VARC-3 defined outcome of valve-in-valve transcatheter aortic valve implantation in stentless compared with stented aortic bioprostheses.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable alternative to redo surgery in selected patients with bioprosthetic valve dysfunction. Most ViV-TAVI procedures have been performed in stented bioprosthetic valves (ST); stentless bioprostheses (SL) lack fluoroscopic markers and could be more challenging for ViV-TAVI. Data on more recent patients applying Valve Academic Research Consortium (VARC)-3 defined outcomes are scarce. We compared patient characteristics, procedural outcomes, and 5-year mortality of patients with SL versus ST aortic bioprosthetic valve failure undergoing ViV-TAVI. METHODS: Patients undergoing ViV-TAVI between 2007 and 2022 (52.5% of cases after 2015) at 3 German centers were included in this analysis. The co-primary outcome measures were technical success, device success, and early safety defined by VARC-3. Mortality was assessed up to 5 years. RESULTS: Overall, 43 (11.8%) SL and 313 (88.2%) ST ViV-TAVI were included. Patients were comparable with regard to age, sex, clinically relevant baseline comorbidities, and surgical risk. Technical success (SL: 83.7% versus ST: 79.9%, p = 0.552), device success (SL: 67.4% versus ST: 54.3%, p = 0.105), and early safety (SL: 74.4% versus ST: 66.5%, p = 0.296) were comparable between groups. The 30-day mortality (SL: 7.0% versus ST: 2.6%, p = 0.136) and 5-year mortality rates (SL: 23.3% versus ST: 24.6%, p = 0.874) were not significantly different between groups. CONCLUSION: SL and ST ViV-TAVI led to comparable short-term outcomes according to VARC-3- defined endpoints and similar mortality rates up to 5 years of follow-up. VARC-3 defined technical success, device success, and early safety as well as 5-year all-cause mortality in patients undergoing valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) into stentless (SL) compared with stented (ST) failed aortic bioprostheses.

Impact of Enterococci vs. Staphylococci Induced Infective Endocarditis after Transcatheter Aortic Valve Implantation.

BACKGROUND: The two most common organisms found in infective endocarditis following transcatheter aortic valve implantation (TAVI-IE) are enterococci (EC-IE) and staphylococci (SC-IE). We aimed to compare clinical characteristics and outcomes of patients with EC-IE and SC-IE. METHODS: TAVI-IE patients from 2007 to 2021 were included in this analysis. The 1-year mortality was the primary outcome measure of this retrospective multi-center analysis. RESULTS: Out of 163 patients, 53 (32.5%) EC-IE and 69 (42.3%) SC-IE patients were included. Subjects were comparable with regard to age, sex, and clinically relevant baseline comorbidities. Symptoms at admission were not significantly different between groups, except for a lower risk for presenting with septic shock in EC-IE than SC-IE. Treatment was performed in 78% by antibiotics alone and in 22% of patients by surgery and antibiotics, with no significant differences between groups. The rate of any complication, in particular heart failure, renal failure, and septic shock during treatment for IE, was lower in EC-IE compared with SC-IE (p < 0.05). In-hospital (EC-IE: 36% vs. SC-IE: 56%, p = 0.035) and 1-year mortality (EC-IE: 51% vs. SC-IE: 70%, p = 0.009) were significantly lower in EC-IE compared with SC-IE. CONCLUSIONS: EC-IE, compared with SC-IE, was associated with a lower morbidity and mortality. However, absolute numbers are high, a finding that should trigger further research in appropriate perioperative antibiotic management and improvement of early IE diagnosis in the case of clinical suspicion.

Treatment of failed aortic bioprostheses: An evaluation of conventional redo surgery and transfemoral transcatheter aortic valve-in-valve implantation.

BACKGROUND: 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). METHODS AND RESULTS: 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. CONCLUSION: 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.

Outcome of patients with previous coronary artery bypass grafting and severe calcific aortic stenosis receiving transfemoral transcatheter aortic valve replacement.

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 < .001). The rate of early safety events at 30 days was comparable between CABG and control (21.2% vs. 24.6%, p = .22) with a higher mortality in CABG (9.6% vs. 5.3%, p = .005). All-cause 1-year mortality was higher in CABG compared to controls (HR 1.51 [95%-CI 1.15-1.97], p = .003). Applying Cox regression analysis, both 30-day (HR 1.57 [95%-CI 0.97-2.53], p = .067) and all-cause 1-year mortality (HR 1.24 [95%-CI 0.91-1.70], p = .174) were not significantly different between groups. After propensity-score matching, the rate of early safety events at 30 days was lower in CABG compared to controls (21.6% vs. 31.7%, p = .02). Thirty-day (9.1% vs. 7.7%, p = .596) and all-cause 1-year mortality (24.0% vs. 23.1%, p = .520, HR 1.14 [95%-CI 0.77-1.69], p = .520) were not different between groups. CONCLUSION: In patients receiving TAVR, previous CABG was not associated with an increase in periprocedural complications and all-cause 1-year mortality when adjusted for other comorbidities.

