Lower Extremity Arterial Revascularization Research Articles

Contemporary Results with the Biosynthetic Glutaraldehyde Denatured Ovine Collagen Graft (Omniflow II) in Lower Extremity Arterial Revascularization in a Septic Context

Peripheral vascular graft infections are poorly-evaluated, despite high mortality and amputation rates. The vascular substitute of choice remains controversial when veins are unavailable. This study aims to evaluate the results of a biosynthetic collagen graft (Omniflow II®) in an infected field when autologous veins are unavailable. This retrospective, multicentric study included all consecutive patients in whom an Omniflow II graft was used for infra-inguinal revascularization in a septic context from January 2015 to January 2020. The primary end-point was freedom from major amputation; secondary end-points were 30-day mortality, survival, patency, and freedom from reinfection estimated using the Kaplan-Meier method. Twenty-nine patients (27 men, median age of 69years interquartile range IQR:60; 76) were included. Fever was present in 58.6%, a septic rupture in 17.9%, a pseudo-aneurysm in 25.0%. The 30-day mortality rate was 3.4%. Median follow-up reached 49months. At 1 and 3years, estimated freedom from major amputation was 88.4% and 83.9%, survival: 96%, primary patency: 74.6% and 65.8%, and reinfection free-survival: 85.6%. There were 7 occlusions (1 iliofemoral, 1 below-knee, and 5 above-knee bypasses), 3 explantations for persistent sepsis, 4 reinfections (all within 6months which led to 1 death and 3 out of 4 major amputations). The risk of major amputation increased with bypass reinfection (P=0.004), occlusion (P=0.005), and polymicrobial infection (P=0.05). In a septic context, the Omniflow II graft shows acceptable freedom from major amputation and reinfection. This usage remains outside the instructions of use, it is, therefore, is essential to pursue longer-term studies in larger cohorts.

Postoperative Low-Dose Heparin Infusion Does Not Change Complication Rates after Limb Revascularization

Postoperative subtherapeutic low-dose heparin infusion (LDHI) is sometimes administered in patients undergoing extremity arterial revascularization to maintain graft patency and decrease the risk of thrombosis. However, the safety of this management strategy is unknown. From 2013 to 2015, we retrospectively reviewed all patients undergoing upper and lower extremity arterial revascularization at a single university-affiliated medical center. Patients were grouped by receipt of LDHI within the first 24-hour postoperative period. Preoperative demographics, comorbidities, intraoperative measures, 30-day postoperative complications, arterial patency rates, and amputation rates were analyzed for each group. We identified 379 patients who received extremity revascularization, and 56 (14.8%) of them had received LDHI. Patients who received LDHI were less likely to have an elective admission on presentation (26.8% vs. 56%, P<0.001) or an admission from home (69.6% vs. 81.7%, P=0.04). They were more likely to have preoperative bleeding (44.6% vs. 22%, P<0.01) and need for emergent operation (23.2% vs. 11.8%, P=0.04). Postoperatively, although patients who received LDHI demonstrated a trend toward increased bleeding (48.2% vs. 33.7%, P=0.053), they did not demonstrate an increase in 30-day mortality (1.79% vs. 1.24%, P=0.55) or reoperation (19.7% vs. 12.4%, P=0.21). Multivariable analysis demonstrated that LDHI did not have a significant association with immediate postoperative bleeding (P=0.99), survival (P=0.13), primary patency (P=0.872), and amputation-free survival (P=0.387). Although LDHI was more likely to be administered in patients who received emergent operations, risk-adjusted analysis demonstrated that it was not associated with increased postoperative bleeding, mortality, short-term need for reintervention, or amputation after extremity arterial revascularization.

Long-term outcomes of Omniflow II biosynthetic vascular graft in lower extremity arterial revascularization.

