OBJECTIVES:The CEASE-AF trial demonstrated that epicardial-endocardial hybrid ablation (HA) had superior effectiveness compared to endocardial catheter ablation (CA) for non-paroxysmal atrial fibrillation (AF), without significantly increasing major complications during a 12-month period. Most contemporary AF ablation trials have not evaluated durability beyond 12 months. Therefore, 24-month effectiveness and safety of HA and CA are compared. METHODS:CEASE-AF is a prospective, multicentre, randomized trial. Patients 18-75 years of age with symptomatic, drug refractory persistent AF and left atrial diameter >4.0 cm or long-standing persistent AF were randomized 2:1 to HA (posterior wall and pulmonary vein isolation with left atrial appendage exclusion) or CA (pulmonary vein isolation). Secondary effectiveness was freedom from AF/atrial flutter/atrial tachycardia off class I/III anti-arrhythmic drugs except for those who previously failed at doses not exceeding those previously failed through a 24-month follow-up period. Major complications and reinterventions were evaluated. RESULTS:The intention-to-treat population was 102 patients with HA and 52 patients with CA. Seventy-five percent were male, 80.5% had persistent AF and 19.5% had long-standing persistent AF, with a mean age of 60.7 ± 7.9 years. Effectiveness for 24 months was 66.3% (63/95) with HA and 33.3% (17/51) with CA [absolute difference 33.0% (95% confidence interval 14.3%, 48.3%; P < 0.001)]. Major complication rates were 10.8% (11/102) with HA and 9.6% (5/52) with CA (P = 1.0), and fewer patients had reinterventions after HA than CA [18.9% (18/95) vs 52.9% (27/51), P < 0.001]. CONCLUSIONS:CEASE-AF demonstrated that the 32.4% absolute benefit of HA over CA for 12 months was durable for 24 months at 33% with continued similar safety rates and fewer reinterventions after HA (funded by AtriCure, Inc.; NCT02695277). CLINICALTRIALS.GOV REGISTRATION:NCT02695277.

Establishing a successful and sustaining atrial fibrillation (AF) program should be current standard of care in cardiac surgery by providing not only sinus rhythm restoration but improving survival significantly. Recognition of AF as a serious cardiac disease impacting a considerable number of patients in terms of stroke, heart failure development and mortality is key when implementing a protocol to identify patients suitable for surgical ablation and a treatment standard according to the underlying pathology. The ablation strategy resulting in the best potential rhythm outcome should be chosen, and the applied access should follow this decision in a way that the optimal lesion set can be executed completely. A thorough follow-up is required to confirm results or make necessary adjustments to the implemented treatment protocol. This should be done in close collaboration with other treatment specialists such as cardiologists, electrophysiologists, primary care physicians, or neurologists. This collaboration might also facilitate an expansion of the program towards stand-alone ablation, ventricular tachycardia ablation, and inappropriate sinus tachycardia ablation.

