Device Reprogramming Research Articles

Feasibility and safety of remote programming in postoperative follow-up of cardiovascular implantable electronic devices

Objective: To explore the feasibility and safety of remote programming technology based on 5G cloud technology support platform in postoperative follow-up of cardiovascular implantable electronic devices(CIED). Methods: This study was a multicenter cross-sectional study. CIED patients from 12 hospitals lacking full-time follow-up specialists in Sichuan Province were enrolled from June 2021 to October 2021. All patients' devices received remote inspecting and programming by the follow-up specialist of the remote follow-up center of the Third People's Hospital of Chengdu through 5G cloud technology support platform. The baseline data, device alarm events, device reprogramming events, adverse reactions and satisfaction questionnaire survey results were collected. Results: A total of 195 CIED implantation patients were included, with an age of (72.5±11.3) years, including 103 males (52.6%). All patients completed remote inspecting and programming successfully, with a duration of (5.8±4.0) min. Ninety-one patients' CIED were reprogrammed, with a total of 104 parameter adjustments. No abnormal communication or adverse events occurred. The satisfaction questionnaire showed that 97.9%(191/195) of the patients trusted or relatively trusted remote follow-up and 86.7%(169/195) of the patients were willing to choose remote follow-up mode for device management. Conclusion: The remote programming based on 5G cloud technology support platform may be feasible and safe for postoperative follow-up of CIED patients.

Perioperative management of patients with cardiac implantable electronic devices.

The use of cardiac implantable electronic devices (CIEDs) has increased significantly in recent years. Consequently, more patients with CIEDs will undergo surgery during their lifetime, and thus the involvement of anesthesiologists in the perioperative management of CIEDs is increasing. With ongoing advancements in technology, many types of CIEDs have been developed, including permanent pacemakers, leadless pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy-pacemakers/defibrillators, and implantable loop recorders. The functioning of CIEDs exposed to an electromagnetic field can be affected by electromagnetic interference, potential sources of which can be found in the operating room. Thus, to prevent potential adverse events caused by electromagnetic interference in the operating room, anesthesiologists must have knowledge of CIEDs and be able to identify each type. This review focuses on the perioperative management of patients with CIEDs, including indications for CIED implantation to determine the baseline cardiovascular status of patients; concerns associated with CIEDs before and during surgery; perioperative management of CIEDs, including magnet application and device reprogramming; and additional perioperative provisions for patients with CIEDs. As issues such as variations in programming capabilities and responses to magnet application according to device can be challenging, this review provides essential information for the safe perioperative management of patients with CIEDs.

Utilization of remote reprogramming to manage insertable cardiac monitor arrhythmia alert burden.

The increasing use of insertable cardiac monitors (ICMs) for long-term continuous arrhythmia monitoring creates a high volume of transmissions and a significant workload for clinics. The ability to remotely reprogram device alert settings without in-office patient visits was recently introduced, but its impact on clinic workflow compared to the previous ICM iteration is unknown. The aim of this real-world study was to evaluate the impact of device reprogramming capabilities on ICM alert burden and on clinic workflow. Deidentified data was obtained from USpatients and a total of 19 525 receiving a LINQ II were propensity score-matched with 19 525 implanted with LINQ TruRhythm (TR) ICM based on age and reason for monitoring. After reprogramming, ICM alerts reduced by 20.5% (p < .001). Compared with patients monitored with LINQ TR, patients with LINQ II had their device reprogrammed sooner after implant and more frequently during follow-up. Adoption of remote programming was projected to lead to an annual total clinic time savings of 211 h per 100 ICM patients managed. These data suggest that utilization of ICM alert reprogramming has increased with remote capabilities, which may reduce clinic and patient burden for ICM follow-up and free clinician time for other valuable patient care activities.

Long-term remote monitoring vs. in-office monitoring of pacemakers: a systematic review and meta-analysis

