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.

Percutaneous coronary intervention without on site surgical back-up; two-years registry of a large Dutch community hospital.

AIMS: To assess safety and efficacy of off-site percutaneous coronary intervention (PCI) in The Dutch invasive cardiovascular system. METHODS AND RESULTS: Descriptive single centre registry of elective and emergency PCI. Setting is a Dutch community hospital, 40 km north of Amsterdam, with an adherent population of 400,000 people. A Clinical follow up of Major Adverse Cardiac and Cerebral Events (MACCE) at 30 days post PCI is performed. The total number of participants eligible for PCI was 781 of whom 545 were men and 236 women. During a two-year period 781 PCI's were performed of which 298 were emergency and 483 elective. Acute complications occurred in 2.1% of participants. MACCE-free was 86.9% in the group with AMI and 95.8% in the elective group. CONCLUSIONS: Off-site PCI is feasible and safe in The Netherlands on the condition that specific key factors for success are taken into consideration.

Emergency cardiac surgery after a failed percutaneous coronary intervention in an interventional centre without on-site cardiac surgery.

BACKGROUND.: Based on experience from other countries, the Medical Centre Alkmaar was granted permission to start the first Dutch PCI programme without on-site cardiac surgery. The cardiology group of the Medical Centre Alkmaar started an off-site PCI programme in 2002 with only primary PCI in the first year and a full PCI programme from November 2003 onwards. We report the first Dutch experience with acute cardiac surgery following a failed PCI procedure in an off-site clinic. PATIENTS.: From October 2002 until February 2007, 2500 patients were treated by PCI in the Medical Centre Alkmaar. These patients were treated for an acute myocardial infarction (33%), acute coronary syndromes (37%) or progressive angina (30%). In this first series of off-site PCI in the Netherlands, the incidence of emergency cardiac surgery following failed PCI was 0.2% All five patients who needed emergency surgery underwent elective PCI for progressive stable coronary artery disease. No emergency surgery was needed for primary PCIs in patients with an acute myocardial infarction. All patients survived emergency surgery following failed PCI. CONCLUSION.: Adherence to the Dutch guidelines of interventional cardiology with protocols describing a close collaboration with cardiac surgeons and an immediate availability of rapid ground transportation are mandatory when performing off-site PCI. This series extends the current expertise of emergency surgery after failed PCI to off-site clinics. With appropriate settings, off-site PCI may not be associated with an increase in the risk of adverse events. (Neth Heart J 2007;15:173-7.).

Hybrid approach for complex coronary artery and valve disease: a clinical follow-up study.

BACKGROUND: For patients suffering from complex coronary artery disease (CAD) with or without concomitant valve disease, no evidence is available in the current guidelines to propose a predefined treatment regimen. We sought to assess the clinical impact of an unconventional or extended definition of the hybrid approach that combines percutaneous coronary intervention (PCI) and cardiac surgery in subjects suffering from severe solitary CAD or combined with valve disease. METHODS AND RESULTS: Between July 2002 and August 2004, 18 consecutive patients with complex CAD with or without significant valve disease who qualified for a hybrid approach were enrolled in a clinical follow-up study. Four patients eventually did not complete the proposed interventions. One patient refused treatment after inclusion, one patient died before treatment could be undertaken and two patients died after surgery but before PCI. In the other 14 cases combined treatment was technically successful. After a mean follow-up period of 15alpha5 months two patients had died, one due to sudden cardiac death and one of a noncardiac cause. No other major adverse clinical events were reported. A marked increase in quality of life was reported in those alive. CONCLUSION: Hybrid approach had a favourable long-term outcome in patients with complex cardiovascular disease undergoing successful treatment; however, this was observed at the expense of significant periprocedural mortality in these high-risk subjects. Therefore we believe that hybrid approaches may provide an alternative for selected cases. (Neth Heart J 2007;15:329-4.).

How to target uncertainty in Dutch invasive cardiovascular care.

Current meetings of the Netherlands Society of Cardiology and the Working Group on Intervention Cardiology have shown that new strategic developments in the Dutch healthcare system have created much turbulence and uncertainty amongst members of the organisations. Both on-site and off-site new cardiac centres with and without surgical backup, respectively, are arising or being planned throughout the Netherlands. These strategic adaptations are related to service delivery failure, despite appropriate quality measures. To understand the reasoning behind this uncertainty and how to deal with it, we need to explore its origin and thinking. Its rationale is based on the assumption that each organisation relies on its ability to survive through innovation and transformation. Cardiologists and cardiac surgeons are key players in a large group of stakeholders participating in the chain of cardiovascular care. In addition, the Dutch healthcare system is deeply embedded in a historical sociopolitical environment. This may explain why ongoing uncertainty may beget more uncertainty. What are the consequences for the content of the route forward?