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Aims: We aimed to evaluate transcatheter mitral valve implantation (TMVI) using predominantly balloon-expandable transcatheter heart valves (THV) in patients with a landing zone for a percutaneously delivered prosthesis., Background: Patients with a degenerated mitral valve bioprosthesis, annuloplasty ring, and mitral annulus calcification (MAC) considered at high surgical risk currently represent a treatment challenge. TMVI is an alternative treatment option., Methods: Retrospective analysis of patients with symptomatic degenerated mitral valve bioprosthesis, or annuloplasty ring, and MAC treated with TMVI between November 2011 and April 2021. Endpoints were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria and included device and procedure success at 30 days as well as mortality at 30 days and 1 year after the procedure., Results: A total of 77 patients underwent TMVI (valve in valve [ViV = 56], valve in ring [ViR = 11], and valve in MAC [ViMAC = 10]). There was a trend toward higher technical success (all = 93.5%, ViV = 96.4%, ViR = 90.9%, ViMAC = 80%, p = 0.06) and lower 30-day (all = 11.7%, ViV = 10.7%, ViR = 9.1%, ViMAC = 20%, p = 0.49) and 1-year mortality (all = 26%, ViV = 23.2%, ViR = 27.3%, ViMAC= 40%, p = 0.36) after ViV and ViR compared to ViMAC., Conclusion: TMVI represents a reasonable treatment option in selected patients with MAC or who are poor candidates for redo mitral valve surgery. Technical success and survival up to 1 year were not significantly dependent on the subgroup in which TMVI was performed., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Data on systemic inflammatory response syndrome (SIRS) after transcatheter aortic valve implantation (TAVI) are scarce and limited to small cohorts. We aimed to investigate its incidence and mid-term impact in a large cohort of TAVI patients., Methods: From January 2018 to December 2020, 717 patients with severe aortic valve stenosis undergoing TAVI were included. SIRS was defined as fulfilling at least two of the following criteria within 48 h from the procedure: leucocyte count >12.0 or <4.0 × 10 9 /l, respiratory rate > 20 breaths per minute or PaCO 2  ≤ 4.3 kPa/32 mmHg, heart rate > 90 beats per minute and temperature > 38.0 °C or <36.0 °C. Clinical endpoints were 1-year rehospitalization for chronic heart failure (CHF) and 2-years all-cause mortality. Event rates during follow-up were calculated as Kaplan-Meier estimates., Results: SIRS developed in 56.3 % (404/717) of patients after TAVI. SIRS occurred more frequently in patients with post-dilatation (SIRS 34.7 % (140/404) vs. no SIRS 23.3 % (73/313); p < 0.001) and major vascular complications (SIRS 16.1 % (65/404) vs. no SIRS 8.6 % (27/313); p = 0.004). Further, ICU days were more in patients who developed SIRS (SIRS 1.56 ± 1.50 days vs. no SIRS 1.22 ± 1.02 days; p = 0.001). At 2-years, all-cause mortality in the entire population was 23.9 %. However, there was no difference in CHF at 1-year (5.9 % vs. 4.1 %; log-rank = 0.347) nor in all-cause mortality at 2-years (22.0 % vs. 26.2 %; log-rank = 0.690) between the groups., Conclusions: SIRS is a common finding after TAVI, which may prolong hospital stay but is without effect on mortality during 2-years follow-up., Competing Interests: Declaration of competing interest Costanza Pellegrini reports receiving a personal research grant from Else Kröner Fresenius not related to the current work. Stiftung. Tobias Rheude received lecture fees from SIS Medical AG and AstraZeneca and travel support from SIS Medical AG (not related to the current work). Stefan Holdenrieder reports receiving research funding or honoraria from Roche Diagnostics, Bristol Myers Squibb, Merck KgaA, Sysmex Inostics and Volition SPRL. Michael Joner reports lecture fees and research grants from Edwards Lifesciences, Cardiac Dimensions, Infraredx, and Boston Scientific; is a consultant for Biotronik, Boston Scientific, Cardiac Dimensions, and Shockwave Medical; has received honoraria from Abbott, AstraZeneca, Biotronik, Boston Scientific, Edwards Lifesciences, Recor, Shockwave Medical, and Orbus Neich; and is a Member of the Board of Biotronik and Shockwave Medical. The other authors report no conflict of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: Systemic inflammatory response syndrome (SIRS) is a common finding after cardiovascular interventions. Data on the incidence of SIRS and its impact on outcome in patients undergoing transcatheter edge-to-edge mitral valve repair (MV-TEER) for mitral regurgitation (MR) is lacking., Methods: From January 2013 to December 2020, 373 patients with moderate or severe MR undergoing MV-TEER were included. SIRS was defined as at least two of the following criteria within 48 h after the procedure: leucocyte count > 12.0 or < 4.0 × 10 9 /l, respiratory rate > 20 breaths per minute or PaCO 2  ≤ 4.3 kPa/32 mmHg, heart rate > 90 bpm and temperature > 38.0 °C or < 36.0 °C. The primary endpoint was 3-years all-cause mortality., Results: SIRS was observed in 49.6% (185/373) of patients. Patients who developed SIRS presented more frequently with NYHA III/IV at baseline [SIRS: 82.4% (149/185) vs. no SIRS: 79.0% (147/188); p = 0.029]. Patients who developed SIRS spent more days on ICU (p < 0.001) and overall length of stay was longer (p < 0.001). Relevant residual MR, defined as MR ≥ III in-hospital, was present more often in patients who developed SIRS [SIRS: 11.3% (20/177) vs. no SIRS: 3.93% (7/178), p = 0.036]. At 3 years, all-cause mortality in the entire population was 33.5% (125/373) with an increased all-cause mortality in patients with SIRS compared to patients without SIRS (HR 1.49, [CI 95% 1.04, 2.13]; p = 0.0264). In the multivariate analysis development of SIRS (HR 1.479 [CI 95% 1.016, 2.154]; p = 0.041) was identified as predictor for 3-years all-cause mortality., Conclusions: SIRS is a common finding after MV-TEER occurring in approximately half of patients. SIRS after MV-TEER was associated with a longer in-hospital stay. In addition, we observed an increased 3-years all-cause mortality in patients with SIRS., (© 2023. The Author(s).)

