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Transcatheter mitral edge-to-edge repair (TEER) with transcatheter devices has become a mainstay in the minimally invasive treatment of patients with severe mitral regurgitation at increased surgical risk. Despite its apparently favorable risk profile, there is uncertainty on the risk and features of cerebrovascular accidents (CVAs) early and long after transcatheter mitral valve repair. We aimed to appraise the incidence and predictors of CVA in patients who underwent TEER. We explicitly queried the data set of an ongoing multicenter prospective observational study dedicated to TEER with MitraClip (Abbott Vascular, Santa Clara, California). The incidence of CVAs after TEER was formally appraised, and we explored potential predictors of such events. Descriptive, bivariate, and diagnostic accuracy analyses were performed. Of 2,238 patients who underwent TEER, CVAs occurred in 33 patients (1.47% [95% confidence interval 1.02% to 2.06%]), including 6 (0.27% [0.10% to 0.58%]) in-hospital strokes and 27 events after discharge (0.99% [0.66% to 1.44%]), over a median follow-up of 14 months. Most CVAs were major ischemic strokes during and after the in-hospital phase. Overall, CVAs were more common in patients with atrial fibrillation (p = 0.018), renal dysfunction (p = 0.032), higher EuroSCORE II (p = 0.033), and, as expected, higher CHA2DS2-VASc score (p = 0.033), despite the limited prognostic accuracy of the score. Notably, the occurrence of CVA did not confer a significantly increased risk of long-term (p = 0.136) or cardiac death (p = 0.397). The incidence of CVA in patients who underwent TEER is low, with most events occurring after discharge and being associated with preexisting risk features. These findings, although reassuring on the safety of TEER, call for proactive antithrombotic therapy whenever CVA risk is increased before and after TEER., Competing Interests: Declaration of competing interest Dr. Adamo has received speaker fees from speaker fees from Abbott Structural Heart. Giuseppe Biondi-Zoccai has consulted for aleph, Amarin, Balmed, Cardionovum, Crannmedical, Endocore Lab, Eukon, Guidotti, Innovheart, Meditrial, Menarini, MicroPort, Opsens Medical, Terumo, and Translumina outside the present work. The remaining authors have no competing interests to declare., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Atrial functional mitral regurgitation (aFMR) has a peculiar pathophysiology that may have distinctive outcomes. We investigated the impact of transcatheter edge-to-edge repair in aFMR compared with other FMR etiologies. The GIOTTO (GIse registry Of Transcatheter treatment of MR) is a multicenter, prospective study enrolling patients with symptomatic MR treated with MitraClip up to 2020. We categorized patients with FMR as aFMR, ischemic FMR (iFMR), and nonischemic ventricular FMR (niFMR). The clinical end points were defined according to the Mitral Valve Academic Research Consortium. Of 1,153 patients, 6% had aFMR, 47% iFMR, and 47% niFMR. Patients with aFMR were older, mostly women, and had a higher atrial fibrillation rate. They had better left ventricular ejection fraction and smaller left ventricular volumes, with no difference in mitral effective regurgitant orifice area. The acute device and procedural success rates were similar among the groups. At the longest available follow-up (median 478 days, interquartile range 91 to 741 days), the rate of MR ≥2+ was similar among the groups. Patients with aFMR had a lower rate of cardiovascular death and heart failure than patients with iFMR (hazard ratio [HR] 0.43, p = 0.02) and niFMR (HR 0.45, p = 0.03). The aFMR etiology remained independently associated with the composite outcome, together with postprocedural MR ≤1+ (HR 0.63, p <0.01) and peripheral arteriopathy (HR 1.82, p = 0.003). The results of this GIOTTO subanalysis suggested that aFMR is less prevalent and associated with better outcomes compared with other causes of FMR treated by transcatheter edge-to-edge repair. Postprocedural MR >1+, peripheral vasculopathy, non-aFMR were independent predictors of worse outcomes., Competing Interests: Declaration of Competing Interest Drs. Giuseppe Tarantini, Bedogni, Grasso, Paolo Denti (PD), Tamburino, Petroni, Montorfano declared speaker fees from Abbott Vascular. The remaining authors have no competing interest to