990 resultados para Stents and prostheses
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Ag and AgxO thin films were deposited by non-reactive and reactive pulsed DC magnetron sputtering, respectively, with the final propose of functionalizing the SS316L substrate with antibacterial properties. The coatings were characterized chemically, physically and structurally. The coatings nanostructure was assessed by X-ray diffraction (XRD) and X-ray photoelectron spectroscopy (XPS), while the coatings morphology was determined by scanning electron microscopy (SEM). The XRD and XPS analyses suggested that Ag thin film is composed by metallic Ag, which crystallizes in fcc-Ag phase, while the AgxO thin film showed both metallic Ag and Ag-O bonds, which crystalize in fcc-Ag and silver oxide phases. The SEM results revealed that Ag thin film formed a continuous layer, while AgxO layer was composed of islands with hundreds of nanometers surrounded by small nanoparticles with tens of nanometers. The surface wettability and surface tension parameters were determined by contact angle measurements, being found that Ag and AgxO surfaces showed very similar behavior, with all the surfaces showing a hydrophobic character. In order to verify the antibacterial behavior of the coatings, halo inhibition zone tests were realized for Staphylococcus epidermidis and Staphylococcus aureus. Ag coatings did not show antibacterial behavior, contrarily to AgxO coating, which presented antibacterial properties against the studied bacteria. The presence of silver oxide phase along with the development of different morphology were pointed as the main factors in the origin of the antibacterial effect found in AgxO thin film. The present study demonstrated that AgxO coating presented antibacterial behavior and its application in cardiovascular stents is promising.
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PURPOSE: The authors analyzed the 30-day and 6-month outcomes of 1,126 consecutive patients who underwent coronary stent implantation in 1996 and 1997. METHODS: The 30-day results and 6-month angiographic follow-up were analyzed in patients treated with coronary stents in 1996 and 1997. All patients underwent coronary stenting with high-pressure implantation (>12 atm) and antiplatelet drug regimen (aspirin plus ticlopidine). RESULTS: During the study period, 1,390 coronary stents were implanted in 1,200 vessels of 1,126 patients; 477 patients were treated in the year 1996 and 649 in 1997. The number of percutaneous procedures performed using stents increased significantly in 1997 compared to 1996 (64 % vs 48%, p=0.0001). The 30-day results were similar in both years; the success and stent thrombosis rates were equal (97% and 0.8%, respectively). The occurrence of new Q wave MI (1.3% vs 1.1%, 1996 vs 1997, p=NS), emergency coronary bypass surgery (1% vs 0.6%, 1996 vs 1997, p=NS) and 30-day death rates (0.2% vs 0.5%, 1996 vs 1997, p=NS) were similar. The 6-month restenosis rate was 25% in 1996 and 27% in 1997 (p= NS); the target vessel revascularization rate was 15% in 1996 and 16% in 1997 (p = NS). CONCLUSIONS: Intracoronary stenting showed a high success rate and a low incidence of 30-day occurrence of new major coronary events in both periods, despite the greater angiographic complexity of the patients treated with in 1997. These adverse variables did not have a negative influence at the 6-month clinical and angiographic follow-up, with similar rates of restenosis and ischemia-driven target lesion revascularization rates.
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OBJETIVE: With the increased use of intracoronary stents, in-stent restenosis has become a clinically significant drawback in invasive cardiology. We retrospectively assessed the short- and long-term outcomes after excimer laser coronary angioplasty of in-stent restenosis. METHODS: Twenty-five patients with 33 incidents of in-stent restenosis treated with excimer laser coronary angioplasty (ELCA) were analyzed. Sixty-six percent were males, mean age of 73±11 years, and 83% were functional class III-IV (NYHA). ELCA was performed using 23 concentric and 10 eccentric catheters with a diameter of 1.6-2.2 mm, followed by balloon angioplasty (PTCA) and ultrasound monitoring. The procedure was performed in the following vessels: left anterior descending artery, 10; left circumflex artery, 8; right coronary artery, 6; left main coronary artery, 2; and venous bypass graft, 7. RESULTS: The ELCA was successful in 71% of the cases, and PTCA was 100% successful. The diameter of the treated vessels was 3.44±0.5mm; the minimal luminal diameter (MLD) increased from 0.30mm pre-ECLA to 1.97mm post-ELCA, and to 2.94mm post-PTCA (p<0.001). The percent stenosis was reduced from 91.4±9.5% before ECLA to 42.3±14.9% after ELCA and to 14.6 ± 9.3% after PTCA (p<0.001). Seventeen (68%) patients were asymptomatic at 6 months and 15 (60%) at 1 year. New restenosis rates were 8/33 (24.2%) at 6 months and 9 /33 (27.3%) at 12 months. CONCLUSION: ELCA is safe and effective for the treatment of in-stent restenosis. In the present sample, a slight increase in new restenotic lesions between 6 and 12 months was found.
