Publications by authors named "Ahmed Kayssi"

47 Publications

The timing of amputation of mangled lower extremities does not predict post-injury outcomes and mortality: A retrospective analysis from the ACS TQIP database.

J Trauma Acute Care Surg 2021 09;91(3):447-456

From the Institute of Health Policy, Management, and Evaluation (B.W.T., M.P.G., A.B.N., B.H.), University of Toronto, Toronto, Ontario, Canada; Interdepartmental Division of Critical Care Medicine (B.W.T., B.H.), University of Toronto, Toronto, Ontario, Canada; Department of Critical Care Medicine (B.W.T., B.H.), Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Surgery (M.P.G., A.B.N., C.dM., A.K., B.H.), University of Toronto, Toronto, Ontario, Canada; Sunnybrook Research Institute (A.B.N., A.K., B.H.), Toronto, Ontario, Canada; Division of Vascular Surgery (C.dM.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada; and Division of Vascular Surgery (A.K.), Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.

Background: While limb salvage does not result in improved functional outcomes among patients with a mangled lower extremity, the impact of attempted limb salvage on mortality and complications is poorly understood. The objective of this study was to evaluate the relationship between attempted limb salvage and in-hospital outcomes among patients with a mangled lower extremity.

Methods: We performed a retrospective cohort study of adults, 16 years or older, with a mangled lower extremity. Data were derived from the American College of Surgeons' Trauma Quality Improvement Program (2012-2017). We compared mortality, complications (severe sepsis, acute kidney injury [AKI], decubitus ulcers) and length of stay between patients managed with the intention of limb salvage (amputation beyond 24 hours or no amputation) and those who underwent early amputation (within 24 hours of presentation). Instrumental variable analysis was used to evaluate the relationship between management strategy and outcomes.

Results: We identified 5,527 patients with a mangled lower extremity, of which 901 (16.3%) underwent early amputation. Among those managed with attempted limb salvage, 42.5% underwent amputation prior to discharge. After adjusting for patient and hospital characteristics, there was no association between initial management strategy and mortality (odds ratio, 1.20; 95% confidence interval [CI], 0.83-1.74 early amputation vs. attempted limb salvage). Early amputation was associated with lower odds of AKI (OR, 0.59; 95% CI, 0.39-0.88) and a trend toward shorter length of stay (relative risk, 0.77; 95% CI, 0.52-1.14).

Conclusion: Over half of patients who sustain a mangled lower extremity undergo amputation during their initial hospital course. While a limb salvage strategy is associated with an elevated risk of AKI, there is no association between attempted limb preservation and mortality. These findings suggest that in patients in which there is no clear indication for early amputation, attempts at limb salvage do not come at the cost of increased mortality.

Level Of Evidence: Therapeutic study, level IV.
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http://dx.doi.org/10.1097/TA.0000000000003302DOI Listing
September 2021

Perioperative Outcomes for Centers Routinely Admitting Postoperative Endovascular Aortic Aneurysm Repair to the ICU.

J Am Coll Surg 2021 06 19;232(6):856-863. Epub 2021 Apr 19.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA. Electronic address:

Background: Intensive care unit (ICU) admission after endovascular aortic aneurysm repair (EVAR) varies across medical centers. We evaluated the association of postoperative ICU use with perioperative and long-term outcomes after EVAR.

Study Design: The Vascular Quality Initiative (2003-2019) was queried for index elective EVARs. Included centers were categorized by percentage of patients with EVARs postoperatively admitted to the ICU; routine ICU (rICU) centers as ≥80% ICU admissions and nonroutine ICU (nrICU) centers as ≤20% ICU admissions. Patients admitted preoperatively or with same day discharge were excluded. Perioperative outcomes and survival were compared between rICU and nrICU centers.

Results: Of 45,310 EVARs in the database, 35,617 were performed at rICU or nrICU centers - 5,443 (15.3%) at 71 rICU centers and 30,174 (84.7%) at 200 nrICU centers. Overall, mean age was 73.4 years and 81.6% were male. Postoperative myocardial infarction, pulmonary complications, stroke, leg ischemia, and in-hospital mortality were similar between rICU and nrICU centers (all p > 0.05). Postoperative length of stay (LOS) was prolonged at rICU centers (mean) (2.2 ± 3.6 vs 2 ± 4.2 days, p < 0.001). One-year survival was similar between rICU and nrICU centers, respectively, (94.9% vs 95.4%, p = 0.085). When compared with nrICU centers, rICU centers had similar 1-year mortality risk (hazard ratio [HR] 1.15, 95% CI 0.99-1.34, p = 0.076), but were associated with longer postoperative LOS (means ratio 1.1, 95% CI 1.08-1.13, p < 0.001).

Conclusions: Routine ICU use after EVAR was associated with prolonged postoperative LOS, without improved perioperative/long-term morbidity or mortality. Updated care pathways to include postoperative admission to lower acuity care units may reduce costs without compromising care.
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http://dx.doi.org/10.1016/j.jamcollsurg.2021.03.035DOI Listing
June 2021

Geographical socioeconomic disadvantage is associated with adverse outcomes following major amputation in diabetic patients.

J Vasc Surg 2021 Oct 15;74(4):1317-1326.e1. Epub 2021 Apr 15.

Johns Hopkins Surgery Center for Outcomes Research, Department of Surgery, The Johns Hopkins Hospital, Baltimore, Md; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins Hospital, Baltimore, Md. Electronic address:

Objective: Socioeconomic disadvantage is a known predictor of adverse outcomes and amputation in patients with diabetes. However, its association with outcomes after major amputation has not been described. Here, we aimed to determine the association of geographic socioeconomic disadvantage with 30-day readmission and 1-year reamputation rates among patients with diabetes undergoing major amputation.

Methods: Patients from the Maryland Health Services Cost Review Commission Database who underwent major lower extremity amputation with a concurrent diagnosis of diabetes mellitus between 2015 and 2017 were stratified by socioeconomic disadvantage as determined by the area deprivation index (ADI) (ADI1 [least deprived] to ADI4 [most deprived]). The primary outcomes were rates of 30-day readmission and 1-year reamputation, evaluated using multivariable logistic regression models and Kaplan-Meier survival analyses.

Results: A total of 910 patients were evaluated (66.0% male, 49.2% Black), including 30.9% ADI1 (least deprived), 28.6% ADI2, 19.1% ADI3, and 21.2% ADI4 (most deprived). After adjusting for differences in baseline demographic and clinical factors, the odds of 30-day readmission was similar among ADI groups (P > .05 for all). Independent predictors of 30-day readmission included female sex (odds ratio [OR], 1.45), Medicare insurance (vs private insurance; OR, 1.76), and peripheral artery disease (OR, 1.49) (P < .05 for all). The odds of 1-year reamputation was significantly greater among ADI4 (vs ADI1; OR, 1.74), those with a readmission for stump complication or infection/sepsis (OR, 2.65), and those with CHF (OR, 1.53) or PAD (OR, 1.59) (P < .05 for all).

