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The study aim was to examine the hemodynamic performance of the BioValsalva porcine aortic valve conduit in the aortic root position.Between February 2007 and April 2012, a total of 223 patients underwent aortic root replacement at the authors' institution. The BioValsalva valved conduit was implanted in 131 patients, and 86 of these patients (mean age 64.7 +/- 9.7 years) consented to participate in the present study. The parameters assessed to evaluate prosthetic valve function included mean pressure gradient (MPG) as measured by transthoracic Doppler echocardiography, and the effective orifice area (EOA) by means of the continuity equation. Hemodynamic data were obtained from all 86 patients within 10 days and six months postoperatively.The mean aortic cross-clamp time was 103 +/- 30 min. Concomitant procedures were performed in 50 patients (56.5%). Four patients developed valve dysfunction due to endocarditis, and underwent a reoperation without the need to perform a redo Bentall. The early MPG across the implanted valve was 12 +/- 4.6 mmHg (range: 4-24.8 mmHg), and the early mean EOA was 1.81 +/- 0.6 cm2 (range: 0.9-3.2 cm2). After six months the MPG was 11.6 +/- 4.6 mmHg (range: 2.2-25.5 mmHg) and the EOA was 1.69 +/- 0.43 cm2 (range: 0.8-2.6 cm2).Based on its special design with a stentless valve, which is not incorporated into the proximal suture line, the BioValsalva conduit has an advantage over intraoperatively prepared conduits in cases of reoperation. Besides simplified intraoperative handling, the BioValsalva conduit exhibits good systolic hemodynamic performance with large EOAs.

Transcatheter aortic valve implantation via transarterial or transapical access is an alternative therapy to treat high-risk patients with severe symptomatic aortic stenosis. Despite growing experience, procedural complications may still occur. We herein report an 86-year-old female patient with fatal left ventricular rupture after transapical transcatheter aortic valve implantation with an Edwards Sapien prosthesis due to severe cardiac amyloidosis.

Aortic stenosis patients with left ventricular dysfunction are at increased risk for morbidity and mortality following surgical aortic valve replacement. There are few published data regarding the outcomes of patients with severe aortic stenosis and left ventricular (LV) dysfunction undergoing transcatheter aortic valve implantation (TAVI) and possible predictors of LV recovery.To compare the baseline characteristics and outcomes between patients with normal LV function and those with LV dysfunction and to assess the predictors of LV recovery after TAVI.We enrolled 505 consecutive patients with severe aortic stenosis who underwent TAVI between November 2007 and January 2010. Patients were stratified according to LV function as follows: normal LV function (ejection fraction [EF]50%), moderate LV dysfunction (EF 35%-50%) and severe LV dysfunction (EF ≤35%). The baseline characteristics and clinical outcomes, up to 6 months, were subsequently compared among the 3 patient subgroups. Univariable and multivariable logistic regression analyses were used to identify independent predictors of LV recovery.Normal LV function was identified in 324 patients (64%) and LV dysfunction in 181 patients (36%); in those with LV dysfunction, 111 patients (22%) had moderate LV dysfunction and 70 patients (14%) had severe LV dysfunction. As compared to patients with normal LV function, those with severe LV dysfunction were more likely to be male, had higher STS and logistic EuroSCORE, more coronary artery disease/previous coronary artery bypass surgery, higher NT-proBNP levels, lower mean transaortic valve gradients, and smaller aortic valve areas. No significant difference in 30-day mortality was observed between the LV function subgroups. The 6-month mortality, however, was 2-fold higher in patients with severe LV dysfunction (27% vs 15%, respectively; P=.03). Recovery of LVEF to more than 50% was observed in 15% of patients with baseline EF ≤35%. Baseline EF was the strongest independent predictor of LV recovery after TAVI (odds ratio, 85; 95% confidence interval, 19-380; P.001).Despite a similar periprocedural outcome, patients with aortic stenosis and severe LV dysfunction exhibit a significantly increased 6-month mortality after TAVI. Survivors with LV dysfunction, however, show a significant potential for LV function recovery.

