Adjunctive Hydrocortisone Improves Hemodynamics in Critically Ill Patients with Septic Shock: An Observational Study Using Transpulmonary Thermodilution.

Introduction: Septic shock is associated with high mortality and hemodynamic impairment. The use of corticoids is a common therapeutic tool in critically ill patients. However, data on the mechanisms and prognostic ability of hemodynamic improvement by adjunctive steroids are rare. This study primarily aimed to evaluate short-term effects of hydrocortisone therapy on catecholamine requirement and hemodynamics derived from transpulmonary thermodilution (TPTD) in 30 critically ill patients with septic shock and a 28 days mortality rate of 50%. Methods: Hydrocortisone was administered with an intravenous bolus of 200 mg, followed by a continuous infusion of 200 mg per 24 h. Hemodynamic assessment was performed immediately before as well as 2, 8, 16, and 24 h after the initiation of corticoids. For primary endpoint analysis, we evaluated the impact of hydrocortisone on vasopressor dependency index (VDI) and cardiac power index (CPI). Results: Adjunctive hydrocortisone induced significant decreases of VDI from 0.41 (0.29-0.49) mmHg-1 at baseline to 0.35 (0.25-0.46) after 2 h (P < .001), 0.24 (0.12-0.35) after 8 h (P < .001), 0.18 (0.09-0.24) after 16 h (P < .001) and 0.11 (0.06-0.20) mmHg-1 after 24 h (P < .001). In parallel, we found an improvement in CPI from 0.63 (0.50-0.83) W/m2 at baseline to 0.68 (0.54-0.85) after 2 h (P = .208), 0.71 (0.60-0.90) after 8 h (P = .033), 0.82 (0.6-0.98) after 16 h (P = .004) and 0.90 (0.67-1.07) W/m2 after 24 h (P < .001). Our analyses revealed a significant reduction in noradrenaline requirement in parallel with a moderate increase in mean arterial pressure, systemic vascular resistance index, and cardiac index. As a secondary endpoint, our results showed a significant decrease in lung water parameters. Moreover, changes in CPI (ΔCPI) and VDI (ΔVDI) after 24 h of hydrocortisone therapy revealed accurate prognostic ability to predict 28 days mortality (AUC = 0.802 vs 0.769). Conclusion: Adjunctive hydrocortisone leads to a rapid decrease in catecholamine requirement and a substantial circulatory improvement in critically ill patients with septic shock.

Improved long-term prognostic value of coronary CT angiography-derived plaque measures and clinical parameters on adverse cardiac outcome using machine learning.

OBJECTIVES: To evaluate the long-term prognostic value of coronary CT angiography (cCTA)-derived plaque measures and clinical parameters on major adverse cardiac events (MACE) using machine learning (ML). METHODS: Datasets of 361 patients (61.9 ± 10.3 years, 65% male) with suspected coronary artery disease (CAD) who underwent cCTA were retrospectively analyzed. MACE was recorded. cCTA-derived adverse plaque features and conventional CT risk scores together with cardiovascular risk factors were provided to a ML model to predict MACE. A boosted ensemble algorithm (RUSBoost) utilizing decision trees as weak learners with repeated nested cross-validation to train and validate the model was used. Performance of the ML model was calculated using the area under the curve (AUC). RESULTS: MACE was observed in 31 patients (8.6%) after a median follow-up of 5.4 years. Discriminatory power was significantly higher for the ML model (AUC 0.96 [95%CI 0.93-0.98]) compared with conventional CT risk scores including Agatston calcium score (AUC 0.84 [95%CI 0.80-0.87]), segment involvement score (AUC 0.88 [95%CI 0.84-0.91]), and segment stenosis score (AUC 0.89 [95%CI 0.86-0.92], all p < 0.05). Similar results were shown for adverse plaque measures (AUCs 0.72-0.82, all p < 0.05) and clinical parameters including the Framingham risk score (AUCs 0.71-0.76, all p < 0.05). The ML model yielded significantly higher diagnostic performance compared with logistic regression analysis (AUC 0.96 vs. 0.92, p = 0.024). CONCLUSION: Integration of a ML model improves the long-term prediction of MACE when compared with conventional CT risk scores, adverse plaque measures, and clinical information. ML algorithms may improve the integration of patient's information to enhance risk stratification. KEY POINTS: • A machine learning (ML) model portends high discriminatory power to predict major adverse cardiac events (MACE). • ML-based risk stratification shows superior diagnostic performance for MACE prediction over coronary CT angiography (cCTA)-derived risk scores or clinical parameters alone. • A ML model outperforms conventional logistic regression analysis for the prediction of MACE.

