Publications by authors named "Richard J Powell"

127 Publications

Reduction in Acute Limb Ischemia with Rivaroxaban versus Placebo in Peripheral Artery Disease after Lower Extremity Revascularization: Insights from VOYAGER PAD.

Circulation 2021 Oct 12. Epub 2021 Oct 12.

Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO; CPC Clinical Research, Aurora, CO.

Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Prior lower extremity revascularization (LER) is associated with increased ALI risk in chronic PAD. However, the pattern of risk, clinical correlates, and outcomes after ALI early after LER are not well-studied, and effective therapies to reduce ALI post-LER are lacking. VOYAGER PAD (NCT02504216) randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of low-dose aspirin. The primary outcome was a composite of ALI, major amputation of vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. ALI was prospectively ascertained and adjudicated by a blinded committee. The cumulative incidence of ALI was calculated using Kaplan Meier estimates, and Cox proportional-hazards models were used to generate hazard ratios and associated confidence intervals. Analyses were performed as intention-to-treat. Among 6,564 patients followed for a median of 2.3 years, 382 (5.8%) had a total of 508 ALI events. In placebo patients, the 3-year cumulative incidence of ALI was 7.8%. After multivariable modeling, prior LER, baseline ABI <0.50, surgical LER, and longer target lesion length were associated with increased risk of ALI. Incident ALI was associated with subsequent all-cause mortality (HR 2.59, 95% CI 1.98-3.39) and major amputation (HR 24.87, 95% CI 18.68-33.12). Rivaroxaban reduced ALI relative to placebo by 33% (absolute risk reduction 2.6% at 3 years, HR 0.67, 95% CI 0.55-0.82, P=0.0001), with benefit starting early (HR 0.45, 95% CI 0.24-0.85, P=0.0068 at 30 days). Benefit was present for severe ALI (associated with death, amputation, or prolonged hospitalization and ICU stay, HR 0.58, 95% CI 0.40-0.83, P=0.003) and regardless of LER type (surgical vs endovascular revascularization, p-interaction=0.42) or clopidogrel use (p-interaction=0.59). After LER for symptomatic PAD, ALI is frequent, particularly early after LER, and is associated with poor prognosis. Low-dose rivaroxaban plus aspirin reduces ALI after LER, including ALI events associated with the most severe outcomes. The benefit of rivaroxaban for ALI appears early, continues over time, and is consistent regardless of revascularization approach or clopidogrel use.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.055146DOI Listing
October 2021

SOCIETY FOR VASCULAR SURGERY CLINICAL PRACTICE GUIDELINES FOR MANAGEMENT OF EXTRACRANIAL CEREBROVASCULAR DISEASE.

J Vasc Surg 2021 Jun 18. Epub 2021 Jun 18.

Management of carotid bifurcation stenosis in stroke prevention has been the subject of extensive investigations, including multiple randomized controlled trials. The proper treatment of patients with carotid bifurcation disease is of major interest to vascular surgeons and other vascular specialists. In 2011, the Society for Vascular Surgery published guidelines for treatment of carotid artery disease. At the time, several randomized trials, comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS), were published. Since that publication, several studies and a few systematic reviews comparing CEA and CAS have been published, and the role of medical management has been re-emphasized. The current publication updates and expands the 2011 guidelines with specific emphasis on five areas: is carotid endarterectomy recommended over maximal medical therapy in low risk patients; is carotid endarterectomy recommended over trans-femoral carotid artery stenting in low surgical risk patients with symptomatic carotid artery stenosis of >50%; timing of carotid Intervention in patients presenting with acute stroke; screening for carotid artery stenosis in asymptomatic patients; and optimal sequence for intervention in patients with combined carotid and coronary artery disease. A separate implementation document will address other important clinical issues in extracranial cerebrovascular disease. Recommendations are made using the GRADE (Grades of Recommendation Assessment, Development and Evaluation) approach, as has been done with other Society for Vascular Surgery guidelines. The committee recommends CEA as the first-line treatment for symptomatic low risk surgical patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 70% to 99%. The perioperative risk of stroke and death in asymptomatic patients must be <3% to ensure benefit for the patient. In patients with recent stable stroke (modified Rankin 0-2), carotid revascularization is considered appropriate in symptomatic patients with greater than 50% stenosis and is recommended and performed as soon as the patient is neurologically stable after 48 hours but definitely before 14 days of onset of symptoms. In the general population, screening for clinically asymptomatic carotid artery stenosis in patients without cerebrovascular symptoms or significant risk factors for carotid artery disease is not recommended. In selected asymptomatic patients who are at increased risk for carotid stenosis, we suggest screening for clinically asymptomatic carotid artery stenosis as long as the patients would potentially be fit for and willing to consider carotid intervention if significant stenosis is discovered. In patients with symptomatic carotid stenosis 50-99%, who require both CEA and CABG, we suggest CEA before or concomitant with CABG to potentially reduce the risk of stroke and stroke/death. The sequencing of the intervention depends on clinical presentation and institutional experience.
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http://dx.doi.org/10.1016/j.jvs.2021.04.073DOI Listing
June 2021

Surgeon experience versus volume differentially affects lower extremity bypass outcomes in contemporary practice.

J Vasc Surg 2021 May 31. Epub 2021 May 31.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Background: Calls for minimum case thresholds to guide surgeon credentialing paradigms are increasing in contemporary practice. To date, the volume-outcome relationship and the role of surgeon experience as a proxy for quality have remained primarily focused on nonvascular extirpative surgery and aneurysm repair. However, it is unclear whether these data can be rightly extrapolated to predict lower extremity bypass (LEB) outcomes. Thus, the purpose of the present study was to examine whether the annualized case volume vs surgeon experience is more consequential in predicting for successful LEB reconstruction.

Methods: A total of 25,852 procedures with sufficient 1-year follow-up data from the Society for Vascular Surgery Vascular Quality Initiative infrainguinal bypass registry (2003-2019) were reviewed for chronic limb threatening ischemia among patients undergoing infrageniculate reconstruction. The procedures were categorized according to surgeon years of practice experience at surgery (ie, 0-5, 6-10, 11-15, >15 years) and the number of LEB procedures performed by the surgeon during the year of surgery (volume quartiles: 1-8, 9-14, 15-21, and >21). Mixed effects logistic and Cox regression models were used to assess the effects of experience, volume, and their interaction on outcomes.

Results: Increasing practice experience was more significantly associated with a reduction of in-hospital complications (odds ratio, 0.97; 95% confidence interval [CI], 0.96-0.99; P = .002) and the risk of major adverse limb events (odds ratio, 0.94; 95% CI, 0.92-0.97; P < .0001) compared with the volume. Increasing experience and volume were both associated with increased freedom from thrombosis (hazard ratio, 0.95; 95% CI, 0.93-0.98; P = .001). In contrast, neither experience nor volume had any significant association with early mortality. However, a higher volume was associated with diminished long-term survival (hazard ratio, 1.04; 95% CI, 1.0-1.1; P = .01). The most experienced surgeons (>15 years' experience) were significantly more likely to perform LEB for rest pain (P < .0001). No significant differences were found in the bypass rates among patients with tissue loss. The most experienced and highest volume surgeons were more likely to use an autogenous and/or composite conduit, in situ reconstruction, and/or pedal targets (P < .05). Similarly, more experienced and higher volume surgeons had less blood loss and shorter procedure times (P < .0001). Overall, the most experienced surgeons (>15 years' experience) were significantly more likely to have a higher volume with a diminished risk for all LEB outcomes.

Conclusions: Surgeon experience appears to have the most important role in predicting for overall LEB performance with improved in-hospital outcomes and major adverse limb events. The more experienced surgeons performed more complex reconstructions with fewer complications. These findings have significant clinical and educational implications as our most experienced surgeons approach retirement. Mentorship strategies to facilitate ongoing technical development among less experienced surgeons are imperative to sustain optimal limb salvage outcomes and have significant ramifications regarding expectations for regulatory and credentialing paradigms.
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http://dx.doi.org/10.1016/j.jvs.2021.05.029DOI Listing
May 2021

Association of Adoption of Transcarotid Artery Revascularization With Center-Level Perioperative Outcomes.

JAMA Netw Open 2021 02 1;4(2):e2037885. Epub 2021 Feb 1.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.

Importance: Transcarotid artery revascularization (TCAR) may serve as a safer alternative to carotid endarterectomy (CEA) for certain patients with carotid artery stenosis.

Objective: To determine the center-level association of TCAR adoption with overall perioperative outcomes for TCAR and CEA combined at centers performing both procedures.

