Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation: The aMAZE Randomized Clinical Trial.

Importance: Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation. Objective: To assess the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to catheter pulmonary vein isolation for nonparoxysmal atrial fibrillation. Design, Setting, and Participants: This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for nonparoxysmal atrial fibrillation present for less than 3 years. Eligible patients were randomized in a 2:1 ratio to undergo left atrial appendage ligation and pulmonary vein isolation or pulmonary vein isolation alone. Use of a 2:1 randomization ratio was intended to provide more device experience and safety data. Patients were enrolled from October 2015 to December 2019 at 53 US sites, with the final follow-up visit on April 21, 2021. Interventions: Left atrial appendage ligation plus pulmonary vein isolation compared with pulmonary vein isolation alone. Main Outcomes and Measures: A bayesian adaptive analysis was used for primary end points. Primary effectiveness was freedom from documented atrial arrythmias of greater than 30 seconds duration 12 months after undergoing pulmonary vein isolation. Rhythm was assessed by Holter monitoring at 6 and 12 months after pulmonary vein isolation, symptomatic event monitoring, or any electrocardiographic tracing obtained through 12 months after pulmonary vein isolation. Primary safety was a composite of predefined serious adverse events compared with a prespecified 10% performance goal 30 days after the procedure. Left atrial appendage closure was evaluated through 12 months after pulmonary vein isolation. Results: Overall, 404 patients were randomized to undergo left atrial appendage ligation plus pulmonary vein isolation and 206 were randomized to undergo pulmonary vein isolation alone. Primary effectiveness was 64.3% with left atrial appendage ligation and pulmonary vein isolation and 59.9% with pulmonary vein isolation only (difference, 4.3% [bayesian 95% credible interval, -4.2% to 13.2%]; posterior superiority probability, 0.835), which did not meet the statistical criterion to establish superiority (0.977). Primary safety was met, with a 30-day serious adverse event rate of 3.4% (bayesian 95% credible interval, 2.0% to 5.0%; posterior probability, 1.0) which was less than the prespecified threshold of 10%. At 12 months after pulmonary vein isolation, complete left atrial appendage closure (0 mm residual communication) was observed in 84% of patients and less than or equal to 5 mm residual communication was observed in 99% of patients. Conclusions and Relevance: Percutaneous left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months compared with pulmonary vein isolation alone for patients with nonparoxysmal atrial fibrillation, but met prespecified safety criteria and demonstrated high rates of closure at 12 months. Trial Registration: ClinicalTrials.gov Identifier: NCT02513797.

Performance of the REAL-AF Same-Day Discharge Protocol in Patients Undergoing Catheter Ablation of Atrial Fibrillation.

BACKGROUND: Same-day discharge (SDD) after catheter ablation of atrial fibrillation (AF) has been widely adopted. Nevertheless, planned SDD has been performed by using subjective criteria rather than standardized protocols. OBJECTIVES: The goal of this study was to determine the efficacy and safety of the previously described SDD protocol in a prospective multicenter study. METHODS: Using the REAL-AF (Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation) SDD protocol eligibility criteria (stable anticoagulation, no bleeding history, left ventricular ejection fraction >40%, no pulmonary disease, no procedures within 60 days, and body mass index <35 kg/m2), operators prospectively determined whether patients undergoing ablation of AF were candidates for SDD (SDD vs non-SDD groups). Successful SDD was achieved if the patient met the protocol discharge criteria. The primary efficacy endpoint was the success rate of SDD. The primary safety endpoints were readmission rates as well as acute and subacute complications. The secondary endpoints included procedural characteristics and freedom from all-atrial arrhythmias. RESULTS: A total of 2,332 patients were included. The REAL-AF SDD protocol identified 1,982 (85%) patients as potential candidates for SDD. The primary efficacy endpoint was achieved in 1,707 (86.1%) patients. The readmission rate for SDD vs non-SDD group was similar (0.8% vs 0.9%; P = 0.924). The SDD group had a lower acute complication rate than the non-SDD group (0.8% vs 2.9%; P < 0.001), and there was no difference in the subacute complication rate between groups (P = 0.513). Freedom from all-atrial arrhythmias was comparable between groups (P = 0.212). CONCLUSIONS: In this large, multicenter prospective registry, the use of a standardized protocol showed the safety of SDD after catheter ablation of paroxysmal and persistent AF. (Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation [REAL-AF]; NCT04088071).

