Epicardial and endocardial surgical ablation of atrial fibrillation: outcomes from CASE-AF Registry.

OBJECTIVES: The German CArdioSurgEry Atrial Fibrillation Registry is a prospective, multicentric registry analysing outcomes of patients undergoing surgical ablation for atrial fibrillation as concomitant or stand-alone procedures. This data sub-analysis of the German CArdioSurgEry Atrial Fibrillation Registry aims to describe the in-hospital and 1-year outcomes after concomitant surgical ablation, based on 2 different ablation approaches, epicardial and endocardial surgical ablation. METHODS: Between January 2017 and April 2020, 17 German cardiosurgical units enrolled 763 consecutive patients after concomitant surgical ablation. In the epicardial group, 413 patients (54.1%), 95.6% underwent radiofrequency ablation. In the endocardial group, 350 patients (45.9%), 97.7% underwent cryoablation. 61.5% of patients in the epicardial group and 49.4% of patients in the endocardial group presenting with paroxysmal atrial fibrillation. Pre-, intra- and post-operative data were gathered. RESULTS: Upon discharge, 32.3% (n = 109) of patients after epicardial surgical ablation and 24.0% (n = 72) of patients after endocardial surgical ablation showed recurrence of atrial fibrillation. The in-hospital mortality rate was low, 2.2% (n = 9) in the epicardial and 2.9% (n = 10) in the endocardial group. The overall 1-year procedural success rate was 58.4% in the epicardial and 62.2% in the endocardial group, with significant symptom improvement in both groups. The 1-year mortality rate was 7.7% (n = 30) in epicardial and 5.0% (n = 17) in the endocardial group. CONCLUSIONS: Concomitant surgical ablation is safe and effective with significant improvement in patient symptoms and freedom from atrial fibrillation. Adequate cardiac rhythm monitoring should be prioritized for higher quality data acquisition.

Surgical ablation of long-standing persistent atrial fibrillation: 1-year outcomes from the CArdioSurgEry Atrial Fibrillation (CASE-AF) registry.

OBJECTIVES: The CArdioSurgEry Atrial Fibrillation (CASE-AF) registry is a prospective, multicentre study for collecting and analysing real-world data of surgical atrial fibrillation (AF) treatment. This study aimed to evaluate outcomes of surgery for long-standing persistent AF at 1 year. METHODS: In total, 17 centres consecutively include all eligible patients with continuous AF lasting for ≥1 year. Exclusion criteria are missing informed consent or age <18 years. For patient-reported outcomes measures, the European Heart Rhythm Association score was used. No presence of AF (based on ECG findings including Holter ECG and/or implanted devices), no re-ablation, no further cardioversion and no rehospitalization due to AF after a 3-month blanking period defined no AF recurrence at 1 year. RESULTS: From January 2017 to January 2020, a total of 1115 patients were enrolled in CASE-AF. Of them, 202 patients (mean age 69.7 ± 7.8 years, 27.2% female) underwent surgical ablation of long-standing persistent AF (study cohort), mostly accompanied by left atrial appendage closure (n = 180 [89%], resection n = 75 [42%]) and predominantly performed as concomitant (n = 174 [86%]) and left atrial only procedure (n = 144 [71%]). Early mortality (30 days) was 2.0% and morbidity was low. At follow-up (median 14.4 months, interquartile range, 12.7-17.6 months, 100% complete), 106 patients (56%) had no AF recurrence and 93% of them were asymptomatic. AF recurrence was accompanied by AF-related rehospitalization (n = 12, P = 0.003), direct current shock cardioversion (n = 23, P < 0.001), AF ablation (n = 7, P = 0.003) and stroke (n = 3, P = 0.059). Multivariable analysis identified cryoablation, predominantly performed endocardially including additional left atrial (74%) and biatrial (42%) lesions, as a significant factor for freedom from AF recurrence (odds ratio 2.7, 95% confidence interval 1.07-6.79, P = 0.035). CONCLUSIONS: According to CASE-AF, surgical ablation of long-standing persistent AF is most effective when concomitantly performed using endocardial cryoablation. Ongoing follow-up allows further elucidation of efficacious treatment strategies.

Transcatheter mitral valve implantation versus conventional redo surgery for degenerated mitral valve prostheses and rings in a multicenter registry.

