Evaluating Safety and Compliance During a Same-Day-Discharge Study for Patients Receiving a Cardiac Implantable Electronic Device

Introduction

Historically, patients receiving a cardiac implantable electronic device (e.g., permanent pacemaker or implantable cardiac defibrillator) were required to spend an overnight period in the hospital to monitor lead function, interrogate device performance, and evaluate patient health as a regular part of a next-day-discharge (NDD) protocol (Figure 1; orange box). In fact, as recently as a decade ago, cardiac implantable electronic device educational videos often informed patients of the potential of a multiple night stay following initial device implantation. More recently, other fields of cardiac therapy have examined same-day-discharge (SDD) protocols in depth, including percutaneous coronary intervention (PCI).^1-5 Upon review of the PCI studies, some general conclusions became apparent about the overall value of SDD when comparing SDD and NDD protocols, including: (1) PCI can be done safely in both settings; (2) cost benefits may be achieved in SDD for some fixed reimbursement models; (3) SDD can allow for better efficiency of “hospital bed utilization”; and (4) patient satisfaction surveys can potentially improve when moving into a SDD protocol.

Even within the field of electrophysiology, SDD protocols have been recently studied in catheter ablation of arrhythmias⁶ and during implantation of cardiac defibrillators.⁷ Importantly, these latter studies have been limited to initial experiences, pilot studies, or feasibility examinations. When considering the usage of SDD for cardiac implantable electronic devices, larger randomized studies are still needed to demonstrate the superiority, inferiority, or noninferiority of this approach compared to NDD, which is currently the standard of care.⁸ Additionally, cost analyses can only be examined when an exhaustive review of the patient care pathway is completed, including: reporting of all complications, evaluation of readmissions, examination of emergency room visits, and usage of staff/hospital resources during both discharge routes.⁸

Recently, the electrophysiology group at Spectrum Health began an evaluation of SDD in patients undergoing an elective implantation for a cardiac electronic device. The primary goal of this study was to evaluate the patient safety during a SDD protocol by examining both major and minor complications. Additionally, the study investigated performance quality matrices as a secondary objective, including: readmission rates, discharge times, and transmission rates with remote home monitoring. Spectrum Health will later publish a larger evaluation of SDD versus NDD protocols when the larger study is completed. However, the early evaluations of this SDD protocol were compelling enough to warrant broader communication and publication of this early substudy data set. 

Methods

This SDD study reviewed 150 consecutive patients (between January 2013 and July 2013) who underwent an elective procedure for a cardiac implantable electronic device at Spectrum Health by one of six board-certified electrophysiologists. The study was approved by the hospital Institutional Review Board and all patients had given informed consent. Each patient was evaluated for the potential of a SDD based on a set of inclusion and exclusion criteria (Table 1). The group of 150 patients that were analyzed in the SDD protocol had on average other commingled cardiac disease associations, including high body mass index, advanced age, hypertension, coronary artery disease, dyslipidemia, and diabetes (Table 2). Consequently, these patients were receiving the cardiac implantable electronic devices for a large variety of cardiac arrhythmias and myopathies (Table 3). Once in the SDD protocol, the patients were triaged and scheduled through a series of tests, evaluations, and imaging sessions which had been previously completed during the next morning before discharge, when NDD protocols were historically used (Figure 1).

Implant procedure and SDD protocol

The patients in the SDD cohort were given a single dose of pre-operative antibiotic with 2 g of cefazolin (3 g if body with >120 kg) and 1 g of vancomycin given intravenously. In this SDD protocol, oral anticoagulation was not systematically discontinued before the procedure, and the implantation occurred when INR was <4. Cardiac implantable electronic devices were preferentially placed in the left subclavian region with an incision along the left deltopectoral groove, and all incisions were covered with a water-resistant dressing to remain in place for one week. 