Educating health professionals in ultrasound guided peripheral intravenous cannulation: A systematic review of teaching methods, competence assessment, and patient outcomes.

BACKGROUND: Peripheral intravenous cannula insertion is the most common invasive healthcare procedure, however failure rates remain unacceptably high, particularly in patients with difficult intravascular access. This leads to treatment delays and increased complication risk, causing poorer outcomes among this patient subset. Ultrasonographic guidance reduces these risks and is therefore becoming a competency required of health professionals. However, there is no consensus on how to design teaching sessions to achieve this competency. METHODS: Systematic review was conducted to identify characteristics of effective teaching sessions for current and training health professions to achieve ultrasound guided peripheral intravenous cannulation competency. Secondary outcomes included defining competency and to assess benefits to patients and healthcare systems. Eligibility for inclusion required description of teaching of ultrasound guided peripheral intravenous cannulation to qualified or training health professionals who went on to perform it in human patients or volunteers with reported outcomes or success rates. Studies were excluded if not accessible in full, not peer-reviewed or presented research that had been presented elsewhere previously. Of the 1085 records identified on review of 6 databases, 35 were included for final review based on eligibility criteria. RESULTS: Almost all (97.1%) used mixed modality teaching comprising of didactic and simulation portions, although time allocated varied widely. A median of 5 proctored procedures was required for competency. Competency was independent of previous experience or staff seniority. Mean reported insertion attempts was 1.7, success rate was 82.5% and first-time success rate was 75.5%. All included studies described improvement in their participants or healthcare system including significantly reduced midline insertion rates, central venous catheter insertion rates and associated bacteremia and sepsis, self-reported cannulation difficulty, specialist input, therapy delays and premature catheter failure rates. Further, there was significantly improved procedural confidence, knowledge and competence. CONCLUSION: Simple teaching interventions can lead to competent ultrasound guided peripheral intravenous cannula insertion by novices, resulting in numerous positive outcomes for patients and healthcare systems.

Markers of coagulation and hemostatic activation aid in identifying causes of cryptogenic stroke.

OBJECTIVE: To test the hypothesis that markers of coagulation and hemostatic activation (MOCHA) help identify causes of cryptogenic stroke, we obtained serum measurements on 132 patients and followed them up to identify causes of stroke. METHODS: Consecutive patients with cryptogenic stroke who met embolic stroke of undetermined source (ESUS) criteria from January 1, 2017, to October 31, 2018, underwent outpatient cardiac monitoring and the MOCHA profile (serum D-dimer, prothrombin fragment 1.2, thrombin-antithrombin complex, and fibrin monomer) obtained ≥2 weeks after the index stroke; abnormal MOCHA profile was defined as ≥2 elevated markers. Prespecified endpoints monitored during routine clinical visits included new atrial fibrillation (AF), malignancy, venous thromboembolism (VTE), or other defined hypercoagulable states (HS). RESULTS: Overall, 132 patients with ESUS (mean age 64 ± 15 years, 61% female, 51% nonwhite) met study criteria. During a median follow-up of 10 (interquartile range 7-14) months, AF, malignancy, VTE, or HS was identified in 31 (23%) patients; the 53 (40%) patients with ESUS with abnormal MOCHA were significantly more likely than patients with normal levels to have subsequent new diagnoses of malignancy (21% vs 0%, p < 0.001), VTE (9% vs 0%, p = 0.009), or HS (11% vs 0%, p = 0.004) but not AF (8% vs 9%, p = 0.79). The combination of 4 normal MOCHA and normal left atrial size (n = 30) had 100% sensitivity for ruling out the prespecified endpoints. CONCLUSION: The MOCHA profile identified patients with cryptogenic stroke more likely to have new malignancy, VTE, or HS during short-term follow-up and may be useful in direct evaluation for underlying causes of cryptogenic stroke.

Outcomes of convergent atrial fibrillation ablation with continuous rhythm monitoring.