Abstract Background Remote monitoring (RM) is increasingly recognised as the standard of care for patients with cardiac implantable electronic devices (CIEDs) according to current practice guidelines, particularly in pacemaker usage which represents the majority of CIEDs. However, there is insufficient evidence to assess the long-term safety of RM compared to in-office (IO) monitoring of pacemakers over extended periods, as well as its effectiveness in reducing in-office visits for device reprogramming. Purpose We aimed to perform a meta-analysis to compare RM and IO monitoring of pacemakers with at least 12 months of follow-up. Methods We systematically systematic search EMBASE, PubMed/MEDLINE, Cochrane, and ClinicalTrials.gov databases for randomized controlled trials (RCTs) comparing remote monitoring (RM) and in-office (IO) monitoring of pacemakers, with a focus on outcomes related to (1) all-cause mortality, (2) stroke, and (3) hospitalizations due to cardiovascular and device-related adverse events. Heterogeneity was assessed using I² statistics, and outcomes with high heterogeneity were analysed using a random-effects model. Results Six RCTs with a total of 3,059 patients were included in the meta-analysis. Of these, 1,495 patients (48.87%) underwent RM. In-office number of follow-ups per year was not significantly different between groups (OR -0.71; 95% CI -1.45 - 0.03; p = 0.06; I² = 99%; Fig. 1a) but tended to favour the RM group. No significant differences were found between RM and IO monitoring in terms of all-cause mortality (OR 1.14; 95% CI 0.83 - 1.55; p = 0.42; I² = 0%; Fig. 1b), stroke (OR 0.82; 95% CI 0.37 - 2.19; p = 0.82; I² = 38%; Fig. 2a), or hospitalizations for cardiovascular or device-related adverse events (OR 0.96; 95% CI 0.72 - 1.28; p = 0.78; I² = 0%. Fig. 2b). Conclusion This is the first meta-analysis comparing RM and IO monitoring for long-term pacemaker usage. Our results suggest that the number of follow-ups tended to be fewer in the RM group, and both monitoring methods appear to be similar in terms of all-cause death, stroke, and hospitalizations for cardiovascular or device-related adverse events.

Long-Term Remote vs. Conventional Monitoring of Pacemakers: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Remote monitoring (RM) is the standard of care for patients with cardiac implantable electronic devices (CIEDs), particularly pacemakers. However, the long-term outcomes of RM versus conventional monitoring (CM) of pacemakers and its effectiveness in reducing in-office (IO) visits for device reprogramming require elucidation. This systematic review and meta-analysis aimed to compare the RM and CM of pacemakers over a long-term follow-up. We systematically searched the PubMed/MEDLINE, Embase, Cochrane, and ClinicalTrials.gov databases for randomized controlled trials (RCTs) comparing RM and CM of pacemakers with at least 12 months of follow-up. Binary endpoints were pooled with risk ratios (RRs), whereas continuous outcomes were computed using mean differences (MDs) or standardized MDs (SMDs). Heterogeneity was assessed using I2 statistics. Among the eight included RCTs, 2159 (48.9%) of 4063 patients underwent RM. Follow-up periods ranged from 12 to 24 months. There were no significant between-group differences in all-cause mortality (RR=1.19; 95% confidence interval [CI], 0.90-1.57; p=0.22; I2=0%), stroke (RR=0.90; 95% CI, 0.43-1.91; p=0.79; I2=23%), hospitalizations for cardiovascular and/or device-related adverse events (RR=0.95; 95% CI, 0.75-1.21; p=0.70; I2=0%), and quality of life (SMD=-0.06; 95% CI, -0.22 to 0.10; p=0.473; I2=0%). RM was associated with fewer IO visits/patient/year (MD=0.98; 95% CI, -1.64 to -0.33; p=0.08; I2=98%) and higher rates of atrial tachyarrhythmia (ATA) detection (RR=1.22; 95% CI, 1.01-1.48; p=0.04; I2=0%) than was CM. This meta-analysis suggests that RM of pacemakers leads to higher rates of ATA detection and fewer IO visits/patient/year, without compromising patient safety.

Optimizing atrial sensing parameters in leadless pacemakers: main findings of the OptiVALL study