Hybrid-stenting with metallic and bioresorbable drug-eluting stents 2-year clinical outcomes in KUM ABSORB registry.

AIM AND OBJECTIVE: We sought to investigate and compare outcomes 2 years after Hybrid-stenting with bioresorbable vascular scaffolds (BVS) and contemporary metallic drug-eluting stents (DES) within the same coronary lesion versus BVS alone. METHODS: Between 11/2012 and 7/2015 at our institution, 134 (33.2%) were treated with Hybrid-stenting for complex or long coronary lesions, 270 patients were treated by BVS alone. The primary outcome of interest was target lesion failure (TLF) at 2-years of follow-up. RESULTS: Patients treated by Hybrid-stenting were more frequently men (80% vs. 70%, p = 0.04) had extensive multivessel disease (84% vs. 71%, p < 0.01) including more complex (89% vs. 52%, p < 0.01) and longer lesions (28.9 mm vs 16.4 ± mm, p < 0.01) resulting in longer treated segments (47.3 mm vs 21.5 mm, p < 0.01) and more residual in-segment stenosis (12.3% vs 8.5%, p < 0.01) compared to BVS alone patients. At 2 years, cumulative incidence of TLF was 9.7% of Hybrid-stenting patients and 11.5% of BVS alone patients (p = 0.62), myocardial infarction (3.0% vs 4.1%, p = 0.59) and mortality (1.5% vs 4.1%, p = 0.17), respectively. Target lesion revascularization occurred in 9 Hybrid-stenting patients (2 located in DES) and in 20 BVS alone patients, cumulative incidence 6.7% vs. 7.4% (p = 0.80). Chronic kidney disease and residual in-segment stenosis >30% were identified as independent predictors of TLF at 2-years. CONCLUSION: Despite differences in clinical and angiographic profile, Hybrid-stenting performed similar to BVS alone at 2 years after percutaneous coronary intervention.

Polymer-free drug-eluting stents for coronary artery disease.

Polymer-free drug-eluting stents (PF-DES) were designed with the expectation of avoiding late restenosis and thrombosis related to the polymer used in traditional DES platforms. Furthermore, due to similarities with bare metal stents after drug elution, PF-DES has been considered as particularly suitable for patients at high bleeding risk. A variety of PF-DES platforms have been clinically tested. Despite their theoretical advantages, PF platforms showed comparable clinical outcomes with modern permanent- or biodegradable polymer-based DES up to 5 years after implantation. Use of more biocompatible polymers on the modern DES platforms is one of the reasons therefore. Their improved safety profile allows already less intensive antithrombotic regimes after DES. Hence, nowadays PF-DES platforms can be considered as one of many DES options for percutaneous treatment of coronary artery disease.

Aortic annulus to left coronary distance as a predictor for persistent left bundle branch block after TAVI.

