Publications by authors named "Daniel G Cacione"

10 Publications

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Treatment for telangiectasias and reticular veins.

Cochrane Database Syst Rev 2021 10 12;10:CD012723. Epub 2021 Oct 12.

Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Telangiectasias (spider veins) and reticular veins on the lower limbs are very common, increase with age, and have been found in 41% of women. The cause is unknown and the patients may be asymptomatic or can report pain, burning or itching. Treatments include sclerotherapy, laser, intense pulsed light, microphlebectomy and thermoablation, but none is established as preferable.

Objectives: To assess the effects of sclerotherapy, laser therapy, intensive pulsed light, thermocoagulation, and microphlebectomy treatments for telangiectasias and reticular veins.

Search Methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 16 March 2021. We undertook additional searches in LILACS and IBECS databases, reference checking, and contacted specialists in the field, manufacturers and study authors to identify additional studies.

Selection Criteria: We included randomised controlled trials (RCTs) and quasi-RCTs that compared treatment methods such as sclerotherapy, laser therapy, intensive pulsed light, thermocoagulation, and microphlebectomy for telangiectasias and reticular veins in the lower limb. We included studies that compared individual treatment methods against placebo, or that compared different sclerosing agents, foam or laser treatment, or that used a combination of treatment methods.

Data Collection And Analysis: Three review authors independently performed study selection, extracted data, assessed risks of bias and assessed the certainty of evidence using GRADE. The outcomes of interest were resolution or improvement (or both) of telangiectasias, adverse events (including hyperpigmentation, matting), pain, recurrence, time to resolution, and quality of life.

Main Results: We included 3632 participants from 35 RCTs. Studies compared a variety of sclerosing agents, laser treatment and compression. No studies investigated intensive pulsed light, thermocoagulation or microphlebectomy. None of the included studies assessed recurrence or time to resolution. Overall the risk of bias of the included studies was moderate. We downgraded the certainty of evidence to moderate or low because of clinical heterogeneity and imprecision due to the wide confidence intervals (CIs) and few participants for each comparison. Any sclerosing agent versus placebo There was moderate-certainty evidence that sclerosing agents showed more resolution or improvement of telangiectasias compared to placebo (standard mean difference (SMD) 3.08, 95% CI 2.68 to 3.48; 4 studies, 613 participants/procedures), and more frequent adverse events: hyperpigmentation (risk ratio (RR) 11.88, 95% CI 4.54 to 31.09; 3 studies, 528 participants/procedures); matting (RR 4.06, 95% CI 1.28 to 12.84; 3 studies, 528 participants/procedures). There may be more pain experienced in the sclerosing-agents group compared to placebo (SMD 0.70, 95% CI 0.06 to 1.34; 1 study, 40 participants; low-certainty evidence). Polidocanol versus any sclerosing agent There was no clear difference in resolution or improvement (or both) of telangiectasias (SMD 0.01, 95% CI -0.13 to 0.14; 7 studies, 852 participants/procedures), hyperpigmentation (RR 0.94, 95% CI 0.62 to 1.43; 6 studies, 819 participants/procedures), or matting (RR 0.82, 95% CI 0.52 to 1.27; 7 studies, 859 participants/procedures), but there were fewer cases of pain (SMD -0.26, 95% CI -0.44 to -0.08; 5 studies, 480 participants/procedures) in the polidocanol group. All moderate-certainty evidence. Sodium tetradecyl sulphate (STS) versus any sclerosing agent There was no clear difference in resolution or improvement (or both) of telangiectasias (SMD -0.07, 95% CI -0.25 to 0.11; 4 studies, 473 participants/procedures). There was more hyperpigmentation (RR 1.71, 95% CI 1.10 to 2.64; 4 studies, 478 participants/procedures), matting (RR 2.10, 95% CI 1.14 to 3.85; 2 studies, 323 participants/procedures) and probably more pain (RR 1.49, 95% CI 0.99 to 2.25; 4 studies, 409 participants/procedures). All moderate-certainty evidence. Foam versus any sclerosing agent There was no clear difference in resolution or improvement (or both) of telangiectasias (SMD 0.04, 95% CI -0.26 to 0.34; 2 studies, 187 participants/procedures); hyperpigmentation (RR 2.12, 95% CI 0.44 to 10.23; 2 studies, 187 participants/procedures) or pain (SMD -0.10, 95% CI -0.44 to 0.24; 1 study, 147 participants/procedures). There may be more matting using foam (RR 6.12, 95% CI 1.04 to 35.98; 2 studies, 187 participants/procedures). All low-certainty evidence. Laser versus any sclerosing agent There was no clear difference in resolution or improvement (or both) of telangiectasias (SMD -0.09, 95% CI -0.25 to 0.07; 5 studies, 593 participants/procedures), or matting (RR 1.00, 95% CI 0.46 to 2.19; 2 studies, 162 participants/procedures), and maybe less hyperpigmentation (RR 0.57, 95% CI 0.40 to 0.80; 4 studies, 262 participants/procedures) in the laser group. All moderate-certainty evidence. High heterogeneity of the studies reporting on pain prevented pooling, and results were inconsistent (low-certainty evidence). Laser plus sclerotherapy (polidocanol) versus sclerotherapy (polidocanol) Low-certainty evidence suggests there may be more resolution or improvement (or both) of telangiectasias in the combined group (SMD 5.68, 95% CI 5.14 to 6.23; 2 studies, 710 participants), and no clear difference in hyperpigmentation (RR 0.83, 95% CI 0.35 to 1.99; 2 studies, 656 participants) or matting (RR 0.83, 95% CI 0.21 to 3.28; 2 studies, 656 participants). There may be more pain in the combined group (RR 2.44, 95% CI 1.69 to 3.55; 1 study, 596 participants; low-certainty evidence).

