Significant Increase In Major Complications Research Articles

Radial Endobronchial Ultrasound-guided Transbronchial Cryobiopsy versus Forceps Biopsy for the Diagnosis of Solitary Pulmonary Nodules: A Prospective Randomised Trial.

Improvements in pulmonary diagnostic imaging and the development of lung cancer screening are increasing the prevalence of Solitary pulmonary nodules (SPNs). Fluoroscopically guided radial endobronchial ultrasound (EBUS) with transbronchial forceps biopsy (TB-FB) has been the conventional diagnostic method. Transbronchial cryobiopsy (TB-CB) is an alternative biopsy method. We sought to compare transbronchial cryobiopsy to transbronchial forceps biopsy for the diagnosis of SPNs. A prospective, single-centre, randomised controlled trial was conducted at the Royal Adelaide Hospital (RAH). Patients with SPNs were randomised to either 5 transbronchial forceps biopsies or one transbronchial cryobiopsy. Complete blinding of investigators and participants was not possible, as transbronchial cryobiopsy required general anaesthesia. The primary outcome was diagnostic yield with secondary outcomes of specimen size, diagnostic yield for subsets challenging to access with forceps and safety. The overall diagnostic yield for the 28 enrolled subjects was 76.8%(22/28). The diagnostic yield was 91.7% (11/12 patients) for transbronchial cryobiopsy and 68.8% (11/16 patients) for forceps biopsy (p=0.14). Median biopsy sizes were consistently larger for the cryobiopsy arm at 7.0mm compared to 2.5mm(p<0.0001). An eccentric EBUS image signalling the probe was adjacent to the nodule occurred in 4/28 cases, and TB-CB confirmed a diagnosis in 3/3 randomised to this arm. There were no major complications with either technique. Transbronchial cryobiopsy under the guidance of fluoroscopy and radial EBUS facilitates larger biopsy specimens without a significant increase in major complications. Further research is required to confirm the effect on diagnostic yield; however, our study supports a role for TB-CB in the diagnosis of SPNs and small, nodule-adjacent biopsies. Reference number of R20160213(HREC/16/RAH/37).

PD07-11 PARTIAL VERSUS RADICAL NEPHRECTOMY FOR COMPLEX RENAL MASS: MULTICENTER COMPARATIVE ANALYSIS OF FUNCTIONAL OUTCOMES (ROSULA COLLABORATIVE GROUP)

PD07-11 PARTIAL VERSUS RADICAL NEPHRECTOMY FOR COMPLEX RENAL MASS: MULTICENTER COMPARATIVE ANALYSIS OF FUNCTIONAL OUTCOMES (ROSULA COLLABORATIVE GROUP)

MP59-10 COMPARISON OF RENAL FUNCTIONAL OUTCOMES AFTER RADICAL OR PARTIAL NEPHRECTOMY FOR COMPLEX RENAL MASS: ANALYSIS FROM THE ROSULA (ROBOTIC SURGERY FOR LARGE RENAL MASS) COLLABORATIVE GROUP

MP59-10 COMPARISON OF RENAL FUNCTIONAL OUTCOMES AFTER RADICAL OR PARTIAL NEPHRECTOMY FOR COMPLEX RENAL MASS: ANALYSIS FROM THE ROSULA (ROBOTIC SURGERY FOR LARGE RENAL MASS) COLLABORATIVE GROUP

Impact of Obesity on Atrial Fibrillation Recurrence Following Stand-Alone Cox Maze IV Procedure

