ProvenCare: quality improvement model for designing highly reliable care in cardiac surgery.

OBJECTIVE: To test whether an integrated delivery system could, through the application of process redesign methodology and reliability science, implement multiple evidence-based medical practices across the continuum of care for a specific surgical intervention and deliver these practices consistently. METHODS: The programme-ProvenCare--had three components: establishing best practices for elective coronary artery bypass graft (CABG) patients; assembling a multidisciplinary team to "hardwire" these best practices into everyday workflow; and implementing the programme with real-time data collection, feedback and focused redesign to reach high reliability. Surgeons reviewed all class I and IIa 2004 ACC/AHA guidelines for CABG surgery and translated them into 19 clinically applicable recommendations. A frontline multidisciplinary team "hardwired" these, resulting in 40 measurable process elements. Feedback of gaps in care was given and the process redesigned as needed. Clinical outcome data on consecutive elective CABG patients seen in the 12 months pre-intervention were then compared with a post-intervention group. RESULTS: Initially, 59% of patients received all 40 elements. At 3 months, compliance reached 100%, fell transiently to 86% and then reached 100% again, and was sustained for the remainder of the study. The overall trend in reliability was significant (p = 0.001). 30-day clinical outcomes showed improved trends in 8/9 measured areas (eg, patient readmissions to ICU decreased from 2.9% to 0.9% and blood products usage decreased from 23.4% to 16.2%). Operative mortality decreased to zero, but only likelihood of discharge was significant (p = 0.033). Frequency and length of readmissions fell, as did mean hospital charges. CONCLUSION: Frontline medical care providers, led by process design specialists, can successfully redesign episodic processes to consistently deliver evidence-based medicine, which may improve patient outcomes and reduce resource use.

Surgical treatment of necrotizing pancreatitis by necrosectomy and closed lavage: changing patient characteristics and outcome in a 19-year, single-center series.

BACKGROUND: Surgical treatment of necrotizing pancreatitis (NP) has undergone considerable changes during the past 2 decades. In this study, we report our experience of necrosectomy and continuous closed lavage over the past 19 years in an attempt to define changes in patient characteristics and outcome at an academic referral center. METHODS: Among 1520 patients admitted with acute pancreatitis, 392 had NP, 285 of whom underwent operative treatment. The total series was evaluated separately for treatment period A (May 1982 until April 1993) and treatment period B (May 1993 until May 2001). RESULTS: Intraoperative bacteriology revealed sterile necrosis in 145 and infected necrosis in 140 patients. Preoperative disease severity did not differ between the groups; however, the extent of pancreatic parenchymal necrosis was less in patients with sterile necrosis (P < .003). Postoperative complications were more frequent in infected necrosis (78%) than in sterile necrosis (61%) (P < .004), with mortality rates of 27% and 23%, respectively. The analysis of the 2 treatment periods revealed that during period B, there was a decrease in operatively treated patients with sterile necrosis (P < .0005). The preoperative systemic disease severity was significantly higher in these patients than in patients with infected necrosis. CONCLUSIONS: Surgical treatment of NP by necrosectomy and closed lavage carries an overall mortality of 25%. Patients with sterile necrosis and early onset high disease severity may represent a distinct clinical entity in whom the optimal treatment strategy remains to be defined.

Effect of resident call status on ABSITE performance. American Board of Surgery In-Training Examination.

BACKGROUND: Long work hours that result in fatigue may adversely affect cognitive function. Chronically sleep-deprived surgical residents fear that being on call the night before sitting for a standardized test puts them at a potential disadvantage. We examined American Board of Surgery In-Training Examination (ABSITE) scores to assess the effect of call status on exam performance. METHODS: Results of the 1994 ABSITE for 424 residents in 15 New England general surgery programs were collected. We compared standard scores of residents for the total test, clinical management, and basic science components with resident call status (on/off) for the night before the exam. RESULTS: Differences were apparent in total test scores (mean: off, 496.1; on, 466.0; P <.03) and clinical management scores (mean: off, 504.3; on, 470.6; P <.02) (t test, Mann-Whitney U test). Multivariate analyses revealed that differences in postgraduate year level and training track were significant contributors to differences in scores in all test components (analysis of covariance). Call status was not a significant factor in score variation after adjusting for these 2 factors. CONCLUSIONS: Differences in ABSITE scores of residents were related to postgraduate year level and training track. Call status had no significant effect on ABSITE performance.

