Mahmoud Malas - Academia.edu (original) (raw)

Papers by Mahmoud Malas

Research paper thumbnail of The role of advanced diagnostic technology in the selection of a patient with symptomatic but hemodynamically insignificant disease for carotid endarterectomy

Journal of Vascular Surgery Cases, 2015

Current Level I evidence demonstrates no benefit for carotid endarterectomy in symptomatic patien... more Current Level I evidence demonstrates no benefit for carotid endarterectomy in symptomatic patients with <50% carotid stenoses. However, unstable plaque morphology is increasingly recognized in the genesis of ischemic cerebral events. New advanced imaging technology, such as contrast-enhanced magnetic resonance angiography and ultrasound imaging, are emerging as important adjuncts in the evaluation of this patient population. We present a case where both modalities were beneficial in identifying plaque instability manifested by intraplaque hemorrhage and neovascularization in a patient with recurrent cerebral ischemic events and hemodynamically insignificant carotid disease. (J Vasc Surg Cases 2015;1:90-3.) Level I evidence derived from the North American Symptomatic Carotid Endarterectomy Trial 1 and the European Carotid Surgery Trial 2 established the role of carotid endarterectomy (CEA) for patients with symptomatic >50% internal carotid artery (ICA) stenoses. Conversely, these investigations demonstrated no benefit for CEA for symptomatic patients with <50% stenoses compared with medical management. We recently encountered a patient with a unilateral hemodynamically insignificant ICA stenosis who experienced recurrent cerebral ischemic events despite maximum medical therapy and without other potential causes. On the basis of magnetic resonance angiography (MRA) and contrast-enhanced duplex findings, we proceeded with CEA. This case illustrates that rarely one may encounter a patient with an unstable plaque in the absence of hemodynamic significance and who should be managed with CEA. The patient consented to publication of this report.

Research paper thumbnail of Macrovascular complications in the elderly diabetic

Textbook of Men's Health and Aging, Second Edition, 2007

Research paper thumbnail of Iliac Artery Aneurysm

Endovascular Interventions, 2013

Research paper thumbnail of Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial

The Lancet Neurology, 2012

Background In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the com... more Background In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the composite primary endpoint of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke thereafter did not diff er between carotid artery stenting and carotid endarterectomy for symptomatic or asymptomatic carotid stenosis. A secondary aim of this randomised trial was to compare the composite endpoint of restenosis or occlusion.

Research paper thumbnail of Preoperative Smoking Cessation is Essential in Preventing Early Graft Failure after Infrainguinal Bypass Surgery

Journal of Vascular Surgery, 2013

Research paper thumbnail of Chronic venous leg ulcer treatment: Future research needs

Wound Repair and Regeneration, 2013

The prevalence and costs of chronic venous ulcer care in the US are increasing. The Johns Hopkins... more The prevalence and costs of chronic venous ulcer care in the US are increasing. The Johns Hopkins University Evidence-Based Practice Center recently completed a systematic review of the comparative effectiveness of advanced wound dressings, antibiotics, and surgical management of chronic venous ulcers. Of 10,066 citations identified in the literature search, only 66 (0.06%) met our liberal inclusion criteria for providing evidence on the effectiveness of interventions for chronic venous ulcers. Based on review of those studies, members of our team and a panel of informed stakeholders identified important research gaps and methodological deficiencies and prioritized specific future research needs. Based on that review, we provide the results of our assessment of future research needs for chronic venous ulcer care. Advanced wound dressings were considered to have the highest priority for future research, followed by venous surgery and antibiotics. An imperative from our assessment is that future research evaluating interventions for chronic venous ulcers meet quality standards. In a time of increasing cost pressure, the wound care community needs to develop high-quality evidence to justify the use of present and future therapeutic modalities.