OBJECTIVES: To identify potential predictors for ventricular conduction delay and to evaluate the impact of interventricular dyssynchrony on mortality after implantation of a balloon-expandable aortic valve (BEV). METHODS AND RESULTS: Clinical, computertomographical (CT), and electrocardiographical (ECG) data from 225 transcatheter aortic valve implantation (TAVI) patients were analyzed. Procedures were performed between May 2010 and September 2013 via transfemoral access using a BEV. Incidence of new-onset left bundle branch block (NOP-LBBB) at discharge was 23.1% (n = 52). Predictive factors for NOP-LBBB were first degree atrioventricular (AV) block (odds ratio (OR): 3.91, 95% confidence interval (CI): 1.58 to 9.64), area cover index (OR: 1.83, 95% CI: 1.26 to 2.67), annulus calcification > first degree (OR: 3.01, 95% CI: 1.36 to 6.66), and annulus to left coronary distance (OR: 0.65, 95% CI: 0.44 to 0.96). At 1-year follow-up, no significant difference was observed concerning all-cause mortality (15.6% among non NOP-LBBB and 9.6% among NOP-LBBB patients, P = 0.278) and cardiovascular mortality (4.6% among non NOP-LBBB and 5.8% among NOP-LBBB patients, P = 0.737). CONCLUSION: In addition to previous predictors, annulus to left coronary distance and area cover index have been identified as new predictors for NOP-LBBB. NOP-LBBB showed no relevant impact on mortality after one year. Further investigation including larger populations and longer follow-up is required to confirm these findings and develop an algorithm for identification of patients at risk for NOP-LBBB associated adverse events. © 2016 Wiley Periodicals, Inc.

Correlation and predictive value of aortic root calcification markers with coronary artery calcification and obstructive coronary artery disease.

OBJECTIVE: To evaluate the correlation between aortic root calcification (ARC) markers and coronary artery calcification (CAC) derived from coronary artery calcium scoring (CACS) and their ability to predict obstructive coronary artery disease (CAD). METHODS: We retrospectively analyzed 189 patients (47% male, age 60.3 ± 11.1 years) with an intermediate probability of CAD who underwent clinically indicated CACS and coronary CT angiography (CCTA). ARC markers [aortic root calcium score (ARCS) and volume (ARCV)] were calculated and compared to CAC markers: coronary artery calcium score (CACS), volume (CACV), and mass (CACM). CCTA datasets were visually evaluated for significant CAD (stenosis ≥ 50%) and the ability of ARC markers to predict obstructive CAD was assessed. RESULTS: ARCS (mean 67.7 ± 189.5) and ARCV (mean 67.3 ± 184.7) showed significant differences between patients with and without CAC (109.4 ± 238.6 vs 9.42 ± 31.4, p < 0.0001; 108.5 ± 232.4 vs 9.9 ± 30.5, p < 0.0001). A strong correlation was found for ARCS and ARCV with CACS, CACM, and CACV (all p < 0.0001). In a multivariate analysis, ARCS (OR 1.09, p = 0.033) and ARCV (OR 1.12, p = 0.046) were independent markers for CAC. Using a receiver-operating characteristics analysis, the AUC to detect severe CAC was 0.71 (p < 0.0001) and 0.71 (p < 0.0001) for ARCS and ARCV, respectively. ARCS (0.67, p < 0.0001) and ARCV (0.68, p < 0.0001) showed discriminatory power for predicting obstructive CAD, yielding sensitivities 61 and 78% and specificities of 62 and 80%, respectively. CONCLUSION: ARC markers are associated with and independently predict the presence of CAC and obstructive CAD. Further testing is required in patients with severe ARC and significant CAD in order to reliably obtain these markers from thoracic-CT or X-ray for proper risk classification.