Authors' Conclusions: Small numbers of studies and participants in each comparison limited our confidence in the evidence. Sclerosing agents were more effective than placebo for resolution or improvement of telangiectasias but also caused more adverse events (moderate-certainty evidence), and may result in more pain (low-certainty evidence). There was no evidence of a benefit in resolution or improvement for any sclerosant compared to another or to laser. There may be more resolution or improvement of telangiectasias in the combined laser and polidocanol group compared to polidocanol alone (low-certainty evidence). There may be differences between treatments in adverse events and pain. Compared to other sclerosing agents polidocanol probably causes less pain; STS resulted in more hyperpigmentation, matting and probably pain; foam may cause more matting (low-certainty evidence); laser treatment may result in less hyperpigmentation (moderate-certainty evidence). Further well-designed studies are required to provide evidence for other available treatments and important outcomes (such as recurrence, time to resolution and delayed adverse events); and to improve our confidence in the identified comparisons.
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http://dx.doi.org/10.1002/14651858.CD012723.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8507602PMC
October 2021

Endoluminal interventions versus surgical interventions for stenosis in vein grafts following infrainguinal bypass.

Cochrane Database Syst Rev 2021 04 28;4:CD013702. Epub 2021 Apr 28.

Evidence Based Medicine, Cochrane Brazil, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Bypass surgery using a large saphenous vein graft, or another autologous venous graft, is a well-recognised treatment option for managing peripheral arterial disease of the lower limb, including chronic limb-threatening ischaemia (CLTI) and intermittent claudication, peripheral limb aneurysms, and major limb arterial trauma. Bypass surgery has good results in terms of limb preservation rates and long-term graft patency but is limited by the possibility of vein graft failure due to stenoses of the graft. Detection of stenoses through clinical and ultrasonographic surveillance, followed by treatment, is used to avoid graft occlusion. The conventional approach to treatment of patients with graft stenosis following infrainguinal bypass consists of open surgical repair, which usually is performed under general anaesthesia. Endoluminal treatment with angioplasty is less invasive and uses local anaesthesia. Both methods aim to improve blood flow to the limb.

Objectives: To assess the effectiveness of endoluminal interventions versus surgical intervention for people with vein graft stenosis following infrainguinal bypass.

Search Methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov to 25 August 2020.

Selection Criteria: We aimed to include all published and unpublished randomised controlled trials (RCTs) that compared endoluminal interventions versus surgical intervention for people with vein graft stenosis following infrainguinal bypass.

Data Collection And Analysis: Two review authors independently assessed all identified studies for potential inclusion in the review. We aimed to use standard methodological procedures in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. The main outcomes of interest were primary patency, primary assisted patency, and all-cause mortality.

Main Results: We identified no RCTs that met the inclusion criteria for this review.

Authors' Conclusions: We found no RCTs that compared endoluminal interventions versus surgical intervention for stenosis in vein grafts following infrainguinal bypass. Currently, there is no high-certainty evidence to support the use of one type of intervention over another. High-quality studies are needed to provide evidence on managing vein graft stenosis following infrainguinal bypass.
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http://dx.doi.org/10.1002/14651858.CD013702.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8081584PMC
April 2021

Pharmacological treatment for Buerger's disease.

Cochrane Database Syst Rev 2020 05 4;5:CD011033. Epub 2020 May 4.

Evidence Based Medicine, Cochrane Brazil, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Buerger's disease (thromboangiitis obliterans) is a non-atherosclerotic, segmental inflammatory pathology that most commonly affects the small and medium sized arteries, veins, and nerves in the upper and lower extremities. The aetiology is unknown, but involves hereditary susceptibility, tobacco exposure, immune and coagulation responses. In many cases, there is no possibility of revascularisation to improve the condition. Pharmacological treatment is an option for patients with severe complications, such as ischaemic ulcers or rest pain.This is an update of the review first published in 2016.

Objectives: To assess the effectiveness of any pharmacological agent (intravenous or oral) compared with placebo or any other pharmacological agent in patients with Buerger's disease.

Search Methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, AMED, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 15 October 2019. The review authors searched LILACS, ISRCTN, Australian New Zealand Clinical Trials Registry, EU Clinical Trials Register, clincialtrials.gov and the OpenGrey Database to 5 January 2020.

