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Yaron Almagor

Publications and source records attributed to Yaron Almagor.

9 recordsLinked to original sources
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

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

Sirolimus-eluting stent in chronic total occlusion: the SICTO study.

Coronary stenting can significantly reduce the restenosis and reocclusion rates after successful balloon angioplasty for chronic total occlusions (CTO). Nevertheless, recanalization of CTO remains among the worst predictors for in-stent restenosis and reocclusion. This multicenter, nonrandomized study assessed the safety and effectiveness of the CYPHER sirolimus-eluting stent in reducing angiographic in-stent late loss in totally occluded native coronary arteries. A total of 25 eligible patients were treated with the CYPHER sirolimus-eluting stent. Baseline clinical and angiographic data were collected and 6-month follow-up angiography and intravascular ultrasound (IVUS) were performed. Clinical follow-up was required at 30 days, 6, 12, 18, and 24 months. Study stent implantation was successful in all patients, with a mean stent length of 28.4 +/- 11 mm. Six-month angiographic outcomes showed that mean lumen diameter stenosis did not change (2.22 +/- 0.56 mm postprocedure; 2.26 +/- 0.60 mm at 6 months follow-up; P = NS). Similarly, mean percent diameter stenosis did not change significantly (15.7 +/- 8.6% postprocedure, 19.3 +/- 11% at follow-up; P = NS). The absolute late lumen loss was -0.03 +/- 0.28 mm with a 6-month in-stent restenosis rate of 0%. IVUS follow-up revealed in-stent obstruction volume of only 4.9 +/- 6.8%. Long-term clinical follow-up showed target lesion revascularization at 12 months was only 4%, with target vessel revascularization of only 12%. The CYPHER sirolimus-eluting stent was safe and effective in the treatment of CTO compared to historical data with bare metal stents.

Aged↗
PubMed2005

Renal fractional flow reserve: a hemodynamic evaluation of moderate renal artery stenoses.

The objective of this study was to perform a hemodynamic evaluation of moderate (50-90%) renal artery stenosis (RAS) under conditions of rest and maximum hyperemia. Identifying patients with RAS who have hemodynamically significant stenoses and are most likely to benefit from revascularization is clinically important. Current methods used to evaluate RAS, including angiography, have limitations. Physiologic evaluation of RAS may have a role in identifying patients with hemodynamically significant stenosis. Patients with suspected renovascular hypertension due to aorto-ostial RAS were included in the study. Hyperemia was induced by administration of intrarenal papavarine. Translesional pressure gradients were measured and renal fractional flow reserve (FFR) was calculated using a 0.014'' pressure guidewire. Thirteen patients and 14 arteries with moderately severe (50-90%) RAS were studied. The mean translesional pressure gradient rose from a baseline of 6.3 +/- 3.9 to 17.5 +/- 10.8 mm Hg with maximal hyperemia. The renal FFR ranged from 0.58 to 0.95. There was a poor correlation between angiographic stenosis measurement and the renal FFR (r = -0.18; P = 0.54) and the hyperemic translesional mean pressure gradient (r = 0.22; P = 0.44). There was an excellent correlation between renal FFR and the resting mean translesional pressure gradient (r = -0.76; P = 0.0016) and the hyperemic mean translesional pressure gradient (r = -0.94; P < 0.0001). Selective renal arterial papavarine administration induces maximum hyperemia, permitting the calculation of renal FFR in renal arteries with aorto-ostial stenoses. The renal FFR correlates well with other hemodynamic parameters of lesion severity, but poorly with angiographic measures of lesion severity.

Aged↗
PubMed2003

Results of coronary artery stenting in women versus men: a single center experience.

BACKGROUND: Prior studies have suggested that women are at higher risk for morbidity and mortality during coronary angioplasty, although long-term prognosis is similar after successful procedures. OBJECTIVES: To examine the role of gender in coronary stenting, including immediate procedural success as well as early and late outcomes. METHODS: The study group comprised 560 consecutive patients (119 women and 441 men) who had undergone stenting over a 3 year period. RESULTS: The indications for coronary stenting were similar among women and men, and stents were successfully deployed at similar rates without complications (92 vs. 90% respectively). Cardiac death or myocardial infarction within 30 days of the procedure was observed in 5% of women and men, whereas none of the women, compared to 1.4% of men, had early revascularization. Bleeding complications occurred in 4% of women and 2% of men. During 10 +/- 2.8 months of follow-up, 58% of women and men underwent repeat cardiac catheterization, revealing similar rates of restenosis, 36 vs. 32% respectively. During the study period, 3.3% of women as compared to 0.9% of men had a cardiac death (not significant). Cardiac death or myocardial infarction was observed in 7% of women and 8% of men, and the combined endpoint of death, myocardial infarction or revascularization, was noted in 24% and 26% respectively. Multivariate Cox analyses of the clinical, angiographic and procedural characteristics revealed that multiple stent deployment was the only predictor of major adverse cardiac event among men, whereas none of these characteristics predicted outcome in women. CONCLUSION: Coronary stenting is performed with similar success rates among women and men, with similar restenosis rates as well as early and late major adverse cardiac events.

