivariable analysis AVCdensity was independently associated with better survival in LEF-LG AS patients (HR 0.73 [0.60-0.88], Pâ¯=â¯.0011), but not in those with PLF-LG AS (HR 0.91 [0.73-1.14], Pâ¯=â¯.42). CONCLUSIONS: Quantification of AVC may not only be of diagnostic but also of prognostic value, as it facilitates the selection of LEF-LG AS patients with higher probability of beneficial outcome after TAVR.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/patología , Calcinosis/clasificación , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Calcinosis/diagnóstico por imagen , Calcinosis/patología , Calcinosis/fisiopatología , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Pronóstico , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Volumen SistólicoRESUMEN
Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.
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Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas , Anuloplastia de la Válvula Mitral , Válvula Mitral/cirugía , Falla de Prótesis , Anciano , Anciano de 80 o más Años , Calcinosis/cirugía , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Válvula Mitral/patología , Anuloplastia de la Válvula Mitral/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/mortalidad , Diseño de Prótesis , Accidente Cerebrovascular/etiología , Resultado del TratamientoRESUMEN
RATIONALE: Ventricular arrhythmias remain the leading cause of death in patients suffering myocardial ischemia. Myeloperoxidase, a heme enzyme released by polymorphonuclear neutrophils, accumulates within ischemic myocardium and has been linked to adverse left ventricular remodeling. OBJECTIVE: To reveal the role of myeloperoxidase for the development of ventricular arrhythmias. METHODS AND RESULTS: In different murine models of myocardial ischemia, myeloperoxidase deficiency profoundly decreased vulnerability for ventricular tachycardia on programmed right ventricular and burst stimulation and spontaneously as assessed by ECG telemetry after isoproterenol injection. Experiments using CD11b/CD18 integrin-deficient (CD11b-/-) mice and intravenous myeloperoxidase infusion revealed that neutrophil infiltration is a prerequisite for myocardial myeloperoxidase accumulation. Ventricles from myeloperoxidase-deficient (Mpo-/-) mice showed less pronounced slowing and decreased heterogeneity of electric conduction in the peri-infarct zone than wild-type mice. Expression of the redox-sensitive gap junctional protein Cx43 (Connexin 43) was reduced in the peri-infarct area of wild-type compared with Mpo-/- mice. In isolated wild-type cardiomyocytes, Cx43 protein content decreased on myeloperoxidase/H2O2 incubation. Mapping of induced pluripotent stem cell-derived cardiomyocyte networks and in vivo investigations linked Cx43 breakdown to myeloperoxidase-dependent activation of matrix metalloproteinase 7. Moreover, Mpo-/- mice showed decreased ventricular postischemic fibrosis reflecting reduced accumulation of myofibroblasts. Ex vivo, myeloperoxidase was demonstrated to induce fibroblast-to-myofibroblast transdifferentiation by activation of p38 mitogen-activated protein kinases resulting in upregulated collagen generation. In support of our experimental findings, baseline myeloperoxidase plasma levels were independently associated with a history of ventricular arrhythmias, sudden cardiac death, or implantable cardioverter-defibrillator implantation in a cohort of 2622 stable patients with an ejection fraction >35% undergoing elective diagnostic cardiac evaluation. CONCLUSIONS: Myeloperoxidase emerges as a crucial mediator of postischemic myocardial remodeling and may evolve as a novel pharmacological target for secondary disease prevention after myocardial ischemia.
