Publications by authors named "Surinder Khelae"

6 Publications

  • Page 1 of 1

Predictors of atrial mechanical sensing and atrioventricular synchrony with a leadless ventricular pacemaker: Results from the MARVEL 2 Study.

Heart Rhythm 2020 Dec 24;17(12):2037-2045. Epub 2020 Jul 24.

NYU Langone Medical Center, New York, New York.

Background: The MARVEL (Micra Atrial TRacking Using a Ventricular AccELerometer) 2 study assessed the efficacy of atrioventricular (AV) synchronous pacing with a Micra leadless pacemaker. Average atrioventricular synchrony (AVS) was 89.2%. Previously, low amplitude of the Micra-sensed atrial signal (A4) was observed to be a factor of low AVS.

Objective: The purpose of this study was to identify predictors of A4 amplitude and high AVS.

Methods: We analyzed 64 patients enrolled in MARVEL 2 who had visible P waves on electrocardiogram for assessing A4 amplitude and 40 patients with third-degree AV block for assessing AVS at rest. High AVS was defined as >90% correct atrial-triggered ventricular pacing. The association between clinical factors and echocardiographic parameters with A4 amplitude was investigated using a multivariable model with lasso variable selection. Variables associated with A4 amplitude together with premature ventricular contraction burden, sinus rate, and sinus rate variability (standard deviation of successive differences of P-P intervals [SDSD]) were assessed for association with AVS.

Results: In univariate analysis, low A4 amplitude was inversely related to atrial function assessed by E/A ratio and e'/a' ratio, and was directly related to atrial contraction excursion (ACE) and atrial strain (Ɛa) on echocardiography (all P ≤.05). The multivariable lasso regression model found coronary artery bypass graft history, E/A ratio, ACE, and Ɛa were associated with low A4 amplitude. E/A ratio and SDSD were multivariable predictors of high AVS, with >90% probability if E/A <0.94 and SDSD <5 bpm.

Conclusion: Clinical parameters and echocardiographic markers of atrial function are associated with A4 signal amplitude. High AVS can be predicted by E/A ratio <0.94 and low sinus rate variability at rest.
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December 2020

The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up.

Heart Rhythm 2020 Jul 19;17(7):1115-1122. Epub 2020 Feb 19.

Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland Ohio.

Background: The World-wide Randomized Antibiotic Envelope Infection Prevention trial reported a 40% reduction in major cardiac implantable electronic device (CIED) infections within 12 months of the procedure with the use of an antibacterial-eluting envelope (TYRX Absorbable Antibacterial Envelope, Medtronic, Mounds View, MN).

Objective: The purpose of this report was to describe the longer-term (>12 months) envelope effects on infection reduction and complications.

Methods: All trial patients who underwent CIED replacement, upgrade, revision, or initial cardiac resynchronization therapy - defibrillator implantation received standard-of-care infection prophylaxis and were randomized in a 1:1 ratio to receive the envelope or not. CIED infection incidence and procedure and system-related complications were characterized through all follow-up (36 months) by using Cox proportional hazards regression modeling.

Results: In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up period 21.0 ± 8.3 months). Major CIED-related infections occurred in 32 envelope patients and 51 control patients (Kaplan-Meier [KM] estimate 1.3% vs 1.9%; hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.41-0.99; P = .046). Any CIED-related infection occurred in 57 envelope patients and 84 control patients (KM estimate 2.1% vs 2.8%; HR 0.69; 95% CI 0.49-0.97; P = .030). System- or procedure-related complications occurred in 235 envelope patients and 252 control patients (KM estimate 8.0% vs 8.2%; HR 0.95; 95% CI 0.79-1.13; P < .001 for noninferiority); the most common were lead dislodgment (1.1%), device lead damage (0.5%), and implant site hematoma (0.4%). Implant site pain occurred less frequently in the envelope group (0.1% vs 0.4%; P = .067). There were no (0.0%) reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics).

Conclusion: The effects of the TYRX envelope on the reduction of the risk of CIED infection are sustained beyond the first year postprocedure, without an increased risk of complications.
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July 2020

Atrioventricular Synchronous Pacing Using a Leadless Ventricular Pacemaker: Results From the MARVEL 2 Study.

JACC Clin Electrophysiol 2020 01 11;6(1):94-106. Epub 2019 Nov 11.

Leon H. Charney Division of Cardiology, NYU Langone Medical Center, New York, New York, USA.

Objectives: This study reports on the performance of a leadless ventricular pacemaker with automated, enhanced accelerometer-based algorithms that provide atrioventricular (AV) synchronous pacing.

Background: Despite many advantages, leadless pacemakers are currently only capable of single-chamber ventricular pacing.

Methods: The prospective MARVEL 2 (Micra Atrial tRacking using a Ventricular accELerometer 2) study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded to the Micra leadless pacemaker for up to 5 h in patients with AV block. The primary efficacy objective was to demonstrate the superiority of the algorithm to provide AV synchronous (VDD) pacing versus VVI-50 pacing in patients with sinus rhythm and complete AV block. The primary safety objective was to demonstrate that the algorithm did not result in pauses or heart rates of >100 beats/min.

