Frequency of CIED remote monitoring: A quality improvement follow‐up study

BackgroundBased on the findings of a prior study of CIED (Cardiac Implantable Electrical Device) remote monitoring (RM) frequency at the same center, the University of Michigan Congenital Heart Center (UMCHC) instituted a quality improvement (QI) change to reduce the frequency of routine CIED RM from every 2 months to every 3 months. The objective of this study is to determine the impact of this QI initiative to reduce workload without compromising patient care.MethodsThis is a single‐center, retrospective cohort study of all UMCHC patients with CIEDs followed via Medtronic CareLink CIED remote monitoring system from July 2015 to June 2017, after the QI change in 2014. The primary outcome was success of transition to new monitoring schedule. Secondary outcomes included complications, incidence of actionable events (AES), patient compliance, and change in workload. Outcomes were compared to the prior study.ResultsThere were 325 patients (mean age was 24  ±  14 years) included, of who 293 (90%) completely transitioned to the new RM schedule. During the study period, 96 transmissions included AES (4% of total), of which 50 (52%) were asymptomatic and discovered on routine monitoring. No patient experienced a complication attributable to decreased RM frequency. The mean number of interrogations decreased by 1.6 per patient over the 2‐year period compared to prior study.ConclusionsThis study demonstrated successful implementation of a QI initiative to reduce CIED monitoring frequency at a single center with no patient adverse events. The intervention reduced workload and potentially improved patient compliance with routine RM.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/150575/1/pace13707_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/150575/2/pace13707.pd

Implantable Cardioverter Defibrillator Outcomes in Pediatric and Congenital Heart Disease: Time to System Revision

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/122425/1/pace12878.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/122425/2/pace12878_am.pd

Decreased inappropriate shocks with new generation ICDs in children and patients with congenital heart disease

ObjectiveInappropriate implantable cardioverter defibrillator (ICD) shocks in children and patients with congenital heart disease (CHD) remain a major complication of device therapy, occurring in as many as 50% of children with ICDs. New generation devices include algorithms designed to minimize inappropriate shocks. This study aimed to evaluate the effect of new generation ICDs on the incidence of inappropriate shocks in the pediatric and CHD population.DesignRetrospective study of patients with CHD or under age 25 receiving ICDs between 2000 and 2015. New generation ICDs were defined as those with Medtronic “SmartShock” algorithms.ResultsTwo hundred eight devices were implanted in 146 patients. Rates of inappropriate shocks were similar between diagnoses (P = .71). The rate of inappropriate shock was 15% over median 5.8 years follow‐up. In the 36 patients (25%) with new generation ICDs, the rate of inappropriate shock was 6.3% over 4 years. Comparing old to new generation ICDs, freedom from first inappropriate shock was 90.6% versus 97.1% at 1 year and 80.4% versus 97.1% at 3 years (P = .01). Lead fracture was associated with having inappropriate shock (hazard ratio 8.5, P < .0001), and there was no significant difference between the device groups when lead fractures were excluded. Clinical actions were taken in 69% of patients after initial inappropriate shock (such as medication or program change, system revision, or explant). When an action was taken, subsequent inappropriate shock was reduced (5.3% vs 49.2% at 1 year; P = .002).ConclusionsPediatric and CHD patients are experiencing reduced inappropriate shocks with new generation ICD systems, though reduced lead fracture may account for this improvement. Clinical interventions after inappropriate shock favorably impact the subsequent rate of shocks once an inappropriate shock occurs.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/144309/1/chd12585_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/144309/2/chd12585.pd

Developed in collaboration with and endorsed by the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the American Heart Association (AHA), and the Association for European Paediatric and Congenital Cardiology (AEPC). Endorsed by the Asia Pacific Heart Rhythm Society (APHRS), the Indian Heart Rhythm Society (IHRS), and the Latin American Heart Rhythm Society (LAHRS).