Research paper thumbnail of Patient Factors and Hospital Open Experience Predominate Outcomes After AAA Repair

Journal of Vascular Surgery, 2015

Research paper thumbnail of Long-Term Outcomes After Open Lower Extremity Revascularization in Young and Middle-Aged Patients

Journal of Vascular Surgery, 2015

Research paper thumbnail of Anesthetic Type and Risk of Myocardial Infarction Following Carotid Endarterectomy in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)

Journal of Vascular Surgery, 2015

Research paper thumbnail of Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial

Journal of Vascular Surgery, 2015

This study compared the performance of the Aorfix endograft (Lombard Medical, Oxfordshire, United... more This study compared the performance of the Aorfix endograft (Lombard Medical, Oxfordshire, United Kingdom) in standard (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;60°), highly angled (60°-90°), and severely angled (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;90°) aortic necks in the PYTHAGORAS study and evaluated changes in neck morphology over time. PYTHAGORAS is a prospective nonrandomized clinical trial of the Aorfix endograft. We divided the endovascular aneurysm repair (EVAR) cohort into groups by standard, high, and severe neck angle. The primary control group was patients concurrently undergoing open repair. Mortality at 30 days, 1 year, and 2 years and 30-day freedom from Society for Vascular Surgery major adverse events for the EVAR groups was compared with the open control. Aneurysm sac change, type I and III endoleaks, graft migration, and the reintervention rate at 1 and 2 years was compared between the standard, highly, and severely angled populations. The relative risk of graft complications with a neck diameter increase &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;10% was also calculated. At predetermined anatomic points, the effect of oversizing on aortic diameter was evaluated by calculating oversize percentage ([1 - outer aortic diameter measured at a given time/stent graft diameter] × 100%) preoperatively and at 3 years. In addition, the average oversizing percentage at 30 days and annually at 1 to 5 years was compared with the preoperative oversizing percentage. Finally, complication rates with ≥30% vs &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;30% planned oversizing were compared. The adverse event rate was lower for every EVAR group than the open control. In addition, the mortality rates at 30 days, 1 year, and 2 years were similar between the standard-angle (1.5%, 3.0%, 4.5%), high-angle (0.9%, 7.3%, 13.8%), and severe-angle (4.8%, 9.5%, 14.3%) EVAR groups and the open control groups (1.3, 6.6%, 10.5%). At 1 and 2 years, there was no difference in graft complications among the EVAR groups. However, with neck dilatation of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;10% at 5 mm above the proximal renal and 1 mm below the distal renal, there was an increased risk of graft migration (relative risk, 4.38 [P = .01] and 4.33 [P = .002], respectively). For all predetermined anatomic points, the oversizing percentage decreased over time. The rate of oversize percentage decrease was faster at more distal aortic locations, reaching &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;10% at 30 days 15 mm below the renal, at 2 years 7 mm below the renal, and at 5 years 1 mm below the renal (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001 for all). Half the oversize percentage achieved at the index procedure remained at 3 years (Pearson correlation coefficient = 0.5). However, there was no difference in complications between the ≥30%…

Research paper thumbnail of The Age Effect In Increasing Operative Mortality Following Delay in Elective Abdominal Aortic Aneurysm Repair

Annals of Vascular Surgery, 2015

Elective repair of large Abdominal Aortic Aneurysms (AAA) is associated with the risk of signific... more Elective repair of large Abdominal Aortic Aneurysms (AAA) is associated with the risk of significant perioperative mortality. When abdominal aneurysm repair is delayed, patients with asymptomatic large AAAs face the risk of death from rupture. In addition to the risk of rupture, the advancing age of the patients adds a future operative risk. This risk has been historically documented in age groups. However, a more accurate representation of the increasing operative risk with age is needed. We analyzed all patients in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database who underwent endovascular or open repair for asymptomatic infrarenal AAA between 2005 and 2012. Multivariable logistic regression was used to evaluate the effect of increasing age and operative delay on 30-day post-operative mortality. There were 27,576 patients who underwent AAA repair during the study period (mean age 73.5years, SD 8.6; 80% male; 24% open repair). There was a linear relative increase of 5% (OR: 1.05, 95%CI 1.04 - 1.06; P&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) in the odds of operative death after AAA repair with each year of operative delay irrespective of treatment approach. There was a linear relative increase of 4% for EVAR (OR: 1.04, 95%CI 1.02 - 1.05; P&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) and 6% for open repair (OR: 1.06, 95%CI 1.04 - 1.08; P&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) with each year of delay in repair. Due to increasing age, delay in surgery is associated with uniform increase in the risk of perioperative mortality in asymptomatic patients who meet criteria for AAA repair. It is important for surgeons to incorporate this more accurate calculation of operative risk into discussions with patients who qualify for treatment yet decide to forgo surgery for the repair of their AAA.

