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James S. Harrop, Alexander R. Vaccaro, R. John Hurlbert, Jared T. Wilsey, Eli M. Baron, Christopher I. Shaffrey, Charles G. Fisher, Marcel F. Dvorak, F. C. Öner, Kirkham B. Wood, Neel Anand, D. Greg Anderson, Moe R. Lim, Joon Y. Lee, Christopher M. Bono, Paul M. Arnold, Y. Raja Rampersaud, Michael G. Fehlings and The Spine Trauma Study Group

Object

A new classification and treatment algorithm for thoracolumbar injuries was recently introduced by Vaccaro and colleagues in 2005. A thoracolumbar injury severity scale (TLISS) was proposed for grading and guiding treatment for these injuries. The scale is based on the following: 1) the mechanism of injury; 2) the integrity of the posterior ligamentous complex (PLC); and 3) the patient’s neurological status. The reliability and validity of assessing injury mechanism and the integrity of the PLC was assessed.

Methods

Forty-eight spine surgeons, consisting of neurosurgeons and orthopedic surgeons, reviewed 56 clinical thoracolumbar injury case histories. Each was classified and scored to determine treatment recommendations according to a novel classification system. After 3 months the case histories were reordered and the physicians repeated the exercise. Validity of this classification was good among reviewers; the vast majority (> 90%) agreed with the system’s treatment recommendations. Surgeons were unclear as to a cogent description of PLC disruption and fracture mechanism.

Conclusions

The TLISS demonstrated acceptable reliability in terms of intra- and interobserver agreement on the algorithm’s treatment recommendations. Replacing injury mechanism with a description of injury morphology and better definition of PLC injury will improve inter- and intraobserver reliability of this injury classification system.

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Paul Park, Kai-Ming Fu, Praveen V. Mummaneni, Juan S. Uribe, Michael Y. Wang, Stacie Tran, Adam S. Kanter, Pierce D. Nunley, David O. Okonkwo, Christopher I. Shaffrey, Gregory M. Mundis Jr., Dean Chou, Robert Eastlack, Neel Anand, Khoi D. Than, Joseph M. Zavatsky, Richard G. Fessler and the International Spine Study Group

OBJECTIVE

Achieving appropriate spinopelvic alignment in deformity surgery has been correlated with improvement in pain and disability. Minimally invasive surgery (MIS) techniques have been used to treat adult spinal deformity (ASD); however, there is concern for inadequate sagittal plane correction. Because age can influence the degree of sagittal correction required, the purpose of this study was to analyze whether obtaining optimal spinopelvic alignment is required in the elderly to obtain clinical improvement.

METHODS

A multicenter database of ASD patients was queried. Inclusion criteria were age ≥ 18 years; an MIS component as part of the index procedure; at least one of the following: pelvic tilt (PT) > 20°, sagittal vertical axis (SVA) > 50 mm, pelvic incidence to lumbar lordosis (PI-LL) mismatch > 10°, or coronal curve > 20°; and minimum follow-up of 2 years. Patients were stratified into younger (< 65 years) and older (≥ 65 years) cohorts. Within each cohort, patients were categorized into aligned (AL) or mal-aligned (MAL) subgroups based on postoperative radiographic measurements. Mal-alignment was defined as a PI-LL > 10° or SVA > 50 mm. Pre- and postoperative radiographic and clinical outcomes were compared.

RESULTS

Of the 185 patients, 107 were in the younger cohort and 78 in the older cohort. Based on postoperative radiographs, 36 (33.6%) of the younger patients were in the AL subgroup and 71 (66.4%) were in the MAL subgroup. The older patients were divided into 2 subgroups based on alignment; there were 26 (33.3%) patients in the AL and 52 (66.7%) in the MAL subgroups. Overall, patients within both younger and older cohorts significantly improved with regard to postoperative visual analog scale (VAS) scores for back and leg pain and Oswestry Disability Index (ODI) scores. In the younger cohort, there were no significant differences in postoperative VAS back and leg pain scores between the AL and MAL subgroups. However, the postoperative ODI score of 37.9 in the MAL subgroup was significantly worse than the ODI score of 28.5 in the AL subgroup (p = 0.019). In the older cohort, there were no significant differences in postoperative VAS back and leg pain score or ODI between the AL and MAL subgroups.

