The impact of CIEDs with automatic "wireless" remote monitoring on efficiency.

BACKGROUND: A 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. OBJECTIVE: To 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. METHODS: Retrospective 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. RESULTS: The 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. CONCLUSIONS: The 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.

Data Management and Integration with Electronic Health Record Systems.

Movement of information from a cardiac implantable electronic device to an electronic health record (EHR) can be a complex and multistep process. It requires unambiguous patient identification, device identification, standardized semantic and syntactic data nomenclature, common secure data transfer methodology, and structured reporting within the EHR. Common workflow using a commonly accepted methodology, such as the implantable device cardiac observation profile or protocol, is mandatory. Once information reaches the EHR, a uniform report structure appropriate for the consumer (physician or patient) is needed. Often there may be separate reports for each consumer class. Finally, patient acceptance and consent are required.

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

BACKGROUND: Based 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. METHODS: This 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. RESULTS: There 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. CONCLUSIONS: This 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.

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

OBJECTIVE: Inappropriate 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. DESIGN: Retrospective 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. RESULTS: Two 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). CONCLUSIONS: Pediatric 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.

Development of quality metrics for ambulatory care in pediatric patients with tetralogy of Fallot.

OBJECTIVE: The objective of this study was to develop quality metrics (QMs) relating to the ambulatory care of children after complete repair of tetralogy of Fallot (TOF). DESIGN: A workgroup team (WT) of pediatric cardiologists with expertise in all aspects of ambulatory cardiac management was formed at the request of the American College of Cardiology (ACC) and the Adult Congenital and Pediatric Cardiology Council (ACPC), to review published guidelines and consensus data relating to the ambulatory care of repaired TOF patients under the age of 18 years. A set of quality metrics (QMs) was proposed by the WT. The metrics went through a two-step evaluation process. In the first step, the RAND-UCLA modified Delphi methodology was employed and the metrics were voted on feasibility and validity by an expert panel. In the second step, QMs were put through an "open comments" process where feedback was provided by the ACPC members. The final QMs were approved by the ACPC council. RESULTS: The TOF WT formulated 9 QMs of which only 6 were submitted to the expert panel; 3 QMs passed the modified RAND-UCLA and went through the "open comments" process. Based on the feedback through the open comment process, only 1 metric was finally approved by the ACPC council. CONCLUSIONS: The ACPC Council was able to develop QM for ambulatory care of children with repaired TOF. These patients should have documented genetic testing for 22q11.2 deletion. However, lack of evidence in the literature made it a challenge to formulate other evidence-based QMs.

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

BACKGROUND: Implantable cardioverter defibrillators (ICDs) are intended to prevent sudden cardiac death yet also impose a risk of morbidity. This study describes the outcomes of ICDs in a pediatric and congenital heart disease (CHD) population from a single center. METHODS: Retrospective cohort study of all patients with an ICD followed at the University of Michigan Congenital Heart Center from 2005-2013. The primary outcome was ICD system revision for any reason excluding routine generator change for battery depletion. RESULTS: There were 191 ICD systems in 131 patients, including 57 with CHD, 24 with hypertrophic cardiomyopathy, and 45 with structurally normal hearts. Median age was 16 years at initial implant. Total follow-up was 850 patient-years; median 4.9 years/patient. There were 43 (33%) patients who required 60 ICD revisions; 70 revisions/1,000 patient-years of follow-up. Revisions included 25 lead extractions with replacement, 21 lead additions, five lead repositions, and four full system revisions. Kaplan-Meier (K-M) median time to appropriate shock was similar to the median time to system revision. K-M time to system revision was significantly affected by recalled lead performance. CONCLUSIONS: The need for ICD system revision is high in this pediatric and CHD population and occurs at a rate similar to the rate of receiving appropriate therapy. These results highlight the need for judicious implant criteria and improved device longevity.

Cardiac implantable electronic device remote monitoring surveillance in pediatric and congenital heart disease: Utility relative to frequency.

BACKGROUND: Heart Rhythm Society expert consensus provides recommendations for surveillance monitoring of cardiac implantable electronic devices (CIEDs), but limited data are available for the pediatric and congenital heart disease population. OBJECTIVE: The purpose of this study was to determine the rate of actionable events during CIED surveillance in this population, assess the utility of routine CIED remote monitoring, and assess the potential benefit from more frequent monitoring. METHODS: This was a retrospective cohort study of all CIED patients followed at a pediatric and congenital heart center and enrolled in the Medtronic Carelink system with either (1) a chronic (implanted for >6 months) CIED followed between July 1, 2010, and July 1, 2012, on a bimonthly schedule; or (2) a new CIED (implanted <6 months) between July 1, 2008, and July 1, 2012, followed on a monthly schedule. RESULTS: Aggregate mean age was 20 ± 13.7 years. There were 608 interrogations on newly implanted CIEDs with an actionable event rate of 11 per 100 patient-years. There were 2614 interrogations of chronic CIEDs with an actionable event rate of 22 per 100 patient-years. The odds of an actionable event on an asymptomatic remote monitoring transmission was lower than if symptomatic (odds ratio 0.04, 95% confidence interval 0.03-0.07). Tachyarrhythmia was the most common event. Predictors of actionable events were identified. CONCLUSION: In this population of pediatric and congenital heart disease patients, the rate of actionable events was low, especially on asymptomatic interrogations. Most actionable events were due to tachyarrhythmia. A more frequent than every 90-day monitoring schedule does not appear to be of significant benefit.

