Long-term outcomes of a randomized clinical trial of supervised exercise, percutaneous transluminal angioplasty or combined treatment for patients with intermittent claudication due to femoropopliteal disease

Background: To compare the long-term outcomes of angioplasty (PTA), supervised exercise (SEP) and combined treatment (PTA+SEP) in patients with intermittent claudication (IC) due to femoropopliteal disease. Methods: Patients recruited to PTA, SEP and PTA+SEP arms of RCT were invited for long-term follow-up from 2010 to 2011.Indicators of limb ischaemia were recorded (ankle-brachial pressure indices, treadmill walking distances (ICD, MWD, PRWD). Duplex ultrasound was also performed. Patients completed SF36 and Vascuqol quality of life(QOL) questionnaires. Results: Of the 178 patients recruited in the trial, 139 were alive at the time of follow-up (PTA=46, SEP=47, PTA+SEP=46). Assessments were completed for 111 patients. Median time to follow-up was 5.2years (IQR 3.8-7.4years). Median age of patients at follow up was 75years. 62.2%(N=69) of patients were symptomatic.16.2%(N= 18) had experienced major cardiovascular event since their last follow-up visit. Intra-group analysis: Improvement was observed in ankle brachial pressure index (ABPI) in all groups. QOL outcomes were inconsistent across individual groups. Inter-group analysis: PTA and PTA+SEP groups demonstrated a significantly higher ABPI as compared to SEP group. No significant difference was observed in walking distances, QOL outcomes, restenosis rates, and new ipsilateral and contralateral lesions on duplex scan. Patients required re-interventions in all group (PTA=14, SEP=10, PTA+SEP=6). Number of re-interventions was higher in PTA group(N=29) as compared to SEP(N=17) and PTA+SEP(N=9) but failed to reach statistical significance. Conclusion: PTA, SEP and combined treatment are equally effective long-term treatment options for patients with femoropopliteal claudication. Addition of SEP to PTA can reduce the symptomatic restenosis and re-intervention rates

Percutaneous transluminal angioplasty results in improved physical function but not balance in patients with intermittent claudication

Objective The aim of this study was to identify whether revascularization by percutaneous transluminal angioplasty (PTA) for patients with intermittent claudication improved measures of functional performance including balance. Methods A prospective observational study was performed at a single tertiary vascular center. Patients with symptomatic intermittent claudication (Rutherford grades 1-3) were recruited to the study. Participants were assessed at baseline (pre-PTA) and then 3, 6, and 12 months post-PTA for markers of (1) lower limb ischemia (treadmill walking distances and ankle-brachial pressure index), (2) physical function (6-minute walk, Timed Up and Go, and chair stand time), (3) balance impairment using computerized dynamic posturography with the Sensory Organization Test, and (4) quality of life (VascuQoL and Short Form Health Survey [SF-36]). Results Forty-three participants underwent PTA. Over 12 months, a significant improvement was demonstrated in initial (P = .04) and maximum treadmill walking distance (P = .019). Physical functional ability improved across all outcome measures (P < .02), and some domains of both generic (P < .03) and disease-specific quality of life (P < .01). No significant improvement in balance was demonstrated by the Sensory Organization Test (P = .24). Conclusions Balance impairment is common in claudicants and does not improve with revascularization. Further research regarding effective treatment of balance impairment is required in this specific group of patients

Fear of falling in claudicants and its relationship to physical ability, balance, and quality of Life

Objectives: Intermittent claudication is associated with poor physical function, quality of life (QoL), and balance impairment. Fear of falling (FoF) is a recognized contributing factor to poor physical ability. Any link between claudication and FoF is yet to be determined. This study aimed to explore the prevalence of FoF in claudicants and its relationship with physical function and QoL. Methods: A prospective observational study was performed. Fear of falling was determined using the Activities-specific Balance Confidence (ABC) questionnaire and the categorical question “Are you afraid of falling?” Physical ability and QoL (Short Form 36 and Vascular QoL) were determined. Results: A total of 161 claudicants (118 men, median age of 69 years) were assessed; 83 answered the categorical question “Are you afraid of falling?” By receiver–operating characteristic curve analysis, an ABC threshol