OBJECTIVES: Degeneration of mitral prostheses/rings may be treated by redo surgery, and, recently, by transcatheter valve-in-valve/ring implantation. This multicenter registry presents results of transcatheter valve-in-valve and repeat surgery for prostheses/rings degeneration. METHODS: Data provided by 10 German heart centers underwent propensity score-matched retrospective analysis. The primary endpoint was 30-day/midterm mortality. Perioperative outcome was assessed according to the Mitral Valve Academic Research Consortium criteria. Further, the influence of moderate or greater tricuspid regurgitation (TR) on 30-day/midterm mortality was analyzed. RESULTS: Between 2014 and 2019, 273 patients (79 transcatheter mitral valve-in-valve [TM-ViV] and 194 redo mitral valve replacement [Re-MVR]) underwent repeat procedure for mitral prosthesis/ring degeneration. Propensity score matching distinguished 79 patient pairs. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II-predicted risk was 15.7 ± 13.7% in the TM-ViV group and 15.0% ± 12.7% in the Re-MVR group (P = .5336). TM-ViV patients were older (74.73 vs 72.2 years; P = .0030) and had higher incidence of atrial fibrillation (54 vs 40 patients; P = .0233). Severe TR incidence was similar (17.95% in TM-ViV vs 14.10%; P = .1741). Sixty-eight TM-ViV patients previously underwent mitral valve replacement, whereas 41 Re-MVR patients underwent valve repair (P < .0001). Stenosis was the leading degeneration mechanism in 42 TM-ViV versus 22 Re-MVR patients (P < .0005). The 30-day/midterm mortality did not differ between groups. Moderate or greater TR was a predictor of total (odds ratio [OR], 4.36; P = .0011), 30-day (OR, 3.76; P = .0180), and midterm mortality (OR, 4.30; P = .0378), irrespective of group. CONCLUSIONS: In both groups, observed mortality was less than predicted. Redo surgery enabled treatment of concomitant conditions, such as atrial fibrillation or TR. TR was shown to be a predictor of total, 30-day, and midterm mortality in both groups.

Surgery for infective endocarditis following low-intermediate risk transcatheter aortic valve replacement-a multicentre experience.

OBJECTIVES: With the expansion of transcatheter aortic valve replacement (TAVR) into intermediate and low risk, the number of TAVR procedures is bound to rise and along with it the number of cases of infective endocarditis following TAVR (TIE). The aim of this study was to review a multicentre experience of patients undergoing surgical intervention for TIE and to analyse the underlying indications and operative results. METHODS: We retrospectively identified and analysed 69 patients who underwent cardiac surgery due to TIE at 9 cardiac surgical departments across Germany. The primary outcome was operative mortality, 6-month and 1-year survival. RESULTS: Median age was 78 years (72-81) and 48(69.6%) were male. The median time to surgical aortic valve replacement was 14 months (5-24) after TAVR, with 32 patients (46.4%) being diagnosed with early TIE. Cardiac reoperations were performed in 17% of patients and 33% underwent concomitant mitral valve surgery. The main causative organisms were: Enterococcus faecalis (31.9%), coagulase-negative Staphylococcus spp. (26.1%), Methicillin-sensitive Staphylococcus aureus (15.9%) and viridians group streptococci (14.5%). Extracorporeal life support was required in 2 patients (2.9%) for a median duration of 3 days. Postoperative adverse cerebrovascular events were observed in 13 patients (18.9%). Postoperatively, 9 patients (13.0%) required a pacemaker and 33 patients (47.8%) needed temporary renal replacement therapy. Survival to discharge was 88.4% and survival at 6 months and 1 year was found to be 68% and 53%, respectively. CONCLUSIONS: Our results suggest that TIE can be treated according to the guidelines for prosthetic valve endocarditis, namely with early surgery. Surgery for TIE is associated with acceptable morbidity and mortality rates. Surgery should be discussed liberally as a treatment option in patients with TIE by the 'endocarditis team' in referral centres.

Fluorescence in situ hybridization for identification and visualization of microorganisms in infected heart valve tissue as addition to standard diagnostic tests improves diagnosis of endocarditis.