Selection Criteria: We included randomised controlled trials (RCTs) involving pharmacological agents used in the treatment of Buerger's disease.

Data Collection And Analysis: Two review authors, independently assessed the studies, extracted data and performed data analysis.

Main Results: No new studies were identified for this update. Five randomised controlled trials (total 602 participants) compared prostacyclin analogue with placebo, aspirin, or a prostaglandin analogue, and folic acid with placebo. No studies assessed other pharmacological agents such as cilostazol, clopidogrel and pentoxifylline or compared oral versus intravenous prostanoid. Compared with aspirin, intravenous prostacyclin analogue iloprost improved ulcer healing (risk ratio (RR) 2.65; 95% confidence interval (CI) 1.15 to 6.11; 98 participants; 1 study; moderate-certainty evidence), and helped to eradicate rest pain after 28 days (RR 2.28; 95% CI 1.48 to 3.52; 133 participants; 1 study; moderate-certainty evidence), although amputation rates were similar six months after treatment (RR 0.32; 95% CI 0.09 to 1.15; 95 participants; 1 study; moderate-certainty evidence). When comparing prostacyclin (iloprost and clinprost) with prostaglandin (alprostadil) analogues, ulcer healing was similar (RR 1.13; 95% CI 0.76 to 1.69; 89 participants; 2 studies; I² = 0%; very low-certainty evidence), as was the eradication of rest pain after 28 days (RR 1.57; 95% CI 0.72 to 3.44; 38 participants; 1 study; low-certainty evidence), while amputation rates were not measured. Compared with placebo, the effects of oral prostacyclin analogue iloprost were similar for: healing ischaemic ulcers (iloprost 200 mcg: RR 1.11; 95% CI 0.54 to 2.29; 133 participants; 1 study; moderate-certainty evidence, and iloprost 400 mcg: RR 0.90; 95% CI 0.42 to 1.93; 135 participants; 1 study; moderate-certainty evidence), eradication of rest pain after eight weeks (iloprost 200 mcg: RR 1.14; 95% CI 0.79 to 1.63; 207 participants; 1 study; moderate-certainty evidence, and iloprost 400 mcg: RR 1.11; 95% CI 0.77 to 1.59; 201 participants; 1 study; moderate-certainty evidence), and amputation rates after six months (iloprost 200 mcg: RR 0.54; 95% CI 0.19 to 1.56; 209 participants; 1 study, and iloprost 400 mcg: RR 0.42; 95% CI 0.13 to 1.31; 213 participants; 1 study). When comparing folic acid with placebo in patients with Buerger's disease and hyperhomocysteinaemia, pain scores were similar, there were no new cases of amputation in either group, and ulcer healing was not assessed (very low-certainty evidence). Treatment side effects such as headaches, flushing or nausea were not associated with treatment interruptions or more serious consequences. Outcomes such as amputation-free survival, walking distance or pain-free walking distance, and ankle brachial index were not assessed by any study. Overall, the certainty of the evidence was very low to moderate, with few studies, small numbers of participants, variation in severity of disease of participants between studies and missing information (for example regarding baseline tobacco exposure).

Authors' Conclusions: Moderate-certainty evidence suggests that intravenous iloprost (prostacyclin analogue) is more effective than aspirin for eradicating rest pain and healing ischaemic ulcers in Buerger's disease, but oral iloprost is not more effective than placebo. Very low and low-certainty evidence suggests there is no clear difference between prostacyclin (iloprost and clinprost) and the prostaglandin analogue alprostadil for healing ulcers and relieving pain respectively in severe Buerger's disease. Very low-certainty evidence suggests there is no clear difference in pain scores and amputation rates between folic acid and placebo, in people with Buerger's disease and hyperhomocysteinaemia. Further well designed RCTs assessing the effectiveness of pharmacological agents (intravenous or oral) in people with Buerger's disease are needed.
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http://dx.doi.org/10.1002/14651858.CD011033.pub4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7197514PMC
May 2020

Transverse versus vertical groin incision for femoral artery approach.

Cochrane Database Syst Rev 2020 04 22;4:CD013153. Epub 2020 Apr 22.

UNIFESP - Escola Paulista de Medicina, Division of Vascular and Endovascular Surgery, Department of Surgery, Rua Borges Lagoa, 564 cj 124, Vila Clementino, São Paulo, Brazil, 04038000.

Background: Access to the femoral vessels is necessary for a wide range of vascular procedures, including treatment of thromboembolic disease, arterial grafts (i.e. bifemoral aortic bypass or infrainguinal bypass), endovascular repair of abdominal aortic aneurysm (EVAR), thoracic endovascular aneurysm repair (TEVAR) and transcatheter aortic valve implantation (TAVI). The surgical technique used to access the femoral artery may be a factor in the occurrence of postoperative complications; this will be the focus of our review. We will compare the transverse surgical technique-a cut made parallel to the groin crease-versus the vertical groin incision surgical technique-classic technique: a surgical cut made across the groin crease-to access the femoral artery, in an attempt to determine which technique has the lower rate of complications, is safer and is more effective.

