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

Background Data about the impact of left-atrial appendage thrombosis (LAAT) on early safety and mortality in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI) are scarce. We aimed to investigate the prevalence and predictors of LAAT and the outcome associated with this condition in patients treated by TF-TAVI. Methods Retrospective data analysis was derived from a prospective single-centre registry comparing patients with and without LAAT regarding early safety at 30 days, according to Valve Academic Research Consortium-2 (VARC-2) and 2-year mortality. Results LAAT was found in 7.6% of the whole cohort (n = 2527) and in 16.6% in those patients with known pre-existing atrial fibrillation (AF cohort, n = 1099). Compared with controls, patients with LAAT were sicker, indicated by a higher Society of Thoracic Surgeons (STS) score and burden of comorbidities. Neither VARC-2–defined early safety at 30 days nor the rate of stroke was different between LAAT and controls in both the whole (early safety: 29.2% vs 24.2%, P = 0.123; stroke: 5.9% vs 4.7%, P = 0.495) and AF cohort (early safety: 29.1% vs 22.9%, P = 0.072; stroke: 5.6% vs 3.3%, P = 0.142). Evaluating the whole cohort in a univariate analysis, the 2-year mortality was significantly higher in LAAT compared with controls (hazard ratio, 1.41; 95% confidence interval, 1.07-1.86; P = 0.014). However, multivariate analysis of the whole cohort and the AF cohort revealed no association between LAAT and 2-year mortality. Conclusions LAAT was frequent in patients undergoing TF-TAVI— in particular, in patients with histories of AF—but it was not associated with an increase in periprocedural complications and did not predict 2-year mortality.

In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention.In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3-5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing.Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68-1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62-1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07-1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17-1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance.There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years.Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.

Background: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available. Methods: The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days. Results: The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 [90% CI, −6.2 to 7.8]; P equivalence =0.015). Event rates for the individual components were as follows: all-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 [90% CI, −2.9 to 4.8]; P equivalence P equivalence P equivalence P equivalence =0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, −0.2 [90% CI, −5.2 to 4.8]; P equivalence =0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, −34.4 [90% CI, −41.0 to −27.8]). Conclusions: Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02737150.

To evaluate the prognostic relevance of aortic annulus (AA) and left ventricular outflow tract (LVOT) Fractal dimension (FD). FD is a mathematical concept that describes geometric complexity of a structure and has been shown to predict adverse outcomes in several contexts. Computed tomography (CT) scans from the SOLVE-TAVI trial, which, in a 2 × 2 factorial design, randomized 447 patients to TAVI with the balloon-expandable Edwards Sapien 3 or the self-expanding Medtronic Evolut R, and conscious sedation or general anesthesia, were analyzed semi-automatically with a custom-built software to determine border of AA and LVOT. FD was measured by box counting using grid calibers between 0.8 and 6.75 mm and was compared between patients with none/trivial and mild/moderate paravalvular regurgitation (PVR). Overall, 122 patients had CT scans sufficient for semi-automatic PVR in 30-day echocardiography. PVR was none in 65(53.3%) patients, trace in 9(7.4%), mild in 46(37.7%), moderate in 2(1.6%) and severe in 0 patients. FD determined in diastolic images was significantly higher in patients with mild/moderate PVR (1.0558 ± 0.0289 vs. 1.0401 ± 0.0284, p = 0.017). Annulus eccentricity was the only conventional measure of AA and LVOT geometry significantly correlated to FD (R = 0.337, p Trial Registration:www.clinicaltrials.gov, identifier: NCT02737150, date of registration: 13.04.2016.

