Clinical, angiographic, and procedural predictors of angiographic restenosis after sirolimus-eluting stent implantation in complex patients

BACKGROUND: The factors associated with the occurrence of restenosis after sirolimus-eluting stent (SES) implantation in complex cases are currently unknown. METHODS AND RESULTS: A cohort of consecutive complex patients treated with SES implantation was selected according to the following criteria: (1) treatment of acute myocardial infarction, (2) treatment of in-stent restenosis, (3) 2.25-mm diameter SES, (4) left main coronary stenting, (5) chronic total occlusion, (6) stented segment >36 mm, and (7) bifurcation stenting. The present study population was composed of 238 patients (441 lesions) for whom 6-month angiographic follow-up data were obtained (70% of eligible patients). Significant clinical, angiographic, and procedural predictors of post-SES restenosis were evaluated. Binary in-segment restenosis was diagnosed in 7.9% of lesions (6.3% in-stent, 0.9% at the proximal edge, 0.7% at the distal edge). The following characteristics were identified as independent multivariate predictors: treatment of in-stent restenosis (OR 4.16, 95% CI 1.63 to 11.01; P<0.01), ostial location (OR 4.84, 95% CI 1.81 to 12.07; P<0.01), diabetes (OR 2.63, 95% CI 1.14 to 6.31; P=0.02), total stented length (per 10-mm increase; OR 1.42, 95% CI 1.21 to 1.68; P<0.01), reference diameter (per 1.0-mm increase; OR 0.46, 95% CI 0.24 to 0.87; P=0.03), and left anterior descending artery (OR 0.30, 95% CI 0.10 to 0.69; P<0.01). CONCLUSIONS: Angiographic restenosis after SES implantation in complex patients is an infrequent event, occurring mainly in association with lesion-based characteristics and diabetes mellitus

Effectiveness of the sirolimus-eluting stent in the treatment of patients with a prior history of coronary artery bypass graft surgery

Objective: Percutaneous coronary intervention in patients with a history of previous coronary artery bypass grafting (CABG) is associated with an increased rate of subsequent adverse events compared to those without prior CABG. We evaluated the impact of utilizing the sirolimus-eluting stent (SES) in this high-risk population. Methods: Since April 2002, SES implantation was utilized as the default strategy for all percutaneous procedures in our hospital. Consecutive patients with a history of previous CABG and de novo lesions (n=47) treated exclusively with SES, were compared to 66 patients who received bare stents in the 6-month period just before SES introduction. Results: There were no significant differences between the groups (SES and bare stent) with respect to baseline clinical or lesion characteristics. The only difference between the groups related to the nominal diameter of stent utilized, which was smaller in the SES group than the bare stent group. (The maximum diameter of SES available was 3.0 mm). At 1 year, the cumulative incidence of major adverse events (defined as death, myocardial infarction, or target vessel revascularization) was significantly lower in the SES group than the bare stent group [8.5 versus 30.3%, hazard ratio 0.37 (95% confidence interval 0.15-0.91); P=0.03]. Conclusions: The utilization of the sirolimus-eluting stent for percutaneous intervention in a high-risk population with a history of previous CABG surgery is associated with a significant reduction in the rate of major adverse cardiac events at 1 year

Very long sirolimus-eluting stent implantation for de novo coronary lesions.

