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Die neuen Leitlinien der ESC zur Diagnose und Behandlung von Vorhofflimmern setzen die vorhandenen Evidenzen aus den Ergebnissen klinischer Studien in eine klare Perspektive zur klinischen Anwendung um. Deutlich wird der generelle Trend zu einer intensiveren individuellen und personalisierten Betrachtung der Patienten mit Vorhofflimmern insbesondere in 2 Bereichen: durch die Einfuhrung der Charakterisierung von Vorhofflimmern mit dem 4S-Schema (Einbeziehung von Schlaganfallrisiko, Symptome, Vorhofflimmerlast, Substrat) als prazisere Methode im Vergleich zur seit vielen Jahren gelebten „PPP“-Klassifizierung (paroxysmal, persistierend, permanent). Dieser Zugang wird auch in den Ablationsempfehlungen sichtbar, in denen geraten wird, die Rezidivrisiken fur das Wiederauftreten von Vorhofflimmern nach einer Ablationsbehandlung bereits vor der Intervention intensiv mit in die Uberlegungen einzubeziehen. Wie schon in den 2016 ESC-Leitlinien wird die integrierte Behandlung von Patienten mit Vorhofflimmern betont und mit dem ABC-Behandlungspfad ein einfacher und intuitiver Weg aufgezeigt, um die wesentlichen Behandlungsschritte klar darzustellen: A fur „anticoagulation/avoid stroke“, B fur „better symptoms“, und C fur „comorbidities“. Auserdem werden erstmalig Empfehlungen fur Qualitatsindikatoren und fur Behandlungsbewertungen durch Patienten (sog. PROs = „patient reported outcomes“) vorgestellt. Im Bereich der Antikoagulation zur Schlaganfallpravention starken die Leitlinien den Einsatz der Nicht-Vitamin-K-Antikoagulanzien entsprechend dem individuellen Schlaganfallrisiko nach CHA2DS2-VASc, empfehlen aber auch die intensivere Beachtung der Blutungsrisiken. Aufgrund fehlender neuer Studiendaten gibt es keine Anderung der Empfehlungen fur den interventionellen Vorhofohrverschluss – es bleibt bei IIb („kann erwogen werden“). Im Bereich der frequenzregularisierenden Behandlung bleiben Kalziumantagonisten und Betablocker ggf. in Kombination mit Digitalis die erste Wahl. In der Rhythmuskontrolle findet sich fur den Bereich der medikamentosen Therapie eine nachvollziehbare Abwertung fur Sotalol aufgrund der bekannten Behandlungsrisiken. Die kurz nach Veroffentlichung der Leitlinien vorgestellte EAST-Studie wird im Hinblick auf die Bedeutung einer antiarrhythmischen Therapie in diesem Kommentar besonders diskutiert. Aufgewertet wird die Katheterablation von Vorhofflimmern in den Leitlinien insbesondere fur Patienten mit Tachykardie-induzierter schwerer Herzinsuffizienz (IB-Empfehlung), aber auch fur Patienten mit Vorhofflimmern und HFrEF bei strukturellen Herzerkrankungen (IIa-Empfehlung).

INTRODUCTION The objective was to analyze the impact of patient age on clinical characteristics, procedural results, safety, and outcome of cryoballoon ablation (CBA) as the primary approach in the interventional treatment of symptomatic atrial fibrillation (AF). METHODS AND RESULTS The single-center prospective observational study investigated consecutive patients who underwent initial left atrial ablation for symptomatic paroxysmal (PAF) or persistent AF (persAF). Age groups (A-F) of less than 40, 40-49, 50-59, 60-69, 70-79 and more than or equal to 80 years were evaluated. Follow-up (FU) included ECG, Holter monitoring and assessment of AF-symptoms. From 2012 to 2016, a total of 786 patients (64 ± 11 years, range 21-85) underwent CBA. With advancing age, more cardiovascular comorbidities and larger LA diameter were observed, more females were included (each p

Supraventrikulare Tachykardien (SVT) sind haufige und in vielen Fallen (hoch)symptomatische Herzrhythmusstorungen. Die neuen ESC-Leitlinien zum Management der SVT stellen die aktuellen Empfehlungen zur Diagnostik und Behandlung supraventrikularer Tachykardien vor. Die im Vergleich zu den letzten Leitlinien aus dem Jahr 2003 wesentlichste Anderung in den neuen Leitlinien 2019 ist fur viele Formen die deutliche Praferenz der nichtmedikamentosen Behandlung durch die Katheterablation vor der medikamentosen antiarrhythmischen Therapie zur Langzeitbehandlung. Die Katheterablation wird fur fast alle Indikationen als Klasse-I-Indikation gefuhrt, Ausnahmen sind die inadaquate Sinustachykardie, multifokale atriale Tachykardien und seltene SVT bei Erwachsenen mit angeborenen Herzfehlern (EMAH). Die elektrische Kardioversion bleibt Methode der ersten Wahl zur Akuttherapie hamodynamisch relevanter Tachykardien. Zur medikamentosen Akuttherapie werden uberwiegend Adenosin, Betarezeptorenblocker und Kalziumantagonisten vom Typ Verapamil/Diltiazem empfohlen. Auch aufgrund der auserst limitierten Daten zur Effektivitat und Behandlungssicherheit der medikamentosen antiarrhythmischen Langzeittherapie von SVT wurden die Empfehlungen und Evidenzgrade fur die pharmakologische Behandlung teilweise deutlich herabgestuft.

Background Pulmonary vein isolation is an established strategy for catheter ablation of atrial fibrillation (AF). However, in a significant number of patients, a repeat procedure is mandatory due to arrhythmia recurrence. In this study, we report safety data and procedural details of patients undergoing index ablation versus repeat ablation in a registry-based real-life setting. Methods Patients from the German Ablation Registry, a prospective, multicentre registry of patients undergoing ablation between January 2007 and January 2010 were included. Results A total of 4155 patients were enrolled in the study. Group I (index ablation) consisted of 3377/4155 (82.1%) and group II (repeat ablation) of 738/4155 (17.9%). Patients in group I had a significantly higher ratio of paroxysmal AF (69.3% vs 61.9%, p p p p 2 vs 3325 cGy × cm2, p = 0.001), and shorter study duration (181.2 min. vs 163.6 min., p p = 0.39), MACE (0.4% vs 0.3%, p = 0.58), MACCE (0.8% vs 0.6%, p = 0.47), composite safety endpoint (1.5% vs 1.4%, p = 0.76), and arrhythmia recurrence (43.8% vs 41.9%, p = 0.37) during 1-year follow-up. Both groups reported to have improved or no symptoms (80.4% vs 77.8%, p = 0.13). Conclusion Repeat catheter ablation is safe and provides a symptomatic relief comparable to index ablation. Repeat procedures are significantly shorter and use less fluoroscopy.

Aims Symptomatic atrial arrhythmias despite complete pulmonary vein isolation (PVI) are common. The purpose was to evaluate ultra-high-density multi-electrode electroanatomical mapping-guided radiofrequency ablation (RFA) in PVI non-responders. Methods and results Ultra-high-density multi-electrode electroanatomical mapping-guided RFA in consecutive symptomatic atrial fibrillation (AF) patients after initial cryoballoon PVI was performed. Patients were included if all pulmonary veins (PVs) were still isolated. Radiofrequency targets were atrial tachycardia (AT), extra-PV trigger, and/or substrate. Procedural results and outcome were evaluated. Of 95 patients, 67 (70.5%) with complete PVI were included (70 years, CHA2DS2Vasc 2.9, left atrium 45 mm, persistent AF 45%, AT 45%). The median time to reablation was 26 months. One hundred and seven maps (1.6/patient) and 11.890 ± 9.018 electrograms were acquired in 33 ± 12 min. Twenty-eight percent of the left atrial (LA) wall showed pathological voltage signals, predominantly at the anterior (37%) and septal wall (26%). Atrial tachycardia (49 left, 4 right) were ablated in 35 patients (52%), extra-PV trigger in two patients (3%). One atrioventricular nodal re-entry tachycardia and seven right atrial isthmus ablation (10%) were performed. In 32 patients (48%), no AT was present and substrate-based ablation was performed. Mean LA area ablated was 7 ± 6 cm2 (7%). No major complication occurred. The mean follow-up time was 772 ± 317 days. Freedom from atrial arrhythmia recurrence off antiarrhythmic drugs was 49% at 12 months. Conclusion Pulmonary vein isolation non-responders are older, mainly suffering from complex atrial arrhythmias. Left atrial substrate is predominantly located at the anterior and septal wall. Ultra-high-density multi-electrode electroanatomical mapping-guided RFA is safe and effective. At 1 year, 5 out of 10 patients were in stable sinus rhythm off antiarrhythmic drugs.

