[The quality of life of patients with atherosclerosis of lower extremities - 15-year observation]. / Jakosc zycia chorych z miazdzyca zarostowa tetnic konczyn dolnych ­ obserwacja 15-letnia.

An improving quality of life of a patient seems to be the primary goal of contemporary medicine facing the controversies arising over the duration of persistent therapy, on the one hand, and mounting costs of health care, on the other. AIM: The aim of the study was to assess the applicability of the SF-36 (Short Form Health Survey) quality-of-life scale to the evaluation of patients with lower-extremity atherosclerosis and to find a link with the new composite endpoint of the study which the quality of life predisposes to. MATERIALS AND METHODS: The patients operated on for lower-extremity atherosclerosis (y-graft) in one centre in the years 1999-2004 were invited to take part in the study. 64 out of 172 patients joined the study. The study participants were assessed for the quality of life, distance intermittent claudication and lower-extremity pulse presence. Information was also collected on their past medical history and life style. The works of the study group undertaken in 2021 thanks to cooperation with the Ministry of Digitalization allowed to determine deaths among the study participants and link them to the information collected earlier, including the quality of life. RESULTS: It was confirmed that the SF-36 scale, a tool from the group of general tools, i.e. a tool not dedicated to any particular disease, allows to perfectly assess the quality of life in the studied group of patients. The assessments obtained in the SF-36 subscales were higher for patients with an at least 10-year post-surgery survival. Yet, it is the differences observed in the analysis of the three variables, namely, social functioning (t=3.825, p<0.001), limitations due to emotional problems (t=3.496, p=0.001) and emotional well-being (t+2.179, p=0.033) that are statistically significant. CONCLUSIONS: The results of the study indicate that the main factors differentiating patients who die within 10 years from the surgery and those with an over-10 survival are primarily emotional well-being related issues.

Assessment of Sirolimus- vs. paCLitaxEl-coated balloon angioPlasty In atherosclerotic femoropopliteal lesiOnS (ASCLEPIOS Study): preliminary results.

BACKGROUND: There appears to be an association between paclitaxel-coated devices and increased 5-year all-cause mortality. METHODS: We are conducting a prospective, randomized, controlled, single-center, noninferiority study. All consecutive patients with femoropopliteal arterial disease who fulfilled the inclusion/exclusion criteria are sequentially and consecutively assigned to either paclitaxel (Ranger, Boston Scientific) or sirolimus (MagicTouch, Concept Medical) coated balloon angioplasty treatment. The primary outcome are procedural success and primary vessel patency at index procedure. The secondary outcomes are 30-day and 12-month freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization), procedural success (≤30% residual diameter stenosis or occlusion after the procedure), Rutherford category improvement (reduction ≤1 category) and ABI improvement (increase ≥0.10 from baseline). RESULTS: A total of six patients have been enrolled in the present study up to now. The mean age was 72.6 years old and five were male. All patients had angiographic evidence of isolated occlusion in the transition segment of the distal femoral superficial artery in the popliteal artery. The mean length was 109 mm. Three patients were treated by sirolimus-coated (group A) and three by paclitaxel coated balloon angioplasty (group B). The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively. CONCLUSIONS: Preliminary results show safety and feasibility of the Sirolimus-coated balloon angioplasty. Further investigation and increase of sample size will allow for more sustained conclusions regarding patency and procedural success of this type of balloons for the endovascular treatment of peripheral arterial disease.

Assessment of Tissue Viability Following Amputation Surgery Using Near-Infrared Fluorescence Imaging With Indocyanine Green.

