Bleeding Complications After Use of Novel Oral Anticoagulants in Patients Undergoing Cardiac Surgery.

BACKGROUND: The study was performed to analyze the results of open-heart surgery and bleeding complications after administration of novel oral anticoagulants (NOAC). METHODS: We investigated 81 consecutive patients (median age 74 years, interquartile range [IQR]: 68 to 78) who underwent open-heart operations at our institution between July 2014 and June 2016. All patients presented for surgery while on NOAC therapy: 37 received rivaroxaban (45.7%), 35 apixaban (43.2%), and 9 dabigatran (11.1%). The calculated risk using the European System for Cardiac Operative Risk Evaluation II was 3.5% (IQR: 2.0% to 8.1%). RESULTS: Surgery was performed at a median 4 days (IQR: 3 to 6) after NOAC withdrawal. Reduced renal function was predictive for length of intensive care unit stay and administration of red blood cells (p < 0.0001 and p = 0.0291, respectively). The NOAC withdrawal interval significantly influenced postoperative drainage volume (p = 0.0056). Five patients needed rethoracotomy because of relevant bleeding (6.2%), 4 after apixaban (11.4%) and 1 after rivaroxaban therapy (2.7%). Apixaban showed a borderline influence on prolonged intensive care unit stay (p = 0.0736). Prolonged cardiopulmonary bypass time was predictive for thrombocyte administration (p = 0.0249). Intensive care unit stay was 2 days after NOAC withdrawal of 10 days, compared with 4.2 days without termination. Thirty-day mortality was 3.7%. CONCLUSIONS: A lengthy NOAC withdrawal period, particularly for patients with reduced renal function, is essential for safe open-heart surgery. We conclude that despite official recommendations, patients should whenever possible not be considered for elective cardiac surgery within 10 days of terminating NOAC treatment.

The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation.

OBJECTIVES: We present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR). BACKGROUND: Transcatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism. METHODS: The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled. RESULTS: Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up. CONCLUSIONS: The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication.

Transcatheter implantation of aortic valve prostheses into degenerated mitral valve bioprostheses and failed annuloplasty rings: outcomes according to access route and Mitral Valve Academic Research Consortium (MVARC) criteria.

AIMS: The study sought to assess outcomes of transcatheter mitral valve-in-valve implantation (TMVIV) for degenerated bioprostheses and transcatheter mitral valve-in-ring implantation (TMVIR) for failed annuloplasty rings according to access route and the Mitral Valve Academic Research Consortium (MVARC) criteria. METHODS AND RESULTS: Twenty-four patients (72±13 years; eight men [33%]) underwent TMVIV (n=14) or TMVIR (n=10) for mitral regurgitation (MR; n=17) or stenosis (n=7) using balloon-expandable bioprostheses. Transapical (TA) access was chosen in 13, and transseptal (TS) access in 11 patients. MVARC technical success, device success and procedural success were 95.8%, 41.7% and 33.3%, respectively, with no differences between access routes. Cardiac output (CO) increased significantly by 1.1±0.8 l/min in TS patients, but not in TA patients (ΔCO=0.0±0.5 l/min; p=0.0051). Overall three-year survival was estimated at 57.6% (95% confidence interval: 33.9-81.3; TA 35.5% [5.2-65.9]; TS 90.9% [73.9-100]). Survival up to four years according to vascular access showed a clear benefit in patients treated transseptally (p=0.045). CONCLUSIONS: Regardless of the access route, TMVIV/TMVIR was associated with high technical success yet impaired device success. In the long term, TA access had a significant adverse impact on survival.

Oral Anticoagulation After Successful Atrial Fibrillation Ablation Operations: Is It Necessary?

BACKGROUND: This study analyzed the results of atrial fibrillation (AF) ablation concomitant to open heart operations using continuous monitoring. METHODS: We investigated 70 consecutive patients (mean age, 72.1 ± 6 years; European System for Cardiac Operative Risk Evaluation II: 9.7% ± 8.2%) who underwent AF ablation concomitant to cardiac operations in our institution between February 2012 and February 2013. For precise rhythm analysis we implanted Reveal XT devices (Medtronic Inc, Minneapolis, MN) in all patients at the end of operations. Twenty-two patients had paroxysmal (31.4%), 20 persistent (28.6%) and 28 longstanding-persistent AF (40%). AF duration time was at a median 18 months. Cardiac rhythm data were obtained by telemonitoring at 1-month intervals, and the AF burden was calculated at 3, 6, and 9 months and at 1 year postoperatively (ablation procedure success was defined as a burden of ≤ 0.5%). Further, a neurologic follow-up was performed at 1 year postoperatively. RESULTS: Overall survival was 95.7% at 30 days and 84.3% at 1 year. At 1 year, 66.7% of patients were in stable sinus rhythm, and AF burden was significantly reduced even in nonresponders: 88.2% of patients were off antiarrhythmic drugs, and oral anticoagulation had been stopped in 92.1%. No late neurologic events had occurred. Sinus rhythm at discharge and paroxysmal type of AF were predictive for later sinus rhythm (p = 0.04 and p = 0.048, respectively). CONCLUSIONS: Considering the long AF duration and the high proportion of longstanding-persistent AF, the overall success of ablation procedures was satisfactory. Even though oral anticoagulation was stopped in most patients, no neurologic events were detected.

