Cryoablation of atrial fibrillation in "very severe" obese patients (BMI ≥ 40): Indications, feasibility, procedural safety and efficacy, and clinical outcome (the ICE-Obese Extreme).

BACKGROUND: Management of atrial fibrillation (AF) in very severe obese patients is challenging. Cryoballoon ablation (CBA) represents an effective rhythm control strategy. However, data in this patient group were limited. METHODS: Highly symptomatic AF patients with body mass index (BMI) ≥ 40 kg/m2 who had failed antiarrhythmic drug therapy and electrocardioversion and failure to achieve targeted body-weight-reduction underwent CBA. RESULTS: Data of 72 very severe obese AF patients (Group A) and 129 AF patients with normal BMI (Group B, BMI < 25 kg/m2) were consecutively collected. Group A had significantly younger age (60.6 ± 10.4 vs. 69.2 ± 11.2 years), higher BMI (44.3 ± 4.3 vs. 22.5 ± 1.6 kg/m2). Procedural pulmonary vein isolation (PVI) was successful in all patients (2 touch-up ablation in Group A). Compared to Group B, Group A had similar procedural (61.3 ± 22.6 vs. 57.5 ± 19 min), similar fluoroscopy time (10.1 ± 5.5 vs. 9.2 ± 4.8 min) but significantly higher radiation dose (2852 ± 2095 vs. 884 ± 732 µGym2). We observed similar rates of real-time-isolation (78.6% vs. 78.5%), single-shot-isolation (86.5% vs. 88.8%), but significantly longer time-to-sustained-isolation (53.5 ± 33 vs. 43.2 ± 25 s). There was significantly higher rate of puncture-site-complication (6.9% vs. 1.6%) in Group A. One-year clinical success in paroxysmal AF was (Group A: 69.4% vs. Group B: 80.2%; p < .001), in persistent AF was (Group A: 58.1% vs. Group B: 62.8%; p = .889). In Re-Do procedures Group A had a numerically lower PVI durability (75.0% vs. 83.6%, p = .089). CONCLUSION: For very severe obese AF patients, CBA appears feasible, leads to relatively good clinical outcome.

Cardiac, possible cardiac, and likely non-cardiac origin of chest pain : A hitherto underestimated parameter in German chest pain units.

BACKGROUND: Current guidelines emphasize the diagnostic value of non-cardiac or possibly cardiac chest pain. The goal of this analysis was to determine whether German chest pain units (CPUs) adequately address conditions with "atypical" chest pain in existing diagnostic structures. METHOD: A total of 11,734 patients from the German CPU registry were included. The analyses included mode of admission, critical time intervals, diagnostic steps, and differential diagnoses. RESULTS: Patients with unspecified chest pain were younger, more often female, were less likely to have classic cardiovascular risk factors and tended to present more often as self-referrals. Patients with acute coronary syndrome (ACS) mostly had prehospital medical contact. Overall, there was no difference between these two groups regarding the time from the onset of first symptoms to arrival at the CPU. In the CPU, the usual basic diagnostic measures were performed irrespective of ACS as the primary working diagnosis. In the non-ACS group, further ischemia-specific diagnostics were rarely performed. Extra-cardiac differential diagnoses were not specified. CONCLUSION: The establishment of broader awareness programs and opening CPUs for low-threshold evaluation of self-referring patients should be discussed. Regarding the rigid focus on the clarification of cardiac causes of chest pain, a stronger interdisciplinary approach should be promoted.

Correlation of Walking Activity and Cardiac Hospitalizations in Coronary Patients for 1 Year Post Cardiac Rehabilitation: The More Steps, the Better!

Problem: Reducing risk by improving fitness is one of the main objectives of cardiac rehabilitation (CR). To estimate how the number of steps/day post-CR affects coronary patients' prognosis, we analyzed its correlation with the occurrence of death, hospitalizations, and heart complaints, and if and how other variables (ejection fraction (EF), gender, age) relate to those. Methods: One hundred eleven patients (male = 91, female = 20; average age ± standard deviation (SD): 61 ± 11 years) who had been in CR due to recent coronary revascularization or chronic coronary syndrome could be enrolled. Patients were advised to document their steps (daily), blood pressure (daily), weight (weekly) and occurrences of a cardiac event in a diary for 1 year post-CR. A Cox proportional hazard model was used to examine the influence of steps/day, EF, gender, and age until the occurrence of an event. Kaplan-Meier curves were generated to compare patients' profiles. Results: Average steps/day of patients post-CR were 7333 (SD 4426). Increased walking activity reduced risk for cardiac hospitalization (constant steps/day: 5000 vs 7500, hazard rate (HR) reduction of 0.43; 10 000 vs 12 500, HR reduction of 0.20) and risk was higher in patients with an EF < 55% versus EF ⩾ 55% (HR increase of 2.88). Median follow-up time post-CR was 218 days. No patient died, 25 were hospitalized. Discussion: Monitoring the number of steps of coronary patients post CR could be valuable for estimating patients' prognosis.

