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Biomedical subjects

Flavio Airoldi

Publications and source records attributed to Flavio Airoldi.

At least 55 records · Page 3Linked to original sources
PubMed2004

N-Acetylcysteine versus fenoldopam mesylate to prevent contrast agent-associated nephrotoxicity.

OBJECTIVES: We performed a study to assess the efficacy of fenoldopam mesylate (a specific agonist of the dopamine-1 receptor) as compared with N-acetylcysteine (NAC) in preventing contrast agent-associated nephrotoxicity (CAN). BACKGROUND: Prophylactic administration of NAC, along with hydration, prevents CAN in patients with chronic renal insufficiency who are undergoing contrast media administration. Preliminary data support the hypothesis that fenoldopam might be as effective as NAC. METHODS: One hundred ninety-two consecutive patients with chronic renal insufficiency, referred to our institution for coronary and/or peripheral procedures, were assigned randomly to receive 0.45% saline intravenously and NAC (1,200 mg orally twice daily; NAC group; n = 97) or fenoldopam (0.10 microg/kg/min; fenoldopam group; n = 95) before and after a nonionic, iso-osmolality contrast dye administration. RESULTS: Baseline creatinine levels were similar in the two groups: NAC group = 1.72 mg/dl (interquartile range, 1.55 to 1.90 mg/dl) and fenoldopam group = 1.75 mg/dl (interquartile range, 1.62 to 2.01 mg/dl) (p = 0.17). An increase of at least 0.5 mg/dl of the creatinine concentration 48 h after the procedure occurred in 4 of 97 patients (4.1%) in the NAC group and in 13 of 95 patients (13.7%) in the fenoldopam group (p = 0.019; odds ratio 0.27; 95% confidence interval 0.08 to 0.85). The amount of contrast media administration was similar in the two groups (NAC group = 160 +/- 82 ml; fenoldopam group = 168 +/- 104 ml; p = 0.54). CONCLUSIONS: N-acetylcysteine seems to be more effective than fenoldopam in preventing CAN.

Acetylcysteine↗
PubMed2004

Effectiveness of sirolimus-eluting stent implantation for treatment of in-stent restenosis after brachytherapy failure.

The impact of the use of sirolimus-eluting stents (SESs) in the treatment of in-stent restenosis in previously irradiated sites has not been adequately evaluated. Fifteen consecutive patients who underwent percutaneous coronary interventions using SESs in lesion sites previously intervened with intracoronary radiation therapy were identified. All stents were implanted successfully, and there were no major in-hospital complications. At 30-day follow-up, there was 1 case of subacute thrombosis that led to target lesion revascularization (TLR). At 6 months, 2 patients underwent TLR because of recurrent angina with angiographic restenosis, and 1 patient underwent target vessel revascularization distally to the SES site; no other major adverse cardiac events occurred at long-term follow-up (mean 17 +/- 8 months).

Adult↗
PubMed2004

Creatine kinase-myocardial band isoenzyme elevation after percutaneous coronary interventions using sirolimus-eluting stents.

We evaluated predictors of increased periprocedural creatine kinase-MB isoenzyme levels after implantation of sirolimus-eluting stents with an intent to fully cover the diseased segment. The total stent length per patient (predisposing factor) and elective use of glycoprotein IIb/IIIa (protective factor) were independent predictors of increased creatine kinase-MB isoenzyme levels.

Angioplasty, Balloon, Coronary↗
PubMed2004

Intraprocedural stent thrombosis during implantation of sirolimus-eluting stents.

BACKGROUND: Intraprocedural stent thrombosis (IPST) is a rare event (<0.01% in our experience with bare metal stents), with the exception of specific settings such as acute myocardial infarction, thrombus-containing lesions, and dissections. We report the occurrence of this event during elective implantation of sirolimus-eluting stents. METHODS AND RESULTS: Between April 2002 and August 2003, 670 patients with 1362 lesions were treated with Cypher (Cordis, Johnson and Johnson Co) sirolimus-eluting stent implantation in San Raffaele Hospital and EMO Centro Cuore Columbus. Diabetes mellitus was present in 142 patients (21%), and 164 (24.5%) had unstable angina. Pretreatment with glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors was carried out in 235 patients (35%). Total stent length per vessel was 42.9+/-28.3 mm. IPST occurred in 5 patients (0.7%). None of the patients with IPST were pretreated with GP IIb/IIIa inhibitors. Using univariate exact logistic regression, only total stent length per vessel, in millimeters (exact OR, 1.03; 95% CI, 1.011 to 1.046; P=0.0028), was associated with the occurrence of IPST. CONCLUSIONS: Stent length was associated with the occurrence of IPST. Particular attention will need to be directed to this potential complication when long sirolimus-eluting stents are being used.

