Mobility enhancement among older adults 75 + in rural areas: Study protocol of the MOBILE randomized controlled trial.

BACKGROUND: Maintaining mobility in old age is crucial for healthy ageing including delaying the onset and progress of frailty. However, the extent of an individuals´ mobility relies largely on their personal, social, and environmental resources as outlined in the Life-Space Constriction Model. Recent studies mainly focus on facilitating habitual out-of-home mobility by fostering one type of resources only. The MOBILE trial aims at testing whether tablet-assisted motivational counselling enhances the mobility of community-dwelling older adults by addressing personal, social, and environmental resources. METHODS: In the MOBILE randomized controlled trial, we plan to enrol 254 community-dwelling older adults aged 75 and older from Havelland, a rural area in Germany. The intervention group will receive a tablet-assisted motivational counselling at the participant´s home and two follow-up telephone sessions. Main focus of the counselling sessions lays on setting and adapting individual mobility goals and applying action planning and habit formation strategies by incorporating the personal social network and regional opportunities for engaging in mobility related activities. The control group will receive postal general health information. The primary mobility outcome is time out-of-home assessed by GPS (GPS.Rec2.0-App) at three points in time (baseline, after one month, and after three months for seven consecutive days each). Secondary outcomes are the size of the GPS-derived life-space convex hull, self-reported life-space mobility (LSA-D), physical activity (IPAQ), depressive symptoms (GDS), frailty phenotype, and health status (SF-12). DISCUSSION: The MOBILE trial will test the effect of a motivational counselling intervention on out-of-home mobility in community-dwelling older adults. Novel aspects of the MOBILE trial include the preventive multi-level intervention approach in combination with easy-to-use technology. The ecological approach ensures low-threshold implementation, which increases the benefit for the people in the region. TRIAL REGISTRATION: The MOBILE trial is prospectively registered at DRKS (Deutsches Register Klinischer Studien, German Registry of Clinical Trials) DRKS00025230 . Registered 5 May 2021.

Optimal CRT Implantation-Where and How To Place the Left-Ventricular Lead?

PURPOSE OF REVIEW: Cardiac resynchronization therapy (CRT) represents a well-established and effective non-pharmaceutical heart failure (HF) treatment in selected patients. Still, a significant number of patients remain CRT non-responders. An optimal placement of the left ventricular (LV) lead appears crucial for the intended hemodynamic and hence clinical improvement. A well-localized target area and tools that help to achieve successful lead implantation seem to be of utmost importance to reach an optimal CRT effect. RECENT FINDINGS: Recent studies suggest previous multimodal imaging (CT/cMRI/ECG torso) to guide intraprocedural LV lead placement. Relevant benefit compared to empirical lead optimization is still a matter of debate. Technical improvements in leads and algorithms (e.g., multipoint pacing (MPP), adaptive algorithms) promise higher procedural success. Recently emerging alternatives for ventricular synchronization such as conduction system pacing (CSP), LV endocardial pacing, or leadless pacing challenge classical biventricular pacing. This article reviews current strategies for a successful planning, implementation, and validation of the optimal CRT implantation. Pre-implant imaging modalities offer promising assistance for complex cases; empirical lead positioning and intraoperative testing remain the cornerstone in most cases and ensure a successful CRT effect.

Atrioventricular dromotropathy: evidence for a distinctive entity in heart failure with prolonged PR interval?

Heart failure (HF) is often accompanied by atrioventricular (AV) conduction disturbance, represented by prolongation of the PR interval on the electrocardiogram. Studies suggest that PR prolongation exists in at least 10% of HF patients, and it seems more prevalent in the presence of prolonged QRS duration. A prolonged PR interval may result in elevated left ventricular (LV) end-diastolic pressure, diastolic mitral regurgitation, and reduced LV pump function. This seems especially the case in patients with heart disease, in whom it is associated with an increased risk for atrial fibrillation, advanced AV heart block, HF, and death. These findings point towards the importance of proper AV coupling in HF patients. A few studies, strongly differing in design, suggest that restoration of AV coupling in patients with PR prolongation by pacing improves cardiac function and clinical outcomes. These observations argue for AV-dromotropathy as a potential target for pacing therapy, but other studies show inconsistent results. Given its potential clinical implications, restoration of AV coupling by pacing warrants further investigation. Additional possible future research goals include assessing different techniques to measure compromised AV coupling, determine the best site(s) of ventricular pacing, and assess a potential influence of diastolic mitral regurgitation in the efficacy of such therapy.

