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Biomedical subjects

Carlo Di Mario

Publications and source records attributed to Carlo Di Mario.

At least 37 records · Page 2Linked to original sources
PubMed2004

Routine use of cerebral protection during carotid artery stenting: results of a multicenter registry of 753 patients.

PURPOSE: To evaluate the short-term outcome of patients who underwent carotid stenting with the routine use of cerebral protection devices. METHODS: In five centers, 808 successful stent procedures (of 815 attempted) were performed in 753 patients (557 [74%] men; mean [+/- SD] age, 70 +/- 8 years). Cerebral protection involved distal filter devices (n=640), occlusive distal balloons (n=144), or proximal balloon protection (n=24). RESULTS: The protection device was positioned successfully in 793 (98.2%) of the 808 attempted vessels. Neurologic complications occurred within 30 days after 46 procedures (5.6%), including seven major strokes, 17 minor strokes, and 22 transient ischemic attacks. There were four deaths (one following a major stroke). The 30-day incidence of stroke and death was 3.3% (27/815). The rate of stroke or death was 3.8% (8/213) for symptomatic lesions and 3.2% (19/602) for asymptomatic lesions (P=0.87), and 3.4% (25/729) in patients aged <80 years and 2% (2/86) in those aged > or =80 years (P=0.81). Protection device-related vascular complications, none of which led to neurologic symptoms, occurred after nine procedures (1.1%). CONCLUSION: In this uncontrolled study, routine cerebral protection during carotid artery stenting was technically feasible and clinically safe. The incidence of major neurologic complications in this study was lower than in previous reports of carotid artery stenting without cerebral protection.

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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

Feasibility and cost of treatment with drug eluting stents of surgical candidates with multi-vessel coronary disease.

OBJECTIVE: To determine the feasibility and cost of treatment with drug eluting stents in patients with multi-vessel coronary disease referred currently for surgical revascularisation. METHODS: Two experienced interventional cardiologists reviewed retrospectively the clinical records and pre-operative coronary angiograms of 209 patients who underwent their first coronary bypass operation for multi-vessel disease without other adjunctive surgical procedures at the Royal Brompton Hospital in 2002. They were classified according to the technical feasibility and completeness of percutaneous revascularisation. A cost decision-analysis model with a cost of drug eluting stents of euro 2,100 and simulated 1-year costs was constructed. RESULTS: Mean age was 64.6+/-8.9 years with 54 diabetics (25.8%). Each patient received at least 1 arterial graft and a mean of 3.0+/-0.8 distal anastomoses. Mean post-operative stay was 8.9+/-7.2 days and total cost euro 19,821+/-1,964. Percutaneous revascularisation was judged to be feasible in 158 (76%) cases. The contraindications were at least 1 unfavourable total occlusion subtending viable myocardium in 48 patients (23%) and extreme tortuosity or calcification in 4 patients (2%). Percutaneous revascularisation of grafted major epicardial vessels was anticipated to be complete in 138 (66%) patients and partial but acceptable in 19 (9.1%) patients. Stenting of the left main, of a 'favourable' total occlusion, of bifurcations or in an ostial location would have been required in 32 (20.4%), 60 (38.2%), 77 (49.0%) and 74 (47.1%), respectively, of cases treated. 3.6+/-1.4 drug eluting stents of total length 72.6+/-37.3 mm were required to treat 3.3+/-1.2 lesions per patient at an estimated cost of euro 17,266+/-2,850. When one year repeat revascularisation was modelled at a rate of 15% in the stent group there was no significant cost saving from stenting. CONCLUSIONS: Although percutaneous revascularisation is feasible in 76% of patients currently undergoing coronary artery bypass grafting for multi-vessel disease, such an approach will involve frequent treatment of complex lesions for which no long term results are available and is unlikely to provide appreciable economic savings.

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PubMed2004

Single vs multivessel treatment during primary angioplasty: results of the multicentre randomised HEpacoat for cuLPrit or multivessel stenting for Acute Myocardial Infarction (HELP AMI) Study.