BACKGROUND: Patients with chronic limb threatening ischemia have a risk of undergoing a major amputation within 1 year of nearly 30% with a substantial risk of re-amputation since wound healing is often impaired. Quantitative assessment of regional tissue viability following amputation surgery can identify patients at risk for impaired wound healing. In quantification of regional tissue perfusion, near-infrared (NIR) fluorescence imaging using Indocyanine Green (ICG) seems promising. METHODS: This pilot study included adult patients undergoing lower extremity amputation surgery due to peripheral artery disease or diabetes mellitus. ICG NIR fluorescence imaging was performed within 5 days following amputation surgery using the Quest Spectrum PlatformⓇ. Following intravenous administration of ICG, the NIR fluorescence intensity of the amputation wound was recorded for 10 minutes. The NIR fluorescence intensity videos were analyzed and if a fluorescence deficit was observed, this region was marked as "low fluorescence." All other regions were marked as "normal fluorescence." RESULTS: Successful ICG NIR fluorescence imaging was performed in 10 patients undergoing a total of 15 amputations. No "low fluorescence" regions were observed in 11 out of 15 amputation wounds. In 10 out of these 11 amputations, no wound healing problems occurred during follow-up. Regions with "low fluorescence" were observed in 4 amputation wounds. Impaired wound healing corresponding to these regions was observed in all wounds and a re-amputation was necessary in 3 out of 4. When observing time-related parameters, regions with low fluorescence had a significantly longer time to maximum intensity (113 seconds vs. 32 seconds, P = 0.003) and a significantly lesser decline in outflow after five minutes (80.3% vs. 57.0%, P = 0.003). CONCLUSIONS: ICG NIR fluorescence imaging was able to predict postoperative skin necrosis in all four cases. Quantitative assessment of regional perfusion remains challenging due toinfluencing factors on the NIR fluorescence intensity signal, including camera angle, camera distance and ICG dosage. This was also observed in this study, contributing to a large variety in fluorescence intensity parameters among patients. To provide surgeons with reliable NIR fluorescence cut-off values for prediction of wound healing, prospective studies on the intra-operative use of this technique are required. The potential prediction of wound healing using ICG NIR fluorescence imaging will have a huge impact on patient mortality, morbidity as well as the burden of amputation surgery on health care.

Comparison of femoropopliteal plain balloon angioplasty for chronic limb-threatening ischemia in the BASIL trial and in a UK contemporary series.

BACKGROUND: Since the turn of the millennium, there has been a worldwide trend towards an endovascular-first strategy where possible revascularization strategy for chronic limb-threatening ischemia. There is concern that this may be inappropriate and can result in net patient harm. The aim of this study, therefore, is to compare important clinical outcomes following femoropopliteal plain balloon angioplasty (FP-PBA), with selective use of bare metal stents (BMSs), in a contemporary series (CS) of patients treated in our unit between 2009 and 2014 with those observed following FP-PBA ± BMS in the United Kingdom National Institute of Health Research Health Technology Assessment-funded Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL-1 [B1]) trial (treated 1999-2004). METHODS: Baseline and clinical outcome data (amputation-free survival [AFS], overall survival [OS], limb salvage, freedom from reintervention, and freedom from major adverse limb events) were obtained from prospectively gathered hospital data and B1 trial case record forms. RESULTS: There were 237 CS and 218 B1 patients. CS patients were older (77 vs 73 years; P = .0002). B1 patients were more likely to be current smokers, less likely to be on best medical therapy, and underwent more extensive endovascular interventions. CS had more hospital admissions (4 vs 2; P < .0001) before they reached their primary endpoint (AFS). Immediate technical success was nonsignificantly higher in the CS patients (87% vs 83%; P = .2). BMS were used in 20 CS (8%) and 2 B1 (1%) patients (P = .0002). AFS (hazard ratio, 0.64; 95% confidence interval, 0.49-0.82; P = .0005) and OS (hazard ratio, 0.58; 95% confidence interval, 0.44-0.76; P = .0001) were significantly worse in the CS cohort. There was no significant difference in limb salvage, freedom from reintervention, or freedom from major adverse limb events. CONCLUSIONS: Patients with chronic limb-threatening ischemia managed in our unit (2009-2014) by means of a FP-PBA ± BMS first (where possible) revascularization strategy experienced significantly worse AFS and OS than patients treated with FP-PBA ± BMS in the B1 trial 10 years earlier (1999-2004).

The association of healthcare disparities and patient-specific factors on clinical outcomes in peripheral artery disease.