Aged↗
PubMed2002

Predictors of clinical outcome following NIR stent implantation for coronary artery disease: analysis of the results of the First International New Intravascular Rigid-Flex Endovascular Stent Study (FINESS trial).

BACKGROUND: Patient and procedural characteristics associated with major adverse cardiac events following balloon angioplasty have been identified. Factors predictive of angiographic restenosis following coronary stent implantation have been reported, although patient variables associated with adverse clinical outcome are not well defined. HYPOTHESIS AND METHODS: To identify predictors of adverse clinical outcome following NIR stent implantation, clinical and angiographic characteristics of patients enrolled in the FINESS Trial were subjected to stepwise logistic regression analysis. From December 1995 through March 1996, NIR stent implantation was attempted in 255 patients (341 lesions) enrolled prospectively in a multicenter registry with broad entry criteria. RESULTS: On stepwise logistic regression analysis, the presence of multivessel disease, diabetes, and the total length of the stented segment were predictive of major adverse cardiac events during 6-month follow-up. For every 1 mm increase in stent length, the risk for the combined end point of death or myocardial infarction increased by 3%. Lesion length was not predictive of clinical events on multivariate analysis. CONCLUSIONS: Our data raise the possibility that an attempt to use shorter stents to cover significant stenoses, but not adjacent areas of visible narrowing, may improve outcome.

Coronary Artery Disease↗
PubMed2001

Provisional bifurcation stenting.

Obstructive coronary lesions involving a branch origin or extending into the branch itself, remain one of the main challenges in the rapidly developing world of interventional cardiology. Acutely, these lesions are prone to the complications resulting in significant residual stenosis or loss of one of the branches. Long-term follow up has also been disappointing with a high incidence of restenosis. Numerous techniques have been developed, aimed at optimizing the acute and long-term results by adapting standard angioplasty hardware, with limited success, particularly in the long term. This article describes a fully dedicated system for bifurcation lesions with stenting of the main vessel to the main branch, yet ensuring side branch patency, with limited risk of branch origin stenosis or stent jailing, allowing for provisional stenting of the branch as dictated by the angiographic outcome.

Journal Article↗
PubMed2000

Clinical and angiographic results with the NIR stent: First International NIR Endovascular Stent Study (FINESS-II).

BACKGROUND: Although safety and efficacy of the NIR trade mark stent have been reported, the long-term angiographic and clinical outcomes have yet to be investigated. The FINESS-II study (First International NIR Endovascular Stent Study) was designed to assess the procedural safety of single 9 and 16 mm NIR stent implantation, the six-month restenosis rate and finally the six- and 12-month clinical outcome of patients treated with this novel coronary stent. METHODS: Patients with angina and a single de novo lesion in a native coronary artery of >3 and <5 mm diameter were included in this multicentre, prospective, observational trial. Clinical follow-up was obtained at one, six and 12 months. Angiography was performed before and after the stent implantation and at six months. The primary endpoint included major adverse cardiac events (death, myocardial infarction and target lesion revascularization) within 30 days after the procedure. Major bleeding complications and subacute stent thrombosis within the first 30 days were also reported as specific endpoints. Secondary endpoints were major cardiac-event-free survival at six- and 12-month follow-up and angiographic restenosis at six months. RESULTS: A total of 156 patients (81% male, mean age 60 +/- 10 years), with stable (54%), unstable (40%) angina pectoris or silent ischemia (6%) were enrolled. The target vessel diameter was 2.94 +/- 0.54 mm. The minimal lumen diameter pre, post and at follow-up was 1.04 +/- 0.32 mm, 2.64 +/- 0.42 mm and 1.88 +/- 0.63 mm, respectively. Restenosis rate according to the >50% diameter stenosis criterion at six month follow-up was 19% (26/136). At 12 months, the event-free survival rate was 83% (two deaths, one Q-wave and three non-Q-wave myocardial infarctions, four bypass surgery and 17 target lesion revascularizations), while 87% of the patients were free of angina pectoris. CONCLUSION: the outcome of the FINESS-II trial is comparable to those observed in previous stent trials (Benestent II), indicating that the coronary NIR stent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with (un)stable angina pectoris.

Journal Article↗