PROTECTED TAVR – Cerebral embolic protection?

PROTECTED TAVR – Cerebral embolic protection?

Higher rates of stroke have been considered as a limitation of transcatheter aortic valve replacement (TAVR) in comparison with surgical aortic valve replacement (SAVR) [1,2]. Stroke following TAVR has been shown to increase the 30 day mortality from 3.7% to 16.7% according to a retrospective report from Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry. The registry had 101 430 patients who were treated with femoral and non-femoral TAVR at 521 US hospitals between 2011 and 2017 [3].

A previous study had used cerebral embolic protection device in 280 of the 802 consecutively enrolled TAVR patients. The use of cerebral embolic protection reduced the rate of disabling and non-disabling stroke from 4.6% to 1.4%. The analysis was by a propensity score matching to account for possible confounders [4]. PROTECTED TAVR trial enrolled 3000 patients across North America, Europe, and Australia. A cerebral embolic protection device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom it was attempted [5].

The incidence of stroke within 72 hours of TAVR or before discharge was not significantly different between those who received the cerebral embolic protection device and those who did not (2.3% vs 2.9%). Disabling stroke occurred in 0.5% of the cerebral embolic protection group and in 1.3% of the control group. There was no significant difference in the mortality, transient ischemic attack, delirium or acute kidney injury between the groups. One patient in the embolic protection group had access site vascular complication.

Authors concluded by saying that though the use of cerebral embolic protection device did not have a significant effect on the incidence of periprocedural stroke for transfemoral TAVR for aortic stenosis, on the basis of the 95% confidence interval around this outcome, the results may not rule a benefit of cerebral embolic protection device during TAVR [5].

References

1. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5. PMID: 21639811.
2. Schaff HV. Transcatheter aortic-valve implantation–at what price? N Engl J Med. 2011 Jun 9;364(23):2256-8. doi: 10.1056/NEJMe1103978. Epub 2011 Jun 5. PMID: 21639812.
3. Huded CP, Tuzcu EM, Krishnaswamy A, Mick SL, Kleiman NS, Svensson LG, Carroll J, Thourani VH, Kirtane AJ, Manandhar P, Kosinski AS, Vemulapalli S, Kapadia SR. Association Between Transcatheter Aortic Valve Replacement and Early Postprocedural Stroke. JAMA. 2019 Jun 18;321(23):2306-2315. doi: 10.1001/jama.2019.7525. PMID: 31211345; PMCID: PMC6582268.
4. Seeger J, Gonska B, Otto M, Rottbauer W, Wöhrle J. Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2297-2303. doi: 10.1016/j.jcin.2017.06.037. Epub 2017 Sep 13. PMID: 28917515.
5. Kapadia SR, Makkar R, Leon M, Abdel-Wahab M, Waggoner T, Massberg S, Rottbauer W, Horr S, Sondergaard L, Karha J, Gooley R, Satler L, Stoler RC, Messé SR, Baron SJ, Seeger J, Kodali S, Krishnaswamy A, Thourani VH, Harrington K, Pocock S, Modolo R, Allocco DJ, Meredith IT, Linke A; PROTECTED TAVR Investigators. Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2022 Sep 17. doi: 10.1056/NEJMoa2204961. Epub ahead of print. PMID: 36121045.