TriGuard™ HDH embolic deflection device for cerebral protection during transcatheter aortic valve replacement.

OBJECTIVES: This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard™HDH in patients undergoing TAVR. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is associated with a high incidence of new cerebral ischemic lesions. The use of an embolic protection device may reduce the frequency of TAVR-related embolic events. METHODS: This prospective, single arm feasibility pilot study included 14 patients with severe symptomatic aortic stenosis scheduled for TAVR. Cerebral diffusion weighted magnetic resonance imaging (DWI) was planned in all patients one day before and at day 4 (±2) after the procedure. Major adverse cerebral and cardiac events (MACCEs) were recorded for all patients. Primary endpoints of this study were I) device performance success defined as coverage of the aortic arch takeoffs throughout the entire TAVR procedure and II) MACCE occurrence. Secondary endpoints included the number and the volume of new cerebral ischemic lesions on DWI. RESULTS: Thirteen patients underwent transfemoral TAVR and one patient a transapical procedure. Edwards SAPIEN valve prosthesis was implanted in 8 (57%) patients and Medtronic CoreValve prosthesis in the remaining 6 (43%). Predefined performance success of the TriGuard™HDH device was achieved in 9 (64%) patients. The composite endpoint MACCE occurred in none of the patients. Post-procedural DWI was performed in 11 patients. Comparing the DWI of these patients to a historical control group showed no reduction in number [median 5.5 vs. 5.0, P = 0.857], however there was a significant reduction in mean lesion volume per patient [median 13.8 vs. 25.1, P = 0.049]. CONCLUSION: This study showed the feasibility and safety of using the TriGuard™HDH for cerebral protection during TAVR. This device did not decrease the number of post-procedural new cerebral DWI lesions, however its use showed decreased lesion volume as compared to unprotected TAVR. © 2016 Wiley Periodicals, Inc.

Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: the nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial.

OBJECTIVE: To evaluate a paclitaxel drug-eluting balloon (DEB) only strategy in primary percutaneous coronary intervention (PPCI), aiming at a comparison with bare metal stent (BMS) alone, DEB followed by BMS, and paclitaxel eluting stent (PES), as assessed in the randomized Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction (DEB-AMI) trial. BACKGROUND: DEB-only seems an attractive strategy in PPCI, as it obviates the risk of stent thrombosis. METHODS: This study is a prospective registry with the same inclusion/exclusion criteria used in the DEB-AMI trial, as it constitutes the fourth, nonrandomized, treatment arm of this trial. Patients presenting with ST-elevation myocardial infarction were allocated to DEB-only (DIOR II, Eurocor GmbH, Bonn, Germany) after successful thrombus aspiration and predilatation. Primary endpoint was 6-month angiographic in-balloon/stent late-luminal loss (LLL). Secondary endpoints were in-balloon/stent binary restenosis and major adverse cardiac events (MACE: death, myocardial infarction, target-vessel revascularization). RESULTS: Forty patients underwent PPCI by DEB-only. Procedural success was achieved in 97.5% with bail-out stenting required in 10.0% of procedures. In DEB-only, LLL was 0.51 ± 0.59 mm as compared to 0.74 ± 0.57 mm in BMS (P = 0.44), 0.64 ± 0.56 mm in DEB+BMS (P = 0.88) and 0.21 ± 0.32 mm in PES (P < 0.01); in-balloon/stent binary restenosis rates were 22.2%, 23.8% (P = 0.67), 28.6% (P = 0.97), and 4.5% (P = 0.07), respectively; and MACE rates were 17.5%, 23.5% (P = 0.20), 20.0% (P = 0.26), and 4.1% (P = 0.90), respectively. No acute or late thrombotic events occurred in the DEB-only group. CONCLUSIONS: PPCI by DEB-only in selected patients yielded an angiographic outcome comparable to BMS alone and DEB followed by BMS. PES proved angiographic superiority to DEB-only. DEB-only is therefore a potential treatment alternative during PPCI in patients with contra-indications to drug-eluting stents.