declare., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Low-flow low-gradient (LF-LG) aortic stenosis (AS) may occur with preserved or depressed left ventricular ejection fraction (LVEF). Both situations represent the most challenging subset of patients to manage and generally have a poor prognosis. Few and controversial data exist on the outcomes of these patients compared with normal flow-high gradient (NF-HG) AS after transcatheter aortic valve replacement (TAVR). We sought to characterize different transvalvular flow-gradient patterns and to examine their prognostic value after TAVR. We enrolled 1,208 patients with severe AS and categorized as follow: 976 patients NF-HG (mean aortic pressure gradient [MPG] ≥40 mm Hg), 107 paradoxical LF-LG (pLF-LG, MPG <40 mm Hg, LVEF ≥50%, stroke volume index <35 ml/m 2 ), and 125 classical LF-LG (cLF-LG) (MPG <40 mm Hg, LVEF <50%, stroke volume index <35 ml/m 2 ). When compared with NF-HG and pLF-LG, cLF-LG had a worse symptomatic status (New York Heart Association III to IV 86% vs 62% and 67%, p <0.001), a higher prevalence of eccentric hypertrophy and a higher level of LV global afterload reflected by a higher valvuloarterial impedance. Valvular function after TAVR was excellent over time in all patients. While 30-day mortality (p = 0.911) did not differ significantly among groups, cLF-LG had a lower 5-year survival rate (LF-LG 50% vs pLF-LG 62% and NF-HG 68%, p <0.05). cLF-LG was associated with a hazard ratio for mortality of 2.41 (95% confidence interval 1.65 to 3.52, p <0.001). In conclusion, TAVR is an effective procedure regardless of transvalvular flow-gradient patterns. However, special care should be given to characterized hemodynamic of AS, as patients with pLF-LG had similar survival rates than patients with NF-HG, whereas cLF-LG is associated with a twofold increased risk of mortality at 5-year follow-up., Competing Interests: Declaration of Competing Interest The authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Despite the growing experience with MitraClip in the broad spectrum of mitral regurgitation (MR), limited data are available regarding the independent prognostic role on survival of different mitral regurgitation etiology subtypes. We sought to evaluate the impact of flail leaflet etiology in a large series of patients with primary MR (PMR) who underwent MitraClip treatment. The study included 588 patients with significant PMR from the multicenter GIOTTO (Italian Society of Interventional Cardiology [GIse] registry Of Transcatheter treatment of mitral valve regurgitaTiOn), stratified into 2 groups according to MR etiology: flail + (n = 300) and flail - (n = 288). The primary end point was a composite of cardiac death and first rehospitalization for heart failure (HF). To account for the baseline differences, patients were propensity score-matched 1:1. Flail leaflet etiology was present in about a half of the patients. Acute technical success was achieved in 98% of the overall cohort, with no significant differences between the study groups (p = 0.789). At the 2-year Kaplan-Meier analysis, the primary end point occurred in 13% of flail + patients compared with 23% in flail - (p = 0.009). The flail + group presented lower rates of both cardiac death and rehospitalization for HF, whereas a similar overall death rate was observed between the groups. A multivariate Cox regression analysis identified flail leaflet etiology as an independent predictor of favorable outcome in terms of the primary end point (hazard ratio 0.141, 95% confidence interval 0.049 to 0.401, p <0.001). After propensity score matching, flail + patients had confirmed lower rates of cardiac mortality and rehospitalization for HF but similar rates of overall death. In conclusion, flail leaflet-related etiology was common in patients with PMR who underwent MitraClip treatment and was an independent predictor of midterm favorable clinical outcomes., Competing Interests: Declaration of Competing Interest Drs. Grasso, Adamo, Denti, Giordano, Bartorelli, Montorfano, Petronio, Tamburino, and Bedogni received consultation and speakers fees from Abbott Vascular outside the submitted work. The remaining authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Up to half of real-world patients with secondary mitral regurgitation who underwent transcatheter edge-to-edge repair (TEER) do not meet the highly selective COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) criteria. No randomized trials or standardized and validated tools exist to evaluate the risk: benefit ratio of TEER in this specific population. We sought to derive and externally validate a clinical risk score to predict the risk of death or heart failure (HF) hospitalization for COAPT-ineligible patients who underwent TEER (CITE score). The study population consisted of patients with secondary mitral regurgitation having at least 1 exclusion criterion of the COAPT trial. The derivation cohort included 489 patients from the GIOTTO (GIse registry of Transcatheter treatment of Mitral Valve regurgitaTiOn) registry. Cox proportional hazards regression was used to identify predictors of 2-year death/HF hospitalization and develop a numerical risk score. The predictive performance was assessed in the derivation cohort and validated in 268 patients from the MiZüBr (Milan-Zürich-Brescia) registry. The CITE score (hemodynamic instability, left ventricular impairment, New York Heart Association class III/IV, peripheral artery disease, atrial fibrillation, brain natriuretic peptide, and hemoglobin) showed a c-index for 2-year death or HF hospitalization of 0.70 (95% confidence interval [CI] 0.67 to 0.73) in the derivation cohort, and 0.68 (95% CI 0.64 to 0.73) in the validation cohort. A cutoff of <12 points was selected to identify patients at lower risk of adverse outcomes, hazard ratio of 0.35 (95% CI 0.26 to 0.46). In conclusion, the CITE score is a simple 7-item tool for the prediction of death or HF hospitalization at 2 years after TEER in COAPT-ineligible patients. The score may support clinical decision-making by identifying those patients who, even if excluded from clinical trials, can still benefit from TEER., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Despite being highly effective in reducing residual mitral regurgitation and improving outcomes, mitral valve transcatheter edge-to-edge repair (MV-TEER) may be associated with high postprocedural residual mitral gradient (rMG). Conflicting results have been reported regarding the relation between rMG and adverse events. This study aimed to evaluate the predictors and the impact of elevated rMG after MV-TEER on clinical events in patients with functional mitral regurgitation (FMR) at 2 years follow-up. We selected a cohort of 864 patients with FMR who were treated with MV-TEER enrolled in the multicentre Italian Society of Interventional Cardiology (GISE) registry of transcatheter treatment of mitral valve regurgitation (GIOTTO). Patients were stratified into tertiles according to rMG. The primary clinical end point was a composite of all-cause death and hospitalization because of heart failure at 2-year follow-up. Overall, 269 patients (31.5%) with an rMG &lt;3 mm Hg, 259 (30.3%) with an rMG ≥3/&lt;4 mm Hg, and 326 (38.2%) with an rMG ≥4 mm Hg were considered. At multivariate logistic regression, ischemic FMR etiology, baseline MG, and the number of implanted clips were independent predictors of an rMG ≥4 mm Hg. Clinical follow-up was available in 570 patients (63.2%). Patients with an rMG ≥4 mm Hg experienced higher rates of the composite end point than patients of the other tertiles (51.1%, vs 42.3% vs 40.8% log-rank test: p = 0.033). In multivariate Cox's regression, both rMG ≥4 mm Hg (hazard ratio 1.54, 95% confidence interval 1.14 to 2.08) and residual mitral regurgitation ≥2+ (hazard ratio 1.36, 95% confidence interval 1.01 to 1.83) were independent predictors of adverse events at 2-year follow-up. In conclusion, we demonstrated that real-world patients who underwent MV-TEER who show an rMG ≥4 mm Hg are at higher risk of death or hospitalization because of heart failure during a 2-year follow-up. Further studies will be needed to confirm our results., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Scarce data exist on mitral valve (MV) infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). This multicenter study included a total of 579 patients with a diagnosis of definite IE after TAVI from the IE after TAVI International Registry and aimed to evaluate the incidence, characteristics, management, and outcomes of MV-IE after TAVI. A total of 86 patients (14.9%) had MV-IE. These patients were compared with 284 patients (49.1%) with involvement of the transcatheter heart valve (THV) only. Two factors were found to be