Incidence, predictors, and prognostic impact of new permanent pacemaker implantation after TAVR with self-expanding valves

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Transcatheter aortic valve replacement with next-generation self-expanding devices: a multicenter, retrospective, propensity-matched comparison of evolut pro versus acurate neo transcatheter heart valves

Abstract OBJECTIVES: The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices. BACKGROUND: The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR. METHODS: The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles. RESULTS: A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation. CONCLUSIONS: (AU)

Clinical, Angiographic, and Procedural Correlates of Very Late Absorb Scaffold Thrombosis: Multistudy Registry Results

OBJECTIVES: The aim of this study was to identify independent correlates of very late scaffold thrombosis (VLST) from an analysis of consecutively treated patients from 15 multicenter studies. BACKGROUND: Recent analyses suggest an increased risk for VLST with the Absorb Bioresorbable Vascular Scaffold compared with drug-eluting stents, but insights as to correlates of risk are limited. METHODS: A total of 55 patients were identified with scaffold thrombosis. They were matched 2:1 with control subjects selected randomly from patients without thrombosis from the same study. Quantitative coronary angiography was available for 96.4% of patients. Multiple logistic and Cox regression analysis were used to identify significant independent outcome correlates from 6 pre-specified characteristics. RESULTS: Patients had scaffold thrombosis at a median of 20 months (interquartile range: 17 to 27 months). Control subjects were followed for 36 months (interquartile range: 24 to 38 months). For the combined groups, reference vessel diameter (RVD) was 2.84 0.50 mm, scaffold length was 26 16 mm, and post-dilatation was performed in56%. Univariate correlates of thrombosis were smaller nominal scaffold/RVD ratio (linear p»0.001; ratio<1.18:1; odds ratio: 7.5; p»0.002) and larger RVD (linear p»0.001;>2.72 mm; odds ratio: 3.4; p»0.001). Post-dilatation at$16 atm, post-dilatation balloon/scaffold ratio, final percentage stenosis, and dual antiplatelet therapy were not correlated with VLST. Only scaffold/RVD ratio remained a significant independent correlate of VLST (p»0.001), as smaller ratio was correlated with RVD (p<0.001). Post hoc analysis of 8 other potential covariates revealed no other correlates of outcome. CONCLUSIONS: In the present analysis, the largest to date of its type, relative scaffold undersizing was the strongest determinant of VLST. Given current understanding of "scaffold dismantling," this finding likely has ramifications for all bioresorbable scaffolds.

Clinical, angiographic, and procedural correlates of acute, subacute, and late absorb scaffold thrombosis

OBJECTIVES: The authors sought to identify and verify independent correlates of device thrombosis from an analysis of multicenter trials and registries. BACKGROUND: Recent analyses suggest an increased risk of device thrombosis with Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) implantation compared with metallic drug-eluting stents, and data from moderate size studies suggest a risk relationship to vessel size and technique. METHODS: From 8,771 consecutively treated patients, 105 patients (1.2%) were identified with scaffold thrombosis within 1 year of implantation. They were matched 2:1 with controls selected randomly from nonthrombosis patients. Data-restricted multiple logistic analysis was used to identify significant independent covariates of the outcome. RESULTS: Early (within 1 month) scaffold thrombosis occurred in 69 patients and late (1 to 12 months) thrombosis occurred in 36 patients. Modelling found significant correlations of thrombosis to be final minimal lumen diameter 1.1:1 balloon/scaffold ratio (OR: 2.3; p = 0.022), and reference vessel diameter <2.40 mm (OR: 2.1; p = 0.036).CONCLUSIONS:Suboptimal vessel sizing, procedural technique, angiographic outcomes, and dual antiplatelet therapy discontinuation appear to be the principal determinants of Absorb scaffold thrombosis risk through 12 months after implantation.

Beneficio de la implementación de un sistema de atención en red sobre las mujeres con infarto agudo de miocardio con elevación del segmento ST / Benefit of the implementation of a ST-segment elevation myocardial infarction network on women

