Clinical outcome of patients with chronic heart failure followed in a specialized heart failure center.

BACKGROUND: Patients with heart failure (HF) have a poor prognosis. Heart failure centers with specialized nurse-supervised management programs have been proposed to improve prognosis. OBJECTIVES: To evaluate the clinical outcome of patients with HF treated at a multidisciplinary HF center of Clalit Health Services in Jerusalem in collaboration with Hadassah University Hospital. METHODS: We evaluated clinical outcome including hospitalizations and death in all HF patients followed at the HF center for 1 year. RESULTS: Altogether, 324 patients were included and followed at the HF center; 58% were males with a mean age of 76 +/- 11 years, and 58% were in New York Heart Association (NYHA) functional class Ill-IV. The overall 1 year survival rate was 91% and the 1 year hospitalization rate 29%. Comparing patients in the HF center to the whole cohort of patients with a diagnosis of HF (N = 6618) in Clalit Health Services in Jerusalem demonstrated a similar 1 year survival rate: 91% vs. 89% respectively but with a significantly reduced hospitalization rate: 29% vs. 42% respectively (P < 0.01). Cox regression analysis demonstrated that treatment in the HF center was a significant predictor of reduced hospitalization after adjustment for other predictors (hazard ratio 0.65, 95% confidence interval 0.53-0.80, P < 0.0001). A subset of patients that was evaluated (N = 78) showed significantly increased compliance. NYHA class improved in these patients from a mean of 3.1 +/- 0.1 to 2.6 +/- 0.1 after treatment (P < 0.0001). CONCLUSIONS: Supervision by dedicated specialized nurses in a HF center increased compliance, improved functional capacity in HF patients, and reduced hospitalization rate. HF centers should be considered part of the standard treatment of patients with symptomatic HF.

Passive and active polymer coatings for intracoronary stents: novel devices to promote arterial healing.

Coronary stent implantation is the second great advance in the treatment of obstructive coronary artery disease since the introduction of balloon catheter angioplasty. However, in-stent restenosis (ISR) caused by neointimal hyperplasia has been a major limitation of stents, occurring in up to 30% of cases. Advances in coronary stent technology both in terms of stent design and function and especially drug-eluting stents (DES) have significantly improved the safety and efficacy of percutaneous coronary intervention (PCI) with stenting, including marked reduction in ISR. This has led to use of DES for increasingly challenging clinical and lesional subsets, with potential for increased risk of stent-associated complications, especially late stent thrombosis (LST). Because restenosis and stent thrombosis are caused by multiple and often interrelated factors, ideal agents for stent coatings should inhibit thrombus formation, inflammatory reaction, and cellular proliferation, while supporting reendothelialization. To avoid undesirable effects of currently applied (durable) polymers, biocompatible, and bioabsorbable polymers as well as DES delivery systems that minimize polymer burden have been produced and tested. Bioabsorbable stents, both polymeric and metallic, have been developed to decrease potential late complications after stent implantation. Novel strategies to address some of these challenges are in various stages of research and development. In this article we outline developments in the field of passive and active stent coatings and evaluate the ongoing role of such coatings in the contemporary era of DES.

Ambulatory discharge after transradial coronary intervention: Preliminary US single-center experience (Same-day TransRadial Intervention and Discharge Evaluation, the STRIDE Study).

BACKGROUND: Although the safety and cost-effectiveness of same-day discharge after uncomplicated transradial percutaneous coronary intervention (TR-PCI) is well established in Europe and Asia, such data are not available for US patients. METHODS: All patients who underwent TR-PCI at our high-volume US medical center between 2004 and 2007 were included in this study. The primary end point was in-hospital adverse clinical outcomes between 6 and 24 hours postprocedure. RESULTS: A total of 450 patients were included in this study (aged 59 +/- 11 years). Of these, 13% were female, 27% were diabetic, 6% had peripheral vascular disease, and 5% had chronic kidney disease. Procedural indications included stable angina (49%), unstable angina (31%), non-ST elevation myocardial infarction (NSTEMI) (17%), and ST elevation myocardial infarction (STEMI) (3%). All patients received an intra-arterial cocktail of heparin, verapamil, and nitroglycerin, and 13% of patients received glycoprotein IIb/IIIa inhibitors. Seven percent of patients had 3-vessel disease, 3% had bypass grafts stenoses, and 20% had class B(2)/C lesions. Procedural success rate was 96%. A total of 24 (5.3%) postprocedural complications were observed; however, none occurred between hours 6 to 24, the time differential between same-day and next-day discharge. Thirteen patients (2.9%) experienced significant complications within the first 6 hours (MI, urgent repeat revascularization, and ventricular tachycardia). Eleven (2.4%) spontaneously resolved minor access complications developed. There were 12 same-day discharges according to the operators' discretion; none required readmission. CONCLUSIONS: Although a low incidence of complications did occur, none would have been impacted by same-day discharge. Those observed before 6 hours would have prevented early discharge, and those occurring after 24 hours would have been unaffected by routine next-day discharge. This observational study demonstrated the safety and feasibility for a prospective evaluation of ambulatory TR-PCI in an American practice setting.