Safety and efficiency of ventricular pacing prevention with an AAI-DDD changeover mode in patients with sinus node disease or atrioventricular block: impact on battery longevity-a sub-study of the ANSWER trial.

AIMS: This ANSWER (EvaluAtioN of the SafeR mode in patients With a dual chambER pacemaker indication) sub-study assesses safety and effectiveness of SafeR™ and the impact of ventricular pacing (VP) prevention on anticipated device longevity and replacement rate. METHODS AND RESULTS: Patients implanted for atrioventricular block (AVB, n = 310) or sinus node dysfunction (SND, n = 336) were randomly assigned to SafeR (n = 314) or DDD (n = 318) and followed for 36 months. Safety, median VP, estimated device longevity (mean difference, 95% confidence interval [CI]), and anticipated replacement rates were analysed by pacing mode and implant indication. No difference in mortality, syncope, or mode intolerance was observed between randomization groups regardless of the indication. Ventricular pacing on SafeR vs. DDD was 11.5 vs. 93.6% in the overall population (P < 0.001), 89.2 vs. 83.8% in permanent AVB (P = 0.944), 53.5 vs. 98.2% in intermittent AVB (P < 0.001), and 2.2 vs. 84.7% in SND (P < 0.001). Anticipated median device longevity increased on SafeR by 14 [Q1 10; Q3 17] months [10; 17] (P < 0.001) in the overall population, 9 months [-5; 22] (P = 0.193) in permanent AVB, 14 months [8; 19] (P < 0.001) in intermittent AVB, and 14 months [9; 19] (P < 0.001) in SND. In intermittent AVB and SND, prolonged estimated battery longevity translated into the prevention of one anticipated replacement in at least 23% of patients. CONCLUSION: SafeR was effective in reducing VP in intermittent AVB and in SND. No effect was observed in permanent AVB. No safety issue was observed. Ventricular pacing reduction by SafeR translated into relevant estimated prolongation of device longevity and anticipated reduction of required replacements.

Long-term clinical effects of ventricular pacing reduction with a changeover mode to minimize ventricular pacing in a general pacemaker population.

AIM: Right ventricular pacing (VP) has been hypothesized to increase the risk in heart failure (HF) and atrial fibrillation (AF). The ANSWER study evaluated, whether an AAI-DDD changeover mode to minimize VP (SafeR) improves outcome compared with DDD in a general dual-chamber pacemaker population. METHODS AND RESULTS: ANSWER was a randomized controlled multicentre trial assessing SafeR vs. standard DDD in sinus node disease (SND) or AV block (AVB) patients. After a 1-month run-in period, they were randomized (1 : 1) and followed for 3 years. Pre-specified co-primary end-points were VP and the composite of hospitalization for HF, AF, or cardioversion. Pre-specified secondary end-points were cardiac death or HF hospitalizations and cardiovascular hospitalizations. ANSWER enrolled 650 patients (52.0% SND, 48% AVB) at 43 European centres and randomized in SafeR (n = 314) or DDD (n = 318). The SafeR mode showed a significant decrease in VP compared with DDD (11.5 vs. 93.6%, P < 0.0001 at 3 years). Deaths and syncope did not differ between randomization arms. No significant difference between groups [HR = 0.78; 95% CI (0.48-1.25); P = 0.30] was found in the time to event of the co-primary composite of hospitalization for HF, AF, or cardioversion, nor in the individual components. SafeR showed a 51% risk reduction (RR) in experiencing cardiac death or HF hospitalization [HR = 0.49; 95% CI (0.27-0.90); P = 0.02] and 30% RR in experiencing cardiovascular hospitalizations [HR = 0.70; 95% CI (0.49-1.00); P = 0.05]. CONCLUSION: SafeR safely and significantly reduced VP in a general pacemaker population though had no effect on hospitalization for HF, AF, or cardioversion, when compared with DDD.

