The sodium-glucose cotransporter 2 inhibitor empagliflozin reduces the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, but whether empagliflozin ...also improves clinical outcomes when initiated in patients who are hospitalized for acute heart failure is unknown. In this double-blind trial (EMPULSE; NCT04157751 ), 530 patients with a primary diagnosis of acute de novo or decompensated chronic heart failure regardless of left ventricular ejection fraction were randomly assigned to receive empagliflozin 10 mg once daily or placebo. Patients were randomized in-hospital when clinically stable (median time from hospital admission to randomization, 3 days) and were treated for up to 90 days. The primary outcome of the trial was clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5 point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90 days, as assessed using a win ratio. More patients treated with empagliflozin had clinical benefit compared with placebo (stratified win ratio, 1.36; 95% confidence interval, 1.09-1.68; P = 0.0054), meeting the primary endpoint. Clinical benefit was observed for both acute de novo and decompensated chronic heart failure and was observed regardless of ejection fraction or the presence or absence of diabetes. Empagliflozin was well tolerated; serious adverse events were reported in 32.3% and 43.6% of the empagliflozin- and placebo-treated patients, respectively. These findings indicate that initiation of empagliflozin in patients hospitalized for acute heart failure is well tolerated and results in significant clinical benefit in the 90 days after starting treatment.
Objectives The purpose of this study was to evaluate whether 123-iodine metaiodobenzylguanidine (123-I MIBG) imaging predicts ventricular arrhythmias causing appropriate implantable ...cardioverter-defibrillator (ICD) therapy (primary end point) and the composite of appropriate ICD therapy or cardiac death (secondary end point). Background Although cardiac sympathetic denervation is associated with ventricular arrhythmias, limited data are available on the predictive value of sympathetic nerve imaging with 123-I MIBG on the occurrence of arrhythmias. Methods Before ICD implantation, patients underwent 123-I MIBG and myocardial perfusion imaging. Early and late 123-I MIBG (planar and single-photon emission computed tomography SPECT) imaging was performed to assess cardiac innervation (heart-to-mediastinum ratio, cardiac washout rate, and 123-I MIBG SPECT defect score). Stress-rest myocardial perfusion imaging was performed to assess myocardial infarction and perfusion abnormalities (perfusion defect scores). During follow-up, appropriate ICD therapy and cardiac death were documented. Results One-hundred sixteen heart failure patients referred for ICD therapy were enrolled. During a mean follow-up of 23 ± 15 months, appropriate ICD therapy (primary end point) was documented in 24 (21%) patients and appropriate ICD therapy or cardiac death (secondary end point) in 32 (28%) patients. Late 123-I MIBG SPECT defect score was an independent predictor for both end points. Patients with a large late 123-I MIBG SPECT defect (summed score >26) showed significantly more appropriate ICD therapy (52% vs. 5%, p < 0.01) and appropriate ICD therapy or cardiac death (57% vs. 10%, p < 0.01) than patients with a small defect (summed score ≤26) at 3-year follow-up. Conclusions Cardiac sympathetic denervation predicts ventricular arrhythmias causing appropriate ICD therapy as well as the composite of appropriate ICD therapy or cardiac death.
Objectives The aim of the current study was to evaluate the relation between the extent of left ventricular (LV) reverse remodeling and clinical/echocardiographic improvement after 6 months of ...cardiac resynchronization therapy (CRT) as well as long-term outcome. Background Despite the current selection criteria, individual response to CRT varies significantly. Furthermore, it has been suggested that reduction in left ventricular end-systolic volume (LVESV) after CRT is related to outcome. Methods A total of 302 CRT candidates were included. Clinical status and echocardiographic evaluation were performed before implantation and after 6 months of CRT. Long-term follow-up included all-cause mortality and hospitalizations for heart failure. Results Based on different extents of LV reverse remodeling, 22% of patients were classified as super-responders (decrease in LVESV ≥30%), 35% as responders (decrease in LVESV 15% to 29%), 21% as nonresponders (decrease in LVESV 0% to 14%), and 22% negative responders (increase in LVESV). More extensive LV reverse remodeling resulted in more clinical improvement, with a larger increase in LV function and more reduction in mitral regurgitation. In addition, more LV reverse remodeling resulted in less heart failure hospitalizations and lower mortality during long-term follow-up (22 ± 11 months); 1- and 2-year hospitalization-free survival rates were 90% and 70% in the negative responder group compared with 98% and 96% in the super-responder group (log-rank p value <0.001). Conclusions The extent of LV reverse remodeling at midterm follow-up is predictive for long-term outcome in CRT patients.