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OBJECTIVE - This study compared the early and late results of the use of one single stent with those of the use of multiple stents in patients with lesions longer than 20mm. METHODS - Prospective assessment of patients electively treated with stents, with optimal stent deployment and followed-up for more than 3 months. From February '94 to January '98, 215 patients with lesions >20mm were treated. These patients were divided into 2 groups as follows: Group A - 105 patients (49%) with one stent implanted; Group B - 110 patients (51%) with multiple stents implanted. RESULTS - The mean length of the lesions was 26mm in group A (21-48mm) versus 29mm in group B (21-52mm) (p=0.01). Major complications occurred in one patient (0.9%) in group A (subacute thrombosis, myocardial infarctionand death) and in 2 patients (1.8%) in group B (one emergency surgery and one myocardial infarction) (p=NS). The results of the late follow-up period (>6 months) were similar for both groups (group A = 82% vs group B = 76%; p=NS), and we observed an event-free survical in 89% of the patients in group A and in 91% of the patients in group B (p=NS). Angina (group A = 11% vs group B = 7%) and lesion revascularization (group A = 5% vs group B = 6%; p=NS) also occurred in a similar percentage. No infarction or death was observed in the late follow-up period; restenosis was identified in 33% and 29% of the patients in groups A and B, respectively (p=NS). CONCLUSION - The results obtained using one stent and using multiple stents were similar; the greater cost-effectiveness of one stent implantation, however, seems to make this strategy the first choice.
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OBJECTIVE: The aim of this work was the follow-up and evaluation of valve replacement in children under 12 years of age. METHODS: Forty-four children less than 12 years old were underwent valve replacement at INCOR-HCFMUSP between January 1986 and December 1992. Forty (91%) were rheumatic, 39 (88.7%) were in functional classes II or IV, 19 (43.2%) were operated upon on an emergency basis, and 6 (13.6%) had atrial fibrillation. Biological prostheses (BP) were employed in 26 patients (59.1%), and mechanical prostheses (MP) in 18 (40.9%). Mitral valves were replaced in 30 (68.7%), aortic valves in 8 (18.2%), a tricuspid valve in 1 (2.3%), and double (aortic and mitral) valves in 5 (11.4) of the patients. RESULTS: Hospital mortality was of 4.5% (2 cases). The mean follow-up period was 5.8 years. Re-operations occurred in 63.3% of the patients with BP and in 12.5% of those with MP (p=0.002). Infectious endocarditis was present in 26.3% of the BP, but in none of the cases of MP (p=0.049). Thrombosis occurred in 2 (12.5%) and hemorrhage in one (6.5%) of the patients with a MP. Delayed mortality occurred in 5 (11.9%) of the patients over a mean period of 2.6 years; four had had BP and one had a MP (NS). Actuarial survival and re-operation-free curves after 10 years were respectively, 82.5±7.7 (SD)% and 20.6±15.9%. CONCLUSION: Patients with MP required fewer re-operation, had less infectious endocarditis and lower late mortality rates compared with patients with bioprostheses. The former, therefore, appear to be the best valve replacement for pediatric patients.
