Mid-term results of aortic root replacement using a self-assembled biological composite graft.

OBJECTIVES To report the mid-term results of aortic root replacement using a self-assembled biological composite graft, consisting of a vascular tube graft and a stented tissue valve. METHODS Between January 2005 and December 2011, 201 consecutive patients [median age 66 (interquartile range, IQR, 55-77) years, 31 female patients (15.4%), median logistic EuroSCORE 10 (IQR 6.8-23.2)] underwent aortic root replacement using a stented tissue valve for the following indications: annulo-aortic ectasia or ascending aortic aneurysm with aortic valve disease in 162 (76.8%) patients, active infective endocarditis in 18 (9.0%) and acute aortic dissection Stanford type A in 21 (10.4%). All patients underwent clinical and echocardiographic follow-up. We analysed survival and valve-related events. RESULTS The overall in-hospital mortality rate was 4.5%. One- and 5-year cardiac-related mortality rates were 3 and 6%, and overall survival was 95 ± 1.5 and 75 ± 3.6%, respectively. The rate of freedom from structural valve failure was 99% and 97 ± 0.4% at the 1- and 5-year follow-up, respectively. The incidence rates of prosthetic valve endocarditis were 3 and 4%, respectively. During a median follow-up of 28 (IQR 14-51) months, only 2 (1%) patients required valve-related redo surgery due to prosthetic valvular endocarditis and none suffered from thromboembolic events. One percent of patients showed structural valve deterioration without any clinical symptoms; none of the patients suffered greater than mild aortic regurgitation. CONCLUSIONS Aortic root replacement using a self-assembled biological composite graft is an interesting option. Haemodynamic results are excellent, with freedom from structured valve failure. Need for reoperation is extremely low, but long-term results are necessary to prove the durability of this concept.

Antioxidant supplementation attenuates oxidative stress in patients undergoing coronary artery bypass graft surgery.

Ischemia-reperfusion has been reported to be associated with augmented oxidative stress in the course of surgery, which might be causally involved in the onset of atrial fibrillation (AF), the most common arrhythmia after cardiac surgery. We hypothesized that supplementation of antioxidants and n-3 polyunsaturated fatty acids (n-3 PUFAs) might lower the incidence of AF following coronary artery bypass graft (CABG) surgery. In the present study, by monitoring oxidative stress in the course of CABG surgery, we analyzed the efficacy of vitamins (ascorbic acid and α-tocopherol) and/or n-3 PUFAs (eicosapentaenoic acid and docosahexaenoic acid). Subjects (n = 75) were divided into 4 subgroups: control, vitamins, n-3 PUFAs, and a combination of vitamins and n-3 PUFAs. Fluorescent techniques were used to measure the antioxidative capacity, i.e. ability to inhibit oxidation. Total peroxides, endogenous peroxidase activity, and antibodies against oxidized LDL (oLAb) were used as serum oxidative stress biomarkers. Post-operative increase in oxidative stress was associated with the consumption of antioxidants and a simultaneous onset of AF. This was confirmed through an increased peroxide level and a decreased oLAb titer in control and n-3 PUFAs groups, indicating the binding of antibodies to oxidative modified epitopes. In both subgroups that were supplemented with vitamins, total peroxides decreased, and the maintenance of a constant IgG antibody titer was facilitated. However, treatment with vitamins or n-3 PUFAs was inefficient with respect to AF onset and its duration. We conclude that the administration of vitamins attenuates post-operative oxidative stress in the course of CABG surgery.

Is preoperative chemotherapy followed by surgery the appropriate treatment for signet ring cell containing adenocarcinomas of the esophagogastric junction and stomach?

