Melissa Fusari

Impact of left ventricular systolic function on clinical and echocardiographic outcomes following transcatheter aortic valve implantation for severe aortic stenosis

BACKGROUND This study aimed to evaluate the impact of baseline left ventricular (LV) systolic function on clinical and echocardiographic outcomes following transcatheter aortic valve implantation (TAVI). Survival of patients undergoing TAVI was also compared with that of a population undergoing surgical aortic valve replacement. METHODS One hundred forty-seven consecutive patients (mean age=80±7 years) undergoing TAVI in 2 centers were included. Mean follow-up period was 9.1±5.1 months. RESULTS At baseline, 34% of patients had impaired LV ejection fraction (LVEF) (<50%) and 66% had normal LVEF (≥50%). Procedural success was similar in these 2 groups (94% vs 97%, P=.41). All patients achieved improvement in transvalvular hemodynamics. At follow-up, patients with a baseline LVEF<50% showed marked LV reverse remodeling, with improvement of LVEF (from 37%±8% to 51%±11%). Early and late mortality rates were not different between the 2 groups, despite a higher rate of combined major adverse cardiovascular events (MACEs) in patients with a baseline LVEF<50%. The predictors of cumulative MACEs were baseline LVEF (HR=0.97, 95% CI=0.94-0.99) and preoperative frailty (HR=4.20, 95% CI=2.00-8.84). In addition, long-term survival of patients with impaired or normal LVEF was comparable with that of a matched population who underwent surgical aortic valve replacement. CONCLUSIONS TAVI resulted in significant improvement in LV function and survival benefit in high-risk patients with severe aortic stenosis, regardless of baseline LVEF. Patients with a baseline LVEF<50% were at higher risk of combined MACEs.

Sutureless aortic valve replacement as an alternative treatment for patients belonging to the “gray zone” between transcatheter aortic valve implantation and conventional surgery: A propensity-matched, multicenter analysis

OBJECTIVE The aim of this propensity-matched, multicenter study was to compare early clinical and echocardiographic outcomes of patients undergoing transapical aortic valve implantation (TA-TAVI) versus patients undergoing sutureless aortic valve replacement (SU-AVR) for severe symptomatic aortic valve stenosis. METHODS We reviewed 468 TA-TAVIs performed in 20 centers from April 2008 to May 2011, and 51 SU-AVRs performed in 3 centers from March to September 2011. Based on a propensity score analysis, 2 groups with 38 matched pairs were created. Variables used in the propensity analysis were age, sex, body surface area, New York Heart Association class, logistic EuroSCORE, peripheral vascular disease, chronic obstructive pulmonary disease, aortic valve area, mitral regurgitation, and left ventricular ejection fraction. RESULTS Preoperative characteristics of the 2 groups were comparable. Hospital mortality was 5.3% and 0% in the TA-TAVI and SU-AVR groups, respectively (P = .49). We did not observe stroke or acute myocardial infarction in the 2 groups. Permanent pacemaker implantation was needed in 2 patients of each group (5.3%, P = 1.0). Dialysis was required in 2 patients (5.3%) in the SU-AVR group and in 1 patient (2.7%) in the TA-TAVI group (P = 1.0). Predischarge echocardiographic data showed that the incidence of paravalvular leak (at least mild) was greater in the TA-TAVI group (44.7% vs 15.8%, P = .001), but there were no differences in terms of mean transprosthetic gradient (10.3 ± 5 mm Hg vs 11 ± 3.7 mm Hg, P = .59). CONCLUSIONS This preliminary experience showed that, in patients at high risk for conventional surgery, SU-AVR is as safe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular leak.

Clinical and hemodynamic outcomes of ''all-comers'' undergoing transapical aortic valve implantation: Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA)

OBJECTIVE The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). METHODS From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, < 20 cases) and learning curve (first 50% cases vs second 50% cases of each center). RESULTS All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm(2). These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P < .001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. CONCLUSIONS TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.

The SOURCE Registry: what is the learning curve in trans-apical aortic valve implantation?