BACKGROUND: Outcomes of catheter ablation for persistent atrial fibrillation (PeAF) are suboptimal. The convergent procedure (CP) may offer improved efficacy by combining endocardial and epicardial ablation. METHODS: We reviewed 113 consecutive patients undergoing the CP at our institution. The cohort was divided into two groups based on the presence (n = 92) or absence (n = 21) of continuous rhythm monitoring (CM) following the CP. Outcomes were reported in two ways. First, using a conventional definition of any atrial fibrillation/atrial tachycardia (AF/AT) recurrence lasting >30 seconds, after a 90 day blanking period. Second, by determining AF/AT burden at relevant time points in the group with CM. RESULTS: Across the entire cohort, 88% had either persistent or long-standing persistent AF, mean duration of AF diagnosis before the CP was 5.1 ± 4.6 years, 45% had undergone at least one prior AF ablation, 31% had impaired left ventricle ejection fraction and 62% met criteria for moderate or severe left atrial enlargement. Mean duration of follow-up after the CP was 501 ± 355 days. In the entire cohort, survival free from any AF/AT episode >30 seconds at 12 months after the blanking period was 53%. However, among those in the CM group who experienced recurrences, mean burden of AF/AT was generally very low (<5%) and remained stable over the duration of follow-up. Ten patients (9%) required elective cardioversion outside the 90 day blanking period, 11 patients (9.7%) underwent repeat ablation at a mean of 229 ± 178 days post-CP and 64% were off AADs at the last follow-up. Procedural complications decreased significantly following the transition from transdiaphragmatic to sub-xiphoid surgical access: 23% versus 3.8% (P = .005) CONCLUSIONS: In a large, consecutive series of patients with predominantly PeAF, the CP was capable of reducing AF burden to very low levels (generally <5%), which appeared durable over time. Complication rates associated with the CP decreased significantly with the transition from transdiaphragmatic to sub-xiphoid surgical access. Future trials will be necessary to determine which patients are most likely to benefit from the convergent approach.

Clinical experience of stereotactic body radiation for refractory ventricular tachycardia in advanced heart failure patients.

BACKGROUND: Stereotactic body radiation therapy (SBRT) has been shown to be effective in treating patients with refractory ventricular tachycardia. OBJECTIVE: The purpose of this study was to describe outcomes for SBRT in advanced heart failure patients admitted for repeated implantable cardioverter-defibrillator (ICD) therapies who were refractory to standard treatments. METHODS: SBRT simulation, planning, and treatments were performed using standard techniques with collaboration from a radiation oncologist, electrophysiologist, and cardiac imaging specialist. Patients were treated with single-fraction 25 Gy while awake. Efficacy was assessed by total durations in seconds of ventricular tachycardia, frequency of antitachycardia pacing (ATP), and quantity of shocks before and after treatment as recorded by an ICD. RESULTS: A total of 10 patients (mean age 61 years; 3 female) were included. Etiologies of heart failure were ischemic in 40% (4/10) and nonischemic in 60% (6/10). Among 8 patients with available ICD data, the total reduction in seconds of detected VT was 69% (pretreatment 1065 seconds/month vs posttreatment 332 seconds/month). The total reduction in ATP sequences was 48% (17.3 pretreatment and 8.9 posttreatment). Reduction in total ICD shocks after SBRT was 68% (2.9 shocks/month pretreatment and 0.9 shocks/month posttreatment). When excluding a single nonresponder, there was a significant reduction in VT seconds (94%; P = .04) and a trend toward ICD shock reduction (90%; P = .07) post-SBRT. CONCLUSION: Noninvasive treatment with SBRT was feasible and modestly effective at reducing VT burden in the critically ill. This suggests that SBRT treatment may be a useful palliation for electrical storm.

Comparison of echocardiographic and fluoroscopic sizing of the left atrial appendage prior to percutaneous closure.

