Measuring surgical performance: A risky game?

BACKGROUND: Interest in performance measurement has been driven by increased demand for better indicators of hospital quality of care. This is due in part to policy makers wishing to benchmark standards of care and implement quality improvements, and also by an increased demand for transparency and accountability. APPROACH: We describe the role of performance measurement, which is not only about quality improvement, but also serves as a guide in allocating resources within health systems, and between health, education, and social welfare systems. As hospital based healthcare is responsible for the most cost within the healthcare system, and treats the most severely ill of patients, it is no surprise that performance measurement has focused attention on hospital based care, and in particular on surgery, as an important means of improving quality and accountability. We are particularly concerned about the choice of mortality as an outcome measure in surgery, as this choice assumes that all mortality in surgery is preventable. In reality, as a low quality indicator of care it risks both gaming, and cream-skimming, unless accurate risk adjustment exists. Further concerns relate to the public reporting of this outcome measure. CONCLUSIONS: As mortality rates are an imperfect measure of quality, the reputation of individual surgeons will be threatened by the public release of this data. Significant effort should be made to communicate the results to the public in an appropriate manner.

Laparoscopic right hemicolectomy for intestinal intussuception.

INTRODUCTION: Adult intussusception is rare and usually associated with carcinoma in 50% of the cases. These have traditionally been managed using an open technique. We herein describe a laparoscopic extended right hemicolectomy in a 62-year-old lady with an intussuception secondary to a transverse colonic tumor. METHODS: The patient presented with 6 weeks of crampy, colicky, abdominal pain. Her CT scan reported intussuception of the proximal large bowel. She underwent an extended laparoscopic right hemicolectomy with primary anastomosis. RESULTS: Her post-operative recovery was uneventful and the histology reported a large bowel adenocarcinoma (pT4, N0, M0) with none out of 25 nodes involved. CONCLUSION: When operative intervention is required, intussuception may be managed using a minimally invasive technique. However, large bowel intussuception in adults may have a malignant cause thus laparoscopic resection should only be performed by surgeons experienced in laparoscopic resections for colorectal malignancies as oncological safety must be the primary concern. This laparoscopic approach facilitates rapid recovery and earlier time to adjuvant therapy if required.

Laparoscopic pelvic sling placement facilitates optimum therapeutic radiotherapy delivery in the management of pelvic malignancy.

BACKGROUND: Radiotherapy has a significant role in the management of pelvic malignancies. However, the small intestine represents the main dose limiting organ. Invasive and non-invasive mechanical methods have been described to displace bowel out of the radiation field. We herein report a case series of laparoscopic placement of an absorbable pelvic sling in patients requiring pelvic radiotherapy. METHODS: Six patients were referred to our minimally invasive unit. Four patients required radical radiotherapy for localised prostate cancer, one was scheduled for salvage localised radiotherapy for post-prostatectomy PSA progression and one patient required adjuvant radiotherapy post-cystoprostatectomy for bladder carcinoma. All patients had excessive small intestine within the radiation fields despite the use of non-invasive displacement methods. RESULTS: All patients underwent laparoscopic mesh placement, allowing for an elevation of small bowel from the pelvis. The presence of an ileal conduit or previous surgery did not prevent mesh placement. Post-operative planning radiotherapy CT scans confirmed displacement of the small intestine allowing all patients to receive safely the planned radiotherapy in terms of both volume and radiation schedule. CONCLUSION: Laparoscopic mesh placement represents a safe and efficient procedure in patients requiring high-dose pelvic radiation, presenting with unacceptable small intestine volume in the radiation field. This procedure is also feasible in those that have undergone previous major abdominal surgery.

Gossypiboma: a case report and review of the literature.

INTRODUCTION: Post-operative complications in surgery may frequently be unavoidable. However, some complications result from human error, both in the intra-operative and post-operative period. One such complication, which is frequently underreported, is the retained swab, or gossypiboma. CASE REPORT: We report a case from our hospital of a patient who presented with unexplained pyrexia, 4 years post-gynaecological surgery in another institution. A 67-year-old woman from overseas presented to our emergency department with a 2-day-history of pyrexia, collapse and confusion. Following a CT guided biopsy, which was inconclusive, she was scheduled for retroperitoneal biopsy. In theatre, a retained swab was discovered. CONCLUSION: Prevention of gossypiboma is far better than cure. Strict adherence to swab counts, and the avoidance of change of staff during procedures is important in decreasing the incidence. Perhaps, with the increasing use of minimally invasive procedures, the incidence of gossypiboma will fall dramatically.

