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.

Practical introduction of novel oral anticoagulants through an anticoagulation nurse. The Leeuwarden model.

INTRODUCTION: This paper describes the implementation of novel oral anticoagulants (NOACs) through an anticoagulation nurse. Logistics and tasks of this new function are described and preliminary data are presented. METHODS: Indications for NOACs are explained by the treating cardiologists. Thereafter, the patient is referred to the anticoagulation nurse before starting a NOAC. After providing a patient with information and checking the creatinine clearance, co-medication and medical history, a prescription for NOAC is made. RESULTS: In 3 months, 51 patients were referred for NOAC therapy. Mean age was 68 years, CHA2DS2-VASc score was 2.9. Renal function was impaired in 28 %. Only 63 % of the patients had an uneventful start-up. NOAC therapy was withheld or prematurely stopped in 22 %. 30 % of patients needed a reduced NOAC dose. In 37 %, the anticoagulation nurse had extended patient contact, mainly because of (presumed) side effects. CONCLUSION: Given the number of interactions that were made using a separate patient contact through the anticoagulation nurse, this seems to be an important improvement in the quality of care and deserves further expansion.

Statins Do Not Reduce Atrial Fibrillation After Cardiac Valvular Surgery: A Single Centre Observational Study.

INTRODUCTION: Statins may theoretically reduce postoperative atrial fibrillation (AF) in patients after cardiac valvular surgery due to preservation of endothelial function and anti-ischaemic, anti-inflammatory and anti-remodelling effects. METHODS: Two hundred seventy-two patients who underwent cardiac workup and subsequently cardiac valvular surgery without AF and concomitant coronary artery bypass grafting (CABG) at our hospital were selected. Preoperative drug use and postoperative AF were recorded. AF was defined as any episode of AF longer than 10 s. In addition, results from echocardiography and blood samples were retrieved. RESULTS: BASELINE CHARACTERISTICS WERE AS FOLLOWS: mean age was 65 ± 11 years, 142 (52%) patients were male, 189 (70%) had undergone aortic valve surgery and the mean left ventricular ejection fraction was 57 ± 12%. Statins were used by 79 patients (29%). Statin users, more often, had a prior percutaneous coronary intervention (25% vs 9%, p < 0.001) or CABG (24% vs 4%, p < 0.001), diabetes mellitus (22% vs 5%, p < 0.001) and more often used ß-blockers (51% vs 24%, p < 0.001). Patients in the non-statin group more often had surgery on more than one valve (10% vs 3%, p = 0.043) and had a higher cholesterol level (222 ± 48 vs 190 ± 43 mg/dl, p < 0.001). Postoperative AF occurred in 54% (43/79) of the patients with and in 55% (106/193) of the patients without statins (p = 0.941). There was also no difference in the timing of onset of AF or duration of hospital stay. CONCLUSION: In this observational study, statin use was not associated with a reduced incidence of AF in patients after cardiac valvular surgery.

No effect of rosuvastatin on left ventricular hypertrophy in patients with hypertension: a prospective randomised open-label study with blinded endpoint assessment.

BACKGROUND: This study tested the hypothesis that statins may reduce left ventricular hypertrophy (LVH) in patients with hypertension and LVH. METHOD: A prospective randomised open-label study with blinded endpoints assessment was performed in 142 patients. Inclusion criteria were hypertension, left ventricular ejection fraction ≥50% and echocardiographic determined LVH, defined as a left ventricular mass index (LVMI) of ≥ 100 g/m(2) in women and ≥ 116 g/m(2) in males. Patients were randomised between rosuvastatin 20mg once daily vs control. For each patient an echocardiogram and blood samples were obtained. These tests were repeated after 6 months. RESULTS: Baseline characteristics: mean age was 62 ± 11year and 62 (44%) were male. In both groups, there was a non-significant reduction in LVMI: 118 ± 22 to 111 ± 19 g/m(2) in the control group and 118 ± 21 to 114 ± 22 in the rosuvastatin group (p=0.376 for the comparison between rosuvastatin and control after 6 months). After six months, LDL-cholesterol was reduced from 3.5 ± 1.0 to 2.1 ± 1.2 mmol/L (40% reduction) in the rosuvastatin group and remained unchanged in the control group (3.5 ± 0.9 vs 3.6 ± 0.9 mmol/L. Hs-CRP decreased more with rosuvastatin compared to control (-38% vs -15%, p=0.006) There was no significant reduction in NT-pro-BNP levels after 6 months. CONCLUSION: Rosuvastatin does not reduce LVH despite a large LDL reduction in patients with hypertension and LVH.