[Metabolic syndrome and atrial fibrillation]. / Metabolisches Syndrom und Vorhofflimmern.

Metabolic syndrome is defined by the simultaneous occurrence of the cardiovascular risk factors obesity, hypertension, diabetes and dyslipidemia. Overweight, in particular, is continuously increasing in many countries. In this respect, metabolic syndrome is a strong risk factor for atrial fibrillation. Only few data are available on the influence of obesity on antiarrhythmic drugs. Sodium channel blockers, in particular, appear to show a reduced effectiveness. Direct oral anticoagulants can be used for anticoagulation in obese patients. With a body weight > 140 kg, a plasma level measurement is recommended. Severe overweight reduces the chances of successful ablation treatment and leads to more complications. Consistent treatment of the metabolic syndrome, and in particular weight reduction, can significantly improve the risk and the frequency of atrial fibrillation, the associated symptoms and the success of treatment for maintaining cardiac rhythm.

[Electromagnetic interference : Pacemakers, cardiac resynchronization therapy devices, implantable cardioverter-defibrillator]. / Elektromagnetische Interferenzen : Schrittmacher, kardiale Resynchronisationstherapie, implantierbarer Kardioverter-Defibrillator.

Patients with cardiac pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy devices (CRT) are exposed to different types of electromagnetic interference (EMI) at home and at work. Due to the constantly increasing role of electrically active appliances in daily use and the introduction of new therapy concepts such as the leadless cardiac pacemaker and the subcutaneous defibrillator, this topic is of great relevance. The further development of the implanted devices and the almost complete use of bipolar leads has reduced the overall risk of EMI. This review article provides information about the current status of possible interference in the private environment and how to avoid it. In addition, information is provided on how to deal with occupational sources of interference.

Unexpected high level of severe events even in low-risk profile chest pain unit patients.

AIMS: Early heart attack awareness programs are thought to increase efficacy of chest pain units (CPU) by providing live-saving information to the community. We hypothesized that self-referral might be a feasible alternative to activation of emergency medical services (EMS) in selected chest pain patients with a specific low-risk profile. METHODS AND RESULTS: In this observational registry-based study, data from 4743 CPU patients were analyzed for differences between those with or without severe or fatal prehospital or in-unit events (out-of-hospital cardiac arrest and/or in-unit death, resuscitation or ventricular tachycardia). In order to identify a low-risk subset in which early self-referral might be recommended to reduce prehospital critical time intervals, the Global Registry of Acute Coronary Events (GRACE) score for in-hospital mortality and a specific low-risk CPU score developed from the data by multivariate regression analysis were applied and corresponding event rates were calculated. Male gender, cardiac symptoms other than chest pain, first onset of symptoms and a history of myocardial infarction, heart failure or cardioverter defibrillator implantation increased propensity for critical events. Event rates within the low-risk subsets varied from 0.5-2.8%. Those patients with preinfarction angina experienced fewer events. CONCLUSIONS: When educating patients and the general population about angina pectoris symptoms and early admission, activation of EMS remains recommended. Even in patients without any CPU-specific risk factor, self-referral bears the risk of severe or fatal pre- or in-unit events of 0.6%. However, admission should not be delayed, and self-referral might be feasible in patients with previous symptoms of preinfarction angina.

Clinical outcomes of complete versus incomplete revascularization in patients treated with coronary artery bypass grafting: insights from the TiCAB trial.