BACKGROUND Recent data suggest primary resection as the preferable approach in patients with signet ring cell gastric cancer (SRC). The aim of our retrospective exploratory study was to evaluate the influence of SRC on prognosis and response in esophagogastric adenocarcinoma treated with neoadjuvant chemotherapy. METHODS A total of 723 locally advanced esophagogastric adenocarcinomas (cT3/4 N any) documented in a prospective database from two academic centers were classified according to the WHO definition for SRC (more than 50 % SRC) and analyzed for their association with response and prognosis after neoadjuvant treatment. RESULTS A total of 235 tumors (32.5 %) contained SRC. Median survival of SRC was 26.3 compared with 46.6 months (p < 0.001) for non-SRC. SRC were significantly associated with female gender, gastric localization, advanced ypT and R1/2 categories, and lower risk of surgical complications and anastomotic leakage (each p < 0.001). Clinical (21.1 vs. 33.7 %, p = 0.001) and histopathological response (less than 10 % residual tumor: 16.3 vs. 28.9 %, p < 0.001) were significantly less frequent in SRC. Clinical response (p = 0.003) and complete histopathological response (pCR) (3.4 %) (p = 0.003) were associated with improved prognosis in SRC. Clinical response, surgical complications, ypTN categories, but not SRC were independent prognostic factors in forward Cox regression analysis in R0 resected patients. Risk of peritoneal carcinomatosis was increased (p < 0.001), while local (p = 0.015) and distant metastases (p = 0.02) were less frequent than in non-SRC. CONCLUSIONS Prognosis of SRC is unfavorable. Although response to neoadjuvant chemotherapy is rare in SRC, it is associated with improved outcome. Thus, chemotherapy might not generally be abandoned in SRC. A stratification based on SRC should be included in clinical trials.

Hepatic steatosis is associated with surgical-site infection after hepatic and colorectal surgery.

BACKGROUND Obesity and increased visceral fat deposits are important risk factors for surgical-site infection (SSI). Interestingly, a potential role of hepatic steatosis on complications after extrahepatic surgery remains unknown. The aim of the present study was to investigate the impact of hepatic steatosis on SSI in patients that underwent open abdominal surgery. METHODS A total of 231 patients that underwent either liver (n = 116) or colorectal (n = 115) resection and received preoperative contrast-enhanced computed tomography scans were retrospectively investigated. Signal attenuation of the liver parenchyma was measured on computed tomography scans to assess hepatic steatosis. RESULTS More SSIs (including types 1, 2, and 3) were found in the group with hepatic steatosis (56/118 [47.5%]) compared with the control group (30/113 [26.6%]; P = .001). Patients with hepatic steatosis showed greater median body mass index than patients without hepatic steatosis (26.6 kg/m(2) [range 16.8-47.0 kg/m(2)] vs 23.2 kg/m(2) [15.9-32.7 kg/m(2)]; P < .001). Patients with hepatic steatosis experienced longer median operation times (297 minutes [52-708 minutes] vs 240 minutes [80-600 minutes]; P = .003). In a multivariate analysis, hepatic steatosis was identified as an independent risk factor for SSI in patients undergoing hepatic (odds ratio 10.33 [95% confidence interval 1.19-89.76]; P = .03) or colorectal (odds ratio 6.67 [95% confidence interval 1.12-39.33]; P = .04) operation. CONCLUSION Hepatic steatosis is associated with SSI after hepatic and colorectal operation.

Mitral valve replacement in patients under 65 years of age: mechanical or biological valves?

PURPOSE OF REVIEW There is controversy regarding the optimal choice of prosthetic valves in patients less than 65 years of age requiring mitral valve replacement (MVR). Recently, trends for valve replacement are moving towards biological prosthesis also in younger patients, which is justified by the fact that a later valve-in-valve procedure is feasible in the case of degeneration of the tissue valve. This strategy is increasingly recommended in aortic valve surgery but is questionable for MVR. The purpose of this review is to evaluate current guidelines and analyse evidence for biological MVR in patients under 65 years. RECENT FINDINGS There are differences between guidelines of the American Heart Association and those of the European Society of Cardiology concerning the choice of prostheses in patients undergoing MVR. Although the European Society of Cardiology recommends a mechanical mitral valve in patients under 65 years of age, the American Heart Association does not provide detailed advice for these patients. Mitral valve replacement with biological valves in patients under 65 years is associated with higher rates of reoperation due to structural valve deterioration. In addition, several studies showed a decreased survival after biological MVR. SUMMARY Evidence for biological MVR in patients less than 65 years without comorbidities or contraindication for oral anticoagulation does not exist. Recommendations for patients less than 65 years of age should not be blurred by current 'en-vogue' methods for promising but not yet proven valve-in-valve strategies.

Aortic valve replacement and concomitant procedures with the Perceval valve: results of European trials.

