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2.
Ann Vasc Surg ; 82: 276-283, 2022 May.
Article in English | MEDLINE | ID: mdl-34785337

ABSTRACT

BACKGROUND: Social deprivation is associated with poor clinical outcomes. It is known to have an impact on length of stay and post-operative mortality across a number of other surgical specialties. This study evaluates the impact of social deprivation on outcomes following fenestrated endovascular aneurysm repair (FEVAR). METHODS: All elective FEVARs performed between 2010 and 2018 at a tertiary vascular center were analyzed. Deprivation (index of multiple deprivation [IMD]) data was sourced from the English indices of deprivation 2019, by postcode. Primary outcome was overall survival by Kaplan-Meier. Secondary outcomes included length of hospital stay (LOS) and complications. Cox-proportional hazard analyses were conducted. RESULTS: Some 132 FEVAR patients were followed-up for 3.7 (SD 2.2) years. Fifty-seven patients lived in areas with high levels of deprivation (IMD 1-3), 34 in areas with moderate deprivation (IMD 4-6) and 41 in areas with the lowest level (IMD 7-10) of deprivation. Groups were comparable for Age, BMI, AAA diameter and co-morbidity. A higher proportion of patients from deprived areas had renal failure (15% [26.3%] vs. 9% [11.8%] P = 0.019) but no overall difference in procedure time was observed (200 min [155-250] vs. 180 min [145-240] P = 0.412). Kaplan-Meier analysis demonstrated significantly poorer survival for patients living in areas with high levels of deprivation (IMD 1-3) (P = 0.03). Mortality was comparable for IMD 4-6 and 7-10 groups. Patients from the most deprived areas had longer hospital stay (6 days [4-9] vs. 5 [3-7] P = 0.005) and higher all-cause complication rates (21 [36.8%] vs. 14 [18.4%] P = 0.02). Decreasing IMD was associated with worse survival (HR -0.85 [0.75-0.97] [P = 0.02]). CONCLUSIONS: Social deprivation was associated with increased mortality, length of stay and all-cause complication rates in patients undergoing FEVAR for complex abdominal aortic aneurysm (AAA). These results may help direct preoptimization measures to improve outcomes in higher risk sub-groups.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aortic Aneurysm, Abdominal/complications , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Humans , Postoperative Complications/etiology , Retrospective Studies , Risk Factors , Social Deprivation , Treatment Outcome
3.
Aorta (Stamford) ; 9(5): 190-192, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34879401

ABSTRACT

With both stenosis and aneurysm, repairing a severely tortuous and coarcted aorta can present certain difficulties. The advent of hybrid arch frozen elephant trunk techniques, as well as other endovascular solutions, has produced safer surgical repair methods for such cases. We present the reconstruction and repair of a Type-1 thoracoabdominal aortic aneurysm using a staged approach in less-than-optimal anatomy. Interventions included hybrid frozen elephant trunk, balloon dilation, and thoracic endovascular repair.

