Associate Full Professor at the Department of Surgery and Anatomy at the Ribeirão Preto Medical School at the University of São Paulo (FMRP-USP) Head of the Vascular and Endovascular Surgery Service at Hospital das Clínicas da FMRP-USP Member of the Brazilian Society of Angiology and Vascular Surgery (SBACV) Scientific Director of the National SBACV Phone: +551666022593 Address: R. Ten. Catão Roxo, 3900 - Vila Monte Alegre Ribeirão Preto - SP 14015-010 Brazil
Diabetic foot is one of the main chronic complications caused by diabetes mellitus and can lead t... more Diabetic foot is one of the main chronic complications caused by diabetes mellitus and can lead to limb amputation. Among the various wound treatment options, negative pressure wound therapy is a treatment modality based on vacuum-sealed drainage and vacuum-assisted closure to create a localized controlled negative pressure environment. In this case report, the patient sought medical attention and underwent surgical debridement of the dorsum of the right foot. Upon worsening of the wound condition, the patient was referred to our hospital for debridement and Renesys Smith Nephew dressing was implanted. After complete coverage of the granulation tissue without infection, elastic suturing was performed in the leg compartment to reduce the size of the dermis and epidermis graft. The patient then underwent a dermal matrix implant procedure, and an epidermis graft was removed from the ipsilateral thigh and placed on the wound. The aim of this study is to report a therapeutic challenge in...
Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The a... more Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains...
Background In-stent restenosis remains a common and important complication after endovascular tre... more Background In-stent restenosis remains a common and important complication after endovascular treatment of superficial femoral artery peripheral artery disease. It occurs in 14 to 35% of cases in 1 year and there is still no efficient treatment for this condition. Paclitaxel-coated balloons have shown promising results. Objective Investigate the 3 year results of superficial femoral artery in-stent restenosis treated with paclitaxel-coated balloon angioplasty, using the Lutonix™ 035 device. Methods We conducted a retrospective observational study with patients with symptomatic (Rutherford 2 to 5) superficial femoral artery in-stent restenosis, that were treated with paclitaxel-coated balloon angioplasty using the Lutonix™ 035 device, in a single center from January 2016 to December 2020. Duplex scan was used to follow the patients. Primary patency was obtained through Kaplan-Meier analysis. Mortality, and amputation rates were also evaluated. Results 105 patients were included. Two ...
BACKGROUND Arterial thoracic outlet syndrome (aTOS) is characterized by compression of the subcla... more BACKGROUND Arterial thoracic outlet syndrome (aTOS) is characterized by compression of the subclavian artery as it exits the thoracic girdle. Chronic and repetitive compression leads to several degrees of arterial wall damage. The treatment is varied and depends on the presentation severity. This study aimed to describe the contemporary experience in managing arterial thoracic outlet syndrome at a large tertiary hospital. METHODS We conducted a single-institution retrospective review of aTOS cases from January 2009 to January 2020. Demographic data, clinical presentation, medical images, operative notes, and outcomes were assessed. RESULTS Thirteen aTOS cases were identified. The mean age was 43 ± 10 years, and 11 (85%) were women. Both sides were equally affected: right (seven cases, 54%) and left (six cases, 46%). The most common clinical presentation was arm claudication (seven cases, 54%). Other presentations were: acute arm ischemia, pulsatile neck mass and distal embolization. Cervical ribs were identified by plain X-rays in most cases. All patients were submitted to surgical decompression through the supraclavicular approach. Patients with early disease stages were not submitted to arterial reconstruction and were followed with duplex scan. Arterial reconstruction was done in advanced disease stages (five cases, 38%): end-to-end anastomosis, interposition graft, and bypass graft. The mean follow-up duration was 32,6 ± 25 months. In all patients, the subclavian artery/graft was patent, and the vascular symptoms were entirely resolved. There were no deaths or amputations. CONCLUSION Arterial thoracic outlet syndrome has a varied clinical presentation. Cervical ribs are the most common anatomic abnormalities. The diagnosis was based on history, physical examination, and imaging exams. Surgery consisted of supraclavicular decompression, arterial resection, and vascular reconstruction, according to the disease stage. The outcomes were excellent.
