Ventricular Pacemaker

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Mario Pascual - One of the best experts on this subject based on the ideXlab platform.

  • predictors of atrial mechanical sensing and atrioVentricular synchrony with a leadless Ventricular Pacemaker results from the marvel 2 study
    Heart Rhythm, 2020
    Co-Authors: Christophe Garweg, Clemens Steinwender, Surinder Kaur Khelae, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    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 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 eʹ/aʹ 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 Conclusion Clinical parameters and echocardiographic markers of atrial function are associated with A4 signal amplitude. High AVS can be predicted by E/A ratio

  • atrioVentricular synchronous pacing using a leadless Ventricular Pacemaker results from the marvel 2 study
    JACC: Clinical Electrophysiology, 2020
    Co-Authors: Clemens Steinwender, Surinder Kaur Khelae, Christophe Garweg, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    Abstract Objectives This study reports on the performance of a leadless Ventricular Pacemaker with automated, enhanced accelerometer-based algorithms that provide atrioVentricular (AV) synchronous ...

  • atrioVentricular synchronous pacing using a leadless Ventricular Pacemaker results from the marvel 2 study
    JACC: Clinical Electrophysiology, 2020
    Co-Authors: Clemens Steinwender, Surinder Kaur Khelae, Christophe Garweg, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    Abstract Objectives We report performance of a leadless Ventricular Pacemaker with automated, enhanced accelerometer-based algorithms to provide atrioVentricular (AV) synchronous pacing. Background Despite many advantages, leadless Pacemakers are currently only capable of single-chamber Ventricular pacing. Methods The prospective Micra Atrial tRacking using a Ventricular accELerometer (MARVEL) 2 study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded for up to 5 hours in patients with AV block implanted with a Micra leadless Pacemaker. 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 >100 bpm. Results Overall, 75 patients from 12 centers were enrolled and received a software download of the accelerometer-based algorithm to their leadless Pacemakers. Among the 40 patients with sinus rhythm and complete AV block included in the primary efficacy objective analysis, the percentage of patients with ≥70% AV synchrony at rest was significantly greater with VDD pacing than with VVI pacing (95% vs. 0%, P Conclusion Accelerometer-based atrial sensing with an automated, enhanced algorithm significantly improved AV synchrony in patients with sinus rhythm and AV block implanted with a leadless Ventricular Pacemaker.

Philippe Ritter - One of the best experts on this subject based on the ideXlab platform.

  • predictors of atrial mechanical sensing and atrioVentricular synchrony with a leadless Ventricular Pacemaker results from the marvel 2 study
    Heart Rhythm, 2020
    Co-Authors: Christophe Garweg, Clemens Steinwender, Surinder Kaur Khelae, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    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 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 eʹ/aʹ 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 Conclusion Clinical parameters and echocardiographic markers of atrial function are associated with A4 signal amplitude. High AVS can be predicted by E/A ratio

  • atrioVentricular synchronous pacing using a leadless Ventricular Pacemaker results from the marvel 2 study
    JACC: Clinical Electrophysiology, 2020
    Co-Authors: Clemens Steinwender, Surinder Kaur Khelae, Christophe Garweg, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    Abstract Objectives This study reports on the performance of a leadless Ventricular Pacemaker with automated, enhanced accelerometer-based algorithms that provide atrioVentricular (AV) synchronous ...

  • atrioVentricular synchronous pacing using a leadless Ventricular Pacemaker results from the marvel 2 study
    JACC: Clinical Electrophysiology, 2020
    Co-Authors: Clemens Steinwender, Surinder Kaur Khelae, Christophe Garweg, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    Abstract Objectives We report performance of a leadless Ventricular Pacemaker with automated, enhanced accelerometer-based algorithms to provide atrioVentricular (AV) synchronous pacing. Background Despite many advantages, leadless Pacemakers are currently only capable of single-chamber Ventricular pacing. Methods The prospective Micra Atrial tRacking using a Ventricular accELerometer (MARVEL) 2 study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded for up to 5 hours in patients with AV block implanted with a Micra leadless Pacemaker. 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 >100 bpm. Results Overall, 75 patients from 12 centers were enrolled and received a software download of the accelerometer-based algorithm to their leadless Pacemakers. Among the 40 patients with sinus rhythm and complete AV block included in the primary efficacy objective analysis, the percentage of patients with ≥70% AV synchrony at rest was significantly greater with VDD pacing than with VVI pacing (95% vs. 0%, P Conclusion Accelerometer-based atrial sensing with an automated, enhanced algorithm significantly improved AV synchrony in patients with sinus rhythm and AV block implanted with a leadless Ventricular Pacemaker.

  • the rationale and design of the micra transcatheter pacing study safety and efficacy of a novel miniaturized Pacemaker
    Europace, 2015
    Co-Authors: Philippe Ritter, Gabor Z Duray, Shu Zhang, Calambur Narasimhan, Kyoko Soejima, Razali Omar, Verla Laager, Kurt Stromberg, Eric R Williams, Dwight Reynolds
    Abstract:

    Aims Recent advances in miniaturization technologies and battery chemistries have made it possible to develop a Pacemaker small enough to implant within the heart while still aiming to provide similar battery longevity to conventional Pacemakers. The Micra Transcatheter Pacing System is a miniaturized single-chamber Pacemaker system that is delivered via catheter through the femoral vein. The Pacemaker is implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and insertion of a pacing lead, thereby potentially avoiding some of the complications associated with traditional pacing systems. Methods and results The Micra Transcatheter Pacing Study is currently undergoing evaluation in a prospective, multi-site, single-arm study. Approximately 720 patients will be implanted at up to 70 centres around the world. The study is designed to have a continuously growing body of evidence and data analyses are planned at various time points. The primary safety and efficacy objectives at 6-month post-implant are to demonstrate that (i) the percentage of Micra patients free from major complications related to the Micra system or implant procedure is significantly higher than 83% and (ii) the percentage of Micra patients with both low and stable thresholds is significantly higher than 80%. The safety performance benchmark is based on a reference dataset of 977 subjects from 6 recent Pacemaker studies. Conclusions The Micra Transcatheter Pacing Study will assess the safety and efficacy of a miniaturized, totally endocardial Pacemaker in patients with an indication for implantation of a single-chamber Ventricular Pacemaker. ClinicalTrials.gov registration ID NCT02004873.

