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Background: As transcatheter aortic valve replacement is performed increasingly in younger, low-risk patients, the need for commissural alignment and coronary access has increased. Design elements of the JenaValve Trilogy (JVT) transcatheter heart valve (THV) ensure both., Objectives: This study sought to evaluate the outcome of patients with aortic stenosis (AS) treated with this novel transfemoral, self-expanding THV., Methods: We included 43 consecutive patients with severe AS treated with the JVT system at 5 German sites. The primary endpoint of the study was technical success of the procedure. Procedural outcomes, hemodynamic valve performance, and clinical outcomes at 30 days were evaluated according to the Valve Academic Research Consortium-3 criteria., Results: The median age was 81 years (Q1-Q3: 77.0-83.9 years) with a median Society of Thoracic Surgeons Risk Score of 3.1% (Q1-Q3: 2.1%-5.9%). Technical success was achieved in 98% (n = 42 of 43). One patient was converted to open surgery. The median aortic gradient was 5.0 mm Hg (Q1-Q3: 4.0-7.0 mm Hg), and no patient had moderate or greater paravalvular regurgitation (88% [n = 37 of 42] with none or trace paravalvular regurgitation). At 30 days, major vascular complications and stroke each occurred in 1 (2.3%) patient, 2 (4.7%) patients had died, and permanent pacemaker implantation was needed in 4.9% (n = 2 of 41). Overall, early safety at 30 days was achieved in 82% (n = 27 of 33) of patients., Conclusions: Treatment of AS patients with this novel transfemoral THV system is safe and effective. The JVT offers an excellent alternative to established transcatheter aortic valve replacement prostheses for patients with AS., Competing Interests: Funding Support and Author Disclosures Dr Tamm has received grants and lecture fees from Edwards Lifesciences, Medtronic, and JenaValve; and proctoring fees for JenaValve. Dr Wienemann has received travel grants from JenaValve. Dr Treede has served as a proctor and advisor for JenaValve. Dr Arnold has served as a proctor for JenaValve; and consultant for Edwards Lifesciences. Dr Braun has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr Kuhn has served on the advisory board for Edwards Lifesciences, Medtronic, and Abbott. Dr von Bardeleben has received lecture and speaker fees from JenaValve, Abbott, Edwards Lifesciences, Medtronic, and Meril. Dr Baldus has received lecture fees from JenaValve and lecture and speaker fees from Edwards Lifesciences. Dr Adam has received lecture or proctoring fees from JenaValve, Abbott, Edwards Lifesciences, and Meril. Dr Rudolph has served as a proctor for JenaValve. All authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Aims: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries., Methods: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety., Results: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%)., Conclusions: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Many patients in need for transcatheter aortic valve implantation (TAVI) present with an aortic annulus size larger than recommended by the manufacturer's instructions for use (IFU)., Aims: To investigate procedural and short-term safety and efficacy of TAVI in patients with extra-large annuli (ELA)., Methods: 30-day clinical outcome and valve performance as defined by VARC 3 of 144 patients with an aortic annulus size exceeding the permitted range were compared to a propensity-score matched control cohort of patients with an aortic annulus size consistent with the IFU., Results: Area and perimeter was 730.4 ± 53.9 mm 2 and 96.7 ± 6.5 mm in the ELA group. Technical (96.5% vs. 94.4%) and device success (82.3% vs. 84.5%) were comparable in patients with ELA (annulus area 730.4 ± 53.9 mm 2 ) and matched controls (annulus area 586.0 ± 48.2 mm 2 ). There was no significant difference in 30-day mortality rate, major intraprocedural complications, type 3 or 4 bleedings, major vascular complications, or stroke. Moderate paravalvular leakage (PVL) occurred more frequent in the ELA group (8.9% vs 2.2%; p = 0.02). The rate of new pacemaker implantation was 7.0% in the ELA cohort and 15.0% in the control cohort, respectively (p = 0.05)., Conclusion: Treatment of ELA patients with third-generation TAVI prostheses is feasible and safe, providing similar device success and complication rates as in matched controls with regular-sized aortic annulus. Post-interventional pacemaker implantation rates were low compared to the control group, yet incidence of moderate PVL remains problematic in ELA patients., (© 2023. The Author(s).)

