The Content of Pre-habilitative Interventions for Patients Undergoing Repair of Abdominal Aortic Aneurysms and Their Effect on Post-Operative Outcomes: A Systematic Review.

OBJECTIVE: Patients requiring abdominal aortic aneurysm (AAA) repair are at risk of post-operative complications due to poor pre-operative state. Pre-habilitation describes the enhancement of functional capacity and tolerance to an upcoming physiological stressor, intended to reduce those complications. The ability to provide such an intervention (physical, pharmacological, nutritional, or psychosocial) between diagnosis and surgery is a growing interest, but its role in AAA repair is unclear. This paper aimed to systematically review existing literature to better describe the effect of pre-habilitative interventions on post-operative outcomes of patients undergoing AAA repair. DATA SOURCES: EMBASE and Medline were searched from inception to October 2020. Retrieved papers, systematic reviews, and trial registries were citation tracked. REVIEW METHODS: Randomised controlled trials (RCTs) comparing post-operative outcomes for adult patients undergoing a period of pre-habilitation prior to AAA repair (open or endovascular) were eligible for inclusion. Two authors screened titles for inclusion, assessed risk of bias, and extracted data. Primary outcomes were post-operative 30 day mortality, composite endpoint of 30 day post-operative complications, hospital length of stay (LOS), and health related quality of life (HRQL) outcomes. The content of interventions was extracted and a narrative analysis of results undertaken. RESULTS: Seven RCTs with 901 patients were included (three exercise based, two pharmacological based, and two nutritional based). Risk of bias was mostly unclear or high and the clinical heterogeneity between the trials precluded data pooling for meta-analyses. The quality of intervention descriptions was highly variable. One exercise based RCT reported significantly reduced hospital LOS and another improved HRQL outcomes. Neither pharmacological nor nutritional based RCTs reported significant differences in primary outcomes. CONCLUSION: There is limited evidence to draw clinically robust conclusions about the effect of pre-habilitation on post-operative outcomes following AAA repair. Well designed RCTs, adhering to reporting standards for intervention content and trial methods, are urgently needed to establish the clinical and cost effectiveness of pre-habilitation interventions.

A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein.

INTRODUCTION: Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment. METHODS: Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life. RESULTS: A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20-54) mm vs. (GA alone) 56 (24-70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6-17.9) vs. 4.3 (IQR 2.7-7.9) P = 0.004). CONCLUSION: The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39.

A Randomised Clinical Trial of Buffered Tumescent Local Anaesthesia During Endothermal Ablation for Superficial Venous Incompetence.

OBJECTIVE/BACKGROUND: Endovenous thermal ablation (EVTA) is the recommended first line intervention for superficial venous incompetence (SVI). While the infiltration of perivenous tumescent local anaesthesia (TLA) is key to procedural success, it is paradoxically the predominant source of patient reported discomfort. This randomised controlled trial investigates the potential to reduce peri-procedural pain and improve patient reported outcome measures (PROMs), including quality of life (QoL) using TLA buffered to physiological pH. METHODS: Patients undergoing great saphenous vein EVTA with concomitant phlebectomies were randomised to either standard (ST) or buffered (BT) TLA. Follow up assessments were performed at weeks 1, 6, and 12. The primary outcome was patient reported peri-procedural pain on a 100 mm visual analogue scale (VAS). Secondary outcomes were one week post-procedural pain VAS and analgesia use, QoL (disease specific: Aberdeen Varicose Vein Questionnaire [AVVQ]; generic: Short Form-36 [SF-36] and EuroQol 5 Dimensions Questionnaire [EQ-5D]), patient satisfaction VAS, technical success on duplex ultrasound (DUS) examination, and complications. RESULTS: Ninety-seven patients were randomised: 50 to ST and 47 to BT. The groups had comparable baseline demographics, Clinical Etiologic Anatomic Pathological, Venous Clinical Severity Score, QoL, and DUS parameters. Equally, intra-procedural parameters (volume of TLA, length of ablation, and linear energy delivered) were also comparable. Peri-procedural pain scores were significantly lower in the BT group with a mean ± SD score of 2.86 ± 3.57 versus 4.44 ± 2.94 (p = .001). Pain scores and analgesia use over the subsequent week were equivalent. SF-36 Bodily Pain domain scores were significantly better in the BT group at week 1 (77 vs. 62; p = .008). AVVQ, SF-36, and EQ-5D scores were otherwise similar between the groups throughout follow up, significantly improving over baseline. Technical success was high in both groups, with no major complications and few minor complications. CONCLUSION: Buffered TLA offers a significantly lower peri-procedural pain experience for patients undergoing EVTA and should replace current tumescent formulae.

A feasibility double-blind randomized placebo-controlled trial of extracorporeal shockwave therapy as a novel treatment for intermittent claudication.

BACKGROUND: Intermittent claudication is the most common symptom of peripheral arterial disease. Previous research has suggested that extracorporeal shockwave therapy (ESWT) may induce angiogenesis in treated tissue. The objective of this feasibility pilot trial was to assess the safety, tolerability, and efficacy of ESWT as a novel treatment. METHODS: Patients with unilateral claudication were randomized to receive ESWT or sham treatment to the calf muscle three times per week for 3 weeks. Primary outcomes were pain-free walking distance (PFWD) and maximum walking distance (MWD). Secondary outcomes included safety and tolerability of ESWT treatment, ankle-brachial index before and after exercise, and quality of life assessed using generic (36-Item Short Form Health Survey, EuroQol-5 Dimension 3-Level) and disease-specific (Vascular Quality of Life) instruments. Participants were assessed at baseline and 4, 8, and 12 weeks after treatment. Feasibility outcomes included recruitment and attendance rates for treatment and follow-up. RESULTS: Thirty patients were recruited in total. Statistically significant (P < .05) improvements at all time points were observed in the active treatment group for both MWD and PFWD compared with the sham treatment group. PFWD improved by 276% in the active group and MWD improved by 167% in the active group at 12 weeks after treatment. There were no immediate or delayed treatment safety concerns or documented adverse effects of treatment with ESWT in this trial. CONCLUSIONS: ESWT is safe and well tolerated when it is applied to the calf and demonstrated significant improvements in walking distances. Current conservative management of intermittent claudication includes supervised exercise. The early results with ESWT as an alternative, noninvasive treatment option show great potential. The mechanism of action, durability of the clinical effect, and cost-effectiveness of ESWT for claudication require further investigation.