Background: Drug-coated balloons (DCBs) are an established treatment strategy for coronary artery disease. Randomized data on the application of DCBs in patients with an acute coronary syndrome (ACS) are limited. We evaluated the impact of clinical presentation (ACS versus chronic coronary syndrome) on clinical outcomes in patients undergoing DCB or drug-eluting stent (DES) treatment in a prespecified analysis of the BASKET-SMALL 2 trial (Basel Kosten Effektivitäts Trial–Drug-Coated Balloons Versus Drug-Eluting Stents in Small Vessel Interventions). Methods: BASKET-SMALL 2 randomized 758 patients with small vessel coronary artery disease to DCB or DES treatment and followed them for 3 years regarding major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target vessel revascularization). Results: Among 758 patients, 214 patients (28.2%) presented with an ACS (15 patients [7%], ST-segment–elevation myocardial infarction; 109 patients [50.9%], non–ST-segment–elevation myocardial infarction; 90 patients [42.1%], unstable angina pectoris). At 1-year follow-up, there was no significant difference in the incidence of the primary end point by randomized treatment in patients with ACS (hazard ratio, 0.50 [95% CI, 0.19–1.26] for DCB versus DES) or chronic coronary syndrome (hazard ratio, 1.29 [95% CI, 0.67–2.47] for DCB versus DES). There was no significant interaction between clinical presentation and treatment effect ( P for interaction, 0.088). For cardiac death ( P for interaction, 0.049) and nonfatal myocardial infarction ( P for interaction, 0.010), a significant interaction between clinical presentation and treatment was seen at 1 year with lower rates of these secondary end points in patients with ACS treated by DCB. At 3 years, there were similar major adverse cardiac event rates throughout groups without significant interaction between clinical presentation and treatment ( P for interaction, 0.301). All-cause mortality was higher in ACS compared with chronic coronary syndrome; however, there was no difference between DCB and DES irrespective of clinical presentation. Conclusions: In this subgroup analysis of the BASKET-SMALL 2 trial, there was no interaction between indication for percutaneous coronary intervention (acute versus chronic coronary syndrome) and treatment effect of DCB versus DES in patients with small vessel coronary artery disease. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01574534.

Objectives To evaluate the impact of diabetes mellitus on 3 year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de-novo lesions. Background For the treatment of de-novo coronary small vessel disease DCB are non-inferior to DES regarding clinical outcome up to 3 years. Methods In this prespecified analysis of a multicenter, randomized, non-inferiority trial, including 758 patients with de-novo lesions in coronary vessels Results In non-diabetic patients (n=506) rates of MACE (13.0% vs. 11.5%, hazard ratio [HR] 1.24, 95% confidence interval [CI] 0.73–2.09, p=0.43), cardiac death (2.8% vs. 2.9%, HR 0.97, 95% CI 0.32–2.92, p=0.96), non-fatal MI (5.1% vs. 4.8%, HR 1.00, 95% CI 0.44–2.28, p=0.99), and TVR (8.8% vs. 6.1%, HR 1.64, 95% CI 0.83–3.25, p=0.16) were similar in DCB and DES. In diabetic patients (n=252) rates of MACE (19.3% vs. 22.2%, HR 0.82, 95% CI 0.45–1.48, p=0.51), cardiac death (8.8% vs. 5.9%, HR 2.01, 95% CI 0.76–5.31, p=0.16), non-fatal MI (7.1% vs. 9.8%, HR 0.55, 95% CI 0.21–1.49, p=0.24) were similar in DCB and DES, whereas TVR was significantly lower with DCB compared to DES (9.1% vs. 15.0%, HR 0.40, 95% CI 0.17–0.94, p=0.036). In addition, need for TVR was highest in diabetic patients treated with DES (Picture 1). Conclusions The rates of MACE are similar in DCB and DES in de-novo coronary lesions of diabetic and non-diabetic patients. In diabetic patients the need for TVR was significantly lower with DCB compared to DES. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG. Picture 1