Background: Permanent pacemaker implantation (PPI) remains a relevant complication after transcatheter aortic valve implantation (TAVI) and its impact on outcome remains controversial., Aims: This study aimed to analyze the effects of implantation depth on PPI at 30 days and assess its impact on outcome with the balloon-expandable Sapien 3 (S3) prosthesis., Methods: Between 2014 and 2018, 849 patients without previous pacemaker undergoing transfemoral TAVI with the S3 were included. Prosthesis implantation depth was measured and divided into Quintiles. An ordinal logistic regression was used to assess its association with PPI, while a multivariate logistic regression was performed to identify predictors of PPI. Survival analyses were performed with the Kaplan-Meier method and a multivariable Cox regression was performed to ascertain the impact of PPI on mortality., Results: Overall, incidence of PPI at 30 days was 9.7%. Implantation depth decreased consistently from a median of 6.7 mm [5.55-8.00] in 2014 to 2.7 mm [2.30-3.50] in 2018 (p < 0.001). When considering Quintiles of implantation depth, incidence of PPI was significantly higher in upper Quintiles and risk for PPI was significantly lower for the 1. Quintile compared to the 5. Quintile (OR: 0.34, 95% CI: [0.16-0.73]; p = 0.003). In the adjusted multivariable logistic regression implantation depth persisted ad independent predictor of PPI at 30 days. Patients requiring PPI at 30 days displayed significantly higher mortality at 4 years compared to patients without PPI (49.5% vs. 40.0%; log-rank = 0.022). In a multivariate analysis, increased logistic EuroScore, diabetes mellitus, and history of atrial fibrillation, were independent predictors of all-cause mortality at 2 years., Conclusions: Higher prosthesis implantation relative to the virtual aortic annulus was significantly associated with reduced risk for PPI at 30 days. Patients with PPI at 30 days exhibited higher mortality during follow-up, however, only logistic EuroScore, diabetes mellitus, and history of atrial fibrillation were identified as independent predictors of mortality at 2 years., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Transcatheter aortic valve implantation (TAVI) was established as a standard treatment for high-operative risk patients with severe aortic stenosis (AS). Although coronary artery disease (CAD) often coexists with AS, clinical and angiographic evaluations of stenosis severity are unreliable in this specific setting. To provide precise risk stratification of coronary lesions, combined near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS) was developed to integrate morphological and molecular information on plaque composition. However, there is a lack of evidence on the association between NIRS-IVUS derived findings such as maximum 4mm lipid core burden index (maxLCBI 4mm ) and clinical outcomes in AS patients undergoing TAVI. This registry aims to assess feasibility and safety of NIRS-IVUS imaging in the setting of routine pre-TAVI coronary angiography to improve assessment of CAD severity., Methods: The registry is designed as a non-randomized, prospective, observational, multicenter cohort registry. Patients referred for TAVI with angiographic evidence of CAD receive NIRS-IVUS imaging and are followed up to 24 months. Enrolled patients are classified as NIRS-IVUS positive and NIRS-IVUS negative, respectively, based on their maxLCBI 4mm to compare their clinical outcomes. The primary endpoint of the registry is major adverse cardiovascular events over a 24-month follow-up period., Conclusions: Identification of patients likely or unlikely to benefit from revascularization prior to TAVI represents an important unmet clinical need. This registry is designed to investigate whether NIRS-IVUS-derived atherosclerotic plaque characteristics can identify patients and lesions at risk for future adverse cardiovascular events after TAVI, in order to refine interventional decision-making in this challenging patient population., Competing Interests: Disclosures T. Rheude received speaker fees from AstraZeneca and SIS Medical, and travel support from SIS Medical. C. Pellegrini has received the Else Kröner-Memorial grant from the Else Kröner-Fresenius-Stiftung. M. Hadamitzky reports a grant from Cleerly, New York. E. Xhepa reports lecture fees and honoraria from AstraZeneca, Boston Scientific and SIS Medical not related to the current work; proctor fees from Abbott Vascular and financial support for attending meetings and/or travel expenses from Abbott Vascular. A. Kastrati reports personal payments from CRF, New York, for participation on the DSMB Microport TARGET IV trial. H. Schunkert reports grants and personal fees from AstraZeneca; and personal fees from Vifor Pharma, Boehringer Ingelheim, Brahms, Medtronic, Sanofi-Aventis, MSD, Bristol-Meyers Squibb, Servier, Bayer Vital GmbH, Daiichi Sankyo, AMGEN, Novartis, Synlab, and Pfizer, outside the submitted work. M. Joner reports personal fees from Abbott, personal fees from Astra Zeneca, personal fees from Biotronik, grants and personal fees from Boston Scientific, personal fees and grants from Cardiac Dimensions, grants, and personal fees from Edwards, grant from Infraredx, a Nipro company, personal fees from Orbus Neich, personal fees from Recor, personal fees from Shockwave, outside the submitted work. The other authors have no relevant conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Aims: Patients with mitral regurgitation (MR) present with considerable heterogeneity in cardiac damage depending on underlying aetiology, disease progression, and comorbidities. This study aims to capture their cardiopulmonary complexity by employing a machine-learning (ML)-based phenotyping approach., Methods and Results: Data were obtained from 1426 patients undergoing mitral valve transcatheter edge-to-edge repair (MV TEER) for MR. The ML model was developed using 609 patients (derivation cohort) and validated on 817 patients from two external institutions. Phenotyping was based on echocardiographic data, and ML-derived phenotypes were correlated with 5-year outcomes. Unsupervised agglomerative clustering revealed four phenotypes among the derivation cohort: Cluster 1 showed preserved left ventricular ejection fraction (LVEF; 56.5 ± 7.79%) and regular left ventricular end-systolic diameter (LVESD; 35.2 ± 7.52 mm); 5-year survival in Cluster 1, hereinafter serving as a reference, was 60.9%. Cluster 2 presented with preserved LVEF (55.7 ± 7.82%) but showed the largest mitral valve effective regurgitant orifice area (0.623 ± 0.360 cm2) and highest systolic pulmonary artery pressures (68.4 ± 16.2 mmHg); 5-year survival ranged at 43.7% (P-value: 0.032). Cluster 3 was characterized by impaired LVEF (31.0 ± 10.4%) and enlarged LVESD (53.2 ± 10.9 mm); 5-year survival was reduced to 38.3% (P-value: <0.001). The poorest 5-year survival (23.8%; P-value: <0.001) was observed in Cluster 4 with biatrial dilatation (left atrial volume: 312 ± 113 mL; right atrial area: 46.0 ± 8.83 cm2) although LVEF was only slightly reduced (51.5 ± 11.0%). Importantly, the prognostic significance of ML-derived phenotypes was externally confirmed., Conclusion: ML-enabled phenotyping captures the complexity of extra-mitral valve cardiac damage, which does not necessarily occur in a sequential fashion. This novel phenotyping approach can refine risk stratification in patients undergoing MV TEER in the future., Competing Interests: Conflict of interest: None declared ., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Aims: To quantify extra-valvular cardiac damage associated with severe aortic valve stenosis (AS), a novel staging model was proposed. This study aimed to validate this model in patients undergoing transcatheter aortic valve replacement (TAVR) as well as to assess its prognostic impact., Methods and Results: Based on echocardiographic findings, the following stages were applied: isolated AS (stage 0), left ventricular (LV) damage (stage 1), left atrial or mitral valve damage (stage 2), pulmonary hypertension or tricuspid regurgitation (stage 3), or right ventricular dysfunction (stage 4). The primary endpoint was 2-year all-cause mortality. The distribution across stages was 0.8% at stage 0, 7.5% at stage 1, 63.3% at stage 2, 18.3% at stage 3, and 10.1% at stage 4. All-cause mortality increased at all stages 1-4 (12.1%, 18.2%, 26.6%, and 28.2%; p = 0.023). In the multivariate model, the stage of cardiac damage, age, New York Heart Association (NYHA) class III/IV, peripheral artery disease, and previous pacemaker were independent predictors of the primary endpoint., Conclusions: Patients treated for severe AS show a high prevalence of extra-valvular cardiac damage. An increase in stage is associated with higher 2-year all-cause mortality. The application of this staging model may add value to current treatment algorithms., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Pellegrini, Duesmann, Rheude, Berg, Alvarez-Covarrubias, Trenkwalder, Mayr, Schürmann, Nicol, Xhepa and Joner.)