Background: Cryoballoon ablation is established for pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (AF). The objective was to evaluate CBA strategy in consecutive patients with persistent AF in the initial AF ablation procedure.Material and Methods: Prospectively, patients with symptomatic persistent AF scheduled for AF ablation all underwent cryoballoon PVI. Technical enhancements, laboratory management, safety, single-procedure outcome, predictors of recurrence, and durability of PVI were evaluated.Results: From 2007 to 2020, a total of 1,140 patients with persistent AF, median age 68 years, underwent cryoballoon ablation (CBA). Median left atrial (LA) diameter was 45 mm (interquantile range, IQR, 8), and Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, prior Stroke or TIA or thromboembolism (doubled), Vascular disease, Age 65 to 74 years, Sex category (CHA2DS2-VASc) score was 3. Acute isolation was achieved in 99.6% of the pulmonary veins by CBA. Median LA time and median dose area product decreased significantly over time (p < 0.001). Major complications occurred in 17 (1.5%) patients including 2 (0.2%) stroke/transitory ischemic attack (TIA), 1 (0.1%) tamponade, relevant groin complications, 1 (0.1%) significant ASD, and 4 (0.4%) persistent phrenic nerve palsy (PNP). Transient PNP occurred in 66 (5.5%) patients. No atrio-esophageal fistula was documented. Five deaths (0.4%), unrelated to the procedure, occurred very late during follow-up. After initial CBA, arrhythmia recurrences occurred in 46.6% of the patients. Freedom from atrial arrhythmias at 1-, and 2-year was 81.8 and 61.7%, respectively. Independent predictors of recurrence were LA diameter, female sex, and use of the first cryoballoon generation. Repeat ablations due to recurrences were performed in 268 (23.5%) of the 1,140 patients. No pulmonary vein (PV) reconduction was found in 49.6% of the patients and 73.5% of PVs. This rate increased to 66.4% of the patients and 88% of PVs if an advanced cryoballoon was used in the first AF ablation procedure.Conclusion: Cryoballoon ablation for symptomatic persistent AF is a reasonable strategy in the initial AF ablation procedure.

PURPOSE To investigate the long-term prognostic value of coronary computed tomography angiography (cCTA)-derived plaque information on major adverse cardiac events (MACE) in patients with and without diabetes mellitus. MATERIALS AND METHODS In all, 64 patients with diabetes (63.3±10.1 y, 66% male) and suspected coronary artery disease who underwent cCTA were matched with 297 patients without diabetes according to age, sex, cardiovascular risk factors, and statin and antithrombotic therapy. MACE were recorded. cCTA-derived risk scores and plaque measures were assessed. The discriminatory power to identify MACE was evaluated using multivariable regression analysis and concordance indices. RESULTS After a median follow-up of 5.4 years, MACE occurred in 31 patients (8.6%). In patients with diabetes, cCTA risk scores and plaque measures were significantly higher compared with nondiabetic patients (all P

Background Data on the optimal treatment strategy for antiarrhythmic drug therapy (AAD) after atrial fibrillation (AF) catheter ablation are inconsistent. While AAD potentially stabilizes sinus rhythm, it also increases the patients' treatment burden. Methods Patients from the prospective German Ablation Registry (n=3275) discharged with or without AAD after AF catheter ablation were compared regarding long-term success, cardiovascular events and patient reported outcome. Results In patients with paroxysmal AF (n=2138) recurrence and rehospitalization rates did not differ when discharged with (n=1051) or without (n=1087) AAD (recurrence: adjusted odds ratio (OR) 1.13, 95% confidence interval (CI) [0.95–1.35]; rehospitalization: OR 1.08, 95% CI [0.90–1.30]). The reablation rate was higher and reduced treatment satisfaction was reported more often in those discharged with AAD (reablation: OR 1.30, 95% CI [1.05–1.61]; reduced treatment satisfaction: OR 1.76, 95% CI [1.20–2.58]). Similar rates of recurrences, rehospitalisations, reablations and treatment satisfaction were found in patients with persistent AF (n=1137) discharged with (n=641) or without (n=496) AAD (recurrence: OR 1.22, 95% CI [0.95–1.56]; rehospitalization: OR 1.16, 95% CI [0.90–1.50]; reablation: OR 1.21, 95% CI [0.91–1.61]; treatment satisfaction: OR 1.24, 95% CI [0.74–2.08]). The incidence of cardiovascular events and mortality did not differ at follow-up in paroxysmal and persistent AF patients discharged with or without AAD. Conclusion The rates of recurrences, cardiovascular events and mortality did not differ between patients discharged with or without AAD after AF catheter ablation. However, AAD should be considered carefully in patients with paroxysmal AF, in whom it was associated with a higher reablation rate and reduced treatment satisfaction. Funding Acknowledgement Type of funding sources: None.

Background Left atrial appendage (LAA) is a potential source of atrial fibrillation (AF) triggers. Hypothesis LAA morphology and dimensions are associated with AF recurrence after pulmonary vein isolation (PVI). Methods From cardiac computed tomography angiography (CCTA), left atrial (LA), pulmonary vein (PV), and LAA anatomy were assessed in cryoballoon ablation (CBA) patients. Results Among 1103 patients undergoing second‐generation CBA, 725 (65.7%) received CCTA with 473 (42.9%) qualifying for detailed LAA analysis (66.3 ± 9.5 years). Symptomatic AF reoccurred in 166 (35.1%) patients during a median follow‐up of 19 months. Independent predictors of recurrence were LA volume, female sex, and mitral regurgitation ≥°II. LAA volume and AF‐type were dependent predictors of recurrence due to their strong correlations with LA volume. LA volumes ≥122.7 ml (sensitivity 0.53, specificity 0.69, area under the curve [AUC] 0.63) and LAA volumes ≥11.25 ml (sensitivity 0.39, specificity 0.79, AUC 0.59) were associated with recurrence. LA volume was significantly smaller in females. LAA volumes showed no sex‐specific difference. LAA morphology, classified as windsock (51.4%), chicken‐wing (20.7%), cactus (12.5%), and cauliflower‐type (15.2%), did not predict successful PVI (log‐rank; p = 0.596). Conclusions LAA volume was strongly correlated to LA volume and was a dependent predictor of recurrence after CBA. Main independent predictors were LA volume, female sex, and mitral regurgitation ≥°II. Gender differences in LA volumes were observed. Individual LAA morphology was not associated with AF recurrence after cryo‐PVI. Our results indicate that preprocedural CCTA might be a useful imaging modality to evaluate ablation strategies for patients with recurrences despite successful PVI.

OBJECTIVES Left ventricular (LV) hypertrophy in resistant hypertensive patients is associated with a reduced intramyocardial perfusion. Renal sympathetic denervation (RDN) has been shown to reduce blood pressure (BP) and sympathetic tone. We aimed to prospectively investigate the effect of RDN on functional myocardial parameters and myocardial perfusion reserve (MPR) using cardiac magnetic resonance imaging (cMRI) in patients with resistant hypertension. METHODS A total of 15 resistant hypertensive patients (11 male individuals, mean age 62±13 y) were included. Adenosine stress-induced cMRI was performed at baseline, 3, 6, and 12 months after RDN. RDN was performed using a single soft-tip radiofrequency catheter (Symplicity). cMRI semiquantitative perfusion analysis was performed using the upslope of myocardial signal enhancement to derive the myocardial perfusion reserve index. RESULTS Both systolic-BP and diastolic-BP significantly decreased from 148±14 to 133±14 mm Hg and 87±14 to 80±10 mm Hg, respectively (P

Aims To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF). Methods and results Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was ‘atrial arrhythmia recurrence’, secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P Conclusions The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF. Trial Registration ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.