Suture closure of the femoral arteriotomy following invasive cardiac procedures: a detailed analysis of efficacy, complications, and the impact of early ambulation in 1,200 consecutive, unselected cases.

The purpose of this study was to assess the efficacy and safety of using a percutaneous suture device to close femoral arteriotomies following invasive cardiac procedures. All patients presenting for invasive cardiac procedures performed from the femoral artery were considered for suture closure. Patients were carefully assessed for access site complications, oozing, and the impact of suture closure on the safety of early ambulation. Clinical follow-up at 3-6 months was performed to assess for late complications. Femoral artery suture closures were performed in 1,200 consecutive cases in 1,097 patients. In 12.8% of cases, the patients ambulated within 1 hr. The success rate was 91.2% and the complication rate was 3.4%. Complications included the development of a hematoma (2.1%), the need for vascular surgery (0.6%), retroperitoneal hemorrhage (0.3%), blood transfusion (0.7%), local infection (0.5%), and pseudoaneurysm formation (0.1%). Factors found to be independently predictive of procedural failure were an age > 70 years, an ACT > 300 sec, left femoral artery access, and the performance of primary angioplasty. Follow-up at 3-6 months revealed no major hemorrhagic complications. We conclude that percutaneous suture closure effectively achieves femoral artery hemostasis in patients undergoing invasive cardiac procedures. The technique permits early ambulation and is associated with a relatively low incidence of complication.

Impact of end-stage renal disease on clinical and angiographic outcomes after coronary stenting.

Although patients with end-stage renal disease (ESRD) are at high risk for restenosis that requires repeat revascularization after balloon angioplasty, their restenosis rate after coronary stenting is still unknown. Over a 4-year period, we performed coronary stenting on 40 lesions in 34 patients with ESRD. We compared these lesions with 80 lesions from patients without renal disease who underwent coronary stenting in the STARS and WINS clinical trials, matched for treatment site, diabetes, lesion length, and reference vessel diameter. Quantitative coronary angiography was performed on all lesions and clinical outcomes were assessed at 9-month follow-up. Clinical and angiographic characteristics were well matched between the 2 groups and acute clinical success rates were similar. Despite comparable initial angiographic results over the 9-month follow-up period, repeat target lesion revascularization was twice as frequent in the ESRD group compared with the control group (35% vs 16%, p <0.05). After adjusting for differences in postprocedural minimum lumen diameter and other angiographic and clinical characteristics, ESRD remained the most important predictor of late target lesion revascularization (relative risk = 2.3, p = 0.04). In addition, overall 9-month mortality was higher for ESRD patients than for the control population (18% vs 2%, p <0.01). Thus, despite similar angiographic results, patients with ESRD are at higher risk for target lesion revascularization after coronary stenting than controls. Nonetheless, most patients with ESRD do not develop restenosis after stent placement, suggesting an important role for stenting in the management of this challenging population.

Synergy between intracoronary stenting and abciximab in improving angiographic and clinical outcomes of primary angioplasty in acute myocardial infarction.

This study examined 650 consecutive patients who presented with an acute myocardial infarction and were treated with primary angioplasty within 12 hours of symptom onset between August 1995 and December 1998. Patients were placed into 4 treatment groups depending on the adjunctive therapy they received: group 1, percutaneous transluminal coronary angioplasty (PTCA) ("balloon PTCA alone"; n = 220); group 2, PTCA plus intracoronary stent placement ("stent"; n = 128); group 3, PTCA plus abciximab therapy ("abciximab"; n = 104); and group 4, PTCA plus intracoronary stent placement plus abciximab therapy ("stent/abciximab"; n = 198). The patients' clinical characteristics, severity of disease, and total ischemia time on presentation were similar. At baseline, abciximab and stent/abciximab groups had a higher incidence of thrombus on coronary angiography. Postprocedural quantitative coronary analysis showed a significantly larger minimum luminal diameter in the stent and stent/abciximab groups than PTCA alone. Overall, stents were most efficacious in reducing target vessel revascularization rate, whereas abciximab was associated with a higher postprocedural Thrombolysis In Myocardial Infarction-3 trial flow and less "no reflow." The best angiographic result was achieved in the stent/abciximab group. Similarly, the primary combined end point of death, myocardial infarction, and target vessel revascularization at 30 days was the lowest (6.1%) in the stent/abciximab group. The combination of abciximab and stenting in primary angioplasty for acute myocardial infarction is thus synergistic and is associated with improved angiographic and clinical results at 30-day follow-up.

