Biomedical subjects

Ran Kornowski

Publications and source records attributed to Ran Kornowski.

At least 19 recordsLinked to original sources

PubMed2007

The impact of renal insufficiency on patients' outcomes in emergent angioplasty for acute myocardial infarction.

BACKGROUND: Renal insufficiency (RF) was shown to be associated with a worsened prognosis following acute myocardial infarction (AMI). OBJECTIVES: The authors analyzed the outcomes of AMI patients with impaired renal function tests treated using primary percutaneous coronary intervention (PCI), to determine factors associated with increased mortality risk. METHODS: This study included 558 consecutive AMI patients treated using primary PCI between January 2001 and June 2005. The authors compared outcome results according to glomerular filtration rate (GFR). An abbreviated equation was used to calculate GFR. Patients were grouped as follow: normal (> or =90 mL/min/1.73 m(2)), mildly impaired (60-89 mL/min/1.73 m(2)), moderately impaired (30-59 mL/min/1.73 m(2)), and severely impaired GFR (< 30 mL/min/1.73 m(2)). RESULTS: There was a stepwise increase in 30-day mortality among patients with normal, mildly, moderately, and severely impaired RF: 2.1%, 3.7%, 8.2%, and 22.2%, respectively (P = 0.004). Seventeen out of the 324 with any degree of RF died within 1 month [5.3%] of these nine patients [53%] died because of cardiac cause. Univariate correlation analysis, factors associated with an increased risk of 1 month mortality included: age > 75 years, left ventricular ejection fraction < 35%, lower GFR, killip class > 1, multivessel coronary artery disease, failure to achieve TIMI flow grade = 3, the occurrence of no-reflow, IABP use, lack of administration of anti GP 2b/3a. The amount of contrast media used during the procedure [mL/Kg] as well as renal function deterioration were also associated with increased mortality. CONCLUSIONS: Clinical and angiographic parameters collected before and during PCI can be used to predict 30-day mortality among AMI patients with RF. Findings indicate that in the setting of contemporary catheter-based reperfusion strategy for AMI, the extent of coronary artery disease, measures of PCI complexity, and degree of renal impairment prior/following the procedure are altogether related to mortality.

Aged↗

PubMed2007

Catheter-based stem cell and gene therapy for refractory myocardial ischemia.

Intramyocardial delivery of genes and cells derived from bone marrow has been evaluated in several small studies of 'no-option' symptomatic patients with chronic ischemic coronary artery disease. Clinical experience with intramyocardial gene delivery is limited to genes encoding isoforms of vascular endothelial cell growth factor. In the largest study (Euroinject One), 80 patients were randomized to receive a plasmid encoding vascular endothelial cell growth factor 165 or placebo. The results of this study suggested no beneficial therapeutic effect of this strategy. The experience with stem cells is limited to use of autologous, nonexpanded, nonmanipulated bone-marrow-derived cells; thus, the number of injected stem cells reflects their natural proportion within the bone marrow. The results of these preliminary studies suggest this approach is feasible and has a high safety profile. Although no conclusion can yet be made regarding efficacy, the improved myocardial perfusion in all four studies described in this Review is encouraging. Data from assessments of individual patients, however, suggests a wide variability in response, underscoring the need for further bench and clinical investigations.

Angiogenesis Inducing Agents↗

PubMed2006

Potential hazards and technical considerations associated with myocardial cell transplantation protocols for ischemic myocardial syndrome.

Cell transplantation has recently emerged as a promising therapeutic approach to ischemic cardiomyopathy syndromes. Clinical studies suggest important benefits, including improved myocardial perfusion and function. The safety profile so far seems to be high overall, although the technique may harbor several adverse effects, such as ventricular arrhythmia, acceleration of atherosclerosis or restenosis, and induction of ischemic events. Multiple factors may affect the safety of cell infusion into the diseased heart, including the mode of delivery, the type of cells injected, compound characterization, and the heart status, function, and arrhythmogenic potential. Also, any adjunctive treatment used to enhance cellular homing and/or transdifferentiation increases the likelihood of unexpected local or systemic toxicity or side effects. In the present review, we discuss the potential hazards of this novel treatment and its relationship to technical considerations.

Animals↗

PubMed2006

Prognostic value of myocardial perfusion imaging in symptomatic and asymptomatic patients after percutaneous coronary intervention.