Background: Hypertension (HTN) constitutes a risk factor for the development of atrial fibrillation (AF), as well as for thromboembolic and bleeding events. We analysed the outcome after catheter ablation of AF in HTN in a cohort from the prospective multicenter German Ablation Registry. Methods: Between 03/2008 and 01/2010, 626 patients undergoing AF-ablation were analysed. Patients diagnosed with HTN (n = 386) were compared with patients without HTN (n = 240) with respect to baseline, procedural and long-term outcome parameters. Results: Patients with HTN were older and more often presented with persistent forms of AF and cardiac comorbidities. Major and moderate in-hospital complications were low. At long-term follow-up, major cardiovascular events were rare in both groups. Rates of AF-recurrence, freedom from antiarrhythmic medication and repeat ablation were not statistically different between groups. Most patients reported improvement of symptoms and satisfaction with the treatment. However, patients with HTN more frequently complained of dyspnea of New York Heart Association (NYHA) class &ge, II and angina. They were more often rehospitalized, particularly when persistent AF had been diagnosed. Conclusion: Catheter ablation of AF is associated with low complication rates and favorable arrhythmia-related results in patients with HTN. Residual clinical symptoms may be due to cardiac comorbidities and require additional attention in this important subgroup of AF-patients.

Purpose Increased angiogenesis after myocardial infarction is considered an important favorable prognostic parameter. The αvβ3 integrin is a key mediator of cell-cell and cell-matrix interactions and an important molecular target for imaging of neovasculature and repair processes after MI. Thus, imaging of αvβ3 expression might provide a novel biomarker for assessment of myocardial angiogenesis as a prognostic marker of left ventricular remodeling after MI. Currently, there is limited data available regarding the association of myocardial blood flow and αvβ3 integrin expression after myocardial infarction in humans. Methods Twelve patients were examined 31 ± 14 days after MI with PET/CT using [18F]Galacto-RGD and [13N]NH3 and with cardiac MRI including late enhancement on the same day. Normal myocardium (remote) and areas of infarction (lesion) were identified on the [18F]Galacto-RGD PET/CT images by correlation with [13N]NH3 PET and cardiac MRI. Lesion/liver-, lesion/blood-, and lesion/remote ratios were calculated. Blood flow and [18F]Galacto-RGD uptake were quantified and correlated for each myocardial segment (AHA 17-segment model). Results In 5 patients, increased [18F]Galacto-RGD uptake was notable within or adjacent to the infarction areas with a lesion/remote ratio of 46% (26–83%; lesion/blood 1.15 ± 0.06; lesion/liver 0.61 ± 0.18). [18F]Galacto-RGD uptake correlated significantly with infarct size (R = 0.73; p = 0.016). Moreover, it correlated significantly with restricted blood flow for all myocardial segments (R = − 0.39; p R = − 0.75; p Conclusion [18F]Galacto-RGD PET/CT allows the visualization and quantification of myocardial αvβ3 expression as a key player in angiogenesis in a subset of patients after MI. αvβ3 expression was more pronounced in patients with larger infarcts and was generally more intense but not restricted to areas with more impaired blood flow, proving that tracer uptake was largely independent of unspecific perfusion effects. Based on these promising results, larger prospective studies are warranted to evaluate the potential of αvβ3 imaging for assessment of myocardial angiogenesis and prediction of ventricular remodeling.

Background: Even among biomarker-negative patients undergoing elective percutaneous coronary intervention (PCI), periprocedural thrombotic and bleeding complications can lead to increased morbidity and mortality. Whether stronger platelet inhibition by an intensified oral loading strategy (ILS) before PCI impacts on outcomes among these patients in contemporary practice remains unclear. Methods: This multicenter, randomized, assessor-blinded trial tested the hypothesis that in elective PCI prasugrel 60 mg (ILS) is superior to standard loading strategy with clopidogrel 600 mg regarding a composite primary end point of all-cause death, any myocardial infarction, definite/probable stent thrombosis, stroke, or urgent vessel revascularization. After PCI, all patients were on clopidogrel 75 mg/day and aspirin. The trial was terminated prematurely because of slower-than-expected recruitment and funding discontinuation. Results: Of 781 patients included in the final analysis, 382 were assigned to ILS and 399 to standard loading strategy. At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63–1.32]; P =0.64). Any myocardial infarction and Bleeding Academic Research Consortium ≥2 bleeding rates were similar among ILS and standard loading strategy groups 16.2% versus 17.5%, odds ratio, 0.91 (95% CI, 0.62–1.32), P =0.62 and 4.2% versus 4.8%, odds ratio 0.87 (95% CI, 0.44–1.73), P =0.70, respectively. Conclusions: In biomarker-negative stable and unstable angina patients undergoing elective PCI, the trial did not find a conclusive difference in efficacy or safety. This observation should be interpreted in the context of wide CIs and premature termination of the trial. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02548611.

To evaluate the long-term prognostic value of coronary CT angiography (cCTA)-derived plaque measures and clinical parameters on major adverse cardiac events (MACE) using machine learning (ML). Datasets of 361 patients (61.9 ± 10.3 years, 65% male) with suspected coronary artery disease (CAD) who underwent cCTA were retrospectively analyzed. MACE was recorded. cCTA-derived adverse plaque features and conventional CT risk scores together with cardiovascular risk factors were provided to a ML model to predict MACE. A boosted ensemble algorithm (RUSBoost) utilizing decision trees as weak learners with repeated nested cross-validation to train and validate the model was used. Performance of the ML model was calculated using the area under the curve (AUC). MACE was observed in 31 patients (8.6%) after a median follow-up of 5.4 years. Discriminatory power was significantly higher for the ML model (AUC 0.96 [95%CI 0.93–0.98]) compared with conventional CT risk scores including Agatston calcium score (AUC 0.84 [95%CI 0.80–0.87]), segment involvement score (AUC 0.88 [95%CI 0.84–0.91]), and segment stenosis score (AUC 0.89 [95%CI 0.86–0.92], all p

Die kardiale Computertomographie mit Kalziumscoring zur Quantifizierung des Koronarkalks und kontrastmittelgestutzter CT-Angiographie (cCTA) zur nichtinvasiven morphologischen und funktionellen Beurteilung von Koronarstenosen ist ein etabliertes Verfahren in der Diagnostik der koronaren Herzerkrankung (KHK) und der zielgerichteten interventionellen Behandlung. Die kardiale Computertomographie eignet sich bei Patienten mit niedriger bis intermediarer Vortestwahrscheinlichkeit zur Risikostratifizierung (Kalziumscoring) und zum Ausschluss einer KHK mittels cCTA. Die rein anatomische Darstellung von Koronarstenosen kann zukunftig durch funktionelle Analysen aufgrund neuer technischer Entwicklungen erganzt werden und erlaubt somit neben einer morphologischen Beurteilung eine Aussage uber die hamodynamische Signifikanz von Koronarstenosen. Durch die vielversprechende kombinierte anatomische und funktionelle Diagnostik konnte der kardialen Computertomographie in Zukunft eine wesentliche Gatekeeper-Funktion hinsichtlich der Indikationsstellung fur Koronarinterventionen zukommen.

