Multimodality imaging to guide transcatheter treatment of severe degenerative tricuspid regurgitation with tricuspid valve-in-ring implantation and paravalvular leak closure.

Tricuspid valve (TV) degeneration after surgical repair with an annuloplasty ring is problematic as redo operation carries high mortality. This can be addressed with transcatheter therapies to implant a valve within in prior ring (tricuspid valve-in-ring). When an incomplete ring is present, paravalvular leak is commonly encountered after tricuspid valve-in-ring (TViR) implant; however, this can be addressed with paravalvular leak closure devices. Multimodality imaging including cardiac computed tomography and three-dimensional (3D) transesophageal echocardiography (TEE) are important for successful TViR implant. We report a case of tricuspid regurgitation after tricuspid repair with an incomplete annuloplasty ring and subsequent paravalvular leak closure.

Anatomic Suitability for Transcaval Access Based on Computed Tomography.

Transcaval access has been used successfully for over 200 transcatheter aortic valve replacements, large-bore percutaneous left ventricular assist devices, and thoracic endovascular aortic aneurysm repairs. This review teaches how to plan transcaval access and closure based on computed tomography. The main planning goals are to: 1) identify calcium-free crossing targets in the abdominal aorta along with optimal fluoroscopic projection angles and level with respect to lumbar vertebrae; 2) identify obstacles such as interposed bowel or pedunculated aortic atheroma; 3) plan covered stent bailout; and 4) identify jeopardized vascular branches such as renal arteries that might be obstructed by bailout covered stents if employed. The aorta and inferior vena cava are segmented (sculpted) using an image reconstruction workstation and crossing targets are highlighted. Important measurements such as aortic lumen diameter and target distance from renal arteries, aortoiliac bifurcation, and right femoral vein puncture site are reported to assist the operator. The proposed classification for transcaval feasibility has been revised, making some previously unfavorable candidates now feasible or favorable based on procedural success to date. Transcaval access allows percutaneous introduction of large devices into the aorta despite small or diseased iliofemoral arteries. By following these simplified procedures, both operators and imaging specialists can easily prepare comprehensive treatment plans.

Early and late changes in quality of life following transcatheter aortic valve implantation using the transfemoral and transapical approaches.

AIMS: To evaluate the effects of access route upon clinical results and quality of life (QoL) in patients undergoing either transfemoral (TF-TAVI) or transapical balloon-expandable transcatheter aortic valve implantation (TA-TAVI) in the real world. METHODS AND RESULTS: A prospective analysis was performed upon 264 consecutive patients receiving TF-TAVI or TA-TAVI. QoL was assessed using the EQ-5D questionnaire. At baseline, TA-TAVI patients reported significantly more problems in mobility, self-care, usual activities and lower overall health status domains (p<0.01 for all). At 30 days, the TF-TAVI group reported fewer problems with usual activity (p=0.01) and pain/discomfort (p<0.01), and higher EQ-5D index and visual analogue scale (VAS) (p=0.01 and p<0.01, respectively) than the TA-TAVI group. Nevertheless, the absolute improvements (ΔEQ-5D index and ΔEQ-5D VAS) were larger in the TA-TAVI group, with most dramatically marked QoL absolute improvements (p<0.01 and p=0.02, respectively). By one year, notwithstanding higher all-cause mortality in the sicker TA-TAVI group, there were no differences between groups in any EQ-5D domain. Indeed, surviving TA-TAVI group's greater absolute improvements remained (p<0.01). CONCLUSIONS: QoL is greater at the earlier time point of 30 days in the TF-TAVI cohort but equatable by one year. However, the magnitude of improvement in QoL is greater in the TA-TAVI patients at both 30 days and one year.

The impact of transcatheter aortic valve implantation on patients' profiles and outcomes of aortic valve surgery programmes: a multi-institutional appraisal.

