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In a multicenter study, 526 patients underwent implantation of a new leadless cardiac pacemaker. Among the first 300 patients who were followed for 6 months, the pacemaker met prespecified sensing and pacing requirements in 90%, and serious adverse events were observed in 6.7%. Each year, nearly 1 million persons worldwide receive conventional transvenous cardiac pacemakers with active-fixation leads to treat bradycardia and heart block. 1 , 2 Despite considerable technological advancements since the clinical introduction of these pacemakers six decades ago, pacemaker-related adverse events occur in 1 in 10 patients. 3 – 11 These events are typically related to the transvenous lead, surgical pocket, or pulse generator. 3 , 4 The leads are susceptible to dislodgement, fracture, or insulation failure and can also cause infection, cardiac perforation, venous occlusion, and tricuspid regurgitation. Pulse generators have been associated with infection, pocket hematoma, and skin erosion. 3 – 9 , 12 A recently developed . . .

The Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) showed a greater benefit with respect to mortality at 5 years among patients who received cardiac-resynchronization therapy (CRT) than among those who received implantable cardioverter-defibrillators (ICDs). However, the effect of CRT on long-term survival is not known. We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more (or a paced QRS duration of 200 msec or more) to receive either an ICD alone or a CRT defibrillator (CRT-D). We assessed long-term outcomes among patients at the eight highest-enrolling participating sites. The primary outcome was death from any cause; the secondary outcome was a composite of death from any cause, heart transplantation, or implantation of a ventricular assist device. The trial enrolled 1798 patients, of whom 1050 were included in the long-term survival trial; the median duration of follow-up for the 1050 patients was 7.7 years (interquartile range, 3.9 to 12.8), and the median duration of follow-up for those who survived was 13.9 years (interquartile range, 12.8 to 15.7). Death occurred in 405 of 530 patients (76.4%) assigned to the ICD group and in 370 of 520 patients (71.2%) assigned to the CRT-D group. The time until death appeared to be longer for those assigned to receive a CRT-D than for those assigned to receive an ICD (acceleration factor, 0.80; 95% confidence interval, 0.69 to 0.92; P = 0.002). A secondary-outcome event occurred in 412 patients (77.7%) in the ICD group and in 392 (75.4%) in the CRT-D group. Among patients with a reduced ejection fraction, a widened QRS complex, and NYHA class II or III heart failure, the survival benefit associated with receipt of a CRT-D as compared with ICD appeared to be sustained during a median of nearly 14 years of follow-up. (RAFT ClinicalTrials.gov number, NCT00251251.).

Left ventricular (LV) dysfunction may be sustained or aggravated during the convalescent months following an acute myocardial infarction (MI) and is difficult to predict. We sought to determine current practice patterns of LV ejection fraction (LVEF) reassessment during the months following MI and evaluate the predictors and clinical significance of LVEF change in a prospective post-MI patient cohort. Patients with an acute MI between June 2010 and August 2014 were identified using the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease registry. Patients with initial LV dysfunction (LVEF <40% with first MI or <45% with multiple MI events) underwent a protocol-driven repeat LVEF assessment in follow-up if routine LVEF reassessment was not performed. Of 5,964 MI patients, follow-up LVEF assessments were attained for 442 of the 695 patients who had significant LV dysfunction. A sizable proportion (25%) had either no increase or a decline in LVEF. Adverse remodeling was associated with an anterior MI location, a greater peak serum troponin T, and a higher baseline LVEF at time of MI. Adverse LV remodeling conferred a 3-fold risk of death (hazard ratio 3.0, 95% CI 1.6-5.7, P=.001) adjusted for baseline LVEF, anterior MI location, and medication use. Current practice of LVEF reassessment during the convalescent months post-MI is suboptimal despite a sizeable proportion of patients that undergo adverse LV remodeling. Targeting processes affecting low rates of LVEF reassessment may reduce missed care opportunities and ensure that patients consistently receive appropriate evidence-based and guideline-recommended care.