The aim of this study was to evaluate the value of myocardial perfusion imaging (MPI) in predicting major adverse cardiovascular events (MACE) in symptomatic and asymptomatic patients after percutaneous coronary intervention (PCI). We revised retrospectively patients after PCI that underwent MPI and were followed for a year for the presence of MACE. We found no differences in the incidence of MACE between symptomatic and asymptomatic patients. On multivariate analysis, the presence of ischemia by MPI was the most important independent predictor of MACE (OR 5.09, CI 95% 2.15-12.05, p < 0.001). The presence of myocardial ischemia by MPI performed after PCI, and no symptom status, predicts a worse outcome during 1 year of follow-up.

Aged↗

PubMed2006

Safety and feasibility of transendocardial autologous bone marrow cell transplantation in patients with advanced heart disease.

The present report contains the final results of a Phase I study that evaluated the feasibility, safety, and potential efficacy of intramyocardial injection of autologous bone marrow (BM) in "no-option" patients with refractory angina and myocardial ischemia. Twenty-seven patients underwent electromechanic mapping-guided transendomyocardial injections (n = 12, 0.2 ml each) of unfractionated autologous BM cells directed to ischemic, noninfarcted myocardial territory. Patients were injected with 28 +/- 27 x 10(6)/ml nucleated cells containing 2.2 +/- 1.4% CD34+ cells. The autologous BM injection procedure was successful in all patients and was associated with no adverse events. At 3 months, the Canadian Cardiovascular Society angina score (3.2 +/- 0.5 vs 2.0 +/- 0.91, p = 0.001) and treadmill exercise duration (418 +/- 136 vs 489 +/- 142 seconds, p = 0.017) had improved significantly. The stress-induced ischemia score within the injected territories (118 segments) had also improved (2.2 +/- 0.8 vs 1.7 +/- 1.1, p < 0.001). At 1 year, the clinical improvement was sustained, although 5 patients had undergone revascularization procedures. The number of total injected nucleated cells (CD45+), progenitor cells (CD34+), and the magnitude of secreted vascular endothelial growth factor and macrophage chemoattractant protein-1 by cultured BM cells failed to predict the clinical response. In conclusion, the 3- and 12-month study results have indicated the safety of catheter-based transendocardial delivery of autologous BM cells in patients with advanced symptomatic ischemic heart disease and may suggest sustained potential efficacy. The cellular and humeral characteristics of autologous BM cells did not predict the clinical response, underscoring the advisability of additional mechanistic exploration.

Angina, Unstable↗

PubMed2006

The impact of circadian variation on outcomes in emergency acute anterior myocardial infarction percutaneous coronary intervention.

OBJECTIVES: We investigated the impact of primary coronary angioplasty performed during night and compared to the impact of that performed during day-time on outcomes of patients with acute ST elevation anterior wall myocardial infarction (AMI). METHODS: We prospectively followed 273 consecutive patients of whom 160 (58.6%) were treated during day time (8:00 a.m. to 6 p.m.) and 113 (41.4%) were treated "off hours"/at night (6 p.m. to 8 a.m.). Baseline demographics, angiographic factors, and clinical outcomes (death, recurrent AMI, and need for repeat revascularization) were compared between the groups. RESULTS: Baseline clinical characteristics were similar between the two groups. Unadjusted mortality at one-month was significantly higher among patients who were treated during night compared with those treated at day-time (9.7% vs. 3.1% P = 0.03), as was adverse cardiac event rate (15.9% vs. 6.9%; P = 0.02). Multiple logistic regression analysis adjusted for the CADILLAC risk score demonstrated that this score, which includes baseline LVEF, renal failure, Killip class, final TIMI flow, age>65 years, anemia, and the number of coronary vessel diseases, is a significant predictor of one-month mortality, while the effect of time of treatment was borderline (night vs. day; odds ratio 2.7; 95% confidence interval, 0.8-9.4; P = 0.095). CONCLUSIONS: The results of this study indicate that patients with anterior myocardial infarction treated during night time have worse unadjusted short-term clinical outcomes despite no delay from onset of symptoms to actual treatment. Larger studies are needed in order to identify potential contributors to this phenomenon.

