Supervised exercise therapy in the management of peripheral arterial disease - an assessment of compliance.

BACKGROUND: Supervised exercise therapy (SET) is an effective option in the management of peripheral arterial disease (PAD). Unfortunately, poor compliance remains prevalent. This study aimed to assess patient exercise compliance and to identify factors influencing symptomatic improvement and SET participation. PATIENTS AND METHODS: Data regarding attendance at SET for this cohort study were extracted from a prospectively maintained database of patients with claudication attending SET at Dublin City University. All patients had ankle brachial index confirmed PAD with associated intermittent claudication. Exercise performance and symptomatic data were gathered retrospectively using patient charts and interviews. RESULTS: Ninety-eight patients were referred for SET during the study period. The mean age was 69.2 (± 10.1) with 18 % being female. Median follow-up was 25.1 months (IQ range 17.0-31.6). Overall, the mean number of sessions attended per patient was 19.5. Exercise compliance was associated with a significant improvement in symptoms (p = 0.001). Other factors including anatomical level of claudication (P = 0.042) and educational level (p = 0.007) were found to affect the outcome of SET. Multivariate analysis revealed hypertension as a predictor of symptomatic outcome after SET (p = 0.045). Furthermore, ex-smokers (p = 0.021) and those previously diagnosed with hypercholesterolaemia (p = 0.020) or ischaemic heart disease (p = 0.029) had superior exercise compliance. Using linear regression, smoking history (p = 0.024) was identified as a predictor of compliance to SET. CONCLUSIONS: Establishing exercise compliance remains challenging in the PAD cohort. Pre-exercise patient education and personalised exercise prescriptions may result in improvements in function and compliance.

Evidence for varicose vein surgery in venous leg ulceration.

BACKGROUND: Venous leg ulcers affect 1-3% of adults with a significant economic impact, utilizing 1% of annual healthcare budgets in some western European countries. OBJECTIVES: To determine the effects of intervention for incompetent superficial veins on ulcer healing and recurrence in patients with active or healed venous ulcers. SEARCH METHODS: In October 2014, we searched Medline, CINAHL, EMBASE, Scopus, the Cochrane library and Web of Science without date or language restriction for relevant randomized or observational studies. Bibliographies of included studies were also searched for additional studies. SELECTION CRITERIA: Observational studies or randomized controlled trials comparing intervention for varicose veins with compression therapy alone for venous leg ulcers were eligible. In addition, studies compared open to endovenous therapy for varicose veins in patients with leg ulcers and those compared treating saphenous and perforating veins to treating saphenous veins only were also included. Studies had to report at least one ulcer-related outcome (healing rate, recurrence or time to healing). DATA COLLECTION AND ANALYSIS: Details of potentially eligible studies were extracted and summarized using a data extraction table. Data extraction and quality assessment were performed independently by two review authors, and any disagreements resolved by consensus or by arbitration of a third author. RESULTS: Intervention for superficial venous reflux improved ulcer healing (risk ratio = 1.11 [1.00, 1.22], 95% CI, p = 0.04) and reduced recurrence (risk ratio = 0.48 [0.32, 0.67], 95% CI, p < 0.0001) compared to compression alone, with low level of evidence. CONCLUSION: This review confirmed that the evidence for a beneficial effect of endovenous and open surgery for varicose vein in venous leg ulcer is at beast weak. A well-structured RCT is required to investigate the role of endovenous ablation of incompetent superficial veins in improving venous leg ulcer outcomes.

Arteriovenous fistula in dialysis patients: Factors implicated in early and late AVF maturation failure.

Increasing numbers of patients are being diagnosed with end-stage renal disease (ESRD), and the demand for on haemodialysis (HD) is rising. Arteriovenous fistulae (AVFs) remain the best conduit for adequate HD, with fewer complications associated with long-term use compared to bypass grafts and central venous catheters. However, it is known that many newly formed fistulae do not mature to provide useful HD access. The paper provides a narrative overview of factors influencing the process of AVF maturation failure.