BACKGROUND: PAD increases the risk of cardiovascular mortality and limb loss, and disparities in treatment and outcomes have been described. However, the association of patient-specific characteristics with variation in outcomes is less well known. METHODS: Patients with PAD from Duke University Health System (DUHS) between January 1, 2015 and March 31, 2016 were identified. PAD status was confirmed through ground truth adjudication and predictive modeling using diagnosis codes, procedure codes, and other administrative data. Symptom severity, lower extremity imaging, and ankle-brachial index (ABI) were manually abstracted from the electronic health record (EHR). Data was linked to Centers for Medicare and Medicaid Services data to provide longitudinal follow up. Primary outcome was major adverse vascular events (MAVE), a composite of all-cause mortality, myocardial infarction (MI), stroke, lower extremity revascularization and amputation. RESULTS: Of 1,768 patients with PAD, 31.6% were asymptomatic, 41.2% had intermittent claudication (IC), and 27.3% had chronic limb-threatening ischemia (CLTI). At 1 year, patients with CLTI had higher rates of MAVE compared with asymptomatic or IC patients. CLTI and Medicaid dual eligibility were independent predictors of mortality. CLTI and Black race were associated with amputation. CONCLUSIONS: Rates of MAVE were highest in patients with CLTI, but patients with IC or asymptomatic disease also had high rates of adverse events. Black and Medicaid dual-eligible patients were disproportionately present in the CLTI subgroup and were at higher risk of amputation and mortality, respectively. Future studies must focus on early identification of high-risk patient groups to improve outcomes in patients with PAD.

An Assessment of Available Information on the World Wide Web for Patients with Lower Limb Arterial Disease.

OBJECTIVE: The quality of patient information relating to intermittent claudication (IC) and peripheral arterial disease (PAD) on the World Wide Web was assessed. METHODS: The quality of websites and YouTube videos was assessed using the search terms "intermittent claudication" and "peripheral arterial disease". The first 50 hits screened for each search term from the three largest search engines by market share, and the first 20 videos from YouTube were screened. Website quality was scored using the University of Michigan Consumer Health Website tool (maximum score 80). Readability was calculated using the Flesch Reading Ease (FRE) score (maximum score 100). Videos were classified by content and upload source. Video reliability was assessed using the JAMA benchmark criteria. Video educational content was assessed using the Global Quality Score (GQS). Subjective content assessment was undertaken. RESULTS: Seventy-six websites were analysed. The majority of websites for both IC (51.7%) and PAD (72.3%) were rated as weak. The median Michigan score for IC (27; interquartile range [IQR] 15, 32.5) was lower that the score for PAD (31; IQR 25.5, 38.8; p = .030). The majority of websites for both IC (69%) and PAD (68.1%) were rated as requiring an above average reading level. The overall median FRE score was 55.9 (IQR 46.6, 60.6) for IC and 55.3 (IQR 44.6, 59.3) for PAD. Twenty-two videos were analysed. Of the 14 videos evaluated as part of the PAD search, the median JAMA score was 2 (2 - 3), the median GQS score was 3 (3 - 3) and the evaluation of content score was 8.5 (7.25 - 11.5). The equivalent scores for the IC search were 2 (2 - 2), 3 (3 - 4), and 5.5 (5 - 8). CONCLUSION: The educational quality and reliability of information both in written and video form on the internet is low. Attention needs to focus on improving the quality of all forms of information delivery to allow proper advocacy for patients.

Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial.

BACKGROUND: Endovascular treatment has become the first-line revascularization technique for femoropopliteal lesions. This technique lacks reliable and accurate morphological control of the arterial segment treated. Intraoperative 2-dimensional angiogram consumes iodinated contrast media and increases X-ray exposure; this subsequently provides no 3-dimensional information on the quality of the revascularization completed, what could explain some of the early and late failures of the technique. We evaluated whether intraoperative optical coherence tomography (OCT) control in addition to standard angiogram could improve the primary patency rate at 12 months in comparison to standard angiogram alone in patients with occlusive femoropopliteal lesions. METHODS: The tomography by optical coherence in femoral artery trial is a multicentric, prospective, randomized, controlled, and single-blind study including patients with long de novo occlusive femoropopliteal lesions. The randomization will be achieved in 2 balanced groups of patients after crossing successfully the lesion: group 1 with intraoperative OCT control in addition to standard angiogram and group 2 with standard angiogram alone. The randomization will be stratified by center. The protocol has been submitted and approved by a French ethic's committee under reference number CPP2019-12-098. The study has been registered under the reference number NCT04434586 on the Web site of clinicaltrials.gov. RESULTS: The primary outcome of the study is the primary patency at 12 months. The number of patients who need to be treated is 166 (83 in each group) considering 5% of no workable data. Symptoms' improvement, target lesion revascularization, target vessel revascularization, quality-of-life questionnaires, cost utility, and cost effectiveness will be analyzed as secondary end-point variables at 12 months. CONCLUSIONS: The present study is to evaluate the potential benefit for patients on the result of endovascular revascularization of long occlusive femoropopliteal lesion at 12 months when using intraoperative OCT control.