PURPOSE: Sizing of the left atrial appendage (LAA) ostium prior to occlusion (LAAO) is routinely performed with transesophageal echocardiography (TEE). We sought to compare the utility of sizing via fluoroscopy to TEE for percutaneous LAAO. METHODS: We retrospectively evaluated all patients undergoing percutaneous LAAO at our institution from April 2015 through January 2018 (n = 195). We evaluated baseline characteristics, maximum measured ostium size (for both TEE and fluoroscopy), and differences in measured size to device size for both techniques. RESULTS: Of the total cohort, 185 (95%) had both intraoperative TEE and fluoroscopic images available for analysis and were included in the final analysis. The mean age was 74 years and 64% were male. Hypertension was present in 89%, diabetes in 30%, and stroke in 32% of patients. The mean ejection fraction was 51%. The most common LAA morphology was "wind sock" (52%). Measured ostial diameter on fluoroscopy was larger compared with TEE (2.04 ± 3.43 mm larger on fluoroscopy, p < 0.001). Ostium diameter on TEE was more closely correlated to the size of the device implanted compared with fluoroscopy (0.76 vs. 0.61, p = 0.001). CONCLUSIONS: Fluoroscopy results in larger estimated LAA ostium diameter compared with TEE. Despite this, TEE was more strongly correlated to operator choice in device sizing, which may reflect practice patterns. Because compression of the ostium on the device is necessary for long-term procedural success, under-sizing may lead to a higher rate of leaks. Prospective evaluation of the utility of routine fluoroscopic sizing compared with TEE is warranted.

The Safety and Feasibility of Same-Day Discharge After Implantation of MICRA Transcatheter Leadless Pacemaker System.

BACKGROUND: Data suggests that same day discharge after implantation of trans-venous pacemakers is safe and feasible. We sought to determine whether same day discharge was feasible and safe following implantation of Medtronic MICRA leadless pacemakers. METHODS: We retrospectively identified all patients undergoing MICRA placement at our institution between April 2014 to August 2018 (n=167). Patients were stratified into two groups: those discharged on the same day as their procedure (SD, n=25), and those observed for at least one night in the hospital (HD, n=142). The primary endpoint included a composite of major complications including: access site complications, new pericardial effusion, device dislodgement, and need for device revision up to approximately 45 days of follow up. RESULTS: SD and HD had similar age (75±13 vs. 75±13 years, p=0.923), prevalence of male sex (49 vs. 44%, p=0.669), and frequency of high-grade heart block as an indication for pacing (38 vs. 32%, p=0.596). There were more Caucasians in the SD group (72 vs. 66%, p=0.038). The rate of the composite endpoint was statistically non-significantly higher in the HD group (3.5% vs. 0.0%, p=1.00). The rates of each individual components comprising the composite endpoint were similar between groups. CONCLUSIONS: Our data suggest that in appropriately selected patients, same day discharge can occur safely following Micra leadless pacemaker implantation.

Development of a Risk Score to Predict New Pacemaker Implantation After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to define risk factors and develop a predictive risk score for new pacemaker implantation (PMI) after transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR has become an accepted treatment alternative for patients with severe aortic stenosis at elevated surgical risk. New PMI is a common occurrence after TAVR and is associated with poorer outcomes. METHODS: All patients without prior valve procedures undergoing elective TAVR with the Edwards SAPIEN 3 at a single institution (n = 1,266) were evaluated. Multivariate analysis was performed to evaluate for predictors of PMI in this population in a derivation cohort of patients with complete data (n = 778), and this model was used to develop the Emory risk score (ERS), which was tested in a validation cohort (n = 367). RESULTS: Fifty-seven patients (7.3%) in the derivation cohort required PMI. In a regression model, history of syncope (odds ratio [OR]: 2.5; p = 0.026), baseline right bundle branch block (OR: 4.3; p < 0.001), QRS duration ≥138 ms (OR: 2.5; p = 0.017), and valve oversizing >15.6% (OR: 1.9; p = 0.041) remained independent predictors of PMI and were included in the ERS. The ERS was strongly associated with PMI (per point increase OR: 2.2; p < 0.001) with an area under the receiver-operating characteristic curve of 0.778 (p < 0.001), which was similar to its performance in the derivation cohort. CONCLUSIONS: A history of syncope, right bundle branch block, longer QRS duration, and higher degree of oversizing are predictive of the need for PMI after TAVR. Additionally, the ERS for PMI was developed and validated, representing a simple bedside tool to aid in risk stratification for patients for undergoing TAVR.

Outcomes of Micra leadless pacemaker implantation with uninterrupted anticoagulation.