Catheter ablation (CA) for atrial fibrillation (AF) has emerged as a widespread first or second line treatment option. However, up to 45% of patients (pts) show recurrence of AF within 12 month after CA. We present prospective multicenter registry data comparing characteristics of pts with and without recurrence of AF within the first year after CA. This study comprises all pts with complete follow-up one year after CA (1-y-FU; n = 3679). During 1y-FU in 1687 (45.9%) pts recurrence of AF occurred. The multivariate analysis revealed female sex and AF type prior to the procedure as predictors for AF recurrence. Furthermore, comorbidities such as valvular heart disease and renal failure as well as an early AF relapse were also predictors of AF recurrence during 1-y-FU. However, despite an AF recurrence rate of 45.9%, the majority of these pts (72.4%) reported a significant alleviation of clinical symptoms. In conclusion in pts with initially successful CA for AF female sex, AF type, in-hospital AF relapse and comorbidities such as renal failure and valvular heart disease are independent predictors for AF recurrence during 1-y-FU. However, the majority of pts deemed their interventions as successful with significant reduction of symptoms irrespective of AF.

We investigated the impact of iterative beam-hardening correction (IBHC) with advanced modeled iterative reconstruction (ADMIRE) of ultra-low radiation-dose tin filtered (Sn100 kVp) CACS acquisitions on image quality, calcium quantification, and risk classification.CT data of 60 patients (55% male, age 62.3 ± 9.8years) who underwent a 3rd generation dual-source CACS scan using a prospectively ECG-triggered 100 kVp sequential acquisition protocol with tin filtration (Sn100 kVp) were reconstructed using IBHC with filtered back projection (FBP) and ADMIRE with strength levels of three and five. Image noise was calculated and Agatston scores were derived from all reconstructions. Image noise, Agatston score categories, and percentile-based cardiac risk categorization of the respective reconstruction techniques were compared.The mean estimated radiation dose equivalent of CACS acquisitions in the study population was 0.20 ± 0.07 mSv. Mean image noise significantly decreased with ADMIRE compared to FBP (both p 0.0001). Agatston scores derived from the respective reconstructions were significantly different in a paired comparison (median [25th and 75th percentile]): FBP 34.7 [1.9, 153.6], ADMIRE 3 28.6 [1.1, 134.5], ADMIRE 5 22.7 [0.3, 116.8]; both p 0.0001). Agatston score categories and cardiac risk categorization showed excellent agreement of ADMIRE 3 and ADMIRE 5 with FBP (ĸ = 0.92 [0.86-0.98] and ĸ = 0.86 [0.79-0.94]; ĸ = 0.94 [0.87-1.00] and ĸ = 0.91 [0.83-0.99]; however, modest cardiac risk reclassifications of 3% and 7% for ADMIRE 3 and ADMIRE 5, respectively, were observed.Iterative reconstruction using IBHC ADMIRE in low voltage, ultra-low dose CACS with tin filtration significantly decreased image noise. However, it also reduced Agatston scores compared to FBP, which may have an impact on subsequent cardiac risk classification, although risk reclassification occurred only in a modest number of subjects.

Als wissenschaftliche Fachgesellschaft vertritt die Deutsche Gesellschaft fur Kardiologie den Standpunkt, dass die Standards zur Durchfuhrung einer Katheterablation bei Patienten mit Vorhofflimmern (VHF) stetig kritisch betrachtet und angepasst werden mussen, um dauerhaft eine gute Behandlungsqualitat mit hoher Erfolgs- und geringer Komplikationsrate zu gewahrleisten. Das ist insbesondere auch deshalb notwendig, weil die Anzahl von Zentren und Kardiologen, die diese Intervention durchfuhren, rasant ansteigt. Im vorliegenden Positionspapier werden daher zunachst die aktuelle Datenlage zur Katheterablation von VHF sowie die Indikationsstellung zur Ablation, Komplikationen des Verfahrens und neueste Entwicklungen detailliert ausgefuhrt, bevor abschliesend eine Darstellung der personellen, technischen und raumlichen, strukturellen sowie organisatorischen Anforderungen an klinische Zentren erfolgt, an denen Katheterablationen von VHF durchgefuhrt werden.

This study investigated the discriminatory value of quantitative atherosclerotic plaque markers derived from coronary computed tomography angiography (cCTA) in patients with first acute coronary syndrome (ACS) compared with patients with stable coronary artery disease (CAD). Forty patients (56.9 ± 9.3 years, 55% men) admitted with their first ACS and Framingham risk score-matched controls with stable CAD were retrospectively analyzed. All patients had undergone cCTA followed by invasive coronary angiography. Total plaque volume, calcified and noncalcified plaque volumes, plaque burden (in %), remodeling index, lesion length, presence of napkin-ring sign, segment involvement score, and segment stenosis score were derived from cCTA and compared between both groups on a per-lesion and per-patient level. Patients with ACS showed a significant higher number of obstructive CAD and higher values for segment stenosis score, segment involvement score, noncalcified plaque volume, lesion length, and remodeling index than the stable angina group (all p0.05). On a per-lesion level, culprit lesions had significantly higher values for plaque burden, total plaque volume, noncalcified plaque volume, remodeling index, lesion length, and prevalence of napkin-ring sign in comparison to nonculprit lesions (all p0.05). On receiver-operating characteristics (ROC) analysis, a stepwise model demonstrated incremental discriminatory power for identifying ACS both per-patient (area under the curve 0.92, p0.0001) as well as per-lesion (area under the curve 0.88, p0.0001). cCTA-derived culprit plaque markers show discriminatory value both on a per-patient and per-lesion level. A combination of markers added to the Framingham risk score yields the greatest discriminatory ability.

Background In the ICD Sports Safety Registry, death, arrhythmia- or shock-related physical injury did not occur in athletes who continue competitive sports after implantable cardioverter-defibrillator (ICD) implantation. However, data from non-competitive ICD recipients is lacking. This report describes arrhythmic events and lead performance in intensive recreational athletes with ICDs enrolled in the European recreational arm of the Registry, and compares their outcome with those of the competitive athletes in the Registry. Methods The Registry recruited 317 competitive athletes ≥ 18 years old, receiving an ICD for primary or secondary prevention (234 US; 83 non-US). In Europe, Israel and Australia only, an additional cohort of 80 ‘auto-competitive’ recreational athletes was also included, engaged in intense physical activity on a regular basis (≥2×/week and/or ≥ 2 h/week) with the explicit aim to improve their physical performance limits. Athletes were followed for a median of 44 and 49 months, respectively. ICD shock data and clinical outcomes were adjudicated by three electrophysiologists. Results Compared with competitive athletes, recreational athletes were older (median 44 vs. 37 years; p = 0.0004), more frequently men (79% vs. 68%; p = 0.06), with less idiopathic ventricular fibrillation or catecholaminergic polymorphic ventricular tachycardia (1.3% vs. 15.4%), less congenital heart disease (1.3% vs. 6.9%) and more arrhythmogenic right ventricular cardiomyopathy (23.8% vs. 13.6%) ( p Conclusions Participants in recreational sports had less frequent appropriate and inappropriate shocks during physical activity than participants in competitive sports. Shocks did not cause death or injury. Recreational athletes with ICDs can engage in sports without severe adverse outcomes unless other reasons preclude continuation.

Age-Related Complication Rates in AF AblationIntroduction Despite a rising demand for catheter ablation (CA) of atrial fibrillation (AF) in an elderly population, complication and success rates are not fully elucidated. We sought to compare complication rates of CA of AF in patients ≥75 versus

Background Different catheter ablation (CA) strategies have been established in the treatment of persistent atrial fibrillation (persAF). Pulmonary vein isolation (PVI) only might be an option for the initial ablation procedure. There is a paucity of outcome data on second-generation cryoballoon (CBG2) PVI in persAF. Methods Patients with symptomatic drug-refractory persAF who underwent initial CA of AF were prospectively enrolled and PVI was performed with CBG2. The primary composite endpoint was freedom from AF, atrial tachycardia, or related symptoms after a 3-month blanking period. The secondary endpoint referred to periprocedural complications. Results One hundred seventy-three consecutive patients (64 ± 10 years, 29% female) with symptomatic drug-refractory persAF were identified. Acute PVI was achieved in 100% of pulmonary veins with the CB technique. The left atrial procedure time was 112 ± 30 min. Major complications occurred in 1.7% (3 of 173 patients) including two phrenic nerve palsies (1%), which resolved until discharge, and one pericardial effusion (0.6%). Follow-up ≥12 months was completed for 157 of 173 patients (91%). Median follow-up was 14 months. At 12 months, the primary composite endpoint was achieved in 129 of 157 patients (82%). However, 22 of 129 patients at risk (17%) were still on antiarrhythmic drugs. A relapse during the blanking period was identified as the only independent predictor for AF recurrence. Conclusion PVI using the second-generation cryoballoon is a reasonable treatment option for patients with symptomatic drug-refractory persAF with a favorable rate of freedom from AF and a low complication rate.