This study aims to evaluate the patency rates and long-term outcomes of femoro-popliteal bypass procedures with Omniflow II biosynthetic vascular grafts in patients with occlusive vascular disease. This retrospective, observational, clinical study included a total of 93 patients (61 males, 32 females; mean age 56.9±7.4 years; range, 43 to 83 years) who underwent femoro-popliteal bypass in which Omniflow II biosynthetic vascular grafts were used due to peripheral arterial disease. The patients were divided into two groups: 62 patients undergoing femoro-popliteal above-knee bypass and 31 patients undergoing the femoro-popliteal belowknee bypass. We evaluated preoperative clinical characteristics, postoperative graft patency rates, and other clinical results. The mean follow-up was 44.9±18.8 months in the femoropopliteal above-knee bypass group and 47.3±22.3 months in the femoro-popliteal below-knee bypass group (p=0.302). The cumulative primary graft patency rates of the femoro-popliteal above-knee bypass and femoro-popliteal below-knee bypass groups at three, four, and five years were 98%, 95% and 78% and 86%, 75% and 45%, respectively (log-rank; p=0.312). The cumulative assisted graft patency rates of the femoro-popliteal above-knee bypass and femoro-popliteal below-knee bypass groups at five years were 87.9% and 65.3%, respectively (log-rank; p=0.530). The Omniflow II biosynthetic vascular graft is suitable for above- and below-knee femoro-popliteal bypass procedures. These grafts may be prefered due to high patency rates, low incidence of aneursym formations, and infections.

Effects on Mortality and Cardiovascular Events of Adherence to Guideline-Recommended Therapy 4 Years after Lower Extremity Arterial Revascularization

All patients with lower extremity peripheral arterial disease (LE-PAD) should benefit from recommended pharmacologic therapies including antiplatelet agents, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), and HMG-CoA-reductase inhibitors (statins). In the present study, this triple therapy was defined as the best medical treatment. This study was designed to determine the current risk of cardiovascular (CV) events and mortality and also to evaluate the effect of pharmacologic treatment on patient's survival, CV events, and additional vascular surgery in vascularized LE-PAD patients. This observational, cohort study analyzed prospectively collected data of 140 consecutive patients after hospitalization for LE-PAD revascularization in the vascular surgery department of our university hospital, between January 1 and June 30, 2013. Data from guideline-recommended classes of medications (ACE, ARB, statins, and antiplatelet agents or anticoagulation) were collected at the time of discharge to hospitalization and at the end of the follow-up. Information about mortality, CV events, and additional vascular surgery was collected during follow-up. The mean follow-up of patients was 41months. Mortality and CV events concerned 24% and 12% of the patients, respectively, and additional vascular surgery was performed in 33% of the patients. There was no difference in mortality and CV event rates according to pharmacologic treatment. Additional vascular surgery rate of LE-PAD patients with best medical treatment tended to be lower than without (incidence rate ratio=0.5777; 95% confidence interval, 0.3101-1.06; P=0.08). Best medical treatment was prescribed in 54% of patients at discharge of hospitalization. This proportion (54%) was statistically unchanged at the end of follow-up. In this small cohort, we failed to show that best medical treatment decreased mortality or CV event rates, but it tended to be associated with decreased additional vascular surgery rate. Further studies taking into consideration the control of CV risk factors could be interesting to demonstrate better outcome from LE-PAD patients with best medical treatment compared with LE-PAD patients without. There is an urgent need for a more effective implementation of currently recommended medication and a continued search after more effective pharmacologic treatment options in LE-PAD.

TCT-405 Drug Eluting Scaffold with an absorbable platform for primary lower extremity arterial revascularization – DESappear Study Initial Results

Bioresorbable scaffolds may address limitations of drug-eluting balloons and stents for superficial femoral artery (SFA) atherosclerotic disease by: preventing acute recoil, reducing restenosis; and allowing area retreatment made difficult with stents. The Akesys Prava is a balloon expandable poly L

Lower extremity arterial revascularization using conditioned small-diameter great saphenous vein

ObjectiveThis study was conducted to determine whether it was feasible to increase the diameter of smaller great saphenous veins (GSVs) in preparation for possible bypass and whether such a conditioned conduit could be used with reasonable patency. MethodsTwenty-five patients (26 cases: 24 peripheral arterial occlusive disease, 2 popliteal aneurysms) with GSV diameters between 2 and 3 mm underwent in situ GSV valvulotomy and were observed for 3 months. After GSV dilation to >3 mm for below-knee revascularization and >3.5 mm for above-knee revascularization, arterial bypass surgery was performed with the valvulotomized GSV. ResultsAdequate GSV diameter was reached in 20 cases (77%). Arterial bypass surgery using valvulotomized GSV was performed an average 131 days (range, 64-373 days) after valvulotomy in 16 patients (61.5%). No deaths, amputations, or aneurysms occurred 2 years after surgery. At 1 and 2 years, primary patency was 81% ± 9.8% and 69% ± 11.8%, respectively, and secondary patency was 87% ± 8.3% and 75% ± 11%, respectively. ConclusionsValvulotomy can be used to expand small-diameter GSV for lower extremity arterial bypass.

