Julia Seeger1, Samir R Kapadia2, Susheel Kodali3, Axel Linke4, Jochen Wöhrle1, Stephan Haussig4, Raj Makkar5, Roxana Mehran6, Wolfgang Rottbauer1, Martin Leon3. 1. Department of Internal Medicine II - Cardiology, University of Ulm, Albert-Einstein-Allee 23, Ulm, Germany. 2. Cleveland Clinic, Department of Cardiology, Euclid Ave, Cleveland, OH, USA. 3. Columbia University Medical Centre, 161 Fort Washington Ave, New York, NY, USA. 4. Herzzentrum Dresden Universitätsklinik, Fetscherstraße 76, Dresden, Germany. 5. Cedars-Sinai Medical Centre, 8631 W 3rd St, Los Angeles, CA, USA. 6. Mount Sinai School of Medicine, 1190 5th Avenue, 1 South, New York, NY, USA.
Abstract
AIMS: The role of cerebral embolic protection (CEP) in transcatheter aortic valve replacement (TAVR) remains controversial. Randomized trials have not been powered to demonstrate a reduction in stroke rates. The aim of this patient level pooled analysis was to validate the impact of the dual-filter CEP device (Claret Medical Inc., CA, USA) on peri-procedural stroke in a large number of TAVR patients. METHODS AND RESULTS: Patients from the SENTINEL US IDE trial were combined with the CLEAN-TAVI and SENTINEL-Ulm study in a patient level pooled analysis (N = 1306). Propensity score matching was performed to adjust for possible confounders. The primary endpoint was procedural stroke within 72 h post-TAVR according to Valve Academic Research Consortium-2 criteria. The secondary endpoint was the combination of all-cause mortality or all-stroke within 72 h after TAVR. In the propensity-matched population, 533 patients underwent TAVR without CEP and 533 patients underwent TAVR with CEP. TAVR patients without vs. with CEP were similar with respect to baseline characteristics, procedural approach, or valve type. In patients undergoing TAVR with dual-filter CEP, procedural all-stroke was significantly lower compared with unprotected procedures [1.88% vs. 5.44%, odds ratio 0.35, 95% confidence interval (CI) 0.17-0.72, relative risk reduction 65%, P = 0.0028]. In addition, all-cause mortality and all-stroke were significantly lower (2.06% vs. 6.00%, odds ratio 0.34, 95% CI 0.17-0.68, relative risk reduction 66%, P = 0.0013). CONCLUSION: Our findings suggest that TAVR with the dual-filter CEP device is associated with a significant lower rate of peri-procedural stroke compared with unprotected procedures. However, randomized trials are still needed to clarify this issue. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: The role of cerebral embolic protection (CEP) in transcatheter aortic valve replacement (TAVR) remains controversial. Randomized trials have not been powered to demonstrate a reduction in stroke rates. The aim of this patient level pooled analysis was to validate the impact of the dual-filter CEP device (Claret Medical Inc., CA, USA) on peri-procedural stroke in a large number of TAVR patients. METHODS AND RESULTS:Patients from the SENTINEL US IDE trial were combined with the CLEAN-TAVI and SENTINEL-Ulm study in a patient level pooled analysis (N = 1306). Propensity score matching was performed to adjust for possible confounders. The primary endpoint was procedural stroke within 72 h post-TAVR according to Valve Academic Research Consortium-2 criteria. The secondary endpoint was the combination of all-cause mortality or all-stroke within 72 h after TAVR. In the propensity-matched population, 533 patients underwent TAVR without CEP and 533 patients underwent TAVR with CEP. TAVR patients without vs. with CEP were similar with respect to baseline characteristics, procedural approach, or valve type. In patients undergoing TAVR with dual-filter CEP, procedural all-stroke was significantly lower compared with unprotected procedures [1.88% vs. 5.44%, odds ratio 0.35, 95% confidence interval (CI) 0.17-0.72, relative risk reduction 65%, P = 0.0028]. In addition, all-cause mortality and all-stroke were significantly lower (2.06% vs. 6.00%, odds ratio 0.34, 95% CI 0.17-0.68, relative risk reduction 66%, P = 0.0013). CONCLUSION: Our findings suggest that TAVR with the dual-filter CEP device is associated with a significant lower rate of peri-procedural stroke compared with unprotected procedures. However, randomized trials are still needed to clarify this issue. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Raj R Makkar; Sung-Han Yoon; Martin B Leon; Tarun Chakravarty; Michael Rinaldi; Pinak B Shah; Eric R Skipper; Vinod H Thourani; Vasilis Babaliaros; Wen Cheng; Alfredo Trento; Sreekanth Vemulapalli; Samir R Kapadia; Susheel Kodali; Michael J Mack; Gilbert H L Tang; Tsuyoshi Kaneko Journal: JAMA Date: 2019-06-11 Impact factor: 56.272
Authors: Paul Toon Lim Chiam; Nien Shen Chan; Yean Teng Lim; Choon Pin Lim; Dinesh Nair; Tai Tian Lim; Chao Yang Soon; Brian Chung Hoe Khoo; Jimmy Lim; Kok Soon Tan; Leslie Lam; Peter Yan; Yau Wei Ooi; Mei Sian Chong Journal: Singapore Med J Date: 2022-02-24 Impact factor: 3.331
Authors: Aleksandra Gasecka; Michał Walczewski; Adam Witkowski; Maciej Dabrowski; Zenon Huczek; Radosław Wilimski; Andrzej Ochała; Radosław Parma; Piotr Scisło; Bartosz Rymuza; Karol Zbroński; Piotr Szwed; Marek Grygier; Anna Olasińska-Wiśniewska; Dariusz Jagielak; Radosław Targoński; Grzegorz Opolski; Janusz Kochman Journal: Front Cardiovasc Med Date: 2022-06-21
Authors: Neel M Butala; Raj Makkar; Eric A Secemsky; Dianne Gallup; Guillaume Marquis-Gravel; Andrzej S Kosinski; Sreekanth Vemulapalli; Javier A Valle; Steven M Bradley; Tarun Chakravarty; Robert W Yeh; David J Cohen Journal: Circulation Date: 2021-02-23 Impact factor: 39.918