BACKGROUND The Perceval (Sorin Group, Milan, Italy) is a self-anchoring sutureless aortic valve prosthesis. We report the short- to midterm results of combined aortic valve replacement (AVR) with concomitant procedures in elderly patients undergoing operation as part of 3 consecutive prospective multicenter European studies. METHODS From April 2007 to February 2013, 243 patients (mean age, 79.7 ± 5.1 years; female patients, 61%; median EuroSCORE, 9%) underwent AVR with concomitant procedures. The concomitant procedures were coronary artery bypass grafting (CABG) (182 cases), septal myectomy (21 cases), CABG + other procedures (18 cases), and 22 other procedures. Primary and secondary end points included implant feasibility and safety (for mortality and morbidity) and efficacy (New York Heart Association [NYHA] class improvement and hemodynamic results) of the prosthesis at the different follow-up periods. Data were expressed as mean ± standard deviation. Kaplan-Meier analysis was performed for survival analysis. RESULTS Mean aortic cross-clamp and extracorporeal circulation (ECC) times were 50.7 ± 22.8 minutes and 78.9 ± 32.3 minutes, respectively. Thirty-day mortality was 2.1%. Mean postoperative gradient and effective orifice area were 10.1 ± 4.7 mm Hg and 1.5 ± 0.4 cm(2) and 8.9 ± 5.6 mm Hg and 1.6 ± 0.4 cm(2), respectively, at 1 year. There were early explantations, 4 of which resulted from paravalvular leaks. One additional valve explantation resulted from aortic root bleeding, probably caused by excessively extensive decalcification. In the late period, there was 1 mild paravalvular leak and no intravalvular insufficiency. No migration, dislodgement, or degeneration of the valve occurred during follow-up. Median follow-up was 444 days. CONCLUSIONS These trials confirm the safety and efficacy of the Perceval sutureless aortic valve, especially in elderly patients requiring AVR + concomitant procedures. In this patient group, sutureless valves may be advantageous compared to transcatheter valve implantations as concomitant procedures other than percutaneous coronary artery angioplasty are not always possible in the latter.

Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study.

OBJECTIVE Sutureless valves are designed to facilitate surgical implantation, including less-invasive techniques in aortic valve replacement, by maintaining surgical precision of implantation compared with transcatheter techniques. Long-term clinical experience with sutureless valves is lacking. We report the 5-year follow-up results of an international, prospective, multicenter study evaluating the clinical performance and safety of the 3f Enable valve (Medtronic Inc, Minneapolis, Minn). METHODS Between March 2007 and December 2009, 141 patients (54 male; mean age, 76.1±5.7 years) undergoing aortic valve replacement with the 3f Enable valve were enrolled in 10 European sites. The mean follow-up was 2.76 years (range, 2 days to 5.1 years; total, 388.7 patient-years). Echocardiographic valvular hemodynamic and morphologic analyses were performed by an independent core laboratory. RESULTS The mean systolic gradient was 10.4±4.4 mm Hg at discharge and 7.7±4.1 mm Hg at 5 years. The mean effective orifice area was 1.7±0.5 cm2 at discharge and 1.6±0.2 cm2 at 5 years. Freedom from all-cause and valve-related mortality was 87.6%±2.9% and 96.8%±1.6% at 1 year (113 patients at risk) and 77.0%±7.5% and 93.8%±4.8% at 5 years (24 patients at risk), respectively. Six patients underwent reoperation (4 because of major paravalvular leakage and 2 because of endocarditis). Freedom from reoperation was 95.4%±1.9% at 1 year and 95.4%±6.1% at 5 years. No structural valve deterioration occurred during the follow-up period. CONCLUSIONS The sutureless 3f Enable valve represents a safe and effective treatment for aortic valve stenosis, providing an excellent hemodynamic profile. This study represents the longest follow-up study for a sutureless bioprosthesis. Sutureless valves may become an option for all patients with indicated biological aortic valve replacement.

Influencing factors on the length of stay in lumbar spine surgery: analysis of the German spine registry

INTRODUCTION Spinal disc herniation, lumbar spinal stenosis and spondylolisthesis are known to be leading causes of lumbar back pain. The cost of low back pain management and related operations are continuously increasing in the healthcare sector. There are many studies regarding complications after spine surgery but little is known about the factors predicting the length of stay in hospital. The purpose of this study was to identify these factors in lumbar spine surgery in order to adapt the postoperative treatment. MATERIAL AND METHODS The current study was carried out as a post hoc analysis on the basis of the German spine registry. Patients who underwent lumbar spine surgery by posterior surgical access and with posterior fusion and/or rigid stabilization, whereby procedures with dynamic stabilization were excluded. Patient characteristics were tested for association with length of stay (LOS) using bivariate and multivariate analyses. RESULTS A total of 356 patients met the inclusion criteria. The average age of all patients was 64.6 years and the mean LOS was 11.9 ± 6.0 days with a range of 2-44 days. Independent factors that were influencing LOS were increased age at the time of surgery, higher body mass index, male gender, blood transfusion of 1-2 erythrocyte concentrates and the presence of surgical complications. CONCLUSION Identification of predictive factors for prolonged LOS may allow for estimation of patient hospitalization time and for optimization of postoperative care. In individual cases this may result of a reduction in the LOS.

