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Cardiovascular Intervention and... Jan 2022This meta-analysis aimed to evaluate the device performance of conventional balloon catheters (POBA), drug-coated balloons (DCB), bare-metal stents (BMS), and... (Meta-Analysis)
Meta-Analysis
This meta-analysis aimed to evaluate the device performance of conventional balloon catheters (POBA), drug-coated balloons (DCB), bare-metal stents (BMS), and drug-eluting stents (DES) in below-the-knee (BTK) ischemic lesions with regard to lesion characteristics. Online searches of PubMed, Web of Science, and Cochrane databases (2010-2019) were conducted for each of the test devices. Primary patency rates (pp) and major amputation rates 1 year after the use of each device were analyzed using a random-effects meta-analysis model. Meta-regression analysis was conducted to test associations between the outcomes and lesion characteristics. The analysis included 18 studies reporting on 24 separate cohorts comprising 2,438 patients. DES demonstrated the best pp among the test devices (83.6%; 95% confidence interval = 78.4-88.8%, studies = 8; I = 66%, P = 0.005). A negative coefficient between lesion length and pp (P = 0.002) was obtained. The ratio of critical limb ischemia (CLI) patients impacted the amputation rates (P = 0.031), whereas no statistically significant difference was found between the devices. DES showed favorable pp in BTK lesions; however, as the lesion lengths using DES were short, pp in long lesions still needs to be evaluated. Shorter lesions gained better pp. A higher ratio of CLI patients resulted in increased amputation rates.
Topics: Angioplasty, Balloon; Chronic Limb-Threatening Ischemia; Drug-Eluting Stents; Humans; Peripheral Arterial Disease; Risk Factors; Stents; Treatment Outcome; Vascular Patency
PubMed: 33547627
DOI: 10.1007/s12928-021-00758-7 -
European Journal of Vascular and... Mar 2021Most major lower limb amputations are related to peripheral artery disease (PAD) or diabetes. Just 40% of patients who undergo major lower limb amputation will use a...
OBJECTIVE
Most major lower limb amputations are related to peripheral artery disease (PAD) or diabetes. Just 40% of patients who undergo major lower limb amputation will use a prosthesis yet measures of surgical success commonly focus on prosthesis use. Patient reported outcome measures (PROMs) are valuable to comprehensively evaluate health related quality of life (HRQL) after surgery. This systematic review aimed to identify and describe PROMs available to assess HRQL in patients after amputation for PAD or diabetes.
METHODS
A search was conducted based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) for systematic reviews of PROMs. Ovid MEDLINE, Ovid EMBASE, PsycINFO, CINAHL, and Cochrane CENTRAL were also searched from inception until August 2019. Included were articles describing the development, measurement properties, or evaluation of HRQL via a PROM in adult patients after amputation for PAD or diabetes. Studies of amputation exclusively for trauma or malignancy were excluded. Data were collected on study characteristics, PROM characteristics (generic/disease specific), and properties of amputation specific PROMs.
RESULTS
Of 3 317 abstracts screened, 111 full text articles were assessed for eligibility and 64 included. Fifty-six studies evaluated HRQL, with 23 (46%) of these using an amputation specific PROM to do so. Eleven different amputation specific PROMs were identified, 10 (91%) of which were developed only for prosthesis users. One measure was suitable for use in all patients after amputation. This "Amputee single item mobility measure" includes a single item evaluating mobility. Nine studies reported some psychometric testing of an amputation specific PROM.
CONCLUSION
A well tested, multidimensional PROM applicable to wheelchair and prosthetic users after amputation is lacking and urgently needed for studies in this field. Future work to develop an appropriate measure is required.