Conclusions: Geographic socioeconomic disadvantage is independently associated with 1-year reamputation, but not 30-day readmission, among Maryland patients undergoing a major amputation for diabetes. A directed approach at improving postoperative management of chronic disease progression in socioeconomically deprived patients may be beneficial to reducing long-term morbidity in this high-risk group.
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http://dx.doi.org/10.1016/j.jvs.2021.03.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8487910PMC
October 2021

The epidemiology of lower extremity amputations, strategies for amputation prevention, and the importance of patient-centered care.

Semin Vasc Surg 2021 Mar 7;34(1):54-58. Epub 2021 Feb 7.

Division of Vascular Surgery, University of Toronto, Toronto, Ontario, Canada. Electronic address:

Dysvascular amputations, defined as those secondary to the complications of peripheral arterial disease or diabetes mellitus, are the most common cause of lower extremity amputations. Despite recent advancements in diabetes mellitus treatments and the many modern innovations in endovascular therapies, the incidence of dysvascular lower extremity amputations has not improved. In this article, we will review the most recent epidemiological data on lower extremity amputations, discuss the latest recommendations from different medical societies for the prevention of limb loss, and explore the role of the vascular surgeon as part of a multidisciplinary team in providing comprehensive care for patients at risk of undergoing amputations for ischemic or diabetic complications. We will also discuss the importance of considering patient perspectives and patient-reported outcomes to better understand the impact of amputations on the patient experience.
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http://dx.doi.org/10.1053/j.semvascsurg.2021.02.011DOI Listing
March 2021

A survey of Canadian surgeons on the indications for home care nursing following vascular surgery.

Can J Surg 2021 03 5;64(2):E149-E154. Epub 2021 Mar 5.

From the Department of Surgery, University of Toronto, Toronto, Ont. (Jacob-Brassard, Al-Omran, Salata, Hussain, Kayssi, Roche-Nagle); the Li Ka Shing Knowledge Institute of St. Michaels Hospital, Toronto, Ont. (Al-Omran, Salata, Hussain, de Mestral); the Sunnybrook Research Institute of Sunnybrook Health Sciences Centre, Toronto, Ont. (Kayssi); and the Peter Munk Cardiac Center of the University Health Network, Toronto, Ont. (Roche-Nagle).

Background: Recent evidence suggests that home care nursing is variably prescribed after vascular surgery, and may reduce emergency department visits and hospital readmissions. We therefore sought to characterize the indications for home care nursing following vascular surgery from the surgeon's perspective.

Methods: An online survey was distributed to the 141 members of the Canadian Society for Vascular Surgery with questions related to home care nursing after carotid endarterectomy (CEA), endovascular aortic aneurysm repair (EVAR), open abdominal aortic aneurysm (AAA) repair and open or hybrid revascularization for peripheral arterial disease (PAD). We included all questionnaires in our analysis; the frequency denominator changes according to the number of respondents who completed each survey item.

Results: There were 46 survey respondents (33% of 141) from across the country. A total of 28 (62% of 45) worked in a teaching hospital. Home care nursing was routinely prescribed by 5%, 10%, 31% and 41% of respondents following CEA, EVAR, open AAA repair and open or hybrid revascularization for PAD, respectively. Across all procedure types, the same procedure-related criteria were most often deemed to warrant a prescription for home care nursing: surgical site infection, wound complications (e.g., open wound, lymphatic leak) and use of negative-pressure wound therapy. Across all procedure types, lack of social support, physical frailty and cognitive impairment were most frequently identified as patient-specific considerations for prescribing home care nursing. Few respondents reported restrictions or standards that informed their prescribing practice.

Conclusion: Most surgeon respondents agreed on the indications for home care nursing after vascular surgery. However, evidence-based standards to guide patient selection for home care nursing after vascular surgery are needed.
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http://dx.doi.org/10.1503/cjs.001220DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8064247PMC
March 2021

Regional health care services and rates of lower extremity amputation related to diabetes and peripheral artery disease: an ecological study.

CMAJ Open 2020 Oct-Dec;8(4):E659-E666. Epub 2020 Oct 27.

Li Ka Shing Knowledge Institute (de Mestral, Hussain, Salata, Verma, Al-Omran), St. Michael's Hospital; ICES Central (de Mestral, Austin, Sivaswamy, Salata); Department of Surgery (de Mestral, Hussain, Forbes, Kayssi, Salata, Verma, Al-Omran), Faculty of Medicine, University of Toronto; Sunnybrook Research Institute (Austin, Kayssi, Wijeysundera), Sunnybrook Health Sciences Centre; Peter Munk Cardiac Centre (Austin, Forbes), University Health Network; Department of Medicine (Wijeysundera), Faculty of Medicine, University of Toronto; Diabetes Action Canada (de Mestral, Forbes, Kayssi, Al-Omran), Toronto, Ont.

Background: The care necessary to prevent amputation from diabetes and peripheral artery disease (PAD) remains disjointed in many jurisdictions. To help inform integrated regional care, this study explores the correlation between regional health care services and rates of lower extremity amputation.

Methods: This ecological study included 14 administrative health regions in Ontario, Canada. All diabetes- or PAD-related major (above ankle) amputations (Apr. 1, 2007, to Mar. 31, 2017) were identified among residents 40 years of age and older. For each region, age-and sex-adjusted amputation rates were calculated as well as per capita counts of key health providers (podiatrists and chiropodists, as well as surgeons) and health care utilization among study patients in the year before the first major amputation (physician visits, publicly funded podiatry visits, emergency department visits, hospital admissions, home care nursing, minor amputation, limb revascularization).

Results: A total of 11 658 patients with major amputation were identified (of whom 79.2% had diabetes and 96.5% had PAD). There was wide regional variation in amputation rates: 2.53 to 11.77 per 100 000 person-quarters. At a regional level, the proportion of study patients who received revascularization showed the strongest negative correlation with amputation rates. The regional proportion of study patients who saw a vascular surgeon showed the strongest negative correlation with amputation rates, relative to other health provider visits. Other measures of health care utilization among patients correlated poorly with regional amputation rates, as did the regional provider counts. The results were similar when we restricted the analysis to diabetes-related amputations.

Interpretation: Amputation rates related to diabetes and PAD vary widely across Ontario. Access to vascular assessment and revascularization must be integrated into regional amputation prevention efforts.
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http://dx.doi.org/10.9778/cmajo.20200048DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7595755PMC
May 2021

Identifying priorities and developing strategies for building capacity in amputation research in Canada.

Disabil Rehabil 2021 09 8;43(19):2779-2789. Epub 2020 Feb 8.

