A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: the POTTER-AF study.

AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.

MR Imaging in Patients with Cardiac Pacemakers and Implantable Cardioverter Defibrillators.

This joint consensus paper of the German Roentgen Society and the German Cardiac Society provides physical and electrophysiological background information and specific recommendations for the procedural management of patients with cardiac pacemakers (PM) and implantable cardioverter defibrillators (ICD) undergoing magnetic resonance (MR) imaging. The paper outlines the responsibilities of radiologists and cardiologists regarding patient education, indications, and monitoring with modification of MR sequences and PM/ICD reprogramming strategies being discussed in particular. The aim is to optimize patient safety and to improve legal clarity in order to facilitate the access of SM/ICD patients to MR imaging. Key Points: · Conventional PM and ICD systems are no longer an absolute but rather a relative contraindication for performing an MR examination. Procedural management includes the assessment of the individual risk/benefit ratio, comprehensive patient informed consent about specific risks and "off label" use, extensive PM/ICD-related and MR-related safety precautions to reduce these risks to the greatest extent possible, as well as adequate monitoring techniques.. · MR conditional pacemaker and ICD systems have been tested and approved for MR examination under specific conditions ("in-label" use). Precise understanding of and compliance with the terms of use for the specific pacemaker system are essential for patient safety.. · The risk for an ICD patient during MR examinations is to be considered significantly higher compared to PM patients due to the higher vulnerability of the structurally damaged myocardium and the higher risk of irreversible damage to conventional ICD systems. The indication for a MR examination of an ICD patient should therefore be determined on a stricter basis and the expected risk/benefit ratio should be critically reviewed.. · This complex subject requires close collaboration between radiology and cardiology.. Citation Format · Sommer T, Bauer W, Fischbach K et al. MR Imaging in Patients with Cardiac Pacemakers and Implantable Cardioverter Defibrillators. Fortschr Röntgenstr 2017; 189: 204 - 217.

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.

Should all dysfunctional high-voltage leads be extracted? Results of a single-centre long-term registry.

AIMS: A considerable number of lead defects occurs during long-term cardioverter defibrillator therapy. Evidence-based strategies for the handling of chronically implanted, non-functional high-voltage (HV) leads are mandatory. METHODS AND RESULTS: Patient outcome after abandonment of HV leads was retrospectively compared with patient outcome following other lead revision strategies and following primary implantation. A total of 903 consecutive patients undergoing 997 implantable cardioverter defibrillator (ICD) implantations or lead revisions were followed for a mean period of 48.8 ± 37.8 months. One or more additional HV leads were placed in 60 patients. An additional pace/sense lead was implanted in 13 patients. Extraction and replacement of a dysfunctional HV lead was performed in 21 patients. The overall rate of complications including artefact sensing, ineffective defibrillation, symptomatic subclavian vein thrombosis, and other lead defects did not differ between patients with and without an additional HV lead (10.0 vs. 8.9%, P = 0.32). Survival without lead associated complications did not differ between groups. Results remained unchanged after correction for covariates. CONCLUSIONS: Abandoned HV leads did not increase the risk of ICD system-related complications in the majority of patients. Thus, a general lead extraction policy of dysfunctional HV leads cannot be advised in an average ICD population. Recommendations may not apply for young and physically active patients, in whom HV lead extraction must be considered.

AV interval optimization using pressure volume loops in dual chamber pacemaker patients with maintained systolic left ventricular function.

BACKGROUND: Atrioventricular (AV) interval optimization is often deemed too time-consuming in dual-chamber pacemaker patients with maintained LV function. Thus the majority of patients are left at their default AV interval. OBJECTIVE: To quantify the magnitude of hemodynamic improvement following AV interval optimization in chronically paced dual chamber pacemaker patients. PATIENTS AND METHODS: A pressure volume catheter was placed in the left ventricle of 19 patients with chronic dual chamber pacing and an ejection fraction >45 % undergoing elective coronary angiography. AV interval was varied in 10 ms steps from 80 to 300 ms, and pressure volume loops were recorded during breath hold. RESULTS: The average optimal AV interval was 152 ± 39 ms compared to 155 ± 8 ms for the average default AV interval (range 100-240 ms). The average improvement in stroke work following AV interval optimization was 935 ± 760 mmHg/ml (range 0-2,908; p < 0.001), which translates into an average improvement of 14 ± 9 % (range 0-28). A 10 ms variation of the AV interval changes the average stroke work by 207 ± 162 mmHg/ml. AV interval optimization also leads to improved systolic dyssynchrony indices (17.7 ± 7.0 vs. 19.4 ± 7.1 %; p = 0.01). CONCLUSION: The overall hemodynamic effect of AV interval optimization in patients with maintained LV function is in the same range as for patients undergoing cardiac resynchronization therapy for several parameters. The positive effect of AV interval optimization also applies to patients who have been chronically paced for years.

