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Article ; Online: Remote Monitoring for Heart Failure Management at Home.

Stevenson, Lynne Warner / Ross, Heather J / Rathman, Lisa D / Boehmer, John P

Journal of the American College of Cardiology

2023 Volume 81, Issue 23, Page(s) 2272–2291

Abstract: Early telemonitoring of weights and symptoms did not decrease heart failure hospitalizations but helped identify steps toward effective monitoring programs. A signal that is accurate and actionable with response kinetics for early re-assessment is ... ...

Abstract	Early telemonitoring of weights and symptoms did not decrease heart failure hospitalizations but helped identify steps toward effective monitoring programs. A signal that is accurate and actionable with response kinetics for early re-assessment is required for the treatment of patients at high risk, while signal specifications differ for surveillance of low-risk patients. Tracking of congestion with cardiac filling pressures or lung water content has shown most impact to decrease hospitalizations, while multiparameter scores from implanted rhythm devices have identified patients at increased risk. Algorithms require better personalization of signal thresholds and interventions. The COVID-19 epidemic accelerated transition to remote care away from clinics, preparing for new digital health care platforms to accommodate multiple technologies and empower patients. Addressing inequities will require bridging the digital divide and the deep gap in access to HF care teams, who will not be replaced by technology but by care teams who can embrace it.
MeSH term(s)	Humans ; COVID-19 ; Hospitalization ; Heart Failure/diagnosis ; Heart Failure/therapy
Language	English
Publishing date	2023-06-01
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	605507-2
ISSN	1558-3597 ; 0735-1097
ISSN (online)	1558-3597
ISSN	0735-1097
DOI	10.1016/j.jacc.2023.04.010
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Article: Nonhemodynamic parameters from implantable devices for heart failure risk stratification.

Boehmer, John P

Heart failure clinics

2015 Volume 11, Issue 2, Page(s) 191–201

Abstract: Implantable devices are well suited to monitor and record several parameters that carry prognostic information. Specifically, the primary function of implantable cardioverter defibrillators (ICDs) is to monitor for changes in heart rhythm and treat both ...

Abstract	"Implantable devices are well suited to monitor and record several parameters that carry prognostic information. Specifically, the primary function of implantable cardioverter defibrillators (ICDs) is to monitor for changes in heart rhythm and treat both tachyarrhythmias and bradyarrhythmias. They are efficient in monitoring the heart rate, incidence of arrhythmias, and patient activity level, which provide prognostic information. Parameters such as thoracic impedance, heart sounds, and respiratory rate and patterns may further refine prognostic information available from ICDs. Combining parameters may provide a better way to interpret and use the available information."
MeSH term(s)	Arrhythmias, Cardiac/diagnosis ; Arrhythmias, Cardiac/etiology ; Arrhythmias, Cardiac/prevention & control ; Blood Pressure Monitoring, Ambulatory ; Cardiography, Impedance/instrumentation ; Cardiography, Impedance/methods ; Defibrillators, Implantable ; Disease Progression ; Heart Failure/complications ; Heart Failure/diagnosis ; Heart Failure/physiopathology ; Heart Rate ; Humans ; Monitoring, Physiologic/instrumentation ; Monitoring, Physiologic/methods ; Prognosis ; Remote Sensing Technology/instrumentation ; Remote Sensing Technology/methods ; Risk Assessment ; Secondary Prevention
Language	English
Publishing date	2015-04
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2212019-1
ISSN	1551-7136
ISSN	1551-7136
DOI	10.1016/j.hfc.2014.12.001
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Article ; Online: Remote Physiologic Monitoring for Heart Failure.

Ali, Omaima / Hajduczok, Alexander G / Boehmer, John P

Current cardiology reports

2020 Volume 22, Issue 8, Page(s) 68

Abstract: Purpose of review: This review will describe the process of remote monitoring in the treatment of heart failure and the clinical trials for different modalities of data collection.: Recent findings: Small studies monitoring weights, sometimes with ... ...