What is the frequency of nerve injuries associated with acetabular fractures?

BACKGROUND Acetabular fractures and surgical interventions used to treat them can result in nerve injuries. To date, only small case studies have tried to explore the frequency of nerve injuries and their association with patient and treatment characteristics. High-quality data on the risk of traumatic and iatrogenic nerve lesions and their epidemiology in relation to different fracture types and surgical approaches are lacking. QUESTIONS/PURPOSES The purpose of this study was to determine (1) the proportion of patients who develop nerve injuries after acetabular fracture; (2) which fracture type(s) are associated with increased nerve injury risk; and (3) which surgical approach was associated with the highest proportion of patients developing nerve injuries using data from the German Pelvic Trauma Registry. Two secondary aims were (4) to assess hospital volume-nerve-injury relationship; and (5) internal data validity. METHODS Between March 2001 and June 2012, 2236 patients with acetabular fractures were entered into a prospectively maintained registry from 29 hospitals; of those, 2073 (92.7%) had complete records on the endpoints of interest in this retrospective study and were analyzed. The neurological status in these patients was captured at their admission and at the discharge. A total of 1395 of 2073 (67%) patients underwent surgery, and the proportions of intervention-related and other hospital-acquired nerve injuries were obtained. Overall proportions of patients developing nerve injuries, risk based on fracture type, and risk of surgical approach type were analyzed. RESULTS The proportion of patients being diagnosed with nerve injuries at hospital admission was 4% (76 of 2073) and at discharge 7% (134 or 2073). Patients with fractures of the "posterior wall" (relative risk [RR], 2.0; 95% confidence interval [CI], 1.4-2.8; p=0.001), "posterior column and posterior wall" (RR, 2.9; CI, 1.6-5.0; p=0.002), and "transverse+posterior wall" fracture (RR, 2.1; CI, 1.3-3.5; p=0.010) were more likely to have nerve injuries at hospital discharge. The proportion of patients with intervention-related nerve injuries and that of patients with other hospital-acquired nerve injuries was 2% (24 of 1395 and 46 of 2073, respectively). They both were associated with the Kocher-Langenbeck approach (RR, 3.0; CI, 1.4-6.2; p=0.006; and RR, 2.4; CI, 1.4-4.3; p=0.004, respectively). CONCLUSIONS Acetabular fractures with the involvement of posterior wall were most commonly accompanied with nerve injuries. The data suggest also that Kocher-Langenbeck approach to the pelvic ring is associated with a higher risk of perioperative nerve injuries. Trauma surgeons should be aware of common nerve injuries, particularly in posterior wall fractures. The results of the study should help provide patients with more exact information on the risk of perioperative nerve injuries in acetabular fractures. LEVEL OF EVIDENCE Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Completion and Publication Rates of Randomized Controlled Trials in Surgery: An Empirical Study.

OBJECTIVE: To investigate the prevalence of discontinuation and nonpublication of surgical versus medical randomized controlled trials (RCTs) and to explore risk factors for discontinuation and nonpublication of surgical RCTs. BACKGROUND: Trial discontinuation has significant scientific, ethical, and economic implications. To date, the prevalence of discontinuation of surgical RCTs is unknown. METHODS: All RCT protocols approved between 2000 and 2003 by 6 ethics committees in Canada, Germany, and Switzerland were screened. Baseline characteristics were collected and, if published, full reports retrieved. Risk factors for early discontinuation for slow recruitment and nonpublication were explored using multivariable logistic regression analyses. RESULTS: In total, 863 RCT protocols involving adult patients were identified, 127 in surgery (15%) and 736 in medicine (85%). Surgical trials were discontinued for any reason more often than medical trials [43% vs 27%, risk difference 16% (95% confidence interval [CI]: 5%-26%); P = 0.001] and more often discontinued for slow recruitment [18% vs 11%, risk difference 8% (95% CI: 0.1%-16%); P = 0.020]. The percentage of trials not published as full journal article was similar in surgical and medical trials (44% vs 40%, risk difference 4% (95% CI: -5% to 14%); P = 0.373). Discontinuation of surgical trials was a strong risk factor for nonpublication (odds ratio = 4.18, 95% CI: 1.45-12.06; P = 0.008). CONCLUSIONS: Discontinuation and nonpublication rates were substantial in surgical RCTs and trial discontinuation was strongly associated with nonpublication. These findings need to be taken into account when interpreting surgical literature. Surgical trialists should consider feasibility studies before embarking on full-scale trials.