The effect of haemodynamic monitoring of pulmonary artery pressure has predominantly been studied in the USA. There is a clear need for randomised trial data from patients treated with contemporary ...guideline-directed-medical-therapy with long-term follow-up in a different health-care system.
MONITOR-HF was an open-label, randomised trial, done in 25 centres in the Netherlands. Eligible patients had chronic heart failure of New York Heart Association class III and a previous heart failure hospitalisation, irrespective of ejection fraction. Patients were randomly assigned (1:1) to haemodynamic monitoring (CardioMEMS-HF system, Abbott Laboratories, Abbott Park, IL, USA) or standard care. All patients were scheduled to be seen by their clinician at 3 months and 6 months, and every 6 months thereafter, up to 48 months. The primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at 12 months. All analyses were by intention-to-treat. This trial was prospectively registered under the clinical trial registration number NTR7673 (NL7430) on the International Clinical Trials Registry Platform.
Between April 1, 2019, and Jan 14, 2022, we randomly assigned 348 patients to either the CardioMEMS-HF group (n=176 51%) or the control group (n=172 49%). The median age was 69 years (IQR 61–75) and median ejection fraction was 30% (23–40). The difference in mean change in KCCQ overall summary score at 12 months was 7·13 (95% CI 1·51–12·75; p=0·013) between groups (+7·05 in the CardioMEMS group, p=0·0014, and –0·08 in the standard care group, p=0·97). In the responder analysis, the odds ratio (OR) of an improvement of at least 5 points in KCCQ overall summary score was OR 1·69 (95% CI 1·01–2·83; p=0·046) and the OR of a deterioration of at least 5 points was 0·45 (0·26–0·77; p=0·0035) in the CardioMEMS-HF group compared with in the standard care group. The freedom of device-related or system-related complications and sensor failure were 97·7% and 98·8%, respectively.
Haemodynamic monitoring substantially improved quality of life and reduced heart failure hospitalisations in patients with moderate-to-severe heart failure treated according to contemporary guidelines. These findings contribute to the aggregate evidence for this technology and might have implications for guideline recommendations and implementation of remote pulmonary artery pressure monitoring.
The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories.
The relative merits of left ventricular (LV) dyssynchrony, LV lead position, and myocardial scar to predict long-term outcome after cardiac resynchronization therapy remain unknown and were evaluated ...in the present study.
In 397 ischemic heart failure patients, 2-dimensional speckle tracking imaging was performed, with comprehensive assessment of LV radial dyssynchrony, identification of the segment with latest mechanical activation, and detection of myocardial scar in the segment where the LV lead was positioned. For LV dyssynchrony, a cutoff value of 130 milliseconds was used. Segments with <16.5% radial strain in the region of the LV pacing lead were considered to have extensive myocardial scar (>50% transmurality, validated in a subgroup with contrast-enhanced magnetic resonance imaging). The LV lead position was derived from chest x-ray. Long-term follow-up included all-cause mortality and hospitalizations for heart failure. Mean baseline LV radial dyssynchrony was 133±98 milliseconds. In 271 patients (68%), the LV lead was placed at the latest activated segment (concordant LV lead position), and the mean value of peak radial strain at the targeted segment was 18.9±12.6%. Larger LV radial dyssynchrony at baseline was an independent predictor of superior long-term survival (hazard ratio, 0.995; P=0.001), whereas a discordant LV lead position (hazard ratio, 2.086; P=0.001) and myocardial scar in the segment targeted by the LV lead (hazard ratio, 2.913; P<0.001) were independent predictors of worse outcome. Addition of these 3 parameters yielded incremental prognostic value over the combination of clinical parameters.
