Vic Velanovich

Quality of life of breast cancer patients with lymphedema.

BACKGROUND Quality of life has increasingly become an important issue in breast cancer treatment. One of the impetuses for sentinel lymph node biopsy or selective axillary lymph node dissection (ALND) is the assumed decreased incidence of lymphedema compared with standard ALND. This is based on the assumption that ALND is associated with a clinically significant incidence of lymphedema and that this lymphedema decreases the quality of life of these patients. However, few data exist on this issue. This study attempts to define the incidence and effect on quality of life of postoperative lymphedema in breast cancer patients. METHODS To determine the incidence of postoperative lymphedema, the Breast Cancer Registry at Henry Ford Hospital was accessed to obtain information on all patients who underwent ALND in the management of breast cancer over a 7-year period. The registry is a prospectively gathered data base to include the development of various complications, such as lymphedema. To determine the effects of lymphedema on quality of life, 101 consecutive, unselected patients who underwent breast surgery were asked to complete the SF-36, a generic quality of life instrument. The SF-36 measures eight domains of quality of life. Patients were then divided into three groups: (1) breast surgery without ALND (-ALND), (2) breast surgery with ALND but no lymphedema (-LE), and (3) breast surgery with ALND and lymphedema (+LE). RESULTS In all, 827 patients with ALND were identified in the registry. Of these, 8.3% developed clinically apparent lymphedema. Patients in -ALND and -LE groups had similar scores in all domains of the SF-36. However, patients in the +LE group had significantly lower scores in the domains of role-emotional and bodily pain. A significantly higher percentage of patients in the +LE group had scores below one standard deviation compared with national norms in the domains of bodily pain (P = 0.005), mental health (P = 0.01), and general health (P = 0.04). CONCLUSIONS Although postoperative lymphedema occurs in a minority of patients, when it does occur it can produce demonstrable diminutions in quality of life. Therefore, efforts to reduce the incidence of lymphedema, such as sentinel lymph node biopsy or selective ALND, would benefit breast cancer patients.

Are the frail destined to fail? Frailty index as predictor of surgical morbidity and mortality in the elderly.

BACKGROUND America’s aging population has led to an increase in the number of elderly patients necessitating emergency general surgery. Previous studies have demonstrated that increased frailty is a predictor of outcomes in medicine and surgical patients. We hypothesized that use of a modification of the Canadian Study of Health and Aging Frailty Index would be a predictor of morbidity and mortality in patients older than 60 years undergoing emergency general surgery. METHODS Data were obtained from the National Surgical Quality Improvement Program Participant Use Files database in compliance with the National Surgical Quality Improvement Program Data Use Agreement. We selected all emergency cases in patients older than 60 years performed by general surgeons from 2005 to 2009. The effect of increasing frailty on multiple outcomes including wound infection, wound occurrence, any infection, any occurrence, and mortality was then evaluated. RESULTS Total sample size was 35,334 patients. As the modified frailty index increased, associated increases occurred in wound infection, wound occurrence, any infection, any occurrence, and mortality. Logistic regression of multiple variables demonstrated that the frailty index was associated with increased mortality with an odds ratio of 11.70 (p < 0.001). CONCLUSION Frailty index is an important predictive variable in emergency general surgery patients older than 60 years. The modified frailty index can be used to evaluate risk of both morbidity and mortality in these patients. Frailty index will be a valuable preoperative risk assessment tool for the acute care surgeon. (J Trauma Acute Care Surg. 2012;72: 1526–1531. Copyright

A Randomized Prospective Multicenter Trial of Pancreaticoduodenectomy With and Without Routine Intraperitoneal Drainage

Objective:To test by randomized prospective multicenter trial the hypothesis that pancreaticoduodenectomy (PD) without the use of intraperitoneal drainage does not increase the frequency or severity of complications. Background:Some surgeons have abandoned the use of drains placed during pancreas resection. Methods:We randomized 137 patients to PD with (n = 68, drain group) and without (n = 69, no-drain group) the use of intraperitoneal drainage and compared the safety of this approach and spectrum of complications between the 2 groups. Results:There were no differences between drain and no-drain cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, baseline quality of life, or operative technique. PD without intraperitoneal drainage was associated with an increase in the number of complications per patient [1 (0-2) vs 2 (1-4), P = 0.029]; an increase in the number of patients who had at least 1 ≥grade 2 complication [35 (52%) vs 47 (68%), P = 0.047]; and a higher average complication severity [2 (0-2) vs 2 (1-3), P = 0.027]. PD without intraperitoneal drainage was associated with a higher incidence of gastroparesis, intra-abdominal fluid collection, intra-abdominal abscess (10% vs 25%, P = 0.027), severe (≥grade 2) diarrhea, need for a postoperative percutaneous drain, and a prolonged length of stay. The Data Safety Monitoring Board stopped the study early because of an increase in mortality from 3% to 12% in the patients undergoing PD without intraperitoneal drainage. Conclusions:This study provides level 1 data, suggesting that elimination of intraperitoneal drainage in all cases of PD increases the frequency and severity of complications.

