Thoracoscopic ablation for the treatment of atrial fibrillation: a systematic outcome analysis of a multicentre cohort.

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.

Freezing Equals Freezing? Performance of Two Cryoablation Devices in Concomitant Mitral Valve Repair.

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 kinase MB (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.

Intraoperative Defibrillation Testing Should Not Be Generally Abandoned for All ICD Procedures-A Multicenter Study on 4,572 Consecutive Patients.

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.

How to establish a successful and sustainable surgical atrial fibrillation program: key considerations on the arrhythmia, training and treatment strategies.

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.

Impact of differential right-to-left shunting on systemic perfusion in pulmonary arterial hypertension.

OBJECTIVES: This study aimed at identifying the ideal right-to-left shunt-fraction to improve cardiac output (CO) and systemic perfusion in pulmonary arterial hypertension (PHT). BACKGROUND: Atrial septostomy (AS) has been a high-risk therapeutic option for symptomatic drug-refractory patients with PHT. Results have been unpredictable due to limited knowledge of the optimal shunt-quantity. METHODS: In nine dogs, an 8-mm shunt-prosthesis was inserted between the superior vena cava (SVC) and the left atrium. With pulmonary artery (PA) banding, mean (± SEM) systolic right ventricular pressure increased from 37 ± 1 mm Hg at baseline to 44 ± 1 mm Hg (moderate PHT, P = 0.005) and 50 ± 2 mm Hg (severe PHT, P < 0.001). Shunt-flow was adjusted by total (forcing all flow through the shunt) or partial occlusion of the SVC and partial or total clamping of the shunt. Caval-, shunt-, and aortic-flow were measured by ultrasonic flow-probes. Blood gases were drawn from the aortic root and PA. RESULTS: At severe PHT, a shunt-flow of 11 ± 1% of CO (253 ± 90 mL/min) increased CO significantly by 25% (1.8 ± 0.1 to 2.4 ± 0.2 L/min, P = 0.005) causing an increase of systemic oxygen delivery index (DO2 I) by 23% (309 ± 23 to 399 ± 32 mL/min/m(2), P = 0.035). Arterial O2 -saturation did not change significantly until a shunt-flow of 18 ± 2% was exceeded, causing a drop from 96 ± 1% to 84 ± 4% (P = 0.013). At moderate PHT, CO or DO2 I did not improve significantly at any shunt-flow. CONCLUSIONS: In severe PHT, a shunt-flow of 11% of CO represented the ideal shunt-fraction. Augmentation of CO compensated for declined O2 -saturation due to right-to-left shunting and improved DO2 I. In moderate PHT, AS is less promising.

Efficacy and safety of hybrid epicardial and endocardial ablation versus endocardial ablation in patients with persistent and longstanding persistent atrial fibrillation: a randomised, controlled trial.

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.

Differential impact of short periods of rapid atrial pacing on left and right atrial mechanical function.

Current techniques to describe atrial function are limited by their load dependency and hence do not accurately reflect intrinsic mechanical properties. To assess the impact of atrial fibrillation on atrial function, combined pressure-volume relationships (PVR) measured by conductance catheters were used to evaluate the right (RA) and left (LA) atrium in 12 isoflurane-anesthetized pigs. Biatrial PVR were recorded over a wide range of volumes during transient caval occlusion at baseline sinus rhythm (SR), after onset of rapid atrial pacing (RAP), after 1 h of RAP, after conversion to SR, and after 1 h of recovery. Cardiac output decreased by 16% (P = 0.008) with onset of RAP. Mean LA and RA pressures increased by 21 and 40% (P < 0.001), respectively, and remained elevated during the entire recovery period. RA reservoir function increased from 51 to 58% and significantly dropped to 43% after resumption of SR (P = 0.017). Immediately after RAP, a right shift of LA end-systolic PVR-intercept for end-systolic volume required to generate an atrial end-systolic pressure of 10 mmHg (24.4 ± 4.9 to 28.1 ± 5.2 ml, P = 0.005) indicated impaired contractility compared with baseline. Active LA emptying fraction dropped from 17.6 ± 7.5 to 11.7 ± 3.7% (P < 0.001), LA stroke volume and ΔP/Δt(max)/P declined by 22% (P = 0.038 and 0.026, respectively), while there was only a trend to impaired RA systolic function. Stiffness quantified by the ratio of pressure to volume at end-diastole was increased immediately after RAP only in the RA (P = 0.020), but end-diastolic PVR shifted rightward in both atria (P = 0.011 LA, P = 0.045 RA). These data suggest that even short periods of RAP have a differential impact on RA and LA function, which was sustained for 1 h after conversion to SR.