Design, Setting, And Participants: This comparative-effectiveness research was conducted with a difference-in-difference analysis using retrospective data from 2015 to 2019 from the Vascular Quality Initiative registry, a consortium of more than 400 centers in North America. Included patients underwent TCAR or CEA for carotid artery stenosis. Patients who underwent transfemoral carotid stenting were excluded. Data were analyzed from December 2019 through August 2020.

Exposures: Center-level adoption of TCAR vs not.

Main Outcomes And Measures: The rate of major adverse cardiovascular events (MACE), a composite of in-hospital stroke, myocardial infarction, or death at 30 days, was measured.

Results: Among 86 027 patients who underwent revascularization for carotid artery stenosis, 7664 patients (8.9%) underwent TCAR (mean [SD] age, 73.1 [9.6] years; 2788 [36.4%] women; 6938 White patients [90.6%]; and 3741 patients with symptoms [48.8%]) and 78 363 patients (91.1%) underwent CEA (mean [SD] age, 70.6 [9.2] years; 30 928 [39.5%] women; 70 663 White patients [90.2%]; and 37 883 patients with symptoms [48.3%]). The number of centers performing both TCAR and CEA increased from 15 centers in 2015 to 247 centers in 2019, a more than 16-fold increase. The proportion of all carotid procedures that were TCARs increased from 90 of 12 276 (0.7%) in 2015 to 2718 of 15 956 (17.0%) in 2019, a 24-fold increase. Overall, the crude rate of MACE was similar for TCAR and CEA (178 patients [2.3%] after TCAR vs 1842 patients [2.4%] after CEA; P = .91). However, the rate of MACE over time decreased for CEA (406 of 16 404 patients [2.5%] in 2015 vs 189 of 10 097 patients [1.9%] in 2019; P for trend < .001). The rate of MACE over time decreased for TCAR as well, but the change was not statistically significant (4 of 128 patients [3.1%] in 2016 vs 59 of 2718 patients [2.2%] in 2019; P for trend = .07). Difference-in-difference analysis demonstrated that centers that adopted TCAR had a 10% decrease in the likelihood of MACE at 12 months after TCAR adoption vs if those centers had continued to perform CEA alone (odds ratio, 0.90; 95% CI, 0.81-0.99; P = .04).

Conclusions And Relevance: This comparative-effectiveness study of a cohort of patients who underwent TCAR or CEA found that availability of TCAR at a hospital was associated with a decrease in the likelihood of perioperative MACE after carotid revascularization.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.37885DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7900862PMC
February 2021

Array-based measurements of aero-allergen-specific IgE correlate with skin-prick test reactivity in asthma regardless of specific IgG4 or total IgE measurements.

J Immunol Methods 2021 05 18;492:112999. Epub 2021 Feb 18.

School of Life Sciences, The University of Nottingham, Nottingham NG7 2UH, UK. Electronic address:

Skin prick testing (SPT) and measurement of serum allergen-specific IgE (sIgE) are used to investigate asthma and other allergic conditions. Measurement of serum total IgE (tIgE) and allergen-specific IgG4 (sIgG4) may also be useful. The aim was to ascertain the correlation between these serological parameters and SPT. Sera from 60 suspected asthmatic patients and 18 healthy controls were assayed for sIgE and sIgG4 reactivity against a panel of 70 SPT allergen preparations, and for tIgE. The patients were also assessed by skin prick tests for reactivity to cat, dog, house dust mite and grass allergens. Over 50% of the patients had tIgE levels above the 75th percentile of the controls. 58% of patients and 39% of controls showed sIgE reactivity to ≥1 allergen. The mean number of allergens detected by sIgE was 3.1 in suspected asthma patients and 0.9 in controls. 58% of patients and 50% of controls showed sIgG4 reactivity to ≥1 allergen. The mean number of allergens detected by sIgG4 was 2.5 in patients and 1.7 in controls. For the patients, a strong correlation was observed between clinical SPT reactivity and serum sIgE levels to cat, dog, house dust mite (HDM) and grass allergens. SPT correlations using sIgE/sIgG4 or sIgE/tIgE ratios were not markedly higher. The measurement of serum sIgE by microarray using SPT allergen preparations showed good correlation with clinical SPT reactivity to cat, dog, HDM and grass allergens. This concordance was not improved by measuring tIgE or sIgG4.
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http://dx.doi.org/10.1016/j.jim.2021.112999DOI Listing
May 2021

Editor's Choice - Protamine Reduces Serious Bleeding Complications Associated with Carotid Endarterectomy in Asymptomatic Patients without Increasing the Risk of Stroke, Myocardial Infarction, or Death in a Large National Analysis.

Eur J Vasc Endovasc Surg 2020 Dec 27;60(6):800-807. Epub 2020 Oct 27.

Division of Vascular Surgery & Endovascular Therapy, University of Florida, Gainesville, FL, USA.

Objective: Controversy persists regarding the use of protamine during carotid endarterectomy (CEA), despite real world evidence to support its use. The purpose of this study was to determine the impact of protamine reversal of heparin anticoagulation on the outcome of CEA in the USA.

Methods: A prospective national registry (Society for Vascular Surgery Vascular Quality Initiative) of 72 787 patients undergoing elective asymptomatic CEA by 1879 surgeons from 316 centres in the USA and Canada from 2012 to 2018 was reviewed. Protamine use varied by both surgeon (20% rare use [< 10%], 30% variable use [11%-79%], 50% routine use [> 80% cases]) and geographical region (44% vs. 96%). Temporal trends in protamine use were also determined. End points included post-operative re-operation for bleeding, as well as potential protamine related thrombotic complications, including stroke, death, and myocardial infarction (MI). Predictors of end points were determined by multivariable logistic regression. Propensity matching was additionally used to control for differences between groups.

Results: Of the 72 787 patients who underwent CEA, 69% received protamine, while 31% did not. Protamine use increased over time from 60% (2012) to 73% (2018). In total, 378 patients (0.7%) in the protamine treated group underwent re-operation for bleeding vs. 342 patients (1.4%) in the untreated cohort (p < .001). Protamine use did not affect the rate of MI (0.7% vs. 0.8%; p = .023), stroke (1.1% vs. 1.0%; p = .20), or in hospital death (0.2% vs. 0.2%; p = 0.70) between treated and untreated patients, respectively. On multivariable analysis, protamine use was independently associated with reduced risk of re-operation for bleeding (odds ratio 0.5, 95% confidence interval 0.39-0.55; p < .001). Independent of protamine exposure, the consequences of a return to the operating room (RTOR) for bleeding were statistically significant, with a sevenfold increase in MI (RTOR 4.9% vs. no RTOR 0.7%; p < .001), an eightfold increase in stroke (RTOR 7.2% vs. no RTOR 0.9%; p < .001), and a 13 fold increase in death (RTOR 2.4% vs. no RTOR 0.2%; p < .001).

Conclusion: Protamine reduces serious bleeding complications at the time of CEA without increasing the risk of MI, stroke, or death, in this large North American analysis. Based on this and previous regional work regarding protamine use in CEA, it is believed that there is now sufficient evidence to support its routine use, and it should be considered as a benchmark for quality during CEA.
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http://dx.doi.org/10.1016/j.ejvs.2020.08.047DOI Listing
December 2020

Medicare reimbursement of lower extremity bypass does not cover cost of care for most patients with critical limb ischemia.

J Vasc Surg 2020 09;72(3):1068-1074

Section of Vascular Surgery at Dartmouth-Hitchcock Medical Center, Lebanon, NH. Electronic address:

Objective: Lower extremity bypass surgery remains an important treatment option for patients with critical limb ischemia (CLI), but is resource intensive. We sought to evaluate the cost and Medicare reimbursement for lower extremity bypass surgery in patients with CLI.

Methods: Hospital cost accounting systems were queried for total technical and professional costs incurred and reimbursement received for patients with CLI undergoing lower extremity bypass at our center between 2011 and 2017. Patients were identified by assignment to Diagnosis-Related Group (DRG) 252, 253, or 254 (other vascular procedure with major complication/comorbidity, with complication/comorbidity, and without complication/comorbidity, respectively). Additional clinical data were incorporated from the Vascular Quality Initiative clinical registry. For non-Medicare patients, reimbursement was indexed to Medicare rates. Contribution margins (reimbursement minus cost) from technical and professional services were analyzed for each patient and summarized by DRG. We compared technical, professional, and total costs; reimbursement; and contribution margins across DRGs using univariate statistics and evaluated factors associated with total contribution margin using median quantile regression.