OBJECTIVES: In infective endocarditis (IE), identification of the causative organism and consecutive treatment are crucial for patient survival. Although the macroscopic aspect resembles infected tissue, standard diagnostic tests often fail to allow one to identify bacteria. Fluorescence in situ hybridization (FISH) is a molecular, culture-independent technique that allows one to identify and visualize microorganisms within tissue and to recognize their morphology, number and activity. We analysed the diagnostic benefit of FISH/polymerase chain reaction (PCR) by comparing its results to those of standard diagnostic tests. METHODS: From September 2015 to April 2018, 128 patients underwent first-time or redo valve surgery to treat IE. Patients were designated according to the modified Duke criteria as definite (n = 61), possible (n = 34) or rejected (n = 33) IE. Tissue specimens obtained intraoperatively were analysed using FISH/PCR in addition to undergoing standard diagnostic testing and PCR alone. RESULTS: We used blood cultures to detect microorganisms in 67/128 patients; valve cultures, in 34/128; PCR, in 67/128; histopathological diagnosis showed IE in 72/128 cases. We were able to detect microorganisms in 103/128 cases using FISH/PCR, with 55/61 in definite IE. Furthermore, we were able to identify 26 cases of bacterial biofilm using FISH/PCR, despite antibiotic treatment of 61 in the definite, 13 in the possible and 1 in the rejected group, including 8/33 patients in the rejected group with active bacteria. In all cases, the patient's therapy was altered. CONCLUSIONS: FISH/PCR was used to identify microorganisms in cases in which standard diagnostic tests failed to provide sufficient results for various reasons. Furthermore, FISH/PCR enabled us to identify bacterial biofilms and to differentiate between active versus degraded bacteria, thus indicating the impact of treatment. Therefore, we suggest FISH/PCR as an additional diagnostic tool in IE alongside standard diagnostic tests.

Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE†.

OBJECTIVES: There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI. METHODS: The Registry of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, European, prospective, observational registry of aortic stenosis patients undergoing TAo-TAVI. Patients were grouped according to the composite end point death, myocardial infarction, stroke/transient ischaemic attack, major vascular complications, life-threatening bleeding, acute kidney injury (AKI) and/or cardiovascular rehospitalization. RESULTS: Two hundred and fifty-three patients with a mean age of 81.5 ± 5.8 years were included, of whom 89 (35.2%) patients met the composite end point (the event group) and 164 (64.8%) patients did not (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal insufficiency (15.7% vs 3.0%; P < 0.001) were more common in the event group. At 1 year, the most common event was death (19.1%), followed by AKI stage II or III (14.7%). The baseline renal insufficiency was the strongest independent predictor of composite end point achievement [odds ratio (OR) 7.55, 95% confidence interval (CI) 2.33-24.56], followed by NYHA class III/IV (OR 2.316, 95% CI 1.06-5.06) and pulmonary disease (OR 2.91, 95% CI 1.45-5.85). Pulmonary disease was also an independent predictor of 1-year mortality (OR 3.01, 95% CI 1.34-6.75). CONCLUSIONS: Long-term outcomes after TAo-TAVI appear to be similar to those for TAVI via other non-transfemoral access routes. Awareness of characteristics associated with poorer outcomes may aid patient selection and identification of those requiring closer post-procedural monitoring. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT01991431.

Early Degeneration Caused by Cusp Tear of First-Generation Trifecta Bioprosthesis.

The Trifecta aortic valve has excellent hemodynamic performance as result of an expansive valve design with a bovine pericardial sheet externally mounted on a titanium stent. We report 2 cases of early Trifecta valve degeneration, both caused by partial rupture of one of the leaflet cusps 3 and 4 years post-implant. Post discharge, both patients had routinely performed echocardiography check-ups, without signs of valve failure. Transesophageal echocardiography performed during emergency hospital readmission due to severe dyspnea revealed transvalvular aortic regurgitation without signs of endocarditis. Urgent redo-surgery was successful in both cases, replacing the Trifecta prosthesis with a different bovine bioprosthesis.

Balloon-expandable transaortic transcatheter aortic valve implantation with or without predilation.

