30-day Major Complications Research Articles

Laparoscopic Colorectal Surgery Produces Better Outcomes for High Risk Cancer Patients Compared to Open Surgery

The excellent outcomes reported for laparoscopic colorectal surgery in selected patients could also be potentially advantageous for high risk patients. This prospective study was designed to examine the feasibility and safety of laparoscopic resection in high risk patients with colorectal cancer. Between 2006 and 2008 consecutive patients undergoing elective surgery for colorectal cancer were stratified into high and low risk groups. High risk was defined as >or=80 years, American Society of Anesthesiologists >or=3, preoperative radiotherapy, T4 tumor and BMI >or=30. Outcomes included median length of stay, lymph node yield, resection margins, 30-day hospital readmission, postoperative mortality and major postoperative complications requiring reoperation within 30 days of surgery. A total of 424 patients underwent elective laparoscopic (224) and open (200) resections. Overall mortality rate for laparoscopic resection was 1 of 224 (0.4%) versus 4 of 200 (2%) for open resection. Median length of stay was 4 (2-33) versus 10 (1-69) days (P < 0.0001), and rate of complications requiring reoperation was 2 of 224 (0.8%) compared with 10 of 200 (5%) (P = 0.02).Among the 280 (66%) "high risk" patients, 146 had laparoscopic resection (8 conversions; 5%) and 134 had open resections. Median hospital stay was 4 (2-33) days in the laparoscopic group versus 11 (1-69) days in the open group (P < 0.0001). Complications requiring reoperation were 2 of 146 (1.4%) after laparoscopic resection versus 7 of 134 (5.2%) after open resection (P < 0.09). Readmission rate after laparoscopic resection was 12.3% versus 5.2% after open resection (P = 0.06). Laparoscopic resection of colorectal cancer can achieve excellent results even in "high risk" patients and is associated with significant reductions in length of stay compared with open resection.

1040 127 Resections for Pancreatic Neuroendocrine Tumor: Evaluating the Impact of Minimally Invasive and Parenchymal-Sparing Surgical Techniques

Background: Gastro-gastric fistulae are a challenging complication of obesity surgery that often requires surgical revision. Performance of endoscopic fistula closure is increasing and may provide a less invasive alternative; nevertheless, the majority of fistulae ultimately require surgical revision. The impact of prior endoscopic intervention on surgical revision outcomes remains unknown. We present the largest series on surgical revision of gastro-gastric fistulae to date and perform cohort analysis to assess the impact of prior endoscopic therapy. Methods: A database of all bariatric surgical revisions performed at a single institution was searched for patients with gastro-gastric fistula. Electronic records and clinic charts were then reviewed. The cohort was divided between patients with attempted endoscopic fistula closure prior to surgical revision, and patients without endoscopic therapy prior to revision. 30-day morbidity and mortality was the primary outcome. Age, sex, initial surgery BMI, revision surgery BMI, type of initial surgery, type of revision surgery, number of prior surgeries, number of endoscopic fistula closure attempts, presence of dilated gastrojejunostomy, number of endoscopic clips placed, number of endoscopic sutures placed, fistula size, smoking status, thyroid disease, presence of diabetes, medical co-morbidities, OR time and 30-day minor and major post-operative complications were collected. Categorical and continuous data were analyzed with Fisher's exact test and Wilcoxon signed-rank test respectively. Results: 68 total cases of surgical revision were reviewed. 35 cases were performed for gastro-gastric fistula. Of 35 cases, 22 had attempted endoscopic closure prior to surgical revision while 13 went directly to surgical revision. In the endoscopy group, 2 minor complications and 7 major complications occurred (total 9/22; 40.9%). In the surgery only group, 3 minor complications and 3 major complications occurred (total 6/13; 46.1%). No deaths occurred. No statistical difference existed in the demographic or primary outcome variables of interest between the two groups. Sub-group analysis of the endoscopy group did suggest a relationship between the number of sutures (p=0.04) and clips p=(0.04) placed at the gastrojejunostomy and major 30-day complications. Conclusion: In the largest study of surgical revision of gastro-gastric fistulae to date, there is no evidence that prior attempts at endoscopic fistula closure lead to increased complications at the time of surgical revision.