Objectives: To evaluate the efficacy and safety of transverse groin incision compared with vertical groin incision for accessing the femoral artery in endovascular surgical procedures and open surgery.

Search Methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases, and the World Health Organization (WHO) International Clinical Trials Registry Platform and ClinicalTrials.gov to 17 February 2020. The review authors searched the IBECS database to 26 March 2020 and reference lists of relevant studies/papers.

Selection Criteria: We included randomized controlled trials (RCTs) and quasi-randomized trials (qRCTs) that compare transverse and vertical groin incision, during either endovascular or open surgery procedures.

Data Collection And Analysis: Two review authors (MVCRC, FCN) independently selected the studies, assessed risk of bias, extracted data, performed data analysis and graded the certainty of evidence according to GRADE.

Main Results: We included one RCT and one qRCT in this review. These two studies had a combined total of 237 participants (283 groins). Infection of the surgical wound was the only outcome that was similar in both studies, and that could therefore be submitted to a combined analysis. Meta-analysis of the two studies showed low-certainty evidence that transverse groin incision resulted in a lower risk of surgical wound infection in the 10- to 28-day period following surgery (risk ratio [RR] 0.25, 95% confidence interval [CI] 0.08 to 0.76; 2 studies; 283 groin incisions). There was low heterogeneity between the studies. We downgraded the certainty of the evidence for surgical wound infection by one level due to serious limitations in the design (there was a high risk of bias in critical domains). The confidence interval for surgical wound infection is relatively wide, further indicating that the certainty of the effect estimate is low. This is likely due to the small number of studies and participants. We observed no evidence of a difference between the two surgical techniques for the other evaluated primary outcome 'lymphatic complications': lymphocele (RR 0.46, 95% CI 0.20 to 1.02; 1 study; 116 groins); and lymphorrhea (RR 2.77, 95% CI 0.92 to 8.34; 1 study; 116 groins). We downgraded the certainty of evidence for lymphatic complications by one level due to serious limitations in the design (there was a high risk of bias in critical domains); and by two further levels because of imprecision (small number of participants and only one study included). High-quality studies are needed to enable a comparison of the two surgical techniques with respect to other outcomes, such as infection of the vascular graft (endoprosthesis/prosthesis), prolonged hospitalization, reoperative surgery, death, neurological deficit (e.g. paresthesia), amputation, graft patency, and postoperative pain.

Authors' Conclusions: In this systematic review, we found low-certainty evidence that performing transverse groin incision to access the femoral artery resulted in fewer surgical wound infections compared with performing vertical groin incision. We observed no evidence of a difference between the two surgical techniques for the other evaluated outcomes (lymphocele and lymphorrhea). Other outcomes were not evaluated in these studies. Limitations of this systematic review are, however, the small sample size, short clinical follow-up period and high risk of bias in critical domains. For this reason, the applicability of the results is limited.
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http://dx.doi.org/10.1002/14651858.CD013153.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7175778PMC
April 2020

Stem cell therapy for treatment of thromboangiitis obliterans (Buerger's disease).

Cochrane Database Syst Rev 2018 10 31;10:CD012794. Epub 2018 Oct 31.

Division of Vascular and Endovascular Surgery, Department of Surgery, UNIFESP - Escola Paulista de Medicina, Rua Borges Lagoa, 564 cj 124, Vila Clementino, São Paulo, Brazil, 04038000.

Background: Thromboangiitis obliterans, also known as Buerger's disease, is a non-atherosclerotic, segmental inflammatory pathology that most commonly affects the small- and medium-sized arteries, veins, and nerves in the upper and lower extremities. The etiology is unknown, but involves hereditary susceptibility, tobacco exposure, immune and coagulation responses. In many cases, there is no possibility of revascularization to improve the condition. Stem cell therapy is an option for patients with severe complications, such as ischemic ulcers or rest pain.

Objectives: To assess the effectiveness and safety of stem cell therapy in individuals with thromboangiitis obliterans (Buerger's disease).

Search Methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 17 October 2017. The review authors searched the European grey literature OpenGrey Database, screened reference lists of relevant studies and contacted study authors.

Selection Criteria: Randomized controlled trials (RCTs) or quasi-RCTs of stem cell therapy in thromboangiitis obliterans (Buerger's disease).

Data Collection And Analysis: The review authors (DC, DM, FN) independently assessed the studies, extracted data and performed data analysis.