Novel bioabsorbable salicylate-based polymer as a drug-eluting stent coating.

BACKGROUND: Permanent polymers used in current drug-eluting stents (DES) can trigger chronic inflammation and hypersensitivity reactions, which may contribute to the increased risk of late thrombosis and rebound restenosis. Therefore, optimal polymer selection and the use of completely absorbable but biocompatible polymers are expected to minimize these risks. OBJECTIVES: We sought to evaluate a novel, potentially innately anti-inflammatory, bioabsorbable salicylate-based polymer as a DES coating, in a clinically relevant animal model. METHODS: Four types of stents were implanted in pig coronary arteries using QCA to optimize stent apposition: bare metal stents (BMS); salicylic acid/adipic acid bioabsorbable polymer-only coated metal stents (SA/AA); biostable polymeric sirolimus-eluting stents (Cypher); and metal stents coated with salicylic acid/adipic acid bioabsorbable polymer containing sirolimus (SA/AA + S). The dose density of sirolimus was 8.3 microg/mm of stent length (similar to Cypher) with in vitro studies demonstrating elution over 30 days and complete polymer degradation in 37 days. Animals underwent angiographic restudy and were terminated at 1 month for complete histopathologic and histomorphometric analyses. RESULTS: Both SA/AA + S and Cypher stents had significantly lower angiographic % stenosis when compared with BMS and SA/AA polymer-only groups (6 +/- 4% and 5 +/- 4% vs. 15 +/- 7% and 16 +/- 5%, respectively, P < 0.001). Intimal thickness was lower for SA/AA + S and Cypher than for BMS (0.14 +/- 0.06 and 0.13 +/- 0.04 mm vs. 0.23 +/- 0.05 mm, respectively, P < 0.001). Histologic % area stenosis was also lower for SA/AA + S and Cypher when compared with BMS (22 +/- 7% and 23 +/- 6% vs. 33 +/- 5%, respectively, P < 0.001). There was a strong trend toward reduced inflammatory response in the SA/AA and SA/AA + S when compared with BMS and Cypher groups (P = 0.072). CONCLUSIONS: This study shows favorable vascular compatibility and efficacy for a novel bioabsorbable salicylate-based polymer as a DES coating, and supports further research and development of this unique class of polymer materials for applications in cardiovascular devices.

Comparison of multidetector 64-slice computed tomographic angiography to coronary angiography to assess the patency of coronary artery bypass grafts.

This study prospectively evaluated the diagnostic accuracy of 64-slice computed tomographic angiography (CTA) in assessing the patency of coronary artery bypass grafts compared with invasive coronary angiography. In total 147 bypass grafts (100 venous grafts and 47 mammary artery grafts) were evaluated in 50 consecutive patients. Contrast-enhanced 64-slice CTA was performed and compared with invasive angiography. The computed tomographic angiographic scan protocol used 64- x 0.5-mm slice collimation and 0.33-second gantry rotation time during simultaneous electrocardiographic gating. Patients with a heart rate >65 beats/min received beta blockers. Overall 145 of 147 bypass grafts (98.6%) were detected by CTA; 2 nonvisualized grafts were occluded at the time of invasive angiography. Of the grafts visualized, 28 were totally occluded, 103 were patent, and 14 had significant stenoses that were confirmed by invasive angiography. Ninety-five percent (111 of 117) of patent grafts demonstrated good run-off distal to anastomoses but without an ability to accurately evaluate the presence of retrograde flow; 83% (97 of 117) of distal anastomoses were adequately evaluated, whereas the remaining 17% (20 of 117) were not well visualized due to vascular clips and/or calcification artifacts. Two grafts were not demonstrated by invasive angiography but were detected by CTA and found to be widely patent. In conclusion, multidetector 64-slice CTA is a valuable tool for direct visualization of coronary bypass grafts and assessment of their patency. Dysfunctional bypass grafts can be detected with high diagnostic accuracy.

