RESUMEN
OBJECTIVE:To compare the 1-year outcomes of complete percutaneous approach versus surgical vascular approach for transfemoral transcatheter aortic valve implantation (TAVI), among "real-world" patients from the multi-center Brazilian TAVI registry.BACKGROUND:Vascular access still remains a major challenge for TAVI via transfemoral approach. Vascular accessthrough complete percutaneous approaches or through open surgical vascular techniques seems to be acutely similar. However, the long-term outcomes of both techniques remain poorly described.METHODS:The study population comprised all patients treated via transfemoral route in the Brazilian TAVI registry, a "real-world", nation-based, multi-center study. Patients were divided according to the initial vascular access approach (percutaneous vs. surgical) and clinically followed-up for 1 year. The primary endpoint was the incidence of combined adverse events all-cause mortality, life-threatening bleeding, and/or major vascular complication at 1 year.RESULTS:A total of 402 patients from 18 centers comprised the study population (percutaneous approach in 182 patients; surgical cutdown approach 220 patients). The incidence of combined adverse events was not different in thepercutaneous and the surgical groups at 30 days (17.6% vs. 16.3%; P = 0.8) and at 1 year (primary endpoint) (30.9% vs. 28.8%; P = 0.8). Also, the study groups overall were comparable regarding the incidence of each individual safety adverse events at 30 days and at 1 year.CONCLUSION:Total percutaneous techniques or surgical cutdown and closure may provide similar safety and effectiveness during the first year of follow-up in patients undergoing transfemoral TAVI.
Asunto(s)
Aorta , Dispositivos de Acceso Vascular , Estenosis Coronaria , Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas CardíacasRESUMEN
BACKGROUND:Cardiac biomarker release signifying myocardial injury post-transcatheter aortic valve replacement (TAVR) is common, yet its clinical impact within a large TAVR cohort receiving differing types of valve and procedural approaches is unknown.OBJECTIVES:This study sought to determine the incidence, clinical impact, and factors associated with cardiac biomarker elevation post TAVR.METHODS:This multicenter study included 1,131 consecutive patients undergoing TAVR with balloon-expandable (58%) or self-expandable (42%) valves. Transfemoral and transapical (TA) approaches were selected in 73.1% and 20.3% of patients, respectively. Creatine kinase-myocardial band (CK-MB) measurements were obtained at baseline and at several time points within the initial 72 h post TAVR. Echocardiography was performed at baseline and at 6- to 12-month follow-up.RESULTS:Overall, 66% of the TAVR population demonstrated some degree of myocardial injury as determined by a rise in CK-MB levels (peak value: 1.6-fold [interquartile range (IQR): 0.9 to 2.8-fold]). A TA approach and major procedural complications were independently associated with higher peak of CK-MB levels (p < 0.01 for all), which translated into impaired systolic left ventricular function at 6 to 12 months post TAVR (p < 0.01). A greater rise in CK-MB levels independently associated with an increased 30-day, late (median of 21 [IQR: 8 to 36] months) overall and cardiovascular mortality (p < 0.001 for all)...