The effect of ICD programming on inappropriate and appropriate ICD Therapies in ischemic and nonischemic cardiomyopathy: the MADIT-RIT trial.

INTRODUCTION: The MADIT-RIT trial demonstrated reduction of inappropriate and appropriate ICD therapies and mortality by high-rate cut-off and 60-second-delayed VT therapy ICD programming in patients with a primary prophylactic ICD indication. The aim of this analysis was to study effects of MADIT-RIT ICD programming in patients with ischemic and nonischemic cardiomyopathy. METHODS AND RESULTS: First and total occurrences of both inappropriate and appropriate ICD therapies were analyzed by multivariate Cox models in 791 (53%) patients with ischemic and 707 (47%) patients with nonischemic cardiomyopathy. Patients with ischemic and nonischemic cardiomyopathy had similar incidence of first inappropriate (9% and 11%, P = 0.21) and first appropriate ICD therapy (11.6% and 14.1%, P = 0.15). Patients with ischemic cardiomyopathy had higher mortality rate (6.1% vs. 3.3%, P = 0.01). MADIT-RIT high-rate cut-off (arm B) and delayed VT therapy ICD programming (arm C) compared with conventional (arm A) ICD programming were associated with a significant risk reduction of first inappropriate and appropriate ICD therapy in patients with ischemic and nonischemic cardiomyopathy (HR range 0.11-0.34, P < 0.001 for all comparisons). Occurrence of total inappropriate and appropriate ICD therapies was significantly reduced by high-rate cut-off ICD programming and delayed VT therapy ICD programming in both ischemic and nonischemic cardiomyopathy patients. CONCLUSION: High-rate cut-off and delayed VT therapy ICD programming are associated with significant reduction in first and total inappropriate and appropriate ICD therapy in patients with ischemic and nonischemic cardiomyopathy.

Time-dependent risk reduction of ventricular tachyarrhythmias in cardiac resynchronization therapy patients: a MADIT-RIT sub-study.

AIMS: Data on the time-dependent benefit of cardiac resynchronization therapy with defibrillator (CRT-D) compared with a dual-chamber implantable cardioverter-defibrillator (ICD) to reduce death or ventricular tachycardia (VT) or ventricular fibrillation (VF) are limited. We aimed to evaluate the time-related risk of death or sustained VT or VF in patients receiving CRT-D vs. ICD in the MADIT-RIT trial. METHODS AND RESULTS: Kaplan-Meier survival analyses and multivariate Cox regression models were utilized to compare the incidence and the risk of death or sustained VT/VF in the CRT-D and ICD subgroups by the elapsed time after device implantation (6 months). Of the ICD (n = 742) and CRT-D (n = 757) patients enrolled, the risk of death was lower in CRT-D vs. in ICD early after device implantation [hazard ratio (HR) = 0.42, 95% confidence interval (CI): 0.17-1.03, P = 0.058] and beyond 6 months of follow-up (HR = 0.39, 95% CI: 0.21-0.73, P = 0.004), with the 6-month interaction P = 0.899. The overall risk of sustained VT/VF was reduced in CRT-D vs. ICD patients (HR = 0.73, 95% CI: 0.52-1.03, P = 0.07). However, the risk was similar in the first 6 months (HR = 1.00, 95% CI: 0.62-1.62, P = 0.988), and a lower risk emerged 6 months after CRT-D implantation (HR = 0.58, 95% CI: 0.38-0.88, P = 0.011), with the 6-month interaction P = 0.059. CONCLUSION: The reduced mortality risk of CRT-D compared with an ICD alone began early after device implantation and was sustained during long-term follow-up; the reduced risk for ventricular tachyarrhythmias did not emerge until 6 months after device implantation. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/ct2/show/NCT00947310.

The effect of weight loss on clinical outcomes in patients implanted with a cardiac resynchronization therapy device-A MADIT-CRT substudy.