Svelte integrated delivery system performance examined through diagnostic catheter delivery: the SPEED registry.

AIMS: The multi-center SPEED registry evaluated the procedural success and in-hospital clinical outcomes of direct stenting with the Svelte 'all-in-one' coronary stent Integrated Delivery System (IDS) through diagnostic catheters to identify the clinical indications for which this approach is appropriately suited. METHODS & RESULTS: Forty-eight (48) patients with 54 lesions of lengths ≤20 mm and RVD 2.5-3.5 mm were targeted for direct stenting through diagnostic catheters (4-6F) via radial or femoral approach. Procedural characteristics early in an investigator's experience (28 lesions) were compared with outcomes following experience (26 lesions). Procedure, device and strategy success were realized in 54 (100%), 50 (93%) and 46 (85%) lesions, respectively, with strategy success significantly related to RVD (P = 0.05), lesion location (P = 0.01), and diagnostic catheter size (P = 0.05). Significant improvement in crossing and intervention time and trends toward improvement in device and strategy success, reductions in procedure and radiation time and contrast use were observed. CONCLUSIONS: Direct stenting through diagnostic catheters via radial or femoral approach using the Svelte IDS is feasible and associated with good in-hospital outcomes. This approach offers the attractive option of assessing lesions via diagnostic catheter and, depending upon vessel anatomy and lesion morphology, continuing with ad-hoc interventional treatment using the same diagnostic catheter. Improvements in strategy success and procedural efficiencies, based on operator experience, facilitate catheter downsizing and reduce intervention time, ancillary product use and overall procedure costs. © 2014 Wiley Periodicals, Inc.

Ex Vivo Pilot Study of Cardiac Magnetic Resonance Velocity Mapping for Quantification of Aortic Regurgitation in a Porcine Model in the Presence of a Transcatheter Heart Valve.

Accuracy of aortic regurgitation (AR) quantification by magnetic resonance (MR) imaging in the presence of a transcatheter heart valve (THV) remains to be established. We evaluated the accuracy of cardiac MR velocity mapping for quantification of antegrade flow (AF) and retrograde flow (RF) across a THV and the optimal slice position to use in cardiac MR imaging. In a systematic and fully controlled laboratory ex vivo setting, two THVs (Edwards SAPIEN XT, Medtronic CoreValve) were tested in a porcine model (n = 1) under steady flow conditions. Results showed a high level of accuracy and precision. For both THVs, AF was best measured at left ventricular outflow tract level, and RF at ascending aorta level. At these levels, MR had an excellent repeatability (ICC > 0.99), with a tendency to overestimate (4.6 ± 2.4% to 9.4 ± 7.0%). Quantification of AR by MR velocity mapping in the presence of a THV was accurate, precise, and repeatable in this pilot study, when corrected for the systematic error and when the best MR slice position was used. Confirmation of these results in future clinical studies would be a step forward in increasing the accuracy of the assessment of paravalvular AR severity.

Assessing Risk in Patients with Stable Coronary Disease: When Should We Intensify Care and Follow-Up? Results from a Meta-Analysis of Observational Studies of the COURAGE and FAME Era.

Background. A large number of clinical and laboratory markers have been appraised to predict prognosis in patients with stable angina, but uncertainty remains regarding which variables are the best predictors of prognosis. Therefore, we performed a meta-analysis of studies in patients with stable angina to assess which variables predict prognosis. Methods. MEDLINE and PubMed were searched for eligible studies published up to 2015, reporting multivariate predictors of major adverse cardiac events (MACE, a composite endpoint of death, myocardial infarction, and revascularization) in patients with stable angina. Study features, patient characteristics, and prevalence and predictors of such events were abstracted and pooled with random-effect methods (95% CIs). Major adverse cardiovascular event (MACE) was the primary endpoint. Results. 42 studies (104,559 patients) were included. After a median follow-up of 57 months, cardiovascular events occurred in 7.8% of patients with MI in 6.2% of patients and need for repeat revascularization (both surgical and percutaneous) in 19.5% of patients. Male sex, reduced EF, diabetes, prior MI, and high C-reactive protein were the most powerful predictors of cardiovascular events. Conclusions. We show that simple and low-cost clinical features may help clinicians in identifying the most appropriate diagnostic and therapeutic approaches within the broad range of outpatients presenting with stable coronary artery disease.

