Discontinuation versus continuation of renin-angiotensin-system inhibitors in COVID-19 (ACEI-COVID): a prospective, parallel group, randomised, controlled, open-label trial.

BACKGROUND: SARS-CoV-2 entry in human cells depends on angiotensin-converting enzyme 2, which can be upregulated by inhibitors of the renin-angiotensin system (RAS). We aimed to test our hypothesis that discontinuation of chronic treatment with ACE-inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) mitigates the course o\f recent-onset COVID-19. METHODS: ACEI-COVID was a parallel group, randomised, controlled, open-label trial done at 35 centres in Austria and Germany. Patients aged 18 years and older were enrolled if they presented with recent symptomatic SARS-CoV-2 infection and were chronically treated with ACEIs or ARBs. Patients were randomly assigned 1:1 to discontinuation or continuation of RAS inhibition for 30 days. Primary outcome was the maximum sequential organ failure assessment (SOFA) score within 30 days, where death was scored with the maximum achievable SOFA score. Secondary endpoints were area under the death-adjusted SOFA score (AUCSOFA), mean SOFA score, admission to the intensive care unit, mechanical ventilation, and death. Analyses were done on a modified intention-to-treat basis. This trial is registered with ClinicalTrials.gov, NCT04353596. FINDINGS: Between April 20, 2020, and Jan 20, 2021, 204 patients (median age 75 years [IQR 66-80], 37% females) were randomly assigned to discontinue (n=104) or continue (n=100) RAS inhibition. Within 30 days, eight (8%) of 104 died in the discontinuation group and 12 (12%) of 100 patients died in the continuation group (p=0·42). There was no significant difference in the primary endpoint between the discontinuation and continuation group (median [IQR] maximum SOFA score 0·00 (0·00-2·00) vs 1·00 (0·00-3·00); p=0·12). Discontinuation was associated with a significantly lower AUCSOFA (0·00 [0·00-9·25] vs 3·50 [0·00-23·50]; p=0·040), mean SOFA score (0·00 [0·00-0·31] vs 0·12 [0·00-0·78]; p=0·040), and 30-day SOFA score (0·00 [10-90th percentile, 0·00-1·20] vs 0·00 [0·00-24·00]; p=0·023). At 30 days, 11 (11%) in the discontinuation group and 23 (23%) in the continuation group had signs of organ dysfunction (SOFA score ≥1) or were dead (p=0·017). There were no significant differences for mechanical ventilation (10 (10%) vs 8 (8%), p=0·87) and admission to intensive care unit (20 [19%] vs 18 [18%], p=0·96) between the discontinuation and continuation group. INTERPRETATION: Discontinuation of RAS-inhibition in COVID-19 had no significant effect on the maximum severity of COVID-19 but may lead to a faster and better recovery. The decision to continue or discontinue should be made on an individual basis, considering the risk profile, the indication for RAS inhibition, and the availability of alternative therapies and outpatient monitoring options. FUNDING: Austrian Science Fund and German Center for Cardiovascular Research.

[Premature ventricular contractions and tachycardia in a structurally normal heart : Idiopathic PVC and VT]. / Ventrikuläre Extrasystolen und Tachykardien bei strukturell normalem Herz : Idiopathische VES und VT.

Premature ventricular contractions (PVC) are a common, often incidental and mostly benign finding. Treatment is indicated in frequent and symptomatic PVC or in cases of worsening of left ventricular function. Idiopathic ventricular tachycardia (VT) is mostly found in patients with a structurally healthy heart. These PVC/VT usually have a focal origin. The most likely mechanism is delayed post-depolarization. Localization of the origin is based on the creation of an activation map with or without combination of pace mapping. Idiopathic PVC/VT are most frequently located on the outflow tracts of the right and left ventricles, including the aortic root. Other typical locations include the annulus of the tricuspid or mitral valve, papillary muscles and Purkinje fibers. Catheter ablation is an alternative to antiarrhythmic medication in symptomatic monomorphic PVC/VT. The success rate is good whereby mapping and ablation can often represent a challenge. This article is the fifth part of a series dedicated to specific advanced training in the field of special rhythmology and invasive electrophysiology. It describes the pathophysiological principles, types and typical findings that can be obtained during an electrophysiological investigation.

Updated Survey on Interventional Electrophysiology: 5-Year Follow-Up of Infrastructure, Procedures, and Training Positions in Germany.