Safety and efficacy of transradial aortoiliac interventions

This study compares transradial approach (TRA) aortoiliac angioplasty/stenting to the transfemoral approach (TFA). We reviewed our peripheral database for aortoiliac interventions performed between 2007 and 2009. Demographics, clinical characteristics, procedural, and lesion details were collected. The efficacy endpoints included procedural success, ankle-brachial index (ABI) improvement, and time to discharge. The safety endpoints were as follows: occurrence of intra-/periprocedural complications, 30-day MACE, and access-site complications (minor/major). The subjects were divided into two groups, TRA and TFA, and compared using appropriate statistics. Twenty-seven patients had 33 lesions treated via TRA, and 41 patients had 47 lesions treated via TFA access. Baseline demographic differences between the TRA and TFA groups were similar, including mean Rutherford category (2.9 vs. 2.6, P = 0.31) and preintervention ABI (0.64 vs. 0.67, P = 0.80). There was a significantly higher percentage of total occlusions in the TRA group (27.3 vs. 8.5%, P = 0.03). Dye use (238 vs. 213 mL, P = 0.35) and fluoroscopy time (30 vs. 27 min, P = 0.60) were similar. Procedural success rate was similar (87.9 vs. 97.8%, P = 0.15), as well as the improvement in mean ABI (TRA: 0.64-0.77 and TFA: 0.67-0.85, P = 0.77). The time to discharge was significantly shorter for the TRA group (14.4 vs. 20.9 hr, P = 0.003). There were no 30-day MACE or major access-site complications, but minor access-site complications were lower in the TRA group (0.0 vs. 7.3%, P = 0.28), although nonsignificant. The TRA to aortoiliac interventions is as safe and effective as the TFA with the advantage of a lower rate of access-site complications and shorter hospitalization time.

Intensive care unit stay not required for patients with obstructive sleep apnea after laparoscopic Roux-en- Y gastric bypass

Background Many programs admit morbidly obese patients with obstructive sleep apnea (OSA) to the intensive care unit after laparoscopic gastric bypass (LGB), fearing pulmonary complications. Our practice has been to admit these patients to the surgical floor. Our objective was to compare the perioperative course and outcomes in morbidly obese patients with OSA to those of patients without OSA undergoing LGB in a physician-led health system with a 325-bed community teaching hospital serving 19 counties. Methods We retrospectively reviewed the medical records of 650 patients who had undergone LGB from 2001 to 2008 and divided them into 2 groups: patients with OSA as confirmed by polysomnography (OSA group) and those without OSA (non-OSA group). The patients who reported a diagnosis of OSA without documentation confirming the diagnosis were excluded. The statistical analysis included t tests and chi-square tests. Results A total of 217 patients met the inclusion criteria for the OSA cohort and 368 for the non-OSA cohort. Of the 650 patients, 65 reported a history of OSA without confirmation and were excluded from the present study, leaving 585 patients. The demographic data were similar between the 2 groups, and no difference was found between the OSA and non-OSA groups for the length of postanesthesia care unit stay (105.4 versus 106.3 minutes), length of hospital stay (2.2 days for both groups), and 30-day major complication rate (3.7% versus 5.2%). No deaths and no intensive care unit admissions for pulmonary complications occurred in either group. Conclusion The results of our study have shown that morbidly obese patients with OSA undergoing LGB have a perioperative course and postoperative pulmonary complication rate similar to that of patients without OSA. Thus, routine admission to the intensive care unit after LGB in patients with OSA is not indicated.

