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1.
Eur J Vasc Endovasc Surg ; 58(4): 529-537, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31439432

RESUMO

OBJECTIVE: The choice for surgical revascularisation for aortoiliac occlusive disease is often tempered by patient comorbidities. This study compares peri-operative outcomes and the association between choice of operation and one year major adverse limb event (MALE) free survival and five year mortality. METHODS: The Vascular Study Group of New England (VSGNE) dataset for supra-inguinal bypass operations from 2009 to 2015 was queried. This study excluded cases with bypass other than aortofemoral (AFB), axillofemoral (AXB), and femorofemoral (FFB), and those with endovascular interventions or femoral endarterectomy. Cases combined with other procedures, indications other than occlusive disease, and missing pathology were also excluded. Patients were divided into three groups: AFB, AXB, and FFB. Thirty day post-operative death (POD) and adverse events were compared using univariable and multivariable analyses. One year MALE free survival was compared between groups with log rank test and Kaplan-Meier plot. Proportional hazard Cox regression was used for adjusted comparison of MALE free and five year survival. RESULTS: In total, 1,602 cases were included: 207 (12.9%) AXB; 872 (54.4%) AFB; 523 (32.6%) FFB. AXB patients were older with more comorbidities. Post-operative complications and POD rates were significantly higher for AXB (p < .05). On adjusted analyses, AXB increased the hazard of one year MALE (hazard ratio [HR] 1.76, 95% confidence interval [CI] 1.12-2.78; p = .014) and five year mortality (HR 1.54; 95% CI 1.11-2.41; p = .009). Both FFB and AFB had similar one year MALE free survival but significantly better one year MALE free survival than AXB. CONCLUSION: After adjusting for confounding variables, and while acknowledging limitations related to the VSGNE data set, FFB led to significantly lower rates of post-operative complications than AXB. FFB may serve as the extra-anatomical operation of choice in high risk patients with extensive disease, who cannot undergo AFB, provided that anatomy permits. AFB should be performed preferentially in low risk patients with appropriate anatomy. Owing to its higher complications rates, the study suggests that AXB should be limited to patients with no other option for revascularisation.

2.
J Vasc Surg ; 2019 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-31395294

RESUMO

OBJECTIVE: It has been suggested that more bypass outflow targets for bypass grafts improve patency and outcomes. Our objective was to examine this in a multicenter contemporary series of axillary to femoral artery grafts. METHODS: The Vascular Quality Initiative database was queried for all axillary-unifemoral (AxUF) and axillary-bifemoral (AxBF) bypass grafts performed between 2010 and 2017 for claudication, rest pain, and tissue loss. Patients with acute limb ischemia were excluded. Patients' demographics and comorbidities as well as operative details and outcomes were recorded. Univariable, multivariable, and Kaplan-Meier analyses were used to assess long-term outcomes. RESULTS: There were 412 (32.9%) AxUF grafts and 839 (67.1%) AxBF grafts identified. Overall, the mean age of the patients was 68.3 years, 51.1% were male, and 84.7% were white. Compared with AxBF grafts, AxUF grafts were more often performed for urgent cases; in patients who were younger, male, nonambulatory, and diabetic; and in those with preoperative anticoagulation, critical limb ischemia, prior bypass, aneurysm repair, peripheral vascular intervention, and major amputation (P < .05 for all). There were no significant differences between AxUF and AxBF grafts in perioperative wound complications (4.2% vs 2.9%; P = .23), cardiac complications (7.3% vs 10.4%; P = .08), pulmonary complications (4.1% vs 6%, P = .18), early stenosis/occlusion (0.2% vs 0.8%; P = .22), perioperative mortality (2.9% vs 3.2%; P = .77), and length of stay (6.4 ± 5.6 days vs 6.7 ± 8 days; P = .29). The mean estimated blood loss (268.1 mL vs 348.6 mL; P < .001) and mean operative time (201 minutes vs 224.1 minutes; P < .001) were significantly lower for AxUF grafts. Kaplan-Meier analysis showed that AxUF and AxBF grafts had similar freedom from graft occlusion (62.6% vs 71.8%; P = .074), major adverse limb event-free survival (57.1% vs 66.6%; P = .052), and survival (86% vs 86%; P = .897) at 1 year. Major amputation-free survival was lower for AxUF grafts (63.7% vs 73%; P = .028). Multivariable analysis also showed that the type of graft configuration did not independently predict occlusion/death (hazard ratio [HR], 1.06; 95% confidence interval [CI], 0.77-1.46; P = .72), amputation/death (HR, 1.12; 95% CI, 0.83-1.51; P = .45), major adverse limb event/death (HR, 0.97; 95% CI, 0.73-1.3; P = .85), or mortality (HR, 0.91; 95% CI, 0.65-1.26; P = .55). Three-year survival after placement of AxUF and AxBF grafts was similar (75.1% vs 78.2%; P = .414). CONCLUSIONS: AxUF and AxBF grafts have similar perioperative and 1-year outcomes. Graft patency was not significantly different between an AxBF graft and an AxUF graft at 1 year. Overall, patients treated with these reconstructions have many comorbidities and low long-term survival.