Exercise training improves exercise capacity and quality of life after transcatheter aortic valve implantation: A randomized pilot trial.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly applied for aortic stenosis in elderly patients with impaired mobility and reduced quality of life. These patients may particularly benefit from postinterventional exercise programs, but no randomized study has evaluated the safety and efficacy of exercise in this population. METHODS: In a prospective pilot study, 30 patients after TAVI (mean age, 81±6 years, 44% female, 83±34 days postintervention) were randomly allocated 1:1 to a training group (TG) performing 8 weeks of supervised combined endurance and resistance exercise or to usual care. The formal primary efficacy end point was between-group difference in change in peak oxygen uptake assessed by cardiopulmonary exercise testing; secondary end points included muscular strength, 6-minute walk distance, and quality of life (Kansas City Cardiomyopathy Questionnaire and Medical Outcomes Study 12-Item Short-Form Health Survey questionnaires). Safety was assessed by documenting training-related adverse events, prosthesis, and renal function. RESULTS: Significant changes in favor of TG were observed for peak oxygen uptake (group difference, 3.7 mL/min per kg [95% CI, 1.1-6.3; P=.007]), muscular strength (bench press, 6 kg [95% CI, 3-10; P=.002]; rowing, 7 kg [95% CI, 3-11; P<.001]; pulldown, 9 kg [95% CI, 4-14; P=.001]; shoulder press, 5 kg [95% CI, 1-8; P=.008]; leg press, 17 kg [95% CI 6-28; P=.005]), components of quality of life (Kansas City Cardiomyopathy Questionnaire physical limitation, 19.2 [95% CI, 4.1-34.2; P=.015]; symptom burden, 12.3 [95% CI, 0.5-24.0; P=.041]; clinical summary, 12.4 [3.4-21.4; P=.009]), but not for other questionnaire subscales and 6-minute walk distance (15 m [95% CI, -23 to 53; P=.428]). Three dropouts unrelated to exercise occurred (TG=2; usual care,=1); prosthesis and renal function were not affected by the exercise intervention. CONCLUSIONS: In patients after TAVI, exercise training appears safe and highly effective with respect to improvements in exercise capacity, muscular strength, and quality of life. CLINICAL TRIAL REGISTRATION: Clinicaltrials.govNCT01935297.

Sex-related effectiveness of bivalirudin versus abciximab and heparin in non-ST-segment elevation myocardial infarction.

BACKGROUND: Female sex independently predicts bleeding risk after percutaneous coronary intervention (PCI). Bivalirudin is safer than abciximab plus heparin in patients with non-ST-segment elevation myocardial infarction (NSTEMI). Thus, a greater benefit of bivalirudin in women would be expected. METHODS: We performed a sex-based analysis of the patients with NSTEMI (n = 1,721, 399 women) enrolled in the ISAR-REACT 4 trial and randomized to receive bivalirudin or abciximab plus heparin. Main outcome was a 30-day composite of death, large recurrent myocardial infarction, urgent target vessel revascularization, or major bleeding. Secondary outcome was 1-year composite of death, myocardial infarction, or target vessel revascularization. RESULTS: No difference in the main outcome was observed in groups with bivalirudin or abciximab plus heparin: 12.6% versus 15.5% (hazard ratio [HR] 0.81, 95% CI 0.48-1.37) among women and 10.6% versus 9.5% (HR 1.12, 95% CI 0.77-1.64) among men. Major bleeding occurred in 4.5% in the bivalirudin group versus 7.5% in the abciximab plus heparin group (HR 0.60, 95% CI 0.26-1.39) among women and 2.0% versus 3.8% (HR 0.52, 0.27-1.02) among men. At 1 year, the secondary outcome was observed in 24.1% in the bivalirudin group versus 28.7% in the abciximab plus heparin group among women, HR of 0.80 (95% CI 0.55-1.17), and in 20.6% and 19.0%, respectively, HR of 1.10 (95% CI 0.86-1.40) among men. CONCLUSION: Despite a higher peri-PCI bleeding risk in women, bivalirudin is as effective as and safer than abciximab plus heparin in women and men with NSTEMI undergoing PCI.

Prognostic Utility of Coronary Computed Tomography Angiography-derived Plaque Information on Long-term Outcome in Patients With and Without Diabetes Mellitus.