Research paper thumbnail of Comparison of surgical bypass with angioplasty and stenting of superficial femoral artery disease

Journal of Vascular Surgery, 2013

To evaluate the contemporary outcome of femoral-popliteal bypass compared with angioplasty and st... more To evaluate the contemporary outcome of femoral-popliteal bypass compared with angioplasty and stenting in patients with symptomatic peripheral arterial disease (PAD) in terms of patency and reintervention rates. We identified all patients evaluated at the Johns Hopkins Bayview Medical Center with the presumptive diagnosis of PAD from September 2005 to September 2010. In this group, we selected all symptomatic patients after failing medical management who received percutaneous transluminal angioplasty/stenting of the superficial femoral artery or femoral-popliteal bypass. We compared the overall patency and reintervention rates between the two groups as well as patency within TransAtlantic Inter-Society Consensus (TASC) II subgroups. Descriptive analyses were performed using χ(2) and two-sided t-tests. The Mann-Whitney U test was used to compare distributions of continuous variables and the Fisher exact test for categorical variables. Cox proportional hazard model was used to examine the treatment effect within each lesion type, using bypass as the reference group. Out of 1237 patients evaluated at Johns Hopkins Bayview Medical Center for PAD from September 2005 to September 2010, we identified 104 symptomatic patients who received percutaneous transluminal angioplasty/stenting of the superficial femoral artery or femoral-popliteal bypass after failing medical management. There were 61 male patients (56%), and the mean age was 68 years in both groups. Both treatment groups had similar risk factors. Overall, 77% of patients with TASC II A and B lesions underwent angioplasty and stenting, whereas 73% of patients with TASC C and D lesions underwent bypass (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .01). The primary patency at 24 months was better for the stent group 67% (95% confidence interval [CI], 0.52-0.78) vs bypass group 49% (95% CI, 0.32-0.64; P = .05). The rate of reintervention within the 2-year period was higher in the bypass group compared with the stent group (54% vs 31%; P = .02). TASC A and B lesions combined demonstrated a reduced hazard of patency failure compared with TASC C or D lesions combined (hazard ratio, 2.42; 95% CI, 1.26, 4.65; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .01). This is the first study that documents higher reintervention rates for femoral-popliteal bypass compared with angioplasty and stenting. We believe that the main reason for this finding is the fact that the bypass patients had significantly more advanced disease. This, emphasizes that one must consider the patient population undergoing intervention when comparing revascularization procedures. A prospective randomized trial is needed to determine the overall better treatment option.

Research paper thumbnail of Differential outcomes of carotid stenting and endarterectomy performed exclusively by vascular surgeons in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)

Journal of Vascular Surgery, 2013

Outcomes in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) did not di... more Outcomes in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) did not differ between carotid artery stenting (CAS) and carotid endarterectomy (CEA) for the composite primary end point of stroke, myocardial infarction (MI), or death during the periprocedural period or ipsilateral stroke within 4 years. Rigorous credentialing and training of interventionists, including vascular surgeons, were required for the randomization phase of CREST. Because the lead-in phase of CREST had suggested higher perioperative risks after CAS performed by vascular surgeons, the purpose of this analysis was to examine differences in outcomes after randomization between CAS and CEA performed by vascular surgeons. CREST is a prospective randomized controlled trial with blinded end point adjudication. Vascular surgeons performed 237 (21%) of the CAS procedures and 765 (65%) of the CEA procedures among 2320 patients who received their assigned treatment. Proportional hazards analyses were used to estimate the relative efficacy of CAS vs CEA for the composite primary end point and also for stroke and death. Among 2502 randomized patients, 1321 (53%) were symptomatic and 1181 (47%) were asymptomatic. For procedures performed exclusively by vascular surgeons, the primary end point did not differ between CAS and CEA at 4-year follow-up (6.2% vs 5.6%, respectively; hazard ratio [HR], 1.30; 95% confidence interval [CI], 0.70-2.41; P = .41) In this subgroup, the periprocedural stroke and death rates were higher after CAS than CEA for symptomatic patients (6.1% vs 1.3%; P = .01). Asymptomatic patients also had slightly higher stroke and death rates after CAS (2.6% vs 1.1%; P = .20), although this difference did not reach statistical significance. Conversely, cranial nerve injuries (0.0% vs 5.0%; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) were less frequent after CAS than CEA. The MI rates were slightly lower after CAS (1.3% vs 2.6%; P = .24). In performing CAS, vascular surgeons had outcomes for the periprocedural primary end point comparable to the outcomes of all interventionists (HR, 0.99; 95% CI, 0.50-2.00) after adjusting for age, sex, and symptomatic status. Vascular surgeons also had similar results after CEA for the periprocedural primary end point compared with other surgeons (HR, 0.73; 95% CI, 0.42-1.27). When performed by surgeons, CAS and CEA have similar net outcomes, although the periprocedural risks vary (lower stroke with CEA and lower MI with CAS). These data suggest that appropriately trained vascular surgeons may safely offer both CEA and CAS for the prevention of stroke. The remarkably low stroke and death rates after CEA performed by vascular surgeons in CREST, particularly among symptomatic patients, represent the best outcomes ever reported after carotid interventions from a randomized controlled trial. ClinicalTrials.gov identifier: NCT0000473.