Background: Coronary artery disease (CAD) is frequently diagnosed in patients with aortic valve stenosis. Treatment options include surgical and interventional approaches. We therefore analyzed short-term outcomes of patients undergoing either coronary artery bypass grafting with simultaneous aortic valve replacement (CABG + AVR) or staged percutaneous coronary intervention and transcatheter aortic valve implantation (PCI + TAVI)., Methods: From all patients treated since 2017, we retrospectively identified 237 patients undergoing TAVI within 6 months after PCI and 241 patients undergoing combined CABG + AVR surgery. Propensity score matching was performed, resulting in 101 matched pairs., Results: Patients in the CABG + AVR group were younger compared with patients in the PCI + TAVI group (71.9 ± 4.9 vs 81.4 ± 3.6 years; p  < 0.001). The overall mortality at 30 days before matching was higher after CABG + AVR than after PCI + TAVI (7.8 vs 2.1%; p  = 0.012). The paired cohort was balanced for both groups regarding demographic variables and the risk profile (age: 77.2 ± 3.7 vs78.5 ± 2.7 years; p  = 0.141) and EuroSCORE II (6.2 vs 7.6%; p  = 0.297). At 30 days, mortality was 4.9% in the CABG + AVR group and 1.0% in the PCI + TAVI group ( p  = 0.099). Rethoracotomy was necessary in 7.9% in the CABG + AVR, while conversion to open heart surgery was necessary in 2% in the PCI + TAVI group. The need for new pacemaker was lower after CABG + AVR than after PCI + TAVI (4.1 vs 6.9%; p  = 0.010). No paravalvular leak (PVL) was noted in the CABG + AVR group, while the incidence of moderate-to-severe PVL after PCI + TAVI was 4.9% ( p  = 0.027)., Conclusion: A staged interventional approach comprises a short-term survival advantage compared with combined surgery for management of CAD and aortic stenosis. However, PCI + TAVI show a significantly higher risk of atrioventricular block and PVL. Further long-term trials are warranted., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: After transcatheter aortic valve implantation (TAVI), the optimal regimen of anticoagulant therapy in patients with an additional indication for oral anticoagulation remains a matter of debate. This study investigates the efficacy of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients after TAVI in a real-world population., Methods: The German Aortic Valve RegistrY (GARY) is a prospective, multicentre registry enrolling patients undergoing invasive treatment for aortic valve disease. From January 2011 to December 2019, 1 41 790 patients from 92 hospitals in Germany were enrolled. Anticoagulatory treatment regimens were assessed at hospital discharge for patients after TAVI procedures. All-cause mortality and the combined endpoint 'cardiac and cerebrovascular events' containing myocardial infarction, stroke, transient ischaemic attack, aortic prosthesis reintervention and all-cause mortality in the first year after TAVI were examined by treatment regimen., Results: Of 45 598 patients (mean age 80.7±5.7 years, 49.3% males) undergoing TAVI, 16 974 patients (37.2%) received an anticoagulant regimen that included VKA or DOAC. Hereof, the majority of patients were prescribed VKA (n=11 333, 66.8%) compared with DOAC (n=5641, 33.2%) with an increase of DOAC use from 9.4% in 2011 to 69.9% in 2019. During the 1-year follow-up, the absolute event rates per 100 person-years for all-cause mortality and the combined endpoint cardiac and cerebrovascular events were 1.9 and 1.3 for VKA-treated and 1.7 and 1.2 for DOAC-treated patients, respectively. After adjustment for baseline confounders, all-cause mortality (HR 0.95, 95% CI 0.88 to 1.01, p=0.114) and cardiac and cerebrovascular event-free survival (HR 0.93, 95% CI 0.86 to 1.01, p=0.071) did not differ significantly between VKA and DOAC groups., Conclusions: This study supports evidence of the efficacy of DOAC use after TAVI in patients with an indication for oral anticoagulation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Patients with severe aortic regurgitation (AR) are often not considered for surgery because of increased surgical risk. Because of unique anatomical characteristics among patients with AR, interventional treatment options are limited, and implantation results are inconsistent compared with those among patients with aortic stenosis., Objectives: The authors describe the initial commercial experience of the first Conformité Européenne-marked transfemoral transcatheter aortic valve replacement system (JenaValve Trilogy [JV]) for the treatment of patients with AR., Methods: This multicenter registry included 58 consecutive patients from 6 centers across Germany. Transcatheter aortic valve replacement was performed with the JV system for isolated severe and symptomatic AR. Patient characteristics, primary implantation outcomes, and valve performance up to 30 days were analyzed using Valve Academic Research Consortium 3 definitions., Results: The mean patient age was 76.5 ± 9 years, with a mean Society of Thoracic Surgeons score of 4.2% ± 4.3%. Device success was achieved in 98% of patients. The mean gradient was 4.3 ± 1.6 mm Hg, and no moderate or severe paravalvular regurgitation occurred. No conversion to open heart surgery or valve embolization was reported. There were no major vascular complications or bleeding events. The rate of new permanent pacemaker implantation was 19.6%. At 30 days, 92% of the patients were in NYHA functional class I or II, and the 30-day mortality rate was 1.7%., Conclusions: Treatment of patients with severe symptomatic AR using the transfemoral JV system is safe and effective. Given its favorable hemodynamic performance and low complication rates, this system may offer a new treatment option for patients with AR not suitable for surgery., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Background: The role of conventional surgical aortic valve replacement (SAVR) is increasingly questioned since the indication for transcatheter aortic valve implantations (TAVIs) is currently extended. While the number of patients referred to SAVR decreases, it is unclear if SAVR should be performed by junior resident surgeons in the course of a heart surgeons training., Methods: Patients with isolated aortic valve replacement (AVR) were analyzed with respect to the surgeon's qualification. AVR performed by resident surgeons was compared with AVR by senior surgeons. The collective was analyzed with respect to clinical short-term outcomes comparing full sternotomy (FS) with minimally invasive surgery and ministernotomy (MS) with right anterior thoracotomy (RAT) after a 1:1 propensity score matching., Results: The 30-day all-cause mortality was 2.3 and 3.4% for resident versus senior AVR groups, cerebrovascular event rates were 1.1 versus 2.6%, and no cases of significant paravalvular leak were detected. Clinical short-term outcomes between FS and minimally invasive access, as well after MS and RAT were comparable., Conclusion: Our current data show feasibility and safety of conventional SAVR procedure performed by resident surgeons in the era of TAVI. Minimally invasive surgery should be trained and performed in higher volumes early in the educational process as it is a safe treatment option., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: Reducing rates of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is important for achieving the best procedural outcomes. The cusp overlap technique (COT) implements procedural steps including an overlap angulation of the right and left coronary cusp to mitigate this complication., Aims: We investigated the incidence of PPI and complication rates following the COT compared to the standard three-cusp implantation technique (3CT) in an all-comers cohort., Methods: A total of 2,209 patients underwent TAVI with the self-expanding Evolut platform from January 2016 to April 2022 at five sites. Baseline, procedural and in-hospital outcome characteristics were compared for both techniques before and after one-to-one propensity score matching., Results: A total of 1,151 patients were implanted using the 3CT and 1,058 using the COT. At discharge, the rates of PPI (17.0 vs 12.3%; p=0.002) and moderate/severe paravalvular regurgitation (4.6% vs 2.4%; p=0.006) were significantly reduced with the COT compared with 3CT within the unmatched cohort. Overall procedural success and complication rates were similar; major bleeding was less common in the COT group (7.0% vs 4.6%; p=0.020). These results remained consistent after propensity score matching. In multivariable logistic regression analysis, right bundle branch block (odds ratio [OR] 7.19, 95% confidence interval [CI]: 5.18-10.0; p<0.001) and diabetes mellitus (OR 1.38, 95% CI: 1.05-1.80; p=0.021) emerged as predictors of PPI, whereas the COT (OR 0.63, 95% CI: 0.49-0.82; p<0.001) was protective., Conclusions: The introduction of the COT was associated with a significant and relevant reduction of PPI and paravalvular regurgitation rates without an increase in complication rates.

Background: Transcatheter mitral valve implantation (TMVI) with self-expanding (SAV) or balloon-expandable (BAV) valves are rising as promising treatment options for high-risk patients with symptomatic mitral valve (MVD) disease unsuitable for alternative treatment options., Aims: The aim of this study was to examine the clinical, procedural and outcome parameters of patients undergoing SAV or BAV for MVD., Methods: In this observational and single-center case series, fifteen consecutive patients treated with the Tendyne Mitral Valve System (SAV) and thirty-one patients treated with SAPIEN prosthesis (BAV) were included., Results: The patients (aged 78 years [interquartile range (IQR): 65.5 to 83.1 years], 41% women, EuroSCORE II 10.3% [IQR: 5.5 to 17.0%] were similar regarding baseline characteristics, despite a higher rate of prior heart valve surgery and prevalence of MV stenosis in the SAV-group. At discharge, the SAV-group had a mean transvalvular gradient of 4.2 mmHg, whereas the BAV-group had a mean transvalvular gradient of 6.2 mmHg. None or trace paravalvular leakage (PVL) was assessed in 85% in SAV-group and 80% in the BAV-group. 320 day all-cause and cardiac mortality rates were comparable in both groups (SAV: 26.7% vs BAV: 20%, p = 0.60). Four deaths occurred early in the SAV-group until 32 days of follow-up., Conclusions: In high-risk patients with MVD, TMVI presents a promising treatment option with encouraging mid-term outcomes and good valve durability. TMVI either with BAV or SAV may be developed to an established treatment option., (© 2022. The Author(s).)