Comparing Supervised Exercise Therapy to Invasive Measures in the Management of Symptomatic Peripheral Arterial Disease.

Peripheral arterial disease (PAD) is associated with considerable morbidity and mortality. Consensus rightly demands the incorporation of supervised exercise training (SET) into PAD treatment protocols. However, the exact role of SET particularly its relationship with intervention requires further clarification. While supervised exercise is undoubtedly an excellent tool in the conservative management of mild PAD its use in more advanced disease as an adjunct to open or endovascular intervention is not clearly defined. Indeed its use in isolation in this cohort is incompletely reported. The aim of this review is to clarify the exact role of SET in the management of symptomatic PAD and in particular to assess its role in comparison with or as an adjunct to invasive intervention. A systematic literature search revealed a total 11 randomised studies inclusive of 969 patients. All studies compared SET and intervention with monotherapy. Study results suggest that exercise is a complication-free treatment. Furthermore, it appears to offer significant improvements in patients walk distances with a combination of both SET and intervention offering a superior walking outcome to monotherapy in those requiring invasive measures.

Preconditioning Shields Against Vascular Events in Surgery (SAVES), a multicentre feasibility trial of preconditioning against adverse events in major vascular surgery: study protocol for a randomised control trial.

BACKGROUND: Patients undergoing vascular surgery procedures constitute a 'high-risk' group. Fatal and disabling perioperative complications are common. Complications arise via multiple aetiological pathways. This mechanistic redundancy limits techniques to reduce complications that target individual mechanisms, for example, anti-platelet agents. Remote ischaemic preconditioning (RIPC) induces a protective phenotype in at-risk tissue, conferring protection against ischaemia-reperfusion injury regardless of the trigger. RIPC is induced by repeated periods of upper limb ischaemia-reperfusion produced using a blood pressure cuff. RIPC confers some protection against cardiac and renal injury during major vascular surgery in proof-of-concept trials. Similar trials suggest benefit during cardiac surgery. Several uncertainties remain in advance of a full-scale trial to evaluate clinical efficacy. We propose a feasibility trial to fully evaluate arm-induced RIPC's ability to confer protection in major vascular surgery, assess the incidence of a proposed composite primary efficacy endpoint and evaluate the intervention's acceptability to patients and staff. METHODS/DESIGN: Four hundred major vascular surgery patients in five Irish vascular centres will be randomised (stratified for centre and procedure) to undergo RIPC or not immediately before surgery. RIPC will be induced using a blood pressure cuff with four cycles of 5 minutes of ischaemia followed by 5 minutes of reperfusion immediately before the start of operations. There is no sham intervention. Participants will undergo serum troponin measurements pre-operatively and 1, 2, and 3 days post-operatively. Participants will undergo 12-lead electrocardiograms pre-operatively and on the second post-operative day. Predefined complications within one year of surgery will be recorded. Patient and staff experiences will be explored using qualitative techniques. The primary outcome measure is the proportion of patients who develop elevated serum troponin levels in the first 3 days post-operatively. Secondary outcome measures include length of hospital and critical care stay, unplanned critical care admissions, death, myocardial infarction, stroke, mesenteric ischaemia and need for renal replacement therapy (within 30 days of surgery). DISCUSSION: RIPC is novel intervention with the potential to significantly improve perioperative outcomes. This trial will provide the first evaluation of RIPC's ability to reduce adverse clinical events following major vascular surgery. TRIAL REGISTRATION: www.clinicaltrials.gov NCT02097186 Date Registered: 24 March 2014.

Total knee replacement under tourniquet control: A prospective study of the peripheral arterial vasculature using colour-assisted duplex ultrasonography.

