Tobias Schmidt1, Martin B Leon2, Roxana Mehran3, Karl-Heinz Kuck4, Maria C Alu2, Ryan E Braumann5, Susheel Kodali2, Samir R Kapadia6, Axel Linke7, Raj Makkar8, Christoph Naber9, Maria E Romero5, Renu Virmani5, Christian Frerker4. 1. Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany. Electronic address: tobiasschmidtmd@gmail.com. 2. Columbia University Irving Medical Center, New York, New York. 3. Mount Sinai School of Medicine, New York, New York. 4. Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany. 5. CVPath Institute, Inc., Gaithersburg, Maryland. 6. Cleveland Clinic, Cleveland, Ohio. 7. Herzzentrum Leipzig GmbH-Universitätsklinik, Leipzig, Germany. 8. Cedars-Sinai Medical Center, Los Angeles, California. 9. University Hospital of Essen, Essen, Germany.
Abstract
OBJECTIVES: This study investigated differences between transcatheter heart valve (THV) types and regarding debris captured by a cerebral embolic protection system (Claret Medical Sentinel, Santa Rosa, California). BACKGROUND: Differences of THV types and cerebral injury after transcatheter aortic valve replacement (TAVR) are not well understood. METHODS: A total of 246 patients pooled from 2 prospective studies (SENTINEL [Cerebral Protection in Transcatheter Aortic Valve Replacement] trial, N = 100; SENTINEL-H [Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement] trial, N = 146) were included in the analysis. Histopathologic assessment and histomorphometric analyses of debris were compared with THV types. Analyses were differentiated by particle size (≥150, ≥500, and ≥1,000 μm), particle count, total particle area, and maximum of largest dimension. Only commercially available THVs were included: 16% Evolut R (EvR), 15% Lotus, 59% SAPIEN 3 (S3), and 10% SAPIEN XT (XT). RESULTS: Particles were captured in 99% of patients. There was a significantly higher amount of debris related to the vascular bed (valve tissue, arterial wall, calcification) in EvR patients compared with S3 patients; 53% of all patients irrespective of valve type had at least 1 particle ≥1 mm. Larger particles (≥500 and ≥1,000 μm) were significantly more frequent in EvR than XT and S3 patients. Lotus patients with particles ≥1,000 μm were significantly more frequent than in S3 patients. Particle count, total particle area, and maximum of largest dimension were significantly higher in both Lotus and EvR patients compared with S3 and XT. CONCLUSIONS: Debris was captured in 99% of patients, of whom 53% had at least 1 particle of debris >1 mm. The number and size of particles captured during a procedure in which EvR or Lotus THV was used were higher and larger than with a Sapien THV. Regardless, embolic debris, including large particles, is universal across valve types and provides mechanistic support for the potential benefit of using cerebral embolic protection in all TAVR procedures.
OBJECTIVES: This study investigated differences between transcatheter heart valve (THV) types and regarding debris captured by a cerebral embolic protection system (Claret Medical Sentinel, Santa Rosa, California). BACKGROUND: Differences of THV types and cerebral injury after transcatheter aortic valve replacement (TAVR) are not well understood. METHODS: A total of 246 patients pooled from 2 prospective studies (SENTINEL [Cerebral Protection in Transcatheter Aortic Valve Replacement] trial, N = 100; SENTINEL-H [Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement] trial, N = 146) were included in the analysis. Histopathologic assessment and histomorphometric analyses of debris were compared with THV types. Analyses were differentiated by particle size (≥150, ≥500, and ≥1,000 μm), particle count, total particle area, and maximum of largest dimension. Only commercially available THVs were included: 16% Evolut R (EvR), 15% Lotus, 59% SAPIEN 3 (S3), and 10% SAPIEN XT (XT). RESULTS: Particles were captured in 99% of patients. There was a significantly higher amount of debris related to the vascular bed (valve tissue, arterial wall, calcification) in EvR patients compared with S3 patients; 53% of all patients irrespective of valve type had at least 1 particle ≥1 mm. Larger particles (≥500 and ≥1,000 μm) were significantly more frequent in EvR than XT and S3 patients. Lotus patients with particles ≥1,000 μm were significantly more frequent than in S3 patients. Particle count, total particle area, and maximum of largest dimension were significantly higher in both Lotus and EvR patients compared with S3 and XT. CONCLUSIONS: Debris was captured in 99% of patients, of whom 53% had at least 1 particle of debris >1 mm. The number and size of particles captured during a procedure in which EvR or Lotus THV was used were higher and larger than with a Sapien THV. Regardless, embolic debris, including large particles, is universal across valve types and provides mechanistic support for the potential benefit of using cerebral embolic protection in all TAVR procedures.
Authors: Sascha Macherey; Max Meertens; Victor Mauri; Christian Frerker; Matti Adam; Stephan Baldus; Tobias Schmidt Journal: J Am Heart Assoc Date: 2021-03-08 Impact factor: 5.501