AbstractIn view of the increasing complexity of both cardiovascular implantable electronic devices (CIEDs) and patients in the current era, practice guidelines, by necessity, have become increasingly specific. This document is an expert consensus statement that has been developed to update and further delineate indications and management of CIEDs in pediatric patients, defined as ≤21 years of age, and is intended to focus primarily on the indications for CIEDs in the setting of specific disease categories. The document also highlights variations between previously published adult and pediatric CIED recommendations and provides rationale for underlying important differences. The document addresses some of the deterrents to CIED access in low- and middle-income countries and strategies to circumvent them. The document sections were divided up and drafted by the writing committee members according to their expertise. The recommendations represent the consensus opinion of the entire writing committee, graded by class of recommendation and level of evidence. Several questions addressed in this document either do not lend themselves to clinical trials or are rare disease entities, and in these instances recommendations are based on consensus expert opinion. Furthermore, specific recommendations, even when supported by substantial data, do not replace the need for clinical judgment and patient-specific decision-making. The recommendations were opened for public comment to Pediatric and Congenital Electrophysiology Society (PACES) members and underwent external review by the scientific and clinical document committee of the Heart Rhythm Society (HRS), the science advisory and coordinating committee of the American Heart Association (AHA), the American College of Cardiology (ACC), and the Association for European Paediatric and Congenital Cardiology (AEPC). The document received endorsement by all the collaborators and the Asia Pacific Heart Rhythm Society (APHRS), the Indian Heart Rhythm Society (IHRS), and the Latin American Heart Rhythm Society (LAHRS). This document is expected to provide support for clinicians and patients to allow for appropriate CIED use, appropriate CIED management, and appropriate CIED follow-up in pediatric patients

The impact of CIEDs with automatic “wireless” remote monitoring on efficiency

BackgroundA benefit of automatically transmitting or “wireless” CIEDs (W‐CIED) is the prompt detection of device malfunction and arrhythmias. We hypothesized that the use of W‐CIEDs would improve the efficiency of remote monitoring by decreasing unnecessary CIED remote transmissions because of the automatic detection of abnormalities.ObjectiveTo compare the frequency of patient‐initiated transmissions in patients with W‐CIEDs versus non‐wireless CIEDs (NW‐CIED) at a single pediatric and congenital heart center.MethodsRetrospective cohort study of patients with W‐CIEDs followed over a 2‐year period compared to a similar cohort of patients with NW‐CIED. All CIED remote transmissions during were reviewed for indication and outcome.ResultsThe W‐CIED cohort had 87 patients; mean age 20 ± 13 years; NW‐CIED cohort had 220 patients; mean age 22 ± (13) years. The mean number of symptomatic patient‐initiated transmissions per patient was 0.93 ± 2.65 in the W‐CIED cohort versus 0.39 ± 0.64 in the NW‐CIED cohort (p ≤ .001). The mean number of asymptomatic patient‐initiated transmission sent per patient in the W‐CIED cohort was 1.86 ± 2.59 versus 0.81 ± 1.41 in the NW‐CIED cohort (p ≤ .0001). Type of device, age, and presence of congenital heart disease were not significantly associated with the incidence of patient‐initiated remote monitoring transmissions.ConclusionsThe frequency of patient‐initiated transmission was higher in the W‐CIED cohort, contradictory to the study hypothesis. This may reflect a lack of patient understanding of the benefit or functionality of W‐CIEDs and may be mitigated by education to both providers and patients.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/170810/1/pace14333_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/170810/2/pace14333.pd

Variations in cardiac implantable electronic device surveillance and ancillary testing in the paediatric and congenital heart disease population: An international multi-centre survey from the Paediatric and Congenital Electrophysiology Society

Background: Expert guidance from scientific societies and regulatory agencies recommend a framework of principles for frequency of in-person evaluations and remote monitoring for patients with cardiac implantable electronic devices. However, there are limited data regarding adherence to recommendations among paediatric electrophysiologists, and there are no data regarding cardiac implantable electronic device-related ancillary testing. Methods: To assess current clinical practices for cardiac implantable electronic device in-person evaluation, remote monitoring, and cardiac implantable electronic device-related ancillary testing, the Paediatric and Congenital Electrophysiology Society members were surveyed. The main outcome measures were variations in frequency of in person evaluation, frequency of remote monitoring, and cardiac implantable electronic device-related ancillary testing. Results: All respondents performed in-person evaluation at least once a year, but \u3c50% of respondents performed an in-person evaluation within 2 weeks of cardiac implantable electronic device implantation. Remote monitoring was performed every 3 months for pacemakers and implantable cardioverter defibrillators by 71 and 75% respondents, respectively. Follow-up echocardiography was performed every 2-3 years by 53% respondents for patients with \u3e50% ventricular pacing. Majority of respondents (75%) did not perform either an exercise stress test or ambulatory Holter monitoring or chest X-ray (65%) after cardiac implantable electronic device implantation. Conclusion: This survey identified significant practice variations in cardiac implantable electronic device in- person evaluation, remote monitoring, and ancillary testing practices among paediatric electrophysiologists. Cardiac implantable electronic device management may be optimised by development of a paediatric-specific guidelines for follow-up and ancillary testing

