A comparison of procedure-related adverse events between two right ventricular leadless pacemakers.

INTRODUCTION: The Medtronic Micra VR and Abbott AVEIR VR are the leadless pacemakers (LPM) currently available in the United States (US). Micra VR employs fixation tines and the AVEIR VR uses an active fixation helix. Micra VR requires fixation before electrical measurements are obtained, while R-waves may be mapped by AVEIR VR without fixation. Little comparative data is available for these LPMs. Accordingly, we compared the incidences of procedure-related major adverse clinical events (MACE) and device problems in the US for Micra VR and AVEIR VR during 2022-2024. METHODS: We searched the FDA's Manufacturer and User Facility Device Experience (MAUDE) database for US reports of MACE and device problems that were filed from April 2022 to December 2023 for AVEIR VR, and from June 2022 to April 2024 for Micra VR. Totals for US-registered LPM implants were obtained from the manufacturers' product performance reports. RESULTS: During the study period, 5990 AVEIR VR and 10 940 Micra VR implants were registered in the US. We found 305 MAUDE reports for AVEIR VR (5.1%), versus 541 MAUDE reports for Micra VR (4.9%) (p = .702). The incidence of MACE was 0.72% (43/5990) for AVEIR VR versus 0.59% (65/10 940) for Micra VR, (p = .387). The incidences of procedure-related death, cardiac perforation. cardiac arrest, emergency pericardial drainage or reparative surgery were similar for both LPMs (p > .05). Micra VR had more unacceptable thresholds requiring LPM replacement compared to AVEIR VR (95;0.9% vs. 24;0.4%; p = .001). AVEIR VR had a statistically higher incidence of device dislodgement during (32) and after (21) implant compared to Micra VR (53 (0.9%) vs. 46 (0.4%), p < .001). CONCLUSIONS: Micra VR and AVEIR VR have similar procedural safety profiles, including the incidences of death and perforation. However, device problems differed significantly, possibly related to their design differences. Compared to Micra VR, AVEIR VR appears to have an advantageous threshold measurement capability but is more prone to device dislodgement.

Telehealth of cardiac devices for CVD treatment.

This review covers currently available cardiac implantable electronic devices (CIEDs) as well as updated progress in real-time monitoring techniques for CIEDs. A variety of implantable and wearable devices that can diagnose and monitor patients with cardiovascular diseases are summarized, and various working mechanisms and principles of monitoring techniques for Telehealth and mHealth are discussed. In addition, future research directions are presented based on the rapidly evolving research landscape including Artificial Intelligence (AI).

Pre- and post-procedural cardiac imaging (computed tomography and magnetic resonance imaging) in electrophysiology: a clinical consensus statement of the European Heart Rhythm Association and European Association of Cardiovascular Imaging of the European Society of Cardiology.

Imaging using cardiac computed tomography (CT) or magnetic resonance (MR) imaging has become an important option for anatomic and substrate delineation in complex atrial fibrillation (AF) and ventricular tachycardia (VT) ablation procedures. Computed tomography more common than MR has been used to detect procedure-associated complications such as oesophageal, cerebral, and vascular injury. This clinical consensus statement summarizes the current knowledge of CT and MR to facilitate electrophysiological procedures, the current value of real-time integration of imaging-derived anatomy, and substrate information during the procedure and the current role of CT and MR in diagnosing relevant procedure-related complications. Practical advice on potential advantages of one imaging modality over the other is discussed for patients with implanted cardiac rhythm devices as well as for planning, intraprocedural integration, and post-interventional management in AF and VT ablation patients. Establishing a team of electrophysiologists and cardiac imaging specialists working on specific details of imaging for complex ablation procedures is key. Cardiac magnetic resonance (CMR) can safely be performed in most patients with implanted active cardiac devices. Standard procedures for pre- and post-scanning management of the device and potential CMR-associated device malfunctions need to be in place. In VT patients, imaging-specifically MR-may help to determine scar location and mural distribution in patients with ischaemic and non-ischaemic cardiomyopathy beyond evaluating the underlying structural heart disease. Future directions in imaging may include the ability to register multiple imaging modalities and novel high-resolution modalities, but also refinements of imaging-guided ablation strategies are expected.