OBJECTIVE Trans-apical aortic valve implantation (TA-AVI) has been shown to be a reproducible technique. Early results from the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry identified major access complications associated with high 30-day mortality. Using the SOURCE Registry, we analyze the learning curve for TA-AVI over the first 2 years after commercialization. METHODS The SOURCE Registry gathered data for 2 consecutive years at European centers following commercialization of the Edwards SAPIEN bioprosthesis, totaling 2339 patients (1038 in COHORT 1 and 1301 in COHORT 2). Only data from centers that provided all of their consecutively treated patients were included in this study. We compared the 30-day results of TA-AVI from COHORT 1 (C-1: January/2008-January/2009) with the 30-day results of COHORT 2 (C-2: February/2009-January/2010). RESULTS This analysis is based on a total number of 575 TA-AVIs in C-1 and 819 TA-AVIs in C-2. Mean age (C-1: 80.7 years, C-2: 80.5 years) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (C-1: 29.1%, C-2 27.3%) were not significantly different. Valve malposition (C-1: 1.6%, C-2: 1.2%), valve migration/embolization (C-1: 0.5%, C-2: 1.0%), and major access complications (C-1: 2.1%, C-2: 1.8%) were in total less frequent, but not statistically significant lower in C-2. However, the reduction of aortic regurgitation >2+ immediately following the procedure (C-1: 4.52%, C-2: 2.1%, p=0.011) and conversion rate to open surgery (C-1: 3.7%, C-2: 1.5%, p=0.0315) reached statistical significance. Postoperative complications included dialysis (C-1: 7.0%, C-2: 5.7%, p=ns), pacemaker implantation (C-2: 7.7%, C-2: 6.7%, p=ns), stroke (C-1: 2.4%, C-2: 2.6%, p=ns), and myocardial infarct (C-1: 0.7%, C-2: 0.4%, p=ns). The total 30-day mortality was 10.8% and not significantly different between the two groups (C-1: 10.8%, C-2: 10.7%, p=ns). CONCLUSIONS Although the incidence of technical intra procedural complications has trended downward, reflecting the learning curve for TA-AVI, 30-day mortality was unchanged, likely due to patient co-morbidities not captured by preoperative risk variables.

Feasibility and accuracy of a comprehensive multidetector computed tomography acquisition for patients referred for balloon-expandable transcatheter aortic valve implantation

BACKGROUND The aim of this study was to assess the accuracy of a comprehensive multidetector computed tomography (MDCT) evaluation of the aortic annulus (AoA), coronary artery disease (CAD), and peripheral vessels in patients referred for transcatheter aortic valve implantation (TAVI). METHODS In 60 patients referred for TAVI, the following parameters were assessed with 64-slices MDCT and compared with transesophageal echocardiography (TEE), invasive coronary angiography (ICA), and peripheral angiography: AoA maximum diameter (Max-AoA-D(MDCT)), minimum diameter (Min-AoA-D(MDCT)), and area; lumen morphology index ([Max-AoA-D(MDCT)/Min-AoA-D(MDCT)]); length of the left, right, and non-coronary aortic leaflets; degree (grades 1-4) of aortic leaflet calcifications; distance between AoA and left main coronary ostium and between AoA and right coronary ostium CAD and peripheral vessel disease. RESULTS The Max-AoA-D(MDCT) and Min-AoA-D(MDCT) were 25.1 ± 2.8 and 21.2 ± 2.2 mm, respectively, with high correlation versus AoA diameter measured with TEE (r = 0.82 and 0.86, respectively). The area of AoA, systolic and diastolic lumen morphology index were 410 ± 81.5 mm(2), 1.19 ± 0.1 and 1.22 ± 0.11, respectively. Aortic leaflet calcification score was 3.3 ± 0.5. The lengths of left, right, and non-coronary aortic leaflets were 14.2 ± 2.4, 13.7.1 ± 2.1, and 14.5 ± 2.6 mm, whereas distances between AoA and the left main coronary ostium and between AoA, and the right coronary ostium were 13.7 ± 2.9 and 15.8 ± 3.5 mm, respectively. Feasibility, negative predictive value, and accuracy for CAD detection versus ICA were 87%, 100% (CI 100-100), and 96% (95% CI 94-100), respectively. All patients (N = 17) who were ineligible for TAVI were correctly detected by MDCT. CONCLUSIONS A comprehensive MDCT evaluation of patients referred for TAVI is feasible, provides more accurate assessment than TEE of AoA morphology, and may replace peripheral angiography in all patients and ICA in patients without significant CAD.