St. John's Rehab Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Canada.

Background: Compared to other patient population groups, the field of amputation research in Canada lacks cohesion largely due to limited funding sources, lack of connection among research scientists, and loose ties among geographically dispersed healthcare centres, research institutes and advocacy groups. As a result, advances in clinical care are hampered and ultimately negatively influence outcomes of persons living with limb loss.

Objective: To stimulate a national strategy on advancing amputation research in Canada, a consensus-workshop was organized with an expert panel of stakeholders to identify key research priorities and potential strategies to build researcher and funding capacity in the field.

Methods: A modified Delphi approach was used to gain consensus on identifying and selecting an initial set of priorities for building research capacity in the field of amputation. This included an anonymous pre-meeting survey ( = 31 respondents) followed by an in-person consensus-workshop meeting that hosted 38 stakeholders (researchers, physiatrists, surgeons, prosthetists, occupational and physical therapists, community advocates, and people with limb loss).

Results: The top three identified research priorities were: (1) developing a national dataset; (2) obtaining health economic data to illustrate the burden of amputation to the healthcare system and to patients; and (3) improving strategies related to outcome measurement in patients with limb loss (e.g. identifying, validating, and/or developing outcome measures). Strategies for moving these priorities into action were also developed.

Conclusions: The consensus-workshop provided an initial roadmap for limb loss research in Canada, and the event served as an important catalyst for stakeholders to initiate collaborations for moving identified priorities into action. Given the increasing number of people undergoing an amputation, there needs to be a stronger Canadian collaborative approach to generate the necessary research to enhance evidence-based clinical care and policy decision-making.IMPLICATIONS FOR REHABILITATIONLimb loss is a growing concern across North America, with lower-extremity amputations occurring due to complications arising from diabetes being a major cause.To advance knowledge about limb loss and to improve clinical care for this population, stronger connections are needed across the continuum of care (acute, rehabilitation, community) and across sectors (clinical, advocacy, industry and research).There are new surgical techniques, technologies, and rehabilitation approaches being explored to improve the health, mobility and community participation of people with limb loss, but further research evidence is needed to demonstrate efficacy and to better integrate them into standard clinical care.
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http://dx.doi.org/10.1080/09638288.2020.1720831DOI Listing
September 2021

Population-based secular trends in lower-extremity amputation for diabetes and peripheral artery disease.

CMAJ 2019 09;191(35):E955-E961

Divisions of Vascular Surgery (Hussain, Al-Omran, Salata, de Mestral) and Cardiac Surgery (Verma), St. Michael's Hospital; Li Ka Shing Knowledge Institute of St. Michael's Hospital (Al-Omran, Verma, de Mestral); Department of Surgery (Hussain, Salata, Forbes, Kayssi), University of Toronto; Diabetes Action Canada (Hussain, Al-Omran, Salata, Forbes, Kayssi), Toronto, Ont.; King Saud University-Li Ka Shing Collaborative Research Program (Aljabri, Verma) and Department of Surgery (Aljabri), King Saud University, Riyadh, Kingdom of Saudi Arabia; ICES (Sivaswamy, de Mestral); Division of Vascular Surgery (Forbes), Peter Munk Cardiac Centre, University Health Network, Toronto, Ont.; Institute of Cardiovascular and Medical Sciences (Sattar), University of Glasgow, Glasgow, Scotland, United Kingdom; Division of Vascular Surgery (Kayssi), Sunnybrook Health Sciences Centre, Toronto, Ont.

Background: The evolving clinical burden of limb loss secondary to diabetes and peripheral artery disease remains poorly characterized. We sought to examine secular trends in the rate of lower-extremity amputations related to diabetes, peripheral artery disease or both.

Methods: We included all individuals aged 40 years and older who underwent lower-extremity amputations related to diabetes or peripheral artery disease in Ontario, Canada (2005-2016). We identified patients and amputations through deterministic linkage of administrative health databases. Quarterly rates (per 100 000 individuals aged ≥ 40 yr) of any (major or minor) amputation and of major amputations alone were calculated. We used time-series analyses with exponential smoothing models to characterize secular trends and forecast 2 years forward in time.

Results: A total of 20 062 patients underwent any lower-extremity amputation, of which 12 786 (63.7%) underwent a major (above ankle) amputation. Diabetes was present in 81.8%, peripheral artery disease in 93.8%, and both diabetes and peripheral artery disease in 75.6%. The rate of any amputation initially declined from 9.88 to 8.62 per 100 000 between Q2 of 2005 and Q4 of 2010, but increased again by Q1 of 2016 to 10.0 per 100 000 ( = 0.003). We observed a significant increase in the rate of any amputation among patients with diabetes, peripheral artery disease, and both diabetes and peripheral artery disease. Major amputations did not significantly change among patients with diabetes, peripheral artery disease or both.

Interpretation: Lower-extremity amputations related to diabetes, peripheral artery disease or both have increased over the last decade. These data support renewed efforts to prevent and decrease the burden of limb loss.
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http://dx.doi.org/10.1503/cmaj.190134DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6721859PMC
September 2019

Authors' Reply to Laneelle et al.: "Vascular Tests for Dermatologists".

Am J Clin Dermatol 2019 10;20(5):737-738

Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.

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http://dx.doi.org/10.1007/s40257-019-00460-8DOI Listing
October 2019

The importance of establishing a framework for regional and international collaboration in the management of the diabetic foot.

J Vasc Surg 2019 07;70(1):335-336

Division of Vascular Surgery and Endovascular Therapy, Michel E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Tex.

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http://dx.doi.org/10.1016/j.jvs.2019.02.017DOI Listing
July 2019

Home care nursing after elective vascular surgery: an opportunity to reduce emergency department visits and hospital readmission.

BMJ Qual Saf 2019 11 24;28(11):901-907. Epub 2019 May 24.

Surgery, University Health Network, Toronto, Ontario, Canada.

Background: Events occurring outside the hospital setting are underevaluated in surgical quality improvement initiatives and research.

Objective: To quantify regional variation in home care nursing following vascular surgery and explore its impact on emergency department (ED) visits and hospital readmission.

Methods: Patients who underwent elective vascular surgery and were discharged directly home were identified from population-based administrative databases for the province of Ontario, Canada, 2006-2015. The index surgeries included carotid endarterectomy, open and endovascular aortic aneurysm repair and bypass for lower extremity peripheral arterial disease. Home care nursing within 30 days of discharge was captured and compared across regions. Using multilevel logistic regression, we characterised the association between home care nursing and the risk of an ED visit or hospital readmission within 30 days of discharge.