Background: Direct comparisons of latest-generation balloon-expandable versus self-expanding transcatheter heart valves (THV) are scarce. To compare outcomes after transcatheter aortic valve replacement (TAVR) with SAPIEN 3 Ultra (Ultra) versus Evolut R or Pro (Evolut) THVs., Methods: 1612 consecutive patients undergoing TAVR with either Ultra (n = 616) or Evolut (n = 996) were included. After propensity score matching (PSM), 467 and 205 matched pairs were identified in the entire cohort and with latest-generation THVs, respectively. Outcomes were investigated up to 30 days after TAVR., Results: After PSM, baseline characteristics were comparable in the entire cohort (n = 934). Device success (92.7% vs. 87.6%; p = 0.011) and need for permanent pacemaker implantation (PPI) (15.2% vs. 8.4%; p = 0.002) were higher for Evolut compared with Ultra. Elevated gradients (≥20 mm Hg) were less frequent (1.6% vs. 10.4%; p < 0.001), whereas rates of ≥ moderate paravalvular leakage (PVL II+) were more frequent for Evolut compared with Ultra (3.7% vs. 1.3%; p = 0.019). With latest-generation THVs (n = 410), device success was comparable (93.2% vs. 89.8%; p = 0.216), whereas the need for PPI was higher for Evolut Pro compared with Ultra (15.6% vs. 9.8%; p = 0.075). Elevated gradients were less frequent (0% vs. 8%; p < 0.001), whereas rates of PVL II+ were more frequent for Evolut compared with Ultra (5.4% vs. 1.5%; p = 0.028)., Conclusions: Device success rates were high with both THV platforms with low rates of adverse events up to 30 days after TAVR. Compared with Ultra, Evolut was associated with higher pacemaker rates as well as PVL II+, but with less elevated gradients., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Aims: To investigate the clinical outcomes associated with an antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement (TAVR)., Methods and Results: This is a study-level meta-analysis including all randomized trials investigating antithrombotic regimens after TAVR. The protocol was registered with PROSPERO (CRD42020191036). We searched electronic scientific databases for eligible studies. The primary outcome was all-cause death. Main secondary outcome was major bleeding. Other outcomes were life-threatening (or disabling) bleeding, myocardial infarction (MI) and stroke. Six eligible trials randomly allocated 3056 TAVR patients to aspirin or oral anticoagulation (OAC) with clopidogrel (n = 1525) versus aspirin and/or OAC without clopidogrel (n = 1531). In the overall estimates, an antithrombotic therapy with clopidogrel versus without displayed a comparable risk of all-cause death [Risk Ratio-RR = 0.83, 95% Confidence intervals-CI (0.57-1.20); P = 0.25] and major bleeding [RR = 1.33, 95% CI (0.61-2.92); P = 0.39]. However, the combination of aspirin or OAC with clopidogrel doubled the risk of major bleeding as compared to aspirin or OAC without clopidogrel [RR = 2.08, 95% CI (1.27-3.42); P = 0.015, P for interaction = 0.021]. Treatment strategies did not differ with respect to the risk of life-threatening bleeding, MI and stroke., Conclusions: In patients receiving TAVR, a therapeutic strategy of aspirin or OAC with clopidogrel significantly increases the risk of major bleeding without impact on mortality and ischemic outcomes compared to aspirin or OAC without clopidogrel. The performance of different antithrombotic regimens in terms of long-term clinical outcomes and bioprosthesis valve function requires further investigation. Forest plots from pairwise and network meta-analyses associated with an antithrombotic therapy with or without clopidogrel Risk ratio for all outcomes of interest calculated with the pairwise meta-analysis (left side) and for main outcomes calculated with the network meta-analysis (right side) in patients allocated to an antithrombotic therapy with clopidogrel or without. The diamonds indicate the point estimate and the left and the right ends of the lines the [95% CI]. CI: Confidence intervals; OAC; oral anticoagulation., (© 2020. The Author(s).)

Background: Bicuspid aortic valve may be associated with increased complications during transcatheter aortic valve implantation (TAVI)., Aims: Compare balloon-expandable transcatheter heart valve (THV) safety and efficacy in severe tricuspid (TAV) and bicuspid (BAV) aortic stenosis., Methods: Transfemoral TAVI was performed in 743 patients (Jan 2014-June 2019) using the SAPIEN 3 THV. Aortic valve morphology was determined using computed tomography. Valve Academic Research Consortium-2 (VARC-2) derived safety and efficacy endpoints at 1 year were evaluated., Results: BAV patients (n = 78), were younger (77 [72, 81] vs. 81 [78, 85] years, p < 0.001) with lower surgical risk (EuroSCORE II 2.96% vs. 4.51% p < 0.001). Bicuspid valves were more calcified (BAV 1308mm 3 , TAV 848mm 3 p < 0.001) with more asymmetric calcification (BAV 63/78 (81%), TAV 239/665 (36%), p < 0.001). Device success (BAV 94%, TAV 90%, p = 0.45) and major vascular complications (BAV 6%, TAV 9%, p = 0.66) were comparable. At 1 year, there was a trend toward lower combined all-cause mortality and rehospitalization for congestive heart failure in BAV patients (BAV 7%, TAV 13%, p = 0.08) with significantly lower all-cause mortality in this cohort (BAV 1%, TAV 9%, p = 0.020). VARC-2 time-related valve safety (BAV 22%, TAV 20%, p = 0.60) was comparable; however, bioprosthetic valve thrombosis remained more common in BAV patients (BAV 7%, TAV 2%, p = 0.010, Hazard ratio 3.57 [95% confidence interval 1.26, 10.10]). After propensity score matching, only bioprosthetic valve thrombosis remained significantly different., Conclusions: Safety and efficacy of the SAPIEN 3 balloon-expandable THV in BAV is comparable with TAV. Higher rates of bioprosthetic valve thrombosis require further investigation., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: The Sentinel Cerebral Protection System (Sentinel-CPS) is increasingly used in transcatheter aortic valve replacement (TAVR). However, the impact of inserting the Sentinel-CPS inside the brain-supplying arteries on cerebral perfusion and oxygenation is unknown., Methods: Twenty patients undergoing transfemoral TAVR with (n = 10) and without (n = 10) cerebral embolic protection using the Sentinel-CPS were prospectively observed. All patients received conscious sedation and cerebral oxygen saturation (rSO 2 ) was continuously measured with near-infrared spectroscopy (NIRS). The cumulative perioperative cerebral desaturation was calculated for each patient by multiplying rSO 2 below an individualized desaturation threshold by time. In addition, rSO 2 values at the time of Sentinel-CPS insertion, filter positioning, and device retraction were analyzed., Results: There was no significant difference in cumulative cerebral desaturation in patients with Sentinel-CPS (median [IQR]) (0 [0/81] s%) and without (median [IQR]) (0 [0/23] s%), p = .762. A total of 6 patients (33.3%) experienced a perioperative decrease in rSO 2 below the individualized desaturation threshold (n = 3 with Sentinel-CPS, n = 3 without Sentinel-CPS; p = 1.000). Cerebral desaturation was detected during valve deployment (n = 5) and after postdilatation (n = 1). No desaturation events occurred during Sentinel-CPS insertion, filter positioning, or retraction., Conclusion: Our pilot study revealed no difference in cumulative perioperative cerebral desaturation between TAVR with and without Sentinel-CPS. Catheter- and filter-based manipulations in the brain-supplying arteries for Sentinel-CPS application were not associated with a decrease of cerebral perfusion and oxygenation., (© 2021 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals LLC.)