Short- and medium-term outcome differences in women and men after primary percutaneous transluminal mechanical revascularization for acute myocardial infarction.

Women presenting with acute myocardial infarction (AMI) have a higher mortality with conventional medical and thrombolytic therapy when compared with men. The outcome after primary percutaneous transluminal mechanical revascularization has not yet been fully investigated. This study was performed to compare the characteristics and the short- and medium-term outcomes of women and men with AMI treated with primary percutaneous revascularization. A total of 182 consecutive patients (62 women and 120 men) were included. Baseline clinical characteristics were similar except that women were older than men, presented more often in cardiogenic shock, and had smaller reference vessel diameters. Stents and abciximab were used equally, but abciximab was stopped more often in women before completion of the 12-hour infusion because of higher bleeding rates. Acute procedural success rates were similar (92% and 97%) but mortality was much higher in women, both at 30-day follow-up (100% vs 0.9%; p <0.05) and during a mean follow-up of 6.9 +/- 4.1 months (15% vs 4.4%; p <0.05). Women also experienced more unfavorable cardiovascular events (recurrent unstable angina or AMI, target vessel revascularization) than men. However, after control for baseline clinical differences in a multivariate analysis, gender was not an independent predictor of survival, whereas age, cardiogenic shock, and completion of a 12-hour abciximab infusion were.

Clinical and angiographic characteristics of exertion-related acute myocardial infarction.

CONTEXT: Vigorous physical exertion transiently increases the risk of acute myocardial infarction (MI), but little is known about the clinical characteristics of exertion-related MI. OBJECTIVE: To compare the clinical and angiographic characteristics of patients who had an exertion-related acute MI vs those who experienced an MI not related to exertion. DESIGN AND SETTING: Prospective observational cohort study of patients with an acute MI referred to a tertiary care hospital for primary angioplasty. PATIENTS: Of 1048 patients with acute MI, 640 (64 who experienced an exertion-related MI and 576 who did not) were selected for treatment with primary angioplasty and admitted between August 1995 and November 1998. MAIN OUTCOME MEASURES: Clinical characteristics of the patients, including their habitual physical activity (determined by the Framingham Physical Activity Index and the Lipid Research Clinic Physical Activity Questionnaire), angiographic findings during coronary angiography, and the relative risk (RR) of MI during exertion. RESULTS: Patients who experienced exertion-related MI were more frequently men (86% vs 68%), hyperlipidemic (62% vs 40%), and smokers (59% vs 37%), were more likely to present with ventricular fibrillation (20% vs 11%), Killip classification III or IV heart failure (44% vs 22%), single-vessel disease (50% vs 28%), and a large thrombus in the infarct artery (64% vs 35%) and were more likely to be classified as having very low or low activity (84% vs 66%). The RR of experiencing an MI during exertion was 10.1 times greater than the risk at other times (95% confidence interval [CI], 1.6-65.6), with the highest risk among patients classified as very low active (RR, 30.5; 95% CI, 4.4-209.9) and low active (RR, 20.9; 95% CI, 3.1-142.1). CONCLUSION: These results show that exertion-related MIs occur in habitually inactive people with multiple cardiac risk factors. These individuals may benefit from modest exercise training and aggressive risk-factor modification before they perform vigorous physical activity.

Enhanced local intracoronary delivery of heparin with the Infiltrator catheter: a comparative study.

