Faculty Bibliography
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Ambulatory Av synchronous pacing over time using a leadless ventricular pacemaker: Regional experience [Meeting Abstract]
Objectives: Prior proof-of-concept studies demonstrated that accelerometer-based mechanically delivered AV synchronous (AVS) pacing is feasible using a leadless ventricular pacemaker; however, ambulatory performance and maintenance of AVS over time have not been studied.
Method(s): AccelAV was a prospective single-arm study to characterize AVS in patients implanted with a Micra AV, which uses the device accelerometer to mechanically detect atrial contractions and promote VDD pacing. The primary objective was to characterize resting AVS at 1 month in patients with complete AV block (AVB) and normal sinus function.
Result(s): A total of 152 patients were enrolled and implanted with a leadless pacemaker, including 19 patients from Hong Kong. Among patients with normal sinus function and complete AVB (n = 54), the mean resting AVS was 85.4% at 1 month, while ambulatory AVS was 74.5%. Mean resting and ambulatory AVS were similar among Hong Kong patients (n = 7; 85.6% resting, 72.7% ambulatory, p > 0.8). Among patients (n = 20) with programming optimization, the mean ambulatory AVS was 82.6%, representing a 10.5% improvement (p < 0.001). Quality of life as measured by the EQ-5D-3L improved significantly from pre-implant to 3 months (p = 0.031). There were no upgrades to dual-chamber devices or CRT through 3 months.
Conclusion(s): Accelerometer-based mechanical atrial sensing significantly improves the quality in patients with AVB and normal sinus function and a leadless pacemaker implanted in the right ventricle. Mean resting and ambulatory AVS among Hong Kong patients were similar to the overall cohort with an increase in ambulatory AVS among patients with programming optimization. There were no upgrades to dual-chamber pacemakers
Method(s): AccelAV was a prospective single-arm study to characterize AVS in patients implanted with a Micra AV, which uses the device accelerometer to mechanically detect atrial contractions and promote VDD pacing. The primary objective was to characterize resting AVS at 1 month in patients with complete AV block (AVB) and normal sinus function.
Result(s): A total of 152 patients were enrolled and implanted with a leadless pacemaker, including 19 patients from Hong Kong. Among patients with normal sinus function and complete AVB (n = 54), the mean resting AVS was 85.4% at 1 month, while ambulatory AVS was 74.5%. Mean resting and ambulatory AVS were similar among Hong Kong patients (n = 7; 85.6% resting, 72.7% ambulatory, p > 0.8). Among patients (n = 20) with programming optimization, the mean ambulatory AVS was 82.6%, representing a 10.5% improvement (p < 0.001). Quality of life as measured by the EQ-5D-3L improved significantly from pre-implant to 3 months (p = 0.031). There were no upgrades to dual-chamber devices or CRT through 3 months.
Conclusion(s): Accelerometer-based mechanical atrial sensing significantly improves the quality in patients with AVB and normal sinus function and a leadless pacemaker implanted in the right ventricle. Mean resting and ambulatory AVS among Hong Kong patients were similar to the overall cohort with an increase in ambulatory AVS among patients with programming optimization. There were no upgrades to dual-chamber pacemakers
EMBASE:640340364
ISSN: 1883-2148
CID: 5511512
Ambulatory AV synchronous pacing over time using a leadless ventricular pacemaker: Primary results from the AccelAV study
BACKGROUND:Prior studies demonstrated that accelerometer-based mechanically-timed AV synchrony (AVS) is feasible using a leadless ventricular pacemaker. OBJECTIVE:This study reports on the performance of a leadless ventricular pacemaker with accelerometer-based algorithms that provide AVS pacing. METHODS:AccelAV was a prospective single-arm study to characterize AVS in patients implanted with a Micra AV, which uses the device accelerometer to mechanically detect atrial contractions and promote VDD pacing. The primary objective was to characterize resting AVS at 1-month in patients with complete AV block (AVB) and normal sinus function. RESULTS:A total of 152 patients (age 77±11 years, 48% female) from 20 centers were enrolled and implanted with a leadless pacemaker. Among patients with normal sinus function and complete AVB (n=54), mean resting AVS was 85.4% at 1-month, while ambulatory AVS was 74.8%. In the subset of patients (n=20) with programming optimization, mean ambulatory AVS was 82.6%, representing a 10.5% improvement (P<0.001). Quality of life as measured by the EQ-5D-3L improved significantly from pre-implant to 3 months (P=0.031). In 37 patients with AVB at both 1-month and 3-months, mean AVS during rest did not differ (86.1% vs 84.1%, P=0.43). There were no upgrades to dual-chamber devices or CRT through 3 months. CONCLUSION/CONCLUSIONS:Accelerometer-based mechanical atrial sensing provided by a leadless pacemaker implanted in the right ventricle significantly improves quality of life in a select cohort of patients with AV block and normal sinus function. AVS remained stable through 3 months and there were no system upgrades to dual-chamber pacemakers.