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OBJECTIVE: Comparative analysis of the in-hospital results after primary implantation of stents or coronary balloon angioplasty in patients with acute myocardial infarction (MI). METHODS: CENIC (National Center of Cardiovascular Interventions) gathered data on 3,924 patients undergoing coronary angioplasty (in the primary form, without the previous use of thrombolytic agents) in the first 24 hours after a MI, during the period of 1996-1998. From these 3,924 patients, 1,337 (34%) underwent stent implantation. We analyzed the success of the procedure and the occurrence of adverse cardiac events. RESULTS: In patients undergoing stent implantation there were more males (77% vs 69%, p=0.001), previous by pass surgery (6.3% vs. 4.5%, p=0.01), anterior MI and stent implantation in left descending artery (55% vs. 48% vs. p=0.009), and saphenous vein bypass grafts (3.3% vs. 1.9%). the procedure was more succesful in the group of stents (97% vs. 84%, p=0.001) and reinfarction rate (2.5 vs. 4%, p=0.002). The need for emergency revascularization was similar (1% vs. 1.1%, NS). Total in-hospital mortality was lower in stent group (3.4% vs. 7. 2%, p=0.0001) and this effect was in patients Killip class III/V (19.5% vs. 32.5%, p= 0.002) because there was no difference in patients class I/II (1.7% vs. 2.8%, p=0.9). CONCLUSION: Primary stent implantation in acute myocardial infarction showed better early results than balloon angioplasty alome.
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Coronary dissection occurs frequently and in several degrees during coronary angioplasty, which is one of the mechanisms for increasing the lumen diameter of a vessel. However the length of the dissection may affect the procedure, becoming the most frequent cause of total occlusion after coronary angioplasty. We report here a case of extensive dissection that occurred during the coronary angioplasty of a focused lesion, which we treated with two long stents.
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OBJECTIVE: To investigate whether patients with heart valve prostheses and similar International Normalized Ratios (INR) have the same level of protection against thromboembolic events, that is, whether the anticoagulation intensity is related to the intensity of hypercoagulability supression. METHODS: INR and plasma levels of prothrombin fragment 1+2 (F1+2) were assessed in blood samples of 27 patients (7 with mechanical heart valves and 20 with biological heart valves) and 27 blood samples from healthy donors that were not taking any medication. RESULTS: Increased levels of F1+2 were observed in blood samples of 5 patients with heart valve prostheses taking warfarin. These findings reinforce the idea that even though patients may have INRs, within the therapeutic spectrum, they are not free from new thromboembolic events. CONCLUSION: Determination of the hypercoagulability marker F1+2 might result in greater efficacy and safety for the use of oral anticoagulants, resulting in improved quality of life for patients.
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OBJECTIVE: To assess the short- and long-term results of the use of streptokinase (SK) for the treatment of thromboses in cardiac valvular prostheses. METHODS: Seventeen patients with cardiac prosthetic thrombosis diagnosed by clinical, echocardiographic, and radioscopic findings underwent fibrinolytic treatment with a streptokinase bolus of 250,000 U followed by 100.000 U/hour. Short- and long-term results were assessed by radioscopy and echocardiography. RESULTS: Of the 17 patients, 12 had mechanical double-disk prostheses (4 aortic, 6 mitral, 2 tricuspid), 4 had single-disk prostheses (2 aortic, 1 mitral, and 1 tricuspid), and 1 had a tricuspid bioprosthesis. The success rate was 64.8%, the partial success rate was 17.6%, and the nonsuccess rate was 17.6%. All patients with a double-disk prosthesis responded, completely or partially, to the treatment. None of the patients with a single-disk prosthesis had complete resolution of the thrombosis. The time of streptokinase infusion ranged from 6 to 80 hours (mean of 56 h). The mortality rate due to the use of streptokinase was 5.8% and was secondary to cerebral bleeding. During streptokinase infusion, 3 (17.6%) embolic episodes occurred as follows: 1 cerebral, 1 peripheral, and 1 coronary. The rethrombosis index was 33% in a mean follow-up of 42 months. CONCLUSION: The use of fibrinolytic agents was effective and relatively safe in patients with primary thrombosis of a double-disk prosthesis. A fatal hemorrhagic complication occurred in 1 (5.8%) patient, and embolic complications occurred in 3 (17.6%) patients. In a mean 42-month follow-up, 67% of the patients were free from rethrombosis.