BACKGROUND: There are no data regarding the effect of weight loss on clinical outcomes in patients undergoing cardiac resynchronization therapy. This study was designed to evaluate the effect of weight loss on clinical outcomes in patients implanted with a cardiac resynchronization therapy with defibrillator (CRT-D). METHODS AND RESULTS: The risk of heart failure (HF) or death, and of death alone, was compared between patients with and without weight loss of ≥2 kg or more at 1 year in the CRT-D arm of the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT). Weight loss was observed in 170 of 994 patients (17%) implanted with a CRT-D. Multivariate analysis showed a significant increase in the risk of HF or death among patients with weight loss compared with those without weight loss (hazard ratio [HR] 1.82, 95% confidence interval [CI] 1.26-2.63; P = .001). Weight loss was associated with a 79% increase in the risk of all-cause mortality (HR 1.79, 95% CI 1.16-3.34; P = .01). When analyzed in a continuous fashion, each kg of weight loss was associated with a 4% increase in the risk of HF or death (P = .03). In left bundle branch block (LBBB) patients with a CRT-D, weight loss was associated with an especially high risk of HF or death (HR 2.23, 95% CI 1.36-3.65; P = .002) and of death alone (HR 2.33, 95% CI 1.07-5.06; P = .03; interaction P = .26). CONCLUSIONS: In patients with mild symptoms of HF receiving CRT-D, weight loss observed at 1 year is associated with adverse clinical outcomes, especially in those with a LBBB electrocardiographic pattern.

Exercise capacity and N-terminal pro-brain natriuretic peptide levels with biventricular vs. right ventricular pacing for atrioventricular block: results from the PREVENT-HF German Substudy.

AIMS: Previous studies showed unfavourable effects of right ventricular (RV) pacing. Ventricular pacing (VP), however, is required in many patients with atrioventricular (AV) block. The PREVENT-HF study explored left ventricular (LV) remodelling during RV vs. biventricular (BIV) pacing in AV block without advanced heart failure. The pre-specified PREVENT-HF German Substudy examined exercise capacity and N-terminal pro-brain natriuretic peptide (NT-proBNP). METHODS AND RESULTS: Patients with expected VP ≥80% were randomized to RV or BIV pacing. Endpoints were peak oxygen uptake (pVO2), oxygen uptake at the anaerobic threshold (VO2AT), ventilatory efficiency (VE/VCO2), and logNT-proBNP. Considering crossover, intention to treat (ITT), and on-treatment (OT) analyses of covariance (ANCOVA) were performed. For exercise testing 44 (RV: 25, BIV: 19), and for NT-proBNP 53 patients (RV: 29, BIV: 24) were included. The ITT analysis revealed significant differences in pVO2 [ANCOVA effect 2.83 mL/kg/min, confidence interval (CI) 0.83-4.91, P = 0.007], VO2AT (ANCOVA effect 2.14 mL/min/k, CI 0.14-4.15, P = 0.03), and VE/VCO2 (ANCOVA effect -5.46, CI -10.79 to -0.13, P = 0.04) favouring BIV randomization. The significant advantage in pVO2 persisted in OT analysis, while VO2AT and VE/VCO2 showed trends favouring BIV pacing. LogNT-proBNP did not differ between groups. (ITT: ANCOVA effect 0.008, CI -0.40 to +0.41, P = 0.97; OT: ANCOVA effect -0.03, CI -0.44 to 0.30, P = 0.90). CONCLUSION: Our study suggests that BIV pacing produces better exercise capacity over 1 year compared with RV pacing in patients without advanced heart failure and AV block. In contrast, we observed no significant changes of NT-proBNP. Larger trials will allow appraising the clinical usefulness of BIV pacing in AV block. ClinicalTrials.gov Identifier: NCT00170326.

Clinical, anatomical, and technical risk factors for postoperative pacemaker or defibrillator lead perforation with particular focus on myocardial thickness.

BACKGROUND: Postoperative lead perforation is a life-threatening complication of cardiac pacing. Identification of precipitating factors for this serious complication may help to anticipate a specific risk profile and to minimize the incidence. METHODS: We conducted a retrospective tertiary referral center analysis to clarify clinical, anatomical, and technical characteristics related to pacemaker (PM) and cardioverter/defibrillator lead perforation. We examined the baseline characteristics and the symptoms. In a subgroup, we investigated the myocardial thickness on contrast-enhanced cardiac computed tomography. RESULTS: We enrolled 26 patients. Female gender appears to put patients at slightly increased risk for lead perforation. In a majority active fixation leads were used. Symptoms occurred in 72%. Pericardial effusion and tamponade were present in 38% and 19%, respectively. Sensing was compromised in 65%. A high pacing threshold or exit block occurred in 92%. Myocardial thickness did not differ between patients with or without perforation. In 96%, the perforation was treated by transvenous withdrawal. CONCLUSION: Chest pain, phrenic stimulation, bad sensing, or exit block early after PM implantation must prompt radiological and echocardiographic evaluation. A missing pericardial effusion particularly late after implantation does not rule out a perforation. Especially active fixating leads have a higher risk of perforation. With cardiac surgery in standby transvenous withdrawal is a safe way to treat lead perforation.

