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Objectives The aim of this study was to assess the safety and efficacy of ticagrelor versus prasugrel for patients with acute coronary syndrome (ACS) according to their estimated glomerular filtration rates (eGFRs). Background The outcomes of ticagrelor versus prasugrel in patients with ACS according to eGFR have not been defined. Methods Patients (n = 4,012) were categorized into 3 groups: low eGFR ( Results Patients with low eGFRs had a higher risk for the primary endpoint compared with patients with intermediate eGFRs (adjusted HR: 1.89; 95% CI: 1.46-2.46]) and those with high eGFRs (adjusted HR: 2.33; 95% CI: 1.57-3.46). A risk excess for low eGFR was also observed for bleeding (adjusted HR: 1.55 [95% CI: 1.12-2.13] vs intermediate eGFR; adjusted HR: 1.59 [95% CI: 1.01-2.50] vs high eGFR). However, eGFR did not affect the relative efficacy and safety of ticagrelor versus prasugrel. In patients with low eGFR, the primary endpoint occurred in 20.5% with ticagrelor and in 14.7% with prasugrel (HR: 1.47; 95% CI: 1.04-2.08; P = 0.029); there was no significant difference in bleeding. Conclusions These results show that among patients with ACS, reduction of eGFR is associated with increased risk for ischemic and bleeding events but has no significant impact on the relative efficacy and safety of ticagrelor versus prasugrel. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome [ISAR-REACT 5]; NCT01944800 )

Gender-based differences in outcomes after successful transcatheter aortic valve implantation (TAVI) in patients without an indication for oral anticoagulation have not been well studied. We aim to evaluate gender-based differences in clinical outcomes after TAVI. In the present analysis of the GALILEO (Global study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement to optimize clinical outcomes) trial, patients with symptomatic severe aortic stenosis and who underwent successful TAVI were stratified by gender. The primary outcome was major adverse cardiac and cerebrovascular events (MACCEs), a composite of all-cause mortality or thromboembolic events (including any stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein thrombosis, or pulmonary embolism). Major bleeding was defined as a composite of major, life-threatening, or disabling Valve Academic Research Consortium-2 bleeding. Of 1,644 patients, 813 were female, and 831 were male. At baseline, female patients were older and at higher surgical risk (Society of Thoracic Surgeons risk score: 4.7 ± 3.6 versus 3.6 ± 3.0, plt;0.0001) than male patients. After adjustment for differences in baseline clinical and procedural parameters, female patients had lower rates of MACCE (hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.49 to 0.96), all-cause mortality (HR 0.54, 95% CI 0.34 to 0.87), and noncardiovascular mortality (HR 0.33, 95% CI 0.15 to 0.75) at a median of 17 months of follow-up. By landmark analyses, these differences appeared to emerge with a longer follow-up time. No significant differences in major, life-threatening, or disabling bleeding, cardiovascular mortality, and stroke were noted. In conclusion, compared with male patients, female patients with severe symptomatic aortic stenosis had a lower risk of MACCE and mortality but a similar risk of bleeding events after TAVI.

Advances in therapy 39(6), 3011-3018 (2022). doi:10.1007/s12325-022-02135-z, Published by Springer Healthcare Communications, Tarporley

Transcatheter aortic-valve replacement (TAVR) for the treatment of aortic stenosis can lead to embolization of debris. Capture of debris by devices that provide cerebral embolic protection (CEP) may reduce the risk of stroke.We randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group). The primary end point was stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat population. Disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CEP access site, and acute kidney injury were also assessed. A neurology professional examined all the patients at baseline and after TAVR.A total of 3000 patients across North America, Europe, and Australia underwent randomization; 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom an attempt was made. The incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group (2.3% vs. 2.9%; difference, -0.6 percentage points; 95% confidence interval, -1.7 to 0.5; P = 0.30). Disabling stroke occurred in 0.5% of the patients in the CEP group and in 1.3% of those in the control group. There were no substantial differences between the CEP group and the control group in the percentage of patients who died (0.5% vs. 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% vs. 3.7%); or had acute kidney injury (0.5% vs. 0.5%). One patient (0.1%) had a vascular complication at the CEP access site.Among patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the results may not rule out a benefit of CEP during TAVR. (Funded by Boston Scientific; PROTECTED TAVR ClinicalTrials.gov number, NCT04149535.).

Objectives To investigate the predictors and clinical impact of left ventricular reverse remodeling (LVRR) after MitraClip (MC) therapy for degenerative (DMR) and functional mitral regurgitation (FMR). Background MC therapy induces LVRR in patients with mitral regurgitation (MR) at high‐risk for surgery. However, specific data on predictors of LVRR therapy are limited. Methods This study included 164 patients treated by MC implantation with complete clinical and echocardiographic evaluation at baseline, 6 months, and 12 months. LVRR was defined as a decrease of ≥10% of the left ventricular end‐diastolic diameter after 12 months and was found in 49% of the patients. Results LVRR was associated with significantly reduced event rate 2 years after MC procedure. In the total cohort, multivariate regression analysis determined severe recurrent/residual MR after 12 months (p = .010, odds ratio [OR] = 0.26), male gender (p = .050, OR = 0.49) and left ventricular ejection fraction (LVEF), publishedVersion

The study sought to evaluate the impact of diabetes mellitus on 3-year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de novo lesions.For treatment of de novo coronary small vessel disease, DCBs are noninferior to DES.In this prespecified analysis of a multicenter, randomized, noninferiority trial, including 758 patients with de novo lesions in coronary vessels 3 mm who were randomized 1:1 to DCB or DES and followed over 3 years for major adverse cardiac events (MACE) (cardiac death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus.In nondiabetic patients (n = 506), rates of MACE (DCB 13.0% vs DES 11.5%; hazard ratio [HR]: 1.24; 95% confidence interval [CI]: 0.73-2.09; P = 0.43), cardiac death (2.8% vs 2.9%; HR: 0.97; 95% CI: 0.32-2.92; P = 0.96), nonfatal MI (5.1% vs 4.8%; HR: 1.00; 95% CI: 0.44-2.28; P = 0.99), and TVR (8.8% vs 6.1%; HR: 1.64; 95% CI: 0.83-3.25; P = 0.16) were similar. In diabetic patients (n = 252), rates of MACE (19.3% vs 22.2%; HR: 0.82; 95% CI: 0.45-1.48; P = 0.51), cardiac death (8.8% vs 5.9%; HR: 2.01; 95% CI: 0.76-5.31; P = 0.16), and nonfatal MI (7.1% vs 9.8%; HR: 0.55; 95% CI: 0.21-1.49; P = 0.24) were similar in DCB and DES. TVR was significantly lower with DCBs vs DES (9.1% vs 15.0%; HR: 0.40; 95% CI: 0.17-0.94; P = 0.036; P = 0.011 for interaction).The rates of MACE are similar in DCBs and DES in de novo coronary lesions of diabetic and nondiabetic patients. In diabetic patients, need for TVR was significantly lower with DCB versus DES. (Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs Drug Eluting Stents in Small Vessel Interventions [BASKET-SMALL2]; NCT01574534).

