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- Richard R. Heuser, MD∗ ()
- ↵∗Department of Cardiology, St. Luke’s Medical Center, 555 North 18th Street, Suite 300, Phoenix, Arizona 85006
I read with interest the results of the SENTINEL (Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement) trial (1). Cerebral embolic protection during transcatheter aortic valve replacement (TAVR) was also discussed in a letter to the editor in the same issue (2) that suggested that the use of embolic protection during TAVR appears to be associated with a significant reduction in death or stroke. In fact, there was a numerically lower stroke rate in the SENTINEL protected group, and the striking part of this study is that even though previous TAVR studies have reported stroke rates of 2% to 7%, this study reported a higher stroke rate of 9.1%, in unprotected patients. The SENTINEL protected patients in the trial experienced 42% fewer lesions volumetrically in the protected areas than the unprotected group. For those individual patients, the 9.1% stroke rate dropped to 5.6% clinically, a relevant reduction in these patients even though the 38% reduction did not achieve statistical significance. What was also remarkable is that 20% of the material found in the capture filters was larger than 500 μm, a significant particle size.
The question is this: What is the utility of the Sentinel Cerebral Protective System device (Claret Medical, Santa Rosa, California) that was used in this study? Should it be used for all TAVR procedures? There is some suggestion that the use of the device during left atrial appendage occlusion, mitral clip treatment, and even thoracic and vascular aortic repair may also be effective. I present a case where this might have also been effective. A 51-year-old man with significant aortic stenosis presented to my office for possible TAVR. He was basically a low-risk patient, although morbidly obese and therefore could not be treated with TAVR. He underwent successful, minimally invasive aortic valve replacement and woke up the next morning with hemiplegia of the left side and double vision, which continued for 2 weeks after the surgical procedure. In fact, the surgeon noted how much material was found on the valve and how calcific it was. Clearly, as seen on the post-operative magnetic resonance angiogram, the material had embolized, resulting in a cerebral event.
The Claret device has shown not to increase the complications of TAVR during use and takes a minimal amount of time for placement. May I suggest that because 1 stroke is 1 too many in these patients, particularly a low-risk man like the patient described, perhaps the Claret device will have other applications. The SENTINEL trial has shown that embolic protection can reduce strokes and decrease the volume of material embolized, even though some of the endpoints of the study were not achieved. As described in a letter to the editor by Gustino et al. (2), study design, sample size, treatment crossover, imaging, neurocognitive assessment dropout, and endpoint ascertainment are difficult, and meta-analysis does not replace adequately powered randomized trials. Certainly, additional evidence is necessary, but again, for an individual patient, 1 stroke is 1 too many.
Please note: Dr. Heuser holds equity in Claret Medical. Deepak L. Bhatt, MD, MPH, served as Guest Editor-in-Chief for this paper.
- 2017 American College of Cardiology Foundation
- Kapadia S.R.,
- Kodali S.,
- Makkar R.,
- et al.
- Giustino G.,
- Sorrentino S.,
- Mehran R.,
- Faggioni M.,
- Dangas G.