OBJECTIVES: This study provides an update and comparison to a 2010 nationwide survey on cardiac electrophysiology (EP), types and numbers of interventional electrophysiological procedures, and training opportunities in 2015. BACKGROUND: In 2010, German cardiology centers performing interventional EP were identified and contacted to provide a survey on cardiac EP. METHODS: German cardiology centers performing interventional EP in 2015 were identified from quality reports and contacted to repeat the 2010 questionnaire. RESULTS: A majority of 131 centers (57%) responded. EP (ablation procedures and device therapy) was mainly part of a cardiology department (89%) and only independent (with its own budget) in 11%. The proportion of female physicians in EP training increased from 26% in 2010 to 38% in 2015. In total, 49,356 catheter ablations (i.e., 81% of reported ablations in 2015) were performed by the responding centers, resulting in a 44% increase compared with 2010 (the median number increased from 180 to 297 per center). Atrial fibrillation (AF) was the most common arrhythmia interventionally treated (47%). At 66% of the centers, (at least) 2 physicians were present during most catheter ablations. A minimum of 50 (75) AF ablations were performed at 80% (70%) of the centers. Pulmonary vein isolation with radiofrequency point-by-point ablation (62%) and cryoablation (33%) were the preferred ablation strategies. About one-third of centers reported surgical AF ablations, with 11 centers (8%) performing stand-alone surgical AF ablations. Only one-third of the responding 131 centers fulfilled all requirements for training center accreditation. CONCLUSIONS: Comparing 2010 with 2015, an increasing number of EP centers and procedures in Germany are registered. In 2015, almost every second ablation was for therapy for AF. Thus, an increasing demand for catheter ablation is likely, but training opportunities are still limited, and most centers do not fulfil recommended requirements for ablation centers.

Impact of intraoperative mechanical ventilation on left ventricular lead function in cardiac resynchronization therapy.

BACKGROUND: Intraoperative controlled mechanical ventilation (CMV) changes the intrathoracic geometry and may impact postoperative left ventricular (LV) lead function after CRT implantation. This multicenter study investigates the effect of intraoperative ventilation setting (spontaneous breathing [SB] vs CMV) on postoperative LV lead function taking into account patients' body mass index (BMI). METHODS: CRT implantation was performed at two centers during SB in 92 and during CMV in 73 patients. Follow-up was carried out after 3 ± 5 and 36 ± 53 days. Functional lead parameters (FLP; pacing threshold and impedance), postoperative adverse events (A;  phrenic nerve stimulation [PNS] and lead malfunction), and patients' BMI were assessed. Delta values of FLP between baseline and follow-up visits were analyzed applying an analysis of covariance model to detect subclinical alterations in LV lead function. RESULTS: AE occurred in a total of 36 (21%) patients. PNS was observed in 26 (15%) patients and LV lead repositioning due to malfunction was necessary in 10 (6%) patients. Both AE and FLP delta values between baseline and follow-up were not associated with intraoperative ventilation settings nor the patients' BMI. CONCLUSIONS: This study demonstrates that there is no impact of the intraoperative ventilation setting (SB vs CMV) on postoperative FLP or the occurrence of AE. This is also the case taking into account the BMI. With respect to these findings both approaches-sedation only or general anaesthesia including CMV-can be safely implemented during CRT implantation.

Long-term outcomes and predictors of recurrence after pulmonary vein isolation with multielectrode ablation catheter in patients with atrial fibrillation.

PURPOSE: Despite various techniques used in atrial fibrillation ablation, recurrence of atrial arrhythmias still constitutes a clinical problem. The aim of this study was to document the long-term outcomes of pulmonary vein isolation with a ring-shaped ablation catheter (PVAC). METHODS: All consecutive patients presenting with paroxysmal or persistent atrial fibrillation (pxAF or perAF, respectively) treated with PVAC (first generation) were enrolled. After standard follow-up during the first year, all patients were contacted for long-term follow-up. In addition to the patient's medical history, 3-day Holter monitoring was performed. Endpoints were atrial fibrillation-related symptoms, ECG documentation of atrial fibrillation or other left atrial arrhythmias and reablation. RESULTS: In total, 125 patients (78% with pxAF) were enrolled. All but two pulmonary veins (0.4% of 485 pulmonary veins) could be successfully isolated. At 12 months, 83% of patients in the pxAF group and 53% of patients in the perAF group were free from symptoms. The mean long-term follow-up was 51 ±â€Š14 months. Regarding long-term efficacy, 56% of patients in the pxAF group and 28% of patients in the perAF group were free from any recurrence at 72 months. Independent predictors of event-free survival were perAF (hazard ratio 2.76, P = 0.001) and the existence of mild valvular disease (hazard ratio 2.69, P = 0.001). No significant complication due to PVAC occurred, especially no ischemic stroke. CONCLUSION: Long-term follow-up indicated for the first time in such a considerable cohort that pulmonary vein isolation with PVAC is a safe and very efficient method for treating pxAF - despite known microembolism issues. Patients with perAF receive less benefit from PVAC and ablation therapy should be reserved to pxAF. Significantly, even mild valvular disease was an independent predictor of atrial fibrillation recurrence.