Risk characteristics of Arab and Jewish women with coronary heart disease in Jerusalem.

BACKGROUND: There is little published information on the coronary risk characteristics of Palestinian women. However, there are documented lifestyle differences as well as socioeconomic inequalities between Arab and Jewish women in Israel. OBJECTIVES: To compare the risk factor characteristics of coronary heart disease patients in Palestinian and Israeli women. METHODS: This study included 546 women (444 Jews and 102 Arabs) aged 35-74, all residents of Jerusalem, who underwent cardiac catheterization at the Hadassah-Hebrew University Medical Center between 2000 and 2003, and were confirmed to have coronary artery disease. Data on multiple risk factors were obtained from patient interviews and files. RESULTS: Compared with Jewish women, Arab women had a higher prevalence of diabetes, had borne more children, were younger, had a lower socioeconomic status, consumed less alcohol and more olive oil, suffered more passive smoking and were less physically active. On the other hand, fewer Arab women had dyslipidemia, used hormone replacement therapy and had a family history of CHD. CONCLUSIONS: Compared to Jewish women, Palestinian Arab women in Jerusalem appear to have more diabetes and exhibit lifestyle factors that generally increase the risk for CHD. Greater attention to primary prevention in this ethnic group is needed. This study suggests the need to investigate determinants of the metabolic syndrome and the possible role of passive smoking in Arab women as well as modes of intervention via health promotion and risk factor management in this population.

Comparison of 4 and 6 French catheters for coronary angiography: real-world modeling.

BACKGROUND: Femoral artery vascular complications are the most common adverse events following cardiac catheterization. Smaller diameter introducer sheaths and catheters are likely to lower the puncture site complication rate but may hinder visualization. OBJECTIVES: To evaluate the safety and angiographic quality of 4 French catheters. METHODS: The study was designed to simulate real-life operator-based experience. Diagnostic angiography was performed with either 4F or 6F diagnostic catheters; the size of the catheter used in each patient was predetermined by the day of the month. Patients undergoing 4F and 6F diagnostic angiography were ambulated after 4 and 6 hours, respectively. The following technical parameters were recorded by the operator: ease of introducer sheath insertion, ease of coronary intubation, ease of injection, coronary opacification, collateral flow demonstration, and overall assessment. Adverse events were recorded in all patients and included minor bleeding, major bleeding (necessitating blood transfusion), minor hematoma, major hematoma, pseudo-aneurysm formation and arteriovenous fistula. RESULTS: The study group included 177 patients, of whom 91 were in the 4F arm and 86 in the 6F arm. Demographic and procedural data were similar in both groups. Seventy-seven percent of 6F and 50% of 4F procedures were evaluated as excellent (P < 0.05). This difference was attributed to easier intubation of the coronary ostium and contrast material injection, increased opacification of the coronary arteries, and demonstration of collateral flow with 6F catheters. Complications occurred in 22% of patients treated with 6F catheters and in 10% of those treated with 4F catheters (P = 0.11). Of the 50 patients who switched from 4F to 6F 12% had complications. In patients undergoing diagnostic angiography, the complication rate was 10% vs. 27% (most of them minor) in the 4F and 6F groups, respectively (P < 0.05). CONCLUSIONS: Patients catheterized with 4F have fewer complications compared with 6F diagnostic catheters even when ambulated earlier. Although 4F had a reduced quality compared to 6F angiographies, they were evaluated as satisfactory or excellent in quality 85% of the time. 4F catheters have a potential for reduced hospitalization stay and are a good option for primary catheterization in patients not anticipated to undergo coronary intervention.

BIOFLOW-III satellite-One-year clinical outcomes of diabetic patients treated with a biodegradable polymer sirolimus-eluting stent and comprehensive medical surveillance.

