Prevention of Sternal Wound Infections in Women Using an External Sternum Fixation Corset

Purpose: Deep sternal wound infection (DSWI) and mediastinitis are devastating complications after median sternotomy. Previous studies demonstrated an effective prevention of sternal wound infection (SWI) using an external sternal corset in high-risk cardiac surgery patients. The aim of this study is to assess the preventive effect of the Stern-E-Fix corset in high-risk poststernotomy female patients.Methods: A total of 145 high-risk female patients undergoing cardiac surgery through median sternotomy were retrospectively analyzed. Patients were divided into group A (n = 71), who received the Stern-E-Fix corset (Fendel & Keuchen GmbH, Aachen, Germany), and group B (n = 74), who received the elastic thorax bandage (SanThorax) postoperatively for 6 weeks. The mean follow-up period was 12 weeks.Results: Incidence of SWI was 7% in group A vs. 17.6% in group B (p = 0.025). One patient presented with DSWI in group A vs. seven patients in group B (p = 0.063). No patient developed mediastinitis in group A vs. four patients in group B (p = 0.121). In all, 4.2% of group A patients required operative wound therapy vs. 16.2% of group B patients (p = 0.026). The length of hospital stay was significantly longer in group B (p = 0.006).Conclusion: Using an external supportive sternal corset (Stern-E-Fix) yields a significantly better and effective prevention against development of sternal dehiscence, DSWI, and mediastinitis in high-risk poststernotomy female patients.     

A prospective randomized study of sternal closure: comparison of Mersilene tape versus standard wire closure.

BACKGROUND: To compare in a prospective randomized study Mersilene tape and standard metal wire for complications and pain upon sternal wound closure. METHODS: Sixty-four patients scheduled for cardiac surgery were prospectively randomized to undergo sternal closure using either Mersilene tape (n=30) or standard metal wire (n=34). The intensity of postoperative pain from the chest wound was assessed using a visual analogue scale (VAS) on the second and seventh postoperative days and one month after surgery. The examinations with chest X-ray and computed tomography (CT) one month after surgery were performed to evaluate the chest wound and sternum. Follow-up data on sternal and wound healing was assessed for up to one year. RESULTS: No deaths, sternal dehiscence or infection occurred in either group. No wound complications were observed in either group during the year following surgery. A review of data revealed that there was no difference in the intensity of postoperative pain according to the VAS between the two groups. Chest CT demonstrated that no patients in either group had cuts in the sternum. CONCLUSION: This prospective randomized study showed Mersilene tape sternal closure not to be more closely associated with increased complications or patient discomfort due to sternal wound than the standard wire closure.     

Polydioxanone sternal sutures for prevention of sternal dehiscence

BACKGROUND: Sternal dehiscence and wound instability are troublesome complications following median sternotomy. Classic sternal approximation with stainless steel wires may not be the ideal approach in patients predisposed to these complications. We tested the efficacy of polydioxanone (PDS) suture in sternal closure and in prevention of complications in comparison to steel wires in high-risk individuals. METHODS: Three hundred sixty-six patients undergoing elective cardiac surgery with full median sternotomy and having body surface area (BSA) less than 1.5 m(2) were randomly assigned to receive PDS (n = 181) or stainless steel (SS, n = 185) sternal approximation. The study was focused on aseptic sternal complications, namely bone dehiscence and superficial wound instability. RESULTS: Both bone dehiscence and superficial wound instability were less frequent in the PDS Group (4 and 3 cases in the SS Group, respectively, vs. no cases in the PDS Group). Cox proportional hazards regression model in the whole study population identified female sex, chronic renal insufficiency, diabetes, advanced age, lower sternal thickness, osteoporosis, corticosteroid therapy, and prolonged CPB or ventilation times as predisposing factors to any of the two studied sternal complications. DISCUSSION: Data suggest that PDS suture can protect against development of aseptic sternal complications following median sternotomy in high-risk patients with little body mass. The adoption of PDS in other subsets of patients, i.e., obese individuals, is to be questioned.     

Sternal wound infections in patients undergoing open heart surgery: randomized study comparing intracutaneous and transcutaneous suture techniques.

BACKGROUND: Intracutaneous suture technique has been our standard method for closing sternal wounds in cardiac surgery, mainly for cosmetic reasons. However, an increased rate of postoperative infections has been reported in cosmetic surgery with this method compared with the percutanous or transcutaneous closure technique. A comparison of these two techniques in cardiac surgery is presented. METHODS: In a randomized study, 300 patients were selected to intracutaneous suture (n = 150) or percutanous suture (n = 150). The endpoints were superficial and deep sternal wound infections within 6 weeks postoperatively. RESULTS: The total infection rate was lower in the percutanous group compared with the intracutaneous group (3% versus 8%) (p = 0.007). The superficial infection rate was lower in the percutaneous group (2.3% versus 6.7%) (p = 0.01), whereas there was no statistically significant difference in the deep infection rate between the groups. CONCLUSIONS: The percutaneous suture technique reduces the incidence of superficial wound infections, but not the deep infection rate in open heart surgery. There was no difference in the cosmetic results on a visual scale, assessed by the patients.     