6569 Role of FDG-PET/CT in predicting pathological response and survival in locally advanced esophageal cancer patients (p) treated with neoadjuvant chemoradiotherapy

We sought to determine the safety and feasibility of esophagectomy after neoadjuvant immunotherapy and chemoradiotherapy in clinical trial patients with locally advanced esophageal cancer.We retrospectively identified patients who were treated with neoadjuvant immunotherapy and chemoradiotherapy (n = 25) or chemoradiotherapy alone (n = 143) at our institution between 2017 and 2020. The primary end point was risk of 30-day major complications (Clavien-Dindo classification system grade ≥ 3), which was assessed between groups using a multivariable log-binomial regression model to obtain adjusted relative risk ratios. Secondary end points were interval to surgery, 30-day readmission rate, and 30-day mortality.All included patients successfully completed neoadjuvant therapy and underwent esophagectomy with negative margins. Age, sex, performance status, clinical stage, histologic subtype, procedure type, and operative approach were similar between groups. Neoadjuvant immunotherapy was not associated with a statistically significantly increased risk of developing a major pulmonary (relative risk, 1.43; 95% confidence interval, 0.53-3.84; P = .5), anastomotic (relative risk, 1.34; 95% confidence interval, 0.45-3.94; P = .6), or other complication (relative risk, 1.29; 95% confidence interval, 0.26-6.28; P = .8). Median (interquartile range) interval to surgery was 54 days (47-61 days) in the immune checkpoint inhibitor group versus 53 days (47-66 days) in the control group (P = .6). Minimally invasive approaches were successful in 72% of cases, with only 1 conversion. Thirty-day mortality and readmission rates were 0% and 17%, respectively, in the immune checkpoint inhibitor group and 1.4% and 13%, respectively, in the control group.On the basis of our preliminary experience, esophagectomy appears to be safe and feasible following combined neoadjuvant immunotherapy and standard chemoradiotherapy for locally advanced esophageal cancer.

Significant perioperative morbidity accompanies contemporary infrainguinal bypass surgery: An NSQIP report

A variety of clinical and anatomic factors influence the choice between infrainguinal bypass surgery (BPG) and percutaneous endovascular procedures (PTA) to treat lower extremity vascular disease. The decision, in part, is dependant on periprocedural morbidity. The goal of this study was to document the contemporary morbidity and mortality of infrainguinal BPG, utilizing the previously validated National Surgical Quality Improvement Program (NSQIP) database. Data from the private sector NSQIP, a prospectively validated systematic-sample database, using Current Procedural Terminology (CPT) codes for all infrainguinal BPG performed between January 1, 2005, and December 31, 2006, were analyzed. Study endpoints included 30-day death and NSQIP-defined major complications, including graft failure, differentiated between systemic vs operative-site related complications. Potentially associated clinical variables were assessed by univariate methods to create the multivariate models of factors associated with study endpoints. There were 2404 infrainguinal BPG (infrapopliteal distal anastomosis 42%, prosthetic 29%) performed in the study interval with patient variables: age 67 +/- 12, male 66%, diabetes 44%, limb salvage indications 48%. The 30-day composite mortality/major morbidity was 19.5%. The overall mortality was 2.7% and correlated with (P value, odds ratio [OR]): patient age (<.001, 1.056), low body weight (.007, 0.988), significant preoperative dyspnea (.03, 1.97), dialysis (.003, 5.26), history transient ischemic attack (.03, 2.43), and bleeding disorder (.02, 2.01). Major complications occurred in 18.7% patients, including 7.4% graft thromboses, and 9.4% wound infections. Major systemic complications occurred in 5.9% and correlated with: age (.001, 1.03), history myocardial infarction (.02, 2.37), dialysis (<.001, 2.52), impaired sensorium (.005, 2.93), and general (vs regional) anesthesia (.04, 1.9). Major operative site-related complications occurred in 15.1% and correlated with: history chronic obstructive pulmonary disease (.04, 1.40), limb salvage indication (<.001, 1.71), impaired sensorium (.01, 2.26), non-independent preoperative functional status (.03, 1.37), and operative time (<.001, 1.002). The combination of dialysis and age >80 was identified as the most powerful high-risk composite for death (13.3-fold) and major complications (2.2-fold). Infrainguinal BPG is accompanied by significant major morbidity and mortality in contemporary practice. These results reinforce the precept that stringent indications for BPG should be maintained, when considering the method of lower extremity revascularization.

