Impact of a Two-Filter Cerebral Embolic Protection Device on the Complexity and Risk of Transcatheter Aortic Valve Replacement

Abstract

Background There is a growing use of cerebral protection devices in patients undergoing transcatheter aortic valve replacement (TAVR). We aimed to analyze if the use of these devices itself has an impact on the complexity and the risk of TAVR.

Methods Between February 2016 and July 2017, 391 patients underwent transfemoral TAVR with Medtronic CoreValve Evolut R (n = 196) or Edwards Sapien 3 (n = 195). In 39 patients, the Claret Sentinel™ embolic protection device (CS-EPD) was used. Prospectively collected data were retrospectively analyzed, comparing fluoroscopy/operation time, amount of contrast used, vascular events, and postprocedural renal function in TAVR patients with (n = 39) and without (n = 352) CS-EPD.

Results The CS-EPD was placed through the right radial (n = 35) or brachial (n = 4) artery. Procedural success rate defined as correct deployment and retraction of both filters was 94.9%. No device-related vascular complications occurred. TAVR patients with CS-EPD showed a significantly higher total operation time, total fluoroscopy time, and amount of used contrast (85.4 ± 39.3 vs. 64 ± 29.8 minutes, p = 0.002; 20.7 ± 9.3 vs. 13.7 ± 7 minutes, p ≤ 0.001; 133.7 ± 42.6 vs. 109.7 ± 44.5 mL, p = 0.001). Comparing the initial third of patients receiving a CS-EPD with the last third of CS-EPD cases, procedural time had decreased significantly (102.5 ± 34.9 vs. 67 ± 11.9; p = 0.002). There were no differences in postprocedural renal failure (p = 0.80).

Conclusion Our data add evidence that the application of the CS-EPD is not associated with an additional risk for the patient. Although procedural time and amount of contrast are still higher when using the CS-EPD, there were no device-related complications or increased incidence of renal failure.

Keywords

brain - heart valve - percutaneous (TAVI) - endovascular procedures - outcomes - surgery - complications

Note

Presented at the 47th Annual Meeting of DGTHG, 17.-20.02.2018 in Leipzig, Germany.

Publication History

Received: 18 October 2018

Accepted: 25 March 2019

Article published online:
15 May 2019

• References

• 1 Kapadia SR, Kodali S, Makkar R. et al; SENTINEL Trial Investigators. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol 2017; 69 (04) 367-377
• 2 Van Mieghem NM, Schipper ME, Ladich E. et al. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation 2013; 127 (22) 2194-2201
• 3 Eggebrecht H, Oldenburg O, Dirsch O. et al. Potential embolization by atherosclerotic debris dislodged from aortic wall during cardiac catheterization: histological and clinical findings in 7,621 patients. Catheter Cardiovasc Interv 2000; 49 (04) 389-394
• 4 Omran H, Schmidt H, Hackenbroch M. et al. Silent and apparent cerebral embolism after retrograde catheterisation of the aortic valve in valvular stenosis: a prospective, randomised study. Lancet 2003; 361 (9365): 1241-1246
• 5 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 (06) 592-601
• 6 Van Mieghem NM, van Gils L, Ahmad H. et al. Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial. EuroIntervention 2016; 12 (04) 499-507
• 7 Giustino G, Mehran R, Veltkamp R, Faggioni M, Baber U, Dangas GD. Neurological outcomes with embolic protection devices in patients undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis of randomized controlled trials. JACC Cardiovasc Interv 2016; 9 (20) 2124-2133
• 8 Naber CK, Ghanem A, Abizaid AA. et al. First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation. EuroIntervention 2012; 8 (01) 43-50
• 9 Schmidt T, Akdag O, Wohlmuth P. et al. Histological findings and predictors of cerebral debris from transcatheter aortic valve replacement: the ALSTER experience. J Am Heart Assoc 2016; 5 (11) 5
• 10 Van Mieghem NM, El Faquir N, Rahhab Z. et al. Incidence and predictors of debris embolizing to the brain during transcatheter aortic valve implantation. JACC Cardiovasc Interv 2015; 8 (05) 718-724
• 11 Kappetein AP, Head SJ, Généreux P. et al; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg 2012; 42 (05) S45-S60
• 12 Smith CR, Leon MB, Mack MJ. et al; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011; 364 (23) 2187-2198
• 13 Popma JJ, Adams DH, Reardon MJ. et al; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol 2014; 63 (19) 1972-1981
• 14 Leon MB, Smith CR, Mack MJ. et al; PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016; 374 (17) 1609-1620
• 15 Grabert S, Lange R, Bleiziffer S. Incidence and causes of silent and symptomatic stroke following surgical and transcatheter aortic valve replacement: a comprehensive review. Interact Cardiovasc Thorac Surg 2016; 23 (03) 469-476
• 16 Adams DH, Popma JJ, Reardon MJ. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014; 371 (10) 967-968
• 17 Leon MB, Smith CR, Mack M. et al; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010; 363 (17) 1597-1607
• 18 Schäfer U. Safety and efficacy of protected cardiac intervention: clinical evidence for sentinel cerebral embolic protection. Interv Cardiol (Lond) 2017; 12 (02) 128-132
• 19 Voss S, Nöbauer C, Lange R, Bleiziffer S. Cerebral protection during transcatheter aortic valve implantation in an extreme high-risk patient. Eur J Cardiothorac Surg 2017; 52 (05) 998-999
• 20 Lansky AJ, Schofer J, Tchetche D. et al. A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial. Eur Heart J 2015; 36 (31) 2070-2078
• 21 Wendt D, Kleinbongard P, Knipp S. et al. Intraaortic protection from embolization in patients undergoing transaortic transcatheter aortic valve implantation. Ann Thorac Surg 2015; 100 (02) 686-691
• 22 Frerker C, Schlüter M, Sanchez OD. et al. Cerebral protection during MitraClip implantation: initial experience at 2 centers. JACC Cardiovasc Interv 2016; 9 (02) 171-179
• 23 Meincke F, Spangenberg T, Kreidel F. et al. Rationale of cerebral protection devices in left atrial appendage occlusion. Catheter Cardiovasc Interv 2017; 89 (01) 154-158