PURPOSE: To investigate the long-term prognostic value of coronary computed tomography angiography (cCTA)-derived plaque information on major adverse cardiac events (MACE) in patients with and without diabetes mellitus. MATERIALS AND METHODS: In all, 64 patients with diabetes (63.3±10.1 y, 66% male) and suspected coronary artery disease who underwent cCTA were matched with 297 patients without diabetes according to age, sex, cardiovascular risk factors, and statin and antithrombotic therapy. MACE were recorded. cCTA-derived risk scores and plaque measures were assessed. The discriminatory power to identify MACE was evaluated using multivariable regression analysis and concordance indices. RESULTS: After a median follow-up of 5.4 years, MACE occurred in 31 patients (8.6%). In patients with diabetes, cCTA risk scores and plaque measures were significantly higher compared with nondiabetic patients (all P <0.05). The following plaque measures were predictors of MACE using multivariable Cox regression analysis (hazard ratio [HR]) in patients with diabetes: segment stenosis score (HR=1.20, P <0.001), low-attenuation plaque (HR=3.47, P =0.05), and in nondiabetic patients: segment stenosis score (HR=1.92, P <0.001), Agatston score (HR=1.0009, P =0.04), and low-attenuation plaque (HR=4.15, P =0.04). A multivariable model showed a significantly improved C-index of 0.96 (95% confidence interval: 0.94-0.0.97) for MACE prediction, when compared with single measures alone. CONCLUSION: Diabetes is associated with a significantly higher extent of coronary artery disease and plaque features, which have independent predictive values for MACE. cCTA-derived plaque information portends improved risk stratification of patients with diabetes beyond the assessment of obstructive stenosis on cCTA alone with subsequent impact on individualized treatment decision-making.

Permanent pacemaker dependency in patients with new left bundle branch block and new first degree atrioventricular block after transcatheter aortic valve implantation.

Conduction disorders with need for permanent pacemaker (PPM) implantation remain frequent complications after transcatheter aortic valve implantation (TAVI). Up to 22% of PPM after TAVI are implanted for new onset left bundle branch block (LBBB) and atrioventricular block (AVB) I. However, clinical benefit and predictors of ventricular pacing in TAVI patients receiving PPM for this indication remain unclear. We retrospectively evaluated pacemaker interrogation data of patients who received a PPM post TAVI for new LBBB and new AVB I. The primary endpoint of this study was relevant ventricular pacing (ventricular pacing rate: Vp ≥ 1%) at the first outpatient pacemaker interrogation. Secondary endpoints were predictors for relevant ventricular pacing. At the first pacemaker interrogation (median follow up at 6.23 [2.8-14.8] months), median ventricular pacing frequency was 1.0% [0.1-17.8]. Out of 61 patients, 36 (59%) had Vp rates ≥ 1%. Patients with frequent ventricular pacing showed longer QRS duration (155 ms ± 17 ms vs. 144 ms ± 18 ms, p = 0.018) at the time of PPM implantation and were less likely treated with a balloon-expandable Edwards Sapiens Valve (39% vs. 12%, p = 0.040). Our findings suggest that the majority of patients with new LBBB and new AVB I after TAVI show relevant ventricular pacing rates at follow up. Further prospective studies are necessary to identify patients at higher risk of pacemaker dependency.

TAVR in nonagenarians: An analysis investigating safety, efficacy, symptomatic improvement, and long-term survival.

BACKGROUND: In the aging western societies, an increasing prevalence of severe, symptomatic aortic stenosis is observed. The aim of this study was to examine the safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients aged 90 years and older. METHODS: All patients with severe symptomatic aortic stenosis undergoing TAVR at LMU Munich-University-Hospital between 2013 and 2018 were included. Procedure-related mortality (<30 days) was defined as the primary endpoint and survival rates at two years, device failure, and procedural complications were defined as secondary endpoints according to the Valve Academic Research Consortium II criteria. RESULTS AND CONCLUSIONS: Out of 2336 patients, 2183 were younger than 90 years (<90y.-group) and 153 patients were aged 90 or older (≥90y.-group). Procedure-related mortality (3.6% <90y.-group vs. 3.3% ≥90y.-group, log-rank p=0.9) and device success (97.2% <90y.-group vs. 96.0% ≥90y.-group, p=0.44) were similar. Estimated survival rates at 2 years were 62.8% (95% CI 55.3 and 71.4) in the elder and 76.0% (95% CI 74.1 and 77.8) in the younger patients (p<0.01). The incidence of acute kidney injury, stroke, major bleeding, and permanent pacemaker implantations were comparable between both groups. TAVR procedure is equally safe and feasible in patients aged 90 years or older compared to younger patients. Differences in 2-year survival appear to be patient-related rather than procedure-related.

Impact of severe left ventricular outflow tract calcification on device failure and short-term mortality in patients undergoing TAVI.