The use of bioprostheses for surgical aortic valve replacement increased substantially within the last years. In case of prosthesis failure, re-SAVR is standard of care, whereas valve-in-valve deployment of a transfemoral transcatheter aortic valve prosthesis (VinV-TFAVI) has recently emerged as an alternative. We sought to evaluate early safety, clinical efficacy, and all-cause 1-year-mortality of VinV-TFAVI and redo surgery for failing aortic bioprostheses (re-SAVR).Patients receiving either VinV-TFAVI (n = 147) or re-SAVR (n = 111) for a degenerated aortic bioprosthesis between 01/2006 and 05/2017 were included in this analysis. All-cause 1-year mortality was the primary outcome measure. Early safety and clinical efficacy according to VARC-2 endpoint definitions were evaluated at 30 days. Baseline characteristics differed significantly between both groups including age, STS-PROM, and incidence of relevant comorbidities. Re-stenosis was the predominant mode of failure in 45.9% of re-SAVR and 63.1% of VinV-TFAVI patients. The rate of "early safety" endpoints was lower with VinV-TFAVI (17.7% vs. 64.9%, p 0.01), the rate of "clinical efficacy" endpoints was lower, e.g. better with re-SAVR (53.1% vs. 32.4%, p 0.01). All-cause 1-year-mortality (VinV-TFAVI 8.8% vs re-SAVR 9.9%, p = 0.84) was not different. Treatment strategy was not associated with 1-year-mortality in a Cox regression analysis. The incidence of prosthesis-patient-mismatch was higher in VinV-TFAVI compared to re-SAVR.VinV-TFAVI represents a viable alternative for treatment of degenerated aortic bioprostheses in patients at increased surgical risk. However, in patients at low risk for reoperation, a better clinical efficacy and acceptable safety may favour re-SAVR.

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

Background The randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial compared newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV) as well as local anesthesia with conscious sedation (CS) and general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Both strategies showed similar outcomes at 30 days. Objectives The purpose of this study was to compare clinical outcomes during 1-year follow-up in the randomized SOLVE-TAVI trial. Methods Using a 2 × 2 factorial design 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral TAVR using either the SEV (Evolut R, Medtronic Inc., Minneapolis, Minnesota) or the BEV (Sapien 3, Edwards Lifesciences, Irvine, California) as well as CS or GA at 7 sites. Results In the valve-comparison strategy, rates of the combined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation were similar between the BEV and SEV group (n = 84, 38.3% vs. n = 87, 40.4%; hazard ratio: 0.94; 95% confidence interval: 0.70 to 1.26; p = 0.66) at 1 year. Regarding the anesthesia comparison, the combined endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred with similar rates in the GA and CS groups (n = 61, 25.7% vs. n = 54, 23.8%; hazard ratio: 1.09; 95% confidence interval: 0.76 to 1.57; p = 0.63). Conclusions In intermediate- to high-risk patients undergoing transfemoral TAVR, newer-generation SEV and BEV as well as CS and GA showed similar clinical outcomes at 1 year using a combined clinical endpoint. (SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI [SOLVE-TAVI]; NCT02737150 )

Drug-coated balloons (DCB) are a novel therapeutic strategy for small native coronary artery disease. However, their safety and efficacy is poorly defined in comparison with drug-eluting stents (DES).; BASKET-SMALL 2 was a multicentre, open-label, randomised non-inferiority trial. 758 patients with de-novo lesions (

Diabetes mellitus (DM) is a risk factor for cardiovascular disease. However, its effect on procedural and follow-up performance after transcatheter aortic valve replacement (TAVR) remains controversial. We performed an observational study of all consecutive patients treated with a transfemoral TAVR in a single-center cohort (n = 1818). All patients were stratified by diabetes status and gender. All-cause 3-year mortality was the primary endpoint. Male patients with DM were identified to have substantially increased 3-year mortality [125/314 (39.8%)] compared to males without DM [142/478 (29.7%), p

Background Patients undergoing transcatheter aortic valve replacement (TAVR) are often characterized by risk factors not reflected in conventional risk scores. In this context, little is known about the outcome of patients suffering from an active cancer disease (ACD). The objective was to determine the prevalence, clinical characteristics, perioperative outcomes, and mortality of patients with ACD undergoing TAVR compared to those with a history of cancer (HCD) and controls without known tumor disease. Methods TAVR patients between 02/2006 and 09/2014 were stratified according to the presence of ACD, HCD, and control. All-cause-mortality at 1-year was the primary end point. All end point definitions were subject to the Valve Academic Research Consortium II definitions. Results Overall, 1821 patients were included: 99 patients (5.4%) suffered from ACD and 251 patients (13.8%) had HCD. ACD was related to a solid organ or hematological source in 72.7% and 27.3%, respectively. Patients with ACD were more often male (P = 0.004) and had a lower logisticEuroScore I (P = 0.033). Overall rates of VARC-II defined periprocedural myocardial infarction, stroke, bleeding, access-site complications, and acute kidney injury were not different between groups. Thirty-day mortality did not differ between patients with ACD, HCD, and controls (6.1% vs 4.4% vs 7.6%, P = 0.176). All-cause 1-year mortality was higher in patients with ACD compared HCD and controls (37.4% vs 16.4% vs 20.8%, P

