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Biomedical subjects

Luis Gruberg

Publications and source records attributed to Luis Gruberg.

At least 19 recordsLinked to original sources
PubMed2006

Duplex ultrasound verified by angiography in patients with severe primary and restenosis of internal carotid artery.

There are very limited data in the literature about the reliability of duplex ultrasound (DU) verified by angiography in patients with restenosis of the internal carotid artery (ICA) after carotid surgery compared with primary carotid artery stenosis patients. Our objective was to compare the reliability of DU verified by conventional angiography in the diagnosis of severe primary stenosis versus restenosis of ICA. One hundred thirty-four patients (238 arteries) were examined by both DU and angiography. Severe stenosis (>70%) was found in 47 primary stenotic arteries and in 70 restenotic arteries. Accuracy, specificity, sensitivity, positive predictive value (PPV), and negative predictive value were obtained for basic DU criteria after verification of ultrasound data by angiography. The best accuracy for detection of >70% stenosis by end diastolic velocity was found for the velocity of 70 cm/sec or more in both groups, but accuracy for the restenosis group was significantly higher (96.9% vs. 89.8%, p = 0.025). Additionally, specificity (p = 0.01) and PPV (p = 0.01) were significantly higher in the restenosis group. The best accuracy for detection of >70% stenosis by peak systolic velocity was found for the velocity of 220 cm/sec or more for restenoses and 200 cm/sec or more for primary stenoses. The accuracy of the ultrasound was significantly higher in the restenosis group (94.6% vs. 87%, p = 0.04), as were specificity (p = 0.01) and PPV (p = 0.02). The diagnosis of severe restenosis by DU is reliable and can be used for decision making regarding surgery or stenting without angiography. In patients with Doppler parameters pointing to borderline moderate/severe primary carotid stenosis and technically complicated cases, angiography in addition to sonography before surgery is recommended.

Adult↗
PubMed2006

Remote-control percutaneous coronary interventions: concept, validation, and first-in-humans pilot clinical trial.

OBJECTIVES: This study was designed to assess the feasibility and safety of a Remote Navigation System (RNS, NaviCath, Haifa, Israel) in which the angioplasty guidewire, the balloon, and the stent are navigated via a computerized system. BACKGROUND: Percutaneous coronary interventions (PCIs) are manually performed under fluoroscopic guidance, requiring lead protection for the operators. A system in which the operator can remotely, safely, and precisely navigate the procedure during PCI would have clear advantages. METHODS: The RNS involves a computer-controlled wire and delivery system navigator. Following preclinical validation, the system was assessed in patients undergoing single-vessel PCI. RESULTS: The study involved 18 patients (age 55.9 years, 16% women). The RNS successfully crossed lesions with the guidewire in 17 patients. The stent was then advanced by the advance/rotate mode and adequately positioned in 15 of 17 cases. Technical malfunction was encountered in three patients in whom the procedure was successfully completed manually. Direct stenting was employed in 10 of 18 patients, pre-dilation in 7 patients, and after-stent balloon dilation in 5 patients. The total fluoroscopy time for 17 RNS patients was compared with the corresponding time of 20 consecutive patients who underwent standard single-lesion PCI. Fluoroscopy time was similar for both procedures, with 8.8 +/- 4.8 min with the RNS versus 9.1 +/- 3.5 min with the standard techniques (p = NS). Clinical success was 100% and technical success 94% for the guidewire and 83% for the overall procedure. CONCLUSIONS: The use of the RNS for guidewire, balloon, and stent manipulation during PCI appears safe and feasible for the treatment of patients with coronary stenosis. The system offers operator radiation safety and may enhance precision of stent placement and balloon dilation strategies.

Adult↗
PubMed2006

Carotid artery stenting in surgical high-risk patients.