BACKGROUND AND PURPOSE: A tourniquet may potentiate rare and devastating arterial complications after total knee replacement (TKR) in patients with peripheral vascular disease (PVD). Most prior studies that evaluated peripheral arterial blood flow primarily used the ankle-brachial index (ABI). METHODS: We assessed the prevalence and risk factors for PVD in a cohort undergoing TKR. Clinical and radiological evaluations, including duplex ultrasonography, were performed one week prior to, and six weeks post-TKR performed under tourniquet control. Forty patients were analysed (20 male, 20 female; mean age 67 yrs, range: 53-80 yrs). MAIN FINDINGS: Hypertension (50%) and hypercholesterolaemia (50%) were the most common co-morbidities. Distal pulses were present in all patients preoperatively. Six patients (15%) had arterial calcification on their preoperative knee X-rays. Three patients (7.5%) had moderate PVD. There was no change in blood flow postoperatively in patients with or without PVD (p > 0.05). Vascular stenosis was less than 50% in all patients preoperatively and postoperatively. No postoperative vascular complications occurred. CONCLUSIONS: Severe PVD is not common in patients undergoing TKR. Performing total knee replacement under tourniquet control does not adversely affect the vasculature in patients with less than 50% vascular occlusion.

Acute limb ischemia in cancer patients: should we surgically intervene?

BACKGROUND: Cancer patients have an increased risk of venous thromboembolic events. Certain chemotherapeutic agents have also been associated with the development of thrombosis. Reported cases of acute arterial ischemic episodes in cancer patients are rare. METHODS: Patients who underwent surgery for acute limb ischemia associated with malignancy in a university teaching hospital over a 10-year period were identified. Patient demographics, cancer type, chemotherapy use, site of thromboembolism, treatment and outcome were recorded. RESULTS: Four hundred nineteen patients underwent surgical intervention for acute arterial ischemia, 16 of these patients (3.8%) had associated cancer. Commonest cancer sites were the urogenital tract (n = 5) and the lungs (n = 5). Eight patients (50%) had been recently diagnosed with cancer, and four (25%) of these cancers were incidental findings after presentation with acute limb ischemia. Four patients (25%) developed acute ischemia during chemotherapy. The superficial femoral artery was the most frequent site of occlusion (50%), followed by the brachial (18%) and popliteal (12%) arteries. All patients underwent thromboembolectomy, but two (12%) patients subsequently required a bypass procedure. Six patients (37%) had limb loss, and in-patient mortality was 12%. Histology revealed that all occlusions were due to thromboembolism, with no tumor cells identified. At follow-up, 44% of patients were found to be alive after 1 year. CONCLUSION: Cancer and chemotherapy can predispose patients to acute arterial ischemia. Unlike other reports that view this finding as a preterminal event most appropriately treated by palliative measures, in this series, early diagnosis and surgical intervention enabled limb salvage and patient survival.

Osteoprotegerin is higher in peripheral arterial disease regardless of glycaemic status.

INTRODUCTION: Peripheral arterial disease (PAD) and type 2 diabetes mellitus (DM) are both associated with excessive vascular calcification and elevated levels of inflammatory markers IL-6 and hsCRP. The recently identified Osteoprotegerin(OPG)/RANKL/TRAIL pathway has been implicated in vascular calcification, but data on levels in PAD and effect of co-existent DM are lacking. MATERIALS AND METHODS: 4 groups of patients were recruited - 26 with PAD and DM, 35 with DM alone, 22 with PAD alone, and 21 healthy individuals. Serum OPG, RANKL, TRAIL, hsCRP and IL-6 were measured using commercial ELISA assays. Presence and severity of PAD was defined using ankle brachial index (ABI). RESULTS: Serum OPG (7.4±0.3 vs.5.8±0.2 pmol/l, p<0.0001), TRAIL (95.5±5.2 ng/ml vs. 76.2±4.4 ng/ml, p=0.006), hsCRP (2.6±0.3 vs. 1.8±0.3 mg/l, p=0.048), and IL-6 (4.1±0.4 vs. 2.9±0.4 pg/ml, p=0.06) were higher in patients with PAD. There was no difference in RANKL. Only OPG was significantly higher in PAD and DM (7.2±0.3 pmol/l) and PAD alone (7.7±0.4 pmol/l) compared to DM only (5.8±0.3 pmol/l) and healthy controls (5.6±0.4 pmol/l), p<0.01, but OPG was no higher in those with DM plus PAD versus those with PAD alone (p<0.3). Only OPG was associated with PAD severity, correlating negatively with ABI (r=-0.26, p=0.03), independent of age, gender, glycaemic status, hsCRP and IL-6. CONCLUSIONS: PAD is associated with higher serum OPG, regardless of the co-existence of DM. This finding, in addition to its correlation with severity of PAD, suggests that OPG may be a novel marker for the presence and severity of PAD, possibly by reflecting the degree of underlying vascular calcification.

