Objective: There is no evidence-based regime for postprocedural antiplatelet and anticoagulation therapy after TAVI. The aim of this study was to evaluate and describe postprocedural bleeding and thrombembolic events after TAVI.

Objectives: Transcatheter aortic valve implantation (TAVI) is an alternative to surgical valve replacement in high risk patients and has become standard of care in inoperable patients with severe aortic stenosis. Complications of TAVI such as paravalvular regurgitation have significant impact on outcomes including mortality and morbidity. The investigational Engager system allows for anatomically-correct fixation and orientation of the bioprosthesis within the aortic annulus by capturing the native leaflets, supported by tactile feedback during implantation thereby mitigating the risk of paravalvular regurgitation. The objectives of this study were to evaluate the safety and performance of the Engager system in patients with severe aortic valve stenosis at high risk for SAVR.

Within the last 5 years, the number of transcatheter aortic valve implantation (TAVI) procedures has increased continuously and, in parallel, the indications for TAVI have expanded (eg, failing surgical valves and rings). Furthermore, alternative TAVI access routes such as transaxillary and transaortic have been applied successfully. We report on, to our knowledge, the first-in-human case of a combined off-pump antegrade transatrial implantation of a transcatheter valve within a mitral and tricuspid annuloplasty ring through an anterolateral minithoracotomy. The patient showed severe mitral valve and tricuspid valve stenosis and regurgitation 15 years after mitral valve repair and 7 years after aortic valve replacement and tricuspid valve repair. (Ann Thorac Surg 2013;95:e25-7) (C) 2013 by The Society of Thoracic Surgeons

Background. Aortic valve repair is associated with fewer long-term valve-related complications as compared with valve replacement, and repair is being performed increasingly. A current problem is the lack of a geometric annuloplasty ring to facilitate reconstruction. This paper describes the first clinical application of such a device designed to permanently restore physiologic annular size and geometry during aortic valve repair.Methods. Based on mathematical studies of human cadaver valves, as well as computed tomography angiographic analyses of awake patients with normal valves, a three-dimensional annuloplasty ring has been developed, consisting of low-profile, one-piece titanium construction and Dacron cloth covering. The ring design incorporates 2:3 elliptical base geometry and 10-degree outwardly flaring subcommissural posts.Results. Appropriately sized rings were implanted in 5 patients with severe aortic insufficiency due to annular dilation and anatomic leaflet defects. The rings restored annular geometry and facilitated leaflet repairs in all patients. Each recovered excellent valve function with minimal residual leak. All patients convalesced uneventfully, were discharged within 7 days after surgery, and continue with stable valve function as long as 6 months after implantation.Conclusions. Initial clinical application of a geometric aortic annuloplasty ring was associated with excellent device performance and perhaps better repairs. Further clinical series and patient follow-up should identify potential benefits of the device, including improved applicability and stability of aortic valve repair. (Ann Thorac Surg 2013;95:94-7) (C) 2013 by The Society of Thoracic Surgeons

Objective: As to date transcatheter aortic valve replacement is reserverd for patients with an exceptional high risk for surgical aortic valve replacement (SAVR).

Objectives The purpose of this study was to investigate the evolution of patient selection criteria for transcatheter aortic valve implantation (TAVI) and its impact on clinical outcomes.Background Anecdotal evidence suggests that patient selection for TAVI is shifting toward lower surgical risk patients. The extent of this shift and its impact on clinical outcomes, however, are currently unknown.Methods We conducted a single-center study that subcategorized TAVI patients into quartiles (Q1 to Q4) defined by enrollment date. These subgroups were subsequently examined for differences in baseline characteristics and 30-day and 6-month mortality rate. The relationship between quartiles and mortality rate was examined using unadjusted and adjusted (for baseline characteristics) Cox proportional hazard models.Results Each quartile included 105 patients (n = 420). Compared with Q4 patients, Q1 patients had higher logistic Euro-SCORES (25.4 +/- 16.1% vs. 17.8 +/- 12.0%, p < 0.001), higher Society of Thoracic Surgeons scores (7.1 +/- 5.5% vs. 4.8 +/- 2.6%, p > 0.001), and higher median N-terminal pro-B-type natriuretic peptide levels (3,495 vs. 1,730 ng/dl, p < 0.046). From Q1 to Q4, the crude 30-day and 6-month mortality rate decreased significantly from 11.4% to 3.8% (unadjusted hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.11 to 1.01; p = 0.053) and from 23.5% to 12.4% (unadjusted HR: 0.49; 95 CI: 0.25 to 0.95; p = 0.07), respectively. After adjustment for baseline characteristics, there were no significant differences between Q1 and Q4 in 30-day mortality rate (adjusted HR ratio: 0.29; 95% CI: 0.08 to 1.08; p = 0.07) and 6-month mortality rate (HR: 0.67; 95% CI: 0.25 to 1.77; p = 0.42).Conclusions The results of this study demonstrate an important paradigm shift toward the selection of lower surgical risk patients for TAVI. Significantly better clinical outcomes can be expected in lower than in higher surgical risk patients undergoing TAVI. (J Am Coll Cardiol 2012;59:280-7) (C) 2012 by the American College of Cardiology Foundation