Background Endocardial catheter ablation (CA) has limited long-term benefit for persistent and longstanding persistent atrial fibrillation (PersAF/LSPAF). We hypothesized hybrid epicardial-endocardial ablation (HA) would have superior effectiveness compared to CA, including repeat (rCA), in PersAF/LSPAF. Methods CEASE-AF (NCT02695277) is a prospective, multi-center, randomized controlled trial. Nine hospitals in Poland, Czech Republic, Germany, United Kingdom, and the Netherlands enrolled eligible participants with symptomatic, drug refractory PersAF and left atrial diameter (LAD) > 4.0 cm or LSPAF. Randomization was 2:1 to HA or CA by an independent statistician and stratified by site. Treatment assignments were masked to the core rhythm monitoring laboratory. For HA, pulmonary veins (PV) and left posterior atrial wall were isolated with thoracoscopic epicardial ablation including left atrial appendage exclusion. Endocardial touch-up ablation was performed 91-180 days post-index procedure. For CA, endocardial PV isolation and optional substrate ablation were performed. rCA was permitted between days 91-180. Primary effectiveness was freedom from AF/atrial flutter/atrial tachycardia >30-s through 12-months absent class I/III anti-arrhythmic drugs except those not exceeding previously failed doses. It was assessed in the modified intention-to-treat (mITT) population who had the index procedure and follow-up data. Major complications were assessed in the ITT population who had the index procedure. Thirty-six month follow-up continues. Findings Enrollment began November 20, 2015 and ended May 22, 2020. In 154 ITT patients (102 HA; 52 CA), 75% were male, mean age was 60.7 +/- 7.9 years, mean LAD was 4.7 +/- 0.4 cm, and 81% had PersAF. Primary effectiveness was 71.6% (68/95) in HA versus 39.2% (20/51) in CA (absolute benefit increase: 32.4% [95% CI 14.3%-48.0%], p < 0.001). Major complications through 30-days after index procedures plus 30-days after second stage/rCA were similar (HA: 7.8% [8/102] versus CA: 5.8% [3/52], p = 0.75). Interpretation HA had superior effectiveness compared to CA/rCA in PersAF/LSPAF without significant procedural risk increase. Funding AtriCure, Inc.

AIMS To perform a systematic outcome analysis in order to provide cardiologists and general pactitioners with more adequate information to guide their decision making regarding rhythm control. Totally thoracoscopic maze (TTmaze) for the treatment of atrial fibrillation (AF) is recommended as a Class 2a indication mainly based on single centre studies including small patient cohorts and inconsistent lesion sets. METHODS AND RESULTS We studied consecutive patients undergoing TTmaze in three European referral centres (2012-15). Primary outcome was freedom from atrial tachyarrhythmia (ATA). Secondary outcomes were 30-day complications, the composite endpoint of ischaemic stroke, haemorrhagic stroke or transient ischaemic attack (TIA), all-cause mortality, and predictors of ATA recurrence. Four hundred and seventy-five patients were included, with a mean age of 61 ± 9 years and 69.5% male. The mean CHA2DS2-VASc score was 1.7 ± 1.3. The overall freedom from ATA was 68.8% after a mean follow-up period of 20 ± 9 months. Freedom from ATA was 72.7% for paroxysmal AF, 68.9% for persistent AF, and 54.2% for longstanding persistent AF. Multivariate analysis revealed female gender [hazard ratio (HR): 1.87, P = 0.005], in-hospital AF (HR: 1.95, P = 0.040), longer duration of preoperative AF (HR: 1.06, P = 0.003) and mitral regurgitation (HR: 1.84, P = 0.025) as independent predictors of ATA recurrence. Overall 30-day freedom from any complication was 92.4%. Freedom from cerebrovascular events after mean follow-up of 30 ± 16 months was 98.7% and overall survival was 98.3%. The observed rate of ischaemic stroke, haemorrhagic stroke, or TIA was low (0.5 per 100 patient-years). CONCLUSION Totally thoracoscopic maze is a safe and effective rhythm control therapy.

Letter to: Reply by the Authors of the Original ArticleThorac Cardiovasc Surg 2017; 65(06): 472-472DOI: 10.1055/s-0036-1597913