4.
Cochrane Database Syst Rev ; 7: CD013662, 2021 07 08.
Article in English | MEDLINE | ID: mdl-34236703

ABSTRACT

BACKGROUND: An abdominal aortic aneurysm (AAA) is an abnormal dilation in the diameter of the abdominal aorta of 50% or more of the normal diameter or greater than 3 cm in total. The risk of rupture increases with the diameter of the aneurysm, particularly above a diameter of approximately 5.5 cm. Perioperative and postoperative morbidity is common following elective repair in people with AAA. Prehabilitation or preoperative exercise is the process of enhancing an individual's functional capacity before surgery to improve postoperative outcomes. Studies have evaluated exercise interventions for people waiting for AAA repair, but the results of these studies are conflicting. OBJECTIVES: To assess the effects of exercise programmes on perioperative and postoperative morbidity and mortality associated with elective abdominal aortic aneurysm repair. SEARCH METHODS: We searched the Cochrane Vascular Specialised register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Physiotherapy Evidence Database (PEDro) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 6 July 2020. We also examined the included study reports' bibliographies to identify other relevant articles. SELECTION CRITERIA: We considered randomised controlled trials (RCTs) examining exercise interventions compared with usual care (no exercise; participants maintained normal physical activity) for people waiting for AAA repair. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, assessed the included studies, extracted data and resolved disagreements by discussion. We assessed the methodological quality of studies using the Cochrane risk of bias tool and collected results related to the outcomes of interest: post-AAA repair mortality; perioperative and postoperative complications; length of intensive care unit (ICU) stay; length of hospital stay; number of days on a ventilator; change in aneurysm size pre- and post-exercise; and quality of life. We used GRADE to evaluate certainty of the evidence. For dichotomous outcomes, we calculated the risk ratio (RR) with the corresponding 95% confidence interval (CI). MAIN RESULTS: This review identified four RCTs with a total of 232 participants with clinically diagnosed AAA deemed suitable for elective intervention, comparing prehabilitation exercise therapy with usual care (no exercise). The prehabilitation exercise therapy was supervised and hospital-based in three of the four included trials, and in the remaining trial the first session was supervised in hospital, but subsequent sessions were completed unsupervised in the participants' homes. The dose and schedule of the prehabilitation exercise therapy varied across the trials with three to six sessions per week and a duration of one hour per session for a period of one to six weeks. The types of exercise therapy included circuit training, moderate-intensity continuous exercise and high-intensity interval training. All trials were at a high risk of bias. The certainty of the evidence for each of our outcomes was low to very low. We downgraded the certainty of the evidence because of risk of bias and imprecision (small sample sizes). Overall, we are uncertain whether prehabilitation exercise compared to usual care (no exercise) reduces the occurrence of 30-day (or longer if reported) mortality post-AAA repair (RR 1.33, 95% CI 0.31 to 5.77; 3 trials, 192 participants; very low-certainty evidence). Compared to usual care (no exercise), prehabilitation exercise may decrease the occurrence of cardiac complications (RR 0.36, 95% CI 0.14 to 0.92; 1 trial, 124 participants; low-certainty evidence) and the occurrence of renal complications (RR 0.31, 95% CI 0.11 to 0.88; 1 trial, 124 participants; low-certainty evidence). We are uncertain whether prehabilitation exercise, compared to usual care (no exercise), decreases the occurrence of pulmonary complications (RR 0.49, 95% 0.26 to 0.92; 2 trials, 144 participants; very low-certainty evidence), decreases the need for re-intervention (RR 1.29, 95% 0.33 to 4.96; 2 trials, 144 participants; very low-certainty evidence) or decreases postoperative bleeding (RR 0.57, 95% CI 0.18 to 1.80; 1 trial, 124 participants; very low-certainty evidence). There was little or no difference between the exercise and usual care (no exercise) groups in length of ICU stay, length of hospital stay and quality of life. None of the studies reported data for the number of days on a ventilator and change in aneurysm size pre- and post-exercise outcomes. AUTHORS' CONCLUSIONS: Due to very low-certainty evidence, we are uncertain whether prehabilitation exercise therapy reduces 30-day mortality, pulmonary complications, need for re-intervention or postoperative bleeding. Prehabilitation exercise therapy might slightly reduce cardiac and renal complications compared with usual care (no exercise). More RCTs of high methodological quality, with large sample sizes and long-term follow-up, are needed. Important questions should include the type and cost-effectiveness of exercise programmes, the minimum number of sessions and programme duration needed to effect clinically important benefits, and which groups of participants and types of repair benefit most.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Elective Surgical Procedures , Physical Conditioning, Human/methods , Preoperative Exercise , Aortic Aneurysm, Abdominal/mortality , Bias , Circuit-Based Exercise , Heart Diseases/epidemiology , Heart Diseases/prevention & control , High-Intensity Interval Training , Humans , Kidney Diseases/epidemiology , Kidney Diseases/prevention & control , Lung Diseases/epidemiology , Lung Diseases/prevention & control , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Postoperative Hemorrhage/epidemiology , Postoperative Hemorrhage/prevention & control , Randomized Controlled Trials as Topic , Reoperation , Time Factors
5.
Ann Vasc Surg ; 75: 120-127, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33905848

ABSTRACT

OBJECTIVE: The COVID-19 pandemic has forced the cancellation of planned surgery and led to significant surgical service reductions. Early intervention in aortovascular disease is often critical and cannot be deferred despite these reductions. There is urgent need to evaluate the provision and outcomes of thoracic aortovascular intervention during the peak of the pandemic. METHODS: Prospective data was collected for patients receiving open and endovascular thoracic aortovascular intervention over two-time points; January-May 2020 and January-May 2019 at three tertiary cardiovascular centres. Baseline demographics, cardiovascular risk and COVID-19 screening results were noted. Primary outcomes were median length of intensive care unit and hospital stay, intra-operative mortality, 30-day mortality, post-operative stroke, and spinal cord injury. RESULTS: Patients operated in 2020 (41) had significantly higher median EuroSCORE II than 2019 (53) (7.44 vs. 5.86, P = 0.032) and rates of previous cardiac (19.5% vs. 3.8%, P = 0.019), aortic (14.6% vs. 1.9%, P = 0.041), and endovascular (22.0% vs. 3.8%, P = 0.009) intervention. There was an increase in proportion of urgent cases in 2020 (31.7% vs. 18.9%). There were no intra-operative deaths in 2020 and 1 in 2019 (P = 1.00). There were no significant differences (P ≥ 0.05) in 30-day mortality (4.9% vs. 13.2%), median intensive care unit length of stay (72 vs. 70 hr), median hospital length of stay (8 vs. 9 days), post-operative stroke (3 vs. 6), or spinal cord injury (2 vs. 1) between 2020 and 2019 respectively. CONCLUSIONS: Despite the increased mortality risk of patients and urgency of cases during COVID-19, complicated by the introduction of cohorting and screening regimens, thoracic aortovascular intervention remained safe with comparable in outcomes to pre-COVID-19.