Results: We analyzed 68 patients with hemodynamically confirmed CLI (46% rest pain, 54% tissue loss), of whom 25% received a prosthetic graft. Mean age was 66.1 ± 11.6 years, 69% were male, 49% diabetic, 44% current smokers, and 4% on dialysis. In general, total infrainguinal bypass cost was adequately compensated for patients assigned only the most complex DRG 252 (median, $2490; interquartile range [IQR], -$1,621 to $10,080). In the majority of patients with less complex DRG 253 (median, -$3,100; IQR, -$8499 to $109) and DRG 254 (median, -$4902; IQR, -$9259 to $1059), reimbursement did not cover the cost of care. Both technical costs and professional costs varied significantly with the complexity of DRG. Although reimbursement from technical services increased alongside increasing complexity of DRG, there was insignificant variation in professional reimbursement as DRG complexity increased. On multivariable modeling, longer length of stay (-$2547 per additional day) and preoperative dialysis (-$5555) were significantly associated with negative margins.

Conclusions: For the majority of patients with CLI, current Medicare reimbursement does not adequately cover the cost of providing care after open bypass surgery. As commercial insurers move toward Medicare reimbursement rates, more granular risk stratification profiles are needed to ensure open surgical care for patients with CLI remains financially sustainable.
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http://dx.doi.org/10.1016/j.jvs.2020.01.062DOI Listing
September 2020

The financial evolution of endovascular aneurysm repair delivery in contemporary practice.

J Vasc Surg 2021 03 21;73(3):1062-1066. Epub 2020 Jul 21.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Objective: The fiscal impact of endovascular repair (EVR) of aortic aneurysms and the requisite device costs have previously highlighted the tenuous long-term financial sustainability among Medicare beneficiaries. The Centers for Medicare & Medicaid Services have since reclassified EVR remuneration paradigms with new Medicare Severity Diagnosis-Related Groups (MS-DRGs) intended to better address the procedure's cost profile. The impact of this change remains unknown. The purpose of this analysis was to compare EVR-specific costs and revenue among Medicare beneficiaries both before and after this change.

Methods: All infrarenal EVRs performed in fiscal years (FYs) 2014 and 2015, before the MS-DRG change, and those performed in FYs 2017 and 2018, after the MS-DRG change, were identified using the DRG codes 238 (n = 108) and 269 (n = 84), respectively. We then identified those who were treated according to the instructions for use guidelines with a single manufacturer's device and billed to Medicare (n = 23 in FY14-15; n = 22 in FY17-18). From these cohorts, we determined total procedure technical costs, technical revenue, and net technical margin in conjunction with the hospital finance department. Results were then compared between these two groups.

Results: The two cohorts demonstrated similar demographic profiles (FY14-15 vs FY17-18 cohort: age, 78 years vs 74 years; median length of stay, 1.0 day vs 1.0 day). Mean total technical costs were slightly higher in the FY17-18 group ($24,511 in FY14-15 vs $26,445 in FY17-18). Graft implants continued to account for a significant portion of the total cost, with the device cost accounting for 56% of the total procedure costs in both cohorts. Net revenue was greater in the FY17-18 group by $5800 ($30,698 in FY14-15 vs $36,498 in FY17-18), resulting in an increased overall margin in the FY17-18 group compared with the FY14-15 group ($6188 in FY14-15 vs $10,053 in FY17-18).

Conclusions: Device costs remain the single greatest cost driver associated with EVR delivery. DRG reclassification of EVR to address total procedure and implant costs appears to better address the requisite associated procedure costs and may thereby better support long-term fiscal sustainability of this procedure for hospitals and health systems alike.
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http://dx.doi.org/10.1016/j.jvs.2020.06.117DOI Listing
March 2021

Association between surgeon case volume and years of practice experience with open abdominal aortic aneurysm repair outcomes.

J Vasc Surg 2021 04 22;73(4):1213-1226.e2. Epub 2020 Jul 22.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Background: Widespread adoption of endovascular aneurysm repair has led to a consequential decline in the use of open aneurysm repair (OAR). This evolution has had significant ramifications on vascular surgery training paradigms and contemporary practice patterns among established surgeons. Despite being the subject of previous analyses, the surgical volume-outcome relationship has remained a focus of controversy. At present, little is known about the complex interaction of case volume and surgeon experience with patient selection, procedural characteristics, and postoperative complications of OAR. The purpose of the present analysis was to examine the association between surgeon annual case volume and years of practice experience with OAR.

Methods: All infrarenal OARs (n = 11,900; elective, 70%; nonelective, 30%) included in the Society for Vascular Surgery Vascular Quality Initiative from 2003 to 2019 were examined. Surgeon experience was defined as years in practice after training. The experience level at repair was categorized chronologically (≤5 years, n = 1667; 6-10 years, n = 1887; 11-15 years, n = 1806; ≥16 years, n = 6540). The annual case volume was determined by the number of OARs performed by the surgeon annually (median, five cases). Logistic regression was used to perform risk adjustment of the outcomes across surgeon experience and volume (five or fewer vs more than five cases annually) strata for in-hospital major complications and 30-day and 1-year mortality.

Results: Practice experience had no association with unadjusted mortality (30-day death: elective, P = .2; nonelective, P = .3; 1-year death: elective, P = .2; nonelective, P = .2). However, more experienced surgeons had fewer complications after elective OAR (25% with ≥16 years vs 29% with ≤5 years; P = .004). A significant linear correlation was identified between increasing surgeon experience and performance of a greater proportion of elective OAR (P-trend < .0001). Risk adjustment (area under the curve, 0.776) revealed that low-volume (five or fewer cases annually) surgeons had inferior outcomes compared with high-volume surgeons across the experience strata for all presentations. In addition, high-volume, early career surgeons (≤5 years' experience) had outcomes similar to those of older, low-volume surgeons (P > .1 for all pairwise comparisons). Early career surgeons (≤5 years) had operated on a greater proportion of elective patients with American Society of Anesthesiologists class ≥4 (35% vs 30% [≥16 years' experience]; P = .0003) and larger abdominal aortic aneurysm diameters (mean, 62 vs 59 mm [≥16 years' experience]; P < .0001) compared with all other experience categories. Similarly, the use of a suprarenal cross-clamp occurred more frequently (26% vs 22% [≥16 years' experience]; P = .0009) but the total procedure time, estimated blood loss, and renal and/or visceral ischemia times were all greater for less experienced surgeons (P-trend < .0001).

Conclusions: Annual case volume appeared to be more significantly associated with OAR outcomes compared with the cumulative years of practice experience. To ensure optimal OAR outcomes, mentorship strategies for "on-boarding" early career, as well as established, low-volume, aortic aneurysm repair surgeons should be considered. These findings have potential implications for widespread initiatives surrounding regulatory oversight and credentialing paradigms.
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http://dx.doi.org/10.1016/j.jvs.2020.07.065DOI Listing
April 2021

Risk factors and impact of postoperative hypotension after carotid artery stenting in the Vascular Quality Initiative.

J Vasc Surg 2021 03 21;73(3):975-982. Epub 2020 Jul 21.

Maine Medical Center (MMC), Portland, Me.

Objective: Hypotension is a frequent complication of carotid artery stenting (CAS). Although common, its occurrence is unpredictable, and association with adverse events has not been well defined. The aim of this study was to identify predictors of postoperative hypotension after CAS and the association with stroke/transient ischemic attack (TIA), major adverse cardiac events (MACEs), increased length of stay (LOS), and in-hospital mortality.

Methods: This is a retrospective analysis of all CAS procedures, including transfemoral CAS (TF-CAS) and transcarotid artery revascularization (TCAR), performed in the Vascular Quality Initiative between 2003 and 2018. The primary study end point was postoperative hypotension, defined as hypotension treated with continuous infusion of a vasoactive agent for ≥15 minutes. Secondary end points included any postoperative neurologic events (stroke/TIA), MACEs (myocardial infarction, congestive heart failure, and dysrhythmias), prolonged LOS (>1 day), and in-hospital mortality. Patients' demographics predictive of hypotension were determined by multivariable logistic regression, and a risk score was developed for correlation with outcomes.