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This thesis is a continuation of the Enterprise-Ireland Research Innovation Fund (RIF) Project entitled’ "Design and Manufacturing of Customised Maxillo-Facial Prostheses" The primary objective of this Internal Research Development Program (IRDP) project was to investigate two fundamental design changes 1 To incorporate the over-denture abutments directly into the implant. 2 To remove the restraining wings by the addition of screws, which affix the. implant to the dense material of the jawbone. The prosthetic was redesigned using the ANSYS Finite Element Analysis software program and analysed to* • Reduce the internal von Mises stress distribution The new prosthetic had a -63.63 % lower von Mises stress distribution when compared with the original prosthetic. • Examine the screw preload effects. A maximum relative displacement of 22 6 * lO^mm between the bone and screw was determined, which is well below the critical threshold of micromotion which prevents osseointegration • Investigate the prosthetic-bone contact interface. Three models of the screw, prosthesis, and bone, were studied. (Axisymmetnc, quarter volume, and full volume), a recommended preload torque of 0 32 Nm was applied to the prosthetic and a maximum von Mises stress of 1.988 MPa was predicted • Study the overdenture removal forces. This analysis could not be completed because the correct plastic multilinear properties of the denture material could not be established The redesigned prosthetic was successfully manufactured on a 3-axis milling machine with an indexing system The prosthetic was examined for dimensional quality and strength The research established the feasibility of the new design and associated manufacturing method.
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Background: Clinical in-stent restenosis (CISR) is the main limitation of coronary angioplasty with stent implantation. Objective: Describe the clinical and angiographic characteristics of CISR and the outcomes over a minimum follow-up of 12 months after its diagnosis and treatment. Methods: We analyzed in 110 consecutive patients with CISR the clinical presentation, angiographic characteristics, treatment and combined primary outcomes (cardiovascular death, nonfatal acute myocardial infarction [AMI]) and combined secondary (unstable angina with hospitalization, target vessel revascularization and target lesion revascularization) during a minimal follow-up of one year. Results: Mean age was 61 ± 11 years (68.2% males). Clinical presentations included acute coronary syndrome (ACS) in 62.7% and proliferative ISR in 34.5%. CISR was treated with implantation of drug-eluting stents (DES) in 36.4%, Bare Metal Stent (BMS) in 23.6%, myocardial revascularization surgery in 18.2%, balloon angioplasty in 15.5% and clinical treatment in 6.4%. During a median follow-up of 19.7 months, the primary outcome occurred in 18 patients, including 6 (5.5%) deaths and 13 (11.8%) AMI events. Twenty-four patients presented a secondary outcome. Predictors of the primary outcome were CISR with DES (HR = 4.36 [1.44–12.85]; p = 0.009) and clinical treatment for CISR (HR = 10.66 [2.53–44.87]; p = 0.001). Treatment of CISR with BMS (HR = 4.08 [1.75–9.48]; p = 0.001) and clinical therapy (HR = 6.29 [1.35–29.38]; p = 0.019) emerged as predictors of a secondary outcome. Conclusion: Patients with CISR present in most cases with ACS and with a high frequency of adverse events during a medium-term follow-up.
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Abstract Background: There are sparse data on the performance of different types of drug-eluting stents (DES) in acute and real-life setting. Objective: The aim of the study was to compare the safety and efficacy of first- versus second-generation DES in patients with acute coronary syndromes (ACS). Methods: This all-comer registry enrolled consecutive patients diagnosed with ACS and treated with percutaneous coronary intervention with the implantation of first- or second-generation DES in one-year follow-up. The primary efficacy endpoint was defined as major adverse cardiac and cerebrovascular event (MACCE), a composite of all-cause death, nonfatal myocardial infarction, target-vessel revascularization and stroke. The primary safety outcome was definite stent thrombosis (ST) at one year. Results: From the total of 1916 patients enrolled into the registry, 1328 patients were diagnosed with ACS. Of them, 426 were treated with first- and 902 with second-generation DES. There was no significant difference in the incidence of MACCE between two types of DES at one year. The rate of acute and subacute ST was higher in first- vs. second-generation DES (1.6% vs. 0.1%, p < 0.001, and 1.2% vs. 0.2%, p = 0.025, respectively), but there was no difference regarding late ST (0.7% vs. 0.2%, respectively, p = 0.18) and gastrointestinal bleeding (2.1% vs. 1.1%, p = 0.21). In Cox regression, first-generation DES was an independent predictor for cumulative ST (HR 3.29 [1.30-8.31], p = 0.01). Conclusions: In an all-comer registry of ACS, the one-year rate of MACCE was comparable in groups treated with first- and second-generation DES. The use of first-generation DES was associated with higher rates of acute and subacute ST and was an independent predictor of cumulative ST.