Adult↗
PubMed2004

Treatment of multivessel coronary artery disease with sirolimus-eluting stent implantation: immediate and mid-term results.

OBJECTIVES: This study evaluated clinical outcome after multivessel stenting with sirolimus-eluting stents (SES) in unselected lesions. BACKGROUND: Safety and effectiveness of multivessel SES implantation is currently unknown. METHODS: Major adverse cardiac events (MACE) (death, myocardial infarction [MI], and repeat revascularization) were analyzed at 30 days and at 6 months after multivessel SES implantation. RESULTS: In 155 consecutive patients, 573 SES were implanted in 3.3 +/- 1.3 lesions per patient. At 30 days, the cumulative MACE rate was 10.3%: 7.1% patients developed a non-Q-wave MI, 1.9% developed a Q-wave MI, 0.6% died for non-cardiac reasons, and 0.6% had a repeat revascularization. Clinical follow-up was obtained in all 112 eligible patients treated for 359 lesions at a mean time of 6.5 +/- 2.2 months. The cumulative MACE rate was 22.3%: 3 (2.7%) deaths (1 for cardiac reasons), 4 (3.6%) MIs, target lesion revascularization (TLR) in 16 (14.3%) patients with 24 (6.7%) lesions. Target vessel revascularization was required in 18 (16.1%) patients due to TLR of lesions treated with SES or to disease progression (1.8% of patients). Cox regression analysis revealed total stent length per patient as the most powerful independent predictor of MACE. Overall stent thrombosis occurred in three (1.9%) patients. CONCLUSIONS: Multivessel SES implantation can be safely performed on patients with complex coronary artery disease. The need for revascularization increases because of the cumulative effect of TLR on patients with multiple lesions.

Aged↗
PubMed2004

Comparison of diamond-like carbon-coated stents versus uncoated stainless steel stents in coronary artery disease.

Stainless steel (SS) and carbon-coated (CC) stents were randomly compared in 347 patients (520 lesions). No differences were observed in in-hospital major adverse cardiac events: 2.8% in the CC group and 4.5% in the SS group (p = 0.286). The 6-month follow-up showed similar rates of binary restenosis (31.8% in the CC group vs 35.9% in the SS group; p = 0.448) and of cumulative major adverse cardiac events (30.5% in the CC group vs 32.7% in the SS group; p = 0.675). In unselected patients and lesions, carbon coating does not provide significant improvements over SS stents with the same design.

Carbon↗
PubMed2004

Incidence, predictors, in-hospital, and late outcomes of coronary artery perforations.

We sought to determine the incidence of coronary perforations, predisposing factors, and in-hospital and late outcome of patients with coronary perforations. Perforations occurred in 0.84% of treated lesions and more frequently in patients with complex lesions after atheroablative procedures and who underwent intravascular ultrasound guided lumen optimization. The incidence of adverse events, emergency coronary artery bypass grafting and death significantly decreased over time.

Causality↗
PubMed2004

Combined Abciximab REteplase Stent Study in acute myocardial infarction (CARESS in AMI).

BACKGROUND: Most patients with acute myocardial infarction (AMI) are admitted to hospitals without percutaneous transluminal coronary angioplasty (PTCA) facilities or are initially managed in a prehospital mobile unit. Thrombolysis remains the most readily available reperfusion treatment in those settings, but the optimal subsequent strategy in those patients is unclear. If a mechanical recanalization is likely to be performed in an emergency, it is probably desirable that the patient receives abciximab, the glycoprotein IIb/IIIa antagonist with the strongest evidence of benefit for angioplasty in AMI. OBJECTIVE: The aim of this trial is to compare the effects on clinical outcome and cost-effectiveness of 2 strategies after immediate treatment with abciximab and half-dose reteplase for ST-elevation AMI: to manage the patients conservatively (referring them for rescue PTCA only if needed) or to immediately send all patients for emergency coronary angioplasty. METHODS: The Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction (CARESS in AMI) is an open, prospective, randomized, multicenter clinical trial conducted in patients with high-risk ST-segment elevation AMI treated within 12 hours from symptom onset in hospitals without PTCA facilities or in a prehospital mobile intensive care unit. Apart from contraindications to thrombolysis, the main exclusion criteria are age > or =75 years and a past history of CABG surgery or a percutaneous coronary intervention procedure involving the infarct-related artery. Enrollment will be performed in hospitals without PTCA facilities or directly in the ambulance if a dedicated system is in place for prehospital diagnosis and treatment of AMI. Patients will receive half-dose reteplase and full-dose abciximab and will subsequently be randomized to conventional medical therapy (with referral for emergency rescue PTCA allowed in selected cases) or emergency angioplasty. The primary end point is the 30-day combined incidence of mortality, reinfarction, and refractory ischemia. In order to obtain a 95% power (2-sided) to detect a 42% reduction in the primary end point, 900 patients are required in each arm of the study. Secondary end points include the 1-year composite end point of mortality, reinfarction, refractory ischemia, and hospital readmission because of heart failure; resource use at 30 days and 1 year; and the incidence of inhospital stroke and bleeding complications in the 2 groups. RESULTS: Seventy-four patients have been randomized (as of March 10, 2004); results are expected in June 2005. CONCLUSION: This study will establish whether angioplasty must be started as soon as possible in all patients who receive combined pharmacologic reperfusion with the glycoprotein IIb/IIIa inhibitor abciximab and half-dose thrombolysis or whether it can be postponed or skipped in patients with signs of successful reperfusion, with obvious organizational advantages.