The impact of immediate breast reconstruction on the time to delivery of adjuvant therapy: the iBRA-2 study

Background: Immediate breast reconstruction (IBR) is routinely offered to improve quality-of-life for women requiring mastectomy, but there are concerns that more complex surgery may delay adjuvant oncological treatments and compromise long-term outcomes. High-quality evidence is lacking. The iBRA-2 study aimed to investigate the impact of IBR on time to adjuvant therapy. Methods: Consecutive women undergoing mastectomy ± IBR for breast cancer July–December, 2016 were included. Patient demographics, operative, oncological and complication data were collected. Time from last definitive cancer surgery to first adjuvant treatment for patients undergoing mastectomy ± IBR were compared and risk factors associated with delays explored. Results: A total of 2540 patients were recruited from 76 centres; 1008 (39.7%) underwent IBR (implant-only [n = 675, 26.6%]; pedicled flaps [n = 105,4.1%] and free-flaps [n = 228, 8.9%]). Complications requiring re-admission or re-operation were significantly more common in patients undergoing IBR than those receiving mastectomy. Adjuvant chemotherapy or radiotherapy was required by 1235 (48.6%) patients. No clinically significant differences were seen in time to adjuvant therapy between patient groups but major complications irrespective of surgery received were significantly associated with treatment delays. Conclusions: IBR does not result in clinically significant delays to adjuvant therapy, but post-operative complications are associated with treatment delays. Strategies to minimise complications, including careful patient selection, are required to improve outcomes for patients

Breast cancer management pathways during the COVID-19 pandemic: outcomes from the UK ‘Alert Level 4’ phase of the B-MaP-C study

Abstract: Background: The B-MaP-C study aimed to determine alterations to breast cancer (BC) management during the peak transmission period of the UK COVID-19 pandemic and the potential impact of these treatment decisions. Methods: This was a national cohort study of patients with early BC undergoing multidisciplinary team (MDT)-guided treatment recommendations during the pandemic, designated ‘standard’ or ‘COVID-altered’, in the preoperative, operative and post-operative setting. Findings: Of 3776 patients (from 64 UK units) in the study, 2246 (59%) had ‘COVID-altered’ management. ‘Bridging’ endocrine therapy was used (n = 951) where theatre capacity was reduced. There was increasing access to COVID-19 low-risk theatres during the study period (59%). In line with national guidance, immediate breast reconstruction was avoided (n = 299). Where adjuvant chemotherapy was omitted (n = 81), the median benefit was only 3% (IQR 2–9%) using ‘NHS Predict’. There was the rapid adoption of new evidence-based hypofractionated radiotherapy (n = 781, from 46 units). Only 14 patients (1%) tested positive for SARS-CoV-2 during their treatment journey. Conclusions: The majority of ‘COVID-altered’ management decisions were largely in line with pre-COVID evidence-based guidelines, implying that breast cancer survival outcomes are unlikely to be negatively impacted by the pandemic. However, in this study, the potential impact of delays to BC presentation or diagnosis remains unknown

Computerized dynamic posturography in the objective assessment of balance in patients with intermittent claudication