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Arritmias Cardíacas/metabolismo , Isquemia Miocárdica/metabolismo , Miocitos Cardíacos/metabolismo , Peroxidasa/deficiencia , Remodelación Ventricular/fisiología , Animales , Arritmias Cardíacas/patología , Células Cultivadas , Humanos , Masculino , Ratones , Ratones Endogámicos C57BL , Ratones Noqueados , Isquemia Miocárdica/patología , Miocitos Cardíacos/patología , Técnicas de Cultivo de ÓrganosRESUMEN
BACKGROUND: Severe mitral regurgitation is associated with impaired prognosis if left untreated. Using the devices currently available, transcatheter mitral valve repair (TMVr) remains challenging in complex anatomical situations. We report the procedural and 30-day results of the first-in-man study of the Edwards PASCAL TMVr system. METHODS: In this multicentre, prospective, observational, first-in-man study, we collected data from seven tertiary care hospitals in five countries that had a compassionate use programme in which patients underwent transcatheter mitral valve repair using the Edwards PASCAL TMVr system. Eligible patients were those with symptomatic, severe functional, degenerative, or mixed mitral regurgitation deemed at high risk or inoperable. Safety and efficacy of the procedure were prospectively assessed at device implantation, discharge, and 30 days after device implantation. The key study endpoints were technical success assessed at the end of the procedure and device success 30 days after implantation using the Mitral Valve Academic Research Consortium definitions. FINDINGS: Between Sept 1, 2016, and March 31, 2017, 23 patients (median age 75 years [IQR 61-82]) had treatment for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the Edwards PASCAL TMVr system. At baseline, the median EuroScore II score was 7·1% (IQR 3·6-12·8) and the median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair was 4·8% (2·1-9·0) and 6·8% (2·9-10·1) for mitral valve replacement. 22 (96%) of 23 patients were New York Heart Association (NYHA) class III or IV at baseline. The implantation of at least one device was successful in all patients, resulting in procedural residual mitral regurgitation of grade 2+ or less in 22 (96%) patients. Six (26%) of 23 patients had two implants. Periprocedural complications occurred in two (9%) of 23 patients (one minor bleeding event and one transient ischaemic attack). Despite the anatomical complexity of mitral regurgitation in the patients in this compassionate use cohort, technical success was achieved in 22 (96%) of 23 patients, and device success at 30 days was achieved in 18 (78%) patients. Three patients (13%) died during the 30 day follow-up. 19 (95%) of 20 patients alive 30 days after implantation were NYHA class I or II. INTERPRETATION: This study establishes feasibility of the Edwards PASCAL TMVr system with a high rate of technical success and reduction of mitral regurgitation severity. Further research is needed on procedural and long-term clinical outcomes. FUNDING: None.
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Anuloplastia de la Válvula Mitral/métodos , Insuficiencia de la Válvula Mitral/cirugía , Anciano , Anciano de 80 o más Años , Ensayos de Uso Compasivo , Ecocardiografía Doppler en Color , Diseño de Equipo , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Anuloplastia de la Válvula Mitral/instrumentación , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Estudios Prospectivos , Resultado del Tratamiento , Disfunción Ventricular Izquierda/etiologíaRESUMEN
Valve-in-valve (ViV) procedures for failing bioprostheses carry a certain risk for device malfunction. We herein report a case of a failing Evolut R in a deteriorated Mitroflow, treated with a Sapien 3. An 81 year old female patient received surgical aortic valve replacement and was treated by ViV due to deterioration. Three years later, echocardiography revealed a pressure gradient of peak/mean 105/63 mmHg. Subsequently, a second ViV procedure with initial intentional rupture of the bioprosthetic stent was performed. Immediate stent recoil of the Evolut R prompted implantation of a Sapien 3. In 30-day follow-up, mean pressure gradient of 30 mmHg and nearly complete symptom relief was documented. Fracture of a surgical bioprosthetic stent is feasible in a ViV configuration. Supra-annular placement of a balloon-expandable THV as ViV-in-valve is feasible with suboptimal hemodynamic results in this case. Risk of re-do surgery should be weighted against anticipated hemodynamic and clinical results.
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Insuficiencia de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Bioprótesis , Implantación de Prótesis Vascular/instrumentación , Prótesis Valvulares Cardíacas , Falla de Prótesis , Stents , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Valvuloplastia con Balón , Implantación de Prótesis Vascular/efectos adversos , Femenino , Hemodinámica , Humanos , Diseño de Prótesis , Resultado del TratamientoRESUMEN
BACKGROUND: Anemia is linked to impaired outcome in patients with cardiovascular diseases. We sought to characterize the impact of baseline anemia on mid-term outcome after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Data of 1201 consecutive TAVI patients were retrospectively analyzed. Baseline anemia was defined according to the WHO (hemoglobin <12g/dl [female], <13g/dl [male]). It was prevalent in 59.0% of patients and associated with a higher preoperative risk (STS-PROM 7.8 ± 5.7 vs. 6.2 ± 4.1%, P < 0.001). Survival was similar at 30 days (90.5 vs. 91.2%, P = 0.626) but NYHA functional capacity was impaired in patients with baseline anemia (classes III/IV: 20.6 vs. 15.6%, P = 0.006). Low baseline hemoglobin (OR 0.85, CI 0.73-0.98, P = 0.025), blood transfusion (OR 2.42, CI 1.38-4.28, P = 0.002), and bleeding complications (OR 2.21, CI 1.27-3.81, P = 0.005) were in addition associated with acute kidney injury after TAVI. Three-year survival was reduced (49.6 vs. 64.9%, P = 0.002) and baseline anemia was linked to increased mid-term mortality (HR 1.43, CI 1.13-1.82, P = 0.003), however its effect was surpassed by the adverse impact of periprocedural complications. CONCLUSIONS: Baseline anemia was associated with increased morbidity and mortality after TAVI. Preprocedural hemoglobin levels need to be assessed for risk stratification and blood conservation management seems essential. As a potentially modifiable target, the role of pretreatment of anemia prior to TAVI remains to be determined. © 2016 Wiley Periodicals, Inc.