BACKGROUND: Drug-eluting stents with biodegradable polymer might be particularly useful in diabetic patients who are at increased risk for target lesion/target vessel revascularization. We therefore aimed at assessing the safety and performance of a biodegradable polymer sirolimus-eluting stent (BP-SES) in combination with comprehensive optimal medical therapy following coronary interventions. METHODS: This prospective, multicenter registry was conducted at six centers in Israel. Aside of stent treatment, we aimed for an LDL-C level<70mg/dl; at one and six months post-intervention a diabetic consultancy was required, and follow-up data were collected at six and twelve months. The primary outcome measure was target vessel failure, a composite of cardiac death, target-vessel myocardial infarction and clinically driven target vessel revascularization. Secondary outcomes were target lesion failure, its individual components, and stent thrombosis. RESULTS: From August 2013 until May 2014, 120 diabetic patients with 158 lesions were treated with a BP-SES. Mean age was 63.9±9.2years, 27.5% were insulin dependent, 28.3% had a history of myocardial infarction, and 47.5% had prior coronary interventions. By visual estimation, lesions were 3.0±0.5mm in diameter and 15.2±7.4mm long; mean stent diameter and length were 3.0±0.5mm and 19.2±6.8mm. Target vessel failure and target lesion failure at 12months occurred in seven (6.4% [95% CI: 3.1-13.0]) and four patients (3.5% [95% CI: 1.3-9.2]), respectively, and definite stent thrombosis in one patient (1.0% [95% CI: 0.1-7.0]). CONCLUSION: Treatment with a BP-SES demonstrated excellent target-vessel and target-lesion revascularization rates in a high-risk diabetic patient population undergoing catheter-based revascularization followed by intensified medical care. ANNOTATED TABLE OF CONTENTS: In 120 high-risk diabetic patients with coronary artery stenosis, treatment with the Orsiro sirolimus-eluting stent with biodegradable polymer and comprehensive antidiabetic therapy resulted in excellent clinical outcomes. Target vessel revascularization occurred in 6.4% of patients and target lesion revascularization in 3.5%.

Ethnic disparity in the clinical characteristics of patients with heart failure.

AIMS: The characteristics of heart failure (HF) patients of different ethnic backgrounds in Israel are unknown. The purpose of the present study was to evaluate the clinical characteristics of Arab vs. Jewish patients with chronic HF. METHODS AND RESULTS: Patients with a diagnosis of HF at a health maintenance organization in Jerusalem, Israel were evaluated. All patients were followed for cardiac-related hospitalizations and death. The study cohort included 6773 HF patients; 4991 (74%) were Jewish and 1735 (26%) were Arab. The overall prevalence of HF in the Jewish vs. Arab population was similar (women, 4.3% vs. 4.7%, respectively, P = 0.06; men, 5.3% vs. 5.2%, P = 0.61). The prevalence of HF was significantly higher in Arab subjects of younger age groups (50-70 years). Arabs developed HF on average 10 years earlier and had a significantly higher rate of diabetes and obesity. Standard of care based on prescribed medications was similar between the ethnic groups. Glucose and cholesterol levels were higher in the Arab cohort. Mortality was similar between the groups at median follow-up (576 days), with the exception of cardiovascular hospitalizations and death that were higher in Arab men. CONCLUSIONS: Arab subjects develop HF at a much younger age compared with their Jewish counterparts and have a higher prevalence of diabetes and obesity. Standard of care and clinical outcome are comparable. Implementation of prevention programmes to reduce risk factors, particularly diabetes and obesity, may help reduce the disparity between Arabs and Jews.

Safety and efficacy of frequency domain optical coherence tomography in pigs.

AIMS: To determine the safety and efficacy of frequency domain OCT, which can scan at much higher rates and make it possible to avoid an occlusion balloon and image during an angiographic injection through guide catheter. The catheters have diameters ranging from 2.7 to 3.5 Fr. The presence of the imaging catheter increases fluid resistance to the injection of viscous solutions necessary for clearing the blood. METHODS AND RESULTS: The Volcano 3.5 Fr frequency domain OCT catheter system was investigated for safety in (a) n=10 porcine studies using acute and 30-day histology, and (b) for efficacy in n=9 in vivo porcine coronary arteries. We found: (a) frequency domain imaging is safe in the porcine model using histology as an endpoint; (b) the addition of a viscous contrast (iodixonal) to saline is superior for lumen clearance compared to saline alone; (c) hand injection, 4 ml/sec, and 6 ml/sec power injection all provided similar vessel wall clearance; (d) the anticipated loss of vessel wall visualisation with left main injection (due to half the injectate in the non-imaged vessel) was not evident in proximal and middle coronary artery OCT catheter positions. CONCLUSIONS: Frequency domain OCT is safe and efficacious in the porcine model.

Novel fully bioabsorbable salicylate-based sirolimus-eluting stent.