Results: During the time period of study, 24,699 patients underwent CAS; 19,716 (80%) were TF-CAS, 3879 (16%) were TCAR, and 1104 (4%) were not defined. Fifty-six percent were for symptomatic disease, 75% were for a primary atherosclerotic lesion, and 72% were performed under local or regional anesthesia. Postoperative hypotension occurred in 15% of TF-CAS and 14% of TCAR patients (P = .50). Patients with hypotension (vs no hypotension) had higher rates of stroke/TIA (7.3% vs 2.6%; P < .001), MACEs (9.6% vs 2.1%; P < .001), prolonged LOS (65% vs 28%; P < .001), and in-hospital mortality (2.9% vs 0.7%; P < .001). By multivariable analysis, risk factors associated with hypotension included an atherosclerotic (vs restenotic) lesion (odds ratio, 2.2; 95% confidence interval, 2.0-2.4; P < .001), female sex (1.3 [1.2-1.4]; P < .001), positive stress test result (1.3 [1.2-1.4]; P < .001), age 70 to 79 years (1.1 [1.1-1.3]; P < .002), age >80 years (1.2 [1.1-1.4]; P < .001), history of myocardial infarction or angina (1.3 [1.2-1.4]; P < .001), and an urgent (vs elective) procedure (1.1 [1.0-1.2]; P < .01). A history of hypertension was protective (0.9 [0.8-0.9]; P < .02). A normalized risk score for hypotension was created from the multivariable model. Increasing risk scores correlated directly with rates of adverse events, including postoperative stroke/TIA, MACEs, increased LOS, and increased in-hospital mortality.

Conclusions: Hypotension after CAS is associated with adverse neurologic and cardiac events as well as with prolonged LOS and in-hospital mortality. A scoring tool may be valuable in stratifying patients at risk. Interventions aimed at preventing postoperative hypotension may improve outcomes with CAS.
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http://dx.doi.org/10.1016/j.jvs.2020.06.116DOI Listing
March 2021

Medicare costs for endovascular abdominal aortic aneurysm treatment in the Vascular Quality Initiative.

J Vasc Surg 2021 03 15;73(3):1056-1061. Epub 2020 Jul 15.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Hanover, NH.

Background: Reintervention after endovascular repair (EVR) of abdominal aortic aneurysms is common. However, the cumulative financial impact of reintervention after EVR on a national scale is poorly defined. Our objective was to describe the cost to Medicare for aneurysm treatment (EVR plus reinterventions) among a cohort of patients with known follow-up for 5 years after repair.

Methods: We identified patients who underwent EVR within the Vascular Quality Initiative who were linked to their respective Medicare claims file (n = 13,995). We excluded patients who underwent EVR after September 30, 2010, and those who had incomplete Medicare coverage (n = 12,788). The remaining cohort (n = 1207) had complete follow-up until death or 5 years (Medicare data available through September 30, 2015). We then obtained and compiled the corresponding Medicare reimbursement data for the index EVR hospitalization and all subsequent reinterventions.

Results: We studied 1207 Medicare patients who underwent EVR and had known follow-up for reinterventions for 5 years. The mean age was 76.2 years (±7.1 years), 21.6% of patients were female, and 91.1% of procedures were elective. The Kaplan-Meier reintervention rate at 5 years was 18%. Among patients who underwent reintervention, 154 (73.7%) had a single reintervention, 40 (19.1%) had two reinterventions, and 15 (7.2%) had three or more reinterventions. The median cost to Medicare for the index EVR hospitalization was $25,745 (interquartile range, $21,131-$28,774). The median cost for subsequent reinterventions was $22,165 (interquartile range, $17,152-$29,605). The cumulative cost to Medicare of aneurysm treatment (EVR plus reinterventions) increased in a stepwise fashion among patients who underwent multiple reinterventions, with each reintervention being similar in cost to the index EVR.

Conclusions: The overall cost incurred by Medicare to reimburse for each reintervention after EVR is roughly the same as for the initial procedure itself, meaning that Medicare cost projections would be greater than $100,000 for any individual who undergoes an EVR with three reinterventions. The long-term financial impact of EVR must be considered by surgeons, patients, and healthcare systems alike as these cumulative costs may hinder the fiscal viability of an EVR-first therapeutic approach and highlight the need for judicious patient selection paradigms.
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http://dx.doi.org/10.1016/j.jvs.2020.06.109DOI Listing
March 2021

Outcomes of Innominate Artery Revascularization Through Endovascular, Hybrid, or Open Approach.

Ann Vasc Surg 2020 Nov 15;69:190-196. Epub 2020 Jun 15.

Department of Surgery, Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Background: Atherosclerotic disease of the innominate artery (IA) is rare and can lead to cerebral, upper extremity, and vertebral steal symptoms. Nonocclusive lesions can be treated with endovascular interventions, often with a hybrid approach while performing a right carotid endarterectomy (RCEA). Calcified IA lesions have a high risk of embolization to bilateral cerebral hemispheres. Occlusive lesions may require treatment through a median sternotomy and bypass. The purpose of our study is to review our short-term and long-term outcomes of IA revascularization.

Methods: Our operative database was used to identify patients who underwent IA revascularization between January 1998 and December 2018. Patients who underwent innominate artery stenting (IAS), combined with RCEA and IAS as well as aortoinnominate bypass (AIB), were identified. Our primary end points were freedom from neurologic event, all-cause mortality, and need for reintervention.

Results: Thirty-three patients (18 females [55%]) who underwent IA revascularization were identified. Average age was 67 ± 8 years, and mean clinical follow-up was 51 ± 21 months. Most patients (30 [91%]) were on a statin and antiplatelet therapy. Twenty-one patients (64%) were symptomatic. Twelve patients (36%) were asymptomatic and underwent combined RCEA with retrograde IAS for critical right carotid stenosis and IA stenosis. Preoperative imaging included a carotid duplex and computed tomography angiography. Eighteen patients (55%) underwent RCEA + IAS, 11 patients (33%) underwent isolated IAS, and 4 patients (12%) underwent AIB. In our attempt to protect bilateral hemispheres during IAS for heavily calcified lesions, we used right common carotid artery (CCA) clamping although open exposure and left CCA embolic protection filter was placed through transfemoral approach. Patients who underwent AIB had chronic heavily calcified IA occlusions or occluded IA stents with failed endovascular interventions. Perioperative stroke rate was 3%, involving 1 patient who developed reperfusion syndrome after RCEA + IAS. Perioperative mortality was 0%. Long-term stroke rate was 0%, and long-term mortality was 15% (5 of 33) because of cardiac disease. Overall restenosis rate was 9%, involving 3 patients who required secondary interventions for IA in-stent restenosis.

Conclusions: IA interventions through a hybrid approach or an open approach are safe, with acceptable perioperative stroke and mortality rates. Long-term patency of these interventions is acceptable. Bilateral cerebral embolic protection can be accomplished by clamping the right CCA through an open exposure and placing a filter in the left CCA through a transfemoral approach. Patients undergoing IAS appear to have a higher rate of restenosis compared with AIB, and therefore, close follow-up with noninvasive imaging is recommended.
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http://dx.doi.org/10.1016/j.avsg.2020.06.005DOI Listing
November 2020

Long-Term Outcomes of Mesenteric Stenting and Analysis of In-Stent Restenosis Duplex Velocity Criteria.

Ann Vasc Surg 2020 Oct 16;68:226-233. Epub 2020 May 16.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Background: Endovascular therapy for chronic mesenteric ischemia (CMI) is the mainstay of treatment. Duplex velocity criteria within stented mesenteric vessels are not well established. We describe single-center outcomes of mesenteric stenting for CMI and analyze duplex velocities associated with in-stent restenosis (ISR).

Methods: We performed a single-center retrospective review of patients undergoing mesenteric stenting for CMI (2012-2018). Primary outcome was reintervention for recurrence of CMI symptoms. Secondary outcomes were occlusion or bypass grafting. Duplex velocities in those with recurrent symptoms, corresponding with clinically significant ISR, were identified. Receiver operating characteristic (ROC) curves were created to identify velocity thresholds for ISR.

Results: Mesenteric stents were placed in 61 patients (71 arteries). Mean age was 72 years (range, 49-92), and the majority were female (55%). Thirty-two (45%) celiac (CA) stents and 39 (55%) superior mesenteric artery (SMA) stents were placed. Ten patients had SMA and CA stents placed. Twenty-five stents were covered (35%). Freedom from reintervention at 1, 2, and 3 years was 83%, 73%, and 60%. Freedom from occlusion or bypass grafting at 1, 2, and 3 years was 100%, 86%, and 86%. No significant difference in patency was seen between covered and bare-metal stents (OR 0.45; 95% CI: 0.15-1.33; P = 0.1383). Median survival was 6.1 years. For CA stents, a peak systolic velocity (PSV) of 440 cm/s corresponded with clinically significant ISR with 100% sensitivity and 86% specificity. For SMA stents, a PSV of 341 cm/s corresponded with clinically significant ISR with only 80% sensitivity and 52% specificity.

Conclusions: A PSV of 440 cm/s for CA stents was indicative of clinically significant ISR with excellent sensitivity and specificity. This should be used in conjunction with clinical findings to identify patients that may benefit from repeat intervention. A similar threshold could not be identified for SMA stents and warrants further collaborative investigation.
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http://dx.doi.org/10.1016/j.avsg.2020.04.064DOI Listing
October 2020

Outcomes of rotational atherectomy in complex lesions of the superficial femoral artery.