Abstract	Purpose of review: This review will describe the process of remote monitoring in the treatment of heart failure and the clinical trials for different modalities of data collection. Recent findings: Small studies monitoring weights, sometimes with other parameters, suggested a significant outcome benefit in meta-analysis. However, this has not been seen in larger studies. Clinical trials of remote monitoring using hemodynamic parameters seems to lead to improved outcomes, with more studies underway. Recently, multi-parameter methods with wearable or implantable devices have shown promise in detecting heart failure. The impact on clinical outcomes is being assessed. When using parameters such as daily weights, remote monitoring for heart failure has not been demonstrated to be broadly beneficial, while remote monitoring of hemodynamic parameters to guide heart failure therapy has met with initial success. Methods of combining multiple physiologic measurements appear to accurately detect worsening heart failure, and clinical trials are underway to assess the impact.
MeSH term(s)	Defibrillators, Implantable ; Heart Failure ; Hemodynamics ; Humans ; Monitoring, Physiologic
Language	English
Publishing date	2020-06-19
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2055373-0
ISSN	1534-3170 ; 1523-3782
ISSN (online)	1534-3170
ISSN	1523-3782
DOI	10.1007/s11886-020-01309-x
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Zs.A 5524: Show issues

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Article ; Online: The right prediction.

Boehmer, John P

Journal of the American College of Cardiology

2012 Volume 60, Issue 6, Page(s) 529–530

MeSH term(s)	Female ; Heart Failure/diagnosis ; Heart Failure/surgery ; Heart Ventricles/diagnostic imaging ; Heart-Assist Devices ; Humans ; Male ; Ultrasonography ; Ventricular Dysfunction, Left/surgery ; Ventricular Dysfunction, Right/diagnostic imaging
Language	English
Publishing date	2012-08-07
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	605507-2
ISSN	1558-3597 ; 0735-1097
ISSN (online)	1558-3597
ISSN	0735-1097
DOI	10.1016/j.jacc.2012.04.033
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Article ; Online: Evaluation of Medicare Claims for the Development of Heart Failure Diagnostics.

Wariar, Ramesh / Wen, Gezheng / Jacobsen, Caroline / Ruble, Stephen / Boehmer, John P

Journal of cardiac failure

2021 Volume 28, Issue 5, Page(s) 756–764

Abstract: Background: Although claims data provide a large and efficient source of clinical events, validation is needed prior to use in heart failure (HF) diagnostic development.: Methods and results: Data from the Multisensor Chronic Evaluations in ... ...

Abstract	Background: Although claims data provide a large and efficient source of clinical events, validation is needed prior to use in heart failure (HF) diagnostic development. Methods and results: Data from the Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients (MultiSENSE) study, used to create the HeartLogic HF diagnostic, were linked with fee-for-service (FFS) Medicare claims. Events were matched by patient ID and date, and agreement was calculated between claims primary HF diagnosis codes and study event adjudication. HF events (HFEs) were defined as inpatient visits, or outpatient visits with intravenous decongestive therapy. Diagnostic performance was measured as HFE-detection sensitivity and false-positive rate (FPR). Linkage of 791 MultiSENSE subjects returned 320 FFS patients with an average follow-up duration of 0.94 years. Although study and claims deaths matched exactly (n = 14), matching was imperfect between study hospitalizations and acute inpatient claims events. Of 239 total events, 165 study hospitalizations (69%) matched inpatient claims events, 28 hospitalizations matched outpatient claims events (12%), 14 hospitalizations were study-unique (6%), and 32 inpatient events were claims-unique (13%). Inpatient HF classification had substantial agreement with study adjudication (κ = 0.823). Diagnostic performance was not different between claims and study events (sensitivity = 75.6% vs 77.6% and FPR = 1.539 vs 1.528 alerts/patient-year). HeartLogic-detected events contributed to > 90% of the HFE costs used for evaluation. Conclusions: Acceptable event matching, good agreement of claims diagnostic codes with adjudication, and equivalent diagnostic performance support the validity of using claims for HF diagnostic development.
MeSH term(s)	Aged ; Heart Failure/diagnosis ; Heart Failure/epidemiology ; Heart Failure/therapy ; Hospitalization ; Humans ; Medicare ; United States/epidemiology
Language	English
Publishing date	2021-11-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	1281194-4
ISSN	1532-8414 ; 1071-9164
ISSN (online)	1532-8414
ISSN	1071-9164
DOI	10.1016/j.cardfail.2021.11.008
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Article ; Online: Letter to the editor to update the article "Remote monitoring for heart failure using implantable devices: a systematic review, meta-analysis, and meta-regression of randomized controlled trials".