The Medtronic Engager aortic valve system is a second-generation transcatheter aortic valve implantation bioprosthesis combined with a delivery system designed for over-the-wire transapical implantation of the valve. The self-expandable stent has control arms to be placed into the native aortic sinuses to achieve correct positioning of the bioprosthesis in a predefined height. The purpose of the lower skirt is to reduce paravalvular leakage. A three-leaflet, bovine pericardium valve is mounted on the stent. The implantation is facilitated by the control arms and rotational positioning of the commissural posts. A multicentre feasibility study showed promising results. The results from the following European pivotal trial led to CE mark approval in 2013. Here, we describe technical details of the device and its implantation technique and highlight special steps of the procedure.

Objective The aim of this study was to investigate the short-term and midterm outcome of the Engager transcatheter aortic valve implantation (TAVI) system, a transapical self-expanding valve device with anatomic orientation. Methods Transapical aortic valve implantation with the Engager valve prosthesis was performed in 10 patients. Endpoints were defined according to the Valve Academic Research Consortium recommendations for reporting outcomes of TAVI in clinical trials. Follow-up has been completed after 30 days and 1 year. Results All patients underwent the implantation procedure successfully. No device-related or delivery system–related complications were observed. One patient died of non–device-related reasons at postoperative day 23 in multiorgan failure. At 30-day follow-up, no more than mild transvalvular and paravalvular aortic regurgitation were seen. After 1 year, no transvalvular regurgitation was observed as assessed by transthoracic echocardiography. None of the patients had more than mild paravalvular leakage. The mean ± SD gradient was 15.3 ± 4.2 mm Hg. New York Heart Association class decreased one degree in mean and sustained until 1-year follow-up. No more patients died until 1-year follow-up. Conclusions Application of the Engager TAVI system is safe and reliable. Prosthesis deployment in an anatomically correct position was facilitated by the design of the valve prosthesis and successful in all patients. No device-related or delivery system–related complications occurred. Procedural, short-term, and midterm results up to 1 year concerning the aortic valve performance are promising, with stable mean gradients and low rates of even mild regurgitation.

Mit der kathetergestutzten Aortenklappenimplantation (TAVI) steht ein alternatives Behandlungsverfahren zum herzchirurgischen Aortenklappenersatz zur Verfugung. Bisher existieren noch keine Richtlinien fur die Indikationsstellung fur eine TAVI-Prozedur.

This study sought to assess the differential adherence to transcatheter heart valve (THV)-oversizing principles between transesophageal echocardiography (TEE) and multislice computed tomography (CT) and its impact on the incidence of paravalvular leak (PVL).CT has emerged as an alternative to 2-dimensional TEE for THV sizing.In our early experience, TEE-derived aortic annular diameters determined THV size selection. CT datasets originally obtained for vascular screening were retrospectively interrogated to determine CT-derived annular diameters. Annular dimensions and expected THV oversizing were compared between TEE and CT. The incidence of PVL was correlated to TEE- and CT-based oversizing calculations.Using TEE-derived annulus measurements, 157 patients underwent CoreValve implantation (23 mm: n = 66; 29 mm: n = 91). The estimated THV oversizing on the basis of TEE was 20.1 ± 8.2%. Retrospective CT analysis yielded larger annular diameters than TEE (p0.0001). When these CT diameters were used to recalculate the percentage of oversizing achieved with the TEE-selected CoreValve, the actual THV oversizing was only 10.4 ± 7.8%. Consequently, CT analysis suggested that up to 50% of patients received an inappropriate CoreValve size. When CT-based sizing criteria were satisfied, the incidence of PVL was 21% lower than that with echocardiography (14% vs. 35%; p = 0.003). Adherence to CT-based oversizing was independently associated with a reduced incidence of PVL (odds ratio 0.36; 95% confidence interval: 0.14 to 0.90; p = 0.029); adherence to TEE-based sizing was not.Retrospective CT-based annular analysis revealed that CoreValve size selection by TEE was incorrect in 50% of patients. The percentage of oversizing with CT was one-half of that calculated with TEE resulting in the majority of patients receiving a THV that was too small.