Baseline and Exercise Predictors of V˙O2peak in Systolic Heart Failure Patients: Results from SMARTEX-HF.

PURPOSE: This study aimed to investigate baseline, exercise testing, and exercise training-mediated predictors of change in peak oxygen uptake (V˙O2peak) from baseline to 12-wk follow-up (ΔV˙O2peak) in a post hoc analysis from the SMARTEX Heart Failure trial. METHODS: We studied 215 patients with heart failure with left ventricular ejection fraction (LVEF) ≤35%, and New York Heart Association (NYHA) classes II-III who were randomized to either supervised high-intensity interval training with exercise target intensity of 90%-95% of peak heart rate (HRpeak) or supervised moderate continuous training (MCT) with target intensity of 60%-70% of HRpeak, or who received a recommendation of regular exercise on their own. Predictors of ΔV˙O2peak were assessed in two models: a logistic regression model comparing highest and lowest tertiles (baseline parameters) and a multivariate linear regression model (test/training/clinical parameters). RESULTS: The change in V˙O2peak in response to the interventions (ΔV˙O2peak) varied substantially, from -8.50 to +11.30 mL·kg·min. Baseline NYHA (class II gave higher odds vs III; odds ratio (OR), 7.1 (2.0-24.9); P = 0.002), LVEF (OR per percent, 1.1 (1.0-1.2); P = 0.005), and age (OR per 10 yr, 0.5 (0.3-0.8); P = 0.003) were associated with ΔV˙O2peak.In the multivariate linear regression, 34% of the variability in ΔV˙O2peak was explained by the increase in exercise training workload, ΔHRpeak between baseline and 12-wk posttesting, age, and ever having smoked. CONCLUSION: Exercise training response (ΔV˙O2peak) correlated negatively with age, LVEF, and NYHA class. The ability to increase workload during the training period and increased ΔHRpeak between baseline and the 12-wk test were associated with a positive outcome.

Cardiac Surgery Compared With Antibiotics Only in Patients Developing Infective Endocarditis After Transcatheter Aortic Valve Replacement.

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<0.001), and mitral regurgitation ≥2 (hazard ratio, 2.91; 95% confidence interval, 1.33-6.37) as factors associated with 1-year mortality. 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.

Impact of active cancer disease on the outcome of patients undergoing transcatheter aortic valve replacement.

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 < 0.001). ACD was an independent predictor of all-cause 1-year mortality (HR 2.10, 95%-CI 1.41-3.13, P < 0.001). CONCLUSION: The presence of ACD in patients undergoing TAVR is associated with significantly higher 1-year mortality.

Exercise training restores the endothelial response to vascular growth factors in patients with stable coronary artery disease.

OBJECTIVE: Exercise training partially corrects endothelial dysfunction in patients with coronary artery disease (CAD). Growth factors like vascular endothelial growth factor (VEGF) as well as erythropoietin (EPO) are known to modulate the bioavailability of nitric oxide and, thereby, contribute to the maintenance of a normal vascular tone. The aim of the present study was to determine the impact of 4 weeks of exercise training on circulating growth factors and to elucidate their involvement in the training-induced changes in vasomotion in patients with CAD. METHODS AND RESULTS: A total of 39 patients were enrolled (training group: n = 20; control group: n = 19). At start of study and after 4 weeks, average peak flow velocity (APV) of the left internal mammary artery (LIMA) in response to acetylcholine was measured invasively in the treatment and control groups. Serum concentrations of VEGF and EPO were determined by enzyme-linked immunosorbent assay. After exercise training, LIMA APV in response to acetylcholine was increased by 93% (from 69 ± 17% at start of study to 133 ± 16% at 4 weeks, p < 0.01 vs. start of study and control). At start of study, there was no association between any of the vascular growth factors and endothelial function. However, after exercise training a close correlation was apparent between the acetylcholine-induced change in APV and EPO (r = 0.69, p < 0.01) and VEGF (r = 0.76, p < 0.01) serum concentrations. In the control group, these correlations were not evident and there was no change in endothelial function either. CONCLUSION: Exercise training improves agonist-mediated endothelium-dependent vasodilatation in CAD, partially through a restoration of the endothelial response to EPO and VEGF.