Clinical Impact of the Microembolic Signal Burden During Catheter Ablation for Atrial Fibrillation: Just a Lot of Noise?

OBJECTIVES: Microembolic signal detection by transcranial Doppler ultrasonography may be considered a surrogate for cerebral events during invasive cardiac procedures. However, the impact of the microembolic signal count during pulmonary vein isolation on the clinical outcome is not well evaluated. We investigated the effect of the microembolic signal count on the occurrence of new silent cerebral embolism measured by diffusion-weighted imaging (DWI)-magnetic resonance imaging (MRI), changes in neuropsychological testing, and the occurrence of clinical events during long-term follow-up after pulmonary vein isolation. METHODS: Pulmonary vein isolation was performed in 41 patients. The total microembolic signal burden (classified into "solid," "gaseous," and "equivocal") and sustained thromboembolic showers of greater than 30 seconds were recorded. Diffusion-weighted imaging-MRI and neuropsychological testing were performed before and after pulmonary vein isolation to assess for silent cerebral embolism and neuropsychological sequelae. Long-term follow-up was performed by telephone to assess for stroke/transient ischemic attack. RESULTS: A total of 68,729 microembolic signals (14,893 solid, 11,909 gaseous, and 41,927 equivocal) with an average of 1676 signals per patient and 42 thromboembolic showers were recorded. No correlation between the microembolic signal/thromboembolic shower count and the occurrence of new DWI lesions or neuropsychological capability was found. After a mean follow-up ± SD of 49 ± 4 months, 1 patient had an overt transient ischemic event, which was not associated with a high microembolic signal count. CONCLUSIONS: In this multicenter study, we found no impact of the intraprocedural microembolic symbol/thromboembolic shower count on the occurrence of new DWI lesions, neuropsychological capability, or overt neurologic deficits after pulmonary vein isolation. Thus, not only the microembolic signal count but also procedural/individual factors may contribute to commensurable clinical damage, which may challenge this method as a valid biomarker during pulmonary vein isolation.

Online Measurement of Microembolic Signal Burden by Transcranial Doppler during Catheter Ablation for Atrial Fibrillation-Results of a Multicenter Trial.

INTRODUCTION: Left atrial pulmonary vein isolation (PVI) is an accepted treatment option for patients with symptomatic atrial fibrillation (AF). This procedure can be complicated by stroke or silent cerebral embolism. Online measurement of microembolic signals (MESs) by transcranial Doppler (TCD) may be useful for characterizing thromboembolic burden during PVI. In this prospective multicenter trial, we investigated the burden, characteristics, and composition of MES during left atrial catheter ablation using a variety of catheter technologies. MATERIALS AND METHODS: PVI was performed in a total of 42 patients using the circular-shaped multielectrode pulmonary vein ablation catheter (PVAC) technology in 23, an irrigated radiofrequency (IRF) in 14, and the cryoballoon (CB) technology in 5 patients. TCD was used to detect the total MES burden and sustained thromboembolic showers (TESs) of >30 s. During TES, the site of ablation within the left atrium was registered. MES composition was classified manually into "solid," "gaseous," or "equivocal" by off-line expert assessment. RESULTS: The total MES burden was higher when using IRF compared to CB (2,336 ± 1,654 vs. 593 ± 231; p = 0.007) and showed a tendency toward a higher burden when using IRF compared to PVAC (2,336 ± 1,654 vs. 1,685 ± 2,255; p = 0.08). TES occurred more often when using PVAC compared to IRF (1.5 ± 2 vs. 0.4 ± 1.3; p = 0.04) and most frequently when ablation was performed close to the left superior pulmonary vein (LSPV). Of the MES, 17.004 (23%) were characterized as definitely solid, 13.204 (18%) as clearly gaseous, and 44.366 (59%) as equivocal. DISCUSSION: We investigated the burden and characteristics of MES during left atrial catheter ablation for AF. All ablation techniques applied in this study generated a relevant number of MES. There was a significant difference in total MES burden using IRF compared to CB and a tendency toward a higher burden using IRF compared to PVAC. The highest TES burden was found in the PVAC group, particularly during ablation close to the LSPV. The composition of thromboembolic particles was balanced. The impact of MES, TES, and composition of thromboembolic particles on neurological outcome needs to be evaluated further. (Clinical Trial Registration: Deutsches Register Klinischer Studien, https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00003465. DRKS00003465.).