Prof. Mohr has an outstanding sense of discovering exceptionally talented stallions. As soon as hewould discover such talent, only a short period of time would pass before he actively stimulated inspiration among his team to integrate this talent. Soon after, a highly motivated and efficient team was created. Working day and night, while demonstrating utmost ambition to pursue innovation, this teamwould then passionately pursue their vision to bring this stallion through the finishing line first. This particular gift of Prof. Mohr explains how various visions at the Leipzig Heart Center have been transformed from just being an initial idea into novel treatment concepts, which were established in clinical practice worldwide. The evolution of rhythm surgery is a very good example for Prof. Mohr’s exceptional gift and its impact on current standards and treatment approaches in cardiac surgery. His friendship with James Cox had given him insights into the effective surgical treatment of atrial fibrillation. In the beginning of the 1990s, Cox had developed the maze operation. Back then, Cox and “his” cardiologist performed intraoperative epicardial electrical mappings and concluded from their findings that biatrial fragmentation by defined transmural cutting lines could treat atrial fibrillation. This surgery is highly effective, but at the same time also highly invasive. The procedure originally required establishing cardiopulmonary bypass as well as additional cross-clamping times of 60 minutes. Long-term follow-up over meanwhile 20 years showed success rates of more than 80% of the patients retaining sinus rhythm. In several centers, especially in the United States, this procedure is being performed as a “standalone” procedure and the good results have proven to be reproducible using current follow-up guidelines. Toward the end of the 1990s, the development of percutaneous catheter ablations was only in its early beginnings. Nevertheless, successful ablation lines were neither transmural nor linear. These were also the years when minimally invasive mitral valve and later tricuspid valve surgery were successfully introduced into clinical practice at the Leipzig Heart Center. The early insights of Prof. Mohr’s friend Randy Chitwood were further developed, modified, and rapidly established in clinical practice there. Prof. Mohr subsequently introduced minimally invasive surgery for the treatment of atrioventricular valves in Europe and, later on, the world.1 Soon after minimally invasive valve surgery was clinically established it received recognition from rhythm specialists, ultimately leading to an exchange of ideas regarding the surgical treatment of “stand-alone” atrial fibrillationwith an interdisciplinary approach. Gerd Hindricks and Hans Kottkamp, who had already developed their ideas to treat atrial fibrillation in Mannheim with Prof. Borggrefe, were keen on performing minimally invasive intraoperative endocardial ablations using high-frequency energies. Following interdisciplinary planning of the operative setting, the first controlled prospective study Intraoperative Radiofrequency Ablation of Atrial Fibrillation (IRAAF) was designed at the Heart Center Leipzig in close collaboration between cardiac surgeons and cardiologists. A total of 130 patients with atrial fibrillation were successfully treated with an outstanding result of 90% sinus rhythm at 1-year follow-up.2 Unfortunately, this novel procedure was associated with several new unexpected complications. Three patients suffered from esophageal perforations with esophagoaswell as broncho-atrialfistulae.3 Early diagnosis of this complication was challenging, as patients complained of nonspecific symptoms beginning usually a week after the ablation procedure. These included fever, chills, strokes, and signs of mediastinitis. Major concerns were expressed, and after identification of the third perforation in our cohort, we discontinued this treatment strategy and began investigating its pathomechanism in depth.4–6Wetested all alternative energy sources which created transmural linear endoand epicardial scars in animal models. The aforementioned complication could be reproducedwhen using unipolar dry highfrequency ablation (►Fig. 1). Furthermore, we were able to

The need to perform an additional atriotomy is a major concern that keeps many surgeons from performing an extended left atrial lesion set in patients with atrial fibrillation during procedures such as aortic valve replacement. This does result either in a suboptimal lesion set or even in ignoring the rhythm disorder, leaving the patient exposed to an increased risk of stroke and possible hemodynamic compromises. This report describes a technique how pulmonary vein isolation, an isolation of the posterior left atrial wall and an anterior mitral annular line, which substitutes for the mitral isthmus line in order to prevent perimitral atrial flutter, can be performed during aortic valve replacement without the need for an atriotomy. This technique allows for an optimal time management by minimizing additional cardiopulmonary bypass-time and cross-clamp-time; however, its equivalent efficacy in successfully treating atrial fibrillation compared to the left atrial Maze IV ablation pattern needs to be revealed in future trials. (C) 2016 by The Society of Thoracic Surgeons