associated with MV-IE: the use of self-expanding valves (adjusted odds ratio 2.49, 95% confidence interval [CI] 1.23 to 5.07, p = 0.012), and the presence of an aortic regurgitation ≥2 at discharge (adjusted odds ratio 3.33; 95% CI 1.43 to 7.73, p <0.01). There were no differences in IE timing and causative microorganisms between groups, but surgical management was significantly lower in patients with MV-IE (6.0%, vs 21.6% in patients with THV-IE, p = 0.001). All-cause mortality rates at 2-year follow-up were high and similar between patients with MV-IE (51.4%, 95% CI 39.8 to 64.1) and patients with THV-IE (51.5%, 95% CI 45.4 to 58.0) (log-rank p = 0.295). The factors independently associated with increased mortality risk in patients with MV-IE were the occurrence of heart failure (adjusted p <0.001) and septic shock (adjusted p <0.01) during the index hospitalization. One of 6 IE episodes after TAVI is localized on the MV. The implantation of a self-expanding THV and the presence of an aortic regurgitation ≥2 at discharge were associated with MV-IE. Patients with MV-IE were rarely operated on and had a poor prognosis at 2-year follow-up., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Increased body mass index (BMI) is an established cardiovascular risk factor. The impact of high BMI on vascular and bleeding complications in patients undergoing transcatheter aortic valve implantation (TAVI) is not clarified. RISPEVA, a multicenter prospective database of patients undergoing TAVI stratified by BMI was used for this analysis. Patients were classified as normal or high BMI (obese and overweight) according to the World Health Organization criteria. A comparison of 30-day vascular and bleeding outcomes between groups was performed using propensity scores methods. A total of 3776 matched subjects for their baseline characteristics were included. Compared with normal BMI, high BMI patients had significantly 30-day greater risk of the composite of vascular or bleeding complications (11.1% vs 8.8%, OR: 1.28, 95% CI [1.02 to 1.61]; p = 0.03). Complications rates were higher in both obese (11.3%) and overweight (10.5%), as compared with normal weight patients (8.8%). By a landmark event analysis, the effect of high versus normal BMI on these complications appeared more pronounced within 7 days after the TAVI procedure. A significant linear association between increased BMI and vascular complications was observed at this time frame (p = 0.03). In conclusion, compared with normal BMI, both obese and overweight patients undergoing TAVI, experience increased rates of 30-day vascular and bleeding complications. These findings indicate that high BMI is an independent risk predictor of vascular and bleeding complications after TAVI., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

The ACC/TVT score is a specific predictive model of in-hospital mortality for patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to test its predictive accuracy in comparison with standard surgical risk models (Logistic Euroscore, Euroscore II, and STS-PROM) in the population of TAVI patients included in the multicenter RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) registry. The study cohort included 3293 patients who underwent TAVI between 2008 and 2019. The 4 risk scores were calculated for all patients. For all scores, the capability to predict 30-day mortality was assessed by means of several analyses testing calibration and discrimination. The ACC/TVT score showed moderate discrimination, with a C-statistics for 30-day mortality of 0.63, not significantly different from the standard surgical risk models. The ACC/TVT score demonstrated, in contrast, better calibration compared with the other scores, as proved by a greater correspondence between estimated probabilities and the actual observations. However, when the ACC/TVT score was tested in the subgroup of patients treated in a more contemporary period (from 2016 on), it revealed a slight tendency to lose discrimination and to overestimate mortality risk. In conclusion, in comparison with the standard surgical risk models, the ACC/TVT score demonstrated better prediction accuracy for estimation of 30-day mortality in terms of calibration. Nevertheless, its predictive reliability remained suboptimal and tended to worsen in patients treated more recently., (Copyright © 2020. Published by Elsevier Inc.)

