Search PubMed⌕ Search

Biomedical subjects

R Seabra-Gomes

Publications and source records attributed to R Seabra-Gomes.

At least 37 records · Page 2Linked to original sources
PubMed2000

Total occlusion trial with angioplasty by using laser guidewire. The TOTAL trial.

AIMS: A randomized trial was performed to assess the safety and efficacy of a laser guidewire, in the treatment of chronic coronary occlusions. METHODS AND RESULTS: In 18 European centres, 303 patients with a chronic coronary occlusion were randomized to treatment with either the laser guidewire (n=144) or conventional guidewires (mechanical guidewire, n=159). The primary end-point of the study was treatment success, defined as reaching the true lumen distal to the occlusion by the allocated wire within 30 min of fluoroscopic time: laser guidewire vs mechanical guidewire; 52.8% (n=76) vs 47.2% (n=75), P=0.33. Serious adverse events following the initial guidewire attempt were 0% (laser guidewire) and 0.6% (mechanical guidewire), respectively. Angioplasty (performed following successful guidewire crossing) was successful in 179 patients (91%, laser guidewire n=79, mechanical guidewire n=100), followed by stent implantation in 149 (79%). At the 6-month angiographic follow-up, the difference in binary restenosis rate (laser guidewire vs mechanical guidewire; 45.5% vs 38.3 %, P=0.72) or reocclusion rate (25.8% vs 16.1%, P=0.15) did not reach statistical significance. At 1, 6 and 12 months, angina and event-free survival were 69%, 35% and 24% (laser guidewire) vs 74%, 40% and 31% (mechanical guidewire). CONCLUSION: Although laser guidewire technology was safe, the increase in crossing success did not reach statistical significance.

Aged↗
PubMed2000

Multicenter evaluation of the phosphorylcholine-coated biodivYsio stent in short de novo coronary lesions: The SOPHOS study.

AIMS: The BiodivYsio trade mark stent (Biocompatibles Ltd, Farnham, UK) is coated with a phosphorylcholine (PC)-containing copolymer to confer biocompatibility. The SOPHOS (Study Of PHosphorylcholine coating On Stents) study was designed to assess the safety and efficacy of this novel coronary stent and by indirect comparison to indicate equivalence with other formal stent studies. METHODS AND RESULTS: Patients with angina and a single short (#x2A7F;12 mm) de novo lesion in a native coronary artery of >/=2.75 mm diameter were included. A total of 425 patients were allocated in 24 centers. Clinical data were collected at one-, six- and nine-month follow-up. Angiography was performed before and after the stent implantation. In addition, in the first 200 patients (SOPHOS A) angiography was routinely performed at six months. The following 225 patients (SOPHOS B) were merely followed up clinically. The primary end-point of the study, the six-month MACE-rate (MACE = Major Adverse Cardiac Events) was 13.4% (two cardiac death; five Q-wave/nine non-Q-wave myocardial infarctions (MI); nine CABG and 32 target lesion revascularization (TLR), which is similar to the calculated 15% MACE-rate in comparable reference studies. Secondary end-points included among others restenosis at six months in the SOPHOS A population. The target vessel diameter was 2.98 +/- 0.48 mm. Minimal lumen diameter pre/post procedure and at follow-up was 1.00 +/- 0.32, 2.69 +/- 0.37, 1.91 +/- 0.71 mm, respectively. The binary restenosis rate (>/=50% diameter stenosis at follow-up) was 17.7%. CONCLUSION: The coronary BiodivYsio stent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with stable or unstable angina pectoris. Clinical and angiographic results are in the statistical range of equivalence with comparable studies with other current stents.

Journal Article↗
PubMed2000

[The angioplasty of chronic coronary occlusions with the excimer laser for debulking followed by stent implantation].