Subject(s)
Aorta, Thoracic/surgery , Aortic Diseases/surgery , COVID-19 , Vascular Surgical Procedures , Aged , Aged, 80 and over , Aorta, Thoracic/diagnostic imaging , Aortic Diseases/diagnostic imaging , Aortic Diseases/mortality , COVID-19/diagnosis , COVID-19/mortality , COVID-19/prevention & control , COVID-19/transmission , COVID-19 Testing , Databases, Factual , England , Female , Hospital Mortality , Humans , Length of Stay , Male , Middle Aged , Patient Safety , Postoperative Complications/etiology , Prospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/mortality
6.
Eur J Vasc Endovasc Surg ; 58(4): 602-608, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31495728

ABSTRACT

OBJECTIVES: The face and construct validity of a novel pulsatile human cadaver model (PHCM) was recently demonstrated for endovascular training. This study aimed to assess the model's educational impact. METHODS: Twenty-four endovascular novices were recruited and split into two equal training groups: PHCM and virtual reality simulator (VRS). Each candidate performed eight consecutive training attempts of endovascular renal artery catheterisation on their designated model, and a final crossover attempt on the alternate model. Performances were video recorded and scored using a validated scoring tool by two independent endovascular experts, blinded to the candidate's identity and attempt number. Each participant was given a task specific checklist score (TSC), global rating score (GRS), and overall procedure score (OPS). RESULTS: In the PHCM group average OPS improved gradually from 19.42 (TSC 8.58, GRS 10.83) to 39.50 (TSC 15.00, GRS 24.5) over eight attempts (p < .0005). In the VRS group OPS improved from 20.54 (TSC 10.29, GRS 10.25) to 36.04 (TSC 14.21, GRS 21.88) between the first and eighth attempts (p < .0005), with limited improvement after the second attempt. PHCM training significantly improved OPS on their VRS crossover attempt (p ≤ .0001), achieving a similar OPS to candidates who had completed VRS training (p = .398). VRS training significantly improved OPS on PHCM (p < 0.05); however, OPS was significantly worse than candidates who had completed PHCM training (p ≤ .001). CONCLUSIONS: PHCM training has a longer learning curve, with gradual improvement, reflecting the enhanced difficulty of a more realistic model. These results support the use of PHCM preceded by VRS training, prior to performing endovascular surgery on patients.


Subject(s)
Cadaver , Catheterization, Peripheral/methods , Education, Medical, Graduate/methods , Education, Medical, Undergraduate/methods , Endovascular Procedures/education , Pulsatile Flow , Renal Artery , Simulation Training , Clinical Competence , Cross-Over Studies , Curriculum , Humans , Learning Curve , Punctures , Students, Medical , Task Performance and Analysis , Video Recording
7.
J Orthop Case Rep ; 9(5): 59-62, 2019.
Article in English | MEDLINE | ID: mdl-32548006

ABSTRACT

INTRODUCTION: Vascular complications occurring secondary to osteochondroma are a rare phenomenona. They typically present insidiously with claudication, however, uncommonly may present with acute limb ischaemia. We present a case of a young boy who presented with acute limb ischaemia secondary to osteochondroma with an intraoperative diagnosis of popliteal pseudoaneurysm. CASE REPORT: A 15-year-old male presented with an acutely ischaemic limb. A computed tomography CT angiogram was performed which demonstrated complete occlusion of his popliteal artery secondary to a tumour of the distal femur. The patient underwent an open biopsy of the tumour followed by thrombectomy which failed to resolve the ischaemia. After further unsuccessful attempts at thrombectomy, angiography was performed which revealed a pseudoaneurysm. . The patient underwent a successful popliteal exclusion bypass using ipsilateral reversed long saphenous vein. The lesion was subsequently identified as an osteochondroma. The patient made a good recovery and at his latest follow-up is ambulant, free from claudication, and demonstrates good flow through the bypass on duplex ultrasonography. CONCLUSION: Acute limb ischaemia is a rare occurrence within the adolescent population and will, therefore, frequently be secondary to an uncommon aetiology. Whilst While osteochondroma are is a common cause of vascular complications in this population, the onset of symptoms is usually more insidious. The acute onset, in this case, therefore, raised uncertainty as to the potential for malignancy. The management of these patients should involve a combination of both vascular and orthopaedic surgery in order to return perfusion whilest also ensuring the offending lesion is managed appropriately. In patients where initial measures do not restore perfusion, then the potential for further complications such as pseudoaneurysm should be considered and managed promptly.

8.
Vasc Endovascular Surg ; 52(8): 607-612, 2018 Nov.
Article in English | MEDLINE | ID: mdl-30033825

ABSTRACT

PURPOSE:: Fenestrated endovascular aneurysm repair (FEVAR) grafts have a 10- to 12-week manufacturing time and are generally not available for emergency cases of symptomatic or ruptured aortic aneurysm. In the absence of other alternatives, conventional off-the-shelf stent grafts can be modified by trained operators to treat these complex cases. The aim of this study is to present a single-center experience of physician-modified FEVAR. METHODS:: A retrospective review was performed of all physician-modified FEVAR identified from the hospital endovascular database at a single tertiary referral center between September 1996 and September 2017. RESULTS:: Eight cases of urgent or emergency endovascular aneurysm repair (EVAR) with physician-modified grafts were identified. Mean follow-up was 44 weeks (range: 5-106 weeks). Outcomes for all implanted grafts (7/8 cases) included 100% technical success, 14% rate of endoleak, no procedure-related complications, no adverse visceral events, 0% 30-day mortality and 100% 1-year target vessel patency, and freedom from aneurysm-related death. There was a 14% (1/7 cases) per patient reintervention rate. CONCLUSION:: Modifying EVAR grafts is a highly technical process requiring meticulous planning and extensive elective experience with FEVAR. The current series demonstrates that physician modification of endografts for urgent or emergency abdominal aortic aneurysm repair is feasible and a safe alternative to open surgical aneurysm repair.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Adult , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/physiopathology , Aortic Rupture/diagnostic imaging , Aortic Rupture/physiopathology , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/etiology , Endovascular Procedures/adverse effects , Female , Humans , Male , Middle Aged , Prosthesis Design , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency
9.
Ann Vasc Surg ; 52: 237-243, 2018 Oct.
Article in English | MEDLINE | ID: mdl-29787852

