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Biomedical subjects

A G Sousa

Publications and source records attributed to A G Sousa.

At least 19 recordsLinked to original sources

Sustained suppression of neointimal proliferation by sirolimus-eluting stents: one-year angiographic and intravascular ultrasound follow-up.

BACKGROUND: We have previously reported a virtual absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting stents. The aim of the present investigation was to determine whether these results are sustained over a period of 1 year. METHODS AND RESULTS: Forty-five patients with de novo coronary disease were successfully treated with the implantation of a single sirolimus-eluting Bx VELOCITY stent in São Paulo, Brazil (n=30, 15 fast release [group I, GI] and 15 slow release [GII]) and Rotterdam, The Netherlands (15 slow release, GIII). Angiographic and volumetric intravascular ultrasound (IVUS) follow-up was obtained at 4 and 12 months (GI and GII) and 6 months (GIII). In-stent minimal lumen diameter and percent diameter stenosis remained essentially unchanged in all groups (at 12 months, GI and GII; at 6 months, GIII). Follow-up in-lesion minimal lumen diameter was 2.28 mm (GIII), 2.32 mm (GI), and 2.48 mm (GII). No patient approached the >/=50% diameter stenosis at 1 year by angiography or IVUS assessment, and no edge restenosis was observed. Neointimal hyperplasia, as detected by IVUS, was virtually absent at 6 months (2+/-5% obstruction volume, GIII) and at 12 months (GI=2+/-5% and GII=2+/-3%). CONCLUSIONS: This study demonstrates a sustained suppression of neointimal proliferation by sirolimus-eluting Bx VELOCITY stents 1 year after implantation.

Blood Vessel Prosthesis Implantation↗

Clinical and economic impact of diabetes mellitus on percutaneous and surgical treatment of multivessel coronary disease patients: insights from the Arterial Revascularization Therapy Study (ARTS) trial.

BACKGROUND: Our aims were to compare coronary artery bypass grafting (CABG) and stenting for the treatment of diabetic patients with multivessel coronary disease enrolled in the Arterial Revascularization Therapy Study (ARTS) trial and to determine the costs of these 2 treatment strategies. METHODS AND RESULTS: Patients (n=1205) were randomly assigned to stent implantation (n=600; diabetic, 112) or CABG (n=605; diabetic, 96). Costs per patient were calculated as the product of each patient's use of resources and the corresponding unit costs. Baseline characteristics were similar between the groups. At 1 year, diabetic patients treated with stenting had the lowest event-free survival rate (63.4%) because of a higher incidence of repeat revascularization compared with both diabetic patients treated with CABG (84.4%, P<0.001) and nondiabetic patients treated with stents (76.2%, P=0.04). Conversely, diabetic and nondiabetic patients experienced similar 1-year event-free survival rates when treated with CABG (84.4% and 88.4%). The total 1-year costs for stenting and CABG in diabetic patients were $12 855 and $16 585 (P<0.001) and in the nondiabetic groups, $10 164 for stenting and $13 082 for surgery. CONCLUSIONS: Multivessel diabetic patients treated with stenting had a worse 1-year outcome than patients assigned to CABG or nondiabetics treated with stenting. The strategy of stenting was less costly than CABG, however, regardless of diabetic status.

Cerebrovascular Disorders↗

Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study.

BACKGROUND: Restenosis remains an important limitation of interventional cardiology. Therefore, we aimed to determine the safety and efficacy of sirolimus (a cell-cycle inhibitor)-coated BX Velocity stents. METHODS AND RESULTS: Thirty patients with angina pectoris were electively treated with 2 different formulations of sirolimus-coated stents (slow release [SR], n=15, and fast release [FR], n=15). All stents were successfully delivered, and patients were discharged without clinical complications. Independent core laboratories analyzed angiographic and 3D volumetric intravascular ultrasound data (immediately after procedure and at 4-month follow-up). Eight-month clinical follow-up was obtained for all patients. There was minimal neointimal hyperplasia in both groups (11.0+/-3.0% in the SR group and 10.4+/-3.0% in the FR group, P:=NS) by ultrasound and quantitative coronary angiography (in-stent late loss, 0.09+/-0.3 mm [SR] and -0.02+/-0.3 mm [FR]; in-lesion late loss, 0.16+/-0.3 mm [SR] and -0.1+/-0.3 mm [FR]). No in-stent or edge restenosis (diameter stenosis >or=50%) was observed. No major clinical events (stent thrombosis, repeat revascularization, myocardial infarction, or death) had occurred by 8 months. CONCLUSIONS: The implantation of sirolimus-coated BX Velocity stents is feasible and safe and elicits minimal neointimal proliferation. Additional placebo-controlled trials are required to confirm these promising results.