Irreversible Electroporation Therapy in the Management of Locally Advanced Pancreatic Adenocarcinoma

BACKGROUND Locally advanced pancreatic cancer patients have limited options for disease control. Local ablation technologies based on thermal damage have been used but are associated with major complications in this region of the pancreas. Irreversible electroporation (IRE) is a nonthermal ablation technology that we have shown is safe near vital vascular and ductal structures. The aim of this study was to evaluate the safety and efficacy of IRE as a therapy in the treatment of locally advanced pancreatic cancer. STUDY DESIGN We performed a prospective multi-institutional pilot evaluation of patients undergoing IRE for locally advanced pancreatic cancer from December 2009 to March 2011. These patients were evaluated for 90-day morbidity, mortality, and local disease control. RESULTS Twenty-seven patients (13 women and 14 men) underwent IRE, with median age of 61 years (range 45 to 80 years). Eight patients underwent margin accentuation with IRE in combination with left-sided resection (n = 4) or pancreatic head resection (n = 4). Nineteen patients had in situ IRE. All patients underwent successful IRE, with intraoperative imaging confirming effective delivery of therapy. All 27 patients demonstrated nonclinically relevant elevation of their amylase and lipase, which peaked at 48 hours and returned to normal at 72 hour postprocedure. There has been one 90-day mortality. No patient has shown evidence of clinical pancreatitis or fistula formation. After all patients have completed 90-day follow-up, there has been 100% ablation success. CONCLUSIONS IRE ablation of locally advanced pancreatic cancer tumors is a safe and feasible primary local treatment in unresectable, locally advanced disease. Confirming these early results must occur in a planned phase II investigational device exemption (IDE) study to be initiated in 2012.

Comparison of generic (SF-36) vs. disease-specific (GERD-HRQL) quality-of-life scales for gastroesophageal reflux disease

The Gastroesophageal Reflux Disease-Health-Related Quality-of-Life (GERD-HRQL) scale was developed to objectively quantify symptom severity. It was compared to a “gold standard” health survey, the SF-36. Forty-three patients treated either medically or surgically for gastroesophageal reflux disease were asked to complete both the GERD-HRQL and the SF-36. They were asked the following: (1) Which questionnaire do you like best? (2) Which questionnaire was easier to understand? (3) Which questionnaire was more reflective of the problems you have with reflux disease? (4) Given the choice, which questionnaire would you rather fill out? Patients were asked to state their overall satisfaction with their present reflux symptom conditions. Multivariate analysis showed that the only significant predictor of patient satisfaction was the total GERD-HRQL score (P < O.OOOOl). Th ere were differences in the SF-36 domains of physical function (88.7 vs. 65.3; P = 0.004) and general health (68 vs. 46.5; P = 0.006). There were no correlations between the total GERD-HRQL scores and the SF-36 domain scores. Fifty-nine percent of patients preferred the GERD-HRQL questionnaire, 62% felt it was easier to understand, 86% felt it was more reflective of their symptoms, and 67% said they would rather use it over the SF-36. The GERD-HRQL better assesses-symptom severity for gastroesophageal reflux disease than the generic SF-36.The Gastroesophageal Reflux Disease-Health-Related Quality-of-Life (GERD-HRQL) scale was developed to objectively quantify symptom severity. It was compared to a “gold standard” health survey, the SF-36. Forty-three patients treated either medically or surgically for gastroesophageal reflux disease were asked to complete both the GERD-HRQL and the SF-36. They were asked the following: (1) Which questionnaire do you like best? (2) Which questionnaire was easier to understand? (3) Which questionnaire was more reflective of the problems you have with reflux disease? (4) Given the choice, which questionnaire would you rather fill out? Patients were asked to state their overall satisfaction with their present reflux symptom conditions. Multivariate analysis showed that the only significant predictor of patient satisfaction was the total GERD-HRQL score (P < O.OOOOl). Th ere were differences in the SF-36 domains of physical function (88.7 vs. 65.3; P = 0.004) and general health (68 vs. 46.5; P = 0.006). There were no correlations between the total GERD-HRQL scores and the SF-36 domain scores. Fifty-nine percent of patients preferred the GERD-HRQL questionnaire, 62% felt it was easier to understand, 86% felt it was more reflective of their symptoms, and 67% said they would rather use it over the SF-36. The GERD-HRQL better assesses-symptom severity for gastroesophageal reflux disease than the generic SF-36.

