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Biomedical subjects

A Cremonesi

Publications and source records attributed to A Cremonesi.

At least 19 recordsLinked to original sources
PubMed2006

Does free cell area influence the outcome in carotid artery stenting?

OBJECTIVES: To identify if carotid stent design, especially free cell area, impacts on the 30-day rates for stroke, death and TIA after carotid artery stenting (CAS). MATERIAL AND METHODS: A CAS database of 3179 consecutive CAS patients was retrospectively assessed. The distribution of neurological complications were analysed for association with the different stent types and designs. Events where subdivided into procedural and postprocedural events. RESULTS: The overall combined rate of TIA, stroke and death was 2.8% at 30 days (late events 1.9%). The post-procedural event rate analyzed for differences stents varied from 1.2% using BSCI Carotid Wallstent to 5.9% using Medtronic Exponent. The late event rates varied from 1.2% to 3.4% for free cell areas <2.5mm(2) and >7.5mm(2) respectively (p<0.05). Post-procedural event rate was 1.3% for closed cells and 3.4% for open cells. All these differences were highly pronounced among symptomatic patients (p<0.0001). CONCLUSIONS: After carotid stenting, complication rates vary according to stent type, free cell area and cell design. In the symptomatic population (and also in the total population), post-procedural complication rates are highest for the open cell types and increase with larger free cell area.

Blood Vessel Prosthesis Implantation↗
PubMed2005

PRIAMUS--proximal flow blockage cerebral protectIon during carotid stenting: results from a multicenter Italian registry.

AIM: The aim of this Italian prospective registry was to evaluate the applicability and efficacy of the Mo.Ma Device (Invatec, Roncadelle, Italy) for the prevention of cerebral embolization during carotid artery stenting (CAS) in a real world population. METHODS: In 4 Italian centers, 416 patients (300 men; mean age 71.6+/-9 years) between October 2001 and March 2005 were enrolled in a prospective registry. Two-hundred and sixty-four symptomatic (63.46%) with >50% diameter stenosis and 152 (36.54%) asymptomatic patients with >70% diameter stenosis were included. The Mo.Ma Proximal Flow Blockage Embolic Protection System was used to perform protected CAS, achieving cerebral protection by endovascular clamping of the common carotid artery (CCA) and of the external carotid artery (ECA). RESULTS: Technical success, defined as the ability to establish protection with the Mo.Ma device and to deploy the stent, was achieved in 412 cases (99.03%). The mean duration of flow blockage was 4.91+/-1.1 min. Transient intolerances to flow blockage were observed in 24 patients (5.76%), but in all cases the procedure was successfully completed. No peri-procedural strokes and deaths were observed. Complications during hospitalization included 16 minor strokes (3.84%), 3 transient ischemic attacks (0.72%), 2 deaths (0.48%) and 1 major stroke (0.24%). This resulted in a cumulative rate at discharge of 4.56% all strokes and deaths, and of 0.72% major strokes and deaths. All the patients underwent thirty-day follow-up. At thirty-day follow-up, there were no deaths and no minor and major strokes, confirming the overall cumulative 4.56% incidence of all strokes and deaths rate, and of 0.72% rate of major strokes and deaths at follow up. In 245 cases (58.89%) there was macroscopic evidence of debris after filtration of the aspirated blood. CONCLUSIONS: This Italian multicenter registry confirms and further supports the efficacy and applicability of the endovascular clamping concept with proximal flow blockage in a broad patient series. Results match favorably with current available studies on carotid stenting with cerebral protection.

Aged↗
PubMed2005

Does carotid artery stenting work on the long run: 5-year results in high-volume centers (ELOCAS Registry).