Aged↗

Acute myocardial infarction in progressively elderly patients. A comparative analysis of immediate results in patients who underwent primary percutaneous coronary intervention.

OBJECTIVE: Analysis of the in-hospital results, in progressively elderly patients who undergo primary percutaneous coronary intervention (PCI) in the first 24 hours of AMI. METHODS: The patients were divided into three different age groups (60/69, 70/79, and > or =80 years) and were treated from 7/95 until 12/99. The primary success rate and the occurrence of major clinical events were analyzed at the end of the in-hospital phase. Coronary stent implantation and abciximab use were employed at the interventionist discretion. RESULTS: We analyzed 201 patients with age ranging from 60 to 93 years, who underwent primary PCI. Patients with ages above 70 were more often female (p=.015). Those with ages above 80 were treated later with PCI (p=.054), and all of them presented with total occlusion of the infarct-related artery. Coronary stents were implanted in 30% of the patients. Procedural success was lower in > or =80 year old patients (p=.022), and the death rate was higher in > or =70 years olds (p=.019). Reinfarction and coronary bypass surgery were uncommon events. A trend occurred toward a higher combined incidence of major in-hospital events according to increased age (p=.064). CONCLUSION: Elderly patients (> or =70 years) presented with adverse clinical and angiographic profiles and patients > or =80 years of age obtained reduced TIMI 3 flow success rates after primary PTCA, and those > or =70 years had a higher death rate.

Age Distribution↗

The use of primary stenting or balloon percutaneous transluminal coronary angioplasty for the treatment of acutely occluded saphenous vein grafts. Results from the Brazilian National Registry--CENIC. Central Nacional de Intervenções Cardiovasculares.

OBJECTIVE: We conducted a comparative analysis of the in-hospital outcomes of patients who underwent primary percutaneous transluminal angioplasty (PTCA) or stent implantation because of an acute myocardial infarction (AMI) related to an acute vein graft occlusion. METHODS: Since 1991 the Brazilian Society of Hemodynamic and Interventional Cardiology has maintained a large database (CENIC). From these, we selected all consecutive patients, who underwent primary PTCA or stenting in the first 24 hours of AMI, with the target vessel being an occluded vein graft. Immediate results and major coronary events occurring up until hospital discharge were analyzed. RESULTS: During this period, 5,932 patients underwent primary PTCA or stenting; 158 (3%) of the procedures were performed because of an acute vein graft occlusion. Stenting was performed in 74 (47%) patients. Patients treated with stents had a higher success rate and lower mean residual stenosis compared with those who underwent primary balloon PTCA. The incidence of reinfarction and death were similar for stenting and balloon PTCA. CONCLUSION: Primary percutaneous treatment of AMI related to acute vein graft occlusion is still an uncommon practice. Primary stenting improved luminal diameter and offered higher rates of success; however, this strategy did not reduce the in-hospital reinfarction and death rate, compared with that occurring with PTCA treatment.

Adult↗

One-year follow-up after primary coronary intervention for acute myocardial infarction in diabetic patients. A substudy of the STENT PAMI trial.

OBJECTIVE: This analysis was undertaken to determine the composite incidence of cumulative adverse events (death, reinfarction, disabling stroke, and target vessel revascularization) at the end of the first year after acute myocardial infarction, in diabetic patients who underwent coronary stenting or primary coronary balloon angioplasty. METHODS: From the STENT PAMI trial, we analyzed the 6-month angiographic and 1-year clinical outcomes of 135 diabetic (112, noninsulin dependent) patients who underwent the randomization process of the trial and compared them with 758 nondiabetic patients. RESULTS: Coronary stenting did not significantly reduce the primary composite clinical end point when compared with PTCA (20 vs. 30%, p=0.2). A significant benefit from stenting was observed in patients with noninsulin dependent diabetes, with a trend toward a lesser need for new revascularization procedures (10 vs. 21%, p<.001), with a significant reduction in the primary composite clinical end point at 1 year (12 vs. 28%, p=. 04). At 6 months, the restenosis rate were significantly reduced only in nondiabetic patients (18 vs. 33%, p<. 001). Diabetic patients had the same restenosis rate (38%) either with stenting or balloon PTCA. CONCLUSIONS: Coronary Stenting in diabetics noninsulin dependent offered a significant reduction in the composite incidence of major clinical adverse events compared with balloon PTCA.

