CLaret Embolic Protection ANd TAVI - CLEAN-TAVI

Aug 09, 2016
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
University of Leipzig Heart Center, Claret Medical, and Medtronic
Date Presented:
09/13/2014
Date Published:
08/09/2016
Date Updated:
08/09/2016
Original Posted Date:
09/13/2014
References

Description:

Stroke remains an important limitation of transcatheter aortic valve replacement (TAVR). Moreover, neuroimaging studies show that ischemic lesions are found in more than two thirds of patients undergoing TAVR. The current trial sought to investigate the utility of a cerebral embolic protection device (CEPD) in patients undergoing transfemoral TAVR with the Medtronic CoreValve.

Contribution to the Literature: The CLEAN-TAVI trial indicates that embolic protection using the CEPD results in fewer cerebral embolic events compared with routine management in patients undergoing TAVR.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patient scheduled to undergo transfemoral TAVR with CoreValve

    Number of enrollees: 100
    Duration of follow-up: 7 days

Exclusions:

  • Prior stroke or transient ischemic attack (TIA) in the last 12 months
  • Carotid stenosis >70%
  • Relevant stenosis of the brachiocephalic trunk or the right subclavian artery
  • Pregnancy

Primary Endpoints:

  • Number of lesions in the protected brain region at 2 days post-TAVR

Secondary Endpoints:

  • Total lesion volume at 2 and 7 days after TAVR
  • Lesion number at 7 days

Drug/Procedures Used:

Patients were randomized in a 1:1 ratio to embolic protection with the Claret Montage device or routine management.

Principal Findings:

A total of 100 patients were randomized at one center, 50 to the use of CEPD and 50 to no filter. Baseline characteristics were fairly similar between the two arms.

At 2 days, there was a significant reduction in the total number of lesions on MRI in the CEPD versus no filter arms (8 vs. 16, p = 0.0023), as well as lesions in the protected regions alone (4 vs. 10, p = 0.0009). Similar results were noted on 7-day MRI for total (5 vs. 10, p = 0.012) and protected region (3 vs. 7, p = 0.0023) lesions. Concordantly, the total lesion volume on MRI was significantly lower in the CEPD arm versus the no filter arm at both time points.

Interpretation:

The results of the CLEAN-TAVI trial indicate that embolic protection using the Claret Montage CEPD results in fewer cerebral embolic events when compared with routine management using no filter in patients undergoing transfemoral TAVR. These results are interesting given the high cerebral embolism rate in patients undergoing TAVR.

Although the highest stroke burden appears to be in the first 48 hours, the risk of clinically manifest stroke within 30 days is approximately 4-5% with TAVR. MRI is a very sensitive measure and even procedures such as atrial fibrillation ablation have been shown to have a high embolic burden on diffusion-weighted imaging studies. Thus, although this is an important field, further studies powered for clinical endpoints in TAVR patients are necessary. The practical feasibility of implanting two CEPDs in each patient, including extra time and additional access requirements, and the cost-effectiveness need to be further assessed as well.

References:

Haussig S, Mangner N, Dwyer MG, et al. Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial. JAMA 2016;316:592-601.

Presented by Dr. Axel Linke at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2014), Washington, DC, September 13, 2014.

Keywords: Stroke, Embolic Protection Devices, Neuroimaging, Intracranial Embolism, Atrial Fibrillation, Magnetic Resonance Imaging, Transcatheter Cardiovascular Therapeutics, Transcatheter Aortic Valve Replacement, Heart Valve Diseases, Cardiac Surgical Procedures


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