QRS Morphology and the Risk of Ventricular Tachyarrhythmia in Cardiac Resynchronization Therapy Recipients.

BACKGROUND: There are conflicting data on the effect of cardiac resynchronization therapy with a defibrillator (CRT-D) on the risk of life-threatening ventricular tachyarrhythmia in heart failure patients. OBJECTIVES: The authors aimed to assess whether QRS morphology is associated with risk of ventricular arrhythmias in CRT recipients. METHODS: The study population comprised 2,862 patients implanted with implantable cardioverter defibrillator (ICD)/CRT-D for primary prevention who were enrolled in 5 landmark primary prevention ICD trials (MADIT-II [Multicenter Automated Defibrillator Implantation Trial], MADIT-CRT [Multicenter Automated Defibrillator Implantation Trial-Cardiac Resynchronization Therapy], MADIT-RIT [Multicenter Automated Defibrillator Implantation Trial-Reduction in Inappropriate Therapy], MADIT-RISK [Multicenter Automated Defibrillator Implantation Trial-RISK], and RAID [Ranolazine in High-Risk Patients With Implanted Cardioverter Defibrillators]). Patients with QRS duration ≥130 ms were divided into 2 groups: those implanted with an ICD only vs CRT-D. The primary endpoint was fast ventricular tachycardia (VT)/ventricular fibrillation (VF) (defined as VT ≥200 beats/min or VF), accounting for the competing risk of death. Secondary endpoints included appropriate shocks, any sustained VT or VF, and the burden of fast VT/VF, assessed in a recurrent event analysis. RESULTS: Among patients with left bundle branch block (n = 1,792), those with CRT-D (n = 1,112) experienced a significant 44% (P < 0.001) reduction in the risk of fast VT/VF compared with ICD-only patients (n = 680), a significantly lower burden of fast VT/VF (HR: 0.55; P = 0.001), with a reduced burden of appropriate shocks (HR: 0.44; P < 0.001). In contrast, among patients with non-left bundle branch block (NLBBB) (N = 1,070), CRT-D was not associated with reduction in fast VT/VF (HR: 1.33; P = 0.195). Furthermore, NLBBB patients with CRT-D experienced a statistically significant increase in the burden of fast VT/VF events compared with ICD-only patients (HR: 1.90; P = 0.013). CONCLUSIONS: Our data suggest a potential proarrhythmic effect of CRT among patients with NLBBB. These data should be considered in patient selection for treatment with CRT.

Effect of Metrics-Based Simulation Training to Proficiency on Procedure Quality and Errors Among Novice Cardiac Device Implanters: The IMPROF Randomized Trial.