Objective: This study aimed to assess short-term outcomes of patients with failed aortic valve bioprosthesis undergoing valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) or redo surgical aortic valve replacement (rSAVR)., Methods: Between 2009 and 2019, 90 patients who underwent ViV-TAVR ( n  = 73) or rSAVR ( n  = 17) due to failed aortic valve bioprosthesis fulfilled the inclusion criteria. Groups were compared regarding clinical end points, including in-hospital all-cause mortality. Patients with endocarditis and in a need of combined cardiac surgery were excluded from the study., Results: ViV-TAVR patients were older (78.0 ± 7.4 vs. 62.1 ± 16.2 years, p  = 0.012) and showed a higher prevalence of baseline comorbidities such as atrial fibrillation, diabetes mellitus, hyperlipidemia, and arterial hypertension. In-hospital all-cause mortality was higher for rSAVR than in the ViV-TAVR group (17.6 vs. 0%, p  < 0.001), whereas intensive care unit stay was more often complicated by blood transfusions for rSAVR patients without differences in cerebrovascular events. The paravalvular leak was detected in 52.1% ViV-TAVR patients compared with 0% among rSAVR patients ( p  < 0.001)., Conclusion: ViV-TAVR can be a safe and feasible alternative treatment option in patients with degenerated aortic valve bioprosthesis. The choice of treatment should include the patient's individual characteristics considering ViV-TAVR as a standard of care., Competing Interests: None declared., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background: Transcatheter aortic valve replacement (TAVR) has become an established alternative to surgical aortic valve replacement (AVR) for higher risk patients. Periprocedural TAVR complications decreased with a growing expertise of implanters. Yet, TAVR can be accompanied by life-threatening adverse events such as intraprocedural cardiopulmonary resuscitation (CPR). This study retrospectively analyzed predictors and outcomes in a cohort of patients from a high-volume center undergoing periprocedural CPR during TAVR., Methods: A total of 729 patients undergoing TAVR, including 59 with intraprocedural CPR, were analyzed with respect to peri- and postprocedural outcomes., Results: Patients undergoing CPR showed a significantly lower left ventricular ejection fraction (LVEF) and lower baseline transvalvular mean and peak pressure gradients. The systolic blood pressure measured directly preoperatively was significantly lower in the CPR cohort. CPR patients were in a higher need for intraprocedural defibrillation, heart-lung circulatory support, and conversion to open heart surgery. Further, they showed a higher incidence of atrioventricular block grade III , valve malpositioning, and pericardial tamponade. The in-hospital mortality was significantly higher after intraprocedural CPR, accompanied by a higher incidence of disabling stroke, new pacemaker implantation, more red blood cell transfusion, and longer stay in intensive care unit., Conclusion: Impaired preoperative LVEF and instable hemodynamics before valve deployment are independent risk factors for CPR and are associated with compromised outcomes. Heart rhythm disturbances, malpositioning of the prosthesis, and pericardial tamponade are main causes of the high mortality of 17% reported in the CPR group. Nevertheless, mechanical circulatory support and conversion to open heart surgery reduce mortality rates of CPR patients., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: Several supra-annular self-expanding transcatheter systems are commercially available for transcatheter aortic valve implantation (TAVI). Comparative data in large-scale multicenter studies are scant., Methods: This study included a total of 5175 patients with severe aortic stenosis undergoing TAVI with the ACURATE neo (n = 1095), Evolut R (n = 3365), or Evolut PRO (n = 715) by a transfemoral approach at five high-volume centers. Propensity score matching resulted in 654 triplets. Outcomes are reported according to the Valve Academic Research Consortium-3 (VARC-3) consensus., Results: Moderate or severe paravalvular regurgitation (PVR) occurred significantly more often in the ACURATE neo group (5.2%) than in the Evolut R (1.8%) and Evolut PRO (3.3%) groups (p = 0.003). The rates of major vascular-/access-related complications (4.6%, 3.8%, and 5.0%; p = 0.56), type 3 or 4 bleeding (3.2%, 2.1%, and 4.1%; p = 0.12), and 30-day mortality (2.4%, 2.6%, and 3.7%; p = 0.40) were comparable. The rate of new permanent pacemaker implantation (PPI) was significantly lower in the ACURATE neo group (9.5%, 17.6%, and 16.8%; p < 0.001). Independent predictors for 2-year survival were a Society of Thoracic Surgeons (STS) risk score ≥5%, diabetes mellitus, a glomerular filtration rate <30 ml/min, baseline mean transvalvular gradient ≤ 30 mm Hg, treating center, and relevant PVR., Conclusion: In this multicenter study, TAVI with the ACURATE neo, Evolut R, or Evolut PRO was feasible and safe. The rate of relevant PVR was more frequent after the ACURATE neo implantation, with, however, lower rates of PPI. Two-year survival was mainly driven by baseline comorbidities., (Copyright © 2022 Hellenic Society of Cardiology. Published by Elsevier B.V. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) is associated with excellent results in patients with severe aortic stenosis. In highly calcified aortic anuli with increased risk of annulus rupture and in favor of the supra-annular design, self-expandable prostheses are frequently used. In this regard, we aimed to perform a comparative analysis of clinical and 30-day outcomes after TAVR using the self-expanding CoreValve ® Evolut R or ACURATE neo™ prosthesis., Methods: Out of 343 consecutive patients treated with either CoreValve ® Evolut R or ACURATE neo™ from January 2014 to December 2017, 76 patients were assigned each per group after 1:1 propensity score matching in regard of preoperative characteristics. Pre- and periprocedural outcomes were retrospectively collected and assessed. Outcomes at 30 days are reported according to the established Valve Academic Research Consortium (VARC-2) criteria., Results: Device success and 30-day survival accounted for 93.4% ( n  = 71), respectively 97.4% ( n  = 74) in both groups (p = 1.00). No statistically significant differences regarding clinical parameters were observed. The combined safety endpoint at 30 days was comparable (84.2% ( n  = 64) CoreValve ® vs 85.5% ( n  = 65) ACURATE neo™; p = 0.848). Except a trend toward higher stroke (p = 0.08) and pacemaker (p = 0.07) rate in the CoreValve ® group, major vascular complications, incidence of life-threatening or disabling bleeding, and incidence of postoperative acute kidney injury were comparable. Postoperative hemodynamic parameters showed no significant differences between the implanted valves., Conclusion: Both self-expandable prostheses showed good postoperative hemodynamic performance with a low incidence of severe paravalvular leakage, all- cause mortality, and comparable clinical outcomes.

