Effect of implantable loop recorder-based continuous rhythm monitoring on incident atrial fibrillation and stroke: An updated systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: In patients with a history of stroke or those at high risk for developing stroke, a continuous rhythm monitoring strategy using an implantable loop recorder (ILR) is often performed to screen for atrial fibrillation (AF). OBJECTIVES: The purpose of this study was to perform a systematic review (MEDLINE and EMBASE) including randomized controlled trials comparing ILR-based continuous rhythm monitoring vs usual care in patients with a history of stroke or patients at high risk for developing stroke. METHODS: A meta-analysis was performed, and aggregate risk ratio (RR) and risk difference (RD) with 95% confidence interval (CI) were calculated. RESULTS: Four randomized controlled trials with 7237 patients (ILR 2114, non-ILR 5123) were included. ILR vs non-ILR was associated with increased detection of incident AF (RR 3.88; 95% CI 2.23-6.75; P <.00001; number needed to treat [NNT] = 7.7; I2 = 61%), increased appropriate initiation of anticoagulation (RR 2.29; 95% CI 2.07-2.55; P <.00001; NNT = 6.7; I2 = 0), and a 25% lower risk of developing stroke (RR 0.75; 95% CI 0.59-0.95]; P = .02; NNT = 100; I2 = 0%). In patients with history of stroke there was no difference in the risk of developing incident stroke (RR 0.83; 95% CI 0.61-1.14]; P = .25; I2 = 0%). CONCLUSION: Our meta-analysis showed that screening for AF with ILR is associated with increased detection of AF and increased initiation of appropriate anticoagulation therapy in patients with a history of stroke or those with risk factors for stroke. The benefit of stroke risk reduction with ILR remains unclear, and future studies focused on the inclusion of patients without a history of stroke are needed to elucidate this uncertainty.

Interventions in the diagnosis and adoption of pacemaker therapy in sinus node dysfunction patients: Results from the IMPROVE Brady study.

AIMS: IMPROVE Brady assessed whether a process improvement intervention could increase adoption of guideline-based therapy in sinus node dysfunction (SND) patients. METHODS: /Results: IMPROVE Brady was a sequential, prospective, quality improvement initiative conducted in India and Bangladesh. Patients with symptomatic bradycardia were enrolled. In Phase I, physicians assessed and treated patients per standard care. Phase II began after implementing educational materials for physicians and patients. Primary objectives were to evaluate the impact of the intervention on SND diagnosis and pacemaker (PPM) implant. SF-12 quality of life (QoL) and Zarit burden surveys were collected pre- and post-PPM implant. A total of 978 patients were enrolled (57.7 ± 14.8 years, 75% male), 508 in Phase I and 470 in Phase II. The diagnosis of SND and implantation of PPM increased significantly from Phase I to Phase II (72% vs. 87%, P < 0.001 and 17% vs. 32%, P < 0.001, respectively). Pacemaker implantation was not feasible in 41% of patients due to insurance/cost barriers which was unaltered by the intervention. Both patient QoL and caregiver burden improved at 6-months post-PPM implant (P < 0.001). CONCLUSIONS: A process improvement initiative conducted at centers across India and Bangladesh significantly increased the diagnosis of SND and subsequent treatment with PPM therapy despite the socio-economic constraints.

Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker.

AIMS: 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: 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: 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: 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).

Patient selection, pacing indications, and subsequent outcomes with de novo leadless single-chamber VVI pacing.

AIMS: Patient selection is a key component of securing optimal patient outcomes with leadless pacing. We sought to describe and compare patient characteristics and outcomes of Micra patients with and without a primary pacing indication associated with atrial fibrillation (AF) in the Micra IDE trial. METHODS AND RESULTS: The primary outcome (risk of cardiac failure, pacemaker syndrome, or syncope related to the Micra system or procedure) was compared between successfully implanted patients from the Micra IDE trial with a primary pacing indication associated with AF or history of AF (AF group) and those without (non-AF group). Among 720 patients successfully implanted with Micra, 228 (31.7%) were in the non-AF group. Reasons for selecting VVI pacing in non-AF patients included an expectation for infrequent pacing (66.2%) and advanced age (27.2%). More patients in the non-AF group had a condition that precluded the use of a transvenous pacemaker (9.6% vs. 4.7%, P = 0.013). Atrial fibrillation patients programmed to VVI received significantly more ventricular pacing compared to non-AF patients (median 67.8% vs. 12.6%; P < 0.001). The overall occurrence of the composite outcome at 24 months was 1.8% with no difference between the AF and non-AF groups (hazard ratio 1.36, 95% confidence interval 0.45-4.2; P = 0.59). CONCLUSION: Nearly one-third of patients selected to receive Micra VVI therapy were for indications not associated with AF. Non-AF VVI patients required less frequent pacing compared to patients with AF. Risks associated with VVI therapy were low and did not differ in those with and without AF.