Research paper thumbnail of PC112. Long-Term Outcomes After Carotid Revascularization in Patients on Hemodialysis

Journal of Vascular Surgery, 2015

Research paper thumbnail of SS14. β-Blockers Use Is Associated With Lower Stroke and Death After Carotid Artery Stenting in the Vascular Quality Initiative

Journal of Vascular Surgery, 2015

Research paper thumbnail of VESS18. Long-Term Outcomes After Open Infrainguinal Bypass in Patients With Scleroderma

Journal of Vascular Surgery, 2015

Research paper thumbnail of BS2. High Angulation and Short Neck Length Do Not Impact AAA Sac Expansion After Repair Using the Lombard Aorfix Device

Journal of Vascular Surgery, 2015

Research paper thumbnail of RR27. Validation of a Modified Frailty Index to Predict Mortality in Vascular Surgery Patients

Journal of Vascular Surgery, 2015

Research paper thumbnail of SS29. Where the Sun Shines: Industry Payments to Vascular Surgeons

Journal of Vascular Surgery, 2015

Research paper thumbnail of PS84. Intravenous Catheter Remains the Primary Access Type of Incident Hemodialysis a Decade After the Fistula First Breakthrough Initiative

Journal of Vascular Surgery, 2014

Research paper thumbnail of The role of advanced diagnostic technology in the selection of a patient with symptomatic but hemodynamically insignificant disease for carotid endarterectomy

Journal of Vascular Surgery Cases, 2015

Current Level I evidence demonstrates no benefit for carotid endarterectomy in symptomatic patien... more Current Level I evidence demonstrates no benefit for carotid endarterectomy in symptomatic patients with <50% carotid stenoses. However, unstable plaque morphology is increasingly recognized in the genesis of ischemic cerebral events. New advanced imaging technology, such as contrast-enhanced magnetic resonance angiography and ultrasound imaging, are emerging as important adjuncts in the evaluation of this patient population. We present a case where both modalities were beneficial in identifying plaque instability manifested by intraplaque hemorrhage and neovascularization in a patient with recurrent cerebral ischemic events and hemodynamically insignificant carotid disease. (J Vasc Surg Cases 2015;1:90-3.) Level I evidence derived from the North American Symptomatic Carotid Endarterectomy Trial 1 and the European Carotid Surgery Trial 2 established the role of carotid endarterectomy (CEA) for patients with symptomatic >50% internal carotid artery (ICA) stenoses. Conversely, these investigations demonstrated no benefit for CEA for symptomatic patients with <50% stenoses compared with medical management. We recently encountered a patient with a unilateral hemodynamically insignificant ICA stenosis who experienced recurrent cerebral ischemic events despite maximum medical therapy and without other potential causes. On the basis of magnetic resonance angiography (MRA) and contrast-enhanced duplex findings, we proceeded with CEA. This case illustrates that rarely one may encounter a patient with an unstable plaque in the absence of hemodynamic significance and who should be managed with CEA. The patient consented to publication of this report.

Research paper thumbnail of Macrovascular complications in the elderly diabetic

Textbook of Men's Health and Aging, Second Edition, 2007

Research paper thumbnail of Iliac Artery Aneurysm

Endovascular Interventions, 2013

Research paper thumbnail of Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial

The Lancet Neurology, 2012

Background In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the com... more Background In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the composite primary endpoint of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke thereafter did not diff er between carotid artery stenting and carotid endarterectomy for symptomatic or asymptomatic carotid stenosis. A secondary aim of this randomised trial was to compare the composite endpoint of restenosis or occlusion.