[AV-reentrant tachycardia and Wolff-Parkinson-White syndrome : Diagnosis and treatment]. / AV-Reentry-Tachykardie und Wolff-Parkinson-White-Syndrom : Diagnostik und Therapie.

The AV-reentrant tachycardia (AVRT) is a supraventricular tachycardia with an incidence of 1-3/1000. The pathophysiological basis is an accessory atrioventricular pathway (AP). Patients with AVRT typically present with palpitations, an on-off characteristic, anxiety, dyspnea, and polyuria. This type of tachycardia may often be terminated by vagal maneuvers. Although the clinical presentation of AVRT is quite similar to AV-nodal reentrant tachycardias, the correct diagnosis is often facilitated by analyzing a standard 12-lead ECG at normal heart rate showing ventricular preexcitation. Curative catheter ablation of the AP represents the therapy of choice in symptomatic patients. This article is the fourth part of a series written to improve the professional education of young electrophysiologists. It explains pathophysiology, symptoms, and electrophysiological findings of an invasive EP study. It focusses on mapping and ablation of accessory pathways.

[AV nodal reentrant tachycardia. Diagnosis and therapy]. / AV-Knoten-Reentrytachykardie. Diagnostik und Therapie.

The AV nodal reentrant tachycardia (AVNRT) is one of the most common arrhythmias encountered in clinical practice. It is characterized by a constant heart rate and an on/off phenomenon. The clinical symptoms may include palpitations, anxiety, polyuria, and dyspnea. Typically, tachycardia may be disrupted by vagal maneuvers in many patients. First-line treatment of symptomatic AVNRT is radiofrequency ablation. The present article deals with the characteristics, differential diagnosis and treatment of AVNRT in the EP lab. It is the second part of a series of manuscripts which may facilitate further education in the specific field of electrophysiology.

Silent cerebral events as a result of left atrial catheter ablation do not cause neuropsychological sequelae--a MRI-controlled multicenter study.

PURPOSE: Recently, diffusion-weighted magnetic resonance imaging (DW-MRI) revealed silent cerebral events (SCEs) as an acute complication of pulmonary vein isolation (PVI). We investigated whether SCEs following PVI are associated with neuropsychological deficits observed during patients' follow-up examinations. METHODS: After PVI, 52 patients were eligible for follow-up. PVI was performed using a variety of ablation technologies (duty-cycled phased radiofrequency (RF) multipolar ablation with the Pulmonary Vein Ablation Catheter® (PVAC) in 24 patients, cooled-tip RF ablation in 23 patients, and cryoballoon ablation in five patients). Fluid-attenuated inversion recovery (FLAIR)- and DW-MRI studies were performed 1 day before PVI and 1 day and 1 month afterward to detect pre-existing cerebral lesions or post-ablation SCEs. At the same times, eight neuropsychological tests were administered. We evaluated changes in patients' neuropsychological capabilities and compared changes in patients with SCEs to those without SCEs. RESULTS: FLAIR-MRI revealed pre-existing cerebral lesions in 42 patients (81 %), and DW-MRI demonstrated new SCEs in 25 patients (48 %) (17 treated with phased RF (PVAC) (71 %), six treated with irrigated RF (26 %), and two treated with cryoablation (40 %)). Neuropsychological test results showed no significant impairment (in median z scores) 1 day and 1 month after the ablation procedure. There was no difference in neuropsychological capabilities between patients with SCEs and those without SCEs except in one subtest (part of the verbal working memory test). CONCLUSIONS: The incidence of pre-existing cerebral lesions and post-ablation SCEs was high. The frequency of SCEs depends on the ablation technology used. Neither PVI nor post-ablation SCEs have any effect on neuropsychological capabilities.

Lone atrial fibrillation as a positive predictor of left atrial volume reduction following ablation of atrial fibrillation.