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Anemia/complicaciones , Estenosis de la Válvula Aórtica/terapia , Válvula Aórtica , Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Anciano , Anciano de 80 o más Años , Anemia/sangre , Anemia/diagnóstico , Anemia/mortalidad , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Biomarcadores/sangre , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Distribución de Chi-Cuadrado , Femenino , Alemania , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Hemoglobinas/metabolismo , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Oportunidad Relativa , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this study was to evaluate safety, feasibility, and efficacy of transaxillary TAVI using a novel self-expandable transcatheter heart valve (THV) via a direct percutaneous technique. METHODS: The analysis comprises 12 consecutive patients with severe aortic stenosis treated with the ACURATE Neo™ THV (Symetis) by direct percutaneous transaxillary access. RESULTS: Patients presented with a mean age of 79.9 ± 6.2 years and high calculated surgical risk (logEuroSCORE I: 19.55 ± 15.00%; STS PROM score: 5.42 ± 3.25%). Transaxillary TAVI was performed in 11/12 via the left and in 1/12 via the right-sided axillary artery. Device success was achieved in all patients (12/12). Mortality rate at 30 days was 0% (0/12). No major and one minor access site complication (1/12) occurred. No major or life-threatening access site-related bleeding resulted. None of the patients suffered from postprocedural stroke/transient ischemic attack. There was no need for a permanent pacemaker. Mean effective orifice area post implantation was 2.1 ± 0.29 cm2 and mean aortic gradient 6.2 ± 1.5 mm Hg. In none of the patients, greater than moderate aortic regurgitation or paravalvular leakage was detected at discharge (0/12). CONCLUSIONS: Our study suggests that the implantation of the second-generation self-expandable ACURATE Neo™ via a transaxillary access is technically feasible and safe and yields excellent short-term clinical results. © 2017 Wiley Periodicals, Inc.
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Estenosis de la Válvula Aórtica/cirugía , Arteria Axilar , Cateterismo Periférico/métodos , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Anciano de 80 o más Años , Insuficiencia de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Arteria Axilar/diagnóstico por imagen , Cateterismo Periférico/efectos adversos , Angiografía por Tomografía Computarizada , Angiografía Coronaria/métodos , Bases de Datos Factuales , Ecocardiografía Transesofágica , Estudios de Factibilidad , Femenino , Humanos , Masculino , Tomografía Computarizada Multidetector , Diseño de Prótesis , Falla de Prótesis , Punciones , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: The majority of transcatheter aortic valve implantation (TAVI) procedures are currently performed by percutaneous transfemoral approach. The potential contribution of the type of vascular closure device to the incidence of vascular complications is not clear. AIM: To compare the efficacy of a Prostar XL- vs. Perclose ProGlide-based vascular closure strategy. METHODS: The ClOsure device iN TRansfemoral aOrtic vaLve implantation (CONTROL) multi-center study included 3138 consecutive percutaneous transfemoral TAVI patients, categorized according to vascular closure strategy: Prostar XL- (Prostar group) vs. Perclose ProGlide-based vascular closure strategy (ProGlide group). Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics. RESULTS: Propensity matching identified 944 well-matched patients (472 patient pairs). Composite primary end point of major vascular complications or in-hospital mortality occurred more frequently in Prostar group when compared with ProGlide group (9.5 vs. 5.1%, P = 0.016), and was driven by higher rates of major vascular complication (7.4 vs. 1.9%, P < 0.001) in the Prostar group. However, in-hospital mortality was similar between groups (4.9 vs. 3.5%, P = 0.2). Femoral artery stenosis occurred less frequently in the Prostar group (3.4 vs. 0.5%, P = 0.004), but overall, Prostar use was associated with higher rates of major bleeding (16.7 vs. 3.2%, P < 0.001), acute kidney injury (17.6 vs. 4.4%, P < 0.001) and with longer hospital stay (median 6 vs. 5 days, P = 0.007). CONCLUSIONS: Prostar XL-based vascular closure in transfemoral TAVI procedures is associated with higher major vascular complication rates when compared with ProGlide; however, in-hospital mortality is similar with both devices.