AIMS: The concept of fully biodegradable stents has emerged as an attractive alternative to current permanent metallic stents, mainly as a potential solution to avoid late stent thrombotic events. We sought to evaluate a novel, fully bioabsorbable sirolimus-eluting stent (SES) synthesised entirely from a unique salicylic-acid polymer, in a clinically relevant animal model. METHODS AND RESULTS: Fully biodegradable balloon-expandable stents (n=45) were implanted in a porcine coronary arteries using quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) to optimise stent apposition. Dose density of sirolimus was 8.3 µg/mm of stent length with in vitro studies demonstrating elution over 30 days and complete stent degradation over 12 months. Animals were terminated at 7, 14, 30, 90, and 180 days for complete histological analysis. Optical coherence tomography (OCT) was also performed for the 90- and 180-days samples. All stents were deployed successfully without notable mechanical difficulties. Angiographic diameter stenosis (DS) was 20±16%, 24±4%, and 23±17%, at one, three, and six months, respectively. In parallel, IVUS showed good stent apposition with DS of 21±9%, 25±7%, and 18±3%; and area stenosis (AS) of 35±13%, 33±7%, and 32±4% at one, three, and six months,respectively. OCT further demonstrated good stent apposition with DS of 28±7% and 20±6%, and AS of 37±10% and 33±13% at three and six months, respectively. OCT showed reduction of stent thickness by 23% from three to six months. Histologic analysis confirmed these in vivo findings and revealed a favourable healing process of absorbable stent incorporation into the arterial wall, without excessive thrombotic or inflammatory reactions. CONCLUSIONS: This study shows favourable vascular compatibility and efficacy for a novel fully bioabsorbable salicylate-based SES. This device has good mechanical performance during deployment and stays well-apposed to the vessel wall at long-term follow-up. These initial results are highly encouraging and support progress into more extensive preclinical studies as well as early clinical testing.

Comparison of the clinical characteristics of apical and non-apical variants of "broken heart" (takotsubo) syndrome in the United States.

OBJECTIVES: The present study was designed to delineate and compare the clinical characteristics of patients with apical and non-apical takotsubo syndrome in a high-volume U.S. hospital. BACKGROUND: A comparison between apical and non-apical variants of the "broken heart," or takotsubo syndrome, has not been performed in the United States. METHODS: From 2004 through 2007, patients with takotsubo syndrome were identified according to the following criteria: acute chest pain with electrocardiographic changes or elevation of cardiac enzymes, absence of significant coronary narrowing, left ventricular (LV) segmental akinesia ("ballooning"), with or without antecedent stressful events. Based upon the location of LV ballooning, the patients were divided into two subgroups: apical and non-apical. RESULTS: Of 38 patients (age 64 +/- 12 years) fulfilling the inclusion criteria, 84% were women, 79% had documented stressors, 76% had apical and 24% non-apical LV ballooning. When compared to non-apical subjects, apical patients presented predominantly with ST-elevation, had a higher incidence of hypertension, had significantly higher levels of Troponin T (8.5 +/- 6.7 ng/ml vs. 3.4 +/- 2.1 ng/ml, respectively; p = 0.032), and lower ejection fraction (31 +/- 9% vs. 43 +/- 5%, respectively; p < 0.001). Severe complications occurred only in apical subjects: pulmonary edema (10.3%), ventricular tachycardia (6.9%), cardiogenic shock (6.9%), LV apical thrombus (3.4%), transient LV outflow tract obstruction (3.4%), and death (3.4%). CONCLUSIONS: Apical and non-apical ballooning subgroups may represent different manifestations of a single syndrome. When compared with non-apical ballooning, the apical ballooning group may represent a more severe subset characterized by more heart failure and an increased rate of cardiac complications.

Clinical and angiographic features of small vessel stenting in the drug-eluting stent era.

