Is it feasible to outsource the remote monitoring of implantable cardiac defibrillators in a large tertiary hospital?

AIM: To provide a detailed description of the workflow at our telecardiology centre and to analyse the workload of real-world remote monitoring with the aim to assess the feasibility to outsource this service. METHODS: A retrospective analysis was conducted on the telecardiology service provided at the University Hospitals of Leuven by extracting patient demographic data, general time usage and detailed information about the type of remote contacts. 10,869 contacts in 948 patients have been included. A 2-week prospective study was conducted on the same service by documenting and monitoring every action performed by specialised nurses when analysing and solving remote monitoring transmissions. 337 contacts in 262 patients were collected during this period. RESULTS: Both analyses indicated similar numbers of events and interventions. Unplanned transmissions were more challenging and required more interventions than planned transmissions. Relatively little time (retrospective median: 1.83 min; prospective median: 1.56 min, per event) was spent on incoming non-actionable 'normal' transmissions (retrospective: 46%; prospective: 40% of all events). Retrospectively 54% and prospectively 60% of transmissions showed abnormalities and were responsible for most of the time expended. Disease-related issues were the most frequent cause for these 'abnormal' alerts. Contacting patients and physicians were key interventions undertaken. Interaction initiated by patients mainly involved the installation process (42%) and bedside monitoring problems (32%). CONCLUSION: External data centres could deal with 40% of the transmissions, but the decline in workload would be negligible for the in-hospital remote monitoring team, because very little time is spent dealing with the many 'non-event' transmissions whereas most of the time is spent solving clinical problems. Providing sufficient resources and optimising communication protocols is necessary to aid in managing the workload of the remote monitoring team.Implications for practiceContacting patients and physicians are key interventions for specialist nurses in remote monitoring centres.Detailed timing confirmed that most time was spent on relevant disease-related clinical problems.Despite dealing with ∼40% of transmissions, outsourcing to external data centres would decrease the workload only by 15-25%.Patient initiated contacts with questions concerning remote monitoring form a high burden and should be countered by scaling the service and creating communication protocols.

Leadless pacemaker for patients following cardiac valve intervention.

BACKGROUND: Permanent pacing is common after valve intervention. The presence of a conventional pacemaker in this population is recognized as a risk factor for infectious events. Therefore, a leadless pacing system could be the preferred strategy when permanent pacing is required after valve intervention. AIM: To report periprocedural outcomes and follow-up of patients undergoing implantation of a leadless pacing system after valve intervention. METHODS: Patients with previous valve intervention at the time of attempted implantation of a leadless pacemaker (Micra™, Medtronic, Minneapolis, MN, USA) were included, and were compared with a control group (patients also implanted with Micra™ without valve intervention). RESULTS: Among a total of 170 Micra™ implantation procedures, 54 patients (31.8%) had a history of valve intervention: 28 after aortic valve replacement; 10 after mitral valve replacement; one after single tricuspid valvuloplasty; and 15 after multiple valve surgery. Median age of the patients was 82.5 (77.0-86.0) years and 53.7% were male. Patients with previous valve intervention had a higher incidence of arterial hypertension (P=0.014) and ischaemic heart disease (P=0.040). The primary indications for permanent pacing after valve intervention were high-degree atrioventricular block (59.3%) and atrial fibrillation with bradycardia (27.8%). Micra™ was successfully implanted in all patients (n=170) without any procedure-related major complications. During a median follow-up of 12 months, electrical performance was excellent and similar in both groups. Also, a similar reduction in left ventricular ejection fraction was observed at 12 months in both groups, which was correlated with the percentage of right ventricular pacing. CONCLUSION: A leadless pacemaker is safe and efficient after valve intervention, and therefore represents an effective pacing option in patients after valve intervention.

Bacteraemia after leadless pacemaker implantation.