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Estenosis de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Dispositivos de Cierre Vascular/efectos adversos , Enfermedades Vasculares/etiología , Lesión Renal Aguda/etiología , Anciano , Anciano de 80 o más Años , Cardiología/normas , Competencia Clínica/normas , Constricción Patológica/etiología , Femenino , Arteria Femoral , Humanos , Curva de Aprendizaje , Masculino , Infarto del Miocardio/etiología , Hemorragia Posoperatoria/etiología , Accidente Cerebrovascular/etiología , Reemplazo de la Válvula Aórtica Transcatéter/instrumentaciónRESUMEN
INTRODUCTION: Implantation of transcatheter heart valves (THV) into degenerated surgical valves is an emerging therapy for selected high-risk patients. Although, CE mark of most THV is limited for native aortic valvular stenosis, transcatheter valve implantation into degenerated bioprostheses, even in mitral position is very intriguing. METHODS AND RESULTS: After placement of a cerebral protection device (Claret Sentinel®), three consecutive patients (age, 79.0 ± 6.1; log EuroSCORE I: 33.3 ± 9.2%) with a degenerated mitral bioprosthesis were treated by transapical implantation of the Lotus® valve (Boston Scientific Inc.). In addition, a SwanGanz catheter was introduced in the pulmonary artery for hemodynamic assessments all patients. Procedural success was 100%. Valve implantation was performed without rapid ventricular pacing. Resheating was performed in two patients due to suboptimal initial positioning. Invasive online hemodynamics revealed stable blood pressure in all patients. After Lotus® valve implantation, valvular mitral regurgitation was completely eliminated in all patients. One patient had a mild paravalvular leak of the surgical bioprosthesis, which was present before implantation. Invasive right and left heart hemodynamics showed an immediate improvement after Lotus® valve implantation. Mean mitral surface area (2.1 ± 0.2 cm(2) ) and mean gradient (3.7 ± 2.1 mm Hg) demonstrated satisfactory results. All patients were immediately extubated and discharged from the hospital without any adverse event. CONCLUSIONS: This study demonstrates for the first time the feasibility of transapical Lotus® Valve implantation in degenerated mitral bioprostheses. The controlled mechanical Lotus® valve expansion with remarkably stable hemodynamics throughout the procedure offers a new and valuable treatment option.
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Bioprótesis , Cateterismo Cardíaco/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral/terapia , Válvula Mitral/cirugía , Falla de Prótesis , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/métodos , Cateterismo de Swan-Ganz , Estudios de Factibilidad , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Hemodinámica , Humanos , Masculino , Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico , Insuficiencia de la Válvula Mitral/etiología , Insuficiencia de la Válvula Mitral/fisiopatología , Diseño de Prótesis , Retratamiento , Resultado del TratamientoRESUMEN
AIMS: This study was performed to compare haemodynamic properties of a novel transcatheter heart valve (THV) with two established valve technologies for treatment of failing surgical aortic bioprosthetic valves (SAV). The ALLEGRA THV has been recently described with a proven safety and performance profile. METHODS AND RESULTS: The study was designed as a retrospective, single-centre study investigating 112 patients (77.7 ± 7.1 years, 53.8% female, STS score 6.8 ± 5.8% and logEuroSCORE I 27.4 ± 16.1%) with failing SAV. Patients were treated with the ALLEGRA THV (NVT, n = 24), the CoreValve/EvolutR (MTD, n = 64) or the Edwards Sapien/Sapien XT/Sapien 3 (EDW, n = 24). Adverse events, haemodynamic outcomes and patient safety were analysed according to VARC-3 definitions. Overall procedural success was high (94.6%), even though 58.9% of the treated SAV were classified as small (true inner diameter < 21 mm). After treatment, the mean pressure gradient was significantly reduced (baseline: 33.7 ± 16.5 mmHg, discharge: 18.0 ± 7.1 mmHg), with a corresponding increase in effective orifice area (EOA). The complication rates did not differ in between groups. There was a trend to lower mean transvalvular gradients after implantation of self-expanding THV with supra-annular valve function, despite a higher frequency of smaller SAVs in the NVT and MTD group. Additionally, comparison between NVT and MTD revealed statistically lower transvalvular gradients (NVT 14.9 ± 5.0 mmHg, MTD 18.7 ± 7.5 mmHg, p = 0.0295) in a subgroup analysis. CONCLUSIONS: Valve-in-valve (ViV) treatment of failing SAV with supra-annular design like the ALLEGRA THV resulted in favourable haemodynamic outcomes with similar low clinical event rates and may therefore be an interesting alternative for VIV TAVI.