Hajduczok, Alexander G / Muallem, Samer N / Nudy, Matthew S / DeWaters, Ami L / Boehmer, John P

Heart failure reviews

2021 Volume 27, Issue 3, Page(s) 985–987

Abstract: Our recently published systematic review and meta-analysis of heart failure (HF) remote monitoring using implantable devices (Hajduczok et al. in HF Reviews 1-20, 1) has been updated to reflected new data from the GUIDE-HF trial (Lindenfeld et al. in ... ...

Abstract	Our recently published systematic review and meta-analysis of heart failure (HF) remote monitoring using implantable devices (Hajduczok et al. in HF Reviews 1-20, 1) has been updated to reflected new data from the GUIDE-HF trial (Lindenfeld et al. in Lancet 398(10304):991-1001, 2). Data from randomized controlled trials (RCTs) was assessed to determine the effectiveness of implantable remote monitoring on the improvement of outcomes in HF patients. With the inclusion of the data from 1000 patients followed for 12 months in GUIDE-HF, our conclusions remain unchanged: Compared to standard of care, remote monitoring using implantable devices did not reduce mortality, CV, or HF hospitalizations. However, right ventricular/pulmonary pressure monitoring may reduce HF hospitalizations.
MeSH term(s)	Heart Failure/diagnosis ; Heart Failure/therapy ; Humans ; Monitoring, Physiologic ; Randomized Controlled Trials as Topic
Language	English
Publishing date	2021-11-09
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Review ; Systematic Review ; Comment
ZDB-ID	1336499-6
ISSN	1573-7322 ; 1382-4147
ISSN (online)	1573-7322
ISSN	1382-4147
DOI	10.1007/s10741-021-10190-x
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Article ; Online: Remote monitoring for heart failure using implantable devices: a systematic review, meta-analysis, and meta-regression of randomized controlled trials.

Hajduczok, Alexander G / Muallem, Samer N / Nudy, Matthew S / DeWaters, Ami L / Boehmer, John P

Heart failure reviews

2021 Volume 27, Issue 4, Page(s) 1281–1300

Abstract: In heart failure (HF) patients, remote monitoring using implantable devices may be used to predict and reduce HF exacerbations and mortality. Data from randomized controlled trials (RCTs) was assessed to determine the effectiveness of implantable remote ... ...

Abstract	In heart failure (HF) patients, remote monitoring using implantable devices may be used to predict and reduce HF exacerbations and mortality. Data from randomized controlled trials (RCTs) was assessed to determine the effectiveness of implantable remote monitoring on the improvement of outcomes in HF patients. A systematic review and meta-analysis of RCTs testing remote monitoring versus standard of care for management of HF patients was performed. Primary endpoints were all-cause mortality and a composite of cardiovascular (CV) and HF hospitalizations. Rate ratios (RRs) and 95% confidence intervals (CI) were calculated. A secondary analysis tested for heterogeneity of treatment effect (HTE) comparing right ventricular/pulmonary pressure monitoring versus impedance-based monitoring on hospitalization. A regression analysis was performed using the mean follow-up time as the moderator on each primary endpoint. Eleven RCTs (n = 6196) were identified with a mean follow-up of 21.9 months. The mean age and reported ejection fraction were 64.1 years and 27.7%, respectively. Remote monitoring did not reduce mortality (RR 0.89 [95% CI 0.77, 1.03]) or the composite of CV and HF hospitalizations (RR 0.98 [0.81, 1.19]). Subgroup analysis found significant HTE for hospitalizations between those studies that used right ventricular/pulmonary pressure monitoring versus impedance-based monitoring (I
MeSH term(s)	Heart Failure/diagnosis ; Heart Failure/etiology ; Heart Failure/therapy ; Hospitalization ; Humans ; Prostheses and Implants ; Randomized Controlled Trials as Topic ; Remote Sensing Technology ; Stroke Volume ; Ventricular Function, Left
Language	English
Publishing date	2021-09-24
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Review ; Systematic Review ; Research Support, Non-U.S. Gov't
ZDB-ID	1336499-6
ISSN	1573-7322 ; 1382-4147
ISSN (online)	1573-7322
ISSN	1382-4147
DOI	10.1007/s10741-021-10150-5
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Article ; Online: Multiparameter diagnostic sensor measurements in heart failure patients presenting with SARS-CoV-2 infection.