HYPOTHESIS: This study was designed to investigate the clinical and angiographic features and procedural outcomes of small-vessel stenting in a real-world experience during the transition era between drug-eluting stents (DES) and bare-metal stents (BMS). METHODS: Using one of the largest single-institutional cohorts, this study evaluated all patients who underwent percutaneous coronary intervention (PCI) from 2002 through 2005. Analysis was restricted to patients receiving a single stent or undergoing balloon-only angioplasty in a single anatomic site. Small-vessel stents (SVS) were defined as 2.00 to 2.75 mm and large-vessel stents (LVS) as 3.00 to 4.00 mm in diameter. RESULTS: A total of 19,580 stents were placed in 10,396 patients. Of 6208 patients fulfilling inclusion criteria, 1630 (26.3%) received SVS, and 4578 (73.7%) received LVS. The SVS group had more female (35.5% vs 26.3%, P < .001) and diabetic patients (27.9% vs 24.2%, P < .003) than the LVS group. Compared with LVS, SVS lesions were shorter (14.5 +/- 5.8 mm vs 15.7 +/- 6.4 mm, P < .0001) and more complex (66% vs 53% class B2/C lesions, P = .041). Indicators of procedural difficulty, including greater contrast volume, number of devices, total inflation time, and fluoroscopy time, were more commonly observed in the SVS group. After adjustment for confounding factors, the incidence of small treatment vessel diameter was significantly higher among the DES vs the BMS group (odds ratio [OR]: = 1.94, 95% confidence interval [CI]: 1.56-2.36). CONCLUSIONS: In addition to identifying distinct patient, lesion, and procedural performance characteristics, our study, one of the largest single-center experiences in small-vessel PCI, suggests that the availability of DES substantially increased the use of SVS, as opposed to balloon-only angioplasty, in this anatomically challenging setting.

Low-dose paclitaxel elution by novel bioerodible sol-gel coating on stents inhibits neointima with low toxicity in porcine coronary arteries.

OBJECTIVES: The present study was designed to evaluate a novel bioerodible sol-gel film coated paclitaxel-eluting stent (sol-gel-PES, 3 microg per stent) in a porcine coronary artery model. BACKGROUND: Although current polymer-based PES decrease restenosis, the permanent polymer and bound drug have raised concerns regarding delayed vessel healing and late stent thrombosis. METHODS: Polymer-based PES (poly-PES, n = 8), sol-gel-PES (n = 15), bare metal (BMS, n = 14), and sol-gel film only (sham, n = 12), stents were implanted in 17 juvenile pigs. Animals were terminated 28 days post-implant for angiographic restudy and complete histopathologic and histomorphometric analyses. RESULTS: Angiographic late loss was equally reduced for both poly-PES and sol-gel-PES (0.51 +/- 0.64 and 0.61 +/- 0.52 mm, respectively) compared to both BMS and sham (0.98 +/- 0.74 and 1.25 +/- 0.72 mm, p < 0.05). Similarly beneficial results were observed for histomorphometric parameters of neointimal thickness and area, yielding reductions of in-stent stenosis by 43% and 48% for poly-PES, as well as 31% and 37% for sol-gel-PES, vs. BMS and sham, respectively (p < 0.05). Re-endothelialization was complete in all groups. Although the inflammatory cell infiltration and intramural thrombus scores were no different between poly- and sol-gel-PES, medial necrosis was increased for poly-PES (p < 0.05 vs. all others). CONCLUSIONS: A novel bioerodible sol-gel film coated with low-dose paclitaxel demonstrates less toxicity to the coronary tunica media, while retaining effective inhibition of neointimal formation at 28 days.

Impact of the definition utilized on the rate of contrast-induced nephropathy in percutaneous coronary intervention.

Several definitions have been used to assess rates of contrast-induced nephropathy (CIN) in patients undergoing percutaneous coronary intervention (PCI). Whether the definition influences observed rates of CIN is unclear. The Oxilan Registry was the first-ever prospective analysis of the efficacy and safety of ioxilan (low-osmolar and low-viscosity contrast medium), including rates of CIN assessed by multiple definitions, in PCI. From July 2006 to June 2007, consecutive patients undergoing PCI using ioxilan were enrolled. Serum creatinine (SCr) and estimated glomerular filtration rate (eGFR) were assessed at baseline and 3 to 5 days after PCI. CIN was defined as SCr increase >or=0.5 mg/dl, eGFR decrease >or=25%, SCr increase >or=25%, or the composite. Of 400 patients (age 62 +/- 11 years), 19% were women, 37% were diabetic, 22% were anemic, and 8% had a history of congestive heart failure. Baseline SCr was 1.12 +/- 0.3 mg/dl and 24% had an eGFR <60 ml/min. CIN rates were 3.3% (SCr increase >or=0.5 mg/dl), 7.6% (eGFR decrease >or=25%), 10.2% (SCr increase >or=25%), and 10.5% (composite). Hospitalization was prolonged in 3.4% of patients with CIN and none required dialysis. There were no deaths or severe allergic reactions. Non-ST-elevation myocardial infarction and repeat revascularization each occurred in 0.8%. In conclusion, in this unselected population undergoing PCI, CIN ranged in frequency from 3.3% to 10.5% depending on the definition used and was not associated with in-hospital mortality or substantial morbidity, such as dialysis. The wide variation in CIN and its lack of association with adverse outcomes underscore the need for a standardized, clinically relevant definition.