Preventing ventricular dysfunction in pacemaker patients without advanced heart failure: results from a multicentre international randomized trial (PREVENT-HF).

AIMS: Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing (VP), however, is required, and cannot be reduced in many patients with atrioventricular (AV) block. The PREVENT-HF study was an international randomized trial that explored differences in left ventricular (LV) remodelling during RV apical vs. biventricular (BIV) pacing in patients with AV block. METHODS AND RESULTS: Patients with an expected VP prevalence ≥80% were assigned to RV apical or BIV pacing. The primary endpoint was the change in LV end-diastolic volume (EDV) >12 months. Secondary endpoints were LV end-systolic volume (ESV), LV ejection fraction (EF), mitral regurgitation (MR), and a combination of heart failure (HF) events and cardiovascular hospitalizations. Overall, 108 patients were randomized (RV: 58; BIV: 50). Intention to treat and on-treatment analyses revealed no significant differences in any of the outcomes. Analysis of covariance (ANCOVA) difference for treatment according to randomization (in mL): LVEDV -3.92 (-18.71 to 10.85), P= 0.6; LVESV -1.38 (-12.07 to 9.31), P= 0.80; LVEF 2.47 (-3.00 to 7.94), P= 0.37. Analysis of covariance difference for the on-treatment analysis: LVEDV -4.90 (-20.02 to 10.22, PP= 0.52; LVESV -6.45 (-17.28 to 4.38), P= 0.24, LVEF 2.18 (-3.37 to 7.73), P= 0.44. Furthermore, secondary endpoints did not differ significantly. CONCLUSION: This study did not demonstrate significant LV volume differences >12 months between RV apical and BIV pacing for AV block. Thus, BIV pacing cannot be recommended as a routine treatment for AV block in these patients. However, the results encourage and inform the design of subsequent larger trials with higher power for detecting small volume changes. ClinicalTrials.gov Identifier: NCT00170326.

The effect of biventricular pacing on cardiac function after weaning from cardiopulmonary bypass in patients with reduced left ventricular function: a pressure-volume loop analysis.

OBJECTIVE: Patients with severely reduced left ventricular function undergoing coronary artery bypass grafting have increased complication rates. We hypothesized that temporary postoperative atrial synchronous biventricular pacing would improve left ventricular function after cardiopulmonary bypass. METHODS: A left ventricular pressure-volume catheter was placed in 21 patients undergoing coronary artery bypass grafting (ejection fraction 29% +/- 5%). Pressure-volume loops were obtained after weaning from cardiopulmonary bypass with atrial synchronous biventricular, left ventricular, and right ventricular outflow tract pacing and atrial-only stimulation at 90 beats/min. RESULTS: Steady-state systolic and preload-independent parameters were superior for atrial synchronous biventricular and left ventricular pacing and atrial-only pacing relative to atrial synchronous right ventricular outflow tract pacing (P < .05). Diastolic parameters, excepting maximum negative rate of left ventricular pressure change, were unaffected. No significant differences were observed between atrial synchronous biventricular and left ventricular pacing and atrial-only pacing. Systolic dyssynchrony was significantly lower for atrial synchronous biventricular pacing (21% +/- 5%), atrial synchronous left ventricular pacing (20% +/- 6%), and atrial-only pacing (20% +/- 6%) versus atrial synchronous right ventricular outflow tract pacing (25% +/- 7%, P < .05). Atrioventricular interval during atrial-only stimulation was positively correlated with difference in stroke work between atrial synchronous biventricular pacing and atrial-only pacing (r(2) = 0.78, P > .001). CONCLUSION: Postoperative atrial synchronous biventricular and left ventricular pacing and atrial-only stimulation significantly improve systolic function relative to atrial synchronous right ventricular outflow tract pacing. If atrioventricular conduction is prolonged, atrial synchronous biventricular pacing is preferable to atrial-only pacing.

The effect of biventricular pacing after coronary artery bypass grafting: a prospective randomized trial of different pacing modes in patients with reduced left ventricular function.