AIM: Although the first long-term results of Carotid Artery Stenting (CAS) became available only recently, CAS has become an accepted treatment for carotid artery disease. We report CAS data up to 5 years, both late stroke rate and patency rates as observed in 4 high-volume European centers. METHODS: Between February 1, 1993 and December 31, 2004, 2 172 patients were selected over the 4 participating centres, with intention to treat endovascularly. Conscientious follow-up was done according to the in-hospital stipulations of each centre and was entered into a database both retrospectively and prospectively. Long-term restenosis and stroke-death rates were investigated and statistically analysed and stratified using the Kaplan-Meier method. RESULTS: Of the 2 172 patients with intention to treat 2 165 (99.7%) were technically successful. Of these 306 (14.1%) were performed without and 1 859 (85.9%) with embolic protection device (EPD); 96 patients (4.4%) received balloon dilation only and stenting was performed in 2 069 (95.6%) cases. Kaplan-Meier analysis of major stroke/all death and of significant restenosis (>50%) for the total population showed stroke/death rates of 4.1% (nar=1 356), 10.1% (nar=476) and 15.5% (nar=138); and restenosis rates of 1% (nar=1 363), 2% (nar=480) and 3.4% (nar=139), after 1, 3 and 5 years respectively. CONCLUSIONS: The patency and stroke/death rates resulting from our database analysis are pleasing and indicate that CAS also on longer term is a valuable treatment method for carotid artery disease. Due to the fact that our dataset contains prospective as well as retrospective data, it may have its limitations. Until this moment, data indicating that certain patient subgroups are at increased risk for neurological complications and in-stent restenosis during and after CAS are sparse. Further multivariant analysis on this unique dataset is mandatory in order to identify any potential links in between plaque morphology, preprocedural neurological complications, risk factor distribution, procedural steps and clinical outcome.

Adult↗
PubMed2000

Clinical Experience with the NIR Stent: Retrospective Observation on Acute Results and Follow-up in 709 Patients.

The NIR stent is an expandable cellular coronary prosthesis with high flexibility and excellent trackability. The very low crossing profile, associated to the high flexibility, makes this stent suitable for complex and distal lesions. The aim of this study was to evaluate the feasibility, safety, and long-term (clinical follow-up) efficacy of elective and/or urgent deployment of the NIR stent in a broad patient group with coronary artery disease. Between June 1996 and May 1997, 986 NIR stents were implanted in 781 vessels (de novo or restenotic lesions in native vessels, saphenous vein grafts and internal mammary conduits) of 709 consecutive patients (498 men, 211 women) undergoing coronary angioplasty in two Villa Maria Group Catheterization Laboratories. Procedural angiographic success was achieved in 98.4% of all the lesions treated, ranging from 100% success rate in type A lesion to 97.6% in type C lesions (overall procedural success, 98.4%). Major adverse cardiac events (MACE) were considered from PTCA/stenting time to the patient discharge. The in-hospital MACE were limited and occurred in 15 patients: urgent surgical revascularization 0.8%, death 0.7%, sub-acute stent thrombosis 0.5% (overall in-hospital MACE rate 2.1%). Clinical follow-up data were obtained at 8.6 +/- 2.8 months following the stenting procedure. The event-free survival rate was 87.9%. The late MACE rate evaluation showed death, target lesion revascularization 9.9% (over-all late MACE rate 12.1%). The NIR stent performances in this broad patient population were excellent, showing very high procedural success rate both in normal and complex coronary anatomy. On the basis of the previous data, we can define NIR stent a safe multifunctional device suitable both for easy and complex situations. The clinical late results are very promising in term of event-free survivals and late MACE.

Journal Article↗
PubMed2000

Multicenter registry to evaluate the efficacy of the NIROYAL stent in de novo or restenotic coronary stenosis.

The purpose of this registry was to document the safety and efficacy of elective deployment of the NIROYAL stent (Boston Scientific SCIMED, Maple Grove, Minnesota) in coronary arteries. This was a prospective, multi-center international registry. NIROYAL stents (9, 16, 25 and 32 mm-long) were manually crimped onto coronary balloons and deployed in de novo or restenotic lesions in 165 male and female patients with angina pectoris and a reference vessel diameter of 2.0-4.5 mm. Stent deployment was successful in 98.8% of the lesions. Mean percent diameter stenosis decreased from 83.5+/-10.8% to 2.7+/- 6.2% after intervention. The interventional procedure of the treatment site was successful in 97.6% of patients. At six-month clinical follow-up, 88.5% had event-free survival [i.e., did not experience a major adverse cardiac event (MACE)] and 95.2% had no anginal symptoms. Furthermore, 87.3% of the patients were free of target vessel failure (defined as a composite of acute procedural failure, target vessel revascularization, myocardial infarction or death at six months). Only three MACE were observed within the first 30 days after stent implantation. A low left ventricular ejection fraction and the percentage stenosis pre-procedure were identified as statistically significant (p<0.05) predictive factors for MACE. The incidences of MACE and target vessel failure after six months follow-up were lower than that seen in other studies, and target lesion revascularization rates were low.