PMID: 36075532
ISSN: 1556-3871
CID: 5337172
Correlation between AV synchrony and device collected AM-VP sequence counter in atrioventricular synchronous leadless pacemakers: A real-world assessment
INTRODUCTION/BACKGROUND:Micra atrioventricular (AV) provides leadless atrioventricular synchronous pacing by sensing atrial contraction (A4 signal). Real-world operation and reliability of AV synchrony (AVS) assessment using device data have not been described. The purposes of this study were to (1) assess the correlation between AVS and atrial mechanical sensed-ventricular pacing (AM-VP) percentages in patients with permanent high-degree AV block and (2) report on the real-world effectiveness of Micra AV. METHODS:The correlation between ECG-determined AVS in-clinic and device-collected %AM-VP was assessed using data from 40 patients with high-degree AV block enrolled in the Micra Atrial tRacking using a Ventricular AccELerometer (MARVEL) 2 study. A retrospective analysis to assess continuously-sampled %AM-VP since last session, device programming, and electrical parameters was performed using Micra AV transmissions from the Medtronic CareLink database. Patients with transmissions ≥180 days postimplant were included. RESULTS:at 28 weeks. In patients with %VP >90% (n = 1662), the median %AM-VP was 74.7%. For the full cohort, median %VP was 65.6% and median projected battery longevity was 10.5 years. CONCLUSION/CONCLUSIONS:In patients with a high pacing burden, %AM-VP provides a reasonable estimation of AVS. The first large real-world analysis of Micra AV patients with >90% VP showed stable atrial sensing over time with a median %AM-VP, a correlate of AVS, of 74.7%.
PMID: 36317470
ISSN: 1540-8167
CID: 5358502
A Tool to Integrate Electrophysiological Mapping for Cardiac Radioablation of Ventricular Tachycardia
PURPOSE/UNASSIGNED:Cardiac radioablation is an emerging therapy for recurrent ventricular tachycardia. Electrophysiology (EP) data, including electroanatomic maps (EAM) and electrocardiographic imaging (ECGI), provide crucial information for defining the arrhythmogenic target volume. The absence of standardized workflows and software tools to integrate the EP maps into a radiation planning system limits their use. This study developed a comprehensive software tool to enable efficient utilization of the mapping for cardiac radioablation treatment planning. METHODS AND MATERIALS/UNASSIGNED:After the scar area is outlined on the mapping surface, the tool extracts and extends the annotated patch into a closed surface and converts it into a structure set associated with the anatomic images. The tool then exports the structure set and the images as The Digital Imaging and Communications in Medicine Standard in Radiotherapy for a radiation treatment planning system to import. Overlapping the scar structure on simulation CT, a transmural target volume is delineated for treatment planning. RESULTS/UNASSIGNED:The tool has been used to transfer Ensite NavX EAM data into the Varian Eclipse treatment planning system in radioablation on 2 patients with ventricular tachycardia. The ECGI data from CardioInsight was retrospectively evaluated using the tool to derive the target volume for a patient with left ventricular assist device, showing volumetric matching with the clinically used target with a Dice coefficient of 0.71. CONCLUSIONS/UNASSIGNED:HeaRTmap smoothly fuses EP information from different mapping systems with simulation CT for accurate definition of radiation target volume. The efficient integration of EP data into treatment planning potentially facilitates the study and adoption of the technique.
