In the last few decades, a combination of new surgical techniques, advances in anaesthesia, and pain control have led to a switch to day-case surgery. Day surgery is a safe and cost-effective approach to surgical health care. In 2013–2014, the average cost for day-case surgical procedures in the UK was £698 ($842.58) and the average elective inpatient care cost was £3375.50 ($4074.66) [5]. The increasing proportion of day-case procedures has helped reduce overall costs. Many other advantages of day surgery are shortening hospital stays, increasing hospital bed availability, and decreasing waiting lists. Day surgery also carries fewer risks of hospital-related infections.
European Heart Rhythm Association (EHRA) conducted a survey in 68 EHRA EP research network centres in 2014 [6]. This survey evaluated all cardiac device implantations including implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy (CRT). 18.30% of the centres performed planned cases as day-case admissions. Forty-seven percent of the centres do a single overnight stay for device procedures, while 8.13% have two-night admissions and 10% more than two nights. The reasons for this diversity may include financial reimbursement of day surgical cases, regulations and incentives in different countries, and individual practices of operators and anaesthetists.
MICRA leadless pacemaker is a single-chamber ventricular pacemaker, and it has a volume of 0.8 cm [3], a length of 25.9 mm, an outer diameter of 6.7 mm, and a weight of 2.0 g [7]. The device sits in a cup at the distal end of a steerable transfemoral catheter delivery system and is delivered through the femoral vein using a 23 French internal diameter/27 French outer diameter introducer. The steerable catheter with preloaded MICRA is advanced into the right ventricle, and the device is deployed by fixation into the myocardium using the associated protraction of the nitinol tines. After confirmation of device fixation and electrical measurements, a tether is cut, and the delivery system is removed. One of the concerns regarding the safety of the day-case MICRA procedure is related to the usage of 27 French outer diameter introducers.
To the best of our knowledge, this is the largest patient population undergoing MICRA leadless pacemaker implantation as a day-case procedure. Kiani et al. [8] evaluated the safety and feasibility of the day-case MICRA procedure at their institution and reported that same-day discharge after the MICRA procedure is safe in appropriately selected individuals. In the Kiani et al. study, only 25 patients underwent MICRA implantation as a day-case procedure. In our study, 52 out of 139 patients were planned day-case patients, and 44 patients were successfully discharged on the same day. The aim of this study was to evaluate the safety of our elective leadless pacemaker implantation practice. The results as detailed above show a high implant success rate (99%) and a stable device function at follow-up at 98% and 96% in each group (p = 0.633). The rate of major procedure-related complications in the two groups was 2% vs 7%, p = 0.223.
Patients in the same-day discharge group in our study were notably younger than patients in the overnight observed group. It means that the same-day discharge group possibly included young, active, and less unwell patients. This data suggested that same-day discharge after MICRA implantation is safe in carefully selected patient cohorts.
Compared to most previous MICRA studies [4, 7,8,9,10], our MICRA population is significantly younger. This is largely related to the restrictions imposed by the National Institute of Health and Care Excellence (NICE, UK) in 2018. NICE (UK) recommends performing MICRA leadless pacemaker implantation only as a part of research or only when the conventional transvenous pacemaker is contraindicated and a multidisciplinary team (MDT) determines that MICRA device should be used [11]. On this basis, many young patients who require pacing may be considered by an MDT to have a contraindication to transvenous leads owing to the complications associated with leads, in the vasculature, over many years.
At our centre, MICRA implantation was started in early 2014 (Figs. 1 and 2). Patients undergoing early MICRA implantation at our centre were inpatients or were scheduled for admission after the procedure. Day-case MICRA implants were started only in 2015 when the clinical team had achieved enough exposure and experience and the number of patients who stayed overnight in the hospital after the procedure had come down subsequently. Day-case MICRA implantation has become the standard for our elective out-patients unless the patient has complex anatomy or other social needs to stay in the hospital after the procedure. Although it can make an impact on the rate of complications and device function, the rate of complications and stable device function at follow-up are similar in both patient groups. The implant success rate in the same-day discharge group was 100%, and 98% of these patients remained on a stable pacing capture threshold at the first routine follow-up in our study. These findings were better than previously reported data in previous MICRA studies [4, 9]. The rate of major complication was 2% in the same-day discharge group, and this finding was consistent with the MICRA Investigational Device Exemption (IDE) study [4]. Apart from mild groin bleeding, there was no major groin puncture site complication occurring in the same-day discharge group.
Fig. 2Number of MICRA implants at our centre since 2014 (ON = observed overnight group, SD = same-day discharge)
留言 (0)