Obesity is a strong and independent factor for the development of atrial fibrillation (AF), and adversely impacts the success of catheter ablation procedures for AF. This study evaluated the impact of body mass index (BMI) on the outcomes following surgical ablation of AF. Between 2003 and 2019, 236 patients underwent a stand-alone biatrial Cox maze IV procedure (CMP-IV) for refractory AF. Obesity was defined as BMI ≥30 kg/m2. Patients were divided into two groups: BMI <30 kg/m2 (n = 100) and BMI ≥30 kg/m2 (n = 136). Freedom from atrial tachyarrhythmia (ATA) was determined using electrocardiography, Holter, or pacemaker interrogation at 1 year and annually thereafter. Recurrence was defined as any documented ATA lasting ≥30 s. Predictors of recurrence were determined using multivariable logistic regression. Preoperative and procedural outcomes were compared between groups. Obese patients had a higher rate of diabetes (16% vs 7%, P = 0.044) and larger left atrial diameter (4.9 ± 1.1 cm vs 4.6 ± 1.0 cm, P = 0.021) when compared to non-obese patients. There was no difference in major complication rate between the groups (4% vs 7%, P = 0.389). There was no operative mortality in either group. During 4.1 ± 2.4 years of follow-up, there was no significant difference in freedom from ATA with or without antiarrhythmic drugs in obese patients when compared to the non-obese group (P > 0.05). Absence of sinus rhythm at discharge predicted AF recurrence up to 7 years postoperatively. As opposed to catheter ablation, obesity did not adversely impact the short and long-term outcomes of stand-alone surgical ablation with CMP-IV, and BMI was not a predictor of AF recurrence. Additionally, there was no significant increase in major complications in obese patients.

Risk score for major complications after total hip arthroplasty: the beneficial effect of neuraxial anesthesia. A retrospective observational study

Background: Total hip arthroplasty (THA) is an effective treatment for symptomatic osteoarthritis after failed nonsurgical therapies. Minimizing perioperative complications is critical for faster recovery and shorter hospital stay. The primary aim of this study was to identify predictors of perioperative major complications (MC) and mortality after THA, and to use these predictors to develop a risk scoring system. Methods: The 2006-2016 National Surgical Quality Improvement Program (NSQIP) database was queried for adult patients who underwent primary elective THA performed under general or neuraxial anesthesia. Univariate and multivariate logistic regression and bootstrap analyses were used to select the strongest predictors for MC. A simple risk score was created based on the beta estimates for the selected predictors. Results: Included were 104,404 cases. The final model had five predictors for MC: age ≥65 yr, congestive heart failure, hypertension, creatinine ≥2 mg/dL, and diabetes mellitus. The model had a fair discrimination ability with an area under the curve (AUC) value of 0.67 on the training sample and 0.65 on the test sample. The model had good calibration for the data in both the training and test samples. Neuraxial anesthesia decreased the risk of MC (OR 0.54 [95% CL, 0.44–0.66], P&lt;0.0001). Risk scores for MC ranged from 0 to 13. A risk score of 4 or greater was associated with a significant increase in MC. Conclusions: Neuraxial anesthesia is associated with decreased risk of MC after THA. The risk model developed may assist with preoperative decision-making regarding the choice of anesthesia, selection of outpatient cases, and postoperative care. Level of Evidence: Level III.

Comparison of Complications of Catheter Ablation for Ventricular Arrhythmias in Adults With Versus Without Structural Heart Disease

Catheter ablation (CA) is an effective treatment for ventricular arrhythmias (VA), with a potential for complications. The presence of structural heart disease (SHD) is associated with a higher complication rate although there is no data comparing CA of VA between patients with SHD and those without. We aimed to compare trends, morbidity, and mortality associated with real world practice of CA for VA (ventricular tachycardia and premature ventricular contraction) based on the presence of SHD. Using weighted sampling in the National Inpatient Sample database, we collected and compared characteristics and outcomes of patients with or without SHD that underwent CA of VA. Among 34,907 patients that underwent CA for VA (1999-2013), 18,014 (51.6%) had SHD. Major and all complications occurred among 1,135/18,014 (6.3%) and 2139/18,014 (11.9%) patients with SHD respectively compared with 355/16,893 (2.1%) and 739/16,893 (4.4%) for patients without SHD, p < 0.001 for both comparisons. Furthermore, 452/18,014 (2.51%) with SHD died versus 20/16,893 (0.12%) without SHD, p < 0.001. Heart failure was associated with an odds ratio (OR) of 3.09 for major complications (95%CI: 1.53-6.27, p = 0.002) for patients with SHD while coronary artery disease OR for major complications was 2.47 (95%CI: 1.44-4.23, p = 0.001) for patients without SHD. There was a significant increase in major complications over the 15-year study period in patients with SHD, p < 0.001. In conclusion, the presence of SHD during CA for VA increased the complication rate of major and any complications by approximately threefold for both and the hospital mortality by >20-fold compared with patients without SHD.