Implementation of an enhanced recovery program for lower extremity bypass.

OBJECTIVE: Enhanced recovery programs (ERPs) have gained wide acceptance across multiple surgical disciplines to improve postoperative outcomes and to decrease hospital length of stay (LOS). However, there is limited information in the existing literature for vascular patients. We describe the implementation and early results of an ERP and barriers to its implementation for lower extremity bypass surgery. Our intention is to provide a framework to assist with implementation of similar ERPs. METHODS: Using the plan, do, check, adjust methodology, a multidisciplinary team was assembled. A database was used to collect information on patient-, procedure-, and ERP-specific metrics. We then retrospectively analyzed patients' demographics and outcomes. RESULTS: During 9 months, an ERP (n = 57) was successfully developed and implemented spanning preoperative, intraoperative, and postoperative phases. ERP and non-ERP patient demographics were statistically similar. Early successes include 97% use of fascia iliaca block and multimodal analgesia administration in 81%. Barriers included only 47% of patients achieving day of surgery mobilization and 19% receiving celecoxib preoperatively. ERP patients had decreased total and postoperative LOS compared with non-ERP patients (n = 190) with a mean (standard deviation) total LOS of 8.32 (8.4) days vs 11.14 (10.1) days (P = .056) and postoperative LOS of 6.12 (6.02) days vs 7.98 (7.52) days (P = .089). There was significant decrease in observed to expected postoperative LOS (1.28 [0.66] vs 1.82 [1.38]; P = .005). Variable and total costs for ERP patients were significantly reduced ($13,208 [$9930] vs $18,777 [$19,118; P < .01] and $29,865 [$22,110] vs $40,328 [$37,820; P = .01], respectively). CONCLUSIONS: Successful implementation of ERP for lower extremity bypass carries notable challenges but can have a significant impact on practice patterns. Further adjustment of our current protocol is anticipated, but early results are promising. Implementation of a vascular surgery ERP reduced variable and total costs and decreased total and postoperative LOS. We believe this protocol can easily be implemented at other institutions using the pathway outlined.

Toe pressure should be part of a vascular surgeon's first-line investigation in the assessment of lower extremity artery disease and cardiovascular risk of a patient.

OBJECTIVE: Toe pressure (TP) is an accurate indicator of the peripheral vascular status of a patient and thus cardiovascular risk, with less susceptibility to errors than ankle-brachial index (ABI). This study aimed to analyze how ABI and TP measurements associate with overall survival and cardiovascular death and to analyze the TP of patients with ABI of 0.9 to 1.3. METHODS: The first ABI and TP measurements of a consecutive 6784 patients treated at the Helsinki University Hospital vascular surgery clinic between 1990 and 2009 were analyzed. Helsinki University Vascular Registry and the national Cause of Death Registry provided the data. RESULTS: The poorest survival was in patients with ABI >1.3 (10-year survival, 15.3%; hazard ratio, 2.2; 95% confidence interval, 1.9-2.6; P < .0001; reference group, ABI 0.9-1.3), followed by the patients with TP <30 mm Hg (10-year survival, 19.6%; hazard ratio, 2.0; 95% confidence interval, 1.7-2.2; P < .0001; reference group, TP ≥80 mm Hg). The best 10-year survival was in patients with TP ≥80 mm Hg (43.9%). Of the 642 patients with normal ABI (0.9-1.3), 18.7% had a TP <50 mm Hg. The highest cardiovascular death rate (64.6%) was in the patients with TP <30 mm Hg, and it was significantly lower than for the patients with TP >50 mm Hg. CONCLUSIONS: Low TP is associated significantly with survival and cardiovascular mortality. Patients with a normal ABI may have lower extremity artery disease (LEAD) and a considerable risk for a cardiovascular event. If only the ABI is measured in addition to clinical examination, a substantial proportion of patients may be left without LEAD diagnosis or adequate treatment of cardiovascular risk factors. Thus, especially if ABI is normal, LEAD is excluded only if TPs are also measured and are normal.

Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions.

