Outcomes in patients with electrocardiographic left ventricular dyssynchrony following transcatheter aortic valve replacement.

BACKGROUND: Left bundle branch block (LBBB) and atrioventricular (AV) conduction abnormalities requiring permanent pacemaker (PPM) implantation occur frequently following transcatheter aortic valve replacement (TAVR). The resultant left ventricular (LV) dyssynchrony may be associated with adverse clinical events. OBJECTIVES: The purpose of this study was to assess the adverse outcomes associated with LV dyssynchrony due to high-burden right ventricular (RV) pacing or permanent LBBB following TAVR in patients with preserved left ventricular ejection fraction (LVEF). METHODS: Consecutive TAVR patients at the University of Michigan from January 2012 to June 2017 were included. Pre-existing cardiac implantable electronic device, previous LBBB, LVEF <50%, or follow-up period <1 year were excluded. The primary outcome was all-cause mortality. Secondary outcomes included cardiomyopathy (defined as LVEF ≤45%), a composite endpoint of cardiomyopathy or all-cause mortality, and the change in LVEF at 1-year follow-up. RESULTS: A total of 362 patients were analyzed (mean age 77 years). LV dyssynchrony group (n = 91 [25.1%]) included 56 permanent LBBB patients, 12 permanent LBBB patients with PPM, and 23 non-LBBB patients with PPM and high-burden RV pacing. Remaining patients served as control (n = 271 [74.9%]). After adjusted analysis, LV dyssynchrony had significantly higher all-cause mortality (adjusted hazard ratio [HR] 2.16; 95% confidence interval [CI] 1.07-4.37) and cardiomyopathy (adjusted HR 14.80; 95% CI 6.31-14.69). The LV dyssynchrony group had mean LVEF decline of 10.5% ± 10.2% compared to a small increase (0.5% ± 7.7%) in control. CONCLUSION: Among TAVR patients with preserved LVEF and normal AV conduction, development of postprocedural LV dyssynchrony secondary to high-burden RV pacing or permanent LBBB was associated with significantly higher risk of death and cardiomyopathy at 1-year follow-up.

Transcatheter Aortic Valve Replacement with a Self-Expanding Prosthesis.

The self-expanding transcatheter heart valve (Medtronic Cardiovascular Corevalve and Evolut) is a supra-annular, trileafet porcine pericardial valves on a diamond lattice nickel-titanium alloy frame. The TAVR device has undergone significant improvements in design and procedural techniques to further increase safety, efficacy, and durability since they it was first released. Unique design characteristics, as well as patient and procedural factors, favor self-expanding over balloon-expandable prostheses in certain situations. The self-expanding transcatheter heart valve has proven to be an excellent option for severe aortic stenosis patients with any level of surgical risk and preliminary data suggest a comparable durability to surgical tissue valves.

Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials.

AIMS: We performed a meta-analysis of randomized controlled trials comparing routine stenting (ST) with percutaneous transluminal angioplasty (PTA) for symptomatic superficial femoral-popliteal artery (SFPA) disease. METHODS AND RESULTS: Ten trials were pooled randomizing patients to ST (n = 724 limbs) or PTA with provisional stenting (n = 718 limbs) with a follow-up period of 9-24 months. The mean lesion length was similar in the two groups (45.8 mm in the ST group and 43.3 mm in the PTA group). We calculated the summary risk ratios (RRs) for immediate technical failure, restenosis, and target vessel revascularization (TVR) using random-effects models. The immediate technical failure was higher in the PTA group than in the ST group [17.1 vs. 5.9%, respectively, RR = 0.28, 95% confidence interval (CI) = 0.15-0.54, P < 0.001], with 10.3% of the PTA patients undergoing stenting because of suboptimal result. There was a trend for lower restenosis in the ST group (37.6% in ST vs. 45.3% in PTA, RR = 0.85, 95% CI = 0.69-1.06, P = 0.146), but no difference in the need for TVR (20% in ST vs. 20.2% in PTA, RR = 0.98, 95% CI = 0.78-1.23, P = 0.89). In an analysis restricted to nitinol stents, there was a trend towards reduction in TVR (RR = 0.79, 95% CI = 0.59-1.06, P = 0.12). CONCLUSION: Despite the higher immediate success, routine stenting was not associated with a significant reduction in the rate of restenosis or TVR. Our data do not support use of routine stenting as the primary endovascular treatment for short SFPA lesions.

Results from a phase II multicenter, double-blind placebo-controlled study of Del-1 (VLTS-589) for intermittent claudication in subjects with peripheral arterial disease.

BACKGROUND: This study compared VLTS-589 (plasmid encoding the angiomatrix protein Del-1 in conjunction with poloxamer 188) with poloxamer 188 control, for the treatment of intermittent claudication in patients with moderate to severe peripheral arterial disease. METHODS: Subjects with bilateral intermittent claudication and peak walking time (PWT) between 1 and 10 minutes on 2 qualifying (reproducible; within 25% of each other) treadmill tests were enrolled. Patients received VLTS-589 or poloxamer 188 control, administered as 21 intramuscular injections to each lower extremity (42 mL in each extremity). In addition to safety and tolerability, efficacy evaluations compared to baseline included the following: change in PWT at 90 days (primary end point), change in claudication onset time, change in ankle brachial index (ABI), and change in quality of life measures. RESULTS: A total of 105 patients were randomized and treated. During the 30, 90, and 180 days follow-up, mean PWT, claudication onset time, and ABI were significantly increased compared to baseline values in both treatment groups with no significant difference between groups in the primary or secondary end points. In addition, both groups demonstrated significantly improved quality of life at follow-up vs baseline, with no significant differences between groups. Serious adverse events were similar in both groups--none were definitely treatment-related. CONCLUSION: Intramuscular delivery of both Del-1 expressing plasmid and the control resulted in significant improvement in exercise capacity compared to baseline at 30, 90, and 180 days. There was no difference in outcome measures associated with the Del-1 plasmid.