Complications, Costs, and Quality Outcomes of Patients Undergoing Cervical Deformity Surgery With Intraoperative BMP Use.

STUDY DESIGN: An epidemiological study using national administrative data from the MarketScan database. OBJECTIVE: The aim of this study was to identify the impact of bone morphogenetic protein (BMP) on postoperative outcomes in patients undergoing adult cervical deformity (ACD) surgery. SUMMARY OF BACKGROUND DATA: BMP has been shown to stimulate bone growth and improve fusion rates in spine surgery. However, the impact of BMP on reoperation rates and postoperative complication rate is controversial. METHODS: We queried the MarketScan database to identify patients who underwent ACD surgery from 2007 to 2015. Patients were stratified by BMP use in the index operation. Patients <18 years and those with any history of tumor or trauma were excluded. Baseline demographics and comorbidities, postoperative complication rates, and reoperation rates were analyzed. RESULTS: A total of 13,549 patients underwent primary ACD surgery, of which 1155 (8.5%) had intraoperative BMP use. The overall 90-day complication rate was 27.6% in the non-BMP cohort and 31.1% in the BMP cohort (P < 0.05). Patients in the BMP cohort had longer average length of stay (4.0 days vs. 3.7 days, P < 0.05) but lower revision surgery rates at 90 days (14.5% vs. 28.3%, P < 0.05), 6 months (14.9% vs. 28.6%, P < 0.05), 1 year (15.7% vs. 29.2%, P < 0.05), and 2 years (16.5% vs. 29.9%, P < 0.05) postoperatively. BMP use was associated with higher payments throughout the 2-year follow-up period ($107,975 vs. $97,620, P < 0.05). When controlling for baseline group differences, BMP use independently increased the odds of postoperative complication (odds ratio [OR] 1.22, 95% confidence interval [CI] 1.1-1.4) and reduced the odds of reoperation throughout 2 years of follow-up (OR 0.49, 95% CI 0.4-0.6). CONCLUSION: Intraoperative BMP use has benefits for fusion integrity in ACD surgery but is associated with increased postoperative complication rate. Spine surgeons should weigh these benefits and drawbacks to identify optimal candidates for BMP use in ACD surgery. LEVEL OF EVIDENCE: 3.

Assessment of the effect of addition of 24 hours of oral tranexamic acid post-operatively to a single intraoperative intravenous dose of tranexamic acid on calculated blood loss following primary hip and knee arthroplasty (TRAC-24): a study protocol for a randomised controlled trial.

BACKGROUND: While it is has been proven that tranexamic acid (TXA) reduces blood loss in primary total hip and knee arthroplasty (THA and TKA), there is little published evidence on the use of TXA beyond 3 h post-operatively. Most blood loss occurs after wound closure and the primary aim of this study is to determine if the use of oral TXA post-operatively for up to 24 h will reduce calculated blood loss at 48 h beyond an intra-operative intravenous bolus alone following primary THA and TKA. To date, most TXA studies have excluded patients with a history of thromboembolic disease. METHODS/DESIGN: This is a phase IV, single-centred, open-label, parallel-group, randomised controlled trial. Participants are randomised to one of three groups: group 1, an intravenous (IV) bolus of TXA peri-operatively plus oral TXA post-operatively for 24 h; group 2, an IV bolus of TXA peri-operatively or group 3, standard care (no TXA). Eligible participants, including those with a history of thromboembolic disease, are allocated to these groups with a 2:2:1 allocation ratio. The primary outcome is the indirectly calculated blood loss 48 h after surgery. Researchers and patients are not blinded to the treatment; however, staff processing blood samples are. Originally 1166 participants were required to complete this study, 583 THA and 583 TKA. However, following an interim analysis after 100 THA and 100 TKA participants had been recruited to the study, the data monitoring ethics committee recommended stopping group 3 (standard care). DISCUSSION: TRAC-24 will help to determine whether an extended TXA dosing regimen can further reduce blood loss following primary THA and TKA. By including patients with a history of thromboembolic disease, this study will add to our understanding of the safety profile of TXA in this clinical situation. TRIAL REGISTRATION: ISRCTN registry, ISRCTN58790500 . Registered on 3 June 2016, EudraCT: 2015-002661-36.

Effects of Intraoperative Fluid Management on Postoperative Outcomes: A Hospital Registry Study.