Long-length stenting has a poor outcome when bare metal stents are used. The safety and efficacy of the sirolimus-eluting stent (SES) in long lesions has not been evaluated. Therefore, the aim of the present study was to evaluate the clinical and angiographic outcomes of SES implantation over a very long coronary artery segment. Since April 2002, all patients treated percutaneously at our institution received a SES as the device of choice as part of the Rapamycin Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. During the RESEARCH registry, stents were available in lengths of 8, 18, and 33 mm. The present report includes a predefined study population consisting of patients treated with >36-mm-long stented segments. Patients had a combination of >or=2 overlapping stents at a minimum length of 41 mm (i.e., one 33-mm SES overlapping an 8-mm SES) to treat native de novo coronary lesions. The incidence of major cardiac adverse events (death, nonfatal myocardial infarction, and target lesion revascularization) was evaluated. The study group comprised 96 consecutive patients (102 lesions). Clinical follow-up was available for all patients at a mean of 320 days (range 265 to 442). In all, 20% of long-stented lesions were chronic total occlusions, and mean stented length per lesion was 61.2 +/- 21.4 mm (range 41 to 134). Angiographic follow-up at 6 months was obtained in 67 patients (71%). Binary restenosis rate was 11.9% and in-stent late loss was 0.13 +/- 0.47 mm. At long-term follow-up (mean 320 days), there were 2 deaths (2.1%), and the overall incidence of major cardiac events was 8.3%. Thus, SES implantation appears safe and effective for de novo coronary lesions requiring multiple stent placement over a very long vessel segment

Prespecified Risk Criteria Facilitate Adequate Discharge and Long‐Term Outcomes After Transfemoral Transcatheter Aortic Valve Implantation

Background Despite the availability of guidelines for the performance of transcatheter aortic valve implantation (TAVI), current treatment pathways vary between countries and institutions, which impact on the mean duration of postprocedure hospitalization. Methods and Results This was a prospective, multicenter registry of 502 patients to validate the appropriateness of discharge timing after transfemoral TAVI, using prespecified risk criteria from FAST‐TAVI (Feasibility and Safety of Early Discharge After Transfemoral [TF] Transcatheter Aortic Valve Implantation), based on hospital events within 1‐year after discharge. The end point—a composite of all‐cause mortality, vascular access–related complications, permanent pacemaker implantation, stroke, cardiac rehospitalization, kidney failure, and major bleeding—was reached in 27.0% of patients (95% CI, 23.3–31.2) within 1 year after intervention; 7.5% (95% CI, 5.5–10.2) had in‐hospital complications before discharge and 19.6% (95% CI, 16.3–23.4) within 1 year after discharge. Overall mortality within 1 year after discharge was 7.3% and rates of cardiac rehospitalization 13.5%, permanent pacemaker implantation 4.2%, any stroke 1.8%, vascular‐access–related complications 0.7%, life‐threatening bleeding 0.7%, and kidney failure 0.4%. Composite events within 1 year after discharge were observed in 18.8% and 24.3% of patients with low risk of complications/early (≤3 days) discharge and high risk and discharged late (>3 days) (concordant discharge), respectively. Event rate in patients with discordant discharge was 14.3% with low risk but discharged late and increased to 50.0% in patients with high risk but discharged in ≤3 days. Conclusions The FAST‐TAVI risk assessment provides a tool for appropriate, risk‐based discharge that was validated with the 1‐year event rate after transfemoral TAVI. Registration URL: https://www.ClinicalTrials.gov ; Unique identifier: NCT02404467

Safety and efficacy of early aggressive versus cholesterol-driven lipid-lowering strategies in heart transplantation: A pilot, randomized, intravascular ultrasound study

Background: Statins are recommended in heart transplantation regardless of lipid levels. However, it remains unknown whether dosing should be maximized or adjusted toward a pre-defined cholesterol threshold. Methods: This pilot, randomized, open-label study compares an early maximal dose of fluvastatin (80 mg/day) with a strategy based on 20 mg/day subsequently titrated to target low-density lipoproteins (LDL) &lt;100 mg/dl. Efficacy outcomes consisted of achieving an LDL level of &lt;100 mg/dl at 12 months after transplant, and change in intracoronary ultrasound parameters. Results: Fifty-two patients were randomized. Overall safety, and efficacy in achieving LDL targets (13 [50%] vs 14 [54%]; p = 0.8) were comparable between study arms, but 17 (65%) patients needed a dose increase in the titrated-dosing arm. Early LDL levels and average LDL burden were lower in the maximal-dosing arm (p &lt; 0.05). Few patients developed an increase in maximal intimal thickness of &gt;0.5 mm, with numerical prevalence in the titrated-dosing arm (3 [12.5%] vs 1 [5%]; p = 0.3). Intimal volume increased in the titrated-dosing (p &lt; 0.01) but not in the maximal-dosing arm (p = 0.1), which accordingly showed a higher prevalence of negative remodeling (p = 0.02). Conclusions: Despite being as effective as the titrated-dosing approach in achieving LDL &lt;100 mg/dl at 12 months after transplant, the maximal-dose approach was associated with a more rapid effect and with potential advantages in preventing pathologic changes in graft coronary arteries