We aimed to evaluate the efficacy and safety of a low-dose imaging protocol to reduce intraprocedural radiation during transcatheter aortic valve implantation (TAVI). Observational analysis: 802 transfemoral TAVI patients receiving balloon-expandable devices ≥23 mm at a high-volume centre. After propensity score matching, a standard-dose group (SD, n = 333) treated between January 2014 and February 2016 was compared with a low-dose group (LD, n = 333) treated between August 2017 and March 2019 after departmental uptake of a low-dose imaging protocol (reduced field size, high table height, use of "fluoro save," 3.75 frames/second acquisition, increased filtering). Primary end point was dose-area product (DAP). Secondary safety end points were VARC-2 device success and a composite of in-hospital complications. The LD protocol was associated with lower DAP (4.64 [2.93, 8.42] vs 22.73 [12.31, 34.58] Gy⋅cm 2 , p <0.001) and fluoroscopy time (10.4 [8.1, 13.9] vs 11.5 [9.1, 15.3] minutes, p = 0.001). Contrast use was higher in the LD group (LD 110 [94, 130] vs SD 100 [80, 135] milliliters, p = 0.042). Device success (LD 88.3% vs SD 91.3%, p = 0.25), and the composite end point (LD 8.1% vs SD 11.4%, p = 0.19) were similar. In multivariate analysis, the low-dose protocol was associated with a 19.8 Gy⋅cm 2 reduction in procedural DAP (p <0.001). In conclusion, compared with standard imaging, a low-dose protocol for TAVI significantly reduced radiation dose without compromising outcomes., Competing Interests: Disclosures This study was performed without external or industry funding. Dr. Michel has received honoraria from Edwards Lifesciences. Dr. Kasel is a consultant and proctor for Edwards Lifesciences. Dr. Frangieh is a consultant and proctor for Edwards Lifesciences. The remaining authors report no disclosures., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Bioprosthetic valve thrombosis may complicate transcatheter aortic valve implantation (TAVI). This meta-analysis sought to evaluate the prevalence and clinical impact of subclinical leaflet thrombosis (SLT) and clinical valve thrombosis (CVT) after TAVI. We summarized diagnostic strategies, prevalence of SLT and/or CVT and estimated their impact on the risk of all-cause death and stroke. Twenty studies with 12,128 patients were included. The prevalence of SLT and CVT was 15.1% and 1.2%, respectively. The risk of all-cause death was not significantly different between patients with SLT (relative risk [RR] 0.77; p = 0.22) and CVT (RR 1.29; p = 0.68) compared with patients without. The risk of stroke was higher in patients with CVT (RR 7.51; p <0.001) as compared with patients without, while patients with SLT showed no significant increase in the risk of stroke (RR 1.81; p = 0.17). Reduced left ventricular function was associated with increased prevalence, while oral anticoagulation was associated with reduced prevalence of bioprosthetic valve thrombosis. Bioprosthetic valve thrombosis is frequent after TAVI, but does not increase the risk of death. Clinical valve thrombosis is associated with a significantly increased risk of stroke. Future studies should focus on prevention and treatment of bioprosthetic valve thrombosis., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to compare outcomes after transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra (Ultra) and SAPIEN 3 (S3) transcatheter heart valves (THVs)., Background: The latest generation balloon-expandable Ultra THV incorporates new technical features and might improve outcomes following TAVR., Methods: This registry included all consecutive patients who underwent TAVR with either the Ultra or S3 between January 2014 and January 2020. One-to-one propensity score matching was performed to account for differences in baseline characteristics. In-hospital and 30-day Valve Academic Research Consortium-2-defined outcomes were investigated., Results: A total of 310 patients (n = 155 Ultra, n = 155 S3) were included. There were no significant differences in baseline characteristics after propensity score matching. Procedures were significantly more often performed under conscious sedation with Ultra compared with S3 (97.4% vs. 71.6%; p < 0.001). Pre-dilatation was more frequent with S3 compared with Ultra (85.2% vs. 42.6%; p < 0.001). In-hospital outcomes, including device success (91.6% vs. 95.5%; p = 0.165), major vascular complications (12.3% vs. 11.0%; p = 0.723), and new pacemaker implantation (5.8% vs. 4.5%; p = 0.608), were comparable between S3 and Ultra patients, respectively. Post-procedural mean transprosthetic gradients (13.2 ± 5.7 mm Hg vs. 13.1 ± 4.7 mm Hg; p = 0.829) and rate of moderate or greater paravalvular leakage (PVL) (1.3% vs. 2.7%; p = 0.414) were comparable, whereas mild PVL was more frequent with S3 compared with Ultra (43.0% vs. 18.7%; p < 0.001)., Conclusions: Device success rates were high with both balloon-expandable THVs, with overall low rates of adverse events up to 30 days after TAVR. Despite a lower frequency of pre-dilatation, significant reduction of mild PVL confirms improved annular sealing properties of the novel Ultra THV., Competing Interests: Author Relationship With Industry Dr. Joner has received lecture fees and research grants from Edwards Lifesciences and Boston Scientific; and is a consultant for Biotronik and Orbus Neich. Dr. Kasel is a consultant and proctor for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: This study compares two latest-generation self-expanding transcatheter heart valves (THV), the supra-annular ACURATE neo (Boston Scientific) and the intra-annular Centera THV (Edwards Lifesciences)., Methods: In this single center observational cohort trial 317 patients treated with the ACURATE neo and 78 patients treated with the Centera TVH were included. The main endpoints were device success and the early safety endpoint at 30 days., Results: Besides higher incidence of diabetes mellitus and higher body mass index in patients treated with the ACURATE neo THV, there were no baseline differences between the groups. Device success was similar in both groups (neo: 91.8% vs. Centera: 93.6%; P=0.598), with numerically higher rates of moderate to severe paravalvular leakage in the ACURATE neo group (4.7% vs. 1.3%; P=0.214). At 30 days all-cause mortality rates were low in both groups (0.3% vs. 0%; P=0.620) and no difference occurred in the early safety at 30 days (19.3% vs. 16.7%; P=0.599). However, all-cause stroke rates were significantly higher in patients treated with the Centera THV (6.4 vs. 1.6%; P=0.015)., Conclusions: The ACURATE neo and the Centera THV show low mortality rates as well as comparable, favorable hemodynamics. The finding of higher stroke rates at 30 days with the repositionable Centera SE-THV needs further assessment., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jtd-20-1700). AMK reports that he is a proctor and consultant for Edwards Lifesciences. The other authors have no conflicts of interest to declare., (2020 Journal of Thoracic Disease. All rights reserved.)

The intensive medical care of COVID-19 patients presents the deployed personnel with as yet unknown challenges. For example, protective equipment is now being extensively used, which was otherwise only used in selected situations. Working in such an environment is to be evaluated differently under the aspect of occupational safety than other patient care, especially as more than 1900 suspected cases of a SARS-CoV-19 occupational disease were reported among healthcare workers in Germany. Even in a pandemic, the legal requirements remain valid and personal protective equipment (PPE) has to comply with given standards. The use of FFP3 masks is required in aerosol-forming situations, such as endotracheal intubation or bronchoscopy. In contrast to surgical face masks, there is a maximum wearing time for FFPs masks. Furthermore, in a pandemic there is a basic danger of PPE shortage and recycling of face masks is under discussion. Therefore, usage of non-EU certified PPE may come into effect but this has to follow the requirements defined by European regulations. The aim of this article is to provide an overview of the currently relevant rules and regulations in Germany.

Transfemoral Transcatheter Aortic Valve Implantation (tf-TAVI) has become an established therapy-option for patients with symptomatic severe aortic stenosis. Conscious sedation (CS) has proven to be an alternative to general anesthesia . So far, the outcome of patients undergoing unplanned periprocedural conversion from CS to general anesthesia has not been investigated. All patients undergoing transfemoral transcatheter aortic valve implantation in CS between 2014 and 2019 were included. The primary end point was early safety at 30 days according to Valve Academic Research Consortium-2 criteria. The reasons for conversion and length of ICU-/ hospital stay were further analyzed. Of 1,058 included patients 35 (3.3%) required a conversion. The end point was documented in 13 (37%) of the converted and 110 (11%) of nonconverted patients (p < 0.001). The causes were: unrest in 11/35 patients, procedural complications in 10/35 patients, respiratory distress in 8/35, and cardiovascular decompensation in 6 patients (17.1%). Compared with the group without conversion (Median (interquartile range ), 4 [4-5] days), length of hospital stay was longest in the group with procedural complications (6 [1-11] days) followed by cardiovascular decompensation (5 [4-7] days). In conclusion, the conversion rate to general anesthesia was low in a large cohort of unselected transcatheter aortic valve implantation patients. Additionally, hospital stay was longer dependent on the reason for conversion., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Aim: Psoas muscle cross-sectional area (CSA) is a proposed marker of frailty associated with mortality after transcatheter aortic valve implantation (TAVI). We assessed the impact of psoas CSA on medium-term mortality over 5 years in a large cohort, adjusted for pre-procedural variables., Method: This single-centre registry-derived analysis assessed 1,731 consecutive TAVI patients between 2007 and 31 April 2015 with available abdominal computed tomography scans. Sex-stratified, height-adjusted psoas CSA was measured mid-body of the fourth lumbar vertebra. Kaplan-Meier survival distributions across psoas CSA quartiles were compared. Cox and logistic regression models were used to assess baseline variables associated with the primary outcome, which was mortality within 5 years., Results: Median age was 81 years (interquartile range, 77 - 85); 52.5% were women. The primary endpoint occurred in 555 patients over a mean follow-up of 775 days. Lower psoas CSA quartile patients were older, had a lower body mass index, lower creatinine clearance, and lower rates of previous cardiac surgery, with higher rates of diabetes, coronary artery disease, pacemaker, anaemia, hypoalbuminaemia, and higher European System for Cardiac Operative Risk Evaluation (EuroSCORE). Unadjusted survival by psoas CSA quartile was significantly different in men (log rank p=0.041) but not women (p=0.099). In Bonferroni-adjusted multivariate analysis, psoas CSA quartiles were not significantly associated with mortality. Hypoalbuminaemia (hazard ratio [HR], 2.10; 95% confidence interval [CI], 1.53 - 2.87 [p<0.001]) and increasing age (HR, 1.03 per year; 95% CI, 1.01 - 1.05 [p=0.002]) were associated with increased risk; female sex (HR, 0.63; 95% CI 0.51 - 0.78 [p<0.001]), and hypercholesterolaemia (HR, 0.67; 95%, CI 0.54 0.83 [p<0.001]) with reduced risk., Conclusions: Psoas CSA was not significantly associated with mortality after adjusting for pre-procedural variables. Hypoalbuminaemia, sex, hypercholesterolaemia, and age were significantly associated with mortality after TAVI., (Copyright © 2019 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.)