Background Patients hospitalised with COVID-19 are at risk for thrombotic events after discharge;... more Background Patients hospitalised with COVID-19 are at risk for thrombotic events after discharge; the role of extended thromboprophylaxis in this population is unknown. Methods In this open-label, multicentre, randomised trial conducted at 14 centres in Brazil, patients hospitalised with COVID-19 at increased risk for venous thromboembolism (International Medical Prevention Registry on Venous Thromboembolism [IMPROVE] venous thromboembolism [VTE] score of ≥4 or 2–3 with a D-dimer >500 ng/mL) were randomly assigned (1:1) to receive, at hospital discharge, rivaroxaban 10 mg/day or no anticoagulation for 35 days. The primary efficacy outcome in an intention-to-treat analysis was a composite of symptomatic or fatal venous thromboembolism, asymptomatic venous thromboembolism on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and cardiovascular death at day 35. Adjudication was blinded. The primary safety outcome was major bleeding. The primary and safety analyses were carried out in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT04662684. Findings From Oct 8, 2020, to June 29, 2021, 997 patients were screened. Of these patients, 677 did not meet eligibility criteria; the remaining 320 patients were enrolled and randomly assigned to receive rivaroxaban (n=160 [50%]) or no anticoagulation (n=160 [50%]). All patients received thromboprophylaxis with standard doses of heparin during hospitalisation. 165 (52%) patients were in the intensive care unit while hospitalised. 197 (62%) patients had an IMPROVE score of 2–3 and elevated D-dimer levels and 121 (38%) had a score of 4 or more. Two patients (one in each group) were lost to follow-up due to withdrawal of consent and not included in the intention-to-treat primary analysis. The primary efficacy outcome occurred in five (3%) of 159 patients assigned to rivaroxaban and 15 (9%) of 159 patients assigned to no anticoagulation (relative risk 0·33, 95% CI 0·12–0·90; p=0·0293). No major bleeding occurred in either study group. Allergic reactions occurred in two (1%) patients in the rivaroxaban group. Interpretation In patients at high risk discharged after hospitalisation due to COVID-19, thromboprophylaxis with rivaroxaban 10 mg/day for 35 days improved clinical outcomes compared with no extended thromboprophylaxis. Funding Bayer.
Background The devastating Coronavirus disease (COVID-19) pandemic is associated with a high prot... more Background The devastating Coronavirus disease (COVID-19) pandemic is associated with a high prothrombotic state. It is unclear if the coagulation abnormalities occur because of the direct effect of SARS-CoV-2 or indirectly by the cytokine storm and endothelial damage or by a combination of mechanisms. There is a clear indication of in-hospital pharmacological thromboprophylaxis for every patient with COVID-19 after bleed risk assessment. However, there is much debate regarding the best dosage regimen, and there is no consensus on the role of extended thromboprophylaxis. Design This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg once daily for 35±4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization. The composite efficacy endpoint is a combination of symptomatic VTE, VTE-related death, VTE detected by bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35±4 post-hospital discharge and symptomatic arterial thromboembolism (myocardial infarction [MI], non-hemorrhagic stroke, major adverse limb events [MALE] and cardiovascular [CV] death) up to day 35±4 post-hospital discharge. The key safety outcome is the incidence of major bleeding according to ISTH criteria. Summary The MICHELLE trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.
Diabetic foot is one of the main chronic complications caused by diabetes mellitus and can lead t... more Diabetic foot is one of the main chronic complications caused by diabetes mellitus and can lead to limb amputation. Among the various wound treatment options, negative pressure wound therapy is a treatment modality based on vacuum-sealed drainage and vacuum-assisted closure to create a localized controlled negative pressure environment. In this case report, the patient sought medical attention and underwent surgical debridement of the dorsum of the right foot. Upon worsening of the wound condition, the patient was referred to our hospital for debridement and Renesys Smith Nephew dressing was implanted. After complete coverage of the granulation tissue without infection, elastic suturing was performed in the leg compartment to reduce the size of the dermis and epidermis graft. The patient then underwent a dermal matrix implant procedure, and an epidermis graft was removed from the ipsilateral thigh and placed on the wound. The aim of this study is to report a therapeutic challenge in...
Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The a... more Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains...
Background In-stent restenosis remains a common and important complication after endovascular tre... more Background In-stent restenosis remains a common and important complication after endovascular treatment of superficial femoral artery peripheral artery disease. It occurs in 14 to 35% of cases in 1 year and there is still no efficient treatment for this condition. Paclitaxel-coated balloons have shown promising results. Objective Investigate the 3 year results of superficial femoral artery in-stent restenosis treated with paclitaxel-coated balloon angioplasty, using the Lutonix™ 035 device. Methods We conducted a retrospective observational study with patients with symptomatic (Rutherford 2 to 5) superficial femoral artery in-stent restenosis, that were treated with paclitaxel-coated balloon angioplasty using the Lutonix™ 035 device, in a single center from January 2016 to December 2020. Duplex scan was used to follow the patients. Primary patency was obtained through Kaplan-Meier analysis. Mortality, and amputation rates were also evaluated. Results 105 patients were included. Two ...
