Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial.

BACKGROUND: The optimal treatment in patients with severe aortic stenosis and small aortic annulus (SAA) remains to be determined. This study aimed to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA. METHODS: This prospective multicenter international randomized trial was performed in 15 university hospitals. Participants were 151 patients with severe aortic stenosis and SAA (mean diameter <23 mm) randomized (1:1) to TAVR (n=77) versus SAVR (n=74). The primary outcome was impaired valve hemodynamics (ie, severe prosthesis patient mismatch or moderate-severe aortic regurgitation) at 60 days as evaluated by Doppler echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes. RESULTS: The mean age of the participants was 75.5±5.1 years, with 140 (93%) women, a median Society of Thoracic Surgeons predicted risk of mortality of 2.50% (interquartile range, 1.67%-3.28%), and a median annulus diameter of 21.1 mm (interquartile range, 20.4-22.0 mm). There were no differences between groups in the rate of severe prosthesis patient mismatch (TAVR, 4 [5.6%]; SAVR, 7 [10.3%]; P=0.30) and moderate-severe aortic regurgitation (none in both groups). No differences were found between groups in mortality rate (TAVR, 1 [1.3%]; SAVR, 1 [1.4%]; P=1.00) and stroke (TAVR, 0; SAVR, 2 [2.7%]; P=0.24) at 30 days. After a median follow-up of 2 (interquartile range, 1-4) years, there were no differences between groups in mortality rate (TAVR, 7 [9.1%]; SAVR, 6 [8.1%]; P=0.89), stroke (TAVR, 3 [3.9%]; SAVR, 3 [4.1%]; P=0.95), and cardiac hospitalization (TAVR, 15 [19.5%]; SAVR, 15 [20.3%]; P=0.80). CONCLUSIONS: In patients with severe aortic stenosis and SAA (women in the majority), there was no evidence of superiority of contemporary TAVR versus SAVR in valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups. These findings suggest that the 2 therapies represent a valid alternative for treating patients with severe aortic stenosis and SAA, and treatment selection should likely be individualized according to baseline characteristics, additional anatomical risk factors, and patient preference. However, the results of this study should be interpreted with caution because of the limited sample size leading to an underpowered study, and need to be confirmed in future larger studies. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03383445.

Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial.

BACKGROUND: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies. OBJECTIVES: The authors sought to compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR. METHODS: Patients with a failed small (≤23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient <20 mm Hg, peak velocity <3 m/s, Doppler velocity index ≥0.25 and less than moderate AR. RESULTS: A total of 98 patients underwent ViV-TAVR (46 BEV, 52 SEV). At 1-year follow-up, patients receiving a SEV had a lower mean transaortic gradient (22 ± 8 mm Hg BEV vs 14 ± 7 mm Hg SEV; P < 0.001), and a higher rate of intended valve performance (BEV: 30%, SEV:76%; P < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA functional class >II, BEV: 7.3%, SEV: 4.1%; P = 0.505) or quality of life (Kansas City Cardiomyopathy Questionnaire, BEV: 77.9 ± 21.2, SEV: 81.8 ± 14.8; P = 0.334). No differences in all-cause mortality (BEV: 6.5%, SEV: 3.8; P = 0.495), heart failure hospitalization (BEV: 6.5%, SEV: 1.9%; P = 0.214), stroke (BEV: 0%, SEV: 1.9%; P = 0.369), myocardial infarction (BEV: 0%, SEV: 1.9%; P = 0.347), or pacemaker implantation (BEV: 2.2%, SEV: 1.9%; P = 0.898) were found. CONCLUSIONS: In patients who underwent ViV-TAVR for failed small aortic bioprostheses, those receiving a SEV exhibited a better valve hemodynamic profile at 1-year follow-up. There were no differences between SEV and BEV regarding functional status, quality of life, or clinical outcomes.

Transcatheter Aortic Valve Replacement Through a Single Femoral Access: A Multicenter Experience.