The association between ischemic and jeopardized myocardia and all-cause mortality in patients with peripheral artery disease.

Peripheral artery disease (PAD) is associated with increased mortality and concomitant coronary artery disease (CAD). However, it is unclear whether uncovering the presence of functional coronary ischemia by single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) would further help stratifying that excess risk. From January 2000 to 2009, 4294 individuals underwent cardiac stress testing within 180 days of ankle-brachial index (ABI) measurements. Of these, 645 had PAD and SPECT MPI stress testing. Abnormal ABI was defined as ⩽ 0.9 or prior lower extremity arterial revascularization. Myocardial ischemic burden and total jeopardized myocardium were represented by the summed difference score (SDS) and summed stress score (SSS), respectively. Univariate and multivariable Cox proportional hazard analyses were used to study the impact of SDS and SSS on all-cause mortality. Additionally, using a hierarchical approach, we examined the step-wise addition of post-stress test coronary and lower extremity arterial revascularizations as time-varying covariates on outcomes. We found no significant difference in all-cause mortality between patients with ischemic myocardium (SDS > 0) and those without (SDS = 0) (adjusted HR: 0.94, 95% CI: 0.53-1.69; p = 0.84). Similarly, the presence of jeopardized myocardium (SSS > 0) did not have a significant impact on mortality (adjusted HR: 1.16, 95% CI: 0.67-2.00; p = 0.59). Moreover, adjustment for post-testing coronary and lower extremity arterial revascularizations did not affect our results. In conclusion, ischemic and jeopardized myocardia are not predictors of all-cause mortality in PAD; thus, SPECT MPI does not appear to be a useful risk stratification tool in these patients.

Abstract 18870: Impact of Atherectomy on Length of Stay and Cost of Care for Lower Extremity Arterial Intervention - A Cross-sectional US Experience

Background: There is lack of data regarding impact of atherectomy on the length of stay (LOS) and cost of hospitalization in lower extremity arterial revascularization. Methods: HCUP’s Nationwide Inpatient Sample (NIS) 2012 was queried using the ICD-9- CM code for peripheral vascular disease and procedural codes 39.90 (bare metal stent - BMS), 00.55 (drug eluting stent - DES), 17.56 (peripheral atherectomy) and 39.50 for angioplasty. Only procedures performed in patients ≥18 years of age were included. Hierarchical mixed effects linear regression models were generated to evaluate multivariate predictors of LOS and hospitalization costs. Results: A total of 13,206 (weighted: 66,030) lower extremity arterial revascularizations were identified (43.8% female &amp; 65.5% white). Out of these, atherectomy was utilized in 23.2%. Atherectomy utilization was associated with significant reduction in LOS (4.96 ± 0.11 days vs. 5.78 ± 0.07 days, p &lt;0.001) but higher hospitalization cost ($ 25196 ± 359 vs. $ 23408 ± 185, p &lt; 0.001). Multivariate analysis showed similar results with decrease in LOS (-0.71 days, -1.00 - - 0.43; p &lt; 0.001) but higher hospitalization cost (+1875 $, +811 - +2940; p = 0.001) with atherectomy, which was matched by propensity score analysis. Additionally, emergent/urgent &amp; weekend admissions and Charlson score ≥2 were further associated with increased LOS and hospitalization costs. (Figure) Conclusion: Our study demonstrates that atherectomy utilization is associated with significant reduction in length of stay, which was counterbalanced by a slight increase in hospitalization costs following lower extremity arterial revascularization.