The efficacy of local drug delivery in the treatment of coronary artery disease is limited by the relatively low delivery efficiency of the available devices. A unique local drug delivery device, the Infiltrator catheter (InterVentional Technologies, Inc.), has been designed specifically to enhance efficiency by injecting drugs directly into the arterial wall through microports mounted on the balloon surface. The purpose of this study was to assess the efficiency of delivery of this device in the porcine coronary model and to compare it to a previously validated device, the hydrogel balloon (Boston Scientific, Maple Grove, Minnesota). Studies were also performed to assess the pattern of intramural heparin deposition following delivery with the Infiltrator catheter and to assess the effect of the microports on vascular integrity. The efficiency of delivery was significantly greater with the Infiltrator catheter than with the hydrogel balloon (4.5% vs. 0.08%; p = 0.02). Similarly, the absolute amount of intramurally deposited heparin was greater with the Infiltrator (111.3 +/- 38.5 units vs. 2.4 +/- 0.85 units; p = 0.02) despite the fact that more heparin was delivered with the hydrogel catheter. Histologic studies revealed characteristic discrete puncture channels in the vessel wall due to penetration of the microports. Other than this histologic finding, there was no significant difference in the extent of architectural disruption between the Infiltrator and conventional balloon inflations. Fluorescein-labeled heparin studies revealed heparin to be diffusely distributed throughout the vessel wall immediately following delivery with the Infiltrator. We conclude that the Infiltrator catheterOs unique mechanism of delivery improves the efficiency of local drug delivery without excessive vessel wall trauma.

Abciximab in primary coronary angioplasty for acute myocardial infarction improves short- and medium-term outcomes.

OBJECTIVES: The purpose of this study was to compare the outcome of primary percutaneous transluminal coronary angioplasty for acute myocardial infarction (MI) when performed with or without the platelet glycoprotein IIb/IIIa antibody, abciximab. BACKGROUND: Abciximab improves the outcome of angioplasty but the effect of abciximab in primary angioplasty has not been investigated. METHODS: Data were collected from a computerized database. Follow-up was by telephone or review of outpatient or hospital readmission records. RESULTS: A total of 182 consecutive patients were included; 103 received abciximab and 79 did not. The procedural success rate was 95% in the two groups. At 30-day follow-up, the composite event rate of unstable angina, reinfarction, target vessel revascularization and death from all causes was 13.5% in the group of patients who did not receive abciximab, 4% (p < 0.05) in the abciximab group and 2.4% (p < 0.05) in the subgroup of patients (n = 87) who completed the 12-h abciximab infusion. At the end of follow-up (mean 7+/-4 months), the composite event rate was 32.4%, 17% (p < 0.05) and 13.1% (p < 0.01) in these three categories respectively. Abciximab bolus followed by a 12-h infusion was an independent predictor of event-free survival, in a Cox proportional hazards model (relative risk 0.49; 95% confidence interval 0.24 to 0.99; p < 0.05). CONCLUSIONS: Abciximab given at the time of primary angioplasty may improve the short- and medium-term outcome of patients with acute MI, especially when a 12-h infusion is completed.

Coronary angioplasty induces a systemic inflammatory response.

C-reactive protein (CRP) levels increased more than sixfold above baseline when measured 48 hours after elective percutaneous transluminal coronary angioplasty (PTCA) in patients without underlying inflammatory conditions and did not change significantly in controls undergoing coronary angiography. Only 3 of the 42 PTCA patients had clinical restenosis and underwent target vessel revascularization during the 6-month follow-up, but 2 of the 3 had very high CRP levels 48 hours after the procedure.

Site-specific intracoronary thrombolysis with urokinase-coated hydrogel balloons: acute and follow-up studies in 95 patients.