Gardner, Roy S / Capodilupo, Robert C / Ahmed, Rezwan / Stolen, Craig M / An, Qi / Averina, Viktoria / Hernandez, Adrian F / Boehmer, John P

ESC heart failure

2021 Volume 8, Issue 5, Page(s) 4026–4036

Abstract: Aims: Implantable device-based sensor measurements including heart sounds, markers of ventilation, and thoracic impedance have been shown to predict heart failure (HF) hospitalizations. We sought to assess how these parameters changed prior to COVID-19 ( ...

Abstract	Aims: Implantable device-based sensor measurements including heart sounds, markers of ventilation, and thoracic impedance have been shown to predict heart failure (HF) hospitalizations. We sought to assess how these parameters changed prior to COVID-19 (Cov-19) and how these compared with those presenting with decompensated HF or pneumonia. Methods and results: This retrospective analysis explores patterns of changes in daily measurements by implantable sensors in 10 patients with Cov-19 and compares these findings with those observed prior to HF (n = 88) and pneumonia (n = 12) hospitalizations from the MultiSENSE, PREEMPT-HF, and MANAGE-HF trials. The earliest sensor changes prior to Cov-19 were observed in respiratory rate (6 days) and temperature (5 days). There was a three-fold to four-fold greater increase in respiratory rate, rapid shallow breathing index, and night heart rate compared with those presenting with HF or pneumonia. Furthermore, activity levels fell more in those presenting with Cov-19, a change that was often sustained for some time. In contrast, there were no significant changes in 1st or 3rd heart sound (S Conclusions: Multi-sensor device diagnostics may provide early detection of Cov-19, distinguishable from worsening HF by an extreme and fast rise in respiratory rate along with no changes in S3.
MeSH term(s)	COVID-19 ; Heart Failure/diagnosis ; Hospitalization ; Humans ; Retrospective Studies ; SARS-CoV-2
Language	English
Publishing date	2021-06-28
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2814355-3
ISSN	2055-5822 ; 2055-5822
ISSN (online)	2055-5822
ISSN	2055-5822
DOI	10.1002/ehf2.13500
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Article ; Online: Small decreases in biventricular pacing percentages are associated with multiple metrics of worsening heart failure as measured from a cardiac resynchronization therapy defibrillator.

Cao, Michael / Stolen, Craig M / Ahmed, Rezwan / Schloss, Edward J / Lobban, John H / Kwan, Brian / Varma, Niraj / Boehmer, John P

International journal of cardiology

2021 Volume 335, Page(s) 73–79

Abstract: Background: Lower BiVentricular (BiV) pacing percentages have been associated with significantly worse survival in patients with chronic heart failure (HF). However, the pathophysiology behind this observation has not been further delineated. This ... ...