RESPOND is a prospective, single-arm study enrolling 1014 transcatheter aortic valve replacement (TAVR) patients. The objective of this analysis is to assess the impact of cerebral embolic protection (CEP) devices and prosthetic valve repositioning on the risk of neurologic complications in patients treated with the fully repositionable Lotus Valve in the RESPOND postmarket study. Valve repositioning and CEP use were at the operators’ discretion. Stroke events were adjudicated by an independent medical reviewer. This analysis assessed the baseline differences among patients according to CEP use and valve repositioning and evaluated the neurological complications at 72 hours after TAVR, hospital discharge, and 30-day follow-up. A multivariate analysis was performed to identify the potential predictors of stroke. Of the 996 patients implanted with the Lotus Valve (mean age: 80.8 years, 50.8% female, STS score 6.0 ± 6.9), 92 cases (9.2%) used CEP. The overall rate of acute stroke/transient ischemic attack (TIA) was 3.0% at 72 hours after TAVR. The 72-hour stroke/TIA rate was 1.1% in patients who had CEP and 3.2% in those who did not. Use of CEP was associated with a 2.1% absolute reduction in the risk of acute neurological events (relative risk reduction: 65.6%), although the difference was not statistically significant (p = 0.51). Repositioning of the Lotus Valve occurred in 313/996 procedures (31.4%); p = 0.86. The 72-hour rate of stroke/TIA was similar in patients who had valve repositioning (2.9%) compared with those who did not (3.1%; ). The selective use of a CEP device in the RESPOND study was associated with a nonsignificantly lower risk for stroke within 72 hours. The use of the repositioning feature of the Lotus Valve did not increase the stroke risk., Journal of Interventional Cardiology, 2020, ISSN:0896-4327, ISSN:1540-8183

Lack of structural equality is a major issue to be addressed in observational studies. Their major disadvantage of these studies compared to randomized controlled trials is the vulnerability towards confounding, but they often better mirror real world patients and, therefore, entail an increased external validity. Numerous approaches have been developed to account for confounding in observational research, including multiple regression, subgroup analysis and matched cohort designs. The latter has been often described as a useful tool if large control data sets are available. In this paper we present a hierarchical matching algorithm entailing two stages which enables a multicentric matched cohort study to be conducted. In particular, the algorithm defines the matching strategy as a combination of exact matching and a subsequent consideration of further matching variables to be controlled using a distance measure (e.g. the propensity score). The algorithm is applied to a study in interventional cardiology and demonstrates high flexibility and usefulness with regard to the aim of finding comparable cases of exposed and non-exposed patients from observational data. The algorithm increased structural equality by balancing the most important covariates which might be of different importance for the matching process. The implementation of the algorithm in the statistical software SAS offers high flexibility regarding an application to various data analysis projects. Specifically, it provides a broader range of features (e.g. diverse distance measures) when compared to other existing solutions for conducting matched cohort analyses.

OBJECTIVES To analyze 30-day and 6-month results after percutaneous mitral valve repair using an IABP as circulatory support. BACKGROUND The use of intra-aortic balloon counterpulsation pump extended the spectrum of cardiovascular interventions. METHODS Since 2014, 17 patients of 365 patients (4.7%) at our center received an IABP during MitraClip implantation procedure. We compare the periprocedural results to a control group of 17 patients treated with MitraClip without an IABP support. To adjust for differences of baseline characteristics a propensity-score matching for age, baseline blood pressure, preoperative EuroSCORE II and left ventricular ejection fraction was performed. The decision for prophylactic implantation of an IABP was at the discretion of the interventionalist. For both groups, clinical results up to 6 months were evaluated. RESULTS The IABP group had higher NT-pro BNP levels at baseline and increased left ventricular diameters. The procedure was more often categorized as "urgent" due to refractory heart failure in the IABP group. All procedures were carried out successfully, thereby achieving a sufficient MR reduction in both groups. Length of hospital stay was significantly longer in the IABP group 11.7 ± 14 days (compared to 6.5 ± 2.9 days in the No IABP group, P

Objectives The aim of this study was to evaluate the debris captured by the Claret Sentinel cerebral embolic dual-filter protection device during transfemoral transcatheter aortic valve replacement (TAVR) with different valve types. Background Risk for embolization of debris during TAVR may vary by TAVR device. Methods The filters of 100 consecutive patients were collected and captured debris was analyzed by histopathology and histomorphometry. Three valve types were implanted: the balloon-expandable Edwards SAPIEN 3 (n = 42), the self-expandable Medtronic Evolut R (n = 35), and the mechanically implantable Boston Scientific Lotus (n = 23). Results Among the 3 groups there was no difference in baseline data, including Society of Thoracic Surgeons score for mortality, calcification, or pre-dilation. The type of captured debris did not differ among the 3 valve types in the proximal or distal filter. With the balloon-expandable valve, there were significantly more patients with large debris measuring ≥1,000 μm. The number of particles in the proximal filter was significantly lower with the Lotus (89.8 ± 106.3) compared with the Evolut R (187.3 ± 176.9) and Edwards SAPIEN 3 (172.3 ± 133.5) valves (p = 0.035). Total tissue area in the proximal filter was significantly smaller for the Lotus compared with the other 2 valve types (7.1 ± 6.3, 20.1 ± 19.0, and 21.3 ± 15.1 mm2; p = 0.0014). In contrast, for the distal filter, there were no differences with respect to valve type for total tissue area, particle size, and number of particles. Conclusions A significant difference was observed in the size and number of captured tissue particles with the double-filter embolic protection device among different valve types in patients undergoing TAVR. The largest particles were observed in patients treated with a balloon-expandable valve.

