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Antonio Colombo

Publications and source records attributed to Antonio Colombo.

At least 37 records · Page 2Linked to original sources
PubMed2006

Gadolinium-based contrast agents and nephrotoxicity in patients undergoing coronary artery procedures.

OBJECTIVE: We tested whether gadolinium-based contrast agent is less nephrotoxic than iodinated-contrast media. BACKGROUND: Iodinated contrast agents are nephrotoxic. Some data suggest that gadolinium-based contrast agent may be less nephrotoxic than iodinated-contrast media. METHODS: Twenty-five consecutive patients with chronic renal insufficiency (creatinine concentration > or = 2.0 mg/dl and/or clearance < or = 40 ml/min), referred to our institution for coronary procedures, were assigned to receive gadolinium-based contrast agents, a solution of gadolinium chelates diluted 3:1 by iso-osmolality contrast media (Gadolinium-based group). A control group of 32 patients with comparable clinical characteristics and treated with iodinated iso-osmolality contrast agent alone (Iodinated-based group) was selected from our database and compared with the Gadolinium-based group. In all cases, prophylactic administration of 0.45% saline intravenously and NAC (1200 mg orally twice daily) was used. RESULTS: Baseline creatinine levels and creatinine clearance were similar in the 2 groups (Gadolinium-based group = 2.30 [IQR: 2.01-2.68] mg/dl and 33 +/- 13 ml/min; Iodinated-based group = 2.24 [IQR: 2.05-2.65] mg/dl and 30 +/- 10 ml/min; P > 0.05 for all). Increase of at least 0.5 mg/dl of the creatinine concentration 48 hr after the procedure occurred in 7/25 (28%) patients in the Gadolinium-based group and in 2/32 (6.5%) patients in the Iodinated-based group (P = 0.034; OR = 4.48; 95% CI = 1.01-19.17). Renal failure requiring temporary dialysis occurred in 2 (8%) patients in the Gadolinium-based group and in none in the Iodinated-based group (P = 0.19). CONCLUSIONS: The strategy of gadolinium-based contrast agent administration does not seem to reduce the rate of CAN, as compared to the iodinated iso-osmolality contrast agent in patients with chronic renal insufficiency.

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PubMed2006

A novel approach to chronic total occlusions: the crosser system.

OBJECTIVES: To evaluate safety and efficacy of the CROSSER CTO Recanalization System (CROSSER). BACKGROUND: The CROSSER, a novel device dedicated to recanalization of chronic total occlusions (CTO), relies on a monorail catheter delivering vibrational energy to facilitate the crossing of occluded coronary arteries. METHODS: We included de novo or restenotic occlusions in native coronary arteries with typically unfavorable characteristics and a prior failed guidewire attempt either performed in a previous procedure or just before the usage of the CROSSER. The end points analyzed were technical success (ability to cross or facilitate a guidewire crossing into the true lumen), angiographic success (<20% residual stenosis and TIMI flow grade 3), and clinical success (angiographic success and freedom from major adverse cardiac events at 30 days). RESULTS: Twenty-eight patients (30 lesions) were included. The morphology was blunt in 83.3% and the length of the occlusion was >20 mm in 76.6%. The median age of the CTO was 9 months (range 3-60 months). Technical success was obtained in 19 (63%) occlusions and angiographic success in 16 (53%): 26.3% in lesions with prior procedural failure and 73.7% when CROSSER was attempted after initial guidewire failure. Complications were: one guidewire perforation without consequences and one peri-procedural myocardial infarction (MI). No events occurred within 30-day follow-up after discharge. CONCLUSIONS: In our experience, the CROSSER System is safe and increases the success of opening CTO refractory to guidewires. This novel device may represent an useful adjunct to the armamentarium of the interventional cardiologist.

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PubMed2006

Direct intramyocardial percutaneous delivery of autologous bone marrow in patients with refractory myocardial angina.

BACKGROUND: Intramyocardial injection of autologous bone marrow (ABM) may induce angiogenesis. We tested the safety and feasibility of catheter-based direct percutaneous intramyocardial delivery of ABM in patients with refractory angina pectoris. METHODS: Ten patients (9 men, 67 +/- 8 years) with refractory angina (Canadian Cardiovascular Society class III-IV) and documented myocardial ischemia were enrolled. After left ventricular electromechanical mapping, freshly aspirated and filtered ABM was percutaneously injected into target myocardial ischemic areas. Clinical symptoms (as assessed according to the Canadian Cardiovascular Society class), quality of life, and myocardial perfusion were evaluated before the procedure and through the follow-up. RESULTS: In all patients, ABM was successfully injected into the target regions. No periprocedural complications occurred. At 12 months, no major cardiac events (death, acute myocardial infarction, stroke, and malignant ventricular arrhythmias) occurred. Severity of angina improved of > or = 2 classes in 3 patients. Quality of life showed a significant improvement in all patients. Myocardial perfusion in the target regions improved in 4 of 8 patients. CONCLUSIONS: Direct percutaneous intramyocardial delivery of ABM appears feasible and safe. Further evaluation is warranted to test its clinical efficacy.