Results: The cohort included 23 617 patients, of whom 9002 (38%) received home care nursing within 30 days of discharge home. Receipt of nursing care after discharge home varied widely across Ontario's 14 administrative health regions (range 16%-84%), even after accounting for differences in patient case mix. A lower likelihood of an ED visit or hospital readmission within 30 days of discharge was observed among patients who received home care nursing following three of four index surgeries: carotid endarterectomy OR 0.74, 95% CI 0.61 to 0.91; endovascular aortic aneurysm repair OR 0.85, 95% CI 0.72 to 0.99; open aortic aneurysm repair OR 1.06, 95% CI 0.91 to 1.23; bypass for lower extremity peripheral arterial disease OR 0.81, 95% CI 0.72 to 0.92.

Conclusion: Home care nursing may contribute to reducing ED visits and hospital readmission and is variably prescribed after vascular surgery.
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http://dx.doi.org/10.1136/bmjqs-2018-009161DOI Listing
November 2019

A systematic review of nonoperative management in blunt thoracic aortic injury.

J Vasc Surg 2019 11 21;70(5):1675-1681.e6. Epub 2019 May 21.

Department of Surgery, University of Toronto, Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute of St. Michaels Hospital, Toronto, Ontario, Canada. Electronic address:

Objective: The objective was to characterize the growing body of literature regarding nonoperative management of blunt thoracic aortic injury (BTAI).

Methods: A systematic search of MedLine, Embase, and Cochrane Central was completed to identify original articles reporting injury characteristics and outcomes in patients with BTAI managed nonoperatively during their index hospitalization. Article title and abstract screening, full-text review, and data abstraction were performed in duplicate, with discrepancies resolved by a third reviewer. The quality of each study was evaluated using the Oxford Centre for Evidence-Based Levels of Evidence.

Results: Of 2162 identified studies, 74 were included and reported on 8606 patients with BTAI who were managed nonoperatively between 1970 and 2016. Only one study was prospective. The median nonoperative sample size per study was 11 patients. The characterization of aortic injury grade differed across studies. Follow-up varied widely from 1 day to 118 months. Injury healing or improvement on follow-up imaging occurred in 34% (226 of 673 patients; reported in 37 studies), most often in the context of grade I intimal injury. Injury progression or requirement for a thoracic endovascular aneurysm repair for injury progression was 7.6% (66 of 873 patients; reported in 46 studies). A total of 37 studies reported aortic-related death, with an overall rate of 4.5% (37 of 827 patients) and a rate of 1% in grade I and II injuries (1 of 153 patients) and 18% in grade III and IV (9 of 50 patients).

Conclusions: An increasing number of reports support nonoperative management of grade I intimal injury, consistent with Society for Vascular Surgery guidelines. However, a retrospective interpretation of the determinants of management, heterogeneous injury characterization, and variable follow-up remain major limitations to the informed use of nonoperative management across all BTAI grades.
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http://dx.doi.org/10.1016/j.jvs.2019.02.023DOI Listing
November 2019

Penetrating paediatric neck trauma.

BMJ Case Rep 2019 May 14;12(5). Epub 2019 May 14.

Division of Vascular Surgery, Toronto General Hospital, Toronto, Ontario, Canada.

Penetrating injuries to the internal carotid artery are infrequent but potentially devastating and can be a significant challenge to the operating surgeon. In this article, we present a case of an 11-year-old girl who suffered a serious vascular injury when she fell on a pencil. We also discuss the most up-to-date recommendations concerning the management of zone II injuries to the neck of a paediatric patient.
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http://dx.doi.org/10.1136/bcr-2018-226436DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6536251PMC
May 2019

Vascular Tests for Dermatologists.

Am J Clin Dermatol 2019 Oct;20(5):657-667

Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.

Dermatologists encounter patients with a variety of lower extremity ulcers including those related to venous insufficiency and peripheral arterial disease. Vascular studies, including ankle brachial pressure index, toe pressure, toe brachial index, Doppler arterial waveform, Duplex ultrasonography, and angiography, play an essential role in the prevention, diagnosis, and management of vascular diseases. In fact, dermatologists are often the first medical providers to see patients with complex vascular conditions. Knowledge of the appropriate indications, interpretations, limitations, and advantages of the various vascular studies is critical to the successful and swift management of each patient presenting with a lower extremity ulcer. This study reviews the most commonly ordered arterial and venous studies and discusses the appropriate indications and interpretation of these studies.
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http://dx.doi.org/10.1007/s40257-019-00441-xDOI Listing
October 2019

Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for the treatment of in-stent restenosis of the femoropopliteal arteries.

Cochrane Database Syst Rev 2019 01 26;1:CD012510. Epub 2019 Jan 26.

Division of Vascular Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Room H287, 2075 Bayview Avenue, Toronto, ON, Canada, M4N 3M5.

Background: Stents are placed in the femoropopliteal arteries for numerous reasons, such as atherosclerotic disease, the need for dissection, and perforation of the arteries, and can become stenosed with the passage of time. When a stent develops a flow-limiting stenosis, this process is known as "in-stent stenosis." It is thought that in-stent restenosis is caused by a process known as "intimal hyperplasia" rather than by the progression of atherosclerotic disease. Management of in-stent restenosis may include performing balloon angioplasty, deploying another stent within the stenosed stent to force it open, and creating a bypass to deliver blood around the stent. The role of drug-eluting technologies, such as drug-eluting balloons (DEBs), in the management of in-stent restenosis is unclear. Drug-eluting balloons might function by coating the inside of stenosed stents with cytotoxic chemicals such as paclitaxel and by inhibiting the hyperplastic processes responsible for in-stent restenosis. It is important to perform this systematic review to evaluate the efficacy of DEB because of the potential for increased expenses associated with DEBs over uncoated balloon angioplasty, also known as plain old balloon angioplasty (POBA).

Objectives: To assess the safety and efficacy of DEBs compared with uncoated balloon angioplasty in people with in-stent restenosis of the femoropopliteal arteries as assessed by criteria such as amputation-free survival, vessel patency, target lesion revascularization, binary restenosis rate, and death. We define "in-stent restenosis" as 50% or greater narrowing of a previously stented vessel by duplex ultrasound or angiography.

Search Methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to November 28, 2017. Review authors also undertook reference checking to identify additional studies.

Selection Criteria: We included all randomized controlled trials that compared DEBs versus uncoated balloon angioplasty for treatment of in-stent restenosis in the femoropopliteal arteries.

Data Collection And Analysis: Two review authors (AK, WA) independently selected appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (AD) adjudicated any disagreements.