J Vasc Surg 2021 01 20;73(1):172-178. Epub 2020 Apr 20.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH. Electronic address:

Background: The effectiveness of rotational atherectomy in the treatment of complex superficial femoral artery (SFA) lesions remains poorly defined. Outcomes of SFA lesions treated with rotational atherectomy were analyzed.

Methods: This retrospective review assessed all patients who underwent rotational atherectomy of the SFA at a single institution between 2015 and 2018. The data of all patients were deidentified, and the study was approved by the Institutional Review Board. Informed consent was not obtained for this retrospective analysis. Main outcomes were Kaplan-Meier primary patency rate, freedom from major amputation, and 2-year survival rate. The effect of drug-coated balloon angioplasty (DCBA) on patency and time to death was investigated with univariate regression. The safety profile for atherectomy and DCBA was assessed by the 30-day incidence of major amputation and all-cause mortality.

Results: Fifty-three patients (mean age, 70.2 ± 9.8 years; 73% male; 65% critical limb-threatening ischemia; 47 [90%] current or former smokers; seven [13%] with prior failed ipsilateral endovascular intervention) underwent rotational atherectomy (Jetstream; Boston Scientific, Marlborough, Mass) with mean follow-up of 543 days. Forty-six (87%) patients underwent DCBA (Lutonix; BD Bard, Covington, Ga) after atherectomy. Mean lesion length was 13.2 ± 9.0 cm. Thirty-one (58%) lesions were TransAtlantic Inter-Society Consensus C or D class. At 1-month follow-up, 39 of 45 (87%) patients experienced improvement in symptoms and Rutherford class. An improvement in ankle-brachial index was also noted in 13% of patients without improvement of symptoms, with no patients progressing to surgical bypass or major amputation. Mean ankle-brachial index increased from 0.54 ± 0.035 to 0.90 ± 0.031 at 1 month after intervention (P < .001) and remained constant out to 18 months. Mean toe pressure increased from 36 ± 3.8 mm Hg to 67 ± 4.5 mm Hg at 1 month after intervention (P < .001) and remained constant out to 18 months. Kaplan-Meier primary patency rate was 75% (95% confidence interval, 61%-85%) at 12 months and 65% (51%-77%) at 24 months. There was a trend toward improved primary patency after adjunctive DCBA compared with plain balloon angioplasty at 1 year (75% vs 43%; P = .1082). There was no significant difference in mortality between adjunctive DCBA and plain balloon angioplasty at 2 years (11% vs 0%). The 2-year incidence of major amputation in critical limb-threatening ischemia patients was 3.9% (1.2%-6.5%). One patient died and none underwent amputation within 30 days.

Conclusions: Rotational atherectomy with adjunctive DCBA of long SFA lesions has excellent long-term patency. Two-year major amputation and mortality rates are low, and the technique has an exceptional safety profile.
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http://dx.doi.org/10.1016/j.jvs.2020.03.040DOI Listing
January 2021

The role of transfemoral carotid artery stenting with proximal balloon occlusion embolic protection in the contemporary endovascular management of carotid artery stenosis.

J Vasc Surg 2020 11 3;72(5):1701-1710. Epub 2020 Apr 3.

Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Mass. Electronic address:

Objective: Recent data have shown that transcarotid artery revascularization (TCAR) with flow reversal provides a superior method of embolic protection compared with transfemoral carotid artery stenting (tfCAS) with distal embolic protection. Flow reversal or flow arrest systems with proximal endovascular balloon occlusion can also be used through the transfemoral approach; however, their outcomes compared with TCAR with flow reversal and tfCAS with distal embolic protection are poorly described.

Methods: We performed a retrospective review of all patients undergoing tfCAS with proximal balloon occlusion, tfCAS with distal embolic protection, and TCAR with flow reversal in the Society for Vascular Surgery Vascular Quality Initiative from March 2005 to May 2019. We assessed in-hospital outcomes in propensity score-matched cohorts of patients using tfCAS with proximal balloon occlusion as the comparison cohort. The primary outcome was stroke or death. Secondary end points included the individual outcomes of stroke, death, transient ischemic attack (TIA), and myocardial infarction.

Results: Of the 24,232 patients undergoing carotid artery stenting, 561 (2.3%) procedures were performed through tfCAS with proximal balloon occlusion, 18,126 (74%) through tfCAS with distal embolic protection, and 5545 (22.9%) through TCAR with flow reversal. After matching, 463 pairs of patients undergoing tfCAS with proximal balloon occlusion and tfCAS with distal embolic protection were identified. There were no differences in stroke or death (proximal balloon, 3.2%; distal embolic protection, 3.7%; relative risk [RR], 0.88; 95% confidence interval [CI], 0.45-1.73; P = .73), stroke (2.4% vs 2.6%; RR, 0.92; 95% CI, 0.42-2.00; P = .83), death (1.1% vs 1.5%; RR, 0.71; 95% CI, 0.41-3.15; P = .80), TIA (1.7% vs 1.5%; RR, 1.14; 95% CI, 0.41-3.15; P = .80), or myocardial infarction (0.4% vs 0.6%; RR, 0.67; 95% CI, 0.11-3.99; P = .65). However, after matching 357 pairs of patients undergoing tfCAS with proximal balloon occlusion and TCAR with flow reversal, tfCAS with proximal balloon occlusion was associated with higher rates of stroke or death (3.1% vs 0.8%; RR, 3.67; 95% CI, 1.02-13.14; P = .03) and a trend toward higher rates of stroke (2.5% vs 0.8%; RR, 3.00; 95% CI, 0.81-11.08; P = .08) and death (0.8% vs 0.0%; P = .08), but no statistically significant differences in TIA (0.8% vs 0.8%; P > .99) or myocardial infarction (0.6% vs 0.3%; RR, 2.00; 95% CI, 0.18-22.06; P = .56).

Conclusions: Compared with tfCAS with distal embolic protection, tfCAS with proximal balloon occlusion has similar major outcomes. However, tfCAS with proximal balloon occlusion does not offer the same degree of embolic protection compared with TCAR with flow reversal, given the significantly higher risk of perioperative stroke or death.
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http://dx.doi.org/10.1016/j.jvs.2020.02.036DOI Listing
November 2020

Adverse cardiac events after vascular surgery are prevalent despite negative results of preoperative stress testing.

J Vasc Surg 2020 11 1;72(5):1584-1592. Epub 2020 Apr 1.

Section of Vascular Surgery, Geisel School of Medicine at Dartmouth, Hanover, NH.

Objective: Cardiac risk assessment is a critical component of vascular disease management before surgical intervention. The predictive risk reduction of a negative cardiac stress test result remains poorly defined. The objective of this study was to compare the incidence of postoperative cardiac events among patients with negative stress test results vs those who did not undergo testing.

Methods: We reviewed all patients who underwent elective open abdominal aortic aneurysm repair, suprainguinal bypass, endovascular aneurysm repair (EVAR), carotid endarterectomy (CEA), and infrainguinal bypass within the Vascular Study Group of New England from 2003 to 2017. We excluded patients with positive stress test results (n = 3312) and studied two mutually exclusive groups: elective surgery patients with a negative stress test result and elective surgery patients with no stress test (total n = 26,910). The primary outcome was a composite of in-hospital postoperative cardiac events (dysrhythmia, heart attack, heart failure) or death.

Results: A preoperative stress test was obtained in 66.3% of open repairs, 42.8% of suprainguinal bypasses, 37.1% of EVARs, 36.0% of CEAs, and 31.2% of infrainguinal bypasses. The proportion of patients receiving a preoperative stress test varied widely across centers, from 37.1% to 80.0%. The crude odds ratio of in-hospital postoperative cardiac event or death was 1.37 (95% confidence interval [CI], 1.07-1.76) for open repair and 1.52 (CI, 1.13-2.03) for suprainguinal bypass, indicating that patients with negative stress test results before these procedures were 37% and 52% more likely to suffer a postoperative event or die compared with patients selected to proceed directly to surgery without testing. Conversely, the crude odds ratio was 0.92 (CI, 0.66-1.29) for EVAR, 0.92 (CI, 0.70-1.21) for CEA, and 1.13 (CI, 0.90-1.40) for infrainguinal bypass, indicating that patients undergoing these procedures had a similar likelihood of sustaining an event whether they had a negative stress test result or proceeded directly to surgery without a stress test.