BACKGROUND: Implantation of the MICRA Leadless pacemaker requires the use of a 27 French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagulation exposes patients to increased risks. We sought to investigate the feasibility and safety of continuing therapeutic anticoagulation during the periprocedural period. METHODS: We evaluated all patients undergoing MICRA placement at our institution between April 2014 and August 2018 with complete follow-up data (n = 170). Patients were stratified into two groups: those on active anticoagulation (OAC, n = 26), defined as having an International normalized ratio >2.0 or having continued a direct oral anticoagulant, and those not anticoagulated (Off-OAC, n = 144). We evaluated for a composite outcome of all major complications, including access site complications and pericardial effusion. RESULTS: OAC and Off-OAC groups had similar mean age (74 ± 13 vs 75 ± 13 years; P = .914). The OAC group had a nonsignificantly lower prevalence of end-stage renal disease (8% vs 17%; P = .375) and aspirin use (27% vs 47%; P = .131). Those in the OAC group were more likely to be on warfarin than those in the Off-OAC group (81% vs 30%; P < .001). The rate of the composite endpoint was similar between the OAC and Off-OAC groups (3.8 % vs 1.4%, respectively; P = .761). Length of stay was similar between groups (1.3 ± 2.6 vs 2.3 ± 3.4 days; P = 0.108). CONCLUSION: Continuation of therapeutic anticoagulation during MICRA implantation appears to be feasible, safe and associated with shorter hospitalization among appropriately selected individuals.

Outcomes of percutaneous vacuum-assisted debulking of large vegetations as an adjunct to lead extraction.

BACKGROUND: Consensus statements on lead extraction give consideration to open surgical removal in the setting of large vegetations, to mitigate the risk of massive embolism that may occur with percutaneous lead removal. Vacuum-assisted debulking (VD) of large vegetations as an adjunct to percutaneous lead extraction may provide an opportunity to mitigate these risks. METHODS: We retrospectively identified all patients undergoing lead extraction at our institution for endovascular infection from 2012 to 2018 and stratified them into two groups based on presence of adjunctive VD (n = 6) or without VD (no-VD, n = 39). VD was performed with the AngioVac system (Angio-Dynamics, Latham, NY, USA). RESULTS: Across the cohort, mean age was 62 ± 15 years, ejection fraction was 41 ± 16%, and 39% had end-stage renal disease on dialysis. Defibrillator systems were present in 71%, and 22% had cardiac resynchronization devices. Mean duration of the oldest extracted lead was 6.3 ± 4.9 years. There were no significant differences in baseline covariates between groups. Those in the VD group were significantly less likely to have Staphylococcus aureus as a causative organism (P = .04). In the VD group, vegetations targeted for debulking ranged in size from 1.8 to 6 cm (longest dimension). There were no operative deaths or clinically evident embolic events in either group. The overall nonfatal complication rate in the VD group was higher (33.3% vs 2.3%, P = .043). CONCLUSION: VD can be performed as an adjunct to percutaneous lead extraction with a reasonable safety profile. The relative safety and efficacy of this approach removal requires further study.

Long-term performance of a pacing lead family: A single-center experience.

BACKGROUND: The performance of Abbott/St. Jude Medical (Sylmar CA) Tendril pacing leads has not been well characterized. OBJECTIVE: We sought to assess the performance of Tendril leads as compared with that of different pacing leads. METHODS: We retrospectively identified patients implanted with the following leads: Tendril leads 1888 TC, 2088 TC, and 1688 TC, Medtronic (Fridely, MN) 4076 CapSureFix Novus, and Boston Scientific (Natick, MA) FINELINE II Sterox Pacing EZ leads (models 4469, 4470, and 4471). The primary end point was the incidence of lead malfunction assessed by Kaplan-Meier analysis. RESULTS: During the study period, 9782 leads were implanted, including 8512 Tendril leads, 731 Medtronic 4076 CapSureFix Novus leads, and 539 FINELINE II leads. A total of 540 leads (5.5%) malfunctioned during a mean follow-up of 3.6 ± 2.9 years. Lead malfunction manifested predominantly as noise and/or low impedance (95%). Lead malfunction rates were significantly higher at 5 years for Tendril vs non-Tendril leads (7.0% vs 2.1%; P < .001). The highest rate of failure at 5 years was seen in the Tendril 1888 TC leads (9.9%), followed by Tendril 1688 (5.7%) and Tendril 2088 (5.2%) leads. In contrast, malfunction rates were significantly lower for the Medtronic 4076 (2.6%) and FINELINE II (1.7%) leads. During follow-up to 10 years, the incidence of lead malfunction for Optim-insulated Tendril leads (models 1888 TC and 2088 TC) was significantly higher than that for the non-Optim-insulated Tendril 1688 TC lead (24.5% vs 7.1%) (P = .008). CONCLUSION: Tendril leads appear to have a higher rate of malfunction than do comparator leads. Optim insulation may partly explain the higher failure rate.