Research paper thumbnail of Preoperative Smoking Cessation is Essential in Preventing Early Graft Failure after Infrainguinal Bypass Surgery

Journal of Vascular Surgery, 2013

Research paper thumbnail of Chronic venous leg ulcer treatment: Future research needs

Wound Repair and Regeneration, 2013

The prevalence and costs of chronic venous ulcer care in the US are increasing. The Johns Hopkins... more The prevalence and costs of chronic venous ulcer care in the US are increasing. The Johns Hopkins University Evidence-Based Practice Center recently completed a systematic review of the comparative effectiveness of advanced wound dressings, antibiotics, and surgical management of chronic venous ulcers. Of 10,066 citations identified in the literature search, only 66 (0.06%) met our liberal inclusion criteria for providing evidence on the effectiveness of interventions for chronic venous ulcers. Based on review of those studies, members of our team and a panel of informed stakeholders identified important research gaps and methodological deficiencies and prioritized specific future research needs. Based on that review, we provide the results of our assessment of future research needs for chronic venous ulcer care. Advanced wound dressings were considered to have the highest priority for future research, followed by venous surgery and antibiotics. An imperative from our assessment is that future research evaluating interventions for chronic venous ulcers meet quality standards. In a time of increasing cost pressure, the wound care community needs to develop high-quality evidence to justify the use of present and future therapeutic modalities.

Research paper thumbnail of Patient Factors and Hospital Open Experience Predominate Outcomes After AAA Repair

Journal of Vascular Surgery, 2015

Research paper thumbnail of Long-Term Outcomes After Open Lower Extremity Revascularization in Young and Middle-Aged Patients

Journal of Vascular Surgery, 2015

Research paper thumbnail of Anesthetic Type and Risk of Myocardial Infarction Following Carotid Endarterectomy in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)

Journal of Vascular Surgery, 2015

Research paper thumbnail of Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial

Journal of Vascular Surgery, 2015

This study compared the performance of the Aorfix endograft (Lombard Medical, Oxfordshire, United... more This study compared the performance of the Aorfix endograft (Lombard Medical, Oxfordshire, United Kingdom) in standard (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;60°), highly angled (60°-90°), and severely angled (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;90°) aortic necks in the PYTHAGORAS study and evaluated changes in neck morphology over time. PYTHAGORAS is a prospective nonrandomized clinical trial of the Aorfix endograft. We divided the endovascular aneurysm repair (EVAR) cohort into groups by standard, high, and severe neck angle. The primary control group was patients concurrently undergoing open repair. Mortality at 30 days, 1 year, and 2 years and 30-day freedom from Society for Vascular Surgery major adverse events for the EVAR groups was compared with the open control. Aneurysm sac change, type I and III endoleaks, graft migration, and the reintervention rate at 1 and 2 years was compared between the standard, highly, and severely angled populations. The relative risk of graft complications with a neck diameter increase &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;10% was also calculated. At predetermined anatomic points, the effect of oversizing on aortic diameter was evaluated by calculating oversize percentage ([1 - outer aortic diameter measured at a given time/stent graft diameter] × 100%) preoperatively and at 3 years. In addition, the average oversizing percentage at 30 days and annually at 1 to 5 years was compared with the preoperative oversizing percentage. Finally, complication rates with ≥30% vs &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;30% planned oversizing were compared. The adverse event rate was lower for every EVAR group than the open control. In addition, the mortality rates at 30 days, 1 year, and 2 years were similar between the standard-angle (1.5%, 3.0%, 4.5%), high-angle (0.9%, 7.3%, 13.8%), and severe-angle (4.8%, 9.5%, 14.3%) EVAR groups and the open control groups (1.3, 6.6%, 10.5%). At 1 and 2 years, there was no difference in graft complications among the EVAR groups. However, with neck dilatation of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;10% at 5 mm above the proximal renal and 1 mm below the distal renal, there was an increased risk of graft migration (relative risk, 4.38 [P = .01] and 4.33 [P = .002], respectively). For all predetermined anatomic points, the oversizing percentage decreased over time. The rate of oversize percentage decrease was faster at more distal aortic locations, reaching &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;10% at 30 days 15 mm below the renal, at 2 years 7 mm below the renal, and at 5 years 1 mm below the renal (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001 for all). Half the oversize percentage achieved at the index procedure remained at 3 years (Pearson correlation coefficient = 0.5). However, there was no difference in complications between the ≥30%…