Background The ongoing technical advances in development of new implantable cardioverter defibrillator (ICD) systems led some investigators to question the routine use of intraoperative defibrillation testing (DT). Therefore, we evaluated retrospectively in a multicenter study effectiveness, safety, and usefulness of intraoperative DT on unbiased large patient population. Methods Data from 4,572 consecutive patients undergoing any ICD intervention were retrospectively analyzed. Besides efficacy of DT, risk factors for DT failure were identified in a multiple logistic regression analysis. Results Overall 5,483 shock data from 4,532 patients were available. Not tested for medical reasons were 13.5%. DT-associated complications were not noted. Primary DT effectiveness was 95.8%, whereas 4.2% were ineffective. Optimization (51.6% increase of DT energy, 10.1% subcutaneous lead array (SQ array), 2% generator exchange, 4.8% lead reposition, 9.3% lead exchange, and 22.2% change of shock parameters) led to successful DT in 152 patients (96.2%). Subanalyses and logistic regression identified implantation of generator in any other position than left subpectoral, age, body mass index and left ventricular ejection fraction as independent predictors for primary DT failure. Conclusion The number of patients, including those undergoing generator exchange, system upgrade, or system revision, with inappropriate intraoperative testshock is relatively high. The results of recent prospective clinical trials can be extrapolated only on first ICD implantations with high-energy generators. For patients undergoing subcutaneous ICD implantation, right-sided implantation, patients with channelopathies and hypertrophic cardiomyopathy, as well as for procedures on already implanted ICD systems, the intraoperative DT might still be recommended.

Background Recent guidelines have recommended the addition of ablation in cardiac surgery for patients presenting with atrial fibrillation (AF). Currently available cryoablation devices use either nitrous oxide or argon gas as cooling agent. Our study aimed to compare success rates of two different devices currently available on the market and applied during concomitant cardiac surgery.Methods Between 2009 and 2012, data were collected from 120 consecutive patients in whom either the aluminum cryoICE ablation probe (AtriCure, Inc., Cincinnati, Ohio, United States) using nitrous oxide or the stainless steel Cardioblate CryoFlexTM 10-S probe (Medtronic, Inc., Minneapolis, Minnesota, United States) using argon gas was applied for concomitant ablation procedures in minimally invasive mitral valve cases. Perioperative variables, myocardial injury biomarkers (MIBs) and Holter monitoring results were compared.Results Perioperative variables such as sex, age, type, and duration of AF, procedure and cross-clamp times, and 30-day mortality did not significantly differ between the groups. Postoperative peak creatinine kinaseMB (CK-MB) levels were significantly higher in the nitrous oxide group (p = 0.047). At a mean follow-up of 20 = 13 months, freedom from AF was significantly higher in the nitrous oxide group (87%) compared with the argon group (71%, p = 0.044). Left atrial (LA) diameter and device used were the only predictors of failure of ablation (p = 0.029 and p = 0.018, respectively).Conclusion The nitrous oxide-based aluminum probe revealed a better outcome than the argon-based stainless steel probe. Besides the cooling agent, probe material and probe-tissue interface might have contributed to the better performance of the cryoICE probe.

Background. Dilatation of the pulmonary autograft is a major fear after the Ross procedure. We analyzed the results after reoperation for autograft dysfunction using a valve-sparing reimplantation technique (David procedure).Methods. From 1995 to 2012, 645 Ross operations were performed, with 630 (98%) of these as freestanding root replacements (mean follow-up, 8.3 +/- 4.6 years). Forty-nine autograft reoperations occurred in 46 patients (0.89%/ patient-year). Between 2005 and 2013, reoperation using a David procedure was performed in 18 of 35 patients (52%) with autograft dilatation at a mean interval of 11 +/- 3.2 years after the Ross operation.Results. The mean age of 18 patients receiving a David procedure as reoperation was 49.8 +/- 13.9 years; 83% were male. The 30-day reoperative mortality was zero. The mean vascular graft size used for reimplantation was 29.5 +/- 1.7 mm. At a mean follow-up time of 3.2 +/- 2.3 years (100% complete), all patients (18 of 18) were alive and in New York Heart Association functional class I. One patient (5%) needed valve replacement for recurrent aortic regurgitation 2.6 years after the David procedure. In the remaining patients (95%), freedom from aortic regurgitation of grade 2 or greater was 100% at 3 years (regurgitation grade <1, 14 of 17; 82%). Aortic valve gradients were clinically insignificant at 5.8 +/- 2.1 mm Hg.Conclusions. Performing a David procedure was successful in the vast majority of patients with dilatation of the pulmonary autograft after a Ross operation and revealed good function of the preserved autograft at midterm follow-up. Reoperations could be performed with low perioperative morbidity and mortality. (C) 2014 by The Society of Thoracic Surgeons