Objetivo: El sistema de atención en red por infarto con elevación del segmento ST «Codi Infart¼ se implementó en Cataluña (España) en junio de 2009. El objetivo del estudio fue evaluar el beneficio de la instauración del Codi Infart para las mujeres atendidas en nuestra institución. Método: Las mujeres referidas para angioplastia primaria se dividieron en 2 grupos de acuerdo con el Codi Infart: grupo no-Codi Infart (enero de 2003 a mayo de 2009) y grupo Codi Infart (junio de 2009 a diciembre de 2012); y se compararon lugar de procedencia, periodos, tratamientos recibidos y tasa de eventos cardiovasculares mayores definida como muerte por todas las causas, reinfarto o accidente cerebrovascular durante el ingreso, a 30 y 180 días. Resultados: De una población total de 2,426 pacientes, 501 (20.7%) eran mujeres. De ellas, 186 mujeres (2,09 casos/mes) pertenecían al grupo no-Codi Infart y 315 mujeres (10,16 casos/mes) al grupo Codi Infart. El porcentaje de mujeres atendidas aumentó desde la introducción del Codi Infart(22.2% vs. 18.5%, p = 0.028). Además, inicialmente el grupo Codi Infart presentó mayor porcentaje de mujeres atendidas fuera de nuestra institución (84.1% vs. 16.7%, p < 0.001), y menores tiempos totales de isquemia (220 [155-380] vs. 272 [196-456], p = 0.003), pero no se detectaron diferencias en eventos cardiovasculares mayores a 180 días (14.2% vs. 15.6%, p = 0.692). Conclusiones: La instauración del Codi Infart permitió aumentar de manera notable la tasa y el porcentaje de mujeres con infarto de miocardio con elevación del segmento ST tratadas mediante angioplastia primaria y reducir los tiempos totales de isquemia.

Objective: The ST-segment elevation myocardial infarction network "Codi Infart" was implemented in Catalonia (Spain) in June 2009. The objective of this study was to evaluate the impact of the implementation of the Codi Infart on women. Method: Women referred for primary percutaneous coronary intervention, were divided into two groups according to Codi Infart: Non-Codi Infart group (January 2003 to May 2009) and Codi Infart group (June 2009 to December 2012). Place of first medical contact, time intervals in diagnosis and treatment, treatments received and rate of major cardiovascular adverse events defined as all-cause death, reinfarction or stroke in-hospital, at 30 and 180 days were compared. Results: From a total population of 2,426 patients, 501 (20.7%) were women. One-hundred eighty-six women (2.09 cases/month) belonged to Non-Codi Infart group and 315 women (10.16 cases/month) to Codi Infart group. The percentage of women attended increased since the introduction of CI (22.2% vs. 18.5%, P = .028). In addition, the Codi Infart group had a higher percentage of women initially attended outside our institution (84.1% vs. 16.7%, P < .001), and lower total ischemia time (220 [155-380] vs. 272 [196-456], P = .003). However, no differences in 180-day major cardiovascular adverse events were detected (14.2% vs. 15.6%, P = .692). Conclusions: The implementation of the major cardiovascular adverse events allowed to increase the rate and the percentage of women with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention and reducing total ischemic time.

Proximal and distal maximal luminal diameters as a guide to appropriate deployment of the ABSORB everolimus-eluting bioresorbable vascular scaffold: a sub-study of the ABSORB Cohort B and the on-going ABSORB EXTEND single arm study

Objectives: Due to the limited distensibility of the everolimus-eluting bioresorbablevascular scaffold (ABSORB) compared to metallic platform stents, quantitative coronaryarteriography (QCA) is a mandatory requirement for ABSORB deployment in theon-going ABSORB EXTEND Single-Arm Study. Visual assessment of vessel size in theABSORB Cohort B study often lead to under and over-sizing of the 3 mm ABSORB incoronary vessels (recommended range of the vessel diameter 2.5 mm and 3.3 mm),with an increased risk of spontaneous incomplete scaffold apposition post ABSORBdeployment. We report whether mandatory QCA assessment of vessel size pre-implantation,utilizing the maximal luminal diameter (Dmax) and established interpolatedreference vessel diameter (RVD) measurements, has improved device/vessel sizing.Methods: Pre-implantation post-hoc QCA analyses of all 101 patients from ABSORBCohort B (102 lesions) and first consecutive 101 patients (108 lesions) from ABSORBEXTEND were undertaken by an independent core-laboratory; all patients had a 3 mmABSORB implanted. Comparative analyses were performed. Results: Within ABSORBCohort B, a greater number of over-sized vessels (>3.3 mm) were identified utilizingthe Dmax compared to the interpolated RVD (17 vessels, 16.7% vs. 3 vessels, 2.9%; P 50.002). Comparative analyses demonstrated a greater number of appropriate vessel-sizeselection (75 vessels, 69.4% vs. 48 vessels, 47.1%; P 5 0.001), a trend towards a reductionin implantation in small (3.3 mm) vessels(4 vessels, 3.7% vs. 17 vessels, 16.7%; P 5 0.002) in ABSORB EXTEND. Bland–Altmanplots suggested a good agreement between operator and core-laboratory calculatedDmax measurements. Conclusions: ...