Remotely monitored physical activity from older people with cardiac devices associates with physical functioning.

INTRODUCTION: Accelerometer-derived physical activity (PA) from cardiac devices are available via remote monitoring platforms yet rarely reviewed in clinical practice. We aimed to investigate the association between PA and clinical measures of frailty and physical functioning. METHODS: The PATTErn study (A study of Physical Activity paTTerns and major health Events in older people with implantable cardiac devices) enrolled participants aged 60 + undergoing remote cardiac monitoring. Frailty was measured using the Fried criteria and gait speed (m/s), and physical functioning by NYHA class and SF-36 physical functioning score. Activity was reported as mean time active/day across 30-days prior to enrolment (30-day PA). Multivariable regression methods were utilised to estimate associations between PA and frailty/functioning (OR = odds ratio, ß = beta coefficient, CI = confidence intervals). RESULTS: Data were available for 140 participants (median age 73, 70.7% male). Median 30-day PA across the analysis cohort was 134.9 min/day (IQR 60.8-195.9). PA was not significantly associated with Fried frailty status on multivariate analysis, however was associated with gait speed (ß = 0.04, 95% CI 0.01-0.07, p = 0.01) and measures of physical functioning (NYHA class: OR 0.73, 95% CI 0.57-0.92, p = 0.01, SF-36 physical functioning: ß = 4.60, 95% CI 1.38-7.83, p = 0.005). CONCLUSIONS: PA from cardiac devices was associated with physical functioning and gait speed. This highlights the importance of reviewing remote monitoring PA data to identify patients who could benefit from existing interventions. Further research should investigate how to embed this into clinical pathways.

Rhythm-Ready: Harnessing Smart Devices to Detect and Manage Arrhythmias.

PURPOSE OF REVIEW: To survey recent progress in the application of implantable and wearable sensors to detection and management of cardiac arrhythmias. RECENT FINDINGS: Sensor-enabled strategies are critical for the detection, prediction and management of arrhythmias. In the last several years, great innovation has occurred in the types of devices (implanted and wearable) that are available and the data they collect. The integration of artificial intelligence solutions into sensor-enabled strategies has set the stage for a new generation of smart devices that augment the human clinician. Smart devices enhanced by new sensor technologies and Artificial Intelligence (AI) algorithms promise to reshape the care of cardiac arrhythmias.

CAR and CSTR Cardiac Computed Tomography (CT) Practice Guidelines: Part 2-Non-Coronary Imaging.

The cardiac computed tomography (CT) practice guidelines provide an updated review of the technological improvements since the publication of the first Canadian Association of Radiologists (CAR) cardiac CT practice guidelines in 2009. An overview of the current evidence supporting the use of cardiac CT in the most common clinical scenarios, standards of practice to optimize patient preparation and safety as well as image quality are described. Coronary CT angiography (CCTA) is the focus of Part I. In Part II, an overview of cardiac CT for non-coronary indications that include valvular and pericardial imaging, tumour and mass evaluation, pulmonary vein imaging, and imaging of congenital heart disease for diagnosis and treatment monitoring are discussed. The guidelines are intended to be relevant for community hospitals and large academic centres with established cardiac CT imaging programs.

Balanced Steady-State Free Precession Cine MR Imaging in the Presence of Cardiac Devices: Value of Interleaved Radial Linear Combination Acquisition With Partial Dephasing.