Abstract Funding Acknowledgements Type of funding sources: None. Backgroung: The MARVEL2 study demonstrated the feasibility of leadless pacemakers in delivering atrioventricular (AV) synchronous pacing with an accelerometer-based algorithm, for up to 5 h. Purpose To assess the AV synchrony (AVS) the device can provide under daily activities and across different heart rate (HR) ranges, and to describe what programming changes are needed to achieve proper atrial tracking and AVS. Methods The OptiVALL study is a single-centre and prospective study of consecutive patients implanted with MICRA AV. Follow-up was routinely performed at 24 hours and at 1, 3, 6 and 12 months. The pacing mode was programmed to VDD in all patients and AV conduction mode switch (VVI +) was deactivated. In each visit a device check was carried out and reprogramming of the atrial sensing parameters was performed according to the manual atrial mechanical tests, as well as information from device counters and rate histograms. A 24-h Holter monitoring was placed at 3-months follow-up and ECG recorded tracings were automatically and blindly analyzed with an ECG delineation system. Cardiac cycles were defined as synchronous if a ventricular event followed the P-wave by ≤300 ms. AVS was calculated by dividing the number of synchronous cycles by the total number of cardiac cycles. The primary efficacy endpoint was defined as AVS≥ 85% of total cardiac cycles during the 24-h Holter-ECG monitor. AVS was also calculated for each HR range of 10 bpm. Results Thirty-two patients (18 males, mean age 78.8 ±15.1, 16 patients with 3rd degree AV block, 15 patients with 2nd degree AV block, 1 patient with bifascicular block) underwent successful Micra AV implant, of whom 31 remained in VDD mode at some visit throughout the follow-up, and 26 remained in VDD mode at 3 months follow-up. Device reprogramming of nominal parameters was needed in all patients at follow-up (table). The automatic A3 window end was disabled, and a fixed and short value was set in 100% of patients. Lower HR was set to 40 bpm in 88.5% (n=23) of patients. Auto A4 threshold and auto A3 threshold were modified in 6 and 3 patients respectively and vector was changed in 3 patients. An ambulatory 24-h Holter monitor was performed 112.8±37.5 days after the implant in the 26 patients who remained in VDD. A comparison between nominal parameters and programming at ambulatory 24-h Holter monitoring is displayed in the table. Total ECG recorded time was 550.8 hours and 2,291,953 cardiac cycles were analyzed. Average ambulatory AVS was 87.3±6.3% (median: 87.6%) and 20 out of 26 patients showed an AVS≥85% of cardiac cycles. AVS across the different heart rate ranges was good and remained ≥85% until 90 bpm (figure) with a substantial drop only with HR over 110 bpm. Conclusions High ambulatory AVS in outpatients with leadless pacemakers can be feasible, although may require manual reprogramming of atrial sensing parameters, especially the A3 window end setting.

Quality improvements anticipated by guideline adherence to peri-operative ICD deactivation

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Recent guidelines have been published by the British Heart Rhythm Society (BHRS) regarding the perioperative management of patients with CIED’s (cardiac implantable electronic devices). The presence of these devices may present a problem when patients undergo operations in which they are exposed to EMI (electromagnetic interference) from surgical diathermy. The current guidelines recommend not deactivating ICD’s when the site of the operation is below the diaphragm. Rather surgery should proceed ahead with a clinical magnet available should it be required. Purpose This goal of the study was to assess compliance with this guideline recommendation in patients who present for surgery in our hospital. Our focus was the response to patients in whom the planned operating site was below the diaphragm. Our hypothesis was that many of these patients had ICDs deactivated prior to surgery regardless of the site of surgery. Methods A logbook of device reprogramming requests for surgical patients was examined from October 2020 to October 2022. The patients name and date of scheduled operation was cross referenced with a data base to determine the site of the surgical operation. The changes made to the device (therapies off, magnet used or no change) were noted. Results Between the 1st December 2020 and 30th October 2022, 29 documented requests were made requesting CIED reprogramming prior to surgery. 22 had surgery below the diaphragm and 7 above. In all surgeries below the diaphragm, therapies function of the device was deactivated. Conclusions Our study demonstrates that a large number of ICD’s are unnecessarily deactivated prior to surgery. In fact, all 29 patients in this audit had their device deactivated regardless of the site of surgery. This is contrary to current guidelines. When the surgical operation is below the diaphragm, the risk of EMI is extremely low. The current evidence recommends close monitoring with immediate availability of a clinical magnet rather than deactivation of therapies. Requests for CIED reprogramming are often made at short notice due to the unscheduled nature of many operations. This places an additional strain on the workload of our department. From a quality improvement perspective, this can lead to delays in surgical start times due to the patient awaiting re programming of their device. In many cases surgery could have proceeded without reprogramming of the device. The repercussions are reduced operating theatre efficiency and increased bed occupancy. The deactivation of an ICD prior to surgery is both labour and time intensive. In some circumstances it is justified, however our data shows there are many instances where it is performed unnecessarily with no clinical benefit to the patient. Compliance with these guidelines will have an immediate positive impact on patient flow and significantly reduce the number of requests for CIED reprogramming to our Cardiology department.