Topics: Amputation, Surgical; Amputees; Artificial Limbs; Dependent Ambulation; Diabetic Angiopathies; Health Status; Humans; Lower Extremity; Mobility Limitation; Patient Reported Outcome Measures; Peripheral Arterial Disease; Prosthesis Fitting; Quality of Life; Treatment Outcome; Wheelchairs
PubMed: 33388237
DOI: 10.1016/j.ejvs.2020.11.043 -
European Journal of Vascular and... Feb 2021Antegrade crossing techniques via transfemoral access are often challenging and may be associated with technical and clinical failure when treating patients with... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Antegrade crossing techniques via transfemoral access are often challenging and may be associated with technical and clinical failure when treating patients with critical limb ischaemia (CLI). The objective of this study was to summarise all available literature regarding retrograde endovascular treatment of patients with CLI and to investigate the technical success and complication rate of retrograde access.
METHODS
A systematic literature search was performed in PubMed, Scopus, and Cochrane Central until May 2020. A meta-analysis of 31 observational studies (29 retrospective and two prospective; 26 and five studies with low and moderate risk of bias, respectively) was conducted with random effects modelling. The incidence of adverse events peri-procedurally and during follow up were calculated.
RESULTS
The 31 studies enrolled 1 910 patients who were treated endovascularly for femoropopliteal and/or infrapopliteal lesions causing CLI. Most of the patients had diabetes while more than half of the overall population had coronary artery disease and dyslipidaemia. All lesions were located in the infra-inguinal segment and most were chronic total occlusions (96%; 95% CI 85%-100%). Seven studies reported moderate or severe calcification in approximately half of the cases (45%; 95% CI 30%-60%). The overall technical success of the retrograde approach was 96% (18 studies; 95% CI 92%-100%). Perforation, flow limiting dissection, distal embolisation, and local haematoma at the retrograde access site were infrequent and observed in 2.1%, 0.6%, 0.1%, and 1.3% of the patients, respectively. The six month primary patency rate was 78% (five studies; 95% CI 46%-99%), the six month limb salvage rate was 77% (four studies; 95% CI 70%-84%).
CONCLUSION
The results indicated that the retrograde or bidirectional antegrade/retrograde approach is safe and effective and facilitates angioplasty when antegrade treatment fails. However, prospective studies with standardised wound care and surveillance protocols are needed to investigate retrograde techniques in patients with CLI who failed antegrade revascularisation, to improve long term limb salvage and survival.
Topics: Endovascular Procedures; Extremities; Humans; Ischemia; Limb Salvage; Peripheral Arterial Disease; Treatment Outcome
PubMed: 33358346
DOI: 10.1016/j.ejvs.2020.11.020 -
Endocrinology and Metabolism (Seoul,... Dec 2020Whether hyperthyroidism is an independent risk factor for cardiovascular events remains controversial. We aimed to evaluate the association of overt and subclinical... (Meta-Analysis)
Meta-Analysis
The Association of Overt and Subclinical Hyperthyroidism with the Risk of Cardiovascular Events and Cardiovascular Mortality: Meta-Analysis and Systematic Review of Cohort Studies.
BACKGROUND
Whether hyperthyroidism is an independent risk factor for cardiovascular events remains controversial. We aimed to evaluate the association of overt and subclinical hyperthyroidism with the risk of ischemic heart disease (IHD), stroke, heart failure, and cardiovascular mortality.
METHODS
Studies regarding the association between hyperthyroidism and cardiovascular events were searched on PubMed and Embase databases. The cardiovascular disease (CVD) risk was classified as high and low, based on pre-existing diseases, including history of coronary, cerebral, or peripheral artery disease; heart failure; atrial fibrillation; diabetes mellitus; or chronic kidney disease.
RESULTS
Thirty-seven cohort studies were included in this meta-analysis. The pooled hazard ratio for subjects with overt hyperthyroidism compared with the control group was 1.11 (95% confidence interval [CI], 1.03 to 1.19) for IHD, 1.35 (95% CI, 1.03 to 1.75) for stroke, and 1.20 (95% CI, 1.00 to 1.46) for cardiovascular mortality. For subjects with subclinical hyperthyroidism, the pooled hazard ratio was 1.24 (95% CI, 1.07 to 1.45) for IHD, when compared with the control group. Subgroup analysis by CVD risk showed that the risk of stroke in overt hyperthyroidism was increased in the low CVD risk group; however, these association was not observed in the high CVD risk group. Similarly, the risk of IHD in subjects with subclinical hyperthyroidism was significantly increased in the low CVD risk group.
