Safety and long-term effects of renal denervation: Rationale and design of the Dutch registry.

BACKGROUND: Percutaneous renal denervation (RDN) has recently been introduced as a treatment for therapy-resistant hypertension. Also, it has been suggested that RDN may be beneficial for other conditions characterised by increased sympathetic nerve activity. There are still many uncertainties with regard to efficacy, safety, predictors for success and long-term effects. To answer these important questions, we initiated a Dutch RDN registry aiming to collect data from all RDN procedures performed in the Netherlands. METHODS: The Dutch RDN registry is an ongoing investigator-initiated, prospective, multicentre cohort study. Twenty-six Dutch hospitals agreed to participate in this registry. All patients who undergo RDN, regardless of the clinical indication or device that is used, will be included. Data are currently being collected on eligibility and screening, treatment and follow-up. RESULTS: Procedures have been performed since August 2010. At present, data from 306 patients have been entered into the database. The main indication for RDN was hypertension (n = 302, 99%). Patients had a mean office blood pressure of 177/100 (±29/16) mmHg with a median use of three (range 0-8) blood pressure lowering drugs. Mean 24-hour blood pressure before RDN was 157/93 (±18/13) mmHg. RDN was performed with different devices, with the Simplicity™ catheter currently used most frequently. CONCLUSION: Here we report on the rationale and design of the Dutch RDN registry. Enrolment in this investigator-initiated study is ongoing. We present baseline characteristics of the first 306 participants.

Platelet aggregation inhibitors in prevention and treatment of coronary thrombosis.

Platelet aggregation plays a key role in the development of complications of atherosclerosis. By inhibiting platelet aggregation in a pharmacological way complications such as myocardial infarction and sudden death may be prevented. This goes for primary as well as secondary prevention. The most relevant substances for this goal are aspirin, clopidogrel and the new glycoprotein IIb/IIIa inhibitors.

Interobserver variation in duplex scanning of infrainguinal arterial bypass grafts.

OBJECTIVE: to determine the degree of interobserver variation of color-flow duplex scanning of infrainguinal arterial bypass grafts. METHODS: two experienced vascular technologists randomly assessed bypass grafts in 32 consecutive patients, using a color-flow duplex scan. In pre-defined segments the highest peak systolic velocity (PSV(max)) and end-diastolic velocity (EDV) were measured and a peak systolic velocity ratio (PSV ratio) was calculated. Results were analyzed as continuous variables (Bland and Altman plots and Intraclass Correlation Coefficient=ICC) and also as categorical data (weighted Kappa coefficient) for the PSV ratio 1-2.5, > or =2.5-4, > or =4.0. RESULTS: the ICC for the PSV(max), PSV ratio and EDV indicated "almost perfect" agreement for all three parameters. However, the Bland and Altman plots showed impressive interobserver variation for the higher values of all three parameters. For the PSV ratio categories a weighted kappa of 0.31 was calculated, indicating only fair agreement. Substantial variation was found for the categories with PSV ratios > or =2.5-4.0 and > or =4.0. CONCLUSION: though performing accurately for the lower values of the assessed parameters, duplex scanning shows considerable interobserver variation for the clinically significant higher values. Particularly in the PSV ratio interval > or =2.5-4.0, most relevant for clinical decision-making, the interobserver variability is unacceptable.