Conclusions: The use of cardiac stress testing before vascular surgery varies widely throughout New England. Whereas patients are often appropriately selected to proceed directly to surgery, a negative preoperative stress test result should not assuage the concern for an adverse outcome as these patients retain a substantial likelihood of cardiac events, especially after large-magnitude procedures.
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http://dx.doi.org/10.1016/j.jvs.2020.01.061DOI Listing
November 2020

Surgeon experience association with patient selection and outcomes after open abdominal aortic aneurysm repair.

J Vasc Surg 2020 10 27;72(4):1325-1336.e2. Epub 2020 Feb 27.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Background: Growing calls for guidelines advocating minimum annual case volumes for surgeon credentialing remain controversial. Although most attention to date has focused on the impact of obligatory case volume, less attention has been devoted to the more complex association between surgeon years of independent practice experience and procedure outcomes after open abdominal aortic aneurysm repair (OAR). Therefore, the purpose of this study was to explore the association of surgeon experience with case selection and real-world outcomes after OAR.

Methods: All Society for Vascular Surgery-Vascular Quality Initiative infrarenal and juxtarenal OARs (n = 11,900; 71% elective; 29% nonelective) from 2003 to 2019 were examined. Surgeon experience was defined by years in practice after training completion. Experience level at time of repair was categorized (≤5 years, n = 1048; 6-10 years, n = 1309; 11-15 years, n = 1244; and ≥16 years, n = 4772) and intergroup univariate comparisons were made. Logistic regression identified independent predictors of complications, 30-day death, and 1-year mortality. Models were constructed with or without surgeon experience strata to determine association with outcomes.

Results: Increasing surgeon experience was associated with performing greater proportions of elective procedures, whereas less experienced surgeons had disproportionate exposure to nonelective operations (elective, 73% ≥16 years vs 62% ≤5 years [P < .0001]; nonelective, ≤5 years, 38% vs 27%, ≥16-years [P < .0001]). Among surgeons who perform five or fewer cases per year, the risk of any aggregate major complication after elective OAR decreased significantly as experience increased (P = .0004), although no differences were detected in nonelective cases or among higher volume surgeons. Similarly, the risk of in-hospital death decreased with increasing experience (P = .004), but only among low-volume surgeons performing elective procedures. Comorbidities were similar across all experience strata for both elective and nonelective presentations; however, more experienced surgeons operated on higher proportions of nonelective patients with coronary disease (P = .04). Early career surgeons more frequently operated on patients with American Society of Anesthesiologists IV designation, larger abdominal aortic aneurysm diameters and used suprarenal/celiac cross-clamps more frequently than later career surgeons. The 1-year survival after elective and nonelective OAR was not impacted by surgeon experience (P > .15 for all comparisons).

Conclusions: Increasing surgeon years of practice experience correlated significantly with a reduced risk of developing multiple postoperative complications, including postoperative death in the elective setting. Surgeons within their first 5 years of practice are exposed to greater proportions of nonelective cases but seem to have similar outcomes after these repairs compared with surgeons with more experience. Notably, surgeons in their first 5 years of practice operate on more complex elective patients as underscored by higher aggregate comorbidity scores, larger aneurysm diameters, and need for suprarenal aortic cross-clamping. These data have important implications on training paradigms, faculty recruitment, and the organization of mentorship when on boarding new surgeons.
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http://dx.doi.org/10.1016/j.jvs.2019.12.031DOI Listing
October 2020

A multi-institutional experience in vascular Ehlers-Danlos syndrome diagnosis.

J Vasc Surg 2020 01 26;71(1):149-157. Epub 2019 Jul 26.

Division of Vascular Surgery, University of California Los Angeles, Los Angeles, Calif.

Objective: Vascular Ehlers-Danlos syndrome (vEDS) is a rare disorder and 1 of 13 types of EDS. The syndrome results in aortic and arterial aneurysms and dissections at a young age. Diagnosis is confirmed with molecular testing via skin biopsy or genetic testing for COL3A1 pathogenic variants. We describe a multi-institutional experience in the diagnosis of vEDS from 2000 to 2015.

Methods: This is a multi-institutional cross-sectional retrospective study of individuals with vEDS. The institutions were recruited through the Vascular Low Frequency Disease Consortium. Individuals were identified using the International Classification of Diseases-9 and 10-CM codes for EDS (756.83 and Q79.6). A review of records was then performed to select individuals with vEDS. Data abstraction included demographics, family history, clinical features, major and minor diagnostic criteria, and molecular testing results. Individuals were classified into two cohorts and then compared: those with pathogenic COL3A1 variants and those diagnosed by clinical criteria alone without molecular confirmation.

Results: Eleven institutions identified 173 individuals (35.3% male, 56.6% Caucasian) with vEDS. Of those, 11 (9.8%) had nonpathogenic alterations in COL3A1 and were excluded from the analysis. Among the remaining individuals, 86 (47.7% male, 68% Caucasian, 48.8% positive family history) had pathogenic COL3A1 variants and 76 (19.7% male, 19.7% Caucasian, 43.4% positive family history) were diagnosed by clinical criteria alone without molecular confirmation. Compared with the cohort with pathogenic COL3A1 variants, the clinical diagnosis only cohort had a higher number of females (80.3% vs 52.3%; P < .001), mitral valve prolapse (10.5% vs 1.2%; P = .009), and joint hypermobility (68.4% vs 40.7%; P < .001). Additionally, they had a lower frequency of easy bruising (23.7% vs 64%; P < .001), thin translucent skin (17.1% vs 48.8%; P < .001), intestinal perforation (3.9% vs 16.3%; P = .01), spontaneous pneumothorax/hemothorax (3.9% vs 14%, P.03), and arterial rupture (9.2% vs 17.4%; P = .13). There were no differences in mortality or age of mortality between the two cohorts.

Conclusions: This study highlights the importance of confirming vEDS diagnosis by testing for pathogenic COL3A1 variants rather than relying on clinical diagnostic criteria alone given the high degree of overlap with other forms genetically triggered arteriopathies. Because not all COL3A1 variants are pathogenic, the interpretation of the genetic testing results by an individual trained in variant assessment is essential to confirm the diagnosis. An accurate diagnosis is critical and has serious implications for lifelong screening and treatment strategies for the affected individual and family members.
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http://dx.doi.org/10.1016/j.jvs.2019.04.487DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7245161PMC
January 2020

A multi-institutional experience in the aortic and arterial pathology in individuals with genetically confirmed vascular Ehlers-Danlos syndrome.

J Vasc Surg 2019 11 21;70(5):1543-1554. Epub 2019 May 21.

Division of Vascular Surgery, University of California Los Angeles, Los Angeles, Calif.

Objective: Vascular Ehlers-Danlos syndrome (vEDS) is a rare connective tissue disorder owing to pathogenic variants in COL3A1 that lead to impaired type III collagen production. We aim to describe the contemporary multi-institutional experience of aortic and arterial pathology in individuals with vEDS, to evaluate disease patterns and refine management recommendations.

Methods: This cross-sectional, retrospective study of individuals with genetically confirmed vEDS was conducted between 2000 and 2015 at multiple institutions participating in the Vascular Low Frequency Disease Consortium. Aortic and arterial events including aneurysms, pseudoaneurysms, dissections, fistulae, or ruptures were studied. Demographics, COL3A1 variants, management, and outcomes data were collected and analyzed. Individuals with and without arterial events were compared.

Results: Eleven institutions identified 86 individuals with pathogenic variants in COL3A1 (47.7% male, 86% Caucasian; median age, 41 years; interquartile range [IQR], 31.0-49.5 years; 65.1% missense COL3A1 variants). The median follow-up from the time of vEDS diagnosis was 7.5 years (IQR, 3.5-12.0 years). A total of 139 aortic/arterial pathologies were diagnosed in 53 individuals (61.6%; 50.9% male; 88.5% Caucasian; median age, 33 years; IQR, 25.0-42.3 years). The aortic/arterial events presented as an emergency in 52 cases (37.4%). The most commonly affected arteries were the mesenteric arteries (31.7%), followed by cerebrovascular (16.5%), iliac (16.5%), and renal arteries (12.2%). The most common management was medical management. When undertaken, the predominant endovascular interventions were arterial embolization of medium sized arteries (13.4%), followed by stenting (2.5%). Aortic pathology was noted in 17 individuals (32%; 58.8% male; 94.1% Caucasian; median age, 38.5 years; IQR, 30.8-44.7 years). Most notably, four individuals underwent successful abdominal aortic aneurysm repair with excellent results on follow-up. Individuals with missense mutations, in which glycine was substituted with a large amino acid, had an earlier onset of aortic/arterial pathology (median age, 30 years; IQR, 23.5-37 years) compared with the other pathogenic COL3A1 variants (median age, 36 years; IQR, 29.5-44.8 years; P = .065). There were 12 deaths (22.6%) at a median age of 36 years (IQR, 28-51 years).

