Author + information
- Tobias Schmidt1,
- Martin Leon2,
- Roxana Mehran3,
- Karl-Heinz Kuck1,
- Tony Fields4,
- Maria Alu5,
- Susheel Kodali6,
- Samir Kapadia7,
- Axel Linke8,
- Maria Romero9,
- Renu Virmani10 and
- Christian Frerker1
- 1Asklepios Klinik St. Georg, Hamburg, Germany
- 2Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States
- 3Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, New York, New York, United States
- 4Claret Medical, Inc., Santa Rosa, California, United States
- 5Columbia University Medical Center, Chicago, Illinois, United States
- 6New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States
- 7Heart and Vascular Institute, Cleveland, Ohio, United States
- 8University of Leipzig Heart Center, Leipzig, Germany
- 9CVPath Institute Inc., Gaithersburg, Maryland, United States
- 10CVPath Institute, Inc., Gaithersburg, Maryland, United States
Differences of transcatheter heart valve (THV) types and cerebral injury after TAVR are not well understood, therefore this study investigated differences between THV types and debris captured by a cerebral embolic protection system (Claret Medical, Santa Rosa, CA).
A total of 246 patients (pts) pooled from two prospective studies (SENTINEL IDE Trial n=100, SENTINEL-H trial n=146) were included in the analysis. Histopathologic assessment as well as histomorphometric analyses of debris were compared with THV types. Analyses were differentiated by particle size (≥150μm, ≥500μm, ≥1000 μm), particle count (PC), total particle area (TPA) and Maximum of largest dimension (MOLD). Only commercially available types of THVs were included: 16% Evolut R (EvR), 15% Lotus, 59% SAPIEN 3 (S3), and 10% SAPIEN XT (XT).
Particles were captured in 99% of all patients. Histopathological findings showed a significantly higher percentage of debris related to the vascular bed (valve tissue, arterial wall, calcification) in EvR pts compared to S3 pts. Overall 53% of all pts irrespective of valve type had at least one particle ≥1mm. Larger particles (≥500μm and ≥1000μm) were significantly more frequent in EvR than XT and S3 pts. Also, Lotus pts with particles ≥1000μm were significantly more frequent than in S3 pts. PC, TPA and MOLD were significantly higher in both Lotus and EvR pts compared to S3 and XT. This distribution was found for all different particle sizes. Outliers as high PCs and large TPAs were found for each THV type. Comparison of patient and procedural characteristics with particle size, PC, TPA and MOLD showed no differences, but valve types and procedural details such as pre-dilatation (EvR > Lotus and S3) and post-dilatation (EvR > Lotus, S3 and XT) were significantly different.
After TAVR, debris was captured in 99% of patients of which 53% had particles of debris larger than 1mm. Quantity of debris, measured by different methods and techniques, revealed more debris in patients receiving an EvR or Lotus valve, than in patients receiving a Sapien 3 or Sapien XT prosthesis. Independent of the valve type, large PC and large TPA, as outliers, were captured in all valve types.
STRUCTURAL: Valvular Disease: Aortic