LapBand System® in Super-Superobese Patients (&gt;60 kg/m2): 4-Year Results

Bariatric surgery in superobese (BMI > 50 kg/m(2)) and super-superobese (BMI > 60 kg/m(2)) patients can be a formidable technical and therapeutic challenge because these patients often present multiple medical, surgical, and anesthetic risks. Only a few dedicated reports on different surgical options in this kind of patient population are available. The aim of this study is the evaluation of laparoscopic adjustable gastric banding (LAGB) results in an unselected populations of super-superobese patients operated during the last 4 years. Super-superobese (BMI > 60 kg/m(2)) patients who underwent LAGB were recruited from the prospective database of our institution. LapBand System (Allergan, Irvine, CA, USA) was positioned in all cases via pars flaccida, 1-2 cm below the gastroesophageal junction and fixed anteriorly with three non-absorbable stitches. The band was not filled at the time of surgery. Operative time, co-morbidities, laparotomic conversion, intra- and postoperative complications, mortality, and weight-loss-related parameters were considered. Data were expressed as mean +/- standard deviation, except as otherwise indicated. From January 2003 to December 2006, 823 patients underwent a bariatric surgical procedure, 95 of whom (11.5%) were BMI > 60 kg/m(2) (59 F/ 36 M; mean BMI, 62.5 +/- 4.2; range, 60.1-77 kg/m(2); mean age 38.5 +/- 13.5, range 18-61 years old). Mortality, intraoperative, and 30-day major complications were absent. One or more preoperative co-morbidities were diagnosed in 90 of 95 (94.7%) patients. After 1 year, co-morbidity-free patients increased from five of 95 (5.3%) to 27 of 95 (28%; p < 0.001). Patients with three or more co-morbidities decreased from 62 of 95 (65.3%) to 0 (p < 0.001). Mean BMI was 43.6 in 95 of 95, 37.9 in 55 of 55, 29.1 in 11 of 11, and 28.9 in five of five patients at 12, 24, 36, and 48 months, respectively. At the same time, %EWL was 53.6, 69.7, 81.3, and 82.1 and %EBL was 50, 66, 90, and 91. LAGB can be considered an appropriate bariatric surgical option in super-superobese patients both for low morbidity rate and weight loss. The end-point of BMI < 30 can be achieved with a multidisciplinary follow-up. Additional studies with more patients and longer follow-up are needed to confirm these observations.

Bands and bypasses: 30-day morbidity and mortality of bariatric surgical procedures as assessed by prospective, multi-center, risk-adjusted ACS-NSQIP data

Previous multi-institution comparisons of open and laparoscopic Roux-en-Y gastric bypass (ORYGB and LRYGB), and laparoscopic adjustable gastric banding (LAGB) have been limited by the lack of unique current procedural terminology (CPT) codes. Specific codes have been available for LRYGB and LAGB since 2005 and 2006, respectively. We compare the short-term safety of these procedures, using risk-adjusted clinical data from a multi-institutional quality improvement program. The America College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Participant Use File (PUF) was used to compare patients undergoing LRYGB with those undergoing ORYGB or LAGB. ORYGB versus LRYGB: The 2-year study period (2005-2006) included 5,777 patients (ORYGB = 1,146, LRYGB = 4,631). Patients undergoing ORYGB experienced a higher 30-day incidence of mortality (0.79% vs. 0.17%; p = 0.002), major complications rate (7.42% vs. 3.37%; p < 0.0001), any complication rate (13.18% vs. 6.69%; p < 0.0001), return visits to the OR (4.97% vs. 3.56%; p = 0.032), and longer postoperative length of stay (LOS) (median 3 vs. 2 days; p < 0.0001). After risk adjustment, ORYGB continued to demonstrate higher odds of major complication (OR = 2.04; [1.54, 2.69]). LAGB versus LRYGB: Analysis of 1 year of data from 2006 included 4,756 patients (LRYGB = 3,580, LAGB = 1,176). Those treated with LAGB experienced an equivalent 30-day mortality (0.09% vs. 0.14%; p = 1.0), and a lower rate of major complications (1.0% vs. 3.3%; p < 0.0001), any complication (2.6% vs. 6.7%; p < 0.0001), return visits to the OR (0.94% vs. 3.6%; p < 0.0001), and shorter postoperative LOS (median 1 vs. 2 days; p < 0.0001). Risk adjustment showed that LAGB was associated with a lower major complication odds (OR = 0.29; [0.16, 0.53]). Compared with LRYGB, ORYGB is associated with higher 30-day mortality and higher risk-adjusted major complication rate. While ORYGB may sometimes be indicated, a laparoscopic approach may be safer for RYGB when feasible. LAGB, compared with LRYGB, has a similarly low mortality rate and a small but statistically significant decrease in risk-adjusted 30-day complications. Clinical efficacy and long-term outcomes will need to be evaluated to determine superiority between these procedures.