Radical cystectomy in patients with disseminated disease: An assessment of perioperative outcomes using the National Surgical Quality Improvement Program database.

We sought to determine the effect of the presence of disseminated disease on perioperative outcomes following radical cystectomy for bladder cancer. We identified 4108 eligible patients who underwent radical cystectomy for bladder cancer using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. We matched patients with disseminated cancer at the time of surgery to those without disseminated cancer using propensity scores. The primary outcome of interest was major complications (death, reoperation, cardiac or neurological event). Secondary outcomes included pulmonary, infectious thromboembolic, and bleeding complications, in addition to prolonged length of stay. Generalized estimating equations were used to examine the association between disseminated cancer and the development of complications. Following propensity score matching and adjusting for the type of urinary diversion, radical cystectomy in patients with disseminated disease was associated with a significant increase in major complications (8.6% vs. 4.0%; odds ratio [OR] 2.50; 95% confidence interval [CI] 1.02-6.11; p=0.045). The presence of disseminated disease was associated with an increase in pulmonary complications (5.8% vs. 1.2%; OR 5.17. 95% CI 1.00-26.66. p=0.049), but not infectious complications, venous thromboembolism, bleeding requiring transfusion, and prolonged length of stay (p values 0.07-0.79). Patients with disseminated cancer undergoing cystectomy are more likely to experience major and pulmonary complications. The strength of these conclusions is limited by sample size, selection bias inherent in observational data, and a lack of specific oncological detail in the database.

Feasibility of Laparoscopic Total Mesorectal Excision with Extended Lateral Pelvic Lymph Node Dissection for Advanced Lower Rectal Cancer after Preoperative Chemoradiotherapy.

The feasibility of additional lateral pelvic lymph node dissection (LPLND) compared with total mesorectal excision (TME) alone in patients treated with preoperative chemoradiotherapy (CRT) is controversial, especially in laparoscopic surgery. This study was performed to evaluate the feasibility of adding laparoscopic LPLND to TME in patients with advanced lower rectal cancer and swollen LPLNs treated with preoperative CRT. We reviewed 327 patients with lower rectal cancer without distant metastasis who underwent preoperative CRT followed by laparoscopic TME. Laparoscopic LPLND was added in patients with swollen LPLNs before CRT. Outcomes were compared between patients with (n=107) and without (n=220) LPLND. LPLN metastasis was found in 26 patients (24.3%) in the LPLND group. The operation time was significantly longer, and total blood loss was significantly greater in the LPLND than TME group (461 vs. 298min and 115 vs. 30mL, respectively; P<0.0001). The major complication rate was similar in the LPLND and TME groups (9.3 vs. 5.5%, respectively; P=0.188), and there were no conversions to open surgery. The LPLND and TME groups also showed a similar 3-year relapse-free survival rate (84.7 vs. 82.0%, respectively; P=0.536) and local recurrence rate (3.2 vs. 5.2%, respectively; P=0.569) despite significantly more patients with pathological lymph node metastasis in the LPLND than TME group (37.4 vs. 22.3%, respectively; P<0.0001). Additional laparoscopic LPLND is feasible in patients with advanced lower rectal cancer and clinically swollen LPLNs treated with preoperative CRT, with no significant increase in major complications compared with TME alone.

Procedural outcomes of chronic total occlusion percutaneous coronary intervention: a report from the NCDR (National Cardiovascular Data Registry).

The aim of this study was to describe contemporary frequency, predictors, and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in the United States. CTO PCI can provide significant clinical benefits, yet there is limited information on its success and safety in unselected patient populations. We analyzed the frequency and outcomes of CTO PCI compared with non-CTO PCI in elective patients, and of successful versus failed CTO PCI between July 1, 2009, and March 31, 2013, in the National Cardiovascular Data Registry CathPCI Registry. Generalized estimating equations logistic regression modeling was used to generate independent variables associated with procedural success and procedural complications. During the study period, CTO PCI represented 3.8% of the total PCI volume for stable coronary artery disease (22,365 of 594,510). Overall, patients undergoing CTO PCI required greater contrast volume and longer fluoroscopy time and had lower procedural success (59% vs. 96%, p < 0.001) and higher major adverse cardiac event (1.6% vs. 0.8%, p < 0.001) rates than non-CTO PCI patients. On multivariable analysis, several parameters (including older age, current smoking, previous myocardial infarction, previous coronary artery bypass graft, previous peripheral arterial disease, previous cardiac arrest, right coronary artery CTO target vessel, and less operator experience) were associated with a lower likelihood of CTO PCI procedural success, whereas operators' annual CTO PCI volume was associated with improved success without a significant increase in major complications. CTO PCI is currently performed infrequently in the United States for stable coronary artery disease and is associated with lower procedural success and higher complication rates compared with non-CTO PCI. Procedural success was associated with several patient factors and operator experience.

