Cerebral Embolic Protection Devices During Transcatheter Aortic Valve Implantation: Systematic Review and Meta-Analysis.

BACKGROUND AND PURPOSE: Silent ischemic embolic lesions are common after transcatheter aortic valve implantation (TAVI). The use of embolic protection devices (EPD) may reduce the occurrence of these embolic lesions. Thus, a quantitative overview and credibility assessment of the literature was necessary to draw a robust message about EPD. Therefore, the aim of this meta-analysis was to study whether the use of EPD reduces silent ischemic and clinically evident cerebrovascular events associated with TAVI. METHODS: We conducted a comprehensive search to identify studies that evaluated patients undergoing TAVI with or without EPD. Random-effects meta-analyses were performed to estimate the effect of EPD compared with no-EPD during TAVI using aggregate data. RESULTS: Sixteen studies involving 1170 patients (865/305 with/without EPD) fulfilled the inclusion criteria. The EPD delivery success rate was reported in all studies and was achieved in 94.5% of patients. Meta-analyses evaluating EPD versus without EPD strategies could not confirm or exclude any differences in terms of clinically evident stroke (relative risk, 0.70; 95% confidence interval [CI], 0.38-1.29; P=0.26) or 30-day mortality (relative risk, 0.58; 95% CI, 0.20-1.64; P=0.30). There were no significant differences in new-single, multiple, or total number of lesions. The use of EPD was associated with a significantly smaller ischemic volume per lesion (standardized mean difference, -0.52; 95% CI, -0.85 to -0.20; P=0.002) and smaller total volume of lesions (standardized mean difference, -0.23; 95% CI, -0.42 to -0.03; P=0.02). Subgroup analysis by type of valve showed an overall trend toward significant reduction in new lesions per patient using EPD (standardized mean difference, -0.41; 95% CI, -0.82 to 0.00; P=0.05), driven by self-expanding devices. CONCLUSIONS: The use of EPD during TAVI may be associated with smaller volume of silent ischemic lesions and smaller total volume of silent ischemic lesions. However, EPD may not reduce the number of new-single, multiple, or total number of lesions. There was only very low quality of evidence showing no significant differences between patients undergoing TAVI with or without EPD with respect to clinically evident stroke and mortality.

Radial versus femoral approach for left ventricular endomyocardial biopsy.

AIMS: Despite the widespread use of the radial approach in coronary interventions, left ventricular endomyocardial biopsy (LV-EMB) is most frequently performed via the femoral artery. We sought to assess the feasibility and safety of radial compared to femoral access in a large cohort of patients undergoing LV-EMB. METHODS AND RESULTS: Data from 264 patients who underwent LV-EMB in Germany, Portugal, Japan and Canada were collected. Clinical, procedural, safety and feasibility data were evaluated and compared between the two groups. LV-EMB was successfully performed by the radial approach in 129 (99%) of 130 and in 134 (100%) patients by the femoral access. Patients in the radial group were older (mean age 55.7 versus 44.3 years) and were more likely to have moderate-severe mitral regurgitation (27.7% versus TF 0%). Sheathless guides were used in 108 (83.1%) of the radial and 2 (1.5%) of the femoral patients, so the mean guiding catheter size (radial 7.0±1.0 Fr versus femoral 8.0±0.0 Fr) was significantly smaller in the radial group (p<0.001). Mild or moderate radial artery spasm occurred in 13 (10.0%) patients but only one (0.8%) patient required conversion to femoral access due to severe spasm. No access site-related complications were reported in the radial group, while 11 (8.2%) patients in the femoral group had access-site haematomas (p=0.001). There were no major complications (mitral valve injury, pericardial tamponade requiring intervention, cerebrovascular accidents, persistent high-degree atrioventricular block, major bleeding or death) in either group. CONCLUSIONS: The radial approach for LV-EMB appears to be safe and associated with a high success rate while possibly leading to fewer access-site bleeding complications compared to the femoral access. The results of this international multicentre study support the radial approach for LV-EMB and further inspire the expansion of "radial first" in the field of interventional cardiology.

Transradial Approach for Left Ventricular Endomyocardial Biopsy.

BACKGROUND: Left ventricular endomyocardial biopsy (LV-EMB) may offer a superior diagnostic yield compared with right ventricular endomyocardial biopsy (RV-EMB) in conditions predominantly affecting the LV but is underused compared with RV-EMB. Despite the steep uptake of radial approach in coronary interventions, LV-EMB is usually performed via the femoral artery in contemporary practice. Therefore, the aim of this study was to assess the safety and feasibility of LV-EMB via a transradial approach in a multicentre registry. METHODS: One-hundred and two patients who underwent LV-EMB via transradial approach were included. Clinical characteristics, procedural, safety and feasibility data were evaluated. RESULTS: LV-EMB was successfully performed via transradial access in 101 (99%) patients. Mild or moderate radial artery spasm occurred in 12 (12%) patients, but only 1 (0.98%) patient required conversion to femoral access due to severe spasm. A total of 80 (78%) patients had LV-EMB via a sheathless guide catheter. Among those, 77 (96.3%) patients had 7.5-French sheathless guides, and 3 (3.8%) patients had 8.5-French sheathless guides inserted. Radial sheaths were used in the remaining 22 patients, with 5-French sheaths in 21 of 22 patients. Heparin was administered to 93.1% of patients at a median dose of 5000 (3000-5000) IU. The remaining patients followed a provisional strategy upon patent hemostasis achievement. No access site-related complications were reported. There were no major complications (pericardial tamponade, life-threatening arrhythmia, cerebrovascular accident or death). CONCLUSIONS: In a population of patients undergoing transradial LV-EMB, the procedural success rate was high and showed an excellent safety profile. Further studies comparing transradial and transfemoral routes may help expand the use of transradial access for LV-EMB.

Transradial left ventricular endomyocardial biopsy: assessment of safety and efficacy.

BACKGROUND: We aimed at assessing the safety and efficacy of a systematic transradial approach for left ventricular endomyocardial biopsy using a new hydrophilic sheathless guiding catheter. METHODS AND RESULTS: Forty-two consecutive patients were included. The transradial success rate was 98% (41 of 42). In one case, cross over to femoral access due to irreversible spasm of the right radial artery was necessary. No radial spasm was observed in the other 41 patients. Depending on the indication, several other procedures, such as coronary angiography or ventricular angiography, were additionally performed through the same transradial access site. Median fluoroscopy time was 7.9 min. The mean dose area product was 1867 cGy × cm(2). All biopsy samples were graded as good or excellent quality. No patient had any complications. Immediate post-procedural ambulation could be achieved in all patients. Radial artery patency was confirmed by duplex sonography 24 h after removal of the guide. CONCLUSION: The present study demonstrates safety and efficacy of a systematic transradial access for left ventricular EMB using a highly hydrophilic sheathless guiding catheter. This is of clinical importance since this new technique may overcome critical limitations of the common approach.