Safety and efficacy of adaptive atrial pacing regulated by blood pressure during low‐level exercise: a proof‐of‐concept study
Aims Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This study aims to compare safety and efficacy of standard pacemaker programming (DDD or DDDR) and a novel pacing algorithm PressurePace™ (BaroPace In...
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| Published in | ESC Heart Failure Vol. 11; no. 4; pp. 2460 - 2463 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
John Wiley & Sons, Inc
01.08.2024
John Wiley and Sons Inc Wiley |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Aims
Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This study aims to compare safety and efficacy of standard pacemaker programming (DDD or DDDR) and a novel pacing algorithm PressurePace™ (BaroPace Inc, Issaquah, WA, USA) which modulates atrial pacing rate based on blood pressure (BPAP).
Methods
This prospective, randomized, double‐blind, non‐significant risk proof of concept study was conducted at two large cardiology clinics in Los Angeles, California, USA. Subjects underwent two modified Bruce protocol graded treadmill exercise tests in which pacemaker programming was randomized to either standard programming (DDD or DDDR), or BPAP at least 1 week apart. Physiological measurements of heart rate (HR), and systolic and diastolic blood pressure (BP) were collected at 2 min intervals. During the BPAP treadmill test, the pacemaker activity sensor was disabled. The PressurePace algorithm instructed the pacemaker technician to modify or leave unchanged the atrial pacing rate based on these BP measurements. Subjects and clinical staff were blinded to pacemaker programming, only the pacemaker technician was unblinded.
Results
Ten subjects with HFpEF associated with hypertension who also had permanent dual‐chamber pacemakers, previously implanted for standard clinical indications, participated in the study. Mean age was 70.1 ± 6.8 years, left ventricular ejection fraction of 54.8 ± 1.9%. Exercise duration increased in all 10 subjects, when paced in the BPAP mode compared with standard pacemaker programming, showing a mean increase of 117 s (26%, P = 0.0016). The algorithm could adjust HR at each 2 min interval. The majority of subjects (60%) had their atrial pacing rate increased an average of 20% at t = 2 min. In the remaining 40% of subjects, the algorithm instructed HR to be unchanged. In two subjects, the pacing rate was not increased until t = 6 min. In contrast, subjects programmed to DDDR experienced an average of 45% increase in atrial pacing rate at t = 2 min. In the post‐treadmill recovery period, SBP was higher for subjects who underwent BPAP. This difference in SBP was most pronounced immediately post‐treadmill and diminished as subjects progressed through the 30 min recovery period. Statistical significance was achieved at t = 0, 20, and 30 min post‐treadmill.
Conclusions
An increase in exercise duration was reported in HFpEF subjects using a pacing algorithm that modulated HR based on BP compared with standard programming. These encouraging results form the basis for a larger, randomized cross‐over trial to confirm these initial observations, further characterize the safety, efficacy, and possible mechanisms of action in both acute and longer‐term treatment. |
|---|---|
| AbstractList | Abstract Aims Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This study aims to compare safety and efficacy of standard pacemaker programming (DDD or DDDR) and a novel pacing algorithm PressurePace™ (BaroPace Inc, Issaquah, WA, USA) which modulates atrial pacing rate based on blood pressure (BPAP). Methods This prospective, randomized, double‐blind, non‐significant risk proof of concept study was conducted at two large cardiology clinics in Los Angeles, California, USA. Subjects underwent two modified Bruce protocol graded treadmill exercise tests in which pacemaker programming was randomized to either standard programming (DDD or DDDR), or BPAP at least 1 week apart. Physiological measurements of heart rate (HR), and systolic and diastolic blood pressure (BP) were collected at 2 min intervals. During the BPAP treadmill test, the pacemaker activity sensor was disabled. The PressurePace algorithm instructed the pacemaker technician to modify or leave unchanged the atrial pacing rate based on these BP measurements. Subjects and clinical staff were blinded to pacemaker programming, only the pacemaker technician was unblinded. Results Ten subjects with HFpEF associated with hypertension who also had permanent dual‐chamber pacemakers, previously implanted for standard clinical