OBJECTIVES: During the past few years, physicians have optimized transcatheter aortic valve replacement and its periprocedural management, with the minimalist approach becoming popular. We aimed to further simplify the procedure using a single femoral access (the "all-in-one" technique). Here, we report a multicenter experience with TAVR with Acurate neo/neo2 transcatheter heart valves (Boston Scientific) through a single, large-bore, femoral sheath. METHODS: Patients underwent TAVR with the Acurate neo or neo2 through a single femoral access at 4 centers. The large sheath was used for both the delivery catheter and the pigtail used to visualize the aortic root. RESULTS: A total of 157 patients (59% women) with a mean age of 82 ± 6 years underwent TAVR with the Acurate neo (n = 100) or the Acurate neo2 (n = 57). The procedure was successfully performed through a single large sheath in all patients. Median duration of hospitalization stay was 2 days (interquartile range, 1-3 days). On echocardiography before discharge, the mean gradient was 7 ± 3 mm Hg and 7 patients (4.4%) had more than mild paravalvular leak. At 30 days, a major vascular complication had occurred in 2 patients (1.3%), 2 patients (1.3%) had suffered a stroke, and only 4 patients (2.5%) had required new permanent pacemaker implantation. A total of 3 patients (1.9%) had died. CONCLUSIONS: An all-in-one access technique allows safe implantation of Acurate neo and neo2 transcatheter heart valves, with low rates of periprocedural complications and favorable short-term outcomes.

Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self-Expanding Valves During Transcatheter Aortic Valve Replacement.

Background No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self-expanding valves. Methods and Results This study included a real-world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1-year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1-year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). Conclusions Repositioning a self-expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1-year mortality, regardless of the type of valve implanted.

Impacto de la técnica de Cusp-Overlap en el requerimiento de marcapasos luego de un implante valvular aórtico percutáneo / Impact of Cusp-Overlap Technique on Pacemaker Requirement after Transcatheter Aortic Valve Implantation

RESUMEN Introducción: Las bradiarritmias persistentes que requieren el implante de un marcapasos definitivo son una complicación frecuente tras el implante valvular aórtico percutáneo (IVAP), pero un implante alto con técnica Cusp-Overlap podría evitar las alteraciones del sistema de conducción. Objetivo: El objetivo fue determinar la tasa de uso de marcapasos en pacientes que recibieron IVAP con la técnica convencional coplanar en comparación con Cusp-Overlap. Material y métodos: Entre 2017 y 2019 se analizaron 65 pacientes consecutivos de dos centros, que recibieron válvulas EvolutR o Evolut-Pro: 50 implante coplanar y 15 Cusp-Overlap. Resultados: La edad promedio era 80 años y no hubo diferencias en el riesgo por puntaje EuroSCORE. Los procedimientos con la técnica de Cusp-Overlap presentaron 0% de requerimiento de marcapasos en comparación con 24,9% en el implante convencional (p = 0,041). También hubo menos complicaciones mayores (6,67% vs 42%; OR = 0,09; IC 95% 0,01-0,8; p = 0,011). Conclusiones: En esta cohorte el IVAP con la técnica de Cusp-Overlap se asoció con una necesidad de marcapasos nula. Dado el potencial impacto a gran escala se necesita validar externamente los resultados obtenidos.

ABSTRACT Background: Persistent bradyarrhythmias requiring permanent pacemaker implantation are a common complication after transcatheter aortic valve implantation (TAVI), but high implantation with cusp-overlap technique could prevent conduction system disturbances. Objective: The aim of this study was to assess the rate of pacemaker use in patients who received TAVI with conventional coplanar technique compared with cusp-overlap technique. Methods: A total of 65 consecutive patients from two centers receiving Evolut-R or Evolut-Pro valve implantation, 50 coplanar and 15 cusp-overlap, were analyzed between 2017 and 2019. Results: Mean age was 80 years, and there were no differences in risk according to the EuroSCORE. The rate of pacemaker requirement was 0% in cusp-overlap procedures compared with 24.9% in those with conventional implantation; p=0.041). In addition, cusp-overlap implants presented lower rate of major complications (6.67% vs. 42%; OR=0.09; 95% CI 0.01-0.8; p=0.011). Conclusions: In this cohort, TAVI procedure with cusp-overlap technique was associated with null pacemaker requirement. Given the potential large-scale impact, external validation of results is needed.