Although the MitraClip (Abbott Vascular, Santa Clara, California) for percutaneous repair of severe mitral regurgitation has been used in more than 25,000 patients, antiplatelet or anticoagulation treatment has not been universally defined. Optimal treatment after MitraClip implantation in patients

The study was aimed at evaluation of the feasibility and potential benefit of image fusion (IF) of pre-procedural CT angiography (CTA) and x-ray (XR) fluoroscopy for image-guided navigation in transfemoral transcatheter aortic valve implantation (TAVI) with the strong focus on guiding the double-filter cerebral embolic protection device and valve prosthesis placement. Methods In 31 patients undergoing TAVI, image registration of CTA-derived 3D anatomical models of the relevant cardiac anatomy and vasculature, and live XR was performed applying a commercially available navigation tool. The approach was evaluated in terms of the accuracy of the overlay. In 27 TAVI patients with IF receiving double-filter cerebral embolic protection device overall procedure time, fluoroscopy time, radiation dose, and total volume of intra-procedural iodinated contrast agent (CA) were registered and compared to those of a control group of prospectively enrolled during the same period of time N=27 patients receiving the same protection system but without IF. Results and conclusions Image co-registration and model-based guidance is feasible in TAVI procedures. The overlay facilitates placement of the embolic protection device, placement of the guide wire in the left ventricle and initial alignment of the valve prosthesis prior to final deployment, thus improving the confidence level of the operators during the procedure without compromising CA or XR dose.

Background Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation is of high clinical relevance, but PPMI rates differ widely between valve types. Although the Lotus valve can be repositioned, reported rates for PPMI are high. The predictors of PPMI after Lotus valve implantation have not been defined yet. Methods We analyzed the impact of preexisting conduction disturbances, depth of implantation, oversizing, and amount of calcification on PPMI in 216 patients with severe symptomatic aortic stenosis underdoing Lotus valve implantation. Results PPMI was required in 39.8% of patients. Patients with need for PPMI compared with patients without need for PPMI had more often the following criteria: male gender ( P = .035); preprocedural right bundle - branch block (RBBB) (16.3% vs 0, P P = .004); higher calcium volume of the left coronary cusp (63.1 ± 87.5 mm 3 vs 42.8 ± 49.3 mm 3 , P = .05); and deeper valve implantation at right coronary ( P = .011), noncoronary ( P = .026), and left coronary ( P = .012) position. Oversizing in relation to annulus and left ventricular outflow tract did not have an impact on need for PPMI. By multiple regression analysis, preprocedural AV block first degree ( P = .005), RBBB ( P P = .006) were independent risk factors for need of PPMI. Conclusions In patients with severe aortic stenosis receiving transfemoral Lotus valve, preexisting AV block first degree, RBBB, and implantation depth are independent predictors of PPMI, highlighting the importance of careful valve positioning.

New generation devices for transcatheter aortic valve replacement have been optimized to improve clinical outcome. We compared procedural, in-hospital, 30 days and 12 months outcome of the new generation repositionable Boston Lotus Valve and the balloon-expandable Edwards Sapien 3 valve with the last generation self-expandable Medtronic CoreValve and the balloon-expandable Edwards Sapien XT. Between 2010 and 2015 consecutive patients treated with the Medtronic CoreValve (N = 100), Edwards Sapien XT (N = 100), Edwards Sapien S3 (N = 100) and Boston Lotus device (N = 100) were enrolled. There was no moderate or severe AR with the new generation devices as compared with 11.5% with last generation devices (p

Predictors for the need of permanent pacemaker implantation (PPMI) in the context of transcatheter aortic valve implantation (TAVI) are not well defined yet. We evaluated the impact of conduction disturbances, calcium volume of the device landing zone, oversizing and implantation depth on PPMI after TAVI with the balloon-expandable Edwards Sapien 3 (ES3). 335 consecutive patients undergoing transfemoral TAVI with the ES3 for the treatment of symptomatic severe aortic stenosis were included (clinicaltrials NCT02162069). Rate of PPMI after TAVI was 18.4%, excluding patients with permanent pacemakers prior to TAVI or valve-in-valve implantations. Patients requiring PPMI more often had first degree atrioventricular block (AVB) at baseline (48.7 vs. 16.5%, p

Use of the dual-filter cerebral embolic protection (CEP) device has been linked to a lower stroke rate in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Captured debris is found in almost every filter. The impact of repositioning on number and area of captured debris has not been studied.Consecutive patients (n = 200) undergoing transfemoral TAVR with double-filter CEP device were included. A total of 400 filters were analyzed. Histopathologic assessment and histomorphometric analyses of debris were compared for TAVR procedures with vs without repositioning. Analyses were differentiated by particle size, particle count, and total particle area.Repositioning was used in 23/200 TAVR procedures (11.5%). Baseline data including sex, diabetes mellitus, and predilation were similar between patients with and without repositioning. Repositioning was associated with a significantly higher number of embolized debris (349 ± 326 vs 509 ± 495; P.04) and larger debris area in both filters (15.56 ± 22.13 mm² vs 38.9 ± 25.57 mm²; P.001) when compared with patients with no valve prosthesis repositioning. Periprocedural stroke rate was statistically not different between the two groups (0.0% vs 2.8%; P=.41), with use of CEP in all patients. Renal failure occurred significantly more often with repositioning of the TAVR prosthesis (8.7% vs 1.7% in patients without repositioning; P.05) due to a significantly higher volume of contrast (139 ± 181 mL in patients with valve repositioning vs 85 ± 35 mL in patients without valve repositioning; P.001).Repositioning of the valve prosthesis during TAVR is associated with a larger number and higher total area of embolized debris captured with the dual-filter CEP device.