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PubMed2006

A randomized, double-blind, placebo-controlled, multicenter, pilot study of the safety and feasibility of catheter-based intramyocardial injection of AdVEGF121 in patients with refractory advanced coronary artery disease.

BACKGROUND: The experience with direct myocardial injection of adenovirus encoding angiogenic growth factor is limited to invasive surgical approach. Accordingly, we sought to evaluate, for the first time, in a randomized, double-blind, placebo-controlled, phase I pilot study the safety and feasibility of percutaneous catheter-based intramyocardial delivery of a replication-deficient adenovector encoding the 121-amino-acid isoform of vascular endothelial growth factor (AdVEGF121). METHODS: Ten "no-option" patients with severe coronary artery disease were randomized (2:1) to receive AdVEGF121 (4 x 10(10) pu) or placebo as fifteen 100 microL, evenly distributed, endomyocardial injections using a nonflouroscopic, 3-dimensional mapping and injection (NOGA) catheter-based system. RESULTS: Injection procedure was successfully completed in all cases and was associated with no major adverse events. AdVEGF121 was considered potentially associated with a single serious adverse event of transient moderate fever. Elevated postprocedure CK and CK-MB fraction levels were recorded in two placebo-treated and three AdVEGF121-treated patients; all CK measured values were <1.5 times upper limit of normal. All adenoviral cultures (urine and throat swab) were negative 24-hr after dosing, and no significant changes in serial plasma VEGF levels were noted over time. At 12 months follow-up, no cancers, proliferative retinal changes, or significant abnormalities in hepatic, renal or hematological indices were observed. CONCLUSIONS: Percutaneous, catheter-based AdVEGF121 intramyocardial injection is a practical, feasible, and potentially safe approach for intramyocardial gene transfer. A larger randomized, phase II efficacy study is warranted.

Adult↗

PubMed2006

Drug-eluting stents in bifurcation lesions: to stent one branch or both?

OBJECTIVES: The objective of this study was to compare two techniques to treat bifurcation lesions: a single drug-eluting stent (DES) implanted in the main branch combined with balloon dilatation for the side branch vs. stenting of both branches (double stent). BACKGROUND: Percutaneous coronary intervention in coronary bifurcation lesions remains challenging. Although DES reduce restenosis in lesions, the double stent procedure has not shown clear advantages over a single stent with balloon dilation. METHODS: Fifty-three symptomatic patients with true bifurcation lesions were treated using either the double stent technique (n = 25) or one stent in the parent vessel plus balloon angioplasty of the side branch (n = 28). Procedural results and major adverse cardiac event rates (MACE: cardiac death, myocardial infarction, target vessel revascularization (TVR)) were compared. RESULTS: Angiographic procedural success (residual stenosis <30% in both branches) was 75% in the single stent group and 100% in the double stent group (P = 0.01). All differences were due to residual stenosis of the side branch. Clinical follow-up (6-18 months) was available for all patients; 90.5% of patients had a coronary angiography or nuclear stress test. Three patients (11%) in the single stent group and two (8%) in the double stent group had ischemia-driven TVR (P = NS). Asymptomatic angiographic restenosis (>50% diameter stenosis) in the ostium of the side branch was seen in two patients in the double-stent group. At 6 months, MACE-free was comparable between groups (89.3% vs. 88%, P = 0.7). CONCLUSIONS: When treating bifurcation lesions with sirolimus-eluting stents, restenosis following a single stent procedure is comparable to stenting both parent and side branch vessels. Thus, stenting the main-branch lesion, coupled with balloon angioplasty in the side branch, produces a high success rate and good clinical outcomes at 6 months.

Aged↗

PubMed2006

Prognostic impact of sex on clinical outcomes following emergent coronary angioplasty in acute myocardial infarction.

