Errors in Surgery: A Case Control Study.

OBJECTIVE: While errors can harm patients they remain poorly studied. This study characterized errors in the care of surgical patients and examined the association of errors with morbidity and mortality. BACKGROUND: Errors have been reported to cause <10% or >60% of adverse events. Such discordant results underscore the need for further exploration of the relationship between error and adverse events. METHODS: Patients with operations performed at a single institution and abstracted into the American College of Surgeons National Surgical Quality Improvement Program from January 1, 2018, to December 31, 2018 were examined. This matched case control study comprised cases who experienced a postoperative morbidity or mortality. Controls included patients without morbidity or mortality, matched 2:1 using age (±10 years), sex, and Current Procedural Terminology (CPT) group. Two faculty surgeons independently reviewed records for each case and control patient to identify diagnostic, technical, judgment, medication, system, or omission errors. A conditional multivariable logistic regression model examined the association between error and morbidity. RESULTS: Of 1899 patients, 170 were defined as cases who experienced a morbidity or mortality. The majority of cases (n=93; 55%) had at least 1 error; of the 329 matched control patients, 112 had at least 1 error (34%). Technical errors occurred most often among both cases (40%) and controls (23%). Logistic regression demonstrated a strong independent relationship between error and morbidity (odds ratio=2.67, 95% confidence interval: 1.64-4.35, P <0.001). CONCLUSION: Errors in surgical care were associated with postoperative morbidity. Reducing errors requires measurement of errors.

Judgment Errors in Surgical Care.

BACKGROUND: Human error is impossible to eliminate, particularly in systems as complex as healthcare. The extent to which judgment errors in particular impact surgical patient care or lead to harm is unclear. STUDY DESIGN: The American College of Surgeons NSQIP (2018) procedures from a single institution with 30-day morbidity or mortality were examined. Medical records were reviewed and evaluated for judgment errors. Preoperative variables associated with judgment errors were examined using logistic regression. RESULTS: Of the surgical patients who experienced a morbidity or mortality, 18% (31 of 170) experienced an error in judgment during their hospitalization. Patients with hepatobiliary procedure (odds ratio [OR] 5.4 [95% CI 1.23 to 32.75], p = 0.002), insulin-dependent diabetes (OR 4.8 [95% CI 1.2 to 18.8], p = 0.025), severe COPD (OR 6.0 [95% CI 1.6 to 22.1], p = 0.007), or with infected wounds (OR 8.2 [95% CI 2.6 to 25.8], p < 0.001) were at increased risk for judgment errors. CONCLUSIONS: Specific procedure types and patients with certain preoperative variables had higher risk for judgment errors during their hospitalization. Errors in judgment adversely impacted the outcomes of surgical patients who experienced morbidity or mortality in this cohort. Preventing or mitigating errors and closely monitoring patients after an error in judgment is prudent and may improve surgical safety.

A Novel Thyroid Ultrasound Proficiency Metric Designed Through a Multidisciplinary Delphi Approach.

BACKGROUND: Thyroid ultrasounds extend surgeons' outpatient capabilities and are essential for operative planning. However, most residents are not formally trained in thyroid ultrasound. The purpose of this study was to create a novel thyroid ultrasound proficiency metric through a collaborative Delphi approach. METHODS: Clinical faculty experienced in thyroid ultrasound participated on a Delphi panel to design the thyroid Ultrasound Proficiency Scale (UPS-Thyroid). Participants proposed items under the categories of Positioning, Technique, Image Capture, Measurement, and Interpretation. In subsequent rounds, participants voted to retain, revise, or exclude each item. The process continued until all items had greater than 70% consensus for retention. The UPS-Thyroid was pilot tested across 5 surgery residents with moderate ultrasound experience. Learning curves were assessed with cumulative sum. RESULTS: Three surgeons and 4 radiologists participated on the Delphi panel. Following 3 iterative Delphi rounds, the panel arrived at >70% consensus to retain 14 items without further revisions or additions. The metric included the following items on a 3-point scale for a maximum of 42 points: Positioning (1 item), Technique (4 items), Image Capture (2 items), Measurement (2 items), and Interpretation (5 items). A pilot group of 5 residents was scored against a proficiency threshold of 36 points. Learning curve inflection points were noted at between 4 to 7 repetitions. CONCLUSIONS: A multidisciplinary Delphi approach generated consensus for a thyroid ultrasound proficiency metric (UPS-Thyroid). Among surgery residents with moderate ultrasound experience, basic proficiency at thyroid ultrasound is feasible within 10 repetitions.