UNLABELLED: Coronary angioplasty (PCI) of chronic total occlusions (CTO), even when successful, are associated to less favourable long term results. The recent use of coronary stents has improved the long term outcome of those interventions. PURPOSE: To evaluate the short term results and long term occurrence of major adverse coronary events (MACE): death, MI, urgent revascularization and the need for a new target vessel revascularization (TVR) in patients with CTO who had previously been submitted to a PCI with excimer laser for plaque debulking followed by a provisional stent. POPULATION: From our database, we selected 19 patients with a mean age of 51 +/- 13 years (18 male) submitted to PCI between 1994 and 1998. Of those patients, 10 had had of a previous MI. Hypertension, smoking habits and hypercholesterolemia were present in 9 patients (42%). Two patients had diabetes. The main reason for PCI was stable angina in 16 patients (84%) and unstable in 3 patients (16%). Single-vessel disease was present in 18 patients (94%) and multiple-vessel in 1 patient (6%); left ventricular ejection fraction was preserved in 18 patients (94%). Single vessel PCI was performed in 16 patients (84%) and double vessel in 3 patients. Plaque debulking with excimer laser was performed in all patients, followed by 23 stents (Multilink--8; Gianturco Roubin--5; Palmaz Schatz--4; others--6). The mean clinical follow-up was 19 months. RESULTS: There were no major short-term clinical events (death, MI or urgent revascularization). During follow-up, TVR was only required in 5 patients (26%), all of them in the first 7 months after PCI. CONCLUSIONS: In the highly selected population, PCI for chronic total occlusion, with excimer laser plaque debulking followed by provisional stents, was a safe procedure with a very acceptable rate of new target vessel revascularization in the follow-up period.

Adult↗
PubMed2000

Prognostic value of cardiac troponin I release kinetics in unstable angina.

BACKGROUND: Cardiac Troponins (cTn) are useful in unstable angina (UA). Moreover the different elevation patterns that can be observed in this condition seem to have different prognostic implications. AIM: To study cTn kinetics and cTn nadir in patients with UA, defined as angina at rest within the last 24 hours before admission accompanied by ischemic ECG changes and no myocardial infarction (MI) enzymatic criteria. POPULATION AND METHODS: Samples were collected from 156 patients for cardiac enzymes and cTnI at admission and at 6, 12, 18 and 24 hours. The chemilluminescence method (Access/Sanofi Pasteur) was used for cTnI. The primary end-point at 30 days was the combined occurrence of death, MI and recurrent ischemia. RESULTS: All determinations were below 0.10 ng/ml (group N) in 114 patients and the other 42 pts (group P) had at least one value equal to or above 0.10 ng/ml. The primary endpoint was observed in 24.6% of group N pts compared with 45.2% of group P pts (p = 0.02). Three different patterns of cTnI kinetics were observed. This enabled the identification of a subgroup--group N pts with increasing cTnI values within the first 12 hours and a total differential value > or = 0.03 ng/ml--with an increased risk (50.0% versus 21.4%--p = 0.02--Kaplan-Meier test). CONCLUSION: Besides the prognostic value conferred by cTnI elevation, cTnI kinetics analysis established another sub-group of patients with an adverse prognosis at 30 days follow-up, despite having a negative cTnI.

Adult↗
PubMed1999

Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial.

