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.

Association between angiographic culprit lesion and out-of-hospital cardiac arrest in ST-elevation myocardial infarction patients.

BACKGROUND: Factors related to the occurrence of out-of-hospital cardiac arrest (OHCA) in ST-elevation myocardial infarction (STEMI) are still poorly understood. The current study sought to compare STEMI patients presenting with and without OHCA to identify angiographic factors related to OHCA. METHODS: This multicenter registry consisted of consecutive STEMI patients, including OHCA patients with return-of-spontaneous circulation. Patients were treated with primary percutaneous coronary intervention (PCI) and therapeutic hypothermia when indicated. Outcome consisted of in-hospital neurological recovery, scored using the Cerebral Performance Categories (CPC) scale, and 1-year survival. Logistic regression was used to identify factors associated with OHCA and survival was displayed with Kaplan-Meier curves and compared using log rank tests. RESULTS: In total, 224 patients presented with OHCA and 3259 without OHCA. Average age was 63.3 years and 75% of patients were male. OHCA occurred prior to ambulance arrival in 68% of patients and 48% required intubation. Culprit lesion was associated with OHCA: risk was highest for proximal left coronary lesions and lowest for right coronary lesions. Also, culprit lesion determined the risk of cardiogenic shock and sub-optimal reperfusion after PCI, which were strongly related to survival after OHCA. Neurological recovery was acceptable (CPC≤2) in 77.1% of OHCA patients and did not differ between culprit lesions. CONCLUSIONS: In the present STEMI population, coronary culprit lesion was associated with the occurrence of OHCA. Moreover, culprit lesion influenced the risk of cardiogenic shock and success of reperfusion, both of which were related to prognosis of OHCA patients.

Management of acute coronary syndrome: achievements and goals still to pursue. Novel developments in diagnosis and treatment.

Acute coronary syndromes contribute a substantial part of the global disease burden. To realize a reduction in mortality and morbidity, the management of patients with these conditions involves the integration of several different approaches. Timely delivery of appropriate care is a key factor, as the beneficial effect of reperfusion is greatest when performed as soon as possible. Innovations in antithrombotic therapy have also contributed significantly to improvements in the prevention of ischaemic complications. However, with the use of such treatment, an increase in the risk of bleeding is inevitable. Therefore, the greatest challenge is now to obtain an optimal balance between the prevention of ischaemic complications and the risk of bleeding. In this regard, identification of patients at highest risk of either one is essential.

Dexamethasone-eluting stents for the prevention of in-stent restenosis: evidence for a differential effect in insulin-dependent and non-insulin-dependent diabetic patients.

UNLABELLED: Diabetes mellitus (DM) is a strong predictor of in-stent restenosis. This may be due to a higher level of vascular inflammation. We hypothesized that diabetic patients will benefit from dexamethasone-eluting stents, since local inflammation and consequently neointimal growth are suppressed and no systemic side effects will occur. METHODS: 21 consecutive patients with DM with 32 lesions were treated with dexamethasone-eluting stents. Excluded were patients with triple vessel disease, bifurcation lesions, previous revascularization of the culprit vessel, and reference diameter smaller than 2.5 or larger than 3.75 mm. MACE (death, myocardial infarction, and revascularization) was counted at 12 months. At 6 months, angiographic follow-up was performed. RESULTS: Of the patients, 38% had insulin-dependent DM. Lesion type was type A/B1 in 56% and B2/C in 44%. Lesion length was 15.7+/-8.4 mm and the reference diameter was 2.83+/-0.53 mm. Event-free survival at 12 months was 62%. Any revascularization procedure was performed in 33% and target lesion revascularization in 24% of the patients. At 6 months in-stent late loss was 1.07+/-0.64 mm. Binary restenosis occurred in 28.1% of the lesions. The event-free survival in insulin-dependent DM was worse compared to non-insulin-dependent DM (92.1 vs. 37.8%; p<0.01). Patients with insulin-dependent DM had higher in-stent late loss compared to non-insulin-dependent DM patients (1.44+/-0.83 vs. 0.83+/-0.51 mm; p<0.01). CONCLUSION: Treatment with dexamethasone-eluting stents in patients with DM is associated with a relatively high restenosis rate. Our data suggest a differential effect of dexamethasone-eluting stents in insulin-dependent compared to non-insulin-dependent DM.

[Percutaneous coronary intervention with stent placement versus bypass operation in symptomatic multiple-vessel disease; lessons from an observational study]. / Dotteren met stentplaatsing versus een bypassoperatie bij symptomatisch meervatslijden; lessen uit een observationeel onderzoek.

In a large observational study comparing percutaneous coronary intervention (PCI) using stent implantation with coronary-artery bypass grafting (CABG), 3-year survival was better after CABG than after PCI with stenting. This was particularly true in patients with triple-vessel disease, and for patients with two-vessel disease with involvement ofthe proximal left anterior descending artery (LAD). Potential explanations for this finding are that with CABG 'future' culprit lesions are bypassed or that CABG allows a more complete revascularization. Based on the results of this study, the CABG procedure is preferable in those patients with symptomatic multiple-vessel disease with involvement of the proximal LAD, especially if they have accompanying reduced left ventricular function or diabetes mellitus.