One-Stage Bilateral Total Hip Arthroplasty Compared With Unilateral Total Hip Arthroplasty: A Prospective Study

It is believed that patients undergoing 1-stage bilateral joint arthroplasty are at higher risk for developing cardiopulmonary and possibly other complications. The aim of this prospective matched study was to evaluate and compare the morbidity profile of patients undergoing 1-stage bilateral uncemented total hip arthroplasty (BTHA) vs unilateral uncemented THA (UTHA). One hundred consecutive patients undergoing 1-stage bilateral THA (50 patients, 100 hips) and unilateral THA (50 patients) were recruited and prospectively followed. There were no statistically significant differences in 90-day mortality, individual major (BTHA, 8%; UTHA, 10%) or minor (BTHA, 20%; UTHA, 26%) complications between the 2 groups. Bilateral THA patients required more autologous and allogenic blood transfusion and had lower hemoglobin at discharge than UTHA patients. Patients undergoing BTHA should expect a slightly higher incidence of complications related to postoperative anemia.

RESPONSE: Re: 30-Day Mortality and Major Complications after Radical Prostatectomy: Influence of Age and Comorbidity

RESPONSE: Re: 30-Day Mortality and Major Complications after Radical Prostatectomy: Influence of Age and Comorbidity

Re: 30-Day Mortality and Major Complications after Radical Prostatectomy: Influence of Age and Comorbidity

Re: 30-Day Mortality and Major Complications after Radical Prostatectomy: Influence of Age and Comorbidity

Does Bilateral Internal Thoracic Artery Grafting Increase Long-Term Survival of Diabetic Patients?

The purpose of the present study was to determine whether long-term survival in diabetic patients increased after bilateral internal thoracic artery (BITA) coronary bypass compared with matched patients with single internal thoracic artery (SITA) coronary bypass. The propensity for BITA was determined using logistic regression analysis and each BITA patient was matched with one SITA patient. Between January 1992 and March 2002, 980 matched diabetic patients (490 BITA versus 490 SITA) underwent coronary artery bypass surgery. Long-term survival data were obtained from the National Death Index (mean follow-up, 4.7 +/- 3.0 years). Groups were compared by Cox proportional hazard models and Kaplan-Meier survival plots. Multivariate Cox regression analysis determined that BITA grafting had no significant effect on long-term survival (hazard ratio 0.89, 95% confidence interval: 0.69 to 1.14, p = 0.343). There were no differences in 30-day mortality (3.9% for BITA versus 3.7%, p = 0.999) and major postoperative complications except for length of stay (11.4 days for BITA versus 12.7 days, p < 0.001). Five-year survival rate was 79.9% in the BITA group and 75.7% in the SITA group (p = 0.252). There was no difference in 5-year survival rate between matched patients younger than 60 or from 70 to 79 years old. However, BITA patients aged 60 to 69 years had better 5-year survival rates (84.1% versus 71.0%, p = 0.0196), whereas the opposite was observed in patients aged more than 79 years (5-year survival for BITA 43.1% versus 70.0%, p = 0.016). Bilateral internal thoracic artery grafting had no significant effect on long-term survival for diabetic patients, but it may increase long-term survival in patients aged 60 to 69 years, whereas SITA grafting may be beneficial for patients more than 79 years old.