Objectives: This study aimed to compare hemodynamic characteristics of different self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THV) in relation to native aortic annulus anatomy., Background: A patient centered THV selection becomes increasingly important as indications for transcatheter aortic valve replacement (TAVR) are extended towards lower risk populations., Methods: Hemodynamic parameters including mean gradient (MG), effective orifice area (EOA), Doppler velocity index (DVI), degree of paravalvular regurgitation (PVR) and patient-prosthesis mismatch (PPM) were compared by valve type, label size and in relation to quintiles of native aortic annulus area., Results: 2609 patients were treated at 3 centers in Germany with SAPIEN 3 (n = 1146), ACURATE Neo (n = 649), Evolut R (n = 546) or Evolut Pro (n = 268) THV. SE THVs provided superior hemodynamics in terms of larger EOA, higher DVI and lower MG compared to BE THV, especially in patients with small aortic annuli. Severe PPM was less frequent in SE treated patients. The rate of PVR ≥ moderate was comparable for SE and BE devices in smaller annular dimensions, but remarkably lower for BE TAVR in large aortic annular dimensions (> 547.64 mm 2 ) (2% BE THV vs. > 10% for SE THV; p < 0.001)., Conclusions: Patients with small aortic annular dimensions may benefit hemodynamically from SE THV. With increasing annulus size, BE THV may have advantages since PVR ≥ moderate occurs less frequently., (© 2022. The Author(s).)

Introduction: The incidence of new permanent pacemaker implantation (PPI) after rapid deployment aortic valve replacement (RDAVR) remains debated. Expertise in this field has significantly increased over the last decade. This study aimed to investigate the need for PPI following implantation of a rapid deployment (RD) valve., Methods: Analysis of n=372 patients who underwent Edwards INTUITY (Edwards Lifesciences, Irvine, CA, USA) (n=251) and Perceval (Sorin/LivaNova Group, Saluggia, Italy) (n=121) valve replacement at the current institution between May 2012 and August 2018 was performed. Coronary artery bypass graft procedures were additionally performed in patients with coronary artery disease. Baseline, preoperative and postoperative outcomes were examined regarding correctness and completeness of the procedure. Statistical analysis was performed using SPSS Version 23.0.0 (IBM Corp, Armonk, NY, USA)., Results: A total of 372 patients (aged 75±6.3 yrs) with a high grade of aortic valve stenosis underwent either Edwards INTUITY (67%) or Perceval (33%) valve replacement. Seventy-six (76) patients (20%) presented with preoperative conduction disorders. Sixty (60) patients (16%) underwent PPI, which in most cases was performed during the first month after the initial operation. Follow-up was performed up to 9 years, presenting a persistent pacemaker dependency rate of 50% among all patients who underwent PPI. Twenty (20) (40%) PPI recipients showed no dependency on pacemaker, while 10 (10%) required temporary pacemaker support. Mean length of ICU stay was 4±5.1 days and in-hospital stay was 8.2±7.6 days., Conclusions: The incidence of PPI after RD valve implantation still remains high compared with conventional aortic valve replacement. However, this study shows that this phenomenon appears to be transient in a significant proportion of the patients undergoing RD valve replacement. These findings might contribute to the scientific discussion and should be taken into consideration for the indication of RD valve replacement., (Copyright © 2022 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Background: In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) and heart failure with severely reduced ejection fraction, prediction of postprocedural left ventricular ejection fraction (LVEF) improvement is challenging. Decision-making and timing for implantable cardioverter defibrillator (ICD) treatment are difficult and benefit is still unclear in this patient population., Objective: Aims of the study were to analyse long-term overall mortality in TAVI-patients with a preprocedural LVEF ≤ 35% regarding LVEF improvement and effect of ICD therapy., Methods and Results: Retrospective analysis of a high-risk TAVI-population suffering from severe AS and heart failure with a LVEF ≤ 35%. Out of 1485 TAVI-patients treated at this center between January 2013 and April 2018, 120 patients revealed a preprocedural LVEF ≤ 35% and had sufficient follow-up. 36.7% (44/120) of the patients suffered from persistent reduced LVEF without a postprocedural increase above 35% within 1 year after TAVI or before death, respectively. Overall mortality was neither significantly reduced by LVEF recovery above 35% (p = 0.31) nor by additional ICD treatment in patients with persistent LVEF ≤ 35% (p = 0.33)., Conclusion: In high-risk TAVI-patients suffering from heart failure with LVEF ≤ 35%, LVEF improvement to more than 35% did not reduce overall mortality. Patients with postprocedural persistent LVEF reduction did not seem to benefit from ICD treatment. Effects of LVEF improvement and ICD treatment on mortality are masked by the competing risk of death from relevant comorbidities., (© 2021. The Author(s).)