BACKGROUND: Transvenous 3 permanent pacemaker-related infection is a severe condition associated with significant morbidity and mortality. Leadless pacemakers may be more resistant to bacterial seeding during bloodstream infection because of its small surface area and encapsulation in the right ventricle. This study reports the incidence and outcomes of bacteraemia in patients implanted with a Micra leadless pacemaker. We present 18 F-fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) findings obtained in a subgroup of patients. METHODS: We report a retrospective cohort study of 155 patients who underwent a Micra TPS implant procedure at the University Hospitals of Leuven between July 2015 and July 2019. We identified the patients who developed an episode of bacteraemia, proved by ≥2 positive blood cultures. RESULTS: Of the 155 patients, 15 patients presented an episode of bacteraemia at a median of 226 days (range: 3-1129) days after the implant procedure. Gram-positive species accounted for 73.3% (n = 11) of the bacteraemia including Staphylococcus (n = 5), Enterococcus (n = 3), and Streptococcus (n = 3). The source of infection was identified in nine patients (60%) including endocarditis in four patients, urinary tract in three patients, and skin in two patients. 18 F-FDG PET/CT imaging performed in six patients did not show sign of infection around the leadless pacemaker. Bacteraemia was resolved in all patients after adequate antibiotherapy. Four patients died early during follow up. For all other patients, there were no recurrence of systemic infection during a median follow up of 263 days (range: 15-1134). CONCLUSION: In our small cohort, no leadless pacemaker endocarditis was observed among patients with bacteraemia.

Determinants of the difficulty of leadless pacemaker implantation.

BACKGROUND: The Micra Transcatheter Pacing System is implanted directly in the right ventricle (RV) through the femoral vein using a steerable transcatheter delivery system. The present study was done to identify determinants of difficult leadless pacemaker implant procedures including operator, patient, and RV anatomical characteristics. METHODS: All patients who underwent a Micra implant from July 2015 to December 2018 at our center were analyzed. From an RV angiogram acquired during implantation, RV geometry including systolic and diastolic volumes and ejection fraction was characterized. The presence of septomarginal trabeculation was noted. RESULTS: One hundred twenty-six patients (mean age: 79 ± 11 years old, mostly male: 77%) were enrolled. Mean Micra RV implant procedure time was 24 ± 23 min, with 1.7 ± 1.3 deployments of the device. No significant change in implant procedure time was observed after the first 30 implants. Eleven patients had a prominent septal component of the septomarginal trabeculation in the RV. Univariate analysis showed that the procedure time was positively correlated with the presence of a prominent septal component of the septomarginal trabeculation (P < .001) or an episode of heart failure (P = .02) and negatively correlated with the number of procedures performed by the operator (P < .001). After multivariable analysis, only the presence of a prominent septal component of the septomarginal trabeculation (P < .001) and the number of procedures performed by the operator (P < .001) were associated with the implant procedure time. CONCLUSIONS: In our experience, implant procedure time of a Micra leadless pacemaker depended on the presence of a prominent septal component of the septomarginal trabeculation and operator experience.

Leadless pacing with Micra TPS: A comparison between right ventricular outflow tract, mid-septal, and apical implant sites.

BACKGROUND: With its steerable transcatheter delivery system, the Micra can be deployed in nonapical positions within the right ventricle, potentially allowing reduction of the paced QRS width. We sought to evaluate the safety and long-term performance of the right ventricular outflow tract (RVOT) pacing using the Micra transcatheter pacing system (TPS). We also compared the paced QRS between RVOT, mid-septal, and apical implant positions. METHODS: All patients who underwent a Micra TPS implantation at the University Hospitals of Leuven were enrolled in this observational study. Right ventricular (RV) position of the device was assessed on per-procedural ventriculography. Paced QRS was analyzed and follow-up completed at 1 month and then every 6 months. RESULTS: Among the 133 patients included (mean follow-up: 13 ± 11 months), 45 were implanted in the RVOT, 58 midseptally, and 30 at the apex. All implant procedures were successful and no pericardial effusion was encountered within the 30 days post-implant. Two major complications were reported with devices implanted at the apex. Pacing impedance was significantly higher in the RVOT compared to the mid-septal and apical position (P < .001). Pacing threshold and R-wave amplitude did not differ over time in either position. The median narrowest paced QRS duration was observed in the RVOT (142 ms) compared to mid-septal (159 ms; P < .001), and apical position (181 ms; P < .001). CONCLUSION: Implantation of the Micra TPS in the RVOT is safe and feasible. Electrical performance over time was comparable to mid-septal and apical positions. The narrowest paced QRS complexes is achieved with RVOT pacing.

Monocentric experience of leadless pacing with focus on challenging cases for conventional pacemaker.