Percutaneous Device to Narrow the Coronary Sinus: Shifting Paradigm in the Treatment of Refractory Angina? A Review of the Literature.

Refractory angina pectoris is defined as a chronic debilitating condition characterized by the presence of chronic anginal symptoms due to a severe obstructive and/or diffuse coronary artery disease that cannot be controlled by the combination of medical therapy and/or revascularization (percutaneous or surgical). In addition, the presence of myocardial ischemia as a cause of the symptoms must have been documented. The coronary sinus reducer (CSR) is a recently introduced percutaneous device to treat patients with severe anginal symptoms refractory to optimal medical therapy and not amenable to conventional revascularization. The purpose of this review is to describe the current evidence from available studies measuring the clinical effect of the CSR implantation on the health and well-being of patients with refractory angina.

Comparative assessment of the antirestenotic efficacy of two paclitaxel drug-eluting balloons with different coatings in the treatment of in-stent restenosis.

BACKGROUND/OBJECTIVES: Preclinical investigations have suggested that coating technology is crucial for the efficacy of drug-eluting balloons (DEB). Aim of this study is to compare the antirestenotic efficacy of two paclitaxel DEB with different coatings in the treatment of in-stent restenosis (ISR) by means of a morphological and functional assessment. METHODS: In a single center, prospective, non-randomized study, the shellac-paclitaxel coated DIOR, and the urea-paclitaxel coated IN.PACT Falcon were compared in the setting of ISR. Quantitative angiography, fractional flow reserve (FFR), and optical coherence tomography (OCT) were performed at baseline, postprocedure and 6-month follow-up. Main endpoints were QCA, FFR and OCT-based parameters of restenosis. RESULTS: Forty-five patients were included, 20 (44 %) received treatment with the DIOR and 25 (56 %) with the IN.PACT Falcon. Angiographic and device success were 100 and 90 % for the DIOR, and 100 and 92 % for the IN.PACT Falcon, respectively. After 6-months, in-segment late lumen loss (-0.03 ± 0.43 vs. 0.36 ± 0.48 mm, p = 0.014) and diameter stenosis (30.7 ± 16.2 vs. 41.3 ± 22.6 %, p = 0.083) were lower for the IN.PACT Falcon. FFR distal of the stent was significantly higher in the IN.PACT Falcon group (0.92 ± 0.07 vs. 0.84 ± 0.13, p = 0.029) and in-stent FFR gradient was lower (0.05 ± 0.05 vs. 0.13 ± 0.12, p = 0.002). Between postprocedure and follow-up, a 16 % decrease in neointimal volume was observed for the IN.PACT Falcon, while a 30 % increase was observed for the DIOR (p = 0.006). CONCLUSIONS: The IN.PACT Falcon DEB showed higher antirestenotic efficacy than the DIOR in the treatment of ISR, demonstrating that DEB with an excipient-based coating is not equally effective.