A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts.

OBJECTIVE: The ideal hemostatic agent for treatment of suture-line bleeding at vascular anastomoses has not yet been established. This study evaluated whether the use of a fibrin sealant containing 500 IU/mL thrombin and synthetic aprotinin (FS; marketed in the United States under the name TISSEEL) is beneficial for treatment of challenging suture-line bleeding at vascular anastomoses of expanded polytetrafluoroethylene (ePTFE) grafts, including those further complicated by concomitant antiplatelet therapies. METHODS: Over a 1-year period ending in 2010, ePTFE graft prostheses, including arterio-arterial bypasses and arteriovenous shunts, were placed in 140 patients who experienced suture-line bleeding that required treatment after completion of anastomotic suturing. Across 24 US study sites, 70 patients were randomized and treated with FS and 70 with manual compression (control). The primary end point was the proportion of patients who achieved hemostasis at the study suture line at 4 minutes after start of application of FS or positioning of surgical gauze pads onto the study suture line. RESULTS: There was a statistically significant difference in the comparison of hemostasis rates at the study suture line at 4 minutes between FS (62.9%) and control (31.4%) patients (P < .0001), which was the primary end point. Similarly, hemostasis rates in the subgroup of patients on antiplatelet therapies were 64.7% (FS group) and 28.2% (control group). When analyzed by bleeding severity, the hemostatic advantage of FS over control at 4 minutes was similar (27.8% absolute improvement for moderate bleeding vs 32.8% for severe bleeding). Logistic regression analysis (accounting for gender, age, intervention type, bleeding severity, blood pressure, heparin coating of ePTFE graft, and antiplatelet therapies) found a statistically significant treatment effect in the odds ratio (OR) of meeting the primary end point between treatment groups (OR, 6.73; P < .0001), as well as statistically significant effects for intervention type (OR, 0.25; P = .0055) and bleeding severity (OR, 2.59; P = .0209). The safety profile of FS was excellent as indicated by the lack of any related serious adverse events. CONCLUSIONS: The findings from this phase 3 study confirmed that FS is safe and its efficacy is superior to manual compression for hemostasis in patients with peripheral vascular ePTFE grafts. The data also suggest that FS promotes hemostasis independently of the patient's own coagulation system, as shown in a representative population of patients with vascular disease under single- or dual-antiplatelet therapies.

Use of fibrin sealant as a hemostatic agent in expanded polytetrafluoroethylene graft placement surgery.

BACKGROUND: The low thrombogenicity, porosity, and limited elasticity of expanded polytetrafluoroethylene (ePTFE) vascular grafts, although beneficial, may exacerbate the problem of suture-line bleeding at vascular anastomoses and consequently lead to increased operating times. The overall objective of this prospective, randomized, controlled, subject-blinded, multicenter phase 2 study was to evaluate the efficacy and safety of a fibrin sealant containing 500 IU/mL thrombin and synthetic aprotinin (FS; marketed in the United States under the name TISSEEL) for hemostasis in subjects undergoing vascular surgery and receiving prosthetic ePTFE vascular grafts. METHODS: FS was compared with manual compression with surgical gauze pads, a standard of care for hemostasis in vascular surgery. Two FS polymerization/setting times (60 and 120 seconds) were investigated to evaluate influence on the efficacy results. Patients undergoing ePTFE graft placement surgery (N = 73) who experienced bleeding that required treatment after surgical hemostasis were randomized to be treated with FS with clamps opened at 60 seconds (FS-60; N = 26), with FS with clamps opened at 120 seconds (FS-120; N = 24), or with manual compression with surgical gauze pads (control; N = 23). The proportion of subjects achieving hemostasis at 4 minutes (primary endpoint) as well as at 6 and 10 minutes (secondary endpoints) in the three treatment groups was analyzed using logistic regression analysis, taking into account gender, age, type of intervention, severity of bleeding, systolic blood pressure, diastolic blood pressure, heparin coating of the ePTFE graft, and platelet inhibitors. RESULTS: There were substantial differences in the proportion of subjects who achieved hemostasis at the study suture line at 4 minutes from treatment application between FS-120 (62.5%) and control (34.8%) groups (a 79.6% relative improvement). Logistic regression analyses found a statistically significant treatment effect at the 10% level in the odds ratio (OR) of achieving hemostasis at 4 minutes between the FS-120 and control groups (OR = 3.98, p = 0.0991). Furthermore, it has been shown that the perioperative administration of platelet inhibitors significantly influences (OR = 3.89, p = 0.0607) hemostasis rates at the primary endpoint. No statistically significant treatment effects were found for the other factors. Logistic regression analyses performed on the secondary endpoints demonstrated a significant treatment effect of achieving hemostasis at 6 minutes (OR = 9.92, p = 0.0225) and at 10 minutes (OR = 6.70, p = 0.0708) between the FS-120 and control groups. Statistically significant effects in the logistic regression analyses were found at the 10% level in the OR of achieving hemostasis at 6 and 10 minutes, respectively, for the following factors: FS-120 versus control group (OR = 9.92; p = 0.0225 and OR = 6.70; p = 0.0708, respectively), type of intervention (OR = 0.3; p = 0.0775 and OR = 0.25; p = 0.0402, respectively), and heparin coating of the ePTFE prosthesis (OR = 4.83; p = 0.0413 and OR = 3.65; p = 0.0911, respectively). FS was safe and well-tolerated, as indicated by the lack of any related serious adverse events. CONCLUSION: The findings from this phase 2 study support the strong safety profile of FS and suggest that it is an efficacious hemostatic agent in ePTFE graft placement surgery, as well as a useful tool in peripheral vascular surgery applications.

