Factors associated with cognitive decline and delirium after transcatheter aortic valve implantation: Preliminary evidence

Background: Transcatheter aortic valve implantation (TAVI) has become the standard for treating severe symptomatic aortic stenosis in those with prohibitive surgical risk. Cognitive complications, including delirium and cognitive decline are common following TAVI, yet an understanding of pre-procedural factors associated with these outcomes is lacking. This prospective observational study set out to identify geriatric pre-procedural factors associated with post-procedural delirium and cognitive decline in patients undergoing TAVI. / Methods: Cognitive outcomes of TAVI patients aged ≥60 years (N=32) were measured over one-year post-TAVI. Pre-procedural measures included frailty, gait, visual symptoms, voice pitch, dysphagia, blink rate, mood, and sleep. Primary outcomes were post-procedural delirium and cognitive decline. / Results: Delirium was present in 25% of patients over two days following TAVI and 26% experienced cognitive decline in the year post-TAVI. Daily physical activity was a protective factor against cognitive decline, and worse baseline visual memory was associated with delirium. While non-significant and with very large confidence intervals, moderate to large effect sizes were found for associations between slowed gait speed, pre-existing atrial fibrillation, and dysphagia for delirium, and slower gait speed, higher blink rate, pre-existing atrial fibrillation for cognitive decline. / Conclusion: Though underpowered, measures of considerable effect size were identified (although non-significant and with large variability). In larger studies, these novel geriatric factors could further be explored for predicting cognitive complications following TAVI. Improvement of risk prediction for cognitive decline and delirium following TAVI could assist with early identification of those at risk, informing clinical decision-making and allowing for targeted intervention to reduce post-procedural incidence of these complications

Safety and performance of the next generation EnligHTN™ renal denervation system in patients with drug-resistant, uncontrolled hypertension: The EnligHTN III first-in-human multicentre study

Background/objectives: Catheter-based renal denervation for the treatment of drug-resistant hypertension has been intensively investigated in recent years. To date, only limited data have been published using multi-electrode radiofrequency ablation systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the next generation EnligHTN™ renal denervation system. Six-month primary endpoint data are presented here. Methods: We conducted this first-in-human, prospective, multi-center, non-randomized study in 39 patients (62% male, mean age 63 years, and mean baseline office blood pressure 174/93 mm Hg) with drug-resistant hypertension. The primary safety and efficacy objectives were to characterize, from baseline to 6 months post-procedure, the rate of serious procedural and device related adverse events, as adjudicated by an independent Clinical Events Committee, and the reduction of office systolic blood pressure. Results: Renal artery denervation, using the next generation EnligHTN multi-electrode system significantly reduced office blood pressure from baseline to 1, 3, and 6 months by −19/7, −26/9 and −25/7 mm Hg, respectively (P ≤ 0.0005). No serious device or procedure related adverse events affecting the renal arteries or renal function occurred through. Conclusions: Renal sympathetic denervation using the next generation EnligHTN renal denervation system resulted in safe, rapid, and significant mean office blood pressure reduction that was sustained through 6 months. Future studies will need to address the utility of this system against an appropriate placebo based comparator