Recent studies have shown that carotid artery angioplasty and stenting may offer a viable alternative for symptomatic and asymptomatic patients with carotid artery stenosis, especially in high-risk patients. We report the results of a prospective single-center registry designed to evaluate the feasibility and safety of carotid artery angioplasty and stenting with and without distal protection devices in high-risk patients. A total of 116 consecutive patients underwent 126 procedures and 127 stents were deployed successfully in 130 lesions. The majority of patients (63%) had restenosis after a prior carotid endarterectomy; 31% were considered to be ineligible for carotid endarterectomy by both the vascular surgeons and the interventional cardiologist and 9% were considered ineligible for surgery due to hostile neck anatomy. Periprocedural and follow-up evaluation included a thorough independent clinical and neurological assessment. Distal embolic protection devices were used in 44% of all cases. Procedural success was achieved in 122 procedures (97%). The overall rate of in-hospital major adverse cerebrovascular events (death, stroke, and myocardial infarction) was 2.6%. Event rates in patients with prior carotid endarterectomy were comparable to patients with de novo lesions with 5.2% vs. 2.4% death/stroke at 30 days and 8.3% and 6.6% stroke/death rates at 1 year, respectively. When distal protection devices were used, death/stroke rates were 0% as compared to 4.5% when distal protection was not used (P = NS). However, minor embolic phenomena were observed in both primary and secondary lesions independent of the use of distal protection. These results support the use of carotid artery angioplasty and stenting in high-risk patients with significant primary or secondary carotid artery stenosis. In both types of lesions, acceptable results justify its use as a valid revascularization method. While clinical embolic events occur in a minority of patients in both lesion types, they are not entirely prevented by distal protection.

Aged↗
PubMed2006

Preprocedural C-reactive protein levels predict myocardial necrosis after successful coronary stenting in patients with stable angina.

BACKGROUND: Myocardial necrosis as assessed by cardiac troponin elevation occurs frequently after coronary stenting and is associated with adverse clinical outcome. Mechanical factors have been implicated in this complication and the role of systemic inflammation is not known. METHODS: We prospectively studied 208 patients with chronic stable angina who underwent elective coronary stenting. All patients had normal troponin levels before the procedure. Blood samples for high-sensitivity C-reactive protein (CRP) were obtained before the procedure and analyzed using a high-sensitivity kit. Cardiac troponin T (cTnT) was obtained 24 hours after the procedure. RESULTS: Postprocedural cTnT elevations were observed in 46 (22%) patients. There were 11 (16%), 14 (20%), and 21 (30%) patients with elevated postprocedural cTnT in the first, second, and third CRP tertile, respectively (P for trend = .045). In a multivariate logistic regression model, adjusting for all the significant univariate predictors and for statin therapy, CRP remained a significant independent predictor of postprocedural cTnT elevation with an odds ratio of 2.6 in patients in the third CRP tertile compared with patients in the first CRP tertile (95% CI 1.1-6.0, P = .02). Patients in the third CRP tertile also had higher cTnT elevations compared with patients in the first and second CRP tertile (P = .03). CONCLUSIONS: Elevated baseline CRP levels are associated with higher risk of postprocedural troponin elevations in patients with stable angina undergoing uncomplicated coronary stenting. These results underscore the role of systemic inflammation in the pathogenesis of periprocedural myocardial injury.

Angina Pectoris↗
PubMed2006

Contrast enhanced multi-detector computed tomography coronary angiography versus conventional invasive quantitative coronary angiography in acute coronary syndrome patients-correlation and bias.

BACKGROUND: Previous studies that compared multi-detector computed tomography (MDCT) non-invasive coronary angiography with conventional coronary angiography, did not assessed the ability of MDCT to detect stenotic lesions correctly in acute coronary syndromes (ACS) patients. The aim of the present study was to assess prospectively the correlation and bias between 16-slice MDCT coronary angiography and quantitative coronary angiography analysis (QCA) in these patients. METHODS: Patients underwent electrocardiogram-gated, 16-slice MDCT coronary angiography and routine invasive percutaneous coronary angiography with quantitative coronary angiography (QCA) analysis blinded to MDCT results. The correlation and the bias between the results of MDCT and QCA were assessed in segments observed by both modalities in vessels > or = 2 mm in diameter. RESULTS: 59 patients (81% male, age 56 +/- 11 years), admitted due to ACS, underwent MDCT and invasive coronary angiography. 544 segments were analyzed. The correlations between MDCT and QCA observed for the left anterior descending coronary artery (LAD), the left circumflex coronary artery (Cx), the right coronary artery (RCA) and for all analyzed segments were 0.74 (P < 0.0001), 0.54 (P < 0.009), 0.72 (P < 0.0001) and 0.70 (P < 0.0001), respectively. By Bland-Altman analysis, a small overestimation of the lesion severity with MDCT of 4.8% for the LAD, 5.9% for the Cx, and 3.3% for the RCA was observed. CONCLUSIONS: In ACS patients, MDCT contrast-enhanced coronary angiography provides good quantification of the luminal diameter as compared to coronary angiography, and it is characterized by a small overestimation bias.