Should incidental asymptomatic angiographic stenoses and occlusions be treated in patients with peripheral arterial disease?

PURPOSE: The clinical importance of angiographically detected asymptomatic lower-limb stenoses and occlusions is unknown. This study aims to (i) assess the clinical outcome of asymptomatic lesions in the lower limb, (ii) identify predictors of clinical deterioration, and (iii) determine which asymptomatic lower-limb lesions should be treated at presentation. MATERIALS AND METHODS: All 918 patients undergoing peripheral angiography with or without angioplasty over a period of 7.5 years (January 1999 through June 2006) at a single institution were retrospectively evaluated. One hundred twenty-two patients (54% men; mean age, 70.3 years; age range, 41-91 y) with angiographic stenoses (> or =50%) or occlusions on the asymptomatic leg were included. The composite endpoint of interest was major adverse clinical outcome (MACO) of the asymptomatic limb at clinical follow-up, which was defined as the development of intermittent claudication (IC), critical limb ischemia (CLI), or need for subsequent endovascular or surgical revascularization. Actuarial freedom from MACO was assessed with Kaplan-Meier curves and multivariable Cox proportional-hazards regression. RESULTS: During a 4.2-year mean follow-up in 122 patients with significant concomitant asymptomatic disease, 32.8% of patients developed symptoms (13.9% with IC, 18.9% with CLI); 42.5% of these cases required revascularization. Cox regression revealed two independent predictors of MACO on the asymptomatic side: contralateral below-knee amputation (BKA; hazard ratio, 2.93; 95% CI, 1.21-7.10; P = .01) and statin treatment (hazard ratio, 3.56; 95% CI, 1.56-8.13; P = .003). CONCLUSIONS: Asymptomatic peripheral angiographic stenoses and occlusions become symptomatic in one third of patients, necessitating treatment in 13.9% overall. Previous contralateral BKA and statin use were independent predictors of adverse outcome in this population. Close clinical follow-up and appropriate risk factor modification are recommended.

Endovascular repair of para-anastomotic aortoiliac aneurysms.

The purpose of this study is to evaluate the use of endovascular stent grafts in the treatment of para-anastomotic aneurysms (PAAs) as an alternative to high-risk open surgical repair. We identified all patients with previous open aortic aneurysm repair who underwent infrarenal endovascular aneurysm repair (EVAR) at our institution from June 1998 to April 2007. Patient demographics, previous surgery, and operative complications were recorded. One hundred forty-eight patients underwent EVAR during the study period and 11 patients had previous aortic surgery. Of these 11 redo patients, the mean age was 62 years at initial surgery and 71 years at EVAR. All patients were male. Initial open repair was for rupture in five (45%) patients. The average time between initial and subsequent reintervention was 9 years. All patients were ASA Grade III or IV. Fifty-five percent of the PAAs involved the iliac arteries, 36% the abdominal aorta, and 9% were aortoiliac. Ten patients had endovascular stent-grafts inserted electively, and one patient presented with a contained leak. Aorto-uni-iliac stent-grafts were deployed in seven patients, and bifurcated stent-grafts in four patients. A 100% successful deployment rate was achieved. Perioperative mortality was not seen and one patient needed surgical reintervention to correct an endoleak. Endovascular repair of PAAs is safe and feasible. It is a suitable alternative and has probably now become the treatment of choice in the management of PAAs.

Development of the Irish National Perception of Quality of Care Survey.