Background:  Rapid deployment aortic valve replacement (RDAVR) and transcatheter aortic valve implantation (TAVI) have emerged as increasingly used alternatives to conventional aortic valve replacement to treat patients at higher surgical risk. Therefore, in this single-center study, we retrospectively compared clinical outcomes and hemodynamic performance of two self-expanding biological prostheses, the sutureless and rapid deployment valve (RDV) Perceval-S (PER) and the transcatheter heart valve (THV) ACURATE neo /TF (NEO) in a 1:1 propensity-score-matching (PSM) patient cohort., Methods:  A total of 332 consecutive patients with symptomatic aortic valve stenosis underwent either singular RDAVR with PER (119) or TAVI with NEO (213) at our institutions between 2012 and 2017. To compare the unequal patient groups, a 1:1 PSM for preoperative data and comorbidities was conducted. Afterward, 59 patient pairs were compared with regard to relevant hemodynamic parameter, relevant paravalvular leak (PVL), permanent postoperative pacemaker (PPM) implantation rate, and clinical postoperative outcomes., Results:  Postoperative clinical short-term outcomes presented with slightly higher rates for 30-day all-cause mortality (PER = 5.1% vs. NEO = 1.7%, p  = 0.619) and major adverse cardiocerebral event in PER due to cerebrovascular events (transient ischemic attack [TIA]-PER = 3.4% vs. TIA-NEO = 1.7%, p  = 0.496 and Stroke-PER = 1.7% vs. Stroke-NEO = 0.0%, p  = 1). Moreover, we show comparable PPM rates (PER = 10.2% vs. NEO = 8.5%, p  = 0.752). However, higher numbers of PVL (mild-PER = 0.0% vs. NEO = 55.9%, p  = 0.001; moderate or higher-PER = 0.0% vs. NEO = 6.8%, p  = 0.119) after TAVI with NEO were observed., Conclusion:  Both self-expanding bioprostheses, the RDV-PER and THV-NEO provide a feasible option in elderly and patients with elevated perioperative risk. However, the discussed PER collective showed more postoperative short-term complications with regard to 30-day all-cause mortality and cerebrovascular events, whereas the NEO showed higher rates of PVL., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: The objective of this study was to assess imaging predictors of mitral regurgitation (MR) improvement and to evaluate the impact of MR regression on long-term outcome in patients undergoing transcatheter aortic valve replacement (TAVR)., Background: Concomitant MR is a frequent finding in patients with severe aortic stenosis but usually left untreated at the time of TAVR., Methods: Mitral regurgitation was graded by transthoracic echocardiography before and after TAVR in 677 consecutive patients with severe aortic stenosis. 2-year mortality was related to the degree of baseline and discharge MR. Morphological echo analysis was performed to determine predictors of MR improvement., Results: 15.2% of patients presented with baseline MR ≥ 3 +, which was associated with a significantly decreased 2-year survival (57.7% vs. 74.4%, P < 0.001). MR improved in 50% of patients following TAVR, with 44% regressing to MR ≤ 2 +. MR improvement to ≤ 2 + was associated with significantly better survival compared to patients with persistent MR ≥ 3 +. Baseline parameters including non-severe baseline MR, the extent of mitral annular calcification and large annular dimension (≥ 32 mm) predicted the likelihood of an improvement to MR ≤ 2 +. A score based on these parameters selected groups with differing probability of MR ≤ 2 + post TAVR ranging from 10.5 to 94.4% (AUC 0.816; P < 0.001), and was predictive for 2-year mortality., Conclusion: Unresolved severe MR is a critical determinant of long term mortality following TAVR. Persistence of severe MR following TAVR can be predicted using selected parameters derived from TTE-imaging. These data call for close follow up and additional mitral valve treatment in this subgroup. Factors associated with MR persistence or regression after TAVR.

Background: Surgical aortic valve replacement (SAVR) is nowadays discussed whether it remains the gold standard of treatment. In the last decade, there has been a tremendous increase in transcatheter aortic valve implantation (TAVI) due to the growing expertise and excellent results of the catheter-based approach. We, therefore, retrospectively compared the rapid deployment valve (RDV), the Edwards Intuity valve (IEV), with the Edwards Sapien 3 (S3V) with regard to post-procedural hemodynamics., Methods: A total of 246 patients treated with TAVI or SAVR between February 2009 and November 2015 were included. One-hundred twenty-five patients were analyzed in the SAVR group and compared with 121 patients undergoing TAVI. Transvalvular pressure gradients (PGs) and the incidence and extent of aortic regurgitation (AR) were compared post-procedurally by echocardiography for each valve size. In vitro hemodynamics were analyzed by placing both valves into an aortic silicone phantom connected to a pulsatile flow pump and measured using phase-contrast magnetic resonance imaging (4D flow MRI)., Results: Post-procedurally, mean transvalvular PGs for the 23 mm valves were 9 (7;11.5) versus 13 (9;18) ( p  < 0.001), whereas maximum PGs were 16.5 (14;22) versus 25.5 mm Hg (17.5;34) ( p  < 0.001) in IEV and S3V patients, respectively. The 21 mm IEV showed significantly lower transvalvular PGs compared with the 23 mm S3V: mean PGs: 11 (8;13) versus 13 (9;18) ( p  < 0.05); maximum PG: 19.5 (13;24) versus 25.5 (18;34) mm Hg ( p  < 0.05). Analysis revealed significantly lower post-procedural transvalvular PGs for larger valves sizes. With respect to AR, the incidence of AR was significantly lower in IEV group ( p  < 0.05). In vitro velocities and turbulent kinetic energy values showed similar results between both valves., Conclusion: Implanted RDVs presented a lower incidence of paravalvular regurgitation and were associated with significantly lower post-procedural transvalvular PGs, especially for small valve sizes. Our data might support the application of rapid deployment aortic valves in patients with small aortic annulus in the TAVI era., Competing Interests: None., (Thieme. All rights reserved.)

Objective: Residual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on residual PVR after TAVR with different next-generation transcatheter heart valves., Methods: 642 patients underwent TAVR with a SAPIEN 3 (S3; n=292), ACURATE neo (NEO; n=166), Evolut R (ER; n=132) or Lotus (n=52). Extent, location and asymmetry of DLZ calcification were assessed from contrast-enhanced CT imaging and correlated to PVR at discharge., Results: PVR was ≥moderate in 0.7% of S3 patients, 9.6% of NEO patients, 9.8% of ER patients and 0% of Lotus patients (p<0.001), and these differences remained after matching for total DLZ calcium volume. The amount of DLZ calcium was significantly related to the degree of PVR in patients treated with S3 (p=0.045), NEO (p=0.004) and ER (p<0.001), but not in Lotus patients (p=0.698). The incidence of PVR ≥moderate increased significantly over the tertiles of DLZ calcium volume (p=0.046). On multivariable analysis, calcification of the aortic valve cusps, LVOT calcification and the use of self-expanding transcatheter aortic valve implantation (TAVI) prostheses emerged as predictors of PVR., Conclusions: The susceptibility to PVR depending on the amount of calcium was mainly observed in self-expanding TAVI prostheses. Thus, DLZ calcification is an important factor to be considered in prosthesis selection for each individual patient, keeping in mind the trade-off between PVR reduction, risk of new pacemaker implantation and unfavourable valve ha emodynamics., Competing Interests: Competing interests: FD received speakers honoraria from Boston Scientific. NS received travel compensation from Edwards and speakers honoraria and travel compensation from Boston Scientific. VR received speakers honoraria from Medtronic. TCWW and NM are proctors for Edwards. SB is a proctor for Edwards and received a research grant from Edwards. US is proctor for Edwards and Symetis SA and received research grants from Symetis SA and Edwards. TR is proctor for Boston Scientific and and received speakers honoraria from Edwards, Medtronic and Boston Scientific/Symetis., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background:  The latest generation of balloon-expandable valve, the Edwards Sapien 3 valve (S3V), was designed to reduce paravalvular regurgitation (PVR). We retrospectively compared S3V with Edwards Sapien XT valve (SXTV) with regard to postprocedural transvalvular pressure gradients (PGs)., Methods:  Analysis of 152 patients receiving SXTV and 125 patients receiving S3V between February 2009 and April 2015 was performed. Transvalvular PGs and the incidence and extent of aortic regurgitation (AR) were compared postprocedurally by echocardiography for each valve size., Results:  Postprocedurally, mean PGs for the 23 mm valves were 10.9 ± 5.3 versus 13.9 ± 5.1 ( p  = 0.017), whereas maximum PGs were 19.9 ± 8.3 versus 26.1 ± 10.4 mm Hg ( p  = 0.005) in SXTV and S3V patients, respectively. For the 26 mm valves, gradients were also significantly higher in S3V patients (mean PG: 11.6 ± 4.9 vs. 9.2 ± 4.2 [ p  = 0.004]; maximum PG: 23.0 ± 10.1 vs. 17.2 ± 7.4 mm Hg [ p  < 0.001]). Analysis revealed no significant differences in postprocedural transvalvular PGs for 29 mm valves (mean PG of 9.3 ± 3.9 and 11.2 ± 4.3 mm Hg [ p  = ns] and maximum PG of 17.5 ± 7.2 vs. 20.9 ± 6.8 mm Hg [ p  = ns]) between SXTV and S3V groups, respectively. With respect to PVR, the incidence of AR was significantly lower in S3V group ( p  = 0.001)., Conclusion:  S3V shows lower incidence of PVR; however, it is associated with significantly higher postprocedural transvalvular PGs for 23 and 26 mm valve sizes. These data might contribute to the scientific discussion, especially with respect to prosthesis selection in individual patients with small annular dimension., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Georg Thieme Verlag KG Stuttgart · New York.)