Angina, Unstable↗
PubMed2006

Rescue percutaneous coronary intervention after failed thrombolysis: results from the Acute Coronary Syndrome Israel Surveys (ACSIS).

BACKGROUND: The benefit of rescue percutaneous coronary intervention (PCI) in acute myocardial infarction patients, who fail to show signs of reperfusion after full dose thrombolysis, is still an unresolved issue. AIM: To assess the outcomes of patients who underwent rescue PCI after full-dose thrombolytic therapy and compare them to patients treated only with thrombolysis in the Acute Coronary Syndrome Israel Surveys (ACSIS). METHODS: ACSIS is a biannual survey on acute myocardial infarction performed in all 26 intensive cardiac care units in Israel during a two-month period. 2,018 patients were admitted with acute myocardial infarction during the two-month period in the 2000 and 2002 surveys, and 796 of them were treated with thrombolytic therapy. RESULTS: Rescue PCI was performed in 99 patients who failed to show signs of reperfusion. The control group consisted of patients with unsuccessful thrombolysis and no further intervention. Patients who underwent rescue PCI had a numerically higher incidence of anterior wall myocardial infarction, diabetes, higher Killip class on admission and cardiogenic shock. Furthermore, almost half of these patients had reduced left ventricular function (P = 0.03). During hospitalization, there was a significantly higher prevalence of recurrent ischemic events and major bleeding complications in patients who underwent rescue PCI. In-hospital, 30-day and one-year mortality rates were similar between the two groups. By multivariate analyses, Killip class 3-4 (OR: 2.62, CI = 0.95-6.58, P = 0.05) and streptokinase treatment (OR: 0.623, CI = 0.4-0.97, P = 0.05) were independent predictors of rescue PCI. Rescue angioplasty was associated with 15% risk-reduction (CI = 0.45-1.97, P = 0.05) in 30-day mortality and recurrent emergent hospitalization. CONCLUSIONS: Patients who underwent rescue PCI had similar short- and long-term mortality rates compared to patients treated with thrombolysis alone, despite differences in baseline characteristics. Rescue angioplasty was associated with a 15% risk reduction in mortality at 30-days, at the cost of higher rate of recurrent ischemic events and bleeding complications. Therefore, rescue angioplasty may be an equalizer in severely ill patients who receive thrombolytic therapy and fail to show signs of reperfusion.

Angioplasty, Balloon, Coronary↗
PubMed2006

The eccentric lumenology.

Coronary angiography has a poor predictive value for the detection of eccentric plaque morphology. Many reports have demonstrated discordance between the angiographic classification and the intravascular ultrasound (IVUS) classification. Although eccentricity is usually considered a dichotomous character, more than two-thirds of all coronary stenosis have some degree of eccentricity. The American College of Cardiology/American Heart Association (ACC/AHA) Task force included lesion eccentricity as a risk factor for moderate procedural success (60-85%) and moderate complications (type B). Although lesion eccentricity has been implicated as a risk factor for reduced short-term procedural results, current available data does not support the adverse impact of eccentricity on procedural success or restenosis. The present article reviews the incidence and the various clinical scenarios known to be associated with the eccentric lumenogram and the impact of coronary artery remodeling contributing to misinterpretation of disease eccentricity. Various therapeutic modalities with reference to eccentric lesions are also considered.

Angioplasty, Balloon, Coronary↗
PubMed2006

16-MDCT coronary angiography versus invasive coronary angiography in acute chest pain syndrome: a blinded prospective study.

