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Frequency and Impact of Adverse Events in Patients Undergoing Surgery for End-Stage Ankle Arthritis.

ABSTRACT: BACKGROUND:This study summarized the frequency and functional impact of adverse events (AEs) that occur after surgery for end-stage ankle arthritis (ESAA) to inform decision making. METHODS:This was a multisite prospective cohort study to compare ankle arthroplasty to ankle arthrodesis in the treatment of ESAA among 6 participating sites. We compared the risk and impact of nonankle AEs and ankle-specific AEs versus no AEs controlling for potential confounding factors, including operative procedure using multinomial logistic regression. We estimated differences in postoperative functional outcomes by AE occurrence using linear mixed effects regression. Among 517 patients who had surgery for ankle arthritis and completed the full baseline assessment, follow-up scores were available in 494 (95%) patients. RESULTS:There were a total of 628 reported AEs (477 in the arthroplasty group and 151 in the arthrodesis group). These occurred in 261 (63%) arthroplasty patients and 67 (65%) arthrodesis patients. There were 50 (8%) ankle-specific AEs. The risk of an ankle-specific AE was slightly higher in the arthrodesis group versus the arthroplasty group, odds ratio (OR) 1.84, 95% confidence interval (CI, 0.85, 3.98). The OR for the risk of non-ankle-specific AE versus no AE was 0.96, 95% CI (0.57, 1.61) for those receiving arthrodesis compared to arthroplasty. Compared to patients with no AEs, those experiencing ankle-specific AEs had significantly less improvement in Foot and Ankle Ability Measure Sports and activities of daily living (ADL) subscores and worst pain outcomes; however, both groups improved significantly in all measures except mental health. CONCLUSIONS:Ankle-specific AEs were infrequent and only weakly associated with operative procedure. Although patients improved in all functional outcomes except mental health, regardless of AE occurrence, ankle-specific AEs negatively impacted patient improvement compared to those with no AEs or a nonankle AE. The logistical effort and cost of tracking nonankle AEs does not seem to be justified. LEVEL OF EVIDENCE:Level II, prospective comparative study.

SUBMITTER: Norvell DC

PROVIDER: S-EPMC6318122 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Frequency and Impact of Adverse Events in Patients Undergoing Surgery for End-Stage Ankle Arthritis.

Norvell Daniel C DC Shofer Jane B JB Hansen Sigvard T ST Davitt James J Anderson John G JG Bohay Donald D Coetzee J Chris JC Maskill John J Brage Michael M Houghton Michael M Ledoux William R WR Sangeorzan Bruce J BJ

Foot & ankle international 20180531 9

<h4>Background</h4>This study summarized the frequency and functional impact of adverse events (AEs) that occur after surgery for end-stage ankle arthritis (ESAA) to inform decision making.<h4>Methods</h4>This was a multisite prospective cohort study to compare ankle arthroplasty to ankle arthrodesis in the treatment of ESAA among 6 participating sites. We compared the risk and impact of nonankle AEs and ankle-specific AEs versus no AEs controlling for potential confounding factors, including op ...[more]

PMID: 29852755

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Project description:BackgroundAnkle replacement and ankle arthrodesis are standard treatments for treating end-stage ankle arthritis when conservative treatment fails. Comparing patient-reported outcome scores to the instrument's minimal important difference (MID) helps physicians and researchers infer whether a meaningful change in health from the patient's perspective has occurred following treatment. The objective of this study was to estimate the MID of the Ankle Osteoarthritis Scale among a cohort of operatively treated end-stage ankle arthritis patients undergoing ankle replacement or arthrodesis.MethodsA survey package including the Ankle Osteoarthritis Scale was completed by participants preoperatively and 2 years postoperatively. Distribution and anchor-based approaches to calculating the MID were used to estimate the MID of the Ankle Osteoarthritis Scale and its 2 domains. The distribution-based approaches used were the small and medium effect size methods, while the mean absolute change method and linear regression method were the anchor-based approaches. Bootstrap sampling was used to obtain the variance of MID estimates. The MID was estimated for sex, age, operative, and baseline health subgroups. The cohort comprised 283 participants, totaling 298 ankles.ResultsThe MID did not vary with sex or operative procedure. Age-based differences in MID values may exist for the Ankle Osteoarthritis Scale total score, and MID values were generally smallest among the oldest patients. Patients with the best and worst ankle-related health preoperatively had higher MID values than patients reporting mid-range Ankle Osteoarthritis Scale values preoperatively.ConclusionThe best estimate of the MID of the Ankle Osteoarthritis Scale total score is 5.81. Our findings indicate that the MID of the Ankle Osteoarthritis Scale may not vary by sex or operative subgroups but likely varies by age and preoperative Ankle Osteoarthritis Scale score.Level of evidenceLevel II, prospective comparative study.