OBJECTIVES To evaluate the impact of previous coronary artery bypass grafting (CABG) on early safety at 30 days and 1-year mortality in patients receiving transcatheter aortic valve replacement (TAVR). BACKGROUND The use of TAVR in patients with previous CABG suffering from severe aortic stenosis has increased in the last years. METHODS Consecutive TAVR patients were stratified according to previous CABG versus no previous cardiac surgery (control). All-cause 1-year mortality and early safety at 30 days were evaluated. RESULTS In the unmatched cohort and compared to control (n = 2,364), CABG (n = 260) were younger, more often male and suffered more often from comorbidities leading to an increased STS-score (p

Introduction Data about the impact of left atrial appendage thrombosis (LAAT) on early safety and midterm mortality in patients undergoing transfemoral (TF) transcatheter aortic valve implantation (TAVI) are scarce. Purpose To investigate the incidence and predictors of LAAT as well as the outcome associated with this condition in a large cohort of patients treated by TF-TAVI. Methods Patients receiving TF-TAVI for native aortic valve stenosis or failed aortic bioprostheses were stratified according to the presence of LAAT diagnosed by transoesophageal echocardiography. Early safety at 30-days according to Valve Academic Research Consortium-2 (VARC-2) and 2-year all-cause mortality were the primary outcome measures. Results From 02/2006 to 06/2016, 2.527 patients (88.5%) out of 2.854 patients treated by TF-TAVI had an available transesophageal echocardiography (TEE) at baseline and formed the analysis cohort. LAAT was found in 7.6% of the whole cohort and in 16.6% in those patients with known pre-existing atrial fibrillation (AF cohort). Patients with LAAT appeared to be sicker compared to controls indicated by a higher STS-Score and burden of comorbidities. Neither VARC-2 defined early safety at 30-days nor the rate of stroke was different between LAAT and controls in both the whole (early safety: 24.2% vs. 29.2%, p=0.123; stroke: 4.7% vs. 5.9%, p=0.495) and AF cohort (early safety: 22.9% vs. 29.1%, p=0.072; stroke: 3.3% vs. 5.6%, p=0.142). Evaluating the whole cohort in a univariate analysis, the 2-year mortality was significantly higher in LAAT compared to controls (HR 1.41 [95% CI 1.07–1.86], p=0.014). However, a multivariate analysis of the whole cohort and a separate examination of the AF cohort revealed no association between LAAT and 2-year mortality. Conclusion LAAT was frequent in patients undergoing TF-TAVI, in particular in patients with a history of AF, but it was not associated with an increase in periprocedural complications. The fact that LAAT was no independent predictor of mortality indicates that it should be interpreted as a marker of an advanced disease stage rather than a prognostic factor.

Aims Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV). Methods and results SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence [rate difference −2.39 (90% confidence interval, CI −9.45 to 4.66); P equivalence = 0.04]. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% [rate difference −0.93 (90% CI −4.78 to 2.92); P equivalence Conclusion In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy.