Randomized trials for percutaneous closure of patent foramen ovale (PFO) have demonstrated a lower rate of recurrent ischemic events compared with medical therapy. The aim of this long-term follow-up analysis was to validate the impact of PFO closure on recurrent ischemic events.A total of 570 patients were enrolled. Patients were followed for recurrent ischemic events for a median of 7.2 years. Mean age at the time of procedure was 49.3 ± 13.1 years. PFO closure was performed with the Amplatzer occluder in 44.9% of patients and with BioStar, Cardia or Premere occluders in 55.1% of patients. Within 10 years of follow-up, recurrent ischemic stroke occurred in 5.1% of patients in the Amplatzer group vs 7.6% with the other occluders (log rank P=.61). There was no difference in the rate of recurrent transient ischemic attack (1.86% vs 1.51%; log rank P=.52) or all-cause mortality (2.9% vs 3.8%; log rank P=.84) between the two groups, in patients with or without an atrial septal aneurysm or with respect to grade of preprocedural shunt. Recurrent stroke was lower in patients45 years old at the time of occluder implantation (hazard ratio, 4.14; 95% confidence interval, 0.94-18.8; log rank P=.05).In this long-term follow-up after PFO closure, the rate of recurrent stroke was low. There were no significant differences in event rates between different occluder devices, the existence of an atrial septal aneurysm, or grade of preprocedural shunt at baseline. Patients45 years old had lower rates of recurrent ischemic stroke.

Background Data on bioresorbable vascular scaffolds (BVS) for the treatment of long lesions are limited. We studied the use of BVS-Absorb in routine clinical practice and compared the outcome of long lesions with short lesions. Implantation of drug-eluting scaffolds without PSP-technique (predilation, proper sizing and postdilation) is associated with an increased thrombotic risk. We compared the long-term outcome up to 36 months of patients with short (

Background: Atrial fibrillation is common in patients with mitral regurgitation (MR) and has a negative impact on the clinical outcome of patients with valvular heart disease. We aimed to evaluate the impact of pre-procedural atrial fibrillation on the long-term clinical outcomes of patients with MR undergoing transcatheter mitral valve repair by MitraClip implantation. Methods: We analysed 355 consecutive patients with and without atrial fibrillation with symptomatic, severe MR and inoperability or high surgical risk undergoing MitraClip implantation in a three-year follow-up. Results: In patients with pre-procedural atrial fibrillation undergoing MitraClip implantation, we found advanced age, higher baseline NT-pro-BNP levels, increased left atrial diameter, and higher rate of severe tricuspid regurgitation, compared to patients with sinus rhythm. In the three-year follow-up after MitraClip implantation, mortality and major adverse cardiovascular and cerebral events (MACCE) occur significantly more often in patients with atrial fibrillation, compared to patients without atrial fibrillation. Multivariate regression analysis confirmed atrial fibrillation (hazard ratio 2.39, 95%-confidence interval 1.06���5.41, p = 0.036) as an independent predictor for three-year-mortality after MitraClip implantation. Conclusions: Atrial fibrillation is an independent predictor for long-term mortality after MitraClip implantation. We demonstrate the association of atrial fibrillation with mortality and MACCE in the long-term follow-up of patients undergoing MitraClip implantation., publishedVersion

The fusion of 3D anatomical models derived from high-fidelity pre-interventional computed tomography angiography (CTA), and x-ray (XR) fluoroscopy to facilitate anatomical guidance is of huge interest for complex cardiac interventions like TAVI procedures with cerebral protection. Co-registration of CTA and XR has been introduced either based on additional intraoperative non-/contrast-enhanced cone-beam computed tomography (CBCT) or two separate aortograms. With the related increase of radiation exposure and/or contrast agent (CA) dose, a potential additional risk for the patient is introduced. Here, we propose a modified co-registration approach making use of arteriograms of the iliofemoral arteries, routinely performed during the femoral puncture and sheath introduction. On-the-fly refinement of the co-registration during the on-going procedure enables accurate co-registration without any additional angiograms, thus reducing CA, XR dose and procedure time, while simultaneously improving operator confidence and procedure safety.

BACKGROUND In randomized clinical trials, the risk of thrombotic events with the absorb bioresorbable vascular scaffold (BVS) was significantly higher than with metallic drug-eluting stents. We evaluated predictors of scaffold thrombosis in the large-scale, multicenter German-Austrian ABSORB RegIstRy. METHODS AND RESULTS 3178 patients with treatment of 4252 lesions using 5020 scaffolds were included. Follow-up rate at 6 months was 97.4%. Forty-five (1.42%) patients experienced definite/probable scaffold thrombosis during follow-up. Multiple regression analysis showed implantation of absorb BVS in bifurcation lesions [odds ratio (OR): 4.43; 95% confidence interval (CI): 1.69-11.59; P=0.0024] or treatment in the years 2013/2014 (OR: 1.88; 95% CI: 1.02-3.47; P=0.04) to be significant predictors of scaffold thrombosis. Excluding bifurcation lesions, the incidence of definite/probable scaffold thrombosis decreased from 1.8% (95% CI: 1.17-2.64%) in 2013/2014 to 0.89% (95% CI: 0.5-1.46%) in 2015/2016. In the latter period, absorb BVS were implanted more often in younger patients with less complex de novo lesions, and debulking devices and postdilatation were used more frequently. Between the two treatment periods, there was a significant reduction in myocardial infarction (2.73-1.24%, P