AIMS: We investigated predictors of left atrial volume reduction (LAVR) in patients with atrial fibrillation (AF) undergoing AF ablation. METHODS AND RESULTS: Sixty patients with AF underwent pulmonary vein isolation (PVI) using a pulmonary vein ablation catheter (PVAC). All patients underwent cardiac imaging by computed tomography or magnetic resonance imaging to determine LAV 1 day before and 140 ± 9.5 days after PVI. Clinical follow-up and 72 h electrocardiogram Holter monitoring were performed 1, 3, and 6 months after ablation, and every 6 months thereafter. Significant LAVR (n = 60, 89.3 ± 3.9 vs. 79.5 ± 3.6 mL, P < 0.0001) was shown for the study group as a whole, caused particularly by the subgroup of patients with ablation success (n = 45, 85.2 ± 4.6 vs. 72.5 ± 3.7 mL, P < 0.0001). In addition, significant LAVR was shown for patients with lone AF (n = 25, 88.8 ± 6.8 vs. 72.7 ± 5.3 mL, P < 0.0001), but not for patients with AF and concomitant arterial hypertension (n = 32, 89 ± 4.8 vs. 86.7 ± 5 mL, P = 0.3), coronary artery disease (n = 12, 91.6 ± 7.8 vs. 89.1 ± 7.8 mL, P = 0.26), or left ventricular hypertrophy (n = 10, 86.3 ± 5.5 vs. 83.1 ± 5.3 mL, P = 0.27). Multivariate analysis revealed absence of arterial hypertension, lone AF, ablation success, and initial LA enlargement as independent predictors for significant LAVR following ablation (each P < 0.05). CONCLUSION: Based on the subgroup of patients with lone AF, PVI leads to a significant LAVR 4 months after the procedure, especially in patients with clinical success in terms of AF freedom. Comorbidities such as arterial hypertension may prevent this reverse atrial remodelling, despite AF freedom. Clinical implications need to be further elucidated.

A survey of German centres performing invasive electrophysiology: structure, procedures, and training positions.

AIMS: To provide a nationwide survey (and reference for the future) on cardiac electrophysiologists, types and numbers of invasive electrophysiological procedures, and training opportunities in 2010. METHODS AND RESULTS: German cardiology centres performing invasive electrophysiology were identified from quality reports and contacted to fill a questionnaire. A majority of 122 centres (65%) responded. Electrophysiology (ablation procedures and device therapy) was mainly part of a cardiology department (82%), and only in 9% independent (own budget). In only 58% of the centres, (at least) two physicians were present during catheter ablations. Although in 2010, women represented 59.4% of physicians <35 years old, only 26% of physicians in electrophysiology training were female. In total, 33 420 catheter ablations were performed with a median number of 180 per centre. Atrial fibrillation (AF) was the most common arrhythmia invasively treated (35%). At least 50 AF ablations were performed in 53% of the centres. Of the centres performing AF ablations, consecutive left atrial arrhythmias were treated by catheter ablation only in 75%, and only 44% had in-house surgical backup. Only one-fourth of the 122 centres fulfilled all requirements for training centre accreditation according to the European Heart Rhythm Association and the German Cardiac Society. CONCLUSION: The results indicate a high number of electrophysiology centres and procedures in Germany. Atrial fibrillation was the most common arrhythmia invasively treated. An increasing demand for catheter ablation is likely, but training opportunities are limited. Women are clearly underrepresented. A co-operation of higher and lower volume electrophysiology centres may be necessary for training purposes.

Potential role of telemedical service centers in managing remote monitoring data transmitted daily by cardiac implantable electronic devices: results of the early detection of cardiovascular events in device patients with heart failure (detecT-Pilot) study.

OBJECTIVE: Implantable cardioverter-defibrillators (ICDs) alone or combined with cardiac resynchronization therapy (CRT-Ds) featuring automatic home monitoring (HM) function can be monitored remotely on a daily basis. Different ways of implementing HM into clinical routines are possible, with efficient patient management being the main objective. In this study, a concept using a telemedical service center (TmSC) to manage HM data was developed and investigated regarding patients' satisfaction, physicians' satisfaction, and alert filtering. SUBJECTS AND METHODS: Fifty-five ICD or CRT-D patients with symptomatic heart failure were enrolled. The TmSC received HM data, identified "actionable parameters" (APs) by following protocol-defined procedures, conducted structured patient interviews, and forwarded selected APs to the respective follow-up clinic. Satisfaction of patients and physicians with the TmSC was evaluated at the end of the study by purpose-designed questionnaires. RESULTS: During a mean follow-up of 402±200 days, 3,831 APs were identified and analyzed at the TmSC (5.28 per patient-month). Most APs were triggered by a pilot detection algorithm for worsening heart failure (2.80 per patient-month), followed by atrial tachyarrhythmia episodes (1.10 per patient-month) and ventricular pacing issues (0.87 per patient-month). The TmSC forwarded 682 APs (18% of all APs) to 10 study sites. Approximately 65% of physicians and patients deemed the TmSC improved patient care. CONCLUSIONS: The TmSC-based management concept was well accepted and appreciated by the majority of physicians and patients. It may be helpful in gaining symptomatic information on top of automatic HM data and in supporting smaller clinics in the follow-up of their device patients.

