Effect of lead design and pacing vector on electrical parameters of quadripolar coronary sinus leads: The RALLY-X4 study

Abstract Background Various lead designs have been developed to accommodate different coronary sinus anatomies. Our objectives were to compare electrical parameters of straight and spiral left ventricular leads, to evaluate capture thresholds and impedances using different pacing vectors, and to study evolution of thresholds over time. Methods The RALLY-X4 study enrolled patients implanted with a lead from the Acuity X4 family (Straight, Spiral Short or Spiral Long). Electrical parameters (including capture thresholds from all 17 vectors) were measured at baseline and follow-up. Results Data from 795 patients who were successfully implanted were analysed. Straight and spiral leads had similar proportions of patients with thresholds 80% of patients. Pacing vectors significantly affect electrical parameters, with higher thresholds in more proximal electrodes and lower thresholds with unipolar and extended bipolar configurations. Capture thresholds slightly decreased over a mean follow-up of one year. This article is protected by copyright. All rights reservedPeer reviewe

A novel calibration phantom for combining echocardiography with electromagnetic tracking

Ultrasound compounding techniques offer the possibility to enlarge the otherwise limited field of view of ultrasound. However, existing works mainly rely on larger ultrasound sensors. In this work, we attach electromagnetic (EM) tracking sensors to small tubular echo probes, namely an intracardiac echocardiographic (ICE) probe and a transesophageal echocardiographic (TEE) transducer. The EM tracking allows, when synchronized to the ultrasound, localization of the probes in either 5 DOF (Degrees of Freedom) or 6 DOF without line-of-sight requirement. For computation of the references between the two systems, we developed a novel customized 3D-printable phantom, which is especially convenient for tubular probes that acquire images laterally. Calibration with the phantom and 3D volume reconstruction was conducted in the Plus Toolkit. The volume reconstructor uses the captured position and orientation information to fuse 2D ultrasound slices into a compounded volume. Mean calibration error is below 2.5 mm for ICE and TEE. An accuracy evaluation of the 3D reconstruction using an object of known geometry revealed that tracking with 5 DOF provides unsatisfactory results, while the combination of 6 DOF and TEE achieved a mean absolute difference of 3.08 mm. Our calibration phantom fCal-Echo1.0 is openly available at http://perk-software.cs.queensu.ca/plus/doc/nightly/modelcatalog/

Left atrial enlargement and clinical considerations in patients with or without a residual interatrial shunt after closure of the left atrial appendage with the WATCHMAN™-device

Abstract Background Interventional closure of the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation, high thromboembolic and bleeding risk or bleeding history is an alternative therapeutic strategy to oral anticoagulation. It is not known if the exclusion of the LAA from the blood circulation affects the left atrial volume (LAV) and consequently its prognostic value or the circulatory performance of the heart in humans. Methods We aimed to prospectively assess potential changes in baseline LAV, left ventricular ejection fraction (LVEF), NT-proBNP-level and the covered distance in the 6-min walk-test 6 weeks and 6 months after LAA closure with the WATCHMAN™ device. We used serial 3-dimensional transthoracic and transesophageal echocardiography to assess LAV, residual interatrial shunt and device performance in 58 consecutive patients with successful LAA closure. Results Accurate 3D–echocardiographic data for LAV measurements were evaluable for 51 (91%) patients. Maximum LAV (LAVmax) at baseline was 102.8 ± 30.8 ml and increased significantly to 107.7 ± 32.8 ml after 6 weeks (p < 0.01) and 113.5 ± 34.2 ml after 6 months (p < 0.01). Minimal LAV (LAVmin) increased from 76.9 ± 29.5 ml at baseline to 81.8 ± 30.2 ml after 45 days (p < 0.01) and 82.1 ± 33.3 ml after 6 months (p < 0.01). Similarly, their indexes to BSA (LAVImax and LAVImin) increased significantly, as well. Patients without a residual left-to-right interatrial shunt showed a significantly higher increase in LAVmax or LAVmin. Baseline LVEF, NT-proBNP-level or the distance covered at the 6-min walk test did not significantly change 6 weeks or 6 months after LAA closure. Conclusions LAVmax and LAVmin increase significantly after interventional LAA closure. LA enlargement does not correlate with clinical progression of heart failure. Persistent left-to-right interatrial shunt counteracts the LA enlargement. A reduced LA compliance after exclusion of the LAA from the blood circulation with consecutive increase in LA pressure may be a potential cause of LA enlargement and warrants further investigation. Trial registration German Clinical Trials Register ID: DRKS00010768 ; Registration Date 07.07.2016