OBJECTIVES: Biventricular pacing acutely improves left ventricular function in patients with heart failure and left ventricular dyssynchrony. Pressure-volume loop analysis has shown acute perioperative hemodynamic benefits of biventricular pacing immediately after weaning from cardiopulmonary bypass in patients undergoing coronary artery bypass grafting, but whether these effects can be maintained for the early postoperative period is unclear. We hypothesized that biventricular pacing is superior to atrioventricular universal pacing at right ventricular outflowtract and atrial inhibited pacing in patients undergoing coronary artery bypass grafting. METHODS: Ninety-four patients (mean age, 67 +/- 9 years; mean ejection fraction, 35% +/- 4%) were prospectively randomized to undergo biventricular, atrioventricular universal, or atrial inhibited pacing at 90 beats/min for 96 postoperative hours. Clinical end points and postoperative hemodynamics, aminoterminal pro-brain natriuretic peptide, inotropic support, atrial fibrillation, ventricular arrhythmias, and renal function were evaluated. RESULTS: Diastolic pulmonary arterial pressure, mean arterial pressure, mixed venous saturation, cardiac index, and cardiac power index did not differ significantly among groups for all time points. Neither raw aminoterminal pro-brain natriuretic peptide nor differential from preoperative values differed significantly among groups at any time point. Median intensive care unit stay (19.5 hours) did not differ significantly by pacing mode. Incidences of postoperative atrial fibrillation were 40% for atrial inhibited, 29% for atrioventricular universal, and 37% for biventricular (differences not significant). Renal function was unaffected by pacing mode. CONCLUSION: Despite short-term hemodynamic benefits for patients with reduced left ventricular function, biventricular pacing did not lead to improved postoperative hemodynamics or clinical outcome.

Evolution of cardiac autonomic nervous activity indices in patients presenting with transient left ventricular apical ballooning.

BACKGROUND: Transient left ventricular (LV) apical ballooning (AB) is characterized by a rapidly reversible, acute LV systolic dysfunction, triggered by physical or emotional stress. Despite observations strongly suggesting catecholamine-mediated myocardial stunning due to enhanced sympathetic activity, the early time course of heart rate variability (HRV) has not been described. METHODS: We prospectively enrolled 39 consecutive patients (median age = 68 years, range 35-85 years, 38 women) with LV AB. Indices of HRV were extracted from 24-hour ambulatory electrocardiograms on the day of hospital admission, on days 2 and 3, and 3 months after the hospitalization. RESULTS: Within 48 hours after hospital admission, the indices of HRV were markedly depressed (standard deviation of normal-to-normal [NN] intervals [SDNN] 89.6 +/- 19.9 ms; mean standard deviation of NN intervals for 5-minute segments [SDNNi] 37.8 +/- 6.2 ms; root mean square of consecutive difference of normal-to-normal intervals [rMSSD] 23.0 +/- 9 ms; standard deviation of the averages of NN intervals for all 5-minute segments [SDANN] 70.1 +/- 18.0 ms; geometric triangular index [TI] 23.7 +/- 5.9 ms), recovered in the subacute phase and had normalized at 3 months follow-up (SDNN 124.7 +/- 24 ms; SDNNi 47.1 +/- 5.7 ms; rMSSD 31.1 +/- 10.5 ms; SDANN 118.5 +/- 27 ms; TI 31.2 +/- 8 ms; all P < 0.05). Mean RR-interval increased from 845 +/- 121 ms on day 1, to 929 +/- 84 ms at 3 months (P=0.06). CONCLUSIONS: A marked depression of cardiac parasympathetic activity was observed in the acute phase of LV AB, followed by recovery of autonomic modulation between the subacute and the chronic phases. The rapid return of parasympathetic function may partially explain the favorable outcomes of patients presenting with LV AB.

The COGNITION study rationale and design: influence of closed loop stimulation on cognitive performance in pacemaker patients.