BACKGROUND: The Superficial Femoral Artery-Popliteal EvidencE Development Study Group developed contemporary objective performance goals (OPGs) for peripheral vascular interventions (PVI) for superficial femoral artery (SFA)-popliteal artery disease using the Registry Assessment of Peripheral Interventional Devices. METHODS: The Society for Vascular Surgery Vascular Quality Initiative PVI registry from January 2010 to October 2016 was used to develop OPGs based on SFA-popliteal procedures (n = 21,377) for intermittent claudication and critical limb ischemia (CLI). OPGs included 1-year rates for target lesion revascularization (TLR), major amputation, and 1 and 4-year survival rates. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (percutaneous transluminal angioplasty [PTA]), self-expanding stenting, atherectomy, and any treatment type. Outcomes were illustrated by unadjusted Kaplan-Meier analyses. RESULTS: Cohorts included PTA (n = 7505), stenting (n = 9217), atherectomy (n = 2510) and any treatment (n = 21,377). The mean age was 69 years, 58% were male, 79% were White, and 52% had CLI. The freedom from TLR OPGs at 1 year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at 1 year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at 1 year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8% (any treatments). The freedom from major amputation OPG at 1 year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). The 4-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments), and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). On a multivariable analysis, which included patient-level, leg-level, and lesion-level covariates, CLI was the single independent factor associated with increased TLR, amputation, and mortality. CONCLUSIONS: The Superficial Femoral Artery-Popliteal EvidencE Development OPGs define a new, contemporary benchmark for SFA-popliteal interventions using a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision-making. It is appropriate to discuss proposals intended for regulatory approval with the US Food and Drug Administration to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance.

Fast-track thrombolysis protocol for acute limb ischemia.

OBJECTIVE: Catheter-directed thrombolysis in the treatment of acute lower extremity arterial occlusions often requires several interventional sessions to generate successful outcomes. It is typically an expensive procedure, necessitating extended hospital length of stay (LOS) that may be associated with an increase in both local and systemic hemorrhagic complications. Five years ago, we created the fast-track thrombolysis protocol for arteries (FTTP-A) to deal with these concerns. The goal of our protocol is to re-establish patency during the first session of thrombolysis, thus decreasing costs and complications associated with prolonged periods of thrombolytic exposure. METHODS: A retrospective study of 42 patients who were treated for acute limb ischemia at our institution by FTTP-A from January 2014 to February 2019 was performed. FTTP-A includes periadventitial lidocaine injection at the arterial puncture site under ultrasound guidance, contrast arteriography of the entire targeted segment, pharmacomechanical rheolytic thrombectomy of the occluded arterial segment, tissue plasminogen activator infusion along the occluded segment, balloon maceration of the thrombus, and (if deemed necessary) placement of a stent in an area of significant (≥30%) stenosis that is refractory to balloon angioplasty and thrombolysis. After the stenosis or thrombus is cleared, patients are prescribed an oral anticoagulant agent. RESULTS: Primary FTTP-A (50 total interventions) was performed in 42 patients. The median age of patients was 67.2 ± 12.2 years (range, 41-98 years), and 54.8% were male; 59.5% of the procedures were performed on the left lower extremity. Initial arterial access was obtained through the common femoral artery in 39 of 42 cases (92.9%); in the remaining 3 cases, it was obtained in a left bypass access site, a right femoral-popliteal graft, and a right femoral-femoral graft. The mean operative time was 148.9 ± 62.9 minutes (range, 83-313 minutes), and the mean volume of tissue plasminogen activator infused was 9.7 ± 4.0 mg (range, 2-20 mg). The median cost including medications and interventional tools was $4673.19 per procedure. The mean postoperative LOS was 3.1 ± 4.5 days (range, 1-25 days). Median postoperative LOS was 1 day. Mean postoperative follow-up was 27 ± 19.2 months (range, 0-62 months). Single-session FTTP-A was successful in 81% (n = 34/42) of patients; the remaining 8 patients (19%) required a single additional session. Of the 42 patients, 34 (81%) required arterial stenting. Periprocedural complications consisted of one patient with hematuria, which resolved, and one patient with thrombocytopenia, which resolved. No patients experienced rethrombosis within 30 days of FTTP-A. During the 5-year study period, there was no significant local or systemic hemorrhage, limb loss, or mortality related to this protocol. CONCLUSIONS: FTTP-A appears to be a safe, efficacious, and cost-effective procedure in the resolution of acute lower extremity arterial occlusions.

Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis.