OBJECTIVE: It has been reported that balloon aortic valvuloplasty immediately before transfemoral or transapical transcatheter aortic valve implantation has mostly little to no clinical value. We aimed to provide data on the need for balloon aortic valvuloplasty in patients undergoing transaortic transcatheter aortic valve implantation. METHODS: Patients undergoing transaortic transcatheter aortic valve implantation with the Edwards SAPIEN XT (Nyon, Switzerland) or 3 transcatheter heart valve were prospectively included at 18 sites across Europe. In the present analysis, we compare the periprocedural and 30-day outcomes of patients undergoing conventional (+ balloon aortic valvuloplasty) versus direct (- balloon aortic valvuloplasty) transaortic transcatheter aortic valve implantation. RESULTS: Of the 300 patients enrolled, 222 underwent conventional and 78 underwent direct transaortic transcatheter aortic valve implantation. Peak and mean transvalvular gradients were improved in both groups with no significant difference between groups. Procedural duration, contrast agent volume, and requirement for postdilation were also comparable. A trend toward fewer periprocedural complications was evident in the direct group (3.9% vs 11.3%; P = .053), with significantly lower rates of permanent pacemaker implantation (0% vs 5.0%; P = .034). Balloon aortic valvuloplasty omission had no significant effect on any of the 30-day safety and efficacy outcomes, including Valve Academic Research Consortium-2 composite end points (early safety events: 22.7% vs 17.4%, odds ratio, 1.17, 95% confidence interval, 0.53-2.62; clinical efficacy events: 20.5% vs 18.7%, odds ratio, 1.14, 95% confidence interval, 0.51-2.55). CONCLUSIONS: For many patients, balloon aortic valvuloplasty predilation seems to have little clinical value in transaortic transcatheter aortic valve implantation using a balloon expandable transcatheter valve and may result in a higher rate of periprocedural complications, particularly in terms of permanent pacemaker implantation.

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.

Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry.

OBJECTIVES: Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information. METHODS: ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed. RESULTS: Of the 301 patients included, 126 (41.9%) received a SAPIEN 3 and 175 (58.1%) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P < 0.001). Balloon dilation was performed less often before (68.0% vs 78.3%; P = 0.045) and after implantation (13.6% vs 30.1%; P = 0.001). No statistically significant differences between the valve types were documented for overall (4.1% SAPIEN 3 vs 7.6% SAPIEN XT; P = 0.21), TAVI-related (0.8% vs 4.7%; P = 0.084) and cardiovascular mortality (2.4% vs 5.9%; P = 0.158). Major vascular complications were less frequent (0.8% vs 5.3%; P = 0.049), and there was a lower rate of moderate-to-severe paravalvular regurgitation (0.8% vs 5.1%; P = 0.050) in the SAPIEN 3 group. CONCLUSIONS: Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis. ClinicalTrials.gov Identifier: NCT01991431.

Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry.

OBJECTIVES: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice. METHODS: ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points. RESULTS: Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P = 0.46 and 1% vs. 3%, P = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥ moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% ( P = 0.76), rates of stroke 2% vs. 0% ( P = 0.24), pacemaker implantation (11% vs. 4%, P = 0.093), and life-threatening bleeding 4% vs. 3% ( P = 0.70). Valve safety (both 85%, P = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups. CONCLUSIONS: Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation. CLINICALTRIALS.GOV: NCT01991431.

14-Year Results of Bilateral versus Single Internal Thoracic Artery Grafts for Left-Sided Myocardial Revascularization in Young Diabetic Patients.

Objectives Despite encouraging late outcomes, the use of bilateral internal thoracic artery (BITA) grafting for myocardial revascularization in diabetic patients remains controversial because of an increased risk of sternal wound complications. In the present study, early- and long-term outcomes of the use of left-sided BITA versus single internal thoracic artery (SITA) grafting in young (< 65 years of age) diabetic patients were reviewed retrospectively. Methods A total of 250 propensity score pair-matched diabetic patients, operated on between February 2000 and December 2011, receiving either BITA (n = 125) or SITA (n = 125) grafting were analyzed retrospectively. In each group, 104 patients were males, and mean age was 60.1 ± 5.3 years. Follow-up was 2.1 to 14.8 years (mean, 9.3 ± 3.5 years) and complete for 100%. Results Incidence of deep sternal wound infection was 2.4 versus 3.2% (p = 0.722). Rethoracotomy due to bleeding occurred in 4.8 versus 3.2% (p = 0.608). The 5-, 10-, and 14-year estimates of survival were 93.4, 76.6, and 67.5% (BITA) versus 89.5, 81.5, and 32.8% (SITA); p = 0.288. Freedom from reangiography/intervention (60.5 vs. 63.9%) during follow-up was comparable (p = 0.507) as well as infarction rate (93.8 vs. 95.1%, p = 0.833) and redoes (p = 0.672, exclusively valve surgery) were comparable. Freedom from thromboembolic or cerebrovascular events did not show any significant differences (94.0 vs. 94.0%, p = 0.78). Multivariate analysis identified poor ejection fraction as predictor for decreased long-term survival. Neither age nor gender or urgency had an influence on long-term mortality. Conclusion Left-sided BITA grafting may be performed routinely even in diabetic patients without increased incidence of postoperative wound-healing complications. Survival rates after 5, 10, and 14 years were comparable for BITA and SITA grafting.

Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry.

OBJECTIVES: The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431). BACKGROUND: TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published. METHODS: ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates. RESULTS: A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation. CONCLUSIONS: TAo access for TAVR seems to be a safe alternative to the transapical procedure.

The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis.

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR. METHODS: The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions. RESULTS: The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation. CONCLUSIONS: In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia obstruction, annular rupture or with limited aortic valve calcification, the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-expanding stent.

Does Bilateral ITA Grafting Increase Perioperative Complications? Outcome of 6,476 Patients with Bilateral versus 5,020 Patients with Single ITA Bypass.

OBJECTIVES: Despite the superior patency of internal thoracic artery (ITA) grafting compared with saphenous veins, frequency of bilateral ITA (BITA) grafting in Europe is still approximately 10%. The aim of the present study was to compare the early outcome of patients receiving either BITA or single ITA (SITA) grafting. METHODS: A total of 11,496 patients with isolated coronary artery bypass grafting (CABG), operated between January 1996 and December 2012, were analyzed retrospectively; 0.6476 patients (mean age 65.2 years, 81.3% males) received BITA and 5,020 patients (mean age 66.6 years, 76.7% males) SITA grafting. Mean body mass index (BMI) was 27.2 versus 27.4, p = 0.017. Incidence of diabetes was 28.9 versus 28.4%, p = 0.08. Ejection fraction (EF) > 50 was 71.3% (BITA) versus 66.3% (SITA), p < 0.001. Elective operations were performed in 88.4% (BITA) versus 83.3% (SITA), and urgent/emergent surgery was necessary in 11.6% (BITA) versus 16.7% (SITA), p < 0.001. RESULTS: Number of grafts was 3.76 (BITA) versus 3.06, p < 0.001. Duration of surgery (194.4 vs. 180.4 minutes) as well as X-clamp time (60.4 vs. 51.7 minutes) was prolonged for BITA, p < 0.001. Perioperative infarction rate revealed 3.2% (BITA) versus 3.6%, p = 0.54. Frequency of rethoracotomy due to bleeding was higher in the BITA group (3.8 vs. 2.1%), p < 0.001. Sternal instabilities occurred in 2.3% (BITA) versus 2.2%, p = 0.749. Duration of mechanical ventilation < 12 hours was 74.6 versus 77.1%, p = 0.09 and duration of in-hospital stay was 10.5 versus 10.4 days, p = 0.68. Thirty-day mortality was 2.4% (BITA) versus 3.0%, p = 0.09. Multivariate analysis identified prolonged duration of surgery, BMI > 30, emergent operations, advanced age, and BITA grafting as predictor for sternal instabilities. EF < 30%, advanced age plus emergency were associated with increased 30-day mortality. CONCLUSION: CABG using BITA can be performed routinely with good clinical results and low mortality. Compared with SITA grafting, bleeding complications were enhanced.

"Blame it on the Comorbidities": A 5-Year Follow-Up of 53 Chronic Dialysis-Dependent Patients Who Underwent Cardiac Surgery.

