Patient perspective on remote monitoring of cardiovascular implantable electronic devices: rationale and design of the REMOTE-CIED study.

BACKGROUND: Remote patient monitoring is a safe and effective alternative for the in-clinic follow-up of patients with cardiovascular implantable electronic devices (CIEDs). However, evidence on the patient perspective on remote monitoring is scarce and inconsistent. OBJECTIVES: The primary objective of the REMOTE-CIED study is to evaluate the influence of remote patient monitoring versus in-clinic follow-up on patient-reported outcomes. Secondary objectives are to: 1) identify subgroups of patients who may not be satisfied with remote monitoring; and 2) investigate the cost-effectiveness of remote monitoring. METHODS: The REMOTE-CIED study is an international randomised controlled study that will include 900 consecutive heart failure patients implanted with an implantable cardioverter defibrillator (ICD) compatible with the Boston Scientific LATITUDE® Remote Patient Management system at participating centres in five European countries. Patients will be randomised to remote monitoring or in-clinic follow-up. The In-Clinic group will visit the outpatient clinic every 3-6 months, according to standard practice. The Remote Monitoring group only visits the outpatient clinic at 12 and 24 months post-implantation, other check-ups are performed remotely. Patients are asked to complete questionnaires at five time points during the 2-year follow-up. CONCLUSION: The REMOTE-CIED study will provide insight into the patient perspective on remote monitoring in ICD patients, which could help to support patient-centred care in the future.

State of the art of ICD programming: Lessons learned and future directions.

The lifesaving benefits of implantable cardioverter defibrillator (ICD) therapy are more and more weighted against possible harm (e.g. unnecessary device therapy, procedural complications, device malfunction etc.) which might have adverse effects on patients' perceived health status and quality of life. Hence, there has been an increasing interest in the optimisation of ICD programming to prevent inappropriate and appropriate but unnecessary device therapy. The purpose of the current report is to give an overview of research into the optimisation of ICD programming and present the design of the on-going ENHANCED-ICD study. The ENHANCED-ICD study is a prospective, safety monitoring study enrolling 60 primary and secondary prophylactic ICD patients at the University Medical Center Utrecht. Patients implanted with any type of ICD with SmartShock technology(TM), and between 18-80 years of age, were eligible to participate. In all patients a prolonged detection of 60/80 intervals was programmed. The primary objective of the study is to investigate whether enhanced programming to further reduce ICD therapies is safe. The secondary objective is to examine the impact of enhanced programming on (i) antitachycardia pacing and shocks (both appropriate and inappropriate) and (ii) quality of life and distress. The first results of the ENHANCED-ICD study are expected in 2015.

Gender disparities in disease-specific health status in postoperative patients with peripheral arterial disease.

OBJECTIVES: To investigate gender disparities in disease-specific health status (HS), 3- and 5-year post-intervention in peripheral arterial disease (PAD) patients. DESIGN: Cohort study. METHODS: Data of 711 consecutively enrolled vascular surgery patients were collected in 11 hospitals in The Netherlands in 2004. HS was assessed with the Peripheral Artery Questionnaire (PAQ). Our sample included patients for whom it was possible to calculate a PAQ summary score at 3- and 5-year follow-up (n = 351). RESULTS: Women experienced worse physical health (52.1 vs. 62.0, P = 0.012), greater disability (64.5 vs. 71.1, P = 0.026), and worse overall HS (58.1 vs. 66.7, P = 0.007) at 3-year follow-up than men. At 5-year follow-up, however, male and female patients reported similar levels of HS. Mean changes in overall HS from 3- to 5-year follow-up were significantly different for men and women (-4.12 vs. 1.69, P = 0.014). In male patients, overall HS was significantly lower at 5-year follow-up compared to the 3-year follow-up (66.7 vs. 62.6, P = 0.001). In female patients, there was no significant difference (58.1 vs. 59.8, P = 0.393). CONCLUSIONS: Men and women experience different levels of HS over time. Attention should be paid to gender disparities in postoperative PAD patients.