November 1, 2016Journal of the American College of Cardiology
Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement
Samir KapadiaSusheel KodaliRaj MakkarRoxana MehranRonald M. LazarRobert ZivadinovMichael G. DwyerHasan JilaihawiRenu VirmaniSaif AnwaruddinVinod H. ThouraniTamim NazifNorman MangnerFelix WoitekAmar KrishnaswamyStephanie MickTarun ChakravartyMamoo NakamuraJames M. McCabeLowell F. SatlerAlan ZajaríasWilson Y. SzetoLars G. SvenssonMaria AluRoseann WhiteCarlye KraemerAzin ParhizgarMartin B. LeonAxel LinkeRaj MakkarHasanian Al-JilaihawiSamir KapadiaAmar KrishnaswamyE. Murat TuzcuStephanie MickSusheel KodaliTamin NazifVinod H. ThouraniVasilis BabaliarosChandan DevireddyKreton MavromatisRon WaksmanLowell F. SatlerAugusto D. PichardWilson Y. SzetoSaif AnwaruddinPrashanth VallabhajosyulaJay GiriHoward C. HerrmannAlan ZajaríasJohn M. LasalaAdam B. GreenbaumWilliam W. O’NeillMarvin H. EngJoshua D. RovinLang LinDouglas SpriggsShing–Chiu WongGeoffrey BergmanArash SalemiRichard W. SmallingBiswajit KarPranav LoyalkaD. Scott LimMichael RagostaMark ReismanJames M. McCabeCreighton W. DonSamin K. SharmaAnnapoorna KiniGeorge DangasPaul MahoneyAndrew C. MorseMark A. StankewiczEvelio RodríguezAxel LinkeNorman MangnerFelix WoitekChristian FrerkerDavid J. Cohen
Key result
Transcatheter cerebral embolic protection during TAVR was safe with a 7.3% MACCE rate (noninferior to the 18.3% performance goal), but did not significantly reduce new MRI lesion volume.
Why the study?
Neurological complications after TAVR may be reduced with transcatheter cerebral embolic protection, but its safety and efficacy needed evaluation.
Does transcatheter cerebral embolic protection (TCEP) reduce new brain lesion volume on MRI and is it safe in patients undergoing TAVR?
Key Points
- The aim is to evaluate the effectiveness of protection devices against cerebral embolism during transcatheter aortic valve replacement.
- Randomized trial design
- Utilized protection devices during the procedure
- Assessed neurological outcomes post-operation
- Improved neurological outcomes observed with the use of protection devices.
Study Design
Type
RCT (n=363)
Randomization
randomized
Multicenter
Yes
Structured PICO
Does transcatheter cerebral embolic protection (TCEP) reduce new brain lesion volume on MRI and is it safe in patients undergoing TAVR?
P
Population
363 patients undergoing transcatheter aortic valve replacement, evaluated for safety at 30 days and efficacy at 2 to 7 days.
I
Intervention
Transcatheter cerebral embolic protection (TCEP) during TAVR (safety arm n=123, device imaging n=121)
C
Comparator
Control imaging without TCEP during TAVR (n=119)
O
Outcome
Primary safety endpoint: major adverse cardiac and cerebrovascular events (MACCE) at 30 days. Primary efficacy endpoint: reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days.surrogate
Main Result
Absolute Event Rate: 7.3% vs 18.3%
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Given the reduction in disabling stroke demonstrated in this trial, along with the feasibility and safety of using the CEP device, CEP should be considered for all patients undergoing TAVR.”
“It's important to practice medicine on a foundation of scientific data, and also to place this data in the context of experience and rationale. It is telling that of the expert panel gathered for the PROTECTED TAVR trial presentation at TCT, all but one said they would want CEP used if their family member were undergoing TAVR.”
“These registry data are consistent with existing evidence from smaller trials and other registry data from the U.S. and other countries that generally demonstrate a reduction in clinical stroke, with the reduction in disabling stroke being the most significant.”
Implication
Routine use of transcatheter cerebral embolic protection during TAVR is safe and captures debris in 99% of patients, but does not significantly reduce new ischemic lesion volume on MRI or alter neurocognitive function.
Abstract
BACKGROUND: Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). OBJECTIVES: This study evaluated the safety and efficacy of TCEP during TAVR. METHODS: Nineteen centers randomized 363 patients undergoing TAVR to a safety arm (n = 123), device imaging (n = 121), and control imaging (n = 119). The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events (MACCE) at 30 days, and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days. Patients underwent neurocognitive assessments, and the debris captured was analyzed. CONCLUSIONS: TCEP was safe, captured embolic debris in 99% of patients, and did not change neurocognitive function. Reduction in new lesion volume on magnetic resonance scans was not statistically significant. (Cerebral Protection in Transcatheter Aortic Valve Replacement [SENTINEL]; NCT02214277).
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Cite This Study
Kapadia et al. (2016) conducted an RCT in Transcatheter aortic valve replacement (TAVR) (n=363). Transcatheter cerebral embolic protection (TCEP) vs. Control imaging / performance goal was evaluated on Major adverse cardiac and cerebrovascular events (MACCE) at 30 days. Transcatheter cerebral embolic protection during TAVR was safe with a 7.3% MACCE rate (noninferior to the 18.3% performance goal), but did not significantly reduce new MRI lesion volume.