Case-control comparison of laparoscopic versus open distal pancreatectomy.

Laparoscopic distal pancreatectomy is becoming an increasingly used modality in the surgical treatment of pancreatic disease. The assumption is that this will lead to shorter hospitalization and faster recovery. However, actual comparative data between open and laparoscopic distal pancreatectomy is lacking. The purpose of this study is to compare these surgical procedures. All patients who underwent either laparoscopic or open distal pancreatectomy/splenectomy were reviewed. Fifteen patients underwent laparoscopic resection, whereas 41 underwent an open resection. The 15 laparoscopic patients were matched to 15 open patients for age, gender, and pancreatic pathology. Data gathered included length of stay, pancreatic leak, postoperative complications, and return to normal activity. Of the 15 laparoscopic patients, three were converted to open operations. Laparoscopic patients had a median length of stay of 5 days (range, 3–9) compared with 8 days (range, 6–23) for the open patients (P = 0.02). The pancreatic leak rate was 13% in each group. Overall postoperative complication rate was 20% in the laparoscopic group compared with 27% in the open group. Laparoscopic patients reported a return to normal activity in 3 weeks (range, 2–7) compared with 6 weeks (range, 4–10) for open patients (P =0.03). Laparoscopic distal pancreatectomy/splenectomy does lead to shorter hospital stay and faster return to normal activity. Pancreatic leak rate and overall complication rate appear similar.

Laparoscopic vs open surgery: a preliminary comparison of quality-of-life outcomes.

BackgroundThe purported advantages of laparoscopic surgery over conventional open techniques are less pain and faster return to normal functional status. Very few studies have included validated measures of quality of life as end points. This study prospectively assessed the health status outcomes of patients undergoing four types of laparoscopic and open operations.MethodsPreoperatively, patients undergoing elective inguinal hernioplasty, esophageal surgery, cholecystectomy, and splenectomy completed the SF-36, a well-tested, validated health-status instrument. This instrument measures physical functioning (PF), role-physical (RP), role-emotional (RE), bodily pain (BP), vitality (VT), mental health (MH), social functioning (SF), and general health (GH) health status domains. Patients then underwent either laparoscopic or open surgery. Patients were reassessed with the instrument ≥6 weeks after surgery. A total of 100 patients underwent these procedures.ResultsCompared to preoperative values, median SF-36 scores for laparoscopic cholecystectomy patients were improved in the domains of PF (85 vs 95, p=0.01), BP (42 vs 75, p=0.002), and VT (47.5 vs 70, p=0.04); open cholecystectomy patients did not show statistically significant improvements over preoperative values. In addition, laparoscopic cholecystectomy patients had a better score than open cholecystectomy patients in the BP domain (75 vs 41, p=0.05). Laparoscopic esophageal surgery patients had better scores than open surgery patients in the domains of RP (100 vs 0, p=0.02) and VT (65 vs 52.5, p=0.05). Compared to preoperative values, laparoscopic splenectomy patients had an improved score in GH (52 vs 77, p=0.02) and better scores than open splenectomy patients in PF (90 vs 45, p=0.05) and BP (84 vs 55.5, p=0.01). Compared to preoperative values, open mesh hernioplasty patients showed improved scores in PF (70 vs 92.5, p=0.03) and MH (72 vs 84, p=0.05). Laparoscopic hernioplasty did not produce improved scores compared to either preoperative values or open hernioplasty.ConclusionsLaparoscopic surgery has demonstrably better quality-of-life outcomes than open surgery for cholecystectomy, splenectomy, and esophageal surgery. However, open hernioplasty has at least as good, if not better, health status outcomes than laparoscopic repair.

A statewide assessment of surgical site infection following colectomy: the role of oral antibiotics.