The role of continued versus interrupted oral anticoagulation (OAC) in patients with atrial fibrillation (AF) who underwent transfemoral transcatheter aortic valve implantation (TF-TAVI) for severe aortic stenosis is uncertain. The aim of this retrospective investigation was to evaluate the impact (1) of continued versus interrupted OAC on early safety and (2) of postoperative anticoagulant management on the 1-year mortality in patients with AF who underwent TF-TAVI. Consecutive patients with AF and on OAC at admission (n = 598) were stratified according to interrupted (iVKA) versus continued vitamin K antagonist (cVKA) versus continued direct oral anticoagulants (DOAC) at the time of TF-TAVI. Valve Academic Research Consortium-2 early safety was the primary outcome measure. Patients with iVKA (n = 299), cVKA (n = 117), and DOAC (n = 182) had comparable baseline characteristics including age (p = 0.25), gender (p = 0.33), and STS-Score (p = 0.072). The proportion of patients having a CHA2DS2-VASc-Score ≥3 (p = 0.791) and HAS-BLED-Score ≥3 (p = 0.185) was not different between groups. The rate of early safety events (with lower values indicating superior safety) was lowest in DOAC (13.2%) and not increased in cVKA (19.7%) compared to iVKA (23.1%) (p = 0.029). Valve Academic Research Consortium-2 defined stroke (p = 0.527) and bleeding (p = 0.097) did not differ between groups. Renal failure occurred more often in iVKA compared to cVKA and DOAC (p = 0.02). All-cause 1-year mortality was 20.1% in iVKA, 13.7% in cVKA, and 8.8% in DOAC (p = 0.015). Multivariate analysis revealed DOAC to be associated with reduced all-cause 1-year mortality (HR 0.56 (95%-CI 0.32 to 0.99), p = 0.047) whereas cVKA was comparable to iVKA (HR 0.75 (95%-CI 0.43 to 1.31), p = 0.307). In conclusion, cVKA did not increase the rate for the composite end point of early safety at 30 days in this cohort of patients. Treatment with a DOAC was associated with a significantly reduced rate of early safety end points at 30 days and lower 1-year mortality.

Background Infective endocarditis ( IE ) after transcatheter aortic valve replacement is a devastating complication associated with a high mortality. Our objective was to determine the impact of cardiac surgery (CS) and antibiotics ( IE ‐ CS ) compared with medical treatment with antibiotics only ( IE ‐ AB x) on 1‐year mortality in patients developing IE after transcatheter aortic valve replacement. Methods and Results Patients developing IE after transcatheter aortic valve replacement were included in this retrospective analysis. All‐cause 1‐year mortality was the primary end point. A total of 20 patients underwent IE ‐ CS compared with 44 patients treated by IE ‐ AB x. In this unmatched cohort, patients treated by IE ‐ AB x were older ( P =0.006), had a higher Society of Thoracic Surgeons score ( P =0.029), and more often had severe chronic kidney disease ( P =0.037). One‐year mortality was not different between groups ( IE ‐CS versus IE‐ABx, 65% versus 68.2%; P =0.802). The rate of any complication during treatment was higher in the IE ‐ CS group ( P =0.024). In a matched cohort, baseline characteristics were not significantly different. All‐cause 1‐year mortality was not different between groups ( IE ‐CS versus IE‐ABx, 65% versus 75%; P =0.490). A Cox regression analysis revealed any indication for surgery (hazard ratio, 6.20; 95% confidence interval, 1.80–21.41; P =0.004), sepsis on admission (hazard ratio, 4.03; 95% confidence interval, 1.97–8.24; P Conclusions In patients developing IE after transcatheter aortic valve replacement, mortality was predicted by the severity of IE and concomitant mitral regurgitation. In this small, and therefore statistically limited, but high‐risk patient cohort, CS provided no significant mortality benefit compared with medical therapy. Individual decision making by a “heart and endocarditis team” is necessary to offer those patients the most reasonable treatment option.

