Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry.

BACKGROUND: Sizing for transcatheter aortic valve implantation in bicuspid aortic valves (BAV) remains controversial. METHODS AND RESULTS: The aim of the BAVARD (Bicuspid Aortic Valve Anatomy and Relationship With Devices) retrospective registry is to capture the sizing ratios used for transcatheter aortic valve implantation in BAV and analyze the second-generation prostheses geometry postimplantation. About 101 patients with BAV along with available pre- and post-transcatheter aortic valve implantation multidetector computed tomography were compared with 88 tricuspid aortic valves (TAV) patients. Preprocedural multidetector computed tomography diagnosed type 0 and type 1 BAV in, respectively, 12.9% and 86.1 % of BAV. At baseline, the ellipticity index was similar between BAV and TAV patients: 1.2±0.1 versus 1.2±0.1, P=0.09. The mean annular oversizing was, respectively, 1.14±0.04 and 1.04±0.04, P<0.001, in TAV and BAV patients. The mean prosthesis intercommissural distance, ratio was 1.03±0.1. The mean diameter of the prostheses at the annulus matched the mean perimeter-derived diameter of the aortic annulus at baseline with TAV (23.3±2.2 versus 23.6±1.9, P=0.4) and was smaller with BAV (24±2.8 versus 26.8±3.1, P<0.01), confirming 11% underexpansion in BAV. Finally, in situ, prosthesis diameter and ellipticity followed the same pattern, with stable values from the distal edge to 12 mm above, in both groups. CONCLUSIONS: Second-generation prostheses similarly reshape the aortic annulus in TAV and BAV. Prostheses keep consistent diameters from distal edge to 12 mm in TAV and BAV. Prosthesis underexpansion is constantly observed in BAV. Annular-based sizing is accurate in BAV with minimal oversizing. The intercommissural distance, 4 mm above the annulus, could be integrated in gray zones. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03495050.

Transcatheter Heart Valve Selection and Permanent Pacemaker Implantation in Patients With Pre-Existent Right Bundle Branch Block.

BACKGROUND: Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM implantations in patients with pre-existent right bundle branch block and categorize for different transcatheter heart valves. METHODS AND RESULTS: We pooled data on 306 transcatheter aortic valve replacement patients from 4 high-volume centers in Europe and selected those with right bundle branch block at baseline without a previously implanted PPM. Logistic regression was used to evaluate whether PPM rate differed among transcatheter heart valves after adjustment for confounders. Mean age was 83±7 years and 63% were male. Median Society of Thoracic Surgeons score was 6.3 (interquartile range, 4.1-10.2). The following transcatheter valve designs were used: Medtronic CoreValve (n=130; Medtronic, Minneapolis, MN); Edwards Sapien XT (ES-XT; n=124) and Edwards Sapien 3 (ES-3; n=32; Edwards Lifesciences, Irvine, CA); and Boston Scientific Lotus (n=20; Boston Scientific Corporation, Marlborough, MA). Overall permanent pacemaker implantation rate post-transcatheter aortic valve replacement was 41%, and per valve design: 75% with Lotus, 46% with CoreValve, 32% with ES-XT, and 34% with ES-3. The indication for PPM implantation was total atrioventricular block in 98% of the cases. Lotus was associated with a higher PPM rate than all other valves. PPM rate did not differ between ES-XT and ES-3. Ventricular paced rhythm at 30-day and 1-year follow-up was present in 81% at 89%, respectively. CONCLUSIONS: Right bundle branch block at baseline is associated with a high incidence of PPM implantation for all transcatheter heart valves. PPM rate was highest for Lotus and lowest for ES-XT and ES-3. Pacemaker dependency remained high during follow-up.

'Jamaican Stone': A potentially lethal remedy for delaying ejaculation.

Poisoning by ingestion of 'Jamaican Stone', a kind of cardioactive steroid, is extremely rare. However, mortality is very high. For this reason, when it occurs, an early and accurate diagnosis represents a critical challenge for clinicians. We present an unusual case of electrical storm caused by this substance.

Impact of permanent pacemaker on mortality after transcatheter aortic valve implantation: the PRAGMATIC (Pooled Rotterdam-Milan-Toulouse in Collaboration) Pacemaker substudy.

AIMS: We sought to evaluate the impact of permanent pacemaker (PPM) implantation on two-year mortality and one-year left ventricular ejection fraction recovery (∆LVEFR=one-year LVEF-baseline LVEF) after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We pooled patient-level data from four European institutions with significant TAVI volume. Outcomes were compared between patients without PPM (no-PPM), patients with PPM prior to TAVI (old-PPM) and patients with PPM implanted after TAVI (new-PPM). Out of 1,062 patients included in the pooled data set, 783 (73.7%) were in the no-PPM group, 164 (15.4%) in the new-PPM group and 115 (10.8%) in the old-PPM group. All-cause and cardiovascular mortality at two years were similar for patients with no-PPM and new-PPM (adjusted HR 1.11, 95% CI: 0.74-1.67; p=0.62; and adjusted HR 1.16, 95% CI: 0.68-1.98; p=0.59). Conversely, old-PPM was associated with increased risk of both all-cause and cardiovascular mortality vs. no-PPM. By multivariable analysis new-PPM did not affect LVEFR, while old-PPM did. We observed a multiplicative interaction, between new-PPM and post-procedural aortic regurgitation ≥1+ on two-year mortality and one-year LVEFR, with increased risk of death and impaired LVEFR in patients with new-PPM and post-procedural aortic regurgitation (PPAR) ≥1+ (both pinteraction<0.0001). CONCLUSIONS: In patients undergoing TAVI, the presence of a PPM at baseline yielded a negative effect on long-term prognosis while new-PPM did not. The combination of new-PPM with PPAR adversely impacts on survival and LV function recovery.

Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation.

BACKGROUND: The majority of transcatheter aortic valve implantation (TAVI) procedures are currently performed by percutaneous transfemoral approach. The potential contribution of the type of vascular closure device to the incidence of vascular complications is not clear. AIM: To compare the efficacy of a Prostar XL- vs. Perclose ProGlide-based vascular closure strategy. METHODS: The ClOsure device iN TRansfemoral aOrtic vaLve implantation (CONTROL) multi-center study included 3138 consecutive percutaneous transfemoral TAVI patients, categorized according to vascular closure strategy: Prostar XL- (Prostar group) vs. Perclose ProGlide-based vascular closure strategy (ProGlide group). Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics. RESULTS: Propensity matching identified 944 well-matched patients (472 patient pairs). Composite primary end point of major vascular complications or in-hospital mortality occurred more frequently in Prostar group when compared with ProGlide group (9.5 vs. 5.1%, P = 0.016), and was driven by higher rates of major vascular complication (7.4 vs. 1.9%, P < 0.001) in the Prostar group. However, in-hospital mortality was similar between groups (4.9 vs. 3.5%, P = 0.2). Femoral artery stenosis occurred less frequently in the Prostar group (3.4 vs. 0.5%, P = 0.004), but overall, Prostar use was associated with higher rates of major bleeding (16.7 vs. 3.2%, P < 0.001), acute kidney injury (17.6 vs. 4.4%, P < 0.001) and with longer hospital stay (median 6 vs. 5 days, P = 0.007). CONCLUSIONS: Prostar XL-based vascular closure in transfemoral TAVI procedures is associated with higher major vascular complication rates when compared with ProGlide; however, in-hospital mortality is similar with both devices.