Clemens Steinwender - One of the best experts on this subject based on the ideXlab platform.

  • predictors of atrial mechanical sensing and atrioVentricular synchrony with a leadless Ventricular Pacemaker results from the marvel 2 study
    Heart Rhythm, 2020
    Co-Authors: Christophe Garweg, Clemens Steinwender, Surinder Kaur Khelae, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    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 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 eʹ/aʹ 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 Conclusion Clinical parameters and echocardiographic markers of atrial function are associated with A4 signal amplitude. High AVS can be predicted by E/A ratio

  • atrioVentricular synchronous pacing using a leadless Ventricular Pacemaker results from the marvel 2 study
    JACC: Clinical Electrophysiology, 2020
    Co-Authors: Clemens Steinwender, Surinder Kaur Khelae, Christophe Garweg, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    Abstract Objectives This study reports on the performance of a leadless Ventricular Pacemaker with automated, enhanced accelerometer-based algorithms that provide atrioVentricular (AV) synchronous ...

  • atrioVentricular synchronous pacing using a leadless Ventricular Pacemaker results from the marvel 2 study
    JACC: Clinical Electrophysiology, 2020
    Co-Authors: Clemens Steinwender, Surinder Kaur Khelae, Christophe Garweg, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    Abstract Objectives We report performance of a leadless Ventricular Pacemaker with automated, enhanced accelerometer-based algorithms to provide atrioVentricular (AV) synchronous pacing. Background Despite many advantages, leadless Pacemakers are currently only capable of single-chamber Ventricular pacing. Methods The prospective Micra Atrial tRacking using a Ventricular accELerometer (MARVEL) 2 study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded for up to 5 hours in patients with AV block implanted with a Micra leadless Pacemaker. 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 >100 bpm. Results Overall, 75 patients from 12 centers were enrolled and received a software download of the accelerometer-based algorithm to their leadless Pacemakers. Among the 40 patients with sinus rhythm and complete AV block included in the primary efficacy objective analysis, the percentage of patients with ≥70% AV synchrony at rest was significantly greater with VDD pacing than with VVI pacing (95% vs. 0%, P Conclusion Accelerometer-based atrial sensing with an automated, enhanced algorithm significantly improved AV synchrony in patients with sinus rhythm and AV block implanted with a leadless Ventricular Pacemaker.

Christophe Garweg - One of the best experts on this subject based on the ideXlab platform.

  • predictors of atrial mechanical sensing and atrioVentricular synchrony with a leadless Ventricular Pacemaker results from the marvel 2 study
    Heart Rhythm, 2020
    Co-Authors: Christophe Garweg, Clemens Steinwender, Surinder Kaur Khelae, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    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 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 eʹ/aʹ 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 Conclusion Clinical parameters and echocardiographic markers of atrial function are associated with A4 signal amplitude. High AVS can be predicted by E/A ratio

  • atrioVentricular synchronous pacing using a leadless Ventricular Pacemaker results from the marvel 2 study
    JACC: Clinical Electrophysiology, 2020
    Co-Authors: Clemens Steinwender, Surinder Kaur Khelae, Christophe Garweg, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    Abstract Objectives This study reports on the performance of a leadless Ventricular Pacemaker with automated, enhanced accelerometer-based algorithms that provide atrioVentricular (AV) synchronous ...

  • atrioVentricular synchronous pacing using a leadless Ventricular Pacemaker results from the marvel 2 study
    JACC: Clinical Electrophysiology, 2020
    Co-Authors: Clemens Steinwender, Surinder Kaur Khelae, Christophe Garweg, Joseph Yatsun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M Epstein, Jonathan P Piccini, Mario Pascual
    Abstract:

    Abstract Objectives We report performance of a leadless Ventricular Pacemaker with automated, enhanced accelerometer-based algorithms to provide atrioVentricular (AV) synchronous pacing. Background Despite many advantages, leadless Pacemakers are currently only capable of single-chamber Ventricular pacing. Methods The prospective Micra Atrial tRacking using a Ventricular accELerometer (MARVEL) 2 study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded for up to 5 hours in patients with AV block implanted with a Micra leadless Pacemaker. 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 >100 bpm. Results Overall, 75 patients from 12 centers were enrolled and received a software download of the accelerometer-based algorithm to their leadless Pacemakers. Among the 40 patients with sinus rhythm and complete AV block included in the primary efficacy objective analysis, the percentage of patients with ≥70% AV synchrony at rest was significantly greater with VDD pacing than with VVI pacing (95% vs. 0%, P Conclusion Accelerometer-based atrial sensing with an automated, enhanced algorithm significantly improved AV synchrony in patients with sinus rhythm and AV block implanted with a leadless Ventricular Pacemaker.

M Winkuang D Shen - One of the best experts on this subject based on the ideXlab platform.