BACKGROUND: To investigate the impact of left ventricular outflow tract (LVOT) calcification on the incidence of device failure and mortality in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: Of 690 consecutive patients undergoing transfemoral TAVI in our center from January 2013 to December 2015, 600 presented with non-severe (NSCALVOT) and 90 (13.0%) with severe (SCALVOT) LVOT calcification. Primary outcome of interest was device failure defined as a composite of procedural death, prosthesis dislocation, annulus rupture or significant para-valvular leakage (PVL). Secondary outcome of interest was 30-day and one-year all-cause mortality. RESULTS: Mean age of the population was 80.8 ±â€¯7.2 years, mean STS score was 5.7 ±â€¯4.6% and 50.6% of the patients were women. Patients with SCALVOT more frequently experienced device failure (10.0% vs. 3.8%, p = 0.009) and were at higher risk of 30 day (10.0% vs. 2.8%, p < 0.001) all cause mortality as compared to those with NSCALVOT. Furthermore, patients with SCALVOT were more frequently in need of post-dilation (15.6% vs. 8.5%, p = 0.032) and showed higher incidence of significant PVL (7.8% vs. 2.5%, p = 0.007). In multivariate analysis, SCALVOT (hazard ratio 2.87; 95% CI 1.20 to 6.34) and use of balloon-expandable prosthesis (hazard ratio 0.32; 95% CI 0.15 to 0.73) were identified as independent predictors of device failure. CONCLUSION: Presence of severe LVOT calcification in patients undergoing transfemoral TAVI is associated with a higher risk of device failure and short-term mortality.

CT-Determined Tricuspid Annular Dilatation Is Associated With Increased 2-Year Mortality in TAVR Patients.

OBJECTIVES: The aim of this study was to investigate the prevalence and prognostic impact of tricuspid annular dilatation (TAD) measured in multislice computed tomography datasets in patients undergoing transfemoral transcatheter aortic valve replacement for severe aortic stenosis. BACKGROUND: TAD is an increasingly recognized entity associated with poor outcomes in patients with valvular heart disease. METHODS: The maximal septolateral diameter of the tricuspid annulus was measured in consecutive patients with 3-dimensional multidetector row computed tomographic datasets undergoing transfemoral transcatheter aortic valve replacement. Receiver-operating curve characteristic analysis was performed to obtain an ideal, body surface area-normalized cutoff for TAD. Ethical approval was obtained from the institutional ethics board. RESULTS: The study included 1,137 patients, of whom 299 died within a mean follow-up period of 1.8 ± 1.0 years. TAD was identified in 446 patients (39.2%) on the basis of a receiver-operating characteristic cutoff of 23 mm/m2. TAD had no impact on procedural outcomes, including device failure defined according to Valve Academic Research Consortium-2 criteria. Patients with TAD experienced significantly greater mortality (hazard ratio: 1.99; 95% confidence interval: 1.59 to 2.51; p < 0.001). Multivariate analysis including clinical and echocardiographic parameters confirmed the predictive value of TAD (hazard ratio: 1.78; 95% confidence interval: 1.33 to 2.38; p < 0.001), while echocardiographic variables, including estimated pulmonary artery pressure and the severity of tricuspid regurgitation, did not reach statistical significance. The predictive value of TAD was incremental to a baseline model of clinical and echocardiographic parameters (continuous net reclassification improvement 0.204; p < 0.01) and incremental to the Society of Thoracic Surgeons score (continuous net reclassification improvement 0.209; p < 0.001). CONCLUSIONS: TAD is an independent predictor of all-cause mortality in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From the CHOICE Randomized Clinical Trial.

OBJECTIVES: The purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years. BACKGROUND: The CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV. METHODS: The CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability. RESULTS: After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm2 vs. 1.9 ± 0.5 cm2; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63). CONCLUSIONS: Five-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202).

Randomized Comparison of Intensified and Standard P2Y12-Receptor-Inhibition Before Elective Percutaneous Coronary Intervention: The SASSICAIA Trial.