Patients were observed in the catheterization laboratory recovery area while undergoing cardiac monitoring, and a device interrogation was completed to verify appropriated lead function and an absence of diaphragm stimulation while pacing. A same-day chest x-ray was obtained and evaluated by a radiologist to rule out lead dislodgement and pneumothorax prior to discharge. Patients were only directed to the SDD exit route when they had completed a detailed survey and checklist of medical requirements with the attending electrophysiologist and the EP laboratory nurse. Before discharge, patients were given a remote home monitoring system, and instructions for setup, usage, and transmission were provided to the patient and family members by an industry representative. At discharge, patients were instructed to send a transmission on the day after implantation or earlier for any unusual cardiac symptoms, including device shock. 

Data collection and statistical analysis

Patient demographic and procedural data were recorded from electronic medical record files, including: patient characteristics, patient cardiac medical history, patient discharge and complication records, procedural times, and hospital readmission records. Remote home monitoring data was collected and reviewed using the Paceart^® System (Medtronic, PLC), which included a catalog of successful remote home monitoring transmissions.

All data were captured into an electronic database for statistical summary and significance testing. Quantitative data are expressed as the mean ± the standard deviation, while nominal data are expressed as a percentage. Comparisons between nominal variables were performed using the chi-square test, and significance was assessed at P<.05.

Results

Patient demographics

The study consisted of 150 patients, of which 149 patients completed the entire study, including follow-up. One patient underwent the SDD protocol, but did not transmit remote home monitoring data and could not be reached for follow-up. Patient demographic evidence demonstrated a considerable rate of cardiac disease, which included cardiac arrhythmias, and 92 patients (61%) had a diagnosis of cardiomyopathy with a mean left ventricular ejection fraction of 41.1%. In this study, there were 123 new cardiac implantable electronic device implants (82%), and the remaining procedures were device upgrades or lead revisions. The majority of the implanted devices (N=102) were defibrillators, of which 77 patients were given defibrillators that were indicated for usage as a primary prevention device.

Complications

In this study, all acute and 30-day post-procedure complications were recorded, and there were two major complications (1.3%; N=2; Table 4). One major complication (lead dislodgement) occurred after the patient was discharged, and it was not noted during the SDD device evaluation and interrogation. The second major complication was a single case report of a patient’s inappropriate shock administered by their cardiac implanted defibrillator device. There were four minor complications (2.7%; N=4; Table 4) including: one wound dehiscence, two minor hematomas of moderate size, and one single case report of pacemaker-induced transient tachycardia. Importantly, this SDD patient cohort observed no cases of pneumothorax, cardiac tamponade, lead fracture, infection, device failure, diaphragmatic stimulation (not resolved by reprogramming), or death. One additional patient was found to have a lead dislodgement before being discharged; this dislodgement was found by device interrogation and confirmed by chest x-ray. The event was recorded as an acute dislodgement that was corrected before discharge, and it was not denoted as a procedural complication in this study design. 

Procedural and follow-up records

By utilizing a SDD protocol, patients in this group were able to leave the hospital in a post-procedural average time of 151.9 ± 50 minutes on the day of the procedure. The 30-day follow-up demonstrated that there were six emergency room visits (4.1%), and four patients (2.7%) were re-admitted to the hospital for suspected device-related issues (Table 4). Two of these readmitted patients were discharged within three days after cardiac implantable electronic device infection was ruled out. The other two readmissions were for a wound dehiscence and an atrial lead dislodgement.

Of the 150 SDD patients, 62 patients (42%) were compliant and did transmit their first remote home monitoring transmission within 24 hours after hospital discharge. At one-month post-procedure, 109 (73%) of SDD patients had transmitted their device record to the remote home monitor system. By comparison, a historic group of NDD patient data collected at Spectrum Health had a remote home monitor transmission rate of 8% (36 patients out of 439 total patients) at one-month post-procedure. This difference in one-month post-procedure transmission compliance rate was statistically significant (SDD at 73% vs NDD at 8%; P<.0001). Similar comparisons to historical NDD data were made at three and six months (Table 4). In both cases, the SDD patient transmission rate to remote home monitors was statistically greater than the rate achieved in the NDD patient historical records (SDD at 82% vs NDD at 31% for three-month time point; SDD at 87% vs 41% for six-month time point; both comparisons are statistically different with P<.0001). 