Objectives This study evaluates midterm survival rates and risk factors for mortality of chronic dialysis-dependent patients undergoing cardiac surgery. Methods Fifty-three dialysis-dependent patients (34 males, aged 67 ± 12 years) with end-stage renal disease operated within March 2007 and May 2012 were analyzed retrospectively. Survival rates were calculated using Kaplan-Meier methods. Predictors of midterm survival were identified with multivariate Cox-regression analysis. Results Twenty-three patients received isolated coronary artery bypass graft surgery, 17 received isolated valve replacement, and 13 received combined procedures. Thirty-day mortality was 24.5% (n = 13). Follow-up was complete for 94.3% (n = 50). Survival rates at 1, 3, and 5 years were: 82, 50, and 17%, respectively. Neither age, gender, poor ejection fraction, emergency, ECC/X-clamp (cross-clamp) time, nor use of left internal thoracic artery or right internal thoracic artery had any influence on midterm survival. Causes of death within midterm follow-up period were related to cardiac events in 16% and neurological events in 16%. In the majority (47%), cause of death was associated with peripheral arterial disease (PAD).The only comorbidity, which could be identified as a significant risk factor, was PAD (p = 0.035). Five patients underwent successful renal transplantation within the follow-up period. Conclusion Although 30-day mortality in this high-risk patient population was increased, midterm survival rates were comparable to the results described in the literature. Cause of death within midterm follow-up period was mostly noncardiac related. Given the limited number of patients, predictors for enhanced 30-day mortality, such as preoperative myocardial infarction, prolonged extracorporeal circulation, operation time, and diabetes mellitus, did not have an influence on midterm survival.

Aortic Dissections Type A during Sexual Intercourse in Male Patients: Accident or Systematic Coincidence? Examination of 365 Patients with Acute Aortic Dissection within 20 Years.

OBJECTIVES: Physical exercise accompanied by arterial hypertension is known to trigger acute aortic dissections. As a booster effect, mental stress leads to aggravation of hypertensive crisis. The aim of the study was to evaluate whether stress factors during sexual intercourse play any role as a catalyst in patients with acute type A aortic dissections. Concerning this subject, only two case reports have been published. METHODS: A total of 365 patients with acute type A aortic dissections, operated between January 1993 and July 2014, were analyzed retrospectively. The main focus was to identify the provoking situation before onset of symptoms. A total of 247 patients were males and mean age was 60.2 years (range, 17.0-91.9 years). Of the total cohort, 86 patients (24%) were younger than 50 years (68 males) and 184 patients (50%) were younger than 60 years (149 males). RESULTS: The explicit trigger could not be determined in 24% of the patients. In majority of the patients, onset of symptoms occurred during physical exercises, such as sports or lifting of heavy weights (68%), without a significant difference between males and females. In only 8% of the patients, symptoms occurred at rest. In 0.9%, Marfan syndrome was evident. Eleven of 68 males < 50 years (16%) and 17 of 149 males < 60 years (11%) but none among females (p = 0.03) experienced sudden onset of symptoms during sexual intercourse. CONCLUSION: Combined physical and emotional stress during sexual intercourse seems to present a meaningful promoter effect for acute aortic dissections, especially in younger males, but not in females. Despite self-evidence of this phenomenon, frequency of this sensitive issue appears to be surprisingly high.

High-Risk Cardiac Surgery in Patients with Intravenous Drug Abuse and/or Active Hepatitis C or HIV Infection: An Ethical Discussion of Six Cases.

OBJECTIVES: To discuss the dilemma of adequate decision making in patients with intravenous drug abuse and recurrent valve prosthesis infections or in patients with positive HIV or hepatitis C status. Ethical, social, and economic considerations, not only in terms of technical feasibility but also in terms of unpromising results and aspects of resources, are discussed. Thoughts are presented about the legitimation of cardiac surgery centers refusing to perform surgery in high-risk patients with HIV or hepatitis C infections. METHODS: Presentation of six cases for discussion. Three patients were addicted to intravenous drugs and had recurrent prosthetic valve endocarditis, and the other three patients had either paravalvular leakage of a mitral valve prosthesis or acute aortic dissection or coronary artery disease. Five of these patients suffered from HIV/AIDS and infective hepatitis C. Four of these patients were refused by other centers due to high risk or a lack of capacity. RESULTS: All six patients were operated during 2013. Mortality was 17%. CONCLUSION: Decision making in noncompliant drug addicts with recurrent prosthesis infection and in HIV-positive patients leads beyond surgical challenges to ethical and economic considerations.