OBJECTIVES: This study aimed to develop a methodology suitable for assessing patients' perception of quality of care received in Irish hospitals nationwide. SETTING: Thirteen acute care hospitals throughout Ireland participated in the study. Patients were surveyed approximately 3-6 weeks following discharge. The development work was undertaken by the Irish Society for Quality in Healthcare. DESIGN: The survey utilized Computer Aided Telephone Interviews to receive and collate patient feedback. The questionnaire was developed through utilization of focus groups and extensive piloting. Patients perceptions in a wide range of areas were examined including admission procedures, pain management, adherence to the patient charter, medication, and overall satisfaction. STUDY PARTICIPANTS: A total of 3757 patients were randomly selected for interview during the study period, of whom 3276 were eligible. The remaining 481 patients were unable to participate because of death, hospital re-admission, illness or severe cognitive impairments. With a total of 1950 respondents, this entire study yielded a response rate of 59.5%. RESULTS: This paper indicates how a national society may assist the health system in developing a survey for assessment of patients' perception of quality of care. The results of the survey assisted organizations in identifying many improvement opportunities, mainly in relation to information and communication.

Powered phlebectomy (TriVex) in treatment of varicose veins.

This study assesses the operation of transilluminated powered phlebectomy for removal of varicose veins. It was a prospective, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of the powered varicose vein extractor for ablation of primary varicose veins. A total of 114 patients (117 limbs) were recruited from four centers in Europe and four centers in the United States. Safety of the varicose vein extractor was evaluated by recording nature and severity of all adverse events and complications. Efficacy was assessed by the patient, an independent study nurse, and the surgeon. Operations were performed under general, spinal, or epidural anesthesia and tumescent anesthesia was added with infusions of dilute lidocaine with epinephrine. Transillumination was achieved with a specially designed cannula, and the vein extraction was done using a vein resector with a rotating tubular inner cannula encased in a stationary outer sheath dissector. Demographic information regarding the 28 men and 89 women included in the study are detailed. Eighty-four percent of the limbs were CEAP class 2 with only 16% being in classes 3 and 4. Accompanying greater saphenous vein stripping was done in 67% of the limbs in the United States and 88% in those in Europe. Proximal ligation only was used in one limb in the United States and eight in Europe. The study showed that transilluminated powered phlebectomy used in varicose vein removal is swift and efficacious with a conservation of operating time and the results being satisfactory to the patient and clinician alike.

Cyclooxygenase isozyme expression and intimal hyperplasia in a rat model of balloon angioplasty.

Prostaglandin formation is enhanced in vascular disease, in part through induction of cyclooxygenase (COX-2) in vascular smooth muscle cells. Because COX regulates cell growth and migration, we examined whether the COX expression plays a role in the development of intimal hyperplasia after vascular injury. Rats undergoing balloon angioplasty of the carotid artery were randomized to receive a selective COX-2 inhibitor (SC-236), a selective COX-1 inhibitor (SC-560) or a combination of the two. Normal, uninjured vessels showed COX-1, but no COX-2 expression. Fourteen days after balloon injury, both COX-1 and COX-2 were expressed in the neointima. Balloon angioplasty resulted in a marked increase in the urinary excretion of prostaglandin (PG) E(2,) PGF(2alpha), and thromboxane (TX) B(2). Both the COX-1 inhibitor SC-560 and the COX-2 inhibitor SC-236 suppressed the generation of PGE(2) and PGF(2alpha), particularly when combined, suggesting a role for both isozymes in the generation of prostaglandins in this model. In contrast, TXA(2) was markedly suppressed by the COX-1 inhibitor SC-560. COX-2 inhibition with SC-236 had no effect on intimal hyperplasia at day 14 (0 versus 8.5%; n = 7 in controls). In contrast, intimal hyperplasia was reduced by SC-560 when administered alone (by 42%; n = 7, p < 0.05) or in combination with SC-236 (by 40%; n = 7, p < 0.05). COX-1 may play a role in the development of intimal hyperplasia, potentially through the inhibition of platelet TXA(2). Despite being expressed in the neointima, COX-2 does not play a role in the development of intimal hyperplasia after vascular injury.