Incidence, Predictive Factors, and Effect of Delirium After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The purpose of this study was to investigate the incidence, predictive factors, and effect of post-operative delirium (POD) among patients treated by transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients undergoing operations that involve valve replacement appear at higher risk of POD than patients subjected to coronary artery bypass surgery alone. In patients with severe aortic stenosis undergoing TAVR, little is known regarding the potential impact of POD on the clinical outcomes. METHODS: A retrospective observational cohort study of 268 consecutive patients who underwent TAVR at our institute was conducted. Delirium was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorder, 4th Edition criteria. The primary outcome of this study was the presence of in-hospital POD after TAVR. RESULTS: The incidence of POD after TAVR was 13.4% (n = 36). Of these cases, 18 were associated with post-procedural complications, including major vascular complications/bleeding (n = 4), stroke (n = 3), acute kidney injury (n = 3), atrial fibrillation (n = 4), and infectious disease (n = 4). POD was most frequently diagnosed on the second day after TAVR (interquartile range [IQR]: 1 to 5 days) and was associated with prolonged in-hospital stay regardless of complications (in uncomplicated TAVR: 6 days [IQR: 5 to 10 days] vs. 5 days [IQR: 4 to 5 days]; p < 0.001; and in complicated TAVR: 9 days [IQR: 8 to 15 days] vs. 6 days [IQR: 5 to 9 days]; p < 0.001). Predictors of POD were nontransfemoral (transapical/transaortic) access (odds ratio [OR]: 7.74; 95% confidence interval [CI]: 3.26 to 18.1), current smoking (OR: 3.99; 95% CI: 1.25 to 12.8), carotid artery disease (OR: 3.88; 95% CI: 1.50 to 10.1), atrial fibrillation (OR: 2.74; 95% CI: 1.17 to 6.37), and age (OR: 1.08; 95% CI: 1.00 to 1.17, per year increase). After a median follow-up of 16 months (IQR: 6 to 27 months), POD remained an independent predictor of mortality in patients undergoing transfemoral TAVR compared with the nontransfemoral TAVR (hazard ratio: 2.81; 95% CI: 1.16 to 6.83 vs. hazard ratio: 0.43; 95% Cl: 0.10 to 1.76), adjusted for possible confounders in a time-dependent Cox-regression model (i.e., age, sex, Logistic EuroSCORE and the occurrence of complications). CONCLUSIONS: POD after TAVR has an incidence of around 13% and occurs early in the post-operative course. Nontransfemoral access is strongly associated with the occurrence of POD. Patients who develop POD show prolonged in-hospital stay and impaired long-term survival.

[Innovative therapies for the treatment of refractory angina: the Reducer, a percutaneous device to narrow the coronary sinus]. / Terapie innovative per il trattamento dell'angina refrattaria: il Reducer, dispositivo percutaneo di restringimento del seno coronarico venoso.

Refractory angina is a chronic condition characterized by the presence of disabling symptoms due to severe obstructive coronary artery disease that is not improved by a combination of medical therapy and percutaneous or surgical revascularization. Mortality rates associated with this condition are quite low in clinically stable patients on optimal medical therapy, but rehospitalization rates remain high. This mandates the need for new therapies targeting an improvement of symptoms in this population, taking into account also the potential impact in terms of healthcare and costs. The increase in coronary sinus pressure seems to reduce myocardial ischemia leading to a redistribution of blood flow to the ischemic territories. The coronary sinus Reducer is a percutaneous implantable device, made of a stainless steel hourglass-shaped stent, designed to achieve controlled narrowing of the coronary sinus and to increase its upstream pressure. In various studies, the Reducer was safely implanted percutaneously via the right jugular vein in patients with refractory angina who were not amenable to revascularization and was associated with an improvement in anginal symptoms and ischemia. These results support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.

Transcatheter aortic valve implantation with the new balloon-expandable Sapien 3 versus Sapien XT valve system: a propensity score-matched single-center comparison.