ABSTRACT

BACKGROUND: We recently described a pulsatile fresh frozen human cadaver model (PHCM) for training endovascular practitioners. This present study aims to assess the construct validity of PHCM; its ability to differentiate between participants of varying expertise. METHODS: Twenty-three participants with varying endovascular experience (12 novice, 4 intermediate, and 7 expert) were recruited. Each attempted catheterization of the left renal artery on PHCM within 10 min under exam conditions. Performances were video recorded and scored using a validated scoring tool by 2 independent endovascular experts, blinded to performer status. Each participant was given a task-specific checklist score (TSC), global rating score (GRS), and overall procedure score (OPS). Finally, examiners were asked whether they would be happy to supervise the participant in theater, with each participant graded as "fail", "borderline," or "pass". RESULTS: All expert and intermediate participants completed the index procedure within the allotted 10 min; however, only one of the 12 novice participants achieved this (P < 0.0005). Endovascular novices had significantly lower TSC, GRS, and OPS than both intermediate participants and endovascular experts. There were no significant differences in TSC, GRS, or OPS between intermediate participants and endovascular experts. When participants were graded as "fail", "borderline," or "pass," there were significant differences between groups (P = 0.001). All of the intermediate and expert participants received a pass. Out of the 12 novice participants, 2 received a pass, 6 received a borderline, and 4 were failed. CONCLUSIONS: The PHCM demonstrates construct validity. Further work is required to determine its educational impact in endovascular training.


Subject(s)
Cadaver , Catheterization, Peripheral , Education, Medical, Graduate/methods , Endovascular Procedures/education , Models, Cardiovascular , Pulsatile Flow , Renal Artery , Clinical Competence , Educational Measurement , Humans , Learning Curve , Punctures , Renal Artery/diagnostic imaging , Task Performance and Analysis , Time Factors , Video Recording
10.
Ann Vasc Surg ; 46: 345-350, 2018 Jan.
Article in English | MEDLINE | ID: mdl-28887245

ABSTRACT

BACKGROUND: The authors have published their design of a pulsatile fresh frozen human cadaver circulation model (PHCM) for endovascular training the face validity of the PHCM for training endovascular practitioners was subsequently assessed. METHODS: Twelve endovascular clinicians performed the same 2 procedures (catheterization of the left renal artery and left subclavian artery) on PHCM and Simbionix angiomentor virtual reality simulator (SVR). They were randomized to begin on either the PHCM or SVR. A pretrial questionnaire determined participants' endovascular experience. After training, participants rated statements relating to their experience on a numerical scale from 1 to 5, with 1 representing the strongest agreement with the statement. RESULTS: When participants were asked to compare the realism of training modalities with live patients, PHCM scored significantly higher than SVR on statements regarding "realism of vascular access" (P = 0.002), "guide-wire manipulation" (P = 0.001), and "vessel catheterization" (P = 0.004). Candidates again favored PHCM as "a valuable learning exercise" (P = 0.016) and strongly favored PHCM as a "useful training model" compared to SVR (P = 0.004). CONCLUSIONS: This is the first published trial in world literature to assess the validity of a PHCM for training endovascular practitioners. The PHCM demonstrates good face validity when compared to both real patients and the SVR model and holds exciting potential.


Subject(s)
Blood Circulation , Cadaver , Catheterization, Peripheral , Education, Medical, Graduate/methods , Endovascular Procedures/education , High Fidelity Simulation Training , Models, Cardiovascular , Pulsatile Flow , Renal Artery , Subclavian Artery , Attitude of Health Personnel , Clinical Competence , Computer Simulation , Humans , Punctures , Radiologists , Renal Artery/diagnostic imaging , Subclavian Artery/diagnostic imaging , Surgeons
11.
Ann Vasc Surg ; 44: 425-430, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28479447

ABSTRACT

BACKGROUND: The objective of this project was to create a model capable of training endovascular skills using a freshly frozen human cadaver (HC). We present the results of our experience creating a cadaveric model for endovascular skills training. We undertook a unique cadaver laboratory-based research project. METHODS: We favor a minimally invasive surgical technique with inflow into the right common carotid artery and outflow through the left common femoral and right superficial femoral arteries. Endovascular access was through the right common femoral artery. RESULTS: Through this technique, the arch, thoracic, abdominal, and iliac vessels are all accessible. We perfuse the model through an open pulsatile flow circuit at varying rates to maximize angiographic image capture while minimizing cadaveric edema thus expanding the models longevity. CONCLUSIONS: A fresh frozen pulsatile human cadaver training model is a feasible and credible training model that has exciting potential for endovascular skills training.