Prospective evaluation of a new sternal closure method with thermoreactive clips.

OBJECTIVES: The role of the sternal closure techniques on the incidence of sternal dehiscence and wound infection are well defined among a high number of other variables involved. In the various series, the incidence of wound complication in cardiac surgery varies from 2 to 8%. The aim of our study is to evaluate the role of thermal-dependent shape-memory Nitillium clips in reducing the incidence of sternal dehiscence following sternotomy. METHODS: We perspectively randomized 1000 consecutive patients requiring cardiac surgery to evaluate the incidence of sternal wound complications (SWC), sternal dehiscence and/or other related complications. We compared Group I (500 patients), in which sternal closure was achieved with standard sternal wires, with Group II (500 patients), in which sternal approximation was carried out by means of thermoreactive Nitillium clips. The two randomized groups were comparable in terms of age, gender, Euroscore and risk factors for sternal/wound complications. RESULTS: In our study the overall incidence of SWC was 4.7%. The incidence of SWC was considerably higher in Group I (6.8%) when compared to Group II (2.6%) (P=0.003). Mechanical sternal dehiscence without infection occurred in 14 patients in Group I and in one patient in Group II (P=0.002). Despite sternotomy wound infection occurred similarly in both groups (15 patients in Group I vs. 12 patients in Group II), sternal revision was performed only in patients of Group I (Group I: 9/15 vs. Group II: 0/12; P=0.001). CONCLUSION: Thermal shape-memory Nitillium clips provided superior results in sternal osteosynthesis following midline sternotomy, due to a considerable reduction of sternal dehiscence and related complications. The clinical benefit of Nitillium clips was demonstrated even in patients with several risk factors for SWC.     

Corpus Sterni Reinforcement Improves the Stability of Primary Sternal Closure in High-Risk Patients

Purpose To compare standard sternal closure techniques with reinforcement longitudinal wire placement in the corpus sterni in high-risk patients undergoing open-heart surgery via median sternotomy. Methods The subjects of this study were 71 high-risk patients, 32 (45%) of whom underwent sternal closure by conventional methods (group 1) and 39 (55%) of whom underwent sternal closure with corpus sterni reinforcement. The patients were followed up for a mean period of 90 days. Results In group 2, none of the patients had sternal dehiscence and no revision was required, but in group 1, five (15.5%) patients had sternal dehiscence. This difference was significant between the groups (P = 0.024), but there were no significant differences in mediastinitis and mortality (P > 0.05). Conclusions Our findings suggest that primary sternal closure with longitudinal wire reinforcement on both sides of the corpus sterni will decrease the risk of infection and improve wound-healing in parallel with a decrease in sternal dehiscence.     

The role of intra-aortic counterpulsation in high-risk OPCAB surgery: a prospective randomized study

BACKGROUND: High-risk patients would benefit the most of OPCAB revascularization. This prospective and randomized study evaluates the efficacy and safety of pre- and perioperative IABC in high-risk OPCAB. MATERIAL: Group A-IABC started prior to induction of anesthesia (n = 15); group B-no preoperative IABC (n = 15). Adult high-risk coronary patients to undergo OPCAB. High risk = (minimum 2) EF < 0.30, left main stenosis, unstable angina, redo. Bailout if hemodynamic instability CPB or IABC in group B. Study endpoints (a) cardiac protection (troponin 1, cardiac index (CI), ECG), (b) inflammatory response (lactate, IL-6), (c) clinical outcome (mortality, morbidity). Emergency operations 33%, re-operation 13%, unstable angina 100%, left main 60% and EF 0.29, without group differences. RESULTS: No bailout group A, 10 in group B, p < 0.0001. Postoperative IABC six (group A) and seven patients (group B), during 6.8 +/- 5.1 hours (group A) versus 41.2 +/- 25.5 hours (group B), p = 0.0110. Myocardial protection without group differences, but CI significantly better in group A. Inflammatory response significantly less in group A. CLINICAL OUTCOMES: one death, one MI and two renal failure in group B, none in group A. Intensive care unit (ICU) stay 27 +/- 3 hours (group A) versus 65 +/- 28 hours (group B), p = 0.0017. LOS 8 +/- 2 days (group A) versus 15 +/- 10 (group B), p = 0.0351. No IABC related complications. CONCLUSIONS: Pre- and perioperative IABC therapy offers efficient hemodynamic support during high-risk OPCAB surgery, lowers the risk of hemodynamic instability, is safe and shortens both ICU and hospital length of stay significantly, and is a cost-effective therapy.     