Aims: To identify predictors of paravalvular regurgitation (PVR) and permanent pacemaker implantation (PPI) following TAVR with a next-generation self-expanding device., Methods and Results: Device landing zone (DLZ) calcification, angiographic implantation depth, and baseline and procedural characteristics were analyzed in 212 patients being treated with the ACURATE neo aortic bioprosthesis. PVR was none/trace in 57.1% and ≥ mild in 42.9% (37% mild, 6% moderate). DLZ calcification (705 (IQR 240-624) vs. 382 (IQR 240-624) mm 3 ; P < 0.001) as well as absolute calcium asymmetry (233 ± 159 vs. 151 ± 151 mm 3 ; P < 0.001) was significantly higher in patients with PVR ≥ mild. On multivariate analysis, calcification of the aortic valve cusps (AVC) > 410.6 mm 3 was independently associated with PVR ≥ mild. PPI rate was 10.3% (n = 20). Patients with and without need for PPI had similar total DLZ calcium volume (740 (IQR 378-920) vs. 536 (IQR 315-822) mm 3 ; P = 0.263), but exhibited different calcium distribution patterns: LVOT calcium > 41.4 mm 3 in the sector below the left coronary cusp (LVOT LC ) was associated with increased PPI risk (26.9 vs. 7.7%; P = 0.008)., Conclusions: The quantity of AVC calcium predicts residual PVR. Multivariable analysis identified LVOT LC calcium, pre-existing RBBB, and age > 82.7 years as independent predictors of PPI. Based on these risk factors, a patient's individual PPI risk can be stratified ranging from 3.8 to 100%.

Background: The frequency of circulating endothelial cells (CEC) in patients' peripheral blood can be assessed as a direct marker of endothelial damage. However, conventional enumeration methods are extremely challenging. We developed a novel, automated approach to determine CEC frequencies and tested this method on two groups of patients undergoing conventional (CAVR) versus trans-catheter aortic valve implantation (TAVI)., Methods: CEC frequencies were assessed by a flow cytometric approach, including automated pre-enrichment of CD34 positive blood cell subpopulation and isotype controls. The efficacy and reproducibility of the CEC enumeration method was validated by spiking blood samples of healthy control donors with defined numbers of endothelial cells., Results: CEC frequencies were significantly higher in the TAVI group before (9.8 ± 4.1 vs. 5.5 ± 2.2, p = 0.019) and 1 h after surgery (13.4 ± 5.1 vs. 8.2 ± 4.1, p = 0.030) corresponding to higher Euroscore, STS score in higher risk patients from the TAVI group. Five days after surgery, CEC frequencies became significantly higher in the more invasive CAVR group (39.0 ± 13.0 vs. 14.3 ± 4.4, p < 0.001) compared to minimally invasive TAVI approach., Conclusions: The new flow cytometric approach might be a robust and reliable method for CEC enumeration. Initial results show that CEC frequency is a valid clinical marker for the assessment of pre-operative risk, invasiveness of surgical procedure and clinical outcome. Further studies are necessary to validate the practical clinical usefulness and the potential superiority compared to conventional markers.

Objectives: The aim of this study was to identify predictors of permanent pacemaker implantation (PPMI) following transcatheter aortic valve replacement (TAVR) with a balloon-expandable transcatheter valve (Edwards SAPIEN 3)., Background: New-onset conduction disturbances requiring PPMI remain a major concern following TAVR. Predictors are not yet well defined., Methods: The influence of angiographic implantation depth, device landing zone calcium volume, oversizing, pre- and post-dilation, and baseline conduction disturbances on PPMI rate was analyzed in 229 patients undergoing TAVR with the SAPIEN 3 device., Results: PPMI was performed in 14.4% of patients. Patients requiring PPMI had higher left ventricular outflow tract (LVOT) calcium volume in the area below the left coronary cusp (LVOT LC ) and the area below right coronary cusp (LVOT RC ) (LVOT LC median calcium 23.7 mm 3 vs. 3.0 mm 3 ; p < 0.001; LVOT RC median calcium 6.6 mm 3 vs. 0.3 mm 3 ; p = 0.014), a higher prevalence of pre-existing right bundle branch block (15% vs. 2%, p = 0.004), and lower implantation depth (ventricular portion of the stent frame 29 ± 12% vs. 21 ± 5%; p < 0.001). On multivariate regression analysis, LVOT LC calcium volume >13.7 mm 3 , LVOT RC calcium volume >4.8 mm 3 , pre-existing right bundle branch block, and implantation depth >25.5% emerged as independent predictors of PPMI. Upon modification of the implantation technique, aiming at a high final valve position, implantation depth decreased from 24% ventricular portion to 21% (p = 0.012), accompanied by a decrease in PPMI rate (19.2% vs. 9.2%; p = 0.038)., Conclusions: LVOT LC and LVOT RC calcium load, baseline right bundle branch block, and implantation depth were identified as independent predictors of the need for PPMI post-TAVR. Patient groups with different PPMI risk could be stratified using these 4 predictors. A slightly higher valve implantation site may prevent excessive PPMI rates., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Antifibrinolytics are widely used in cardiac surgery to save blood perioperatively. In the present study we evaluated the hemostatic effects of tranexamic acid (TXA) to decrease bleeding tendency and transfusion requirements in high-risk patients following transapical aortic valve implantation (TA-AVI)., Methods: A retrospective analysis was performed on aortic stenosis patients undergoing TA-AVI with or without intraoperative TXA administration to determine postoperative blood loss and transfusion requirements. From January 2009 to August 2010 in total 92 patients were treated without intraoperative TXA administration, from August 2010 to July 2011 54 patients received TXA intraoperatively., Results: Early postoperative (24 h) blood loss was significantly lower in TXA-group than in non-TXA group (327 ± 274 mL vs. 481.1 ± 318.8 mL; p = 0.003). In the TXA group 53.7% of patients received allogeneic blood products during the hospital stay as compared to 72.8% in the non-TXA group (p = 0.242). TXA group required fewer transfusions (2.1 ± 1.9 vs. 2.9 ± 3.5 Units; p = 0.046) and had no increased incidence of thrombotic or neurological complications. There was no significant difference in the length of ICU, hospital stay, or 30-day mortality. Administration of tranexamic acid was found to be significantly associated with lower blood loss postoperatively (p = 0.002). Furthermore, there was a significant correlation between the postoperative blood loss (p = 0.036) and red blood cell transfusion (p = 0.001) with 30-day mortality., Conclusion: Low dose prophylactic intraoperative administration of tranexamic acid appears to be effective in reducing postoperative bleeding and the need for allogeneic blood products following TA-AVI.