Abciximab↗
PubMed2004

Statin administration before percutaneous coronary intervention: impact on periprocedural myocardial infarction.

AIMS: Peri-procedural non-Q-wave myocardial infarction is a frequent and prognostically important complication of percutaneous coronary intervention (PCI). It has been postulated that statins may reduce the rate of myocardial injury after PCI. METHODS AND RESULTS: Four hundred and fifty-one patients scheduled for elective PCI and not on statins were randomly assigned to either no treatment or to statin treatment. Statin administration was started at least 3 days before the procedure.Incidence of peri-procedural myocardial injury was assessed by analysis of creatinine kinase myocardial isoenzyme (CK-MB: upper limit of normal [ULN] 3.5 ng/ml) and cardiac troponin I (cTn I, ULN 0.10 ng/ml) before, 6 and 12 h after the intervention. A large non-Q-wave myocardial infarction was defined as a CK-MB elevation >5 times ULN alone or associated with chest pain or ST segment or T wave abnormalities. Median CK-MB peak after PCI was 1.70 (interquartile ranges 1.10-3.70) ng/ml in the Statin group and 2.20 (1.30-5.60) ng/ml in the Control group (p=0.015). Median peak of cTnI after PCI was 0.13 (0.05-0.45) ng/ml in the Statin group and 0.21 (0.06-0.85) ng/ml in the Control group (p=0.033). The incidence of a large non-Q-wave myocardial infarction was 8.0% in the Statin group and 15.6% in the Control group (p=0.012: OR=0.47; 95% CI=0.26-0.86). The incidence of cTnI elevation >5 times ULN was 23.5% in the Statin group and 32% in the Control group (p=0.043: OR=0.65; 95% CI=0.42-0.98). By logistic regression analysis, the independent predictors of CK-MB elevation >5 times ULN after PCI were intra-procedural angiographic complications (OR=9.36; 95% CI=3.06-28.64; p<0.001), statin pre-treatment (OR=0.33; 95% CI=0.13-0.86; p=0.023) and age >65 years (OR=2.58; 95% CI=1.09-6.11; p=0.031). CONCLUSIONS: Pre-procedural statin therapy reduces the incidence of large non-Q-wave myocardial infarction after PCI.

Angioplasty, Balloon, Coronary↗
PubMed2004

Endovascular stenting for stenoses in surgically reconstructed brachiocephalic bypass grafts: immediate and midterm outcomes.

PURPOSE: To report the use of endovascular stenting for treatment of patients with symptomatic obstruction of brachiocephalic surgical reconstructions. METHODS: Twenty-two patients (17 men; mean age 65+/-6 years) with 24 symptomatic obstructions of brachiocephalic Dacron bypass grafts (2 aorto-innominate, 9 subclavian-carotid, and 11 carotid-subclavian) were treated with balloon-expandable stents delivered via a percutaneous brachial access or surgical exposure of the common carotid artery. A distal protection device was utilized in the 9 patients with subclavian-carotid bypass grafts. All patients were followed by clinical and Doppler examinations. RESULTS: Procedural success was 100%; 1 (4.5%) patient developed transient intraprocedural aphasia owing to intolerance to the distal protection balloon occlusion. All 22 patients reported complete relief of their presenting symptoms. Over a 29-month follow-up, 3 (13.6%) restenoses were found, but none was due to stent compression. CONCLUSIONS: Stenting for obstructed brachiocephalic reconstructions appears to be a safe, effective, and durable therapeutic strategy.