BACKGROUND: Balanced steady-state free precession (bSSFP) is important in cardiac MRI but suffers from off-resonance artifacts. The interpretation-limiting artifacts in patients with cardiac implants remain an unsolved issue. PURPOSE: To develop an interleaved radial linear combination bSSFP (lcSSFP) method with partial dephasing (PD) for improved cardiac cine imaging when implanted cardiovascular devices are present. STUDY TYPE: Prospective. PHANTOM AND SUBJECTS: Flow phantom adjacent to a pacemaker and 10 healthy volunteers (mean age ± standard deviation: 31.9 ± 2.9 years, 4 females) with a cardioverter-defibrillator (ICD) positioned extracorporeally at the left chest in the prepectoral region. FIELD STRENGTH/SEQUENCE: A 3-T, 1) Cartesian bSSFP, 2) Cartesian gradient echo (GRE), 3) Cartesian lcSSFP, and 4) radial lcSSFP cine sequences. ASSESSMENT: Flow artifacts mitigation using PD was validated with phantom experiments. Undersampled radial lcSSFP with interleaving across phase-cyclings and cardiac phases (RLC-SSFP), combined with PD, was then employed for achieving improved quality of cine images from left ventricular short-axis view. The image quality in the presence of cardiac devices was qualitatively assessed by three independent raters (1 = worst, 5 = best), regarding five criteria (banding artifacts, streak artifacts, flow artifacts, cavity visibility, and overall image quality). STATISTICAL TESTS: Wilcoxon rank-sum test for the five criteria between Cartesian bSSFP cine and RLC-SSFP with PD. Fleiss kappa test for inter-reader agreement. A P value < 0.05 was considered statistically significant. RESULTS: Based on simulations and phantom experiments, 60 projections per phase cycling and 1/6 PD were chosen. The in vivo experiments demonstrated significantly reduced banding artifacts (4.8 ± 0.4 vs. 2.7 ± 0.7), fewer streak artifacts (3.7 ± 0.6 vs. 2.6 ± 0.7) and flow artifacts (4.4 ± 0.4 vs. 3.7 ± 0.6), therefore improved cavity visibility (4.1 ± 0.4 vs. 2.9 ± 0.9) and overall quality (4.0 ± 0.4 vs. 2.7 ± 0.7). DATA CONCLUSION: RLC-SSFP method with PD may improve cine image quality in subjects with cardiac devices. EVIDENCE LEVEL: 2. TECHNICAL EFFICACY: Stage 1.

Infective endocarditis involving MitraClip© devices: a systematic literature review.

PURPOSE: Progress of interventional cardiology has boosted the use of newer cardiac devices. These devices are perceived to be less prone to infections compared to traditional surgical prostheses, but little data are currently available. In this systematic review (SR), we summarize current literature regarding the clinical characteristics, management, and outcomes of patients with MitraClip-related infective endocarditis (IE). METHODS: We conducted a SR of PubMed, Google Scholar, Embase, and Scopus between January 2003 and March 2022. MitraClip-related IE was defined according to 2015 ESC criteria whereas MitraClip involvement as vegetation on the device or on the mitral valve. Risk of bias was assessed through standardized checklist and potential bias of underestimation cannot be excluded. Data regarding clinical presentation, echocardiography, management, and outcome were collected. RESULTS: Twenty-six cases of MitraClip-related IE were retrieved. The median age of patients was 76 [61-83] years with a median EuroScore of 41%. Fever was present in 65.8% of patients followed by signs and symptoms of heart failure (42.3%). IE occurred early in 20 (76.9%) cases with a median time between MitraClip implantation and IE symptom onset of 5 [2-16] months. Staphylococcus aureus was the major causative microorganism (46%). Surgical mitral valve replacement was needed in 50% of patients. A conservative medical approach was considered in the remainder. The overall in-hospital mortality rate was 50% (surgical group: 38.4%; medical group: 58.3%; p = 0.433). CONCLUSION: Our results suggest that MitraClip-related IE affects elderly, comorbid patients, is mostly due to Staphylococcus aureus, and has a poor prognosis irrespective of the therapeutic approach. Clinicians must be aware of the features of this new entity among cardiovascular infections.

Pharmacological options for Candida albicans Endocarditis at the roadblock with irrecoverable prosthetics and drug interactions: a case report and review of literature.

