Reducing donor acceptance practice variation - Learnings from a discussion forum.

PURPOSE: Although waitlist mortality is unacceptably high, nearly half of donor heart offers are rejected by pediatric heart transplant centers. The Advanced Cardiac Therapy Improving Outcome Network (ACTION) and Pediatric Heart Transplant Society (PHTS) convened a multi-institutional donor decision discussion forum (DDDF) aimed at assessing donor acceptance practices and reducing practice variation. METHODS: A 1-h-long virtual DDDF for providers across North America, the United Kingdom, and Brazil was held monthly. Each session typically included two case presentations posing a real-world donor decision challenge. Attendees were polled before the presenting center's decision was revealed. Group discussion followed, including a review of relevant literature and PHTS data. Metrics of participation, participant agreement with presenting center decisions, and impact on future decision-making were collected and analyzed. RESULTS: Over 2 years, 41 cases were discussed. Approximately 50 clinicians attended each call. Risk factors influencing decision-making included donor quality (10), size discrepancy (8), and COVID-19 (8). Donor characteristics influenced 63% of decisions, recipient factors 35%. Participants agreed with the decision made by the presenting center only 49% of the time. Post-presentation discussion resulted in 25% of participants changing their original decision. Survey conducted reported that 50% respondents changed their donor acceptance practices. CONCLUSION: DDDF identified significant variation in pediatric donor decision-making among centers. DDDF may be an effective format to reduce practice variation, provide education to decision-makers, and ultimately increase donor utilization.

Impact of intensive follow-up of cardiac implantable electronic devices via remote monitoring: A pilot study.

Background: The volume of remote monitoring (RM) data generates a significant workload and is generally dealt with by clinic staff during standard office hours, potentially delaying clinical action. Objective: The purpose of this study was to determine the clinical efficiency and workflow of implementing intensive RM (IRM) in patients with cardiac implantable electronic device (CIED) when compared with standard RM (SRM). Methods: From a cohort of >1500 remotely monitored devices, 70 patients were randomly selected to undergo IRM. For comparison, an equal number of matched patients were prospectively selected for SRM. Intensive follow-up occurred via automated vendor-neutral software with rapid alert processing by International Board of Heart Rhythm Examiners-certified device specialists. Standard follow-up was conducted by clinic staff during office hours via individual device vendor interfaces. Alerts were categorized on the basis of the level of acuity as actionable (red [high], yellow [moderate]), or green [not requiring action]). Results: Over 9 months of follow-up, 922 remote transmissions were received; 339 (36.8%) were coded as actionable alerts (118 in IRM and 221 in SRM; P < .001). The median time from initial transmission to review was 6 hours (interquartile range [IQR] 1.8-16.8 hours) in the IRM group compared with 10.5 hours (IQR 6.0-32.2 hours) in the SRM group (P < .001). The median time from transmission to review of actionable alerts in the IRM group was 5.1 hours (IQR 2.3-8.9 hours) compared with 9.1 hours (IQR 6.7-32.5 hours) in the SRM group (P < .001). Conclusion: Intensive and managed RM results in a significant reduction in time to review alerts and number of actionable alerts. Monitoring with enhanced alert adjudication is needed to facilitate device clinic efficiency and optimize patient care. Study Registration: ACTRN12621001275853.

Device-detected atrial fibrillation in a large remote-monitored cohort: implications for anticoagulation and need for new pathways of service delivery.