Anesthesia Duration as a Marker for Surgical Complications in Office-Based Plastic Surgery

Office-based plastic surgery has continued to rise in the past 2 decades with the increased demand for cosmetic surgery. Although several large studies have shown the safety of office-based surgery, current regulations place some restrictions on ambulatory office-based surgical facilities. To provide further evidence-based literature on the safety of office-based plastic surgery, we examine surgical complication rates as a function of anesthesia duration. This is a retrospective review of 2595 patients who underwent office-based plastic surgery procedures between October 2000 and January 2005. All patients received general anesthesia for a broad range of cosmetic surgeries. The primary measured outcome was minor and major surgical complications. Complication rates were examined as a function of anesthesia duration of less than or greater than 4 hours. The follow-up period was 30 days. Statistical analysis was completed using SPSS v.19. Most of the patients were female with an average age of 41 years. An increase in the occurrence of minor surgical complications such as postoperative nausea and vomiting (2.8% vs 5.7%, P=0.0175) and urinary retention (0.7% vs 7.6%, P<0.0001) was noted in the greater than 4-hour anesthesia duration group. Overall, there were 66 (2.5%) patients that required reoperation because of surgical complications with no statistical difference between the 2 groups (P=0.098). The only major morbidities were 1 pulmonary embolism (<4 hours) and 1 deep vein thrombosis (>4 hours). Five (0.19%) patients were admitted to the hospital during the follow-up period for surgical and/or medical management (3 hematomas, 1 deep vein thrombosis, and 1 pulmonary embolism). There were no cases of reintubation, major cardiac complications, or death in this series. Duration of general anesthesia in office-based plastic surgery does not seem to be an indicator of major morbidity and mortality. Although minor complications such as postoperative nausea and vomiting and urinary retention were higher in patients with anesthesia greater than 4 hours, there was no significant increase in major complications. Change in surgical venue would not likely alter the outcome of the increase in minor complications. Therefore, anesthesia duration should not be used as a guideline for safety of office-based plastic surgery.

The Use of Acellular Dermal Matrix in Immediate Two-Stage Tissue Expander Breast Reconstruction

Acellular dermal matrix is commonly used in implant-based breast reconstruction to allow for quicker tissue expansion with better coverage and definition of the lower pole of the breast. This study was performed to analyze complications associated with its use in immediate two-stage, implant-based breast reconstruction and to subsequently develop guidelines for its use. A retrospective analysis of 628 consecutive immediate two-stage tissue expander breast reconstructions at a single institution over a 3-year period was conducted. The reconstructions were divided into two groups: reconstruction with acellular dermal matrix and reconstruction without it. Demographic information, patient characteristics, surface area of acellular dermal matrix, and complications were analyzed and compared. A total of 407 patients underwent 628 immediate two-stage, implant-based breast reconstructions; 442 reconstructions (70.3 percent) used acellular dermal matrix and 186 (29.6 percent) did not. The groups had similar patient characteristics; however, major complications were significantly increased in the acellular dermal matrix group (15.3 versus 5.4 percent; p = 0.001). These complications included infection requiring intravenous antibiotics (8.6 versus 2.7 percent; p = 0.001), flap necrosis requiring excision (6.7 versus 2.7 percent; p = 0.015), and explantation of the tissue expander (7.7 versus 2.7 percent; p = 0.004). Use of acellular dermal matrix in immediate two-stage, implant-based breast cancer reconstruction is associated with a significant increase in major complications. Therefore, it should only be used in specific patients and in minimal amounts. Indications for its use include single-stage permanent implant reconstruction and inadequate local muscle coverage of the tissue expander. Therapeutic, III.