Aims: Elevated gradients have been proposed to be associated with haemodynamic structural valve deterioration (SVD) after transcatheter aortic valve implantation (TAVI); however, data regarding their characterisation remain scarce. This study sought to investigate the prevalence and predictors of moderate or greater SVD and the prevalence of valve thrombosis during follow-up after TAVI with balloon-expandable valves., Methods and Results: A total of 691 patients undergoing transfemoral TAVI were enrolled. The primary endpoint was moderate or severe haemodynamic SVD during 12-month follow-up after TAVI, defined as (I) mean transvalvular gradient ≥20 mmHg or (II) mean transvalvular gradient increase ≥10 mmHg. The primary endpoint was observed in 10.3% after TAVI. Use of a 20 mm valve, valve-in-valve procedure and oral anticoagulation (OAC) were independently associated with haemodynamic SVD, whereas valve-in-valve procedure and OAC were the only significant variables after accounting for death as a competing event. OAC was significantly associated with haemodynamic SVD (RR 8.65; p=0.004) and death (RR 3.57; p=0.06), whereas valve-in-valve procedure was only associated with haemodynamic SVD (RR 52.76; p<0.001). Valve thrombosis was present in 0.87% (6/691) of the patients., Conclusions: The prevalence of moderate or greater haemodynamic SVD during the first 12 months after TAVI is 10.3%. Procedural factors and pharmacotherapy seem to play a key role during manifestation. Future studies should focus on the underlying mechanisms.

Objectives: To evaluate 1-year outcome using the ACURATE neo (Symetis S.A., a Boston Scientific Company, Ecublens, Switzerland) according to the updated Valve Academic Research Consortium (VARC-2) with emphasis on the composite endpoints "clinical efficacy after 30 days" and "time-related valve safety"., Background: Initial reports on the clinical performance of patients treated with the ACURATE neo are promising; however, information regarding one-year outcome is scarce, especially with regard to the composite endpoints proposed by the VARC-2., Methods: One hundred and fifty one consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) with the ACURATE neo for severe aortic valve stenosis were enrolled. Data were prospectively collected and event rates during follow-up were calculated as the Kaplan-Meier estimates., Results: Mean age was 81.1 ± 5.9 years and 49.7% (75/151) were female with a median logistic EuroScore of 13.8% [8.2-20.5]. Device success was achieved in 88.1% (133/151) and procedure related mortality was 0.7% (1/151). At one-year, all-cause mortality was 3.3% (5/151), while permanent pacemaker implantation occurred in 12.7% (19/151) of patients. The "clinical efficacy after 30 days" was observed in 24.8% (37/151), where the main contributor was symptom worsening in 14.8% (22/151) of cases. "Time-related valve safety" occurred in 22.0% (33/151) with structural valve deterioration as main contributor in 10.7% (16/151) of cases., Conclusions: Using the ACURATE neo, we found a favorable safety profile with low all-cause mortality at 1 year. The reported VARC-2 defined composite endpoints at 1 year reveal low rates of "clinical efficacy after 30 days" and "time-related valve safety"., (© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

Aims: To evaluate 1-year outcome after transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (S3) prosthesis with emphasis on the composite endpoints "clinical efficacy after 30 days" and "time-related valve safety" proposed by the updated Valve Academic Research Consortium (VARC-2)., Methods and Results: Four hundred and two consecutive patients undergoing transfemoral TAVI with the S3 were enrolled. Mean age was 81 ± 6 years, 43% were female and median logistic EuroSCORE I was 12% [8-19]. Device success was achieved in 93% (374/402) with moderate or severe paravalvular leakage (PVL) in 2%. At 1 year all-cause mortality was 8.9% [95% CI 6.4-12.2] and new permanent pacemaker implantation rate was 16% [95% CI 12.7-20.4]. The composite endpoint time-related valve safety occurred in 29% with structural valve deterioration, defined as elevated gradients or more than moderate PVL, occurring in 13%. The clinical efficacy endpoint after 30 days was observed in 37% of patients with the main contributor symptom worsening with New York Heart Association functional class III + in 17% of cases., Conclusions: For the first time, VARC-2-defined composite endpoints at 1 year are reported and reveal a considerable proportion of patients experiencing the endpoint of time-related valve safety (29%) and clinical efficacy after 30 days (37%).

Patients referred for transcatheter aortic valve implantation (TAVI) are typically elderly with several co-morbidities, which might limit prognosis despite successful procedural outcome. To date, the prevalence and clinical impact of iron deficiency (ID) in patients with severe aortic stenosis who underwent TAVI remains poorly defined. This study included 495 patients who underwent transfemoral TAVI for severe symptomatic aortic stenosis. ID was defined as ferritin <100 ng/ml or ferritin 100 to 300 ng/ml, when transferrin saturation was <20%. The primary end point of the study was a composite of all-cause mortality, unplanned readmission for worsening heart failure or red blood cell transfusions during the first year after TAVI, which occurred in 22% (109 of 495) of the population. ID was present in 54% (268 of 495) of the entire cohort and was associated with a higher rate of the primary end point (27.6% [74 of 268] vs 15.4% [35 of 227]; p = 0.001). After multivariable adjustment, the association of ID with the primary end point remained significant (hazard ratio 1.64, 95% confidence interval [1.08 to 2.48]; p = 0.019). In a subgroup of ferropenic patients (n = 56), treatment with intravenous iron before TAVI was feasible, resulting in a considerable improvement of ferritin, transferrin saturation and symptoms at 30-day follow-up. In conclusion, ID is common in TAVI patients and is associated with adverse clinical outcome after TAVI. Correction of ID with intravenous iron seems feasible in contemporary TAVI patients. Whether this reduces transfusion rates and impacts clinical outcome after TAVI remains to be investigated in future prospective trials., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Marital status has been described to affect outcome in cardiovascular diseases, however its impact on patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. We therefore aimed to assess the impact of marital status in patients undergoing TAVI., Methods: Between 2011 and 2015, 779 patients undergoing transfemoral TAVI with known marital status were included in the analysis. The primary endpoint of the study was the composite of cardiac death and readmission for congestive heart failure (CHF) at one year., Results: Mean age was 80.7±5.9 years, 47.8% were female and median logistic EuroScore was 12.7% (8.13-19.39%). Forty-three point three percent of patients were not married. Compared to married patients, unmarried patients were older (82.4±5.5 vs . 79.5±5.8 years; P<0.001), more often female (73.3% vs . 28.3%; P<0.001), presented with a higher logistic EuroScore [13.1% (9.5-21.5%) vs . 11.7% (7.0-18.5%); P<0.001], and more symptomatic with New York Heart Association functional class III/IV (69.7% vs . 60.6%; P=0.009). At one year the incidence of the primary endpoint was higher in unmarried patients (18.7% vs . 12.0%; P=0.011) which was mainly driven by more admissions for CHF (14.1% vs . 7.8%; P=0.007). After multivariable adjustment, marital status was borderline significant regarding CHF (HR 0.61, 95% CI: 0.37-1.02; P=0.06) but not the primary endpoint., Conclusions: Unmarried patients undergoing TAVI showed a higher incidence of cardiac death or CHF at one year. Hence, marital status should be taken into account in patients with aortic stenosis subjected to TAVI. Whether closer monitoring and intensified medical follow-up improves outcomes remains to be investigated in future studies., Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare.