OBJECTIVES: The aim of this retrospective multicenter study was to assess how the development of transcatheter aortic valve implantation (TAVI) influenced the characteristics and outcomes of patients undergoing aortic valve procedures. METHODS: We reviewed 1395 patients who underwent isolated surgical aortic valve replacement (SAVR) or TAVI in three centres with a high-volume TAVI programme. Patients were divided into two groups: 'Pre-TAVI' (395 patients, 28.3%) and 'Post-TAVI' (1000 patients, 71.7%) operated on before and after the introduction of TAVI into clinical practice. We evaluated age, logistic EuroSCORE I (LES) and hospital mortality according to time periods and the procedure performed, whether SAVR or TAVI. RESULTS: 'Post-TAVI' patients were older (78.2 ± 7.8 vs 76.8 ± 6.7 years; P = 0.002) and with a significantly higher LES (17.8 ± 14.7 vs 9.1 ± 9.2%; P < 0.001) than 'Pre-TAVI' patients. Hospital mortality was not significantly different between groups ('Pre-TAVI' vs 'Post-TAVI': 2 vs 3.4%; P = 0.17). Of the 1000 'Post-TAVI' patients, 605 (60.5%) underwent TAVI and 395 (39.5%), SAVR. Patients undergoing TAVI were older (79.9 ± 7.1 vs 75.5 ± 9.2 years; P < 0.001) and with a higher LES (22.9 ± 15.3 vs 9.7 ± 9.3%; P < 0.001) than 'Post-TAVI' SAVR patients, but their hospital mortality was similar (3.9 vs 2.5%; P = 0.22). LES was similar between 'Pre-TAVI' and 'Post-TAVI' SAVR patients (9.1 ± 9.2 vs 9.7 ± 9.3%; P = 0.26). Furthermore, we did not find significant differences in the overall hospital mortality between SAVR and TAVI patients: 2.3 vs 3.9%, P = 0.08. CONCLUSIONS: This analysis shows that the development of TAVI has caused an increase in the preoperative risk profile of patients scheduled for aortic valve procedures (SAVR or TAVI) without increasing hospital mortality.

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.

Clopidogrel, aspirin and proton pump inhibition after percutaneous valve implants: an update.

OBJECTIVES: This paper reviews literary evidence on antithrombotic therapies currently employed in TAVR to assess validity and efficacy; duration and modality are also considered. In the absence of firm guidelines and reliable trial results, we analyze current knowledge of interaction between PPI and antithrombotic drugs. BACKGROUND: TAVR has been associated with Double Antiplatelet Therapy since 2002. This was an empirical approach for a new stentmounted tissue valve to prevent early and late MACCE that affect survival and quality of life. DATA SOURCES: Systematic searches of major bibliographic databases, contact with experts in the field, and review of primary articles, review papers, and guidelines has been performed. METHODS: We analyze TAVR features and pitfalls in existing trials to understand which therapy would fit patients better and we confront these with established clinical practice guidelines of the population treated for cardiovascular disease. CONCLUSIONS: TAVR is a new technology that compresses a tissue valve onto an expandable stent. Technical and procedural issues have been solved, but strokes and major bleeding still affect patients' life despite double antiplatelet therapy given to reduce MACCE. To balance pros and cons, antithrombotic therapy with Warfarin or new anticoagulants can be used in patients with previous AF or NOAF to prevent stroke; while single antiplatelet with PPI is a better alternative in patients with liver disease, gastric ulcer or drug abuse to avoid bleeding events. While waiting for randomized trials, a tailored therapy based upon physician's experience and close patient follow-up is the safest, most effective treatment.

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.

Case series of bail-out procedures with a balloon-expandable sheath after unsuccessful introduction of the NovaFlex device.

OBJECTIVE: Vascular complications remain the main problem of transcatheter aortic valve replacement, despite downsizing of delivery catheter diameter and judicious patient selection. In case of diffusely calcified and/or very tortuous access vessels, the SoloPath Balloon Expandable TransFemoral Introducer (Onset Medical Corporation, Irvine, CA USA), providing the smallest insertion profile of any sheath in its class, may enable exceptional trackability and offer the largest working diameter, thus helping to prevent feared vascular complications. We report the successful use of SoloPath sheath to face six cases of NovaFlex (Edwards Lifesciences Inc, Irvine, CA USA) sheath failed insertion due to vessel tortuosity and calcifications. METHODS: In six patients enrolled for transfemoral transcatheter Edwards SAPIEN XT replacement, resistance to NovaFlex sheath pushing was encountered, subsequent to the bending of the distal portion of the sheath due to vessel tortuosity and calcifications. Damaged Edwards sheaths were exchanged for a SoloPath sheath with a 21-French inner diameter. SoloPath Controlled Deployment Technology design provides the introducer, once expanded, with great radial and pillar resistance. RESULTS: The unexpanded SoloPath sheath-dilator combination tracked without resistance or kinking over a stiff guide wire through the iliofemoral axis and then was expanded. All transcatheter prostheses were successfully deployed within the native annulus, showing good hemodynamic function. CONCLUSIONS: We report six successful bail-out procedures with the SoloPath Balloon Expandable TransFemoral sheath after unsuccessful introduction of the NovaFlex device. If similar results are confirmed, use of the SoloPath during transcatheter aortic valve replacement may help prevent vascular complications and eliminate the need for other preoperative steps (eg, vascular stenting), therefore reducing procedural mortality, surgical expense, and patient recovery time.

