Preclinical determination of the best functional position for transcatheter heart valves implanted in rapid deployment bioprostheses.

AIMS: The aim of this study was to determine the best functional position of a transcatheter heart valve (THV) implanted as a valve-in-valve (ViV) procedure in small rapid deployment valves (RDV) in an in vitro model. METHODS AND RESULTS: A 21 mm Perceval, Enable or INTUITY RDV was mounted into a pulse duplicator and a 23 mm balloon-expandable or a self-expanding THV was deployed (valve-in-valve) in two different positions. Under physiological hydrodynamic conditions, the performance of the THV was characterised by mean transvalvular pressure gradient (MPG), effective orifice area (EOA) and regurgitation volume (RV). Leaflet kinematics were assessed with high-speed video recordings, and X-ray images were acquired. All THV/RDV combinations met ISO requirements regarding hydrodynamic performance. In most cases, the higher position of the THV performed better than the lower one in terms of a lower MPG and increased EOA. Leaflet motion of the implanted THV was impaired in the lower position. In contrast, regurgitation volumes were relatively small and similar, regardless of the THV position. CONCLUSIONS: ViV implantation of a THV in a small RDV yielded satisfactory hydrodynamic results. In most cases, a high implantation position achieved lower MPG, higher EOA and a reduced risk of impaired THV leaflet function. Fluoroscopy images of the best functional ViV positions are presented as a blueprint for patient procedures.

Calcium distribution patterns of the aortic valve as a risk factor for the need of permanent pacemaker implantation after transcatheter aortic valve implantation.

AIMS: New-onset conduction disturbances still represent a considerable problem after transcatheter aortic valve implantation (TAVI). The aim of this study was to identify calcification patterns with an elevated risk for permanent pacemaker implantation (PPI) after TAVI and investigate underlying mechanisms in an ex vivo setting. METHODS AND RESULTS: One hundred and sixty-two patients who underwent TAVI with the Edwards SAPIEN XT® or Medtronic CoreValve® at our institution were analysed. The calcium load of the device landing zone was quantified with 3mensio®, and calcium patterns with an elevated risk for PPI were identified. Ex vivo simulations of balloon valvuloplasty were performed in 3D-printed silicone annuli of patients matching the identified risk profile. Patients with a calcium load of the left coronary cusp (LCC) above 209 mm3 had a higher rate of PPI than patients below this threshold (16.7 vs. 2.6%, P = 0.003). Multivariate regression revealed pre-existing right bundle branch block (RBBB) and increased LCC calcification as independent predictors for PPI. Simulation of the TAVI procedure in a silicone annulus revealed an off-centreline shift of the valvuloplasty balloon and transcatheter heart valve away from the LCC towards the commissure between right- and non-coronary cusp. CONCLUSION: Pre-existing RBBB and elevated LCC calcification were identified as independent predictors for PPI. These two risk factors enabled us to distinguish between patients according to their risk for PPI after TAVI. Ex vivo simulations suggested an off-centreline shift of the balloon as a possible explanation.

Predictors for permanent pacemaker implantation after concomitant surgical ablation for atrial fibrillation.

OBJECTIVES: Concomitant surgical atrial fibrillation (AF) ablation is a safe and feasible procedure, recommended in guidelines. Pacemaker dependency is a known complication of AF ablation. We sought to determine independent predictors for pacemaker implantation after surgical AF ablation. METHODS: Between January 2003 and November 2012, 594 patients underwent concomitant surgical AF ablation. Various energy sources, including cryoablation (n = 139), unipolar radiofrequency (n = 278), and bipolar radiofrequency (n = 177), were used. Left atrial (n = 463, 77.9%) and biatrial (n = 131, 22.1%) ablation was performed. Univariate and multivariate logistic regression analysis was used to identify independent predictors for pacemaker implantation within 30 days after surgical AF ablation. RESULTS: The mean patient's age was 68.6 ± 9.4 years, and 66.8% were male. No major ablation-related complications occurred. A total of 41 (6.9%) of patients received pacemaker implantation during the 30-day follow-up period. Indications for pacemaker implantation were atrioventricular block in 25 (60.9%) of patients, sinus bradycardia or sinus arrest in 9 (22.0%) of patients, and bradyarrhythmia in 7 (17.1%) of patients. Demographic data, type of surgical procedure, and type of energy source did not have a significant impact on pacemaker implantation rate. However, biatrial ablation led to a significant pacemaker implantation rate compared with isolated left-sided ablation (6.3% vs 13.6%; P = .028). CONCLUSIONS: Concomitant surgical AF ablation showed a pacemaker implantation rate of 6.9% after 30-day follow-up. Univariate and multivariate analysis showed biatrial lesion set as the only statistically significant predictor for pacemaker implantation after surgical AF ablation.

Rhythm outcome predictors after concomitant surgical ablation for atrial fibrillation: a 9-year, single-center experience.