Conventional balloon angioplasty in the presence of intracoronary thrombus is associated with an elevated risk for acute myocardial infarction, emergency bypass surgery, and death. The purpose of this study was to assess the safety and efficacy of a new technique to treat thrombus-containing stenoses consisting of the local delivery of urokinase directly to the site of intraluminal clot with hydrogel-coated balloons. Ninety-five patients with angiographically apparent intracoronary thrombus were treated with urokinase-coated hydrogel balloons either prior to (n = 74) or following (n = 21) conventional balloon angioplasty. Clinical diagnoses for the study group included acute myocardial infarction in 50 patients, postinfarction angina in 23 patients, and unstable angina in 22 patients. All hydrogel balloons were initially coated with urokinase by immersing the inflated balloon in a concentrated Abbokinase solution (50,000 units/ml) for 60 s. All patients were subsequently treated with drug-coated balloons using a balloon:artery ratio of 1:1, a mean of 2.2 +/- 1.2 inflations, and a mean total inflation time of 7.5 +/- 4.9 min. Use of urokinase-coated balloons resulted in angiographic disappearance of intracoronary thrombus in 78 patients, improvement in 14, and no change in the remaining 3 patients. Following hydrogel balloon use for the entire 95 patients, TIMI flow increased from 1.4 +/- 1.2 to 2.9 +/- 0.4, minimal lumen diameter increased from 0.4 +/- 0.4 to 2.0 +/- 0.6 mm, and thrombus score decreased from 2.0 +/- 0.9 to 0.2 +/- 0.6 (all P < 0.01). Procedural and early in-hospital complications were noted in 7 of the 95 patients (7.4%) and included abrupt closure in 3 patients, distal embolization in 1 patient, no reflow in 1 patient, sidebranch occlusion in 1 patient, and late closure in 1 patient. Two of the 3 patients with abrupt closure and the single patient with late closure required intracoronary stenting to maintain vessel patency. Two of these 7 patients sustained small myocardial infarctions, although no patient required emergency bypass surgery or experienced a procedural death. Late clinical follow-up (mean = 8.3 +/- 6.6 months; range = 2 wk to 29 mo) demonstrated adverse recurrent events in 29 of the 95 patients (30.5%), including death (n = 5), myocardial infarction (n = 2), and recurrence of angina (n = 22). The results of this study suggest that intracoronary thrombolysis can be safely and rapidly achieved by using limited quantities of urokinase delivered directly to the site of intraluminal clot with hydrogel balloons. Use of this technique may result in improved acute outcomes in comparison with conventional techniques currently being used to treat thrombus-containing stenoses.

Treatment of thrombotic saphenous vein bypass grafts using local urokinase infusion therapy with the Dispatch catheter.

Percutaneous treatment of thrombotic stenoses or total occlusions in aged saphenous vein bypass grafts is associated with a significant incidence of complications primarily related to distal embolization. The purpose of this study was to assess the efficacy of local urokinase delivery with the Dispatch catheter prior to balloon angioplasty and/or intragraft stent placement as a new technique of vein graft revascularization. Local urokinase delivery with the Dispatch catheter was performed in 15 saphenous vein grafts (mean age = 11.7 +/- 2.5 yr) in 13 patients with unstable or postinfarction angina. The target lesion was a total occlusion in 5 of the procedures and a severe vein graft stenosis in the remaining 10. In all cases, urokinase was administered directly to the site of the stenosis/occlusion via the Dispatch catheter at 0.5 cc/min and at a concentration of 30,000 units/cc. The mean urokinase infusion time for the 15 procedures was 33 +/- 10 min (range = 10-60 min) and the mean urokinase dose was 495,000 +/- 158,000 units (range = 150,000-900,000 units). Following Dispatch therapy, mean minimal lumen diameter increased from 0.34 +/- 0.32 to 1.81 +/- 0.78 mm (P < 0.01), mean TIMI flow increased from 1.9 +/- 1.4 to 2.8 +/- 0.8 (P < 0.06), and mean thrombus score was reduced from 2.3 +/- 0.6 to 0.3 +/- 0.8 (P < 0.01). Mild no reflow was noted in two cases, although no patient demonstrated angiographic evidence of gross distal embolization. One of the patients with no reflow also demonstrated a small increase in cardiac enzymes. Subsequent balloon angioplasty/stent placement was successful in 14 of the 15 procedures (93% success rate). This preliminary report suggests that pretreatment of thrombotic saphenous vein graft stenoses with local urokinase delivery via the Dispatch catheter may decrease intragraft thrombus and possibly decrease the incidence of vascular complications associated with percutaneous intervention. This technique may allow for recanalization of totally occluded vein grafts with large clot burdens by using significantly less urokinase and shorter drug administration times than conventional infusion protocols.