3.
J Vasc Surg ; 2019 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-31443977

RESUMO

OBJECTIVE: Although the effect of body mass index (BMI) on the treatment of infrainguinal peripheral artery disease has been reported, outcomes of patients on the upper end of the obesity spectrum, including morbid obesity (MO) and superobesity (SO), are unclear. Our goal was to analyze perioperative outcomes after lower extremity bypass (LEB) and peripheral vascular interventions (PVIs) in this population of patients. METHODS: The Vascular Quality Initiative was reviewed for all infrainguinal peripheral artery disease interventions from 2010 to 2017. All patients were categorized into four groups: nonobese (BMI 18.5-29.9 kg/m2), obese (BMI 30-39.9 kg/m2), morbidly obese (BMI 40-49.9 kg/m2), and superobese (BMI ≥50 kg/m2). Patient and case details were recorded. Multivariable analysis was used to analyze outcomes. For statistical analysis, MO and SO groups were combined. RESULTS: We identified 29,138 LEB cases (68.5% nonobese, 28.3% obese, 2.9% morbidly obese, 0.3% superobese) and 81,405 PVI cases (66.6% nonobese, 29.2% obese, 3.6% morbidly obese, 0.5% superobese). For both LEB and PVI, patients with MO and SO were more likely to be younger, female, nonsmokers, and ambulatory (P < .05). They also more often had diabetes, end-stage renal disease, congestive heart failure, and fewer previous inflow procedures (P < .05). LEB and PVI interventions in patients with MO and SO were less often elective and more often performed for tissue loss. Multivariable analysis showed that LEB in patients with MO and SO was not significantly associated with increased perioperative cardiac complications, return to the operating room, or mortality. Patients with MO and SO were significantly associated with increased surgical site infection (odds ratio, 1.43; 95% confidence interval, 1.02-1.98; P = .03) and increased respiratory complications (odds ratio, 1.6; 95% confidence interval, 1.11-2.31; P = .01). Multivariable analysis showed that MO and SO were not significantly associated with periprocedural access site hematoma, access site stenosis or occlusion, or mortality after PVI. CONCLUSIONS: MO and SO were significantly associated with increased incidence of wound infections and respiratory complications after LEB but were not significantly associated with increased incidence after PVI. Overall, patients with MO and SO have more comorbidities and more advanced presentation of vascular disease at the time of intervention, but MO and SO alone should not deter necessary and appropriate revascularization.

4.
Vasc Endovascular Surg ; : 1538574419868869, 2019 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-31416401

RESUMO

INTRODUCTION: Preoperative hypoalbuminemia is associated with poor outcomes across many surgical fields. However, the effects on outcomes after lower extremity bypass (LEB), particularly over the 90-day global surgical period, are unclear. Our goal was to analyze the effect of hypoalbuminemia within 90 days after LE bypass. METHODS: We performed a single-center retrospective review of all infrainguinal LEBs from 2007 to 2017. Patients were categorized into 3 preoperative albumin groups: severe hypoalbuminemia (SH; albumin ≤2.8g/dL), mild-moderate hypoalbuminemia (MH; albumin >2.8-3.5g/dL), and normal albumin (albumin >3.5g/dL). Patient and procedural details were recorded. Outcomes analyzed included wound infection, myocardial infarction (MI), pulmonary complications, early graft occlusion (≤30 days), mortality, and emergency department (ED) presentation and readmissions within 30 and 90 days. Multivariable analysis was performed. RESULTS: We identified 313 patients undergoing LEB-45 (14.4%) with SH, 133 (42.5%) with MH, and 135 (43.1%) with normal albumin. Overall, the mean age was 65.7 years, and 63.3% were male. The SH group more frequently had tissue loss, diabetes, hypertension, end-stage renal disease, preoperative hematocrit <30%, and patients admitted preoperatively (all P < .05). There were no significant differences in wound complications, MI, pulmonary complications, early graft occlusion, 30-day or 90-day mortality, and 30-day ED presentation. Severe hypoalbuminemia compared to MH and normal albumin, respectively, had significantly higher rates of 30-day readmission (40% vs 30.8% vs 17.8%, P = .005), 90-day ED presentation (55.6% vs 33.8% vs 29.6%, P = .006), and 90-day readmission (66.7% vs 48.9% vs 35.6%, P = .001). Multivariable analysis showed that SH was independently associated with 90-day ED presentation (odds ratio [OR]: 2.8, 95% confidence interval [CI]: 1.23-6.36, P = .014) and 90-day readmission (OR: 2.63, 95% CI: 1.21-5.71, P = .015). CONCLUSION: Our study suggests that patients with SH undergoing LEB had similar perioperative complication rates compared to normal albumin and MH groups, and SH was independently associated with 90-day ED presentation and readmission. Further studies are needed to assess other factors associated with ED visits and readmission.

5.
Sci Rep ; 9(1): 9439, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-31263163

RESUMO

Type 2 diabetes (T2D) affects the health of millions of people worldwide. The identification of genetic determinants associated with changes in glycemia over time might illuminate biological features that precede the development of T2D. Here we conducted a genome-wide association study of longitudinal fasting glucose changes in up to 13,807 non-diabetic individuals of European descent from nine cohorts. Fasting glucose change over time was defined as the slope of the line defined by multiple fasting glucose measurements obtained over up to 14 years of observation. We tested for associations of genetic variants with inverse-normal transformed fasting glucose change over time adjusting for age at baseline, sex, and principal components of genetic variation. We found no genome-wide significant association (P < 5 × 10-8) with fasting glucose change over time. Seven loci previously associated with T2D, fasting glucose or HbA1c were nominally (P < 0.05) associated with fasting glucose change over time. Limited power influences unambiguous interpretation, but these data suggest that genetic effects on fasting glucose change over time are likely to be small. A public version of the data provides a genomic resource to combine with future studies to evaluate shared genetic links with T2D and other metabolic risk traits.