PO-04-057 ATRIAL FIBRILLATION CURED BY PACEMAKER REPROGRAMMING

Atrial fibrillation (AF) is commonly detected by remote monitoring of implanted devices. A common question is whether to start anticoagulation in patients with detected AF at risk of stroke. However, the cause of AF is rarely able to be diagnosed or corrected. Repetitive non-reentrant ventriculoatrial synchrony (RNRVAS) is a pacemaker mediated arrhythmia that can occur in patients with intact ventriculoatrial (VA) conduction. Ventricular pacing with retrograde atrial activation that falls within the PVARP is followed by atrial pacing, often delivered while the atrium is refractory. Retrograde atrial activation from the next ventricular paced beat facilitates a repetitive (but non-reentrant) process. Atrial arrhythmias may occasionally result. To highlight the importance of recognizing and correcting RNRVAS as a cause of device-mediated arrhythmia. NA A 68-year-old man with hypertension and sinus node dysfunction underwent dual chamber pacemaker implant (Abbott Assurity). Device interrogation 5-years later showed repetitive episodes of AF that might warrant anticoagulation. Device tracings revealed RNRVAS: retrograde atrial activation falling in PVARP, followed by competitive sensor driven atrial pacing with non-capture, until a captured atrial event initiated AF (Figure, red arrow). Anticoagulation was deferred in favor of device reprogramming, including: 1) reduction in the lower rate; 2) reduction in paced AV delay; and 3) disabling of rate-response. The patient had no further AF episodes. RNRVAS is largely benign but may facilitate initiation of AF or other supraventricular arrhythmias that lead to symptoms or inappropriate therapy. Both RNRVAS and device-triggered AF may be underrecognized. Current devices do not have automatic diagnostic or treatment algorithms. Therefore, it is important to be aware of RNRVAS triggered AF in patients with a dual-chamber device and newly diagnosed AF. RNRVAS tends to occur with a long programmed AV delay (such as is often used to avoid ventricular pacing) and a relatively fast lower rate. Reprogramming to shorten the AV delay, decrease the lower rate or decrease the PVARP are the primary methods of correction. Awareness of pacemaker triggered AF may help avoid inappropriate initiation of anticoagulation or other therapies.

Subcutaneous Implantable Cardioverter-defibrillator Lead Repositioning Due to Device Sensing Impairment in a Patient with Scoliosis

Abstract Despite many well-documented benefits of the transvenous implantable cardioverter-defibrillator in appropriate patients, there is a strong preference today for subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation due to the significant late complications associated with intravenous leads, especially in young patients. We report on an 18-year-old woman with S-ICD due to hypertrophic cardiomyopathy who had idiopathic dextroscoliosis. In the follow-up analysis, we observed a disturbance in the normal detection of QRS complexes by the device, which significantly reduced when the patient changed the position from standing to supine and when the brace was closed. According to the absence of lead displacement in the chest radiograph, S-ICD sense impairment was suggested due to skeletal deformity. Due to not solving this problem with device reprogramming, we had to reposition of the S-ICD lead in our patient.

Fusion CRT pacing: septal flash significance in super responder patients

Abstract Background LV only CRT pacing is an option that may be considered to maximize response to CRT and at least as an alternative in non-responders to biventricular (BiV) pacing. However, criteria to best titrate therapy on an individual basis are lacking in fusion pacing. On the other hand, septal flash (SF) is a strong predictor of favorable response for patients (pts) with BiV pacing. Purpose To analyze the relationship between SF and the response to fusion CRT pacing. Methods Consecutive pts with exclusive fusion CRT-P were included. Right atrium/left ventricle leads DDD CRT pacing system were used in all patients. Prospective data were collected at every 6 months follow-up visits: device interrogation, exercise test, echocardiographic parameters. Exercise tests, device reprogramming and medication optimization were performed regular in order to maximize CRT response. Patients were divided in 2 groups: super-responders (SR) and responders (R). SRs were defined those with left ventricular end-systolic volume (LVESV) improvement ≥30% and stable ejection fraction (LVEF) ≥45%. Results 69 pts with NYHA II–III heart failure and non-ischemic dilated cardiomyopathy were initially included. 5 pts were non responders and excluded (non LBBB, spontaneous QRS &amp;lt;149 ms). Final analyzed group had 64 pts (35 male) aged 60±12 y.o. The mean follow-up was 54±19 months; 22 pts (34%) were SRs. At baseline, SF was found in all SR pts and in 55% of R pts. SF was corrected post CRT in all patients, except one. For this patient (LV lead in a posterior branch of the coronary sinus – CS) the strategy included an upgrade to triple chamber device with a second lead in a lateral branch of the CS and became SR from R. Mitral regurgitation decreased in 38 patients (all SR, 40% R). Interesting, baseline left atrium volume and pulmonary sistolic artery pressure were smaller in SR versus R group, however SF did not corelate with LA volume/diastolic dysfunction. Conclusions Septal flash seems to be a strong predictor of super-response in patients with fusion CRT pacing. This finding could improve the selection of candidates for fusion CRT-P, however larger studies are needed to assess SF in this categories of patients. Funding Acknowledgement Type of funding sources: None.