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Abstract Background: Transcatheter aortic valve implantation has become an option for high-surgical-risk patients with aortic valve disease. Objective: To evaluate the in-hospital and one-year follow-up outcomes of transcatheter aortic valve implantation. Methods: Prospective cohort study of transcatheter aortic valve implantation cases from July 2009 to February 2015. Analysis of clinical and procedural variables, correlating them with in-hospital and one-year mortality. Results: A total of 136 patients with a mean age of 83 years (80-87) underwent heart valve implantation; of these, 49% were women, 131 (96.3%) had aortic stenosis, one (0.7%) had aortic regurgitation and four (2.9%) had prosthetic valve dysfunction. NYHA functional class was III or IV in 129 cases (94.8%). The baseline orifice area was 0.67 ± 0.17 cm2 and the mean left ventricular-aortic pressure gradient was 47.3±18.2 mmHg, with an STS score of 9.3% (4.8%-22.3%). The prostheses implanted were self-expanding in 97% of cases. Perioperative mortality was 1.5%; 30-day mortality, 5.9%; in-hospital mortality, 8.1%; and one-year mortality, 15.5%. Blood transfusion (relative risk of 54; p = 0.0003) and pulmonary arterial hypertension (relative risk of 5.3; p = 0.036) were predictive of in-hospital mortality. Peak C-reactive protein (relative risk of 1.8; p = 0.013) and blood transfusion (relative risk of 8.3; p = 0.0009) were predictive of 1-year mortality. At 30 days, 97% of patients were in NYHA functional class I/II; at one year, this figure reached 96%. Conclusion: Transcatheter aortic valve implantation was performed with a high success rate and low mortality. Blood transfusion was associated with higher in-hospital and one-year mortality. Peak C-reactive protein was associated with one-year mortality.
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The goal of the present work was assess the feasibility of using a pseudo-inverse and null-space optimization approach in the modeling of the shoulder biomechanics. The method was applied to a simplified musculoskeletal shoulder model. The mechanical system consisted in the arm, and the external forces were the arm weight, 6 scapulo-humeral muscles and the reaction at the glenohumeral joint, which was considered as a spherical joint. The muscle wrapping was considered around the humeral head assumed spherical. The dynamical equations were solved in a Lagrangian approach. The mathematical redundancy of the mechanical system was solved in two steps: a pseudo-inverse optimization to minimize the square of the muscle stress and a null-space optimization to restrict the muscle force to physiological limits. Several movements were simulated. The mathematical and numerical aspects of the constrained redundancy problem were efficiently solved by the proposed method. The prediction of muscle moment arms was consistent with cadaveric measurements and the joint reaction force was consistent with in vivo measurements. This preliminary work demonstrated that the developed algorithm has a great potential for more complex musculoskeletal modeling of the shoulder joint. In particular it could be further applied to a non-spherical joint model, allowing for the natural translation of the humeral head in the glenoid fossa.
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A cardiac-triggered free-breathing three-dimensional (3D) balanced fast field-echo projection renal magnetic resonance (MR) angiographic sequence was investigated for in-stent lumen visualization of a dedicated metallic renal artery stent. Fourteen prototype stents were deployed in the renal arteries of six pigs (in two pigs, three stents were deployed). Projection renal MR angiography was compared with standard contrast material-enhanced 3D breath-hold MR angiography. Artifact-free in-stent lumen visualization was achieved with both projection MR angiography and contrast-enhanced MR angiography. These promising results warrant further studies for visualization of in-stent restenosis.