Maurizio D'Amico

Mid-term prognostic value of coronary artery disease in patients undergoing transcatheter aortic valve implantation: a meta-analysis of adjusted observational results.

AIMS Coronary artery disease (CAD) negatively affects prognosis in patients undergoing surgical aortic valve replacement, being currently evaluated in the most common used risk score. Our meta-analysis aims to clarify the prognostic role of CAD on mid-term survival in patients undergoing TAVI. METHODS AND RESULTS Studies reporting multivariate predictors of adverse outcomes in patients undergoing TAVI were systematically searched for and pooled, when appropriate, using a random-effect method. 960 citations were first screened and finally 7 studies (2472 patients) were included. Diagnosis of CAD was reported in 52%(42-65) of patients and 1169 Edwards SAPIEN and 1303 CoreValve prostheses were implanted. After a median follow up of 452 days (357-585) 24% of patients (19-33) died, and 23 (14-32) for cardiovascular death. At pooled analysis of multivariate approach, diagnosis of coronary artery disease did not increase risk of death (OR 1.0, 95% CI, confidence interval, 0.67-1.50 I(2) 0%). CONCLUSION CAD does not affect mid-term TAVI outcome: this finding should be weighted to accurately evaluate risk and strategies for patients with severe aortic stenosis.

Meta-Analysis of the Usefulness of Mitraclip in Patients With Functional Mitral Regurgitation

Midterm outcomes for patients presenting with heart failure and functional mitral regurgitation (MR) treated with Mitraclip remain unclear. Pubmed, Medline, and Google Scholar were systematically searched for studies enrolling patients with severe-moderate MR who underwent Mitraclip implantation. All events after at least 6 months were the primary safety end point (including death, rehospitalization for heart failure, and reinterventions), whereas change in the ejection fraction, left ventricular volumes, arterial pulmonary pressure, and left atrial diameters were considered as secondary end points. Meta-regression analysis was performed to evaluate the effect of baseline clinical and echocardiographic parameters on efficacy outcomes: 875 patients were included in 9 studies; 1.48 clips (1.3 to 1.7) for patients were implanted, and after a median follow-up of 9 months (6 to 12), 409 patients (78% [75% to 83%]) were in class New York Heart Association I/II and 57 (11% [8% to 14%]) still had moderate-to-severe MR. Overall adverse events occurred in 137 (26% [20% to 31%]) of the patients and 78 (15% [1% to 17%]) of them died; 6-minute walk test improved by 100 m (83 to 111), whereas a significant reduction in left ventricular volumes and systolic pulmonary pressure was reported. At meta-regression analysis, an increase in left ventricle systolic volumes positively affected reduction of volumes after Mitraclip, whereas atrial fibrillation reduced the positive effect of the valve implantation on ejection fraction on end-diastolic and -systolic volumes. In conclusion, Mitraclip represents an efficacious strategy for patients with heart failure and severe MR. It offers a significant improvement in functional class and in cardiac remodeling, in patients with severely dilated hearts as well, although its efficacy remains limited in the presence of atrial fibrillation.

Impact of contrast-induced acute kidney injury definition on clinical outcomes

BACKGROUND Contrast-induced acute kidney injury (CIAKI) is a frequent complication after infusion of contrast media in patients undergoing percutaneous coronary intervention. A wide range of CIAKI rates occurs after intervention between 3% and 30%, depending on the definition. The aim of this study was to identify which methodology was more effective at recognizing patients at high risk for in-hospital and out-of-hospital adverse events. METHODS AND RESULTS Serum creatinine increases, after contrast agent infusion, were evaluated in 755 consecutive and unselected patients. Incidences of CIAKI diagnosed by 2 common definitions varied from 6.9% (creatinine increase of ≥0.5 mg/dL, CIAKI-0.5) to 15.9% (creatinine increase of ≥25%, CIAKI-25%). Significant differences appeared between the 2 definitions of sensitivity to predict renal failure according to receiver operating characteristic curve analysis (98% for CIAKI-0.5 and 62% for CIAKI-25%), using a cutoff value of postprocedural glomerular filtration rate of 60 mL/min. Both definitions of CIAKI were related to composite adverse events, but CIAKI-0.5 showed a stronger predicting value (odds ratio 2.875 vs 1.802, P = .036). In multivariate linear regression, only CIAKI-0.5 was a predictive variable of death (odds ratio 3.174, 95% CI 1.368-7.361). CONCLUSIONS An increase in serum creatinine of ≥0.5 mg/dL is more sensitive because it recognizes more selectively those patients with a higher risk of mortality and morbidity. Serum creatinine increases of ≥25% overestimate CIAKI by including many patients without postprocedural relevant deterioration of renal function and affected by a lower risk of adverse events at follow-up.

30 days and midterm outcomes of patients undergoing percutaneous replacement of aortic valve according to their renal function: A multicenter study