PMCID:10320498
PMID: 37415904
ISSN: 2452-1094
CID: 5539402
Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker
AIMS/OBJECTIVE:There is limited information on what clinical factors are associated with the development of pericardial effusion after leadless pacemaker implantation. We sought to determine predictors of and to develop a risk score for pericardial effusion in patients undergoing Micra leadless pacemaker implantation attempt. METHODS AND RESULTS/RESULTS:Patients (n = 2817) undergoing implant attempt from the Micra global trials were analysed. Characteristics were compared between patients with and without pericardial effusion (including cardiac perforation and tamponade). A risk score for pericardial effusion was developed from 18 pre-procedural clinical variables using lasso logistic regression. Internal validation and future prediction performance were estimated using bootstrap resampling. The scoring system was also externally validated using data from the Micra Acute Performance European and Middle East (MAP EMEA) registry. There were 32 patients with a pericardial effusion [1.1%, 95% confidence interval (CI): 0.8-1.6%]. Following lasso logistic regression, 11 of 18 variables remained in the model from which point values were assigned. The C-index was 0.79 (95% CI: 0.71-0.88). Patient risk score profile ranged from -4 (lowest risk) to 5 (highest risk) with 71.8% patients considered low risk (risk score ≤0), 16.6% considered medium risk (risk score = 1), and 11.7% considered high risk (risk score ≥2) for effusion. The median C-index following bootstrap validation was 0.73 (interquartile range: 0.70-0.75). The C-index based on 9 pericardial effusions from the 928 patients in the MAP EMEA registry was 0.68 (95% CI: 0.52-0.83). The pericardial effusion rate increased significantly with additional Micra deployments in medium-risk (P = 0.034) and high-risk (P < 0.001) patients. CONCLUSION/CONCLUSIONS:The overall rate of pericardial effusion following Micra implantation attempt is 1.1% and has decreased over time. The risk of pericardial effusion after Micra implant attempt can be predicted using pre-procedural clinical characteristics with reasonable discrimination. CLINICAL TRIAL REGISTRATION/BACKGROUND:The Micra Post-Approval Registry (ClinicalTrials.gov identifier: NCT02536118), Micra Continued Access Study (ClinicalTrials.gov identifier: NCT02488681), and Micra Transcatheter Pacing Study (ClinicalTrials.gov identifier: NCT02004873).
PMID: 35025987
ISSN: 1532-2092
CID: 5118952
Urgent catheter ablation for treatment refractory symptomatic atrial fibrillation: Health care utilization and outcomes
PMID: 35490709
ISSN: 1556-3871
CID: 5215712
Subcutaneous Versus Transvenous Implantable Defibrillator in Patients with Hypertrophic Cardiomyopathy
BACKGROUND:Hypertrophic cardiomyopathy (HCM) is the most prevalent inherited cardiomyopathy. Implantable Cardioverter Defibrillator (ICD) is important for prevention of sudden cardiac death (SCD) in patients at high risk. In recent years the subcutaneous ICD (S-ICD) has emerged as a viable alternative to the transvenous ICD (TV-ICD). The S-ICD does not require intravascular access, but cannot provide antitachycardia pacing therapy (ATP). OBJECTIVE:To assess the real world incidence of ICD therapy in patients with HCM implanted with TV-ICD versus S-ICD. METHODS:We compared the incidence of ATP and shock therapies between all HCM patients with S-ICD and TV-ICD enrolled in the Boston Scientific ALTITUDE database. Cumulative Kaplan Meier incidence was used to compare therapy free survival and Cox proportional hazard ratios were calculated. We performed an unmatched as well as propensity match analysis. RESULTS:We included 2047 patients with TV-ICD and 626 patients with S-ICD followed for an average of 1650.5±1038.5 and 933.4±550.6 days, respectively. Patients with HCM and TV-ICD had significantly higher rate of device therapy as compared to those with S-ICD (32.7 vs. 14.5 therapies /100 patient year; p<0.001), driven by a high incidence of ATP therapy in the TV-ICD group which accounted for more than 67% of therapies delivered. Shock incidence was similar between groups, both in the general and in the matched cohorts. CONCLUSIONS:Patients with HCM and S-ICD had significantly lower therapy rate than patients with TV-ICD without difference in shock therapy, suggesting potentially unnecessary ATP therapy. Empiric ATP programing in patients with HCM may be unbeneficial.
PMID: 35038570
ISSN: 1556-3871
CID: 5131402
Symphony to Leadless pacing - An Ode to Joy [Editorial]
Ludwig van Beethoven's 9th Symphony is regarded by many musicologists as one of the finest works in the history of music. It is notable for several reasons, particularly being the first example of a composer using voices, with words sung by a chorus and vocal soloist in the final movement. This article is protected by copyright. All rights reserved.
PMID: 35233870
ISSN: 1540-8167
CID: 5174422
Author Correction: Genome-wide association analyses identify new Brugada syndrome risk loci and highlight a new mechanism of sodium channel regulation in disease susceptibility
PMID: 35474365
ISSN: 1546-1718
CID: 5205632
The Marvel of Leadless Technology [Editorial]
PMID: 35032671
ISSN: 1556-3871
CID: 5119232