Baseline LV radial dyssynchrony, discordant LV lead position, and myocardial scar in the region of the LV pacing lead were independent determinants of long-term prognosis in ischemic heart failure patients treated with cardiac resynchronization therapy. Larger baseline LV dyssynchrony predicted superior long-term survival, whereas discordant LV lead position and myocardial scar predicted worse outcome.
Cardiac resynchronization therapy for heart failure with left bundle branch block reduces left ventricular (LV) conduction delay, contraction asynchrony, and LV end-systolic volume ("reverse ...remodeling"). Up to one third of patients do not improve, and the electric requirements for reverse remodeling are unclear. We hypothesized that reverse remodeling is predicted by the left bundle branch block ventricular activation sequence, the paced activation sequence, and interactions between these 2 conditions.
Twelve-lead ECGs during left bundle branch block and cardiac resynchronization therapy were analyzed in 202 consecutive patients (New York Heart Association class III to IV heart failure, ejection fraction < or =35%) for predictors of reverse remodeling (> or =10% reduction in end-systolic volume) at 6 months. Greater longest baseline LV activation time predicted increased odds of reverse remodeling (odds ratio confidence interval=1.30 1.11, 1.52 per 10-ms increase), whereas higher QRS scores for LV scar predicted reduced reverse remodeling (odds ratio confidence interval=0.49 0.27, 0.88 for each 1-point increase from 0 to 4; 0.92 0.83, 1.01 for each 1-point increase >4). After cardiac resynchronization therapy, increasing R amplitudes in leads V(1) through V(2) (odds ratio confidence interval=2.76 1.01, 7.51 for each 1x increase over baseline Rx4.5) and left-->right frontal axis shift (odds ratio confidence interval=2.00 0.99, 4.02), indicators of ventricular activation wavefront fusion, were positive predictors of reverse remodeling. Predicted probability of reverse remodeling ranged from <20% for patients with adverse predictors to 99% for those with positive predictors.
Ventricular activation with the use of the ECG accurately predicts LV reverse remodeling during cardiac resynchronization therapy. Greater longest baseline LV activation time and smaller scar volume combined with wavefront fusion on the paced ECG, anticipate higher probability of reverse remodeling.
Aims
To evaluate safety of leadless pacemaker implantation through the internal jugular vein in a larger cohort with longer follow‐up. Moreover, feasibility of non‐apical pacing as well as relation ...between pacing site and QRS duration were assessed.
Methods
Eighty Two consecutive patients, who received a leadless pacemaker though the internal jugular vein, were included. Electrical parameters were measured at regular follow‐up and any complications were registered. Paced QRS interval was compared for three pacing sites, RVOT, RV mid septum, and RV apical septum.
Results
In all patients, the leadless pacemaker was implanted successfully. In 69 patients, the device was implanted in a non‐apical position. In 71% of cases, the device could be deployed at first attempt. The median fluoroscopy time was 4.4 min (range 0.9−51) The paced QRS interval was significantly narrower for non‐apical pacing sites compared to apical pacing si 156 vs. 179 ms. p = .04, respectively. During mean follow‐up of 16 months (range 0–43 months), electrical parameters remained stable. Two complications occurred, which could be resolved during the implant procedure. There were no access site related complications.
Conclusion
The jugular approach for leadless pacemaker implantation is feasible and may avoid vascular complications. It facilitates non‐apical positioning of leadless pacemakers leading to a narrower paced QRS interval. The jugular approach allows for immediate post procedural ambulation.