Three-dimensional printing for perioperative planning of complex aortic arch surgery

Purpose In this study, we show the use of three-dimensional printing models for preoperative planning of surgery for patients with complex aortic arch anomalies. Description A 70-year-old man with an extensively arteriosclerotic aneurysm reaching from the ascending aorta to the descending aorta was referred to our center for complete aortic arch replacement. We visualized and reconstructed computed tomography data of the patient and fabricated a flexible three-dimensional model of the aortic arch including the aneurysm. Evaluation This model was very helpful for the preoperative decision making and planning of the frozen elephant trunk procedure owing to the exact and lifelike illustration of the native aortic arch. Conclusions Three-dimensional models are helpful in preoperative planning and postoperative evaluation of frozen elephant trunk procedures in patients with complex aortic anatomy.

Is the acetabular cup orientation after total hip arthroplasty on a two dimension or three dimension model accurate?

Purpose Malposition of the acetabular component in total hip arthroplasty (THA) is a common surgical problem that can lead to hip dislocation, reduced range of motion and may result in early loosening. The aim of this study is to validate the accuracy and reproducibility of a single x-ray image based 2D/3D reconstruction technique in determining cup inclination and anteversion against two different computer tomography (CT)-based measurement techniques. Methods Cup anteversion and inclination of 20 patients after cementless primary THA was measured on standard anteroposterior (AP) radiographs with the help of the single x-ray 2D/3D reconstruction program and compared with two different 3D CT-based analyses [Ground Truth (GT) and MeVis (MV) reconstruction model]. Results The measurements from the single x-ray 2D/3D reconstruction technique were strongly correlated with both types of CT image-processing protocols for both cup inclination [R²=0.69 (GT); R²=0.59 (MV)] and anteversion [R²=0.89 (GT); R²=0.80 (MV)]. Conclusions The single x-ray image based 2D/3D reconstruction technique is a feasible method to assess cup position on postoperative x-rays. CTscans remain the golden standard for a more complex biomechanical evaluation when a lower tolerance limit (+/-2 degrees) is required.

A complete-pelvis segmentation framework for image-free total hip arthroplasty (THA): methodology and clinical study

Background Complete-pelvis segmentation in antero-posterior pelvic radiographs is required to create a patient-specific three-dimensional pelvis model for surgical planning and postoperative assessment in image-free navigation of total hip arthroplasty. Methods A fast and robust framework for accurately segmenting the complete pelvis is presented, consisting of two consecutive modules. In the first module, a three-stage method was developed to delineate the left hemipelvis based on statistical appearance and shape models. To handle complex pelvic structures, anatomy-specific information processing techniques were employed. As the input to the second module, the delineated left hemi-pelvis was then reflected about an estimated symmetry line of the radiograph to initialize the right hemi-pelvis segmentation. The right hemi-pelvis was segmented by the same three-stage method, Results Two experiments conducted on respectively 143 and 40 AP radiographs demonstrated a mean segmentation accuracy of 1.61±0.68 mm. A clinical study to investigate the postoperative assessment of acetabular cup orientations based on the proposed framework revealed an average accuracy of 1.2°±0.9° and 1.6°±1.4° for anteversion and inclination, respectively. Delineation of each radiograph costs less than one minute. Conclusions Despite further validation needed, the preliminary results implied the underlying clinical applicability of the proposed framework for image-free THA.

Safe vaginal uterine morcellation following total laparoscopic hysterectomy.

The minimally invasive approach for hysterectomy with proven benefits and lower morbidity has become the gold standard, even in women with large uterine masses. Most women with a malignant condition present with abnormal vaginal bleeding and/or suspicious imaging such that few are diagnosed by final histopathology after surgery. However, if a malignancy is not diagnosed preoperatively, intraabdominal morcellation for uterus extraction has an increased risk for potential tumor spread and peritoneal metastases, especially in cases of unexpected leiomyosarcoma. We describe a simple method to wrap the uterus in a contained environment with a plastic bag through the posterior vaginal fornix prior to conventional coring morcellation for vaginal extraction in total laparoscopic hysterectomy. We further describe our experience with a risk stratification and treatment algorithm to implement this procedure in daily routine. A video and an illustrating sketch demonstrate the simplicity and safety of the procedure.