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Estenosis de la Válvula Aórtica , Bioprótesis , Prótesis Valvulares Cardíacas , Terfenadina/análogos & derivados , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Femenino , Masculino , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estudios Retrospectivos , Resultado del Tratamiento , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Diseño de PrótesisRESUMEN
Patients with severe symptomatic tricuspid regurgitation face a significant dilemma in treatment options, as the yearly mortality with medical therapy and the surgical mortality for tricuspid repair or replacement are high. Transcatheter edge-to-edge repair (TEER) for the tricuspid valve is becoming a viable option in patients, although procedural success is dependent on high-quality imaging. While transesophageal echocardiography remains the standard for tricuspid TEER procedures, intracardiac echocardiography (ICE) with three-dimensional (3D) multiplanar reconstruction (MPR) has many theoretical and practical advantages. The aim of this article was to describe the in vitro wet lab-based imaging work done to facilitate the best approach to 3D MPR ICE imaging and the procedural experience gained with 3D MPR ICE in tricuspid TEER procedures with the PASCAL device.
RESUMEN
AIMS: Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study. METHODS AND RESULTS: Thirty patients were enrolled in this single-arm, multicentre, prospective study. Patients were evaluated as having ≥moderate, symptomatic functional TR and deemed inoperable due to unacceptable surgical risk. Clinical, functional, and echocardiographic data were prospectively collected up to two years (mean duration 604±227 days). At baseline, 83% were in NYHA Class III-IV, and the mean LVEF was 58%. Technical success was 100%. At two years, there were eight deaths. Echocardiography showed a significant reduction in septolateral annular diameter of 16% (p=0.006) and 72% of patients (p=0.016) with ≤moderate TR grade; 82% of patients were in NYHA Class I-II (p=0.002). Six-minute walk distance and KCCQ score improved by 73 m (p=0.058) and 14 points (p=0.046), respectively. CONCLUSIONS: These results demonstrate that the Cardioband tricuspid system showed favourable results in patients with symptomatic, ≥moderate functional TR. Annular reduction and TR severity reduction remained significant and sustained at two years. Patients experienced improvements in quality of life and exercise capacity. ClinicalTrials.gov Identifier: NCT02981953.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Estudios Prospectivos , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugíaRESUMEN
BACKGROUND: Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options. OBJECTIVES: This is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR. METHODS: Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints. RESULTS: Of the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001). CONCLUSIONS: In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313).
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Anuloplastia de la Válvula Cardíaca/instrumentación , Procedimientos Endovasculares/instrumentación , Insuficiencia de la Válvula Tricúspide/cirugía , Válvula Tricúspide/cirugía , Anciano , Anciano de 80 o más Años , Anuloplastia de la Válvula Cardíaca/estadística & datos numéricos , Ecocardiografía , Procedimientos Endovasculares/estadística & datos numéricos , Estudios de Factibilidad , Femenino , Humanos , Masculino , Estudios Prospectivos , Resultado del Tratamiento , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagenRESUMEN
OBJECTIVES: The study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricuspid regurgitation (TR). BACKGROUND: Increasing severity of TR is associated with progressively higher morbidity and mortality; however, treatment options for isolated significant disease are limited. METHODS: In this single-arm, multicenter, prospective Food and Drug Administration-approved early feasibility study (EFS), 30 patients with severe or greater symptomatic functional TR were enrolled who were deemed candidates for transcatheter tricuspid repair with the Cardioband tricuspid system by the local heart team and multidisciplinary screening committee. RESULTS: The mean patient age was 77 years, 80% were women, 97% had atrial fibrillation, 70% were in New York Heart Association functional class III to IV with mean left ventricular ejection fraction of 58%, and 27% had severe, 20% massive, and 53% torrential TR. Device success was 93% and all patients were alive at 30 days. Between baseline and 30 days, septolateral tricuspid annular diameter was reduced by 13% (p < 0.001), 85% of patients had ≥1 grade TR reduction and 44% had ≤moderate TR, 75% were in New York Heart Association functional class I to II (p < 0.001), and overall Kansas City Cardiomyopathy Questionnaire score improved by 16 points (p < 0.001). CONCLUSIONS: In patients with severe symptomatic functional TR, this is the first study in the United States with the Cardioband tricuspid system for direct transcatheter annular reduction. This early feasibility study demonstrates high procedural feasibility with no 30-day mortality. There is significant reduction of functional TR with clinically significant improvements in functional status and quality of life. (Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study; NCT03382457).