30-Day Mortality and Major Complications after Radical Prostatectomy: Influence of Age and Comorbidity

Radical prostatectomy is associated with excellent long-term disease control for localized prostate cancer. Prior studies have suggested an increased risk of short-term complications among older men who underwent radical prostatectomy, but these studies did not adjust for comorbidity. We examined mortality and complications occurring within 30 days following radical prostatectomy among all 11,010 men who underwent this surgery in Ontario, Canada, between 1990 and 1999 using multivariable logistic regression modeling. We adjusted for comorbidity using two common comorbidity indices. Statistical tests were two-sided. Overall, 53 men (0.5%) died, and 2195 [corrected] (19.9%[corrected]) had one or more complications within 30 days of radical prostatectomy. In models adjusted for comorbidity and year of surgery, age was associated with an increased risk of 30-day mortality (odds ratio = 2.04 per decade of age, 95% confidence interval [CI] = 1.23 to 3.39). However, the absolute 30-day mortality risk was low, even in older men, at 0.66% (95% CI = 0.2 to 1.1%) for men aged 70-79 years. In adjusted models, age was associated with an increased risk of cardiac (Ptrend < .001), respiratory (Ptrend = .01), and miscellaneous medical (Ptrend = .058) complications. Similarly, increasing comorbidity was associated with a higher risk of all categories of complications. Increasing comorbidity is a stronger predictor than age of almost all categories of early complications after radical prostatectomy. The risk of postoperative mortality after radical prostatectomy is relatively low for otherwise healthy older men up to age 79.

The potential for bronchoscopic lung volume reduction using bronchial prostheses. A pilot study

The potential for bronchoscopic lung volume reduction using bronchial prostheses. A pilot study

The society of thoracic surgeons: 30-day operative mortality and morbidity risk models

Background Although 30day risk-adjusted operative mortality (ROM) has been used for quality assessment, it is not sufficient to describe the outcomes after coronary artery bypass grafting (CABG) surgery. Risk-adjusted major morbidity may differentially impact quality of care (as complications occur more frequently than death) and enhance a surgical team’s ability to assess their quality. This study identified the preoperative risk factors associated with several complications and a composite outcome (the presence of any major morbidity or 30-day operative mortality or both). Methods For CABG procedures, the 1997 to 1999 Society of Thoracic Surgeons (STS) National Adult Cardiac Surgery Database was used to develop ROM and risk-adjusted morbidity (ROMB) models. Risk factors were selected using standard STS univariate screening and multivariate logistic regression approaches. Risk model performance was assessed. Across STS participating sites, the association of observed-to-expected (O/E) ratios for ROM and ROMB was evaluated. Results The 30-day operative death and major complication rates for STS CABG procedures were 3.05% and 13.40%, respectively (503,478 CABG procedures), including stroke (1.63%), renal failure (3.53%), reoperation (5.17%), prolonged ventilation (5.96%), and sternal infection (0.63%). Risk models were developed (c-indexes for stroke [0.72], renal failure [0.76], reoperation [0.64], prolonged ventilation [0.75], sternal infection [0.66], and the composite endpoint [0.71]). Only a slight correlation was found, however, between ROMB and ROM indicators. Conclusions Used in combination, ROMB and ROM may provide the surgical team with additional information to evaluate the quality of their care as well as valuable insights to allow them to focus on areas for improvement.

Successful “pre-closure” of 7Fr and 8Fr femoral arteriotomies with a 6Fr suture-based device (the Multicenter Interventional Closer Registry)