Research paper thumbnail of The Age Effect In Increasing Operative Mortality Following Delay in Elective Abdominal Aortic Aneurysm Repair

Annals of Vascular Surgery, 2015

Elective repair of large Abdominal Aortic Aneurysms (AAA) is associated with the risk of signific... more Elective repair of large Abdominal Aortic Aneurysms (AAA) is associated with the risk of significant perioperative mortality. When abdominal aneurysm repair is delayed, patients with asymptomatic large AAAs face the risk of death from rupture. In addition to the risk of rupture, the advancing age of the patients adds a future operative risk. This risk has been historically documented in age groups. However, a more accurate representation of the increasing operative risk with age is needed. We analyzed all patients in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database who underwent endovascular or open repair for asymptomatic infrarenal AAA between 2005 and 2012. Multivariable logistic regression was used to evaluate the effect of increasing age and operative delay on 30-day post-operative mortality. There were 27,576 patients who underwent AAA repair during the study period (mean age 73.5years, SD 8.6; 80% male; 24% open repair). There was a linear relative increase of 5% (OR: 1.05, 95%CI 1.04 - 1.06; P&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) in the odds of operative death after AAA repair with each year of operative delay irrespective of treatment approach. There was a linear relative increase of 4% for EVAR (OR: 1.04, 95%CI 1.02 - 1.05; P&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) and 6% for open repair (OR: 1.06, 95%CI 1.04 - 1.08; P&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) with each year of delay in repair. Due to increasing age, delay in surgery is associated with uniform increase in the risk of perioperative mortality in asymptomatic patients who meet criteria for AAA repair. It is important for surgeons to incorporate this more accurate calculation of operative risk into discussions with patients who qualify for treatment yet decide to forgo surgery for the repair of their AAA.

Research paper thumbnail of Comparison of surgical bypass with angioplasty and stenting of superficial femoral artery disease

Journal of Vascular Surgery, 2013

To evaluate the contemporary outcome of femoral-popliteal bypass compared with angioplasty and st... more To evaluate the contemporary outcome of femoral-popliteal bypass compared with angioplasty and stenting in patients with symptomatic peripheral arterial disease (PAD) in terms of patency and reintervention rates. We identified all patients evaluated at the Johns Hopkins Bayview Medical Center with the presumptive diagnosis of PAD from September 2005 to September 2010. In this group, we selected all symptomatic patients after failing medical management who received percutaneous transluminal angioplasty/stenting of the superficial femoral artery or femoral-popliteal bypass. We compared the overall patency and reintervention rates between the two groups as well as patency within TransAtlantic Inter-Society Consensus (TASC) II subgroups. Descriptive analyses were performed using χ(2) and two-sided t-tests. The Mann-Whitney U test was used to compare distributions of continuous variables and the Fisher exact test for categorical variables. Cox proportional hazard model was used to examine the treatment effect within each lesion type, using bypass as the reference group. Out of 1237 patients evaluated at Johns Hopkins Bayview Medical Center for PAD from September 2005 to September 2010, we identified 104 symptomatic patients who received percutaneous transluminal angioplasty/stenting of the superficial femoral artery or femoral-popliteal bypass after failing medical management. There were 61 male patients (56%), and the mean age was 68 years in both groups. Both treatment groups had similar risk factors. Overall, 77% of patients with TASC II A and B lesions underwent angioplasty and stenting, whereas 73% of patients with TASC C and D lesions underwent bypass (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .01). The primary patency at 24 months was better for the stent group 67% (95% confidence interval [CI], 0.52-0.78) vs bypass group 49% (95% CI, 0.32-0.64; P = .05). The rate of reintervention within the 2-year period was higher in the bypass group compared with the stent group (54% vs 31%; P = .02). TASC A and B lesions combined demonstrated a reduced hazard of patency failure compared with TASC C or D lesions combined (hazard ratio, 2.42; 95% CI, 1.26, 4.65; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .01). This is the first study that documents higher reintervention rates for femoral-popliteal bypass compared with angioplasty and stenting. We believe that the main reason for this finding is the fact that the bypass patients had significantly more advanced disease. This, emphasizes that one must consider the patient population undergoing intervention when comparing revascularization procedures. A prospective randomized trial is needed to determine the overall better treatment option.