OBJECTIVES: Concomitant surgical ablation is a safe and feasible procedure, recommended by the guidelines for patients with atrial fibrillation (AF) undergoing cardiac surgery. We performed a single-center data analysis to identify the predictors of rhythm outcome in such patients. METHODS: From January 2003 to January 2012, 503 patients with persistent (n = 296, 58.8%) or paroxysmal (n = 207, 41.2%) AF underwent concomitant surgical AF ablation. The lesions were limited to a pulmonary vein isolation (n = 76, 15.1%), a more complex left atrial lesion set (n = 353, 70.2%), or biatrial lesions (n = 74, 14.7%). Follow-up rhythm evaluations were based on either 24-hour Holter electrocardiograms or event recorder interrogation at 3, 6, and 12 months postoperatively. A sinus rhythm (SR) immediately postoperatively was defined as the first documented rhythm after weaning from extracorporeal circulation. RESULTS: The mean patient age was 68.0 ± 9.5 years, and 336 (66.8%) were men. No major ablation-related complications occurred. After 1 year of follow-up, 59.9% of all patients were in SR, with significantly better results in patients with paroxysmal AF than in those with persistent AF (67.3% vs 54.8%, P = .0053). Additional statistically significant factors influencing SR after 1 year were left atrial diameter (P = .0019), AF duration (P = .018), and immediate postoperative SR (P < .001). Regarding only patients with persistent or longstanding-persistent AF, those with biatrial lesions had significantly greater rates of conversion to SR than those with solitary left atrial ablation (SR, 64.9% vs 51.4%; P = .044) after 12 months. CONCLUSIONS: The statistically significant predictors for SR after 1 year were left atrial diameter, AF duration, preoperative paroxysmal AF, immediate postoperative SR, and biatrial ablation for persistent AF.

Safety and feasibility of concomitant surgical ablation of atrial fibrillation in patients with severely reduced left ventricular ejection fraction.

OBJECTIVES: Concomitant surgical ablation of atrial fibrillation (AF) is a safe and feasible procedure. However, many surgeons are reluctant to perform it in patients with heart failure. We investigated the safety and efficacy of AF ablation in patients with a severely reduced left ventricular ejection fraction (LVEF <35%). METHODS: Between July 2003 and August 2011, 59 patients with severely reduced LVEF underwent concomitant surgical AF ablation, by either left atrial (LA) lesion set or bilateral pulmonary vein isolation in patients with paroxysmal AF, and biatrial lesion set in patients with persistent AF. Follow-up echocardiography (ECG) was conducted after 12 months; rhythm monitoring was accomplished by either 24-h Holter echocardiography or event recorder monitoring. RESULTS: The patients' mean age was 68 ± 9 years (male patients, 71%). Paroxysmal AF was present in 24 (41%) and persistent AF in 35 (59%) patients. No ablation-related adverse events occurred. The one-year survival rate was 95% without differences in patients with and without restoration of sinus rhythm (SR). The overall rate of SR was 54% after 1 year, showing a superior result in patients with preoperative paroxysmal AF compared with those with preoperative persistent AF (70 vs 41%, P < 0.001). LVEF improved from 29 ± 8% preoperatively to 39 ± 7% after 12 months of follow-up. The improvement in LVEF was significantly higher in patients with restored SR than in those with AF (16 vs 5%; P < 0.001). Only patients with restoration of SR showed a statistically significant reduction in New York Heart Association functional class at the 12-month follow-up (P = 0.0013). CONCLUSIONS: Surgical AF ablation was safe and feasible in patients with severely reduced LVEF. The restoration of SR led to a significantly higher improvement in LVEF and alleviation of clinical heart failure symptoms, not observed if AF persisted postoperatively.

Concomitant surgical atrial fibrillation ablation and event recorder implantation: better monitoring, better outcome?

OBJECTIVES: Concomitant ablation is an established therapy in cardiac surgical patients with atrial fibrillation (AF). Post-discharge care seems to be an essential factor for clinical outcome. We analysed the influence of event recorder (ER) implantation and therapy guidance by the results of continuous rhythm monitoring of consecutive postoperative follow-up by our department of electrophysiology. METHODS: Between July 2003 and August 2010, 401 cardiac surgical patients underwent concomitant surgical AF ablation therapy. Since August 2009, an ER (REVEAL XT, Medtronic, Inc., Minneapolis, MN, USA) was implanted in 98 patients intraoperatively. ER interrogation was performed by our department of electrophysiology 3, 6 and 12 months postoperatively. Results and outcomes were compared with a matched cohort of patients with ablation and no ER implantation. In those patients, rhythm follow-up was obtained by 24-h Holter ECG. Primary end-point of the study was sinus rhythm rate after 12 months. RESULTS: Mean patient's age was 67.0 ± 9.7 years, and 68.4% were male. No major ablation-related complications occurred. The overall sinus rhythm rate was 65.3% after 1-year follow-up. The sinus rhythm rate off antiarrhythmic drugs was 60.3%. The conversion rate tended to be higher in patients with an implanted ER (69.3 vs 60.1%, respectively; P = 0.098). Also, the sinus rhythm rate of anti-arrhythmic drugs was higher in the ER group (64.3 vs 56.2). Patients with ER were seen more often by a cardiologist in the first postoperative year (3.1 ± 0.8 vs 1.5 ± 0.9; P < 0.05) and received significantly more additional procedures, like electrical cardioversion or additional catheter-based ablation (16.1 vs 4.3%; P < 0.001; 11.2 vs 3.1%; P < 0.001). CONCLUSIONS: Implantation of an ER with link-up to a cardiology and/or electrophysiology provides optimized anti-arrhythmic drug management and higher rates of consecutive procedures like cardioversion or additional catheter-based ablation. As a result, a trend to higher sinus rhythm conversion rate was observed after 1-year follow-up.