BACKGROUND:Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). Moreovver, stroke is a well-documented potential risk of all structural cardiac interventions. One such intervention is the recently FDA-cleared Sentinel Cerebral Protection System (Sentinel; Claret Medical, Santa Rosa, CA, USA) designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
OBJECTIVES:We will evaluate in an all-comer prospective study the impact of cerebral embolic protection with the Claret Sentinel device (Claret Medical Inc., Santa Rosa, California) in terms of the importance of capturing and removing embolic debris during TAVI; mitral valve repair with MitraClip system, PFO closure, Left atrial appendix closure, and all procedure with transeptal puncture.
METHODS:All percutaneous procedure (TAVI, MitraClip, PFO closure, Left atrial appendix closure, etc) will be performed according to the good clinical practice and standardize procedure. The decision for transcatheter approach will be decided in the interdisciplinary heart team. Patients will be prospectively included in our observational registry and will be collected data about diagnostic evaluation with routine laboratory testing, medical history with current medication, Society of Thoracic Surgeons (STS) score, New York Heart Association functional class, electrocardiography, echocardiography and heart catheterization. The filters and the debries (2 from each patient) will be analyzed.
CONCLUSIONS:We hypothesize that TCEP is safe, capturing embolic debris in an hight rate of patients. In the SENTINEL IDE Study, and in a more recent all-comers trial, Sentinel significantly reduced periprocedural strokes by 63 and 70 % respectively.
As the field of interventional cardiology has grown, so too has interest in mitigating severe adverse outcomes such as stroke. Unfortunately, the risk of stroke is increased by many underlying disease conditions (atrial fibrillation, patent foramen ovale, carotid artery disease and other vascular disease affecting brain perfusion, etc.), making clear differentiation between cardiac intervention-related cerebral infarction and the effect of other coexisting factors very difficult. In this regard, the prevalence of atrial fibrillation in average transcatheter aortic valve replacement (TAVR) patient cohorts has been reported to be over 31 % and the prevalence of previous stroke has been reported as high as 10.8 % confounding the attribution of stroke to TAVR procedures.
In the last 15 years, TAVR has emerged as an important therapeutic option for patients with severe aortic stenosis, particularly those at increased risk of operative mortality or morbidity with traditional surgical aortic valve replacement (SAVR). Although TAVR has consistently demonstrated similar or better outcomes than SAVR, neurological complications remain a concern. As TAVR populations, procedures and devices have matured, reported rates of overt clinical stroke within controlled clinical trials, and in real-world practice, remain a critical health issue.
Despite cerebral embolism is more common during TAVR procedure due to calcified debris , in all transcatheter valve treatment could develop thrombotic embolism. Indeed, mitral regurgitation (MR) is the second most common manifestation of valvular heart disease in adult and the occurrence of a stroke or a transient ischemic attack (TIA) is one of the potential complications during a MitraClip procedure. Incidences of 0.2% to 2.6% have been reported. Blazek et al. showed that the MitraClip procedure resulted in new ischemic cerebral lesions on diffusion-weighted magnetic resonance imaging (MRI) in 23 (85.7%) of 27 patients studied. This adverse events is more common in patients underwent left atrial appendage closure. In contrast, the actually international guidelines both American and European, do not suggest the use of filters for the cerebral protection in order to reduce the stroke rate. Probably because, in the most of case, the embolism of calcified or thrombus debris do not imply a symptomatic neurologic syndrome and it develops as subclinical event demonstrable only with cerebral magnetic resonance.
Several studies suggest that the presence of mild parkinsonian signs and dementia in the elderly might reflect, in part, the accumulation of chronic ischemic events due to embolism events and vascular pathology caused by preventable vascular diseases.
On the basis of these pathophysiological aspect and recent data published, it is possible to hypothesize that cerebral protection during all transcatheter valve treatment could be protective whether for stoke, TIA or vascular injury in terms to reduce the incidence of parkinsonian disease, dementia and other cerebral syndrome developed in elderly patients.
Improved operative and postoperative management, together with advances in prosthetic technology, have greatly improved the results of TAVI, MitralClip and other transcatheter valve treatment and structural interventions, especially in patients with comorbidities and intermediate/high surgical risk. According to the international research, in the future will be fundamental demonstrated that the application of same parameters are useful to optimize late patient survival.