CONCLUSIONS

MIS techniques did not achieve optimal spinopelvic alignment in most cases. However, age appears to impact the degree of sagittal correction required. In older patients, optimal spinopelvic alignment thresholds did not need to be achieved to obtain similar symptomatic improvement. Conversely, in younger patients stricter adherence to optimal spinopelvic alignment thresholds may be needed.

https://thejns.org/doi/abs/10.3171/2018.4.SPINE171153

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Clinical outcomes research in spine surgery: what are appropriate follow-up times?

Presented at the 2018 AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves

Oliver G. S. Ayling, Tamir Ailon, Greg McIntosh, Alex Soroceanu, Hamilton Hall, Andrew Nataraj, Christopher S. Bailey, Sean Christie, Alexandra Stratton, Henry Ahn, Michael Johnson, Jerome Paquet, Kenneth Thomas, Neil Manson, Y. Raja Rampersaud and Charles G. Fisher

OBJECTIVE

There has been a generic dictum in spine and musculoskeletal clinical research that a minimum 2-year follow-up is necessary for patient-reported outcomes (PROs) to adequately assess the therapeutic effect of surgery; however, the rationale for this duration is not evidence based. The purpose of this study was to determine the follow-up time necessary to ensure that the effectiveness of a lumbar surgical intervention is adequately captured for three lumbar pathologies and three common PROs.

METHODS

Using the different PROs of pain, physical function, and mental quality of life from the Canadian Spine Outcomes and Research Network (CSORN) prospective database, the authors assessed the time course to the recovery plateau following lumbar spine surgery for lumbar disc herniation, degenerative spondylolisthesis, and spinal stenosis. One-way ANOVA with post hoc testing was used to compare scores on the following standardized PRO measures at baseline and 3, 12, and 24 months postoperatively: Disability Scale (DS), visual analog scale (VAS) for leg and back pain, and SF-12 Mental Component Summary (MCS) and Physical Component Summary (PCS).

RESULTS

Significant differences for all spine pathologies and specific PROs were found with one-way ANOVA (p < 0.0001). The time to plateaued recovery after surgery for lumbar disc herniation (661 patients), lumbar stenosis (913 patients), and lumbar spondylolisthesis (563 patients) followed the same course for the following PRO measures: VAS for back and leg pain, 3 months; DS, 12 months; PCS, 12 months; and MCS, 3 months. Beyond these time points, no further significant improvements in PROs were seen. Patients with degenerative spondylolisthesis or spinal stenosis who had undergone fusion surgery plateaued at 12 months on the DS and PCS, compared to 3 months in those who had not undergone fusion.

CONCLUSIONS

Specific health dimensions follow distinctly different recovery plateaus, indicating that a 2-year postoperative follow-up is not required for all PROs to accurately assess the treatment effect of lumbar spinal surgery. Ultimately, the clinical research question should dictate the follow-up time and the outcome measure utilized; however, there is now evidence to guide the specific duration of follow-up for pain, physical function, and mental quality of life dimensions.

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Kai-Ming G. Fu, Justin S. Smith, David W. Polly Jr., Joseph H. Perra, Charles A. Sansur, Sigurd H. Berven, Paul A. Broadstone, Theodore J. Choma, Michael J. Goytan, Hilali H. Noordeen, D. Raymond Knapp Jr., Robert A. Hart, Reinhard D. Zeller, William F. Donaldson III, Oheneba Boachie-Adjei and Christopher I. Shaffrey

Object

The purpose of this study was to evaluate the prospectively collected Scoliosis Research Society (SRS) database to assess the incidences of morbidity and mortality (M&M) in the operative treatment of degenerative lumbar stenosis, one of the most common procedures performed by spine surgeons.