Objective: Various devices have been proposed for ring annuloplasty in patients with mitral valve disease. This study reports for the first time early results with the novel, rigid saddle-shaped Medtronic Profile 3D® annuloplasty ring which is supposed to preserve the 3-dimensional annular saddle-shape.

Background: There is growing evidence that paravalvular regurgitation after transcatheter aortic valve implantation impairs long-term survival. We aimed to identify CTderived parameters associated with postprocedural regurgitation. Methods: One hundred and forty-three preprocedural computed tomography data sets of patients who had undergone CoreValve (Medtronic, Inc.) implantation with the 26mm (n 58) and the 29mm (n 85) prosthesis between 06/2007 and 09/2010 were analysed retrospectively. The ellipticity of the aortic annulus was defined as the ratio of the maximum and minimum diameter. Annulus size was measured by perimeter and area. The degree of calcifications in the three sinuses was assessed. Prosthesis-annulus oversizing was calculated by the perimeter of the prosthesis in relation to annulus perimeter. The degree of aortic regurgitation and depth of prosthesis implantation was assessed from the intraprocedural angiography. Results: Thirty-eight patients (26.6%) had an angiographic AI °I. The t-test revealed a significantly larger perimeter (82.1 8.6mm vs 78.8 6.9mm, p 0.037) and annulus area (5.2 1.1cm vs 4.7 0.8cm, p 0.031), a significantly higher degree of calcification of the right, left and non-coronary cusp (total calcium 1222 794 vs 699 493, p 0.001), and significantly less oversizing (6.1 7.4% vs 11.5 7.6%, p 0.001) in patients with an AI °I, while the ellipticity of the annulus and implantation depth were not associated with AI. Regression analysis revealed calcification of the left coronary cusp (p 0.020) and less oversizing (p 0.014) as significant independent predictors for an AI °I. Kaplan Meier survival analysis showed an insignificant trend towards a better 1-year survival in patients with an AI °I (83.0% vs 77.5%, p 0.118). Conclusions: Aortic regurgitation after transcatheter valve implantation can be predicted by CT measurements. Our data support the evidence of impaired survival in patients with an AI larger than grade I. As a large annulus anatomy and amount of calcification are unmodifiable variables more valve sizes might be needed to better fit all anatomies. According to our data, an oversizing of at least 10% should be attempted for CoreValve implantation.

Objectives: Aortic stenosis patients with left ventricular dysfunction are at increased risk for morbidity and mortality following surgical aortic valve replacement. There is little published data regarding the outcomes of patients with severe aortic stenosis and left ventricular (LV) dysfunction undergoing transcatheter aortic valve implantation (TAVI). Aim is to compare the clinical outcomes between patients with normal and abnormal LV function undergoing TAVI.

Background. The impact of atrioventricular valve regurgitation in patients who undergo transcatheter aortic valve implantation (TAVI) is not known. We examined the clinical outcome after TAVI in patients with moderate or more severe concomitant mitral or tricuspid regurgitation (TR).Methods. Two hundred sixty-eight consecutive patients who underwent TAVI at our institution since July 2007 were enrolled in this study. Patients had preoperative echocardiographic assessment of aortic stenosis and concomitant valve disease. At 6 months and 1 year, survival, New York Heart Association (NYHA) functional status, self-assessed state of health, and severity of mitral regurgitation (MR) and tricuspid regurgitation (TR) were assessed.Results. Preoperatively, 22.4% of patients (60/268) had moderate or more severe MR, 20.1% (54/268) had moderate or more severe TR, and 9.3% (25/268) had moderate or more severe MR and TR. With moderate or more severe TR, 1 year all-cause mortality was significantly higher compared with that of mild or less severe TR (33.9% and 20.9%, respectively; log rank p = 0.028). With moderate or more severe MR, 1-year all-cause mortality was 30.2% compared with 21.2% in mild or less severe MR (log rank p = 0.068). Neither moderate or more severe MR nor TR emerged as an independent risk factor. At 6 months, heart failure symptoms were significantly reduced regardless of the extent of atrioventricular valve regurgitation. Sixty-seven percent of patients with moderate or more severe MR and 50% of patients with moderate or more severe TR had an improvement of valve regurgitation.Conclusions. Atrioventricular valve regurgitation is present in a subgroup of patients undergoing TAVI whose survival is impaired. The majority of surviving patients exhibit the clinical benefits of TAVI with amelioration of heart failure symptoms and a decrease in severity of atrioventricular valve regurgitation. At present, moderate or more severe atrioventricular valve regurgitation cannot be considered a contraindication for TAVI. (Ann Thorac Surg 2013;95:77-84) (C) 2013 by The Society of Thoracic Surgeons

