Characterization of Cerebral Embolic Capture Using the SENTINEL Device During Transcatheter Aortic Valve Implantation in Low to Intermediate-Risk Patients: The SENTINEL-LIR Study

Rika Kawakami, Hemal Gada, Michael J Rinaldi, Tamim M Nazif, Martin B Leon, Samir Kapadia, Amar Krishnaswamy, Atsushi Sakamoto, Yu Sato, Masayuki Mori, Kenji Kawai, Anne Cornelissen, Ji-Eun Park, Saikat Kumar B Ghosh, Biniyam G Abebe, Maria Romero, Renu Virmani, Aloke V Finn, Rika Kawakami, Hemal Gada, Michael J Rinaldi, Tamim M Nazif, Martin B Leon, Samir Kapadia, Amar Krishnaswamy, Atsushi Sakamoto, Yu Sato, Masayuki Mori, Kenji Kawai, Anne Cornelissen, Ji-Eun Park, Saikat Kumar B Ghosh, Biniyam G Abebe, Maria Romero, Renu Virmani, Aloke V Finn

No abstract available

Keywords: aortic valve; dilatation; incidence; ischemic stroke; transient ischemic attack.

Figures

Figure.

Histological characteristics of debris captured by the SENTINEL cerebral protection system. A, Debris capture rate for each tissue type. Debris was captured in all 49 patients (100%). The captured debris was composed of arterial wall fragments (98% of patients), acute thrombus (96%), valve tissue (71%), calcification (55%), and foreign materials (43%). Myocardium (20%), organizing thrombus (4%), and necrotic core (4%) were found less frequently. This tendency was identical in patients treated with CoreValve and Sapien 3 valves (arterial wall fragments: CoreValve 100%, Sapien 96%, P=0.26; acute thrombus: CoreValve 93%, Sapien 100%, P=0.19; valve tissue: CoreValve 70%, Sapien 73%, P=0.86; calcification: CoreValve 59%, Sapien 50%, P=0.52; foreign materials: CoreValve 37%, Sapien 50%, P=0.36; myocardium: CoreValve 22%, Sapien 18%, P=0.73; organizing thrombus: CoreValve 4% vs Sapien 5%, P=0.88; necrotic core; CoreValve 4%, Sapien 5%, P=0.88). B, Number of captured debris particles and percentages of captured debris by size. Median number of particles ≥150 μm in size was 25 (first–third quartiles, 14–67). No statistically significant differences in particle numbers and sizes were observed in patients implanted with CoreValve and Sapien 3 valves (all particle counts: CoreValve (median [first–third quartiles], 261 [152–407], Sapien 215 [150–620]; particles ≥150 μm in size: CoreValve 26 [20–62], Sapien 23 [12–69], P=0.49; total debris tissue area: CoreValve 2.25 [0.86–4.07], Sapien 1.28 [0.42–4.93], P=0.17). The majority of debris particles ranged in size from 150 to 499 μm (78% of particles were ≥150 μm in size); 17% of particles were 500–999 μm in size. Particles 1000–1999 μm and ≥2000 μm in size comprised 5% of the captured particles (100–1999 μm: 4%; ≥2000 μm: 1%). These observations were similar among patients implanted with CoreValve and Sapien 3 valves. Boxes with bars in the left graph indicate interquartile ranges corresponding to each median. Whiskers indicate the minima and maxima. Boxes with error bars in the right graph indicate medians and 75% quartiles. C, Effects of predilatation and postdilatation on captured debris. Performing predilatation or postdilatation did not impact the number of particles or the total tissue area of debris observed in the current study (number of particles ≥150 μm in size: predilatation, 34 [21–77], predilatation, 22 [12–52], P=0.06; postdilatation, 34 [17–81], postdilatation, 25 [13–60], P=0.40; total tissue area, predilatation, 2.25 [1.45–5.86], predilatation, 1.05 [0.56–3.88], P=0.05; postdilatation, 2.13 [0.54–5.35], postdilatation, 1.69 [0.65–4.06], P=0.74). Boxes with bars indicate interquartile ranges corresponding to each median. Whiskers indicate the minima and the maxima. Categorical variables were analyzed with the χ2 test or Fisher exact method. Non-normally distributed data were compared with the Wilcoxon rank-sum test. A P value <0.05 was considered significant. All statistical analysis was performed utilizing JMP software (version 15.0, SAS, Cary, NC).