Purpose. Only bipolar clamps create reliable transmural lesions on the beating heart. This study evaluated the performance of a new radiofrequency (RF) device on the beating heart in an acute porcine model. Description. Six domestic pigs were ablated with a novel bipolar RF linear device on the beating heart (ablation time of 40 s, 3 each on right and left atria and 1 each on superior and inferior vena cavae). The heart was stained with 2, 3, 5-triphenyl-tetrazolium chloride, and each lesion was cross-sectioned for lesion depth and transmurality. Evaluation. Transmurality was documented in 89% of the cross-sections. Sixty-three percent of lesions were transmural along the entire lesion length. Overall, 85% of the nontransmural cross-sections were located on the right atrium, and half of the nontransmural sections were in the superior or inferior vena cavae lesions. Conclusions. This novel device was able to create transmural lesions on the beating heart, more effectively in the left atrium than in the right atrium. (C) 2014 by The Society of Thoracic Surgeons

Background. The enthusiasm about the advantages of a viable autologous transplant faded with recent reports of autograft deterioration and associated reoperations after the Ross procedure. This report evaluates predictors for autograft failure and outcomes extending into the second decade after a Ross procedure.Methods. From 1995 through 2012, 645 consecutive patients (mean age, 42.3 +/- 14.2 years; 76% males) underwent a Ross operation using mainly the root replacement technique (98%). They were prospectively followed up with clinical and echocardiographic evaluations. Total follow-up was 5,349 patient-years and was 96% complete. Mean follow-up duration was 8.4 +/- 4.6 years (range, 0 to 17.4 years).Results. Early mortality was 0.9% (n = 6). Cumulative survival at 15 years was 92.7% (95% confidence interval, 90.1% to 95.3%) and did not differ from the general German population (p = 0.261). Freedom from reoperation on the autograft or the pulmonary allograft at 12 years was 91.6% (95% confidence interval, 88.5% to 94.9%) and 95.0% (95% confidence interval, 92.8% to 97.2%), respectively. Sixty-five patients (10.1%) required a total of 78 valve-related reoperations after a Ross procedure (1.5%/patient-year) with a reoperative hospital mortality of 3.8% (n = 3). Forty-seven autograft reoperations were observed in 44 patients (0.87%/patient-year); 22 of them (47%) could be performed as a valve-sparing procedure. Preoperative aortic valve regurgitation and an aortic annulus of at least 26 mm were identified as predictors for autograft failure.Conclusions. In this large series, the Ross procedure resulted in excellent long-term survival rates with a low risk of valve-related morbidity and a considerably low rate of reoperations in young and middle-aged patients and should be considered as an important treatment option in this cohort. (c) 2014 by The Society of Thoracic Surgeons