Incidence and outcomes of systemic infections in patients with leadless pacemakers: Data from the Micra IDE study.

BACKGROUND: The Micra clinical trials have enrolled more than 2500 patients without any reported device-related infections that required removal during follow-up. Leadless pacemakers might be more resistant to bacterial seeding due to smaller surface area and a greater tendency for encapsulation. OBJECTIVE: To analyze the incidence and outcomes of serious infectious events (SIEs: bacteremia or endocarditis) that developed during follow-up in patients with history of Micra leadless pacemaker implantation. METHODS: SIE and outcomes were characterized based upon adverse event reports. Among 720 patients implanted with Micra in the investigational device exemption trial, we identified 16 patients who had documented 21 SIEs during follow-up. RESULTS: Among patients with SIEs, mean age was 71.9 ± 11.7 years. SIEs occurred at a mean 4.8 ± 4.5 months after implant and patients were followed for 13.1 ± 9.1 months after documentation of SIE. All events were adjudicated as unrelated to the Micra device or procedure. Bacteremia was documented to be related to a gram-positive organism in 13 events (seven Staphylococcus, three Streptococcus, two Enterococcus, and one uncharacterized gram-positive bacteria), and gram-negative organisms in three events. In five events, the type of organism was not characterized (two patients with endocarditis). No persistent cases of bacteremia after antibiotic cessation were seen over the duration of follow-up CONCLUSION: In this small series of Micra patients who developed SIEs postimplant, the occurrence of bacteremia and/or endocarditis did not appear to lead to persistent bacteremia off antibiotics; most events resolved with antibiotic treatment.

Leadless pacemaker implant in patients with pre-existing infections: Results from the Micra postapproval registry.

INTRODUCTION: Leadless pacemakers may provide a safe and attractive pacing option to patients with cardiac implantable electronic device (CIED) infection. We describe the characteristics and outcomes of patients with a recent CIED infection undergoing Micra implant attempt. METHODS AND RESULTS: Patients with prior CIED infection and device explant with Micra implant within 30 days, were identified from the Micra post approval registry. Procedure characteristics and outcomes were summarized. A total of 105 patients with prior CIED infection underwent Micra implant attempt ≤30 days from prior system explant (84 [80%] pacemakers and 13 [12%] ICD/CRT-D). All system components were explanted in 93% of patients and explant occurred a median of 6 days before Micra implant, with 37% occurring on the day of Micra implant. Micra was successfully implanted in 99% patients, mean follow-up duration was 8.5 ± 7.1 months (range 0-28.5). The majority of patients (91%) received IV antibiotics preimplant, while 42% of patients received IV antibiotics postprocedure. The median length of hospitalization following Micra implant was 2 days (IQR, 1-7). During follow-up, two patients died from sepsis and four patients required system upgrade, of which two patients received Micra to provide temporary pacing support. There were no Micra devices explanted due to infection. CONCLUSION: Implantation of the Micra transcatheter pacemaker is safe and feasible in patients with a recent CIED infection. No recurrent infections that required Micra device removal were seen. Leadless pacemakers appear to be a safe pacing alternative for patients with CIED infection who undergo extraction.

Physical activity detection in patients with intracardiac leadless pacemaker.