Conclusions: Most of the vEDS arterial manifestations were managed medically in this cohort. When intervention is required for an enlarging aneurysm or rupture, embolization, and less frequently stenting, seem to be well-tolerated. Open repair of abdominal aortic aneurysm seems to be as well-tolerated as in those without vEDS; vEDS should not be a deterrent to offering an operation. Future work to elucidate the role of surgical interventions and refine management recommendations in the context of patient centered outcomes is warranted.
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http://dx.doi.org/10.1016/j.jvs.2019.01.069DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8240141PMC
November 2019

The rise and fall of beta-blockers?

Authors:
Richard J Powell

J Vasc Surg 2019 04;69(4):1173

Lebanon, NH.

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http://dx.doi.org/10.1016/j.jvs.2018.09.021DOI Listing
April 2019

UK Immunotherapy Study: Reanalysis by a combined symptom and medication score.

J Allergy Clin Immunol 2018 12 24;142(6):1998-1999.e3. Epub 2018 Aug 24.

Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; Center for Rhinology and Allergology, Wiesbaden, Germany. Electronic address:

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http://dx.doi.org/10.1016/j.jaci.2018.07.034DOI Listing
December 2018

Disparity in Medicaid physician payments for vascular surgery.

J Vasc Surg 2018 12 29;68(6):1946-1953. Epub 2018 Jul 29.

Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Objective: Medicare reimbursements are standardized nationwide on the basis of resource-dependent inputs of physicians' time, intensity, practice costs, and malpractice costs, whereas Medicaid payments vary and are determined by individual states. Our objectives were to determine Medicaid reimbursement to physicians for common vascular procedures for the seven states in the Northeast that compose the New England Society for Vascular Surgery and to compare Medicaid payments with Medicare.

Methods: Using publicly available data, we obtained Medicaid physician payments in Connecticut, Massachusetts, Maine, New Hampshire, New York, Rhode Island, and Vermont for 10 commonly performed vascular surgery procedures. For comparison, Medicare physician payments for these procedures were adjusted for regional differences using Medicare geographic payment cost indices. Descriptive statistics were calculated by state; Wilcoxon signed rank test was used to compare fees, and one-way analysis of variance was used to compare variance.

Results: Medicaid payments varied widely by state. Within individual states (except Vermont), there was no relationship between Medicaid and Medicare payments. Medicaid reimbursement for common vascular procedures ranged from 25% to 91% of Medicare rates and had up to a threefold variation in payment among states for a single procedure. The mean Medicaid payment was 60% of Medicare payment. The greatest state-to-state variance in payment was for open abdominal aortic repair (standard deviation, $227.31); the least was for femoral artery exposure (standard deviation, $31.86). For a Medicaid-based, frequency-weighted analysis of services, New Hampshire exhibited the lowest payments (43% Medicare) and Vermont the highest (80% Medicare).

Conclusions: Among the seven Northeast states considered, with the exception of Vermont, there is no logical relationship between Medicaid and Medicare payments. Because Medicare payments are determined by the Centers for Medicare and Medicaid Services with consideration of resource-based inputs, we conclude that in six of the seven states, Medicaid payments bear no relationship to resource utilization. With Medicaid expansion, access to vascular procedures may be limited by payments insufficient to meet resource needs.
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http://dx.doi.org/10.1016/j.jvs.2018.03.422DOI Listing
December 2018

A signalome screening approach in the autoinflammatory disease TNF receptor associated periodic syndrome (TRAPS) highlights the anti-inflammatory properties of drugs for repurposing.

Pharmacol Res 2017 Nov 30;125(Pt B):188-200. Epub 2017 Aug 30.

School of Life Sciences, The University of Nottingham, Life Sciences Building, University Park, Nottingham NG7 2RD, UK.

TNF receptor associated periodic syndrome (TRAPS) is an autoinflammatory disease caused by mutations in TNF Receptor 1 (TNFR1). Current therapies for TRAPS are limited and do not target the pro-inflammatory signalling pathways that are central to the disease mechanism. Our aim was to identify drugs for repurposing as anti-inflammatories based on their ability to down-regulate molecules associated with inflammatory signalling pathways that are activated in TRAPS. This was achieved using rigorously optimized, high through-put cell culture and reverse phase protein microarray systems to screen compounds for their effects on the TRAPS-associated inflammatory signalome. 1360 approved, publically available, pharmacologically active substances were investigated for their effects on 40 signalling molecules associated with pro-inflammatory signalling pathways that are constitutively upregulated in TRAPS. The drugs were screened at four 10-fold concentrations on cell lines expressing both wild-type (WT) TNFR1 and TRAPS-associated C33Y mutant TNFR1, or WT TNFR1 alone; signalling molecule levels were then determined in cell lysates by the reverse-phase protein microarray. A novel mathematical methodology was developed to rank the compounds for their ability to reduce the expression of signalling molecules in the C33Y-TNFR1 transfectants towards the level seen in the WT-TNFR1 transfectants. Seven high-ranking drugs were selected and tested by RPPA for effects on the same 40 signalling molecules in lysates of peripheral blood mononuclear cells (PBMCs) from C33Y-TRAPS patients compared to PBMCs from normal controls. The fluoroquinolone antibiotic lomefloxacin, as well as others from this class of compounds, showed the most significant effects on multiple pro-inflammatory signalling pathways that are constitutively activated in TRAPS; lomefloxacin dose-dependently significantly reduced expression of 7/40 signalling molecules across the Jak/Stat, MAPK, NF-κB and PI3K/AKT pathways. This study demonstrates the power of signalome screening for identifying candidates for drug repurposing.
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http://dx.doi.org/10.1016/j.phrs.2017.08.012DOI Listing
November 2017

Reimbursement in hospital-based vascular surgery: Physician and practice perspective.

J Vasc Surg 2017 07 11;66(1):317-322. Epub 2017 May 11.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Objective: The purpose of this study was to determine change in value of a vascular surgery division to the health care system during 6 years at a hospital-based academic practice and to compare physician vs hospital revenue earned during this period.

Methods: Total revenue generated by the vascular surgery service line at an academic medical center from 2010 through 2015 was evaluated. Total revenue was measured as the sum of physician (professional) and hospital (technical) net revenue for all vascular-related patient care. Adjustments were made for work performed, case complexity, and inflation. To reflect the effect of these variables, net revenue was indexed to work relative value units (wRVUs), case mix index, and consumer price index, which adjusted for work, case complexity, and inflation, respectively. Differences in physician and hospital net revenue were compared over time.

Results: Physician work, measured in RVUs per year, increased by 4%; case complexity, assessed with case mix index, increased by 10% for the 6-year measurement period. Despite stability in payer mix at 64% to 69% Medicare, both physician and hospital vascular-related revenue/wRVU decreased during this period. Unadjusted professional revenue/wRVU declined by 14.1% (P = .09); when considering case complexity, physician revenue/wRVU declined by 20.6% (P = .09). Taking into account both case complexity and inflation, physician revenue declined by 27.0% (P = .04). Comparatively, hospital revenue for vascular surgery services decreased by 13.8% (P = .07) when adjusting for unit work, complexity, and inflation.

Conclusions: At medical centers where vascular surgeons are hospital based, vascular care reimbursement decreased substantially from 2010 to 2015 when case complexity and inflation were considered. Physician reimbursement (professional fees) decreased at a significantly greater rate than hospital reimbursement for vascular care. This trend has significant implications for salaried vascular surgeons in hospital-based settings, where the majority of revenue generated by vascular surgery care is the technical component received by the facility. Appropriate care for patients with vascular disease is increasingly resource intensive, and as a corollary, reimbursement levels must reflect this situation if high-quality care is to be maintained.
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http://dx.doi.org/10.1016/j.jvs.2017.03.417DOI Listing
July 2017

Stent placement in the superficial femoral and proximal popliteal arteries with the innova self-expanding bare metal stent system.

Catheter Cardiovasc Interv 2017 May 15;89(6):1069-1077. Epub 2017 Mar 15.

Ev. Luth. Diakonissenanstalt Flensburg, Flensburg, Germany.

Objectives: The SuperNOVA trial was designed to evaluate performance of the Innova Vascular Self-Expanding Stent System (Boston Scientific, Marlborough, MA) for treating lesions in the femoropopliteal arteries.