Improving dialysis access: regional anesthesia improves arteriovenous fistula prevalence.

An autologous arteriovenous (AV) fistula is the preferred form of angioaccess for chronic hemodialysis. A prospective study was carried out to evaluate the potential of regional anesthesia to improve AV fistula prevalence. One hundred ninety-three patients underwent preoperative duplex ultrasound evaluation over a 14-month period. The qualification of each patient to receive either an autologous AV fistula or a prosthetic graft was based on specific sonographic criteria. Patients scheduled for placement of a graft received an ultrasound-directed supraclavicular brachial plexus block, which produces dense sympathetic blockade. After the regional block, those patients who met criteria for primary fistula construction on repeat ultrasound received a fistula instead of a graft. Of 62 patients scheduled to receive an AV graft, 23 or 37 per cent were recruited to receive a fistula instead. The outcome of the recruited fistulas was compared with the 121 planned fistulas. There was no statistically significant difference in primary failure rate (4.3 vs. 5.8%). The recruited fistulas had a shorter average maturation time, 83 +/- 48 versus 132 +/- 82 days (P = 0.023). Within the study population, functioning fistula prevalence was increased from 61.7 to 79.8 per cent. Regional anesthesia and immediate preoperative ultrasound is a useful strategy for increasing fistula prevalence.

Surgical errors and the relationships of disease, risks, and adverse events.

BACKGROUND: Relationships between surgical errors and adverse events have not been fully explored and were examined in this study. MATERIALS AND METHODS: This retrospective cohort study reviewed records of deceased surgical patients over 12 months. Bivariate associations between predictors and errors were examined. RESULTS: 84 deaths occurred following 5,209 operations. Errors in care (63%) compared to those without had significantly more adverse events, (98% vs 80% respectively, p = 0.004). Significant association occurred between error and emergency status, p = 0.016); length of stay >10 days, p = 0.011; adverse events, p = 0.005). Regression results indicated number of adverse events (OR = 1.27, 95% CI (1.08-1.49), p = 0.003) and length of stay (OR = 1.05, 95% CI (1.01-1.09), p = 0.008) were associated with surgical errors. CONCLUSIONS: Examining postoperative adverse events in error cases identified opportunities for improvement. Reducing medical errors requires measuring medical errors.

Management of subclavian arterial injuries following inadvertent arterial puncture during central venous catheter placement.

Subclavian artery injuries after central venous catheter placement constitute a rare but potentially fatal complication. In this case series, the authors describe several endovascular treatment options in the management of iatrogenic subclavian arterial injuries resulting from inadvertent arterial placement of central catheters.

Absorbable cyanoacrylate as a vascular hemostatic sealant: a preliminary trial.