6.
J Vasc Surg ; 2019 Jul 18.
Artigo em Inglês | MEDLINE | ID: mdl-31327606

RESUMO

OBJECTIVE: Infectious complications of arteriovenous grafts (AVGs) are a major source of morbidity. Our aim was to characterize contemporary risk factors for upper extremity AVG infection. METHODS: The Vascular Quality Initiative (2011-2018) was queried for all patients undergoing upper extremity AVG creation. AVG infection was classified as an infection treated with antibiotics, incision and drainage, or graft removal. Multivariable analyses were used to evaluate risk factors for short- and long-term AVG infection. RESULTS: Of 1758 upper extremity AVGs, 49 (2.8%) developed significant infection within 3 months, resulting in incision and drainage in 24% and graft removal in 76% of cases. None were managed with antibiotics alone in the study sample. Patients with significant AVG infection were more likely to be white, to be insured, to have a history of coronary artery bypass graft and intravenous (IV) drug use, to be undergoing a concomitant vascular procedure, and to be discharged on an anticoagulant. In multivariable analysis, significant AVG infection within 3 months was associated with IV drug use history (odds ratio [OR], 5; 95% confidence interval [CI], 1.75-14.3; P = .003), discharge to a health care facility (OR, 2.66; 95% CI, 1.07-6.63; P = .035), discharge on an anticoagulant (OR, 2.31; 95% CI, 1.13-4.72; P = .021), white race (OR, 2.3; 95% CI, 1.21-4.34; P = .011), and female sex (OR, 2.02; 95% CI, 1.06-3.85; P = .033). Kaplan-Meier analysis showed that freedom from graft site infection at 1 year was 96.4%. Longer term graft infection at 1 year was independently associated with IV drug use history (hazard ratio [HR], 1.98; 95% CI, 1.06-3.68; P = .032), initial discharge to a health care facility (HR, 1.88; 95% CI, 1.19-2.97; P = .007), and white race (HR, 1.64; 95% CI, 1.23-2.19; P = .001). CONCLUSIONS: Although significant AVG infection was uncommon in the Vascular Quality Initiative, the majority were treated with graft removal. In select high-risk patients, extra care should be taken and alternative forms of arteriovenous access may be considered.

7.
Stat Med ; 38(21): 4112-4130, 2019 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-31256435

RESUMO

Two-way enriched design (TED) is a novel approach addressing placebo response in clinical trials. It is a two-stage, randomized, placebo-controlled trial design with enrichment in placebo non-responders and treatment responders at the second stage. All data from the first stage and data from placebo non-responders and treatment responders in the second stage are used for the final analysis of the treatment effect. The existing methods for the analysis of TED data include score tests with one, two, and three degrees of freedom. All these methods are only applicable to binary outcomes. However, there is an interest in continuous outcomes in clinical trials in psychiatry. In this manuscript, we apply some novel methods, including a repeated measures model, a weighted repeated measures model with weights from propensity score, and weights from K-means clustering, to analyze TED data for both binary outcomes and continuous outcomes. The simulation study indicates that the repeated measures model performs consistently well in preserving the type I error and achieving the minimum mean standard error as well as a higher power. The performance of the weighted repeated measures model with weights from K-means clustering improves with increasing sample size. Investigators can choose from these analytic approaches under different scenarios.

8.
J Vasc Surg ; 70(5): 1446-1455, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31147111

RESUMO

OBJECTIVE: Randomized trials have shown no benefit for repair of small abdominal aortic aneurysms (AAAs), although repair of small AAAs is widely practiced. It has also been suggested that repair of large-diameter AAAs may incur worse outcomes. We sought to examine differences in patient selection, operative outcomes, and survival after elective endovascular aneurysm repair (EVAR) based on AAA diameter thresholds. METHODS: Elective EVARs for asymptomatic AAAs in the Vascular Quality Initiative were studied from 2003 to 2017. AAAs were classified by diameter as small (<5 cm in women, <5.5 cm in men), medium (5-6.5 cm in women, 5.5-6.5 cm in men), and large (≥6.5 cm). Patient characteristics and operative factors were compared using univariate analyses and established risk prediction models. Effects of AAA diameter on reintervention and mortality were assessed using Kaplan-Meier and multivariable Cox regression analyses. RESULTS: Of 22,975 patients undergoing EVAR, 41% (9353), 47% (10,842), and 12% (2780) had small, medium, and large AAAs, respectively. Patients with small AAAs were younger and had fewer comorbidities. Consequently, patients with small AAAs were more likely to have low predicted operative mortality risk and 5-year mortality risk based on risk models (P < .001 for both). For operative outcomes, 30-day mortality was significantly different across diameter categories (small, 0.4%; medium, 0.9%; large, 1.6%; P < .001). EVAR for large AAAs had the highest rates of multiple medical complications, including myocardial infarction (P < .001), respiratory complications (P = .001), and renal complications (P < .001). In contrast, EVAR for small AAAs had the lowest rates of type I endoleak at completion and reoperation during index hospitalization, shortest operative times, and shortest hospital length of stay (P < .001 for all). Aneurysm diameter was associated with differential 1-year reintervention-free survival (92% small vs 89% medium vs 82% large; P < .001) and 5-year overall survival (88% small vs 81% medium vs 75% large; P < .001). Multivariable models showed that compared with medium AAAs, small AAAs had an independent protective effect against 1-year reintervention or death (hazard ratio [HR], 0.82; P = .003) and 5-year mortality (HR, 0.78; P = .001). Conversely, compared with medium AAAs, large AAAs carried an independent increased risk of 1-year reintervention or death (HR, 1.75; P < .001) and 5-year mortality (HR, 1.50; P < .001). CONCLUSIONS: Small AAAs represent >40% of elective EVARs in the Vascular Quality Initiative. Patients with small AAAs selected for repair are younger and have fewer comorbidities. Consequently, EVAR for small AAAs carries lower risk of operative and 5-year mortality. Aneurysm diameter is independently associated with reinterventions and mortality after EVAR, suggesting that AAA diameter may have an important clinical effect on outcomes.