INTRODUCTION: The Micra Transcatheter Pacing System provides a rate adaptive pacing using an individually programmable three-axis accelerometer. We evaluated the short- and mid-term performance of the Micra activity sensor by testing all three available activity vectors during the exercise tests. METHODS AND RESULTS: Implantation and follow-up data were prospectively collected from the patients undergoing Micra implantation at our institution. Patients underwent a 5-minute exercise test for each vector at predischarge (initial testing) and at scheduled in-office visits (repeat testing). On the basis of measurements of activity counts during the test, vectors were categorized to be adequate (excellent or acceptable) or poor. A total of 278 tests with 818 vector measurements were analyzed in 51 patients during follow-up (median duration was 18 months). Initial testing revealed the adequate quality of the nominal Vector 1 in 74.5% of the patients. Upon repeated testing at subsequent in-office visits, Vectors 1 and 3 were comparable (adequate quality in 64.7% vs 68.6% of the patients; P = 0.65) but better compared with Vector 2 (51.0%; P = 0.10 vs Vector 1, P = 0.01 vs Vector 3). In a subgroup of 45 patients programmed to VVIR mode, Vector 1 was selected in 46.7% of the patients after the initial test (Vector 2, 8.9%; Vector 3, 44.4%). Vector change was performed in 10 patients (22.2%) following repeated tests within 3 months of postimplantation. CONCLUSION: The three-axis accelerometer-based rate adaptive pacing feature proved to be feasible after manual selection of an adequate activity vector. Vector testing in Micra patients with chronotropic incompetence appears to be beneficial compared with the use of nominal Vector 1.

Health-related quality of life impact of a transcatheter pacing system.

BACKGROUND: Transcatheter pacing systems (TPS) provide a novel, minimally invasive approach in which a miniaturized, leadless pacemaker (PM) is transfemorally implanted in the right ventricle. We evaluated the health-related quality of life (HRQoL) impact, patient satisfaction, and activity restrictions following TPS in a large prospective multicenter clinical trial. METHODS AND RESULTS: Patients who underwent a Micra TPS implantation between December 2013 and May 2015 were included. HRQoL impact was evaluated using the Short-Form-36 (SF-36) questionnaire at baseline, 3, and 12 months. Patient satisfaction was assessed using a three-item questionnaire determining recovery, activity level, and esthetic appearance at 3 months. Implanting physicians compared the patient activity restrictions for TPS to traditional PM therapy. A total of 720 patients were implanted with a TPS (76 ± 11 years; 59% male). Of these patients, 702 (98%), 681 (95%), and 635 (88%) completed the SF-36 at baseline, 3 and 12 months, respectively. Improvements were observed at 3 and 12 months in all SF-36 domains and all attained statistical significance. Of 693 patients who completed the patient satisfaction questionnaire, 96%, 91%, 74% were (very) satisfied with their esthetic appearance, recovery, and level of activity, respectively. TPS discharge instructions were rated less restrictive in 49%, equally restrictive in 47%, and more restrictive in 4% of cases compared with traditional PM systems. CONCLUSIONS: TPS resulted in postimplant HRQoL improvements at 3 and 12 months, and high levels of patient satisfaction at 3 months. Further, TPS was associated with less activity restrictions compared with traditional PM systems.

To retrieve, or not to retrieve: System revisions with the Micra transcatheter pacemaker.

BACKGROUND: Early experience with leadless pacemakers has shown a low rate of complications. However, little is known about system revision in patients with these devices. OBJECTIVE: The purpose of this study was to describe the system revision experience with the Micra Transcatheter Pacing System (TPS). METHODS: Patients with implants from the Pre-market Micra Transcatheter Pacing Study and the Micra Transcatheter Pacing System Continued Access Study (N = 989) were analyzed and compared with 2667 patients with transvenous pacemakers (TVPs). Revisions included TPS retrieval/explant, repositioning, replacement, or electrical deactivation (with or without prior attempt at retrieval, generally followed by TVP implant) for any reason. Kaplan-Meier revision rates were calculated to account for varying follow-up duration and were compared using a Fine-Gray competing risk model. RESULTS: The actuarial rate for revision at 24 months postimplant was 1.4% for the TPS group (11 revisions in 10 patients), 75% (95% confidence interval 53%-87%; P < .001) lower than the 5.3% for the TVP group (123 revisions in 117 patients). TPS revisions occurred 5-430 days postimplant for elevated pacing thresholds, need for alternate therapy, pacemaker syndrome, and prosthetic valve endocarditis; none were due to device dislodgment or device-related infection. TPS was disabled and left in situ in 7 cases, 3 were retrieved percutaneously (range 9-406 days postimplant), and 1 was surgically removed during aortic valve surgery. CONCLUSION: The overall system revision rate for patients with TPS at 24 months was 1.4%, 75% lower than that for patients with TVPs. TPS was disabled and left in situ in 64% of revisions, and percutaneous retrieval was successful as late as 14 months postimplant.