AIM: Leadless cardiac pacemaker has been developed to reduce complications related to cardiac pacing and is considered as an alternative to conventional pacemaker although safety and efficacy data in clinical practice are limited. The purpose of this study was to investigate the safety and efficacy profile of Micra Transcatheter Pacing System (TPS) used in daily clinical activity with a focus on challenging cases for conventional pacing. METHODS: A total of 66 patients (46 men, 79.1 ± 9.7 years) having a Class I or II indication for ventricular pacing underwent a Micra TPS implant procedure. All patients were enrolled in a prospective registry. Follow-up visits were scheduled at discharge and after 1, 3, 6 and 12 months. RESULTS: Primary indication for pacing was third degree atrioventricular block (30.3%), sinus node dysfunction (21.2%) or permanent atrial fibrillation with bradycardia (45.5%). The device was successfully implanted in 65 patients (98.5%). During follow-up of 10.4 ± 6.1 months (range 1-23 months), electrical measurements remained stable. Mean pacing capture threshold, pacing impedance and R-wave sensing were respectively 0.57 ± 0.32 V, 580 ± 103 Ohms, 10.62 ± 4.36 mV at the last follow-up. One major (loss of function) and three minor adverse events occurred. Pericardial effusion, dislodgement, device related infection or pacemaker syndrome were not observed. Micra TPS implantation was straightforward for patients with congenital or acquired cardiac and/or vascular abnormalities, previous tricuspid surgery and after heart transplantation. CONCLUSION: Our experience confirms that implantation of Micra is safe and efficient in a real world population including patients who present a challenging condition for conventional pacing.

The impact of changes in LVEF and renal function on the prognosis of ICD patients after elective device replacement.

BACKGROUND: A proportion of patients with an implantable cardioverter-defibrillator (ICD) in prevention of sudden cardiac death will only receive their first appropriate ICD therapy (AT) after device replacement. Clinical reassessment at the time of replacement could be helpful to guide the decision to replace or not in the future. METHODS: All patients with an ICD for primary or secondary prevention in ischemic (ICM) or nonischemic cardiomyopathy were included in a single-center retrospective registry. The association of changes in left ventricular ejection fraction (LVEF; cut-off at 35%), worsening renal function (decrease in estimated glomerular filtration rate > 15 mL/min), and worsening New York Heart Association class at elective device replacement with mortality and AT was analyzed using adjusted Cox regression analysis. RESULTS: A total of 238 (33%) out of 727 patients received elective device replacement (86.1% male, 74.4% ICM, 42.9% primary prevention). During this replacement 20.2% received a device upgrade. The mean time to replacement was 6.4 ± 2.0 years and mean follow-up after replacement was 3.4 ± 3.0 years. Of patients who did not receive AT before replacement 23.1% received their first AT after replacement. Worsening renal function (hazard ratio [HR] 2.79, 95% confidence interval [CI] 1.50-5.18) and a consistently LVEF ≤35% compared to a consistently LVEF >35% (HR 2.15, 95% CI 1.10-4.19) at the time of replacement were independent predictors of mortality. Independent predictors of first AT after replacement could not be identified. CONCLUSION: Although reassessment of LVEF and renal function at replacement can be helpful in predicting total mortality, the clinical utility to guide reimplantation seemed limited. Our experience indicates that approximately 25% of patients received their first AT only after replacement.

Potential role of remote monitoring for scheduled and unscheduled evaluations of patients with an implantable defibrillator.