OBJECTIVES: In this post hoc analysis of the Ticagrelor in coronary artery bypass grafting (CABG) trial, we aimed to analyse patients treated with CABG receiving either complete revascularization (CR) or incomplete revascularization (ICR) independent from random allocation to either ticagrelor or aspirin. METHODS: Of 1859 patients enrolled in the Ticagrelor in CABG trial, 1550 patients (83.4%) received CR and 309 patients (16.6%) ICR. Outcomes were evaluated regarding all-cause mortality, cardiovascular death, myocardial infarction (MI), repeat revascularization, stroke and bleeding within 12 months after CABG. RESULTS: Baseline parameters revealed significant differences regarding clinical presentation (stable angina pectoris: CR 68.9% vs ICR 71.2%, instable angina pectoris: 14.1% vs 7.8%, non-ST elevation MI: 17.0% vs 21.0%, P ˂ 0.01), lesion characteristics (chronic total occlusion: CR 91.3% vs ICR 96.8%, P ˂ 0.01), operative technique [off-pump coronary artery bypass surgery (OPCAB): CR 3.0% vs ICR 6.1%, P ˂ 0.01] and number of utilized grafts (total number of grafts: 2.69/patient vs 2.49/patient, P ˂ 0.001). ICR patients displayed a significantly increased risk of repeat revascularization [hazard ratio (HR) 1.91, 95% confidence interval (CI) 1.16-3.16; P < 0.01] and percutaneous coronary intervention (HR 1.95, 95% CI 1.13-3.35; P < 0.05) within 12 months after CABG. Higher risk for repeat revascularization in ICR patients was independent from random allocation to either ticagrelor or aspirin and persisted after adjustment for baseline imbalances. CONCLUSIONS: Patients with ICR presented more stable at the time of admission, but received less grafts, highly likely due to a higher rate of chronic total occlusion lesions and performed OPCAB. Although mortality presented no difference between groups, our results suggest that patients benefit from CR with regard to prevention of repeat revascularization.

Ticagrelor monotherapy versus aspirin in patients undergoing multiple arterial or single arterial coronary artery bypass grafting: insights from the TiCAB trial.

OBJECTIVES: We evaluated the effect of ticagrelor monotherapy on outcomes after multiple arterial grafting (MAG) or single arterial grafting (SAG) in coronary artery bypass grafting (CABG). METHODS: In a post hoc, non-randomized analysis of the TiCAB (Ticagrelor in CABG; ClinicalTrials.gov NCT01755520) trial, we compared event rates for ticagrelor versus aspirin in patients undergoing MAG and SAG. Primary outcome was the composite of cardiovascular death, non-fatal myocardial infarction (MI), stroke or repeat revascularization 1 year after CABG. Secondary outcomes included individual components of the primary end point, all-cause death and bleeding. RESULTS: Among 1753 patients, 998 patients underwent MAG and 755 patients underwent SAG. There was no significant difference in the 1-year primary composite outcome for ticagrelor versus aspirin with MAG [7.2% vs 7.9%; hazard ratio (HR) 0.90, 95% confidence interval (CI) 0.57-1.43; P = 0.66] or SAG (12.3% vs 8.6%; HR 1.47, 95% CI 0.93-2.31; P = 0.10). Event rates for cardiovascular death, MI, stroke, repeat revascularization and all-cause death were similar for both treatment groups with MAG and SAG. No significant difference in major bleeding was observed for ticagrelor versus aspirin with MAG (2.6% vs 2.7%; HR 0.95, 95% CI 0.44-2.05; P = 0.90) or SAG (5.8% vs 4.0%; HR 1.49, 95% CI 0.77-2.89; P = 0.24). CONCLUSIONS: In patients undergoing either MAG or SAG in the TiCAB trial, ticagrelor monotherapy compared with aspirin did not affect the rate of cardiovascular death, non-fatal MI, stroke or repeat revascularization, or the rate of bleeding, at 1 year after CABG.

Ticagrelor-based antiplatelet regimens in patients treated with coronary artery bypass grafting: a meta-analysis of randomized controlled trials.

OBJECTIVES: The optimal antiplatelet strategy in patients undergoing CABG remains unclear. This is the first meta-analysis investigating the clinical outcomes associated with ticagrelor-based antiplatelet regimens in patients receiving CABG. METHODS: Relevant scientific databases were searched for studies investigating antiplatelet regimens after CABG from inception until April 1, 2019. Studies which randomly assigned CABG patients to either ticagrelor-based or control antiplatelet regimens were eligible. The primary outcome of this analysis was all-cause death. The main secondary outcome was MI. Other outcomes of interest were cardiac death, major adverse cardiac events, stroke and bleeding. This study is registered with PROSPERO, number CRD42019122192. RESULTS: Five trials comprising 3996 patients (2002 assigned to ticagrelor-based and 1994 to control antiplatelet regimens) were eligible for quantitative synthesis. The median follow-up was 12 months. Control antiplatelet regimens consisted of either aspirin or clopidogrel or both. As compared to control, ticagrelor-based regimens reduced the risk of all-cause death [0.61 (0.43-0.87); P = 0.007], cardiac death [0.58 (0.39-0.86); P = 0.007] and major adverse cardiac events [0.79 (0.63-0.98); P = 0.03], without difference in the risk of MI [0.76 (0.50-1.18); P = 0.22], stroke [0.99 (0.56-1.78); P = 0.98] or bleeding [1.04 (0.95-1.14); P = 0.41]. There was a treatment effect modification for the primary outcome associated with trials enrolling predominantly patients with acute coronary syndrome (P for interaction = 0.038). CONCLUSIONS: In patients receiving CABG, ticagrelor-based regimens reduce mortality and major adverse cardiac events without excess bleeding risk as compared with aspirin monotherapy or the combination of aspirin and clopidogrel. The benefit of ticagrelor-based regimens is more relevant in those studies enrolling predominantly patients with acute coronary syndrome. These findings require further confirmation in randomized trials focused on this subset of patients and powered for clinical outcomes.