Abstract	Background: Lower BiVentricular (BiV) pacing percentages have been associated with significantly worse survival in patients with chronic heart failure (HF). However, the pathophysiology behind this observation has not been further delineated. This analysis evaluated whether small incremental decreases in BiV pacing percentages were associated with worse measures, related to HF physiology using individual sensor trends and the HeartLogic composite index. Methods: Sensor data was obtained from 900 ambulatory HF patients with implanted CRT devices. The percent of cardiac cycles with BiV pacing was assessed for periods (median = 7.3 days) between data downloads (median = 55 periods/patient). Results: The third heart sound (S3), respiration rate, RSBI, and night-time heart rate were significantly elevated with sub-optimal pacing (<98%), while the first heart sound (S1), thoracic impedance, and activity were significantly lower. All sensor changes were in the direction associated with worsening HF. While IN the HeartLogic alert state (threshold above an Index of 16) the odds of optimal BiV pacing (≥98%) were less than when OUT of the HeartLogic alert state for a given subject (OR: 0.655; 95% CI: 0.626-0.686; p < 0.0001). The percent BiV pacing was reduced and the HeartLogic Index was increased in the periods surrounding HFhospitalizations. Conclusion: Lower BiV pacing percent is associated with multiple sensor changes indicative of worsening HF, and patients in HeartLogic alert are more likely to have suboptimal BiV pacing. Collectively, these data provide strong evidence that even small decreases in BiV percent pacing can lead to worsening HF.
MeSH term(s)	Benchmarking ; Cardiac Pacing, Artificial ; Cardiac Resynchronization Therapy ; Defibrillators ; Heart Failure/diagnosis ; Heart Failure/therapy ; Heart Rate ; Humans ; Treatment Outcome
Language	English
Publishing date	2021-04-02
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	779519-1
ISSN	1874-1754 ; 0167-5273
ISSN (online)	1874-1754
ISSN	0167-5273
DOI	10.1016/j.ijcard.2021.03.073
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Article ; Online: Design of the remedē System Therapy (rēST) study: A prospective non-randomized post-market study collecting clinical data on safety and effectiveness of the remedē system for the treatment of central sleep apnea.

Goldberg, Lee R / Fox, Henrik / Stellbrink, Christoph / Bozkurt, Biykem / Boehmer, John P / Mora, Jorge I / Doshi, Rahul / Morgenthaler, Timothy I / Levy, Wayne C / Meyer, Timothy E / McKane, Scott W / Germany, Robin

Sleep medicine

2022 Volume 100, Page(s) 238–243

Abstract: Background: Central sleep apnea (CSA) is a disorder defined by lack of respiratory drive from the brain stem on breathing efforts. There is a lack of established therapies for CSA and most available therapies are limited by poor patient adherence, ... ...

Abstract	Background: Central sleep apnea (CSA) is a disorder defined by lack of respiratory drive from the brain stem on breathing efforts. There is a lack of established therapies for CSA and most available therapies are limited by poor patient adherence, limited randomized controlled studies, and potentially adverse cardiovascular effects. The remedē System (ZOLL Respicardia, Inc., Minnetonka, Minnesota) uses transvenous phrenic nerve stimulation to stimulate the diaphragm, thereby restoring a more normal breathing pattern throughout the sleep period. Methods: The remedē System Therapy (rēST) Study is a prospective non-randomized multicenter international study evaluating long-term safety and effectiveness of the remedē System in the post-market setting. Up to 500 adult patients with moderate to severe CSA will be enrolled and followed up to 5 years at approximately 50 sites in the United States and Europe. Safety objectives include evaluation of adverse events related to the implant procedure, device or delivered therapy, death, and hospitalizations. Effectiveness endpoints include assessment of changes in sleep-disordered breathing metrics from polysomnograms and home sleep tests, changes in daytime sleepiness using the Epworth Sleepiness Scale, and changes in QoL using the PROMIS-29 and Patient Global Assessment questionnaires. The subgroup of patients with heart failure will undergo additional assessments including echocardiography to assess cardiac reverse remodeling, 6-min walk distance, QoL assessment by Kansas City Cardiomyopathy Questionnaire and measurement of biomarkers. Conclusion: This will be the largest prospective study evaluating long-term safety and effectiveness of transvenous phrenic nerve stimulation for the treatment of moderate to severe CSA in adult patients.
MeSH term(s)	Adult ; Humans ; Sleep Apnea, Central/therapy ; Sleep Apnea, Central/etiology ; Prospective Studies ; Quality of Life ; Electric Stimulation Therapy/adverse effects ; Electric Stimulation Therapy/methods ; Treatment Outcome
Language	English
Publishing date	2022-09-06
Publishing country	Netherlands
Document type	Clinical Trial ; Multicenter Study ; Journal Article
ZDB-ID	2012041-2
ISSN	1878-5506 ; 1389-9457
ISSN (online)	1878-5506
ISSN	1389-9457
DOI	10.1016/j.sleep.2022.08.026
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