BACKGROUND: The new balloon-expandable Sapien 3 transcatheter heart valve (S3-THV) incorporates new features to reduce aortic regurgitation (AR) and vascular complications in transcatheter aortic valve implantation. Aim of this study is to compare the outcomes of the S3-THV with the preceding Sapien XT THV (SXT-THV) in patients who underwent transcatheter aortic valve implantation for symptomatic severe native aortic stenosis. METHODS AND RESULTS: Eligible patients were retrospectively identified in our institutional database and periprocedural clinical and imaging data were collected. Non-parsimonious one-to-many propensity score matching was performed to account for differences in baseline characteristics. Between November 2011 and December 2014, 167 patients underwent balloon-expandable transcatheter aortic valve implantation with either the S3-THV (n=49) or SXT-THV (n=118). Forty-four (89.8%) S3-THV patients were matched to 66 (55.9%) SXT-THV patients (mean age 80.3±8.4 and 80.5±7.8 years, median EuroSCORE 15.8 and 16.5%, respectively). In the S3-THV and SXT-THV groups, transfemoral approach (77.3% versus 78.8%) and postdilatation rates (15.9% versus 12.1%) were similar. Predischarge echocardiography demonstrated a lower incidence of ≥mild AR (15.9% versus 46.2%, P=0.003) for the S3-THV, despite reduced annulus area to prosthesis oversizing (8.2±5.1 versus 18.2±10.7%, P=0.001). Transfemoral access site-related life-threatening or major bleedings and vascular complications were absent in the S3-THV group (0% versus 7.7%, P=0.15). No differences were observed in pacemaker implantation rate (9.8% versus 8.8%, P=0.94) and 30-day mortality (both 5%). CONCLUSIONS: In this retrospective, propensity score-matched analysis, the S3-THV performed superiorly to the SXT-THV, as demonstrated by improved valve patency and increased transfemoral access safety.

Silent ischemic brain lesions after transcatheter aortic valve replacement: lesion distribution and predictors.

AIMS: Silent ischemic brain lesions and ischemic stroke are known complications of transcatheter aortic valve replacement (TAVR). We aimed to investigate the occurrence and distribution of TAVR-related silent ischemic brain lesions using diffusion-weighted magnetic resonance imaging (DWI). METHODS: Consecutive patients with severe aortic valve stenosis treated with TAVR underwent cerebral DWI within 5 days after the index procedure. DWI scans were analyzed for the occurrence and distribution of new ischemic lesions post-TAVR. RESULTS: Forty-two patients were enrolled in this study. After TAVR, a total of 276 new cerebral ischemic lesions were detected in 38 (90 %) patients, with a median of 4.5 (interquartile range 2.0-7.0) lesions per patient. A total of 129 (47 %) lesions were detected in the cortical regions, 97 (35 %) in the subcortical regions, and 50 (18 %) in the cerebellum or brainstem. The median lesion volume was 20.2 µl (10.0, 42.7) and the total ischemic lesion volume was 132.3 µl (42.8, 336.9). The new ischemic brain lesions were clinically silent in 37 (97 %) patients; the other patient had a transient ischemic attack. Age (B = 0.528, p = 0.015), hyperlipidaemia (B = 5.809, p = 0.028) and post-dilatation of the implanted prosthesis (B = 7.196, p = 0.029) were independently associated with the number of post-TAVR cerebral DWI lesions. In addition, peak transaortic gradient was independently associated with post-procedural total infarct volume. CONCLUSION: Clinically silent cerebral infarcts occurred in 90 % of patients following TAVR, most of which were small (<20 µl) and located in the cortical regions of the cerebral hemispheres. An independent association was found between age, hyperlipidaemia and balloon post-dilatation and the number of post-TAVR ischemic brain lesions. Only peak transaortic gradient was independently associated with post-procedural total infarct volume.

Embrella embolic deflection device for cerebral protection during transcatheter aortic valve replacement.

