Background
Lower limb peripheral arterial disease (PAD) is a type of cardiovascular disease where the blood vessels that carry the blood to the legs are hardened and narrowed. Its most severe state (critical limb ischaemia (CLI)), results in symptoms of pain when resting, non-healing wounds and ulceration, gangrene or both. PAD affects more than 200 million people worldwide and approximately 3% to 5% of people aged above 40 have PAD, rising to 18% in people above 70 years of age. Of those who show symptoms of PAD, between 5% and 10% will progress to CLI over a five-year period. Of those with PAD with no symptoms, 7% will go on to develop symptoms of cramping in the legs when walking and of these patients, 21% will progress to CLI within five years. The treatment options include using a balloon or stent (a device that sits in the artery) to open it up and allow the blood to flow (angioplasty), taking a vein from the opposite leg or arm and attaching it to the artery above and below the blocked artery (bypass), or removal of the limb (amputation), when the life of the patient is at risk due to infection. People with CLI have a high risk of death and worsening health.
Despite recent advances in surgical technology, anaesthesia, and care during and after surgery, a number of surgical patients have a poor recovery. Presurgery conditioning (prehabilitation) is carried out prior to surgery and includes exercise with a nutritional or psychological intervention or both. Exercise consists of aerobic training, such as walking, running or swimming (ideally three to five times a week) and training to build muscle and strength, using weights or resistance bands (ideally two times a week). The nutritional intervention includes eating or drinking a protein supplement daily, after training or with meals, to improve the effects of any training. Psychological interventions may include breathing exercises, meditation, mindfulness, coping techniques or cognitive behavioural therapy, with an aim to reduce the anxiety of having surgery.
Presurgery conditioning has become popular in bowel surgery and for elderly patients undergoing an operation. It is used as a means of improving the condition of the patient as a way to reduce complications during and after surgery. People with PAD have difficulty walking and doing their daily living activities and as a result are often very unfit. They therefore have the potential to improve their recovery during and after surgery from presurgery conditioning. However, as presurgery conditioning requires a big commitment from both the hospital and the patient, it is important to know how presurgery conditioning compares to usual practice (preoperative assessment, including blood and urine tests and information about the operation) for reducing the number of deaths or postoperative complications, or both.
Study characteristics and key results
We performed a review of the literature (current up to 25 September 2019) to determine whether prehabilitation was associated with reduced complications and death after surgery. We identified no randomised controlled trials on this topic.
Certainty of the evidence
We found no studies undertaken to address our objectives; therefore we were not able to assess the certainty of the evidence.
Conclusion
We found no evidence to determine if presurgery conditioning is better than usual care in reducing the number of deaths or postoperative complications. Although presurgery conditioning trials are difficult to do with people with lower limb peripheral arterial disease, randomised controlled trials are needed to provide solid evidence on this topic.
We found no RCTs conducted to determine the effects of prehabilitation on mortality or other postoperative outcomes when compared to usual care for patients with PAD. As a consequence, we were unable to provide any evidence to guide the treatment of patients with PAD undergoing surgery. To perform a randomised controlled trial of presurgery conditioning would be challenging but trials are warranted to provide solid evidence on this topic.
Lower limb peripheral arterial disease (PAD) is a type of cardiovascular disease where the blood vessels that carry the blood to the legs are hardened and narrowed. The most severe manifestation of PAD is critical limb ischaemia (CLI). This condition results in symptoms of intractable rest pain, non-healing wounds and ulceration, gangrene or both. PAD affects more than 200 million people worldwide and approximately 3% to 5% of people aged over 40 have PAD, rising to 18% in people over 70 years of age. Between 5% to 10% of symptomatic PAD patients will progress to CLI over a five-year period and the five year cumulative incidence rate for asymptomatic patients with PAD deteriorating to intermittent claudication is 7%, with 21% of these progressing to CLI. Treatment options include angioplasty, bypass or amputation of the limb, when life or limb is threatened. People with CLI have a high risk of mortality and morbidity. The mortality rates during a surgical admission are approximately 5%. Within one year of surgery, the mortality rate rises to 22%. Postoperative complications are as high as 30% and readmission rates vary between 7% to 18% in people with CLI.
Despite recent advances in surgical technology, anaesthesia and perioperative care, a proportion of surgical patients have a suboptimal recovery. Presurgery conditioning (prehabilitation) is a multimodal conditioning intervention carried out prior to surgery using a combination of exercise, with or without nutritional or psychological interventions, or both. The use of prehabilitation is gaining momentum, particularly in elderly patients undergoing surgery and patients undergoing colorectal cancer surgery, as a means of optimising fitness to improve the prognosis for people undergoing the physiological stress of surgery. People with PAD are characterised by poor mobility and physical function and have a lower level of fitness as a result of disease progression. Therefore, prehabilitation may be an opportunity to improve their recovery following surgery. However, as multimodal prehabilitation requires considerable resources, it is important to assess whether it is superior to usual care.
This review aimed to compare prehabilitation with usual care (defined as a preoperative assessment, including blood and urine tests). The key outcomes were postoperative complications, mortality and readmissions within 30 days of the surgical procedure, and one-year survival rates.
To assess the effectiveness of prehabilitation (preoperative exercise, either alone or in combination with nutritional or psychological interventions, or both) on postoperative outcomes in adults with PAD undergoing open lower limb surgery.
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 25 September 2019.
We considered all published and unpublished randomised controlled trials (RCTs) comparing presurgery interventions and usual care. Primary outcomes were postoperative complications, mortality and readmission to hospital within 30 days of the surgical procedure.
Two review authors independently reviewed all records identified by the searches conducted by the Cochrane Vascular Information Specialist. We planned to undertake data collection and analysis in accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions.
We found no RCTs that met the inclusion criteria for this review.