In patients at increased surgical risk, transcatheter edge-to-edge mitral valve repair by MitraClip implantation for severe mitral regurgitation (MR) has proven to relieve symptoms of MR, reduce New York Heart Association (NYHA) functional class and improve quality of life. Rehospitalization for decompensated heart failure occurs frequently after MitraClip implantation, negatively impacting quality of life. We aimed here to determine predictors of 1-year rehospitalization for decompensated heart failure.A total of 355 consecutive patients who underwent MitraClip implantation at our centre were evaluated for their baseline and procedural characteristics, peri-procedural outcome and clinical endpoints. Rate of rehospitalization for decompensated heart failure was reduced from 52.7% (n = 187) in the year before MitraClip procedure to 18.0% (n = 64) (P 0.0001) in the first year after MitraClip implantation. The mean duration until rehospitalization was 117 days after MitraClip implantation. Multivariate Cox proportional hazards regression analysis identified baseline left ventricular ejection fraction (P = 0.020), baseline troponin T (P = 0.003) and pre-procedural NYHA class (P = 0.020) as independent predictors for 1-year rehospitalization after MitraClip implantation. Rehospitalization correlated significantly with all-cause mortality (odds ratio 2.3, 95% confidence interval 1.3-4.1; P = 0.004) and cardiovascular mortality (odds ratio 3.3, 95% confidence interval 1.7-6.1; P = 0.0003).After MitraClip implantation, annual rate of rehospitalization for decompensated heart failure was reduced by 65.8%. Baseline left ventricular ejection fraction, baseline troponin T and pre-procedural NYHA functional class are independent predictors for rehospitalization within the first year after MitraClip implantation. Patients readmitted for decompensated heart failure after MitraClip implantation had a 2.3-fold increased risk of all-cause mortality and a 3.3-fold increased risk of cardiovascular mortality compared to patients not requiring rehospitalization.

Aims The role of cerebral embolic protection (CEP) in transcatheter aortic valve replacement (TAVR) remains controversial. Randomized trials have not been powered to demonstrate a reduction in stroke rates. The aim of this patient level pooled analysis was to validate the impact of the dual-filter CEP device (Claret Medical Inc., CA, USA) on peri-procedural stroke in a large number of TAVR patients. Methods and results Patients from the SENTINEL US IDE trial were combined with the CLEAN-TAVI and SENTINEL-Ulm study in a patient level pooled analysis (N = 1306). Propensity score matching was performed to adjust for possible confounders. The primary endpoint was procedural stroke within 72 h post-TAVR according to Valve Academic Research Consortium-2 criteria. The secondary endpoint was the combination of all-cause mortality or all-stroke within 72 h after TAVR. In the propensity-matched population, 533 patients underwent TAVR without CEP and 533 patients underwent TAVR with CEP. TAVR patients without vs. with CEP were similar with respect to baseline characteristics, procedural approach, or valve type. In patients undergoing TAVR with dual-filter CEP, procedural all-stroke was significantly lower compared with unprotected procedures [1.88% vs. 5.44%, odds ratio 0.35, 95% confidence interval (CI) 0.17–0.72, relative risk reduction 65%, P = 0.0028]. In addition, all-cause mortality and all-stroke were significantly lower (2.06% vs. 6.00%, odds ratio 0.34, 95% CI 0.17–0.68, relative risk reduction 66%, P = 0.0013). Conclusion Our findings suggest that TAVR with the dual-filter CEP device is associated with a significant lower rate of peri-procedural stroke compared with unprotected procedures. However, randomized trials are still needed to clarify this issue.

The aim of this study was to adapt patient-specifically a co-registration procedure for image fusion (IF) of a pre-interventional CT dataset with real-time X-ray (XR) fluoroscopy during transfemoral transcatheter aortic valve implantation (TAVI), enabling improved performance of the procedure. The ability to use 3D models of the respective anatomies to complement the anatomic information obtained by XR fluoroscopy and provide a greater degree of real-time anatomical guidance holds great potential for complex cardiac interventions, especially for TAVI procedures with cerebral protection. Initial registration of two datasets was performed during the femoral puncture and sheath introduction using routinely acquired arteriographies. On-time refinement of the co-registration was then performed during the on-going procedure avoiding additional angiograms for the co-registration. Performance of the method was evaluated quantitatively in terms of procedural characteristics and clinical events. Significant reduction of the radiation dose [51 (42–55) vs. 64 (49–81) Gy cm2, p = 0.032] and contrast agent (CA) volume [80 (50–95) vs. 100 (80–110) ml, p = 0.010] was achieved with the optimized approach as compared to the control group without IF, with simultaneous decrease of procedural [48 (41–58) vs. 61 (53–67) min, p = 0.002] and fluoroscopy times [14.8 (12.7–18.5) vs. 17.8 (14.3–19.4), p = 0.108]. In this proof-of-concept study we have demonstrated a novel co-registration approach for IF during TAVI not requiring any additional CA or XR scan. We have evaluated its potential benefit with the strong focus on guiding the femoral puncture, placement of the double-filter cerebral embolic protection device, and deployment of the valve prosthesis. We achieved improved performance and safety of the procedure with the introduced approach.

Correct sizing of the aortic annulus in aortic valve stenosis is crucial for successful transcatheter aortic valve implantation (TAVI). Multislice computed tomography (MSCT) seems to be most promising imaging modality for this pre-interventional diagnostic work-up, but has the disadvantage of exposing mostly co-morbid patients to iodine and nephrotoxic contrast agents. To establish a useful sizing method for TAVI without the use of contrast media, we compared measurements of a non-contrast magnetic resonance imaging (MRI) technique with MSCT serving as the reference standard. Fifty-two patients who underwent TAVI were previously examined with MSCT and MRI, respectively. MRI examination included a 3D steady-state free-precession sequence covering the entire ascending aorta. Perimeter and area of the aortic root were analyzed by two blinded readers in consensus using a dedicated software. Decisions for Sapien 3 valve size of both imaging modalities were compared using the mean derived annulus diameter. Mean age of the study cohort was 82.2 ± 4.9 years, log EuroScore was 25.2 ± 4.8 %. Mean aortic annulus perimeter as measured by MSCT was 76.7 ± 6.9 mm. MRI yielded a mean perimeter of 76.5 ± 6.7 mm with a good correlation coefficient (r = 0.93, p

Background The rate of paravalvular aortic insufficiency (AI) with transcatheter aortic valve implantation (TAVI) with first generation devices was higher compared with surgical replacement. Residual AI after TAVI has been linked to an increased mortality rate. We compared two second generation TAVI devices — the repositionable Lotus valve with the balloon-expandable Edwards Sapien 3 valve — regarding procedural and 30day outcome. Methods and results In 78 patients with severe aortic stenosis undergoing transfemoral TAVI we evaluated post-procedural paravalvular AI, device success and early safety according to VARC criteria. Valve size was based on a 256-multislice computed tomography. Patients were followed for 30days. The Lotus valve (N=26) and the Edwards Sapien 3 valve (N=52) were implanted under fluoroscopic guidance. Baseline characteristics were similar between groups. Perimeter derived annulus diameter did not differ with 25.7±1.6mm for Lotus and 25.2±2.1mm for Edwards Sapien 3 patients. After TAVI aortography and transthoracic echocardiography revealed no moderate or severe AI. The rate of mild AI was 12% for Lotus and 15% for Edwards Sapien 3 (p=0.62). There were no deaths, stroke, annulus rupture or coronary obstruction. Device success was 96% and 98% (p=0.61), early safety according to VARC 11.5% in both groups (p=1.0) and the need for pacemaker implantation 27% and 4% (p Conclusions TAVI with second-generation devices was associated with no moderate or severe AI and a low rate of mild AI. Device success was high for Lotus and Edwards Sapien 3 while the need for permanent pacemaker was significantly higher with the Lotus valve.