BACKGROUND: Candidemia is the fourth most common nosocomial bloodstream infection. Endocarditis from candidemia is a rare but possibly fatal complication. The efficacy of amphotericin and echinocandins for induction and azoles for suppression has been well studied. Source control of infection, including removal of foreign bodies, remains the cornerstone for the success of any antifungal therapy. CASE PRESENTATION: We are describing a case of a 63-years old patient with multiple comorbidities who developed candidemia secondary to Candida albicans. The prospect of curing the fungemia was made difficult by prosthetic devices, including prosthetic heart valves, intracardiac defibrillator, and inferior vena filter, which could not be extracted due to poor cardiovascular status and higher postoperative mortality risk. Combination therapy with amphotericin and 5-Flucytosine (5FC) was used with the first recurrence. Suppression with fluconazole was contraindicated due to prolonged corrected QT (QTc) interval. Isavuconazole was employed for chronic lifelong suppression. CONCLUSION: Retaining prosthetics in higher surgical risk patients presents us with unique clinical and pharmacological challenges regarding breakthrough infections, drug interaction, and side effects from prolonged suppressive therapies.

Evaluating the magnet response in deep subcutaneous implanted cardioverter defibrillator implants.

INTRODUCTION: The manufacturer of subcutaneous implantable cardioverter defibrillators (S-ICDs) acknowledges that 'deep implants' may fail to elicit a magnet response, however, does not define 'deep implant' or recommend a maximum implant depth. This study aims to systematically evaluate the effect of subcutaneous tissue depth and magnet types on evoked magnet response. METHODS: Sunshine Coast University Hospital's S-ICD cohort underwent magnet response evaluation; where bar and donut magnets were compared and the evoked magnet response was recorded in three separate zones, guided by a template. Ordinal regression (OR) models assessed the relationship between the evoked magnet response and tissue depth (TD), measured via post-implant X-Ray. The patient's ability to hear the magnet response audible tone was recorded. RESULTS: Patients (n = 39) with measurable TD (n = 30) were analyzed. The bar magnet evoked a magnet response in all zones in 53% of patients, compared with 73% of patients with the donut magnet (p = 0.18). The relationship between bar magnet response and TD showed the odds of an evoked magnet response decreased by 11% every 1 mm increase in TD (OR of 0.89, p < 0.01), whereas the donut magnet decreased by 16% per 1 mm (OR of 0.84, p < 0.01). Directly over the S-ICD was the most effective in evoking magnet response with the bar (85% of patients), and off-centre was most effective for the donut magnet (100%). BMI and Praetorian score were not significantly associated with magnet response. We found 23% of patients were unable to detect the audible tone. CONCLUSION: We observed a statistically significant association between TD and ability to evoke magnet response. The bar magnet was less reliable than the donut magnet for therapy inhibition in deep implants.

Insights of tricuspid regurgitation mechanisms in patients with right ventricular apical pacing by three-dimensional echocardiography.

OBJECTIVE: Device lead-induced tricuspid regurgitation (LITR) mechanisms are well-defined by 3D transthoracic echocardiography (3D-TTE). There is a lack of data on the Latin-American population. The objective of this study was to describe the prevalence of several mechanisms and insights in patients with permanent right ventricular (RV) implanted devices by 3D-TTE examination. METHODS: We performed a cross-sectional analysis of 101 patients with permanent cardiac devices such as pacemakers or defibrillators. 3D-TTE was obtained on all patients in RV-focused apical views to perform a complete tricuspid valve (TV) evaluation: leaflets, subvalvular apparatus, precise lead location, and functional assessment to evaluate possible mechanisms of tricuspid regurgitation (TR). RESULTS: In a total of 101 patients, the leads did not interfere with TV function in 53 p. (59%), while LITR was observed in 38 (41%) patients. Adherent, impinging, entangled, and mixed lead-induced mechanisms were observed. Time in years since device implantation was significantly higher in patients with LITR. CONCLUSIONS: LITR was present in a high proportion of our population. LITR is the result of damage to the TV as well as its subvalvular apparatus due to the fibrotic and inflammatory response over time when leads are situated in unfavorable locations.

