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Surgical risk scores fail to accurately predict mortality after transcatheter aortic valve implantation (TAVI). The aim of this study was to develop and validate a dedicated risk score for accurate estimation of mortality risk in these patients. All consecutive patients who underwent TAVI at 6 international institutions were enrolled. Predictors for 1-year all-cause mortality were identified by means of Cox multivariate analysis and incorporated in a prediction score. Accuracy of the score was derived and externally validated for 30-day and 1-year mortality. The net classification improvement compared with the Society of Thoracic Surgeons (STS) score was appraised. A total of 1,064 patients constituted the derivation cohort and 180 patients constituted the external validation cohort. A total of 165 patients (15%) died at 1-year follow-up. Previous stroke (odds ratio [OR] 1.80, 1.4 to 3), inverse of renal clearance (OR 8, 6 to 14), and systolic pulmonary arterial pressure ≥50 mm Hg (OR 2.10, 1.5 to 3) were independently related to 1-year mortality. Area under the curve (AUC) of the survival post TAVI (STT) for 1-year mortality was 0.68 (0.62 to 0.71). At 30 days, 65 patients (7%) had died and the AUC for the STT at this time point was 0.66 (0.64 to 0.75). In the external validation cohorts, the AUC of the STT were 0.66 (0.56 to 0.7) for 30-day and 0.67 (0.62 to 0.71) for 1-year mortality. Net reclassification improvement for STT compared with STS was 31% (p <0.001) for 30-day mortality and 14% (p <0.001) for 1-year mortality. In conclusion, the STT score represents an easy and accurate tool to assess the risk of short-term and mid-term mortality in patients undergoing TAVI., (Copyright © 2014 Elsevier Inc. All rights reserved.)

The impact of gender-related pathophysiologic features of severe aortic stenosis on transcatheter aortic valve implantation (TAVI) outcomes remains to be determined, as does the consistency of predictors of mortality between the genders. All consecutive patients who underwent TAVI at 6 institutions were enrolled in this study and stratified according to gender. Midterm all-cause mortality was the primary end point, with events at 30 days and at midterm as secondary end points. All events were adjudicated according to Valve Academic Research Consortium definitions. Eight hundred thirty-six patients were enrolled, 464 (55.5%) of whom were female. At midterm follow-up (median 365 days, interquartile range 100 to 516) women had similar rates of all-cause mortality compared with men (18.1% vs 22.6%, p = 0.11) and similar incidence of myocardial infarction and cerebrovascular accident. Gender did not affect mortality also on multivariate analysis. Among clinical and procedural features, glomerular filtration rate <30 ml/min/1.73 m(2) (hazard ratio [HR] 2.55, 95% confidence interval [CI] 1.36 to 4.79) and systolic pulmonary arterial pressure >50 mm Hg (HR 2.26, 95% CI 1.26 to 4.02) independently predicted mortality in women, while insulin-treated diabetes (HR 3.45, 95% CI 1.47 to 8.09), previous stroke (HR 3.42, 95% CI 1.43 to 8.18), and an ejection fraction <30% (HR 3.82, 95% CI 1.41 to 10.37) were related to mortality in men. Postprocedural aortic regurgitation was independently related to midterm mortality in the 2 groups (HR 11.19, 95% CI 3.3 to 37.9). In conclusion, women and men had the same life expectancy after TAVI, but different predictors of adverse events stratified by gender were demonstrated. These findings underline the importance of a gender-tailored clinical risk assessment in TAVI patients., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Introduction: Despite encouraging short-term and mid-term results, transcatheter aortic valve