Main Results: We only included one RCT (18 participants with thromboangiitis obliterans) comparing the implantation of stem cell derived from bone marrow with placebo and standard wound dressing care in this review. We identified no studies that compared stem cell therapy (bone marrow source) versus stem cell therapy (umbilical cord source), stem cell therapy (any source) versus pharmacological treatment and stem cell therapy (any source) versus sympathectomy. Ulcer healing was assessed in the form of ulcer size. The mean ulcer area decreased more in the stem cell implantation group: from 5.04 cm (standard deviation (SD) 0.70) to 1.48 cm (SD 0.56) compared with the control group: mean ulcer size area decreased from 4.68 cm (SD 0.62) to 3.59 cm (SD 0.14); mean difference (MD) -2.11 cm, 95% confidence interval (CI) -2.49 to -1.73; 1 study, 18 participants; very low-quality evidence. Pain-free walking distance showed more of an improvement in the stem cell implantation group: from mean of 38.33 meters (SD 17.68) to 284.44 meters (SD 212.12) compared with the control group: mean walking distance increased from 35.66 meters (SD 19.79) to 78.22 meters (SD 35.35); MD 206.22 meters, 95% CI 65.73 to 346.71; 1 study; 18 participants; very low-quality evidence.Outcomes such as rate of amputation, pain, amputation-free survival and adverse effects were not assessed.The quality of evidence was classified as very low, with only one study, small numbers of participants, high risk of bias in many domains and missing information regarding tobacco exposure status.

Authors' Conclusions: Very low-quality evidence suggests there may be an effect of the use of bone marrow-derived stem cells in the healing of ulcers and improvement in the pain-free walking distance in patients with Buerger's disease. High-quality trials assessing the effectiveness of stem cell therapy for treatment of patients with thromboangiitis obliterans (Buerger's disease) are needed.
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http://dx.doi.org/10.1002/14651858.CD012794.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6516882PMC
October 2018

Controlled hypotension versus normotensive resuscitation strategy for people with ruptured abdominal aortic aneurysm.

Cochrane Database Syst Rev 2018 06 13;6:CD011664. Epub 2018 Jun 13.

Division of Vascular and Endovascular Surgery, Department of Surgery, UNIFESP - Escola Paulista de Medicina, São Paulo, Brazil.

Background: An abdominal aortic aneurysm (AAA) is the pathological enlargement of the aorta and can develop in both men and women. Progressive aneurysm enlargement can lead to rupture. The rupture of an AAA is frequently fatal and accounts for the death from haemorrhagic shock of at least 45 people per 100,000 population. The outcome of people with ruptured AAA varies among countries and healthcare systems, with mortality ranging from 53% to 90%. Definitive treatment for ruptured AAA includes open surgery or endovascular repair. The management of haemorrhagic shock is crucial for the person's outcome and aims to restore organ perfusion and systolic blood pressure above 100 mmHg through immediate and aggressive fluid replacement. This rapid fluid replacement is known as the normotensive resuscitation strategy. However, evidence suggests that infusing large volumes of cold fluid causes dilutional and hypothermic coagulopathy. The association of these factors may exacerbate bleeding, resulting in a 'lethal triad' of hypothermia, acidaemia, and coagulopathy. An alternative to the normotensive resuscitation strategy is the controlled (permissive) hypotension resuscitation strategy, with a target systolic blood pressure of 50 mmHg to 100 mmHg. The principle of controlled or hypotensive resuscitation has been used in some management protocols for endovascular repair of ruptured AAA. It may be beneficial in preventing blood loss by avoiding the clot disruption caused by the rapid increase in systolic blood pressure; avoiding dilution of clotting factors, platelets and fibrinogen; and by avoiding the temperature decrease that inhibits enzyme activity involved in platelet and clotting factor function. This is an update of a review first published in 2016.

Objectives: To compare the effects of controlled (permissive) hypotension resuscitation and normotensive resuscitation strategies for people with ruptured AAA.

Search Methods: The Cochrane Vascular Information Specialist searched the Specialised Register (August 2017), the Cochrane Register of Studies (CENTRAL (2017, Issue 7)) and EMBASE (August 2017). The Cochrane Vascular Information Specialist also searched clinical trials databases (August 2017) for details of ongoing or unpublished studies.

Selection Criteria: We sought all published and unpublished randomised controlled trial (RCTs) that compared controlled hypotension and normotensive resuscitation strategies for the management of shock in patients with ruptured abdominal aortic aneurysms.

Data Collection And Analysis: Two review authors independently assessed identified studies for potential inclusion in the review. We used standard methodological procedures in accordance with the Cochrane Handbook for Systematic Review of Interventions.

Main Results: We identified no RCTs that met the inclusion criteria.

Authors' Conclusions: We found no RCTs that compared controlled hypotension and normotensive resuscitation strategies in the management of haemorrhagic shock in patients with ruptured abdominal aortic aneurysm that assessed mortality, presence of coagulopathy, intensive care unit length of stay, and the presence of myocardial infarct and renal failure. High quality studies that evaluate the best strategy for managing haemorrhagic shock in ruptured abdominal aortic aneurysms are required.
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http://dx.doi.org/10.1002/14651858.CD011664.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6513606PMC
June 2018

Surgical sympathectomy for Buerger's disease.

JRSM Open 2017 Aug 1;8(8):2054270417717666. Epub 2017 Aug 1.

Department of Surgery, Federal University of São Paulo (UNIFESP), São Paulo 55 04038000, Brazil.