Clinical nutrition: opportunity in a changing health care environment.

This article summarizes presentations from a satellite symposium, "Clinical Nutrition: Opportunity in a Changing Health Care Environment," held July 26, 1997, at the 37th annual meeting of the American Society for Clinical Nutrition in Montreal. The symposium was cosponsored by the American Society for Clinical Nutrition and the American Society for Parenteral and Enteral Nutrition. The diverse topics served as a practical forum for sharing information on innovative responses, concerns, and impediments in the rapidly evolving practice environment.

Surgical margin in hepatic resection for colorectal metastasis: a critical and improvable determinant of outcome.

OBJECTIVE: To update the analysis of technical and biologic factors related to hepatic resection for colorectal metastasis in a large single-institution series to identify important prognostic indicators and patterns of failure. SUMMARY BACKGROUND DATA: Surgical therapy for colorectal carcinoma metastatic to the liver is the only potentially curable treatment. Careful patient selection of those with resectable liver-only metastatic disease is crucial to the success of surgical therapy. METHODS: Two hundred forty-four consecutive patients undergoing curative hepatic resection for metastatic colorectal carcinoma were analyzed retrospectively. Variables examined included sex, stage of primary lesion, size of liver lesion(s), number of lesions, disease-free interval, ploidy, differentiation, preoperative carcinoembryonic antigen level, and operative factors such as resection margin, use of cryotherapy, intraoperative ultrasound, and blood loss. RESULTS: Surgical margin, number of lesions, and carcinoembryonic antigen (CEA) levels significantly control prognosis. Patients with only one or two liver lesions, a 1-cm surgical margin, and low CEA levels have a 5-year disease-free survival rate of more than 30%. Disease-free interval, original stage, bilobar involvement, size of metastasis, differentiation, and ploidy were not significant predictors of recurrence. The pattern of failure correlates with surgical margin. Routine use of intraoperative ultrasound resulted in an increased incidence of negative surgical margin during the period examined. CONCLUSIONS: Surgical resection or cryotherapy of hepatic metastasis from colorectal cancer is safe and curable in appropriately selected patients. Biologic factors, such as number of lesions and carcinoembryonic antigen levels, determine potential curability, and surgical margin governs the patterns of failure and outcome in potentially curable patients. Optimization of selection criteria and surgical resection margins will improve outcome.

Locally advanced rectal carcinoma: pelvic control and morbidity following preoperative radiation therapy, resection, and intraoperative radiation therapy.