Methods

All patients who underwent surgical treatment for degenerative lumbar stenosis between 2004 and 2007 were identified from the SRS M&M database. Inclusion criteria for analysis included an age ≥ 21 years and no history of lumbar surgery. Patients were treated with either decompression alone or decompression with concomitant fusion. Statistical comparisons were performed using a 2-sided Fisher exact test.

Results

Of the 10,329 patients who met the inclusion criteria, 6609 (64%) were treated with decompression alone, and 3720 (36%) were treated with decompression and fusion. Among those who underwent fusion, instrumentation was placed in 3377 (91%). The overall mean patient age was 63 ± 13 years (range 21–96 years). Seven hundred nineteen complications (7.0%), including 13 deaths (0.1%), were identified. New neurological deficits were reported in 0.6% of patients. Deaths were related to cardiac (4 cases), respiratory (5 cases), pulmonary embolus (2 cases), and sepsis (1 case) etiologies, and a perforated gastric ulcer (1 case). Complication rates did not differ based on patient age or whether fusion was performed. Minimally invasive procedures were associated with fewer complications and fewer new neurological deficits (p = 0.01 and 0.03, respectively).

Conclusions

The results from this analysis of the SRS M&M database provide surgeons with useful information for preoperative counseling of patients contemplating surgical intervention for symptomatic degenerative lumbar stenosis.

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Justin S. Smith, Christopher I. Shaffrey, Eric Klineberg, Virginie Lafage, Frank Schwab, Renaud Lafage, Han Jo Kim, Richard Hostin, Gregory M. Mundis Jr., Munish Gupta, Barthelemy Liabaud, Justin K. Scheer, Bassel G. Diebo, Themistocles S. Protopsaltis, Michael P. Kelly, Vedat Deviren, Robert Hart, Doug Burton, Shay Bess and Christopher P. Ames

OBJECTIVE

Although 3-column osteotomy (3CO) can provide powerful alignment correction in adult spinal deformity (ASD), these procedures are complex and associated with high complication rates. The authors' objective was to assess complications associated with ASD surgery that included 3CO based on a prospectively collected multicenter database.

METHODS

This study is a retrospective review of a prospectively collected multicenter consecutive case registry. ASD patients treated with 3CO and eligible for 2-year follow-up were identified from a prospectively collected multicenter ASD database. Early (≤ 6 weeks after surgery) and delayed (> 6 weeks after surgery) complications were collected using standardized forms and on-site coordinators.

RESULTS

Of 106 ASD patients treated with 3CO, 82 (77%; 68 treated with pedicle subtraction osteotomy [PSO] and 14 treated with vertebral column resection [VCR]) had 2-year follow-up (76% women, mean age 60.7 years, previous spine fusion in 80%). The mean number of posterior fusion levels was 12.9, and 17% also had an anterior fusion. A total of 76 early (44 minor, 32 major) and 66 delayed (13 minor, 53 major) complications were reported, with 41 patients (50.0%) and 45 patients (54.9%) affected, respectively. Overall, 64 patients (78.0%) had at least 1 complication, and 50 (61.0%) had at least 1 major complication. The most common complications were rod breakage (31.7%), dural tear (20.7%), radiculopathy (9.8%), motor deficit (9.8%), proximal junctional kyphosis (PJK, 9.8%), pleural effusion (8.5%), and deep wound infection (7.3%). Compared with patients who did not experience early or delayed complications, those who had these complications did not differ significantly with regard to age, sex, body mass index, Charlson Comorbidity Index, American Society of Anesthesiologists score, smoking status, history of previous spine surgery or spine fusion, or whether the 3CO performed was a PSO or VCR (p ≥ 0.06). Twenty-seven (33%) patients had 1–11 reoperations (total of 44 reoperations). The most common indications for reoperation were rod breakage (n = 14), deep wound infection (n = 15), and PJK (n = 6). The 24 patients who did not achieve 2-year follow-up had a mean of 0.85 years of follow-up, and the types of early and delayed complications encountered in these 24 patients were comparable to those encountered in the patients that achieved 2-year follow-up.