Sternal closure techniques and postoperative sternal wound complications in elderly patients.

OBJECTIVE: Postoperative sternal wound complications (PSWC) including deep sternal wound infection (DSWI) and sternal dehiscence (SD) cause significant morbidity and mortality. Elderly patients with several risk factors are particularly prone to suffer PSWC. METHODS: We present (I) a subset of 86 patients, all aged > or =75 years out of 339 cardiac surgery patients prospectively randomised to receive either conventional sternal closure or a Robicsek type closure. Primary end-points were SD and DSWI; secondary end-points included a composite of clinical parameters; (II) we retrospectively assessed data of 54/5273 patients with mediastinitis regarding the influence of advanced age. In addition, we report an epidemiological overview of different sternal closure techniques. RESULTS: (I) The Robicsek technique showed an impact on SD and DSWI, and several secondary end-points: ventilator support (p=0.03), postoperative blood loss (p=0.04), and chest pain >3 days (p=0.04). (II) A total of 54/5273 (1.02%) patients developed postoperative mediastinitis. Twelve out of 54 (22%) patients died within 6 months of the initial operation. Predictors of mortality were insulin-dependent diabetes mellitus (p=0.05), renal insufficiency (p=0.01), delayed sternal closure (p=0.05), ICU-stay >10 days (p=0.01), and methicillin-resistant Staphylococcus aureus (p=0.03) or fungal infection (p=0.02). CONCLUSIONS: No statistical difference in sternal dehiscence or mediastinitis was found irrespective of whether the bilateral and longitudinal parasternal closure or the conventional peri/trans-sternal wiring technique was used, but there was an obvious, positive influence on sternal dehiscence, deep sternal wound infection, and clinical parameters. However, the study population is relatively small.     

Delayed Introduction of Reduced-Dose Tacrolimus, and Renal Function in Liver Transplantation: The 'ReSpECT' Study

We report a multicenter, prospective, randomized, open-label trial investigating the effect of lower levels and delayed introduction of tacrolimus on renal function in liver transplant recipients. Adult patients with good renal function undergoing primary liver transplant were randomized to either: group A (standard-dose tacrolimus [target trough levels >10 ng/mL] and corticosteroids; n = 183); group B (mycophenolate mofetil [MMF] 2g/day, reduced-dose tacrolimus [target trough levels ≤8 ng/mL], and corticosteroids; n = 170); group C (daclizumab induction, MMF, reduced-dose tacrolimus delayed until the fifth day posttransplant and corticosteroids, n = 172). The primary endpoint was change from baseline in estimated glomerular filtration rate (eGFR) at 52 weeks. The eGFR decreased by 23.61, 21.22 and 13.63 mL/min in groups A, B and C, respectively (A vs C, p = 0.012; A vs B, p = 0.199). Renal dialysis was required less frequently in group C versus group A (4.2% vs. 9.9%; p = 0.037). Biopsy-proven acute rejection rates were 27.6%, 29.2% and 19.0%, respectively. Patient and graft survival was similar. In conclusion, daclizumab induction, MMF, corticosteroids and delayed reduced-dose tacrolimus was associated with less nephrotoxicity than therapy with standard-dose tacrolimus and corticosteroids without compromising efficacy or tolerability.     

Cardiovascular surgery prophylaxis. A randomized, controlled comparison of cefazolin and cefuroxime

A prospective double-blind trial was performed at a tertiary care center to evaluate perioperative cephalosporin prophylaxis in cardiac operations. Patients were randomized to receive either cefazolin (n = 104) or cefuroxime (n = 109), the preoperative dose being given within 1 hour before the initial incision. Drugs were continued for 48 hours (cefazolin, 1 gm intravenously every 8 hours; cefuroxime, 1.5 gm intravenously every 12 hours). Postoperative infections were assessed by trained nurse clinicians, and data were analyzed by the intention-to-treat principle. Sternal wound infections or mediastinitis occurred in one of 104 patients treated with cefazolin and 10 of 109 treated with cefuroxime (p = 0.01). Deep sternal wounds (including mediastinitis and sternal osteomyelitis) occurred in none of the cefazolin-treated patients and five cefuroxime-treated patients (p = 0.06). Although overall nosocomial infection rates were similar (16.3 versus 19.3 per 100), wound infection occurred somewhat more frequently with streptococci (groups B and D) in patients receiving cefazolin (four versus zero, p = 0.110); conversely staphylococcal infections were more frequent in the cefuroxime group (seven versus one, p = 0.066). Mean and median postoperative stay was 1 day shorter in the cefazolin group. In contrast to findings of a previous report, our data indicate that cefazolin prevented more sternal wound infections than cefuroxime, a finding that supports prophylaxis with a first-generation cephalosporin.     