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PubMed2006

Clinical effectiveness of bare-metal stenting compared with balloon angioplasty in total coronary occlusions: insights from a systematic overview of randomized trials in light of the drug-eluting stent era.

BACKGROUND: We sought to compare, using meta-analytic techniques, bare-metal stent versus balloon angioplasty in the percutaneous treatment of total coronary occlusions by means of a quantitative systematic review and to indicate new avenues for future treatments. METHODS: MEDLINE and CENTRAL were searched. Inclusion criteria were random allocation, prospective comparison, and intention to treat. Random-effect odds ratios (ORs) with 95% confidence intervals (CIs) for death, myocardial infarction (MI), repeated revascularization, major adverse cardiac events (MACE), and angiographic restenosis and reocclusion were computed. RESULTS: Nine trials (1409 patients) were included. Death rate was not different in the 2 groups, 0.4% after stenting versus 0.7% after balloon angioplasty (OR 0.72, 95% CI 0.21-2.50). MI rate was significantly increased after stenting (6.7% vs 3.4%, OR 2.06, 95% CI 1.22-3.46), mainly because of a higher rate of periprocedural non-Q-wave MI. By contrast, the risk of repeated revascularization was significantly reduced by stenting (17% vs 32%, OR 0.41, 95% CI 0.31-0.53). This yielded to an overall reduction in the rate of MACE after stenting (23.2% vs 35.4%, OR 0.49, 95% CI 0.36-0.68). Angiographic restenosis and reocclusion were also decreased by stent (41.1% vs 60.9%, OR 0.36, 95% CI 0.23-0.57; 6.8% vs 16%, OR 0.36, 95% CI 0.22-0.59, respectively). CONCLUSIONS: In total coronary occlusions, stenting yields an important benefit over balloon angioplasty in reduction of MACE, repeated revascularizations, and angiographic restenosis and reocclusion. However, these events remain frequent. Moreover, the finding of an increased rate of periprocedural minor myocardial damage after stenting casts caution. New strategies aimed to reduce the need of repeated revascularizations and periprocedural MIs should be further investigated.

Angioplasty, Balloon, Coronary↗
PubMed2006

Elective versus provisional intraaortic balloon pumping in unprotected left main stenting.

BACKGROUND: Elective intraaortic balloon pump (IABP) may reduce acute complications during unprotected left main (ULM) stenting. However, few data exist on criteria for elective IABP support during ULM stenting. METHODS: Since January 1993, 219 consecutive patients underwent elective ULM stenting: 69 had elective IABP support (elective IABP group), whereas 150 patients had conventional procedure (conservative group). Criteria for elective IABP support were (1) lesion located in the distal segment of the left main (bifurcation lesion), (2) left ventricular ejection fraction <40%, (3) atherectomy, (4) unstable angina, and (5) critical disease of the right coronary artery. Incidence of intraprocedural major adverse cardiac events (eg, severe hypotension and/or shock, myocardial infarction, urgent bypass surgery, and death) was assessed. RESULTS: Euroscore >6 (identifying high-risk patients) occurred in 38% in the elective IABP group and 13% in the conservative group (P < .001). Severe hemodynamic instability occurred in 12 patients (8%) in the conservative group and in none in the elective IABP group (P = .020). Intraprocedural major adverse cardiac event was higher in the conservative group (9.5% vs 1.5%, P = .032). Elective IABP support (OR 0.08, 95% CI 0.01-0.69, P = .022) and presence of Euroscore >6 plus bifurcation lesion (OR 5.49; 95% CI 1.47-20.51; P = .011) were the independent predictors of intraprocedural events. CONCLUSIONS: Elective IABP may prevent intraprocedural events in elective ULM stenting, especially in patients at higher risk.

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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

An overview of the TAXUS Express, paclitaxel-eluting stent clinical trial program.

Restenosis remains a problem following percutaneous coronary intervention in patients with coronary artery disease. Drug-eluting stents (DES), which combine mechanical and pharmacologic properties, have been shown to prevent or reduce neointimal growth after deployment. This review describes the TAXUS paclitaxel-eluting stent clinical trial expansion program (TAXUS Express, Boston Scientific, Natick, MA). This program comprises the largest data set of randomized controlled trials (RCTs) of DES to date, with over 6,200 patients enrolled since 2000. The program includes treatment of de novo lesions, as well as higher-risk lesion and patient populations. In this review, we discuss the results from the TAXUS family of randomized clinical trials, and compare the findings with data from TAXUS registries. The data from the randomized clinical trials suggest that the paclitaxel-eluting stent provides consistent and durable benefits across multiple lesion and patient types. Evidence from peri-and post-approval registries, where patient populations are more heterogeneous than those eligible and included in the RCTs, corroborate these findings, with overall low rates of cardiac events, including reinterventions.