BACKGROUND: Several studies have shown that women had greater risk for adverse clinical outcomes following coronary angioplasty. We aimed to assess the impact of sex on clinical results following emergent coronary angioplasty in acute myocardial infarction. METHODS: We used our database of patients treated for acute myocardial infarction using emergent coronary angioplasty between January 2001 and December 2003. Procedural and angiographic results and clinical outcomes up to 6 months were collected and adjudicated for major cardiac adverse events. The outcome of 352 patients with acute myocardial infarction (71 women, 281 men, no cardiogenic shock) undergoing emergent angioplasty was analyzed and compared according to sex. RESULTS: Acute myocardial infarction occurred at an older age among women who tended to suffer more from diabetes mellitus and hypertension. In addition, on average, women had smaller culprit vessel diameters than men. The immediate post-procedural data were notable for higher frequency of 'no/slow re-flow' angiographic phenomenon in women than in men (10.5 vs. 3.4%, P=0.04). In-hospital and 30-day mortality was three times higher in women than men (women vs. men: in hospital 7 vs. 2.1%, P=0.05; 30 days 9.9 vs. 3.2%, P=0.02). At 6 months, major adverse cardiac events rate was 28 vs. 15% among women vs. men (P=0.01). Multivariate analysis showed a strong trend towards increased mortality at 30 days among women undergoing acute myocardial infarction angioplasty although it was not significantly or independently related to increased mortality (odds ratio=3.1; confidence intervals=0.8-12.5; P=0.11). CONCLUSION: Our results indicate a trend towards higher early mortality among female patients sustaining acute myocardial infarction and treated using emergent percutaneous coronary intervention that was probably because of increased age and worse coronary flow restoration results among women compared with men.

Aged↗

PubMed2006

Modalities to assess myocardial viability in the modern cardiology era.

Detection of viable myocardium in patients with left ventricular dysfunction has become an increasingly important guide to prognosis and treatment. This article reviews the current status and future potential for the application of modalities to assess myocardial viability. Imaging and other techniques that are reviewed are myocardial perfusion imaging by single-photon-emission computed tomography, positron-emission tomography, echocardiography, cardiac magnetic resonance technology, computed tomography and catheter-based endocardial mapping.

Contrast Media↗

PubMed2006

Influence of orthostatic hypotension on mortality among patients discharged from an acute geriatric ward.

BACKGROUND: Orthostatic hypotension (OH) is a common finding among older patients. The impact of OH on mortality is unknown. OBJECTIVE: To study the long-term effect of OH on total and cardiovascular mortality. PATIENTS AND METHODS: A total of 471 inpatients (227 males and 244 females), with a mean age of 81.5 years who were hospitalized in an acute geriatric ward between the years 1999 and 2000 were included in the study. Orthostatic tests were performed 3 times during the day on all patients near the time of discharge. Orthostatic hypotension was defined as a fall of at least 20 mmHg in systolic blood pressure (BP) and/or 10 mmHg in diastolic BP upon assuming an upright posture at least twice during the day. Patients were followed until August 31, 2004. Mortality data were taken from death certificates. RESULTS: One hundred and sixty-one patients (34.2%) experienced OH at least twice. Orthostatic hypotension had no effect on all cause and cause specific mortality. Over a follow-up of 3.47+/-1.87 years 249 patients (52.8%) had died 83 of whom (33.3%) had OH. Age-adjusted mortality rates in those with and without OH were 13.4 and 15.7 per 100 person-years, respectively. Cox proportional hazards model analysis demonstrated that male gender, age, diabetes mellitus, and congestive heart failure increased and high body mass index decreased total mortality. CONCLUSIONS: Orthostatic hypotension is relatively common in elderly patients discharged from acute geriatric wards, but has no impact on vascular and nonvascular mortality.

Adrenergic beta-Antagonists↗

PubMed2006

FX MiniRAIL catheter usage for treatment of de novo complex coronary lesions: results from the "OFFAR".

INTRODUCTION: Gradual prolonged balloon angioplasty may cause less arterial trauma, higher success rates, and fewer complications than conventional angioplasty (POBA). The OFFAR aimed to determine the safety and effectiveness of the FX MiniRAIL (FX) catheter, used with a slow, stepwise inflation protocol. METHODS AND RESULTS: From June to December 2003, 181 consecutive patients (age 61.9 +/- 10.6 years) with de novo coronary artery lesions (n = 217) were treated by FX and stent implantation in 11 European centers. Fifty-one patients (28.2%) had diabetes, and 70 (38.7%) had prior MI; 73 patients (40.3%) presented with stable angina and 85 (47.0%) with unstable angina. Fifty-five lesions (25.3%) were in small vessels (<2.5 mm), 40 (18.6%) were highly calcific, and 133 (62%) were long lesions (>18 mm). Stenosis resolution pressure was 7.17 +/- 4.2 atm; inflation time was 116.5 +/- 54.6 seconds. FX technical success (residual stenosis <50% post-FX) was obtained in 191 lesions (88.0%), and FX optimal success (residual stenosis <20% post-FX) in 117 (54.9%). Dissection was observed in 34 lesions (15.9%), 27 (79.3%) of which were type A or B. No coronary ruptures occurred. Nine (5.0%) in-hospital events occurred, all non-Q-wave MI. During 6-month follow-up, major adverse clinical events occurred in 14.4% of cases (n = 26; 3 cardiac deaths, 1 Q-wave MI, 2 non-Q-wave MI, 3 CABG, and 17 re-PTCA). CONCLUSION: The results of the OFFAR suggest that FX utilization for treatment of de novo complex coronary lesions is safe and effective.