Diagnostic electrocardiographic trap: A case of conduction system pacing.

His-bundle pacing (HBP) is a relatively new method of cardiac pacing, with recent studies showing an association between HBP and a lower risk of developing right ventricular heart failure compared to classical pacing methods. However, HBP is also associated with a higher risk of lead dislodgement, undersensing, and loss of capture. As such, a detailed assessment of pacing effectiveness in pacemaker patients is vital. In the presented case, an electrocardiogram (ECG) recording seems to present successful selective His-bundle pacing, while pacemaker follow-up demonstrated the loss of ventricular capture. In conclusion, patients receiving HBP should undergo ECG alongside pacing parameter analysis and pacing electrograms, as differences in successful and unsuccessful pacing ECG can be very subtle.

Analysis of the use of empiric antimicrobial prophylaxis for temporary cardiac devices at a large academic medical center.

INTRODUCTION: Varying rates of access site infections with temporary percutaneous cardiac devices have been reported in the literature. The purpose of this study is to determine the impact of a change in institutional practice in utilizing antimicrobial prophylaxis to prevent access site infections in patients with these devices. METHODS: This observational, pre-post implementation analysis evaluated the benefit of prophylactic antimicrobial therapy in adult patients with temporary percutaneous cardiac devices admitted to cardiac intensive care units. Patients in the pre-cohort received prophylactic antibiotics for the duration of device insertion. Patients in the post-cohort received a single dose of intravenous antibiotics for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or Impella® 5.5 device placement, and no antimicrobial prophylaxis for all other devices placed. The primary endpoint was the incidence of definitive access site infection. Secondary endpoints included the incidence of Clostridium difficile infection and initiation of broad-spectrum antibiotics. RESULTS: Fifty patients in the pre-cohort and 45 patients in the post-cohort were evaluated. Devices included intra-aortic balloon pumps, VA-ECMO, Impella® CP and Impella® 5.5. The median duration of device insertion was four days. No significant difference in the primary outcome was seen between the two groups. A significant reduction in prophylactic antimicrobial utilization and total days of antimicrobial exposure was observed in the post-implementation cohort. CONCLUSION: Based on the results of our study, the implemented guideline reduces the utilization of antimicrobial prophylaxis in patients with temporary percutaneous cardiac devices and does not result in an increased rate of infections.

Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure.

BACKGROUND: Patients with heart failure (HF) and reduced ejection fraction suffer from a relapsing and remitting disease course, where early treatment changes may improve outcomes. We assessed the clinical integration and safety of the HeartLogic multisensor index and alerts in HF care. METHODS: The Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) study enrolled 200 patients with HF and reduced ejection fraction (<35%), New York Heart Association functional class II-III symptoms, implanted with a cardiac resynchronization therapy-defibrillator or and implantable cardioverter defibrillator, who had either a hospitalization for HF within 12 months or unscheduled visit for HF exacerbation within 90 days or an elevated natriuretic peptide concentration (brain natriuretic peptide [BNP] of ≥150 pg/mL or N-terminal pro-BNP [NT-proBNP] of ≥600 pg/mL). This phase included the development of an alert management guide and evaluated changes in medical treatment, natriuretic peptide levels, and safety. RESULTS: The mean age of participants was 67 years, 68% were men, 81% were White, and 61% had a HF hospitalization in prior 12 months. During follow-up, there were 585 alert cases with an average of 1.76 alert cases per patient-year. HF medications were augmented during 74% of the alert cases. HF treatment augmentation within 2 weeks from an initial alert was associated with more rapid recovery of the HeartLogic Index. Five serious adverse events (0.015 per patient-year) occurred in relation to alert-prompted medication change. NTproBNP levels decreased from median of 1316 pg/mL at baseline to 743 pg/mL at 12 months (P < .001). CONCLUSIONS: HeartLogic alert management was safely implemented in HF care and may optimize HF management. This phase supports further evaluation in larger studies. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03237858).