Objective: Contrast-induced nephropathy (CIN) is the third most common cause of acute renal failure and is associated with increased morbidity and in-hospital mortality. Some recent studies identified female sex as a risk factor of CIN. The aim of this study was to determine the relative impact of female sex on the development and clinical outcome of CIN in patients with preexisting renal impairment after transapical transcatheter aortic valve implantation (TAVI)., Methods: From February 2008 to February 2011, a total of 55 TAVI patients [82.4 (6.5) years] with preprocedural serum creatinine level of greater than 1.1 mg/dL were retrospectively investigated. The incidence of postprocedural CIN, lengths of intensive care unit and hospital stay, and short-term mortality among men and women were compared. Contrast-induced nephropathy was defined as a creatinine increase of greater than 0.5 mg/dL or greater than 25% from baseline within 3 days after contrast medium (CM) exposure., Results: The women had significantly lower body surface area [1.8 (0.18) vs 1.95 (0.17) m2; P = 0.002), lower hemoglobin levels [11.5 (1.3) vs 12.7 (1.6) g/dL, P < 0.001], and lower estimated glomerular filtration rate [34.2 (9.7) vs 49.4 (12.3) mL/min per 1.73 m2, P = 0.002]. The amount of CM given was significantly higher in the women relative to body surface area [67.3 (42.5) vs 48.3 (16.6) mL/m2, P = 0.043]. The women received a higher number of blood cell transfusion units [4.4 (3.4) vs 2.1 (2.7) U, P = 0.006]. The frequency of CIN within 72 hours after CM exposure was significantly higher in the women (62.1% vs 26.9%, P = 0.009). A total of 31% of the women (n = 9) versus 7.7% of the men (n = 2) needed hemodialysis (P = 0.031). Analysis of the postoperative morbidity in terms of length of intensive care unit and hospital stay revealed no significant difference between the two groups. Mortality results reached a significant difference at 60 days, with 31% (n = 9) mortality in the women compared with 7.7% (n = 2) in the men (P = 0.031)., Conclusions: Women with preexisting renal impairment are at higher risk than men for CIN, with resultant higher early mortality after transapical TAVI.

Background: We determined our 30-day results after transapical aortic valve implantation (TA-AVI) according to Valve Academic Research Consortium criteria, analyzed midterm outcome, and summarize our institutional learning experience., Methods: From February 2008 to July 2011, 150 high-risk patients underwent TA-AVI. Endpoints of this retrospective analysis were safety as indicated by morbidity and 30-day mortality and midterm survival with a follow-up period up to 3.4 years (mean follow-up 14.1 months). In addition we analyzed our institutional learning curve by comparing the outcome of our first 50 patients (group 1) to the following 100 patients (group 2)., Results: Procedural success was 98% (147 patients). All-cause and cardiovascular cause 30-day mortality was 11.3% (n = 17) and 7.3% (n = 11), respectively. The cumulative survival rates were 78.7% at one year, 62.8% at two years, and 50.8% at three years. As compared to group 1, there was a significantly reduced incidence of relevant bleeding complications (0% vs. 14%[n = 7]; p < 0.001) and a reduced incidence of acute kidney injury (35%[n = 35] versus 56% (n = 28); p < 0.05) in group 2, resulting in a combined safety endpoint at 30 days of 22% in group 2 versus 40% in group 1 (p < 0.05). One-year mortality (group 2, n = 20 [20%] versus group 1, n = 10 [20%]; p = 1) and midterm survival (p = 0.998; Hazard ratio 1.001; 95% CI 0.5141 to 1.949) did not differ significantly., Conclusions: Although the incidence of technical complications decreased significantly over time, 30-day and midterm mortality were unaltered, most likely due to patients' comorbidities. The development of more accurate risk scores may improve future outcome., (© 2012 Wiley Periodicals, Inc.)