indications, participated in the study. Mean age was 70.1 ± 6.8 years, left ventricular ejection fraction of 54.8 ± 1.9%. Exercise duration increased in all 10 subjects, when paced in the BPAP mode compared with standard pacemaker programming, showing a mean increase of 117 s (26%, P = 0.0016). The algorithm could adjust HR at each 2 min interval. The majority of subjects (60%) had their atrial pacing rate increased an average of 20% at t = 2 min. In the remaining 40% of subjects, the algorithm instructed HR to be unchanged. In two subjects, the pacing rate was not increased until t = 6 min. In contrast, subjects programmed to DDDR experienced an average of 45% increase in atrial pacing rate at t = 2 min. In the post‐treadmill recovery period, SBP was higher for subjects who underwent BPAP. This difference in SBP was most pronounced immediately post‐treadmill and diminished as subjects progressed through the 30 min recovery period. Statistical significance was achieved at t = 0, 20, and 30 min post‐treadmill. Conclusions An increase in exercise duration was reported in HFpEF subjects using a pacing algorithm that modulated HR based on BP compared with standard programming. These encouraging results form the basis for a larger, randomized cross‐over trial to confirm these initial observations, further characterize the safety, efficacy, and possible mechanisms of action in both acute and longer‐term treatment. Aims Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This study aims to compare safety and efficacy of standard pacemaker programming (DDD or DDDR) and a novel pacing algorithm PressurePace™ (BaroPace Inc, Issaquah, WA, USA) which modulates atrial pacing rate based on blood pressure (BPAP). Methods This prospective, randomized, double‐blind, non‐significant risk proof of concept study was conducted at two large cardiology clinics in Los Angeles, California, USA. Subjects underwent two modified Bruce protocol graded treadmill exercise tests in which pacemaker programming was randomized to either standard programming (DDD or DDDR), or BPAP at least 1 week apart. Physiological measurements of heart rate (HR), and systolic and diastolic blood pressure (BP) were collected at 2 min intervals. During the BPAP treadmill test, the pacemaker activity sensor was disabled. The PressurePace algorithm instructed the pacemaker technician to modify or leave unchanged the atrial pacing rate based on these BP measurements. Subjects and clinical staff were blinded to pacemaker programming, only the pacemaker technician was unblinded. Results Ten subjects with HFpEF associated with hypertension who also had permanent dual‐chamber pacemakers, previously implanted for standard clinical indications, participated in the study. Mean age was 70.1 ± 6.8 years, left ventricular ejection fraction of 54.8 ± 1.9%. Exercise duration increased in all 10 subjects, when paced in the BPAP mode compared with standard pacemaker programming, showing a mean increase of 117 s (26%, P = 0.0016). The algorithm could adjust HR at each 2 min interval. The majority of subjects (60%) had their atrial pacing rate increased an average of 20% at t = 2 min. In the remaining 40% of subjects, the algorithm instructed HR to be unchanged. In two subjects, the pacing rate was not increased until t = 6 min. In contrast, subjects programmed to DDDR experienced an average of 45% increase in atrial pacing rate at t = 2 min. In the post‐treadmill recovery period, SBP was higher for subjects who underwent BPAP. This difference in SBP was most pronounced immediately post‐treadmill and diminished as subjects progressed through the 30 min recovery period. Statistical significance was achieved at t = 0, 20, and 30 min post‐treadmill. Conclusions An increase in exercise duration was reported in HFpEF subjects using a pacing algorithm that modulated HR based on BP compared with standard programming. These encouraging results form the basis for a larger, randomized cross‐over trial to confirm these initial observations, further characterize the safety, efficacy, and possible mechanisms of action in both acute and longer‐term treatment. Aims Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This study aims to compare safety and efficacy of standard pacemaker programming (DDD or DDDR) and a novel pacing algorithm PressurePace™ (BaroPace Inc, Issaquah, WA, USA) which modulates atrial pacing rate based on blood pressure (BPAP). Methods This prospective, randomized, double‐blind, non‐significant risk proof of concept study was conducted at two large cardiology clinics in Los Angeles, California, USA. Subjects underwent two modified Bruce protocol graded