PURPOSE: To determine the impact of intraoperative radiation therapy (IORT) combined with preoperative external beam irradiation and surgical resection in patients with locally advanced, unresectable rectal carcinoma. METHODS AND MATERIALS: Between 1982 and 1993, 40 patients with locally advanced colorectal cancer unresectable at initial presentation were treated with preoperative external beam radiation therapy (median dose 50.4 Gy). Thirty patients received concurrent 5-fluorouracil. Twenty-seven patients had primary tumors and 13 had recurrent disease; 1 patient had a solitary hepatic metastasis at the time of surgery. Four to 6 weeks after radiation, surgical resection was undertaken, and if microscopic or gross residual disease was encountered, IORT was delivered to the tumor bed. Patients with an unevaluable or high-risk margin were also considered for IORT. IORT was delivered through a dedicated 300-kVp orthovoltage unit. The median dose of IORT was 12.5 Gy (range 8-20). The dose was typically prescribed to a depth of 1-2 cm. The median follow-up was 33 months (range 5-100). RESULTS: Thirty-three patients were able to undergo a curative resection (83%). Five patients had gross residual disease despite aggressive surgery. Seven patients did not receive IORT: six because of clear margins, and one with gross disease that could not be treated for technical reasons. The remainder of the patients (26) received IORT to the site of pelvic adherence. The crude local control rates for patients following complete resection with negative margins were 92% for patients treated with IORT and 33% for patients without IORT. IORT was ineffective for gross residual disease. Pelvic control was none of four in this setting. The crude local control rate of patients with primary cancer was 73% (16 of 22), as opposed to 27% (3 of 11) for these with recurrent cancer. The 5-year actuarial overall survival and local control rates for patients undergoing gross complete resection and IORT were 64% and 75%, respectively. Seventeen of the 26 patients (65%) who received IORT experienced pelvic complications, as opposed to two patients (28%) who did not receive IORT. The incidence of complications was similar in the patients with primary versus recurrent disease. All cases were successfully treated with the placement of a posterior thigh myocutaneous flap. Of note, no pelvic osteoradionecrosis was seen in this series. CONCLUSION: Patients with locally advanced carcinoma of the rectum were aggressively treated with combined modality therapy consisting of preoperative external beam radiotherapy, surgery, and IORT. The pelvic control rate was 82% for patients with minimal residual disease. IORT failed to control gross residual disease. The incidence of pelvic wound healing problems was 65% in this series; however, a reconstructive procedure which replaced irradiated tissue with a vascularized myocutaneous flap was successful in treating this complication. We believe that IORT has therapeutic merit in the treatment of locally advanced rectal cancer, particularly in the setting of minimal residual disease.

Central venous catheter related thrombosis.

Central vein thrombosis is increasingly recognized as a long-term problem of chronic venous access. The incidence, causative factors, and diagnosis of central vein thrombosis are discussed, along with preventative measures and treatment strategies.

A technique for the exchange of tunneled polymeric silicone catheters and implantable infusion ports.

Tunneled polymeric silicone catheters and implantable infusion ports are used with increasing frequency. Complications may occur with catheter placement or ongoing use. A new technique is described that minimizes the risks associated with catheter reinsertion in patients with tunneled polymeric silicone catheters that are either malfunctioning or mispositioned. This procedure allows for the exchange of these catheters without incurring the risk of a new venipuncture.

General surgery considerations in the diabetic patient.

Early studies implicated diabetes as a risk factor for serious postoperative complications, but many of these conclusions have not withstood the scrutiny of analyses correcting for comorbid conditions. Asymptomatic gallstones in the diabetic patient are not an indication for preemptive surgery. Biliary tract surgery can be undertaken in the diabetic with little or no increased risk compared with the nondiabetic with similar physical status. Attempts at laparoscopic cholecystectomy, however, are more likely to require conversion to an open procedure. Whether or not rates of wound infection are increased by diabetes, when they do occur they are likely to be more severe than in the nondiabetic patient. Regardless of whether diabetes is a primary risk factor for complications following surgery or merely a marker for the existence of comorbid conditions that increase risk, the presence of diabetes in a patient requires careful assessment for and correction of conditions that occur frequently in diabetics and may contribute to surgical morbidity.

Intraoperative ultrasound imaging of the liver at the time of colorectal cancer resection.

