The role of transcatheter cerebral embolic protection (TCEP) devices in decreasing risk of periprocedural stroke during transcatheter aortic valve implantation (TAVI) remains controversial. |
The Sentinel™ cerebral protection system (CPS) is the only US Food and Drug Administration (FDA)-approved TCEP device. |
We performed a systematic review and meta-analysis to identify the risk of periprocedural stroke in patients undergoing TAVI with the Sentinel™ CPS. |
Our meta-analysis demonstrated that the Sentinel™ CPS was not associated with a lower risk of periprocedural stroke; however, it was associated with a lower risk of periprocedural disabling stroke when compared to no TCEP, and not associated with a difference in other outcomes. |
Introduction
Methods
Results
Included Studies, Summary, and Baseline Characteristics
PROTECTED TAVR [11] | SENTINEL [6] | MISTRAL-C [5] | CLEAN-TAVI [4] | |
---|---|---|---|---|
Sample size (N) | 3000 (1501 TCEP vs. 1499 control) | 363 (121 TCEP, 123 safety, 119 control) | 65 (32 TCEP vs. 33 control) | 100 (50 TCEP vs. 50 control) |
Trial timeline | 02/2020–01/2022 | 03/2016–06/2016 | 11/2013–07/2015 | 04/2013–06/2014 |
TAVR device utilized | SAPIEN 3: 64% Evolut R/Evolut PRO: 24.1% ACURATE: 6.9% PORTICO: 2.7% Lotus Edge: 1% | SAPIEN 3: 52.4% Evolut R: 25.9% SAPIEN XT: 17.8% CoreValve: 4% | SAPIEN 3: 54% CoreValve: 25% SAPIEN XT: 15% Ballon Dilation: 5% PORTICO: 1% | CoreValve 100% |
Geographic region | United States, Europe, and Australia | United States and Germany | Netherlands | Germany |
Inclusion criteria | Patient with aortic valve stenosis and treated with an approved TAVR device via transfemoral access Subject has recommended artery diameter sizes for filter placement (9–15 mm for brachiocephalic artery and 6.5–10 mm in left common carotid artery as determined by CT) | Severe symptomatic aortic stenosis with TAVR planned High-surgical-risk patients Vascular anatomy suitable for the Sentinel TCEP device | Patients at high risk for SAVR Aortic arch anatomy size appropriate for Sentinel CPS Brachiocephalic trunk measured 9–15 mm and left common carotid measured 6.5–10 mm | Symptomatic patients with severe aortic stenosis Increased risk for SAVR; determined by STS PROM and logistic EuroSCORE The aortic annulus was required to have a size between 20 and 29 mm via CT |
Exclusion criteria | Arterial stenosis > 70% in either left common carotid or brachiocephalic artery Brachiocephalic or left carotid artery with significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the ostium Compromised blood flow to right upper extremity Excessive tortuosity in access vessels Uncorrected bleeding disorder Contraindication to anticoagulation or antiplatelet therapy | Contraindications for right radial or brachial artery access Inability to undergo MRI brain evaluation for any reason | Excessive tortuosity Arterial stenosis > 70% of left common carotid or brachiocephalic artery Presence of permanent pacemaker or implantable cardiac defibrillator History of prior stroke | Anatomy unsuitable for safe CoreValve implantation Preexisting permanent pacemaker Stroke within the last 12 months Carotid artery stenosis > 70% Significant stenosis of the right subclavian artery or the brachiocephalic trunk Expected non-compliance to follow-up visits Participation in another clinical study Severe renal failure (GFR < 30 ml/min/1.73 m2) Pregnancy |