treadmill exercise tests in which pacemaker programming was randomized to either standard programming (DDD or DDDR), or BPAP at least 1 week apart. Physiological measurements of heart rate (HR), and systolic and diastolic blood pressure (BP) were collected at 2 min intervals. During the BPAP treadmill test, the pacemaker activity sensor was disabled. The PressurePace algorithm instructed the pacemaker technician to modify or leave unchanged the atrial pacing rate based on these BP measurements. Subjects and clinical staff were blinded to pacemaker programming, only the pacemaker technician was unblinded. Results Ten subjects with HFpEF associated with hypertension who also had permanent dual‐chamber pacemakers, previously implanted for standard clinical indications, participated in the study. Mean age was 70.1 ± 6.8 years, left ventricular ejection fraction of 54.8 ± 1.9%. Exercise duration increased in all 10 subjects, when paced in the BPAP mode compared with standard pacemaker programming, showing a mean increase of 117 s (26%, P = 0.0016). The algorithm could adjust HR at each 2 min interval. The majority of subjects (60%) had their atrial pacing rate increased an average of 20% at t = 2 min. In the remaining 40% of subjects, the algorithm instructed HR to be unchanged. In two subjects, the pacing rate was not increased until t = 6 min. In contrast, subjects programmed to DDDR experienced an average of 45% increase in atrial pacing rate at t = 2 min. In the post‐treadmill recovery period, SBP was higher for subjects who underwent BPAP. This difference in SBP was most pronounced immediately post‐treadmill and diminished as subjects progressed through the 30 min recovery period. Statistical significance was achieved at t = 0, 20, and 30 min post‐treadmill. Conclusions An increase in exercise duration was reported in HFpEF subjects using a pacing algorithm that modulated HR based on BP compared with standard programming. These encouraging results form the basis for a larger, randomized cross‐over trial to confirm these initial observations, further characterize the safety, efficacy, and possible mechanisms of action in both acute and longer‐term treatment. Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This study aims to compare safety and efficacy of standard pacemaker programming (DDD or DDDR) and a novel pacing algorithm PressurePace™ (BaroPace Inc, Issaquah, WA, USA) which modulates atrial pacing rate based on blood pressure (BPAP). This prospective, randomized, double-blind, non-significant risk proof of concept study was conducted at two large cardiology clinics in Los Angeles, California, USA. Subjects underwent two modified Bruce protocol graded treadmill exercise tests in which pacemaker programming was randomized to either standard programming (DDD or DDDR), or BPAP at least 1 week apart. Physiological measurements of heart rate (HR), and systolic and diastolic blood pressure (BP) were collected at 2 min intervals. During the BPAP treadmill test, the pacemaker activity sensor was disabled. The PressurePace algorithm instructed the pacemaker technician to modify or leave unchanged the atrial pacing rate based on these BP measurements. Subjects and clinical staff were blinded to pacemaker programming, only the pacemaker technician was unblinded. Ten subjects with HFpEF associated with hypertension who also had permanent dual-chamber pacemakers, previously implanted for standard clinical indications, participated in the study. Mean age was 70.1 ± 6.8 years, left ventricular ejection fraction of 54.8 ± 1.9%. Exercise duration increased in all 10 subjects, when paced in the BPAP mode compared with standard pacemaker programming, showing a mean increase of 117 s (26%, P = 0.0016). The algorithm could adjust HR at each 2 min interval. The majority of subjects (60%) had their atrial pacing rate increased an average of 20% at t = 2 min. In the remaining 40% of subjects, the algorithm instructed HR to be unchanged. In two subjects, the pacing rate was not increased until t = 6 min. In contrast, subjects programmed to DDDR experienced an average of 45% increase in atrial pacing rate at t = 2 min. In the post-treadmill recovery period, SBP was higher for subjects who underwent BPAP. This difference in SBP was most pronounced immediately post-treadmill and diminished as subjects progressed through the 30 min recovery period. Statistical significance was achieved at t = 0, 20, and 30 min post-treadmill. An increase in exercise duration was reported in HFpEF subjects using a pacing algorithm that modulated HR based on BP compared with standard programming. These encouraging results form the basis for a larger, randomized cross-over trial to confirm these initial observations, further characterize the safety, efficacy, and possible mechanisms of action in both acute and longer-term treatment. Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This study aims to compare safety and efficacy of standard pacemaker programming (DDD or DDDR) and a novel pacing algorithm PressurePace™ (BaroPace Inc, Issaquah, WA, USA) which modulates atrial pacing rate based on blood pressure (BPAP).AIMSDespite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This study aims to compare safety and efficacy of standard pacemaker programming (DDD or DDDR) and a novel pacing algorithm PressurePace™ (BaroPace Inc, Issaquah, WA, USA) which modulates atrial pacing rate based on blood pressure (BPAP).This prospective, randomized, double-blind, non-significant risk proof of concept study was conducted at two large cardiology clinics in Los Angeles, California, USA. Subjects underwent two modified Bruce protocol graded treadmill exercise tests in which pacemaker programming was randomized to either standard programming (DDD or DDDR), or BPAP at least 1 week apart. Physiological measurements of heart rate (HR), and systolic and diastolic blood pressure (BP) were collected at 2 min intervals. During the BPAP treadmill test, the pacemaker activity sensor was disabled. The PressurePace algorithm instructed the pacemaker technician to modify or leave unchanged the atrial pacing rate based on these BP measurements. Subjects and clinical staff were blinded to pacemaker programming, only the pacemaker technician was unblinded.METHODSThis prospective, randomized, double-blind, non-significant risk proof of concept study was conducted at two large cardiology clinics in Los Angeles, California, USA. Subjects underwent two modified Bruce protocol graded treadmill exercise tests in which pacemaker programming was randomized to either standard programming (DDD or DDDR), or BPAP at least 1 week apart. Physiological measurements of heart rate (HR), and systolic and diastolic blood pressure (BP) were collected at 2 min intervals. During the BPAP treadmill test, the pacemaker activity sensor was disabled. The PressurePace algorithm instructed the pacemaker technician to modify or leave unchanged the atrial pacing rate based on these BP measurements. Subjects and clinical staff were blinded to pacemaker programming, only the pacemaker technician was unblinded.Ten subjects with HFpEF associated with hypertension who also had permanent dual-chamber pacemakers, previously implanted for standard clinical indications, participated in the study. Mean age was 70.1 ± 6.8 years, left ventricular ejection fraction of 54.8 ± 1.9%. Exercise duration increased in all 10 subjects, when paced in the BPAP mode compared with standard pacemaker programming, showing a mean increase of 117 s (26%, P = 0.0016). The algorithm could adjust HR at each 2 min interval. The majority of subjects (60%) had their atrial pacing rate increased an average of 20% at t = 2 min. In the remaining 40% of subjects, the algorithm instructed HR to be unchanged. In two subjects, the pacing rate was not increased until t = 6 min. In contrast, subjects programmed to DDDR experienced an average of 45% increase in atrial pacing rate at t = 2 min. In the post-treadmill recovery period, SBP was higher for subjects who underwent BPAP. This difference in SBP was most pronounced immediately post-treadmill and diminished as subjects progressed through the 30 min recovery period. Statistical significance was achieved at t = 0, 20, and 30 min post-treadmill.RESULTSTen subjects with HFpEF associated with hypertension who also had permanent dual-chamber pacemakers, previously implanted for standard clinical indications, participated in the study. Mean age was 70.1 ± 6.8 years, left ventricular ejection fraction of 54.8 ± 1.9%. Exercise duration increased in all 10 subjects, when paced in the BPAP mode compared with standard pacemaker programming, showing a mean increase of 117 s (26%, P = 0.0016). The algorithm could adjust HR at each 2 min interval. The majority of subjects (60%) had their atrial pacing rate increased an average of 20% at t = 2 min. In the remaining 40% of subjects, the algorithm instructed HR to be unchanged. In two subjects, the pacing rate was not increased until t = 6 min. In contrast, subjects programmed to DDDR experienced an average of 45% increase in atrial pacing rate at t = 2 min. In the post-treadmill recovery period, SBP was higher for subjects who underwent BPAP. This difference in SBP was most pronounced immediately post-treadmill and diminished as