Impact of operator experience and training strategy on procedural outcomes with leadless pacing: Insights from the Micra Transcatheter Pacing Study.

BACKGROUND: Leadless pacemaker systems have been designed to avoid the need for a pocket and transvenous lead. However, delivery of this therapy requires a new catheter-based procedure. This study evaluates the role of operator experience and different training strategies on procedural outcomes. METHODS: A total of 726 patients underwent implant attempt with the Micra transcatheter pacing system (TPS; Medtronic, Minneapolis, MN, USA) by 94 operators trained in a teaching laboratory using a simulator, cadaver, and large animal models (lab training) or locally at the hospital with simulator/demo model and proctorship (hospital training). Procedure success, procedure duration, fluoroscopy time, and safety outcomes were compared between training methods and experience (implant case number). RESULTS: The Micra TPS procedure was successful in 99.2% of attempts and did not differ between the 55 operators trained in the lab setting and the 39 operators trained locally at the hospital (P = 0.189). Implant case number was also not a determinant of procedural success (P = 0.456). Each operator performed between one and 55 procedures. Procedure time and fluoroscopy duration decreased by 2.0% (P = 0.002) and 3.2% (P < 0.001) compared to the previous case. Major complication rate and pericardial effusion rate were not associated with case number (P = 0.755 and P = 0.620, respectively). There were no differences in the safety outcomes by training method. CONCLUSIONS: Among a large group of operators, implantation success was high regardless of experience. While procedure duration and fluoroscopy times decreased with implant number, complications were low and not associated with case number. Procedure and safety outcomes were similar between distinct training methodologies.

Implantable Cardioverter Defibrillators for Primary Prevention of Mortality in Patients With Nonischemic Cardiomyopathy: A Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Implantable cardioverter defibrillators (ICDs) improve survival in patients with heart failure due to ischemic cardiomyopathy, but their benefit in nonischemic cardiomyopathy (NICM) has been recently questioned. We performed a meta-analysis of randomized clinical trials to examine the effect of ICDs on total mortality and arrhythmic death in patients with NICM. We also examined the impact of age and cardiac resynchronization therapy (CRT) on the relative effect of ICD compared to control. METHODS AND RESULTS: We searched the MEDLINE and EMBASE databases for randomized trials evaluating the effect of ICD versus control in patients with NICM. Hazard ratios (HR) with 95% confidence interval (CI) were calculated using a random effects model. Six trials involving 2,967 patients were included (ICD, n = 1,553; control, n = 1,414). Based on the pooled estimate across the six studies, the use of ICD was associated with a significant reduction in total mortality (HR = 0.78, 95% CI 0.66-0.92; P = 0.003), as well as arrhythmic death (HR = 0.46, 95% CI 0.29-0.71; P = 0.0005) compared to control. ICD decreased total mortality in younger patients compared to control (HR = 0.63, 95% CI 0.46-0.86; P = 0.004), but not in older patients (HR = 0.97, 95% CI 0.56-1.68; P = 0.92). In patients with CRT, ICD reduced total mortality compared to control (HR = 0.78, 95% CI 0.65-0.95; P = 0.02), but not in patients with CRT (HR = 0.71, 95% CI 0.40-1.26). CONCLUSIONS: ICDs decrease total mortality and arrhythmic deaths in patients with NICM. The benefit of ICD appears to be dependent on age and concomitant use of CRT.

Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study.

BACKGROUND: Early performance of the Micra transcatheter pacemaker from the global clinical trial reported a 99.2% implant success rate, low and stable pacing capture thresholds, and a low (4.0%) rate of major complications up to 6 months. OBJECTIVE: The purpose of this report was to describe the prespecified long-term safety objective of Micra at 12 months and electrical performance through 24 months. METHODS: The Micra Transcatheter Pacing Study was a prospective single-arm study designed to assess the safety and efficacy of the Micra VVIR leadless/intracardiac pacemaker. Enrolled patients met class I or II guideline recommendations for de novo ventricular pacing. The long-term safety objective was freedom from a system- or procedure-related major complication at 12 months. A predefined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates. RESULTS: The long-term safety objective was achieved with a freedom from major complication rate of 96.0% at 12 months (95% confidence interval 94.2%-97.2%; P < .0001 vs performance goal). The risk of major complications for patients with Micra (N = 726) was 48% lower than that for patients with transvenous systems through 12 months postimplant (hazard ratio 0.52; 95% confidence interval 0.35-0.77; P = .001). Across subgroups of age, sex, and comorbidities, Micra reduced the risk of major complications compared to transvenous systems. Electrical performance was excellent through 24 months, with a projected battery longevity of 12.1 years. CONCLUSION: Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.