Subject(s)
Aorta, Abdominal/surgery , Cadaver , Education, Medical, Graduate/methods , Endovascular Procedures/education , Models, Anatomic , Models, Cardiovascular , Perfusion/methods , Pulsatile Flow , Aorta, Abdominal/diagnostic imaging , Aorta, Abdominal/physiology , Carotid Artery, Common/physiology , Carotid Artery, Common/surgery , Cryopreservation , Femoral Artery/physiology , Femoral Artery/surgery , Humans , Regional Blood Flow
12.
Ann Transl Med ; 5(3): 42, 2017 Feb.
Article in English | MEDLINE | ID: mdl-28251121

ABSTRACT

BACKGROUND: Three-dimensional (3D) printing is a manufacturing process in which an object is created by specialist printers designed to print in additive layers to create a 3D object. Whilst there are initial promising medical applications of 3D printing, a lack of evidence to support its use remains a barrier for larger scale adoption into clinical practice. Endovascular virtual reality (VR) simulation plays an important role in the safe training of future endovascular practitioners, but existing VR models have disadvantages including cost and accessibility which could be addressed with 3D printing. METHODS: This study sought to evaluate the feasibility of 3D printing an anatomically accurate human aorta for the purposes of endovascular training. RESULTS: A 3D printed model was successfully designed and printed and used for endovascular simulation. The stages of development and practical applications are described. Feedback from 96 physicians who answered a series of questions using a 5 point Likert scale is presented. CONCLUSIONS: Initial data supports the value of 3D printed endovascular models although further educational validation is required.

13.
Cochrane Database Syst Rev ; (12): CD010957, 2015 Dec 04.
Article in English | MEDLINE | ID: mdl-26636644

ABSTRACT

BACKGROUND: Pulmonary embolism is a potentially life-threatening condition in which a clot can travel from the deep veins, most commonly in the leg, up to the lungs. Previously, a pulmonary embolism was treated with the anticoagulants heparin and vitamin K antagonists. Recently, however, two forms of direct oral anticoagulants (DOACs) have been developed: oral direct thrombin inhibitors (DTI) and oral factor Xa inhibitors. The new drugs have characteristics that may be favourable over conventional treatment, including oral administration, a predictable effect, lack of frequent monitoring or re-dosing and few known drug interactions. To date, no Cochrane review has measured the effectiveness and safety of these drugs in the long-term treatment (minimum duration of three months) of pulmonary embolism. OBJECTIVES: To assess the effectiveness of oral DTIs and oral factor Xa inhibitors for the long-term treatment of pulmonary embolism. SEARCH METHODS: The Cochrane Vascular Trials Search Co-ordinator searched the Specialised Register (last searched January 2015) and the Cochrane Register of Studies (last searched January 2015). Clinical trials databases were also searched for details of ongoing or unpublished studies. We searched the reference lists of relevant articles retrieved by electronic searches for additional citations. SELECTION CRITERIA: We included randomised controlled trials in which patients with a pulmonary embolism confirmed by standard imaging techniques were allocated to receive an oral DTI or an oral factor Xa inhibitor for the long-term (minimum duration three months) treatment of pulmonary embolism. DATA COLLECTION AND ANALYSIS: Two review authors (LR, JM) independently extracted the data and assessed the risk of bias in the trials. Any disagreements were resolved by discussion with the third author (PK). We used meta-analyses when we considered heterogeneity low. The two primary outcomes were recurrent venous thromboembolism and pulmonary embolism. Other outcomes included all-cause mortality and major bleeding. We calculated all outcomes using an odds ratio (OR) with a 95% confidence interval (CI). MAIN RESULTS: We included five randomised controlled trials with a total of 7897 participants. Two studies tested oral DTIs (dabigatran) and three studies tested oral factor Xa inhibitors (one rivaroxaban, one edoxaban and one apixaban).Analysis showed no difference in the effectiveness of oral DTIs and standard anticoagulation in preventing recurrent pulmonary embolism (OR 1.02, 95% CI 0.50 to 2.04; two studies; 1602 participants; high quality evidence), recurrent venous thromboembolism (OR 0.93, 95% CI 0.52 to 1.66; two studies; 1602 participants; high quality evidence), deep vein thrombosis (DVT) (OR 0.79, 95% CI 0.29 to 2.13; two studies; 1602 participants; high quality evidence) and major bleeding (OR 0.50, 95% CI 0.15 to 1.68; two studies; 1527 participants; high quality evidence).For oral factor Xa inhibitors, when we combined the three included studies together in meta-analyses, there was significant heterogeneity for recurrent pulmonary embolism (OR 1.08, 95% CI 0.46 to 2.56; two studies; 4509 participants; I(2) = 58%; moderate quality evidence). The oral factor Xa inhibitors were no more or less effective in the prevention of recurrent venous thromboembolism (OR 0.85, 95% CI 0.63 to 1.15; three studies; 6295 participants; high quality evidence), DVT (OR 0.72, 95% CI 0.39 to 1.32; two studies; 4509 participants; high quality evidence), all-cause mortality (OR 1.16, 95% CI 0.79 to 1.70; one study; 4817 participants; moderate quality evidence) or major bleeding (OR 0.97, 95% CI 0.59 to 1.62; two studies; 4507 participants; high quality evidence). None of the studies measured quality of life. AUTHORS' CONCLUSIONS: Moderate to high quality evidence suggests that there are no differences between DOACs and standard anticoagulation for the long-term treatment of pulmonary embolism, for the outcomes recurrent pulmonary embolism, recurrent venous thromboembolism, DVT, all-cause mortality and major bleeding.