Main Results: Three trials that randomized a combined total of 263 participants met the review inclusion criteria. All three trials examined the treatment of symptomatic in-stent restenosis within the femoropopliteal arteries. These trials were carried out in Germany and Austria and used paclitaxel as the agent in the drug-eluting balloons. Two of the three trials were industry sponsored. Two companies manufactured the drug-eluting balloons (Eurocor, Bonn, Germany; Medtronic, Fridley, Minnesota, USA). The trials examined both anatomical and clinical endpoints. We noted heterogeneity in the frequency of bailout stenting deployment between studies as well as in the dosage of paclitaxel applied by the DEBs. Using GRADE assessment criteria, we determined that the certainty of evidence presented was very low for the outcomes of amputation, target lesion revascularization, binary restenosis, death, and improvement of one or more Rutherford categories. Most participants were followed up to 12 months, but one trial followed participants for up to 24 months.Trial results show no difference in the incidence of amputation between DEBs and uncoated balloon angioplasty. DEBs showed better outcomes for up to 24 months for target lesion revascularization (odds ratio (OR) 0.05, 95% confidence Interval (CI) 0.00 to 0.92 at six months; OR 0.24, 95% CI 0.08 to 0.70 at 24 months) and at six and 12 months for binary restenosis (OR 0.28, 95% CI 0.14 to 0.56 at six months; OR 0.34, 95% CI 0.15 to 0.76 at 12 months). Participants treated with DEBs also showed improvement of one or more Rutherford categories at six and 12 months (OR 1.81, 95% CI 1.02 to 3.21 at six months; OR 2.08, 95% CI 1.13 to 3.83 at 12 months). Data show no clear differences in death between DEBs and uncoated balloon angioplasty. Data were insufficient for subgroup or sensitivity analyses to be conducted.

Authors' Conclusions: Based on a meta-analysis of three trials with 263 participants, evidence suggests an advantage for DEBs compared with uncoated balloon angioplasty for anatomical endpoints such as target lesion revascularization (TLR) and binary restenosis, and for one clinical endpoint - improvement in Rutherford category post intervention for up to 24 months. However, the certainty of evidence for all these outcomes is very low due to the small number of included studies and participants and the high risk of bias in study design. Adequately powered and carefully constructed randomized controlled trials are needed to adequately investigate the role of drug-eluting technologies in the management of in-stent restenosis.
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http://dx.doi.org/10.1002/14651858.CD012510.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6353053PMC
January 2019

A call for integrated foot care and amputation prevention pathways for patients with diabetes and peripheral arterial disease across Canada.

Can J Public Health 2019 04 7;110(2):253-255. Epub 2019 Jan 7.

Li Ka Shing Knowledge Institute of St. Michaels Hospital, 30 Bond Street, 7-080 Bond Wing, Toronto, Ontario, M5B 1W8, Canada.

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http://dx.doi.org/10.17269/s41997-018-0166-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6964593PMC
April 2019

Hypogastric Preservation During Treatment of Aortoiliac Aneurysms.

Tech Vasc Interv Radiol 2018 Sep 14;21(3):175-180. Epub 2018 Jun 14.

INOVA Heart and Vascular Institute, INOVA Health system, Fairfax, VA. Electronic address:

The advent of endovascular technology for treating aortoiliac aneurysms has sometimes necessitated the occlusion of the hypogastric artery to prevent an endoleak or to achieve an adequate distal seal, resulting in significant morbidity for some patients. The use of iliac branch devices, in conjunction with aortic stent grafts, has made it possible to preserve the hypogastric arteries in select patients with suitable anatomy. The purpose of this review will be to discuss the indications for hypogastric preservation during treatment of aortoiliac aneurysms, as well as highlight the key procedural steps and potential technical challenges encountered during this procedure.
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http://dx.doi.org/10.1053/j.tvir.2018.06.007DOI Listing
September 2018

Peripheral artery disease among Indigenous Canadians: What do we know?

Can J Surg 2018 10;61(5):305-310

From the Divisions of Vascular Surgery (Bonneau, Hussain, Al-Omran) and Cardiac Surgery (Verma), St. Michael’s Hospital, Toronto, Ont.; the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Ont. (Verma, Al-Omran); the University of British Columbia Northern Medical Program, University of British Columbia Centre for Excellence in Indigenous Health, Prince George, BC (Caron); the Department of Surgery, University of Toronto, Toronto, Ont. (Hussain, Kayssi, Verma, Al-Omran); the Division of Vascular Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, Ont. (Kayssi); the King Saud University–Li Ka Shing Collaborative Research Program (Verma, Al-Omran); and the Department of Surgery, King Saud University, Riyadh, Saudi Arabia (Al-Omran).

Indigenous Canadians experience a disproportionate burden of chronic atherosclerotic diseases, including peripheral artery disease (PAD). Despite an estimated prevalence of 800 000 patients with PAD in Canada, the burden of the disease among Indigenous Canadians is unclear. Available evidence suggests that this population has a higher prevalence of several major risk factors associated with PAD (diabetes, smoking and kidney disease). Unique socioeconomic, geographic and systemic obstacles affecting Indigenous Canadians’ health and health care access may worsen chronic disease outcomes. Little is known about the cardiovascular and limb outcomes of Indigenous peoples with PAD. A novel approach via multidisciplinary vascular health teams engaging Indigenous communities in a culturally competent manner may potentially provide optimal vascular care to this population. Further research into the prevalence and outcomes of PAD among Indigenous Canadians is necessary to define the problem and allow development of more ffective initiatives to alleviate the disease burden in this marginalized group.
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http://dx.doi.org/10.1503/cjs.013917DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153097PMC
October 2018

Evaluating Quality Metrics and Cost After Discharge: A Population-based Cohort Study of Value in Health Care Following Elective Major Vascular Surgery.

Ann Surg 2019 08;270(2):378-383

University Health Network, Toronto, Ontario, Canada.

Background: Early readmission to hospital after surgery is an omnipresent quality metric across surgical fields. We sought to understand the relative importance of hospital readmission among all health services received after hospital discharge.

Objective: The aim of this study was to characterize 30-day postdischarge cost and risk of an emergency department (ED) visit, readmission, or death after hospitalization for elective major vascular surgery.

Methods: This is a population-based retrospective cohort study of patients who underwent elective major vascular surgery - carotid endarterectomy, EVAR, open AAA repair, bypass for lower extremity peripheral arterial disease - in Ontario, Canada, between 2004 and 2015. The outcomes of interest included quality metrics - ED visit, readmission, death - and cost to the Ministry of Health, within 30 days of discharge. Costs after discharge included those attributable to hospital readmission, ED visits, rehab, physician billing, outpatient nursing and allied health care, medications, interventions, and tests. Multivariable regression models characterized the association of pre-discharge characteristics with the above-mentioned postdischarge quality metrics and cost.

Results: A total of 30,752 patients were identified. Within 30 days of discharge, 2588 (8.4%) patients were readmitted to hospital and 13 patients died (0.04%). Another 4145 (13.5%) patients visited an ED without requiring admission. Across all patients, over half of 30-day postdischarge costs were attributable to outpatient care. Patients at an increased risk of an ED visit, readmission, or death within 30 days of discharge differed from those patients with relatively higher 30-day costs.