Objective:To determine the utility of adding oral nonabsorbable antibiotics to the bowel prep prior to elective colon surgery. Summary Background Data:Bowel preparation prior to colectomy remains controversial. We hypothesized that mechanical bowel preparation with oral antibiotics (compared with without) was associated with lower rates of surgical site infection (SSI). Methods:Twenty-four Michigan hospitals participated in the Michigan Surgical Quality Collaborative–Colectomy Best Practices Project. Standard perioperative data, bowel preparation process measures, and Clostridium difficile colitis outcomes were prospectively collected. Among patients receiving mechanical bowel preparation, a logistic regression model generated a propensity score that allowed us to match cases differing only in whether or not they had received oral antibiotics. Results:Overall, 2011 elective colectomies were performed over 16 months. Mechanical bowel prep without oral antibiotics was administered to 49.6% of patients, whereas 36.4% received a mechanical prep and oral antibiotics. Propensity analysis created 370 paired cases (differing only in receiving oral antibiotics). Patients receiving oral antibiotics were less likely to have any SSI (4.5% vs. 11.8%, P = 0.0001), to have an organ space infection (1.8% vs. 4.2%, P = 0.044) and to have a superficial SSI (2.6% vs. 7.6%, P = 0.001). Patients receiving bowel prep with oral antibiotics were also less likely to have a prolonged ileus (3.9% vs. 8.6%, P = 0.011) and had similar rates of C. difficile colitis (1.3% vs. 1.8%, P = 0.58). Conclusions:Most patients in Michigan receive mechanical bowel preparation prior to elective colectomy. Oral antibiotics may reduce the incidence of SSI.

Simplified Frailty Index to Predict Adverse Outcomes and Mortality in Vascular Surgery Patients

BACKGROUND Frailty has been established as an important predictor of health-care outcomes. We hypothesized that the use of a modified frailty index would be a predictor of mortality and adverse occurrences in vascular surgery patients. METHODS Under the data use agreement of the American College of Surgeons, and with institutional review board (IRB) approval, the National Surgical Quality Improvement Program (NSQIP) Participant Utilization File was accessed for the years 2005-2008 for inpatient vascular surgery patients. Using the Canadian Study of Health and Aging Frailty Index (FI), 11 variables were matched to the NSQIP database. An increase in FI implies increased frailty. The outcomes assessed were mortality, wound infection, and any occurrence. We then compared the effect of FI, age, functional status, relative value units (RVU), American Society of Anesthesiology (ASA) score, and wound status on mortality. Statistical analysis was done using chi-square analysis and stepwise logistic regression. RESULTS A total of 67,308 patients were identified in the database, 3913 wound occurrences, 6691 infections, 12,847 occurrences of all kinds, and 2800 deaths. As the FI increased, postoperative wound infection, all occurrences, and mortality increased (P < 0.001). Stepwise logistic regression using the FI with the NSQIP variables of age, work RVU, ASA class, wound classification, emergency status, and functional status showed FI to have the highest odds ratio (OR) for mortality (OR = 2.058, P < 0.001). CONCLUSIONS A simplified FI can be obtained by easily identifiable patient characteristics, allowing for accurate prediction of postoperative morbidity and mortality in the vascular surgery population.

Frailty as a predictor of morbidity and mortality in inpatient head and neck surgery.

IMPORTANCE The increasing number of elderly and comorbid patients undergoing surgical procedures raises interest in better identifying patients at increased risk of morbidity and mortality, independent of age. Frailty has been identified as a predictor of surgical complications. OBJECTIVE To establish the implications of frailty as a predictor of morbidity and mortality in inpatient otolaryngologic operations. DESIGN Retrospective review of medical records. SETTING National Surgical Quality Improvement Program (NSQIP) participating hospitals. PATIENTS NSQIP participant use files were used to identify 6727 inpatients who underwent operations performed by surgeons specializing in otolaryngology between 2005 and 2010. The study sample was 50.3% male and 10.2% African American, with a mean (range) age of 54.7 (16-90) years. MAIN OUTCOMES AND MEASURES A previously described modified frailty index (mFI) was calculated on the basis of NSQIP variables. The effect of increasing frailty on morbidity and mortality was evaluated using univariate analysis. Multivariate logistic regression was used to compare mFI with age, ASA, and wound classification. RESULTS The mean (range) mFI was 0.07 (0-0.73). As the mFI increased from 0 (no frailty-associated variables) to 0.45 (5 of 11) or higher, mortality risk increased from 0.2% to 11.9%. The risk of Clavien-Dindo grade IV complications increased from 1.2% to 26.2%. The risk of all complications increased from 9.5% to 40.5%. All results were significant at P < .001. In a multivariate logistic regression model to predict mortality or serious complication, mFI became the dominant significant predictor. CONCLUSIONS AND RELEVANCE The mFI is significantly associated with morbidity and mortality in this retrospective survey. Additional study with prospective analysis and external validation is needed. The mFI may provide an improved understanding of preoperative risk, which would facilitate perioperative optimization, risk stratification, and counseling related to outcomes.