BACKGROUND: Remote monitoring (RM) can facilitate early detection of subclinical and symptomatic atrial fibrillation (AF), providing an opportunity to evaluate the need for stroke prevention therapies. We aimed to characterize the burden of RM AF alerts and its impact on anticoagulation of patients with device-detected AF. METHODS: Consecutive patients with a cardiac implantable electronic device, at least one AF episode, undergoing RM were included and assigned an estimated minimum CHA2DS2-VASc score based on age and device type. RM was provided via automated software system, providing rapid alert processing by device specialists and systematic, recurrent prompts for anticoagulation. RESULTS: From 7651 individual, 389,188 AF episodes were identified, 3120 (40.8%) permanent pacemakers, 2260 (29.5%) implantable loop recorders (ILRs), 987 (12.9%) implantable cardioverter defibrillators, 968 (12.7%) cardiac resynchronization therapy (CRT) defibrillators, and 316 (4.1%) CRT pacemakers. ILRs transmitted 48.8% of all AF episodes. At twelve-months, 3404 (44.5%) AF < 6 min, 1367 (17.9%) 6 min-6 h, 1206 (15.8%) 6-24 h, and 1674 (21.9%) ≥ 24 h. A minimum CHA2DS2-VASc score of 2 was assigned to 1704 (63.1%) of the patients with an AF episode of ≥ 6 h, 531 (31.2%) who were not anticoagulated at 12-months, and 1031 (61.6%) patients with an AF episode duration of ≥ 24 h, 290 (28.1%) were not anticoagulated. CONCLUSIONS: Despite being intensively managed via RM software system incorporating cues for anticoagulation, a substantial proportion of patients with increased stroke risk remained unanticoagulated after a device-detected AF episode of significant duration. These data highlight the need for improved clinical response pathways and an integrated care approach to RM. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry: ACTRN12620001232921.

Validity of the Parsley Symptom Index-an Electronic Patient-Reported Outcomes Measure Designed for Telehealth: Prospective Cohort Study.

BACKGROUND: Electronic patient-reported outcomes measures (e-PROMs) are a valuable tool for the monitoring and management of chronic conditions over time. However, there are few validated tools available that capture symptoms across body systems in telehealth settings. The Parsley Symptom Index (PSI) is a recently developed symptom assessment for adults with chronic disease in telehealth settings. A previous study demonstrated the feasibility and acceptability of the PSI in a clinical telehealth setting. OBJECTIVE: The purpose of this study was to assess convergent validity between the PSI and the self-rated health (SRH) item. METHODS: This prospective cohort study took place from January 15, 2021, to December 15, 2021, among a sample of 10,519 adult patients at Parsley Health, a subscription-based holistic medical practice. The PSI and the SRH were completed by patients via an online portal. The association between the PSI and SRH was assessed via polyserial and polychoric correlations, while weighted κ scores provided information related to agreement between the PSI and SRH. RESULTS: From 22,748 responses, there were moderate levels of association (polyserial r=0.51; polychoric r=0.52) and agreement (weighted κ=0.46) between the PSI and SRH. In total, 74.13% (n=16,865) of responses between the PSI and SRH were relatively congruent while 36.17% (n=8229) were literally congruent. CONCLUSIONS: The PSI demonstrates convergent validity with the SRH for adults with chronic disease in a telehealth setting. This finding further supports the validation of the PSI in a real-world clinical setting. Although it is conceptually similar to the 1-question SRH, the PSI is a 45-item PROM designed to capture quality of life and specific symptoms by body system. Future studies will compare the PSI to multi-item PROMs.

Should We Check It? Assessing Interrogation of Cardiac Implantable Electronic Devices in the Emergency Department-The CHECK-ED Study: Implications for Service Planning and Care Delivery.

BACKGROUND: Requests from the emergency department (ED) for cardiac implantable electronic device (CIED) checks constitute a large workload for cardiac electrophysiology services. We sought to determine the yield of, and clinical characteristics associated with, clinically relevant (remarkable) issues from ED CIED checks. METHODS: Consecutive CIED checks from our ED over a 12-month period were studied. A remarkable issue (RI) was defined as arrhythmia relating to the presentation or device/lead issue requiring reprogramming or intervention. The association between the presenting complaint and an RI was assessed using regression analysis. Multivariable regression model was used to identify pre-specified patient-level characteristics that were predictive of a RI. RESULTS: A RI was found in 28% (n=98) of 354 ED CIED checks for 306 patients (76±16 yrs, 59% male). Most patients had no RI (n=224, 73%). One third of checks occurred after-hours and these had a higher yield of RIs than those during routine clinic hours (35% vs 23%, p=0.018). Presenting with a perceived ICD shock was predictive of a RI (odds ratio [OR] 6.0, 95% CI=1.8-20.0). Syncope/presyncope was five-fold less likely to be predictive of a RI (OR 0.19, 95% CI=0.13-0.28) despite being the most common indication for CIED check (51%, n=180 checks). Only history of AF was predictive of RI while advancing age was predictive of not finding a RI. CONCLUSION: Almost three-quarters of ED CIED checks did not yield any RI. Patient-reported ICD shock and history of AF were predictive of RI, while syncope/presyncope was not. New models of care especially during after-hours, may help to reduce the burden on cardiac electrophysiology services and health care costs.