Transapical aortic valve implantation: mid-term outcome from the SOURCE registry.

OBJECTIVES Transapical (TA) aortic valve implantation using the Edwards SAPIEN bioprosthesis was commercially introduced in Europe in January 2008. Limited data on the mid-term results are available. METHODS Using data from the SOURCE-Registry (largest consecutive cohort treated using Edwards SAPIEN bioprosthesis in Europe), we report on the mid-term results (≥30 days-2 years) of TA patients. RESULTS Between November 2007 and December 2009, a total of 1387 patients from 38 European centres underwent TA aortic valve implantation. The mean follow-up is 14.9 months, with 1004 patients who completed 1 year and 464 patients who completed the 2-year follow-up. The mean age of patients was 80.6 ± 7.1 years with a logistic-EuroSCORE of 27.6%. The main co-morbidities were coronary artery disease (55.8%), previous bypass grafting (25.5%), porcelain aorta (10.2%), previous stroke (6.5%) and peripheral vascular disease (26.4%). A total of 840 patients (60.6%) received a 26 mm and 535 (38.6%) a 23 mm Edwards SAPIEN bioprosthesis. Survivals at 30 days, 1 year and 2 years were 88.7, 73.8 and 65.1%, respectively. Causes of the 276 deaths observed between >30 days and 2-year follow-up were cardiac in 86 patients (31.2%), non-cardiac in 142 (51.4%) and unknown in 48 (17.4%). Cardiac causes of death included heart failure (33.7%), sudden cardiac death (33.7%), myocardial infarct (8.1%), endocarditis (5.8%) and others (18.6%). Non-cardiac deaths were related to pulmonary disease (21.1%), cancer (12.7%), renal failure (11.3%), stroke (10.6%), gastrointestinal disease (7.7%) and others (36.6%). Using univariable and multivariable analyses, logistic EuroSCORE, renal insufficiency and liver diseases were identified as independent predictors of 2-year mortality. CONCLUSIONS These results demonstrate that in elderly patients with severe co-morbidities, TA aortic valve implantation results in excellent mid-term results. Causes of death during the mid-term follow-up are mainly non-cardiac and related to co-morbidities.

Redo in aortic homograft replacement: Transcatheter aortic valve as a valid alternative to surgical replacement

CLINICAL SUMMARY A 48-year-old woman was referred to our hospital with symptoms of ingravescent severe dyspnea. Fifteen years earlier, she had undergone placement of a 21-mm aortic valve Bravo 400 stentless xenograft (Cryolife International, Atlanta, Ga). Four years later, she underwent a valve replacement with a 21-mm mechanical prosthesis (Carbomedics, Austin, Tex) for valve degeneration, and subsequently, she received a homograft for aortic valve endocarditis. The echocardiographic control, performed during the last 15 years, showed progressive calcific valve degeneration with a peak transvascular pressure gradient of 41 mm Hg and aortic valve area of 0.5 cm. Preoperative computed tomographic angiographic analysis showed diffuse aortic root

Left Main Coronary Artery Occlusion After Percutaneous Aortic Valve Implantation

Left main coronary artery occlusion occurred immediately after transfemoral aortic valve implantation in an 87-year-old woman, which resulted in ventricular fibrillation and hemodynamic collapse. This life-threatening complication was promptly diagnosed with transesophageal echocardiography, which showed the disappearance of diastolic left main coronary artery jet flow and was confirmed with aortic root angiography. After prompt defibrillation, hemodynamic support was obtained with intra-aortic balloon pump and inotropic drugs. Functional recovery and survival were achieved with coronary stenting. This report highlights the importance of an integrated team approach of highly skilled specialists for these novel interventions.