OBJECTIVE: Evaluate the dose-response relationship between intraoperative fluid administration and postoperative outcomes in a large cohort of surgical patients. BACKGROUND: Healthy humans may live in a state of fluid responsiveness without the need for fluid supplementation. Goal-directed protocols driven by such measures are limited in their ability to define the optimal fluid state during surgery. METHODS: This analysis of data on file included 92,094 adult patients undergoing noncardiac surgery with endotracheal intubation between 2007 and 2014 at an academic tertiary care hospital and two affiliated community hospitals. The primary exposure variable was total intraoperative volume of crystalloid and colloid administered. The primary outcome was 30-day survival. Secondary outcomes were respiratory complications within three postoperative days (pulmonary edema, reintubation, pneumonia, or respiratory failure) and acute kidney injury. Exploratory outcomes were postoperative length of stay and total cost of care. Our models were adjusted for patient-, procedure-, and anesthesia-related factors. RESULTS: A U-shaped association was observed between the volume of fluid administered intraoperatively and 30-day mortality, costs, and postoperative length of stay. Liberal fluid volumes (highest quintile of fluid administration practice) were significantly associated with respiratory complications whereas both liberal and restrictive (lowest quintile) volumes were significantly associated with acute kidney injury. Moderately restrictive volumes (second quintile) were consistently associated with optimal postoperative outcomes and were characterized by volumes approximately 40% less than traditional textbook estimates: infusion rates of approximately 6-7 mL/kg/hr or 1 L of fluid for a 3-hour case. CONCLUSIONS: Intraoperative fluid dosing at the liberal and restrictive margins of observed practice is associated with increased morbidity, mortality, cost, and length of stay.

Intraoperative cholangiography during cholecystectomy among hospitalized medicare beneficiaries with non-neoplastic biliary disease.

BACKGROUND: Prior studies of Medicare beneficiaries with both neoplastic and non-neoplastic indications for cholecystectomy demonstrated a reduced risk of common bile duct (CBD) injury when intraoperative cholangiography (IOC) was used. We sought to determine the association between IOC and CBD injury during inpatient cholecystectomy for non-neoplastic biliary disease and compare survival among those with or without CBD injury. METHODS: Retrospective study of patients ≥66 who underwent inpatient cholecystectomy (2005-2010) for gallstones, cholecystitis, cholangitis, or gallbladder obstruction. The association between IOC and CBD injury was analyzed using multivariable logistic regression and survival after cholecystectomy was analyzed using multivariable Cox regression. RESULTS: Among 472,367 patients who underwent cholecystectomy, 0.3% had a CBD injury. IOC was associated with increased CBD injury (adjusted OR 1.41[1.27-1.57]). CBD injury was associated with increased hazards of death (adjusted HR 1.37[1.25-1.51]). CONCLUSIONS: IOC in patients with non-neoplastic biliary disease was associated with increased odds of CBD injury. This likely reflects its selective use in patients at higher risk of CBD injury or as a confirmatory test when an injury is suspected.

Cost-effectiveness of intravenous acetaminophen for pediatric tonsillectomy.

OBJECTIVE: The primary outcome of this study was to examine the cost-effectiveness of the intraoperative combination of intravenous (IV) acetaminophen and IV opioids, versus IV opioids alone, as a part of an inhalational anesthetic technique for tonsillectomy in children. METHODS: We used Decision Maker® software to construct and analyze a decision analytic model. Base-case and sensitivity analyses were performed. We studied the use of rescue analgesics in the postanesthesia care unit (PACU), adverse effects of acetaminophen and opioids, and costs associated with adverse effects. Costs were in 2013 US dollars, and effectiveness was measured as frequency of avoiding the need for rescue analgesics. Direct medical costs included medication, equipment, supplies, and labor associated with the treatment of adverse events from pain medications. Medication costs assumed single-dose vials. RESULTS: In the base case, IV acetaminophen in combination with opioids was both less costly ($17.12) and more effective (3.3% fewer rescue events). In sensitivity analyses, the combination strategy remained cost-effective as long as the frequency of rescue analgesic administration was less than that in the opioid-alone strategy. Although medication costs of the combination strategy were higher, the overall costs were less than the competing strategy due to reduced adverse effects and reduced time spent in PACU. CONCLUSIONS: The routine use of IV acetaminophen as an adjuvant to IV opioids for tonsillectomy with or without adenoidectomy in children aged <17 years should be considered as a means to reduce the need for rescue analgesia and in turn reduce costs.

[A comparative assessment of immediate results of correction of mitral insufficiency from the left-auricular and transventruicular accesses in patients with postinfarction aneurysm].

Reconstruction of postinfarction aneurysm of the left ventricle (LV) and plasty of the mitral valve without implantation in combination with coronary shunting or without it were used in 81 patients with ischemic heart disease. Correction of mitral insufficiency was fulfilled in 40 patients by an access via the left atrium, in 41 patients--from the LV in its reconstruction. Lethality in the nearest postoperative period was 3.7%. Mitral insufficiency after operation was absent in 70% of patients with the left atrium access and in 58.5% with the transventricular access, in the rest of the patients the mitral insufficiency was not more than of the II degree. Significant differences between the immediate results depending on the access to the mitral valve were not found.