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Anciano , Cateterismo Cardíaco , Estudios de Factibilidad , Femenino , Humanos , Masculino , Estudios Prospectivos , Calidad de Vida , Índice de Severidad de la Enfermedad , Volumen Sistólico , Factores de Tiempo , Resultado del Tratamiento , Insuficiencia de la Válvula Tricúspide/cirugía , Función Ventricular IzquierdaRESUMEN
BACKGROUND: Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients. METHODS: This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg. RESULTS: Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, P<0.001). CONCLUSIONS: In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patients died after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.
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Implantación de Prótesis de Válvulas Cardíacas , Hipertensión Pulmonar , Insuficiencia de la Válvula Tricúspide , Disfunción Ventricular Derecha , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Femenino , Humanos , Hipertensión Pulmonar/diagnóstico , Hipertensión Pulmonar/etiología , Hipertensión Pulmonar/terapia , Masculino , New York , Sistema de Registros , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/complicaciones , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugía , Disfunción Ventricular Derecha/diagnóstico por imagen , Disfunción Ventricular Derecha/etiología , Disfunción Ventricular Derecha/terapiaRESUMEN
AIMS: The high frequency of screening failure for anatomical reasons in patients with severe mitral valve regurgitation (MR) is a limiting factor in the screening process for transcatheter mitral valve replacement (TMVR). However, data on optimal patient selection are scarce. The present study aimed to develop a screening algorithm based on TMVR screening data. METHODS AND RESULTS: A total of 195 screenings for six different TMVR devices were performed in 94 high-risk patients with severe MR. We compared baseline echocardiographic and multislice computed tomography (MSCT) parameters between the subgroups of patients accepted (N=33) and rejected for TMVR (N=61). Reasons for screening failure were assessed, and a decision tree algorithm was statistically derived. Reasons for screening failure were small LV dimensions (30.6%), small (7.5%) or large (22.5%) annular size, potential risk of LVOT obstruction (22.0%) or mitral annulus calcification (15.6%). A four-step decision tree algorithm to assess TMVR eligibility was developed resulting in an AUC of 0.80 (95% CI: 0.71, 0.89, p<0.0001). CONCLUSIONS: This study presents the first screening algorithm to assess anatomical eligibility for TMVR in patients with severe MR, based on simple MSCT criteria. Given the high rate of TMVR screening failure, this algorithm may facilitate the identification of potential TMVR candidates.
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Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Insuficiencia de la Válvula Mitral/cirugía , Algoritmos , Árboles de Decisión , Humanos , Válvula Mitral , Resultado del TratamientoRESUMEN
OBJECTIVE: Residual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on residual PVR after TAVR with different next-generation transcatheter heart valves. METHODS: 642 patients underwent TAVR with a SAPIEN 3 (S3; n=292), ACURATE neo (NEO; n=166), Evolut R (ER; n=132) or Lotus (n=52). Extent, location and asymmetry of DLZ calcification were assessed from contrast-enhanced CT imaging and correlated to PVR at discharge. RESULTS: PVR was ≥moderate in 0.7% of S3 patients, 9.6% of NEO patients, 9.8% of ER patients and 0% of Lotus patients (p<0.001), and these differences remained after matching for total DLZ calcium volume. The amount of DLZ calcium was significantly related to the degree of PVR in patients treated with S3 (p=0.045), NEO (p=0.004) and ER (p<0.001), but not in Lotus patients (p=0.698). The incidence of PVR ≥moderate increased significantly over the tertiles of DLZ calcium volume (p=0.046). On multivariable analysis, calcification of the aortic valve cusps, LVOT calcification and the use of self-expanding transcatheter aortic valve implantation (TAVI) prostheses emerged as predictors of PVR. CONCLUSIONS: The susceptibility to PVR depending on the amount of calcium was mainly observed in self-expanding TAVI prostheses. Thus, DLZ calcification is an important factor to be considered in prosthesis selection for each individual patient, keeping in mind the trade-off between PVR reduction, risk of new pacemaker implantation and unfavourable valve ha emodynamics.