Performing the Left Atrial Maze Ablation Pattern Without Atriotomy.

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.

European multicenter experience with valve-sparing reoperations after the Ross procedure.

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.

Quo vadis pulmonary autograft--the ross procedure in its second decade: a single-center experience in 645 patients.

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.

Epicardial ablation performance of a novel radiofrequency device on the beating heart in pigs.

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.

The David procedure for salvage of a failing autograft after the Ross operation.

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.

[Surgical ablation of atrial fibrillation. Indications, techniques and results]. / Operative Verfahren zur Vorhofflimmerablation. Indikationen, Techniken und Ergebnisse.

Catheter ablation has been the preferred choice of treatment for many patients with atrial fibrillation (AF) and advanced to a first line treatment option. However, incomplete ablation lines and varying long-term success rates remain a problem in certain subgroups, especially patients with persistent AF or large left atria. Alternative energy sources and advances in the device design have shifted the surgeons' focus on less invasive procedures. Minimally invasive performed endocardial ablation or even endoscopical ablation on the beating heart reveals success rates of 90 % freedom from atrial fibrillation at 2 years independent from the duration or type of AF. The randomized FAST-trial demonstrated superiority of endoscopic ablation compared to catheter ablation after 1 year. Given the multiple theories of the mechanism causing AF and the results that can be achieved by minimally invasive surgery, a thoroughly assessment of the individual patients is mandatory and surgery should be considered in all symptomatic patients who have failed catheter ablation or who are not good candidates for catheter ablation.

[Surgical closure of the left atrial appendage in patients with atrial fibrillation. Indications, techniques and results]. / Operative Verfahren zum Verschluss des linken Vorhofohrs bei Patienten mit Vorhofflimmern. Indikationen, Techniken und Ergebnisse.

Cardiac embolisation in patients with atrial fibrillation accounts for the most serious complication of cerebral infarction. The left atrial appendage resembles the origin of these cardiac emboli in the majority of cases, although other anatomical areas of the left atrium might also be prerequisites for thrombus formation. Surgical closure of the left atrial appendage during an ablation therapy incorporates the theoretical possibility of reducing the rate of cardiac cerebral infarction. In order to achieve closure, different surgical strategies exist: either exclusion by over-sewing or snaring or excision by using scissors or a stapling device. All therapies incorporate pros and cons. One of the major complications and most feared side-effect is the recanalisation of a formerly closed left atrial appendage, especially in a thrombus filled left atrial appendage cavity. But also reopening of the formerly closed orificium and still existing remnants with communication to the left atrium might stand for an increased risk. Due to the good results of left atrial appendage excision, this surgical therapy at the moment presents the surgical gold standard, as this therapy is recommended in the updated ESC guidelines for the management of atrial fibrillation. If excision of the left atrial appendage will reduce the risk of cardiac embolisation needs to be examined in large prospective-randomized trials with a controlled systemic follow-up. So far, excision of the left atrial appendage as an alternative to oral anticoagulation, especially in patients with atrial fibrillation, is not recommended.

Safeguards and pitfalls in minimally invasive mitral valve surgery.