Sabine Bleiziffer, Nicolo Piazza, Domenico Mazzitelli, Andrea Hutter, Anke Opitz, Hendrik Ruge, Robert Bauernschmitt, Rüdiger Lange. German Heart Center, Munich, Germany. Objective: To review our single-center experience with more than 500 patients receiving transcatheter aortic valve implantation (TAVI) over three years. Methods: From June 2007 to December 2010, 512 patients underwent TAVI through different access sites by the same interdisciplinary team. Statistical analysis was performed by dividing the patients into first, second and third tertial of experience. Results: 30-day and 6-month survival improved over time, though not significant. Access site selection changed significantly with a decrease of transfemoral implantation and an increase of other access sites like subclavian artery access (p 0.001). The cumulative incidence of intraand peri-procedural complications (conversion to SAVR, valve malplacement, stroke, vascular complications, pericardial tamponade, and myocardial infarction) could be reduced significantly in the third tertial of patients. Patient selection changed with a trend towards mid-risk patients. The data are summarized in Table 1. Conclusions: With growing experience, the selection and decision making processes for TAVI could be optimized, resulting in an improved survival and a reduction of complications. Demonstrating the increasing safety of the procedures, we believe TAVI can be offered to a broader patient population in the future.

OBJECTIVES:This study sought to review the acute procedural outcomes of patients who underwent transcatheter aortic valve (TAV)-in-surgical aortic valve (SAV) implantation at the German Heart Center, Munich, and to summarize the existing literature on TAV-in-SAV implantation (n = 47). BACKGROUND:There are several case reports and small case series describing transcatheter aortic valve implantation for a failing surgical aortic valve bioprosthesis (TAV-in-SAV implantation). METHODS:From January 2007 to March 2011, 20 out of 556 patients underwent a TAV-in-SAV implantation at the German Heart Center Munich. Baseline characteristics and clinical outcome data were prospectively entered into a dedicated database. RESULTS:The mean patient age was 75 ± 13 years, and the mean logistic European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons' Risk Model scores were 27 ± 13% and 7 ± 4%, respectively. Of the 20 patients, 14 had stented and 6 had stentless surgical bioprostheses. Most cases (12 of 20) were performed via the transapical route using a 23-mm Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, California). Successful implantation of a TAV in a SAV with the patient leaving the catheterization laboratory alive was achieved in 18 of 20 patients. The mean transaortic valve gradient was 20.0 ± 7.5 mm Hg. None-to-trivial, mild, and mild-to-moderate paravalvular aortic regurgitation was observed in 10, 6, and 2 patients, respectively. We experienced 1 intraprocedural death following pre-implant balloon aortic valvuloplasty ("stone heart") and 2 further in-hospital deaths due to myocardial infarction. CONCLUSIONS:TAV-in-SAV implantation is a safe and feasible treatment for high-risk patients with failing aortic bioprosthetic valves and should be considered as part of the armamentarium in the treatment of aortic bioprosthetic valve failure.

Objective: The left-ventricular trans-apical access has become well established for trans-catheter aortic valve implantation, especially for patients in whom a retrograde trans-arterial implantation is contraindicated. We report on the short- and long-term implications of the apical-access-site-specific complications. Methods: Between June 2007 and August 2010, 143 patients were scheduled for trans-apical aortic valve implantation (mean age 80 ± 6 years, n = 116 females, mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) 21 ± 13%). The patients are followed up at 30 days, 6 months, and then annually. Results: Severe apical bleeding complications occurred in 10 patients (7%). In three of these patients, the procedure was terminated, and no valve was implanted. In the remaining, the bleeding was controlled with cardiopulmonary bypass support (n = 3), via median sternotomy (n = 1), or both (n = 1) ± later re-exploration. Two additional patients required postprocedural re-exploration for apical bleeding. An apical pseudo-aneurysm developed in two patients (2%), one of whom was treated by surgical revision. Survival was significantly impaired when either apical bleeding, aneurysm, or re-exploration occurred (75% ± 0.082 survival at 30 days and 59% ± 0.122 at 1 year vs 94% ± 0.023 and 80% ± 0.043 in patients without apical complications, p = 0.012). Twelve patients (8%) experienced secondary wound healing. An apical hypo- or akinesia was detected in 18/54 (33%) patients at 6 months’ echocardiographic investigation, and in 11/30 (37%) 1 year after the procedure. Conclusions: The trans-apical access for trans-catheter aortic valve implantation might be challenging in elderly patients with fragile tissue. Severe bleeding complications or aneurysm formation significantly impairs survival. The clinical impact of subsequent apical hypo- or akinesia has to be further followed up.