Effect of gradual computerized angioplasty on outcomes of patients undergoing coronary stenting.

Mechanical trauma caused by percutaneous coronary intervention is a major factor contributing to subsequent cardiac events, restenosis, and the need for target lesion revascularization (TLR). To minimize this trauma, we developed a Computerized Angioplasty Pressure Sensor and Inflator Device (CAPSID) for gradual inflation. The objective of the present prospective randomized study was to examine whether the use of this novel device reduced TLR, as well as cardiac events, in patients undergoing stenting. Patients undergoing coronary stenting were eligible and randomized to receive CAPSID or standard manual percutaneous coronary intervention. In the CAPSID group, slow, gradual balloon inflation was performed using a personal computer. Patients with acute ST-elevation myocardial infarction or the need for percutaneous coronary intervention for total occlusions, left main disease, and vein grafts were excluded. Clinical follow-up for major adverse cardiac events, including death, acute myocardial infarction, and TLR, was performed at 12 months. A total of 310 patients were enrolled in the study. No significant differences were found in the clinical characteristics between the CAPSID and control groups. At 1 year of follow-up, the CAPSID group had had a significantly lower rate of major adverse cardiac events (8% vs 18%, p <0.01) driven by significantly lower rates of acute myocardial infarction (1% vs 7%, p <0.01) and TLR (5% vs 12%, p <0.05). In conclusion, gradual computerized balloon inflation using CAPSID as a platform for angioplasty and stenting significantly reduced TLR and major adverse cardiac events at 1 year in patients undergoing coronary stenting. The use of this novel device may improve outcomes in patients undergoing coronary stenting.

A third generation ultra-thin strut cobalt chromium stent: histopathological evaluation in porcine coronary arteries.

AIMS: The present study was designed to evaluate a novel third generation bare-metal stent (BMS) comprised of an ultra-thin-strut, cobalt-chromium platform with fixed geometry, uniform cell size, and superior surface finish in a porcine coronary artery model. METHODS AND RESULTS: A total of 47 BMS of two types were implanted in pig coronary arteries using QCA to optimise stent apposition: a commercially available cobalt alloy thin-strut stent (91 microm) as control (Driver; n=17), and an ultra-thin-strut (65 microm) cobalt-chromium stent (Protea; n=18). Animals underwent angiographic restudy and termination one week and one month post-implant for coronary artery histology. In addition, 12 overlapping Protea stents were analysed at one month. At one week, comparable thin neointima and mild inflammation were observed in both groups. At one month, Protea demonstrated significantly lower angiographic % stenosis (2+/-1% vs. 17+/-5%, p=0.006), intimal thickness (0.11+/-0.01 mm vs. 0.23+/-0.03 mm, p=0.003), and histologic % area stenosis (19+/-2% vs. 32+/-3%, p=0.003). Mean stent strut injury scores were low and similar between groups. Angiographic % stenosis, intimal thickness, and histologic % area stenosis of overlapping Protea stents were 3+/-1%, 0.13+/-0.01 mm, and 22+/-2%, respectively, and similar to the single Protea group. Stable fibrocellular neointimal incorporation, with complete endothelialisation and minimal inflammation, were observed at one month in all stents, including overlapped Protea segments. CONCLUSIONS: When compared to a commercially available cobalt alloy BMS, the new third generation Protea stent demonstrated favourable coronary arterial response with significant reduction of neointimal formation in the porcine model. Our results showed how seemingly trivial improvements to the BMS technology can result in substantial biological responses. Future, long-term investigations are needed to ascertain the clinical applicability and implications of these findings.

Evaluation of a novel slow-release paclitaxel-eluting stent with a bioabsorbable polymeric surface coating.