Objective: To evaluate quantitative markers derived from coronary CT angiography (coronary CTA) performed prior to percutaneous coronary intervention (PCI) with stent placement for predicting in-stent restenosis (ISR) as defined by quantitative coronary angiography (QCA).Materials and methods: We retrospectively analyzed the data of 74 patients (60 +/- 12 years, 72% male) who had undergone dual-source coronary CTA within 3 months prior to a PCI procedure that included stent placement. Quantitative markers of the target vessel were derived from coronary CTA: Total plaque volume (TPV), calcified and non-calcified plaque volumes (CPV and NCPV), plaque burden (PB in %), remodeling index (RI), and lesion length (LL). Marker performance for predicting ISR, as defined by QCA at follow-up, was assessed.Results: Twenty-one of 74 stented lesions showed ISR on follow-up (mean 616 +/- 447 days). When comparing stent length and LL in patients with ISR, a trend towards less complete stent coverage of the target lesion was observed in cases with ISR (17/21 vs. 4/53 cases, p = 0.07). In multivariate analysis (corrected for dyslipidemia), the following markers showed predictive value for ISR (odds ratio [OR]): NCPV (OR 1.08, p = 0.045), LL (OR 138, p = 0.0024), and RI (OR 1.13, p = 0.0019). Sensitivity and specificity for ISR were: NCPV 65% and 80%, LL 74% and 74%, and RI 71% and 78%. At receiver-operating characteristics analysis, NCPV (0.72, p = 0.001), LL (0.77, p Conclusion: Coronary CTA-derived NCPV, LL, and RI portend predictive value for ISR with incremental predictive value when combining these parameters. (C) 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

Stratification of patients with atrial fibrillation (AF) according to mechanistic and prognostic criteria may optimize the effectiveness and safety of catheter ablation. In women, AF is associated with more severe symptoms and worse prognosis.We sought to assess sex-related differences in catheter ablation procedures and outcome in a large cohort of patients with AF.A total of 3652 patients (1198 women [33%]; 2454 men [67%]) included in the German Ablation Registry were analyzed. Periprocedural parameters and outcome at 12-month follow-up were compared between male and female patients.Women were older at the time of ablation (women: 63.6 years; men: 59.1 years; P.0001) and exhibited a higher prevalence of paroxysmal AF (women: 72%; men: 61%; P.0001). They were less often affected by cardiovascular disease and reduced left ventricular function. Energy application duration and overall procedure duration were shorter in women. Conversely, the rate of major inhospital complications was increased in female patients (1.9% vs 0.8%; P = .023) and mainly driven by major bleeding events. At follow-up, women experienced higher AF recurrence rates (women: 50%; men: 45%; P = .017) and more often received oral medication for rhythm and rate control. In addition, the rate of pacemaker implantation was higher in the female cohort. Women more frequently reported femoral access site complications (women: 6%; men: 3%; P.001). Overall, male patients were more often free from AF-related symptoms and satisfied with the treatment.Catheter ablation of AF was associated with a distinct sex-related outcome and complication profile that requires consideration in clinical practice.

Background Autologous progenitor cell therapy comprising granulocyte-colony stimulating factor (G-CSF) for mobilization of bone-marrow derived progenitor cells (BMPCs) into peripheral blood and inhibition of dipeptidylpeptidase-IV by sitagliptin for enhanced myocardial recruitment of circulating BMPCs has been shown to improve survival after acute myocardial infarction (MI) in preclinical studies. In the SITAGRAMI trial we found that during short-term follow-up G-CSF plus sitagliptin (GS) failed to show a beneficial effect on cardiac function and clinical events in patients with acute MI that underwent successful PCI. The objective of the present analysis was to assess the impact of GS versus placebo treatment on long-term clinical outcomes of the SITAGRAMI trial patient population. Methods In the randomized, prospective, double-blind, placebo-controlled SITAGRAMI trial, 174 patients with acute MI were assigned to GS or placebo in a 1:1 ratio. The primary outcome for the present long-term analysis was the composite of death, MI or stroke on long-term follow-up. Results The median [IQR] follow-up duration was 4.50 [3.56–5.95] years. The primary outcome occurred in 12.8% of patients assigned to placebo and 9.2% assigned to GS (HR 0.69, 95% CI 0.28–1.69; p=0.42). The incidence of the combined cardiovascular outcome was 47.7% in the placebo- and 41.4% in the GS-group (HR 0.75, 95% CI 0.48–1.18; p=0.21). Overall, there was no significant difference in MACCE rates between both treatment groups (p=0.41). Conclusion These long-term follow-up data indicate that GS therapy does not improve clinical outcomes of patients with acute MI.

Background Although radiofrequency (RF) ablation has long been the standard of care for atrial fibrillation (AF) ablation, cryoballoon technology has emerged as a feasible approach with promising results. Prospective multicenter registry data referring to both ablation technologies in AF ablation are lacking so far. Objective The purpose of this study was to report data from the German ablation registry with respect to efficacy and safety in pulmonary vein ablation with different energy sources for paroxysmal AF after 1-year follow-up. Methods A total of 2306 patients with symptomatic paroxysmal AF from the German ablation registry were included in this analysis. The cohort was divided into two groups according to the ablation energy source used: cryoballoon and RF ablation. MACCE was defined as a combination of death, myocardial infarction, or stroke. Results AF recurrence rate after a single ablation procedure at 1 year follow-up was not significantly different between the two groups (45.8% after cryoablation and 45.4% after RF ablation, P = .87). Also, the rate of patients without AF recurrence and free of antiarrhythmic drug at 12-month follow-up was similar (cryoablation 44.2% and RF 41.4%, P = .25). MACCE occurred with an incidence of 0.7% within 500 days after cryoablation and 1.4% after RF ablation ( P = .30). Persistent phrenic nerve palsy was more common after cryoablation compared to RF ablation (1.1% vs 0.3%, P Conclusion AF recurrence rate at 1-year follow-up was similar in RF ablation compared to cryoablation, whereas the spectrum and relevance of complications were significantly different between the two ablation methods. This finding might influence the choice of ablation method offered to the individual paroxysmal AF patient.