Angioplasty, Balloon, Coronary↗

Safety and efficacy of coronary stent implantation. Acute and six month outcomes of 1,126 consecutive patients treated in 1996 and 1997.

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.

Aged↗

Percutaneous handling of coronary lesions >20mm through stents. Is there a first choice strategy?

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.

Aged↗

Primary coronary angioplasty and stent implantation in acute myocardial infarction. Comparative analysis of the in-hospital results in the CENIC/SBHCI registry. National Center of Cardiovascular Interventions members.

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.

Angioplasty, Balloon, Coronary↗

Coronary angioplasty in Brazil.

In 1979, the first transluminal coronary angioplasty (PTCA) was performed in Brazil, two years after the original contribution of Andreas Gruentzig, in Zurich. In the years which followed, the development of PTCA in the country grew and in the mid eighties several centres had already had the experience of more than 600 cases. In the beginning of the nineties, PTCA underwent an additional promotion with a large number of procedures, now subventioned by the bodies of public health. In addition to this, the introduction of new technologies such as directional atherectomy, rotablator, laser and stents. In 1991, the Brazilian Society of Interventional Cardiology created a national registry (CENIC) to gather data on the coronary procedures performed in the country. The CENIC data for the 1992/1993 and 1996/1997 bienniums were compared and it was observed that there had been a significant increase in the number of cases treated (from 16,429 in 92/93 to 22,025 in 96/97), complex lesions of the B/C type (from 71.4% to 92.3%), patients with previous revascularisation (from 22% to 28.3%), acute myocardial infarction (from 16% to 17.4%) and multiarterial lesions (from 34.4% to 38.8%). However, despite a greater clinical and angiographic complexity, the success of the procedure grew (from 89.7% to 92.8%) and complications reduced: acute occlusion (from 3.2% to 1.5%); acute myocardial infarction (from 2.5% to 1.2%) and death (from 1.8% to 1.4%). Interventional cardiology in Brazil has consequently progressed at the same rate as that of other countries. The incorporation of new technologies, particularly coronary endoprostheses has increased, guaranteeing better success rates, better results and a decrease in complications arising from acute occlusion of the target vessel.

Angioplasty, Balloon, Coronary↗

[Percutaneous myocardial revascularization procedures in Brazil in 1996-1997 compared to the 1992-1993 period. A report of the National Registry--National Center for Cardiovascular Interventions (CENIC)].

PURPOSE: To report the results of percutaneous coronary interventions, in Brazil, in the years 1996-97, comparing them to those of 1992-93. METHODS: Data were collected in a standard form and the 1996-97 results were compared to those of 1992-93. RESULTS: The current Registry received data from 79% effective members of the SBHCI in 127 hospitals, including 22,025 patients, 60.67% of whom underwent PTCA, 36.57% stent implantation, 2.3% PTRA, 0.06% DCA and 0.4% laser angioplasty. Balloon angioplasty was the most frequent procedure in 1996-97, but its overall rate fell from 6.75% to 55.8% (p = 0.0001) concomitantly, there was a 35% relative increase in the use of stents from 1992-93 to 1996-97. The success rate of the later period was higher (89.7% vs 92.8%, p = 0.000001), with lower residual stenosis (22% vs 19%, p = 0.001). Besides, there were lower major complications rates: acute myocardial infarction (2.5% vs 1.2%, p = 0.002) and death (1.8% vs 1.4%, p = 0.0003). CONCLUSION: The procedures most often carried out in both periods were balloon angioplasty (60.67%) and implantation of stents (36.57%); the success rate high, abrupt closure rate was low (1.5%). These favorable results corroborate the high standards of the Brazilian Interventional Cardiology.