Antitachycardia pacemakers in congenital heart disease.

BACKGROUND: Many patients with congenital heart disease (CHD) acquire rhythm abnormalities related to their repair, most commonly intraatrial reentrant tachycardia (IART). Treatment of IART in CHD is often multifaceted, and may include medication, ablation, and pacing. Evidence regarding the use of antitachycardia pacing therapies is limited. OBJECTIVE: The aim of the study is to define the use and efficacy of antitachycardia pacing in patients with CHD at a single center. RESULTS: Eighty implants were performed on 72 patients between 2000 and 2010. Follow-up data of more than 3 months were available for 56 patients; median follow-up time was 2.8 years. Twenty (36%) patients received successful antitachycardia pacing at a median 1.3 years postimplant. For those patients with IART after implant, antitachycardia pacing was successful in 57%. Patients with two-ventricle repairs were more likely to have successful antitachycardia pacing than those with one-ventricle palliation (45% vs. 17%, P = .04). Patients with documented IART had more successful antitachycardia pacing than those with no documented atrial tachycardia prior to implant (46% vs. 7%, P = .006). Early complications of antitachycardia pacemaker implant occurred in six patients (11%); late complications after implant occurred in three patients (5.6%). Of the initial 72 patients implanted, there were six deaths (8%). CONCLUSIONS: Antitachycardia pacing therapies were successful in the majority of CHD patients who had IART after implant. Patients without documented atrial tachycardia prior to implant were unlikely to require or receive successful therapy from antitachycardia pacemaker. Those patients postatrial switch procedure who had documented IART prior to implant had the highest incidence of successful antitachycardia pacing therapies. Antitachycardia pacemaker implantation is an adjunct to the management of IART in CHD patients, but may not benefit patients who have not yet demonstrated IART.

The Multicenter Pediatric and Adult Congenital EP Quality (MAP-IT) Initiative-rationale and design: report from the pediatric and congenital electrophysiology society's MAP-IT taskforce.

Multicenter clinical registries are increasingly recognized as valuable tools for establishing benchmarks, facilitating patient-centered quality improvement and research. In 2010, the Pediatric and Congenital Electrophysiology Society convened a taskforce of its members to design, construct, and implement a clinical registry known as the Multicenter Pediatric and Adult Congenital EP Quality (MAP-IT) Initiative. The present aim of the MAP-IT Initiative is to create an infrastructure by which we can measurably improve patient-centered outcomes and reduce complications associated with electrophysiology studies and catheter ablation in pediatric and congenital heart disease patients. The purpose of this writing is to report the progress to date from three of the four subcommittees of the MAP-IT taskforce. Specifically, we present our initial set of key data elements and definitions, recommended database table structure, and considerations regarding wide-scale implementation of the registry. Development of a risk/complexity score for use in the MAP-IT registry is presented in a separate companion manuscript. It is our intent that these manuscripts will serve to introduce the electrophysiology and pediatric cardiology community to the MAP-IT initiative and provide a rationale for its design and recommended implementation strategy.

Pattern of recovery for transient complete heart block after open heart surgery for congenital heart disease: duration alone predicts risk of late complete heart block.

Transient complete heart block (TCHB) is defined as complete interruption of atrioventricular conduction (AVC) after cardiac surgery followed by return of conduction. This study aimed to assess the risk for the development of late complete heart block (LCHB) after recovery of TCHB and to examine the electrocardiographic and electrophysiologic properties of the AVC system after TCHB. Of the 44 patients in this study who experienced TCHB, 37 recovered completely. Seven patients progressed from TCHB to intermittent CHB or LCHB requiring pacemaker implantation. Preoperative, early postoperative, and late postoperative electrocardiograms as well as postoperative atrial stimulation were obtained. The results showed that the median duration of TCHB was 5 days in the TCHB group compared with 9 days in the LCHB group (p = 0.01). All 37 subjects with TCHB recovered AVC within 12 days, but only two with LCHB did so (p = 0.02). The risk of LCHB for the patients with 7 days of postoperative TCHB or longer was 13 times greater than for the patients with fewer than 7 days of TCHB (p = 0.01). The median late postoperative PR interval was slightly but significantly longer in the LCHB group than in the TCHB group (p = 0.02). In contrast, the electrophysiologic properties between the two groups did not differ significantly. From those findings, we concluded that delayed recovery of AVC after surgical TCHB (≥7 days), but not electrophysiologic properties of recovered AVC assessed early in the postoperative period strongly, predicts risk of LCHB. Follow-up evaluation of AVC is particularly indicated for the delayed recovery group.