OBJECTIVES: To evaluate the accuracy of intraoperative ultrasound (IOUS) liver imaging at the time of primary colorectal cancer resection, which might eliminate incurable patients from adjuvant chemotherapy trials or permit earlier resection of curable metastases. DESIGN: A prospective trial of routine IOUS liver imaging during resections of primary colorectal cancer. The rate of detection of occult metastases by IOUS imaging alone and the false-negative rate over 22.7 months of follow-up were determined. SETTING: A tertiary care referral center in Boston, Mass. PATIENTS: Fifty-five patients undergoing 56 operations for colorectal carcinoma between May 1990 and June 1992. MAIN OUTCOME MEASURES: The rate of detection, by IOUS imaging alone, of otherwise occult hepatic metastases, the total number of patients with metastases detected at any time during follow-up, and the rate of false-negative findings on IOUS imaging and direct examination. RESULTS: Occult hepatic metastases were detected by IOUS imaging alone in 5% of patients. Restriction of IOUS imaging to patients with T3 or T4 lesions or recurrent cancers would have identified all metastases and increased the detection rate to 10%. Occult metastases were detected by IOUS imaging alone in 12.5% of patients with T3, N0 lesions. The rate of false-negative findings on IOUS imaging was 13% overall, 0% for patients with T1 or T2 lesions, 3% for patients with node-negative findings, and 7% for patients with T3, N0 lesions. CONCLUSIONS: The small increment in the detection of occult metastases by IOUS liver imaging does not warrant its use in all patients with colorectal cancer. Selective use in patients with T3 or T4 lesions or recurrent cancers increased the incremental gain in detection. The observed frequency of occult metastases in patients with T3, N0 lesions is sufficient to impact on results of adjuvant chemotherapy trials. Longer follow-up in more patients is needed to determine whether a negative IOUS study is an additional favorable prognosticator in patients with T1 and T2 lesions and node-negative findings.

Effect of combined modality therapy on the surgical management of locally advanced rectal carcinoma.

The treatment of locally advanced rectal carcinoma is one of the more complicated problems in the management of colorectal carcinoma. More than any other site successful treatment requires a multimodality approach as surgery alone is frequently insufficient to completely eradicate all disease. This review focuses primarily on the management of patients who present without prior treatment and discusses the role of preoperative radiation therapy as well as intraoperative radiation therapy. Although much less gratifying, patients who present after failing previous therapy may also benefit from an aggressive multimodality approach.

Technical and biological factors in disease-free survival after hepatic resection for colorectal cancer metastases.

Careful patient selection for hepatic resection of colorectal cancer metastases is essential to improve current poor results. Carcinoembryonic antigen level and number of metastases were significant preoperative prognostic indicators of 5-year disease-free survival in patients selected clinically for hepatic surgery. Surgical margin, weight of hepatic tissue resected, carcinoembryonic antigen level, and flow cytometry were significant postoperative prognostic indicators. Patients with a carcinoembryonic antigen level less than 200 ng/mL, 1-cm surgical margins, and less than 1,000 g of liver tissue removed had a greater than 50% estimated 5-year disease-free survival rate. If the metastases were diploid on flow cytometry, an additional survival advantage may have been gained. Inadequate surgical margins led to high rates of liver-only recurrence. Nonhepatic recurrence was unrelated to surgical margins. Intraoperative liver examination by ultrasound during primary colon cancer resection and adjuvant chemotherapy may offer earlier selection of biologically appropriate patients and improved outcome; both recommendations require clinical trials.

Venous access. Preoperative, operative, and postoperative dilemmas.

The past two decades have seen a tremendous increase in the use of central venous catheters and its associated complications. The increased sophistication that physicians now have with regard to nutritional and metabolic needs has escalated the use of central venous catheters. As the acquired immunodeficiency syndrome epidemic grows, so too will the number of patients with infections and metabolic complications, many of whom will have conditions severe enough to benefit from the use of central venous catheters to deliver antimicrobial drugs and other supportive intravenous therapy. Our ability to sustain patients with short-bowel syndrome also relies critically on central venous access. Likewise, treatment of patients with leukemias and certain solid tumors frequently requires placement of these catheters. Central venous catheters are essential for bone marrow transplantation. Efforts to minimize the risks associated with placement of a central venous catheter by more frequent use of catheter exchange rather than another venipuncture should be encouraged when possible. Techniques to prevent arrhythmia during overinsertion of guide wires are also important. Vigilant searches for, and prompt treatment of, catheter-related sepsis and central vein thrombosis are critical. Better prophylaxis against the development of catheter-related sepsis and catheter-related thrombosis is also needed. Further prospective investigations should be performed, however, to define precisely cost-effective methods of detection and duration of therapy for patients with both catheter-related sepsis and catheter-related thrombosis. Further advances in the technology and management of catheters need to continue to meet these ongoing challenges.