Results: Overall, 75 patients from 12 centers were enrolled; an accelerometer-based algorithm was downloaded to their leadless pacemakers. Among the 40 patients with sinus rhythm and complete AV block included in the primary efficacy objective analysis, the proportion of patients with ≥70% AV synchrony at rest was significantly greater with VDD pacing than with VVI pacing (95% vs. 0%; p < 0.001). The mean percentage of AV synchrony increased from 26.8% (median: 26.9%) during VVI pacing to 89.2% (median: 94.3%) during VDD pacing. There were no pauses or episodes of oversensing-induced tachycardia reported during VDD pacing in all 75 patients.

Conclusions: Accelerometer-based atrial sensing with an automated, enhanced algorithm significantly improved AV synchrony in patients with sinus rhythm and AV block who were implanted with a leadless ventricular pacemaker. (Micra Atrial Tracking Using a Ventricular Accelerometer 2 [MARVEL 2]; NCT03752151).
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January 2020

Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies.

Heart Rhythm 2018 09 11;15(9):1363-1371. Epub 2018 May 11.

Department of Cardiology, Kepler University Hospital, Linz, Austria; Paracelsus Medical University Salzburg, Salzburg, Austria.

Background: Micra is a leadless pacemaker that is implanted in the right ventricle and provides rate response via a 3-axis accelerometer (ACC). Custom software was developed to detect atrial contraction using the ACC enabling atrioventricular (AV) synchronous pacing.

Objective: The purpose of this study was to sense atrial contractions from the Micra ACC signal and provide AV synchronous pacing.

Methods: The Micra Accelerometer Sensor Sub-Study (MASS) and MASS2 early feasibility studies showed intracardiac accelerations related to atrial contraction can be measured via ACC in the Micra leadless pacemaker. The Micra Atrial TRacking Using A Ventricular AccELerometer (MARVEL) study was a prospective multicenter study designed to characterize the closed-loop performance of an AV synchronous algorithm downloaded into previously implanted Micra devices. Atrioventricular synchrony (AVS) was measured during 30 minutes of rest and during VVI pacing. AVS was defined as a P wave visible on surface ECG followed by a ventricular event <300 ms.

Results: A total of 64 patients completed the MARVEL study procedure at 12 centers in 9 countries. Patients were implanted with a Micra for a median of 6.0 months (range 0-41.4). High-degree AV block was present in 33 patients, whereas 31 had predominantly intrinsic conduction during the study. Average AVS during AV algorithm pacing was 87.0% (95% confidence interval 81.8%-90.9%), 80.0% in high-degree block patients and 94.4% in patients with intrinsic conduction. AVS was significantly greater (P <.001) during AV algorithm pacing compared to VVI in high-degree block patients, whereas AVS was maintained in patients with intrinsic conduction.

Conclusion: Accelerometer-based atrial sensing is feasible and significantly improves AVS in patients with AV block and a single-chamber leadless pacemaker implanted in the right ventricle.
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September 2018

Beta-blocker use and risk of symptomatic bradyarrhythmias: a hospital-based case-control study.

J Geriatr Cardiol 2016 Sep;13(9):749-759

Department of Cardiology, Sultanah Aminah Hospital, Jalan Masjid Abu Bakar, Johor Bahru, Johor, Malaysia.

Objective: To investigate the risk factors of symptomatic bradyarrhythmias in relation to β-blockers use.

Methods: A hospital-based case-control study [228 patients: 108 with symptomatic bradyarrhythmias (cases) and 120 controls] was conducted in Sultanah Aminah Hospital, Malaysia between January 2011 and January 2014.

Results: The mean age was 61.1 ± 13.3 years with a majority of men (68.9%). Cases were likely than control to be older, hypertensive, lower body mass index and concomitant use of rate-controlling drugs (such as digoxin, verapamil, diltiazem, ivabradine or amiodarone). Significantly higher level of serum potassium, urea, creatinine and lower level of estimated glomerular filtration rate (eGFR) were observed among cases as compared to controls. On univariate analysis among patients on β-blockers, older age (crude OR: 1.07; 95% CI: 1.03-1.11, = 0.000), hypertension (crude OR: 5.6; 95% CI: 1.51-20.72, = 0.010), lower sodium (crude OR: 0.04; 95% CI: 0.81-0.99, = 0.036), higher potassium (crude OR: 2.36; 95% CI: 1.31-4.26, = 0.004) and higher urea (crude OR: 1.23; 95% CI: 1.11-1.38, = 0.000) were associated with increased risk of symptomatic bradyarrhythmias; eGFR was inversely and significantly associated with symptomatic bradyarrhythmias in both 'β-blockers' (crude OR: 0.97; 95% CI: 0.96-0.98, = 0.000) and 'non-β-blockers' (crude OR: 0.99; 95% CI: 0.97-0.99, = 0.023) arms. However, eGFR was not significantly associated with symptomatic bradyarrhythmias in the final model of both 'β-blockers' (adjusted OR: 0.98; 95% CI: 0.96-0.98, = 0.103) and 'non-β-blockers' (adjusted OR: 0.99; 95% CI: 0.97-1.01, = 0.328) arms. Importantly, older age was a significant predictor of symptomatic bradyarrhythmias in the 'β-blockers' as compared to the 'non-β-blockers' arms (adjusted OR: 1.09; 95% CI: 1.03-1.15, = 0.003 . adjusted OR: 1.03; 95% CI: 0.98-1.09, = 0.232, respectively).

Conclusion: Older age was a significant predictor of symptomatic bradyarrhythmias in patients on β-blockers than those without β-blockers.
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September 2016