Atrioventricular conduction in PM recipients after transcatheter aortic valve implantation: Implications using Wenckebach point measurement.

BackgroundAtrioventricular (AV) conduction disturbances requiring permanent pacemaker implantation (PPI) are a common complication after transcatheter aortic valve implantation (TAVI). However, a significant proportion of patients might recover AV conduction at follow-up.ObjectivesThe aim of our study was to evaluate the recovery of AV conduction by determination through Wenckebach point in patients with PPI and therefore identify patients who could benefit from device reprogramming to avoid unnecessary RV pacing.MethodsWe enrolled 43 patients that underwent PM implantation after TAVI at our Department from January 2018 to January 2021. PM interrogation was performed at follow-up and patients with native spontaneous rhythm were further assessed for AV conduction through WP determination.ResultsA total of 43 patients requiring a PM represented the final study population, divided in patients with severely impaired AV conduction (no spontaneous valid rhythm or WP < 100; 26) and patients with valid AV conduction (WP ≥ 100; 17). In the first group patients had a significantly higher number of intraprocedural atrioventricular block (AVB) (20 vs. 1, p < 0.005), showed a significant higher implantation depth in LVOT (7.7 ± 2.2 vs. 4.4 ± 1.1, p < 0.05) and lower ΔMSID (−0.28 ± 3 vs. −3.94 ± 2, p < 0.05).ConclusionAV conduction may recover in a significant proportion of patients. In our study, valve implantation depth in the LVOT and intraprocedural AV block are associated with severely impaired AV conduction. Regular PM interrogation and reprogramming are required to avoid unnecessary permanent right ventricular stimulation in patients with AV conduction recovery.

AV synchronous pacing in patients implanted with leadless pacemakers: a real-world cohort study

Abstract Funding Acknowledgements Type of funding sources: None. Backgroung Leadless pacemakers (LPM) were developed to overcome complications related to endovenous devices. Devices carrying an accelerometer-based atrial sensing algorithm provided good AV synchrony in a 5-hours study. Methods Prospective study of patients implanted with LPM capable of AV synchronous pacing at our institution. We performed a close follow-up consisting of device check-ups 24 h after the implant and 1-3-6-12 months later. Changes in programming were guided by device counters and rate histograms. Once AV synchrony derived from counters (AM-VP + AM-VS) remained stable for at least two consecutive months, a 24 hours Holter monitoring was performed. ECG recordings were automatically and blindly analyzed with a delineation system based on the wavelet transform developed by Martinez et al.1 Cardiac cycles were defined as synchronous if a ventricular event followed the P-wave by ≤300 ms. AV synchrony was calculated by dividing the number of synchronous cycles by the total number of cardiac cycles. Our aim was to describe AV synchrony in a real-world setting and to determine which echocardiographic and programming parameters were related to optimal AV synchrony (≥85% of total cardiac cycles). Results A total of 18 patients (12 males, mean age 82.6 ±8.1) were included. Indications for pacing were complete AV block (n=10) and second-degree AV block (n=8). Device reprogramming was needed in all patients at follow-up. The 24 h Holter monitoring was performed 118.8±43.8 days after the implant. Implant data and, device settings and programming at Holter date is displayed in Table 1. One patient was excluded from the analysis due to the development of severe sinus node disease. Total ECG recorded time was 386.8 hours and 1,537,995 cardiac cycles were analyzed. Median AV synchrony, after Holter monitoring analysis, was 88.2% (interquartile range 79.9-95,1%) and 12 out of 17 patients showed an AV synchrony ≥85% of cardiac cycles. Optimal AV synchrony was related to smaller right atrium size (13.2±3.4 cm2 vs 15.6±1.2 cm2 for AV synchrony ≥85 and &amp;lt;85%, respectively) but no association appeared between diastolic parameters (E, A, E/A ratio, E´, A´) and AV synchrony. Rate smoothing algorithm was associated with higher rates of optimal AV synchrony (81.8% of patients with algorithm OFF vs 50% of patients activated). Besides, higher A3 threshold (7.1±3.5 m/s2 vs 4.2 ± 1.1 m/s2) and longer A3 window (620.8±25.7 ms vs 600 ms for AV synchrony ≥85% and &amp;lt;85%, respectively) were also linked to optimal AV synchrony. Multivariate analysis did not show any independent predictor of AV synchrony. Conclusions In our cohort of LPM patients we obtained high percentages of AV synchronous pacing in a real-life setting. Device reprogramming was often needed, and larger studies are desirable to confirm our data.