Discussion

The Spectrum Health evaluation of 150 patients in a SDD protocol demonstrated a low rate of major and minor complications (1.3% and 2.7%, respectively). This low rate of complications was achieved in a patient cohort of rather sick and diseased individuals. These SDD patients had common cardiac comorbidities that are often associated with candidate patients who elect to have a cardiac implantable electronic device, including: hypertension, coronary artery disease, dyslipidemia, and diabetes. The primary diagnosis for cardiac device implantation included cardiomyopathy, sick sinus syndrome, AV block, syncope, and cardiac arrhythmias.

However, while using the SDD protocol, patients were able to leave the hospital on the day of procedure in an average time of about 152 minutes post-device implantation. These same patients had a low rate of hospital readmissions within 30 days (2.7%), and their compliance to complete remote home monitoring was high at six months (87% patient transmissions). The SDD protocol was very similar to the Spectrum Health NDD guidelines; however, critical patient evaluation tasks that were typically conducted on the next morning (post-procedure) were moved to the same day of the procedure in the SDD protocol (Figure 1). Importantly, no patient health evaluation or imaging was removed when moving from the NDD protocol to the SDD protocol. 

One additional difference between SDD and NDD patients was the rate of compliance to remote home monitoring. Our hypothesis is that SDD patients felt some personal ownership with their healthcare follow-up because of the unique discharge route and a pre-planned (in-hospital) cardiac device education session. The SDD patients were given strict instructions and training about the importance of device transmission to assess device performance on the next day (post discharge). They were advised that this transmission should take place the next day at home. It is entirely possible (and likely) that NDD patients can potentially increase the rate of compliance to remote home monitoring when a similar education and training session/program is given in this group. 

During this SDD protocol, one patient did have a lead dislodgement that was observed after the patient discharge, and this event was denoted as a major complication. The lead dislodgement was noted at a follow-up device clinic and not by the next day remote home monitoring. It is possible that this dislodgement may have been detected prior to discharge if the patient stayed overnight, but we cannot be certain that the lead was not a late dislodgement that occurred after the first 24 hours (post procedure). This is the only potential complication that may have had an earlier detection with a NDD policy. Ultimately, this event did not result in any significant morbidity; however, each EP clinic must evaluate their own experience and complication rate(s) when moving to a SDD program. At Spectrum Health, the SDD protocol is being used regularly on qualified patients that meet the checklist criteria.

Study Limitations

This was a single-center study that evaluated the SDD protocol as a single-arm observational examination; further study is needed and planned to compare NDD protocols. Importantly, in-depth patient care pathways and economic modeling are necessary before definitive statements can be made about cost savings or efficiencies. Some of these activities are planned in the larger Spectrum Health study that will be nearing completion. Also, a direct safety/complication comparison is needed between SDD and NDD protocols before a definitive statement can be made about relative safety; however, it was noteworthy that the total complication rate of this SDD protocol was 4%.

Conclusion

Ultimately, there may be healthcare system efficiencies or cost savings as more cardiac procedures move into a SDD setting; however, larger studies are needed before these efficiencies or savings can be evaluated for cardiac implantable electronic devices. This current study of 150 SDD patients is part of a large planned evaluation by Spectrum Health. While the SDD protocol did eliminate the traditional overnight stay, a larger evaluation of patient records is needed to determine if these efficiencies and savings were a “single-line-item” factor with no effect(s) on any other part(s) of the patient care pathway continuum. 

Disclosures: The authors have no conflicts of interests to report regarding the content herein.  Outside the submitted work, Dr. Elmouchi reports personal fees from Medtronic, St. Jude Medical, Boston Scientific, and BIOTRONIK.

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