Esophageal tissue injury following pulmonary vein isolation using the PVAC: assessment by endoscopy and magnetic resonance imaging.

BACKGROUND: We investigate the frequency of esophageal tissue injury (ETI) following ablation of atrial fibrillation (AF) using the pulmonary vein ablation catheter (PVAC) ascertained by esophageal endoscopy (ESE) and corresponding magnetic resonance imaging (MRI). METHODS: A total of 41 patients with symptomatic AF presenting for pulmonary vein isolation (PVI) were included consecutively in two observational groups. Group A received MRI the day before and ESE plus MRI within 3-4 weeks following the ablation procedure using the PVAC. Group B received MRI the day before and ESE plus MRI within 2 days after PVI. MRI included T2-weighted and T1-weighted postcontrast with fat suppression (fs) and late-enhancement scans to demonstrate postprocedural edema and contrast enhancement of the esophageal wall. RESULTS: A total of 13 (32%) patients were enrolled in Group A (26 ± 11 days post-PVI), and 28 (68%) patients in Group B (2 ± 0.6 days post-PVI). ETI was found by ESE in one (2%) patient (Group B) and resolved under conservative therapy. Corresponding MRI showed a false negative result with no alterations of esophageal structures using T1-weighted, T2-weighted, and late enhancement scans. In addition, false positive results were demonstrated by late-enhancement MRI in five (12%) patients (three patients in Group A and two patients in Group B), which could not be verified by corresponding ESE. CONCLUSIONS: Endoluminal ETI is a rare but possible complication, which should be considered following PVAC procedures. MRI of the esophagus is currently not a reliable screening method due to false positive and negative findings compared to ESE.

Shock or no shock - a question of philosophy or should intraoperative implantable cardioverter defibrillator testing be recommended?

OBJECTIVES: Implantation of implantable cardioverter defibrillators (ICDs) in patients with a high risk for life-threatening ventricular arrhythmias is a standard therapy. The development of new ICD leads, shock algorithms, high-energy defibrillators and rapid energy supply has improved the devices. Nevertheless, the discussion regarding 'shock or no shock' to test the system intraoperatively has not silenced yet. METHODS: In this study, all 718 patients (60.0 ± 14.2 years old, 570 male) who were treated with a first ICD at our institution since 2005 were analysed. The indication for implantation was primarily prophylactic in 511 patients (71.3%). Underlying diseases included ischaemic cardiomyopathy (358 patients, 50%), dilated cardiomyopathy (270 patients, 37.7%) and others (12.3%). Mean ejection fraction was 27.4 ± 11.8%. Intraoperative ventricular fibrillation was induced with a T-wave shock or burst stimulation. The primary end-point was failing the initial intraoperative testing. RESULTS: During the initial testing, 28 patients (3.9%) had a defibrillation threshold (DFT) >21 J. The mean age of these patients was 51 ± 14 years, ranging from 22 to 71 years, 20 were male, and the ejection fraction was 23.8 ± 11.8%. The indication for ICD implantation was prophylactic in 13 patients. Twenty-one of the 28 patients suffered from dilated cardiomyopathy, whereas seven patients had ischaemic cardiomyopathy. Twenty-four ICDs were implanted on the left side and four on the right side. None of the patients had been treated with amiodarone at the time of implantation. All patients achieved a sufficient DFT ≤ 21 J by changing the ICD leads, device repositioning and/or optimizing the shock configuration. CONCLUSIONS: The standard of care intraoperative ICD testing remains necessary.

Accelerating three-dimensional molecular cardiovascular MR imaging using compressed sensing.