BACKGROUND: Even among biomarker-negative patients undergoing elective percutaneous coronary intervention (PCI), periprocedural thrombotic and bleeding complications can lead to increased morbidity and mortality. Whether stronger platelet inhibition by an intensified oral loading strategy (ILS) before PCI impacts on outcomes among these patients in contemporary practice remains unclear. METHODS: This multicenter, randomized, assessor-blinded trial tested the hypothesis that in elective PCI prasugrel 60 mg (ILS) is superior to standard loading strategy with clopidogrel 600 mg regarding a composite primary end point of all-cause death, any myocardial infarction, definite/probable stent thrombosis, stroke, or urgent vessel revascularization. After PCI, all patients were on clopidogrel 75 mg/day and aspirin. The trial was terminated prematurely because of slower-than-expected recruitment and funding discontinuation. RESULTS: Of 781 patients included in the final analysis, 382 were assigned to ILS and 399 to standard loading strategy. At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63-1.32]; P=0.64). Any myocardial infarction and Bleeding Academic Research Consortium ≥2 bleeding rates were similar among ILS and standard loading strategy groups 16.2% versus 17.5%, odds ratio, 0.91 (95% CI, 0.62-1.32), P=0.62 and 4.2% versus 4.8%, odds ratio 0.87 (95% CI, 0.44-1.73), P=0.70, respectively. CONCLUSIONS: In biomarker-negative stable and unstable angina patients undergoing elective PCI, the trial did not find a conclusive difference in efficacy or safety. This observation should be interpreted in the context of wide CIs and premature termination of the trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02548611.

Long-term follow-up and predictors of target lesion failure after implantation of everolimus-eluting bioresorbable scaffolds in real-world practice.

BACKGROUND: Bioresorbable scaffolds (BRS) have been shown to be inferior to drug-eluting stents in randomized trials. Nevertheless, patients treated during daily routine differ from those treated within randomized trials and thus need further long-term evaluation. The present investigation aims to address this lack. METHODS: Consecutive patients with coronary artery disease treated with implantation of everolimus-eluting BRS at 5 centers in Germany were included. Clinical follow-up was assessed up to 3 years. Analysis of clinical outcomes was performed by pooling of the individual patient data sets of each center. The major clinical endpoints of interest was target lesion failure (TLF) a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization. Furthermore occurrence of definite scaffold thrombosis was evaluated. A multivariable Cox regression analysis was applied to identify independent predictors of TLF. RESULTS: A total of 1614 patients treated with BRS were analyzed (mean age 64.0 ± 10.9 years, 75.8% male, 28.3% diabetics). A total 1817 lesions were treated with BRS and 56.0% were considered to be complex. At 3 years, the rate of TLF was 17.1% and definite scaffold thrombosis was noted in 2.6%. Independent predictors of TLF were a higher age, diabetes, bifurcation, complex lesions and the use of small BRS. CONCLUSIONS: In this large-scale analysis of patients undergoing BRS implantation in daily routine, event rates were high, but in line with randomized studies. Predictors of TLF were identified which may optimize patient and lesion selection for BRS.

Sex and long-term outcomes after implantation of the Absorb bioresorbable vascular scaffold for treatment of coronary artery disease.

AIMS: Women and men suffering from coronary artery disease differ in their risk profiles. We sought to investigate the impact of sex on two-year outcomes after BVS implantation in routine clinical practice. METHODS AND RESULTS: Sex-based analysis of clinical outcomes was carried out by pooling the individual patient data of the ISAR-ABSORB and KUM-ABSORB registries performed in four high-volume tertiary centres in Munich. Of the total of 1,032 patients, 259 (25.1%) were women. The primary composite endpoint of death, target vessel myocardial infarction (TV-MI) and target lesion revascularisation (TLR) up to two years occurred in 13.2% of women and 17.9% of men (p=0.12). Compared to men, women experienced numerically lower rates of TLR and definite or probable BVS thrombosis - 7.5% vs 12.4% (p=0.051) and 1.2% and 2.7% (p=0.20), respectively. Independent predictors of increased risk for TLR were use of smaller size BVS (HR 1.28, 95% CI: 1.02-1.62), while being a woman was a protective factor (HR 0.59, 95% CI: 0.35-1.00). CONCLUSIONS: BVS used in a routine setting tend to perform better among women compared to men, which might be partially related to the lower complexity of their coronary artery disease.