BACKGROUND: Bolus fibrinolytic therapy facilitates early efficient institution of reperfusion therapy. Tenecteplase is a genetically engineered variant of alteplase with slower plasma clearance, better fibrin specificity, and high resistance to plasminogen-activator inhibitor-1. We did a double-blind, randomised, controlled trial to assess the efficacy and safety of tenecteplase compared with alteplase. METHODS: In 1021 hospitals, we randomly assigned 16,949 patients with acute myocardial infarction of less than 6 h duration rapid infusion of alteplase (< or = 100 mg) or single-bolus injection of tenecteplase (30-50 mg according to bodyweight). All patients received aspirin and heparin (target activated partial thromboplastin time 50-75 s). The primary outcome was equivalence in all-cause mortality at 30 days. FINDINGS: Covariate-adjusted 30-day mortality rates were almost identical for the two groups--6.18% for tenecteplase and 6.15% for alteplase. The 95% one-sided upper boundaries of the absolute and relative differences in 30-day mortality were 0.61% and 10.00%, respectively, which met the prespecified criteria of equivalence (1% absolute or 14% relative difference in 30-day mortality, whichever difference proved smaller). Rates of intracranial haemorrhage were similar (0.93% for tenecteplase and 0.94% for alteplase), but fewer non-cerebral bleeding complications (26.43 vs 28.95%, p=0.0003) and less need for blood transfusion (4.25 vs 5.49%, p=0.0002) were seen with tenecteplase. The rate of death or non-fatal stroke at 30 days was 7.11% with tenecteplase and 7.04% with alteplase (relative risk 1.01 [95% CI 0.91-1.13]). INTERPRETATION: Tenecteplase and alteplase were equivalent for 30-day mortality. The ease of administration of tenecteplase may facilitate more rapid treatment in and out of hospital.

Aged↗
PubMed1999

Thrombolysis with saruplase versus streptokinase in acute myocardial infarction: five-year results of the PRIMI trial.

BACKGROUND: Short-term safety and efficacy of thrombolysis with saruplase in acute myocardial infarction have been shown in several trials. To assess long-term outcome of patients treated with saruplase or streptokinase for myocardial infarction, a 5-year follow-up of patients included in the Pro-Urokinase in Myocardial Infarction Trial was performed. METHODS AND RESULTS: Follow-up data are available from 8 centers on 255 (92.4%) of 276 included patients. The 5-year mortality rate was comparable with 20.8% of patients in the saruplase group and 16.9% in the streptokinase group (odds ratio 1.29, 95% confidence interval 0.69 to 2.42). In both groups, a considerable number of fatal cardiovascular events occurred more than 1 year after study inclusion. Rates of percutaneous transluminal coronary angioplasty and coronary artery bypass grafting were comparable in both groups. Reinfarction within 5 years occurred in 19.0% of patients in the saruplase group and tended to be less frequent at 10.8% after streptokinase treatment (odds ratio 1.94, 95% confidence interval 0.98 to 3.84). In both groups, the majority of reinfarctions took place more than 3 months after study inclusion. The 5-year stroke rate was 3.6% and 7.2% in the saruplase and streptokinase groups, respectively (odds ratio 0.49, 95% confidence interval 0.16 to 1.47). Subjective symptoms of heart failure and angina pectoris were comparable in both groups. CONCLUSIONS: Our data are consistent with a similar long-term outcome for patients treated with saruplase or streptokinase. Despite the low-risk profile of the patient cohort, there were considerable adverse event rates over a 5-year period.

Aged↗
PubMed1999

Laser angioplasty of restenosed coronary stents: results of a multicenter surveillance trial. The Laser Angioplasty of Restenosed Stents (LARS) Investigators.

OBJECTIVES: This study evaluated safety and efficacy of excimer laser angioplasty for treatment of restenosed or occluded coronary stents. BACKGROUND: Balloon angioplasty of in-stent restenosis is limited by a high recurrence rate. Debulking by laser angioplasty is a novel concept to treat in-stent restenosis. METHODS: A total of 440 patients with restenoses or occlusions in 527 stents were enrolled for treatment with concentric or eccentric laser catheters and adjunctive balloon angioplasty. RESULTS: Laser angioplasty success (< or =50% diameter stenosis after laser treatment or successful passage with a 2.0-mm or 1.7-mm eccentric laser catheter) was achieved in 92% of patients. Adjunctive balloon angioplasty was performed in 99%. Procedural success (laser angioplasty success followed by < or =30% stenosis with or without balloon angioplasty) was 91%. There was neither a significant difference in success with respect to lesion length, nor were there differences between small and large vessels or native vessels and vein grafts. Success was higher and residual stenosis lower using large or eccentric catheters. Serious adverse events included death (1.6%, not directly laser catheter related), Q-wave myocardial infarction (0.5%), non-Q-wave infarction (2.7%), cardiac tamponade (0.5%) and stent damage (0.5%). Perforations after laser treatment occurred in 0.9% of patients and after balloon angioplasty in 0.2%. Dissections were visible in 4.8% of patients after laser treatment and in 9.3% after balloon angioplasty. Reinterventions during hospitalization were necessary in 0.9% of patients; bypass surgery was performed in 0.2%. CONCLUSIONS: Excimer laser angioplasty with adjunctive balloon angioplasty is a safe and efficient technology to treat in-stent restenoses. These data justify a randomized comparison with balloon angioplasty.

