Steerable Delivery Sheath for Left Atrial Appendage Closure in Patients With Severely Enlarged Left Atria.

Background: Enlarged left atrium (LA) is frequently identified in patients who undergo left atrial appendage closure (LAAC) and negatively affects the device's final position and intervention results. Steerable delivery sheath (SDS) could represent an option to overcome these difficulties. We aimed to assess the feasibility of SDS-assisted procedures and compare their efficacy to the standard sheath strategy. Methods: This study analyzed patients from our institution's LAAC registry who had severe LA enlargement on CT scan (index LA volume >90 mL/m2) and underwent AMULET device implantation between January 2019 and March 2023. The patients underwent postprocedural CT scan to assess the device's position, residual LAA filling, and peridevice leaks. Results: A total of 195 consecutive patients were screened and 47 (24%) met the inclusion criteria (n = 22 SDS group; n = 25 standard group). There was no difference in baseline clinical, anatomical, or procedural characteristics. The procedural technical success (96%) and complication rates (9% vs 4%; P = .59) were comparable in both groups. Post-LAAC CT scans were obtained in 19 SDS group and 22 standard group patients. We observed significantly lower incidences of residual patent LAA (26% vs 72%; P = .005), peridevice leaks (16% vs 64%; P = .004), and off-axis device position (0% vs 27%; P = .02) in SDS compared to the standard group, suggesting a better LAA sealing. Conclusions: Severe LA enlargement was frequent among LAAC candidates. In this situation, the use of SDS appears feasible and safe, leading to more efficient closures on follow-up imaging without a higher risk of periprocedural complications.

IMPELLA® or Extracorporeal Membrane Oxygenation for Left Ventricular Dominant Refractory Cardiogenic Shock.

Mechanical circulatory support (MCS) devices are effective tools in managing refractory cardiogenic shock (CS). Data comparing veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and IMPELLA® are however scarce. We aimed to assess outcomes of patients implanted with these two devices and eligible to both systems. From 2004 to 2020, we retrospectively analyzed 128 patients who underwent VA-ECMO or IMPELLA® in our institution for refractory left ventricle (LV) dominant CS. All patients were eligible to both systems: 97 patients were first implanted with VA-ECMO and 31 with IMPELLA®. The primary endpoint was 30-day all-cause death. VA-ECMO patients were younger (52 vs. 59.4, p = 0.006) and had a higher lactate level at baseline than those in the IMPELLA® group (6.84 vs. 3.03 mmol/L, p < 0.001). Duration of MCS was similar between groups (9.4 days vs. 6 days in the VA-ECMO and IMPELLA® groups respectively, p = 0.077). In unadjusted analysis, no significant difference was observed between groups in 30-day mortality: 43.3% vs. 58.1% in the VA-ECMO and IMPELLA® groups, respectively (p = 0.152). After adjustment, VA-ECMO was associated with a significant reduction in 30-day mortality (HR = 0.25, p = 0.004). A higher rate of MCS escalation was observed in the IMPELLA® group: 32.3% vs. 10.3% (p = 0.003). In patients eligible to either VA-ECMO or IMPELLA® for LV dominant refractory CS, VA-ECMO was associated with improved survival rate and a lower need for escalation.

Feasibility and safety of transfemoral transcatheter aortic valve implantation performed with a percutaneous coronary intervention-like approach.

BACKGROUND: Transfemoral percutaneous transcatheter aortic valve implantation (TF-TAVI) is a safe, reproducible and established procedure, mainly performed under local anaesthesia, which is mostly administered and monitored by a dedicated anaesthesia team (regular approach). Our centre has developed a standardized pathway of care, and eligible patients are selected for a minimalist TF-TAVI, entirely managed by operators without the presence of the anaesthesia team in the operating room, like most interventional coronary procedures ("percutaneous coronary intervention-like" approach [PCI approach]). AIM: To compare the safety and efficacy of TF-TAVI performed with the PCI approach versus the regular approach. METHODS: The analysis population comprised all patients who underwent TF-TAVI with the PCI or regular approach in our institution from November 2016 to July 2019. The two co-primary endpoints were early safety composite and early efficacy composite at 30days as defined by the Valve Academic Research Consortium-2. The PCI (n=137) and Regular (n=221) approaches were compared using the propensity score based method of inverse probability of treatment weighting. RESULTS: No differences were observed after comparison of TAVI performed with the PCI or regular approach regarding the composite safety endpoint (7.3% vs. 11.3%; odds ratio 0.63, 95% confidence interval 0.37 to 1.07; P=0.086) or the composite efficacy endpoint (4.4% vs. 6.3%; odds ratio 0.78, 95% confidence interval 0.41 to 1.49; P=0.45). CONCLUSIONS: This study suggests that the efficacy and safety of TF-TAVI entirely managed by a PCI approach for selected patients are not different to those when TF-TAVI is performed with the attendance of a full anaesthesia care team. The PCI approach appears to be a safe and efficient clinical pathway, providing an appropriate and rational utilization of anaesthesiology resources, and could be used for the majority of TF-TAVI procedures.