Subject(s)
Anticoagulants/therapeutic use , Antithrombins/therapeutic use , Factor Xa Inhibitors/therapeutic use , Pulmonary Embolism/drug therapy , Administration, Oral , Dabigatran/therapeutic use , Humans , Pyrazoles/therapeutic use , Pyridines/therapeutic use , Pyridones/therapeutic use , Randomized Controlled Trials as Topic , Recurrence , Rivaroxaban/therapeutic use , Secondary Prevention , Thiazoles/therapeutic use , Venous Thromboembolism/prevention & control , Venous Thrombosis/prevention & control
14.
Cochrane Database Syst Rev ; (6): CD010956, 2015 Jun 30.
Article in English | MEDLINE | ID: mdl-26123214

ABSTRACT

BACKGROUND: Deep vein thrombosis (DVT) is a condition in which a clot forms in the deep veins, most commonly of the leg. It occurs in approximately 1 in 1,000 people. If left untreated, the clot can travel up to the lungs and cause a potentially life-threatening pulmonary embolism (PE). Previously, a DVT was treated with the anticoagulants heparin and vitamin K antagonists. However, two forms of novel oral anticoagulants (NOACs) have been developed: oral direct thrombin inhibitors (DTI) and oral factor Xa inhibitors. The new drugs have characteristics that may be favourable over conventional treatment, including oral administration, a predictable effect, lack of frequent monitoring or re-dosing and few known drug interactions. To date, no Cochrane review has measured the effectiveness and safety of these drugs in the treatment of DVT. OBJECTIVES: To assess the effectiveness of oral DTIs and oral factor Xa inhibitors for the treatment of DVT. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched January 2015) and the Cochrane Register of Studies (last searched January 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations. SELECTION CRITERIA: We included randomised controlled trials in which people with a DVT confirmed by standard imaging techniques, were allocated to receive an oral DTI or an oral factor Xa inhibitor for the treatment of DVT. DATA COLLECTION AND ANALYSIS: Two review authors (LR, JM) independently extracted the data and assessed the risk of bias in the trials. Any disagreements were resolved by discussion with the third review author (PK). We performed meta-analyses when we considered heterogeneity low. The two primary outcomes were recurrent VTE and PE. Other outcomes included all-cause mortality and major bleeding. We calculated all outcomes using an odds ratio (OR) with a 95% confidence interval (CI). MAIN RESULTS: We included 11 randomised controlled trials of 27,945 participants. Three studies tested oral DTIs (two dabigatran and one ximelagatran), while eight tested oral factor Xa inhibitors (four rivaroxaban, two apixaban and two edoxaban). We deemed all included studies to be of high methodological quality and low risk of bias. The quality of the evidence was graded as high as the outcomes were direct and effect estimates were consistent and precise, as reflected in the narrow CIs around the ORs. Meta-analysis of three studies (7596 participants) comparing oral DTIs with standard anticoagulation groups showed no difference in the rate of recurrent VTE (OR 1.09; 95% CI 0.80 to 1.49), recurrent DVT (OR 1.08; 95% CI 0.74 to 1.58), fatal PE (OR 1.00; 95% CI 0.27 to 3.70), non-fatal PE (OR 1.12; 95% CI 0.66 to 1.90) or all-cause mortality (OR 0.82; 95% CI 0.60 to 1.13). However, oral DTIs were associated with reduced bleeding (OR 0.68; 95% CI 0.47 to 0.98). Meta-analysis of eight studies (16,356 participants) comparing oral factor Xa inhibitors with standard anticoagulation demonstrated a similar rate of recurrent VTE between the two treatments (OR 0.89; 95% CI 0.73 to 1.07). Oral factor Xa inhibitors were associated with a lower rate of recurrent DVT (OR 0.75; 95% CI 0.57 to 0.98). However, this was a weak association, heavily dependent on one study. The rate of fatal (OR 1.20; 95% CI 0.71 to 2.03), non-fatal PE (OR 0.94; 95% CI 0.68 to 1.28) and all-cause mortality (OR 0.90; 95% CI 0.65 to 1.23) was similar between the two treatment groups. Oral factor Xa inhibitors were also associated with reduced bleeding (OR 0.57; 95% CI 0.43 to 0.76). None of the included studies measured post-thrombotic syndrome or health-related quality of life. AUTHORS' CONCLUSIONS: NOACs such as DTIs and factor Xa inhibitors may be an effective and safe alternative to conventional anticoagulation treatment for acute DVT.


Subject(s)
Antithrombins/administration & dosage , Factor Xa Inhibitors/administration & dosage , Venous Thrombosis/drug therapy , Administration, Oral , Azetidines/administration & dosage , Benzylamines/administration & dosage , Dabigatran/administration & dosage , Humans , Pyrazoles/administration & dosage , Pyridines/administration & dosage , Pyridones/administration & dosage , Randomized Controlled Trials as Topic , Rivaroxaban/administration & dosage , Thiazoles/administration & dosage
15.
Cochrane Database Syst Rev ; (8): CD005507, 2013 Aug 11.
Article in English | MEDLINE | ID: mdl-23934945