DESIGN: Prospective randomized, multicentre study. RATIONALE: Recanalisation of the culprit lesion is the main goal of primary angioplasty for acute myocardial infarction. With the exception of cardiogenic shock, staged procedures are performed in the presence of multivessel disease. The study hypothesis is that with modern non-thrombogenic stents (heparin coated) complete revascularization with multivessel treatment can be safely achieved during the primary angioplasty procedure with a lower need of subsequent revascularization procedures and at a lower cost. ENDPOINTS: PRIMARY: 12-month incidence of repeat revascularization (any revascularization, infarct related artery as well as non-infarct-related artery). SECONDARY: (1) in hospital repeat revascularization, reinfarction and death; (2) total hospital cost (including a 12 months follow-up period). METHODS: 69 patients with ST elevation Acute Myocardial Infarction (AMI), <12 hours after symptoms onset, undergoing primary angioplasty, with documented multivessel disease and both culprit lesion and 1 to 3 other lesions suitable for stent implantation. Unbalanced randomization between culprit lesion treatment only (n = 17) and complete multivessel treatment (n = 52, with 71 additional lesions treated). RESULTS: The two groups were well balanced in terms of clinical characteristics, number of diseased vessels and angiographic characteristics of the culprit lesion. In the complete multivessel treatment group 2.36 +/- 0.64 lesions per patient were treated using 2.73 +/- 0.78 heparin coated stents (1.00 lesions and 1.29 +/- 0.61 stents in the culprit treatment group, both p < 0.001). The duration of the procedure increased from 53 +/- 21 min (culprit treatment group) to 69 +/- 32 min (p = 0.032) and the amount of contrast used from 242 +/- 102 ml (culprit treatment group) to 341 +/- 163 ml (multivessel complete treatment), p = 0.025. A similar low incidence of in-hospital major adverse cardiac events was observed in the 2 groups (0 and 3.8% in culprit and multivessel treatment groups, p = 0.164). The increase in the incidence of new revascularisation in the culprit treatment group at 12 month follow-up was not significant (35 vs 17%, p = 0.247) but was sufficient to compensate the initial higher in-hospital cost, with a similar 12 month hospital cost in the 2 groups (Euro 22,330 +/- Euro 13,653 vs Euro 20,382 +/- Euro 11,671, p = 0.231). CONCLUSION: Multivessel treatment during primary PTCA was safe in this controlled trial. However, when only the culprit lesion was initially treated, the need for subsequent clinically driven revascularization remained low and no clinical or economical advantages were obtainable with a more aggressive initial approach. In clinical practice, a staged approach to multivessel treatment during primary angioplasty avoids to treat unnecessarily non clinically relevant lesions.

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PubMed2004

Drug-eluting bioabsorbable magnesium stent.

Current stent technology is based on the use of permanent implants that remain life long in the vessel wall, far beyond the time required for the prosthesis to accomplish its main goals of sealing dissection and preventing wall recoil. With the possibility to implant long vessel segments using antiproliferative drugs to prevent restenosis, the practice of transforming the coronary vessels into stiff tubes with a full metal jacket covering all side branches and being unable to adjust to the long-term wall changes, including wall remodeling with lumen ectasia becomes a serious concern. In this article, we describe the first biodegradable stent based on a magnesium alloy that allows controlled corrosion with release to the vessel wall and the blood stream of a natural body component such as magnesium with beneficial antithrombotic, antiarrhythmic, and antiproliferative properties. We also discuss the animal experiments and the initial clinical applications in 20 patients with implants below the knee, with final results soon to be released, and the plans for the first coronary study. The results of these last two studies will indicate whether the absence of a permanent implant and the antiproliferative properties shown in animals are sufficient to prevent the restenotic process in humans or whether the prosthesis must be modified by adding the biodegradable coating with conventional antiproliferative drugs.

Absorbable Implants↗
PubMed2003

Association of insulin resistance, hyperleptinemia, and impaired nitric oxide release with in-stent restenosis in patients undergoing coronary stenting.

BACKGROUND: Previously undiagnosed diabetes, impaired glucose tolerance, and insulin resistance are common in patients with acute myocardial infarction and coronary heart disease (CHD) and might be involved in early restenosis after stent implantation. To evaluate whether markers of insulin resistance syndrome, including leptin, and endothelial dysfunction are related to increased rate of early restenosis, we studied nondiabetic patients with CHD after successful coronary stenting. METHODS AND RESULTS: Both patients with CHD undergoing coronary stenting (120 patients) and control subjects (58 patients) were submitted to an oral glucose tolerance test (OGTT). Fasting leptin levels and fasting and postglucose load insulin sensitivity were assessed. Endothelial function was measured by nitrite and nitrate release (NOx) during OGTT. More than 50% of patients treated with stent implantation presented impaired glucose tolerance or type 2 diabetes, which was previously undiagnosed. These patients also had higher glucose, insulin, and leptin levels than control subjects. Among the stented patients, insulin and leptin levels were higher in patients with restenosis than in patients without restenosis. A significant increase in NOx levels was found during OGTT both in patients without restenosis and in control subjects. On the contrary, NOx profiles were blunted in patients with restenosis. At multiple regression analysis, only DeltaAUC-NOx areas and insulin sensitivity index showed an independent correlation with the minimal lumen diameter at follow-up. CONCLUSIONS: We demonstrated that insulin resistance and endothelial dysfunction are independent predictors of early restenosis after coronary stenting.

Area Under Curve↗
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%).

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PubMed2003

Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: the Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts (RECOVERS) Trial.