It’s the procedure not the patient: the operative approach is independently associated with an increased risk of complications after rectal prolapse repair

This study compares 30-day outcomes following rectal prolapse repair, examining potential surgical and patient factors associated with perioperative complications. Using the NSQIP database, patients with rectal prolapse were categorized by surgical approach to repair (perineal or abdominal) and abdominal cases were further subdivided by procedure (resection compared with rectopexy alone). Univariate and multivariate analyses compared major and minor complication rates between the groups. Of 1275 patients, the perineal group (n=706, 55%) was older, with more comorbidity, than those undergoing an abdominal procedure. There were fewer minor (odd ratio (OR)=0.35; 95% confidence interval (CI), 0.20-0.60; P=0.0038) and major complications (OR=0.46; 95% CI, 0.31-0.80; P=0.0038) in the perineal compared with the abdominal cohort. There was a significant increase in major complications amongst patients undergoing a resection compared with rectopexy only (OR=2.15; 95% CI, 1.10-4.41; P=0.0299). There was no difference in major complications between abdominal rectopexy and a perineal approach, but the latter had a lower chance of minor complications (OR=0.47; 95% CI, 0.24-0.94; P=0.0287). A perineal approach is safer than an abdominal approach to the treatment of rectal prolapse. Regarding an abdominal operation, rectopexy has fewer major complications than resection.

Complications in abdominoplasty: A risk factor analysis

Abdominoplasty is one of the most popular body-contouring procedures. However, it is associated with a significant number of complications, the most common being seroma and wound-healing problems. In this study, we analysed postoperative complications following abdominoplasty and evaluated the presence of statistically significant correlations between pre-existing risk factors and postoperative complications. We carried out a retrospective chart review of all patients who underwent abdominoplasty from June 1994 to April 2004 at our institution. Patient demographics, risk factors (smoking, previous abdominal surgery, obesity, and male gender) and complications (minor and major) were noted from the patient's medical record. In all, 139 patients were included in the study (126 female and 13 male), with a mean age of 42.8 years at the time of surgery. Minor and major complications were seen in 40 (28.8%) and 16 patients (11.5%), respectively. Smoking and previous abdominal surgery were not associated with a significantly increased complication rate. However, patients without previous surgery displayed a significantly increased complication rate (43.2% vs. 22.1% for minor and 25% vs. 5.3% for major complications; p<0.05). Obesity (BMI >30 kg/m(2)) was associated with a significant increase in major complications (20.8% vs. 9.7%; p<0.05). Male gender was predisposed to increased minor and major complications; however, this was not statistically significant. Despite its popularity, abdominoplasty is still associated with a significant rate of complications. In particular, obese patients and those with no previous history of abdominal surgery seem to be at risk for complications. The role of male gender needs to be evaluated further.

Fiberoptic Bronchoscopy in Coronary Care Unit Patients: Indications, Safety, and Clinical Implications

To evaluate the indications, safety, therapeutic impact, and outcome of fiberoptic bronchoscopy (FOB) in coronary care unit (CCU) patients. Retrospective review of all CCU patients undergoing FOB during a 6-year period. Tertiary care university hospital. Among 8,330 patients admitted to the CCU; 40 (0.5%) patients underwent FOB to evaluate pulmonary abnormalities, most often (78%) to appraise clinically suspected pneumonia. Thirty-five (88%) patients were intubated and 21 (53%) had acute myocardial infarction (MI) before FOB. There were two major complications (bleeding, intubation) occurring within 24 h of FOB, one of which appeared due to the procedure. No episodes of chest pain or ischemic events were recorded and no significant increase in major complications was noted in MI patients (3% vs 5%). Patients having FOB within 10 days of MI had higher survival (79%) than those undergoing FOB later (29%) (p = 0.05). Seven different bacterial pathogens were isolated in 6 (15%) patients, probably reflecting prior empiric antibiotics in 32 (80%) patients. Therapy was changed in 64% of patients in whom a potential pathogen was identified. Despite alterations in treatment, patients with clinically suspected pneumonia and any organisms isolated by FOB had greater mortality (79% vs 31%, p = 0.003) than those with sterile FOB cultures. FOB may be diagnostically useful in the evaluation of pulmonary abnormalities in selected patients with acute cardiac disease, can be performed safely, and may influence management decisions. Positive bronchoscopy cultures often influence therapy but are associated with higher mortality, suggesting a lethal effect of nosocomial pneumonia in this subset of CCU patients. The risks of FOB must be weighed with the impact of FOB results on patient outcome, and its role requires further investigation.