ABSTRACT

BACKGROUND: Percutaneous balloon angioplasty is an endovascular technique for restoring blood flow through an artery that has become narrowed or blocked by atherosclerosis. Narrowing of the artery following angioplasty (restenosis) is the major cause of long-term failure. Cryoplasty offers a different approach to improving long-term angioplasty results. It combines the dilation force of balloon angioplasty with cooling of the vessel wall. This systematic review evaluated cryoplasty in peripheral arterial disease and provides focus for further research in the field. This is an update of a review first published in 2007. OBJECTIVES: To assess the efficacy of, and complications associated with, cryoplasty for maintaining patency in the iliac, femoropopliteal and crural arteries in the short and medium term. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched October 2012) and CENTRAL (2012, Issue 10). Trial databases were searched for ongoing or unpublished studies. We also searched the reference lists of relevant articles. SELECTION CRITERIA: All randomised controlled trials in which participants with peripheral arterial disease (PAD) of the lower limbs, or lower limb bypass graft stenoses, were randomised to cryoplasty with or without another procedure versus a procedure without cryoplasty were considered. This included trials where all participants received angioplasty and the randomisation was for cryoplasty versus no cryoplasty and trials where cryoplasty was used as an adjunct to conventional treatment (for example stenting) against a control. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed, assessed and selected trials, extracted data and assessed risk of bias. MAIN RESULTS: Seven trials (six primary cryoplasty and one adjunctive cryoplasty trial) with a combined total of 478 patients were included in this review. The trials reported patency and restenosis either by participant, lesion or vessel location. Follow-up ranged from 30 days to three years.Target lesion patency measured at various time points in two primary cryoplasty trials showed no statistically significant difference between the treatment groups. The adjunctive cryoplasty study showed that cryoplasty was associated with improved patency only at six months (OR 5.37, 95% CI 1.09 to 26.49, n = 90).Restenosis measured per patient (two primary cryoplasty trials) showed no statistically significant difference between the treatments. Restenosis measured by lesion (two primary cryoplasty trials) showed a statistically significant difference only within 24 hours of the procedure (OR 0.08, 95% CI 0.04 to 0.18, n = 192) favouring cryoplasty.Need for re-intervention was not significantly different in primary cryoplasty trial participants (per participant: OR 0.27, 95% CI 0.05 to 1.52, n = 241, I(2) = 89%; per lesion: OR 0.59, 95% CI 0.06 to 5.69, n = 307, I(2) = 94%). The adjunctive cryoplasty trial did not report on need for intervention.Immediate success of procedure (within 24 hours) was not significantly different in primary cryoplasty trial participants (per participant: OR 1.63, 95% CI 0.14 to 19.55, n = 340, I(2) = 95%; per lesion: OR 1.81, 95% CI 0.19 to 17.36, n = 397, I(2) = 90%). The adjunctive cryoplasty trial reported 100% success.Limb loss, deaths from all causes and the risk of complications immediately after treatment showed no statistically significant differences between the treatments. AUTHORS' CONCLUSIONS: The benefit of cryoplasty over conventional angioplasty cannot be established as the number of randomised controlled trials is small and their quality is not sufficiently high. The technical success and primary patency rates seen in these trials are inconsistent and do not necessarily suggest a future role for cryoplasty in the treatment of PAD, but they cannot be reliably interpreted. Currently there are insufficient data to support the routine use of cryoplasty over conventional balloon angioplasty in the treatment of PAD.


Subject(s)
Angioplasty, Balloon/methods , Atherosclerosis/therapy , Cryotherapy/methods , Peripheral Vascular Diseases/therapy , Combined Modality Therapy/methods , Humans , Randomized Controlled Trials as Topic , Recurrence , Retreatment , Time Factors
16.
Cochrane Database Syst Rev ; 11: CD006512, 2012 Nov 14.
Article in English | MEDLINE | ID: mdl-23152237

ABSTRACT

BACKGROUND: Aortic dissection is a potentially life-threatening condition that occurs when a tear forms in the inner lining of the aorta. It has traditionally been treated by blood pressure control (medical treatment) or open surgery, both with high mortality rates. More recently stent-graft repair has been suggested as an alternative. OBJECTIVES: To identify the best management for uncomplicated (without rupture of the organs or malperfusion of the extremities) subacute or chronic type B aortic dissection. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched their Specialised Register (last searched May 2012) and CENTRAL (2012, Issue 4). Clinical trials databases were searched for ongoing or unpublished studies. SELECTION CRITERIA: All randomised controlled trials designed to compare the outcome of uncomplicated (without rupture of the organs or malperfusion of the extremities) chronic (occurring more than two weeks previously) type B aortic dissection when treated by stenting adjunctive to best medical treatment versus best medical treatment alone were included. DATA COLLECTION AND ANALYSIS: Data on all cause and aorta-related mortality at two years was collected and analysed. In addition, secondary outcome measures were analysed, including morbidity, complications (additional endovascular or open surgery for rupture, expansion or malperfusion) and quality of life. MAIN RESULTS: A single trial was identified that fulfilled the inclusion criteria (INSTEAD trial). The two-year all cause survival was not statistically significantly different between study groups (95.6% ± 2.5% in the optimised medical therapy (OMT) group and 88.9% ± 3.7% in the thoracic endovascular aneurysm repair (TEVAR) + OMT group; log rank test P = 0.15). AUTHORS' CONCLUSIONS: Overall, the data at two years were insufficient to make any practice recommendations. However, the data on the anatomic remodeling of dissected aortas observed after TEVAR + OMT is encouraging and future studies should follow up cases for at least five years to see if early endovascular interventions, even in stable initially uncomplicated type B patients, are of long-term benefit.