Minimally invasive mitral valve surgery has been established in many institutions worldwide. Appropriate indications and patient selection for this procedure must be based on a thorough understanding of its limitations and specific pitfalls. Particular risks can be minimized with careful attention to detail when planning and performing the surgery. The following chapter offers a stepwise description of the procedure; we point out particular advantages, discuss our rationale for certain steps, as well as focus on potential dangers of minimally invasive mitral valve surgery. Several graphics have also been provided to illustrate our approach and demonstrate important structural and anatomical concepts of the mitral valve apparatus.

Strategies for biological heart valve replacement: stentless xenografts fail to evolve into an alternative pulmonary valve substitute in a Ross procedure.

The Ross operation is a complex procedure for aortic valve replacement in which the pulmonary autograft is replaced by a homograft. However, homograft availability is becoming limited. This report evaluates the performance of porcine stentless prostheses as alternative pulmonary substitutes. Echocardiographic results from two patient cohorts were compared at time of discharge and 1 year after a Ross procedure. Thirty-three patients (median age 42 years, range 17-62 years, 76% male) received a stentless prosthesis (median size 25.6 mm, range 25-29 mm) for right ventricular outflow tract reconstruction. Clinical data were not significantly different from 106 patients (median age 47 years, range 2-68 years, 75% male) who received cryopreserved homografts (median size 26 mm, range 20-33 mm). At time of discharge, peak pressure gradients (ΔPmax ) across the stentless valve (median ΔPmax 13 mmHg, range 2-26 mmHg) were higher compared to homografts (median ΔPmax 7 mmHg, range 1-32 mmHg, p<0.001). At 1 year, gradients increased in both groups, but were significantly higher across stentless valves (median ΔPmax 23 mmHg, range 10-81 mmHg vs. median ΔPmax 13 mmHg, range 2-74 mmHg, p<0.001). Eleven patients (33%) in the stentless-valve group were classified "at risk" with a ΔPmax of ≥30 mmHg. Four of them (12%) had to be re-operated. In conclusion, stentless valves showed higher pressure gradients and their performance was inferior to cryopreserved homografts. See accompanying commentary by Ulrich Stock DOI: 10.1002/biot.201200341.

The David procedure in different valve pathologies: a single-center experience in 236 patients.

BACKGROUND: Reports of the long-term outcome after the David procedure in different valve pathologies are limited. We compared our results in patients with tricuspid and bicuspid aortic valves, including those who required additional cusp repair. METHODS: Between 1997 and 2011, 236 patients (76% males; mean age, 56 ± 15; range, 12 to 79 years) underwent valve-sparing aortic root replacement (David procedure) for aortic regurgitation and were prospectively followed up clinically and echocardiographically. RESULTS: The follow-up was 94% complete. Cumulative follow-up time was 896 patient-years (mean follow-up time, 4.5 ± 2.7; range, 0.6 to 13.7 years). The 30-day mortality was 1.7% (4 of 236), and late mortality was 4% (10 of 232), with one cardiac-related death due to aortic valve regurgitation. Overall freedom from valve replacement was 94% and 87% at 5 and 10 years, respectively. In 201 patients with tricuspid aortic valves, freedom from reoperation was 94% and 90% at 5 and 10 years, respectively. This was comparable to the 53 patients with bicuspid aortic valves, with a freedom from reoperation of 97% at 5 years (p = 0.632). Forty-two patients (18%) required additional cusp repair and had a 100% freedom from reoperation at 5 years. Overall, 10 patients (4%) required reoperation, with a mean interval of 11.5 ± 10.7 months. Reasons for reoperation were recurrent aortic valve regurgitation grade II (n = 6), aortic stenosis (n = 2), endocarditis (n = 1), and a ruptured central plication (n = 1). CONCLUSIONS: The David procedure revealed excellent long-term outcomes independently from the valve morphology. Rates of reoperations and valve-related morbidity were acceptably low. Additional cusp repair was no predictor for failure of this procedure.