CONCLUSION
Overt hyperthyroidism is associated with increased risk of IHD, stroke, and cardiovascular mortality, and subclinical hyperthyroidism is associated with increased risk of IHD. These associations were particularly observed in the low risk CVD group without underlying CVD.
Topics: Cardiovascular Diseases; Cohort Studies; Humans; Hyperthyroidism; Myocardial Ischemia; Risk; Stroke
PubMed: 33238332
DOI: 10.3803/EnM.2020.728 -
The Cochrane Database of Systematic... Nov 2020This review was published originally in 1999 and was updated in 2001, 2002, 2009, 2017, and 2020. Updating was deemed necessary due to the high incidence of hip... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This review was published originally in 1999 and was updated in 2001, 2002, 2009, 2017, and 2020. Updating was deemed necessary due to the high incidence of hip fractures, the large number of official societies providing recommendations on this condition, the possibility that perioperative peripheral nerve blocks (PNBs) may improve patient outcomes, and the major role that PNBs may play in reducing preoperative and postoperative opioid use for analgesia.
OBJECTIVES
To compare PNBs used as preoperative analgesia, as postoperative analgesia, or as a supplement to general anaesthesia versus no nerve block (or sham block) for adults with hip fracture. Outcomes were pain on movement at 30 minutes after block placement, acute confusional state, myocardial infarction, chest infection, death, time to first mobilization, and costs of an analgesic regimen for single-injection blocks. We undertook the update to look for new studies and to update the methods to reflect Cochrane standards.
SEARCH METHODS
For the updated review, we searched the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 11), in the Cochrane Library; MEDLINE (Ovid SP, 1966 to November 2019); Embase (Ovid SP, 1974 to November 2019); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (EBSCO, 1982 to November 2019), as well as trial registers and reference lists of relevant articles.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) assessing use of PNBs compared with no nerve block (or sham block) as part of the care provided for adults 16 years of age and older with hip fracture. DATA COLLECTION AND ANALYSIS: Two review authors independently screened new trials for inclusion, assessed trial quality using the Cochrane Risk of Bias-2 tool, and extracted data. When appropriate, we pooled results of outcome measures. We rated the certainty of evidence using the GRADE approach.
MAIN RESULTS
We included 49 trials (3061 participants; 1553 randomized to PNBs and 1508 to no nerve block (or sham block)). For this update, we added 18 new trials. Trials were published from 1981 to 2020. Trialists followed participants for periods ranging from 5 minutes to 12 months. The average age of participants ranged from 59 to 89 years. People with dementia were often excluded from the included trials. Additional analgesia was available for all participants. Results of 11 trials with 503 participants show that PNBs reduced pain on movement within 30 minutes of block placement (standardized mean difference (SMD) -1.05, 95% confidence interval (CI) -1.25 to -0.86; equivalent to -2.5 on a scale from 0 to 10; high-certainty evidence). Effect size was proportionate to the concentration of local anaesthetic used (P = 0.0003). Based on 13 trials with 1072 participants, PNBs reduce the risk of acute confusional state (risk ratio (RR) 0.67, 95% CI 0.50 to 0.90; number needed to treat for an additional beneficial outcome (NNTB) 12, 95% CI 7 to 47; high-certainty evidence). For myocardial infarction, there were no events in one trial with 31 participants (RR not estimable; low-certainty evidence). From three trials with 131 participants, PNBs probably reduce the risk for chest infection (RR 0.41, 95% CI 0.19 to 0.89; NNTB 7, 95% CI 5 to 72; moderate-certainty evidence). Based on 11 trials with 617 participants, the effects of PNBs on mortality within six months are uncertain due to very serious imprecision (RR 0.87, 95% CI 0.47 to 1.60; low-certainty evidence). From three trials with 208 participants, PNBs likely reduce time to first mobilization (mean difference (MD) -10.80 hours, 95% CI -12.83 to -8.77 hours; moderate-certainty evidence). One trial with 75 participants indicated there may be a small reduction in the cost of analgesic drugs with a single-injection PNB (MD -4.40 euros, 95% CI -4.84 to -3.96 euros; low-certainty evidence). We identified 29 ongoing trials, of which 15 were first posted or at least were last updated after 1 January 2018. AUTHORS' CONCLUSIONS: PNBs reduce pain on movement within 30 minutes after block placement, risk of acute confusional state, and probably also reduce the risk of chest infection and time to first mobilization. There may be a small reduction in the cost of analgesic drugs for single-injection PNB. We did not find a difference for myocardial infarction and mortality, but the numbers of participants included for these two outcomes were insufficient. Although randomized clinical trials may not be the best way to establish risks associated with an intervention, our review confirms low risks of permanent injury associated with PNBs, as found by others. Some trials are ongoing, but it is unclear whether any further RCTs should be registered, given the benefits found. Good-quality non-randomized trials with appropriate sample size may help to clarify the potential effects of PNBs on myocardial infarction and mortality.