Background: This study investigated the impact of prophylactic veno-arterial extracorporeal membrane oxygenation (pECMO) in patients with depressed left ventricular ejection fraction (dLVEF) undergoing transcatheter aortic valve implantation (TAVI)., Methods: Out of 1490 patients undergoing TAVI at two centers (2010-2015), 222 patients had dLVEF (≤ 40%). Of these, 21 patients (10%) underwent TAVI with pECMO. Complications and outcome according to pECMO were analyzed in the entire and in a propensity-matched population., Results: In the entire population, patients with pECMO had a higher logEuroScore I (33% ± 19 vs. 25% ± 17; p = 0.037), worse LVEF (26% ± 7 vs. 32% ± 7; p = 0.001), more major bleedings (29% vs. 9%; p = 0.015), higher transfusion rate (30% vs. 10%; p = 0.019) and longer in-hospital stay (9.0 [7.0;14.0] vs. 7.0 [5.0;10.0] days; p = 0.024). After propensity matching only transfusion rate remained higher with pECMO (30% vs. 7%; p = 0.025). In the entire population, rate and risk of 30-day mortality was higher with pECMO (24% vs. 6%, HR 95%CI 4.29 [1.51-12.19]; p = 0.006). In the matched population, this effect was attenuated (24% vs. 12%, HR 95%CI 2.09 [0.61-7.23]; p = 0.243). Cumulative rate and risk of 1-year mortality did not differ in the entire (log-rank p = 0.069; 39% vs. 22%, HR 95%CI 1.99 [0.94-4.24]; p = 0.074) nor in the matched population (log-rank p = 0.520; 39% vs. 31%, HR 95%CI 1.34 [0.55-3.28]; p = 0.523)., Conclusion: In patients with dLVEF undergoing TAVI, periprocedural pECMO support does not seem to improve patient outcome.

Introduction and Objectives: The incidence of permanent pacemaker implantation (PPI) and new conduction abnormalities (CA) with the ACURATE neo (Symetis S.A., Eclubens, Switzerland) has not been studied in detail. We aimed to analyze their predictors, evaluating patient- and device-related factors, including implantation depth and device-to-annulus ratio (DAR)., Methods: Two analyses of a multicenter population were performed: new PPI in pacemaker-naive patients (n = 283), and PPI/new-CA in patients without prior CA or pacemaker (n = 232)., Results: A new PPI was required in 9.9% of patients, who had a higher body mass index, higher rate of right bundle branch block and bradycardia. Neither implantation depth nor DAR differed in patients with PPI compared with those without. In the multivariable analysis neither DAR (OR, 1.010; 95%CI, 0.967-1.055; P = .7) nor implantation depth (OR, 0.972; 95%CI, 0.743-1.272; P = .8) predicted PPI. Only high body mass index, bradycardia and right bundle branch block persisted as independent predictors. PPI/new-onset CA occurred in 22.8% of patients and was associated with a higher logistic EuroSCORE. Neither implantation depth nor DAR differed in patients with PPI/new-CA vs those without (7.3 ± 1.9 vs 7.1 ± 1.5mm; P = .6 and 41.0 ± 7.9 vs 42.2 ± 10.1%; P = .4). The only predictor of PPI/new-CA was a higher logistic EuroSCORE (OR, 1.039; 95%CI, [1.008-1.071]; P = .013)., Conclusions: New PPI and new-onset CA rates were low with the ACURATE neo. These were mainly influenced by patient characteristics and not by device-depending factors., (Copyright © 2018 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Objective: Transfemoral Transcatheter Aortic Valve Implantation (TAVI) has become a standard therapy for patients with aortic valve stenosis. Fluoroscopic imaging is essential for TAVI with the anesthesiologist's workplace close to patient's head side. While the use of lead-caps has been shown to be useful for interventional cardiologists, data are lacking for anesthesiologists., Methods: A protective cap with a 0.35 lead-equivalent was worn on 15 working days by one anesthesiologist. Six detectors (three outside, three inside) were analyzed to determine the reduction of radiation. Literature search was conducted between April and October 2018., Results: In the observational period, 32 TAVI procedures were conducted. A maximum radiation dose of 0.55 mSv was detected by the dosimeters at the outside of the cap. The dosimeters inside the cap, in contrast, displayed a constant radiation dose of 0.08 mSv., Conclusion: The anesthesiologist's head is exposed to significant radiation during TAVI and it can be protected by wearing a lead-cap., Competing Interests: The authors have declared that no competing interests exist.

Background: Transfemoral TAVR (tf-TAVR) under conscious sedation (CS) has become popular. The need of anesthesiologic support during tf-TAVR has been questioned. Critical events during the procedure might require immediate action. We analyzed the frequency of periprocedural critical adverse events (CAE) during tf-TAVR with CS in our institution., Methods: Tf-TAVR has been performed at our institution since 2007. We excluded patients from the first four years to minimize the influence of any learning curve. CAE were defined as occurrence of 1.) "CPR", 2.) "defibrillation", 3.) "emergency extracorporeal circulation (ECC)" and 4.) "conversion to general anesthesia (GA) not related to 1.)-3.)". Data was prospectively collected in our AVIATOR TAVR registry., Results: 601 patients were analyzed retrospectively. Overall, CAE were recorded in 54 patients (9%). CPR was necessary in 12 patients (2%) and defibrillation in 10 patients (1.6%). ECC was rarely needed (n = 2, 0.3%). Conversion to GA was necessary in 34 patients (5.65%). Procedure-related conversion was necessary in 10 patients. With 24 patients, sedation-related conversion occurred more frequently. Unrest and pain were the most common reasons for conversion (n = 13, 2%) and respiratory distress in 11 patients (2%). Catecholaminergic support was needed in 269 (45%) patients. Vasopressors were more often applied (n = 249, 41%) than inotropes (n = 59, 10%)., Conclusion: Even in a high-volume center, CAE may occur in nearly every tenth patient. Conversion to GA was the most common CAE. Catecholaminergic support (primary vasopressor support) was needed in nearly every second patient. These points underline the necessity of a cardiac anaesthesiologist to be in the room during the procedure., Summary: Despite experience, critical adverse events (CAE) still occur in TAVR patients. We analyzed the occurrence of CAE and the need for catecholaminergic support in sedated TAVR patients., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Although the incidence of periprocedural complications has decreased in transcatheter aortic valve implantation (TAVI), life-threatening complications occur and emergency veno-arterial extracorporeal membrane oxygenation (vaECMO) can provide immediate circulatory stabilization. We report our two-center experience of vaECMO during life-threatening complications in TAVI., Methods: From January 2010 to December 2015, 1,810 consecutive patients underwent TAVI at two centers. Clinical characteristics, type of complication, outcome and temporal trends in the requirement of emergency vaECMO were evaluated., Results: Life-threatening complications requiring vaECMO occurred in 1.8% of cases (33 patients; 22 transfemoral, 11 transapical). Indications for vaECMO were ventricular rupture (30%, 10/33), low output (15%, 5/33), bleeding (12%, 4/33), coronary artery impairment (9%, 3/33), ventricular arrhythmias (6%, 2/33), severe aortic regurgitation (6%, 2/33), aortic annular rupture (6%, 2/33), and aortic dissection (3%, 1/33). In 4 cases, no definite cause for hemodynamic instability was identified. Conversion to open heart surgery was necessary in 42% of patients (14/33). Percutaneous coronary intervention was performed in all cases with coronary artery impairment (9%, 3/33). Patients with severe aortic regurgitation (6%, 2/33) underwent emergency valve-in-valve implantation. Other patients received, in addition to vaECMO support conservative treatment (42%, 14/33). In-hospital mortality and 30-day mortality were 46% (15/33). Of patients discharged, 67% (12/18) had no neurological impairment, whereas mild and severe neurological impairment was found in 11% (2/18) and 22% (4/18), respectively. From 2010 to 2015, with increasing procedures (from n = 43 to n = 553) requirement of vaECMO decreased from 9.3% to 0.9% (P for the trend <0.001)., Conclusion: Over a 6-year period, need for emergency vaECMO during TAVI significantly decreased over time. Despite high in-hospital mortality, vaECMO represents a feasible strategy for hemodynamic support in case of life-threatening complications., (© 2017 Wiley Periodicals, Inc.)

