Transcatheter Mitral Valve Repair and Replacement
Mitral valve disease is the second most common manifestation of valvular heart disease in adults.1 A minimally-invasive approach to challenging mitral valve surgery has been developed in the form of the MitraClip, a transcatheter technology.
The incidence of stroke or TIA after a MitraClip procedure has been shown to be up to 2.6%.2 However, the clinically evident stroke rate does not tell the whole story.
The Mitral Valve Academic Research Consortium (MVARC) has stated that transcatheter mitral valve therapies may predispose patients to the formation of thrombus.3 Acute thrombus can develop at the transseptal sheath, as well as the guiding catheter and the clip delivery system due to the stasis phenomenon predisposing them to thrombogenic behavior. Maleki et al.4 reported up to 9% thrombus formation on regular transseptal sheaths despite adequate anti-coagulation and irrigation.
In addition, Feld et al.5 have shown that the Brockenbrough transseptal needle used during the MitraClip procedure generates potentially embolic particles when advanced through the dilator and transseptal sheath. Incidences of 0.2% to 2.6% have been reported.2, 6, 7 Blazek et al.8 showed that the MitraClip procedure without cerebral protection resulted in new ischemic cerebral lesions on diffusion-weighted magnetic resonance imaging (MRI) in 86% of patients. While most of the MRI-detected cerebral lesions remained clinically silent, other studies have shown that clinically silent cerebral lesions were associated with neurocognitive impairment and the development of dementia.9, 10
In an initial experience with 14 high surgical risk patients at two German centers using the Sentinel Cerebral Protection System (CPS) during MitraClip implantation, the Sentinel CPS demonstrated 100% procedural success. No transient ischemic attacks, strokes, or deaths occurred peri-procedurally or during a median follow-up interval of 8.4 months in patients protected with the Sentinel CPS.
In the study, embolic debris was identified in all 14 patients. The most common debris types were acute thrombus and small fragments of non-polarizable basophilic foreign material that were morphologically consistent with hydrogel, a material coating several devices used during the MitraClip procedure, including the transseptal sheath for transseptal puncture and the guide catheter for the MitraClip system.
No evidence was found of foreign material arising from the Sentinel CPS or its coating in this study; in fact, even after investigators manually scraped the surface of the Sentinel filters, no foreign material was observed under high-magnification microscopy.
The study’s investigators recommended that further studies are warranted to assess the impact of cerebral protection on the incidence of cerebrovascular events after MitraClip therapy.
- Christian Frerker, MD, Michael Schlüter, PHD, Oscar D. Sanchez, MD, Sebastian Reith, MD, Maria E. Romero, MD, Elena Ladich, MD, Jörg Schröder, MD, Tobias Schmidt, MD, Felix Kreidel, MD, Michael Joner, MD, Renu Virmani, MD, Karl-Heinz Kuck, MD, Cerebral Protection During MitraClip Implantation
- Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet 2006;368:1005-11
- Glower DD, Kar S, Trento A, et al. Percutaneous mitral valve repair for mitral regurgitation in highrisk patients: results of the EVEREST II study. J Am Coll Cardiol 2014;64:172–81.
- Stone GW, Adams DH, Abraham WT, et al. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. J Am Coll Cardiol 2015;66:308–21.
- Maleki K, Mohammadi R, Hart D, Cotiga D, Farhat N, Steinberg JS. Intracardiac ultrasound detection of thrombus on transseptal sheath: incidence, treatment, and prevention. J Cardiovasc Electrophysiol 2005;16:561–5.
- Feld GK, Tiongson J, Oshodi G. Particle formation and risk of embolization during transseptal catheterization: comparison of standard transseptal needles and a new radiofrequency trans- septal needle. J Interv Card Electrophysiol 2011; 30:31–6.
- Feldman T, Foster E, Glower DD, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med 2011;364:1395–406.
- Nickenig G, Estevez-Loureiro R, Franzen O, et al. Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011–2012 Pilot European Sentinel Registry. J Am Coll Cardiol 2014;64:875–84.
- Blazek S, Lurz P, Mangner N, et al. Incidence, characteristics and functional implications of cerebral embolic lesions after the MitraClip procedure. EuroIntervention 2015;10:1195–203.
- Vermeer SE, Prins ND, den Heijer T, Hofman A, Koudstaal PJ, Breteler MM. Silent brain infarcts and the risk of dementia and cognitive decline. N Engl J Med 2003;348:1215–22.
- Ghanem A, Müller A, Nähle CP, et al. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. J Am Coll Cardiol 2010;55:1427–32.
- Frerker, et al. Cerebral Protection During MitraClip Implantation, J Am Coll Cardiol Intv. 2016;9(2):171-179.
The Sentinel CPS has received the CE Mark and is commercially available in Europe. It is limited to investigational use in the United States.