implantation (TAVI) interventions are still burdened from high rates of adverse events, stressing the need for accurate predictive risk instruments. We compared available surgical risk scores to describe unfavorable outcomes after TAVI., Methods: The Age, Creatinine, and Ejection fraction (ACEF) score, the logistic Euroscore, and the Society of Thoracic Surgeons Mortality score (STS) were appraised for their independent power of prediction and for their accuracy (C-index) to predict 30-day and medium-term mortality, according to the Valve Academic Research Consortium., Results: Nine hundred and sixty-two patients were included. All the scores demonstrated a moderate positive correlation. The closest correlation was observed between the STS score and Euroscore. After logistic regression analysis, STS score and Logistic Euroscore provided independent prediction for short-term all-cause mortality [P = 0.02, odds ratio (OR) 1.1; 95% confidence interval (CI) 1.06-1.31 and P = 0.027, OR 1.03; 95% CI 1.01-1.405]. For in-hospital complications, only STS score performed significantly (P = 0.005, OR 1.05; 95% CI 1.01-1.06). ACEF, Euroscore, and STS score showed low accuracy for 30-day all-cause mortality (area under the curve 0.6, 0.44-0.75; vs. 0.53, 0.42-0.61; vs. 0.62, 0.52-0.71, respectively), whereas STS score performed better for in-hospital complications (0.59, 0.55-0.64). Moreover, after Cox-multivariate adjustments, only ACEF score was near to significance to predict all-cause mortality at mid-term (OR 1.7; 0.8-2.9; P = 0.058), showing the highest accuracy (0.63, 0.55-0.71)., Conclusion: In TAVI patients, ACEF score, STS score and Logistic Euroscore provided only a moderate correlation and a low accuracy both for 30-day and medium-term outcomes. Dedicated scores are needed to properly tailor time and kind of approach.

Objectives: We assessed the safety and effectiveness of a selective percutaneous revascularization strategy before TAVI in a single-center prospective registry., Background: Management of Coronary Artery Disease (CAD) before Transcatheter Aortic Valve Implantation (TAVI) is not yet established., Methods: Percutaneous Coronary Intervention (PCI) was scheduled in proximal-to-mid coronary segment lesions on major coronary branches. TAVI was performed by percutaneous trans-femoral, trans-subclavian or trans-apical approach, using either the self-expandable III generation CoreValve (Medtronic, Minneapolis, Minnesota USA) or the Edwards SAPIEN(™) /SAPIEN XT balloon-expandable prosthesis (Edwards Lifesciences Irvine, CA). Clinical and echocardiographic follow-up was collected at 30-day, 3,6,12-month and yearly thereafter., Results: Out of 191 patients who underwent TAVI, 113 (59.2%) had CAD. Mean age was 80.5 ± 6.9 years (57.6% female), logistic EuroSCORE was 21.4% ± 13.4. Twenty-seven (14.1%) patients had previous percutaneous and 29 (15.2%) surgical revascularization. PCI was performed as scheduled before TAVI in 39 (20.4%) patients, without adverse events. Complete anatomical revascularization was obtained in 38 of 113 CAD patients (33.6%). After TAVI, 30-day mortality was 4.2%, and was comparable between CAD and no-CAD patients (P = ns), while 30-day myocardial infarction incidence was 2.6% and occurred only in the CAD group (4.4%, P = 0.06). Overall mortality at follow-up (12.9 ± 9.5 months) was 14.8%, without difference between groups (P = 0.88). At follow-up, five patients underwent coronary revascularization., Conclusions: In this study, the incidence of CAD is high in patients referred for TAVI. A selective, clinical based, coronary revascularization before TAVI seemed to be safe, and was associated with an outcome similar to those observed in no-CAD TAVI patients., (Copyright © 2012 Wiley Periodicals, Inc.)