MitraClip is a validated treatment for significant mitral regurgitation (MR) in high-risk patients. Aims of the study were to evaluate immediate changes in mitral valve (MV) geometry induced by MitraClip and correlations between baseline geometry and cardiac remodeling. Eighty patients who underwent MitraClip for primary (48%) or secondary (52%) MR were enrolled. Intraoperative transesophageal echocardiographic 3D images were acquired immediately before and after the procedure for MV annulus (MVA) morphology analysis. Transthoracic 3D echocardiography was performed preoperatively and at 6 months follow-up (6MFU). Patients were classified on the basis of MR reduction (ΔMR) at 6MFU as Optimal (ΔMR ≥ 2) or Suboptimal (ΔMR < 2). An optimal result was reached in 60 (75%) patients, whereas 20 subjects showed a ΔMR< 2 at 6MFU. The Optimal showed significantly smaller baseline MVA (antero-posterior diameter 4.05 ± 0.59 vs 4.43 ± 0.68 cm; anterolateral-posteromedial diameter 4.38 ± 0.56 vs 4.70 ± 0.73 cm; MVA circumference 14.1 ± 1.7 vs 15.1 ± 2.3 cm; and 3D area 14.8 ± 3.9 vs 17.4 ± 5.3 cm 2 ), lower sphericity index and nonplanar angle compared with Suboptimal. A value of antero-posterior diameter ≥4.44cm was identified (receiver-operating characteristic curve) as a possible cut-off for preoperative identification of Suboptimal patients. Postoperatively, MitraClip induced reduction of MVA flattening (nonplanar angle), sphericity index, and size (as expressed by antero-posterior diameter, MVA circumference and area). At 6MFU, the Optimal showed significant decrease in left ventricular volumes and pulmonary artery systolic pressure. In conclusion, MitraClip induces remarkable changes in MVA geometry and favorable left ventricular remodeling is detected in patients with optimal mid-term outcome; a preprocedural antero-posterior diameter <4.44cm seems to be a potential predictor of mid-term optimal result., (Copyright © 2018. Published by Elsevier Inc.)

The evaluation of the aortic root in patients referred for transcatheter aortic valve implantation is crucial. The aim of the present study was to compare the accuracy of cardiac magnetic resonance (CMR) evaluation of the aortic annulus (AoA) with transthoracic and transesophageal echocardiography and multidetector computed tomography (MDCT) in patients referred for transcatheter aortic valve implantation. In 50 patients, maximum diameter, minimum diameter and AoA, length of the left coronary, right coronary, and noncoronary aortic leaflets, degree (grades 1 to 4) of aortic leaflet calcification, and distance between AoA and coronary artery ostia were assessed. AoA maximum diameter, minimum diameter, and area by CMR were 26.4 ± 2.8 mm, 20.6 ± 2.3 mm, 449.8 ± 86.2 mm(2), respectively. The length of left coronary, right coronary, and noncoronary leaflets by CMR were 13.9 ± 2.2, 13.3 ± 2.1, and 13.4 ± 1.8 mm, respectively, whereas the score of aortic leaflet calcifications was 2.9 ± 0.8. Finally, the distances between AoA and left main and right coronary artery ostia were 16.1 ± 2.8 and 16.1 ± 4.4 mm, respectively. Regarding AoA area, transthoracic and transesophageal echocardiography showed an underestimation (p <0.01), with a moderate agreement (r: 0.5 and 0.6, respectively, p <0.01) compared with CMR. No differences and excellent correlation were observed between CMR and MDCT for all parameters (r: 0.9, p <0.01), except for aortic leaflet calcifications that were underestimated by CMR. In conclusion, aortic root assessment with CMR including AoA size, aortic leaflet length, and coronary artery ostia height is accurate compared with MDCT. CMR may be a valid imaging alternative in patients unsuitable for MDCT., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Acute kidney injury (AKI) occurs frequently in patients with acute coronary syndromes (ACS) and is associated with adverse short- and long-term outcomes. To date, however, no standardized definition of AKI has been used for patients with ACS. As a result, information on its true incidence and the clinical and prognostic relevance according to the severity of renal function deterioration are still lacking. We retrospectively studied 3,210 patients with ACS. AKI was identified on the basis of the changes in serum creatinine during hospitalization according to the AKI Network criteria. Overall, 409 patients (13%) developed AKI: 262 (64%) had stage 1, 25 (6%) stage 2, and 122 (30%) stage 3 AKI. In-hospital mortality was greater in patients with AKI than in those without AKI (21% vs 1%; p <0.001). The adjusted risk of death increased with increasing AKI severity. Compared to no AKI, the adjusted odds ratio for death was 3.5 (95% confidence interval 1.79 to 6.83) with stage 1 AKI and 31.2 (95% confidence interval 16.96 to 57.45) with stage 2 to 3 AKI. A significant parallel increase in major adverse cardiac events was also observed comparing patients without AKI and those with stage 2 to 3 AKI. In conclusion, in patients with ACS, AKI is a frequent complication, and the graded increase of its severity, as assessed using the AKI Network classification, is associated with a progressive increased risk of in-hospital morbidity and mortality., (Copyright © 2013 Elsevier Inc. All rights reserved.)