Adolescent↗
PubMed2000

Endovascular treatment of carotid atherosclerotic disease: early and late outcome in a non-selected population.

BACKGROUND: Carotid angioplasty and stenting are still not widely accepted treatments for carotid stenosis. This registry was aimed at investigating the efficacy of endovascular therapy of the extracranial carotid arteries in a non-selected population. METHODS: One hundred nineteen consecutive patients (93 males and 26 females, mean age 70.4 +/- 7.2 years) were enrolled to undergo percutaneous angioplasty and/or stenting of the extracranial carotid artery. The primary endpoint of this study was to evaluate the feasibility, safety and efficacy of carotid elective angioplasty and stenting in a "real life group" of patients (> 50 years, without strict target vessel selection or inclusion criteria) with carotid occlusive disease. During a 6-12 month follow-up period late major adverse events were evaluated, either related to the endovascular treatment or due to other pathological conditions. RESULTS: Percutaneous procedure was effective in 118/119 patients (99.16%). Procedural success rate was 99.16%, in-hospital major neurological symptomatic complications 0%, in-hospital minor neurological symptomatic complications 3.36% (two minor strokes, one transient ischemic attack and one subarachnoid hemorrhage). The follow-up observation time ranged from 6 to 36 months following the percutaneous procedure. Overall follow-up data showed absence of late major adverse events related to carotid disease (stroke, permanent neurological damage, death), in-stent restenosis 5.04%, balloon expandable stent crush 0.84%, stent migration 0.84%. CONCLUSIONS: Our data confirm that percutaneous dilation and stenting of the carotid artery represent an effective method which, during the periprocedural phase and the follow-up, does not expose the patient to any greater risk of complications than traditional surgery.

Aged↗
PubMed1999

The use of coronary angioplasty devices in carotid endovascular interventions: encouraging results in 21 consecutive patients.

Severe atherosclerotic lesion of carotid artery is the main cause of stroke and transient ischemic attack (TIA). Its incidence may reach 5-7% per annum in patients with carotid artery stenosis higher than 70% with or without symptoms. While time-honored carotid endarterectomy is still regarded as the "gold standard" therapy for most of the patients, carotid angioplasty with stent may be the only alternative to this treatment when endarterectomy is too risky or impossible. Although percutaneous angioplasty has been fully acknowledged as far as coronary or peripheral artery disease is concerned, the issue is still controversial in the endovascular treatment of carotid artery disease with regard to its indications, devices to be used and long-term results. Assessment of risk relating to carotid angioplasty with stent in comparison to carotid endarterectomy continues to be difficult, since materials and methods for this approach have not been standardized yet. Our initial experience in carotid angioplasty with stent performed in 21 consecutive patients by using devices for coronary angioplasty is extremely encouraging.

Angioplasty, Balloon↗
PubMed1998

Femoral Arterial Hemostasis using the Angio-Sealª System after Coronary and Vascular Percutaneous Angioplasty and Stenting.