No absorbable cyanoacrylate tissue adhesive for safe internal surgical use is available. This prospective multicenter preliminary study was designed to evaluate the safety and effectiveness of an investigational absorbable cyanoacrylate (IAC) as an adjunct to hemostasis in arteriovenous shunt (AVS) procedures for dialysis access. Consenting adults (10) underwent placement of expanded polytetrafluoroethylene (ePTFE) upper extremity vascular grafts for AVS access using continuous 5-0 or 6-0 polypropylene after heparinization (> or =3000 units i.v.). Arterial anastomoses were evaluated after sealing with IAC followed by 120 seconds of polymerization time. After vascular clamp removal, the mean time to hemostasis was 9.1 +/- 28.8 seconds. Additionally, 90 per cent (9/10) and 100 per cent (10/10) achieved hemostasis by 1 and 5 minutes, respectively. No patients required further adjunctive hemostatic measures. Adverse event safety data analysis through 12 weeks revealed occlusion of graft or vessel in four patients and graft thrombosis in one patient, all thought unrelated to sealant use. Other unrelated adverse events (bleeding, death, deep venous thrombosis, edema, erythema, hematoma, infection, and rash) occurred in single patients. Thus, IAC could be a useful sealant for vascular procedures with a potentially satisfactory safety profile. Larger, randomized, multicenter, prospective trials to further evaluate the use of this material are indicated and appropriate.

Fibrin sealant facilitates hemostasis in arteriovenous polytetrafluoroethylene grafts for renal dialysis access.

A prospective randomized study was performed to evaluate the efficacy of fibrin sealant (FS) in patients undergoing upper-extremity polytetrafluoroethylene (PTFE) graft placement for dialysis. This procedure appears to be a reproducible and clinically relevant model for evaluating FS in vascular surgery. Consenting adult patients (n = 28) undergoing placement of a PTFE graft (6 mm) were randomized to either the treatment group using FS (Hemaseel APR, Haemacure Corp., Sarasota, FL) or control comparator groups (four) of bovine thrombin (T) (Thrombogen, GenTrac Inc., Middleton, WI), pressure (P), bovine thrombin (Thrombogen, GenTrac Inc.) -soaked cellulose sponges (TG) (Gelfoam, Upjohn Co., Kalamazoo, MI), or oxidized regenerated cellulose (S) (Surgicel, Johnson & Johnson, New Brunswick, NJ). All patients received heparin (3000 IU intravenous push) before placement of vascular clamps. The mean time to hemostasis was 29.3 seconds for FS, 147.4 seconds for T, 872.2 seconds for P, 346 seconds for TG, and 1044.5 seconds for S. There were no significant adverse events. FS appeared to be a superior hemostatic agent in these vascular procedures. No complications from FS were noted.

Surgeon-performed ultrasound for primary hyperparathyroidism.

The role of preoperative parathyroid imaging continues to evolve. This study evaluated whether surgeon-performed ultrasound (U/S) obviates the need for other imaging studies and leads to a focused exploration with a high degree of surgical success. From July 2010 to February 2012, 200 patients presenting with nonfamilial primary hyperparathyroidism underwent neck U/S in the surgeon's office. The U/S interpretation was classified as Class 1 if an adenoma was identified with high confidence, Class 2 if a possible but not definite enlarged gland was imaged, and Class 0 (zero) if no adenoma was identified. The findings were correlated with subsequent intraoperative findings. There were 144 Class 1 U/Ss (72%); of 132 patients coming to surgery, 96.2 per cent had surgical findings concordant with preoperative U/S and all had apparent surgical cure. Twenty-nine patients (14.5%) had Class 2 U/S; the 31 per cent confirmed false-positives in this group were usually colloid nodules. Fourteen of 27 with Class 0 U/S underwent surgery after being offered dynamically enhanced computed tomography scan. All 200 patients were apparent surgical cures. Surgeon-performed U/S is expedient, convenient, inexpensive, and accurate. A clearly identified adenoma can safely lead to a focused limited exploration and avoid additional imaging 93 per cent of the time.

Mechanical pleurodesis aided by peritoneal drainage: procedure for hepatic hydrothorax.

BACKGROUND: Hepatic hydrothorax in the setting of decompensated cirrhosis is a challenging and common clinical problem. Traditional therapies such as diuretics and transjugular intrahepatic portosystemic shunts can be effective therapies in selected patients but in patients ineligible for, or intolerant of, these traditional therapies, few effective therapeutic options remain for the management of hepatic hydrothorax. METHODS: We present a series of 5 consecutive patients with refractory hepatic hydrothorax who underwent combined thorascopically guided mechanical and chemical pleurodesis aided by an intraperitoneal drain that prevented reaccumulation of the ascites while pleural inflammation and adhesion were progressing. We speculate that the prolonged contact between the parietal and visceral pleura allowed by prevention of reaccumulation of intraabdominal ascites and subsequent flux through the pleural space enhanced the efficacy of this procedure in comparison with those presented in the literature. RESULTS: Despite the fact that all of our patients presented with decompensated cirrhosis, the surgical procedure and subsequent hospitalization were tolerated well by our entire cohort. Colonization of the pleural and peritoneal drainage fluid was a common complication of this procedure but was not associated with prolonged morbidity or mortality. CONCLUSIONS: We present a therapy for the difficult clinical problem of refractory hepatic hydrothorax that may allow selected patients an opportunity for prolonged symptomatic control.