Objectives: The aim of this investigation was to identify patient's characteristics and periprocedural variables related to periprocedural transfusion in transfemoral Transcatheter Aortic Valve Implantation (tf-TAVI)., Background: Transfusion of allogenic red-blood cells (RBC) in tf-TAVI and the number of transfused units has been linked to an increased 30-day mortality. In line with the trend of minimization and cost-effectiveness, transfusion should be avoided, wherever possible., Methods: Between 2007 and 2015, 1,734 procedures were analyzed from our prospective registry for RBC-transfusion. Multiple logistic regression analysis was used to identify the dependent variables., Results: Transfusion was considered necessary in 14% (n = 243) of the patients. Female gender (OR [95% CI]) (1.680 [1.014-2.783]) and preprocedural moderate (7.594 [4.404-13.095]) and severe anemia (8.202 [0.900-74.752]) according to WHO were the most important preprocedural variables. Periprocedural, pericardial effusion (12.109 [3.753-39.063]), emergency extracorporeal circulation (54.5288 [6.178-481.259]) and major vascular injury (2.647 [1.412-4.962]) were related to transfusion. The same applies to moderate (4.255 [1.859-9.740]) and severe anemia (31.567 [8.560-116.416]) as well as periprocedural experience (0.072 [0.035-0.149] - 0.141[0.079-0.251], P < 0.001) CONCLUSION: Procedural experience, serious adverse events, low pre- and periprocedural Hb levels and female gender were the main variables relating to transfusion. Even in experienced high-volume centers, transfusion is still necessary in a considerable number of patients., (© 2017 Wiley Periodicals, Inc.)

Purpose: Different sedation regimens have been described for use during transfemoral transcatheter aortic valve implantation (tf-TAVI) for treatment in patients with severe aortic stenosis. The purpose of this study was to compare dexmedetomidine (DEX) with a combination of propofol-opioid (PO) with respect to periprocedural gas exchange and hemodynamic support., Methods: Data from a cohort of patients sedated with either DEX or PO for tf-TAVI were retrospectively analyzed from a prospectively maintained TAVI registry. Operative risk was determined from comorbidities and risk scores. Periprocedural partial pressure of carbon dioxide (P a CO 2 ) was chosen as the primary endpoint. Other differences in gas exchange, need for catecholamine therapy, the frequency of conversion to general anesthesia, and need for sedative "rescue therapy" (in DEX patients) were secondary endpoints. Inverse probability of treatment weighting (IPTW) was used for analysis to minimize any selection bias., Results: Of the 297 patients (140 PO, 157 DEX) included, the median [interquartile range] periprocedural P a CO 2 values of DEX patients were significantly lower than in PO patients (40 [36-45] mmHg vs 44 [40-49] mmHg, respectively; median difference -4 mmHg; 95% confidence interval, -5 to -3 mmHg; P < 0.001). Hypercapnia (P a CO 2 > 45 mmHg) was significantly less frequent in DEX patients compared with the PO group (25% vs 42%, respectively; P = 0.005). Vasopressor support was more frequent in the PO group compared with DEX (68% vs 25%, respectively; P < 0.001). Conversion to general anesthesia was not different between groups (9%, PO vs 3%, DEX; P = 0.051). Additional sedatives/opioids were required in 25 (16%) of the DEX patients., Conclusions: In sedated TAVI patients, DEX was associated with lower P a CO 2 values and reduced requirements for vasopressor support, making it a promising alternative to PO for sedation during TAVI., Trial Registration: www.ClinicalTrials.gov (NCT01390675). Registered 11 July 2011.

Multislice computed tomography (MSCT) has emerged as the mainstay in patients planned for transcatheter aortic valve implantation (TAVI). Incidental findings (IF) in MSCT are common. However, the exact incidence, clinical relevance and further consequences of IF are unclear and it is controversial whether IF adversely affect patients' outcome. We analyzed MSCT data of 1050 patients screened for TAVI between January 2011 and December 2014. Median follow-up of patients was 20 months. In total, 3194 IF were identified, which were classified into clinically non-relevant IF (2872, 90%) and clinically relevant IF (322, 10%). In 25% of patients (258/1050) at least one clinically relevant IF was present. Age (80 ± 7 vs. 80 ± 7 years; p = 0.198) and EuroSCORE II (3.6% [2.1-5.7] vs. 3.6% [2.1-5.9]; p = 0.874) was similar between patients with and without a clinically relevant IF. TAVI was performed less frequently in patients with a clinically relevant IF (76% vs. 85%; p < 0.001), with more patients receiving surgical aortic valve replacement in that group (14% vs. 11%; p = 0.042), possibly due to the high rate of incidental aneurysms of the ascending aorta (n = 48). If TAVI was performed mortality did not differ (30-days: 4% vs. 3%; p = 0.339, 1-year: 11% vs. 14%; p = 0.226) between patients with and without a clinically relevant IF. Our study is the largest study to analyze prevalence, clinical relevance and therapeutic consequences of IF during screening for TAVI. IF in pre-procedural MSCT are common and clinically relevant in one-quarter of patients. However, these findings had no impact on overall mortality.

Elevated carbohydrate antigen 125 (CA125) and N-terminal pro-brain natriuretic peptide (NTproBNP) have been associated with adverse outcome after transcatheter aortic valve implantation (TAVI). This study performs a comparison of both biomarkers for prognosis after TAVI. The study includes 363 patients. The primary end point was all-cause death or readmission for worsening congestive heart failure within 1 year after TAVI, and this end point occurred in 16% of the population. The optimal cutoff to predict the primary end point was 18.4 U/ml for CA125 and 2,570 ng/L for NTproBNP. Elevated CA125 levels were present in 52% and were associated with a higher rate of the primary end point (27% vs 3%; p <0.001). In parallel, elevated NTproBNP levels were present in 42% and were also associated with a higher rate of the primary end point (27% vs 8%; p <0.001). After multivariable adjustment, elevated CA125 (hazard ratio [HR] 5.26; p <0.001) and elevated NTproBNP (HR 2.12; p = 0.022) were independent predictors of the primary end point. To explore the utility of combining both biomarkers, CA125 was added to the model containing baseline variables and NTproBNP. Elevated CA125 (HR 4.62; p = 0.001), but not NTproBNP (HR 1.58; p = 0.194), persisted as an independent predictor of the primary end point. Addition of CA125 significantly improved the predictive capability of the model (C-statistic: 0.805 vs 0.776) and the net reclassification index (50%, 95% confidence interval [20 to 84]) with an integrated discriminative improvement of 3.0%. In conclusion, elevated CA125 and NTproBNP predict adverse clinical outcome after TAVI. However, when combining both biomarkers, the predictive capacity of CA125 was superior., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Introduction: Anemia is frequent in patients undergoing transcatheter aortic valve implantation (TAVI) with a strong negative prognostic impact. The prevalence and prognosis of anemia and separately of iron-deficiency anemia in contemporary patients are unclear., Methods and Results: In total, 549 consecutive patients undergoing transfemoral TAVI were included in the single-center study. Baseline anemia was defined as a hemoglobin level <13g/dL in men and <12g/dL in women. In an unselected subgroup of anemic patients (n=115), a complete iron status was obtained and anemia was classified as iron-deficiency versus non-iron-deficiency. The primary endpoint was death or re-hospitalization for worsening heart failure within one year after TAVI. Anemia was present in 45% (249/549) of the population and was significantly associated with a higher rate of the primary endpoint (25% (63/249) vs. 8% (25/300); p<0.001). In a multivariable model adjusted for variables associated with the primary endpoint, baseline anemia was an independent predictor of the primary endpoint (hazard ratio 2.81, 95% confidence interval [1.69-4.67]; p<0.001). Iron-deficiency anemia was present in 79% (91/115) of the subgroup and the rate of the primary endpoint was comparable to non-iron-deficiency anemia (31% (28/91) vs. 21% (5/24); p=0.338)., Conclusion: In contemporary TAVI patients, anemia remains a common comorbidity and independently predicts adverse outcome. In an unselected subgroup of anemic patients, iron-deficiency was common and had similar clinical outcome compared to non-iron-deficiency. Whether correction of iron-deficiency anemia impacts prognosis remains to be investigated., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