CONCLUSIONS

Among 82 ASD patients treated with 3CO, 64 (78.0%) had at least 1 early or delayed complication (57 minor, 85 major). The most common complications were instrumentation failure, dural tear, new neurological deficit, PJK, pleural effusion, and deep wound infection. None of the assessed demographic or surgical parameters were significantly associated with the occurrence of complications. These data may prove useful for surgical planning, patient counseling, and efforts to improve the safety and cost-effectiveness of these procedures.

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Christopher K. Kepler, Alexander R. Vaccaro, Eric Chen, Alpesh A. Patel, Henry Ahn, Ahmad Nassr, Christopher I. Shaffrey, James Harrop, Gregory D. Schroeder, Amit Agarwala, Marcel F. Dvorak, Daryl R. Fourney, Kirkham B. Wood, Vincent C. Traynelis, S. Tim Yoon, Michael G. Fehlings and Bizhan Aarabi

OBJECT

In this clinically based systematic review of cervical facet fractures, the authors’ aim was to determine the optimal clinical care for patients with isolated fractures of the cervical facets through a systematic review.

METHODS

A systematic review of nonoperative and operative treatment methods of cervical facet fractures was performed. Reduction and stabilization treatments were compared, and analysis of postoperative outcomes was performed. MEDLINE and Scopus databases were used. This work was supported through support received from the Association for Collaborative Spine Research and AOSpine North America.

RESULTS

Eleven studies with 368 patients met the inclusion criteria. Forty-six patients had bilateral isolated cervical facet fractures and 322 had unilateral isolated cervical facet fractures. Closed reduction was successful in 56.4% (39 patients) and 63.8% (94 patients) of patients using a halo vest and Gardner-Wells tongs, respectively. Comparatively, open reduction was successful in 94.9% of patients (successful reduction of open to closed reduction OR 12.8 [95% CI 6.1–26.9], p < 0.0001); 183 patients underwent internal fixation, with an 87.2% success rate in maintaining anatomical alignment. When comparing the success of patients who underwent anterior versus posterior procedures, anterior approaches showed a 90.5% rate of maintenance of reduction, compared with a 75.6% rate for the posterior approach (anterior vs posterior OR 3.1 [95% CI 1.0–9.4], p = 0.05).

CONCLUSIONS

In comparison with nonoperative treatments, operative treatments provided a more successful outcome in terms of failure of treatment to maintain reduction for patients with cervical facet fractures. Operative treatment appears to provide superior results to the nonoperative treatments assessed.

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Justin S. Smith, Eric Klineberg, Virginie Lafage, Christopher I. Shaffrey, Frank Schwab, Renaud Lafage, Richard Hostin, Gregory M. Mundis Jr., Thomas J. Errico, Han Jo Kim, Themistocles S. Protopsaltis, D. Kojo Hamilton, Justin K. Scheer, Alex Soroceanu, Michael P. Kelly, Breton Line, Munish Gupta, Vedat Deviren, Robert Hart, Douglas C. Burton, Shay Bess, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications.

METHODS

As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years.

RESULTS

Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2%). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2%) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6%) affected. Overall, 469 complications (207 minor; 262 major) were documented, with 203 patients (69.8%) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury).

CONCLUSIONS

This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.