According to current guidelines prophylactic implantable cardioverter-defibrillator (ICD) therapy is recommended in patients with significantly impaired left ventricular systolic function. However, the recently published DANISH trial did not find a significantly lower long-term rate of death from any cause compared with usual clinical care in patients with non-ischemic cardiomyopathy. We investigated whether registry data from a multi-center ‘real-life’ registry on patients with non-ischemic cardiomyopathy are similar to this trial. The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5451 patients receiving device implantations in 50 German centers. The present analysis of DEVICE focused on patients with non-ischemic cardiomyopathy and a left ventricular ejection fraction ≤35% who received a prophylactic ICD. Out of 779 patients with symptomatic heart failure and nonischemic cardiomyopathy, 33.1% received a single chamber ICD (VVI), while 11.0% were implanted with a dual-chamber ICD (DDD), and 55.8% received a defibrillator system for cardiac resynchronization therapy. Median follow-up was 16.1 months. 90.7% were alive at follow-up, 9.3% had died during this period. Overall mortality after one year was 5.4%. Overall mortality one year after implantation was significantly increased in patients 68 years and older(7.9%) as compared to younger patients (59–68 years: 2.5%; < 59 years: 3.8%; p

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is a mainstay of the prevention of stent thrombosis following percutaneous coronary intervention (PCI). In the 2015 European guidelines for the management of acute coronary syndrome (ACS), prasugrel (PRA) and ticagrelor (TICA) combined with aspirin are recommended as first-line therapy. Clopidogrel (CLO) is recommended as an alternative medication for patients with contradictions to these new drugs. This single-center study analyzed the platelet function of 809 ACS patients undergoing PCI and treatment with DAPT. The platelet response to ADP was determined using Multiplate® analyzer at a median of 3 days after PCI in 254 patients treated with PRA (loading dose [LD] 60 mg, 10 mg qd), 162 patients receiving TICA (LD 180 mg, D 90 mg bid), and 393 CLO-treated patients (LD 600 mg, 75 mg qd). An aggregation >468 arbitrary units (AU)*min was defined as "high on-treatment platelet reactivity" (HPR)

The second-generation cryoballoon (CBG2) is highly effective for pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (PAF). One-year outcome data are consistent among different research groups. First results suggest that a shortened application time might be equally effective. The objective of the study was to compare procedural and outcome data for a 240 and 180-s protocol. Prospectively, consecutive patients with symptomatic PAF underwent initial PVI with CBG2. In succession, two groups were created: the application time was 240 s in group 1 and 180 s in group 2. In both groups, a bonus application was applied. Periprocedural data, complications, and freedom from atrial fibrillation (AF)/AT/symptoms were compared between the groups. From May 2012 to June 2013, 114 patients (57 per group, 38 % female) were included. The mean left atrial dwelling time decreased by 19 min (−16 %) in group 2 compared to group 1 (p = 0.005). Intraprocedural pulmonary vein (PV) reconduction occurred infrequently (0.4 % in both groups, p = 1.0). One persistent PNP occurred and resolved during the follow-up. Complications were without significant differences. One patient was lost to follow-up. The cumulative rates of freedom from recurrence at 12 months are 76.8 % in group 1 and 83.6 % in group 2. After a mean follow-up of 491 ± 208 days, the rates of freedom from AF/AT/symptoms at last visit were 38/57 (67 %) and 44/56 (78.6 %) in groups 1 and 2 (p = 0.14), respectively. Female sex was identified as a predictor for recurrence. Compared to a protocol with cryoballoon applications of 240 s, a shortened application time to 180 s results in a faster procedure with comparable high rates of freedom from AF at 16 months. Female sex seems to be predictive for recurrences; this finding has to be reconfirmed in a larger population.

A consensus document from the Study Group of Sports Cardiology of the Working Group of Cardiac Rehabilitation and Exercise Physiology and the Working Group of Myocardial and Pericardial Diseases of the European Society of Cardiology.

This study investigated the performance of coronary computed tomography angiography (cCTA) with cCTA-derived fractional flow reserve (CT-FFR) compared with invasive coronary angiography (ICA) with fractional flow reserve (FFR) for therapeutic decision making in patients with suspected coronary artery disease (CAD). Seventy-four patients (62 +/- 11 years, 62% men) with at least 1 coronary stenosis of >= 50% on clinically indicated dual source cCTA, who had subsequently undergone ICA with FFR measurement, were retrospectively evaluated. CT-FFR values were computed using an on-site machine learning algorithm to assess the functional significance of CAD. The therapeutic strategy (optimal medical therapy alone vs revascularization) and the appropriate revascularization procedure (percutaneous coronary intervention vs coronary artery bypass grafting) were selected using cCTA-CT-FFR. Thirty-six patients (49%) had a functionally significant CAD based on ICA-FFR. cCTA-CT-FFR correctly identified a functionally significant CAD and the need of revascularization in 35 of 36 patients (97%). When revascularization was deemed indicated, the same revascularization procedure (32 percutaneous coronary interventions and 3 coronary artery bypass grafting) was chosen in 35 of 35 patients (100%). Overall, identical management strategies were selected in 73 of the 74 patients (99 %). cCTA-CTFFR shows excellent performance to identify patients with arid without the need for revascularization and to select the appropriate revascularization strategy. cCTA-CT-FFR as a noninvasive "one-stop shop" has the potential to change diagnostic workflows and to directly inform therapeutic decision making in patients with suspected CAD.

This study investigated the prognostic value of coronary computed tomography angiography (cCTA)-derived fractional flow reserve (CT-FFR) in patients with acute coronary syndrome (ACS) and multivessel disease to gauge significance and guide management of non-culprit lesions. We retrospectively analyzed data of 48 patients (56 ± 10 years, 60% men) who were admitted for symptoms suggestive of ACS and underwent dual-source cCTA followed by invasive coronary angiography with culprit lesion intervention. Culprit lesions were retrospectively identified on cCTA using images obtained during invasive coronary angiography. Non-culprit lesions with ≥25% luminal stenosis and deferred intervention were evaluated using a machine learning CT-FFR algorithm to determine lesion-specific ischemia (CT-FFR ≤0.80). Follow-up was performed. CT-FFR identified lesion-specific ischemia in 23 of 81 non-culprit lesions. After a median follow-up of 19.5 months, 14 patients (29%) had major adverse cardiac events (MACE). Univariate Cox regression analysis revealed that CT-FFR ≤0.80 (hazard ratio [HR] 3.77 [95% confidence interval 1.16 to 12.29], p = 0.027), Framingham risk score (FRS) (HR 2.96 [1.01 to 7.63], p = 0.038), and a CAD-RADS classification ≥3 (HR 3.12 [1.03 to 10.17], p = 0.051) were predictors of MACE. In a riskadjusted model controlling for FRS and CAD-RADS ≥3, CT-FFR ≤0.80 remained a predictor of MACE (1.56 [1.01 to 2.83], p = 0.048). Receiver operating characteristics analysis including FRS, CAD-RADS ≥ 3, and CT-FFR ≤0.80 (area under the curve 0.78) showed incremental discriminatory power over FRS alone (area under the curve 0.66, p = 0.032). CT-FFR of non-culprit lesions in patients with ACS and multivessel disease adds prognostic value to identify risk of future MACE.

Atrial fibrillation (AF) is the most common cause of ischemic stroke. Recent data suggest that AF patients after successful ablation have the same risk for thromboembolic events (TE) as patients without AF. Despite current guideline recommendations it is still under debate if oral anticoagulation (OAC) can be safely discontinued after ablation. We analyzed follow-up (FU) after ablation of paroxysmal AF (PAF) in a high- (previous stroke; group 1) and a low-risk group (no previous stroke; group 2) based on data from the German Ablation Registry to reveal real-life prescription behavior. Overall 29 centers in Germany participated by performing AF-ablation. Between April 2008 and April 2011, 83 patients in group 1 and 377 patients in group 2 with a first ablation of PAF were included in the registry. Mean CHA2DS2-VASc-Score was 4.2 ± 1.4 (group 1) vs. 1.6 ± 1.2 (group 2) (p

BACKGROUND: Catheter ablation (CA) for atrial fibrillation (AF) is an effective therapeutic option for the treatment of symptomatic drug-refractory AF. According to current guidelines, the prevention of stroke and embolism is the most important therapeutic goal in AF and the recommendations for anticoagulation (OAC) after successful CA are based upon the CHA2DS2-VASc-Score 3. The aim of this study was to evaluate the use of OAC in patients with a high risk for thromboembolic events 1 year after CA and to identify predictor variables for discontinuation of OAC. METHODS: Between January 2007 and January 2010 13092 patients were enrolled in the study. A total of 52 German electrophysiological centers agreed to participate in this prospective multicenter registry. 41 centers included patients undergoing CA for AF. Analysis included patients who were discharged with OAC after CA and had a CHA2DS2-VASc-Score ≥ 2. A centralized 1 year follow-up (FU) was conducted via telephone. RESULTS: 1300 patients fulfilled the inclusion criteria. One year after CA 51.8 % of these patients were on OAC. Factors significantly associated with discontinuation of OAC included no AF recurrence in FU (adjusted odds ratio (OR): 2.14, [95 % confidence interval (CI): 1.73-2.66], P < 0.001) and paroxysmal AF (OR: 1.53 [95 % CI: 1.29-1.81], P < 0.001). Factors associated with continuation of OAK were patient age (OR per 10 years: 0.79 [95 % CI: 0.68-0.91], P = 0.002), valvular heart disease (OR: 0.67 [95 % CI: 0.48-0.92], P = 0.013), an implanted pacemaker, defibrillator or a cardiac resynchronization therapy system (OR: 0.55 [95 % CI: 0.41-0.74], P < 0.001) and neurological events in hospital or during FU (OR: 0.40 [95 % CI: 0.18-0.88], P < 0.022). CONCLUSION: Almost half of the patients with an indication for OAC are not adequately anticoagulated one year after CA for AF. Paroxysmal AF or freedom from AF is significantly associated with discontinuation of OAC.