Experiencia multicéntrica de implante valvular aórtico percutáneo discriminada por riesgo en centros de Latinoamérica / Multicenter Experience of Transcatheter Aortic Valve Implantation Stratified by Risk in Latin American Centers

RESUMEN Introducción: El implante valvular aórtico percutáneo ha sido valorado en diferentes escenarios del amplio espectro de la población portadora de estenosis aórtica grave sintomática. La elección del tipo de tratamiento parte de una evaluación del riesgo de un equipo multidisciplinario. Objetivos: El objetivo de este estudio fue analizar las características y conocer los resultados de los pacientes sometidos a IVAP en Latinoamérica según el riesgo. Material y métodos: Se incluyeron a partir de marzo de 2009 a diciembre de 2018 pacientes en forma continua del registro multicéntrico latinoamericano de implante valvular aórtico percutáneo. La indicación de implante valvular aórtico percutáneo fue realizada en cada caso por un equipo multidisciplinario local. Se estratifica la población en función del riesgo quirúrgico evaluado por el puntaje STS-PROM. Se definieron tres grupos en función de los puntos de corte del STS -PROM establecidos: riesgo alto (RA, mayor del 8%), riesgo intermedio (RI, entre el 4% y el 8%) y riesgo bajo (RB, menordel 4%). Resultados: Se incluyeron en el análisis 770 pacientes; la mitad era de sexo femenino (50,2%) con una mediana de edad de 81 años (RIC 75,6-85,7). Del total, 230 pacientes (29,8%) fueron incluidos en el grupo AR (STS-PROM medio 11 [9,3-16,7]); 339 pacientes (44%), al riesgo intermedio (STS-PROM medio 6 [4,8-6,71]); y los restantes 201 (26,1%), al bajo riesgo (STS-PROM medio 2,7 [2-3,24]). La proporción de pacientes de bajo riesgo se incrementó a lo largo del período del registro (ptrend 0,011). Se utilizó acceso femoral (95%), y fue percutáneo en el 69% de los pacientes. Se implantaron en el 80% válvulas autoexpandibles. Del total de válvulas implantadas, el 23% (n = 177) resultaron ser reposicionables sin diferencias a través de los grupos. No se evidenciaron diferencias en mortalidad a los 30 días (RA 10,4%, RI 6,48%, RB 5,9%, p: 0,154) Tanto en el RA como en el de RB se observó una reducción de la mortalidad (RA 13,7%-4,1%, p: 0,001; RB 11,7%-0%; p: 0,0023). Conclusiones: La estratificación de riesgo mediante puntajes quirúrgicos continúa representando una guía de gran utilidad, sin embargo la indicación de implante valvular percutáneo en el mundo real incorpora otros factores no contemplados en la puntuación clásica, que modifica nuestras decisiones en la práctica diaria.

SUMMARY Introduction: Transcatheter aortic valve implantation (TAVI) has been evaluated in different scenarios of the broad spectrum of patients with severe symptomatic aortic stenosis. The choice of treatment starts through a risk assessment guided by a multidisciplinary team. Purpose: The aim of this study was to analyze the population undergoing TAVI in Latin America according to their risk. Methods: From March 2009 to December 2018, consecutive TAVI procedures registered in the Latin American multicenter registry were included. The indication of TAVI was made in each case by a multidisciplinary team set up by each center. The population is stratified according to the surgical risk evaluated by the STS-PROM score. Three groups were defined, based on the established STS-PROM cut-off points: high risk (RA, higher 8%), intermediate risk (IR, between 4%-8%) and low risk (RB, lower 4%). Results: 770 patients were included in the analysis, resulting 50,2% female, with a mean age of 81 y/o (IQR 75.6-85.7). 29.8% were included in the AR group (STS-PROM 11 (9.3-16.7), 44% at intermediate risk (STS-PROM 6 (4.8-6.71) and 26.1% at low risk (STS-PROM 2.7 (2-3.24). The proportion of low-risk patients has increased significantly over the period of inclusion (ptrend 0.011). Femoral access (95%), being percutaneous in 69% of patients. Self-expanding valves were implanted in 80%. 23% of the valves were repositionable without differences across the groups. There was no differences in 30-day mortality (RA 10.4%, IR 6.48%, RB 5.9%, p 0.154). Reduction in mortality were observed (RA 13, 7-4.1%, p0.001; RB 11.7-0%; p 0.0023) during the analyzed period. Conclusions: Risk stratification through surgical "scores" continues to represent a very useful guide, however the indication of TAVI in the real world incorporates other factors not contemplated in the classical score, which modifies our decisions in daily practice.