In patients with ST-segment elevation acute myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), abrupt reperfusion can induce myocardial injury and apoptotic cell death. Reperfusion-induced myocardial damage, however, cannot be easily evaluated in clinical practice because of the lack of specific biomarkers. Cytochrome c, a mitochondrial protein, is released on reperfusion into the cytosol, where it triggers the apoptotic process. It can reach the external fluid and circulating blood when cell rupture occurs. We measured the cytochrome c circulating levels in patients with STEMI undergoing pPCI, and correlated them with the clinical signs of myocardial necrosis and reperfusion. The plasma creatine kinase-MB mass and serum cytochrome c (enzyme-linked immunosorbent assay method) were serially measured in 55 patients with STEMI undergoing pPCI. The angiographic and electrocardiographic signs of myocardial reperfusion were also assessed. Cytochrome c transiently increased in all patients with STEMI, with a curve that paralleled that of creatine kinase-MB. A significant relation was found between the peak values of the 2 biomarkers (R = 0.35, p = 0.01) and between the areas under the 2 curves (R = 0.33, p = 0.02). The creatine kinase-MB peak value correlated significantly with the clinical features of infarct extension. In contrast, the cytochrome c peak value correlated inversely with the myocardial blush grade. Patients with clinical signs of myocardial reperfusion injury had a significantly greater cytochrome c peak value than patients without reperfusion injury (median 1.65 ng/ml, interquartile range 1.20 to 2.20, vs 1.1 ng/ml, interquartile range 0.65 to 1.55; p = 0.04). In conclusion, serum cytochrome c is detectable in the early phase of STEMI treated with pPCI and is associated with clinical signs of impaired myocardial reperfusion., (Copyright © 2010 Elsevier Inc. All rights reserved.)

The investigators conducted a review to evaluate the diagnostic performance of multidetector computed tomography (MDCT) for coronary stent evaluation. The prespecified inclusion criteria selected prospective or retrospective human studies published in English. Studies that did not report raw numbers of diagnostic accuracy for the detection of in-stent restenosis were excluded. The data from 24 studies are reported, 6 performed with old-generation scanners (4-, 16-, and 40-slice MDCT) and 18 performed with 64-slice MDCT or dual-source MDCT. With old-generation MDCT, up to 18% of coronary stents were missed, the rate of nonevaluable stents ranged from 2.6% to 23.5%, and the overall feasibility and diagnostic accuracy were 90.4% and 90%, respectively. With 64-slice MDCT, no stent was missed, and the overall feasibility and diagnostic accuracy were 90.4% and 91.9%, respectively. Advancements in MDCT and stent technologies may further reduce the number of nonassessable stents and improve diagnostic performance., (Copyright 2010 Elsevier Inc. All rights reserved.)

Noninvasive assessment of coronary in-stent restenosis (ISR) is clinically useful but 4- and 16-slice multidetector computed tomography is limited due to stent strut artifacts. We evaluated the feasibility and accuracy of 64-slice multidetector computed tomography in the diagnosis of ISR to validate its accuracy in ISR quantification and identify factors that may affect stent patency evaluability. One hundred patients with previously implanted coronary stents (n = 179) underwent 64-slice multidetector computed tomography followed by invasive coronary angiography. After multidetector computed tomography, each stent was classified as "evaluable" or "unevaluable." Obstructive ISR was visually and quantitatively determined in evaluable stents. Correlations between quantitative multidetector computed tomography and quantitative coronary angiography were estimated. In a subgroup, multidetector computed tomographic and intravascular ultrasound measurements were correlated. Feasibility of stent visualization was 95%. Thirty-four of 39 ISRs (87%) were correctly detected and localized by multidetector computed tomography. ISR was correctly ruled out for 77% (128 of 131) of remaining stented lesions. Sensitivity, specificity, and positive and negative predictive values of multidetector computed tomography for ISR identification were 87%, 98%, 92%, and 96%, respectively. There was good correlation between percent stenosis evaluated by multidetector computed tomography versus quantitative coronary angiography and intravascular ultrasound (r = 0.794, p <0.001, and r = 0.943, p <0.0001, respectively) and good reproducibility of multidetector computed tomographic measurements (interobserver coefficient k 0.81 for diameter and 0.79 for area). Heart rate, complexity of stenting procedure, stent diameter, and strut thickness were factors limiting feasibility and accuracy. In conclusion, 64-slice multidetector computed tomography provides reliable and reproducible noninvasive evaluation of coronary stent patency and quantification of ISR.