Different venous approaches for implantation of cardiac electronic devices. A network meta-analysis.

OBJECTIVES: Many of the complications arising from cardiac device implantation are associated to the venous access used for lead placement. Previous analyses reported that cephalic vein cutdown (CVC) is safer but less effective than subclavian vein puncture (SVP). However, comparisons between these techniques and axillary vein puncture (AVP) - guided either by ultrasound or fluoroscopy - are lacking. Thus, we aimed to compare safety and efficacy of these approaches. METHODS: We searched for articles assessing at least two different approaches regarding the incidence of pneumothorax and/or lead failure (LF). When available, bleeding and infectious complications as well as procedural success were analyzed. A frequentist random effects network meta-analysis model was adopted. RESULTS: Thirty-six studies were analyzed. Most articles assessed SVP versus CVC. Compared to SVP, both CVC and AVP were associated with reduced odds of pneumothorax (OR: 0.193, 95%CI: 0.136-0.275 and OR: 0.128, 95%CI: 0.050-0.329; respectively) and LF (OR: 0.63, 95%CI: 0.406-0.976 and OR: 0.425, 95%CI: 0.286-0.632; respectively). No significant differences between AVP and CVC were demonstrated. Limited data suggests no major impact of different approaches on infectious and bleeding complications. Initial CVC approach required significantly more often an alternate/additional venous access for lead placement, compared to both AVP and SVP. No differences between these two were identified. CONCLUSION: Both AVP and CVC seem to decrease incident pneumothorax and LF, compared to SVP. Initial AVP approach seems to decrease the need of alternate venous access, compared to CVC. These results suggest that AVP should be further clinically tested.

Role of Cardiac MRI Imaging of Focal and Diffuse Inflammation and Fibrosis in Cardiomyopathy Patients Who Have Pacemakers/ICD Devices.

PURPOSE OF REVIEW: This focused report aims to discuss and summarize the use of conventional and emerging methods using cardiovascular magnetic resonance (CMR) imaging in cardiomyopathy patients with implanted cardiac devices to identify diffuse and focal inflammation and fibrosis. RECENT FINDINGS: Many cardiomyopathy patients with diffuse and focal myocardial fibrosis have a unique need for cardiac imaging that is complicated by cardiovascular implantable electronic devices (CIEDs). CMR imaging can accurately image myocardial fibrosis and inflammation using T1 mapping and late gadolinium enhancement (LGE) imaging. CMR imaging in CIED patients, however, has been limited due to severe imaging artifacts associated with the devices. The emergence of wideband imaging variants of LGE and T1 mapping techniques can successfully reduce or eliminate CIED artifacts for the evaluation of myocardial substrate in cardiomyopathy patients. Wideband imaging variants of LGE and T1 mapping techniques provide new tools for imaging focal and diffuse fibrosis and imaging in cardiomyopathy patients with implanted cardiac devices. These emerging techniques have the potential for great impact in clinical care of such patients as well as clinical research where imaging endpoints are desired.

Neural Network Detection of Pacemakers for MRI Safety.

Flagging the presence of cardiac devices such as pacemakers before an MRI scan is essential to allow appropriate safety checks. We assess the accuracy with which a machine learning model can classify the presence or absence of a pacemaker on pre-existing chest radiographs. A total of 7973 chest radiographs were collected, 3996 with pacemakers visible and 3977 without. Images were identified from information available on the radiology information system (RIS) and correlated with report text. Manual review of images by two board certified radiologists was performed to ensure correct labeling. The data set was divided into training, validation, and a hold-back test set. The data were used to retrain a pre-trained image classification neural network. Final model performance was assessed on the test set. Accuracy of 99.67% on the test set was achieved. Re-testing the final model on the full training and validation data revealed a few additional misclassified examples which are further analyzed. Neural network image classification could be used to screen for the presence of cardiac devices, in addition to current safety processes, providing notification of device presence in advance of safety questionnaires. Computational power to run the model is low. Further work on misclassified examples could improve accuracy on edge cases. The focus of many healthcare applications of computer vision techniques has been for diagnosis and guiding management. This work illustrates an application of computer vision image classification to enhance current processes and improve patient safety.