PURPOSE: To accelerate the acquisition of three-dimensional (3D) high-resolution cardiovascular molecular MRI by using Compressed Sensing (CS) reconstruction. MATERIALS AND METHODS: Molecular MRI is an emerging technique for the early assessment of cardiovascular disease. This technique provides excellent soft tissue differentiation at a molecular and cellular level using target-specific contrast agents (CAs). However, long scan times are required for 3D molecular MRI. Parallel imaging can be used to speed-up these acquisitions, but hardware considerations limit the maximum acceleration factor. This limitation is important in small-animal studies, where single-coils are commonly used. Here we exploit the sparse nature of molecular MR images, which are characterized by localized and high-contrast biological target-enhancement, to accelerate data acquisition. CS was applied to detect: (a) venous thromboembolism and (b) coronary injury and aortic vessel wall in single- and multiple-coils acquisitions, respectively. RESULTS: Retrospective undersampling showed good overall image quality with accelerations up to four for thrombus and aortic images, and up to three for coronary artery images. For higher acceleration factors, features with high CA uptake were still well recovered while low affinity targets were less preserved with increased CS undersampling artifacts. Prospective undersampling was performed in an aortic image with acceleration of two, showing good contrast and well-defined tissue boundaries in the contrast-enhanced regions. CONCLUSION: We demonstrate the successful application of CS to preclinical molecular MR with target specific gadolinium-based CAs using retrospective (accelerations up to four) and prospective (acceleration of two) undersampling.

Three-dimensional imaging of the aortic vessel wall using an elastin-specific magnetic resonance contrast agent.

OBJECTIVE: The aim of this study was to demonstrate the feasibility of high-resolution 3-dimensional aortic vessel wall imaging using a novel elastin-specific magnetic resonance contrast agent (ESMA) in a large animal model. MATERIALS AND METHODS: The thoracic aortic vessel wall of 6 Landrace pigs was imaged using a novel ESMA and a nonspecific control agent. On day 1, imaging was performed before and after the administration of a nonspecific control agent, gadolinium diethylenetriamine pentaacetic acid (Gd-DTPA; Bayer Schering AG, Berlin, Germany). On day 3, identical scans were repeated before and after the administration of a novel ESMA (Lantheus Medical Imaging, North Billerica, Massachusetts). Three-dimensional inversion recovery gradient echo delayed-enhancement imaging and magnetic resonance (MR) angiography of the thoracic aortic vessel wall were performed on a 1.5-T MR scanner (Achieva; Philips Medical Systems, the Netherlands). The signal-to-noise ratio and the contrast-to-noise ratio of arterial wall enhancement, including the time course of enhancement, were assessed for ESMA and Gd-DTPA. After the completion of imaging sessions, histology, electron microscopy, and inductively coupled plasma mass spectroscopy were performed to localize and quantify the gadolinium bound to the arterial vessel wall. RESULTS: Administration of ESMA resulted in a strong enhancement of the aortic vessel wall on delayed-enhancement imaging, whereas no significant enhancement could be measured with Gd-DTPA. Ninety to 100 minutes after the administration of ESMA, significantly higher signal-to-noise ratio and contrast-to-noise ratio could be measured compared with the administration of Gd-DTPA (45.7 ± 9.6 vs 13.2 ± 3.5, P < 0.05 and 41.9 ± 9.1 vs 5.2 ± 2.0, P < 0.05). A significant correlation (0.96; P < 0.01) between area measurements derived from ESMA scans and aortic MR angiography scans could be found. Electron microscopy and inductively coupled plasma mass spectroscopy confirmed the colocalization of ESMA with elastic fibers. CONCLUSION: We demonstrate the feasibility of aortic vessel wall imaging using a novel ESMA in a large animal model under conditions resembling a clinical setting. Such an approach could be useful for the fast 3-dimensional assessment of the arterial vessel wall in the context of atherosclerosis, aortic aneurysms, and hypertension.

Oxygen Kinetics and Heart Rate Response during Early Recovery from Exercise in Patients with Heart Failure.

Background. The purpose of this study was to assess the post-exercise O(2) uptake and heart rate response in patients with heart failure (HF) in comparison to healthy individuals. Methods and Results. Exercise testing of all subjects was conducted according to the RITE-protocol. The study subjects were classified according to their peak oxygen uptake (peak VO(2)) in four groups: healthy individuals with a peak VO(2) >22 mL/kg/min (group 1, n: 50), and patients with HF and a peak VO(2) of 18-22 mL/kg/min, (group 2, n: 48), 14-18 mL/kg/min (group 3, n: 57), and <14 mL/kg/min (group 4, n: 31). Both peak VO(2) and HR declined more slowly in the patients with HF than in the normal subjects. Recovery of VO(2) and HR followed monoexponential kinetics in the early post-recovery phase. This enabled the determination of a time constant for both HR and VO(2) (TC VO(2) and TC HR). From group 1 to 4 there was a prolongation of the time constant for VO(2) and HR: TC VO(2) (group 1: 110 ± 34, group 2: 197 ± 43, group 3: 238 ± 80, and group 4: 278 ± 50 sec), and TC HR (group 1: 148 ± 82, group 2: 290 ± 65, group 3: 320 ± 58, and group 4: 376 ± 55 sec). Conclusion. The rate of decline of VO(2) and HR in the early post-exercise phase is inversely related to the peak VO(2). The time constant for oxygen uptake (TC VO(2)) and heart rate (TC HR) might prove a useful parameter for more precise monitoring and grading of HF.