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Justin K. Scheer, Justin S. Smith, Aaron J. Clark, Virginie Lafage, Han Jo Kim, John D. Rolston, Robert Eastlack, Robert A. Hart, Themistocles S. Protopsaltis, Michael P. Kelly, Khaled Kebaish, Munish Gupta, Eric Klineberg, Richard Hostin, Christopher I. Shaffrey, Frank Schwab, Christopher P. Ames and the International Spine Study Group

OBJECT

Back and leg pain are the primary outcomes of adult spinal deformity (ASD) and predict patients' seeking of surgical management. The authors sought to characterize changes in back and leg pain after operative or nonoperative management of ASD. Outcomes were assessed according to pain severity, type of surgical procedure, Scoliosis Research Society (SRS)–Schwab spine deformity class, and patient satisfaction.

METHODS

This study retrospectively reviewed data in a prospective multicenter database of ASD patients. Inclusion criteria were the following: age > 18 years and presence of spinal deformity as defined by a scoliosis Cobb angle ≥ 20°, sagittal vertical axis length ≥ 5 cm, pelvic tilt angle ≥ 25°, or thoracic kyphosis angle ≥ 60°. Patients were grouped into nonoperated and operated subcohorts and by the type of surgical procedure, spine SRS-Schwab deformity class, preoperative pain severity, and patient satisfaction. Numerical rating scale (NRS) scores of back and leg pain, Oswestry Disability Index (ODI) scores, physical component summary (PCS) scores of the 36-Item Short Form Health Survey, minimum clinically important differences (MCIDs), and substantial clinical benefits (SCBs) were assessed.

RESULTS

Patients in whom ASD had been operatively managed were 6 times more likely to have an improvement in back pain and 3 times more likely to have an improvement in leg pain than patients in whom ASD had been nonoperatively managed. Patients whose ASD had been managed nonoperatively were more likely to have their back or leg pain remain the same or worsen. The incidence of postoperative leg pain was 37.0% at 6 weeks postoperatively and 33.3% at the 2-year follow-up (FU). At the 2-year FU, among patients with any preoperative back or leg pain, 24.3% and 37.8% were free of back and leg pain, respectively, and among patients with severe (NRS scores of 7–10) preoperative back or leg pain, 21.0% and 32.8% were free of back and leg pain, respectively. Decompression resulted in more patients having an improvement in leg pain and their pain scores reaching MCID. Although osteotomies improved back pain, they were associated with a higher incidence of leg pain. Patients whose spine had an SRS-Schwab coronal curve Type N deformity (sagittal malalignment only) were least likely to report improvements in back pain. Patients with a Type L deformity were most likely to report improved back or leg pain and to have reductions in pain severity scores reaching MCID and SCB. Patients with a Type D deformity were least likely to report improved leg pain and were more likely to experience a worsening of leg pain. Preoperative pain severity affected pain improvement over 2 years because patients who had higher preoperative pain severity experienced larger improvements, and their changes in pain severity were more likely to reach MCID/SCB than for those reporting lower preoperative pain. Reductions in back pain contributed to improvements in ODI and PCS scores and to patient satisfaction more than reductions in leg pain did.

CONCLUSIONS

The authors' results provide a valuable reference for counseling patients preoperatively about what improvements or worsening in back or leg pain they may experience after surgical intervention for ASD.

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Amit Jain, Hamid Hassanzadeh, Varun Puvanesarajah, Eric O. Klineberg, Daniel M. Sciubba, Michael P. Kelly, D. Kojo Hamilton, Virginie Lafage, Aaron J. Buckland, Peter G. Passias, Themistocles S. Protopsaltis, Renaud Lafage, Justin S. Smith, Christopher I. Shaffrey, Khaled M. Kebaish and the International Spine Study Group

OBJECTIVE

Using 2 complication-reporting methods, the authors investigated the incidence of major medical complications and mortality in elderly patients after surgery for adult spinal deformity (ASD) during a 2-year follow-up period.