Realtime Remote Programming in Patients Carrying Cardiac Implantable Electronic Devices Requiring Emergent Reprogramming.

To protect cardiac implantable electronic device (CIED) patients with arrhythmia or possible device malfunction, it is important for health care professionals to provide emergent device evaluation and reprogramming. This case series illustrated the clinical application of realtime remote programming in CIED patients requiring emergent in-person evaluation and reprogramming (ChiCTR2100046883 chictr.org). All remote sessions were performed safely and efficiently by remote electrophysiologists without being in the physical presence of a patient. The implementation of realtime remote programming not only largely reduces the response time to urgent events but also greatly helps to minimize personnel exposure to COVID-19 infection.

Combined Use of S-ICD and Absorbable Antibacterial Envelopes: A Proof-of-concept Study.

Absorbable antibacterial envelopes (AAEs) are currently recommended in patients undergoing a transvenous ICD implantation in cases at high risk of infection, who are now preferably implanted with a subcutaneous ICD (S-ICD). Nevertheless, experiences using a combined approach with S-ICD and AAE have not been reported. The aim of our study was to evaluate this strategy in patients at very high risk of infection. Twenty-five patients were implanted with the S-ICD+AAE using our combined approach, restricted to patients who would fit our decisional flow algorithm identifying very high-risk patients. Patients were followed up 1 month after discharge and every 6 months thereafter. Complications were defined as device-related events requiring medical or surgical intervention for resolution and/or device reprogramming. Twenty-five patients (92% males, mean age 58.5±14.1 years) were implanted with the S-ICD device and the AAE using our combined approach. The most common high-infective risk factors were diabetes requiring insulin treatment (80%) and CKD requiring hemodialysis (48%), with 7 (28%) patients presenting with more than 2 risk factors. A single mild early post-operative hematoma was observed that was managed conservatively with a spontaneous resolution. Despite a very high-risk cohort, only a single late pocket infection was detected and solved conservatively with antibiotic therapy. The preliminary data of this proof-of-concept study show how a combined deployment of AAE and S-ICD in selected patients at very high risk of infection is a safe and feasible technique and may offer a reliable treatment option in specific and selected clinical settings.

Bridging The Ep & Hf Gap: A Dual Aprn Model Can Optimize Post-crt Management.

<h3>Introduction</h3> Subspecialty management of heart failure (HF) patients after cardiac resynchronization therapy (CRT) is often inharmonious, leading to limited medical and device therapy optimization. <h3>Hypothesis</h3> We hypothesized that a novel, dual advanced practice registered nurse (APRN) subspecialty care model would allow for device optimization, medical therapy titration, and identification of end-stage heart failure patients. <h3>Methods</h3> We designed a multidisciplinary clinic to assess patients six months post CRT implantation. That team consisted of an APRN from our heart failure team, an APRN from our electrophysiology team, and a HF nurse. Patients underwent device interrogation, 12-lead electrocardiogram, transthoracic echocardiogram, six-minute walk test, and completed a Minnesota Living with Heart Failure Questionnaire. Both APRNs simultaneously evaluated the patient and developed a unified plan of care which included device reprogramming to achieve greater than 98% CRT pacing, medical therapy titration, and referral to the advanced heart failure program. Pre and post device implantation characteristics were summarized with descriptive statistics. A CRT responder was defined as a 5% or greater improvement in ejection fraction with 10% or greater decrease in left ventricular end-systolic volume. <h3>Results</h3> Thirty-three consecutive patients were seen in the clinic from September 2020 to April 2021. Three were excluded from this analysis due to missing data. Mean age was 68 years; 23 (77%) were male; 26 (87%) were Caucasian and 4 (13%) were African American. Sixteen (53%) had ischemic cardiomyopathy. Twelve patients (40%) were CRT responders at six months. Nine patients (30%) underwent device programming modifications and 11 (37%) had medications titrated on this visit. One patient (3%) was referred for advanced therapies. <h3>Conclusions</h3> A dual APRN model of post-CRT HF patients can be an effective clinical workflow to optimize medical and device-based therapies.