The arterial sheath remains a cause of vascular complications, restricted mobility, and discomfort in patients who have undergone percutaneous interventional procedures. The rate of vascular complications and bleeding increases with longer sheath dwell times. Larger sheath sizes further elevate this risk, as might the administration of antithrombotic agents and intravenous glycoprotein IIb/IIIa inhibitors. Arterial closure devices have been advocated as a means of increasing patient comfort and facilitating rapid ambulation after interventional procedures, while possibly decreasing complication rates. Arterial closure with the 8Fr or 10Fr suture-based Prostar-Plus (Perclose Inc., Redwood City, California) has previously been shown to provide effective hemostasis. Use of the 6Fr suture-based Techstar has been shown to be effective for closure of 6Fr sheaths, but use of the smaller 6Fr device for 7Fr and 8Fr holes has not been systematically examined. Although the 8Fr device can provide hemostasis for 8Fr sheaths effectively, the current version requires subcutaneous dissection with formation of a soft tissue tract from the skin to the level of the artery. Such a tract can lead to continuous oozing, particularly in the presence of glycoprotein IIb/IIIa blockade. Potentially, such a tract may also increase the risk of infection. Therefore, use of a smaller device to close the hole formed by a larger sheath, without the need for tract formation, could represent an advance in suture-based arterial closure. The goal of this study was to determine if such an approach is safe and effective. • • • The Closer trial is a prospective registry of 380 patients conducted at 10 centers in the United States from March 2000 to December 2000. Of these, 160 patients undergoing coronary or peripheral intervention through 7Fr to 8 Fr sheaths had percutaneous sutures deployed before sheath placement (“preclose” arm), with tying of sutures after sheath removal. The preclose arm of the Closer trial was prespecified and independently powered for analysis. Informed consent was obtained from all patients. The technique of preclosure involves initial placement of a smaller size sheath than the size intended for the procedure (Figure 1). Specifically, a 6Fr sheath was placed initially. An angiogram of the femoral artery was performed to ensure placement of the sheath above the bifurcation of the superficial femoral artery and the profunda femoris branch. A femoral artery diameter of at least 5 mm and absence of any significant atheroma at the puncture site were required. If these conditions were met, then the sheath was exchanged over a guidewire for the 6Fr Closer device. The device was positioned in the artery, the sutures deployed, and the device removed over the wire, with placement of the 7Fr or 8Fr sheath. The interventional procedure was performed and once completed, the sheath was removed and the sutures tied, obtaining hemostasis. If the operator elected to maintain arterial access during this last step, the wire was reintroduced as the knot was tightened, with the wire removed just before the knot was cinched. The prespecified historical control consisted of interventional patients randomized to manual compression from the Suture To Ambulate aNd Discharge (STAND II) trial. The primary safety end point was the incidence of 30-day major groin complications, whereas the primary efficacy end point was time to discharge, measured from the time of sheath removal to the time the patient left the hospital. Secondary end points included time to hemostasis and ambulation, as well as device and procedural success. Differences in means were calculated with 95% confidence intervals. Tests of significance were performed using the nonparametric Wilcoxon method. Statistical calculations were performed with Intercooled Stata 6.0 (Stata Corp., College Station, Texas) and Microsoft Excel 5.0 (Microsoft Corp., Redmond, Washington). The mean activated clotting time was 232 seconds in the Closer patients. There were no significant differences in baseline characteristics, other than more From the Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland Ohio; Evanston Hospital, Evanston, Illinois; Wake Forest University School of Medicine, Winston-Salem, North Carolina; Arkansas Heart Hospital, Little Rock, Arkansas; Arizona Heart Institute, Phoenix, Arizona; Sacred Heart Hospital, Pensacola, Florida; Fountain Valley Regional Hospital, Fountain Valley, California; and the St. Joseph’s Hospital, Atlanta, Georgia. Dr. Bhatt’s address is: Cleveland Clinic Foundation, Department of Cardiovascular Medicine/Desk F25, 9500 Euclid Avenue, Cleveland, Ohio 44195. E-mail: bhattd@ccf.org. Manuscript received August 29, 2001; revised manuscript received and accepted November 27, 2001.

Potential Impact of Magnetic Resonance Cholangiopancreatography on Endoscopic Retrograde Cholangiopancreatography Workload and Complication Rate in Patients Referred Because of Abdominal Pain