subjects progressed through the 30 min recovery period. Statistical significance was achieved at t = 0, 20, and 30 min post-treadmill.An increase in exercise duration was reported in HFpEF subjects using a pacing algorithm that modulated HR based on BP compared with standard programming. These encouraging results form the basis for a larger, randomized cross-over trial to confirm these initial observations, further characterize the safety, efficacy, and possible mechanisms of action in both acute and longer-term treatment.CONCLUSIONSAn increase in exercise duration was reported in HFpEF subjects using a pacing algorithm that modulated HR based on BP compared with standard programming. These encouraging results form the basis for a larger, randomized cross-over trial to confirm these initial observations, further characterize the safety, efficacy, and possible mechanisms of action in both acute and longer-term treatment. |
| Author | Ellenbogen, Kenneth Polosajian, Leo Gang, Eli Burnam, Michael Develle, Robert Nalbandian, Shakeh |
| AuthorAffiliation | 1 BaroPace, Inc Issaquah WA USA 4 Cardiovascular Research Foundation Beverly Hills & Cedars‐Sinai Smidt Heart Institute Los Angeles CA USA 2 Cardiac Rhythm Specialists, Inc Los Angeles CA USA 3 Virginia Commonwealth University School of Medicine Richmond VA USA |
| AuthorAffiliation_xml | – name: 3 Virginia Commonwealth University School of Medicine Richmond VA USA – name: 1 BaroPace, Inc Issaquah WA USA – name: 4 Cardiovascular Research Foundation Beverly Hills & Cedars‐Sinai Smidt Heart Institute Los Angeles CA USA – name: 2 Cardiac Rhythm Specialists, Inc Los Angeles CA USA |
| Author_xml | – sequence: 1 givenname: Michael surname: Burnam fullname: Burnam, Michael organization: BaroPace, Inc – sequence: 2 givenname: Robert surname: Develle fullname: Develle, Robert organization: BaroPace, Inc – sequence: 3 givenname: Leo surname: Polosajian fullname: Polosajian, Leo organization: Cardiac Rhythm Specialists, Inc – sequence: 4 givenname: Shakeh surname: Nalbandian fullname: Nalbandian, Shakeh organization: Cardiac Rhythm Specialists, Inc – sequence: 5 givenname: Kenneth surname: Ellenbogen fullname: Ellenbogen, Kenneth organization: Virginia Commonwealth University School of Medicine – sequence: 6 givenname: Eli surname: Gang fullname: Gang, Eli email: gang@cvmg.com organization: Beverly Hills & Cedars‐Sinai Smidt Heart Institute |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38783689$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1161/CIRCHEARTFAILURE.108.822627 10.1097/00008483‐200603000‐00007 10.1001/jama.2023.0675 10.1016/j.jchf.2018.03.003 10.1161/CIRCULATIONAHA.106.632745 10.1001/jamacardio.2022.5320 |
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| Copyright | 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. 2024. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the "License"). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| Keywords | Exercise tolerance HFpEF Cardiac pacing Chronotropic incompetence Rate adaptive atrial pacing |
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| References | 2018; 6 2009; 2 2023; 8 2023; 329 2006; 114 2006; 26 e_1_2_8_3_1 e_1_2_8_2_1 e_1_2_8_5_1 e_1_2_8_4_1 e_1_2_8_7_1 e_1_2_8_6_1 |
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| Snippet | Aims
Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This... Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This study... Aims Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited. This... Abstract Aims Despite half of all heart failure patients suffering from heart failure with preserved ejection fraction (HFpEF), treatment options are limited.... |
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| SubjectTerms | Aged Algorithms Blood pressure Blood Pressure - physiology Cardiac pacing Cardiac Pacing, Artificial - methods Chronotropic incompetence Conflicts of interest Double-Blind Method Ejection fraction Exercise - physiology Exercise Test Exercise tolerance Female Fitness equipment Heart Atria - physiopathology Heart failure Heart Failure - physiopathology Heart Failure - rehabilitation Heart Failure - therapy Heart rate Heart Rate - physiology HFpEF Humans Hypertension Male Middle Aged Pacemakers Patients Proof of Concept Study Prospective Studies Rate adaptive atrial pacing Short Communication Sinuses Stroke Volume - physiology Treatment Outcome White people |
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| Title | Safety and efficacy of adaptive atrial pacing regulated by blood pressure during low‐level exercise: a proof‐of‐concept study |
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