Coagulation markers and echocardiography predict atrial fibrillation, malignancy or recurrent stroke after cryptogenic stroke.

We evaluated the utility of left atrial volume index (LAVI) and markers of coagulation and hemostatic activation (MOCHA) in cryptogenic stroke (CS) patients to identify those more likely to have subsequent diagnosis of atrial fibrillation (AF), malignancy or recurrent stroke during follow-up.Consecutive CS patients who met embolic stroke of undetermined source (ESUS) who underwent transthoracic echocardiography and outpatient cardiac monitoring following stroke were identified from the Emory cardiac registry. In a subset of consecutive patients, d-dimer, prothrombin fragment 1.2, thrombin-antithrombin complex and fibrin monomer (MOCHA panel) were obtained ≥2 weeks post-stroke and repeated ≥4 weeks later if abnormal; abnormal MOCHA panel was defined as ≥2 elevated markers which did not normalize when repeated. We assessed the predictive abilities of LAVI and the MOCHA panel to identify patients with subsequent diagnosis of AF, malignancy, recurrent stroke or the composite outcome during follow-up.Of 94 CS patients (mean age 64 ± 15 years, 54% female, 63% non-white, mean follow-up 1.4 ± 0.8 years) who underwent prolonged cardiac monitoring, 15 (16%) had new AF. Severe LA enlargement (vs normal) was associated with AF (P < .06). In 42 CS patients with MOCHA panel testing (mean follow-up 1.1 ± 0.6 years), 14 (33%) had the composite outcome and all had abnormal MOCHA. ROC analysis showed LAVI and abnormal MOCHA together outperformed either test alone with good predictive ability for the composite outcome (AUC 0.84).We report the novel use of the MOCHA panel in CS patients to identify a subgroup of patients more likely to have occult AF, occult malignancy or recurrent stroke during follow-up. A normal MOCHA panel identified a subgroup of CS patients at low risk for recurrent stroke on antiplatelet therapy. Further study is warranted to evaluate whether the combination of an elevated LAVI and abnormal MOCHA panel identifies a subgroup of CS patients who may benefit from early anticoagulation for secondary stroke prevention.

Left Atrial Appendage Occlusion, Shared Decision-Making, and Comprehensive Atrial Fibrillation Management.

The epidemic of atrial fibrillation (AF) requires a comprehensive management strategy that uses the full force of available data and technology, including anticoagulation, ablative therapy, and left atrial appendage occlusion. Patient-centered care with an emphasis on shared decision-making is particularly relevant to the authors' understanding of the complexity of AF and has helped them tailor therapy in this ever-growing patient population.

Increased healthcare utilization associated with complete atrioventricular block in pacemaker patients.

PURPOSE: The purpose of the current study is to characterize and quantify the impact of complete atrioventricular block (cAVB) on heart failure hospitalization (HFH) and healthcare utilization in pacemaker (PM) patients. METHODS: Patients ≥ 18 years implanted with a dual-chamber PM from April 2008 to March 2014 were selected from the MarketScan® Commercial and Medicare Supplemental claims databases. Patients with ≤ 1-year continuous MarketScan enrollment prior to and post-implant, and those with prior HF diagnosis were excluded. Patients were dichotomized into those with cAVB, defined as a 3rd degree AVB diagnosis or AV node ablation in the year prior to PM implant, versus those without any AVB (noAVB). Post-implant HFH and associated costs were compared based on inpatient claims. RESULTS: The study cohort included 21,202 patients, of which 14,208 had no AVB and 6994 had cAVB, followed for 2.39 and 2.27 years, respectively. Patients with cAVB were associated with a significantly increased risk of cumulative HFH (HR 1.59 [95% CI 1.35-1.86] p < 0.001) and significantly higher costs ($636 [609-697] vs $369 [353-405] per pt-year, p < 0.001) compared to those with no AVB. CONCLUSIONS: Among dual-chamber PM patients without prior HF, cAVB is associated with a significantly increased risk of HFH and greater HF-related healthcare utilization. Identifying patients at high risk for HF in the setting of RV pacing, and potentially earlier use of biventricular or selective conduction system pacing, may reduce HF-related healthcare utilization.