Abstract 18615: Impact of Peripheral Atherectomy Utilization on the Outcomes of Lower Extremity Arterial Intervention - A Cross-sectional US Experience

Background: Contemporary outcome data regarding effects of atherectomy in lower extremity arterial revascularization is lacking. Methods: We queried HCUP’s Nationwide Inpatient Sample (NIS) for 2012 using the appropriate primary ICD 9-CM diagnostic code for peripheral vascular disease and procedural codes 39.90 (bare metal stent - BMS), 00.55 (drug eluting stent - DES), 17.56 (peripheral artherectomy) and 39.50 for angioplasty. Only procedures performed in patients &gt;= 18 years were included. Hierarchical mixed effects logistic regression models were generated to evaluate multivariate predictors of outcomes. Results: In total 13,206 (weighted: 66,030) lower extremity arterial revascularization were analyzed (65.5% white, 56.2% Male &amp; 97.4% angioplasty). Atherectomy utilization (23.2%) was associated with significant reduction in amputation (11.5% vs 13.4%), any complications (13.2% vs 16.3%) and in hospital morality (0.8% vs 1.4%) compared to no atherectomy group (p &lt; 0.001). Multivariate analysis showed similar results with decrease amputation (OR, 95% CI; p - value) (0.83, 0.71 - 0.97, p = 0.02) and in hospital mortality/any complication (0.79, 0.69 - 0.90, p = 0.001) with atherectomy (similar results were observed with propensity score matching). “Atherectomy only” was utilized only in 2.3%. post-hoc analysis also shows better outcomes when atherectomy was used with either angioplasty or stenting (figure a &amp; b). subgroup multivariate analysis shows significant reduction in amputation when atherectomy was utilized in chronic limb ischemia (0.74, 0.59 - 0.93, p = 0.01) and with angioplasty (0.72, 0.60 - 0.87, p = 0.001) and trend towards advantage while used along with stents but not reaching statistical significant. Conclusion: Lower extremity atherectomy utilization was associated with significant reduction in amputation and overall complication. We observed better outcomes when atherectomy was used in conjunction with angioplasty.

Abstract 45: Higher Reintervention Rate But Similar Amputation-free Survival With Endovascular Procedures For Peripheral Arterial Disease Compared To Bypass Surgery

Background: Over the last decade, the number of endovascular procedures for peripheral arterial disease (PAD) has surpassed the number of open surgical bypass procedures. Yet, the effectiveness of endovascular procedures in comparison to open procedures is not fully understood. The aim of this study was to compare the outcomes of open and endovascular procedures for PAD in a population-based study. Methods: We used the Patient Discharge Data (PDD) from California’s Office of Statewide Health Planning and Development (OSHPD) to identify all patients &gt;35 years of age who underwent a lower extremity arterial intervention from 2005 to 2009. OSHPD has been recording ambulatory surgery data since 2005. The PDD is linked to the death database. A look back period of five years was used to exclude patients with prior lower extremity endovascular or open procedures. Cox proportional hazards regression was used to compare amputation-free survival and logistic regression was used to compare 12-month reintervention rate between the endovascular and open groups adjusting for age, gender, race/ethnicity, insurance status, severity of illness, and comorbidities. Results: Between 2005 and 2009, 41,507 individuals underwent lower extremity arterial interventions. 25,635 (61.7%) underwent endovascular procedures and 15,872 underwent open procedures. There were 17,942 women (43.2%) and 23,565 men. 4,094 (25.8%) of the patients in the open group and 8,593 (33.5%) of patients in the endovascular group underwent reintervention for PAD. The 12-month reintervention rate was significantly associated with endovascular procedures ( p &lt;0.001). The odds ratio for 12-month reintervention was 1.38 in the endovascular group (95% CI 1.32-1.45) compared to the open group. However, there was no difference in the amputation-free survival following endovascular procedures compared to open procedures ( p =0.154); the hazard ratio was 1.07 in the endovascular group (95%CI 0.97-1.15) compared to the open group. Conclusions: Nearly a third of all patients who undergo a lower extremity arterial revascularization procedure require reintervention within the first year. Our results demonstrate that although endovascular procedures are more likely than open procedures to require reintervention, the amputation-free survival is not improved with endovascular procedures. Cost analysis of multiple reinterventions can be beneficial in understanding the cost-effectiveness of endovascular procedures. Further research is also needed to understand patient characteristics that distinguish patients who benefit more from endovascular procedure for PAD.