Emergency transcatheter aortic valve replacement in patients with cardiogenic shock due to acutely decompensated aortic stenosis.

AIMS: To assess outcomes of TAVR as a rescue therapy in patients with cardiogenic shock due to acutely decompensated aortic stenosis. METHODS AND RESULTS: Of 771 high-risk patients who underwent TAVR, 27 (3.5%; 78±9 years; 12 men) were treated emergently due to acutely decompensated aortic stenosis with cardiogenic shock. SAPIEN and CoreValve prostheses were implanted in 11 and 16 patients, respectively: the transfemoral access route was used in 25. Three patients died within 72 hours of successful valve deployment, and a further six died within a month, giving a 30-day mortality of 33.3%, which was significantly higher than in electively treated patients (7.7%, p<0.0001). Univariate predictors of 30-day mortality in cardiogenic-shock patients were baseline cardiac output <3.0 l/min, reduced cardiac power index, impaired renal function, and mechanical ventilation, as well as severe acute kidney injury after TAVR. Estimated one-year survival was 59.3% in emergently and 82.7% in electively treated patients (p=0.0009). However, 30-day landmark analysis showed no difference in cumulative survival between TAVR modalities. In cardiogenic-shock patients without concomitant reduced cardiac output and impaired renal function at baseline (n=22), estimated one-year survival was 72.7%. CONCLUSIONS: TAVR should be considered a reasonable rescue therapy in patients with cardiogenic shock secondary to decompensated aortic stenosis.

Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation.

OBJECTIVES: This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation. BACKGROUND: Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. METHODS: Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. RESULTS: Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. CONCLUSIONS: Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.

Transcatheter aortic valve implantation of a second-generation valve for pure aortic regurgitation: procedural outcome, haemodynamic data and follow-up.

OBJECTIVES: The second-generation Jenavalve prosthesis (Jenavalve Technology, Inc., Munich, Germany) is the first transcatheter valve Conformité Européene (CE) marked for treatment of both aortic stenosis (AS) and pure aortic regurgitation (AR). Although the feasibility of the Jenavalve transcatheter aortic valve implantation (TAVI) in patients with pure AR has been described, haemodynamic and follow-up data are lacking. METHODS: We report on a series of 10 transapical Jenavalve implantations for pure AR between December 2012 and September 2013. The patients were determined for TAVI by heart team decision at high surgical risk [log EuroSCORE (European System for Cardiac Operative Risk Evaluation) >20%], frailty or Charlson Comorbidity Index (CCI). Transaortic gradients and right heart haemodynamics were measured invasively before and after TAVI. Ventriculography and transoesophageal echocardiography were used to determine paravalvular regurgitation. All-cause mortality, NYHA functional class and echocardiographic measurements were followed up at 30 days and at 3, 9 and 12 months postoperatively. RESULTS: Overall, mean age was 79 ± 9 years, mean left ventricular ejection fraction 50 ± 17% and mean log EuroSCORE 28.3 ± 17.1%. There were no perioperative complications. Paravalvular regurgitation immediately after implantation was graded none (n = 6), trace (n = 3) or mild (n = 1). Overall 30-day mortality was 30% (3/10). Three patients refused further treatment, such as haemodialysis or treatment of mitral regurgitation. Rate for pacemaker implantation was 2/10 (20%). CONCLUSIONS: Intraprocedural success and haemodynamic data in our cases were good. The mortality in our group highlighted the importance of careful patient selection, especially for this pathology. The Jenavalve prosthesis proved to be suitable for treatment of AR in surgical high-risk patients.

Implantable loop recorders after atrial ablation: patient compliance and data surveillance in clinical practice.

OBJECTIVE: Recent data suggest continuous monitoring by implanted loop recorder (ILR) to be the criterion standard for rhythm surveillance after atrial ablation. Studies describing patient compliance and pitfalls in the perioperative period are lacking. It was the aim of this study to evaluate patient compliance and time invested by physicians for obtaining data during the follow-up period after implanting an ILR. METHODS: We prospectively collected data of 70 consecutive patients undergoing concomitant cardiac surgery, atrial ablation, and implantation of an ILR. Patient compliance was calculated as the ratio of incoming/expected data transmission. We documented total time spent by physicians with preoperative and postoperative supervision. RESULTS: Between February 2012 and February 2013, a total of 70 patients had an ILR implanted; 49 of 70 patients were eligible for evaluation of data at 3-month follow-up. The ratio of incoming/expected data transmission was 12/49 (24%). The mean ± SD time spent with ILR-related issues during hospital stay was 88 ± 19 minutes. Assessment of incoming data and information of the patient and the general practitioner took 132 ± 13 minutes per patient. Overall, a mean ± SD of 220 ± 16 minutes per patient was needed for appropriate data acquisition, from implantation to first data transmission. CONCLUSIONS: In the patients having an ILR after surgical atrial ablation, initial compliance regarding data transmission was low. A substantial time effort was necessary to obtain sufficient data on cardiac rhythm. Device-related complications were observed. Patient selection should therefore be handled with care. Beneficial therapeutic decisions can be expected only when reliable data are obtained by efficient management.