Aged↗

[Risk factors for acute myocardial infarction in Brazil. FRICAS Study].

PURPOSE: To determine risk factors related to acute myocardial infarction (AMI) in Brazil. METHODS: Five hundred ninety one patients were selected in 20 medical centers in Brazil, between January/94 and March/95. Two-hundred-ninety-nine patients were cases, and 292 controls with a variety of acute diseases not related to the suspected or known risk factors for acute myocardial infarction. All data were collected through a structured questionnaire filled by the patients. The evaluation of the variables was done through univariate analysis with a significance level of 5%. RESULTS: The factors related to acute myocardial infarction were respectively to cases and controls: Hypercholesterolemia--210.93 +/- 46.74 mg/dl and 185.71 +/- 45.45 mg/dl, (p = 0.000); smoking--41.69% and 27.20% (p = 0.000); hypertension--52.35% and 20.88% (p = 0.000); diabetes--19.70% and 9.93% (p = 0.001); family history--related to the patient's father in 42.14% and 33.22% (p = 0.025) and to the mother in 42.14% and 30.82% (p = 0.007); socioeconomic level--88.99% and 60.20% owned house (p = 0.002); 44.45% and 33.21% owned car (p = 0.010); physical activity--56.83% and 48.28% had the habit of walking in the year prior to study entry (p = 0.029); diet--38.79% and 28.42% consumed canned food (p = 0.013). The mean weight was 72.50 +/- 26.89 kg and 69 +/- 12.26 kg (p = 0.0271). The mean height was 166.56 +/- 8.81 cm and 166.66 +/- 8.47 cm. CONCLUSION: This study confirmed the importance of hypercholesterolemia, hypertension, diabetes mellitus, overweight and family history as risk factors for acute myocardial infarction. There was a significant relation between socioeconomic level and the prevalence of acute myocardial infarction.

Adult↗

[Influence of the clinical presentation on immediate and long-term results after rotational atherectomy].

PURPOSE: To analyse the influence of unstable coronary syndromes (UCS) in the early and late prognosis after rotational atherectomy (RA). METHODS: We treated 236 patients with RA between Aug/1992 and May/1996. Patients were divided into two groups: A) stable coronary syndromes 120 (51%) patients; B) UCS: 116 (49%) patients. DEFINITIONS: 1) procedure success (PS)--lesion success in all locations were RA use was attempted, without a major complication; 2) late coronary events (LCE)--angina, MI, additional revascularization or death. RESULTS: There was a significant predominance of age > 70 (A = 14% x B = 24%, p = 0.03) in B and previous MI (A = 32% x B = 11%, p = 0.0001) in A. Other characteristics were similar in both groups, including complex lesions (type B2/C), which were observed in 77% A stenosis and 80% B lesions. PS was 95% in A and 92% in B (p = NS). In-hospital major complications were observed in 2.5% A and 4.3% B patients, (p = NS). One patient died in each group. A and B patients had similar time of follow-up. LCE occurred in 25% A and 39% B patients (p = 0.002). Recurrence of angina (36% x 23%; p = 0.01) and target lesion revascularization (29% x 18%; p = 0.03) were also more frequently required in B cases. CONCLUSION: This study suggests that UCS (group A) does not implicate in worse acute results after RA. However, UCS patients present greater incidence of late coronary events, particularly recurrence of angina and target-lesion revascularization.

Aged↗

[Coronary angioplasty in patients with restenosis. Characterization of clinical and angiographic profiles, hospital clinical course, and implications for the selection of patients].