The randomized PROTECT AF trial demonstrated non-inferiority of left atrial appendage (LAA) closure to oral anticoagulation with warfarin. Current guidelines give a class IIb recommendation for LAA closure. We evaluated the efficacy and safety of LAA closure in a consecutive series of non-valvular atrial fibrillation patients with contraindications to long-term oral anticoagulation or at high bleeding risk. 101 consecutive non-valvular atrial fibrillation patients (age 74.7 ± 7.5 years) at high risk for stroke (CHA2DS2-VASc Score 4.4 ± 1.6) and high bleeding risk (HAS-BLED Score 4.2 ± 1.3) received LAA closure with either the Watchman closure device (n = 38) or the Amplatzer cardiac plug (n = 63). Dual antiplatelet therapy with aspirin and clopidogrel was recommended for 3–6 months after device implantation, followed by long-term antiplatelet therapy with aspirin. No anticoagulation was given after device implantation. Mean follow-up was 400 days. One patient (1 %) experienced a transient ischemic attack, and two patients (2 %) suffered from ischemic stroke. While on recommended antiplatelet therapy, bleeding occurred in 12/101 patients (12 %). Bleeding was significantly reduced with 3 compared with 6 months dual antiplatelet therapy (3.0 vs. 16.2 %, p

The impact of persistent left bundle-branch block (pLBBB) on long-term clinical outcome remains to be determined.New-onset of pLBBB occurs frequently after transfemoral aortic valve implantation (TAVI).Seven hundred and seven consecutive patients who underwent TAVI were analyzed for baseline and procedural characteristics and clinical outcome in an up to 2-year follow-up. Patients were divided into either a group with pLBBB until hospital discharge or a group without LBBB. We performed propensity-score matching and analyzed baseline characteristics, procedural data and clinical outcome of both groups. Patients received balloon-expandable valves in 56.4%, mechanically expandable valves in 37.5%, and self-expandable valves in 6.3%.A new-onset, pLBBB was observed in 47.5% of patients after TAVI. The implantation of a mechanically expandable valve was associated with higher rate of pLBBB (54.2% vs. 20.8%, P 0.001), whereas implantation of a balloon-expandable valve was associated with lower incidence of pLBBB (39.8% vs. 73.1%, P 0.001). Deeper ventricular implantation at left-coronary side led to higher rates of pLBBB (7.5 ± 2.5 vs. 6.7 ± 2.6 mm, P 0.001). The occurrence of pLBBB was associated with higher rates of permanent pacemaker implantation (40.9% vs. 15.9%, P 0.001). By multivariate analysis, implantation of a mechanically expandable valve (Boston Scientific Lotus valve) was identified as independent predictor of occurrence of pLBBB (odds ratio 4.7, confidence interval 3.2-7.0, P 0.001). In the 2-year follow-up, there were no significant differences between "pLBBB" and "no LBBB"-groups regarding mortality and rehospitalization due to heart failure.The occurrence of pLBBB is associated with the choice of valve type and implantation depth and requires significantly higher rates of permanent pacemaker implantations. Importantly, there are no differences in the 2-year follow-up regarding mortality and rehospitalization due to heart failure.

To compare early device success, procedural success, and 30-day safety endpoint according to the new Mitral Valve Academic Research Consortium criteria (MVARC) in severe primary and secondary mitral regurgitation (MR) patients.A total of 210 patients were enrolled; 105 patients with primary MR were compared with 105 patients with secondary MR. All patients were highly symptomatic (New York Heart Association III/IV 79.0% vs 87.6%). Decision for MitraClip therapy was done by the heart team. Patients were on optimal medical heart failure therapy. Preprocedural MR grade was 3.4 ± 0.5 in secondary MR vs 3.7 ± 0.4 in primary MR (P.001). Device success according to MVARC was high in both groups (93.3% in secondary MR vs 94.3% in primary MR), treated with 1.4 ± 0.6 vs 1.3 ± 0.5 MitraClips (P=.14). Reduction of New York Heart Association class from baseline to 30-day follow-up was 1.7 ± 1.1 in secondary MR vs 2.2 ± 1.2 in primary MR (P.01). Rate of MVARC minor vascular complications was low. Thirty-day safety endpoint according to MVARC criteria was low in both groups (4.8% in secondary MR vs 5.7% in primary MR (P=non-significant).Percutaneous mitral valve repair using the MitraClip device is safe and effective in patients with primary and secondary MR, with a high early device success rate and low 30-day safety endpoint according to the MVARC criteria.