Subject(s)
Aortic Aneurysm, Thoracic/therapy , Aortic Dissection/therapy , Stents , Aortic Dissection/mortality , Aortic Aneurysm, Thoracic/mortality , Chronic Disease , Endovascular Procedures/methods , Humans , Randomized Controlled Trials as Topic
17.
Angiology ; 61(1): 74-7, 2010.
Article in English | MEDLINE | ID: mdl-19689992

ABSTRACT

OBJECTIVE: Assess outcomes of ilio-politeal grafting for complex ilio-femoral atherosclerotic disease. DESIGN: Retrospective review of patients undergoing iliopopliteal grafting between January 1998 and January 2007. METHODS: Patients were identified from our unit database. Case notes and radiology were retrieved. Data were extracted and entered into the database for analysis. RESULTS: 19 grafts were undertaken in 19 patients. Primary graft patency was 45% at 1 year (95% CI, 22% - 68%). Secondary graft patency was 82.5% at one year (95% CI, 64% - 100%). 25 subsequent surgical and radiological interventions were undertaken in 12 patients. Lower limb amputation was rare; limb survival was 88% (95% CI, 72% - 100%) at one year and 73% (95% CI 44% - 100%) at 4 years. CONCLUSIONS: Iliopopliteal grafts are rarely undertaken severe disease requiring their use is infrequently encountered. High mortality and low primary patency mean its use can only be advocated in exceptional circumstances.


Subject(s)
Atherosclerosis/surgery , Blood Vessel Prosthesis , Iliac Artery/surgery , Peripheral Vascular Diseases/surgery , Popliteal Artery/surgery , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Retrospective Studies , Treatment Outcome , Vascular Surgical Procedures/methods
18.
Cases J ; 2(1): 107, 2009 Jan 30.
Article in English | MEDLINE | ID: mdl-19183456

ABSTRACT

INTRODUCTION: The management of concurrently occurring abdominal aortic aneurysm and another intra-abdominal pathology is controversial and represents a difficult management problem for the surgeon. Most surgeons are reluctant to perform a second non vascular procedure at the time of the aneurysm repair because of the risk of graft infection. Some evidence suggests that the one-stage elective surgical treatment in selected patients with concomitant abdominal aortic aneurysm and other pathologies; especially Gastro-Intestinal malignancies, is safe with superior cost effectiveness. However, there is a major dilemma in the management patients with large aneurysm which require an urgent repair and presented with concomitant pathologies that carry a high risk of sepsis. In this case report, we describe an unusual presentation of a large aneurysm with concomitant Acute Appendicitis where both needed an urgent surgical intervention. To our best knowledge, there has been no similar case report published in literature. CASE REPORT: A 66 years old Caucasian male presented with a dual pathology of large abdominal aortic aneurysm and acute appendicitis. The diagnosis was confirmed by Computerized Tomography scan of his abdomen. He underwent a 2-stage operation; open Appendicectomy followed by open repair of his aneurysm to avoid the risk of graft infection. He had an uneventful recovery period with a full return to normal life. CONCLUSION: The incidence of patients with abdominal aortic aneurysm and coexistent intra-abdominal surgical pathology is increasing, and the surgical strategy for those patients remains controversial. There are not enough studies that looked directly into the management of large abdominal aortic aneurysm which require an urgent repair and presented with concomitant pathologies that carry a high risk of sepsis. In such situations, simultaneous operations should be avoided because of the risk of prosthetic graft infection and priority should be given to the symptomatic or most life threatening condition. The second pathology should be dealt with as soon as possible; preferably within the same admission. More studies are needed to look into this issue; however, this would be rather difficult because of the uncommon and complex nature of such presentations.

20.
Curr Drug Saf ; 1(3): 281-7, 2006 Aug.
Article in English | MEDLINE | ID: mdl-18690939

ABSTRACT

INTRODUCTION: Patients requiring major cardiovascular surgery are likely to be prescribed antiplatelet agents either alone or in combination. By virtue of antiplatelet agent effect, they can potentially increase bleeding complications, especially if used in combination. This article aims to review the evidence and make appropriate recommendations regarding these agents. ASPIRIN: 16 papers are reviewed which concern surgery whilst taking aspirin. The bulk of the evidence is from the coronary bypass setting. CLOPIDOGREL: 14 papers are reviewed which concern surgery whilst taking clopidogrel. DIPYRIDAMOLE: 2 papers are reviewed concerning dipyridamole. CILOSTAZOL: No trials are available concerning surgery and cilostazol. Several relevant publications are reviewed. CONCLUSION: It is the recommendation of the authors that aspirin should usually be continued perioperatively, whilst clopidogrel should be stopped for seven days prior to surgery if at all possible.


Subject(s)
Cardiovascular Surgical Procedures , Platelet Aggregation Inhibitors/adverse effects , Postoperative Hemorrhage/chemically induced , Postoperative Hemorrhage/epidemiology , Aspirin/adverse effects , Aspirin/therapeutic use , Cilostazol , Clopidogrel , Dipyridamole/adverse effects , Dipyridamole/therapeutic use , Humans , Platelet Aggregation Inhibitors/therapeutic use , Risk , Tetrazoles/adverse effects , Tetrazoles/therapeutic use , Ticlopidine/adverse effects , Ticlopidine/analogs & derivatives , Ticlopidine/therapeutic use
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