Single ring isolation for atrial fibrillation ablation: Impact of the learning curve.

INTRODUCTION: Although single ring isolation is an accepted strategy for undertaking pulmonary vein (PV) and posterior wall isolation (PWI) during atrial fibrillation (AF) ablation, the learning curve associated with this technique as well as procedural and clinical success rates have not been widely reported. METHODS AND RESULTS: Prospectively collected data from 250 consecutive patients undergoing de novo AF ablation using single ring isolation. PWI was achieved in 212 patients (84.8%) and PV isolation without PWI was achieved in 37 patients (14.4%). Thirty-one cases (12.4%) demonstrated inferior line sparing where PWI was achieved without a continuous posterior wall inferior line. A learning curve was observed, with higher rates of PWI (98% last 50 vs. 82% first 50 cases, p = .016), higher rates of inferior line sparing (20% last 50 vs. 8% first 50 cases, p = .071) and lower ablation times (43.8 min (interquartile range [IQR]: 34.6-57.0 min) last 50 versus. 96.5 min (IQR: 80.8-115.8 min) first 50 cases; p < .001). Three (1.3%) major procedure-related complications were observed. Twelve-month, single-procedure freedom from atrial arrhythmia without drugs was 70.5% (95% confidence interval [CI]: 61.5%-77.7%) and 60.0% (95% CI: 50.2%-68.4%) for paroxysmal and persistent/longstanding persistent AF. Twelve-month multi-procedure freedom from atrial arrhythmia was 92.2% (95%CI: 85.6%-95.9%) and 85.6% (95%CI: 77.2%-91.0%) for paroxysmal and persistent/longstanding persistent AF. CONCLUSION: Employing a single ring isolation approach, PWI can be achieved in most cases. There is a substantial learning curve with higher rates of PWI, reduced ablation times, and higher rates of inferior line sparing as procedural experience grows. Long-term freedom from arrhythmia is comparable to other AF ablation techniques.

Atrial fibrillation burden during the coronavirus disease 2019 pandemic.

AIMS: The aim of this study is to determine the association between the coronavirus disease 2019 (COVID-19) pandemic and atrial fibrillation (AF) occurrence in individuals with cardiac implantable electronic devices (CIEDs). METHOD AND RESULTS: Multi-centre, observational, cohort study over a 100-day period during the COVID-19 pandemic (COVID-19) in the USA. Remote monitoring was used to assess AF episodes in patients with a CIED (pacemaker or defibrillator; 20 centres, 13 states). For comparison, the identical 100-day period in 2019 was used (Control). The primary outcomes were the AF burden during the COVID-19 pandemic, and the association of the pandemic with AF occurrence, as compared with 1 year prior. The secondary outcome was the association of AF occurrence with per-state COVID-19 prevalence. During COVID-19, 10 346 CIEDs with an atrial lead were monitored. There were 16 570 AF episodes of ≥6 min transmitted (16 events per 1000 patient days) with a significant increase in proportion of patients with AF episodes in high COVID-19 prevalence states compared with low prevalence states [odds ratio 1.34, 95% confidence interval (CI) 1.21-1.48, P < 0.001]. There were significantly more AF episodes during COVID-19 compared with Control [incident rate ratio (IRR) 1.33, 95% CI 1.25-1.40, P < 0.001]. This relationship persisted for AF episodes ≥1 h (IRR 1.65, 95% CI 1.53-1.79, P < 0.001) and ≥6 h (IRR 1.54, 95% CI 1.38-1.73, P < 0.001). CONCLUSION: During the first 100 days of COVID-19, a 33% increase in AF episodes occurred with a 34% increase in the proportion of patients with AF episodes observed in states with higher COVID-19 prevalence. These findings suggest a possible association between pandemic-associated social disruptions and AF in patients with CIEDs. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry: ACTRN12620000692932.