Implantable cardiac devices in geriatric patients: a primer for primary and geriatric physicians.

In the next 20 years, the percentage of people older than 65 years of age in the United States is expected to double. Heart disease is the leading cause of mortality in developed nations, including the United States. Due to the increased incidence of cardiac disease in elderly patients, the need for special treatment considerations, including cardiac devices, may be necessary to reduce morbidity and mortality in this patient population. The purpose of this review is to provide a primer of the common cardiac devices used in the management of cardiac disorders in the geriatric patient population. In order to do this, we have performed a literature review for articles related to cardiac devices published between 2000 and 2020, in addition to reviewing guidelines and recommendations from relevant professional societies. We provide readers with an overview of several cardiac devices including implantable loop recorders, pacemakers, cardiac resynchronization therapy, automated implantable cardiac defibrillators, watchman devices, and ventricular assist devices. Indications, contraindications, clinical trial data, and general considerations in the geriatric population were included. Due to the aging population and increased incidence of cardiac disease, clinicians should be aware of the indications and contraindications of cardiac device therapy in the management of various cardiac conditions that afflict the geriatric population.

Cost-effectiveness of cardiac resynchronization therapy plus an implantable cardioverter-defibrillator in patients with heart failure: a systematic review.

INTRODUCTION: Heart failure (HF) is an unusual heart function that causes reduction in cardiac or pulmonary output. Cardiac resynchronization therapy (CRT) is a mechanical device that helps to recover ventricular dysfunction by pacing the ventricles. This study planned to systematically review cost-effectiveness of CRT combined with an implantable cardioverter-defibrillator (ICD) versus ICD in patients with HF. METHODS: We used five databases (NHS Economic Evaluation Database, Cochrane Library, Medline, PubMed, and Scopus) to systematically reviewed studies published in the English language on the cost-effectiveness of CRT with defibrillator (CRT-D) Vs. ICD in patients with HF over 2000 to 2020. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist was applied to assess the quality of the selected studies. RESULTS: Five studies reporting the cost-effectiveness of CRT-D vs ICD were finally identified. The results revealed that time horizon, direct medical costs, type of model, discount rate, and sensitivity analysis obviously mentioned in almost all studies. All studies used quality-adjusted life years (QALYs) as an effectiveness measurement. The highest and the lowest Incremental cost-effectiveness ratio (ICER) were reported in the USA ($138,649per QALY) and the UK ($41,787per QALY), respectively. CONCLUSION: Result of the study showed that CRT-D compared to ICD alone was the most cost-effective treatment in patients with HF.

Lead age as a predictor for failure in pediatrics and congenital heart disease.

BACKGROUND: Pediatric and congenital heart disease (CHD) patients have a high rate of transvenous (TV) lead failure. OBJECTIVE: To determine whether TV lead age can aid risk assessment for lead failure to guide the decision of whether a lead should be replaced or reused at the time of a generator change. METHODS: Retrospective cohort study of patients <21 years old undergoing TV device implant from 2000 to 2014 at our institution. Patient, device, and lead variables were collected. Leads were compared in groups based on how many generator changes were completed. RESULTS: A total of 393 leads in 257 patients met inclusion criteria, 60 leads failed (15%). Failed leads were more likely to have not yet undergone generator change (p = .048). CHD (p = .045), Tendril lead type (p = .02) and silicone insulation (p = .02) were associated with failure. In multivariate analysis, younger leads (p = .022), number of generator changes (p = .003), CHD (p = .005) and silicone insulation (p = .004) remained significant while Tendril lead type did not (p = .052). Survival curves show an early decline around 4 years. CONCLUSIONS: Lead failure rate in pediatric and CHD patients is high. Leads that have not yet undergone a generator change were more likely to fail in this cohort. The strategy of serial replacement based on lead age needs further research to justify in this population.