Importance: In cardiac device implant training, there is no common system to objectively assess trainees' ability to perform tasks at predetermined performance levels before in vivo practice; therefore, patients are potentially exposed to risks related to operators' early learning curve. Objective: To assess the effect on implant performance quality of novel metrics-based simulation training to proficiency (proficiency-based progression [PBP]) vs traditional simulation-based training (SBT). Design, Setting, and Participants: In this prospective randomized trial, conducted between March 8, 2022 and November 24, 2022, novice implanters were randomized (blinded) 1:1 to participate in an SBT curriculum (procedural knowledge e-learning and in-person simulation training) at an international skills training center, with proficiency demonstration requirements at each training stage for advancing (PBP approach) or without the requirements. Ultimately, trainees performed a cardiac resynchronization therapy (CRT) implant using virtual reality simulation. The procedure was video-recorded and subsequently scored using previously validated metrics by 2 independent assessors blinded to group. Physicians who had already implanted more than 20 pacemakers or defibrillators and fewer than 200 CRT systems as the first operator were eligible. Thirty-two implanters from 10 countries voluntarily enrolled in the training program and were randomized; 30 (15 per group) started and completed training. Data analysis was performed from November 27 to December 22, 2022. Intervention: Training with PBP vs SBT. Main Outcome and Measures: The primary outcome comprised 4 objectively assessed performance metrics derived from the video-recordings: number of procedural steps completed, errors, critical errors, and all errors combined. Results: Baseline experience of the 30 participants (19 [63%] male; mean [SD] number of years in implant practice, 2.0 [1.8]; median [IQR] number of implanted pacemakers or defibrillators, 47.5 [30.0-115.0]; median [IQR] number of implanted CRT systems, 3.0 [1.25-10.0]) was similar between study groups. Compared with the SBT group, the PBP group completed 27% more procedural steps (median [IQR], 31 [30-32] vs 24 [22-27]; P < .001) and made 73% fewer errors (median [IQR], 2 [1-3] vs 7 [5-8]; P < .001), 84% fewer critical errors (median [IQR], 1 [0-1] vs 3 [3-5]; P < .001), and 77% fewer all errors combined (errors plus critical errors) (median [IQR], 3 [1-3] vs 11 [8-12]; P < .001); 14 of the 15 PBP trainees (93%) demonstrated the predefined target performance level vs 0 of the 15 SBT trainees. Conclusions and Relevance: In this randomized trial, the PBP approach to novice implanter training generated superior objectively assessed performance vs SBT. If implemented broadly and systematically, PBP training may ensure safe and effective performance standards before trainees proceed to (supervised) in vivo practice. Future studies are needed to verify implications on procedure-related patient complications. Trial Registration: ClinicalTrials.gov Identifier: NCT05952908.

Implementation of the ESC STEMI guidelines in female and elderly patients over a 20-year period in a large German registry.

AIMS: We investigated the implementation of new guidelines in ST-segment elevation myocardial infarction (STEMI) patients in a large real-world patient population in the metropolitan area of Berlin (Germany) over a 20-year period. METHODS: From January 2000 to December 2019, a total of 25 792 patients were admitted with STEMI to one of the 34 member hospitals of the Berlin-Brandenburg Myocardial Infarction Registry (B2HIR) and were stratified for sex and age < 75 and ≥ 75 years. RESULTS: The median age of women was 72 years (IQR 61-81) compared to 61 years in men (IQR 51-71). PCI treatment as a standard of care was implemented in men earlier than in women across all age groups. It took two years from the 2017 class IA ESC STEMI guideline recommendation to prefer the radial access route rather than femoral until > 60% of patients were treated accordingly. In 2019, less than 60% of elderly women were treated via a radial access. While the majority of patients < 75 years already received ticagrelor or prasugrel as antiplatelet agent in the year of the class IA ESC STEMI guideline recommendation in 2012, men ≥ 75 years lagged two years and women ≥ 75 three years behind. Amongst the elderly, in-hospital mortality was 22.6% (737) for women and 17.3% (523) for men (p < 0.001). In patients < 75 years fatal outcome was less likely with 7.2% (305) in women and 5.8% (833) in men (p < 0.001). After adjustment for confounding variables, female sex was an independent predictor of in-hospital mortality in patients ≥ 75 years (OR 1.37, 95% CI 1.12-1.68, p = 0.002), but not in patients < 75 years (p = 0.076). CONCLUSION: In-hospital mortality differs considerably by age and sex and remains highest in elderly patients and in particular in elderly females. In these patient groups, guideline recommended therapies were implemented with a significant delay.

Ventricular tachycardia or ventricular fibrillation occurs less often in patients with left bundle branch block and combined resynchronization and defibrillators than in patients with narrow QRS and conventional defibrillators.

