No abstract

http://clinicaltrials.gov. Unique identifier: NCT01700244.

The objective of this study was to identify electrocardiographic (ECG) and further predictors for atrioventricular (AV) block with a need for pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI). Pre- and post-procedural ECGs of patients with severe aortic stenosis and ongoing TAVI were investigated in a prospective study. From 50 consecutive patients enrolled in the study (mean age 80 +/- 6 years, 46% men), 17 (34%) experienced an AV block with subsequent requirement of a permanent PM [16 of 36 (44.4%) with CoreValve System and 1 of 14 (7.1%) with Edwards Sapiens System]. In patients with right bundle branch block (RBBB), PM implantation had to be performed more frequently [6 of 6 (100%) with CoreValve System and none with Edwards Sapiens System], P = 0.005. An AV block (Mobitz II second degree and third degree) occurred mostly within the first 24 h (range: Days 0-13) after the index procedure. No recovery of AV conduction with a change in PM indication occurred in a mean follow-up time of 13 +/- 6 days. Our data demonstrate that patients with pre-operative RBBB and those receiving CoreValve prosthesis are at a significantly higher risk for PM implantation after TAVI. Therefore, patients with the presence of RBBB before TAVI may be at lower risk for PM implantation using the Edwards Sapiens System.

Aims To assess the impact of MultiPoint™ Pacing (MPP)—programmed according to the physician’s discretion—in non-responders to standard biventricular pacing after 6 months. Methods and results The study enrolled 1921 patients receiving a quadripolar cardiac resynchronization therapy (CRT) system capable of MPP™ therapy. A core laboratory assessed echocardiography at baseline and 6 months and defined volumetric non-response to biventricular pacing as <15% reduction in left ventricular end-systolic volume (LVESV). Clinical sites randomized patients classified as non-responders in a 1:1 ratio to receive MPP (236 patients) or continued biventricular pacing (231 patients) for an additional 6 months and evaluated rate of conversion to echocardiographic response. Baseline characteristics of both groups were comparable. No difference was observed in non-responder to responder conversion rate between MPP and biventricular pacing (31.8% and 33.8%, P = 0.72). In the MPP arm, 68 (29%) patients received MPP programmed with a wide LV electrode anatomical separation (≥30 mm) and shortest LV1–LV2 and LV2–RV timing delays (MPP-AS); 168 (71%) patients received MPP programmed with other settings (MPP-Other). MPP-AS elicited a significantly higher non-responder conversion rate compared to MPP-Other (45.6% vs. 26.2%, P = 0.006) and a trend in a higher conversion rate compared to biventricular pacing (45.6% vs. 33.8%, P = 0.10). Conclusions After 6 months, investigator-discretionary MPP programming did not significantly increase echocardiographic response compared to biventricular pacing in CRT non-responders.

This large-scale real-life patient cohort of primary stationary pacemaker implantation showed that gender has an impact onto pacemaker implantation, with less favourable outcomes for women.