Loss of ventricular preexcitation during noninvasive testing does not exclude high-risk accessory pathways: A multicenter study of WPW in children

BACKGROUND: Abrupt loss of ventricular preexcitation on noninvasive evaluation, or nonpersistent preexcitation, in Wolff-Parkinson-White syndrome (WPW) is thought to indicate a low risk of life-threatening events. OBJECTIVE: The purpose of this study was to compare accessory pathway (AP) characteristics and occurrences of sudden cardiac arrest (SCA) and rapidly conducted preexcited atrial fibrillation (RC-AF) in patients with nonpersistent and persistent preexcitation. METHODS: Patients 21 years or younger with WPW and invasive electrophysiology study (EPS) data, SCA, or RC-AF were identified from multicenter databases. Nonpersistent preexcitation was defined as absence/sudden loss of preexcitation on electrocardiography, Holter monitoring, or exercise stress test. RC-AF was defined as clinical preexcited atrial fibrillation with shortest preexcited R-R interval (SPERRI) ≤ 250 ms. AP effective refractory period (APERP), SPERRI at EPS , and shortest preexcited paced cycle length (SPPCL) were collected. High-risk APs were defined as APERP, SPERRI, or SPPCL ≤ 250 ms. Results: Of 1589 patients, 244 (15%) had nonpersistent preexcitation and 1345 (85%) had persistent preexcitation. There were no differences in sex (58% vs 60% male; P=.49) or age (13.3±3.6 years vs 13.1±3.9 years; P=.43) between groups. Although APERP (344±76 ms vs 312±61 ms; P\u3c.001) and SPPCL (394±123 ms vs 317±82 ms; P\u3c.001) were longer in nonpersistent vs persistent preexcitation, there was no difference in SPERRI at EPS (331±71 ms vs 316±73 ms; P=.15). Nonpersistent preexcitation was associated with fewer high-risk APs (13% vs 23%; P\u3c.001) than persistent preexcitation. Of 61 patients with SCA or RC-AF, 6 (10%) had nonpersistent preexcitation (3 SCA, 3 RC-AF). Conclusion: Nonpersistent preexcitation was associated with fewer high-risk APs, though it did not exclude the risk of SCA or RC-AF in children with WPW

2021 PACES expert consensus statement on the indications and management of cardiovascular implantable electronic devices in pediatric patients

In view of the increasing complexity of both cardiovascular implantable electronic devices (CIEDs) and patients in the current era, practice guidelines, by necessity, have become increasingly specific. This document is an expert consensus statement that has been developed to update and further delineate indications and management of CIEDs in pediatric patients, defined as ≤21 years of age, and is intended to focus primarily on the indications for CIEDs in the setting of specific disease categories. The document also highlights variations between previously published adult and pediatric CIED recommendations and provides rationale for underlying important differences. The document addresses some of the deterrents to CIED access in low- and middle-income countries and strategies to circumvent them. The document sections were divided up and drafted by the writing committee members according to their expertise. The recommendations represent the consensus opinion of the entire writing committee, graded by class of recommendation and level of evidence. Several questions addressed in this document either do not lend themselves to clinical trials or are rare disease entities, and in these instances recommendations are based on consenus expert opinion. Furthermore, specific recommendations, even when supported by substantial data, do not replace the need for clinical judgment and patient-specific decision-making. The recommendations were opened for public comment to Pediatric and Congenital Electrophysiology Society (PACES) members and underwent external review by the scientific and clinical document committee of the Heart Rhythm Society (HRS), the science advisory and coordinating committee of the American Heart Association (AHA), the American College of Cardiology, (ACC) and the Association for European Paediatric and Congenital Cardiology (AEPC). The document received endorsement by all the collaborators and the Asia Pacific Heart Rhythm Society (APHRS), the Indian Heart Rhythm Society (IHRS), and the Latin American Heart Rhythm Society (LAHRS). This document is expected to provide support for clinicians and patients to allow for appropriate CIED use, appropriate CIED management, and appropriate follow-up in pediatric patients