Transcatheter vs. surgical aortic valve replacement: a retrospective analysis assessing clinical effectiveness and safety.

OBJECTIVE: To compare, in terms of clinical effectiveness and safety, patients who underwent transcatheter aortic valve implantation (TAVI) with those who underwent surgical aortic valve replacement (S-AVR) for the treatment of severe aortic stenosis during the same period. METHODS: One hundred and eighty-seven consecutive patients were included: 81 with S-AVR and 106 with TAVI. Primary and secondary outcomes were reported in accordance with published reporting guidelines for valve surgery. A propensity matching model was computed in the attempt to reduce confounding effects of covariates. RESULTS: Thirty-day mortality and morbidity, as well as follow-up events, did not differ between the two therapeutic options, except for ICU stay, in favor of TAVI, and occurrence of pleural effusions, in favor of S-AVR. TAVI accomplished significant mean aortic gradient reduction (better than S-AVR in the immediate postoperative and at least comparable at follow-up) and improvement in valve area and functional class (always higher than S-AVR). Although for the first year, survival was at least comparable between TAVI and S-AVR (both whole and matched groups); at later times, TAVI all-cause and noncardiac mortality was higher in the whole sample, as expected from age and comorbidities of TAVI patients. At later follow-up, in the matched subsamples, 1-year mortality rates were replicated, with a significantly higher incidence of cardiac deaths in S-AVR patients. CONCLUSION: TAVI morbidity and mortality registered in this series are lower than those estimated for conventional surgery in high-risk patients and compare to those associated with S-AVR in good surgical candidates.

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.

Hemodynamic and clinical impact of prosthesis-patient mismatch after transcatheter aortic valve implantation.

OBJECTIVES: This study examined the mid-term hemodynamic and clinical impact of prosthesis-patient mismatch (PPM) in patients undergoing transcatheter aortic valve implantation (TAVI) with balloon-expandable valves. BACKGROUND: PPM can be observed after aortic valve surgery. However, little is known about the incidence of PPM in patients undergoing TAVI. METHODS: Echocardiography and clinical assessment were performed in 165 patients at baseline, before hospital discharge, and at 6 months after TAVI. PPM was defined as an indexed effective orifice area ≤0.85 cm(2)/m(2). RESULTS: Thirty patients (18.2%) showed PPM before hospital discharge. At baseline, patients with PPM had a larger body surface area (1.84 ± 0.18 m(2) vs. 1.73 ± 0.18 m(2), p = 0.003) and a greater severity of aortic stenosis (indexed valve area 0.35 ± 0.09 cm(2)/m(2) vs. 0.40 ± 0.10 cm(2)/m(2), p = 0.005) than patients without PPM. Patients with PPM demonstrated a slower and smaller reduction in mean transaortic gradient, limited left ventricular (LV) mass regression, and left atrial volume reduction over 6 months compared with patients without PPM. LV filling pressure, measured by E/e', tended to remain elevated in patients with PPM. Importantly, a higher proportion of patients with PPM did not improve in New York Heart Association functional class compared with patients without PPM (36.7% vs. 1.5%, p < 0.001), although major adverse valve-related and cardiovascular events did not differ between the 2 groups. CONCLUSIONS: PPM may be observed after TAVI and when present may be accompanied by less favorable changes in transvalvular hemodynamics, limited LV mass regression, persistent elevated LV filling pressure, and less improvement in clinical functional status.

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.

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.

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.

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.

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.

Incidental detection of a giant ductus arteriosus aneurysm by low-dose multidetector computed tomography in an asymptomatic adult.

Aneurysm of the ductus arteriosus is a very rare congenital lesion in adults that can be associated with thromboembolism, rupture, and death. Its detection in a silent clinical phase is very important for planning appropriate treatment and avoiding potentially fatal complications. We report a case of a patent ductus arteriosus aneurysm of very large size (65.5 mm) that was incidentally discovered with low-dose (3.2 mSv) multidetector computed tomography in an asymptomatic 67-year-old man. The presence of coronary disease was also ruled out with this non-invasive imaging modality. Further evaluation with echocardiography and selective angiography confirmed the diagnosis. At surgery, the aneurysm was successfully resected via a left posterolateral thoracotomy.