OBJECTIVE:Although the procedural feasibility of transcatheter aortic valve implantation has been shown by multiple groups, longer-term data are rare. We report on 2-year follow-up clinical and echocardiographic results after transcatheter aortic valve implantation in 227 patients. METHODS:Patients' mean age was 81 ± 7 years, 59% were female, mean European System for Cardiac Operative Risk Evaluation was 21% ± 14%, mean Society of Thoracic Surgeons score was 7% ± 5%, and access routes were transfemoral (n = 164), transapical (n = 54), axillary (n = 5), or transaortic (n = 4). A CoreValve (Medtronic Inc, Minneapolis, Minn) prosthesis was implanted in 174 patients, and a SAPIEN prosthesis (Edwards Lifesciences, Irvine, Calif) was implanted in 53 patients. Clinical and echocardiographic investigations were performed at 6 months, 1 year, and 2 years. RESULTS:Survival was 88.5% at 30 days, 75.9% at 6 months, 74.5% at 1 year, and 64.4% at 2 years. Patients improved significantly in New York Heart Association class after 6 months (from 3.2 ± 0.5 to 1.7 ± 0.7, P < .001) and up to 2 years (1.9 ± 0.7). Cumulative incidences of myocardial infarction, stroke, and life-threatening or major bleeding were 2.7%, 6.2%, and 16.2% at 2 years, respectively. The postprocedural mean transprosthetic gradient was 12 ± 4 mm Hg for all valves and did not change up to 2 years, and the effective orifice area was 1.5 ± 0.4 cm² with no change over 2 years of follow-up. Moderate or severe prosthetic regurgitation was present in 8% of patients at 2 years. In 6% of patients, the paravalvular or valvular regurgitation grade increased significantly over time. CONCLUSIONS:With excellent functional recovery of the patients, good systolic valve function, and overall low morbidity at 2 years, transcatheter aortic valve implantation may be considered the treatment of choice for aortic valve stenosis in elderly patients with an increased risk for surgery with a heart-lung machine.

Background Acute kidney injury (AKI) can occur in up to one third of patients after surgical aortic valve replacement and can be associated with increased mortality. Little data exist, however, about the incidence, predictors, and prognostic implications of AKI after transcatheter aortic valve implantation (TAVI).Objectives The aim of this study was to examine the incidence, predictors, and prognostic implications of AKI after TAVI.Methods Between January 2007 and January 2010, we prospectively enrolled 234 consecutive patients who underwent TAVI with the Medtronic CoreValve System (Medtronic CoreValve, Minneapolis, Minnesota) or Edwards SAPIEN (Edwards Lifesciences, Inc, Irvine, CA) heart valve. Acute kidney injury was defined according to the risk, injury, failure, loss, end-stage criteria. Patients with preoperative end-stage renal failure requiring dialysis were excluded. Baseline characteristics and procedural-related factors were examined as predictors for AKI in a multivariable regression model.Results Acute kidney injury was identified in 46 (19.6%) of 234 patients, and 24 (10.3%) of 234 patients required renal replacement therapy. The unadjusted in-hospital mortality rate was 15.2% in those patients without AKI and 7.7% in those with AKI (P = .015). Univariable logistic regression analysis identified preoperative serum creatinine, preoperative blood urea nitrogen, peripheral vascular disease, and blood transfusion to be associated with AKI. Preoperative serum creatinine level remained as the only independent predictor of AKI (OR 3.7 95%, CI 1.24-11.3, P = .019). The amount of contrast used (in milliliters) was not associated with AKI (OR 1.8 95%, CI 0.94-3.5, P = .07).Conclusion In this study, we observed that one fifth of patients developed AKI after TAVI and that AKI was associated with increased in-hospital mortality. Preoperative serum creatinine level was identified as the only predictor of AKI. (Am Heart J 2011; 161: 735-9.)