Stent thrombosis (ST) is an infrequent (0.5% to 1.5%) complication of intracoronary stenting, with severe clinical consequences. This multicenter, randomized study evaluated the clinical outcome in 479 patients (598 lesions treated) who underwent elective coronary stenting with a Carbofilm-coated stent (CarboStent) who met prespecified eligibility criteria and were randomly assigned to receive aspirin alone (n = 235) or aspirin plus a thienopyridine antiplatelet regimen (n = 244). Clinical, angiographic, and procedural characteristics were similar between groups. The primary end point was the incidence of 30-day ST; secondary end points included major vascular or bleeding complications within 30 days and death, acute myocardial infarction, and target vessel revascularization at 6 months. ST occurred in 4 patients (1.4%) in the aspirin-only group and in 1 patient (0.3%) in the aspirin-plus-thienopyridine group (relative risk 0.23, 95% confidence interval 0.03 to 2.08, p = NS). After careful review of cases, 89 patients (19%) with protocol deviations were identified. When they were excluded from the analysis, no ST was observed in either group. Secondary end points were reached by 4% of the aspirin-alone group and 8% of the aspirin-plus-thienopyridine group (relative risk 2.35, 95% confidence interval 0.94 to 5.85, p = NS). In conclusion, after optimal intracoronary implantation of the CarboStent, antiplatelet therapy with aspirin alone was safe and provided efficacy comparable to aspirin plus a thienopyridine in the prevention of ST.

Eighty-eight patients referred for transcatheter closure of atrial septal or patent foramen ovale defects underwent 3-dimensional transesophageal echocardiography to correlate preclosure anatomy with the morphology and positioning of the atrial septal occluder. Despite the effectiveness of the trancatheter closure and absence of complications, 2 linear indentations of the aortic root by the 2 discs of the device were clearly demonstrated in 16 cases, suggesting caution in the choice of very large occluders.

Intimal hyperplasia within the body of the stent is the primary mechanism for in-stent restenosis; however, stent edge restenosis has been described after brachytherapy. Our current understanding about the magnitude of in vivo intimal hyperplasia and edge restenosis is limited to data obtained primarily from select, symptomatic patients requiring repeat angiography. The purpose of this study was to determine the extent and distribution of intimal hyperplasia both within the stent and along the stent edge in relatively nonselect, asymptomatic patients scheduled for 6-month intravascular ultrasound (IVUS) as part of a multicenter trial: Heparin Infusion Prior to Stenting. Planar IVUS measurements 1 mm apart were obtained throughout the stent and over a length of 10 mm proximal and distal to the stent at index and follow-up. Of the 179 patients enrolled, 140 returned for repeat angiography and IVUS at 6.4 +/- 1.9 months and had IVUS images adequate for analysis. Patients had 1.2 +/- 0.6 Palmaz-Schatz stents per vessel. There was a wide individual variation of intimal hyperplasia distribution within the stent and no mean predilection for any location. At 6 months, intimal hyperplasia occupied 29.3 +/- 16.2% of the stent volume on average. Lumen loss within 2 mm of the stent edge was due primarily to intimal proliferation. Beyond 2 mm, negative remodeling contributed more to lumen loss. Gender, age, vessel location, index plaque burden, hypercholesterolemia, diabetes, and tobacco did not predict luminal narrowing at the stent edges, but diabetes, unstable angina at presentation, and lesion length were predictive of in-stent intimal hyperplasia. In a non-radiation stent population, 29% of the stent volume is filled with intimal hyperplasia at 6 months. Lumen loss at the stent edge is due primarily to intimal proliferation.