PURPOSE: To define the clinical and angiographic profile of patients undergoing to a 2nd or a 3rd coronary angioplaty (PTCA) for the treatment of restenosis, and assess the safety and efficacy of redilatation. METHODS: Patients submitted to PTCA for a 1st (1stRE) or a 2nd (2ndRE) restenosis, from Jan/1980 through Dec/1993, were retrospectively identified, and compared to those undergoing to PTCA for de novo lesions (DN). RESULTS: A total of 5,736 underwent to dilatation of primary lesions, 610 of a 1stRE, and 64 of a 2ndRE. Patients with restenotic lesions had a higher prevalence of diabetes, smoking, history of prior infarction (1stRE e 2ndRE) and hyperlipidemia (2ndRE) as compared with primary lesions (p < 0.05). Besides patients with a 2ndRE had a higher incidence of left ventricular dysfunction, as compared to those with DN or a 1stRE (31.3% with EF < 45% in group 2ndRE, vs 19.8% and 23.1% in groups 1stRE and DN, respectively, p < 0.05). Primary success, infarct rate and mortality were similar in all groups, but emergency bypass surgery was significantly higher in the DN (2.1% vs 0.8% in 1stRE and 0% in 2ndRE, p < 0.05). CONCLUSION: Restenosis can be effectively treated by redilatation. Patients with clinical and angiographic features predisposing to further recurrence can be better treated with other interventions (i.e., coronary stents, bypass surgery).

Angioplasty, Balloon, Coronary↗

[Inefficacy of diltiazem in restenosis prevention after coronary angioplasty].

PURPOSE: To evaluate the efficacy of diltiazem in preventing restenosis after balloon angioplasty (PTCA). METHODS: Eighty-nine patients who were undergone to successful PTCA, were divided them in 2 groups (G): A) 44 patients (50%) who received diltiazem (180 mg tid) immediately after PTCA and were kept on it for 6 months); B) 45 patients (50%) who received placebo. Fifty two lesions were dilated in GA and 54 in GB. Patients were excluded from analysis for several reasons, including: necessity of diltiazem or others calcium channel blockers use; heart failure, bradicardia, AV block of any degree, PTCA to chronic total occlusion, ostial lesions and AMI less than 30 days prior to PTCA. Patients were randomized to either the active drug or placebo in a double blind fashion. Restenosis was defined as a 50% lesion. Patients underwent late angiography either at 6 months or sooner if clinically indicated. RESULTS: Both G were similar to age > 70 years (A = 7% vs B = 4%-p = NS), sex (A = 13% vs B = 11%-p = NS), stable angina (A = 43% vs B = 51%), unstable angina (A = 57% vs B = 49%-p = NS) and single vessel (A = 91% vs B = 87%-p = NS) or multivessel (A = 9% vs B = 13%-p = NS) PTCA. We studied 39/44 (89%) patients in GA and 43/45 (96%) in GB (p = NS). We observed restenosis in 17/39 (43%) in GA and 16/43 (37%) in GB (p = NS). The restenosis rate per lesion was 39% in GA and 31% in GB (p = NS). CONCLUSION: Diltiazem was ineffective in the prevention of restenosis following PTCA.

Aged↗

[Percutaneous cardiovascular intervention procedures in Brazil (1992-1993). Report of the National Registry-National Center for Cardiovascular Interventions].

PURPOSE: To report the data on the first 2 years (1992-1993) of activity of the National Registry of Cardiovascular Interventions (CENIC) of the Hemodynamic and Angiography Department (DHA) of the Brazilian Society of Cardiology (SBC). METHODS: The full members of the DHA of the SBC sent their data on seven types of interventions: balloon angioplasty (PTCA), mitral balloon valvoplasty (MBV), pulmonary balloon valvoplasty (PBV), aortic balloon valvoplasty (ABV), tricuspid balloon valvoplasty (TBV), aortic balloon dilation (AoB) and balloon dilation of pulmonary branches (PBB), to the CENIC. RESULTS: Ninety-seven interventional cardiologists and 71 hospitals in 14 states, participated in this data bank. During this time, 16,429 PTCA, 551 MBV, 347 PBV, 62 ABV, 61 AoB, 3 TBV and 3 PBB were registered. PTCA was therefore the most performed procedure (94%); primary success rate was 89.7%. As for the major complications, there were 2.5% acute myocardial infarction; 0.8% emergency bypass surgery and 1.8% death. As for the other interventions, the primary success rate was 92.9% for MBV, 88.5% for PBV, 80.3% for AoB, 72.6% for ABV, 66.7% for TBV with 0.54% deaths for MBV patients and 3.23% for ABV patients. CONCLUSION: The performance of the interventional cardiology in Brazil reflects the difusion of intervention methods in the main hospitals of the country. The results demonstrate a high efficacy and safety rate, characterizing an excellent performance.

Adolescent↗