Stroke Happens

Stroke is an unpredictable and devastating event which is under diagnosed and under reported in TAVI, as well as in Surgical Aortic Valve Replacement (SAVR)

The majority of TAVI stroke is peri-procedural. Cerebrovascular events as a result of TAVI are shown to occur most frequently at Day 0-1, with the median time to major stroke being 1 day. More than 50% of identified strokes are classified as major, with more than 95% of those being ischemic.1, 4

In the SENTINEL trial, prospective assessment by neurologists revealed a 30-day all-stroke rate in unprotected TAVI of 9.1%.2 In other words, almost 1 in 10 TAVI patients show overt signs of ischemic brain injury as a result of the procedure.

The American Association of Neurological Surgeons (AANS) and Society of NeuroInterventional Surgery (SNIS) have endorsed the key role of SENTINEL CPS in the reduction of stroke during TAVI.

Protection Works

Protected TAVI™ with Claret Medical’s SENTINEL™ CPS gives you the power to reduce stroke.  In the SENTINEL pivotal US IDE, peri-procedural stroke rate was reduced by 63%4 when SENTINEL CPS was used.

The 63% peri-procedural (≤ 72 hours) stroke reduction was confirmed in an independent real-world academic study from Ulm Germany, which demonstrated compelling 70% reduction in neurologist adjudicated TAVI Stroke, and Stroke or Mortality in the first 7-days post TAVI.

Click here to read a study in Journal of American College of Cardiology (JACC) that underscores how SENTINEL CPS reduces TAVI 7-Day All-Stroke  and 7-Day All-Stroke or All-Cause Mortality by 70%.5

Cerebral Damage More Pervasive Than Originally Thought

When neurologists examine TAVI patients’ brains post-procedure, they are seeing more damage than has been reported to-date. Neurological deficit has been observed in 28% of TAVI patients that did not receive cerebral protection as evaluated by a neurologist two days post-procedure.

Past clinical studies on surgical valve replacement have reported stroke rates as determined by cardiovascular surgeons. When neurologists are part of the Heart Team that clinically examines the patient following surgery, clinical stroke is reported more frequently than previously thought. A de novo surgical aortic valve replacement study found that the surgeon-reported stroke rate was 6.6%, which rose to 17% upon clinical and MRI review by a neurologist.4

References:

  1. Tchétché, et al. J Am Coll Cardiol Intv. 2014;7(10):1138-45.
  2. Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377.
  3. Nombela-Franco, et. al. Circulation. 2012;126:3041-53.
  4. Seeger, J. et. al. in press. JACC 2017 September.
  5. Seeger J 2017, TCT oral presentation, (manuscript submitted and under review)
  6. Seeger J. presented at TVT 2018

The SENTINEL CPS has received the CE Mark and is commercially available in Europe.

Claret Medical is now a part of Boston Scientific.     SH-568318-AA