Methods: Patients with chronic lower limb peripheral artery disease (Rutherford category 2, 3, or 4) and atherosclerotic lesions in the native superficial femoral and/or proximal popliteal artery (lengths 30-190 mm) were enrolled in this single-arm, multinational study. Major adverse events (MAEs) were defined as all-cause death through 1 month, target limb major amputation, and target lesion revascularization (TLR). Vessel primary patency was defined as core laboratory-adjudicated duplex ultrasonography-derived peak systolic velocity ratio ≤2.4 in the absence of TLR, surgical bypass of the target lesion, or major amputation of the target limb. Primary safety and efficacy endpoints were evaluated at 12 months, with follow-up through 24 months also reported.

Results: SuperNOVA patients (N = 299; mean age 67.4 ± 9.7 years, 74% men, 41% with diabetes) had a mean lesion length of 93.2 mm. The MAE-free rate was 99.7% at 30 days, 85.8% at 12 months, and 77% at 24 months. Kaplan-Meier estimates of primary patency and TLR-free rates were 68.7% and 78.0%, respectively, at 24 months. Clinical improvements were sustained through 2 years, with 80% of patients displaying no or minimal symptoms (Rutherford category 0-1) at 24 months.

Conclusions: In the SuperNOVA study, the Innova Stent System demonstrated an excellent safety profile and acceptable clinical outcomes despite the challenging anatomical characteristics of the lesions. © 2017 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/ccd.26976DOI Listing
May 2017

Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System.

Stem Cells Int 2017 17;2017:4137626. Epub 2017 Jan 17.

Fortis Escorts Heart Institute and Research Centre, New Delhi, India.

Critical limb ischemia (CLI) is the end stage of lower extremity peripheral vascular disease (PVD) in which severe obstruction of blood flow results in ischemic rest pain, ulcers and/or gangrene, and a significant risk of limb loss. This open-label, single-arm feasibility study evaluated the safety and therapeutic effectiveness of autologous bone marrow cell (aBMC) concentrate in revascularization of CLI patients utilizing a rapid point-of-care device. Seventeen (17) no-option CLI patients with ischemic rest pain were enrolled in the study. Single dose of aBMC, prepared utilizing an intraoperative point-of-care device, the Res-Q™ 60 BMC system, was injected intramuscularly into the afflicted limb and patients were followed up at regular intervals for 12 months. A statistically significant improvement in Ankle Brachial Index (ABI), Transcutaneous Oxygen Pressure (TcPO), mean rest pain and intermittent claudication pain scores, wound/ ulcer healing, and 6-minute walking distance was observed following aBMC treatment. Major amputation-free survival (mAFS) rate and amputation-free rates (AFR) at 12 months were 70.6% and 82.3%, respectively. In conclusion, aBMC injections were well tolerated with improved tissue perfusion, confirming the safety, feasibility, and preliminary effectiveness of aBMC treatment in CLI patients.
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http://dx.doi.org/10.1155/2017/4137626DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5282442PMC
January 2017

Below-Knee Amputation Failure and Poor Functional Outcomes Are Higher Than Predicted in Contemporary Practice.

Vasc Endovascular Surg 2016 Nov 14;50(8):554-558. Epub 2016 Dec 14.

1 Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.

Objective: The perceived functional benefit of below-knee amputation (BKA) must be carefully weighed against the need for potential reinterventions. This study sought to examine the contemporary clinical and functional outcomes of patients undergoing BKA in the endovascular era.

Methods: All patients who underwent BKA from January 2008 to December 2014 at a single tertiary medical center were retrospectively reviewed. Demographics, comorbidities, ambulation status, and transcutaneous oximetry (TcPO2) values were recorded. Study end points included freedom from conversion to above-knee amputation (AKA), freedom from conversion to AKA or death, BKA healing, and ambulation. Statistical modeling was performed to determine associations with BKA failure.

Results: Over the study interval, 130 limbs underwent BKA in 120 patients. Transcutaneous oximetry studies were obtained in 65% (n = 85). Thirty-eight percent (n = 46) of all BKA patients went on to heal and ambulate. Twenty-five percent (n = 33) required reintervention, 24 with conversion to AKA, and 9 with BKA revision. One-year freedom from conversion to AKA was 76% and was decreased among those with lower TcPO2 levels (60% TcPO2 <40 vs 81% TcPO2 ≥40; P = .04). One-year composite freedom from conversion to AKA/death was 60% and was decreased among those with lower TcPO2 readings (39% TcPO2 <40 vs 69% TcPO2 ≥40; P = .01).

Conclusion: Despite a perceived functional bias toward knee salvage at the time of major amputation, most patients failed to postoperatively ambulate. Those with decreased TcPO2 levels (<40 mm Hg) have a 2-fold higher risk of AKA conversion or death, while nearly one-fourth of all BKA patients will succumb to the same fate irrespective of TcPO2. This suggests that many BKA patients in the endovascular era fail to derive the perceived benefit of knee salvage at the time of their index amputation. These findings highlight the need for careful patient selection and for a shared decision-making model in this frail population.
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http://dx.doi.org/10.1177/1538574416682159DOI Listing
November 2016

Multicenter Experience of Surgical Explantation of Carotid Stents for Recurrent Stenosis.

Vasc Endovascular Surg 2016 Nov 23;50(8):547-553. Epub 2016 Nov 23.

3 Department of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA.

Objective: A significant cohort of patients who have undergone carotid artery stenting (CAS) will have in-stent restenosis (ISR). The optimal management of symptomatic or severe ISR remains poorly defined. The purpose of this study was to describe the indications, treatment, and mid- to long-term outcomes of patients undergoing CAS explantation for ISR.

Methods: All patients undergoing internal carotid artery stent explantation with carotid artery reconstruction at Mayo Clinic Rochester, Dartmouth-Hitchcock Medical Center, and Beth-Israel Deaconess Medical Center from 2003 to 2013 were retrospectively reviewed. Isolated common carotid artery stents were excluded. Demographics, comorbidities, indications for explantation, operative details, and perioperative and postoperative outcomes were reviewed.

Results: Over the study interval, a total of 971 patients underwent carotid stenting across the 3 centers. Of these, 8 patients ultimately underwent CAS explantation with carotid artery reconstruction. Mean age was 69 years and 5 patients were male. Index stent placement was for symptomatic stenosis in 4 patients, asymptomatic restenosis after endarterectomy in 2 patients, asymptomatic high lesion in 1 patient, and asymptomatic critical stenosis in 1 patient. Indications for explantation were symptomatic ISR in 4 patients and asymptomatic severe ISR in 4 patients. Method of repair was stent explantation and patch angioplasty in 5 and en bloc carotid resection with bypass in 3 patients. There were no perioperative neurologic events or cranial nerve injuries. At a mean follow-up of 38.7 months, there were 2 late disabling ipsilateral strokes (14.4 months and 19.1 months).

Conclusion: A significant cohort of patients who have undergone CAS will have ISR. Although excellent perioperative results after surgical explantation can be obtained, this patient subgroup remains at risk for late neurologic events. Appropriate patient selection and diligent long-term follow-up are mandated to obtain optimal outcomes.
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http://dx.doi.org/10.1177/1538574416677668DOI Listing
November 2016

Design and Rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial.

J Am Heart Assoc 2016 07 8;5(7). Epub 2016 Jul 8.

Division of Cardiology, Massachusetts General Hospital, Boston, MA.

Background: Critical limb ischemia (CLI) is increasing in prevalence, and remains a significant source of mortality and limb loss. The decision to recommend surgical or endovascular revascularization for patients who are candidates for both varies significantly among providers and is driven more by individual preference than scientific evidence.

Methods And Results: The Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial is a prospective, randomized, multidisciplinary, controlled, superiority trial designed to compare treatment efficacy, functional outcomes, quality of life, and cost in patients undergoing best endovascular or best open surgical revascularization. Approximately 140 clinical sites in the United States and Canada will enroll 2100 patients with CLI who are candidates for both treatment options. A pragmatic trial design requires consensus on patient eligibility by at least 2 investigators, but leaves the choice of specific procedural strategy within the assigned revascularization approach to the individual treating investigator. Patients with suitable single-segment of saphenous vein available for potential bypass will be randomized within Cohort 1 (n=1620), while patients without will be randomized within Cohort 2 (n=480). The primary efficacy end point of the trial is Major Adverse Limb Event-Free Survival. Key secondary end points include Re-intervention and Amputation-Free-Survival and Amputation Free-Survival.

Conclusions: The BEST-CLI trial is the first randomized controlled trial comparing endovascular therapy to open surgical bypass in patients with CLI to be carried out in North America. This landmark comparative effectiveness trial aims to provide Level I data to clarify the appropriate role for both treatment strategies and help define an evidence-based standard of care for this challenging patient population.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02060630.
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http://dx.doi.org/10.1161/JAHA.116.003219DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5015366PMC
July 2016
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