Objectives: This study investigates the influence of implantation depth and prosthesis oversizing on conduction abnormalities (CA) and permanent pacemaker implantation (PPI) after SAPIEN 3 (Edwards Lifesciences, Irvine, California) implantation., Background: CA and PPIs are frequent complications after transcatheter aortic valve replacement with a next-generation balloon-expandable transcatheter heart valve (SAPIEN 3). The potential underlying mechanisms are incompletely understood., Methods: Of 244 patients treated with SAPIEN 3,208 without a previous pacemaker and 184 without baseline CA were analyzed. We assessed the association of angiographic implantation depth (% of frame height below the annulus) and degree of oversizing with PPI and CA., Results: New PPI and new or worsened CA or PPI occurred in 16% (34 of 208) and 31% (57 of 184), respectively. Patients requiring PPI had a higher prevalence of atrial fibrillation (44% vs. 24%; p = 0.017), complete right bundle branch block (27% vs. 5%; p = 0.001), and bradycardia (<60 beats/min, 38% vs. 21%; p = 0.034). In patients with new CA or PPI, implantation depth was lower (at septal side: 29 ± 8% vs. 25 ± 7%; p = 0.003), and rate of oversizing was higher (19% [11 of 57] vs. 6% [8 of 126]; p = 0.007). Independent predictors of new or worsened CA or PPI were implantation depth at septal side (odds ratio [OR]: 1.063 [95% confidence interval (CI): 1.017 to 1.110]; p = 0.006 per % of frame below the aortic annulus), oversizing (OR: 3.489 [95% CI: 1.236 to 9.848]; p = 0.018), and QRS duration (OR: 1.033 [95% CI: 1.011 to 1.056]; p = 0.003 per ms)., Conclusions: Implantation depth and prosthesis oversizing were associated with a higher rate of new CA or PPI using the SAPIEN 3. Thus, avoidance of deep implantation and extreme oversizing may reduce these complications., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) is a treatment strategy for patients with severe aortic stenosis. Although general anaesthesia (TAVI-GA) and sedation (TAVI-S) have previously been described for TAVI, the difference in safety and efficacy of both methods has not been studied in a randomized trial., Methods: The INSERT trial was a single centre, controlled parallel-group trial with balanced randomization. Sixty-six patients (68-94 yr) with acquired aortic stenosis undergoing transfemoral CoreValve™ were assigned to TAVI-GA or TAVI-S. Comparable operative risk was determined from risk-scores (EUROscore, STS-Score). Monitoring and anaesthetic drugs were standardized. Near-Infrared-Spectroscopy was used to monitor cerebral-oxymetry blinded. Primary outcome was the perioperative cumulative cerebral desaturation. As secondary outcomes, changes in neurocognitive function and respiratory and haemodynamic adverse events were evaluated., Results: Of 66 included patients, 62 (TAVI-GA: n=31, TAVI-S: n=31) were finally analysed. Baseline characteristics were comparable. In 24 patients (39%) cerebral desaturation was observed. Cumulative cerebral desaturation was comparable (TAVI-GA:(median [IQR]) (0[0/1308] s%) vs. TAVI-S:(0[0/276] s%); P=0.505) between the groups. Neurocognitive function did not change within and between groups. Adverse events were more frequently observed in TAVI-S patients (P<0.001). Bradypnoea (n=16, 52%) and the need for airway manoeuvres (n=11, 36%) or bag-mask-ventilation (n=6, 19%) were the most common respiratory adverse events., Conclusions: Cerebral desaturation occurred in both patient groups, but there was no significant difference between the two groups. Based on primary outcome, both methods were shown to be comparable. Neurocognitive outcome was similar. The higher incidence of adverse events in the sedation group suggests a potential advantage of general anaesthesia., Clinical Trial Registration: NCT 01251328., (© The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objectives: Evaluation of 30-day outcomes after transcatheter aortic valve replacement (TAVR) with the novel balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) emphasizing the updated Valve Academic Research Consortium (VARC-2) criteria., Background: Preliminary data on clinical performance with the S3 THV are promising. However, information regarding 30-day outcome is limited., Methods: A total of 250 consecutive patients undergoing transfemoral TAVR with the S3 THV at our center were enrolled, and outcomes according to VARC-2 criteria were analyzed at 30 days., Results: The mean age was 81.0 ± 6.2 years, median logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) and Society of Thoracic Surgeons score were 12.1% and 4.4%, respectively. VARC-2-defined device success was achieved in 244 patients (97.6%); moderate paravalvular leakage developed in 5 patients (2.0%). One patient (0.4%) died of a noncardiac cause and 8 patients (3.2%) had a stroke. Life-threatening bleeding and major vascular complications occurred in 12 (4.8%) and 9 (3.6%) of the patients, respectively. From discharge to 30 days, 5 patients (2.0%) were hospitalized due to valve-related symptoms or worsening of heart failure. The VARC-2 composite early safety endpoint was observed in 25 patients (10.0%). Permanent pacemaker implantation rate at 30 days was 15.2%. Myocardial infarction, coronary obstruction requiring intervention, valve-related dysfunction, and endocarditis were not observed., Conclusions: We found very good 30-day results using the novel S3 THV with a low rate of clinical events according to VARC-2 criteria. The S3 THV is associated with high procedural success and favorable early safety profile. The need for pacemaker implantations appears to be more frequent than with its predecessor., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transfemoral transcatheter aortic valve implantation (TAVI) is nowadays a routine therapy for elderly patients with severe aortic stenosis (AS) and high perioperative risk. With growing experience, further development of the devices, and the expansion to "intermediate-risk" patients, there is increasing interest in performing this procedure under conscious sedation (TAVI-S) rather than the previously favoured approach of general anesthesia (TAVI-GA). The proposed benefits of TAVI-S include; reduced procedure time, shorter intensive care unit (ICU) length of stay, reduced need for intraprocedural vasopressor support, and the potential to perform the procedure without the direct presence of an anesthetist for cost-saving reasons. To date, no randomized trial data exists. We reviewed 13 non-randomized studies/registries reporting data from 6,718 patients undergoing TAVI (3,227 performed under sedation). Patient selection, study methods, and endpoints have differed considerably between published studies. Reported rates of in-hospital and longer-term mortality are similar for both groups. Up to 17% of patients undergoing TAVI-S require conversion to general anesthesia during the procedure, primarily due to vascular complications, and urgent intubation is frequently associated with hemodynamic instability. Procedure related factors, including hypotension, may compound preexisting age-specific renal impairment and enhance the risk of acute kidney injury. Hypotonia of the hypopharyngeal muscles in elderly patients, intraprocedural hypercarbia, and certain anesthetic drugs, may increase the aspiration risk in sedated patients. General anesthesia and conscious sedation have both been used successfully to treat patients with severe AS undergoing TAVI with similar reported short and long-term mortality outcomes. The authors believe that the significant incidence of complications and unplanned conversion to general anesthesia during TAVI-S mandates the start-to-finish presence of an experienced cardiac anesthetist in order to optimize patient outcomes. Good quality randomized data is needed to determine the optimal anesthetic regimen for patients undergoing TAVI.