In the past decades there has been a substantial evolution in data management and data processing techniques. New data architectures made analysis of big data feasible, healthcare is orienting towards personalized medicine with digital health initiatives, and artificial intelligence (AI) is becoming of increasing importance. Despite being a trendy research topic, only very few applications reach the stage where they are implemented in clinical practice. This review provides an overview of current methodologies and identifies clinical and organizational challenges for AI in healthcare.

Two-dimensional (2D) strain analysis is constrained by geometry-dependent reference directions of deformation (i.e. radial, circumferential, and longitudinal) following the assumption of cylindrical chamber architecture. Three-dimensional (3D) principal strain analysis may overcome such limitations by referencing intrinsic (i.e. principal) directions of deformation. This study aimed to demonstrate clinical feasibility of 3D principal strain analysis from routine 2D cine MRI with validation to strain from 2D tagged cine analysis and 3D speckle tracking echocardiography. Thirty-one patients undergoing cardiac MRI were studied. 3D strain was measured from routine, multi-planar 2D cine SSFP images using custom software designed to apply 4D deformation fields to 3D cardiac models to derive principal strain. Comparisons of strain estimates versus those by 2D tagged cine, 2D non-tagged cine (feature tracking), and 3D speckle tracking echocardiography (STE) were performed. Mean age was 51 ± 14 (36% female). Mean LV ejection fraction was 66 ± 10% (range 37–80%). 3D principal strain analysis was feasible in all subjects and showed high inter- and intra-observer reproducibility (ICC range 0.83–0.97 and 0.83–0.98, respectively—p < 0.001 for all directions). Strong correlations of minimum and maximum principal strain were respectively observed versus the following: 3D STE estimates of longitudinal (r = 0.81 and r = −0.64), circumferential (r = 0.76 and r = −0.58) and radial (r = −0.80 and r = 0.63) strain (p < 0.001 for all); 2D tagged cine estimates of longitudinal (r = 0.81 and r = −0.81), circumferential (r = 0.87 and r = −0.85), and radial (r = −0.76 and r = 0.81) strain (p < 0.0001 for all); and 2D cine (feature tracking) estimates of longitudinal (r = 0.85 and −0.83), circumferential (r = 0.88 and r = −0.87), and radial strain (r = −0.79 and r = 0.84, p < 0.0001 for all). 3D principal strain analysis is feasible using routine, multi-planar 2D cine MRI and shows high reproducibility with strong correlations to 2D conventional strain analysis and 3D STE-based analysis. Given its independence from geometry-related directions of deformation this technique may offer unique benefit for the detection and prognostication of myocardial disease, and warrants expanded investigation.

Background Cardiac implantable electronic devices (CIED) are being inserted with increasing frequency. Severe surgical site infections (SSI) that occur after device implantation substantially impact patient morbidity and mortality and can result in multiple hospital admissions and repeat surgeries. It is important to understand the costs associated with these infections as well as healthcare utilization. Therefore, we conducted a population-based study in the province of Alberta, Canada to understand the economic burden of these infections. Methods A cohort of adult patients in Alberta who had CIEDs inserted or generators replaced between January 1, 2011 and December 31, 2019 was used. A validated algorithm of International Classification of Diseases (ICD) codes to identify complex (deep/organ space) SSIs that occurred within the subsequent year was applied to the cohort. The overall mean 12-month inpatient and outpatient costs for the infection and non-infection groups were assessed. In order to control for variables that may influence costs, propensity score matching was completed and incremental costs between those with and without infection were calculated. As secondary outcomes, number of outpatient visits, hospitalizations and length of stay were assessed. Results There were 26,049 procedures performed during our study period, of which 320 (1.23%) resulted in SSIs. In both unadjusted costs and propensity score matched costs the infection group was associated with increased costs. Overall mean cost was $145,312 in the infection group versus $34,264 in the non-infection group. The incremental difference in those with infection versus those without in the propensity score match was $90,620 (Standard deviation $190,185). Approximately 70% of costs were driven by inpatient hospitalizations. Inpatients hospitalizations, length of stay and outpatient visits were all increased in the infection group. Conclusions CIED infections are associated with increased costs and are a burden to the healthcare system. This highlights a need to recognize increasing SSI rates and implement measures to minimize infection risk. Further studies should endeavor to apply this work to full economic evaluations to better understand and identify cost-effective infection mitigation strategies.

Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications. We conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting. Among the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (±SD) atrial capture threshold was 0.82±0.70 V, and the mean P-wave amplitude was 3.58±1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001). The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, NCT05252702.).

There are approximately 2 million Americans with congestive heart failure, and about 400,000 new cases are diagnosed each year. 1 The population-based mortality rate from congestive heart failure is 1.8 times as high for black men as for white men and 2.4 times as high for black women as for white women. 2 , 3 The higher mortality among blacks has been attributed to differences between blacks and whites in the severity and causes of heart failure, the prevalence of coexisting conditions, socioeconomic and cultural factors, and access to high-quality medical care. 4 – 6 Not all studies, however, have found a higher mortality among . . .

To establish the epidemiology of cardiac implantable electronic device (CIED) infections in Alberta, Canada, using validated administrative data. Retrospective, population-based cohort study. Alberta Health Services is a province-wide health system that services all of Alberta, Canada. Adult patients who underwent first-time CIED implantation or generator replacement in Alberta, Canada, between January 1, 2011, and December 31, 2019. CIED implant patients were identified from the Paceart database. Patients who developed an infection within 1 year of the index procedure were identified through validated administrative data (International Classification of Diseases, Tenth Revision in Canada). Demographic characteristics of patients were summarized. Logistic regression models were used to analyze device type, comorbidities, and demographics associated with infection rates and mortality. Among 27,830 CIED implants, there were 205 infections (0.74%). Having 2 or more comorbidities was associated with higher infection risk. Generator replacement procedures (odds ratio [OR], 0.55; 95% confidence interval [CI], 0.34-0.84; P = .008), age increase of every 10 years (OR, 0.73; 95% CI, 0.66-0.82; P ≤ .001), and index procedure after 2014 were associated with decreased risk. Comparing the infected to uninfected groups, the hospitalization rates were 2.63 compared to 0.69, and the mortality rates were 10.73% compared to 3.49%, respectively (P < .001). There is a slightly lower overall rate of CIED infections Alberta, Canada compared to previously described epidemiology. Implants after 2014, and generator replacements showed a decreased burden of infection. Patients with younger age, and 2 or more comorbidities are at greatest risk of CIED infection. The burden of hospitalization and mortality is substantially higher in infected patients.

BackgroundRoughly one in six patients receiving conventional transvenous pacemaker systems experience significant complications within 1 year of implant, mainly due to the transvenous lead and subcutaneous pocket. A new helix-fixation single-chamber ventricular leadless pacemaker (LP) system capable of pre-deployment exploratory electrical mapping is commercially available. Such an LP may mitigate complications while streamlining the implantation. In this study, the initial real-world implant experience of the helix-fixation LP was evaluated following its commercial release.MethodsIn patients indicated for single-chamber right ventricular pacing, helix-fixation Aveir VR LPs (Abbott, Abbott Park, IL) were implanted using the dedicated loading tool, introducer, and delivery catheter. Implant procedural characteristics, electrical parameters, and any 30-day procedure-related adverse events of consecutive implant attempts were retrospectively evaluated.ResultsA total of 167 patients with Class I indication for permanent pacing received implants in four North American centers (57% male, 70 years old). Pre-fixation electrical mapping of potential sites allowed repositioning to be avoided in 95.7% of patients. Median [interquartile range] LP procedure and fluoroscopy durations were 25.5 min [20.0, 35.0] and 5.7 min [4.0, 9.2], respectively. Pacing capture threshold, sensed R-wave amplitude, and impedance were 0.8 V [0.5, 1.3], 9.0 mV [6.0, 12.0], and 705 Ω [550, 910], respectively. Implantation was successful in 98.8% of patients, with 98.2% free from acute adverse events.ConclusionsThe initial, real-world experience of the helix-fixation ventricular leadless pacemaker demonstrated safe and efficient implantation with minimal repositioning, viable electrical metrics, and limited acute complications.Helix-fixation single-chamber ventricular leadless pacemakers were implanted in 167 patients, with a median procedure time of 25.5 minutes, 98.8% implant success, and 98.2% freedom from acute adverse events.