OBJECTIVE: The purpose of our study was to prospectively evaluate the usefulness of CT coronary angiography versus invasive coronary angiography for the detection of clinically significant coronary artery disease in patients hospitalized for acute chest pain syndrome. SUBJECTS AND METHODS: Sixty-six consecutive patients (52 men and 14 women; average age, 57 +/- 11 [SD] years) who were hospitalized for acute chest pain syndrome underwent CT coronary angiography and invasive coronary angiography within an average time interval of 4 days. ECG-gated CT coronary angiography was performed with a 16-MDCT scanner (0.42-sec rotation time, 16 x 0.75 mm detector collimation). Beta-blockers were not administered routinely, and thus the average heart rate was 71 +/- 11 beats per minute. CT coronary angiographic images were evaluated concurrently by two radiologists, who were blinded to invasive coronary angiography results, for stenoses having a diameter of 50% or more, using a 15-segment classification, including all segments 2 mm or more in diameter. The consensus interpretation was compared with results of invasive coronary angiography. RESULTS: CT coronary angiography was technically successful in 59 patients (89%). After exclusion of 20 (3.1%) of 649 coronary segments, which were classified as nonevaluable by CT coronary angiography, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of CT coronary angiography for identifying significant coronary artery disease in the remaining 629 coronary segments were 80% (68/85), 89% (482/544), 52% (68/130), 97% (482/499), and 87% (550/629), respectively. The overall accuracy for the main vessels (left main, left anterior descending, left circumflex, and right coronary arteries) was 93%, 88%, 86%, and 86%, respectively. CONCLUSION: CT coronary angiography using a 16-MDCT scanner enables accurate noninvasive detection of significant coronary artery disease in patients hospitalized for acute chest pain syndrome. Furthermore, relative high sensitivity and specificity of CT coronary angiography can be achieved without pharmacologic manipulation of patient heart rates.

Acute Disease↗
PubMed2006

Glycoprotein IIb/IIIa inhibitors during rescue percutaneous coronary intervention in acute myocardial infarction.

Although percutaneous coronary intervention (PCI) following full-dose thrombolytic therapy (rescue angioplasty) is a common procedure, there is ample controversy regarding the usefulness of the procedure. Moreover, few data are available concerning the safety and efficacy of concomitant treatment with glycoprotein (GP) IIb/IIIa inhibitors in these patients. The aim of the present study was to compare the clinical outcomes of patients who underwent rescue PCI with stents and were treated with GP IIb/IIIa inhibitors. A total of 59 consecutive patients underwent rescue PCI at our institution during the study period, 29 patients (49.2%) were treated concomitantly with a GP IIb/IIIa inhibitor and 30 patients (50.8%) were not. Baseline clinical characteristics were similar between the two groups. In-hospital outcomes regarding death, reinfarction and the need for urgent target vessel revascularization was significantly lower in patients treated with GP IIb/IIIa inhibitors compared to those who were not treated (3.4% vs. 26.7%; p = 0.01, respectively). However, GP IIb/IIIa inhibitor administration was not an independent predictor of better outcomes by multivariate analysis. There was a higher rate of major bleeding complications in patients who received GP IIb/IIIa inhibitors, though it did not achieve statistical significance (6.9% vs. 0%; p = 0.14, respectively). The composite endpoint of major, minor bleeding and vascular complications was similar in both groups (24.1% vs. 16.7%; p = 0.48). In conclusion, the administration of GP IIb/IIIa inhibitors in patients undergoing rescue PCI after failed thrombolysis with stents was safe and may have a beneficial effect on 30-day event-free survival rates, without a significant increase in bleeding or vascular complications. These results warrant further investigation.

Abciximab↗
PubMed2006

[Percutaneous carotid artery stenting in high-risk patients].