9.
J Vasc Surg ; 70(5): 1514-1523.e2, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31147137

RESUMO

BACKGROUND: Single-segment great saphenous vein (GSV) has been the preferred conduit for femoral-popliteal (FP) bypass, particularly for a popliteal artery target below the knee. Yet, controversy persists surrounding whether prosthetic conduit can yield comparable outcomes to GSV for FP bypass to either the above-knee (AK) or below-knee (BK) popliteal artery. We sought to analyze national variation in conduit use and to compare contemporary outcomes in FP bypass. METHODS: A retrospective review of elective FP bypass in the Vascular Quality Initiative database using single-segment GSV or polytetrafluoroethylene (PTFE) from 2003 to 2018 was performed. Variation in conduit use was examined on a regional and center level. Characteristics of the patients and operative factors were compared. Effects of conduit on 1-year outcomes were assessed using Kaplan-Meier and multivariable Cox regression analyses. RESULTS: Of 7430 FP bypasses performed in the Vascular Quality Initiative, 3930 (53%) used GSV and 3500 (47%) used PTFE. Conduit use differed for AK-popliteal bypass (38% GSV and 62% PTFE) and BK-popliteal bypass (67% GSV and 33% PTFE). PTFE use was inversely correlated with preoperative vein mapping among centers (ρ = -0.55; P < .001). This inverse correlation was stronger for AK-popliteal bypasses (ρ = -0.61; P < .0001) than for BK-popliteal bypasses (ρ = -0.34; P = .0004). Overall, patients undergoing FP bypass with PTFE were more likely to be older and to have multiple medical comorbidities. Operative outcomes were similar between groups, although FP bypass with GSV incurred higher rates of wound infection (P < .001) and reoperation for bleeding, thrombosis, or revision (P < .01). At 1-year follow-up, GSV patients had higher graft occlusion-free survival (83% vs 78%; P < .001) and amputation-free survival (87% vs 82%; P < .001). These differences were observed for both AK-popliteal and BK-popliteal artery subgroups. On multivariable analyses stratified by bypass target, PTFE use was independently associated with increased risk of graft occlusion (AK-popliteal: hazard ratio [HR], 1.4 [P = .002]; BK-popliteal: HR, 1.3 [P = .02]) and amputation (AK-popliteal: HR, 1.4 [P = .006]; BK-popliteal: HR, 1.6 [P < .001]) at both target levels. CONCLUSIONS: PTFE is frequently used in FP bypass, representing two-thirds of AK-popliteal FP bypasses and one-third of BK-popliteal FP bypasses. However, PTFE use varies widely among centers. GSV was associated with higher rates of wound infection and reoperation and PTFE was associated with inferior 1-year outcomes independent of target artery level. GSV should be used for FP bypass whenever it is clinically feasible. Decreasing variation in prosthetic conduit use may be a useful quality improvement metric.

10.
Ann Vasc Surg ; 60: 327-334.e2, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31200055

RESUMO

BACKGROUND: Infrainguinal peripheral vascular interventions (PVIs) can be performed with a variety of sheath sizes. Our aim was to investigate the effect of sheath size on postprocedural complications after infrainguinal PVIs. METHODS: The Vascular Quality Initiative (2010-2017) was queried for patients undergoing infrainguinal PVIs via retrograde common femoral artery access. Univariable and multivariable methods were performed to compare the effects of sheath size on access site complications, length of stay (LOS), and 30-day mortality. RESULTS: Of the 36,901 infrainguinal PVI procedures in the data set, the mean age was 69 years, and 59.1% of patients were male. Indications for intervention were claudication (41.6%), rest pain (13.2%), and tissue loss (45.2%). The femoropopliteal and tibial arteries were treated in 84.7% and 35.4% of cases, respectively. Interventions included stenting (39.2%) and atherectomy (21.3%). Sheath sizes of 7F, 6F, 5F, and 4F were used in 5225 (14.1%), 24,541 (66.5%), 6221 (16.9%), and 914 (2.5%) cases, respectively. Differences among sheath sizes were observed based on the ambulatory status; presence of diabetes, end-stage renal disease, previously stented ipsilateral extremities, anemia, preprocedural anticoagulation; and procedural details including indications, location of intervention, and intervention type (P < 0.001 for all). On univariable analysis, sheath size (7F vs 6F vs 5F vs 4F) was associated with differences in access site hematoma (3.5% vs 2.7% vs 2.5% vs 1.2%, P < 0.001), postprocedural LOS > 1 day (18.1% vs 25.3% vs 31.1% vs 27.9%, P < 0.001), and 30-day mortality (0.9% vs 1.4% vs 1.5% vs 1.5%, P = 0.007). There was no difference in hematoma requiring intervention or access site stenosis/occlusion based on sheath size. Multivariable analysis revealed that a larger sheath size was independently associated with access site hematoma (7F: odds ratio [OR] = 4.24, 95% confidence interval [CI] = 2.28-7.89, P < 0.001; 6F: OR = 3.11, 95% CI = 1.69-5.7, P < 0.001; 5F: OR = 2.72, 95% CI = 1.46-5.05, P = 0.002) and postprocedural LOS > 1 day (7F: OR = 1.69, 95% CI = 1.39-2.05, P < 0.001; 6F: OR = 1.5, 95% CI = 1.26-1.78, P < 0.001; 5F: OR = 1.51, 95% CI = 1.26-1.8, P < 0.001). Access site hematoma requiring intervention and 30-day mortality were not independently associated with sheath size. CONCLUSIONS: In infrainguinal PVIs, larger sheaths increased the risk of minor access site hematomas, but not major morbidity or mortality. Larger sheaths were associated with longer postprocedural LOS, possibly because of conservative management of hematomas.

