BACKGROUND:Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). OBJECTIVES: This study evaluated the safety and efficacy of TCEP during TAVR. METHODS:Nineteen centers randomized 363 patients undergoing TAVR to a safety arm (n = 123), device imaging (n = 121), and control imaging (n = 119). The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events (MACCE) at 30 days, and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days. Patients underwent neurocognitive assessments, and the debris captured was analyzed. RESULTS: The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, pnoninferior < 0.001) and not statistically different from that of the control group (9.9%; p = 0.41). New lesion volume was 178.0 mm3 in control subjects and 102.8 mm3 in the device arm (p = 0.33). A post hoc multivariable analysis identified pre-existing lesion volume and valve type as predictors of new lesion volume. Strokes at 30 days were 9.1% in control subjects and 5.6% in patients with devices (p = 0.25) Neurocognitive function was similar in control subjects and patients with devices, but there was a correlation between lesion volume and neurocognitive decline (p = 0.0022). Debris found within filters in 99% of patients included thrombus, calcification, valve tissue, artery wall, and foreign material. CONCLUSIONS:TCEP was safe, captured embolic debris in 99% of patients, and did not change neurocognitive function. Reduction in new lesion volume on magnetic resonance scans was not statistically significant. (Cerebral Protection in Transcatheter Aortic Valve Replacement [SENTINEL]; NCT02214277).
RCT Entities:
BACKGROUND:Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). OBJECTIVES: This study evaluated the safety and efficacy of TCEP during TAVR. METHODS: Nineteen centers randomized 363 patients undergoing TAVR to a safety arm (n = 123), device imaging (n = 121), and control imaging (n = 119). The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events (MACCE) at 30 days, and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days. Patients underwent neurocognitive assessments, and the debris captured was analyzed. RESULTS: The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, pnoninferior < 0.001) and not statistically different from that of the control group (9.9%; p = 0.41). New lesion volume was 178.0 mm3 in control subjects and 102.8 mm3 in the device arm (p = 0.33). A post hoc multivariable analysis identified pre-existing lesion volume and valve type as predictors of new lesion volume. Strokes at 30 days were 9.1% in control subjects and 5.6% in patients with devices (p = 0.25) Neurocognitive function was similar in control subjects and patients with devices, but there was a correlation between lesion volume and neurocognitive decline (p = 0.0022). Debris found within filters in 99% of patients included thrombus, calcification, valve tissue, artery wall, and foreign material. CONCLUSIONS:TCEP was safe, captured embolic debris in 99% of patients, and did not change neurocognitive function. Reduction in new lesion volume on magnetic resonance scans was not statistically significant. (Cerebral Protection in Transcatheter Aortic Valve Replacement [SENTINEL]; NCT02214277).
Authors: Robert J Lederman; Vasilis C Babaliaros; Toby Rogers; Jaffar M Khan; Norihiko Kamioka; Danny Dvir; Adam B Greenbaum Journal: JACC Cardiovasc Interv Date: 2019-07-08 Impact factor: 11.195
Authors: Jordan B Strom; Yuansong Zhao; Kamil F Faridi; Hector Tamez; Neel M Butala; Linda R Valsdottir; Jeptha Curtis; J Matthew Brennan; Changyu Shen; Mike Boulware; Jeffrey J Popma; Robert W Yeh Journal: Circ Cardiovasc Interv Date: 2019-11-07 Impact factor: 6.546
Authors: Jaffar M Khan; Adam B Greenbaum; Vasilis C Babaliaros; Toby Rogers; Marvin H Eng; Gaetano Paone; Bradley G Leshnower; Mark Reisman; Lowell Satler; Ron Waksman; Marcus Y Chen; Annette M Stine; Xin Tian; Danny Dvir; Robert J Lederman Journal: JACC Cardiovasc Interv Date: 2019-06-12 Impact factor: 11.195
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