INTRODUCTION Chronic kidney disease (CKD) constitutes a predictor of adverse events for surgical aortic valve replacement. In patients undergoing TAVI no study was performed to evaluate outcomes according to renal clearance, which represents the most accurate instrument to assess kidney function. METHODS From January 2007 to December 2011 all TAVI patients of our institutions were prospectively divided into 3 cohorts. Preserved renal function those with clearance more or equal to 60 ml/min/1.73 m2, moderate CKD those between 30 and 60, and severe CKD those between 15 and 30. Patients with a clearance less than 15 or in dialysis were excluded. All outcomes were adjudicated according to VARC criterion. RESULTS 72 patients with preserved renal function, 219 with moderate and 73 with severe CKD were included; those in the latter group were older and with lower ejection fraction. At 30 days, severe CKD was associated with a trend toward a higher risk of major events than preserved and moderate CKD: cardiovascular death (2.8% vs 6.7% vs 9%; p=0.256) life threatening bleedings (10% vs 10% vs 16%; p=0.384), major stroke (1.4% vs 2.3% vs 4.1%; p=0.763). At a medium follow-up of 540 ± 250 days, cardiovascular death incidence was higher in patients with severe CKD (7% vs 8 vs 19%; p<0.0001), however this difference was not consistently significant after multivariable adjustment (p=0.300). Overall, 2% of patients developed kidney failure, whereas 47.1% of patients with severe CKD improved to moderate renal impairment. CONCLUSIONS Patients with severe chronic renal disease presented higher risk of adverse events, mainly driven by increased hazard of bleedings. TAVI procedures could offer kidney functional improvement in an important subset of patients.

Inaccuracy of available surgical risk scores to predict outcomes after transcatheter aortic valve replacement

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.

Impact of TAVI on mitral regurgitation: a prospective echocardiographic study.

Objective: This study aims to assess changes in mitral regurgitation (MR) severity after transcatheter aortic valve implantation (TAVI). Background: Existing data on MR after TAVI are contradictory. Methods: Thirty‐five patients with MR graded ≥ 2+ were followed after undergoing TAVI with either the Edwards Sapien or CoreValve device. Echocardiography was performed the week before and 3 months after the procedure. MR was graded on a scale of 0 to 4+, classified as organic or functional, and the effective regurgitant orifice area (EROA) and MR index were calculated. Results: At baseline, MR was graded 4+ in 4 (11.4%) patients, 3+ in 10 (28.6%), and 2+ in 21 (60%). At follow‐up, MR was graded at 3+ in 4 (11.4%) patients, 2+ in 8 (22.9%), and 1+ in 19 (54.3%); 4 (11.4%) exhibited no MR. EROA (24.4 ± 11.5 mm2 pre‐TAVI vs. 11.2 ± 10.3 mm2 post‐TAVI, P < 0.001) and MR index (1.9 ± 0.3 pre‐TAVI vs. 1.3 ± 0.7 post‐TAVI, P < 0.001) were reduced with TAVI, independent of the etiology. MR decreased by at least 1 grade in 28 (80%) patients, with a reduction ≥2 grades in 10 (28.6%) patients; no patient showed a worsened condition. Subgroup analyses showed that the reduction in MR was significant in patients treated with the Edwards Sapien device but not in patients treated with the CoreValve device. Conclusions: This multiparametric echocardiographic evaluation showed that MR improved significantly after TAVI and that this result may be related to the type of valve implanted.

Two cases of aneurysm of the anterior mitral valve leaflet associated with transcatheter aortic valve endocarditis: A mere coincidence?

From the Division of Cardiology, Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands; the Division of Cardiology, University of Turin, San Giovanni Battista Hospital, Turin, Italy; the Division of Cardiology, St Paul’s Hospital, Vancouver, British Columbia, Canada; the Division of Cardiac Surgery, University of Turin, San Giovanni Battista Hospital, Turin, Italy; and the Division of Cardiac Surgery, Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands. Disclosures: None. Received for publication Nov 1, 2009; accepted for publication Nov 6, 2009; available ahead of print Feb 18, 2010. Address for reprints: Patrick W. Serruys, MD, PhD, FACC, Ba 583, Thoraxcenter, Erasmus Medical Center, Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands (E-mail: p.w.j.c.serruys@erasmusmc.nl). J Thorac Cardiovasc Surg 2010;140:e36-8 0022-5223/

Optical coherence tomography evaluation of intermediate-term healing of different stent types: systemic review and meta-analysis

36.00 Copyright 2010 by The American Association for Thoracic Surgery doi:10.1016/j.jtcvs.2009.11.012

A Gender Based Analysis of Predictors of All Cause Death After Transcatheter Aortic Valve Implantation

Aims The intermediate-term incidence of strut malapposition (SM) and uncovered struts (US), and the degree of neointimal thickness (NIT) according to stent type have not been characterized. Methods and results All studies of >50 patients in which optical coherence tomography was performed between 6 and 12 months after stent implantation were included. The incidences of SM and US were the co-primary end points, while NIT was the secondary end point. A total of 458 citations were initially appraised at the abstract level, and 11 full-text studies (280 652 analysed struts, 921 patients) were assessed. The 6–12 months incidences of SM and US were 5.0 and 7.8%, respectively, and the mean NIT was 206 &mgr;m. Biolimus-eluting stents (BES) and bioresorbable vascular scaffolds (BVS) had the highest SM rates (2.7 and 3.8%, respectively), while everolimus-eluting stents (EES) and fast-release zotarolimus-eluting stents (ZES) had the lowest SM rates (0.9 and 0.1%, respectively). BES and sirolimus-eluting stents (SES) had the highest US rates (7.7 and 8.8%, respectively), while bare metal stents (BMS) and ZES had the lowest US rates (0.3 and 0.3%, respectively). BMS had the greatest NIT (340 &mgr;m), while SES, EES, and BES had the least NIT. Conclusion Second-generation drug-eluting stents (DES) have better intermediate-term strut apposition and coverage than first-generation DES, BVS, and BMS. EES demonstrate the overall best combination of healing with suppression of neointimal hyperplasia at 6–12 months. Further studies with clinical correlation are warranted to determine the implications of these findings.

Aortic valve replacement and mitral valve repair as treatment of complications after percutaneous core valve implantation.

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.