11.
J Vasc Surg ; 2019 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-31147124

RESUMO

OBJECTIVE: Smoking has been associated with poor postoperative outcomes across various surgical procedures. However, the effect of quitting smoking preoperatively for elective operations is unclear. Our goal was to assess the temporal effect of smoking cessation before elective lower extremity bypass (LEB) and open abdominal aortic aneurysm (AAA) repair on perioperative outcomes. METHODS: The Vascular Quality Initiative was reviewed for all patients with a documented smoking history and who underwent an elective LEB or open AAA repair from 2010 to 2017. Patients were then categorized into three groups: long-term smoking cessation (LTSC; defined as quitting smoking ≥8 weeks before surgery), short-term smoking cessation (STSC; defined as quitting smoking < 8 weeks before surgery), and current smokers (CS). Patient and procedure details were recorded. Univariate and multivariate analysis for crude and propensity-matched data were used to compare outcomes among groups. RESULTS: We identified 15,950 patients with a documented smoking history who underwent an elective LEB (43.3% LTSC, 2.2% STSC, 54.5% CS) and 5215 patients who underwent an elective open AAA repair (42.9% LTSC, 2.4% STSC, 54.7% CS). LTSC patients compared with STSC and CS, respectively, were more often obese, diabetic, on aspirin, on a statin, had coronary artery disease, and had congestive heart failure, but were less likely to have chronic obstructive pulmonary disease (all P < .05). Perioperative outcomes demonstrated significant differences comparing LTSC with STSC and CS for myocardial infarction (3.4% vs 1.4% vs 1.4%), dysrhythmia (4.2% vs 2.5% vs 2.7%), 30-day mortality (1.6% vs .3% vs .9%), in-hospital mortality (1.1% vs 0% vs 0.5%; all P < .001) and congestive heart failure (1.8% vs .8% vs 1.5%; P = .003). There was no difference in outcomes after analysis of propensity-matched data for LTSC or STSC on any postoperative outcomes for LEB. For open AAA repair, LTSC compared with CS patients, respectively, were older, more often male, obese, on a statin, diabetic, and less frequently had chronic obstructive pulmonary disease (P < .05 for all). Perioperative outcomes demonstrated differences in pulmonary complications when comparing LTSC with STSC and CS (9.5% vs 8.0% vs 12.5%; P = .002). Multivariate analysis demonstrated that LTSC patients compared with CS were less likely to experience pulmonary complications (odds ratio, 0.65; 95% confidence interval, 0.53-0.79; P < .001). Propensity-matched multivariate analysis confirmed that LTSC remained significantly less likely to encounter pulmonary complications (odds ratio, 0.49; 95% confidence interval, 0.33-0.74; P = .001). CONCLUSIONS: In our propensity-matched, risk-adjusted cohort, LTSC and STSC were not associated with perioperative outcomes after elective LEB. LTSC was associated with a significantly decreased odds of pulmonary complications after elective open AAA repair. STSC was not associated with perioperative outcomes after elective open AAA repair. If time permits, a longer period of smoking cessation should be attempted before elective open AAA repair.

12.
J Vasc Surg ; 2019 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-31147128

RESUMO

OBJECTIVE: Lower extremity arteriovenous (AV) access is an alternative when upper extremity access options have been exhausted. Our goal was to assess short- and medium-term outcomes of lower extremity hemodialysis access. METHODS: The Vascular Quality Initiative was reviewed for all lower extremity AV hemodialysis cases. Patient and case details were recorded. Multivariable analysis was used to analyze outcomes. RESULTS: We identified 463 lower extremity AV access cases in the VQI registry. There were 56 AVF (12.1%) and 407 AVG (87.9%). The mean age was 56 ± 15 years, 46.9% were male, and 40.7% were Caucasian. The majority (90%) had a previous upper extremity AV access and 25.4% had a prior lower extremity access. More than one-half (57.9%) had a tunneled line at the time of the procedure. Patients undergoing an AVF vs AVG creation were younger, more often ambulatory, and less often with peripheral arterial disease. For AVF, the superficial femoral artery was more often used for access inflow (76.8% vs 49.4%; P < .001), compared with AVG, and there was no difference in using femoral vein as the main outflow (78.6% vs 82.6%; P = .466). For AVF, compared with AVG, there was no difference in wound infection (12.5% vs 9.6%; P = .571), ischemic steal (5% vs 2.2%; P = .273), or leg swelling (2.5% vs 3.3%; P = .99) at 6 months. Kaplan-Meier analysis of the overall cohort showed that freedom from loss of primary patency at 6 months was 52.9%, freedom from any reintervention at 6 months was 75.3%, and the 1-year survival was 81.9%. Survival at 5 years was 65.5%. Multivariable analysis showed no significant association of access type (AVF vs AVG) with primary patency loss or death (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.36-1.5; P = .4), any reintervention or death (HR, 1.65; 95% CI, 0.82-3.33; P = .163), or mortality (HR, 1.94; 95% CI, 0.71-5.33; P = .197). Factors independently associated with primary patency loss or death included peripheral arterial disease (HR, 1.6; 95% CI, 1.06-2.42; P = .03) and obesity (HR, 1.5; 95% CI, 1.1-2.05; P = .01). Any reintervention or death was associated with obesity (HR, 1.67; 95% CI, 1.09-2.56; P = .015). Mortality was associated with congestive heart failure (HR, 1.82; 95% CI, 1.13-2.94; P = .015) and white race (HR, 1.71; 95% CI, 1.08-2.73; P = .023). CONCLUSIONS: In our contemporary multicenter analysis, patients undergoing lower extremity AV access creation have low primary access patency and almost 20% mortality at 1 year. These results should be considered when suggesting a lower extremity dialysis access, as well as other dialysis alternatives when available.