Remote Monitoring Alert Burden: An Analysis of Transmission in >26,000 Patients.

OBJECTIVES: This study sought to determine the remote monitoring (RM) alert burden in a multicenter cohort of patients with a cardiac implantable electronic device (CIED). BACKGROUND: RM of CIEDs allows timely recognition of patient and device events requiring intervention. Most RM involves burdensome manual workflow occurring exclusively on weekdays during office hours. Automated software may reduce such a burden, streamlining real-time alert responses. METHODS: We retrospectively analyzed 26,713 consecutive patients with a CIED undergoing managed RM utilizing PaceMate software between November 2018 and November 2019. Alerts were analyzed according to type, acuity (red indicates urgent, and yellow indicates nonurgent) and CIED category. RESULTS: In total, 12,473 (46.7%) patients had a permanent pacemaker (PPM), 9,208 (34.5%) had an implantable cardioverter-defibrillator (ICD), and 5,032 (18.8%) had an implantable loop recorder (ILR). Overall, 82,797 of the 205,804 RM transmissions were alerts, with the remainder being scheduled transmissions. A total of 14,638 (54.8%) patients transmitted at least 1 alert. Permanent pacemakers were responsible for 25,700 (31.0%) alerts, ICDs for 15,643 (18.9%) alerts, and ILRs for 41,454 (50.1%) alerts, with 3,935 (4.8%) red alerts and 78,862 (95.2%) yellow alerts. ICDs transmitted 2,073 (52.7%) red alerts; 5,024 (32.1%) ICD alerts were for ventricular tachyarrhythmias and antitachycardia pacing/shock delivery. CONCLUSIONS: In an RM cohort of 26,713 patients with CIEDs, 54.8% of patients transmitted at least 1 alert during a 12-month period, totaling over 82,000 alerts. ILRs were overrepresented, and ICDs were underrepresented, in these alerts. The enormity of the number of transmissions and the growing ILR alert burden highlight the need for new management pathways for RM.

Ventricular arrhythmia burden during the coronavirus disease 2019 (COVID-19) pandemic.

AIMS: Our objective was to determine the ventricular arrhythmia burden in implantable cardioverter-defibrillator (ICD) patients during COVID-19. METHODS AND RESULTS: In this multicentre, observational, cohort study over a 100-day period during the COVID-19 pandemic in the USA, we assessed ventricular arrhythmias in ICD patients from 20 centres in 13 states, via remote monitoring. Comparison was via a 100-day control period (late 2019) and seasonal control period (early 2019). The primary outcome was the impact of COVID-19 on ventricular arrhythmia burden. The secondary outcome was correlation with COVID-19 incidence. During the COVID-19 period, 5963 ICD patients underwent remote monitoring, with 16 942 episodes of treated ventricular arrhythmias (2.8 events per 100 patient-days). Ventricular arrhythmia burden progressively declined during COVID-19 (P < 0.001). The proportion of patients with ventricular arrhythmias amongst the high COVID-19 incidence states was significantly reduced compared with those in low incidence states [odds ratio 0.61, 95% confidence interval (CI) 0.54-0.69, P < 0.001]. Comparing patients remotely monitored during both COVID-19 and control periods (n = 2458), significantly fewer ventricular arrhythmias occurred during COVID-19 [incident rate ratio (IRR) 0.68, 95% CI 0.58-0.79, P < 0.001]. This difference persisted when comparing the 1719 patients monitored during both the COVID-19 and seasonal control periods (IRR 0.69, 95% CI 0.56-0.85, P < 0.001). CONCLUSIONS: During COVID-19, there was a 32% reduction in ventricular arrhythmias needing device therapies, coinciding with measures of social isolation. There was a 39% reduction in the proportion of patients with ventricular arrhythmias in states with higher COVID-19 incidence. These findings highlight the potential role of real-life stressors in ventricular arrhythmia burden in individuals with ICDs. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry; URL: https://www.anzctr.org.au/; Unique Identifier: ACTRN12620000641998.

Magnetic resonance imaging in non-conditional pacemakers and implantable cardioverter-defibrillators: a systematic review and meta-analysis.