Angioplasty, Balloon, Coronary↗
PubMed2006

Sandwich drug-eluting stenting: a novel method to treat high-risk coronary lesions.

OBJECTIVES: To describe a novel approach to drug-eluting stent (DES) implantation, the sandwich technique, comprised of the simultaneous implantation of two completely overlapping DES in the same target lesion. BACKGROUND: DES effectively prevent restenosis in selected coronary lesions. However, adverse lesion characteristics may detrimentally affect outcomes after DES implantation by means of plaque prolapse, recoil or excessive neointimal hyperplasia. METHODS: From July 2002 to November 2004, the sandwich technique was performed in 10 patients with very high-risk lesions. Two DES of identical size and length were implanted, one inside the other, with almost complete overlap. High-pressure postdilatation (up to 28 atm) was carried out in 6 cases. The endpoints of this preliminary evaluation were: technical feasibility, early (30-day) safety, restenosis rate and freedom from adverse events at 9-month follow up. RESULTS: Procedural and angiographic success was achieved in all cases. At follow-up, there were no deaths, myocardial infarctions or stent thromboses. All patients underwent angiographic follow-up; target lesion revascularization was carried out in 3 patients (30%). Of note, in no case was there evidence of aneurysmal remodeling. CONCLUSIONS: This study suggests that implanting 2 DES, one inside the other in a sandwich fashion, is feasible and apparently safe. This approach could be considered in situations such as plaque prolapse or stent recoil where additional scaffolding may be needed.

Adult↗
PubMed2006

[Non-pharmacological treatment of hypertrophic obstructive cardiomyopathy guided by echocardiography].

As a relevant cause of symptoms and adverse clinical prognosis, left ventricular obstruction should be regarded as an important therapeutic target in patients with hypertrophic obstructive cardiomyopathy. The surgical approach (including septal myectomy or mitral valve surgery) and percutaneous transluminal septal myocardial ablation offer a non-pharmacological option for the treatment of symptomatic left ventricular obstruction and symptoms unresponsive to medical treatment. The surgical approach is established as an effective strategy for relieving symptoms from dynamic obstruction. Percutaneous septal ablation, on the other hand, has only recently been introduced into clinical practice and, despite its efficacy as an obstructive abolisher, little is known about the prognostic long-term impact of procedural-induced myocardial damage. Due to its accuracy and diagnostic versatility, including intraprocedural use, Doppler echocardiography provides essential information for the planning and monitoring of non-pharmacological therapy in patients with hypertrophic obstructive cardiomyopathy.

Angioplasty, Balloon, Coronary↗
PubMed2006

High-frequency mechanical vibration to recanalize chronic total occlusions after failure to cross with conventional guidewires.

BACKGROUND: Crossing chronic total occlusions (CTO) of coronary arteries continues to challenge interventional cardiologists. A clinical study was undertaken in four European centers to examine the feasibility of using the new CROSSER system that utilizes high-frequency mechanical vibration to penetrate atherosclerotic plaque material to cross CTOs in patients where conventional guidewire techniques had failed. The objective of the study was to determine whether the CROSSER system could safely cross such CTOs. PATIENTS AND METHODS: A total of 55 CTO lesions in 53 patients were treated in two clinical phases: (1) Phase 1 feasibility study (30 CTOs), with a primary focus on device safety; and (2) Phase 2 pivotal study (25 CTOs) using an improved version of the device, with a primary focus on effectiveness. RESULTS: The primary endpoint of device efficacy and the secondary endpoint of clinical success were both 76% (19 of 25) in the pivotal study phase. No major adverse cardiac events of death, Q-wave myocardial infarction or target lesion revascularization (by either coronary artery bypass graft surgery or percutaneous coronary intervention) were observed through 30-day follow up. No coronary perforation or pericardial tamponade occurred. CONCLUSIONS: The CROSSER system is a safe device that can cross many occlusions after a conventional guidewire failure. With additional refinement and improvements to the device, this success rate could be further increased.

Adult↗
PubMed2005

Relation of various plasma growth factor levels in patients with stable angina pectoris and total occlusion of a coronary artery to the degree of coronary collaterals.