AIMS: To compare the extent of cerebral ischemic injury after transcatheter aortic valve replacement (TAVR) with the use of an Embrella Embolic Deflector System versus unprotected TAVR. METHODS: Fifteen patients with severe symptomatic aortic stenosis underwent TAVR with use of the Embrella Embolic Deflector System for cerebral protection. Cerebral diffusion-weighted magnetic resonance imaging (DWI) was performed in all patients at day 4 after the procedure and images were retrospectively compared to 37 patients who had previously undergone TAVR without a protection device (TAVR-only group). RESULTS: Successful placement of the Embrella device was achieved in all patients. DWI revealed an increase in the number of ischemic lesions in the Embrella group compared with the TAVR-only group (9.0 vs 5.0, P = .044). The use of the Embrella device was however associated with a significant reduction in single-lesion volume: 9.7 µL [5.8, 18.4] versus 17.8 µL [9.5, 38.7] (P < .001). Moreover, total infarct volumes of more than 1000 µL were only seen in the TAVR-only group. More lesions occurred in the right side of the brain in the Embrella group, whereas in the TAVR-only group lesions were distributed equally between left and right. One patient in the TAVR-only group suffered from a transient ischemic attack. Postoperative evaluation was clinically uneventful in the Embrella group. CONCLUSIONS: The use of the Embrella device during TAVR increased the number of cerebral ischemic lesions on postprocedural brain imaging. This increase in number was however accompanied by a significant reduction in single-lesion volume and the absence of large total infarct volumes.

Incidence, predictors, and impact on prognosis of systolic pulmonary artery pressure and its improvement after transcatheter aortic valve implantation: a multicenter registry.

AIMS: Elevated values of systolic pulmonary artery pressure (sPAP) represent a common finding in patients with aortic stenosis and severe left ventricular hypertrophy. Prognostic impact of sPAP and its potential improvement after transcatheter aortic valve implantation (TAVI) remains to be determined. METHODS AND RESULTS: This is a multicenter retrospective registry in five European institutions. All consecutive patients undergoing TAVI were enrolled, and divided into two groups according to sPAP evaluated with echocardiography: ≤40 mm Hg and >40 mm Hg. All-cause mortality at follow-up of at least 1 year was the primary endpoint, while 30-day mortality, periprocedural complications, myocardial infarction, stroke, and reintervention rates at follow-up were the secondary endpoints. Among 674 patients enrolled, a total of 319 (47%) had sPAP >40 mm Hg. This was associated with higher mortality at 30 days (4.5% vs 8.5%; P=.03) and at a median follow-up of 477 days (17% vs 26%; P=.03). Improvement of sPAP was reported in 113 patients (27%), occurring more frequently in absence of moderate or severe mitral regurgitation and of right ventricle dysfunction. With multivariate adjustment, reduced renal function, insulin-dependent diabetes mellitus, and sPAP >40 mm Hg were independent predictors of all-cause mortality, improvement in sPAP values was related to a better survival, while ejection fraction was not. CONCLUSION: Elevated values of sPAP represent a common finding in patients undergoing TAVI. This parameter, along with its improvement, may be used to stratify risk and determine prognosis for patients undergoing TAVI.

Meta-analysis of comparison between self-expandable and balloon-expandable valves for patients having transcatheter aortic valve implantation.

Two different devices, 1 self-expanding and 1 balloon-expandable, have been developed for patients who underwent transcatheter aortic valve implantation with contrasting data about efficacy and safety. Pubmed, Medline, and Google Scholar were systematically searched for studies of these different devices, with data derived from randomized controlled trial or registries with multivariate analysis. All-cause death at 30 days and at follow-up were the primary end points, whereas postprocedural moderate or severe aortic regurgitation (AR), stroke, major vascular complications, bleedings, and pacemaker implantation the secondary ones. Six studies with 957 self-expanding and 947 balloon-expandable valves were included: 1 randomized controlled trial and 5 observational studies. At 30 days follow-up, rates of death did not differ between self-expanding and balloon-expandable valves (odds ratio [OR] 0.74, 95% confidence interval [CI] 0.47 to 1.17), whereas balloon expandable reduced rates of moderate or severe AR (OR 0.51, 95% CI 0.27 to 0.99) and of pacemaker implantation (OR 0.28, 95% CI 0.17 to 0.47). After a follow-up of 360 days (300 to 390), rates of all-cause death did not differ between the 2 groups. In conclusion, risks of moderate or severe AR and pacemaker implantation were lower with the balloon-expandable devices without an impact on 30 days and midterm mortality.