The study aim was to investigate the incidence of patient-prosthesis mismatch (PPM) with new catheter valves, and its influence on the patients' clinical state. At present, few echocardiographic data are available on the incidence and impact of PPM with the CoreValve and Sapien prostheses for transcatheter aortic valve implantation (TAVI).The reliability of effective orifice area (EOA) measurements was assured by awaiting an interval of six months after TAVI. Of 256 survivors after TAVI, 149 complete echocardiographic data sets were available for the assessment of the indexed EOA (iEOA). In total, 106 CoreValve prostheses and 43 Sapien prostheses were implanted in this high-risk cohort (mean age 81 +/- 6 years, mean logistic EuroSCORE 20 +/- 13%).The overall incidence of PPM (iEOA0.85 cm2/m2) was 61%. Patients with a larger body surface area were more likely to develop PPM (p = 0.001), while the prosthesis type, native annulus diameter, preoperative EOA, gender and prosthesis size had no influence. The mean aortic gradient was significantly higher in patients with PPM. A reduction in the left ventricular end-diastolic diameter was seen in all patients, without significant differences between groups. There were no differences in postoperative NYHA class or self-assessed health state between patients with or without PPM.PPM was common after TAVI in the presented cohort, presumably because the native calcium masses narrow the outflow area available for blood flow. As expected for low gradients, there was no impairment of left ventricular dimension regression or clinical state of the patients, even if severe PPM was present. Based on the presented data, it is assumed that PPM might be less relevant in TAVI patients.

Summary There is a paucity of data describing acute kidney injury (AKI) following transcatheter aortic valve implantation and its impact on mortality remains unknown. We therefore evaluate the incidence, predictors and impact of AKI following transcatheter aortic valve implantation. We searched MEDLINE for studies from 2008 to 2013, evaluating AKI after transcatheter aortic valve implantation. All studies were compared according to the incidence, predictors and impact of AKI following transcatheter aortic valve implantation. AKI was diagnosed according to the Valve Academic Research Consortium definition using the RIFLE criteria. Thirteen studies with more than 1900 patients were included. AKI occurred in 8.3–57% of the patients. The following factors were associated with AKI: blood transfusion; transapical access; preoperative creatinine concentration; peripheral vascular disease; hypertension; and procedural bleeding events. The 30-day mortality rate in patients with AKI ranged from 13.3% to 44.4% and was 2–6-fold higher than in patients without AKI. The amount of contrast agent used was not associated with the occurrence of AKI. AKI is a common complication, with an incidence of 8.3–57% following transcatheter aortic valve implantation. Patients with AKI had higher 30-day and late mortality rates. However, AKI was related to the amount of contrast volume used in only one study.

Clara, CA) procedure have been shown for mitral regurgitation (MR) from mixed etiology, but have not been elucidated in functional MR alone. Also, there is a misconception that reducing functional MR may lead to a detrimental change in acute hemodynamics. Methods: A retrospective review was performed on 85 consecutive patients with functional MR (mean age 76 11 years, 30 (35%) females) who had full set of hemodynamics prior to and after the MitraClip procedure. 57 (67%) patients were included in the high-risk registry (mean STS score 14.9 7.4%) with 78 (92%) in NYHA functional class III or IV and 77 (91%) with MR grade 4 . There were 34 (40%) patients with left ventricular ejection fraction (LVEF) 35% (mean 26 6%); overall mean left ventricular end systolic diameter of 40 10mm. Results: There were significant improvements in the cardiac index (CI; mean pre CI of 1.92 0.47 L/min/m2 vs. post CI 2.43 0.61 L/min/m2, p 0.001) and mean left atrial pressures (MLAP; mean pre MLAP of 20.7 6.7 mmHg vs. post MLAP 17.2 5.7 mmHg, p 0.001). Improvements in CI and MLAP was observed in 75/85 (88%) and 50/74 (68%) patients respectively. At a mean follow-up of 13 9months, 76/85 (89%) was in NYHA functional class I or II (from 78/85 (92%) in NYHA class III or IV at baseline, p 0.001) and 71/85 (84%) had MR grade 2 (from 85/85 (100%) in MR grade 3 or 4 at baseline, p 0.001). Conclusions: In patients with functional MR, the MitraClip procedure resulted in a significant change in CI and MLAP.