A real-world experience of atrioventricular synchronous pacing with leadless ventricular pacemakers.

The MicraTM transcatheter pacing system (TPS) (Medtronic) is the only leadless pacemaker that promotes atrioventricular (AV) synchrony via accelerometer-based atrial sensing. Data regarding the real-world experience with this novel system are scarce. We sought to characterize patients undergoing MicraTM -AV implants, describe percentage AV synchrony achieved, and analyze the causes for suboptimal AV synchrony. In this retrospective cohort study, electronic medical records from 56 consecutive patients undergoing MicraTM -AV implants at the Mayo Clinic sites in Minnesota, Florida, and Arizona with a minimum follow-up of 3 months were reviewed. Demographic data, comorbidities, echocardiographic data, and clinical outcomes were compared among patients with and without atrial synchronous ventricular pacing (AsVP) ≥ 70%. Sixty-five percent of patients achieved AsVP ≥ 70%. Patients with adequate AsVP had smaller body mass indices, a lower proportion of congestive heart failure, and prior cardiac surgery. Echocardiographic parameters and procedural characteristics were similar across the two groups. Active device troubleshooting was associated with higher AsVP. The likely reasons for low AsVP were small A4-wave amplitude, high ventricular pacing burden, and inadequate device reprogramming. Importantly, in patients with low AsVP, subjective clinical worsening was not noted during follow-up. With the increasing popularity of leadless pacemakers, it is paramount for device implanting teams to be familiar with common predictors of AV synchrony and troubleshooting with MicraTM -AV devices.

Long-Term Implications of Pacemaker Insertion in Younger Adults: A Single Centre Experience

The long-term implications of pacemaker insertion in younger adults are poorly described in the literature. We performed a retrospective analysis of consecutive younger adult patients (18-50 yrs) undergoing pacemaker implantation at a quaternary hospital between 1986-2020. Defibrillators and cardiac resynchronisation therapy devices were excluded. All clinical records, pacemaker checks and echocardiograms were reviewed. Eighty-one (81) patients (median age 41.0 yrs IQR=35-47.0, 53% male) underwent pacemaker implantation. Indications were complete heart block (41%), sinus node dysfunction (33%), high grade AV block (11%) and tachycardia-bradycardia syndrome (7%). During a median 7.9 (IQR=1.1-14.9) years follow-up, nine patients (11%) developed 13 late device-related complications (generator or lead malfunction requiring reoperation [n=11], device infection [n=1] and pocket revision [n=1]). Five (5) of these patients were <40 years old at time of pacemaker insertion. At long-term follow-up, a further nine patients (11%) experienced pacemaker-related morbidity from inadequate lead performance managed with device reprogramming. Sustained ventricular tachycardia was detected in two patients (2%). Deterioration in ventricular function (LVEF decline >10%) was observed in 14 patients (17%) and seven of these patients required subsequent biventricular upgrade. Furthermore, four patients (5%) developed new tricuspid regurgitation (>moderate-severe). Of 69 patients with available long-term pacing data, minimal pacemaker utilisation (pacing <5% at all checks) was observed in 13 (19%) patients. Pacemaker insertion in younger adults has significant long-term implications. Clinicians should carefully consider pacemaker insertion in this cohort given risk of device-related complications, potential for device under-utilisation and issues related to lead longevity. In addition, patients require close follow-up for development of structural abnormalities and arrhythmias.

Should they stay, or should they go: Do we need to remove the old cardiac implantable electronic device if a new system is required on the contralateral side?

BackgroundIpsilateral approach in patients requiring cardiac implantable electronic device (CIED) revision or upgrade may not be feasible, primarily due to vascular occlusion. If a new CIED is implanted on the contralateral side, a common practice is to explant the old CIED to avoid device interaction.ObjectiveThe purpose of this study was to assess a conservative approach of abandoning the old CIED after implanting a new contralateral device.MethodsWe used an artificial intelligence algorithm to analyze postimplant chest radiographs to identify those with multiple CIEDs. Outcomes of interest included device interaction, abandoned CIED elective replacement indicator (ERI) behavior, subsequent programming changes, and explant of abandoned CIED. Theoretical risk of infection with removal of abandoned CIED was estimated using a validated scoring system.ResultsAmong 12,045 patients, we identified 40 patients with multiple CIEDs. Occluded veins were the most common indication for contralateral implantation (n = 27 [67.5%]). Fifteen abandoned CIEDs reached ERI, with 4 reverting to VVI 65. One patient underwent explant due to device interaction, and 2 required device reprogramming. Of 32 patients with an implantable cardioverter-defibrillator, 8 (25%) had treated ventricular arrhythmia. There were no failed or inappropriate therapies due to interaction. Eighteen patients (45%) had hypothetical >1% annual risk of hospitalization for device infection if the abandoned CIED had been explanted.ConclusionIn patients requiring new CIED implant on the contralateral side, abandoning the old device is feasible. This approach may reduce the risk of infection and concerns regarding abandoned leads and magnetic resonance imaging scans. Knowledge of ERI behavior is essential to avoid device interactions.