Long-term outcomes in leadless Micra transcatheter pacemakers with elevated thresholds at implantation: Results from the Micra Transcatheter Pacing System Global Clinical Trial.

BACKGROUND: Device repositioning during Micra leadless pacemaker implantation may be required to achieve optimal pacing thresholds. OBJECTIVE: The purpose of this study was to describe the natural history of acute elevated Micra vs traditional transvenous lead thresholds. METHODS: Micra study VVI patients with threshold data (at 0.24 ms) at implant (n = 711) were compared with Capture study patients with de novo transvenous leads at 0.4 ms (n = 538). In both cohorts, high thresholds were defined as >1.0 V and very high as >1.5 V. Change in pacing threshold (0-6 months) with high (1.0 to ≤1.5 V) or very high (>1.5 V) thresholds were compared using the Wilcoxon signed-rank test. RESULTS: Of the 711 Micra patients, 83 (11.7%) had an implant threshold of >1.0 V at 0.24 ms. Of the 538 Capture patients, 50 (9.3%) had an implant threshold of >1.0 V at 0.40 ms. There were no significant differences in patient characteristics between those with and without an implant threshold of >1.0 V, with the exception of left ventricular ejection fraction in the Capture cohort (high vs low thresholds, 53% vs 58%; P = .011). Patients with an implant threshold of >1.0 V decreased significantly (P < .001) in both cohorts. Micra patients with high and very high thresholds decreased significantly (P < .01) by 1 month, with 87% and 85% having 6-month thresholds lower than the implant value. However, when the capture threshold at implant was >2 V, only 18.2% had a threshold of ≤1 V at 6 months and 45.5% had a capture threshold of >2 V. CONCLUSIONS: Pacing thresholds in most Micra patients with elevated thresholds decrease after implant. Micra device repositioning may not be necessary if the pacing threshold is ≤2 V.

Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial.

AIMS: Although cardiac resynchronization therapy (CRT) is effective in patients with systolic heart failure (HF) and a wide QRS interval, a substantial proportion of patients remain non-responsive. The SonR contractility sensor embedded in the right atrial lead enables individualized automatic optimization of the atrioventricular (AV) and interventricular (VV) timings. The RESPOND-CRT study investigated the safety and efficacy of the contractility sensor system in HF patients undergoing CRT. METHODS AND RESULTS: RESPOND-CRT was a prospective, randomized, double-blinded, multicentre, non-inferiority trial. Patients were randomized (2:1, respectively) to receive weekly, automatic CRT optimization with SonR vs. an Echo-guided optimization of AV and VV timings. The primary efficacy endpoint was the rate of clinical responders (patients alive, without adjudicated HF-related events, with improvement in New York Heart Association class or quality of life), at 12 months. The study randomized 998 patients. Responder rates were 75.0% in the SonR arm and 70.4% in the Echo arm (mean difference, 4.6%; 95% CI, -1.4% to 10.6%; P < 0.001 for non-inferiority margin -10.0%) (Table 2). At an overall mean follow-up of 548 ± 190 days SonR was associated with a 35% risk reduction in HF hospitalization (hazard ratio, 0.65; 95% CI, 0.46-0.92; log-rank P = 0.01). CONCLUSION: Automatic AV and VV optimization using the contractility sensor was safe and as effective as Echo-guided AV and VV optimization in increasing response to CRT. CLINICALTRIALS.GOV NUMBER: NCT01534234.

Rate adaptive pacing in an intracardiac pacemaker.