AIMS: There is growing evidence that magnetic resonance imaging (MRI) scanning in patients with non-conditional cardiac implantable electronic devices (CIEDs) can be performed safely. Here, we aim to assess the safety of MRI in patients with non-conditional CIEDs. METHODS AND RESULTS: English scientific literature was searched using PubMed/Embase/CINAHL with keywords of 'magnetic resonance imaging', 'pacemaker', 'implantable defibrillator', and 'cardiac resynchronization therapy'. Studies assessing outcomes of adverse events or significant changes in CIED parameters after MRI scanning in patients with non-conditional CIEDs were included. References were excluded if the MRI conditionality of the CIEDs was undisclosed; number of patients enrolled was <10; or studies were case reports/series. About 35 cohort studies with a total of 5625 patients and 7196 MRI scans (0.5-3 T) in non-conditional CIEDs were included. The overall incidence of lead failure, electrical reset, arrhythmia, inappropriate pacing and symptoms related to pocket heating, or torque ranged between 0% and 1.43%. Increase in pacing lead threshold >0.5 V and impedance >50Ω was seen in 1.1% [95% confidence interval (CI) 0.7-1.8%] and 4.8% (95% CI 3.3-6.4%) respectively. The incidence of reduction in P- and R-wave sensing by >50% was 1.5% (95% CI 0.6-2.9%) and 0.4% (95% CI 0.06-1.1%), respectively. Battery voltage reduction of >0.04 V was reported in 2.2% (95% CI 0.2-6.1%). CONCLUSION: This meta-analysis affirms the safety of MR imaging in non-conditional CIEDs with no death or implantable cardioverter-defibrillator shocks and extremely low incidence of lead or device-related complications.

Feasibility, Safety, and Efficacy of Posterior Wall Isolation During Atrial Fibrillation Ablation: A Systematic Review and Meta-Analysis.

BACKGROUND: The posterior left atrium is an arrhythmogenic substrate that contributes to the initiation and maintenance of atrial fibrillation (AF); however, the feasibility, safety, and efficacy of posterior wall isolation (PWI) as an AF ablation strategy has not been widely reported. METHODS: We undertook a systematic review and meta-analysis of studies performing PWI to assess (1) acute procedural success including the ability to achieve PWI and the number of procedure-related complications, (2) Long-term, clinical success including rates of arrhythmia recurrence and posterior wall reconnection, and (3) The efficacy of PWI compared with pulmonary vein isolation on preventing arrhythmia recurrence. MEDLINE, EMBASE, and Web of Science databases were searched in May 2018 to retrieve relevant studies. Results were pooled using a random effects model. RESULTS: Seventeen studies (13 box isolation, 3 single ring isolation, and 1 debulking ablation) comprising 1643 patients (31.3% paroxysmal AF, left atrial diameter 41±3.1 mm) were included in the final analysis. In studies focusing specifically on PWI, the acute procedural success rate for achieving PWI was 94.1% (95% CI, 87.2%-99.3%). Single-procedure 12-month freedom from atrial arrhythmia was 65.3% (95% CI, 57.7%-73.9%) overall and 61.9% (54.2%-70.8%) for persistent AF. Randomized control trials comparing PWI to pulmonary vein isolation (3 studies, 444 patients) yielded conflicting results and could not confirm an incremental benefit to PWI. Fifteen major complications (0.1%), including 2 atrio-esophageal fistulas, were reported. CONCLUSIONS: PWI as an end point of AF ablation can be achieved in a large proportion of cases with good rates of 12-month freedom from atrial arrhythmia. Although the procedure-related complication rate is low, it did not eliminate the risk of atrio-esophageal fistula. Registration: URL: http://www.crd.york.ac.uk/prospero. PROSPERO registration number: CRD42018107212.