Background Impaired left ventricular (LV) ejection fraction is a common finding in patients with aortic stenosis and serves as a predictor of morbidity and mortality after transcatheter aortic valve replacement. However, conflicting data on the most accurate measure for LV function exist. We wanted to examine the impact of LV ejection fraction, mean pressure gradient, and stroke volume index on the outcome of patients treated by transcatheter aortic valve replacement. Methods and Results Patients treated by transcatheter aortic valve replacement were primarily separated into normal flow ( NF ; stroke volume index >35 mL/m 2 ) and low flow ( LF ; stroke volume index ≤35 mL/m 2 ). Afterwards, patients were divided into 5 groups: “NF–high gradient,” “NF–low gradient” ( NF ‐ LG ), “LF–high gradient,” “paradoxical LF‐LG,” and “classic LF‐LG.” The 3‐year mortality was the primary end point. Of 1600 patients, 789 (49.3%) were diagnosed as having LF , which was characterized by a higher 30‐day ( P =0.041) and 3‐year ( P LF was an independent predictor of all‐cause (hazard ratio, 1.29; 95% confidence interval, 1.03–1.62; P =0.03) and cardiovascular (hazard ratio, 1.37; 95% confidence interval, 1.06–1.77; P =0.016) mortality. Neither mean pressure gradient nor LV ejection fraction was an independent predictor of mortality. Patients with paradoxical LF‐LG (35.0%), classic LF‐LG (35.1%) and LF –high gradient (38.1%) had higher all‐cause mortality at 3 years compared with NF –high gradient (24.8%) and NF ‐ LG (27.9%) ( P =0.001). However, surviving patients showed a similar improvement in symptoms regardless of aortic stenosis entity. Conclusions LF is a common finding within the aortic stenosis population and, in contrast to LV ejection fraction or mean pressure gradient, an independent predictor of all‐cause and cardiovascular mortality. Despite increased long‐term mortality, high procedural success and excellent functional improvement support transcatheter aortic valve replacement in patients with LF severe aortic stenosis.

The use of bioprosthetic valves has increased over the last two decades. However, the major drawback is their deterioration and failure over time, requiring redo surgery. Conventional surgical replacement (re-SAVR) has been standard of care, but valve-in-valve deployment of transcatheter aortic

The facilitated recruitment of vascular progenitor cells (VPCs) to ischemic areas might be a therapeutic target for neovascularization and repair. However, efficient and directed attraction of VPCs remains a major challenge in clinical application. To enhance VPC homing, we developed a fusion protein (S1FG), based on the biology of stroma-derived factor-1/CXCL12 and the mucin backbone taken from fractalkine/CXCL12. A GPI-anchor was included to link the fusion-protein to the cell surface. HUVECs transfected with S1FG were capable of increasing firm adhesion of CXCR4+-mononuclear cells (THP-1) under shear stress conditions in vitro. In an in vivo rabbit model of chronic hind limb ischemia, local S1FG application enhanced the recruitment of adoptively transferred embryonic EPCs (eEPCs) to the ischemic muscles 2.5-fold. S1FG combined with eEPClow (2 × 106) yielded similar capillary growth as eEPChigh (5 × 106) alone. Compared to controls, collateral formation was increased in the S1FG eEPClow group, but not the eEPChigh group without S1FG, whereas perfusion was found enhanced in both groups. In addition, S1FG also increased collateral formation and flow when combined with AMD3100 treatment, to increase circulating levels of endogenous VPC. These data demonstrate that the fusion protein S1FG is capable of enhancing the recruitment of exogenously applied or endogenously mobilized progenitor cells to sites of injury. Recombinant versions of S1FG applied via catheters in combination with progenitor cell mobilization may be useful in the treatment of chronic ischemic syndromes requiring improved perfusion.

The incidence of atrial fibrillation with the need of anticoagulation in patients receiving transcatheter aortic valve replacement (TAVR) is high and it may influence outcome. The aim was to study the impact of pre-existing atrial fibrillation (PEAF) and new-onset atrial fibrillation (NOAF) on

Transcatheter aortic valve replacement (TAVR) has become the standard of care in high-risk patients and patients that are not suitable for surgery. Postdilatation (PD) is mainly performed due to remaining paravalvular aortic regurgitation (AR). However, there are concerns regarding leaflet function

Studies of infective endocarditis (IE) in transcatheter aortic valve replacement patients are limited by univariate analysis of predictors [(1)][1], incomplete patient data (particularly non-IE cases [[2]][2]), or low number of endpoints [(3)][3]. We aimed to investigate the incidence, treatment

Transcatheter aortic valve replacement (TAVR) has become the standard of care for inoperable patients and higher risk patients with severe symptomatic aortic valve stenosis over the last years. Complication rates decreased over time and outcomes improved considerably. Data from recent studies and