Objective: Transcatheter aortic valve implantation (TAVI) has been developed to minimize the operative trauma in high-risk patients. Patient selection for TAVI is still subject to debate and octogenarians are often regarded as high-risk patients., Methods: In this single-center study, data of 169 octogenarians who received conventional AVR (90) or TAVI (79) have been analyzed retrospectively according to the endpoint definitions of the Valve Academic Research Consortium to answer the following questions: (a) Should patients due to their age of 80 years or older be considered as high risk? (b) Is the EuroSCORE a suitable tool for estimating mortality after AVR or TAVI in octogenarians? (c) Is TAVI the procedure of choice for octogenarians?, Results: TAVI patients showed higher comorbid conditions concerning an existing renal dysfunction (31 vs. 56%, p = 0.001), peripheral vascular disease (6 vs. 30%, p < 0.001), diabetes (19% vs. 49%, p < 0.001), a decreased ejection fraction (LVEF < 30%: 2 vs. 13%, p < 0.05), and pulmonary hypertension (23 vs. 48%; p < 0.005) with an increase of the perioperative risk represented by logistic EuroSCORE (AVR 11% ± 1.27 vs. TAVI 38% ± 1.35; p < 0.0005) and STS Score (7% ± 0.52 vs. 14% ± 0.56; p < 0.0005). All-cause and cardiovascular-cause in-hospital or 30-day mortality was 5.6% (n = 5) and 3.4% (n = 3) in the AVR cohort and 8.8% (n = 7) and 7.6% (n = 6) in TAVI-patients (p = 0.55; p = 0.31), respectively. The overall combined safety endpoint at 30 days was 22.2% (n = 20) in AVR patients and 29.1% (n = 23) with regard to the TAVI group (p = 38). Analysis of cerebrovascular complications, vascular complications, and pacemaker revealed no significant differences. In the AVR group, actuarial survival at 6 months and 1 and 2 years was 89, 78, and 74%, respectively. Data of the TAVI patients are only available for a follow-up of 6 months and revealed a survival of 85%., Conclusion: AVR and TAVI in octogenarians show comparable results, but the analyzed cohorts differ significantly in their risk profile. The results indicate an overrated perioperative mortality using the EuroSCORE but on the other hand logistic EuroSCORE represents articulately the different risk profile of the two groups. For this reason, we consider the EuroSCORE still to be a useful tool for preoperative risk assessment. Moreover, octogenarians cannot per se be considered as "true high risk" patients. Differentiated clinical judgment is most important for reasonable decision making., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: Patients undergoing transapical aortic valve implantation (TA-AVI) are usually over 80 years old and have a high prevalence of chronic kidney disease. However, transcatheter valve therapies require the use of contrast injections with the risk of nephrotoxicity. The aim of this study was to evaluate post-operative kidney function and survival in patients with pre-existing renal impairment with regard to the amount of contrast media used during TA-AVI., Methods: From January 2008 to March 2011, 50 patients (52% females, mean age 80.7 ± 5.3 years) with a serum creatinine level of >1.3 mg/dl were investigated. Patients receiving a dose of <100 ml of a contrast agent (low-dose group, n = 24) were separated from those who received >100 ml of a contrast agent (high-dose group, n = 26). An acute contrast-induced nephropathy (CIN) was defined as a serum creatinine increase of 0.5 mg/dl or by >25% of a baseline value within 48 h from contrast medium administration. Patients in both groups had similar characteristics in terms of age, sex, body mass index and comorbidities., Results: The median pre-contrast creatinine was 1.67 (1.37-1.83) mg/dl in the low-dose group and 1.51 (1.26-1.98) mg/dl in the high-dose group (P = 0.76). The post-contrast creatinine at 48 h was 1.53 (1.33-2.05) and 2.29 (1.67-2.86) mg/dl in the groups receiving low- and high-dose contrast agents, respectively (P = 0.007). CIN occurred in 41.7% (n = 10) of patients in the low-dose contrast group and in 69.2% (n = 18) in the high-dose contrast group (P = 0.046). Haemodialysis is necessary for 16.7% of the low-dose group and 38.5% of the high-dose group (P = 0.12). Trends towards longer intensive care unit and hospital stay were seen in patients with an extensive use of contrast media [4.3 (2.5-6.5) vs. 5 (3-7.8) days and 12 (9-14.3) vs. 13 (9-18) days, P = 0.091 vs. P = 0.546, respectively]. Regarding death, 3-month and 3-year mortality were significantly higher in the high-dose group (8.3 vs. 30.8%, P = 0.036 and 25 vs. 61.5%, P = 0.004, respectively)., Conclusions: Our results indicate a possible association between higher CIN and mortality rate and the extensive use of contrast media during TA-AVI among high-risk patients with pre-existing renal impairment.

Background: The new technique of minimally invasive transapical aortic valve implantation (TAP-AVI) deals with high-risk patients and despite the absence of cardiopulmonary bypass it might lead to renal impairment. The aim of this study was to estimate the risk of the development of acute kidney injury (AKI) after TAP-AVI and to identify possible risk factors with regard to the morbidity and mortality of the patients., Methods: Data of 30 consecutive patients undergoing TAP-AVI were recorded and followed up for 8 weeks. Postoperative AKI has been defined according to RIFLE criteria. Two patients on chronic hemodialysis have been followed up., Results: Of 28 patients, AKI occurred in 16 patients (57%). Statistical analysis revealed no influence on the risk of developing AKI caused by the dose of applicated contrast medium (p = 0.09), the patient's age (p = 0.5), or the existence of diabetes (p = 0. 16). Analysis concerning the relationship between a preexisting coronary heart disease and AKI showed a tendency to be associated with a higher risk of the development of AKI (70% preexisting congenital heart disease in the AKI group versus 50%; p = 0.28). Only a preoperative serum creatinine greater than 1.1 mg/dL was a strong predictor for developing AKI (p < 0.01). Length of stay in the intensive care unit and the complete length of hospital stay revealed no difference with regard to postoperative development of AKI though statistical analysis showed a trend to a higher mortality in the AKI group (27% vs 6%); univariate analysis did not reach statistical significance (p = 0.13)., Conclusions: The TAP-AVI seems to be a feasible procedure for high-risk patients with a clear risk of developing AKI. Patients at risk should be identified and, if indicated, already preoperatively treated in collaboration with the attending nephrologists., (2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background Advanced visualization software tools have been used in clinics to improve the safety and accuracy of transcatheter procedure. Imaging techniques have greatly evolved during the era of transcatheter aortic valve implantation (TAVI). In a retrospective analysis, we investigated the feasibility of augmented fluoroscopy for iliofemoral access using a novel "Vascular Outlining" roadmapping technology. Methods The Vascular Outlining prototype device (Philips Healthcare) application was used with iliofemoral angiography of 10 patients undergoing transfemoral TAVI. The software processes any conventional angiographic sequences, extracting the static outline of vessels and projecting the two-dimensional vessel margins as a roadmap on live fluoroscopy. Post-processed results were clinically assessed to determine whether the technical performance of the tool is sufficient. Results Augmented imaging was possible in all investigated angiography sequences. The analysis of software-generated images showed accurate projection of the two-dimensional outline of the iliofemoral vessels as an overlay on the live fluoroscopy image in most cases. Overlay inaccuracy was only observed in cases with low contrast or patient movement. Conclusion In static and contrasted angiography sequences, "Vascular Outlining" showed accurate image overlay. We identified that the quality of the vascular outline is dependent on the opacification of the contrast injection and the stability of the patient on the table. With further development. this application might increase the accuracy of femoral puncture and reduce the incidence of vascular complications. Clinical trials are needed to confirm these hypotheses. [ABSTRACT FROM AUTHOR]