Conclusion: Events occurring outside the hospital setting should be integral to the evaluation of quality of care and cost after hospitalization for major vascular surgery.
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http://dx.doi.org/10.1097/SLA.0000000000002767DOI Listing
August 2019

Using Texting for Clinical Communication in Surgery: A Survey of Academic Staff Surgeons.

Surg Innov 2018 Jun 14;25(3):274-279. Epub 2018 Mar 14.

1 University of Toronto, ON, Canada.

Background: Text messaging has become ubiquitous and is being increasingly used within the health care system. The purpose of this study was to understand texting practices for clinical communication among staff surgeons at a large academic institution.

Methods: Staff surgeons in 4 subspecialties (vascular, plastics, urology, and general surgery) were surveyed electronically.

Results: A total of 62 surgeons from general surgery (n = 33), vascular surgery (n = 6), plastic surgery (n = 13), and urology (n = 10) completed the study (response rate 30%). When conveying urgent patient-related information, staff surgeons preferred directly calling other staff surgeons (61.5%) and trainees (58.8%). When discussing routine patient information, staff surgeons used email to reach other staff surgeons (54.9%) but preferred texting (62.7%) for trainees. The majority of participants used texting because it is fast (65.4%), convenient (69.2%) and allows transmitting information to multiple recipients simultaneously (63.5%). Most felt that texting enhances patient care (71.5%); however, only half believed that it enhanced trainees' educational experiences. The majority believed that texting identifiable patient information breaches patient confidentiality.

Conclusions: Our data showed high adoption of text messaging for clinical communication among surgeons, particularly with trainees. The majority of surgeons acknowledge security concerns inherent in texting for patient care. Existing mobile communication platforms fail to meet the needs of academic surgeons. Further research should include guidelines related to texting in clinical practice, educational implications of texting, and technologies to better meet the needs of clinicians working in an academic surgical settings.
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http://dx.doi.org/10.1177/1553350618761980DOI Listing
June 2018

Optimization of rifampin coating on covered Dacron endovascular stent grafts for infected aortic aneurysms.

J Vasc Surg 2019 01 1;69(1):242-248.e1. Epub 2018 Mar 1.

Division of Vascular Surgery, Department of Surgery, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. Electronic address:

Objective: In the treatment of an infected aorta, open repair and replacement with a rifampin-impregnated Dacron vascular graft decrease the risk of prosthetic graft infections, with several protocols available in the literature. We hypothesize that the same holds true for endovascular aneurysm repair, and after studying and optimizing rifampin solution concentration and incubation period to maximize the coating process of rifampin on Dacron endovascular stent grafts (ESGs), we propose a rapid real-time perioperative protocol.

Methods: Several prepared rifampin solutions, including a negative control solution, were used to coat multiple triplicate sets of Dacron endovascular aortic stent grafts at different but set incubation periods. Rifampin elution from the grafts was studied by spectroscopic analysis. Once an optimized solution concentration and incubation time were determined, the elution of rifampin over time from the graft and the graft's surface characteristics were studied by ultraviolet-visible spectroscopy and atomic force microscopy.

Results: All coated ESGs with any concentration of prepared rifampin solution, regardless of incubation time, immediately demonstrated a visible bright orange discoloration and subsequently after elution procedures returned to the original noncolored state. At the 25-minute incubation time (standard flush), there was no statistical difference in the amount of rifampin coated to the ESGs with 10-mg/mL, 30-mg/mL, and 60-mg/mL solutions (0.06 ± 0.01, 0.07 ± 0.05, and 0.044 ± 0.01, respectively; P > .05). This was also true for a 10-minute incubation time (express flush) of 10-mg/mL and 60-mg/mL rifampin solution concentrations (0.04 ± 0.007 and 0.066 ± 0.014, respectively; P = .22). The elution-over-time of coated rifampin ESG, although not statistically significant, did seem to plateau and to reach a steady state by 50 hours and was confirmed by surface characteristics using atomic force microscopy.

Conclusions: Having studied two variables of rifampin coating techniques to Dacron ESGs, the authors propose a rapid real-time perioperative coating protocol by using a 10-mg/mL rifampin solution for a 10-minute incubation period. As rifampin loosely binds to Dacron ESGs by weak intermolecular forces, a rifampin-coated ESG would need to be inserted in a timely fashion to treat the diseased aorta and to deliver its antibiotic affect. A rapid perioperative coating protocol followed by immediate deployment makes our proposed technique especially useful in an urgent and unstable clinical scenario.
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http://dx.doi.org/10.1016/j.jvs.2017.10.069DOI Listing
January 2019

The spectrum and management of noniatrogenic vascular trauma in the pediatric population.

J Pediatr Surg 2018 Apr 29;53(4):771-774. Epub 2017 Apr 29.

Division of General & Thoracic Surgery, Hospital for Sick Children, 555 University Avenue Toronto, ON, Canada M5G 1X8.

Background: To describe the spectrum of noniatrogenic pediatric vascular injuries and their outcomes at a large tertiary pediatric hospital.

Methods: Retrospective review of a prospectively-maintained trauma database, identifying children with noniatrogenic vascular injuries managed between 1994 and 2014.

Results: A total of 198 patients were identified. Those patients with a digital or intracerebral vascular injury (92/198) were excluded from further analysis. The remaining 106 patients represented 1.2% of all traumas managed at our institution during the 21-year study period. The majority were male (75%), and between 1 and 12years of age (71% of all patients). Median time from trauma scene to any hospital was 48min (range 0-132), and most patients were transferred from another hospital (64%). Three patients were declared dead upon arrival (3%). Penetrating injuries accounted for most injuries (72%), while blunt injuries accounted for the remainder. Ulnar, radial, or brachial artery trauma accounted for 47% of injuries. Most vessels were treated operatively, by primary repair (49%), vessel ligation (15%), or interposition graft (12%). Fourteen patients (13%) were managed nonoperatively and most patients (74%) experienced no complications in hospital or during follow-up.

Conclusion: Noniatrogenic pediatric vascular injuries are rare and represent a highly heterogeneous population. Most children recover well, with minimal perioperative complications.

Level Of Evidence: IV (case series with no comparison group).
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http://dx.doi.org/10.1016/j.jpedsurg.2017.04.015DOI Listing
April 2018

Smart(phone) Learning Experience Among Vascular Trainees Using a Response System Application.

J Surg Educ 2017 Jul - Aug;74(4):638-643. Epub 2017 Jan 24.

Department of Vascular Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.

Objectives: Smartphones have become the most important personal technological device. M-learning is learning through mobile device educational technology. We aim to assess the acceptability of a smartphone learning experience among the vascular trainees and determine if results could inform formal teaching efforts.