Although transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is becoming an established technique, the effect of gender-related differences is poorly described. We performed a gender-based comparison of high-risk patients undergoing TAVI with the self-expandable CoreValve Revalving System for severe aortic stenosis to evaluate early and mid-term clinical outcomes. From the Italian prospective CoreValve registry, 659 consecutive patients (55.8% women) who underwent TAVI were included in the present study. We analyzed the gender-based differences in terms of clinical, angiographic, and procedural features and the differences in the rate of early and mid-term major adverse cardiac and cerebrovascular events. The men were younger, presented more often with severe left ventricular dysfunction, and had a greater rate of previous myocardial infarction, coronary revascularization, peripheral artery disease, renal failure, and heart conduction disorders than the women. The logistic European System for Cardiac Operative Risk Evaluation score did not differ between the 2 groups. The overall unadjusted and adjusted analyses failed to show significant differences between genders in terms of major adverse cardiac and cerebrovascular events at a median follow-up of 13 months (range 8 to 18). At late follow-up (landmark analysis >12 months), a survival benefit was observed in women (hazard ratio 0.27, 95% confidence interval 0.09 to 0.84, p = 0.02). In conclusion, in this multicenter registry, the gender-based comparison of TAVI patients showed that men, despite the younger age, had more extensive atherosclerotic burden compared to women. Overall, the early and mid-term outcomes were similar between genders, although women might have a survival benefit with longer follow-up., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objectives: This study reports on mid-term safety and performance of valve-in-valve implantation as rescue strategy to overcome acute PPL after TAVI., Background: Moderate to severe para-prosthetic leaks (PPL) after transcatheter aortic valve implantation (TAVI) have been described with both self-expandable and balloon-expandable device., Methods: We analyzed data regarding patients who underwent valve-in-valve implantation, enrolled in the ongoing single-center prospective registry of TAVI, the Padova University REVALVing experience Registry. All procedures were performed by a totally percutaneous approach, using the self-expanding Medtronic CoreValve (Medtronic, Minneapolis, MN)., Results: Out of 87 patients who underwent TAVI, six received valve-in-valve implantation because of persisting severe PPL, due to prosthesis malposition. In all patients, the second device was successfully deployed, with a significant reduction in aortic regurgitation: PPL was no longer appreciable in two of six patients, and it decreased from severe to mild or trivial in four patients. Four patients developed atrio-ventricular block requiring pace-maker implantation. At follow-up (6-24 months) two patients died, whereas no prosthesis-related death occurred. Transprosthesis pressure gradient, effective orifice area, and aortic regurgitation did not change at serial echocardiograms throughout the follow-up., Conclusions: Valve-in-valve implantation using self-expandable bioprosthesis seems safe and highly effective to overcome severe PPL due to prosthesis malposition early after TAVI. Moreover, the implantation of two valves does not affect the performance of prosthesis at follow-up., (Copyright © 2011 Wiley Periodicals, Inc.)

The aims of the present study were to investigate the incidence and characteristics of conduction disorders (CDs) after transcatheter aortic valve implantation (TAVI), to analyze the predictors of permanent pacemaker (PPM) implantation, and to evaluate the outcomes of CDs over time. In particular, we sought to investigate whether the depth of deployment and other technical aspects of valve implantation might predict the need for PPM implantation after TAVI. TAVI has been reported to favor the onset or worsening of CDs often requiring PPM implantation. A total of 70 patients with aortic stenosis due to dystrophic calcification underwent TAVI with third-generation CoreValve Revalving System from May 2007 to April 2009. We collected electrocardiograms at baseline, during TAVI, during hospitalization and at the 1-, 3-, 6-, and 12-month follow-up visits thereafter. The clinical, anatomic, and procedural variables were tested to identify the predictors of PPM implantation. The PPM dependency at follow-up was analyzed. Six patients were excluded from the analysis because of a pre-existing PPM. Of the 64 patients, 32 (50%) had one or more atrioventricular-intraventricular CDs at baseline. TAVI induced a worsening in the CDs in 49 (77%) of the 64 patients, with 25 (39%) requiring in-hospital PPM implantation. On multivariate analysis, the independent predictors of PPM implantation were the depth of the prosthesis implantation (p = 0.039) and the pre-existing right bundle branch block (p = 0.046). A trend in the recovery of the CDs over time was recorded, although 2 patients required PPM implantation 1 month after discharge for late complete atrioventricular block. In conclusion, TAVI often induces or worsens CDs, requiring PPM in more than one third of patients, although a trend in the recovery of CDs during the midterm was recorded. The independent predictors of PPM implantation were the depth of prosthesis implantation and pre-existing right bundle branch block., (Copyright © 2011 Elsevier Inc. All rights reserved.)