An Intra-Cycle Optimal Control Framework for Ventricular Assist Devices Based on Atrioventricular Plane Displacement Modeling

A promising treatment for congestive heart failure is the implementation of a left ventricular assist device (LVAD) that works as a mechanical pump. Modern LVADs work with adjustable constant rotor speed and provide therefore continuous blood flow; however, recently undertaken efforts try to mimic pulsatile blood flow by oscillating the pump speed. This work proposes an algorithmic framework to construct and evaluate optimal pump speed policies with respect to generic objectives. We use a model that captures the atrioventricular plane displacement, which is a physiological indicator for heart failure. We employ mathematical optimization to adapt this model to patient specific data and to find optimal pump speed policies with respect to ventricular unloading and aortic valve opening. To this end, we reformulate the cardiovascular dynamics into a switched system and thereby reduce nonlinearities. We consider system switches that stem from varying the constant pump speed and that are state dependent such as valve opening or closing. As a proof of concept study, we personalize the model to a selected patient with respect to ventricular pressure. The model fitting results in a root-mean-square deviation of about 6 mmHg. The optimization that considers aortic valve opening and ventricular unloading results in speed modulation akin to counterpulsation. These in silico findings demonstrate the potential of personalized hemodynamical optimization for the LVAD therapy

Hemodynamic Assessment of the Pathological Left Ventricle Function under Rest and Exercise Conditions

Purpose: The analysis of pathological human left ventricular hemodynamics using high-resolved image-based blood flow simulations shows a major potential for examining mitral valve insufficiency (MI) under exercise conditions. Since capturing and simulating the patient-specific movement of the left ventricle (LV) during rest and exercise is challenging, this study aims to propose a workflow to analyze the hemodynamics within the pathologically moving LV. Methods: Patient-specific ultrasound (US) data of ten patients with MI in different stages were captured with three-dimensional real-time echocardiography. US measurements were performed while patients were resting and while doing handgrip exercise (2–4 min work). Patient-specific hemodynamic simulations were carried out based on the captured ventricular wall movement. Velocity and kinetic energy were analyzed for rest and exercise and for the different MI stages. Results: The results reveal a dependency of the kinetic energy over time in the ventricular volume curves. Concerning the comparison between rest and exercise, the left ventricular function reveals lower systolic kinetic energy under exercise (kinetic energy normalized by EDV; mean ± standard deviation: rest = 0.16 ± 0.14; exercise = 0.06 ± 0.05; p-value = 0.04). Comparing patients with non-limiting (MI I) and mild/moderate (MI II/III) MI, lower velocities (mean ± standard deviation: non-limiting = 0.10 ± 0.03; mild/moderate = 0.06 ± 0.02; p-value = 0.01) and lower diastolic kinetic energy (kinetic energy normalized by EDV; mean ± standard deviation: non-limiting = 0.45 ± 0.30; mild/moderate = 0.20 ± 0.19; p-value = 0.03) were found for the latter. Conclusion: With the proposed workflow, the hemodynamics within LVs with MI can be analyzed under rest and exercise. The results reveal the importance of the patient-specific wall movement when analyzing intraventricular hemodynamics. These findings can be further used within patient-specific simulations, based on varying the imaging and segmentation methods

An evidence map of systematic reviews on models of outpatient care for patients with chronic heart diseases