Predictive value of left atrial volume measured by non-invasive cardiac imaging in the treatment of paroxysmal atrial fibrillation.

PURPOSE: We investigate the role of left atrial volume (LAV) as a predictor of outcome following pulmonary vein isolation (PVI) in patients with exclusive paroxysmal atrial fibrillation (AF). METHODS: PVI was performed in 213 patients (80 females, aged 60 ± 10 years) with paroxysmal AF using either the pulmonary vein ablation catheter (PVAC, n = 78) or conventional single-tip ablation (n = 135). LAV was assessed by multi-detector computed tomography (n = 39) or cardiac magnetic resonance imaging (n = 174) prior to ablation. LA diameter (LAD) and LA area were determined by echocardiography. Patients were followed up for 12 months clinically and with 72-h Holter ECG. RESULTS: The mean LAV was 85 ± 28 ml (range, 22-189 ml). Mean LAD and mean LA area were 43 ± 6 mm and 23 ± 6 cm². After a follow-up period of 18 ± 5 months, 202 patients were analyzed. AF recurrence was documented in 50 (23%) patients. Univariate analysis showed age (59 ± 11 vs. 65 ± 6 years, p = 0.049), LA area (23 ± 5 vs. 27 ± 6 cm², p = 0.03), and LAV (80 ± 27 vs. 96 ± 28 ml, p = 0.04) to be significantly associated with the outcome. Multivariate analysis revealed that none of these parameters were statistically significant (hazards ratio LAV, 0.52-1.12, p = 0.058; LA area, 0.63-1.14, p = 0.069; and age, 0.90-1.09, p = 0.41). In the case of AF recurrence, patients with LAV >95 ml showed a significantly higher probability for the occurrence of persistent AF (24% vs. 8%, p = 0.02). CONCLUSIONS: The assessment of LA size should not be incorporated as a main factor with regard to predicted ablation success in patients with paroxysmal AF being considered for PVI, as PVI may be successful even with considerable LA enlargement. Ablation should be performed promptly in patients with LAV ≤ 95 ml to prevent further LA dilatation, as patients with LAV >95 ml have an increased probability to develop persistent AF in the case of ablation failure.

Evaluation of pulmonary vein stenosis after pulmonary vein isolation using a novel circular mapping and ablation catheter (PVAC).

BACKGROUND: Pulmonary vein stenosis (PVST) is a well-known complication of pulmonary vein isolation (PVI). Specific anatomically designed ablation catheters for antral PVI have not been evaluated with regard to the incidence of PVST. We investigated the incidence, severity, and characteristics of PVST after PVI with the Pulmonary Vein Ablation Catheter (PVAC) and phased radiofrequency technology. METHODS AND RESULTS: A total of 100 patients (55 men) underwent PVI for atrial fibrillation using the PVAC. PVI was guided by selective angiography of each pulmonary vein (PV) in 70 (70%) patients and by reconstructed 3D atriography (ATG) in 30 (30%) patients. Gadolinium-enhanced MRI or multidetector CT was performed in all patients before treatment and 93±78 days after PVI. PVST was classified as follows: insignificant (<25%), mild (25%-50%), moderate (50%-75%), or severe (>75%). A total of 410 PVs were analyzed. Cardiac imaging demonstrated a detectable narrowing of the PV diameter in 23 (23%) patients and in 28 (7%) PVs. In detail, insignificant PVST was observed in 12 (2.9%) PVs, mild PVST in 15 (3.7%), and moderate PVST in 1 (0.2%). No instances of severe PVST were observed. The use of 3D-ATG was associated with a lower incidence of PVST (0.8% [95% CI, 0.0%-2.2%] versus 5.4% [95% CI, 2.7%-8.1%], P=0.027). CONCLUSIONS: To our knowledge, this study is the first to report the incidence of PVST using the PVAC. In this regard, the PVAC seems to be safe if used in an experienced center. In addition, the use of 3D-ATG may decrease the risk of PVST.