Methods: A survey of the vascular trainees at a single center was conducted following a trial of smartphone learning experience. A vascular fellow used a smartphone response system application (Polltogo, Inspirapps Inc.) to send a daily multiple-choice question to the vascular residents for 20 consecutive working days. The application allows for only one attempt from each user, and the answers are registered anonymously. However, each participant receives instant feedback on his/her response by viewing the correct answer after answering each question along with a distribution of answers among other users.

Results: A total of 9 trainees participated in the trial, and all of them filled a posttrial survey. All the trainees possessed smartphones. The majority (78%) were not aware of the concept of m-learning. The mobile engagement score (number of answers received divided by total possible answers) was 145/180 (81%). All the trainees were "satisfied" or "very satisfied" with the experience, and the same number stated that they were "likely" or "very likely" to use this technology in the future. The majority (89%) agreed that such an application could assist them in preparing for their board examination. On 3 occasions, 75% or more of the participating trainees answered the multiple-choice question incorrectly, which resulted in addressing the relevant topics in the unit's weekly teaching conference.

Conclusion: Using smartphones for education is acceptable among the vascular trainees, and the trial of a response system application with instant written feedback represents a novel method for using smartphones for collaborative learning. Such an application can also inform program directors and surgical trainers of their trainees' learning needs.
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http://dx.doi.org/10.1016/j.jsurg.2016.12.006DOI Listing
May 2018

Development of a Limb-Preservation Program.

Blood Purif 2017 24;43(1-3):218-225. Epub 2017 Jan 24.

Inova Heart and Vascular Institute, Division of Vascular Surgery, Department of Surgery, Inova Fairfax Medical Campus, Falls Church, VA, USA.

In the global scenario, as the prevalence of renal failure and diabetes increases, healing and limb preservation assume increasing clinical importance for patients and healthcare systems. Unfortunately, there continues to be variation in the care delivered to patients at risk of losing a limb based on geography, race, socioeconomic status, and insurance status. There are also a variety of therapeutic approaches to patients with limb-threatening ischemia; 25% undergo primary amputation, 25% undergo medical therapy, and only 50% undergo any attempt at revascularization. Nearly 50% of patients undergoing major amputation have not had a simple diagnostic arteriogram to assess the possibility of limb preservation. The Society of Vascular Surgery and the American Podiatric Medical Association have recognized the benefits of a multidisciplinary approach to limb preservation. Benefits to the patient include rapid assessment, improved healing, and enhanced revascularization. Advantages for the providers include the ability to efficiently manage complex patients with help from the appropriate specialties, an increase in referrals, enhanced identity of the institution, and clinical research and trials. Such a program requires the coordinated effort of physicians, nurses, allied health professionals, and administrators dedicated to the preservation of functional limbs. Beneficial components include identifiable space, a vascular laboratory, hyperbaric oxygen therapy, and protocol-driven care involving diagnostic and therapeutic modalities such as endovascular revascularization, open bypass, and soft tissue reconstruction. Prosthetic expertise is also important to maintain function in those patients for whom amputation is appropriate. But, the key to a program is cooperation and communication among the participants who have a passion for limb preservation. Video Journal Club 'Cappuccino with Claudio Ronco' at http://www.karger.com/?doi=452746.
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http://dx.doi.org/10.1159/000452746DOI Listing
March 2017

Avulsion injury to the profunda femoris artery after total hip arthroplasty.

J Vasc Surg 2016 Aug 21;64(2):494-496. Epub 2015 Oct 21.

Division of Vascular Surgery, University of Toronto, Toronto, Ontario, Canada. Electronic address:

Vascular injuries are a rare complication of total hip arthroplasty (THA). We describe the case of 71-year-old man who underwent an elective left THA and developed a pseudoaneurysm from an avulsion injury to the first branch of the profunda femoris artery. The patient underwent urgent open primary repair of the pseudoaneurysm and recovered without any complications. This case demonstrates the importance of assessing for vascular injuries after THA and of educating patients about the associated signs and symptoms.
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http://dx.doi.org/10.1016/j.jvs.2015.08.088DOI Listing
August 2016

The diabetic foot.

Curr Probl Surg 2016 Sep 11;53(9):408-37. Epub 2016 Aug 11.

Department of Medicine, George Washington University, Washington, DC; Department of Surgery, George Washington University, Washington, DC.

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http://dx.doi.org/10.1067/j.cpsurg.2016.07.003DOI Listing
September 2016

Rehabilitation Trends After Lower Extremity Amputations in Canada.

PM R 2017 May 21;9(5):494-501. Epub 2016 Sep 21.

Division of Vascular Surgery, University Health Network, University of Toronto, 200 Elizabeth Street, EN, 6th Floor, Rm 218, Toronto, ON M5G 2C4, Canada(‖). Electronic address:

Background: The heterogeneity of medical complications that lead to amputation has resulted in a diverse patient population with differing rehabilitation needs; however, the rehabilitation trends for patients with lower extremity amputations across Canada have not been studied previously.

Objective: To describe trends in rehabilitation after lower extremity amputations and the factors affecting rehabilitation length of stay in Canada.

Design: Retrospective cohort analysis.

Setting: Canadian inpatient rehabilitation facilities that received persons with lower extremity amputations discharged from academic or community hospitals.

Participants: Patients underwent lower extremity amputations between 2006 and 2009 for nontraumatic indications and were then discharged to a rehabilitation facility. Patients were identified from the Canadian Institute for Health Information's Discharge Abstract Database that includes hospital admissions across Canada except Quebec.

Interventions: Inpatient rehabilitation after lower extremity amputations.

Main Outcome Measures: Length of stay, discharge destination, and change in total and motor function scores.

Results: The analysis included 5342 persons who underwent lower extremity amputations, 1904 of whom were transferred to a rehabilitation facility (36%). Patients most commonly underwent single below-knee (74%) and above-knee (17%) amputations. The duration of rehabilitation varied by whether the amputation was performed by a vascular (median = 36 days), orthopedic (median = 38 days), or general surgeon (median = 35 days). The overall median length of stay was 36 days. Most patients (72%) subsequently were discharged home and 9% were readmitted to hospital. Predictors of longer rehabilitation included amputation by an orthopedic surgeon (beta = 5.0, P ≤ .01), older age (beta = 0.2, P ≤ .01), and a history of ischemic heart disease (beta = 3.8, P = .03) or congestive heart failure (beta = 5, P = .04). Patients who spent <7 days in hospital were significantly more likely to have a shorter rehabilitation stay (beta = -4, P = .03). Advanced patient age was the only predictor for hospital readmission (odds ratio = 1.03, P ≤ .01).