Aged↗
PubMed2003

Effectiveness of treatment of in-stent restenosis with an 8-French compatible atherectomy catheter.

The study reports the results of directional atherectomy with an 8Fr guiding catheter-compatible atherectomy catheter in a series of 31 in-stent restenotic lesions. This preliminary experience indicates a favorable safety profile, with events limited to non-Q-wave myocardial infarction occurring in 3.6% of patients. The secondary end point regarding the incidence of angiographic restenosis at 6 months showed a high restenosis rate (65%).

Aged↗
PubMed2003

Preliminary observations regarding angiographic pattern of restenosis after rapamycin-eluting stent implantation.

BACKGROUND: Restenosis after implantation of drug-eluting stents (DES) is a rare phenomenon, occurring more frequently peri-stent. METHODS AND RESULTS: We evaluated the pattern of restenosis occurring after implantation of DES in unselected lesions. From April 15 to December 6, 2002, we treated 368 patients with 735 lesions by using 841 rapamycin-eluting stents (Cypher, Cordis, a Johnson & Johnson Company). Mean baseline lesion length was 17.48+/-12.19 mm, and mean stent length was 27.59+/-14.02 mm. Follow-up ischemia-driven angiography was performed in 24 patients. Eleven patients had angiographic restenosis (> or =50% diameter stenosis) in 14 stented segments (stent and 5 mm proximal and distal to the stent). The pattern of restenosis in all 14 stented segments was focal, and in 6 of them it was multifocal, occurring inside the stents. Mean length of restenotic lesions was 5.62+/-1.90 mm, with a range from 2.54 to 8.44 mm. One multifocal restenosis involved also the distal stent margin. Intravascular ultrasound evaluation at follow-up, performed in 2 patients, showed significant lumen obstruction attributable to in-stent hyperplasia in both cases. Individual cases can be viewed in the Data Supplement. CONCLUSIONS: The pattern of restenotic lesions after rapamycin-eluting stent implantation was focal and mostly inside the stent.

Aged↗
PubMed2003

Modified T-stenting technique with crushing for bifurcation lesions: immediate results and 30-day outcome.

We report a new stenting technique employed in 20 consecutive patients to treat true bifurcation lesions using the Cypher stent (Cordis, Warren, NJ). Both stents are advanced at the site of the bifurcation. The proximal marker of the side-branch stent must be situated in the main branch at a distance of 4-5 mm proximal to the carina of the bifurcation and the main branch stent must cover the bifurcation as well as the protruding segment of the side-branch stent. The side-branch stent is deployed first and balloon and wire are removed. The stent deployed in the main branch completely covers and crushes the protruding segment of the side branch stent against the vessel wall of the main branch. Following main- and side-branch predilatation, stents were successfully deployed in all lesions. Final kissing balloon inflation was performed in seven patients. Two patients had in-hospital myocardial infarction and one patient underwent in-hospital re-PTCA due to a dissection distal to a stent. No other major adverse cardiac events were observed in-hospital and during 1-month clinical follow-up. Treatment of bifurcation lesions using crushing stent technique is feasible with acceptable rate of procedural complications. Angiographic follow-up is necessary to prove the advantage of this specific technique to give complete coverage of the ostium of the side branch with a drug-eluting stent.

Angioplasty, Balloon, Coronary↗
PubMed2003

Initial experience with a new 8 French-compatible directional atherectomy catheter: immediate and mid-term results.

The purpose of this study was to evaluate the safety and efficacy of the new Fox Hollow atherectomy device (FHT) designed for more efficient and easier plaque removal. The FHT has short rigid section and low-profile cutter mounted on a monorail catheter. The FHT catheter was utilized in 77 patients with 98 lesions. Mean reference vessel diameter was 2.75 +/- 0.51 mm. Successful atherectomy with tissue retrieval was performed in 94 lesions (96%). Following atherectomy, mean diameter stenosis was reduced from 71.1% to 31.9% and further to 10.4% following adjunctive treatment. Angiographic complications were one coronary perforation and one adventitial staining, both successfully treated with prolong balloon inflation and stent implantation. Nine patients (11.7%) had in-hospital non-Q-wave myocardial infarction (MI). One patient died (1.3%) for noncardiac reasons and one had MI (1.3%) at 6-month follow-up. Target lesion revascularization was required in 13 (13.8%) lesions and target vessel revascularization in 15 (20.3%) patients. There was target vessel failure in 17 (23.0%) patients. Plaque debulking with the FHT catheter can be performed safely and effectively in relatively small vessels and complex lesions located in mid-distal artery segments with 6-month clinical outcome similar to prior atherectomy devices.