13.
J Vasc Surg ; 70(5): 1499-1505.e1, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31068266

RESUMO

OBJECTIVE: Although modern rates of stroke after carotid endarterectomy (CEA) have been low, the functional outcomes of stroke after CEA are unclear. Our goal was to assess the degree of initial disability in patients without baseline stroke-related impairment who had undergone CEA and experienced an early postoperative stroke. METHODS: The National Surgical Quality Improvement Program CEA-targeted database was queried for CEA cases from 2011 to 2014. Patients who had experienced a postoperative stroke were included, and the modified Rankin scale (mRS) was used to assess the degree of initial disability from stroke (0, none; 1, no significant; 2, slight; 3, moderate; 4, moderately severe; 5, severe disability; 6, dead). The mRS score was categorized as not applicable (NA) in the absence of any stroke. Patients were excluded if they had had a preoperative mRS score >1. The 30-day outcomes among the cohorts with a postoperative mRS score of NA/0 to 1, 2 to 3, and 4 to 5 were compared. Multivariable analysis was used to determine the predictors of higher initial postoperative mRS scores. RESULTS: A total of 8797 patients with CEA and preoperative mRS scores of NA/0 to 1 were identified. Their mean age was 71 ± 8.8 years, and 61% were men. Most were asymptomatic (88%) and had been taking antiplatelet agents (90%) and statins (82%) preoperatively. At 30 days, the postoperative stroke rate was 1.1% and mortality was 0.6%. Of the patients with a postoperative stroke after CEA, 35.4% had had stable initial postoperative mRS scores of NA/0 to 1, and most had had increased initial postoperative disability with mRS scores of 2 to 3 (32.3%) or 4 to 5 (32.3%). The cohorts with greater initial postoperative mRS scores exhibited a longer length of stay (2.2 ± 3.3 vs 5.8 ± 3.9 vs 11.9 ± 18.8 days; P < .001) and greater rates of major adverse cardiac events (2.7% vs 100% vs 100%; P < .001). Multivariable analysis showed that the initial postoperative disability, determined by a greater mRS score, was independently associated with preoperative bleeding disorder/chronic anticoagulation (odds ratio, 1.79; 95% confidence interval, 1.04-3.11; P = .037) and operative time by hour (odds ratio, 1.38; 95% confidence interval, 1.11-1.7; P = .003). CONCLUSIONS: Although the rate of stroke after CEA has been low, almost two thirds of patients who experienced a stroke within 30 days postoperatively developed some degree of initial postoperative disability and one third developed initial moderately severe to severe disability. These findings provide an evidence base for improved informed consent and risk-benefit discussions with patients.

14.
J Vasc Surg ; 69(5): 1559-1565, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31010519

RESUMO

OBJECTIVE: Advancement in academic medicine is multifactorial. Our objectives were to characterize academic appointments in vascular surgery and to investigate what factors, particularly publications, influenced academic appointment. METHODS: Academic vascular surgeons at Accreditation Council for Graduate Medical Education vascular training programs or at primary sites of U.S. allopathic medical schools were included. Those with qualified titles, such as "adjunct" or a "clinical" prefix, were excluded. Sex, education, region, board certification, and affiliation details were recorded. Web of Science was queried for publication details and h-index. The h-index is a "personal impact factor" defined as "x" number of publications cited at least "x" number of times. After surgeons' information was deidentified, univariate and multivariable analyses were completed for academic appointment and appointment as division chief. RESULTS: There were 642 vascular surgeons who met criteria: 297 (46.3%) assistant professors, 150 (23.4%) associate professors, and 195 (30.4%) professors. There were 96 (15%) division chiefs and 10 (1.6%) chairs of surgery, and 83.2% were male. Surgeons worked in the Northeast (33.5%), Southern (32.6%), Central (20.1%), and Western (13.9%) United States. The mean (±standard deviation) number of publications was 13.7 ± 15.4 for assistant professors, 33.9 ± 28.8 for associate professors, and 86.8 ± 63.6 for professors (P < .001). Mean number of first or last author publications was 5.3 ± 6.4 for assistant professors, 12.2 ± 12.7 for associate professors, and 38.7 ± 35.3 for professors (P < .001). Mean h-index was 5.9 ± 5.4 for assistant professors, 12 ± 7.7 for associate professors, and 24.9 ± 12.6 for professors (P < .001). In multivariable analysis, vascular surgery board certification (adjusted odds ratio [OR], 6.08; 95% confidence interval [CI], 1.15-32.2; P = .03), academic appointment at a public medical school (OR, 1.99; 95% CI, 1.18-3.37; P = .01), years since medical school graduation (OR, 1.13; 95% CI, 1.09-1.18; P < .001, per year), and number of publications (OR, 1.05; 95% CI, 1.03-1.06; P < .001, per publication) were independently associated with associate professor. Factors independently associated with professor were years since medical school graduation (OR, 1.18; 95% CI, 1.12-1.24; P < .001, per year) and number of first or last author publications (OR, 1.05; 95% CI, 1.02-1.09; P = .003, per publication). Appointment as division chief was independently associated with h-index (OR, 1.04; 95% CI, 1.01-1.08; P = .016, per point). CONCLUSIONS: Total number of publications was independently associated with associate professor, with number of first or last author publications particularly important for professor. The h-index was not independently associated with academic appointment, but it was for appointment as division chief. This study provides relevant data for promotional guidance in academic vascular surgery.