Conclusions: Rehabilitation length of stay in Canada after lower extremity amputation varies by the type of surgeon performing the amputation. Advanced age, undergoing surgery in the province of Manitoba, and having a history of ischemic heart disease or congestive heart failure predict a longer rehabilitation stay. A shorter perioperative hospitalization period (<7 days) predicts a shorter rehabilitation duration. Future studies are needed to explore these issues and to optimize the delivery of rehabilitation services to Canadians after lower extremity amputation.

Level Of Evidence: II.
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http://dx.doi.org/10.1016/j.pmrj.2016.09.009DOI Listing
May 2017

Combined Coil Embolization and Foam Sclerotherapy for the Management of Varicose Veins.

Ann Vasc Surg 2017 Jan 12;38:293-297. Epub 2016 Aug 12.

Division of Vascular and Interventional Radiology, Department of Medical Imaging, University of Toronto, Toronto, Ontario, Canada.

Background: We propose a novel technique for endovenous treatment of varicose veins (VVs) using combined coil embolization and foam sclerotherapy of the great saphenous vein (GSV).

Methods: A retrospective case-series analysis on patients undergoing fluoroscopically guided coil embolization of the GSV and foam sclerotherapy of the GSV and below-knee varices at a single Canadian center.

Results: Twenty-two patients underwent the procedure on 23 legs. Most patients (78.3%) presented for follow-up 57.2 ± 21.9 days postoperatively. Doppler studies demonstrated complete GSV occlusion in all patients. While 3 patients (13.6%) noted skin discoloration overlying the treated VVs, none complained of pain on follow-up or developed leg numbness, deep vein thrombosis, or pulmonary emboli.

Conclusions: Coil embolization and foam sclerotherapy are a novel and effective treatment for VVs that uses existing and readily available angiographic equipment.
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http://dx.doi.org/10.1016/j.avsg.2016.05.101DOI Listing
January 2017

Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs.

Cochrane Database Syst Rev 2016 Aug 4(8):CD011319. Epub 2016 Aug 4.

Division of Vascular Surgery, University of Toronto, Eaton North, 6th Floor, Room EN 6-214, 200 Elizabeth Street, Toronto, ON, Canada, M5G 2C4.

Background: Atherosclerotic peripheral arterial disease (PAD) can lead to disabling ischemia and limb loss. Treatment modalities have included risk factor optimization through life-style modifications and medications, or operative approaches using both open and minimally invasive techniques, such as balloon angioplasty. Drug-eluting balloon (DEB) angioplasty has emerged as a promising alternative to uncoated balloon angioplasty for the treatment of this difficult disease process. By ballooning and coating the inside of atherosclerotic vessels with cytotoxic agents, such as paclitaxel, cellular mechanisms responsible for atherosclerosis and neointimal hyperplasia are inhibited and its devastating complications are prevented or postponed. DEBs are considerably more expensive than uncoated balloons, and their efficacy in improving patient outcomes is unclear.

Objectives: To assess the efficacy of drug-eluting balloons (DEBs) compared with uncoated, nonstenting balloon angioplasty in people with symptomatic lower-limb peripheral arterial disease (PAD).

Search Methods: The Cochrane Vascular Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched December 2015) and Cochrane Register of Studies (CRS) (2015, Issue 11). The TSC searched trial databases for details of ongoing and unpublished studies.

Selection Criteria: We included all randomized controlled trials that compared DEBs with uncoated, nonstenting balloon angioplasty for intermittent claudication (IC) or critical limb ischemia (CLI).

Data Collection And Analysis: Two review authors (AK, TA) independently selected the appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (DKR) adjudicated any disagreements.

Main Results: Eleven trials that randomized 1838 participants met the study inclusion criteria. Seven of the trials included femoropopliteal arterial lesions, three included tibial arterial lesions, and one included both. The trials were carried out in Europe and in the USA and all used the taxane drug paclitaxel in the DEB arm. Nine of the 11 trials were industry-sponsored. Four companies manufactured the DEB devices (Bard, Bavaria Medizin, Biotronik, and Medtronic). The trials examined both anatomic and clinical endpoints. There was heterogeneity in the frequency of stent deployment and the type and duration of antiplatelet therapy between trials. Using GRADE assessment criteria, the quality of the evidence presented was moderate for the outcomes of target lesion revascularization and change in Rutherford category, and high for amputation, primary vessel patency, binary restenosis, death, and change in ankle-brachial index (ABI). Most participants were followed up for 12 months, but one trial reported outcomes at five years.There were better outcomes for DEBs for up to two years in primary vessel patency (odds ratio (OR) 1.47, 95% confidence interval (CI) 0.22 to 9.57 at six months; OR 1.92, 95% CI 1.45 to 2.56 at 12 months; OR 3.51, 95% CI 2.26 to 5.46 at two years) and at six months and two years for late lumen loss (mean difference (MD) -0.64 mm, 95% CI -1.00 to -0.28 at six months; MD -0.80 mm, 95% CI -1.44 to -0.16 at two years). DEB were also superior to uncoated balloon angioplasty for up to five years in target lesion revascularization (OR 0.28, 95% CI 0.17 to 0.47 at six months; OR 0.40, 95% CI 0.31 to 0.51 at 12 months; OR 0.28, 95% CI 0.18 to 0.44 at two years; OR 0.21, 95% CI 0.09 to 0.51 at five years) and binary restenosis rate (OR 0.44, 95% CI 0.29 to 0.67 at six months; OR 0.38, 95% CI 0.15 to 0.98 at 12 months; OR 0.26, 95% CI 0.10 to 0.66 at two years; OR 0.12, 95% CI 0.05 to 0.30 at five years). There was no significant difference between DEB and uncoated angioplasty in amputation, death, change in ABI, change in Rutherford category and quality of life (QoL) scores, or functional walking ability, although none of the trials were powered to detect a significant difference in these clinical endpoints. We carried out two subgroup analyses to examine outcomes in femoropopliteal and tibial interventions as well as in people with CLI (4 or greater Rutherford class), and showed no advantage for DEBs in tibial vessels at six and 12 months compared with uncoated balloon angioplasty. There was also no advantage for DEBs in CLI compared with uncoated balloon angioplasty at 12 months.

Authors' Conclusions: Based on a meta-analysis of 11 trials with 1838 participants, there is evidence of an advantage for DEBs compared with uncoated balloon angioplasty in several anatomic endpoints such as primary vessel patency (high-quality evidence), binary restenosis rate (moderate-quality evidence), and target lesion revascularization (low-quality evidence) for up to 12 months. Conversely, there is no evidence of an advantage for DEBs in clinical endpoints such as amputation, death, or change in ABI, or change in Rutherford category during 12 months' follow-up. Well-designed randomized trials with long-term follow-up are needed to compare DEBs with uncoated balloon angioplasties adequately for both anatomic and clinical study endpoints before the widespread use of this expensive technology can be justified.
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http://dx.doi.org/10.1002/14651858.CD011319.pub2DOI Listing
August 2016
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