Abstract Background Chronic heart disease affects millions of people worldwide and the prevalence is increasing. By now, there is an extensive literature on outpatient care of people with chronic heart disease. We aimed to systematically identify and map models of outpatient care for people with chronic heart disease in terms of the interventions included and the outcomes measured and reported to determine areas in need of further research. Methods We created an evidence map of published systematic reviews. PubMed, Cochrane Library (Wiley), Web of Science, and Scopus were searched to identify all relevant articles from January 2000 to June 2021 published in English or German language. From each included systematic review, we abstracted search dates, number and type of included studies, objectives, populations, interventions, and outcomes. Models of care were categorised into six approaches: cardiac rehabilitation, chronic disease management, home-based care, outpatient clinic, telemedicine, and transitional care. Intervention categories were developed inductively. Outcomes were mapped onto the taxonomy developed by the COMET initiative. Results The systematic literature search identified 8043 potentially relevant publications on models of outpatient care for patients with chronic heart diseases. Finally, 47 systematic reviews met the inclusion criteria, covering 1206 primary studies (including double counting). We identified six different models of care and described which interventions were used and what outcomes were included to measure their effectiveness. Education-related and telemedicine interventions were described in more than 50% of the models of outpatient care. The most frequently used outcome domains were death and life impact. Conclusion Evidence on outpatient care for people with chronic heart diseases is broad. However, comparability is limited due to differences in interventions and outcome measures. Outpatient care for people with coronary heart disease and atrial fibrillation is a less well-studied area compared to heart failure. Our evidence mapping demonstrates the need for a core outcome set and further studies to examine the effects of models of outpatient care or different interventions with adjusted outcome parameters. Systematic review registration PROSPERO (CRD42020166330)

Effects of the Peroxisome Proliferator-Activated Receptor-γ Agonist Pioglitazone on Peripheral Vessel Function and Clinical Parameters in Nondiabetic Patients: A Double-Center, Randomized Controlled Pilot Trial

Objective: Despite the advanced therapy with statins, antithrombotics, and antihypertensive agents, the medical treatment of atherosclerotic disease is less than optimal. Therefore, additional therapeutic antiatherosclerotic options are desirable. This pilot study was performed to assess the potential antiatherogenic effect of the peroxisome proliferator-activated receptor-γ agonist pioglitazone in nondiabetic patients. Methods: A total of 54 nondiabetic patients were observed in a prospective, double-blind, placebo-controlled study. Patients were randomized to pioglitazone or placebo. The following efficacy parameters were determined by serial analyses: artery pulse wave analysis and carotid-femoral pulse wave velocity (PWV), static and dynamic retinal vessel function, and the common carotid intima-media thickness (IMT). The main secondary endpoint was the change in different biochemical markers. Results: After 9 months, no relevant differences could be determined in the two treatment groups in PWV (pioglitazone 14.3 ± 4.4 m/s vs. placebo 14.2 ± 4.2 m/s), retinal arterial diameter (pioglitazone 112.1 ± 23.3 μm vs. placebo 117.9 ± 21.5 μm) or IMT (pioglitazone 0.85 ± 0.30 mm vs. placebo 0.79 ± 0.15 mm). Additionally, there were no differences in the change in biochemical markers like cholesteryl ester transfer protein, lowdensity lipoprotein cholesterol, high-sensitivity C-reactive protein or white blood cell count. Conclusions : Treatment with a peroxisome proliferator-activated receptor-γ agonist in nondiabetic patients did not improve the function of large and small peripheral vessels (PPP Trial, clinicaltrialsregister. eu: 2006-000186-11)

Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator:Primary results of the REMOTE-CIED randomized trial

Aims The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD). Methods and results The sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3–6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients’ medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients’ health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed. Conclusion Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation

Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator : primary results of the REMOTE-CIED randomized trial

AIMS: The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD). METHODS AND RESULTS: The sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients' medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed. CONCLUSION: Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586