UNLABELLED: Recent studies have shown that percutaneous carotid artery angioplasty and stenting can be safely performed in patients with carotid artery stenosis, especially those considered to be at high-risk for surgery. AIM: We evaluated the safety and feasibility of carotid artery angioplasty and stenting, with and without distal protection devices in patients at high-risk for surgical endarterectomy. METHODS: A total of 169 consecutive patients underwent 185 procedures and 189 stents were deployed successfully in 195 lesions. The majority of patients (51%) had restenosis after a prior carotid endarterectomy, 40% were considered to be ineligible for carotid endarterectomy by both the vascular surgeons and the interventional cardiologist and 7% were considered ineligible for surgery due to hostile neck anatomy. RESULTS: Distal embolic protection devices were used in 52% of all cases. Procedural success was achieved in 181 of 185 procedures (98%). The overall rate of in-hospital major adverse cerebrovascular events (death, major stroke, and myocardial infarction) was 2.4%. In-hospital event rates in patients with prior carotid endarterectomy were comparable to patients with de novo lesions with 3.3% vs. 1.1% death/ stroke at 30 days, and 3.3% and 3.3% stroke/death rates at 30 days, respectively. When distal protection devices were used death/stroke rates were 0% as compared to 4.7% when distal protection was not used (p = NS). However, minor embolic phenomena were observed in both primary and secondary lesions independent of the use of distal protection. CONCLUSIONS: These results support the use of carotid artery angioplasty and stenting in high-risk patients with significant primary or secondary carotid artery stenosis. In both types of lesions, acceptable results justify its use as a valid revascularization method. While clinical embolic events occur in a minority of patients in both lesion types, they are not entirely prevented by distal protection devices.

Aged↗
PubMed2006

Five-year clinical follow up after intracoronary radiation for the prevention of in-stent restenosis.

Intracoronary radiation therapy (IRT), utilizing both gamma- and beta-emitting radiation sources, is considered to be a safe and effective treatment for in-stent restenosis (ISR). Although no longer in clinical use, a significant number of patients were treated in the past with IRT, and their long-term outcomes have not been well documented. The aim of the present analysis was to document the long-term outcomes of all patients who underwent IRT at our institution for the prevention of recurrence of ISR. Data were collected from 132 patients (148 irradiated lesions) treated with IRT at our institution between March 1999 and January 2004. Clinical and angiographic data were collected over a 5-year period. Patients were divided into 2 groups: those with failed IRT (n = 65), defined as a procedure that resulted in a major adverse cardiac event: death, myocardial infarction, target lesion revascularization, target vessel revascularization or coronary artery bypass graft surgery at any time during the follow-up period, and patients with successful IRT (n = 67). Both groups were identical regarding baseline clinical and angiographic characteristics, with the exception of a higher percentage of multivessel disease and diffuse restenosis in patients who failed IRT (p = 0.01). At 1-year follow up, slightly less than half (43%) of those patients in the failure group experienced a major adverse cardiac event. During the long-term follow up period, half of all patients who underwent IRT at our institution experienced a major adverse cardiac event, 61 patients (46%) either died or underwent a revascularization procedure, 16 patients (24%) had a myocardial infarction or died, and 55 patients (42%) required repeat coronary revascularization. The average time to develop a major adverse cardiac event was 14.6 +/- 15 months. Therefore, during long-term follow up following IRT for the prevention of ISR, half of all patients developed a major cardiovascular event, mainly due to the need for repeat revascularization procedures.

Aged↗
PubMed2005

Impact of renal function on coronary plaque morphology and morphometry in patients with chronic renal insufficiency as determined by intravascular ultrasound volumetric analysis.

The aim of the present study was to use intravascular ultrasonography (IVUS) to assess plaque morphology and morphometry in patients with varying degrees of chronic renal insufficiency, including end-stage renal disease (ESRD) on dialysis replacement. Cardiovascular disease is the main cause of death for patients with chronic renal insufficiency, particularly in patients with ESRD. The impact of several degrees of renal insufficiency (including ESRD) on coronary plaque characteristics has not been determined. A total of 142 patients who underwent IVUS imaging of a de novo native coronary artery stenosis before percutaneous intervention were matched for age, gender, and diabetes and were grouped according to calculated creatinine clearance (CrCl): CrCl >70 ml/min (n = 39); CrCl 50 to 69 ml/min (n = 41); CrCl <50 ml/min, (n = 37), and ESRD (n = 25). Standard clinical, angiographic, and IVUS parameters were measured. The ESRD group had more African-American (p = 0.002) and hypertensive (p = 0.002) patients. No significant difference was found in any of the IVUS measurements among patients with CrCl >70, 50 to 69, and <50 ml/min: reference and lesion site arterial, lumen, and plaque areas and volumes, and arterial calcium (p = NS for all comparisons). Conversely, patients with ESRD had larger reference segment arterial and lumen areas and volumes; larger lesion site arterial, lumen, and plaque areas; and larger arcs of calcium (p <0.05 for all post hoc comparisons between patients with ESRD and patients with CrCl >70, 50 to 69, and <50 ml/min). Thus, chronic renal insufficiency in the absence of dialysis is not associated with increased reference segment or lesion site plaque burden and calcium. However, the transition to the need for dialysis is associated with progressive calcific atherosclerosis (larger lesion plaque area and calcium).