15.
J Vasc Surg ; 70(2): 554-561, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30837175

RESUMO

OBJECTIVE: Radial artery-based wrist arteriovenous fistulas (AVFs) are commonly created as an initial upper extremity arteriovenous access. A more distal access site, such as the anatomic snuffbox AVF, can also be created. Although much has been written about wrist AVFs, outcomes of snuffbox AVFs are unclear. Our goal was to compare perioperative and midterm outcomes between these two types of distal access. METHODS: The Vascular Quality Initiative database was queried for all patients undergoing snuffbox AVFs and wrist AVFs from 2011 to 2017. Unmatched and matched analyses were performed for baseline characteristics and outcomes at 6 months for ischemic steal, wound infection, and arm swelling. Multivariable analysis was performed for unmatched and matched analyses for primary patency, surgical or endovascular repair, and patient survival. Kaplan-Meier matched analysis was performed for primary patency, freedom from surgical or endovascular intervention, and survival. RESULTS: We identified 4525 distal forearm fistulas: 179 (4%) snuffbox AVFs and 4346 (96%) wrist AVFs. The average age was 59 ± 14.7 years, and 72.3% of patients were male. There were no significant differences in baseline demographics or comorbidities of patients with snuffbox AVFs and wrist AVFs except that patients with snuffbox AVFs had fewer tunneled lines at access creation (70.2% vs 65.2%; P = .046) and had a lower American Society of Anesthesiologists class. There were no significant differences in unmatched outcomes at 6 months for ischemic steal (0.8% vs 1.9%; P = .336), wound infection (0% vs 0.2%; P = .649), and arm swelling (0.8% vs 1.3%; P = .592). Matched analysis showed no significant differences in baseline characteristics and outcomes at 6 months for ischemic steal (0% vs 1.8%; P = .146), wound infection (0% vs 0%), and arm swelling (0.9% vs 1.2%; P = .789). Kaplan-Meier matched analysis showed no significant differences between snuffbox AVFs and wrist AVFs at 6 months for primary patency (51% vs 48%; P = .61), freedom from endovascular intervention (84.5% vs 82.5%; P = .98), freedom from surgical intervention (90% vs 86%; P = .08), and survival (92% vs 96%; P = .1). In multivariable analysis of unmatched data, snuffbox AVFs and wrist AVFs had similar primary patency (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.75-1.26; P = .83), likelihood of surgical intervention (HR, 0.61; 95% CI, 0.35-1.05; P = .074) and endovascular intervention (HR, 0.96; 95% CI, 0.65-1.42; P = .83), and survival (HR, 1.47; 95% CI, 0.9-2.4; P = .128). CONCLUSIONS: Snuffbox AVFs have midterm results similar to those of wrist AVFs.

16.
JCI Insight ; 4(2)2019 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-30674715

RESUMO

The antiinflammatory effects of i.v. Ig (IVIG) in the treatment of autoimmune disease are due, in part, to the Fc fragments of Ig aggregates. In order to capitalize on the known antiinflammatory and tolerogenic properties of Ig Fc aggregates, we created a recombinant human IgG1 Fc multimer, GL-2045. In vitro, GL-2045 demonstrated high-avidity binding to Fc receptors, blocked the binding of circulating immune complexes from patients with rheumatoid arthritis to human Fcγ receptors (FcγRs), and inhibited antibody-mediated phagocytosis at log order-lower concentrations than IVIG. In vivo, administration of GL-2045 conferred partial protection against antibody-mediated platelet loss in a murine immune thrombocytopenic purpura (ITP) model. GL-2045 also suppressed disease activity in a therapeutic model of murine collagen-induced arthritis (CIA), which was associated with reduced circulating levels of IL-6. Furthermore, GL-2045 administration to nonhuman primates (NHPs) transiently increased systemic levels of the antiinflammatory cytokines IL-10 and IL-1RA, reduced the proinflammatory cytokine IL-8, and decreased surface expression of CD14 and HLA-DR on monocytes. These findings demonstrate the immunomodulatory properties of GL-2045 and suggest that it has potential as a treatment for autoimmune and inflammatory diseases, as a recombinant alternative to IVIG.

17.
Clin Transl Sci ; 12(2): 180-188, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30597771

RESUMO

This phase Ib study randomized patients with stable sickle cell disease (SCD) aged 18-65 years to twice-daily PF-04447943 (a phosphodiesterase 9A inhibitor; 5 or 25 mg) or placebo, with/without hydroxyurea coadministration, for up to 29 days. Blood samples were collected at baseline and various posttreatment time points for assessments of PF-04447943 pharmacokinetics (PKs)/pharmacodynamics (PDs). Change from baseline in potential SCD-related biomarkers was evaluated. Of 30 patients, 15 received hydroxyurea and 28 completed the study. PF-04447943, with/without hydroxyurea, was generally well tolerated, with no treatment-related serious adverse events. Plasma PF-04447943 exposure was dose proportional. Twice-daily PF-04447943 25 mg significantly reduced the number and size of circulating monocyte-platelet and neutrophil-platelet aggregates and levels of circulating soluble E-selectin at day 29 vs. baseline (adjusted P < 0.15). PF-04447943 demonstrated PK/PD effects suggestive of inhibiting pathways that may contribute to vaso-occlusion. This study also provides guidance regarding biomarkers for future SCD studies.

18.
J Vasc Surg ; 69(4): 1160-1166.e2, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30527937

RESUMO

OBJECTIVE: Ipsilateral antegrade access (AA) is an alternative access option for contralateral retrograde access (RA) in treating infrainguinal occlusive disease. Our goal was to assess whether AA is associated with higher access site complications. METHODS: The Vascular Quality Initiative database was searched from 2010 to 2017 for all infrainguinal peripheral vascular interventions. Cases without access through the common femoral artery or those with multiple accesses were excluded. Access types were classified on the basis of whether the approach was AA or RA. Propensity matching and multivariable analyses were performed to determine the effect of AA on access site complications. RESULTS: There were 45,816 access events identified, 6600 (14.4%) AA and 39,216 (85.6%) RA cases. Patients with AA were older (70.7 vs 69.1 years) and more frequently male (66.5% vs 59.1%), white (79.4% vs 74.6%), and on Medicare (58.4% vs 56%); they were more likely to have end-stage renal disease (12.1% vs 11%), and they were less frequently obese (29.3% vs 36.1%) and less likely to be currently smoking (25.5% vs 28.7%), to be diabetic (56% vs 59.8%), to have chronic obstructive pulmonary disease (20.7% vs 21.8%), and to ambulate independently (69.8% vs 72.5%; P < .05 for all). Patients with AA were more likely to have a history of a prior percutaneous vascular intervention (9.3% vs 7%), inflow bypass (6.2% vs 1.8%), and leg bypass (12.6% vs 8.9%; P < .001 for all). The AA technique was more frequently used in the setting of tissue loss (51.8% vs 45.1%) and for tibial intervention (46.3% vs 35.3%; P < .001 for both). There were no significant differences between AA and RA in overall hematoma (3% vs 2.7%; P = .21) or hematoma requiring intervention (0.4% vs 0.4%; P = .75) rates. There was no significant difference in access site occlusion or stenosis between AA and RA (0.2% vs 0.3%; P = .68). These findings were confirmed with 2:1 matching based on preoperative data and type of intervention. Multivariable analysis demonstrated that AA is not associated with increased risk of any hematoma (odds ratio [OR], 1.15; 95% confidence interval [CI], 0.98-1.35; P = .082) or hematoma requiring intervention (OR, 0.88; 95% CI, 0.57-1.35; P = .56). Multivariable analysis of the matched data confirmed these findings between AA and RA for hematoma (OR, 0.88; 95% CI, 0.73-1.06; P = .17) and hematoma requiring intervention (OR, 1.17; 95% CI, 0.7-1.95; P = .55). CONCLUSIONS: AA is safe, and it was not found to be associated with increased access site complications, such as hematoma, in the large Vascular Quality Initiative sample. This approach remains a viable alternative to traditional RA.