OBJECTIVES: We sought to evaluate a new second-generation drug-eluting stent (DES), comprising a slow-release biodegradable polylactide coglycolide (PLGA) polymer and low-dose paclitaxel on a thin-strut cobalt chromium stent platform, in a clinically relevant animal model. BACKGROUND: Our previous work demonstrated subacute vascular toxicity and necrosis triggering late excess neointima in pig coronaries, with a moderate paclitaxel dose eluted from an erodible polymer. The use of slower-releasing absorbable polymers with lower doses of paclitaxel is expected to minimize such adverse outcomes. METHODS: Three types of stents were implanted in pig coronary arteries using quantitative coronary angiography to optimize stent apposition: bare-metal stents (BMS); absorbable, slow-release polymer-coated-only stents (POLY); and absorbable polymer-based paclitaxel-eluting stents (PACL). The dose density of paclitaxel was 0.15 microg/mm(2) with in vitro studies demonstrating a gradual elution over the course of 12 to 16 weeks. Animals underwent angiographic restudy and were terminated at 1 and 3 months for complete histopathologic and histomorphometric analyses. RESULTS: At 1 month, intimal thickness varied significantly according to stent type, with the lowest level for the PACL group compared with the BMS and POLY groups (0.06 +/- 0.02 mm vs. 0.17 +/- 0.07 mm, 0.17 +/- 0.08 mm, respectively, p < 0.001); histological percent area stenosis was 18 +/- 4% for PACL compared with 27 +/- 7% for BMS and 30 +/- 12% for POLY, respectively (p = 0.001). At 3 months, PACL showed similar neointimal thickness as BMS and POLY (0.09 +/- 0.05 mm vs. 0.13 +/- 0.10 mm and 0.11 +/- 0.03 mm respectively, p = 0.582). Histological percent area stenosis was 23 +/- 8% for PACL versus 23 +/- 11% for BMS and 23 +/- 2% for POLY, respectively (p = 1.000). CONCLUSIONS: This study shows favorable vascular compatibility and efficacy for a novel DES that elutes paclitaxel in porcine coronary arteries. These results support the notion that slowing the release rate and lowering the dose of paclitaxel favorably influences the vascular biological response to DES implant, decreasing early toxicity and promoting stable healing while still suppressing neointima formation.

Late angiographic stent thrombosis: the LAST straw for drug-eluting stents?

The long-term patency advantage of drug-eluting stents represents a quantum leap in the percutaneous treatment of ischemic heart disease. Although initial landmark trials demonstrated equivalent safety to bare-metal stents, subsequent follow-up analyses have suggested a slight late thrombotic risk. This widely publicized issue poses major public health implications for the medical and lay communities. However, available data indicate that this late risk is counterbalanced by the dramatic drug-eluting stent reduction in target lesion revascularizations, resulting in equivalent overall major adverse cardiovascular event rates than that of the bare-metal stents The recent Food and Drug Administration's guidelines regarding these devices are delineated in detail. Specifically, compliance with dual antiplatelet therapy (minimum 1 year) is of paramount consideration in patient selection for drug-eluting stents. Moreover, when deployed for "on-label" indications, they provide significant restenosis advantage, with a slight late thrombotic risk but without overall increase in death or infarction.

Abnormal vasomotor function of porcine coronary arteries distal to sirolimus-eluting stents.

OBJECTIVES: This study sought to determine vasomotor functional responses of conduit coronary artery distal to bare-metal stents (BMS), polymer-only stents (POLY), and sirolimus-eluting stents (SES) in a clinically relevant animal model. BACKGROUND: Drug-eluting stents (DES) reduce in-stent restenosis, and also affect neointima formation and vascular remodeling in downstream coronary segments. Whether distal artery vasomotor function is also influenced by DES has not been determined. METHODS: Pigs (n = 12) received coronary stent implants, and hearts were harvested at 1 month. Arterial segments >or=15 mm distal to stents were excised and studied in an organ-chamber apparatus. Endothelium-dependent and endothelium-independent relaxation and contraction to classical agonists were measured. RESULTS: The SES showed increased lumen area and reduced neointima; abnormal vasomotor function of conduit arteries distal to SES also was observed. Contraction to endothelin-1 was significantly enhanced for SES compared with both BMS and POLY. Endothelium-dependent relaxation to a maximal dose of substance P was attenuated for SES compared with both BMS and POLY (46 +/- 6% vs. 71 +/- 3% and 78 +/- 3%, respectively, p < 0.001). Endothelium-independent relaxation to sodium nitroprusside was potentiated for SES, compared with BMS and POLY (100 +/- 5% vs. 69 +/- 7% and 77 +/- 5%, respectively, p = 0.02). CONCLUSIONS: Stent-based local delivery of sirolimus profoundly inhibited neointima formation but caused vasomotor dysfunction in distal conduit vessel segments. These observations suggest that distal coronary vasospasm may be more readily evoked in the presence of DES and contribute to pathophysiological sequela.