Safety and performance of the second generation EnligHTN™ Renal Denervation System in patients with drug-resistant, uncontrolled hypertension.

BACKGROUND AND AIMS: 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 performance of the second generation EnligHTN™ Renal Denervation System. METHODS: This first-in-human, prospective, multi-center, non-randomized study included 39 patients (62% male, mean age 63 years, and mean baseline office blood pressure 174/93 mmHg) with drug-resistant hypertension. The primary safety and performance 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 second generation EnligHTN multi-electrode system significantly reduced office blood pressure from baseline to 1, 3, 6, 12, 18 and 24 months by 19/7, 26/9, 25/7, 23/7, 25/8 and 27/9 mmHg, respectively (p ≤ 0.0005). No serious device or procedure related adverse events affecting the renal arteries or renal function occurred through 24 months of follow-up. CONCLUSIONS: Renal sympathetic denervation using the second generation EnligHTN Renal Denervation System resulted in safe, rapid, and significant mean office blood pressure reduction that was sustained through 24 months. Future studies will need to address the utility of this system against an appropriate sham based comparator.

Drug-eluting stent-induced left anterior descending coronary artery aneurysm: repair by pericardial patch--where are we headed?

Deployment of drug-eluting stents has been associated with late thrombosis and restenosis on withdrawal of antiplatelet agents. We report a complication of inflammation and localized coronary artery aneurysms immediately adjacent to the stent after 4 years of implantation. Late chronic inflammatory responses may evolve for up to 4 years after sirolimus-eluting stent implantation and can cause weakening, erosion, and aneurysms of the coronary arteries.

The clinical outcome of restricting drug-eluting stents to patients at highest risk of restenosis.

AIMS: To assess the clinical outcomes of patients where drug eluting stents (DES) were restricted to those at highest risks of restenosis, we compared three different strategies for stent implantation: bare metal stents (BMS) only, DES only and a group where DES use was restricted (RES). METHOD AND RESULTS: Initial comparison was made between BMS only (279 patients, 316 lesions) and DES only (272 patients, 302 lesions). The endpoints of death, non-fatal myocardial infarction and target lesion revascularisation (TLR) [MACE] were assessed at 12 months. The incidence of MACE in the BMS only and DES only groups were 14% and 7% (p=0.002) and TLR was 8% and 1% (p<0.0001). Comparison was then made between these results and a third group where DES was restricted to patients at highest risk of restenosis. The restricted group (RES) comprised 249 patients (271 lesions) of which 53% received DES. RES remained significantly better than BMS, MACE (14% vs. 8%, p=0.02) and TLR (8% vs. 3%, p=0.02). When RES was compared with DES only, there was no significant difference in MACE (8% vs. 7% p=0.42), but there was a significantly lower TLR rate in the DES only group (1% vs. 3% p=0.04). CONCLUSIONS: The overall incidence of events in patients where DES use was restricted to 53% of patients remains low and this may be an acceptable treatment strategy to reduce costs.