Buerger's disease is characterized by recurring progressive inflammation and occlusions in small and medium arteries and veins of the limbs. Its cause is unknown, but it is most common in young men with a history of tobacco use. It is responsible for ischemic ulcers and extreme pain in the hands and feet. In many cases, notably in patients with the most severe presentations, there is no possibility of improving the condition with surgery (limb revascularisation), and therefore, alternative therapies (e.g. sympathectomy) is used. This review assessed the effectiveness of surgical sympathectomy compared with any other therapy in patients with Buerger's disease. As a result, only one randomised controlled study (162 participants) compared sympathectomy with prostacyclin analogue (iloprost) was incorporated to the review. Such comparison shown that iloprost is more effective than sympathectomy to complete healing ulcers at four weeks (risk ratio 0.65; 95% confidence interval 0.45 to 0.95; P = 0.02; very low quality evidence) and at twenty four weeks (risk ratio 0.62; 95% confidence interval 0.48 to 0.82; P < 0.01; very low quality evidence) after the start of treatment and to relief rest pain at four weeks (risk ratio 1.90; 95% confidence interval 1.17 to 3.10; P = 0.01; very low quality evidence) but not more effective at twenty four weeks (risk ratio 1.68; 95% confidence interval 1.00 to 2.84; P = .10; very low quality evidence) after the start of treatment. We concluded, with very low quality of evidence, that intravenous iloprost is more effective than lumbar sympathectomyin the healing of ischemic ulcers and pain at rest in patients with Buerger's disease. Therefore, until now, the preference of the usage of intravenous iloprost over the lumbar sympathectomy (and vice versa) does not find robust evidence for its routine use.
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http://dx.doi.org/10.1177/2054270417717666DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5542326PMC
August 2017

Controlled hypotension versus normotensive resuscitation strategy for people with ruptured abdominal aortic aneurysm.

Cochrane Database Syst Rev 2016 May 13(5):CD011664. Epub 2016 May 13.

Division of Vascular and Endovascular Surgery, Department of Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: An abdominal aortic aneurysm (AAA) is the pathological enlargement of the aorta and can develop in both men and women. Progressive aneurysm enlargement can lead to rupture. The rupture of an AAA is frequently fatal and accounts for the death from haemorrhagic shock of at least 45 people per 100,000 population. The outcome of people with ruptured AAA varies among countries and healthcare systems, with mortality ranging from 53% to 90%. Definitive treatment for ruptured AAA includes open surgery or endovascular repair. The management of haemorrhagic shock is crucial for the person's outcome and aims to restore organ perfusion and systolic blood pressure above 100 mm Hg through immediate and aggressive fluid replacement. This rapid fluid replacement is known as the normotensive resuscitation strategy. However, evidence suggests that infusing large volumes of cold fluid causes dilutional and hypothermic coagulopathy. The association of these factors may exacerbate bleeding, resulting in a 'lethal triad' of hypothermia, acidaemia, and coagulopathy. An alternative to the normotensive resuscitation strategy is the controlled (permissive) hypotension resuscitation strategy, with a target systolic blood pressure of 50 to 100 mm Hg. The principle of controlled or hypotensive resuscitation has been used in some management protocols for endovascular repair of ruptured AAA. It may be beneficial in preventing blood loss by avoiding the clot disruption caused by the rapid increase in systolic blood pressure; avoiding dilution of clotting factors, platelets and fibrinogen; and by avoiding the temperature decrease that inhibits enzyme activity involved in platelet and clotting factor function.

Objectives: To compare the effects of controlled (permissive) hypotension resuscitation and normotensive resuscitation strategies for people with ruptured AAA.

Search Methods: The Cochrane Vascular Information Specialist searched the Specialised Register (April 2016) and the Cochrane Register of Studies (CENTRAL (2016, Issue 3)). Clinical trials databases were searched (April 2016) for details of ongoing or unpublished studies.

Selection Criteria: We sought all published and unpublished randomised controlled trial (RCTs) that compared controlled hypotension and normotensive resuscitation strategies for the management of shock in patients with ruptured abdominal aortic aneurysms.

Data Collection And Analysis: Two review authors independently assessed identified studies for potential inclusion in the review. We used standard methodological procedures in accordance with the Cochrane Handbook for Systematic Review of Interventions.

Main Results: We identified no RCTs that met the inclusion criteria.

Authors' Conclusions: We found no RCTs that compared controlled hypotension and normotensive resuscitation strategies in the management of haemorrhagic shock in patients with ruptured abdominal aortic aneurysm that assessed mortality, presence of coagulopathy, intensive care unit length of stay, and the presence of myocardial infarct and renal failure. High quality studies that evaluate the best strategy for managing haemorrhagic shock in ruptured abdominal aortic aneurysms are required.
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http://dx.doi.org/10.1002/14651858.CD011664.pub2DOI Listing
May 2016

Pharmacological treatment for Buerger's disease.