Topics: Aged; Aged, 80 and over; Anesthetics, Local; Confusion; Early Ambulation; Female; Hip Fractures; Humans; Male; Middle Aged; Movement; Myocardial Infarction; Nerve Block; Pain Management; Pain Measurement; Pain, Postoperative; Peripheral Nerves; Pneumonia; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Time Factors
PubMed: 33238043
DOI: 10.1002/14651858.CD001159.pub3 -
Journal of Vascular Surgery Apr 2021Individual studies of peripheral artery disease (PAD) have indicated that gender discrepancies exist in the symptoms, functional status, and treatment usage. It remains... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Individual studies of peripheral artery disease (PAD) have indicated that gender discrepancies exist in the symptoms, functional status, and treatment usage. It remains uncertain whether these discrepancies result in different long-term outcomes. We examined the potential gender differences in mortality and major adverse cardiovascular events (MACE) in patients with symptomatic PAD.
METHODS
The PubMed and Embase databases were searched for studies from 2000 to January 2019. After a review of 13,582 citations, 14 articles were analyzed. The reported age-adjusted hazard ratios (HRs) for gender differences in mortality and MACE were included in the meta-analysis. The mortality outcomes were stratified according to the clinical presentation and study context.
RESULTS
Male gender was associated with a greater risk of all-cause mortality (HR, 1.13; 95% confidence interval [CI], 1.10-1.16; P < .001) and MACE (HR, 1.10; 95% CI, 1.06-1.14; P < .001). In a stratified analysis, male gender was associated with a higher mortality risk for patients presenting with either critical limb ischemia (HR, 1.08; 95% CI, 1.05-1.10; P < .001) or mixed clinical presentations (HR, 1.16; 95% CI, 1.11-1.21; P < .001) but not for those with intermittent claudication (HR, 1.13; 95% CI, 0.98-1.30; P = .09). Elevated mortality risk was evident after revascularization (HR, 1.11; 95% CI, 1.04-1.19; P = .003), hospitalization (HR, 1.15; 95% CI, 1.08-1.22; P < .001), and amputation (HR, 1.09; 95% CI, 1.08-1.10; P < .001), although not in outpatient clinics (HR, 1.13; 95% CI, 0.97-1.32; P = .13), in men compared with women.
CONCLUSIONS
Greater mortality and MACE rates in men with PAD occurred despite other accepted gender disparities. The mechanisms underlying these gender differences in the outcomes for PAD patients require further investigation.
Topics: Amputation, Surgical; Disease Progression; Health Status Disparities; Humans; Intermittent Claudication; Ischemia; Limb Salvage; Peripheral Arterial Disease; Risk Assessment; Risk Factors; Sex Factors; Time Factors; Treatment Outcome
PubMed: 33161072
DOI: 10.1016/j.jvs.2020.09.039 -
Angiology Mar 2021Peripheral arterial disease (PAD) is associated with reduced lower limb blood flow and tissue perfusion. The consequent reduction in vessel wall shear stress as well as...