AIMS: Mortality in chronic heart failure (CHF) patients with left bundle branch block (LBBB) is high. Cardiac resynchronization therapy (CRT) reduces symptoms and mortality in CHF patients with LBBB. Whether CRT promotes or prevents ventricular tachycardia (VT)/ventricular fibrillation (VF) remains controversial, however. Therefore, we aimed to analyse arrhythmia-related CRT effects and characterized the VT/VF incidence in CRT-defibrillator patients and matched controls with conventional implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden cardiac death. METHODS AND RESULTS: We enrolled 134 patients [110 men, left ventricular ejection fraction (LVEF) 24 ± 8%, 71 coronary artery disease, CRT-ICD 67, conventional ICD matched controls 67, follow-up 31 ± 17 months] and monitored overall survival and the time to a first VT/VF episode. Controls did not have LBBB. They were otherwise matched for age, LVEF, and follow-up duration. Gender and underlying disease did not differ between the groups. Kaplan-Meier analysis revealed more favourable arrhythmia-free survival in CRT-ICD vs. conventional ICD patients [hazard ratio (HR) 2.26, confidence interval (CI) 1.09-4.67, log rank P = 0.023]. The difference persisted in the multivariate Cox regression analysis (HR 3.25, CI 1.18-8.93, P= 0.022). Overall survival was similar in both groups (HR 1.45, CI 0.55-3.82, P = 0.45). CONCLUSIONS: Chronic heart failure patients with LBBB treated with CRT-ICD, experience less and delayed VT/VF episodes compared with matched controls without LBBB receiving conventional ICD. In the long-term, CRT appears to exert antiarrhythmic effects and to attenuate the particularly high arrhythmia-related risk of CHF patients with LBBB. The incremental benefit of adding the ICD option to CRT pacing in LBBB patients appears questionable.

Extraordinarily favorable left ventricular reverse remodeling through long-term cardiac resynchronization: super-response to cardiac resynchronization.

BACKGROUND: Some chronic heart failure (CHF) patients show remarkable improvement in left ventricular (LV) remodeling after cardiac resynchronization therapy (CRT), for unclear reasons. This study aimed at identifying predictors of an extraordinarily favorable response to CRT. METHODS: We studied 136 CRT patients (104 men, median 66 years, QRS 162 ms, left ventricular ejection fraction 24 ± 7%, 70% coronary disease, all left bundle branch block [LBBB]). We measured LV end diastolic diameter (LVEDD) before and after long-term (9.4 ± 6.3 months) CRT. At baseline, LV pre-ejection interval (LVPEI), interventricular mechanical delay (IVMD), LV dyssynchrony (standard deviation of electromechanical delays [SDEMD] in eight LV segments), exercise capacity (pVO(2)), and ventilatory efficiency (VE/VCO(2)) were assessed. Patients with a LVEDD reduction beyond the 80th percentile (high responders [HR]) were compared to low responders (LR). RESULTS: In the HR group (n = 22), LVEDD was reduced from 71 to 52 mm (LR 64-61 mm, P < 0.001). HR had predominantly nonischemic heart disease (HR: 72%, LR: 44%, P = 0.019), tended to have a wider QRS (HR: 178 ms, LR: 162 ms, P = 0.066), had a longer LVPEI (HR: 179 ms, LR: 155 ms, P = 0.004), wider IVMD (HR: 60 ms, LR 48 ms, P = 0.05), larger LVEDD (P = 0.002), higher SDEMD (HR: 69 ms, LR: 46 ms, P = 0.044), but higher pVO(2) (HR: 17.5 mL/min/kg, LR: 13.5 mL/kg/min, P = 0.025) and lower VE/VCO(2) (HR: 31, LR: 35, P = 0.043), all compared to LR patients. CONCLUSION: Extraordinarily favorable reverse LV remodeling through CRT in CHF and LBBB appears to require a particularly dilated LV due to nonischemic heart disease with pronounced electromechanical alteration, but with a fairly preserved functional capacity before CRT.

[Artificial intelligence in cardiology : Relevance, current applications, and future developments]. / Künstliche Intelligenz in der Kardiologie : Relevanz, aktuelle Anwendungen und nächste Schritte.

Big data and applications of artificial intelligence (AI), such as machine learning or deep learning, will enrich healthcare in the future and become increasingly important. Among other things, they have the potential to avoid unnecessary examinations as well as diagnostic and therapeutic errors. They could enable improved, early and accelerated decision-making. In the article, the authors provide an overview of current AI-based applications in cardiology. The examples describe innovative solutions for risk assessment, diagnosis and therapy support up to patient self-management. Big data and AI serve as a basis for efficient, predictive, preventive and personalised medicine. However, the examples also show that research is needed to further develop the solutions for the benefit of the patient and the medical profession, to demonstrate the effectiveness and benefits in health care and to establish legal and ethical standards.