Clinical validation of a novel software for quantitative analysis of coronary intravascular ultrasound.

PURPOSE: CAAS IntraVascular (CAAS-IV) is a recently released software that provides options for sophisticated quantitative coronary ultrasound (QCU) analysis. The aim of this study was to validate CAAS-IV for QCU in diseased human coronaries. METHODS: Ten preprocedural and 5 postprocedural IVUS studies were derived from daily practice. Intraobserver, interobserver, intersoftware (CAAS-IV vs. Curad) and interplatform (CAAS-IV vs. Volcano console) variability were assessed for cross-sectional area (CSA) measurements. Interobserver and intersoftware comparisons were made for volume measurements. RESULTS: Measurements of lumen, EEM, plaque and stent CSA demonstrated small differences in the intraobserver (0.0±3.7%, -0.7±2.8%, -0.5±7.0% and -0.9±3.4%), interobserver (0.1±4.4%, 0.1±3.4%, -0.5±8.2% and -0.8±4.3%), intersoftware (-0.3±4.5%, 0.2±2.4%, 0.4±6.8% and -0.5±3.2%) and interplatform (0.7±7.9%, 0.9±4.0%, -1.1±12%, -1.8±3.6%) comparisons. For lumen, EEM, plaque and stent volume, the interobserver (-2.1±9.3%, 0.9±5.6%, 3.4±7.2% and -0.2±3.6%) and intersoftware (-2.2±6.2%, -2.6±6.1%, -2.7±12% and -4.1±3.2%) differences were substantially larger. Excluding large side-branches and calcifications, post-hoc measurements of lumen, EEM, plaque and stent volume showed small differences in the interobserver (-0.3±3.2%, 0.9±2.4%, 2.9±4.4% and -1.3±1.8%) and intersoftware (0.5±2.5%, -1.2±1.7%, -3.4±5.1% and -1.5±2.2%) comparisons. Analysis time for entire pullbacks was reduced by 19.2 [14.9-30.0]% using CAAS-IV (p<0.01). CONCLUSIONS: CAAS-IV demonstrated reliable QCU with excellent agreement with previously validated software and the IVUS imaging console. Precision and reproducibility of measurements were high, proving CAAS-IV to be a valid option for QCU analysis in clinical practice and research. Interactive contour editing reduced analysis time by 20%.

Transcatheter aortic valve implantation in patients with severe aortic valve stenosis and large aortic annulus, using the self-expanding 31-mm Medtronic CoreValve prosthesis: first clinical experience.

OBJECTIVES: With the introduction of the 31-mm Medtronic CoreValve prosthesis, patients with large aortic annulus have become eligible for transcatheter aortic valve implantation. The aim of this study was to evaluate the feasibility, efficacy, and safety of transcatheter aortic valve implantation using the 31-mm Medtronic CoreValve in patients with severe aortic valve stenosis and large aortic annulus. METHODS: Five institutions in the Netherlands and Italy participated in a retrospective multicenter registry. Clinical, procedural, and imaging data of patients treated with the 31-mm Medtronic CoreValve were retrospectively collected in accordance with the Valve Academic Research Consortium-2 criteria. RESULTS: Between August 2011 and November 2012, 47 patients (44 men, mean age 77.6 ± 8.9 years) received the 31-mm Medtronic CoreValve prosthesis for severe aortic stenosis. Device success (correct positioning of a single valve with intended performance and no all-cause 30-day mortality) was achieved in 31 patients (66.0%). Reasons for failing the device success criteria were significant prosthetic aortic regurgitation in 3 patients (6.4%), second valve implantation in 10 patients (21.2%) (8 cases of malpositioning with high-grade aortic regurgitation, 1 acute valve dislocation, and 1 delayed valve dislocation), 1 of whom died intrahospital, and in-hospital mortality in a further 3 patients (6.4%). Peak and mean transaortic gradients decreased significantly (P < .01). The rate of new pacemaker implantations was 41.7%. CONCLUSIONS: In this retrospective multicenter registry, transcatheter treatment of severe aortic valve stenosis with the 31-mm Medtronic CoreValve seemed to be challenging, even in experienced hands. If the prosthesis is properly implanted, it offers adequate valve hemodynamics and proper functioning.