The procedures of left cardiac catheterization and revascularization by angioplasty are associated with a substantial risk of hemorrhagic complications. This risk increases clearly in patients with an intravascular stent who require early high doses of anticoagulant therapy. The first purpose of our study was to evaluate the effectiveness of a mechanical system of femoral hemostasis (Angio-Sealª, Sherwood Davis & Geck, St. Louis, Missouri) deployed in a group of 411 consecutive patients (302 males, 109 females, mean age 59 +/- 15) who successfully underwent percutaneous angioplasty (PA) and application of an intravascular stent (378 coronary, 33 vascular). The arterial closure system consists of a small absorbable anchor and a collagen pad connected to a suture thread which, at the end of the procedure, is positioned by percutaneous introduction at the site of the femoral puncture. All the patients studied received long-term platelet anti-aggregant therapy (ticlopidine 500 mg/day and ASA 150 mg/day) for 3Ð4 days before and for one month after the procedure, and an anticoagulant regimen of heparin sodium administered via intravenous bolus (10,000 IU) during the procedure, followed by subcutaneous heparin calcium (12,500 IU/day) for 21 days. Thirteen patients were treated intravenously with 10 mg abciximab and seven received pre-procedure coumadin. The ACT when the hemostasis system was positioned was 355 +/- 43 seconds. Successful hemostasis was reached in more than 95% of the patients (394/411 pts., 95.86%). In 17 (4.14%) of the 411 patients studied, the system failed; nine (2.19%) of these were attributed by the operator to a failure of the positioning device procedure, and the remaining 8 (1.95%) were attributed to a malfunction of the system. Overall complications were observed in 23/411 (5.6%) of the patients (pts) studied; eighteen were minor non-surgical hemorrhagic complications (bleeding and/or hematoma) which occurred primarily in the first 4 hours. In 4 cases (1%) vascular surgery was necessary for femoral pseudoaneurysm repair (2 pts) and femoral hematoma (2 pts). One patient (0.24%) complained of severe claudication related to a severe stenosis in the femoral artery caused by a malpositioning of the anchor. This patient was successfully treated with balloon angioplasty and stenting of the femoral artery. The average time to early mobilization was 9 hours, and all the patients without complications were completely mobile within 12 hours after the procedure; 380/411 (92.46%) of the patients were discharged 18Ð24 hours after percutaneous angioplasty. The second purpose of our study was to compare data from 411 consecutive patients treated with the Angio-Sealª device after coronary and vascular angioplasty and stenting (Angio-Seal group), to a group of 387 consecutive patients where the femoral arterial hemostasis was obtained using manual compression after coronary angioplasty and stenting (manual compression group). We found significant differences (p < 0.01) in the most important elements concerning general patient management after the interventional procedure, with excellent improvements using the Angio-Seal device, including: successful hemostasis (95.86% vs. 88.37%); reduction of non-surgical hematomas (1.22% vs. 4.65%); reduction of surgical hematomas (0.49% vs. 2.84%); mobilization time (9 +/- 3 hours vs. 19 +/- 8 hours); and discharge within 18Ð24 hours (92.46% vs. 0.00%).

Journal Article↗
PubMed1997

Hemodynamic evaluation of the Carbomedics R, St Jude Medical HP and Sorin-Bicarbon valve in patients with small aortic annulus.

UNLABELLED: A Doppler echocardiographic study was performed to evaluate the hemodynamic performance of three 19 mm size currently used bileaflet valve prosthesis (St Jude Medical Hydrodinamic Plus, Sorin-Bicarbon and Carbomedic Reduced) implanted in aortic position. METHODS: Patients, 30, with the same profile receiving 19 mm size valve (ten for each valve type) were selected when body surface area (BSA) was > 1.7 m2. Doppler echocardiography was carried out at rest and after exercise, 60 days after surgery. Peak (Pg) and mean (Mg) gradients across the valve were recorded: the effective orifice area (EOA), and performance index (PI) were calculated. RESULTS: No significant differences were observed between St Jude Medical and Sorin Bicarbon as far as peak and mean gradient, effective orifice area and performance index at rest and after exercise. A significant difference (P < 0.05) was demonstrated in the above mentioned parameters when Carbomedics-R valve were tested. This type of valve showed a lower EOA and PI with higher Pg and Mg gradient both at rest and after exercise. CONCLUSION: The St Jude Hydrodymanic plus (Hp) and Sorin Bicarbon valves had similar performance and a better hemodynamic trend when compared to the Carbomedics-R valve in patients with large body surface areas. The Carbomedics-R valve shows a ineffective use of the total area of the prosthesis both at rest and after exercise.

Aged↗
PubMed1991

Tricuspid valve incompetence caused by nonpenetrating thoracic trauma.

Tricuspid valve incompetence from ruptured papillary muscle or chordae as a result of nonpenetrating trauma is uncommon. Blunt trauma causing partial detachment of a leaflet from the annulus is very rare. We report the case of a young adult involved in a car accident who had these findings. Operative repair with resuture of the leaflet to the annulus and annuloplasty using a Carpentier ring resulted in complete recovery.

Adult↗