Adult↗
PubMed1999

Microwave ablation of atrial flutter.

Radiofrequency (RF) ablation of the isthmus between the inferior vena cava and the tricuspid ring has proven to be a safe and successful method of treating atrial flutter (AF). However, RF ablation lesions are small in size requiring a considerable number of energy applications to ablate the AF circuit. The aim of this study was to evaluate the feasibility and efficacy of microwave energy for AF ablation. We report a case of sustained typical AF treated successfully and safely by 1 pulse of microwave (MW) energy. This showed it is possible to treat AF with a small number of pulse applications.

Atrial Flutter↗
PubMed1999

[Elective coronary angioplasty in acute coronary syndromes: early versus delayed treatment].

BACKGROUND: In patients with acute coronary syndromes (ACS) the optimal time required to stabilize the patient before attempting coronary intervention (PTCA) is uncertain. The recent use of newer devices and antiplatelet drugs allowed earlier percutaneous intervention. OBJECTIVE: We examined the efficacy and safety of coronary angioplasty in patients with ACS according to the period of stabilization with medical therapy. METHODS: We included 83 patients, 15 female, 54 with unstable angina and 29 with non-ST elevation myocardial infarction. We studied the rate of complications related to the procedure, the duration of CCU and hospital stay according to the period of stabilization with medical therapy: < 48 hours (early PTCA) and > or = 48 hours (delayed PTCA). RESULTS: No significant differences were found between the two groups of patients with respect to success rate (92% in early PTCA vs 98% in delayed PTCA), stents implantation (74% vs 78%), use of abeiximab (42% vs 24%), abrupt closure during procedure (3% vs 2%), infarct related procedure (0% vs 7%), re-PTCA (5% vs 7%) and surgical revascularization (0% vs 2%). No deaths occurred, CCU stay (2.5 vs 6.7 days, p < 0.001) and hospital stay (4 vs 9.4 days, p = 0.001) were significantly shorter in the group of early PTCA. CONCLUSIONS: In the present group of patients with ACS, early coronary intervention was a safe procedure with a shorter CCU and hospital stay compared with deferred PTCA.

Abciximab↗
PubMed1999

Coronary angioplasty in Portugal.

Coronary angioplasty began in Portugal in 1984 at the Santa Cruz Hospital and has developed progressively, being practiced in twelve hospitals since 1997. The number of patients with ischemic cardiopathy per annum that are submitted to this form of therapy has also increased. The increase is mainly in the past five years, from 684 procedures in 1993 to 3,005 in 1997. With regard to new devices, the use of intracoronary stents, which began in 1990 in Portugal is currently practised in all hospitals, 2,364 stents were implanted in 1997. This development of angioplasty has made it definitively established in Portugal, even in hospitals without cardiac surgery, as an alternative treatment to coronary surgery and medical treatment. In the absence of a national registry of interventional cardiology, which allows data to be gathered on the type of patients and the clinical situations in which angioplasty is used, it is not possible to ascertain whether medical treatment or surgical treatment have gained patients. Without evidence that surgery has decreased, it is presupposed that the increase in angioplasty is mainly the result of a greater number of diagnostic coronariographies. The current continued growth which has been observed, gives the impression that the development of the early diagnostic suspicion of coronary disease, easier access to coronariographies even in district hospitals and the improvement of technical conditions and manpower in central hospitals will sustain the increase in angioplasty in coming years. In becoming the solution to the problem of restenosis, angioplasty may undisputedly become the most promising therapeutic alternative in ischemic cardiopathy, in parallel with hypercholesterolemia control and other coronary risk factors.