[Travelling with a pacemaker or implanted defibrillator]. / Mit Herzschrittmacher oder Defibrillator auf Reisen.

There are no guidelines for patients travelling with implanted pacemakers or defibrillators. Only few publications deal with specific problems that this patient group might face. In this article different aspects of travelling with implanted electric devices are summarized. Patients with pacemakers and implanted defibrillators have nearly no limits when travelling. An exception to that rule is scuba diving, which mostly is limited because of the device. In general it is the underlying heart disease or arrhythmia that limits patients' travel activities. It is reasonable to travel after implantation only after wound healing is complete because arm movement on the implant site is limited and the risk of wound infection and lead dislocation is elevated in the early phase. However, if necessary, flying is possible 2 days after an uncomplicated implantation if pneumothorax can be excluded. Security checks can be passed safely by patients with pacemakers/defibrillators. Only repetitive movement of a handheld metal detector over the device should be avoided. When travelling to different time zones it might be reasonable to deactivate a programmed sleep rate (Medtronic, Biotronik). Patients at risk for ventricular arrhythmia (mainly patients with an implantable cardioverter-defibrillator) must make sure to take all possible preventive measures to avoid travelers' diarrhea. In case of infection early replacement of fluids and electrolytes is essential.

Walking activity during ambulant cardiac rehabilitation is related to maximum working capacity, age, and smoking behavior.

BACKGROUND: A total of 6,500 to 8,000 steps per day are recommended for cardiovascular secondary prevention. The aim of this research was to examine how many steps per day patients achieve during ambulant cardiac rehabilitation (CR), and if there is a correlation between the number of steps and physical and cardiological parameters. METHODS: In all, 192 stable CR patients were included and advised for sealed pedometry. The assessed parameters included maximum working capacity and heart rate, body mass index (BMI), New York Heart Association (NYHA) class, ejection fraction (EF), coronary artery disease status, beta-blocker medication, age, sex, smoking behavior, and laboratory parameters. A regularized regression approach called least absolute shrinkage and selection operator (LASSO) was used to detect a small set of explanatory variables associated with the response for steps per day. Based on these selected covariates, a sparse additive regression model was fitted. RESULTS: The model noted that steps per day had a strong positive correlation with maximum working capacity (P=0.001), a significant negative correlation with higher age (P=0.01) and smoking (smoker: P<0.05; ex-smoker: P=0.01), a positive correlation with high-density lipoprotein (HDL), and a negative correlation with beta-blockers. Correlation between BMI and walking activity was nonlinear (BMI 18.5-24: 7,427±2,730 steps per day; BMI 25-29: 6,448±2,393 steps/day; BMI 30-34: 6,751±2,393 steps per day; BMI 35-39: 5,163±2,574; BMI >40: 6,077±1,567). CONCLUSION: Walking activity during CR is reduced in patients who are unfit, older, smoke, or used to smoke. In addition to training recommendations, estimated steps per day during CR could be seen as a baseline orientation that helps patients to stay generally active or even to increase activity after CR.

Is mortality a useful parameter for public reporting in pacemaker implantation? Results of an obligatory external quality control programme.

