Comparison of acute recoil after valve deployment and after post-dilation in patients undergoing transfemoral-transcatheter aortic valve replacement with SAPIEN-3 valve.

BACKGROUND: Transcatheter aortic valves are prone to acute recoil similar to the metal-based coronary stents. However, it is not clear if recoil remains a factor only after the initial valve deployment or also after post-dilation. METHODS: We conducted a retrospective observational study of patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with SAPIEN-3 valve. Acute recoil at the upper, central, and lower levels of the valve was calculated in both anteroposterior right anterior oblique (RAO) and lateral left anterior oblique (LAO) views after initial deployment as well as after post-dilation. The average recoil of the RAO and LAO views was also calculated and described as RAO/LAO. RESULTS: The acute recoil in the RAO/LAO views (mean ± SD) was 3.9 ± 1.1% after valve deployment in the whole study population (n = 257). Among the subset of patients who required post-dilation (n = 133), the mean acute recoil in the RAO/LAO views was found to be greater after initial valve deployment as compared with after post-dilation (3.8 ± 1.1% vs. 3.0 ± 0.9%; p < .001). Further, acute recoil was significantly greater in the RAO view than the LAO view and at the central level of the prosthesis as compared with the upper and lower levels. Those findings were consistent after initial deployment as well as after post-dilation. Clinical outcomes were similar between patients who required post-dilation compared to those who did not. In multivariable logistic regression analysis, only smaller valve cover index was found to be an independent predictor of 30-day mild or greater aortic regurgitation (OR 0.007; 95% CI 0.0001-0.707; p = .035). CONCLUSION: Acute elastic recoil of the SAPIEN-3 valve was significantly less after post-dilation as compared with after deployment. It was also greater when measured in the RAO view as compared with the LAO view. Furthermore, acute recoil was not homogenous across the height of the valve stent frame.

The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center.

INTRODUCTION: Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose versus double Perclose for perclosure of large bore access during TAVR. METHODS: Patients undergoing Transfemoral (TF) TAVR from January 2014 to December 2017 within the Cleveland Clinic Aortic Valve Center were identified. A retrospective review of medical charts was conducted. Vascular complications were defined according to the VARC-2 criteria. RESULTS: A total of 740 patients were included; 487 (65.8%) received a single Perclose device while 253 (34.2%) received double Perclose devices. Baseline characteristics were similar with no differences between the single versus double Perclose groups, respectively. The access sheath size was similar in both groups with (14, 16, and 18 F) being the most common sizes utilized. Of the total 487 patients with single Perclose, 75.6% needed additional closure device (AngioSeal). With double Perclose strategy, additional closure device (AngioSeal) was used in 40.3% patients with 470 (63.5%) patients being successfully perclosed. Vascular complication rates including hematoma, stenosis requiring stenting, pseudoaneurysm, and other major vascular complications were similar between both groups. CONCLUSION: Single 6F ProGlide use for preclosure is a safe strategy for TF TAVR using the S3 valve. Additional closure device was not needed in almost one-quarter of the patients. When necessary, residual bleeding can be controlled with the AngioSeal Device at the end of the procedure. This single device preclose strategy can help to reduce the cost of TAVR procedure without increasing risk.

Effect of High-Density Lipoprotein Cholesterol Levels on Overall Survival and Major Adverse Cardiovascular and Cerebrovascular Events.

Several studies designed to augment high density lipoprotein (HDL) levels have so far been unsuccessful in reducing rates of major adverse cardiovascular and cerebrovascular events (MACCE). In this study, we report the effect of HDL-C levels on overall survival outcomes and rates of MACCE following percutaneous coronary intervention (PCI). We reviewed patients who underwent PCI at the Cleveland Clinic from 2005 to 2017 and followed them through the end of 2018. Restricted cubic splines incorporated into Cox proportional hazard regression models were used to assess the outcomes. The HDL-C level associated with the lowest mortality was used as a reference value.15,633 patients underwent PCI during the study period, of which 70% were male, 81% were white, and 73% were on statins. The mean age at the time of procedure was 65.8 ± 11.8 years. After adjusting for demographics, co-morbidities, lipid profile, statin use, and date of procedure, our model demonstrated a U-shaped association between HDL-C and overall mortality, with HDL-C levels of 30-50 mg/dl associated with the most favorable outcomes, and HDL-C levels < 30 mg/dl or > 50 mg/dl associated with worse outcomes. A sensitivity analysis in men yielded a similar U-shaped association. In conclusion, our study shows that both low and high levels of HDL-C are associated with worse overall survival, with no effect on rates of MACCE in PCI patients. Further studies are required to understand the mechanism of this association between elevated HDL-C levels with increased overall mortality in patients with atherosclerotic cardiovascular disease (ASCVD).