AIMS: Follow-up of implantable cardioverter defibrillator (ICD) patients, with regular in-office visits every 3-6 months, puts a significant burden on specialized electrophysiology clinics. New technology allows for remote monitoring of device function. We wanted to investigate its potential reliability and to which extent its use can reduce in-office visits. METHODS AND RESULTS: We retrospectively analysed data from 1739 prospectively coded ICD visits in a random set of 169 patients (followed between 2 month and 10.4 year in an academic centre). We defined (i) whether the visit was planned or not, (ii) what were the reasons for unplanned visits, (iii) whether any relevant finding was made, (iv) whether a remote monitoring system with the ability or not to detect pacing threshold would have been able to capture the problem, and (v) what actions were taken. The standard follow-up scheme consisted of in-office visits 1 month after implantation and then every 6 months, unless approaching battery depletion. From the 1739 visits, 1530 were performed according to clinical schedule (88%) and in 1197 of those (78.2%), no relevant finding was made. In 0.52% (n = 8) early post-implant pacing threshold increases would not have been detected by remote monitoring without the ability to determine thresholds (although two patients showed a high impedance). Moreover, in 6% of the planned visits, reprogramming would require a consecutive in-office visit (4%) or hospitalization (2%). Only 175 visits (9.6% of all) were conducted prior to the planned follow-up date due to patient symptoms [another 42 (2.4%) were due to planned surgery or safety warnings]. The proportion of relevant findings during unscheduled visits was significantly higher than during scheduled visits (80.6 vs. 21.8%; P < 0.0001) and a higher proportion of those was arrhythmia- and/or device-related (85.1 vs. 55.3%, P < 0.0001). Reprogramming was required more often (33.1 vs. 4%; P < 0.0001) and hospitalization rate was higher (18.3 vs. 2%; P < 0.0001), so that 51.4% of unscheduled visits would require in-office evaluation. Overall, remote follow-up would correctly exclude device function abnormalities or arrhythmic problems in 1402 (82.2%), identify an arrhythmic problem in 262 (15.3%), correctly identify a device-related problem in 35 (2.1%), but potentially miss an isolated pacing problem in 6 (0.46%). Clinical evaluation would diagnose a relevant clinical problem in the absence of any device interrogation abnormality in 170 patients (10%). CONCLUSION: ICD remote monitoring can potentially diagnose >99.5% of arrhythmia- or device-related problems if combined with clinical follow-up by the local general practitioner and/or referring cardiologist. It may provide a way to significantly reduce in-office follow-up visits that are a burden for both hospitals and patients.

Ablation of focally induced atrial fibrillation: selective or extensive?

INTRODUCTION: Focally induced atrial fibrillation (AF) often is due to ectopic activity in the pulmonary veins (PV). Although initial approaches were aimed at ablating only the ectopic foci, more extensive ablation approaches have evolved that isolate all PVs empirically and/or create circumferential ablation lines in the left atrium (LA). These techniques last longer and may be associated with more risks. We retrospectively evaluated the outcome and risks of ablation for focally induced AF in a single-center patient population. METHODS AND RESULTS: We report on 47 patients (32 men and 15 women; age 47 +/- 10 years) in whom 52 ablations were performed. In 19 patients (22 sessions), ablation was directed at the site(s) of overt ectopic activity ("selective" group), whereas in 28 patients (30 sessions) without sufficient ectopy to determine the culprit PV a mean of 3.5 PVs were empirically targeted for bidirectional disconnection from the LA ("extensive" group). On a preprocedural Holter recording, the "selective" group had significantly more isolated atrial ectopy (3,276 +/- 2,933 vs 620 +/- 937 beats/24 hours) and runs of atrial tachycardia (330 +/- 202 vs 53 +/- 87 runs/24 hours) than the "extensive" group (P < 0.01 for both). Only 11% had persistent AF before ablation. Acute procedural success was 81% (elimination of all ectopy) and 83%, respectively (bidirectional and fully circumferential isolation of all targeted PVs). Procedure and fluoroscopy times were significantly shorter in the "selective" group. There were no major complications, but 7 minor complications and 2 acute PV stenoses > 50% in the 30 "extensive" procedures were observed. Mean follow-up was 8.4 +/- 8.5 months (median 6.9). Kaplan-Meier analysis, excluding recurrences during only the first month ("delayed cure"), showed AF recurrence in 45% after 6 months and in 55% after 1 year. Outcome was not dependent on ablation approach ("selective" or "extensive") nor was time to first AF (22 +/- 64 days and 30 +/- 69 days). AF recurrence tended to be higher in patients with larger LA (P = 0.08), underlying heart disease or hypertension (P = 0.08), and those "extensive" patients in whom not all 4 PVs were targeted (P = 0.07). CONCLUSION: Trigger-directed ablation for focally induced AF is associated with a relatively high recurrence rate during follow-up. Apart from recurrence of the ectopic trigger, this may point to underlying structural changes in the atrial substrate not addressed by the ablation. Prospective evaluation of the risk-to-benefit profile of any technique (selective, extensive, including linear lines) is required.