One-third of all elderly patients fall each year and impaired balance has been recognized as a specific risk factor. Intermittent claudication is common among the elderly population, affecting approximately 5% of the population over the age of 50. The aim of this proof-of-concept study was to assess the prevalence of impaired balance among elderly claudicants and to assess each patient's insight into their own risk of falling. A total of 58 claudicants (45 men), median age of 70 (interquartile range = 65-73) years, underwent objective balance assessment by using computerized dynamic posturography. As compared with 195 (5%) historic controls, 24 (41%) of the claudicants demonstrated abnormal balance when the Sensory Organization Test (SOT) was used. Vestibular dysfunction occurred in 52% of the claudicants. Abnormalities including somatosensory (22%), visual function (17%), and preferential reliance on inaccurate visual cues (17%) occurred less often. Prolonged Motor Control Test latency times were uncommon (n = 13) and were in most cases evenly distributed between those with normal (n= 7) and abnormal (n = 6) composite SOT scores. There was a significant difference in history of falling between claudicants with abnormal and normal SOT scores (p = 0.003), with a higher number of patients with abnormal SOT having experienced falling in the past year. However, no correlation between fear of falling and composite SOT score was found (Spearman rank correlation, r= 0.124; p = 0.381). Impaired balance, particularly secondary to vestibular problems, is very common among claudicants and may predispose to a high incidence of falls. Claudicants with abnormal balance are more likely to have a history of falls but not a fear of falling, thus potentially rendering these patients to be at a greater risk

Balance impairment, physical ability, and its link with disease severity in patients with intermittent claudication

BackgroundTo determine whether increasing claudication severity is associated with impaired balance and physical functional ability.MethodsA prospective observational study in claudicants was performed. Disease severity was determined according to Rutherford's criteria. Patient's balance was assessed objectively using computerized dynamic posturography (CDP-Sensory Organization Test [SOT]; NeuroCom). "Bedside" assessment of balance was performed using the Timed Up and Go (TUG) test (dynamic balance) and the Full Tandem Stance test (static balance). Physical function was assessed using the Summary Physical Performance Battery (SPPB) score.Results185 claudicants were assessed (median age of 69 [IQR 63-74] years; 137 [74.1%] men). Fourteen claudicants were classified as Rutherford grade 0, 26 as grade I, 76 as grade II, and 69 as grade III. All Rutherford groups were comparable for age, gender, BMI, and comorbidities.Increasing Rutherford grade was associated with a significant deterioration in objective balance as determined by a failed SOT test: 3 (21.4%) in grade 0; 9 (34.6%) in grade I; 39 (52.7%) in grade II; and 41 (59.4%) in grade III (chi-squared 9.693, df 3, P = 0.021). A significant difference was also found with dynamic balance (TUG test), but not static balance (full tandem stance).Increasing claudication severity was also associated with significantly worse physical function: SPPB score.ConclusionsSpecific objective tests demonstrate impaired balance and physical function are common in claudicants and become more frequent with increasing severity of claudication. Simple "bedside" measures may be sufficiently sensitive to detect this

Patients' perspective of functional outcome after elective abdominal aortic aneurysm repair: a questionnaire survey

BackgroundTo evaluate patients' awareness, functional outcome, and satisfaction after abdominal aortic aneurysm (AAA) repair.MethodsA study-specific questionnaire was developed with collaboration of a multidisciplinary team. Lists of patients who underwent elective open AAA repair and endovascular aneurysm repair (EVAR) between January 2006 and December 2008 were obtained from the departmental database and cross-checked against hospital database for survival status. Emergency AAA repairs were excluded. Study questionnaires were posted to 138 patients (113 open, 25 EVAR) with self-addressed stamped return envelopes. Statistical analysis was performed using SPSS v16.0.ResultsResponse rate was 89% (n = 123; 102 open, 21 EVAR). Seventy-one percent (n = 88) were unaware of this condition before diagnosis. Ninety-seven percent (n = 120) indicated their understanding of the need for surgery. Ninety-two percent (n = 113) stated that the operation was adequately explained to them. Ninety percent (n = 111) reported full recovery after surgery, with 60% (n = 74) recovering within 6 months. Eighty-seven percent (n = 108) were satisfied with the overall experience, and 85% (n = 105) stated that they would recommend the operation to family and/or friends if required.ConclusionsThere is a lack of awareness regarding AAA in elderly population. However, after being diagnosed, patients understand the implications and are satisfied with the overall results and would recommend AAA repair to family and/or friends if required