Angioplasty, Balloon, Coronary↗
PubMed1999

[Peripheral revascularization by cardiologists].

OBJECTIVE: To analyse the initial experience in peripheral arterial revascularization, using percutaneous techniques, by interventional cardiologists. DESIGN: Retrospective clinical study. SETTING: Cardiology department of a specialised public non-university hospital. PATIENTS: Twenty patients, 18 male and 2 female, with ages between 37 and 84 years, who underwent peripheral interventions between May 5 1989 and February 20 1998. INTERVENTIONS: Patients were subdivided into two groups: Group I, 9 patients, 8 male, average age of 56 +/- 13 years, undergoing renal artery angioplasty; Group II, 11 patients, 10 male, average age of 63 +/- 10 years, undergoing angioplasty of the distal aorta (1), of the right subclavian artery (1), of the iliac arteries (6) and of the femoral arteries (3). In Group I, 11 arteries were dilated, 6 by balloon angioplasty and 5 with stent implantation (Palmaz-Schatz--4 and Symphony--1). In Group II, 12 arteries were dilated, 5 by balloon angioplasty and 7 with 12 stent implantations (Palmaz-Schatz--6, Symphony--5 and NIRTM--1). In 8 patients, 1 of Group I and 7 of Group II, coronary angioplasty was also performed in 14 arteries and 18 segments, exclusively by balloon (3 patients) or with 10 stent implantations (5 patients). RESULTS: There was angiographic success in all patients (100%) and clinical success in 85% (17/20) of patients. All clinical complications occurred in Group I patients: retroperitoneal bleeding in one; right femoral artery pseudoaneurysm requiring surgery in one patient: acute renal failure in one patient. There were no cardiac complications in patients undergoing peripheral and cardiac angioplasties at the same stage. In the mean follow-up period of 26 months, one patient required reangioplasty of a right iliac artery and another underwent iliac-femoral bypass, both of Group II and before peripheral stents were available. CONCLUSIONS: Percutaneous peripheral arterial revascularization performed by experienced interventional cardiologists seems safe and efficient, being perfectly justified in patients requiring simultaneous coronary angioplasty.

Adult↗
PubMed1999

[The Brugada syndrome--a clinical case].

A case report of a patient with syncope and family history of sudden death is presented. The precordial recordings in the standard 12-lead ECG showed a right bundle-branch block pattern with persistent ST elevation in V1 and V2-V3. After a thorough evaluation, we found no underlying organic cardiomyopathy. The diagnosis of symptomatic Brugada syndrome was made. A cardioverter-defibrillator was implanted.

Bundle-Branch Block↗
PubMed1999

Relationship between radionuclide right ventricular ejection fraction and clinical status in patients with left ventricular dysfunction after myocardial infarction.