BACKGROUND Arterial thoracic outlet syndrome (aTOS) is characterized by compression of the subcla... more BACKGROUND Arterial thoracic outlet syndrome (aTOS) is characterized by compression of the subclavian artery as it exits the thoracic girdle. Chronic and repetitive compression leads to several degrees of arterial wall damage. The treatment is varied and depends on the presentation severity. This study aimed to describe the contemporary experience in managing arterial thoracic outlet syndrome at a large tertiary hospital. METHODS We conducted a single-institution retrospective review of aTOS cases from January 2009 to January 2020. Demographic data, clinical presentation, medical images, operative notes, and outcomes were assessed. RESULTS Thirteen aTOS cases were identified. The mean age was 43 ± 10 years, and 11 (85%) were women. Both sides were equally affected: right (seven cases, 54%) and left (six cases, 46%). The most common clinical presentation was arm claudication (seven cases, 54%). Other presentations were: acute arm ischemia, pulsatile neck mass and distal embolization. Cervical ribs were identified by plain X-rays in most cases. All patients were submitted to surgical decompression through the supraclavicular approach. Patients with early disease stages were not submitted to arterial reconstruction and were followed with duplex scan. Arterial reconstruction was done in advanced disease stages (five cases, 38%): end-to-end anastomosis, interposition graft, and bypass graft. The mean follow-up duration was 32,6 ± 25 months. In all patients, the subclavian artery/graft was patent, and the vascular symptoms were entirely resolved. There were no deaths or amputations. CONCLUSION Arterial thoracic outlet syndrome has a varied clinical presentation. Cervical ribs are the most common anatomic abnormalities. The diagnosis was based on history, physical examination, and imaging exams. Surgery consisted of supraclavicular decompression, arterial resection, and vascular reconstruction, according to the disease stage. The outcomes were excellent.
Background Patients hospitalised with COVID-19 are at risk for thrombotic events after discharge;... more Background Patients hospitalised with COVID-19 are at risk for thrombotic events after discharge; the role of extended thromboprophylaxis in this population is unknown. Methods In this open-label, multicentre, randomised trial conducted at 14 centres in Brazil, patients hospitalised with COVID-19 at increased risk for venous thromboembolism (International Medical Prevention Registry on Venous Thromboembolism [IMPROVE] venous thromboembolism [VTE] score of ≥4 or 2–3 with a D-dimer >500 ng/mL) were randomly assigned (1:1) to receive, at hospital discharge, rivaroxaban 10 mg/day or no anticoagulation for 35 days. The primary efficacy outcome in an intention-to-treat analysis was a composite of symptomatic or fatal venous thromboembolism, asymptomatic venous thromboembolism on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and cardiovascular death at day 35. Adjudication was blinded. The primary safety outcome was major bleeding. The primary and safety analyses were carried out in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT04662684. Findings From Oct 8, 2020, to June 29, 2021, 997 patients were screened. Of these patients, 677 did not meet eligibility criteria; the remaining 320 patients were enrolled and randomly assigned to receive rivaroxaban (n=160 [50%]) or no anticoagulation (n=160 [50%]). All patients received thromboprophylaxis with standard doses of heparin during hospitalisation. 165 (52%) patients were in the intensive care unit while hospitalised. 197 (62%) patients had an IMPROVE score of 2–3 and elevated D-dimer levels and 121 (38%) had a score of 4 or more. Two patients (one in each group) were lost to follow-up due to withdrawal of consent and not included in the intention-to-treat primary analysis. The primary efficacy outcome occurred in five (3%) of 159 patients assigned to rivaroxaban and 15 (9%) of 159 patients assigned to no anticoagulation (relative risk 0·33, 95% CI 0·12–0·90; p=0·0293). No major bleeding occurred in either study group. Allergic reactions occurred in two (1%) patients in the rivaroxaban group. Interpretation In patients at high risk discharged after hospitalisation due to COVID-19, thromboprophylaxis with rivaroxaban 10 mg/day for 35 days improved clinical outcomes compared with no extended thromboprophylaxis. Funding Bayer.
Background The devastating Coronavirus disease (COVID-19) pandemic is associated with a high prot... more Background The devastating Coronavirus disease (COVID-19) pandemic is associated with a high prothrombotic state. It is unclear if the coagulation abnormalities occur because of the direct effect of SARS-CoV-2 or indirectly by the cytokine storm and endothelial damage or by a combination of mechanisms. There is a clear indication of in-hospital pharmacological thromboprophylaxis for every patient with COVID-19 after bleed risk assessment. However, there is much debate regarding the best dosage regimen, and there is no consensus on the role of extended thromboprophylaxis. Design This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg once daily for 35±4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization. The composite efficacy endpoint is a combination of symptomatic VTE, VTE-related death, VTE detected by bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35±4 post-hospital discharge and symptomatic arterial thromboembolism (myocardial infarction [MI], non-hemorrhagic stroke, major adverse limb events [MALE] and cardiovascular [CV] death) up to day 35±4 post-hospital discharge. The key safety outcome is the incidence of major bleeding according to ISTH criteria. Summary The MICHELLE trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.
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