The cost-effectiveness of transfemoral/transapical TAVI vs. medical management (MM) has been established in a number of studies using data from the PARTNER B trial. To date no cost-effectiveness analysis has employed prospective data collected solely for the CoreValve device. This study uses one

BACKGROUND: Optimal transcatheter aortic valve (TAVI) results require accurate valve positioning, including anatomically correct orientation and secure fixation within the aortic annulus, thereby potentially decreasing paravalvular regurgitation. The new Engager (Medtronic 3F Therapeutics, Santa Ana, CA) transapical valve system captures the native leaflets for sealing and allows for tactile feedback during valve placement. We report initial safety and performance outcomes of the Engager system through 6 months in patients with severe aortic valve stenosis at high risk for surgical aortic valve replacement. METHODS: An interim analysis was performed on the first 61 enrolled September 2011 through May 2012. Inclusion criteria comprised severe aortic stenosis, New York Heart Association functional class of II or greater, logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 20% or greater, or contraindication to surgical aortic valve replacement. The primary endpoint was all-cause mortality at 30 days. Patients were evaluated 24 to 48 hours post-procedure, at hospital discharge, 30 days and 6 months. Follow-up is planned annually through five years. RESULTS: Baseline characteristics for the 61 patients were mean age 81.9 ± 4.4 years, 62.3% female, 88.5% New York Heart Association class III/IV, 52.5% coronary artery disease, and 54.2% extracardiac arteriopathy. For all of the attempted implantations (n = 60), the Engager prosthesis was positioned in the correct anatomic position without conversions to surgery, second valve implantation, device malposition, aortic annular rupture, or coronary obstruction. All-cause mortality was 9.9% at 30 days and 16.9% at 6 months. The baseline mean aortic valve gradient was 43.7 ± 16.7 mm Hg and 11.5 ± 5.0 mm Hg at 30 days, and showed similar reduction at 6 months (13.9 ± 6.2 mm Hg). There was no paravalvular regurgitation greater than mild through 6 months. CONCLUSIONS: Early postoperative results support implantation success and valve safety. Analysis for 6 month outcomes shows stable hemodynamic performance and clinical outcome. (Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System-the Engager European Pivotal Trial; NCT01348438).

Transcatheter aortic valve implantation was predominantly developed for patients with severe calcified aortic stenosis, as most devices are designed to anchor within the native valve calcium. We report on a patient with pure insufficiency of a non-calcified aortic valve, in whom an anatomically oriented catheter valve was implanted successfully. The design of the prosthesis with position feelers engaging the native aortic valve leaflets proved to be suitable for the treatment of pure aortic insufficiency.

N-terminal pro-brain natriuretic peptide (NT-proBNP) has been found to correlate with the severity of aortic valve stenosis and to provide prognostic information in aortic stenosis patients undergoing surgical aortic valve replacement. There is a paucity of data describing the association between clinical outcomes after TAVI and NT-proBNP levels. We investigated the evolution and prognostic value of NT-proBNP levels after TAVI.We prospectively collected data on the baseline characteristics, NT-proBNP levels (baseline, post-treatment and discharge) and adverse clinical outcomes of patients undergoing TAVI from 2007 to 2010. Using a univariable and multivariable Cox regression model, pre- and postimplantation NT-proBNP tertile levels were correlated to 30-day and 1-year mortality. A total of 373 patients underwent TAVI with either the Medtronic CoreValve or Edwards SAPIEN prosthesis. The cumulative 30-day and 1-year mortality was 7.3% and 18%, respectively. Rehospitalization for heart failure was observed in 0.8% at 30 days and 7.8% at 1 year. The tertile baseline NT-proBNP levels were identified as ≤1570 ng/L, 1571 to 4690 ng/L and ≥4691 ng/L. In the univariable analysis, baseline (HR, 1.01; 95% CI, 1.001-1.02; P=.02) and post-treatment NT-proBNP (HR 1.02; 95% CI, 1.002-1.04; P=.04) were predictors for 1-year mortality. In the multivariable analysis, however, only baseline NT-proBNP and atrial fibrillation were identified as predictors for the 1-year mortality (HR, 1.02; 95% CI, 1.01-1.05; P=.006 and HR, 3.4; 95% CI, 1.25-9.5; P=.017, respectively).NT-proBNP and atrial fibrillation were predictors for 1-year mortality, offer independent prognostic information, and identify patients being at increased risk for mortality. Thus, NT-proBNP reveals more incremental value for patient selection and should be included in the risk stratification of patients undergoing TAVI.