Peri-operative blood transfusion increases length of hospital stay and number of postoperative complications in non-cardiac surgical patients.

OBJECTIVES: To test the hypothesis that blood transfusion alone was a significant risk factor for in-hospital morbidity in non-cardiac patients. DESIGN: Propensity analysis. SETTING: University teaching hospital, Hong Kong. PATIENTS: Consecutive non-cardiac patients seen in our department from 2006 to early 2009 who underwent a major procedure under general or spinal anaesthesia were included. Propensity analysis was performed to neutralise the confounding effects of preoperative variables and identify the true effects of transfusions on surgical outcomes. MAIN OUTCOME MEASURES: Receipt of intra-operative and postoperative blood transfusion was established and the difference in proportions between patients who did and did not receive donor blood tested for mortality, overall morbidity, individual complications, and number of adverse events. RESULTS: Transfused patients were significantly older and sicker, more likely to be male, to have lower haemoglobin values and undergo longer and more emergency surgical procedures than those not receiving a transfusion. Blood transfusion was predictive of length of postoperative hospital stay and number of complications before discharge. The amount of transfused blood was predictive of in-hospital mortality, with an odds ratio of 1.4 for each unit of blood received. The risk of a surgical wound infection was almost doubled when the patient had received a blood transfusion. CONCLUSION: After controlling for the factors associated with an increased likelihood for receiving a blood transfusion, the actual transfusion was predictive of a slower and more eventful postoperative recovery with associated costs to both the patient and health services.

Dosimetric characteristics of a low-kV intra-operative x-ray source: implications for use in a clinical trial for treatment of low-risk breast cancer.

The dosimetric characteristics of a low-kV x-ray device for performing intra-operative irradiations, the Intrabeam (Photoelectron Corporation, Lexington, MA), are examined. Two dosimetric models are considered--an analytical model considering only the primary x-ray beam, and a Monte Carlo model utilizing the EGSnrc code and a spherical simulation geometry. Both models prove reliable for verifying measured dose distributions for the device. The Monte Carlo model is necessary for examining spectral variations and the influence of inhomogeneities. The predictions of the Monte Carlo model are utilized to examine points of consideration for a multi-center clinical trial using the Intrabeam in the intra-operative, single fraction post-resection treatment of low-risk breast cancer. Predicted differences in radiological equivalence of breast tissue and water suggest a 3-5% under-dose of breast tissue (in a 50 kV beam) when dose fall-off data in water is used. A substantial dose enhancement in bone (i.e., ribs) adjacent to the treatment site is predicted though, based on published clinical data for radiation-induced rib fracture, it is concluded that induction of radiation-induced rib fracture would not pose a significant risk. Dose-volume changes with size of the treatment area (defined by the size of the resection volume) are examined indicating large variations in dose-volume characteristics across the range of possible "target" volumes.

Unexpected cardiac arrest among children during surgery, a North American registry to elucidate the incidence and causes of anesthesia related cardiac arrest.

Relatively rare adverse events, such as unexpected cardiac arrest, are difficult to study in the clinical setting. These events are often unpredictable in their occurrence (prompting interest in their investigation) and do not occur with sufficient frequency in any single institution to provide an adequate sample for analysis. A disease-specific registry is an epidemiological technique that can be used to collect data on a set of relatively rare unpredictable events. This approach was adopted for investigation of cardiac arrest in children when it became apparent from analysis of malpractice claims that a significant clinical problem existed. This report provides a brief historical account of the development of the Pediatric Peri-Operative Cardiac Arrest (POCA) Registry and elaborates on the methodology including strengths, weaknesses, and practical implementation issues.

Intraoperative radiation therapy and hyperthermia. Morbidity and mortality from this combined treatment modality for unresectable intra-abdominal carcinomas.

This is a report of a phase I trial of intraoperative radiation therapy in combination with intraoperative hyperthermia for the treatment of locally advanced, unresectable intra-abdominal carcinomas. Using an ultrasound transducer system specifically designed for intraoperative applications, 19 patients have been successfully treated, demonstrating the feasibility of this combination modality. The morbidity (58%) and mortality (11%) rates reported in this series are comparable to rates reported in series of similar patients receiving intraoperative radiation therapy alone. There is still a great need for considerable technological development to enable the use of intraoperative hyperthermia to treat large, complexly shaped intra-abdominal tumors, and phase II and III trials of this combination treatment modality should be performed.