Functional status as a prognostic factor for primary revascularization for critical limb ischemia

Lower extremity arterial revascularization (LEAR) is the gold-standard for critical lower limb ischemia (CLI). The goal of this study was twofold. First, we evaluated the long-term functional status of patients undergoing primary LEAR for CLI. Second, prognostic factors of long-term functional status and survival after primary LEAR for CLI were assessed. All primary LEAR procedures were analyzed. Patients were stratified by preoperative functional status: ambulatory (group I) vs nonambulatory (group II). Patients were followed-up after 3 and 6 years. Adverse events (AEs) were categorized according to predefined standards: minor, surgical, failed revascularization, and systemic. Associated patient demographic/clinical data were analyzed using univariate and multivariate methods. There were 106 LEAR patients (group I: n = 42, 40% vs group II: n = 64, 60%). Group II patients were significantly older (75 vs 62 years; P = .00), were classified ASA 3-4 more frequently (78% vs 52%; P < .02), had more cardiac disease (n = 42, 66% vs n = 10, 24%; P = .00), renal disease (n = 26, 41% vs n = 7, 17%; P = .00), diabetes (n = 36, 56% vs n = 8, 19%; P = .00), hypertension (n = 47, 73% vs n = 13, 31%; P = .00) and severe CLI (n = 42, 66% vs n = 18, 38%; P < .01). Group II patients had a higher incidence of death (65.6% vs 14.3%; P = .00), minor AEs (n = 38, 26% vs n = 10, 22%; P = .00), surgical AEs (n = 48, 33% vs n = 12, 26%; P < .02) and systemic AEs (n = 24, 86% vs n = 4, 9%; P < .02). Also more unplanned reinterventions occurred in group II (n = 148, 76% vs n = 47, 24%; P = .00). Nonambulatory status was a multivariate independent predictor of nonambulatory status after LEAR during 6 years follow-up (odds ration [OR[: 21.47; 95% confidence interval [CI]: 2.76-166.77; P = .00). Pulmonary disease (OR: 7.49; 95% CI: 2.17-25.80; P = .00), not prescribing beta-blockers (OR: 4.67; 95% CI: 1.28-17.03; P < .02), nonambulatory status (OR: 22.99; 95% CI: 6.27-84.24; P = .00), and systemic AEs (OR: 9.66; 95% CI: 1.84-50.57; P < .01) were independent predictors of death. Functional status was not improved in group II after long-term follow-up. Nonambulatory patients suffer from extensive comorbid conditions. They are accompanied with an increased occurrence of AEs, unplanned reinterventions, and poor long-term survival rates. Successful LEAR did not improve their functional status after 6 years. This emphasizes that attempts for limb salvage must be carefully considered in these patients.

Morbidity and Mortality Caused by Cardiac Adverse Events after Revascularization for Critical Limb Ischemia

We assessed cardiac adverse events (AEs) after primary lower extremity arterial revascularization (LEAR) for critical lower limb ischemia (CLI) in order to evaluate the impact of cardiac AEs on the clinical outcome. We created an optimized care protocol concerning CLI patients' preoperative work-up as well as intra- and postoperative surveillance according to recent important literature and guidelines. We conducted a prospective analysis of clinical outcome after LEAR using patient-related risk factors, comorbidity, surgical therapy, and AEs. This cohort was divided into patients with and without AEs. AEs were categorized according to predefined standards: minor, surgical, failed revascularization, and systemic. The consequences of AEs were reoperation, additional medication, irreversible physical damage, and early death. There were 106 patients (Fontaine III n=49, 46%, and Fontaine IV n=57, 56%) who underwent primary revascularization by bypass graft procedure (n=67, 63%) or balloon angioplasty (n=39, 37%). No difference in comorbidity was registered between the two groups. Eighty-four AEs were registered in 34 patients (32%). Patients experiencing AEs had significantly less antiplatelet agents (without AEs n=63, 88%, vs. with AEs n=18, 53%; p=0.000) and/or beta-blockers (without AEs n=66, 92%, vs. with AEs n=16, 47%; p=0.000) compared to patients without AEs. The two most harmful consequences of AEs were irreversible physical damage (n=3) and early death (n=8). Sixty percent (n=9) of systemic AEs were heart-related. The postprocedural mortality rate was 7.5%, with a 75% (n=6) heart-related cause of death. AEs occur in >30% of CLI patients after LEAR. The most harmful AEs on the clinical outcome of CLI patients were heart-related, causing increased morbidity and death. Significant correlations between prescription of beta-blockers and antiplatelet agents and prevention of AEs were observed. A persistent focus on the prevention of systemic AEs in order to ameliorate the outcome after LEAR for limb salvage remains of utmost importance. Therefore, we advise the implementation of an optimized care protocol by discussing patients in a strict manner according to a predetermined protocol, to optimize and standardize the preoperative work-up as well as intra- and postoperative patient surveillance.