Project description:ImportanceInformation regarding the performance and outcomes of noncardiac surgery (NCS) in patients with left ventricular assist devices (LVADs) is scarce, with limited longitudinal follow-up data that are mostly limited to single-center reports.ObjectiveTo examine the trends, patient characteristics, and outcomes associated with NCS among patients with LVAD.Design, setting, and participantsThis cohort study examined patients enrolled in Medicare undergoing durable LVAD implantation from January 2012 to November 2017 with follow-up through December 2017. The study included all Medicare Provider and Analysis Review Part A files for the years 2012 to 2017. Patients identified by International Classification of Diseases, Ninth Revision Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision (ICD-10) procedure codes for new LVAD implantation were included. Data analysis was performed from November 2019 to February 2020.ExposuresNCS procedures were identified using the ICD-9-CM and ICD-10 procedural codes and divided into elective and urgent or emergent.Main outcomes and measuresThe primary outcome was major adverse cardiovascular events (MACEs), defined as in-hospital or 30-day all-cause mortality, ischemic stroke, or intracerebral hemorrhage after NCS. Early (<60 days after NCS) and late (≥60 days after NCS) mortality after NCS were analyzed in both subgroups using time-varying covariate and landmark analysis using patients who did not undergo NCS as reference.ResultsOf the 8118 patients with LVAD (mean [SD] age, 63.4 [10.8] years; 6484 men [79.9%]), 1326 (16.3%, or approximately 1 in 6) underwent NCS, of which 1000 procedures (75.4%) were emergent or urgent and 326 (24.6%) were elective. There was no difference in age between patients who underwent NCS and patients who did not (mean [SD] age, 63.6 [10.6] vs 63.4 [10.9] years). The number of NCS procedures among patients with LVAD increased from 64 in 2012 to 304 in 2017. The median (interquartile range) time from LVAD implantation to NCS was 309 (133-606) days. The most frequent type of NCS was general (613 abdominal, pelvic, and gastrointestinal procedures [46.2%]). Perioperative MACEs occurred in 169 patients (16.9%) undergoing emergent or urgent NCS and 23 patients (7.1%) undergoing elective NCS. Urgent or emergent NCS was associated with higher mortality early (adjusted hazard ratio [aHR], 8.78; 95% CI, 7.20-10.72; P < .001) and late (aHR, 1.71; 95% CI, 1.53-1.90; P < .001) after NCS compared with patients with LVAD who did not undergo NCS. Elective NCS was also associated with higher mortality early (aHR, 2.65; 95% CI, 1.74-4.03; P < .001) and late (aHR, 1.29; 95% CI, 1.07-1.56; P = .008) after NCS.Conclusions and relevanceOne of 6 patients with LVAD underwent NCS. Perioperative MACEs were frequent. Higher mortality risk transcended the early postoperative period in urgent or emergent and elective surgical procedures.

Dataset Information

Frequency and Impact of Adverse Events in Patients Undergoing Surgery for End-Stage Ankle Arthritis.

Publications

Frequency and Impact of Adverse Events in Patients Undergoing Surgery for End-Stage Ankle Arthritis.

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