[Position paper on required competencies of nonphysician employees in telemedicine centers]. / Positionspapier zum Anforderungsprofil von nichtärztlichen Assistenzkräften in Telemedizinzentren.

The non-physician employees in telemedicine centers (TMC) play a decisive role in the care and treatment of patients with heart failure. For this reason, a holistic profile consisting of professional and methodological as well as social and personal competences is necessary, which should be built up or promoted in corresponding training concepts. This position paper underlines the urgency of appropriate and standardized further training of non-physician employees for quality assurance in TMCs and summarizes the requirements for the additional qualification of a telemedical assistant across the board.

A validation study of intraoperative performance metrics for training novice cardiac resynchronization therapy implanters.

AIMS: Pacing/cardiac resynchronization therapy (CRT) implant training currently lacks a common system to objectively assess trainee ability to perform required tasks at predetermined performance levels. The purpose of this study was to primarily examine construct validity and reliability, secondarily discriminative validity of novel intraoperative performance metrics, developed for a reference approach to training novice CRT implanters. METHODS: Fifteen novice and eleven experienced CRT implanters performed a 3-lead implant procedure on a virtual reality simulator. Performances were video-recorded, then independently scored using predefined metrics endorsed by an international panel of experts. First, Novice and Experienced group scores were compared for steps completed and errors made. Secondly, each group was split in two around the median score of the group and subgroup scores were compared. RESULTS: The mean number of scored metrics per performance was 108 and the inter-rater reliability for scoring was 0.947. Compared with novices, experienced implanters completed more procedural Steps correctly (mean 87% vs. 73%, p = 0.001), made fewer procedural Errors (6.3 vs. 11.2, p = 0.005), Critical Errors (1.8 vs. 4.4, p = 0.004), and total errors (8.1 vs. 15.6, p = 0.002). Furthermore, the differences between the two Novice subgroups were 25% for steps completed correctly and 94% for total errors made (p < 0.001); the differences between the two Experienced subgroups were respectively 16% and 191% (p < 0.001). CONCLUSIONS: The procedure metrics used in this study reliably distinguish novice and experienced CRT implanters' performances. The metrics further differentiated performance levels within a group with similar experience. These performance metrics will underpin quality-assured novice implanter training.

Changes in treatment for NSTEMI in women and the elderly over the past 16 years in a large real-world population.

AIMS: This study investigates the changes in therapy for Non-ST-Elevation Myocardial Infarction (NSTEMI) over the past 16 years in a large German registry. In particular, the high-risk population of female and elderly patients was analyzed. METHODS: In total, 19.383 patients presenting with NSTEMI were included in this study. Patients were stratified by age groups <75 years and ≥75 years and by sex. Four different time periods from 2000-2004, 2005-2008, 2009-2012 and 2013-2016 were compared. Influence on hospital mortality as the primary outcome measure was assessed by logistic regression analysis. Secondary outcome measures included percutaneous coronary intervention (PCI), the use of drug eluting stents (DES), radial access route and major adverse cardiovascular events (MACE), defined as all-cause mortality, stroke, re-infarction, percutaneous re-intervention, intervention-related bleeding, cardiopulmonary resuscitation and new onset of cardiogenic shock or need for mechanical ventilation. RESULTS: Mortality decreased in all age groups between the initial time period and the most recent one (8.9% vs. 4.5%, p < 0.01), particularly in female patients ≥75 years (18.2% in 2000-2004 vs. 7.9% in 2013-2016, p < 0.01). Revascularization rates differed by gender (68.3% in women vs. 78.1% in men, p < 0.01) and by age (64.2% for ≥75 years vs. 80.9% for <75 years, p < 0.01). PCI rates in elderly female patients increased from 28.7% to 69.8% (p < 0.01) from the initial to the latest period. CONCLUSIONS: The present study demonstrates, that revascularization rates improved in all patient groups over the study period. However, females and elderly patients still remain less likely to be treated according to current guidelines.