Perioperative Sensor and Algorithm Programming in Patients with Implanted ICDs and Pacemakers for Cardiac Resynchronization Therapy.

Background: ICDs and pacemakers for cardiac resynchronization therapy (CRT) are complex devices with different sensors and automatic algorithms implanted in patients with advanced cardiac diseases. Data on the perioperative management and outcome of CRT carriers undergoing surgery unrelated to the device are scarce. Methods: Data from 198 CRT device carriers (100 with active rate responsive sensor) were evaluated regarding perioperative adverse (device-related) events (A(D)E) and lead parameter changes. Results: Thirty-nine adverse observations were documented in 180 patients during preoperative interrogation, which were most often related to the left-ventricular lead and requiring intervention/reprogramming in 22 cases (12%). Anesthesia-related events occurred in 69 patients. There was no ADE for non-cardiac surgery and in pacemaker-dependent patients not programmed to an asynchronous pacing mode. Post-operative device interrogation showed significant lead parameter changes in 64/179 patients (36%) requiring reprogramming in 29 cases (16%). Conclusion: The left-ventricular pacing lead represents the most vulnerable system component. Comprehensive pre and post-interventional device interrogation is mandatory to ensure proper system function. The type of ICD function suspension has no impact on each patient’s outcome. Precautionary activity sensor deactivation is not required for non-cardiac interventions. Routine prophylactic device reprogramming to asynchronous pacing appears inessential. Most of the CRT pacemakers do not require surgery-related reprogramming.

Validation of leadless atrioventricular synchronous pacing with Holter-ECG: a pilot study

Abstract Background The novel MICRA AV leadless pacemaker can provide atrioventricular (AV) synchronous pacing using an accelerometer-based atrial sensing algorithm. Purpose To describe the performance of MICRA AV pacemaker in a real-life setting and to determine the agreement between AV synchrony determined by the device counters and AV synchrony obtained by a 24 h ECG Holter test. Methods This pilot study included the first ten patients implanted with a MICRA AV leadless pacemaker at our institution. All implants were performed according to standard protocols and under deep sedation. A close follow-up was performed, and atrial sensing parameters were adjusted following AV synchrony given by the device counters. Patients underwent a 24 h ECG Holter test once AV synchrony remained stable for at least two months. The ECG Holter signal was analyzed in a blinded manner by an automatic delineation system based on the wavelet transform (Figure). This algorithm has a sensivity of 98.9% and a positive predictive value of 91.9% to detect p waves. Cardiac cycles were defined as synchronous if a QRS complex followed the P-wave by ≤300 ms, according to MARVEL 2 study criterion. AV synchrony obtained from the 24 h Holter test was compared with AV synchrony extracted from the device counters (AM-VP + AM-VS) during the same 24 h. Results From June to November 2020, 10 patients (7 males, mean age 83.5±5.4) were implanted with a MICRA AV leadless pacemaker (5 patients due to complete AV block and 5 patients due to second degree AV block). All devices were implanted after 1 deployment and no major complications appeared. Data related to implant parameters are displayed in Table 1. Device reprogramming was needed in all patients during follow-up. The 24 h ECG Holter monitoring was performed 141.4±45 days after the implant (mean time). Device settings and programming at Holter date is displayed in Table 1. Total ECG recorded time was 210.6 h and 915,488 cardiac cycles were analyzed. The mean percentage of synchronous cardiac cycles was 88.6±8.5% of total cycles while the mean AV synchrony determined by the device counters (AM-VP + AM-VS) during those 24 h was 89.8±5.5%. A good patient to patient correlation between these two measures was found (coefficient of intraclass correlation = 0.72). Conclusions We obtained high rates of AV synchrony with MICRA AV leadless pacemaker, in our short-term follow-up pilot study. Manual adjustment of the atrial sensing parameters, guided by the device counters, seems to be useful to obtain an optimal performance. Funding Acknowledgement Type of funding sources: None.