Differential effect of everolimus on progression of early and late cardiac allograft vasculopathy in current clinical practice

Randomized trials showed that mTOR inhibitors prevent early development of cardiac allograft vasculopathy (CAV). However, the action of these drugs on CAV late after transplant is controversial, and their effectiveness for CAV prevention in clinical practice is poorly explored. In this observational study we included 143 consecutive heart transplant recipients who underwent serial intravascular ultrasound (IVUS), receiving either everolimus or mycophenolate as adjunctive therapy to cyclosporine. Ninety-one recipients comprised the early cohort, receiving IVUS at weeks 36 and year 1 after transplant, and 52 the late cohort, receiving IVUS at years 1 and 5 after transplant. Everolimus independently reduced the odds for early CAV (0.14 [0.010.77]; p=0.02) but it did not appear to influence late CAV progression. High-dose statins were found to be associated with reduced CAV progression both early and late after transplant (p0.05). Metabolic abnormalities, such as high triglycerides, were associated with late, but not with early CAV progression. By highlighting a differential effect of everolimus and metabolic abnormalities on early and late changes of graft coronary morphology, this observational study supports the hypothesis that everolimus may be effective for CAV prevention but not for CAV treatment, and that risk factors intervene in a time-dependent sequence during CAV development

Coronary artery bypass grafting vs percutaneous coronary intervention in a 'real-world' setting: A comparative effectiveness study based on propensity score-matched cohorts

OBJECTIVES: Most studies comparing coronary artery bypass grafting (CABG) and percutaneous coronary interventions (PCI) showed that fewer patients who had undergone CABG required repeat revascularizations , but no difference in survival, with the exception of some subgroups of patients. However, long-term real-world evidence on patients in whom both procedures are technically feasible is yet not available. The aim of this study was to compare 5-year rates of death, myocardial infarction (MI), target vessel revascularization (TVR) and stroke in a large cohort of patients with left main coronary artery (LMCA) or multivessel disease, treated with CABG or PCI (with or without DES) or PCI with DES only. METHODS: Two propensity score (PS)-matched cohorts of patients undergoing revascularization procedures at the regional public and private centres of Emilia-Romagna over the period July 2002-December 2008 were used to compare long-term outcomes of PCI (6246 patients) and CABG (5504 patients). RESULTS: PCI was associated with higher risk of death (HR = 1.6; 95% CI 1.4-1.8, P < 0.0001), MI (HR = 3.3; 95% CI 2.7-4.0, P < 0.0001) and TVR (HR = 4.5; 95% CI 3.8-5.2, P < 0.0001) at 5 years. No significant difference was shown for stroke (HR = 1.1; 95% CI 0.9-1.4, P = 0.43). CABG benefit was more evident in the risk of death in patients with two-vessel disease plus LMCA and in those with threevessel disease, LVEF <35%, congestive heart failure and diabetes. Adjusted comparison with PS between PCI with DES only and CABG confirmed significant differences in favour of CABG for mortality, MI and TVR rates. Competing risk analysis showed that the difference in the mortality rate was due to higher rate of MI in PCI. CONCLUSIONS: In the 'real-world' setting of this study, CABG was associated with significantly lower rates of death, MI and TVR in patients with LMCA or multivessel disease, so it remains the standard of care, particularly for patients with more extensive coronary disease and diabetes. ©The Author 2013.Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved

Multislice spiral computed tomography coronary angiography in patients with stable angina pectoris