Peripheral arterial disease (PAD) is associated with reduced lower limb blood flow and tissue perfusion. The consequent reduction in vessel wall shear stress as well as ischemia-reperfusion injury has also been associated with systemic endothelial dysfunction and inflammation. We aimed to explore the impact of lower limb revascularization on (1) lower limb blood flow, (2) tissue perfusion, and (3) systemic endothelial function. We performed a systematic literature search using the MEDLINE, Embase, and Web of Science databases. Eligible studies measured changes in lower limb blood flow, perfusion, or systemic endothelial function following revascularization for the treatment of symptomatic PAD. We found 19 eligible studies, which were limited by considerable heterogeneity. Current evidence suggests that revascularization has a positive effect on flow, perfusion, and systemic endothelial dysfunction. Any changes may take a number of weeks to become apparent. There is a need for well-designed studies to explore the association between flow, perfusion, and endothelial dysfunction.
Topics: Aged; Aged, 80 and over; Endothelium, Vascular; Endovascular Procedures; Female; Humans; Intermittent Claudication; Ischemia; Lower Extremity; Male; Middle Aged; Observational Studies as Topic; Peripheral Arterial Disease; Recovery of Function; Regional Blood Flow; Reperfusion Injury; Risk Factors; Treatment Outcome; Vascular Surgical Procedures
PubMed: 33143447
DOI: 10.1177/0003319720969543 -
Emergency Medicine International 2020Our objective was to comprehensively present the evidence of preoperative risk factors for short-term postoperative mortality of acute mesenteric ischemia after... (Review)
Review
OBJECTIVE
Our objective was to comprehensively present the evidence of preoperative risk factors for short-term postoperative mortality of acute mesenteric ischemia after laparotomy.
METHODS
PubMed, Embase, and Google Scholar were searched from January 2000 to January 2020. Studies evaluating the postoperative risk factors for short-term postoperative mortality of acute mesenteric ischemia after laparotomy were included. The outcome extracted were patients' demographics, medical history, and preoperative laboratory tests.
RESULTS
Twenty studies (5011 patients) met the inclusion criteria. Studies were of high quality, with a median Newcastle-Ottawa Scale Score of 7. Summary short-term postoperative mortality was 44.38% (range, 18.80%-67.80%). Across included studies, 49 potential risk factors were examined, at least two studies. Meta-analysis of predictors based on more than three studies identified the following preoperative risk factors for higher short-term postoperative mortality risk: old age (odds ratio [OR], 1.90, 95% confidence interval [CI], 1.57-2.30), arterial occlusive mesenteric ischemia versus mesenteric venous thrombosis (OR, 2.45, 95% CI 1.12-5.33), heart failure (OR 1.33, 95% CI 1.03-1.72), renal disorders (OR 1.61, 95% CI 1.24-2.07), and peripheral vascular disease (OR 1.38, 95% CI 1.00-1.91). Nonsurvivors were older (standardized mean difference [SMD], 0.32, 95% CI 0.24-0.40), had higher creatinine levels (SMD 0.50, 95% CI 0.25-0.75), and had lower platelet counts (SMD -0.32, 95% CI -0.50 to -0.14).
CONCLUSION
The short-term postoperative mortality of acute mesenteric ischemia who underwent laparotomy is still high. A better understanding of these risk factors may help in the early identification of high-risk patients, optimization of surgical procedure, and improvement of perioperative management.
PubMed: 33083058
DOI: 10.1155/2020/1382475 -
The Cochrane Database of Systematic... Sep 2020Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an alternative procedure, in which atheroma is cut or ground away within the artery. This is the first update of a Cochrane Review published in 2014.
OBJECTIVES
To evaluate the effectiveness of atherectomy for peripheral arterial disease compared to other established treatments.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 August 2019.
SELECTION CRITERIA
We included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or critical limb ischaemia and evidence of lower limb arterial disease.
DATA COLLECTION AND ANALYSIS
Two review authors screened studies for inclusion, extracted data, assessed risk of bias and used GRADE criteria to assess the certainty of the evidence. We resolved any disagreements through discussion. Outcomes of interest were: primary patency (at six and 12 months), all-cause mortality, fatal and non-fatal cardiovascular events, initial technical failure rates, target vessel revascularisation rates (TVR; at six and 12 months); and complications.