Primary endpoint | Stroke within 72 h after TAVR or before discharge | Primary safety endpoint, including MACCE at 30 days Primary efficacy endpoint was reduction in new lesion volume in protected brain territories on MRI at 2–7 days post-procedure | Incidence of new brain lesions found by DW-MRI, new lesion, and total lesion volumes 5–7 days after TAVR | Numerical difference in new positive post-procedure DW-MRI brain lesions 2 days after TAVR in TCEP protected territories |
Primary outcomes | A total of 34 strokes occurred in the TCEP group vs. 43 in the control Disabling strokes: 8 in TCEP group vs. 20 in control group Non-disabling strokes: 26 in TCEP group vs. 23 in control group | MACCE at 30 days was lower in TCEP group compared to control, but not statistically significant New lesion volume was smaller in the TCEP group compared to the control, but not statistically significant | TCEP group had numerically fewer new lesions and smaller total lesion volume | Number of new lesions was lower in the filter group compared to the control group. New lesion volume after TAVR was lower in the filter group compared to the control group |
Stroke outcome | 2.3% TCEP group vs. 2.9% control, P = 0.30 | 5.6% TCEP vs. 9.1% control, P = 0.25 | 0% TCEP group vs. 6% control, P = NS | 10% TCEP group vs. 10% control, P = NS |
Limitations | Small number of end points, short-term follow-up, non-ideal stroke reporting, TCEP group contained greater percent of female patients | Variability in MRI technique and acquisition, participant noncompliance with follow-up, small sample size, non-randomization of various valve devices | Small sample size, high MRI dropout rate, higher STS PROM score in control group | Single-center study, short-term follow-up, only one TAVI device utilized, interventional team could not be blinded |
PROTECTED TAVR [11] | SENTINEL [6] | MISTRAL-C [5] | CLEAN-TAVI [4] | Cumulative | |
---|---|---|---|---|---|
Demographic characteristics | |||||
Sample size, n | 3000 | 363 | 65 | 100 | 3528 |
Age (years); mean | 78.9 | 83.4 | 82 | 79.7 | 79.4 |
Female sex; (%) | 40% | 52.10% | 48% | 57% | 41.9% |
STS PROM score; % mean | 3.4 | 6 | 4.8 | 5.4 | 3.8 |
EuroSCORE II; % mean | 4.5 | – | – | – | 4.6 |
Logistic EuroSCORE (mean); % mean | – | – | – | 15.5 | 15.5 |
Clinical characteristics; no./total no. (%) | |||||
Diabetes mellitus | 1023/3000 (34.1%) | 127/363 (35%) | 13/65 (20%) | 45/100 (45%) | 1208/3528 (34.2%) |
Hypertension | 2618/3000 (87.3%) | – | 44/65 (68%) | 91/100 (91%) | 2753/3165 (87%) |
Peripheral vascular disease | 327/3000 (10.9%) | 55/363 (15.2%) | 20/65 (31%) | 6/100 (6%) | 408/3528 (11.6%) |
Coronary artery disease | 1730/3000 (57.7%) | 193/363 (53.2%) | – | 51/100 (51%) | 1974/3463 (57%) |
Previous coronary revascularization (PCI or CABG) | 1043/3000 (34.8%) | 125/363 (34.4%) | – | 23/100 (23%) | 1191/3463 (34.4%) |
History of cerebrovascular events or transient ischemic attacks | 394/3000 (13.1%) | 48/363 (13.2%) | 12/65 (19%) | 4/100 (4%) | 458/3528 (13%) |
Atrial fibrillation or atrial flutter | 980/3000 (32.7%) | 115/363 (31.7%) | 16/65 (28%) | 34/100 (34%) | 1145/3528 (32.5%) |
Congestive heart failure | – | – | – | 92/100 (92%) | 92/100 (92%) |
NYHA class I | – | – | – | 10/100 (10%) | 10/100 (10%) |
NYHA class II | – | – | 11/65 (17%) | 26/100 (26%) | 37/165 (22.4%) |
NYHA class III and IV | – | 295/355 (83.1%) | 43/65 (66%) | 64/100 (64%) | 402/520 (77.3%) |