Leadless left ventricular stimulation with WiSE-CRT System - Initial experience and results from phase I of SOLVE-CRT Study (nonrandomized, roll-in phase).

BACKGROUND: Left ventricular (LV) endocardial pacing is a promising method to deliver cardiac resynchronization therapy (CRT). WiSE-CRT is a wireless LV endocardial pacing system, and delivers ultrasonic energy to an LV electrode. OBJECTIVE: The purpose of this study was to present short-term outcomes with the WiSE-CRT system in centers with no prior implanting experience. METHODS: Data were prospectively collected from 19 centers where WiSE-CRT systems were implanted during the roll-in phase of the SOLVE-CRT trial. Patients were followed at 1, 3, and 6 months, including transthoracic echo (TTE) at 6 months. RESULTS: The WiSE-CRT was successfully implanted in all 31 attempted cases, and 30 patients completed the 6-month follow-up. One patient underwent heart transplantation 1 month after implantation, and was excluded. Fourteen (46.7%) patients demonstrated ≥1 NYHA class improvement. TTE data were available in 29 patients. LV ejection fraction, LV end-systolic volume, and LV end-diastolic volume improved from 28.3% ± 6.7% to 33.5% ± 6.9% (P < .001), 134.9 ± 51.3 mL to 111.1 ± 40.3 mL (P = .0004), and 185.4 ± 58.8 mL to 164.9 ± 50.6 mL (P = .0017), respectively. There were 3 (9.7%) device-related type 1 complications: 1 insufficient LV pacing, 1 embolization of an unanchored LV electrode, and 1 skin infection. CONCLUSIONS: We demonstrated a high success rate of LV endocardial electrode placement in centers with no prior implanting experience. Favorable clinical responses in heart failure symptoms and significant LV reverse remodeling were noted.

Effect of new and persistent left bundle branch block after transcatheter aortic valve replacement on long-term need for pacemaker implantation.

Cardiac conduction abnormalities, including left bundle branch block (LBBB), are common following transcatheter aortic valve replacement (TAVR). This study assessed the incidence and outcomes of new or widening persistent LBBB following TAVR. Data regarding 550 consecutive patients undergoing TAVR between 2012 and 2016 at our institution were retrospectively reviewed. Both 30-day and 1-year outcomes of patients with isolated new or worsening LBBB following TAVR were reviewed. Fifty-two patients (9.5%) developed new or worsening LBBB. Six of the 52 (11.5%) patients received a permanent pacemaker (PPM) for LBBB prior to discharge. For patients discharged home following TAVR without a PPM, the 1-year PPM requirement was 15.2% in patients with new or worsening LBBB compared to 4.5% in patients without new or worsening LBBB (P = 0.01). One-year mortality rates for patients who did not have a new PPM placed before discharge were 15.2% in patients with new or worsening LBBB, 13.9% in patients without new or worsening LBBB, and 11.9% in patients with preoperative PPMs (P = 0.81). Patients with new or worsening persistent LBBB discharged without a PPM experience a higher requirement for PPM implantation in the year following TAVR compared to patients without new or worsening persistent LBBB.

Atrial Fibrillation is Associated with Increased Pacemaker Implantation Rates in the Placement of AoRTic Transcatheter Valve (PARTNER) Trial.

Atrial fibrillation (AF) is associated with worse outcomes in many cardiovascular diseases. There are few data examining pacemaker implantation rates and indications in patients with AF who undergo transcatheter aortic valve replacement (TAVR). To examine the impact of AF on the incidence of and indications for pacemakers in patients undergoing TAVR, we evaluated data of 1723 patients without pre-existing pacemakers who underwent TAVR in the Placement of AoRTic TraNscathetER Valve (PARTNER) trial. Permanent pacemaker implantation rates and indications were compared in groups based on baseline and discharge heart rhythm: sinus rhythm (SR) vs. AF. 1211 patients manifested SR at baseline/SR at discharge (SR/SR), 105 SR baseline/AF discharge (SR/AF), and 407 AF baseline/AF discharge (AF/AF). Patients who developed and were discharged with AF (SR/AF) had the highest rates of pacemaker implantation at 30 days (13.7% SR/AF vs. 5.4% SR/SR, p=0.0008 and 5.9% AF/AF, p=0.008) and 1 year (17.7% SR/AF vs. 7.1% SR/SR, p=0.0002 and 8.1% AF/AF, p=0.0034). Conversion from SR to AF by discharge was an independent predictor of increased pacemaker implantation at 30 days (HR 2.19 vs. SR/SR, 95% CI 1.23-3.93, p=0.008) and 1 year (HR 1.91 vs. SR/SR, 95% CI 1.33-3.80). Pacemaker indications differed between groups, with relatively more implanted in the AF groups for sick sinus syndrome (SSS) versus AV block. In conclusion, conversion to AF is an independent predictor of permanent pacemaker implantation in TAVR patients. Indications differ depending on heart rhythm, with patients in AF manifesting clinically significant tachy-brady syndrome versus AV block.