Aged↗
PubMed2005

Effect of obesity on the relationship between plasma C-reactive protein and coronary artery stenosis in patients with stable angina.

INTRODUCTION: The association between plasma C-reactive protein (CRP) and the extent of coronary artery disease (CAD) in patients with stable angina remains controversial. Obesity is strongly associated with elevated CRP levels, potentially confounding the relationship between CRP and CAD severity. METHODS AND RESULTS: We studied 830 subjects without CAD and 218 patients with CAD undergoing elective coronary angiography. Geometric means of CRP were computed in a two-way analysis of covariance model in which study participants were stratified into nine groups according to CAD status (no CAD, single-vessel disease or multivessel disease) and tertiles of BMI. There was a significant interaction between CAD and categories of BMI with regard to CRP level (P=0.002). In the lower tertile of BMI, patients with CAD had markedly higher CRP concentration compared to control subjects (1.16, 1.80 and 2.82 mg/L in subjects without CAD, patients with single-vessel disease and patients with multivessel disease, respectively; P=0.003). However, the relationship between CRP and CAD became weaker for patients in the second BMI tertile (P=0.15), whereas no significant relationship was observed for patients in the third BMI tertile (P=0.75). In patients undergoing coronary angioplasty (n=195), BMI was independently related to the magnitude of the angioplasty-induced CRP elevations (P=0.002). CONCLUSION: The level of obesity is essential to the interpretation of the relationship between CRP and severity of CAD. The production of inflammatory mediators with increasing levels of obesity becomes the dominant determinant of plasma CRP levels and masks the vascular contribution due to CAD.

Angina Pectoris↗
PubMed2005

Impact of body mass index on the outcome of patients with multivessel disease randomized to either coronary artery bypass grafting or stenting in the ARTS trial: The obesity paradox II?

The effect of body mass index (BMI) on outcomes after coronary artery revascularization remains controversial. We studied 1,203 patients who had multivessel coronary artery disease and underwent stenting (n = 599) or coronary artery bypass grafting (CABG; n = 604) in the Arterial Revascularization Therapies Study. Patients were assigned to 1 of 3 groups according to BMI: <25, 25 to 30, and >30 kg/m(2). At 3-year follow-up, the incidence of death, cerebrovascular events, or myocardial infarction was similar for these BMI categories regardless of the revascularization technique used. Rates of repeat revascularization procedures were significantly higher among patients who had been randomized to stenting but were similar across BMI groups. For patients who had been randomized to undergo CABG, there was a significant decrease in repeat revascularization procedures in obese patients (p = 0.03). Among patients who underwent stenting, BMI had no effect on the 3-year combined end point of rate of major adverse cardiac or cerebrovascular events. Among patients who underwent CABG, major adverse cardiac or cerebrovascular event rates were significantly lower for patients who were obese (11%) or overweight (16%) compared with patients who had a normal BMI (24%; p = 0.008). Thus, in a large cohort of patients who had multivessel coronary artery disease and underwent surgical or percutaneous revascularization, BMI had no effect on 3-year outcome of those who underwent stenting. Conversely, among patients who underwent CABG, those who were overweight or obese had a significantly better outcome than did those who had a normal BMI with regard to survival without major adverse cardiac or cerebrovascular events, mainly due to lower rates of repeat revascularization procedures.

Angioplasty, Balloon, Coronary↗