Oral Anticoagulant Type and Outcomes After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The purpose of the study was to investigate the impact of oral anticoagulation (OAC) type on clinical outcomes 1 year after transcatheter aortic valve replacement (TAVR). BACKGROUND: Non-vitamin K oral anticoagulants (NOACs) are superior to vitamin K antagonists (VKAs) in nonvalvular atrial fibrillation (AF), while their comparative performance among patients in need of OAC undergoing TAVR is underinvestigated. METHODS: The study enrolled 962 consecutive patients who underwent TAVR in 4 tertiary European centers and were discharged on either NOACs (n = 326) or VKAs (n = 636). By using propensity scores for inverse probability of treatment weighting (IPTW), the comparison of treatment groups was adjusted to correct for potential confounding. RESULTS: Mean age and Society of Thoracic Surgeons score of the population were 81.3 ± 6.3 years and 4.5% (interquartile range: 3.0% to 7.3%); 52.5% were women and a balloon-expandable valve was used in 62.7% of cases. The primary outcome of interest, combined incidence of all-cause mortality, myocardial infarction, and any cerebrovascular event at 1-year after TAVR, was 21.2% with NOACs versus 15.0% with VKAs (hazard ratio [HR]: 1.44; 95% confidence interval [CI]: 1.00 to 2.07; p = 0.050, IPTW-adjusted). The 1-year incidence of any Bleeding Academic Research Consortium bleeds and all-cause mortality were comparable between the NOAC and VKA groups, 33.9% versus 34.1% (HR: 0.97; 95% CI: 0.74 to 1.26; p = 0.838, IPTW-adjusted) and 16.5% versus 12.2% (HR: 1.36; 95% CI: 0.90 to 2.06; p = 0.136, IPTW-adjusted), respectively. CONCLUSIONS: Chronic use of both NOACs and VKAs among patients in need of OAC after TAVR are comparable regarding 1-year bleeding risk. The higher ischemic event rate observed with NOACs needs to be evaluated in large randomized trials.

Impact of Discharge Location After Transcatheter Aortic Valve Replacement on 1-Year Outcomes in Women: Results From the WIN-TAVI Registry.

BACKGROUND: Several clinical and procedural factors determine outcomes after transcatheter aortic valve replacement (TAVR), but data are scarce on the impact of post-TAVR discharge disposition on long-term outcomes. We sought to analyse whether discharge location after TAVR is associated with 1-year outcomes in women undergoing contemporary TAVR. METHODS: The Women's INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) registry is the first all-female TAVR registry to study the safety and performance of contemporary TAVR in women (n = 1019). Information on discharge location was available in 817 patients (80.2%). We compared women discharged home vs those discharged to another location (nursing home, rehabilitation, or other hospital). One-year outcomes were adjusted using multivariable Cox regression methods with discharge home as the reference group. RESULTS: Of the study subjects, 75.2% (n = 614) were discharged home and 24.8% (n = 203) to another location. Women discharged to other locations were older with a greater prevalence of severe lung disease requiring home oxygen and renal failure on dialysis but were less frequently considered frail or at high surgical risk compared with women discharged home. After multivariable adjustment, non-home discharge was associated with greater hazard for 1-year Valve Academic Research Consortium 2 efficacy (21.3% vs 10.8%, hazards ratio [HR] 1.9, 95% confidence interval [CI] 1.2-2.9) and safety endpoints (31.5% vs 15.2%, HR 2.1, 95% CI 1.5-3.0), cardiovascular death (12.7% vs 5.5%, HR 2.0, 95% CI 1.1-3.6), and stroke (6.5% vs 0.8%, HR 8.5, 95% CI 2.9-25.6). CONCLUSIONS: In women undergoing contemporary TAVR, discharge disposition significantly affects 1-year risk of outcomes even after adjustment for recorded baseline differences. This might suggest the necessity of considering additional factors beyond comorbidities in the TAVR decision-making process.