Background: Autograft valve preservation at reoperation may conserve some of the advantages of the Ross procedure. However, results of long-term follow-up are lacking. In this retrospective multicenter study, we present our experience with valve-sparing reoperations after the Ross procedure, with a focus on long-term outcome.Methods: A total of 86 patients from 6 European centers, who underwent valve-sparing reoperation after the Ross procedure between 1997 and 2013, were included in the study.Results: Reoperation was performed a median of 9.1 years after the Ross procedure in patients with a median age of 38.4 years (interquartile range: 27.1-51.6 years). Preoperative severe autograft regurgitation (grade >= 3) was present in 46% of patients. In-hospital mortality was 1%. During a median follow-up of 4.3 years, 3 more patients died of noncardiac causes, resulting in a cumulative survival at 8 years of 89% (95% confidence interval: 65%-97%). Fifteen patients required a reintervention after valve-sparing reoperation, mostly owing to prolapse or retraction of autograft cusps. Freedom from reintervention was 76% (95% confidence interval: 57%-87%) at 8 years. The reintervention hazard was increased in patients who had isolated and/or severe aortic regurgitation at valve-sparing reoperation. In patients without reintervention after valve-sparing autograft reoperation (n = 63), severe aortic regurgitation was present in 3% at last follow-up.Conclusions: Valve-sparing autograft reoperations after the Ross procedure carry a low operative risk, with acceptable reintervention rates in the first postoperative decade. Patients with isolated and/or severe autograft regurgitation have an increased hazard of reintervention after valve-sparing reoperation; for these patients, careful preoperative weighing of surgical options is required.

Eine häufige und klinisch schwerwiegende Komplikation des Vorhofflimmerns stellt der kardioembolische zerebrale Gefäßverschluss dar. Ort dieser Emboliequelle ist in der Mehrzahl der Fälle das linke Vorhofohr. Durch einen chirurgischen Verschluss des linken Auriculums im Rahmen einer Ablationstherapie gelingt vermutlich eine Reduktion dieser Schlaganfälle. Als mögliche Therapie stehen unterschiedliche chirurgische Techniken zur Verfügung: die Exklusion durch Übernähung oder Knotenverschluss oder die Exzision mittels Schere oder Klammernaht. Alle genannten Techniken weisen ein gewisses Restrisiko in Bezug auf Rekanalisation, Wiedereröffnung, weiterhin bestehende Kommunikation mit dem linken Vorhof oder erneute Thrombenbildung auf. In Anbetracht der postoperativen Ergebnisse stellt die chirurgische Exzision die Therapie der Wahl zum Ausschluss des linken Vorhofohres dar. Ob dieser Eingriff tatsächlich zu einer Reduktion der Schlaganfallsrate, insbesondere bei Patienten mit Vorhofflimmerrezidiv nach Ablationstherapie, führt, muss anhand von großen, prospektiv randomisiert kontrollierten Studien untersucht werden.

Die Entwicklung moderner epikardialer Ablationssonden, die endoskopisch am schlagenden Herzen eingesetzt werden können, bietet dem symptomatischen, medikamentenrefraktären Patienten mit Vorhofflimmern heute eine schonende und risikoarme Behandlungsoption mit Erfolgsraten von 90 %, auch bei persistierendem Vorhofflimmern. Zusätzlich kann das linke Herzohr als eine der Hauptemboliequellen während eines solchen Eingriffs entfernt werden. Die perkutane Katheterablation steht im Stufenplan der Vorhofflimmertherapie vor den chirurgischen Verfahren. Sie ist wenig belastend für den Patienten und erzielt bei paroxysmalem Vorhofflimmern gute Ergebnisse. Allerdings sind hierfür meist multiple Interventionen notwendig. Zudem sind Patienten mit langanhaltend persistierendem Vorhofflimmern mit diesem Verfahren schwierig zu therapieren. Haissaguerre, als Pionier der kathetergestützen Pulmonalvenenisolation, veröffentlichte erst kürzlich doch eher ernüchternde 5-Jahres-Erfolgsraten von unter 30 % für eine Single-Prozedur. Die erste randomisierte Studie zum Vergleich der Effektivität von Katheterablation und thorakoskopischer Ablation am schlagenden Herzen (FAST) zeigte eine signifikant höhere Erfolgsrate des chirurgischen Verfahrens. Bei einem derart multifaktoriellen Krankheitsbild wie dem Vorhofflimmern ist eine generelle Therapieempfehlung zweifellos schwierig und sollte v. a. bei Patienten, bei denen eine Katetherablation erfolglos geblieben ist oder die schlechte Kandidaten für eine solche sind, unter Berücksichtigung aller individuellen Besonderheiten und aller zur Verfügung stehenden Therapieoptionen erfolgen.