BACKGROUND: The Micra transcatheter pacemaker was designed to have similar functionality to conventional transvenous VVIR pacing systems. It provides rate adaptive pacing using a programmable 3-axis accelerometer designed to detect patient activity in the presence of cardiac motion. OBJECTIVE: The purpose of this study was to evaluate the system's performance during treadmill tests to maximum exertion in a subset of patients within the Micra Transcatheter Pacing Study. METHODS: Patients underwent treadmill testing at 3 or 6 months postimplant with algorithm programming at physician discretion. Normalized sensor rate (SenR) relative to the programmed upper sensor rate was modeled as a function of normalized workload in metabolic equivalents (METS) relative to maximum METS achieved during the test. A normalized METS and SenR were determined at the end of each 1-minute treadmill stage. The proportionality of SenR to workload was evaluated by comparing the slope from this relationship to the prospectively defined tolerance margin (0.65-1.35). RESULTS: A total of 69 treadmill tests were attempted by 42 patients at 3 and 6 months postimplant. Thirty tests from 20 patients who completed ≥4 stages with an average slope of 0.86 (90% confidence interval 0.77-0.96) confirmed proportionality to workload. On an individual test basis, 25 of 30 point estimates (83.3%) had a normalized slope within the defined tolerance range (range 0.46-1.08). CONCLUSION: Accelerometer-based rate adaptive pacing was proportional to workload, thus confirming rate adaptive pacing commensurate to workload is achievable with an entirely intracardiac pacing system.

Comparison of QT Interval Readings in Normal Sinus Rhythm Between a Smartphone Heart Monitor and a 12-Lead ECG for Healthy Volunteers and Inpatients Receiving Sotalol or Dofetilide.

INTRODUCTION: A variety of medications ranging from antiarrhythmics to psychotropics, as well as conditions such as bradycardia, can prolong the QT interval, increasing the risk for life-threatening arrhythmias. Monitoring the corrected QT interval (QTc) is therefore critical for patient safety. The recent development of smart phone heart monitors (SHM) may allow for easier QTc monitoring. We sought to evaluate the accuracy of an SHM for assessing the QTc, as compared to the standard 12-lead ECG. METHODS AND RESULTS: We compared the QTc interval in lead-I and lead-II between an SHM and 12-lead ECG. Healthy volunteers and hospitalized patients in sinus rhythm being loaded on dofetilide or sotalol were included. Manual and automatic measurements were studied. Across 99 healthy volunteers, the SHM QTc demonstrated good agreement (bias = 4 milliseconds, standard deviation of bias = 11 milliseconds) compared to the 12-lead ECG, using the Bland-Altman method of agreement. Across all hospitalized patients, the SHM was capable of demonstrating QTc prolongation. Between the 12-lead ECG and SHM, lead-I measurements had reasonable agreement (bias = 3 milliseconds, standard deviation of bias = 46 milliseconds). A QTc of > 500 milliseconds was associated with a higher likelihood (OR = 12.0; 95% CI 1.5-111.4; P = 0.02) to not achieve perfect agreement. CONCLUSION: The SHM is accurate in measuring QTc interval in sinus rhythm when compared to 12-lead ECG in healthy volunteers. For patients receiving QT prolonging antiarrhythmics, SHM is capable of detecting QTc prolongation, and lead-I of the SHM is most accurate in measuring the QTc if < 500 milliseconds.

A Leadless Intracardiac Transcatheter Pacing System.

BACKGROUND: A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead. METHODS: In a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up. The primary safety end point was freedom from system-related or procedure-related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation). The safety and efficacy end points were evaluated against performance goals (based on historical data) of 83% and 80%, respectively. We also performed a post hoc analysis in which the rates of major complications were compared with those in a control cohort of 2667 patients with transvenous pacemakers from six previously published studies. RESULTS: The device was successfully implanted in 719 of 725 patients (99.2%). The Kaplan-Meier estimate of the rate of the primary safety end point was 96.0% (95% confidence interval [CI], 93.9 to 97.3; P<0.001 for the comparison with the safety performance goal of 83%); there were 28 major complications in 25 of 725 patients, and no dislodgements. The rate of the primary efficacy end point was 98.3% (95% CI, 96.1 to 99.5; P<0.001 for the comparison with the efficacy performance goal of 80%) among 292 of 297 patients with paired 6-month data. Although there were 28 major complications in 25 patients, patients with transcatheter pacemakers had significantly fewer major complications than did the control patients (hazard ratio, 0.49; 95% CI, 0.33 to 0.75; P=0.001). CONCLUSIONS: In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).