OBJECTIVE: To evaluate the influence of right ventricular (RV) function, determined by RV ejection fraction, on the clinical status of patients with ischemic heart disease and left ventricular (LV) EF under 40%. BACKGROUND: The role of RV function as a marker of prognosis in heart failure has been debated. We hypothesized that the degree of RV dysfunction is a determinant of the clinical status and outcome of patients with LV dysfunction after myocardial infarction. PATIENTS AND METHODS: 30 patients, 25 male, with previous myocardial infarction, more than 6 months age, were studied by equilibrium radionuclide angiography. Functional capacity was evaluated by cardiopulmonary exercise test with Naughton protocol. Patients were followed during a 12 month period for major clinical events: death or hospitalisation for congestive heart failure. Two groups of patients were considered according the value of RVEF (< or = 30% and > 30%). RESULTS: The values of EF were: LV = 25 +/- 7% and RV = 35 +/- 9%. Maximum oxygen consumption correlated with RVEF (r = 0.78, p < 0.001) but not with LVEF (r = 0.12, NS). The group of patients with RVEF > 30% had a greater exercise time (712 +/- 229 versus 441 +/- 208 seconds, p = 0.003), higher oxygen consumption (19.8 +/- 5.3 versus 13.5 +/- 3.3 ml/kg/min, p = 0.001) and oxygen consumption in relation to the maximum predicted for age and sex (71 +/- 19 versus 50 +/- 13%, p = 0.002). Cumulative frequency of major clinical events was greater in the group with RVEF < or = 30% (58% vs 6%, relative risk 3.14, 95% CI 1.23 to 5.05). There was no correlation between the values of LVEF and outcome. CONCLUSIONS: In this setting of ischemic LV dysfunction, the RVEF correlates with functional capacity in cardio-pulmonary exercise test and the presence of RV dysfunction is associated to a higher incidence of clinical events.

Adult↗
PubMed1998

Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)

BACKGROUND: The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. METHODS: 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. FINDINGS: Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis > or =50%) of 16% and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient. INTERPRETATION: Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.

Adult↗
PubMed1998

Beta-blockers and antithrombotic treatment for secondary prevention after acute myocardial infarction. Towards an understanding of factors influencing clinical practice. The European Secondary Prevention Study Group.

AIMS: Long-term beta-blockade reduced mortality after acute myocardial infarction by about a quarter in a series of published trials. Representative data on beta-blocker use for secondary prevention are scanty but indicate wide variations. We have analysed European practice, and sources of variation, by regional sampling of acute myocardial infarction patients admitted to hospital in 11 countries during the period January 1993-June 1994. METHODS AND RESULTS: Treatment data for 4035 representative patients were collected for the hospital phase and 6 months after discharge. A logistic regression model was developed to describe the predictors of beta-blocker use. In the 11 regional samples, 6-38% (20% overall) of patients had no recorded contraindications but were discharged without a beta-blocker. In the absence of perceived contraindications, there was a strong, independent negative association between age and odds of treatment (P < 0.001), and women were less likely to be treated than men (adjusted odds ratio 0.76, 95% CI 0.58-0.99). Discontinuation of beta-blocker treatment by 6 months was significantly less likely in regions where the proportion given such treatment at discharge was high. In contrast, use of antithrombotic agents in the samples was consistently high. CONCLUSIONS: There is persisting low use of beta-blocker secondary prophylaxis, particularly in the elderly and in women, not attributable to perceived contraindications or intolerance. Considerable regional variations persist despite shared trials evidence. Discharge treatment strongly influences long-term medication.

Adrenergic beta-Antagonists↗
PubMed1998

Use of coronary angiography and revascularization procedures following acute myocardial infarction. A European perspective.

AIMS: There is little evidence to inform routine practice in the use of coronary angiography and revascularization procedures after acute myocardial infarction. Large differences in the uptake of these procedures have been reported but representative data are scarce. Outcome studies have produced opposing conclusions concerning the impact of the high rate of these cardiac procedures. METHODS AND RESULTS: A population-based patient sampling approach was utilized to identify routine practice in representative samples from 11 European countries. Data were collected retrospectively on treatment in the 6 months following acute myocardial infarction (n=2807). There was wide variation in utilization of coronary angiography and revascularization procedures. Even after restricting the analysis to patients <65 years (n=1262), there remained a 6 13 fold variation in the use of these procedures. A decreased likelihood of undergoing these procedures was associated with older age. In addition, there was an independent and negative association between female sex and utilization of coronary angiography and coronary artery bypass grafting (CABG). CONCLUSION: The effect on patient outcome of the observed variation in use of these procedures is not known but has important cost and resource implications for the health services. Outcome research is needed to define patient selection criteria and to measure the cost-utility of different angiography and revascularization rates.

Adult↗