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Insuficiencia de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/patología , Válvula Aórtica/cirugía , Calcinosis/cirugía , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Calcinosis/diagnóstico por imagen , Calcinosis/fisiopatología , Femenino , Alemania , Hemodinámica , Humanos , Masculino , Diseño de Prótesis , Recuperación de la Función , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this study was to assess the value of echocardiographic right ventricular (RV) and systolic pulmonary artery pressure (sPAP) assessment in predicting transcatheter tricuspid edge-to-edge valve repair (TTVR) outcome. BACKGROUND: RV dysfunction and pulmonary hypertension are associated with poor prognosis and are systematically sought during tricuspid regurgitation evaluation. The value of echocardiographic assessment in predicting TTVR outcome is unknown. METHODS: Data were taken from the TriValve (Transcatheter Tricuspid Valve Therapies) registry, which includes patients undergoing TTVR at 14 European and North American centers. The primary outcome was 1-year survival free from hospitalization for heart failure, and secondary outcomes were 1-year survival and absence of hospital admission for heart failure at 1 year. RESULTS: Overall, 249 patients underwent TTVR between June 2015 and 2018 (mean tricuspid annular plane systolic excursion [TAPSE] 15.8 ± 15.3 mm, mean sPAP 43.6 ± 16.0 mm Hg). Tricuspid regurgitation grade ≥3+ was found in 96.8% of patients at baseline and 29.4% at final follow-up; 95.6% were in New York Heart Association functional class III or IV initially, compared with 34.3% at follow-up (p < 0.05). Final New York Heart Association functional class did not differ among TAPSE and sPAP quartiles, even when both low TAPSE and high sPAP were present. Rates of 1-year survival and survival free from hospitalization for heart failure were 83.9% and 78.7%, respectively, without significant differences according to baseline echocardiographic RV characteristics (TAPSE, fractional area change, and end-diastolic area) and sPAP (p > 0.05 for all). CONCLUSIONS: TTVR provides clinical improvement, with 1-year survival free from hospital readmission >75% in patients with severe tricuspid regurgitation. Conventional echocardiographic parameters used to assess RV function and sPAP did not predict clinical outcome after TTVR.
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Presión Arterial , Cateterismo Cardíaco , Ecocardiografía , Arteria Pulmonar/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/terapia , Función Ventricular Derecha , Presión Ventricular , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Progresión de la Enfermedad , Europa (Continente) , Femenino , Insuficiencia Cardíaca/etiología , Insuficiencia Cardíaca/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , América del Norte , Valor Predictivo de las Pruebas , Estudios Prospectivos , Arteria Pulmonar/fisiopatología , Recuperación de la Función , Sistema de Registros , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Insuficiencia de la Válvula Tricúspide/complicaciones , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/fisiopatologíaRESUMEN
OBJECTIVES: The aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI). BACKGROUND: The use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR. METHODS: The study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width ≥14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR ≤2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year. RESULTS: Baseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly lower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio: 1.91; 95% confidence interval: 1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048). CONCLUSIONS: Baseline massive or torrential TR is associated with an increased risk for all-cause mortality and rehospitalization for heart failure 1 year after TTVI. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential TR. (International Multisite Transcatheter Tricuspid Valve Therapies Registry [TriValve]; NCT03416166).
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Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide/cirugía , Válvula Tricúspide/cirugía , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Progresión de la Enfermedad , Europa (Continente) , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Masculino , América del Norte , Readmisión del Paciente , Recuperación de la Función , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/fisiopatología , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/mortalidad , Insuficiencia de la Válvula Tricúspide/fisiopatologíaRESUMEN
BACKGROUND: Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. OBJECTIVES: This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. METHODS: Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. RESULTS: A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). CONCLUSIONS: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).