Background We aimed to evaluate efficacy and safety of left atrial appendage (LAA) closure with the new Watchman FLX and analyze procedural features in a consecutive series of high risk non-valvular atrial fibrillation patients. Methods and results Twelve consecutive non-valvular atrial fibrillation patients (age 76.6 ± 7.8 years) at high risk for stroke (CHA 2 DS 2 -VASc-Score 5.5 ± 0.9) and bleeding (HAS-BLED-Score 3.8 ± 0.9), received LAA closure with the Watchman FLX. Bench testing demonstrated easy repositioning as well as optimized sealing and anchoring. Follow-up was done at 30 days, and at 3 and 6 months including transesophageal echocardiography after 3 months. Compression was calculated as occluder size to diameter at shoulder in final position. The device was successfully implanted in all patients. Partial recapture was necessary in 6 (50%) of cases, and full recapture in one (8.3%). There were no procedure-related complications. In 83.3% of cases ( N = 10/12) compression was between 10 and 27%, and mean compression was 24.0 ± 11.1%. Mean implantation depth was 4.0 ± 4.4 mm distal of LAA ostium. There was no residual flow. Proximal shift in device position was noticed in 2 patients. One device was embolized at 30 day follow-up, and another device showed thrombus formation. There was no disabling or non-disabling stroke through 6 months of follow-up with dual antiplatelet therapy for 3 months. Conclusion LAA closure with the new Watchman FLX is associated with a good periprocedural safety, complete sealing of the LAA and simple repositioning. Summary We evaluated the efficacy and safety of left atrial appendage (LAA) closure with the new Watchman FLX and analyzed procedural features in a consecutive series of high risk non-valvular atrial fibrillation patients. This is a first observational study demonstrating procedural safety, complete sealing of the LAA and simple technique for repositioning. There was no stroke within a 6 month follow-up.

Background— New generation devices for transfemoral aortic valve replacement were optimized on valve positioning and reduction of residual aortic regurgitation. We compared 30-day, 12-month, and 24-month outcomes of the Boston Scientific Lotus valve (Lotus) and the balloon-expandable Edwards Sapien 3 (ES3) valve. Primary end point was all-cause mortality or disabling stroke within 12 months. Methods and Results— Between 2014 and 2016, 537 patients were enrolled at our center, and 202 patients received Lotus and 335 ES3. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation was lower with the repositionable and retrievable Lotus valve compared with the ES3. Rate of pacemaker implantation was significantly higher with the Lotus valve compared with the ES3 valve (36.1% versus 14.9%, P P =0.87), rate of disabling stroke (Lotus, 1.5%; ES3, 2.1%; P =0.62), or major vascular complications (Lotus, 2.9%; ES3, 2.4%; P =0.69). The primary end point at 12 months was similar between groups. In a propensity score–matched comparison, there was no difference in the primary end point within 12 months (Lotus, 15.5%; ES3, 18.6%; P =0.69) and 24 months (Lotus, 21.9%; ES3, 26.4%; P =0.49). Conclusions— Transfemoral aortic valve replacement with the ES3 and the Lotus were associated with similar 30-day, 12-month, and 24-month clinical outcomes. Need for permanent pacemaker implantation was significantly higher with the repositionable Lotus device. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT02162069.

Aims The aim of the study was to evaluate the procedural and 30-day results for the repositionable Lotus valve in patients undergoing transfemoral aortic valve implantation in a single-centre experience. Methods and results We prospectively enrolled 110 patients with severe symptomatic aortic stenosis (NCT02162069). All procedures were performed without general anaesthesia by the transfemoral approach. Patients were followed for 30 days. Patients received the 23 mm (n=20), 25 mm (n=43) or 27 mm (n=47) Lotus device. Mean oversizing in relation to annulus or left ventricular outflow tract (LVOT) did not differ among groups. There was no residual moderate or severe aortic regurgitation. The rate of mild aortic regurgitation was low at 9.1%. There was no valve embolisation, no need for a second valve and no conversion to surgery. The need for a new pacemaker implantation due to complete (third degree) or type II (Mobitz) second degree atrioventricular block was 24.1%, excluding patients with previously implanted devices. Within 30 days the rates of all-cause mortality and stroke were low. Conclusions In patients with severe aortic stenosis, transfemoral TAVI with the repositionable Lotus valve was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complications and mortality within 30 days.

Residual aortic regurgitation (AR) after transfemoral aortic valve implantation (TAVI) is associated with increased mortality. The new Edwards Sapien 3 valve (ES3) is designed to reduce paravalvular AR.To compare a new-generation and a late-generation balloon-expandable transcatheter heart valve.In this study, 100 consecutive patients treated with the ES3 for symptomatic native severe aortic stenosis were compared with 100 consecutive patients treated with the Edwards Sapien XT valve (EXT); all valves were implanted via transfemoral access. We compared residual AR, rate of permanent pacemaker implantation, device success according to the second Valve Academic Research Consortium (VARC-2) criteria and 30-day follow-up.With the ES3, the risk of moderate/severe AR was lower (0% vs 3%), the risk of mild AR was lower (31% vs 40%) and the final result with no AR was higher (P=0.07). The mean aortic gradient was significantly higher with the ES3 (12.2±4.6 vs 9.4±3.9mmHg; P0.01). Device success according to the VARC-2 criteria was high with the ES3 and the EXT (97% vs 95%; P=0.48). Pacemaker implantation because of higher-grade atrioventricular block was similar: 9.3% after ES3 implantation and 6.9% after EXT implantation (P=0.56). There was significantly less major or life-threatening bleeding with the ES3: 5% vs 14% (P=0.03) and 0% vs 8% (P0.01), respectively. After 30 days, the VARC-2 early-safety endpoint was significantly lower with the ES3 (P0.01).In conclusion, TAVI with the ES3 in patients with symptomatic severe aortic stenosis was associated with no moderate/severe AR, a trend towards a lower rate of mild AR, a significantly lower rate of major or life-threatening bleeding and early safety according to VARC-2 criteria within 30 days compared with the EXT.

Management of femoral access site is an important issue in transfemoral transcatheter aortic valve implantation (TAVI) and crucial for acute and long-term outcome. Data on vascular closure devices in this setting are limited. We evaluated safety and efficacy of the Prostar XL compared to the ProGlide suture-based vascular closure device.We enrolled 585 patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TAVI). Outcomes were defined according to Valve academic research consortium (VARC)-2 criteria. In 237 (40.5%) patients femoral access site closure was performed using the Prostar and in 348 patients (59.6%) using the ProGlide vascular closure device. There was no significant difference in patient baseline characteristics including single and dual antiplatelet therapies. Sheath outer diameter was significantly larger in the ProGlide compared with the Prostar group (7.7±1.5 vs. 7.9±0.5mm; p=0.001). Closure device failure according to VARC-2 criteria was significantly more frequent with the Prostar versus ProGlide device (19% vs. 4.6%; p0.01). Need for surgical repair (11.8% vs. 0%, p0.01), major (12.2% vs. 2.3%, p0.01) and minor (17.3% vs. 5.7%, p0.01) vascular complications and bleeding complications (5.5% vs. 2.0%, p=0.02) occurred significantly more often with the Prostar device compared with the ProGlide system. In addition, in-hospital mortality was higher with Prostar compared with ProGlide (5.9% vs. 2.0%; p=0.01).Femoral access site closure with the ProGlide device compared with the Prostar device in transfemoral aortic valve implantation was associated with significantly lower rates of closure device failure, minor and major bleedings and a significantly lower in-hospital mortality.clinicaltrials.govNCT02162069.