BACKGROUND: Treatment of lesions located in saphenous vein grafts (SVGs) is associated with increased procedural risk and a high rate of restenosis. METHODS AND RESULTS: We conducted a randomized, multicenter trial to evaluate the usefulness of a polytetrafluoroethylene (PTFE)-covered stent compared with a bare stainless steel (SS) stent for prevention of restenosis and major adverse cardiac events (MACE) in patients undergoing SVG treatment. The primary end point was angiographic restenosis at 6 months. Secondary end points were 30-day and 6-month MACE rates, defined as the cumulative of death, myocardial infarction (MI), and target lesion revascularization. Between September 1999 and January 2002, 301 patients with SVG lesions were randomized to either the PTFE-covered JoStent coronary stent graft (PTFE group, n=156) or the SS JoFlex stent (control group, n=145). Angiographic and procedural success rates were similar between the 2 groups (97.4% versus 97.9% and 87.3% versus 93.8%, respectively). The incidence of 30-day MACE was higher in the PTFE group (10.9% versus 4.1%, P=0.047) and was mainly attributed to MI (10.3% versus 3.4%, P=0.037). The primary end point, the restenosis rate at 6-month follow-up, was similar between the 2 groups (24.2% versus 24.8%, P=0.237). Although the 6-month non-Q-wave MI rate was higher in the PTFE group (12.8% versus 4.1%, P=0.013), the cumulative MACE rate was not different (23.1% versus 15.9%, P=0.153). CONCLUSIONS: The study did not demonstrate a difference in restenosis rate and 6-month clinical outcome between the PTFE-covered stent and the SS stent for treatment of SVG lesions. However, a higher incidence of nonfatal myocardial infarctions was found in patients treated with the PTFE-covered stent.

Adult↗
PubMed2003

Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE).

OBJECTIVES: We sought to investigate the success rate and the acute and 12-month clinical outcome of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in the contemporary era. BACKGROUND: The technique of PCI involving CTO has improved over time. However, limited data on acute and follow-up results in patients treated with PCI on CTO in recent years are available. METHODS: Four hundred nineteen consecutive patients scheduled for PCI of CTO of > or =30 days of duration were enrolled in 29 centers; 390 CTOs were confirmed in 376 patients in an independent core laboratory. The end points were technical and procedural success, in-hospital and 12-month major adverse cardiac events (MACE) occurrence, and 12-month symptomatic status. RESULTS: Technical and procedural success was obtained in 77.2% and 73.3% of lesions, respectively. In-hospital major adverse cardiac events occurred in 5.1% of patients. Multivariate analysis identified CTO length >15 mm or not measurable, moderate to severe calcifications, duration > or =180 days, and multivessel disease as significant predictors of PCI failure. At 12 months, patients with a successful procedure experienced a lower incidence of cardiac deaths or myocardial infarction (1.05% vs. 7.23%, p = 0.005), a reduced need for coronary artery bypass surgery (2.45% vs. 15.7%, p < 0.0001), and were more frequently free of angina (88.7% vs. 75.0%, p = 0.008) compared with patients who had an unsuccessful procedure. CONCLUSIONS: Successful PCI was achieved in a high percentage of CTOs with a low incidence of complications. At one-year follow-up, patients with successful PCI of a CTO had a significantly better clinical outcome than those whose PCI was unsuccessful.

Angioplasty, Balloon, Coronary↗
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.

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PubMed2003

A new dedicated stent and delivery system for the treatment of bifurcation lesions: preliminary experience.

We report the first clinical experience in eight patients with a new stent and delivery system specifically designed for the treatment of bifurcational lesions. The device (AST SLK-View system) consists of a premounted stent and a delivery system. The stent has a side aperture, which orients toward the ostium of the side branch. The system allows deployment of the stent while the access to both main and side branches is maintained by two wires. We evaluated this system in nine bifurcations. The location of bifurcations was left descending artery/diagonal branch in four lesions, left circumflex/obtuse marginal branch in three lesions, and postero-lateral branch/posterior descending artery in two lesions. Predilation was performed in six lesions of the main branches and in five lesions of the side branches. The stent was effectively delivered to all bifurcations except for one, in which the target lesion was located at a distal segment and the device could not be delivered. Following stent implantation in the main branch, two lesions at the side branches were treated by stent, while the other lesions were treated by balloon angioplasty without difficulty. Final kissing balloon was performed in four bifurcation lesions. No adverse event was observed during 1 month of clinical follow-up. Treatment of bifurcation lesions with this new dedicated device appears to be feasible. This new device may introduce a new approach for the treatment of coronary bifurcation lesions.

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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

Treatment of bifurcation coronary lesions: a review of current techniques and outcome.

Percutaneous treatment of coronary bifurcation lesions, pose a number of technical challenges to the interventional cardiologist. Each lesion has to be approached with its own, targeted solution in the context of the clinical picture, anatomy, and pathology. To achieve acceptable clinical outcomes a number of established techniques are available. The exact anatomy of the lesion determines the technique used. The most common approach is to stent the main vessel across the ostium of the side branch. The side branch can be additionally treated with a second stent or balloon angioplasty depending on the severity of the ostial lesion and/or evidence of active ischemia. Other techniques involve stenting the main branch up to the carina but sparing the side branches, multiple 'kissing stent' approaches ('Y','T', and 'V') or the 'culottes' technique. Follow-up data demonstrates a high (over 90%) technical success rate. Clinical outcome is variable but with conventional stents restenosis rates higher than 30% have been reported in most studies and there is no added advantage in routine stenting of both main vessel and side branch. Recent introduction of drug-eluting stents has resulted in a lower event rate and reduction of main vessel restenosis in comparison with historical controls. Side branch ostial restenosis remains a problem, which may require the development of novel 'bifurcate' stent designs to allow complete coverage with a single stent.

Angioplasty, Balloon↗
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.

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