Hintergrund Die Kryoballonablation ist ein Standardverfahren zur Isolation der Pulmonalvenen bei symptomatischem Vorhofflimmern. Die zweite Generation des Kryoballons wurde 2012 eingefuhrt, eine hohere Effizienz aufgrund mehrerer Verbesserungen des Systems wurde erwartet.

Aims Cryoballoon (CB) ablation with the second-generation cryoballoon (CBG2) seems to be more effective than its predecessor [first-generation cryoballoon (CBG1)], but phrenic nerve palsies were observed more frequently. The aim of this study was to compare the safety and efficacy of CBG1 and CBG2 in a substudy of the prospective multicentre, multinational FREEZE Cohort Study. Methods and results Periprocedural data were analysed, and a total of 532 patients with paroxysmal atrial fibrillation (AF) were examined ( n = 224 for CBG1 and n = 308 for CBG2). Procedure time decreased significantly from 149 to 130 min when comparing CBG1 with CBG2 ( P < 0.0001), and pulmonary vein isolation (PVI) was achieved in 97.8 and 97.6% of PVs with CBG1 and CBG2 ( P = 0.77), respectively. The need for dual-balloon usage within a procedure dropped (20.1 vs. 9.0%, P < 0.001), and the fluoroscopy time was reduced when operating the CBG2. Atrial fibrillation recurrence rates until discharge were similar (5.0 vs. 5.8%, P = 0.69). Comparable low rates of major complications were observed with both CBs, and there was a non-significant trend for more phrenic nerve palsies. Conclusion Second-generation cryoballoon demonstrated a high rate of acute PVI in a significant faster procedure, which also utilized less radiation exposure and less dual-balloon usage during an average procedure. The safety profile remains favourable with a non-significant trend for more phrenic nerve palsies. If the enhancements lead to a higher clinical benefit has to be determined. The 1-year outcome data from the ongoing FREEZE Cohort Study comparing radiofrequency and CB ablation will shed some light on that issue. Clinical Trials.gov Identifier: NCT01360008.

Aims: The FREEZE-cohort study (NCT 01360008) is a prospective observational, multicenter and multinational study to evaluate safety and effectiveness of cryoballoon ablation for pulmonary vein isolation as compared to radiofrequency ablation in patients with paroxysmal or persistent atrial fibrillation (lasting < one year) under the conditions of clinical routine. Methods and Results: The study started in 2011 and anticipates inclusion up to 2000 patients in each of the two treatment groups. A total of 37 centers from 8 countries worldwide, all experienced in at least one of the two ablation techniques, participate in the study. The primary outcome parameter of the study is defined as atrial fibrillation recurrence rate during twelve months of follow-up. Secondary outcome parameters include primary success rates, complication rates in general, specific complications with respect to phrenic nerve palsy and pulmonary vein stenosis, radiation exposure, clinical course including death and repeat ablation. Finally specific procedural aspects will be evaluated in a descriptive manner. Preliminary data of the first 1882 patients show that in clinical practice cryoablation is preferentially performed in patients with paroxysmal atrial fibrillation, whereas application of radiofrequency ablation is equally distributed between patients with persistent and paroxysmal atrial fibrillation. Conclusion: Based on multi-center and multi-national data the FREEZE-cohort study will provide important information on long-term efficacy, clinical effectiveness, complication rates and procedural differences between atrial fibrillation patients treated with either cryoablation or radiofrequency ablation.

Acute Complication Rate in AF Ablation Introduction Catheter ablation (CA) has emerged as a widespread therapeutic option in the treatment of atrial fibrillation (AF). Currently, no safety data with regard to the impact of the underlying structural heart diseases (SHD) are available. We sought to assess the risk for acute and long-term complications during CA of AF in relation to underlying SHD. Methods and Results We included 6,211 patients in a prospective registry undergoing CA of AF in 41 nationwide centers. All patients were divided into 4 groups according to the underlying heart disease: No SHD (69.4%), hypertensive heart disease (HHD) (12.0%), coronary artery disease (CAD) (15.1%), and cardiomyopathy (CM) (3.6%). In univariate analysis, patients with HHD had an overall complication rate of 7.28%, whereas patients without an SHD had a significantly lower rate of 6.01% (P < 0.01). Multivariate analysis revealed that HHD (adjusted odds ratio [OR]: 1.97 [95% confidence interval (CI): 1.02–3.83], P = 0.0442) and age (years; OR: 1.04 [95% CI: 1.01–1.07], P = 0.0155) were independent predictors of severe, nonfatal complications and death. Other SHD including CAD (OR: 1.48 (0.73–3.00), P = 0.2797) and CM (OR: 2.37 [0.70–7.99], P = 0.1630) failed to reach statistical significance. Male sex was protective (OR: 0.47 [95% CI: 0.27–0.81], P = 0.0062). Conclusion In general, CA of AF has a low number of severe complications. In our prospective registry HHD emerged as an independent predictor of severe, nonfatal complications during AF ablation but other SHD including CAD and CM did not. The influence of HHD on the complication rate should be considered in patient selection.

Background Catheter ablation is used extensively with curative intention in atrial fibrillation. Radiofrequency ablation has long been a standard of care, while cryoballoon technology has emerged as a feasible approach with promising results. Prospective multicenter registry data referring to both ablation technologies in AF ablation therapy are lacking. Methods Between January 2007 and August 2011, a total of 3,775 consecutive patients with symptomatic paroxysmal AF who underwent PV ablation in their respective centers were enrolled. The cohort was divided into 2 groups according to the ablation energy source used: cryoballoon ablation (group 1, n = 905 [24.0%], median age 63 years, 64.3% men) and RF ablation (group 2, n = 2870 [76.0%], median age 63 years, 62.7% men). Comorbidities and baseline clinical characteristics were similar in both groups. Results Acute success rate was similar in both groups (97.5% in cryo vs 97.6% in RF; P = 0.81). Procedure times were similar, ablation and fluoroscopy times were higher in cryoballoon when compared to RF ablation. Overall complication rate was similar in cryo- (4.6%) and RF-ablation (4.6%; P = 1.0). Phrenic nerve palsy was more often in cryo versus RF ablation (2.1% in cryo vs 0.0% in RF; P Conclusion RF ablation is the most widespread ablation method in Germany, but use of cryoballoon increased significantly. Procedure times were similar, but ablation and fluoroscopy times were longer in cryoballoon ablation. No significant differences were found in terms of acute success and overall complication rate.