Implication of ventricular pacing burden and atrial pacing therapies on the progression of atrial fibrillation: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Atrial fibrillation (AF) is common after pacemaker implantation. However, the impact of pacemaker algorithms in AF prevention is not well understood. OBJECTIVE: The purpose of this study was to evaluate the role of pacing algorithms in preventing AF progression. METHODS: A systematic search of articles using the PubMed and Embase databases resulted in a total of 754 references. After exclusions, 21 randomized controlled trials (8336 patients) were analyzed, comprising studies reporting ventricular pacing percentage (VP%) (AAI vs DDD, n = 1; reducing ventricular pacing [RedVP] algorithms, n = 2); and atrial pacing therapies (atrial preference pacing [APP], n = 14; atrial antitachycardia pacing [aATP]+APP, n = 3; RedVP+APP+aATP, n = 1). RESULTS: Low VP% (<10%) lead to a nonsignificant reduction in the progression of AF (hazard ratio [HR] 0.80; 95% confidence interval [CI] 0.57-1.13; P = .21; I2 = 67%) compared to high VP% (>10%). APP algorithm reduced premature atrial complexes (PAC) burden (mean difference [MD] -1117.74; 95% CI -1852.36 to -383.11; P = .003; I2 = 67%) but did not decrease AF burden (MD 8.20; 95% CI -5.39 to 21.80; P = .24; I2 = 17%) or AF episodes (MD 0.00; 95% CI -0.24 to 0.25; P = .98; I2 = 0%). Similarly, aATP+APP programming showed no significant difference in AF progression (odds ratio 0.65; 95% CI 0.36-1.14; P = .13; I2 = 61%). No serious adverse events related to algorithm were reported. CONCLUSION: This meta-analysis of randomized controlled trials demonstrated that algorithms to reduce VP% can be considered safe. Low burden VP% did not significantly suppress AF progression. The atrial pacing therapy algorithms could suppress PAC burden but did not prevent AF progression.

Condition-specific Streaming versus an Acuity-based Model of Cardiovascular Care: A Historically-controlled Quality Improvement Study Evaluating the Association with Early Clinical Events.

BACKGROUND: Ensuring optimal evidence translation is challenging when health-service design has not kept pace with developments in care. Differences in patient outcomes were evident when specific cardiac conditions were discordant with the subspecialty of the cardiologists managing their care. We prospectively explored the clinical and health service implications of a "condition-based" redesign in cardiac care delivery, rather than acuity-based, within a tertiary hospital. METHODS: Prospective evaluation of a disease-specific streaming model of care compared to propensity-matched historical controls, among cardiac patients admitted to a tertiary hospital cardiology unit was undertaken. The outcome measures of 30-day death, and readmission for myocardial infarction, cardiac arrhythmia, and heart failure were explored. RESULTS: In total, 2018 patients admitted subsequent to the implementation of the streaming model were compared with 1830 patients admitted prior. The median age was 68.9 years, and 39.5% were female. There was no significant difference in the overall proportion of patients admitted with an acute coronary syndrome, arrthythmia or heart failure, nor their Charlson index before and after streaming. Subsequent to the implementation, there was a reduction in the use of angiography (pre: 35.4% vs. post: 31.2%, p=0.007) and echocardiography (pre: 59.4% vs. post: 55.6%, p=0.007). A reduction in length of length-of-stay was observed in the entire cohort (pre: 2.7 (range: 1.2-5.0) days vs. post: 2.3 (range 1.0-4.5) days, p=0.0003). By 30 days, the propensity-adjusted hazard ratio for major adverse cardiac events and death or any cardiovascular admission was 0.76 (95% C.I. 0.59-0.97, p=0.026). CONCLUSION: Cardiac service redesign that streams cardiac patients by presenting diagnosis into teams designed to treat that condition may provide capacity and productivity gains for health services striving to improve outcome and efficiency.

Auditing Operating Room Recycling: A Management Case Report.

Much waste arises from operating rooms (ORs). We estimated the practical and financial feasibility of an OR recycling program, weighing all waste from 6 ORs in Melbourne, Australia. Over 1 week, 237 operations produced 1265 kg in total: general waste 570 kg (45%), infectious waste 410 kg (32%), and recyclables 285 kg (23%). The achieved recycling had no infectious contamination. The achieved recycling/potential recycling rate was 285 kg/517 kg (55%). The average waste disposal costs were similar for general waste and recycling. OR recycling rates of 20%-25% total waste were achievable without compromising infection control or financial constraints.