Objectives This study was designed to prospectively evaluate the diagnostic performance of multislice spiral computed tomography (MSCT) coronary angiography for the detection of significant lesions in all segments of the coronary tree potentially suitable for revascularization. Background Noninvasive MSCT coronary angiography is a promising coronary imaging technique. Methods Sixteen-row MSCT coronary angiography was performed in 128 patients (89% men, mean age 58.9 ± 11.7 years) in sinus rhythm with stable angina pectoris scheduled for conventional coronary angiography. Sixty percent (77 of 128) of patients received pre-scan oral beta-blockers, resulting in a mean heart rate of 57.7 ± 7.7 beats/min. The diagnostic performance of MSCT for detection of significant lesions (≥50% diameter reduction) was compared with that of quantitative coronary angiography (QCA). Results The sensitivity of MSCT for detection of significant lesions was 92% (216 of 234, 95% confidence interval [CI]: 88 to 95). Specificity was 95% (1,092 of 1,150, 95% CI: 93 to 96), positive predictive value 79% (216 of 274, 95% CI: 73 to 88), and negative predictive value 98% (1,092 of 1,110, 95% CI: 97 to 99). Two ≥50% lesions were missed because of motion artifacts and two because of severe coronary calcifications. The rest (78%, 14 of 18) were detected but incorrectly classified as <50% obstructions. All patients with and 86% (18 of 21) of patients without significant lesions on QCA were correctly classified by MSCT. All patients with significant left main disease or total occlusions were correctly identified on MSCT. Conclusions Sixteen-row MSCT coronary angiography permits reliable detection of significant obstructive coronary artery disease in patients with stable angina in sinus rhythm

La rete per il trattamento dell’infarto miocardico acuto con sopraslivellamento del tratto ST in Italia. Risultati della rilevazione RETE IMA WEB

BACKGROUND: The organization of a regional system of care (RSC) for ST-elevation myocardial infarction (STEMI) is recommended by the Italian Federation of Cardiology (FIC) and international guidelines in order to increase the number of patients treated with primary coronary angioplasty and, more in general, with reperfusion therapy, speed up the diagnostic and therapeutic processes, and ultimately improve the outcome. METHODS: The "RETE IMA WEB" survey was launched in 2007 from the Italian Society of Invasive Cardiology (SICI-GISE) in collaboration with the FIC, with the aim of evaluating the current state of RSC for STEMI in Italy. The personnel of the 118 Emergency System participated in the survey. Data collection was made using different electronic forms with access limited by personal passwords. We assessed the organization of the RSC together with local resource availability, with specific attention to the distance from a Hub center. RESULTS: The survey ended in December 31, 2008. We censored 701 hospitals admitting STEMI patients, 157 (22.4%) with uninterrupted access (h24/7 days) to the catheterization laboratory (2.67 per million inhabitants). An operative network was present in 36/103 (35.9%) provinces, with important geographic variability. Among hospitals without a full-time primary angioplasty facility, only 46% was within a RSC. ECG was available in 72% of the national territory, telemedicine in 50%. Prehospital fibrinolysis was available in 16% of the country. Overall, 92.4% of the Italian population resides within 60 min of a Hub center. CONCLUSIONS: In 2008, despite an adequate framework, the RSC for STEMI in Italy was heterogeneous and still suboptimal. Healthcare administrators, scientific societies and all operators involved in the process of care for STEMI should make efforts to implement current guidelines

Strain-engineered self-organized InAs/GaAs quantum dots for long wavelength (1.3 mu m-1.5 mu m) optical applications

InAs/GaAs quantum dot systems can emit light at the wavelengths above 1.3 mu m by covering the InAs quantum dots with an InxGa1-xAs strain reducing capping layer (SRCL). The presence of the SRCL relaxes the strain in the growth direction while the in-plane compressive strain remains nearly unchanged. This results in an aspect ratio increase of the quantum dot. Both the strain relaxation in the growth direction and the aspect ratio change induce a non-linear red shift. This work studies the dependence of the emission wavelength on the thickness and the indium composition of the SRCL. Experimental topologies have been simulated and a close quantitative match is found