Background The PERfECT Stent Study compared paclitaxel-coated balloon (PCB) angioplasty plus bare-metal stent (BMS) implantation with BMS alone in de-novo lesions in native coronary artery disease. Angiographic follow-up after 6 months showed the superiority of the additional PCB. We evaluated a potential late catch-up phenomenon with the use of PCB. Methods and results In the prospective, multicenter, single-blind, randomized PERfECT Stent trial, 120 patients were assigned to either PCB angioplasty plus BMS implantation or BMS alone. For BMS, the endothelial progenitor cell capturing stent was used. Dual antiplatelet therapy was recommended for 3 months. The clinical endpoint for 5-year follow-up was a composite of cardiac death, myocardial infarction attributed to the target vessel, or target lesion revascularization. The follow-up rate after 5 years was 97%. Baseline and procedural characteristics did not differ. At the 5-year follow-up, clinically driven target lesion revascularization was 23.2% in the BMS group versus 15% with PCB plus BMS (P=0.26). The clinical endpoint (major adverse cardiac event) was 30.4% with BMS and with 23.5% lower with PCB plus BMS. No definite or probable stent thrombosis was found in either group with a dual antiplatelet therapy for 3 months for the total period. Conclusion PCB angioplasty plus BMS was superior to BMS alone for the treatment of de-novo lesions. The combined clinical endpoint was lower with PCB plus BMS at 6 months and remained lower after 5 years. There was no late catch-up phenomenon (http://www.clinicaltrials.gov; NCT 00732953).

Surgical aortic bioprosthetic valves deteriorate 10 to 20 years after operation. Valve-in-valve implantation with first generation transcatheter aortic valve implantation (TAVI) devices has shown to be feasible. We report a first case series with the new Edwards Sapien 3 valve for transfemoral aortic valve-in-valve implantation.Nine patients underwent valve-in-valve-TAVI with the Edward Sapien 3 valve. Seven patients presented with severe aortic stenosis and two patients with severe aortic insufficiency of surgical aortic bioprosthesis. Procedures were performed in local anaesthesia under fluoroscopic guidance with pre-procedural 256 multislice computed tomography for procedural planning. In all patients the Edwards Sapien 3 was successfully implanted decreasing the mean echocardiographic gradient from 42 ± 22mmHg to 18 ± 7mmHg (p 0.01). Device success according to VARC 2 criteria was achieved in 8 out of 9 patients. There was no death, coronary obstruction, use of second valve or need for post-dilation. Furthermore there were no access-site complications, no minor or major bleedings or vascular injury. Two patients required pacemaker implantation within the first 7 days after valve-in-valve TAVI. Post-procedural echocardiography demonstrated no or trace aortic regurgitation. Early safety events within 30 days according to VARC-2 definition occurred in 1 patient.The Edwards Sapien 3 valve for treatment of failed surgical bioprostheses is feasible and is associated with no relevant post-procedural aortic regurgitation and a low risk of access site complications. © 2016 Wiley Periodicals, Inc.

Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is a well-established and safe therapeutic option. However, data on TAVI in bicuspid aortic valve stenosis are limited and show a higher rate of moderate-severe aortic regurgitation compared with TAVI for tricuspid aortic valve stenosis. We report for the first time, to our knowledge, the use of the mechanically deployed Lotus valve in bicuspid aortic stenosis. In our patient who had severe bicuspid aortic stenosis and was at high surgical risk, the implantation of the repositionable and completely retrievable Lotus valve was a safe and controlled procedure resulting in no relevant aortic regurgitation.

Background It is not known whether biomarkers of hemodynamic stress, myocardial necrosis, and renal function might predict adverse outcome in patients undergoing percutaneous repair of severe mitral valve insufficiency. Thus, we aimed to assess the predictive value of various established and emerging biomarkers for major adverse cardiovascular events (MACE) in these patients. Methods Thirty-four patients with symptomatic severe mitral valve insufficiency with a mean STS-Score for mortality of 12.6% and a mean logistic EuroSCORE of 19.7% undergoing MitraClip therapy were prospectively included in this study. Plasma concentrations of mid regional-proatrial natriuretic peptide (MR-proANP), Cystatin C, high-sensitive C-reactive protein (hsCRP), high-sensitive troponin T (hsTnT), N-terminal B-type natriuretic peptide (NT-proBNP), galectin-3, and soluble ST-2 (interleukin 1 receptor-like 1) were measured directly before procedure. MACE was defined as cardiovascular death and hospitalization for heart failure (HF). Results During a median follow-up of 211 days (interquartile range 133 to 333 days), 9 patients (26.5%) experienced MACE (death: 7 patients, rehospitalization for HF: 2 patients). Thirty day MACE-rate was 5.9% (death: 2 patients, no rehospitalization for HF). Baseline concentrations of hsTnT (Median 92.6 vs 25.2 ng/L), NT-proBNP (Median 11251 vs 1974 pg/mL) and MR-proANP (Median 755.6 vs 318.3 pmol/L, all p

Aims The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications. Methods and Results 235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 29mm (N = 67) valve based on pre-procedural 256 multislice computer tomography. Mean oversizing did not differ between the 3 valves. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation and regurgitation index did not differ between groups. There was no switch to general anesthesia or conversion to surgery. Rate of major vascular complication was 3.0% with no difference between valve and delivery sheath sizes. Within 30 days rates of all cause mortality (2.6%) and stroke (2.1%) were low. Conclusions In patients with severe aortic stenosis transfemoral TAVI with the Edwards Sapien 3 valve without general anesthesia was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complication, mortality and stroke within 30 days with no difference between the 3 valve sizes. Trial Registration ClinicalTrials.gov NCT02162069