PURPOSE: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2-4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]). RESULTS: In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes. CONCLUSIONS: In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.

Tissue optical perfusion pressure: a simplified, more reliable, and faster assessment of pedal microcirculation in peripheral artery disease.

Oscillometry is an alternative to continuous-wave Doppler (cw-Doppler) to determine peripheral artery disease (PAD) severity using the ankle-brachial index (ABI). cw-Doppler ABI differentiates systolic pressure of ATP and ADP where either one of both values in most patients is higher (high) and the other value is lower (low). In contrast, oscillometric ABI measures the strongest signal and hence misses the lower value. Both do not take pedal perfusion into consideration. Simultaneous determination of tissue microperfusion cares for pedal PAD. ABI was determined by cw-Doppler and oscillometry. Tissue optical perfusion pressure (TOPP) was taken from the first toe using photoplethysmography. 323 patients were evaluated retrospectively in 3 independent groups. group 1 (99 patients) compared TOPP and oscillometric ABI with systolic cw-Doppler-pressure and cw-Doppler ABI. In group 2 (103 patients) TOPP was compared with toe pressure (TP). In group3 (121 symptomatic patients) TOPP and ABI at rest and after stress were compared (ultrasound examination and magnetic resonance angiography (MRA) or computer tomography angiography (CTA) as control). Bland-Altman-plot analysis presented no significant difference between oscillometric ABI and the high cw-Doppler ABI (group 1). TOPP showed a difference of 26mmHg to the low cw-Doppler-pressure and none to the high cw-Doppler-pressure. In group 2 TOPP correlates to TP but presented a difference of 37 mmHg. group 3 showed weak or no correlation between ABI and walking distance. Oscillometric ABI correlates significantly to TOPP. To conclude, data after stress present a better correlation than at rest. We conclude that TOPP provides absolute values of pedal macro-/microcirculation at rest and after stress tests.NEW & NOTEWORTHY This new application of photoplethysmography investigated the microcirculation in peripheral artery disease at the level of the toe pad and determined the tissue optical perfusion pressure as the first pulsatile signal during automatic cuff deflation at the ankle. It is the first time that this method has been integrated for simultaneous routine examination in an automatic oscillometric ankle-brachial index (ABI) system. This quick and simple measurement technique provides clinical information on the microcirculation downstream the routine ABI measurement at rest and in particular after stress test.

Vascular Assessment of the Lower Extremity with a Chronic Wound.

Peripheral arterial disease (PAD) affects many individuals worldwide and is associated with increased morbidity and mortality. Controversy exists on whether or not to screen asymptomatic patients. Further complicating this is that many patients with a chronic lower extremity wound are often asymptomatic. PAD and traditional noninvasive vascular studies may be inaccurate in providing a correct diagnosis. A review of current and novel vascular assessment modalities along with their benefits and limitations are presented here. A combination of these vascular assessments may help improve accuracy in diagnosis, providing timely care to those patients in need.

Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.

INTRODUCTION: Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD. METHODS AND ANALYSIS: The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.

Assessment of Atherosclerosis in Peripheral and Central Circulation in Adult ß Thalassemia Intermedia Patients by Color Doppler Ultrasound: Egyptian Experience.

BACKGROUND: Atherosclerosis has been extensively studied in thalassemia major (TM) and sickle cell disease but not yet in ß thalassemia intermedia (TI). Previous studies concerned with TM were performed in children. TI patients usually live longer and, thus, are more prone to complications of atherosclerosis. AIM: In our study, we applied color Doppler for the determination of arterial conduit and flow velocities in ß TI patients. METHODS: For central circulation, we measured right and left middle cerebral arteries (MCAs) and basilar artery (BA) mean flow velocity (MFV), pulsatility index (PI), and peak systolic velocity (PSV) as well as carotid intimal media thickness, and to assess peripheral circulation, we studied ankle/brachial index and posterior and anterior tibial arteries' (ATA, PTA) pressure and PSV. This was applied for 30 adult TI patients and 20 age-, sex-, and ethnic group-matched controls. RESULTS: Transcranial Doppler findings among cases and controls showed that the MFV, PSV of MCAs, and PSV, PI, and MFV of the BA were statistically higher in cases than controls. A comparison between splenectomized and nonsplenectomized patients showed that total leukocyte count, platelet count, lactate dehydrogenase, ferritin, PSV and MFV of the left MCA were all statistically higher in splenectomized cases. Differences between males and females with TI with respect to laboratory and Doppler findings were all statistically insignificant except for intima media thickness, PTA pressure, ATA pressure, and PSV. CONCLUSION: More than one parameter should be applied to assess atherosclerosis in TI. There is evidence of an increased risk of central ischemia rather than peripheral ischemia in these patients.