The purpose of this study was to assess the incidence, predictors, and outcome of inappropriate shocks in implantable cardioverter-defibrillator (ICD) patients.
Despite the benefits of ICD therapy, ...inappropriate defibrillator shocks continue to be a significant drawback. The prognostic importance of inappropriate shocks outside the setting of a clinical trial remains unclear.
From 1996 to 2006, all recipients of defibrillator devices equipped with intracardiac electrogram storage were included in the current analysis and clinically assessed at implantation. During follow-up, the occurrence of inappropriate ICD shocks and all-cause mortality was noted.
A total of 1,544 ICD patients (79% male, age 61 ± 13 years) were included in the analysis. During the follow-up period of 41 ± 18 months, 13% experienced ≥1 inappropriate shocks. The cumulative incidence steadily increased to 18% at 5-year follow-up. Independent predictors of the occurrence of inappropriate shocks included a history of atrial fibrillation (hazard ratio HR: 2.0, p < 0.01) and age younger than 70 years (HR: 1.8, p = 0.01). Experiencing a single inappropriate shock resulted in an increased risk of all-cause mortality (HR: 1.6, p = 0.01). Mortality risk increased with every subsequent shock, up to an HR of 3.7 after 5 inappropriate shocks.
In a large cohort of ICD patients, inappropriate shocks were common. The most important finding is the association between inappropriate shocks and mortality, independent of interim appropriate shocks.
Leadless pacing: Going for the jugular Saleem‐Talib, Shmaila; Driel, Vincent J.; Chaldoupi, Sevasti‐Maria ...
Pacing and clinical electrophysiology,
April 2019, Letnik:
42, Številka:
4
Journal Article
Recenzirano
Odprti dostop
Background
Leadless pacing is generally performed from a femoral approach. However, the femoral route is not always available. Until now, data regarding implantation using a jugular approach other ...than a single‐case report were lacking.
Methods
The case records of all patients who underwent internal jugular venous (IJV) leadless pacemaker implantation (Micra, Medtronic, Dublin, Ireland) at our center were analyzed retrospectively.
Results
Nineteen patients underwent IJV leadless pacemaker implantation, nine females, mean age of 77.5 ±9.6 years; permanent atrial fibrillation in all patients with normal left ventricular ejection fraction. Implant indication was atrioventricular conduction disturbance in 10, pre‐AV node ablation in seven, and replacement of a conventional VVI pacemaker in two (infection in one and lead malfunction in the other). The device was positioned at the superior septum in seven patients, apicoseptal in seven patients, and midseptal in five patients. In 12 patients, a sufficient device position was obtained at the first attempt, in three at the second, in one at the third, in one at the fourth, and in two at the sixth attempt.
The mean pacing threshold was 0.56 ± 0.39V at 0.24‐ms pulse width, sensed amplitude was 9.1 ± 3.2 mV, mean fluoroscopy duration was 3.1 ± 1.6 min. There were no vascular or other complications. At follow‐up, electrical parameters remained stable in 18 of 19 patients.
Conclusion
Although experience is minimal, we suggest that the IJV approach is safe and may be considered in patients where the femoral approach is contraindicated.
The number of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) implantations is increasing drastically worldwide, and hence, the number of implanting centers ...is also increasing. Despite abundant data on the beneficial effect of these devices, little is known regarding safety and complication rates. Eleven ICD and 7 CRT trials were systematically reviewed to provide data on the frequency of in-hospital mortality and complications related to the implantation. Average in-hospital mortality was 2.7% in trials using both thoracotomy and nonthoracotomy ICDs, 0.2% in trials using nonthoracotomy ICDs, and 0.3% in CRT trials. The pneumothorax rate was similar between the nonthoracotomy ICD and CRT trials (0.9%) Coronary sinus complications occurred in 2.0% of patients undergoing CRT. Lead dislodgement rates were higher in CRT trials (5.7%) than in nonthoracotomy ICD trials (1.8%).
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