METHODS

The authors queried a multicenter, prospective, surgeon-maintained database (SMD) to identify patients 65 years or older who underwent surgical correction of ASD from 2008 through 2014 and had a minimum 2 years of follow-up (n = 153). They also queried a Centers for Medicare & Medicaid Services claims database (MCD) for patients 65 years or older who underwent fusion of 8 or more vertebral levels from 2005 through 2012 (n = 3366). They calculated cumulative rates of the following complications during the first 6 weeks after surgery: cerebrovascular accident, congestive heart failure, deep venous thrombosis, myocardial infarction, pneumonia, and pulmonary embolism. Significance was set at p < 0.05.

RESULTS

During the perioperative period, rates of major medical complications were 5.9% for pneumonia, 4.1% for deep venous thrombosis, 3.2% for pulmonary embolism, 2.1% for cerebrovascular accident, 1.8% for myocardial infarction, and 1.0% for congestive heart failure. Mortality rates were 0.9% at 6 weeks and 1.8% at 2 years. When comparing the SMD with the MCD, there were no significant differences in the perioperative rates of major medical complications except pneumonia. Furthermore, there were no significant intergroup differences in the mortality rates at 6 weeks or 2 years. The SMD provided greater detail with respect to deformity characteristics and surgical variables than the MCD.

CONCLUSIONS

The incidence of most major medical complications in the elderly after surgery for ASD was similar between the SMD and the MCD and ranged from 1% for congestive heart failure to 5.9% for pneumonia. These complications data can be valuable for preoperative patient counseling and informed consent.

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Michael P. Kelly, Lukas P. Zebala, Han Jo Kim, Daniel M. Sciubba, Justin S. Smith, Christopher I. Shaffrey, Shay Bess, Eric Klineberg, Gregory Mundis Jr., Douglas Burton, Robert Hart, Alex Soroceanu, Frank Schwab, Virginie Lafage and International Spine Study Group

OBJECT

The goal of this study was to examine the effectiveness of preoperative autologous blood donation (PABD) in adult spinal deformity (ASD) surgery.

METHODS

Patients undergoing single-stay ASD reconstructions were identified in a multicenter database. Patients were divided into groups according to PABD (either PABD or NoPABD). Propensity weighting was used to create matched cohorts of PABD and NoPABD patients. Allogeneic (ALLO) exposure, autologous (AUTO) wastage (unused AUTO), and complication rates were compared between groups.

RESULTS

Four hundred twenty-eight patients were identified as meeting eligibility criteria. Sixty patients were treated with PABD, of whom 50 were matched to 50 patients who were not treated with PABD (NoPABD). Nearly one-third of patients in the PABD group (18/60, 30%) did not receive any autologous transfusion and donated blood was wasted. In 6 of these cases (6/60, 10%), patients received ALLO blood transfusions without AUTO. In 9 cases (9/60, 15%), patients received ALLO and AUTO blood transfusions. Overall rates of transfusion of any type were similar between groups (PABD 70% [42/60], NoPABD 75% [275/368], p = 0.438). Major and minor in-hospital complications were similar between groups (Major PABD 10% [6/60], NoPABD 12% [43/368], p = 0.537; Minor PABD 30% [18/60], NoPABD 24% [87/368], p = 0.499). When controlling for potential confounders, PABD patients were more likely to receive some transfusion (OR 15.1, 95% CI 2.1-106.7). No relationship between PABD and ALLO blood exposure was observed, however, refuting the concept that PABD is protective against ALLO blood exposure. In the matched cohorts, PABD patients were more likely to sustain a major perioperative cardiac complication (PABD 8/50 [16%], NoPABD 1/50 [2%], p = 0.046). No differences in rates of infection or wound-healing complications were observed between cohorts.

CONCLUSIONS

Preoperative autologous blood donation was associated with a higher probability of perioperative transfusions of any type in patients with ASD. No protective effect of PABD against ALLO blood exposure was observed, and no risk of perioperative infectious complications was observed in patients exposed to ALLO blood only. The benefit of PABD in patients with ASD remains undefined.