19.
J Vasc Surg ; 69(3): 863-874.e1, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30527215

RESUMO

OBJECTIVE: The frailty index has been linked to adverse outcomes after surgical procedures. In this study, we evaluated the association between frailty index and outcomes after elective lower extremity bypass (LEB) for lower extremity ischemia. METHODS: The American College of Surgeons National Surgical Quality Improvement Program data set (2005-2012) was used to identify patients who underwent elective LEB using diagnostic and procedure Current Procedural Terminology codes. Modified frailty index (mFI) scores, derived from the Canadian Study of Health and Aging, were categorized into three groups: low, medium, and high. Association of mFI with 30-day postoperative death (POD), myocardial infarction (MI), cardiopulmonary events (CPEs), deep tissue surgical site infection (SSI), and graft failure (GF) was evaluated. Both univariate and multivariable regression analyses-adjusted for age, sex, American Society of Anesthesiologists class, body mass index, and creatinine levels-were used to assess the effect of frailty on each outcome. RESULTS: Of 12,677 patients (mean age, 67.7 ± 11.1 years) identified who underwent elective LEB, POD occurred in 265 (2.1% overall). Postoperative MI, SSI, CPEs, and GF occurred in 1.6%, 2.5%, 3.1%, and 4.3%, respectively. The mean mFI of the entire sample was 0.3 ± 0.1. Adjusted odds ratio for development of any morbidity in the group with the highest mFI was 1.36 (95% confidence interval, 1.08-1.72; P = .010) compared with the low frailty group. Patients with higher mFI were more likely to develop MI and CPEs but not SSI or GF. Univariate and multivariable analyses showed a significantly increased risk of POD among those in the highest mFI tertile. Female sex and age, increased American Society of Anesthesiologists class and creatinine levels, and decreased body mass index independently predicted increased mortality. The addition of categorical mFI improved models with these variables. CONCLUSIONS: Higher mFI is independently associated with higher mortality and morbidity. Preoperative mFI assessment may be considered an additional screening tool for risk stratification among patients undergoing LEB.

20.
J Vasc Surg ; 70(1): 193-198, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30591289

RESUMO

OBJECTIVE: Infection of a prosthetic arteriovenous graft (AVG), in patients who have many comorbidities and limited access options, is a feared complication. Our objective was to investigate our contemporary series of infected AVG operations and analyze perioperative and long-term outcomes. METHODS: We performed a retrospective analysis of AVGs removal, in the setting of infection, from 2005 to 2017 at a single institution. Procedures were classified as total excision if all graft material was removed, subtotal excision if small cuffs remained, and revision if a segment was removed and the graft was revised. Demographics, medical history, perioperative details, and follow-up data were collected. RESULTS: There were 47 patients who underwent an operation for an infected AVG-forearm (27.7%), upper arm (63.8%), and femoral (8.5%). The mean age was 57.7 years and 59.6% were male. The average time from AVG placement to operation for infection was 20.4 months and 85.1% of grafts were placed at our institution. There were 33 patients (70.2%) who had a previous access before the infected graft. Patients with infected AVGs presented with bacteremia (57.4%), sepsis (36.2%), purulent drainage (55.3%), and bleeding at the graft site (31.9%). The majority of grafts (61.7%) were patent on presentation. There were patients 17 (36.2%) who had a fistulogram and 16 (34%) underwent an endovascular intervention within 90 days of graft excision. With regard to procedure type, 40.4%, 38.3%, and 21.3% of AVGs were treated with total excision, subtotal excision, and revision, respectively. Bacterial growth was present in 84.8% of specimens with the most common bacterial species being any Staphylococcus aureus (53.2%), methicillin-resistant S aureus (17%), coagulase-negative S species (10.6%), and Pseudomonas aeruginosa (8.5%). Postoperative intensive care unit admission occurred in 21.3% of cases. There were 25 postoperative complications that occurred in 17 patients (36.2%). The most frequent postoperative complications were nongraft site infections (28%) followed by graft-related events (16%). Mortality at 90 days and 1 year were 2.1% and 12.8%, respectively. Readmissions at 30 and 90 days were 30% and 55%, respectively. Reoperation for infection in the index limb occurred in 10.6% of patients-40% from those who had subtotal excision and 60% from those who underwent revision. New access was placed in 52% of eligible patients at 1 year. CONCLUSIONS: Removal of an infected AVG is associated with high morbidity and resource use. Many eligible patients do not receive a definitive access within the first year of graft excision. Close follow-up is necessary to allow opportunities in reassessing for potential new access creation.

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