American Heart Association 68th Scientific Sessions, Anaheim, California, November 13 to 15, 1995.

Dr Elliott Antman, of Harvard Medical School and Brigham and Women’s Hospital in Boston, Massachusetts, presented the results of the Thrombolysis in Myocardial Infarction (TIMI) 9B study at a Satellite Symposium sponsored by George Washington University immediately prior to the American Heart Association Meetings in Anaheim, California, in November 1995. The TIMI 9 trial was a randomized, double-blind study conducted in 150 clinical centers that was designed to compare the efficacy and safety of intravenous heparin versus the direct-acting thrombin inhibitor hirudin in patients with acute myocardial infarction (<12 hours from onset) treated with a thrombolytic agent (streptokinase or tissue-type plasminogen activator [TPA], at the discretion of the treating physician). The TIMI 9A study (n=757) was suspended in April 1994 because of excessive bleeding in both the heparin and hirudin groups. The TIMI 9B trial was restarted in May 1994 with lower doses of both heparin and hirudin; enrollment (n=3002) continued through August 1995. The primary end point of the study was the 30-day incidence of death, myocardial infarction, congestive heart failure, and shock. At 30 days, there was no significant difference in the primary end point between heparin (11.8%) and hirudin (12.8%) and no difference in the incidence of death and myocardial infarction (9.3% in the heparin group, 9.6% in the hirudin group). Similarly, there was no significant difference in major bleeding events (including intracranial hemorrhage) between treatment groups. The TIMI 9 Investigators concluded that hirudin was equally effective as but not superior to heparin with respect to either clinical outcome or bleeding risk in patients with acute myocardial infarction receiving thrombolytic therapy. Also at the George Washington University Satellite Symposium, Dr Eugene Braunwald, of Harvard Medical School and Brigham and Women’s Hospital in Boston, presented the results of the TIMI 10A phase I trial. TIMI 10A is an …

The patterns of care outcome study for cancer of the uterine cervix results of the second national practice survey

This report summarizes the outcome results of the Patterns of Care Study (PCS) of cancer of the uterine cervix from 565 patients treated in 1978. The 5-year survival with no evidence of disease was: Stage I, 74%; Stage II, 56%; and Stage III, 33%. The 5-year local in-field failure rate was: Stage I, 12%, Stage II, 27%; and Stage III, 51%. Extent of parametrial involvement, unilateral versus bilateral, may be important in determining survival and local failure. The four-year actuarial survival was 58% for unilateral involvement versus 47% for bilateral (P = 0.06), and the local failure rate was 32% for unilateral versus 45% for bilateral (P less than 0.05). When analyzed by stage, patients with Stage IIb disease with unilateral parametrial involvement showed a trend toward improved survival and decreased local failure compared with those with bilateral Stage IIb cancers (P = 0.1). The use of intracavitary irradiation significantly improved survival and reduced local failures. Furthermore, the number of intracavitary applications was important. When two or more intracavitary applications were used compared with one application, local in-field failure was significantly reduced, 29% versus 17% at 4 years (P less than 0.001), and four-year survival was improved, 60% versus 73% (P = 0.01). The four-year actuarial rate of major complications depended on the stage: Stage I, 8%; Stage II, 15%; and Stage III, 13%. There was a statistically significant increase in major complications in patients undergoing laparotomy for staging versus no laparotomy 23% versus 11% at 4 years (P less than or equal to 0.01) and a trend toward increased major complications in patients who were thin or had prior abdominal surgery. This study confirmed the stage-dependent outcome of treatment of cancer of the uterine cervix with radiation and indicated that further division of Stage IIb to indicate prognostic significance of unilateral or bilateral parametrial involvement may be warranted. This study also confirmed the importance of intracavitary radiation in optimizing control established by the 1973 PCS. It further suggests that where possible, two intracavitary insertions may yield better results than one insertion.