Cochrane Database Syst Rev 2016 Mar 11;3:CD011033. Epub 2016 Mar 11.

Department of Surgery, UNIFESP - Escola Paulista de Medicina, Rua Borges Lagoa, 564 cj 124, Vila Clementino, São Paulo, Brazil, 04038000.

Background: Buerger's disease (thromboangiitis obliterans) is a non-atherosclerotic, segmental inflammatory pathology that most commonly affects the small and medium sized arteries, veins, and nerves in the upper and lower extremities. The etiology is unknown, but involves hereditary susceptibility, tobacco exposure, immune and coagulation responses. In many cases, there is no possibility of revascularization to improve the condition. Pharmacological treatment is an option for patients with severe complications, such as ischaemic ulcers or rest pain.

Objectives: To assess the effectiveness of any pharmacological agent (intravenous or oral) compared with placebo or any other pharmacological agent in patients with Buerger's disease.

Search Methods: The Cochrane Vascular Trials Search Co-ordinator searched their Specialised Register (last searched in April 2015) and the Cochrane Register of Studies (Issue 3, 2015). The review authors searched trial registers and the European grey literature; screened reference lists of relevant studies, and contacted study authors and major pharmaceutical companies.

Selection Criteria: Randomised controlled trials (RCTs) involving pharmacological agents used in the treatment of Buerger's disease.

Data Collection And Analysis: Two review authors, independently assessed the studies, extracted data and performed data analysis.

Main Results: Five randomised controlled trials (total 602 participants) compared prostacyclin analogue with placebo, aspirin, or a prostaglandin analogue, and folic acid with placebo. No studies assessed other pharmacological agents such as cilostazol, clopidogrel and pentoxifylline or compared oral versus intravenous prostanoid.Compared with aspirin, intravenous prostacyclin analogue iloprost improved ulcer healing (risk ratio (RR) 2.65; 95% confidence interval (CI) 1.15 to 6.11; 98 participants; one study; moderate quality evidence), and helped to eradicate rest pain after 28 days (RR 2.28; 95% CI 1.48 to 3.52; 133 participants; one study; moderate quality evidence), although amputation rates were similar six months after treatment (RR 0.32; 95% CI 0.09 to 1.15; 95 participants; one study; moderate quality evidence). When comparing prostacyclin (iloprost and clinprost) with prostaglandin (alprostadil) analogues, ulcer healing was similar (RR 1.13; 95% CI 0.76 to 1.69; 89 participants; two studies; I² = 0%; very low quality evidence), as was the eradication of rest pain after 28 days (RR 1.57; 95% CI 0.72 to 3.44; 38 participants; one study; low quality evidence), while amputation rates were not measured. Compared with placebo, the effects of oral prostacyclin analogue iloprost were similar for: healing ischaemic ulcers (iloprost 200 mcg: RR 1.11; 95% CI 0.54 to 2.29; 133 participants; one study; moderate quality evidence, and iloprost 400 mcg: RR 0.90; 95% CI 0.42 to 1.93; 135 participants; one study; moderate quality evidence), eradication of rest pain after eight weeks (iloprost 200 mcg: RR 1.14; 95% CI 0.79 to 1.63; 207 participants; one study; moderate quality evidence, and iloprost 400 mcg: RR 1.11; 95% CI 0.77 to 1.59; 201 participants; one study; moderate quality evidence), and amputation rates after six months (iloprost 200 mcg: RR 0.54; 95% CI 0.19 to 1.56; 209 participants; one study, and iloprost 400 mcg: RR 0.42; 95% CI 0.13 to 1.31; 213 participants; one study). When comparing folic acid with placebo in patients with Buerger's disease and hyperhomocysteinaemia, pain scores were similar, there were no new cases of amputation in either group, and ulcer healing was not assessed (very low quality evidence).Treatment side effects such as headaches, flushing or nausea were not associated with treatment interruptions or more serious consequences. Outcomes such as amputation-free survival, walking distance or pain-free walking distance, and ankle brachial index were not assessed by any study.Overall, the quality of the evidence was very low to moderate, with few studies, small numbers of participants, variation in severity of disease of participants between studies and missing information regarding for example baseline tobacco exposure.

Authors' Conclusions: Moderate quality evidence suggests that intravenous iloprost (prostacyclin analogue) is more effective than aspirin for eradicating rest pain and healing ischaemic ulcers in Buerger's disease, but oral iloprost is not more effective than placebo. Verylow and low quality evidence suggests there is no difference between prostacyclin (iloprost and clinprost) and the prostaglandin analogue alprostadil for healing ulcers and relieving pain respectively in severe Buerger's disease. Very-low quality evidence suggests there is no difference in pain scores and amputation rates between folic acid and placebo, in people with Buerger's disease and hyperhomocysteinaemia. High quality trials assessing the effectiveness of pharmacological agents (intravenous or oral) in people with Buerger's disease are needed.
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http://dx.doi.org/10.1002/14651858.CD011033.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7104255PMC
March 2016

Pharmacological treatment for Buerger's disease.