We assessed (1) angiogenic factors in patients with stable angina and longstanding (> or =24 months) total occlusion of a single coronary artery and (2) the relation between plasma levels of angiogenic factors and the development of collateral vessels as evaluated by coronary angiography. Plasma concentrations of vascular endothelial growth factor (VEGF(165)), fibroblast growth factor, placenta-derived growth factors (PlGFs), and hepatocyte growth factor were assessed in 96 patients with stable angina and longstanding (> or =24 months) total occlusion of a single coronary artery. According to coronary angiographic results, 18 patients had no visible collaterals (group 0), 21 patients had visible collaterals but no filling of the recipient epicardial vessel (group 1), and 57 patients showed filling (partial or complete) of the recipient epicardial vessel by collaterals (group 2). Plasma VEGF(165) and PlGF concentrations were higher in group 1 than in groups 0 and 2 (VEGF(165) 75 pg/ml, range 24 to 105, vs 23 pg/ml, range 15 to 29, and 19 pg/ml, range 10 to 41, respectively, F = 5.53, p = 0.006; PlGF 35 pg/ml, range 3.5 to 105, vs 1 pg/ml, range 1 to 38, and 1 pg/ml, range 1 to 5, respectively, F = 7.09, p = 0.008). Plasma VEGF(165) and PlGF levels were similar in groups 0 and 2. There was no significant difference in plasma levels of fibroblast and hepatocyte growth factor concentrations across the 3 groups. In conclusion, plasma levels of angiogenic growth factors differ among patients with stable angina pectoris and longstanding total coronary occlusion.

Aged↗
PubMed2005

Peristent remodeling and neointimal suppression 2 years after polymer-based, paclitaxel-eluting stent implantation: insights from serial intravascular ultrasound analysis in the TAXUS II study.

BACKGROUND: The purpose of this study was to evaluate long-term vascular responses as long as 2 years after implantation of polymer-based, paclitaxel-eluting stents in contrast to uncoated stents. METHODS AND RESULTS: TAXUS II is a randomized, double-blind trial comparing slow-release (SR) and moderate-release (MR) TAXUS stents with bare-metal control stents (BMSs). One hundred sixty-one event-free patients (SR, 43; MR, 41; and BMS, 77) underwent serial intravascular ultrasound (IVUS) analysis after the procedure and at 6 months and 2 years. At 2 years, neointimal responses continued to be significantly suppressed in the SR and MR groups when compared with the BMS group (BMS, 1.49+/-1.12 mm2; SR, 0.94+/-0.76 mm2 [P=0.004]; and MR, 1.06+/-0.90 mm2 [P=0.02]). Between 6 months and 2 years, the BMS group showed compaction of the neointima (Delta, -0.22+/-1.05 mm2 [P=0.08]). In contrast, both the SR and MR groups exhibited an increase (Delta SR, 0.30+/-0.76 mm2 (P=0.01); MR, 0.41+/-0.94 mm2 [P=0.009]). Between 6 months and 2 years, the initial increase in plaque outside the stent regressed in the BMS and SR groups to levels comparable to those after the procedure, whereas expansive remodeling partially regressed in the MR group (Delta between after the procedure and 2 years BMS, -0.34+/-1.28 mm2 [P=0.05]; SR, -0.02+/-1.40 mm2 [P=0.93]; MR, 0.32+/-1.56 mm2 [P=0.27]). CONCLUSIONS: The 2-year follow-up demonstrates that neointimal suppression was dose independent and that this effect was still sustained at 2 years. However, the increase in area outside the stent seen at 6 months regressed to different extents in a dose-dependent manner at 2 years.

Aged↗
PubMed2005

Early outcome of treatment of ostial de novo left anterior descending coronary artery lesions with drug-eluting stents.

We investigated early and mid-term clinical and angiographic outcomes of patients who had de novo ostial left anterior descending coronary artery (LAD) lesions that were treated with drug-eluting stents (DESs) or bare metal stents (BMSs). We identified 43 consecutive patients who underwent percutaneous intervention for isolated de novo ostial LAD lesions with implantation of DESs and compared them with 43 patients who had similar lesions that were treated with BMSs. All stents were successfully implanted. There were no significant differences with respect to major in-hospital complications between the 2 groups. One patient in the BMS group died during hospitalization. Non-Q-wave myocardial infarction occurred in 2 patients (4.7%) in the DES and in 1 patient (2.3%) in the BMS group. At 9-month follow-up, 3 patients (7%) in the DES group and 11 (25.6%) in the BMS group underwent target lesion revascularization (p = 0.038); major adverse cardiac events were less frequent in the DES than in the BMS group (9.3% vs 32.6%, p = 0.015). Angiographic follow-up was available in 82% of patients in the DES group and 75% of those in the BMS group (p = 0.6) and showed lower binary restenotic rates (5.7% vs 31.3%, p = 0.01) and smaller late loss (0.30 +/- 0.81 vs 1.23 +/- 0.93 mm, p = 0.0001) in the DES group. In conclusion, DES implantation in de novo ostial LAD lesions appears safe and effective and is associated with a significant decrease in restenotic rates compared with historical experience with BMSs.

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