Endoscopic retrograde cholangiopancreatography (ERCP) has a significant mortality, morbidity, and failed cannulation rate. Magnetic resonance cholangiopancreatography (MRCP) is a safer, noninvasive method of imaging the pancreaticobiliary tree. A substantial number of patients are referred for ERCP because of abdominal pain, a high proportion of whom have normal ducts or pathology not requiring interventional ERCP. The aim was to assess the potential impact of MRCP on overall ERCP workload and patient outcome if MRCP were the primary investigation in patients referred for ERCP because of abdominal pain. 1758 consecutive ERCPs performed in 1148 patients over a 3-year period in a single tertiary referral center in the pre-MRCP era were reviewed. Cannulation failure, ERCP findings, need for follow-up ERCP and all 30-day major complication rates were analyzed with regard to clinical indications. The overall workload comprised 1108 (63 %) successful initial ERCPs, 188 (11 %) failed cannulation attempts and 462 (26 %) follow-up ERCPs. Of the patients, 299 (27 %) had normal ERCP findings, 331 (30 %) had choledocholithiasis and 246 (22 %) had strictures. lf MRCP had been used as the primary imaging investigation in the 451 patients (39 %) referred for ERCP because of abdominal pain, we estimate that 197 patients (44 %) would have avoided ERCP, and the overall ERCP workload would have been reduced by 13 %. Initial MRCP in suspected gallstone pancreatitis and certain miscellaneous groups, it was estimated, would have further decreased ERCP workload by 9 %. Four of 40 major ERCP-related complications (3.5 %) and one of four ERCP-related deaths (0.35 %) would potentially have been avoided. Initial MRCP in patients referred with abdominal pain would potentially have avoided ERCP in 44 % of cases, reduced ERCP workload by 13 % and significantly reduced patient morbidity and mortality. The relatively small reduction in ERCP workload among these patients reflects the fact that over half of them had probable sphincter dysfunction, a significant proportion of whom might have benefited from biliary manometry and/or endoscopic intervention despite a normal MRCP. Furthermore, a small number of patients with calculi and subtle biliary and pancreatic strictures would be missed by this approach.

Mid-term clinical and angiographic follow-up outcome after placement of a new balloon expandable stent in native coronary arteries.

The widely disparate characteristics that exist among the different stent designs currently available for clinical use may impact on their acute and late angiographic and clinical results. The BeStent (Medtronic Instent, MN) is a relatively new stainless steel, laser-cut, serpentine stent design with only very limited data regarding its performance. In this report, we examined the results of 74 consecutive patients (54 men, 20 women; mean age, 58 years) treated with 76 BeStents in 75 native coronary arteries with a mean reference size of 2.8 mm. Successful stenting without 30-day major adverse cardiac complications was achieved in 97.3% of procedures, resulting in a significant improvement in diameter stenosis from 85% to 2% (P = 0.0001). Six-month angiographic restudy in 88% of patients revealed a per-lesion in-stent restenosis rate of 27%. At a mean follow-up period of 9.3 months, there were no deaths or myocardial infarctions. In summary, the present study demonstrates that the BeStent has an excellent performance profile, is associated with a low risk of stent thrombosis, and yields an acceptable restenosis rate despite the inclusion of a high proportion of patients with diabetes (41%) and small vessels (< 3.0 mm in diameter; 77%).

Rapid-staged strategy for concomitant critical carotid and left main coronary disease with left ventricular dysfunction: IABP use

Background. Few reports address the high-risk patient population with concomitant critical carotid and left main coronary disease with left ventricular dysfunction. To decrease the risks involved with the simultaneous and traditional staged surgical approaches, we developed a rapid staging strategy using an intraaortic balloon pump. Methods. Between 1992 and 1996, 20 patients presented with a high-risk “triad” defined by greater than 70% stenosis of the left main coronary artery, ejection fraction less than 0.30, and greater than 90% stenosis of the internal carotid artery. An intraaortic balloon pump was placed immediately before carotid endarterectomy under angiographic guidance. Less than 24 hours later (mean, 18 hours) coronary artery bypass grafting was performed, and the intraaortic balloon pump was removed the day of coronary artery bypass grafting in all cases (total IABP duration, <36 hours). Results. Eighteen patients (18/20) were extubated on the day of coronary artery bypass grafting (mean, 12 hours). Sixteen patients (16/20) were transferred from the intensive care unit within 48 hours, with total hospital stay ranging from 6 to 12 days (mean, 8 days). There were no 30-day postoperative deaths, myocardial infarctions, or neurologic, vascular, bleeding, or other major complications. At a mean 29.4-month follow-up, there were two noncardiac deaths and no neurologic events. Six-month, 1-year, and 2-year follow-up ultrasounds showed all operative carotid arteries remained patent. Conclusions. A rapid staged procedure with angiographically guided placement of the intraaortic balloon pump was safe and effective in this very high risk patient population. It may be an option to decrease the risks involved with simultaneous operations and increase the efficiency and safety of “traditional” staged carotid and coronary artery bypass grafting procedures.