Impact of previous cardiac operations on patients undergoing transapical aortic valve implantation: results from the Italian Registry of Transapical Aortic Valve Implantation.

OBJECTIVES Redo cardiac surgery has an increased risk of morbidity and mortality when compared with the initial operation. The aim of this study was to assess the impact of previous cardiac operations on patients undergoing transapical aortic valve implantation (TA-TAVI). METHODS We analysed data from 566 patients included in the Italian Registry of Transapical Aortic Valve Implantation who underwent TA-TAVI implantation with the Sapien valve (Edwards Lifesciences, Irvine, CA, USA) from April 2008 through May 2011. Of these, 110 patients (19.4%) had already undergone at least one previous cardiac operation with opening of the pericardium (group R) while for 456 patients (80.6%) TA-TAVI was the first cardiac procedure (group F). Data were prospectively collected at each of the 20 participating centres and then sent to a central database for storage and analysis. RESULTS Preoperative logistic EuroSCORE was higher in group R (35 ± 18.6 vs. 23.5 ± 11.9%; P < 0.001). Hospital mortality occurred in eight (7.2%) and 36 (7.9%) patients in groups R and F, respectively (P = 0.8). Mean follow-up was 10.4 ± 7.9 months (range: 1-34). Overall 2-year Kaplan-Meier survival was 64.2 ± 9.8 and 75.4 ± 3.5% in groups R and F, respectively (P = 0.69). Incidence of operative complications, postoperative bleeding, pacemaker implantation, myocardial infarction and stroke did not show statistically significant differences between groups. The univariate analysis showed that arterial hypertension, logistic EuroSCORE, porcelain aorta, left ventricular ejection fraction and previous percutaneous coronary interventions were significantly associated with 30-day mortality in group R. CONCLUSIONS According to our data, patients undergoing TAVI with previous cardiac operations have a higher preoperative risk profile but have similar outcomes when compared with patients undergoing a first operation. In these subset of patients, TAVI is a promising therapeutic option.

Transapical aortic valve implantation in high-risk patients with severe aortic valve stenosis.

BACKGROUND Transapical aortic valve implantation (TA-TAVI) represents an alternative in patients with symptomatic severe aortic valve stenosis (SSAVS) who cannot be operated on or have a high surgical risk. The aim of this prospective multicenter observational study was to assess early and 2-year clinical and hemodynamic outcomes after TA-TAVI. METHODS From May 2008 to September 2010, 179 patients with inoperable conditions or high-risk patients underwent TA-TAVI at 4 institutions. Indications for TA-TAVI were SSAVS and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) greater than 20% or porcelain aorta in patients with severe aortoiliac disease. Patients underwent clinical and echocardiographic follow-up visits at hospital discharge, 3 and 6 months after TA-TAVI, and every 6 months thereafter. The impact of the learning curve for the centers and of intraoperative complications on patient outcomes was also evaluated. RESULTS Mean age was 81 ± 6 years. Mean logistic EuroSCORE was 22% ± 12%. Transapical delivery was successful in all patients. Seventeen severe intraoperative complications occurred in 13 (7.3%) patients. Thirty-day mortality was 3.9% (7 patients). Mean follow-up was 9.2 ± 6.5 months. Late mortality occurred in 9 patients. Two-year survival was 88% ± 3%. An intraoperative severe complication was identified as the only significant independent predictor of 1-year mortality. A significant benefit was found when comparing 2-year survival of the second versus the first 50% patients at each center (93% ± 2% versus 84% ± 3 %; p = 0.046). A significant reduction of both mean and peak gradients from the preoperative to the postoperative period, which remained stable during follow-up, was found. CONCLUSIONS TA-TAVI provides excellent early and 2-year results in terms of survival, valve-related adverse events, and hemodynamic performance. Survival after TA-TAVI is affected by the center learning curve and by the occurrence of an intraoperative complication.