Research paper thumbnail of Differential outcomes of carotid stenting and endarterectomy performed exclusively by vascular surgeons in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)

Journal of Vascular Surgery, 2013

Outcomes in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) did not di... more Outcomes in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) did not differ between carotid artery stenting (CAS) and carotid endarterectomy (CEA) for the composite primary end point of stroke, myocardial infarction (MI), or death during the periprocedural period or ipsilateral stroke within 4 years. Rigorous credentialing and training of interventionists, including vascular surgeons, were required for the randomization phase of CREST. Because the lead-in phase of CREST had suggested higher perioperative risks after CAS performed by vascular surgeons, the purpose of this analysis was to examine differences in outcomes after randomization between CAS and CEA performed by vascular surgeons. CREST is a prospective randomized controlled trial with blinded end point adjudication. Vascular surgeons performed 237 (21%) of the CAS procedures and 765 (65%) of the CEA procedures among 2320 patients who received their assigned treatment. Proportional hazards analyses were used to estimate the relative efficacy of CAS vs CEA for the composite primary end point and also for stroke and death. Among 2502 randomized patients, 1321 (53%) were symptomatic and 1181 (47%) were asymptomatic. For procedures performed exclusively by vascular surgeons, the primary end point did not differ between CAS and CEA at 4-year follow-up (6.2% vs 5.6%, respectively; hazard ratio [HR], 1.30; 95% confidence interval [CI], 0.70-2.41; P = .41) In this subgroup, the periprocedural stroke and death rates were higher after CAS than CEA for symptomatic patients (6.1% vs 1.3%; P = .01). Asymptomatic patients also had slightly higher stroke and death rates after CAS (2.6% vs 1.1%; P = .20), although this difference did not reach statistical significance. Conversely, cranial nerve injuries (0.0% vs 5.0%; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001) were less frequent after CAS than CEA. The MI rates were slightly lower after CAS (1.3% vs 2.6%; P = .24). In performing CAS, vascular surgeons had outcomes for the periprocedural primary end point comparable to the outcomes of all interventionists (HR, 0.99; 95% CI, 0.50-2.00) after adjusting for age, sex, and symptomatic status. Vascular surgeons also had similar results after CEA for the periprocedural primary end point compared with other surgeons (HR, 0.73; 95% CI, 0.42-1.27). When performed by surgeons, CAS and CEA have similar net outcomes, although the periprocedural risks vary (lower stroke with CEA and lower MI with CAS). These data suggest that appropriately trained vascular surgeons may safely offer both CEA and CAS for the prevention of stroke. The remarkably low stroke and death rates after CEA performed by vascular surgeons in CREST, particularly among symptomatic patients, represent the best outcomes ever reported after carotid interventions from a randomized controlled trial. ClinicalTrials.gov identifier: NCT0000473.

Research paper thumbnail of PC112. Long-Term Outcomes After Carotid Revascularization in Patients on Hemodialysis

Journal of Vascular Surgery, 2015

Research paper thumbnail of SS14. β-Blockers Use Is Associated With Lower Stroke and Death After Carotid Artery Stenting in the Vascular Quality Initiative

Journal of Vascular Surgery, 2015

Research paper thumbnail of VESS18. Long-Term Outcomes After Open Infrainguinal Bypass in Patients With Scleroderma

Journal of Vascular Surgery, 2015

Research paper thumbnail of BS2. High Angulation and Short Neck Length Do Not Impact AAA Sac Expansion After Repair Using the Lombard Aorfix Device

Journal of Vascular Surgery, 2015

Research paper thumbnail of RR27. Validation of a Modified Frailty Index to Predict Mortality in Vascular Surgery Patients

Journal of Vascular Surgery, 2015

Research paper thumbnail of SS29. Where the Sun Shines: Industry Payments to Vascular Surgeons

Journal of Vascular Surgery, 2015

Research paper thumbnail of PS84. Intravenous Catheter Remains the Primary Access Type of Incident Hemodialysis a Decade After the Fistula First Breakthrough Initiative

Journal of Vascular Surgery, 2014