Thorac Cardiovasc Surg 2016; 64 - OP245
DOI: 10.1055/s-0036-1571675

Use of Endovascular Dual Filtration System for Cerebral Protection in Transcatheter Heart Valve Implantation Procedures

F. Deuschl 1, N. Schofer 1, B. Vogel 2, M. Seiffert 1, C. Frerker 3, L. Conradi 2, H. Treede 2, E. Lubos 1, J. Schirmer 2, D. Schewel 3, K.-H. Kuck 3, H. Reichenspurner 2, S. Blankenberg 1, U. Schäfer 1
  • 1University Heart Center Hamburg, UKE, General and Interventional Cardiology, Hamburg, Germany
  • 2University Heart Center Hamburg, UKE, Cardiovascular Surgery, Hamburg, Germany
  • 3Asklepios Klinik St. Georg, Cardiology, Hamburg, Germany

Objectives: Endovascular cerebral protection devices aim for the reduction of periprocedural stroke rate during transcatheter aortic valve implantation (TAVI). Aim of this study was to evaluate the device success rate as well as the rate of stroke or TIA after TAVI performed with the dual filtration system Claret Montage™ which has been replaced by Claret Sentinel™ (introduced in 03/2014).

Methods and Results: The analysis comprises 120 patients, who underwent TAVI between September 2011 and December 2014 in two Heart Centers. Inclusion criterion was a suspected increased risk for stroke. Patients had atrial fibrillation in 49.7%, mobile structures or very severe calcification at the aortic valve in 44.2%, history of stroke in 18.1%, or a present LAA-thrombus in 8.4% of cases. In 20.1% TAVI was performed as a valve-in-valve procedure. A second generation repositionable device was used in 12.3% of patients. After administration of heparin (ACT >250 second), the cerebral embolic protection devices (Claret Montage™ n = 51, Claret Sentinel™ n = 69) were inserted immediately before initiation of any valvular manipulation via the right radial (n = 116) or brachial artery (n = 4). Data of clinical stroke/TIA was retrospectively analyzed and will be prospectively collected during a follow up of 12 months.

Patients were 57.3% male with a mean age of 79.3 ± 7.1 years. All patients were considered to be at high-risk for surgical aortic valve replacement, reflected by a mean logistic EuroSCORE I of 21.6 ± 16.9% and a mean STS PROM of 6.2 ± 5.9%. Successful deployment of the protection devices was achieved in all but 3 patients (97,5%). No device associated major vascular complications were observed. No acute stroke/TIA occurred within 48 hours post procedure. 30-day stroke/TIA rate after TAVI was 0.8% (TIA n = 1, Stroke n = 0), all-cause 30-day mortality rate was 6.7% (n = 8).

Conclusion: Use of the Claret montage™ and Claret sentinel™ devices is safe and results in a low 30-day stroke/TIA rate. However, the results need to be validated in a larger, randomized clinical trial.