Automatic atrial threshold measurement and adjustment in pediatric patients.

BACKGROUND: Automatic threshold measurement and output adjustment are used as default settings in modern pacemakers. The purpose of the study was to assess Atrial Capture Management (ACM) of Medtronic pacemakers in pediatric patients. METHODS: Forty children were enrolled in two centers. Median age was 9.8 years (range 0.8-17.5 years). Half had undergone surgery for congenital heart defects; 45% of patients had an epicardial atrial lead. The pacing indication was atrioventricular block in 82% of patients and sinus node disease in 18%. Manually determined atrial thresholds and ACM measurements were compared. RESULTS: ACM measurements were within the expected variation in 37/40 (93%) of the patients. In one patient the threshold was 0.625-V lower manually than with ACM. One patient had too high an intrinsic atrial rate for ACM to be able to measure threshold. The mean threshold at 0.4 ms was 0.69 +/- 0.32 V manually and 0.68 +/- 0.35 V with ACM (two-tailed paired t-test, P = 0.52) in all patients. The mean difference was 0.012 V (95% confidence interval: -0.027, 0.053). The mean endocardial threshold was 0.70 +/- 0.36 V manually and 0.69 +/- 0.38 V with ACM; epicardial threshold was 0.67 +/- 0.27 V manually and 0.68 +/- 0.32 V with ACM. The difference between the measurements was 0.012 V for endocardial and 0.014 V for epicardial leads. No atrial arrhythmias due to ACM measurements were observed. CONCLUSIONS: ACM measures atrial thresholds reliably in pediatric patients with both endocardial and epicardial leads, allowing its use in both. Constant high intrinsic atrial rate may prevent automatic threshold measurement in young children.

Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.

OBJECTIVES: The purpose of this study was to evaluate remote pacemaker interrogation for the earlier diagnosis of clinically actionable events compared with traditional transtelephonic monitoring and routine in-person evaluation. BACKGROUND: Pacemaker patient follow-up procedures have evolved from evaluating devices with little programmability and diagnostic information solely in person to transtelephonic rhythm strip recordings that allow monitoring of basic device function. More recently developed remote monitoring technology leverages expanded device capabilities, augmenting traditional transtelephonic monitoring to evaluate patients via full device interrogation. METHODS: The time to first diagnosis of a clinically actionable event was compared in patients who were followed by remote interrogation (Remote) and those who were followed per standard of care with office visits augmented by transtelephonic monitoring (Control). Patients were randomized 2:1. Remote arm patients transmitted pacemaker information at 3-month intervals. Control arm patients with a single-chamber pacemaker transmitted at 2-month intervals. Control arm patients with dual-chamber devices transmitted at 2-month intervals with an office visit at 6 months. All patients were seen in office at 12 months. RESULTS: The mean time to first diagnosis of clinically actionable events was earlier in the Remote arm (5.7 months) than in the Control arm (7.7 months). Three (2%) of the 190 events in the Control arm and 446 (66%) of 676 events in the Remote arm were identified remotely. CONCLUSIONS: The strategic use of remote pacemaker interrogation follow-up detects actionable events that are potentially important more quickly and more frequently than transtelephonic rhythm strip recordings. The use of transtelephonic rhythm strips for pacemaker follow-up is of little value except for battery status determinations. (PREFER [Pacemaker Remote Follow-up Evaluation and Review]; NCT00294645).

Design of the Pacemaker REmote Follow-up Evaluation and Review (PREFER) trial to assess the clinical value of the remote pacemaker interrogation in the management of pacemaker patients.

BACKGROUND: Although pacemakers are primarily used for the treatment of bradycardia, diagnostic data available in current pacemakers allow them to be also used as sophisticated, continuous monitoring devices. Easy access to these stored data may assist clinicians in making diagnostic and therapeutic decisions sooner, thus avoiding potential long-term sequelae due to untreated clinical disorders. Internet-based remote device interrogation systems provide clinicians with frequent and complete access to stored data in pacemakers. In addition to monitoring device function, remote monitors may be a helpful tool in assisting physicians in the management of common arrhythmia disorders. METHODS: The Pacemaker REmote Follow-up Evaluation and Review (PREFER) trial is a prospective, randomized, parallel, unblinded, multicenter, open label clinical trial to determine the utility of remote pacemaker interrogation in the earlier diagnosis of clinically actionable events compared to the existing practice of transtelephonic monitoring. There have been 980 patients enrolled and randomized to receive pacemaker follow up with either remote interrogation using the Medtronic CareLink(R) Network (CareLink) versus the conventional method of transtelephonic monitoring (TTM) in addition to periodic in-person interrogation and programming evaluations. The purpose of this manuscript is to describe the design of the PREFER trial. The results, to be presented separately, will characterize the number of clinically actionable events as a result of pacemaker follow-up using remote interrogation instead of TTM. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00294645.