We retrospectively analysed our experience with the subclavian access transcatheter aortic valve implantation (TAVI) with the self-expandable CoreValve prosthesis and compared the results with transfemorally treated patients.For TAVI, a subclavian access is alternatively used when the femoral arteries are diseased or very small.Between June 2007 and February 2011, 341 patients underwent CoreValve implantation in the German Heart Center, Munich through either transfemoral (n = 301) or subclavian (n = 40) approach. The subclavian approach was chosen where transfemoral approach was not possible.There was no difference in baseline characteristics between the groups. There were no significant differences between groups for parameters potentially related to improved valve positioning (contrast medium, fluoroscopy time, implantation of a second valve, post-implantation balloon dilatation, valve dislocation, pacemaker implantation, aortic regurgitation), while the procedure duration was longer (105 ± 40 vs. 82 ± 33 min, p = 0.001). With the Kaplan-Meier estimate, survival was not different among groups. Strokes, myocardial ischaemia, and access vessel complications occurred in 2.5, 0, and 7.5 % (subclavian group) vs. 4.3, 2.0, 10.6 % (transfemoral group), ns.Our results demonstrate the safety of the subclavian access for TAVI and comparability with the transfemoral approach. With longer duration of the procedure and no significant advantages in clinical outcome, the subclavian access will have an indication for selected patients, while transfemoral TAVI should be considered first choice.

1. Division of Cardiovascular Surgery, University Hospital Zurich, Zurich, Switzerland; 2. Clinic for Cardiac Surgery, Heart Center Leipzig, Leipzig, Germany; 3. Clinic for Cardiac Surgery, German Heart Center Munich, Munich, Germany; 4. Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany

With great interest we read the recent report by Reynolds et al. ([1][1]) reporting on the health-related quality-of-life (HRQOL) outcomes in Cohort A of the PARTNER (Placement of Aortic Transcatheter Valves) randomized controlled trial. Using 3 different standardized questionnaires at 1, 6, and 12

TA access for TAVI has seen little standardization due to the absence of automated preclosure and carries a risk for bleeding and increased morbidity compared to TF TAVI. Here we report the 12-month follow-up of patients after use of a novel device to facilitate safe and reliable, automated access

With great interest, we read the recent paper by Del Trigo et al. [(1)][1], being the first study to systematically scrutinize valve hemodynamic deterioration (VHD) in a multicenter cohort of patients after transcatheter aortic valve replacement (TAVR). Because there is some evidence suggesting

Sutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year.From February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%.One-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up.The Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population.

The safety and efficacy of transcatheter aortic valve replacement procedures are directly related to proper imaging. This report revisits the existing noninvasive and invasive approaches that have concurrently evolved to meet the demands for optimal selection and guidance of patients undergoing transcatheter aortic valve replacement. The authors summarize the published evidence and discuss the strengths and pitfalls of echocardiographic, computed tomographic, and calibrated aortic balloon valvuloplasty techniques in sizing the aortic valve annulus. Specific proposals for 3-dimensional tomographic reconstructions of complex 3-dimensional aortic root anatomy are provided for reducing intermodality variability in annular sizing. Finally, on the basis of the sizing approaches discussed in this review, the authors provide practical recommendations for balloon-expandable and self-expandable prostheses selection. Strategic use of echocardiographic, multislice computed tomographic, and angiographic data may provide complementary information for determining the anatomical suitability, efficacy, and safety of the procedure.