Cochrane Database Syst Rev 2016 Feb 1;2:CD011033. Epub 2016 Feb 1.

Department of Surgery, UNIFESP - Escola Paulista de Medicina, Rua Borges Lagoa, 564 cj 124, Vila Clementino, São Paulo, Brazil, 04038000.

Background: Buerger's disease (thromboangiitis obliterans) is a non-atherosclerotic, segmental inflammatory pathology that most commonly affects the small and medium sized arteries, veins, and nerves in the upper and lower extremities. The etiology is unknown, but involves hereditary susceptibility, tobacco exposure, immune and coagulation responses. In many cases, there is no possibility of revascularization to improve the condition. Pharmacological treatment is an option for patients with severe complications, such as ischaemic ulcers or rest pain.

Objectives: To assess the effectiveness of any pharmacological agent (intravenous or oral) compared with placebo or any other pharmacological agent in patients with Buerger's disease.

Search Methods: The Cochrane Vascular Trials Search Co-ordinator searched their Specialised Register (last searched in April 2015) and the Cochrane Register of Studies (Issue 3, 2015). The review authors searched trial registers and the European grey literature; screened reference lists of relevant studies, and contacted study authors and major pharmaceutical companies.

Selection Criteria: Randomised controlled trials (RCTs) involving pharmacological agents used in the treatment of Buerger's disease.

Data Collection And Analysis: Two review authors, independently assessed the studies, extracted data and performed data analysis.

Main Results: Five randomised controlled trials (total 602 participants) compared prostacyclin analogue with placebo, aspirin, or a prostaglandin analogue, and folic acid with placebo. No studies assessed other pharmacological agents such as cilostazol, clopidogrel and pentoxifylline or compared oral versus intravenous prostanoid.Compared with aspirin, intravenous prostacyclin analogue iloprost improved ulcer healing (risk ratio (RR) 2.65; 95% confidence interval (CI) 1.15 to 6.11; 98 participants; one study; moderate quality evidence), and helped to eradicate rest pain after 28 days (RR 2.28; 95% CI 1.48 to 3.52; 133 participants; one study; moderate quality evidence), although amputation rates were similar six months after treatment (RR 0.32; 95% CI 0.09 to 1.15; 95 participants; one study; moderate quality evidence). When comparing prostacyclin (iloprost and clinprost) with prostaglandin (alprostadil) analogues, ulcer healing was similar (RR 1.13; 95% CI 0.76 to 1.69; 89 participants; two studies; I² = 0%; very low quality evidence), as was the eradication of rest pain after 28 days (RR 1.57; 95% CI 0.72 to 3.44; 38 participants; one study; low quality evidence), while amputation rates were not measured. Compared with placebo, the effects of oral prostacyclin analogue iloprost were similar for: healing ischaemic ulcers (iloprost 200 mcg: RR 1.11; 95% CI 0.54 to 2.29; 133 participants; one study; moderate quality evidence, and iloprost 400 mcg: RR 0.90; 95% CI 0.42 to 1.93; 135 participants; one study; moderate quality evidence), eradication of rest pain after eight weeks (iloprost 200 mcg: RR 1.14; 95% CI 0.79 to 1.63; 207 participants; one study; moderate quality evidence, and iloprost 400 mcg: RR 1.11; 95% CI 0.77 to 1.59; 201 participants; one study; moderate quality evidence), and amputation rates after six months (iloprost 200 mcg: RR 0.54; 95% CI 0.19 to 1.56; 209 participants; one study, and iloprost 400 mcg: RR 0.42; 95% CI 0.13 to 1.31; 213 participants; one study). When comparing folic acid with placebo in patients with Buerger's disease and hyperhomocysteinaemia, pain scores were similar, there were no new cases of amputation in either group, and ulcer healing was not assessed (very low quality evidence).Treatment side effects such as headaches, flushing or nausea were not associated with treatment interruptions or more serious consequences. Outcomes such as amputation-free survival, walking distance or pain-free walking distance, and ankle brachial index were not assessed by any study.Overall, the quality of the evidence was very low to moderate, with few studies, small numbers of participants, variation in severity of disease of participants between studies and missing information regarding for example baseline tobacco exposure.

Authors' Conclusions: Moderate quality evidence suggests that intravenous iloprost (prostacyclin analogue) is more effective than aspirin for eradicating rest pain and healing ischaemic ulcers in Buerger's disease, but oral iloprost is not more effective than placebo. Verylow and low quality evidence suggests there is no difference between prostacyclin (iloprost and clinprost) and the prostaglandin analogue alprostadil for healing ulcers and relieving pain respectively in severe Buerger's disease. Very-low quality evidence suggests there is no difference in pain scores and amputation rates between folic acid and placebo, in people with Buerger's disease and hyperhomocysteinaemia. High quality trials assessing the effectiveness of pharmacological agents (intravenous or oral) in people with Buerger's disease are needed.
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http://dx.doi.org/10.1002/14651858.CD011033.pub2DOI Listing
February 2016
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