MAIN RESULTS
We included seven studies, with a total of 527 participants and 581 treated lesions. We found two comparisons: atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. Overall, the evidence from this review was of very low certainty, due to a high risk of bias, imprecision and inconsistency. Six studies (372 participants, 427 treated lesions) compared atherectomy versus BA. We found no clear difference between atherectomy and BA for the primary outcomes: six-month primary patency rates (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.94 to 1.20; 3 studies, 186 participants; very low-certainty evidence); 12-month primary patency rates (RR 1.20, 95% CI 0.78 to 1.84; 2 studies, 149 participants; very low-certainty evidence) or mortality rates (RR 0.50, 95% CI 0.10 to 2.66, 3 studies, 210 participants, very low-certainty evidence). One study reported cardiac failure and acute coronary syndrome as causes of death at 24 months but it was unclear which arm the participants belonged to, and one study reported no cardiovascular events. There was no clear difference when examining: initial technical failure rates (RR 0.48, 95% CI 0.22 to 1.08; 6 studies, 425 treated vessels; very low-certainty evidence), six-month TVR (RR 0.51, 95% CI 0.06 to 4.42; 2 studies, 136 treated vessels; very low-certainty evidence) or 12-month TVR (RR 0.59, 95% CI 0.25 to 1.42; 3 studies, 176 treated vessels; very low-certainty evidence). All six studies reported complication rates (RR 0.69, 95% CI 0.28 to 1.68; 6 studies, 387 participants; very low-certainty evidence) and embolisation events (RR 2.51, 95% CI 0.64 to 9.80; 6 studies, 387 participants; very low-certainty evidence). Atherectomy may be less likely to cause dissection (RR 0.28, 95% CI 0.14 to 0.54; 4 studies, 290 participants; very low-certainty evidence) and may be associated with a reduction in bailout stenting (RR 0.26, 95% CI 0.09 to 0.74; 4 studies, 315 treated vessels; very low-certainty evidence). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. We used subgroup analysis to compare the effect of plain balloons/stents and drug-eluting balloons/stents, but did not detect any differences between the subgroups. One study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, so comparison was extremely limited and subject to imprecision. This study did not report primary patency. The study reported one death (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence) and three complication events (RR 7.04, 95% CI 0.80 to 62.23; 155 participants; very low-certainty evidence) in a very small data set, making conclusions unreliable. We found no clear difference between the treatment arms in cardiovascular events (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence). This study found no initial technical failure events, and TVR rates at six and 24 months showed little difference between treatment arms (RR 2.27, 95% CI 0.95 to 5.46; 155 participants; very low-certainty evidence and RR 2.05, 95% CI 0.96 to 4.37; 155 participants; very low-certainty evidence, respectively).
AUTHORS' CONCLUSIONS
This review update shows that the evidence is very uncertain about the effect of atherectomy on patency, mortality and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. We detected no clear differences in initial technical failure rates or TVR, but there may be reduced dissection and bailout stenting after atherectomy although this is uncertain. Included studies were small, heterogenous and at high risk of bias. Larger studies powered to detect clinically meaningful, patient-centred outcomes are required.
Topics: Acute Coronary Syndrome; Angioplasty, Balloon; Atherectomy; Cause of Death; Heart Failure; Humans; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Stents
PubMed: 32990327
DOI: 10.1002/14651858.CD006680.pub3 -
The Cochrane Database of Systematic... Sep 2020Lower 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...
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. 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.
OBJECTIVES
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.
SEARCH METHODS
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.
SELECTION CRITERIA
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.
DATA COLLECTION AND ANALYSIS
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.
MAIN RESULTS
We found no RCTs that met the inclusion criteria for this review.
AUTHORS' CONCLUSIONS
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.
Topics: Humans; Lower Extremity; Peripheral Arterial Disease; Physical Conditioning, Human; Preoperative Care
PubMed: 32964423
DOI: 10.1002/14651858.CD013407.pub2