Background— Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry. Methods and Results— The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients. Conclusions— The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.

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.

Aortic valve stenosis (AVS) is the most frequent acquired valvular heart disease in western industrialized countries and its prevalence considerably increases with age. Once becoming symptomatic severe AVS has a very poor prognosis. Progressive and rapid symptom deterioration leads to an impairment of functional status and compromised healthrelated quality-of-life (HrQoL) simultaneously. Until recently, surgical aortic valve replacement (SAVR) has been the only effective treatment option for improving symptoms and prolonging survival. Transcatheter aortic valve replacement (TAVR) emerged as an alternative treatment modality for those patients with severe symptomatic AVS in whom the risk for SAVR is considered prohibitive or too high. TAVR has gained clinical acceptance with almost startling rapidity and has even quickly become the standard of care for the treatment of appropriately selected individuals with inoperable AVS during recent years. Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality. As per current evidence, TAVR significantly improves HrQoL in high-surgical risk patients with severe AVS with sustained effects up to two years when compared with optimal medical care and demonstrates comparable benefits relative to SAVR. Along with a provision of a detailed overview of the current literature regarding functional and HrQoL outcomes in patients undergoing TAVR, this review article addresses specific considerations of the HrQoL aspect in the elderly patient and finally outlines the implications of HrQoL outcomes for medico-economic deliberations.

The European transcatheter aortic valve implantation experience began in 2002, and ever since, numerous centers have started a program, resulting in a "transcatheter aortic valve implantation pandemic." Considerable experience has been gained with various access routes for implantation and with valve-in-surgical bioprosthetic valve procedures. Reimbursement differs among the European countries and is currently undergoing rapid changes. Accordingly, the implantation rates in various European countries still differ considerably, with the greatest in Switzerland and Germany: 77 implants per 1 million treatable inhabitants. The Edwards Source and the Medtronic Advance trials, designed as postcommercialization studies, demonstrated a steady improvement in results, which was also reflected in the single-center mid-term data up to 3 years. The preliminary results from national European registries have been remarkably comparable in terms of survival and stroke. The "glimpse into the future" points toward implantation in intermediate-risk patients in contrast to high-risk or inoperable patients. The results of the Medtronic Surgical Replacement and Transcatheter Aortic Valve Implantation and Edwards Placement of Aortic Transcatheter Valves Trial 2 trials will show whether this change in paradigm is justified.

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.

OBJECTIVES: The aim was to investigate the safety and feasibility of the redesigned Engager™ transcatheter aortic valve implantation (TAVI) system. METHODS: Transapical aortic valve implantation with the Engager™ valve prosthesis was intended in 11 patients, and performed in 10. Endpoints were defi ned according to the valve academic research consortium recommendations for reporting outcomes of TAVI in clinical trials. RESULTS: All 10 patients were implanted successfully. No devicerelated or delivery system complications like coronary obstruction or aortic dissection emerged. One patient (10%) died from non-device-related reasons at post-operative day 23 of multi-organ failure. The invasively measured peak-to-peak gradient after valve implantation was 7.1 ± 3.5 mmHg. In 90%, there was no or only trivial (≤grad I) aortic regurgitation due to paravalvular leakage. In 10% of the patients, aortic regurgitation grade I–II was observed. At 30-day follow up, the mean gradient was 15.6 ± 4.9 mmHg, and no more than a mild transvalvular and paravalvular aortic regurgitation was seen as assessed by transthoracic echocardiography. CONCLUSIONS: Application of the Engager™ TAVI system is safe and feasible. Prosthesis deployment in an anatomically correct position was facilitated by the design of the valve prosthesis and was successful in all patients. No device or delivery-system-related complications emerged. Safety and feasibility endpoints were met. Good results concerning the aortic valve performance after implantation and at 30-day follow up were ascertained. These results encouraged the start of a European Pivotal trial including patients to date.