BACKGROUND: Several studies showed the beneficial effect of pacemaker implantation on cognitive performance in patients with bradycardia. But it has never been investigated if patients with chronotropic incompetence may improve their cognitive performance if treated by a rate-adaptive system reacting to mental stress in comparison to the most frequently used accelerometer-driven pacing. METHODS: The randomized, single-blind, multicenter COGNITION study evaluates if closed loop stimulation (CLS) offers incremental benefit in the speed of cognitive performance and the overall well-being of elderly patients with bradycardia compared with accelerometer-based pacing. Four hundred chronotropically incompetent patients older than 55 years will be randomized 3-6 weeks after implantation to CLS or accelerometer sensor. Follow-up visits are performed after 12 and 24 months. The speed of cognitive performance, which is the underlying function influencing all other aspects of cognitive performance, will be assessed by the number connection test, a standardized psychometric test for the elderly. Secondary endpoints include patient self-assessment of different aspects of health (by visual analogue scales), quality of life (by SF-8 health survey), the incidence of atrial fibrillation (episodes lasting for longer than 24 hours), and the frequency of serious adverse events. CONCLUSION: In the ongoing COGNITION study, we aim at long-term comparison of two rate-adaptive systems, focusing on the cognitive performance of the patients, which was neglected in the past evaluation of pacemaker sensors.

The effects of facilitated primary PCI by guide wire on procedural and clinical outcomes in acute ST-segment elevation myocardial infarction.

BACKGROUND: Reperfusion of the infarct related artery (IRA) prior to PCI is prognostically important in patients with acute ST segment elevation myocardial infarction (STEMI). Reperfusion is either achieved spontaneously, facilitated by GP IIb/ IIIa inhibitors, or mechanically by crossing the guide wire beyond the lesion. In order to test the hypothesis that a visible coronary anatomy is independently associated with procedural and clinical outcomes, we evaluated the frequency and prognostic impact of guide wire facilitated reperfusion of the IRA before primary PCI. METHODS AND RESULTS: We enrolled 311 consecutive patients with successful primary PCI for STEMI (TIMI grade > or =2 flow) within 12 h after onset of symptoms. Among these, 90 patients (28.9%) had a spontaneously reperfused IRA on initial angiogram, 56 patients (18.0%) achieved reperfusion after crossing of the guide wire, and 165 patients (53.1%) successful reperfusion only after PCI. Variables associated with successful guide wire facilitated reperfusion were younger age, no history of arterial hypertension, active smoking status, negative cardiac troponin T on admission, and an infarct in the territory of the right coronary artery. Patients with spontaneous reperfusion or reperfusion after crossing of the guide wire required less fluoroscopic time and less contrast material during angiography and had higher procedural success rates (TIMI grade 3 flow 91.1 vs 79.4%, p=0.048) than patients without initial reperfusion. In addition, patients with reperfusion after crossing the lesion with the guide wire had lower mortality rates at 30 days (3.6 vs 9.1%) and after a median of 16 months (3.6 vs 13.9%, p=0.03) than those with reperfusion after PCI. CONCLUSIONS: Reperfusion of an occluded IRA by crossing the guide wire is associated with higher procedural success rates and better outcomes. Better roadmapping and device selection represent potential reasons but the exact mechanism for these benefits is still illusive.

Incidence and significance of far-field R wave sensing in a VDD-implantable cardioverter defibrillator.

BACKGROUND: A VDD-implantable cardioverter-defibrillator (ICD) provides atrioventricular (AV) synchronous stimulation when necessary and incorporates the advantages of dual chamber arrhythmia discrimination algorithms both at potentially lower costs and less periprocedural complications than a DDD-ICD system. A prerequisite for correct dual chamber ICD function is reliable atrial sensing. METHODS: We evaluated atrial near- and ventricular far-field sensing and its impact on the dual-chamber detection algorithm in 106 patients with a single-lead VDD-ICD during a 12-month follow-up period. RESULTS: Six hundred and thirty-nine follow-ups were included. Mean near-field amplitude was 3.82 +/- 1.76 mV; mean far-field amplitude was 0.31 +/- 0.15 mV. 46% of patients had far-fields >0.35 mV and 35% of patients showed atrial EGM markers corresponding to a ventricular far-field in at least one follow-up. Six hundred and forty-five tachycardia episodes were evaluated. Due to far-field sensing, three of 66 episodes (4.5%) of sinus tachycardia were misclassified as ventricular tachycardia (VT), leading to antitachycardia therapies. Delayed detection of VT was seen in a 12 of 323 episodes (3.7%) in five of 62 patients (8%) having VT events (delay 6.4 +/- 6.0 seconds (range 2-24 seconds)). Stable far-field amplitudes <0.2 mV in a follow-up had a high negative predictive value for the occurrence of malfunction during tachycardia-conversely, high far-field amplitudes or a high incidence of far-field markers are only moderately correlated with malfunction. CONCLUSIONS: Ventricular far-field sensing in a VDD-ICD is not uncommon, however, tachycardia detection by the dual chamber algorithm is not seriously impaired by far-field sensing.