AIMS: To evaluate if public reporting of pacemaker implantation-associated mortality is meaningful in a large contemporary patient cohort. METHODS AND RESULTS: The database of the obligatory external quality control programme in the Federal State of Hessen, Germany, of patients undergoing permanent pacemaker (PPM) implantation was evaluated retrospectively. We compared the baseline features of patients who died compared with those who did not during hospitalization after PPM. Of 5079 patients who underwent PPM implantation in 2009, 74 (1.5%) died during the hospital stay. Cause of death was available in 70/74 patients (94.6%) who died. Deceased patients were older (79.6 ± 8.7 vs. 76.3 ± 9.9 years, P = 0.006), had worse American Society of Anesthesiologists (ASA) physical status (P < 0.001), lower ejection fraction (P < 0.001), a greater prevalence of high-degree atrioventricular-block (44.3 vs. 35.0%, P = 0.001), and were more likely to receive single-chamber devices (41.4 vs. 25.0%, P < 0.002). Perioperative complications were similar in both cohorts. Death was not attributable directly to PPM procedure in any patients but was related to (i) non-device-related infections (28.6%), (ii) heart failure (25.7%), (iii) extracardiac diseases (21.4%), (iv) multiorgan failure (8.6%), (v) previous resuscitation with hypoxic brain damage (8.6%), and (vi) arrhythmogenic death (7.1%). CONCLUSION: Mortality associated with PPM implantation in vast majority of cases was not related to the procedure, but to comorbidities and other existing diseases at the time of PPM implantation. Thus, PPM implantation in-hospital mortality should not be chosen for public reporting comparing hospital quality, even after adjusting for baseline risk.

Implantable cardioverter/defibrillators for primary prevention in dilated cardiomyopathy post-DANISH: an updated meta-analysis and systematic review of randomized controlled trials.

BACKGROUND: Sudden cardiac death (SCD) is frequent in patients with heart failure due to dilated cardiomyopathy (DCM). Implantable cardioverter/defibrillator (ICD) device therapy is currently used for primary prevention. However, publication of the DANISH trial has recently given reason for doubt, showing no significant improvement in all-cause mortality in comparison to contemporary medical therapy. METHODS: We performed a meta-analysis of all randomized controlled trials comparing ICD therapy to medical therapy (MT) for primary prevention in DCM. The primary outcome was all-cause mortality; secondary analyses were performed on sudden cardiac death, cardiovascular death and non-cardiac death. RESULTS: Five trials including a total of 2992 patients were included in the pooled analysis. Compared to contemporary medical treatment there was a significant mortality reduction with ICD device therapy [odds ratio (OR) 0.77, 95% confidence interval (CI) 0.64-0.93; p = 0.006]. SCD was decreased significantly (OR 0.43, CI 0.27-0.69; p = 0.0004), while cardiovascular death and non-cardiac death showed no differences. Sensitivity analyses showed no influence of amiodarone therapy on overall results. Analysis of MT details revealed the DANISH population to adhere the most to current guideline recommendations. In addition, it was the only study including a substantial amount of CRT devices (58%). CONCLUSIONS: Our meta-analysis of all available randomized evidence shows a survival benefit of ICD therapy for primary prevention in DCM. DANISH results suggest an attenuation of this ICD advantage when compared to contemporary medical and cardiac resynchronization therapy. Until larger trials have confirmed this finding, ICD therapy should remain the recommendation for primary prevention of SCD in DCM.

Association between hospital procedure volume and early complications after pacemaker implantation: results from a large, unselected, contemporary cohort of the German nationwide obligatory external quality assurance programme.

AIMS: Several studies demonstrated an inverse relationship between cardioverter-defibrillator implantation volume and complication rates, suggesting better outcomes for higher volume centres. However, the association of institutional procedural volume with patient outcomes for permanent pacemaker (PPM) implantation remains less known, especially in decentralized implantation systems. METHODS AND RESULTS: We performed retrospective examination of data on patients undergoing PPM from the German obligatory quality assurance programme (2007-12) to evaluate the relationship of hospital PPM volume (categorized into quintiles of their mean annual volume) with risk-adjusted in-hospital surgical complications (composite of pneumothorax, haemothorax, pericardial effusion, or pocket haematoma, all requiring intervention, or device infection) and pacemaker lead dislocation. Overall 430 416 PPM implantations were documented in 1226 hospitals. Systems included dual (72.8%) and single (25.8%) chamber PPM and cardiac resynchronization therapy (CRT) devices (1.1%). Complications included surgical (0.92%), and ventricular (0.99%), and atrial (1.22%) lead dislocation. Despite an increase in relatively complex procedures (dual chamber, CRT), there was a significant decrease in the procedural and fluoroscopy times and complications from lowest to highest implantation volume quintiles (P for trend <0.0001). The greatest difference was observed between the lowest (1-50 implantations/year-reference group) and the second-lowest (51-90 implantations/year) quintile: surgical complications [odds ratio (OR) 0.69; confidence interval (CI) 0.60-0.78], atrial lead dislocations (OR 0.69; CI 0.59-0.80), and ventricular lead dislocations (OR 0.73; CI 0.63-0.84). CONCLUSIONS: Hospital annual PPM volume was directly related to indication-based implantation of relatively more complex PPM and yet inversely with procedural times and rates of early surgical complications and lead dislocations. Thus, our data suggest better performance and lower complications with increasing procedural volume.