Assessment of foot perfusion: Overview of modalities, review of evidence, and identification of evidence gaps.

Patients with critical limb ischemia have nonhealing wounds and/or ischemic rest pain and are at high risk for amputation and mortality. Accurate evaluation of foot perfusion should help avoid unnecessary amputation, guide revascularization strategies, and offer efficient surveillance for patency. Our aim is to review current modalities of assessing foot perfusion in the context of the practical clinical management of patients with critical limb ischemia.

Gender Differences in the Outcomes of Drug-Coated Balloon Treatment in Symptomatic Femoropopliteal Arterial Disease.

OBJECTIVES: To assess 24-month outcome differences based on sex in symptomatic femoro-popliteal arterial disease of patients treated with drug-coated balloon (DCB). BACKGROUND: Peripheral artery disease affects over 12 million people in the United States. Drug-coated balloons have shown to be effective in treating patients with symptomatic femoropopliteal arterial occlusive disease. Debate remains regarding its safety and efficacy in female gender. We investigated the differential treatment effect between genders. METHODS: Patients (93 females and 102 males) with symptomatic femoropopliteal arterial disease treated with DCB from November 2014 to November 2015 were included in this retrospective study. We compared the resting ankle-brachial indices (ABIs) and peak systolic velocities (PSVs) by arterial duplex between the male and female patients at 6, 12, and 24 months postintervention. RESULTS: Females had significantly smaller vessels (4.70 ± 0.9, P = .02) and higher body mass index (BMI; 30.0 ± 3.7, P = .002) than males. Females had significantly decreased ABI and PSV at the 6-month (ABI: 0.90 ± 0.15, P = .05 and PSV: 188.30 ± 103.1, P = .02), 12-month (ABI: 0.86 ± 0.15, P < .0001 and PSV: 219.10 ± 100.10, P = .001), and at 24-month (ABI: 0.84 ± 0.2, P = .0001 and PSV: 251.0 ± 135.9, P < .0001) intervals when compared to males. Females had increased clinically driven target lesion revascularization (TLR) at 6 months (females = 8 vs males = 4, P = .22), 12 months (females = 12 vs males = 4, P = .02), and 24 months (females = 14 vs males = 6, P = .03). In simple logistic regression analysis, BMI, age, reference vessel diameter (RVD), and gender were strongly associated with target lesion restenosis. The final model included the above and it produced the following odds ratios (ORs): BMI (OR = 1.07, 95% confidence interval [CI]: 0.98-1.2), age (OR: 1.0, CI: 0.96-1.03), RVD (OR: 1.6, CI: 1.02-2.4), and gender (OR: 3.5, CI: 1.6-7.8). CONCLUSION: Females treated with DCBs have significantly decreased ABI, PSVs, and an increased rate of TLR than their male counterparts.

Functional ambulatory status as a potential adjunctive decision-making tool following wound, level of ischemia, and severity of foot infection assessment.

The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System has been developed to stratify amputation risk on the basis of extent of the wound, level of ischemia, and severity of foot infection (WIfI). However, there are no currently validated metrics to assess, grade, and consider functional status, especially ambulatory status, as a major consideration during limb salvage efforts. Therefore, we propose an adjunct to the current WIfI system to include the patient's ambulatory functional status after initial assessment of limb threat. We propose a functional ambulatory score divided into grade 0, ambulation outside the home with or without an assistive device; grade 1, ambulation within the home with or without an assistive device; grade 2, minimal ambulation, limbs used for transfers; and grade 3, a person who is bed-bound. Adding ambulatory function as a supplementary assessment tool can guide clinical decision making to achieve optimal future functional ambulatory outcome, a patient-centered goal as critical as limb preservation. This adjunct may aid limb preservation teams in rapid, effective communication and clinical decision making after initial WIfI assessment. It may also improve efforts toward patient-centered care and functional ambulatory outcome as a primary objective. We suggest a score of functional ambulatory status should be included in future trials of patients with chronic limb-threatening ischemia.