The effects of leg/body position on transcutaneous oxygen measurements after lower-extremity arterial revascularization

A postoperative nursing goal in a patient with peripheral artery disease requiring lower-extremity arterial reconstruction surgery is to maintain blood flow and tissue oxygenation to the revascularized extremity. This may be achieved through extremity positioning. Transcutaneous oxygen (TcPO(2)) measurements provide a noninvasive objective determination of oxygen at the skin surface and assessment of underlying circulation and tissue oxygenation. The purpose of this study was to determine which lower-extremity position afforded the highest TcPO(2) in 10 subjects with a lower-extremity arterial revascularization procedure preoperatively and 24 and 48 hours postoperatively. Hypotheses included comparing preoperative and postoperative TcPO(2) measurements, leg skin temperatures, and limb volumes. The subjects were studied in three different leg/body positions: supine with legs extended, sitting with legs extended, and supine with legs-elevated 20 degrees using the Radiometer TCM30 (Radiometer; Copenhagen) and PhysitempTH-5 Thermalert (Physitemp; Clifton, NJ) monitors. There was no change in the postoperative leg TcPO(2) measurements or limb volumes compared with preoperative measurements (P = .12-.92). A small sample size and lack of peripheral artery disease stratification were among study limitations. Significant to the nursing care of patients with vascular dsease is the finding that any of the leg/body positions in this study could be used postoperatively on the revascularized extremity without decreasing TcPO(2) measurements.

The effects of leg/body position on transcutaneous oxygen measurements in age-matched healthy subjects and peripheral artery disease subjects after lower extremity arterial revascularization

The effects of leg/body position on transcutaneous oxygen measurements in age-matched healthy subjects and peripheral artery disease subjects after lower extremity arterial revascularization

Effects of leg and body position on transcutaneous oxygen measurements in healthy subjects and subjects with peripheral artery disease after lower-extremity arterial revascularization: A pilot study

Transcutaneous oxygen (TcPO2) measurements provide a noninvasive, objective determination of the oxygen level at the skin surface. This offers a means of estimating the underlying circulation and tissue oxygenation. The purpose of the pilot study was to measure the TcPO2 value of the lower extremity of healthy men and women and of patients with peripheral arterial disease (PAD) in 4 different body and leg positions 24 hours after peripheral vascular surgery reconstruction. The specific aim was to determine if lower-extremity TcPO2 measurements were affected by changes in extremity position in these subject populations. A convenience sample of 4 healthy health care professionals and 4 patients who had peripheral vascular reconstruction surgery 24 hours before the measurements were studied. Subjects were studied in 4 different leg and body positions: supine with legs extended, sitting with legs dependent, a 5° head-up reverse Trendelenburg, and supine with legs elevated 10 in. The Radiometer TCM30 TcPO2 monitor was used to carry out these measures. Findings revealed a statistically significant difference in TcPO2 measurements between the 2 groups, with the healthy subjects having a significantly higher TcPO2 measurement in all extremity positions compared with the revascularized subjects with PAD (P =.02−.05). Significant changes were noted in both the foot temperature (P =.03) and TcPO2 measurements with extremity positions within the healthy subject group (P =.001). The foot and leg TcPO2 measurements affect from leg and body position did not reach significance (P =.09) in the subjects with PAD. No change in foot temperature with extremity positioning (P =.42) was noted in the subjects with PAD. This pilot study provides a base in which additional research will be performed with TcPO2 measurements in both the healthy and revascularized person. (J Vasc Nurs 2002;20:125-35)

Dartmouth Atlas of Vascular Health Care review: Impact of hospital volume, surgeon volume, and training on outcome

Dartmouth Atlas of Vascular Health Care review: Impact of hospital volume, surgeon volume, and training on outcome

Continuous recording of blood oxygen tensions by polarography.

Continuous recording of blood oxygen tensions by polarography.