Magnetic resonance imaging safety in nonconditional pacemaker and defibrillator recipients: A meta-analysis and systematic review.

BACKGROUND: Recommendations regarding performance of magnetic resonance imaging (MRI) in non-MRI conditional pacemaker and defibrillator recipients are evolving. Previous studies have suggested low adverse event rates with MRI in nonconditional cardiac implantable electronic device (CIED) recipients, but low power limits optimal characterization of risk. OBJECTIVE: The purpose of this study was to perform a systematic review and meta-analysis to characterize the clinical risk associated with MRI in CIED recipients in order to improve power. METHODS: PubMed and CINAHL indexed articles from 1990 to 2017 were queried. A random effects model was used for meta-analysis of continuous variables. Safety outcomes were evaluated with descriptive statistics. RESULTS: Seventy studies of non-MRI conditional devices undergoing MRI were identified, allowing for analysis of 5099 patients who underwent a total of 5908 MRI studies. Heterogeneity in lead parameter changes was observed within studies, although smaller variances were noted between studies. All lead characteristics and battery voltages showed very small, clinically insignificant changes when assessed as a pooled cohort, although cases of clinically relevant outcomes were also noted (lead failure 3, implantable cardioverter-defibrillator shock 1, electrical reset 94). Electrical resets were found only in older devices. Defibrillator function was unchanged, and inappropriate shocks were avoided with pre-MRI programming changes. CONCLUSION: This review demonstrated low lead failure and clinical event rates in non-MRI conditional pacemaker and defibrillator recipients undergoing MRI. Observed changes were small and interstudy variance was low, suggesting that the composite event rates offer a reasonable estimate of true effect. The observed adverse events reinforce the need for ongoing vigilance and caution, particularly with older devices.

Atrial Fibrillation Predictors on Mobile Cardiac Telemetry in Cryptogenic Ischemic Stroke.

BACKGROUND AND PURPOSE: The objective of our study was to evaluate magnetic resonance imaging (MRI) and echocardiographic characteristics that would identify patients with cryptogenic ischemic stroke (IS) and transient ischemic attack (TIA) who subsequently developed paroxysmal atrial fibrillation (PAF) on mobile cardiac outpatient telemetry (MCOT). METHODS: All patients with cryptogenic IS or TIA seen at the Emory University Hospital and Emory University Hospital Midtown from January 1, 2009, to June 30, 2013, who underwent MCOT were included in this analysis. Location (cortical, high subcortical, or neither) of current and prior strokes on MRI and left atrial (LA) functional and anatomical echocardiographic parameters were evaluated to determine their association with subsequent detection of PAF. RESULTS: Of 132 patients, 17 (13%) had evidence of newly diagnosed PAF on MCOT (mean duration of monitoring = 25 days). The presence (vs absence) of ≥1 cortical infarct on baseline MRI was a significant predictor of identifying PAF (odds ratio: 5.2, 95% confidence interval: 1.3-19; P = .01). On baseline echocardiography, patients who had PAF (vs non-PAF) had significantly higher mean LA diameters (4.2 vs 3.7 cm, P = .03) and lower tissue Doppler velocity (a'; 5.5 vs 13.5 cm/s, P = .03). In receiver operating characteristic analysis, the ratio of LA volume index to the septal Doppler velocity (LAVI/a') of >4.6 was associated with a higher likelihood of PAF. Combining MRI with echocardiographic variables did not improve the predictive ability beyond echocardiography alone. CONCLUSION: Although the presence of cortical-based infarcts on MRI in patients with cryptogenic IS or TIA increases the likelihood of detecting PAF on MCOT, LA functional and anatomic parameters alone best predicted which patients subsequently had PAF.