Angioplasty, Balloon, Coronary↗

PubMed2006

[Primary angioplasty for acute myocardial infarction in octogenarian patients].

This study aimed to evaluate clinical outcomes in octogenarian patients with acute myocardial infarction (AMI) treated by primary angioplasty. We used our clinical database consisting of all patients treated using primary angioplasty (< or = 12 hours) for acute ST elevation myocardial infarction excluding patients with cardiogenic shock. The clinical and angiographic results of non-shock patients, distinguished according to age < 80 years and > or = 80 years, was characterized by higher 30-day mortality among the elderly compared to younger patients (12% versus 3.3%) and overall major cardiac events (17.5% versus 7.4%). Thus, primary angioplasty in the octogenarian patients, albeit feasible and relatively safe, is associated with 30-days death rates that are higher in octogenarian patients as compared to younger patients.

Aged, 80 and over↗

PubMed2006

[Current perspectives on emergent coronary angioplasty for acute ST-elevation myocardial infarction].

In recent years, emergent catheter-based angioplasty has become the preferred treatment for acute ST-elevation myocardial infarction. The use of balloon angioplasty, stents and recently introduced drug eluting stents allowed optimized and sustained coronary patency. However, it became apparent that epicardial patency would not guarantee optimized myocardial tissue perfusion. Therefore, additional work is required to preserve the damaged tissue afflicted by myocardial infarction. There is also a need for more research directed towards improved prognosis and myocardial preservation.

Angioplasty, Balloon, Coronary↗

PubMed2006

Predictors of left ventricular dysfunction in patients with first acute anterior myocardial infarction undergoing primary angioplasty.

BACKGROUND: The degree of left ventricular dysfunction determines the prognostic outcome of patients with acute myocardial infarction. OBJECTIVES: To define the clinical, angiographic and procedural variables related to LV dysfunction in patients with anterior wall AMI referred for primary percutaneous coronary intervention. METHODS: The sample included 168 patients treated by primary PCI for first anterior wall AMI. Clinical, demographic and medical data were collected prospectively into a computerized registry, and clinical outcome (death, reinfarction, major cardiovascular event) were evaluated during hospitalization and 30 days after discharge. Patients were divided into three groups by degree of LV dysfunction (mild, moderate, severe) and compared for clinical, angiographic and procedural variables. RESULTS: LV dysfunction was associated with pre-PCl renal failure (serum creatinine > 1.4 mg/dl), peripheral vascular disease, high peak creatine kinase level, longer door to balloon time, low TIMI flow grade before and after PCl, and use of an intraaortic balloon pump. On multivariate analysis adjusted for baseline differences, peak creatine kinase level (r = 0.3, P = 0.0001) and door to needle time (r = 0.2, P = 0.008) were the most significant independent predictors of moderate or severe LV dysfunction after anterior AMI. CONCLUSION: Abnormal LV function after first anterior AMI can be predicted by door to balloon time and the size of the infarction as assessed by creatine kinase levels. Major efforts should be made to decrease the time to myocardial reperfusion.

Angioplasty, Balloon, Coronary↗

PubMed2005

A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease.