Aged↗
PubMed2003

Elective versus provisional intra-aortic balloon pumping in high-risk percutaneous transluminal coronary angioplasty.

BACKGROUND: Elective intra-aortic balloon pump (IABP) support may reduce acute complications occurring during percutaneous coronary interventions (PCI) in patients with severe depression of the left ventricular ejection fraction (EF < or = 30%). METHODS: Since February 1998, 133 consecutive patients with EF < or =30% underwent elective PCI in our institution; 61 had elective preprocedural IABP support (group A) and 72 patients had conventional PCI (group B). Jeopardy score was calculated in each patient from the coronary angiograms to quantify the myocardium at risk. RESULTS: EF was similar in the 2 groups. Jeopardy score was higher in group A (8.0 +/- 2.8 vs 6.7 +/- 2.4, P =.008). The other principal clinical and angiographic characteristics were similar in the 2 groups. Severe hypotension and/or shock occurred in 11 patients, all in group B (P =.001). All required urgent IABP support, and 3 eventually died. Intraprocedural major adverse cardiac and cerebral events (eg, myocardial infarction, severe hypotension and/or shock, urgent bypass surgery, stroke, and death) were higher in group B (17% vs 0%, P =.001). By stepwise logistic regression analysis, elective IABP support (odds ration [OR] 0.11 [95% CI 0.21-0.60], P =.011), jeopardy score (OR 5.37 [95% CI 1.10-8.70], P =.040), and female sex (OR 2.72 [95% CI 1.85-3.10], P =.015), were the correlates of intraprocedural events. CONCLUSIONS: This study supports the potential usefulness of elective versus provisional IABP to prevent intraprocedural major adverse cardiac and cerebral events in high-risk PCI.

Aged↗
PubMed2003

Regional thrombolytic therapy and stent implantation in an acutely occluded aortobifemoral bypass graft.

PURPOSE: To present a case highlighting the efficacy of local thrombolysis followed by stent implantation in acute occlusion of an aortobifemoral bypass graft. CASE REPORT: A 47-year-old man was referred to our catheterization laboratory for acute bilateral limb ischemia occurring 18 hours after an aortobifemoral bypass procedure. Angiography documented total occlusion due to massive thrombosis of the grafts. After 24 hours of local thrombolysis, repeat angiography showed complete lysis of the thrombus and an intimal flap in the abdominal aorta. A Palmaz stent was successfully implanted to cover the flap and restore adequate flow. At 1 year, the patient remains asymptomatic, and angiography showed patency of both the stent and the grafts. CONCLUSIONS: Based on this patient's response, local thrombolysis followed by stenting may be a safe and effective alternative to reoperation for the treatment of acute graft thrombosis caused by an intimal aortic flap. More experience with this approach is necessary to determine if this is an acceptable and effective mode of treatment.

Acute Disease↗
PubMed2003

A randomized comparison of direct stenting versus stenting with predilatation in native coronary artery disease: results from the multicentric Crosscut study.

Stenting without predilatation has become possible due to the availability of a new generation of flexible, low-profile, securely crimped, balloon-expandable stents. This study compared the feasibility, efficacy and cost-effectiveness of direct stenting (DS) to the standard predilatation technique (PS) using the premounted Crossflex LC stent (Cordis Corporation, Miami Lakes, Florida). The study is a randomized prospective multicenter evaluation including 271 patients (140 patients in the DS group and 131 patients in the PS group) with 1 or 2 de novo or restenotic lesions located in native coronary arteries. Procedural success was 98.9% and 98.7% in the DS and PS groups, respectively (p = NS); crossover to PS was required in 22/166 lesions (13.2%) enrolled in the DS group because of inability to cross the target lesion without predilatation. Nonsignificant reductions in procedural time (-10.5%), fluoroscopy time (-4.7%) and amount of contrast (-3.8%) were observed in the DS group in comparison to the PS group. The number of balloons used (-76.6%) and the global cost of the procedure (-18.8%) were significantly lower in the DS group (p < 0.01 for both comparisons). After 6 months, no differences were observed in the restenosis rate between the two groups (22.0% for DS group versus 18.1% for PS group; p = NS) and in the incidence of major adverse clinical events (5.0% for DS group versus 3.0% for PS group; p = NS). Direct stenting is safe and feasible for the treatment of lesions in native coronary arteries and obtains a significant reduction in procedural cost, mainly due to the lower number of balloons used. Clinical and angiographic results at 6 months are comparable to those obtained after a conventional predilatation-stenting strategy.

Catheterization↗