Fibrin sealant improves hemostasis in peripheral vascular surgery: a randomized prospective trial.

OBJECTIVE: To evaluate the efficacy and safety of an investigational fibrin sealant (FS) in a randomized prospective, partially blinded, controlled, multicenter trial. SUMMARY BACKGROUND DATA: Upper extremity vascular access surgery using polytetrafluorethylene (PTFE) graft placement for dialysis was chosen as a reproducible, clinically relevant model for evaluating the usefulness of FS. The FS consisted of pooled human fibrinogen (60 mg/mL) and thrombin (500 NIH U/mL). Time to hemostasis was measured, and adverse events were monitored. METHODS: Consenting adult patients (n = 48) undergoing placement of a standard PTFE graft were randomized in a 2:1:1 ratio to the treatment group using FS (ZLB Bioplasma AG, Bern, Switzerland), oxidized regenerated cellulose (Surgicel, Johnson & Johnson, New Brunswick, NJ), or pressure. Patients received heparin (3,000 IU IVP) before placement of vascular clamps. If the treatment was FS, clamps were left in place for 120 seconds after the application of study material to permit polymerization. If treatment was Surgicel, clamps were left in place until the agent had been applied according to manufacturer's instructions. If the treatment was pressure, clamps were released as soon as the investigator was ready to apply compression. Immediately after release of the last clamp, the arterial and venous suture lines were evaluated for bleeding. The time to hemostasis at both the venous and arterial sites was recorded. RESULTS: Significant (P < or =.005) reduction in time to hemostasis was achieved in the FS group. Thirteen (54.2%) patients randomized to FS experienced immediate hemostasis at both suture lines following clamp removal compared to no patients using Surgicel or pressure. Only one patient (7.1%) in the Surgicel group and no patients in the pressure group experienced hemostasis at 120 seconds from clamp removal, compared to 13 (54.2%) patients for FS. Adverse events were comparable in all groups. There were no seroconversions. CONCLUSIONS: FS achieved more rapid hemostasis than traditional techniques in this peripheral vascular procedure. FS use appeared to be safe for this procedure.

Utility of percutaneous intervention in the management of tunneled hemodialysis catheters.

A variety of interventional techniques have been developed to restore function to dysfunctional tunneled hemodialysis catheters (THC). The relative efficacies of these techniques were evaluated retrospectively to determine which therapy might be most beneficial. The records of malfunctioning THCs referred to interventional radiology between November 1995 and December 1999 were retrospectively reviewed. Dysfunctional THCs were studied using DSA images obtained while injecting contrast through the lumens of the THCs. The interventions performed were categorized into 1 of 5 groups: no treatment or conservative measures such as vigorous flushing; advancing a guidewire through the THC to reposition the catheter tip or to dislodge a small thrombus; catheter exchange over a guidewire; fibrin stripping of the THC using a loop snare; or prolonged (4 or more hr) direct thrombolytic infusion. A Cox Proportional Hazards model was developed to compare the rate of failure among the procedures. There were 340 THC studies. The catheters were managed as follows: 93 patients received conservative management only, 15 had a guidewire advanced through the catheter, 147 underwent catheter exchange, 62 were treated with a fibrin stripping procedure, and 23 received a thrombolytic infusion. Estimated 30-day patency rates for THCs were 38.2% for conservative management, 30.9% for guidewire manipulation of catheter tip, 53.6% for catheter exchange, 76.1% for fibrin stripping, and 69.8% for thrombolytic infusion. Differences among the treatments were observed (p < 0.01) and pairwise comparisons were made among the treatment groups. Failure rates were significantly higher in the catheter exchange (p <0.01) and guidewire manipulation at catheter tip (p <0.01) groups when compared with the fibrin stripping group. The catheter exchange and guidewire manipulation groups also experienced higher rates of failure when compared with the thrombolytic infusion group, although the differences were not statistically significant (p = 0.08, p = 0.17, respectively). Four procedure-related complications requiring hospitalization or other intervention occurred. Three of these were in the catheter exchange group with one incidence of sepsis, one drug reaction, and one hematoma. Fibrin stripping and thrombolytic infusion provided the greatest efficacy in the treatment of poorly functioning THCs, but all therapies demonstrated wide-ranging results. Central line exchanges did not provide a superior secondary patency and experienced more complications.