Prospective data on the usage of 3-dimensional imaging based annulus sizing on the outcome of TAVI is not available yet and there is general uncertainty about the optimal degree of oversizing. In the current study we therefore assessed a 3-D MSCT guided over-sizing approach and evaluated the clinical outcome of different degrees of oversizing.TAVI-size-selection was done using systolic MSCT-annulus cross-sectional-area (CSA) measurements in 107 patients with severe aortic stenosis with the goal to oversize the 3rd generation balloon expandable Edwards Sapien XT (ESTV) device in relation to the native aortic annulus CSA.Among different degrees of oversizing there were no differences in the occurrence of stroke, myocardial infarction and death. No aortic injuries were observed. The overall rate ofmild postprocedural aortic regurgitation (PAR) was 7.6%. Increasing oversizing ratios are associated with lower rates ofmild PAR (r = -0.236, p0.02) with the lowest rate ofmild PAR in patients with area based oversizing ratios25% and the highest rate in patients with oversizing ratios15% (0% vs. 15.8%, p0.02). The rate of postprocedural permanent pacemakers tended to be lower in patients with15% oversizing compared to those with25% oversizing (5.3 vs. 16.7%, p0.23).MSCT guided ESTV-device sizing is safe and is associated with significantly lower than previously reported rates for PAR. A device/annulus oversizing ratio of 15-25% based on area and 7-12% based on mean diameter appears to provide the best risk-benefit ratio in terms of PAR reduction and conduction disorders.

To evaluate the performance of three-dimensional semi-automated evaluation software for the assessment of myocardial blood flow (MBF) and blood volume (MBV) at dynamic myocardial perfusion computed tomography (CT).Volume-based software relying on marginal space learning and probabilistic boosting tree-based contour fitting was applied to CT myocardial perfusion imaging data of 37 subjects. In addition, all image data were analysed manually and both approaches were compared with SPECT findings. Study endpoints included time of analysis and conventional measures of diagnostic accuracy.Of 592 analysable segments, 42 showed perfusion defects on SPECT. Average analysis times for the manual and software-based approaches were 49.1 ± 11.2 and 16.5 ± 3.7 min respectively (P 0.01). There was strong agreement between the two measures of interest (MBF, ICC = 0.91, and MBV, ICC = 0.88, both P 0.01) and no significant difference in MBF/MBV with respect to diagnostic accuracy between the two approaches for both MBF and MBV for manual versus software-based approach; respectively; all comparisons P 0.05.Three-dimensional semi-automated evaluation of dynamic myocardial perfusion CT data provides similar measures and diagnostic accuracy to manual evaluation, albeit with substantially reduced analysis times. This capability may aid the integration of this test into clinical workflows.• Myocardial perfusion CT is attractive for comprehensive coronary heart disease assessment. • Traditional image analysis methods are cumbersome and time-consuming. • Automated 3D perfusion software shortens analysis times. • Automated 3D perfusion software increases standardisation of myocardial perfusion CT. • Automated, standardised analysis fosters myocardial perfusion CT integration into clinical practice.

For the treatment of increasingly complex cardiac arrhythmias, new catheter designs as well as alternative energy sources are constantly being developed. However, there is presently no in vitro method available for assessment of the temperature changes induced at various myocardial levels during energy delivery. Therefore, our study was aimed at developing an in vitro model to record and display the temperature kinetics during ablation in the entire muscle cross section. A sapphire glass pane was inserted into one wall of the in vitro experimental set-up. Due to its thermodynamic properties, the temperature distribution in an adjacent cross section of the cardiac muscle can be measured exactly (±1 °C) through this pane by means of a thermography camera. Computer-supported image processing enables the colour-coded and two-dimensional display of the temperature kinetics during the energy application at any location of the myocardial cross section (±0.5 mm). This new measuring methodology was validated by direct temperature measurements utilizing several intramyocardial thermo elements. This new method allows a temporal and spatial analysis of the temperature phenomena during ablation without the interference and spatial limitation of intramyocardial temperature probes. New ablation technologies can thus be evaluated, independent of the catheter configuration or source of energy used.

Objective This study evaluated if there are gender differences in the manifestation of tako-tsubo cardiomyopathy (TTC). Background TTC predominantly occurs in elderly females and mimics acute myocardial infarction (AMI) where men and women are known to have a different clinical profile. Methods 324 patients from 37 hospitals were prospectively included in a TTC registry. Clinical, electrocardiographic, angiographic and outcome data from male and female patients were compared. Results Of 324 patients 296 (91%) were female and 28 (9%) male. Mean age (68±12 vs 66±12years) and prehospital delay were similar. A triggering event preceded TTC onset in 76% of women and 86% of men. Physical stress was more frequent in men (30% vs 57%, p=0.005) whereas more women experienced emotional or no stress. The prevalence of angina and dyspnea did not differ. Fewer females were admitted in cardiogenic shock and/or after out of hospital cardiac arrest (1% vs 14%, p=0.0006), and cardiac troponin was lower (median 7.2 vs 10.7 times the upper limit of normal, p=0.03). The QTc interval was longer in females than in males only on the day of admission (468±52 vs 441±51ms, p=0.047). Overall, complications during the acute course (53% vs 40%) were comparable in both sexes. Conclusions In this large TTC registry, males and females showed a similar clinical profile. In males, physical stress as a trigger event and shock or cardiac arrest as presenting symptoms were more frequent. The QTc interval was longer in females only on admission but similar in males and females during the following days.

Complete occlusion of the pulmonary veins (PV) is crucial for successful PV isolation. While two different sizes of cryoballoons (23 and 28 mm) are available, complete occlusion is not always achieved in any given PV. We investigated the role of PV ostial anatomy during cryoballoon PV occlusion grading and atrial fibrillation (AF) recurrence rate.PV ostial diameter was analyzed in 168 consecutive patients (111 men, 61 ± 10 years, 124 paroxysmal (px) and 44 persistent AF) using cardiac computed tomography (CT) prior to procedure. The ovality index at the PV ostial level was calculated in any given PV. During follow-up, 7-day holter monitors were performed at 1, 3, 6, 9, 12, 18 and 24 months post-ablation.The success rate at 12 ± 6 months follow-up was 69% including a 3-month blanking period (px AF: 66%; persistent AF 77%). The ovality index of the left-sided PVs was significantly larger ("more oval") than that of the right-sided PVs (p0.001). An optimized PV occlusion in all individual PVs (complete occlusion, grading 4/4) was achieved during ablation in 49% of patients with AF recurrence and in 73% of patients without AF recurrence (p=0.004). Patients with AF recurrence had "more oval" left-sided PVs compared to patients free from AF recurrence (LSPV 0.40 ± 0.2 vs. 0.33 ± 0.2; p=0.04 and LIPV 0.41 ± 0.3 vs. 0.32 ± 0.2; p=0.03), whereas no significant association was found for right sided PVs.The ostial PV anatomy seems to have an important impact on clinical outcome and should be considered when planning and performing cryoballoon AF ablation procedures.

TAVI is a novel treatment option for patients at too high risk for surgery. Risk scores for surgical valve replacement failed to accurately predict outcomes after TAVI and alternative risk parameters are lacking so far.We evaluated the CT-derived aortic valve calcification score as a predictor for outcome during and after TAVI.Transfemoral TAVI using the CoreValve device was performed in 68 patients, in whom the aortic valve calcium score was determined from preprocedural 64-sclice ECG gated CT-scans.30-day MACE rate (death, stroke, MI) was 10.3%, 1-year mortality was 11.8%. Using linear regression analysis the aortic valve calcium score was the only significant predictor for 30-day MACE and for 1-year mortality and was also associated with the incidence and severity of post procedural aortic regurgitation (r=0.33, p0.05). Patients withvalve calcium scores750 had a significant lower 1-year survival rate compared to patients with scores750 (58% vs. 98%, p0.05). The aortic valve calcium score is also inversely associated with the absolute improvement of NYHA-class after TAVI (regression coefficient=-0.43, p0.02).The degree of aortic valve calcification is associated with post procedural aortic regurgitation, procedural complications, 1-year mortality and with the degree of functional improvement of patients who underwent TAVI using the CoreValve device. Due to the fact that the aortic valve calcium score can be determined from CT-datasets that are used for preprocedural planning, this parameter may be incorporated in the general work up and may be used for risk stratification and patient selection.