OBJECTIVES: This study was a randomized, patient- and evaluator-blinded, placebo-controlled trial in patients treated using percutaneous myocardial laser revascularization. BACKGROUND: Previous studies using similar therapies have been confounded by placebo bias. METHODS: A total of 298 patients with severe angina were randomly assigned to receive low-dose or high-dose myocardial laser channels or no laser channels, blinded as a sham procedure. The primary end point was the change in exercise duration from baseline examination to six months. RESULTS: The incidence of 30-day death, stroke, myocardial infarction, coronary revascularization, or left ventricular perforation occurred in two patients in the placebo, eight patients in the low-dose, and four patients in the high-dose groups (p = 0.12); 30-day myocardial infarction incidence was higher in patients receiving either low-dose or high-dose laser (nine patients) compared with placebo (no patients, p = 0.03). At six months, there were no differences in the change in exercise duration between those receiving a sham (28.0 s, n = 100), low-dose laser (33.2 s, n = 98), or high-dose laser (28.0 s, n = 98, p = 0.94) procedure. There were also no differences in the proportion of patients improving to better than Canadian Cardiovascular Society class III angina symptoms at six months. The follow-up visual summed stress single-photon-emission computed tomography scores were not significantly different from baseline in any group and were no different between groups. The modest improvement in angina symptoms assessed by the Seattle Angina Questionnaire also was not statistically different among the arms. CONCLUSIONS: Treatment with percutaneous myocardial laser revascularization provides no benefit beyond that of a similar sham procedure in patients blinded to their treatment status.

Angina Pectoris↗

PubMed2005

Three-dimensional coronary reconstruction from routine single-plane coronary angiograms: in vivo quantitative validation.

BACKGROUND: Current X-ray technology displays the complex 3-dimensional (3-D) geometry of the coronary arterial tree as 2-dimensional (2-D) images. To overcome this limitation, an algorithm was developed for the reconstruction of the 3-D pathway of the coronary arterial tree using routine single-plane 2-D angiographic imaging. This method provides information in real-time and is suitable for routine use in the cardiovascular catheterization laboratory. OBJECTIVES: The purpose of this study was to evaluate the precision of this algorithm and to compare it with 2-D quantitative coronary angiography (QCA) system. METHODS: Thirty-eight angiographic images were acquired from 11 randomly selected patients with coronary artery disease undergoing diagnostic cardiac catheterization. The 2-D images were analyzed using QCA software. For the 3-D reconstruction, an algorithm integrating information from at least two single-plane angiographic images taken from different angles was formulated. RESULTS: 3-D acquisition was feasible in all patients and in all selected angiographic frames. Comparison between pairs of values yielded greater precision of the 3-D than the 2-D measurements of the minimal lesion diameter (P<0.005), minimal lesion area (P<0.05) and lesion length (P<0.01). CONCLUSIONS: The study validates the 3-D reconstruction algorithm, which may provide new insights into vessel morphology in 3-D space. This method is a promising clinical tool, making it possible for cardiologists to appreciate the complex curvilinear structure of the coronary arterial tree and to quantify atherosclerotic lesions more precisely.

Aged↗

PubMed2005

Acute and intermediate-term procedural results using cypher stenting to treat multi-vessel coronary artery disease.

OBJECTIVE: We examined our experience using the sirolimus eluting stents (Cypher) as an alternative to surgical revascularization in carefully selected cohort of patients undergoing multi-vessel percutaneous coronary intervention. METHODS: Fifty consecutive patients with multi-vessel disease who were good candidates for both surgical and percutaneous revascularization were included in the current analysis. All patients underwent a careful clinical evaluation prior to the intervention, and they were followed for procedural and clinical outcomes for nine months. RESULTS: Mean age was 64+/-11 years (40 males, 30% diabetics) and 10 patients (20%) had three-vessel disease. Angina class was 2.7+/-0.6 at baseline. Overall, 116 lesions were treated using 122 stents (mean 2.4 stents per patient). Total mean stent length was 43+/-12 mm (range: 21-90 mm). Overall, one patient died during follow-up (2%), no patient had stroke or Q wave MI and one patient experienced non-Q myocardial infarction. There was no documented stent thrombosis and two patients (4%) underwent target-vessel revascularization. The hierarchical cumulative major adverse cardiac event rate was 8% and the cardiac event-free survival rate was thus 92%. CONCLUSION: Multi-vessel stenting using Cypher stents is a viable treatment strategy in selected group of patients with multi-vessel coronary artery disease. It is associated with excellent intermediate-term clinical outcomes and thus it could serve as the primary revascularization strategy of choice in appropriate candidates.

Aged↗