Usefulness and validation of the survival posT TAVI score for survival after transcatheter aortic valve implantation for aortic stenosis.

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.

A gender based analysis of predictors of all cause death after transcatheter aortic 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.

Meta-analysis of predictors of all-cause mortality after transcatheter aortic valve implantation.

The aim of this study was to identify predictors of 30-day and midterm mortality after transcatheter aortic valve implantation (TAVI) by means of a systemic review. TAVI was demonstrated to be safe and efficacious in patients with severe aortic stenosis. An accurate estimation of procedural risk of these patients represents an actual challenge. The PubMed and Cochrane Collaboration databases were systematically searched for studies reporting on the incidence and independent predictors of 30-day and midterm mortality. Adverse events were pooled with random effect, whereas independent predictors are reported as odds ratios (ORs) with 95% confidence intervals (CIs). A total of 25 studies with 8,874 patients were included (median age 82.5 ± 1.5 years, 54.6% women). At 30 days, 7.5% of patients (n = 663) died. At midterm follow-up (median 365 days, interquartile range 267 to 365 days), the cumulative mortality rate was 21.6% (n = 1,917). Acute kidney injury (AKI) stage ≥2 (OR 18.0, 95% CI 6.3 to 52), preprocedural hospitalization for heart failure (OR 9.4, 95% CI 2.6 to 35), periprocedural acute myocardial infarction (OR 8.5, 95% CI 2.6 to 33.5), and increased pro-brain natriuretic peptide (pro-BNP) levels (OR 5.4, 95% CI 1.7 to 16.5) were the most important independent predictors of 30-day mortality. Increased pro-BNP levels (OR 11, 95% CI 1.5 to 81), AKI stage 3 (OR 6.8, 95% CI 2.6 to 15.7), left ventricular ejection fraction <30% (OR 6.7, 95% CI 3.5 to 12.7), and periprocedural acute myocardial infarction (OR 6.5, 95% CI 2.3 to 18.1) represented the predictors of midterm mortality. In conclusion, in this large meta-analysis of patients undergoing TAVI, we found that high pro-BNP levels and postprocedural AKI were the strongest independent predictors of both 30-day and 1-year mortality. These findings may contribute to a better understanding of the risk assessment process of patients undergoing TAVI.

Optimisation of transcatheter aortic balloon-expandable valve deployment: the two-step inflation technique.

AIMS: To evaluate the two-step inflation technique aimed at achieving optimal valve implantation depth (defined as 40% of prosthesis height extending below the lower sinus border on angiography) during balloon-expandable transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Between September 2010 and March 2013, 103 patients (67 females, mean age 80.9±5.6 years) were treated with the Edwards SAPIEN XT prosthesis using the two-step inflation technique. Implantation depth was measured on angiography. A historical control group (treated with Edwards SAPIEN) was used for comparison (n=20). Deviation from the defined optimum implantation depth (expressed as a percentage of stent frame height) was significantly less in the study group versus controls (7.0 [3.4-14.1]% vs. 13.9 [5.4-18.9]%; p=0.048). Valve placement was graded "as intended"/"within range"/"out of range" (defined as ≤10%, >10% but ≤20% and >20% deviation, respectively) in 66%/22%/12% of the study group and 35%/40%/25% of historical controls (p=0.02). Corrections in valve position were made in 20 procedures (20%), resulting in placement as intended in 16 cases (80%), with highest efficacy in the transapical and direct aortic approaches. CONCLUSIONS: The two-step inflation technique improves valve placement towards optimal implantation depth and may thereby prevent adverse events due to malpositioning.