Preoperative intraaortic balloon pumps in high-risk patients undergoing open heart surgery

BACKGROUND: The use of the preoperative intraaortic balloon pump (IABP) in patients with severe left ventricular dysfunction or unstable angina with critical coronary anatomy is becoming more frequent as surgical casemix changes. The aim of this study was to determine the impact of preoperative IABP use on survival in high-risk patients having open heart surgery. METHODS: Prospectively collected data for 645 consecutive patients were reviewed. Patients receiving an IABP were identified and grouped as follows: group A (preoperative IABP for high-risk nonemergent cases), group B (preoperative IABP for emergent cases), and group C (intra/postoperative IABP). Risk-adjusted hospital mortality rates in these three groups was compared using the modified Parsonnet score for preoperative risk stratification. RESULTS: IABPs were used in 101 cases (16%). The predicted versus actual hospital mortality rate was 20% versus 5.7% in group A, 32.1% versus 47.6% in group B, and 12.6% versus 22.2% in group C (group A vs group B, p = 0.0014; group A vs group C, p = 0.012). IABP-related morbidity occurred in 3% of cases (all in group C). CONCLUSIONS: Risk-adjusted mortality was significantly lower in high-risk cases with preoperative IABPs compared with emergent cases and intraoperative/postoperative IABPs. We encourage the use of preoperative IABPs in selected high-risk patients.     

Midterm Results of Sternal Band Closure in Open Heart Surgery and Risk Analysis of Sternal Band Removal

Sternal dehiscence, which is responsible for the development of mediastinitis, is a serious complication after cardiothoracic surgery. We retrospectively compared the results of two methods for sternal closure after cardiothoracic surgery performed during January 2009 to May 2012. The methods comprised closure with sternal bands and steel wires (group A, n = 92) versus conventional closure using steel wires alone (group B, n = 442). Although not significantly different between the two groups, no patients undergoing sternal band closure experienced dehiscence or mediastinitis. The incidence of having to remove materials used for sternal closure was significantly higher in group A than in group B. In each case of removal in group A, the materials removed were sternal bands whose tips had caused direct cutaneous irritation. Thus, although sternal bands may be effective for rigid sternal closure, they must sometimes be removed because of chest discomfort caused by the tip of the band.     

The reinforced sternal closure system is reliable to use in elderly patients

BACKGROUND: Sternal dehiscence is a rare, but serious complication after cardiac surgery procedures when performed through mid-line sternotomy. Osteoporosis, especially at advanced age, may be a significant factor in the unfavorable results of sternum fixation. The present prospective, randomized study was carried out to evaluate whether the reinforced sternal-closure system is an effective and safe fixation and approximation of the sternum in cardiac procedures, and to compare with the conventional sternal-closure method in elderly patients. METHODS: Forty elderly patients underwent various cardiac procedures via mid-line sternotomy under cardiopulmonary bypass. Patients were randomized into two groups: group I (n = 20) closed with the reinforced sternal-closure system, and group II (n = 20) with standard stainless steel wires. The mean age of patients in group I was 70.5 years, and group II with 70.4 years. RESULTS: Superficial wound infection appeared in only one case of stapler group and in two cases of control group. Deep wound infections or dehiscence was not detected in the patients of both groups. There were no significant differences in the patient's age, drainage, pain index, time of removal of the drains, and postoperative hospital stay between the groups (p > 0.05). CONCLUSIONS: The reinforced sternal-closure system provided no additional risk with similar postoperative pain index and postoperative hospital stay compared with conventional method. It is reliable to use in elderly patients undergoing open heart surgery, in the cases presenting a risk factor such as osteoporosis for increased incidence of sternal dehiscence.     

Reinforced sternal closures for prevention of sternal dehiscence in high risk patients

BACKGROUND: Sternal dehiscence is still a frequent complication after cardiac surgery procedures, performed through midline sternotomy. Its cumulative incidence has been reported to be around 2.5%, but several risk factors for increased incidence have also been identified. In past years several techniques have been proposed to achieve reinforced sternal approximation, mainly considered for the treatment of sternal dehiscence, more than for its prevention. The objective of this paper is the evaluation of the results, in terms of prevention of sternal dehiscence in high-risk patients, using reinforced closure techniques compared to standard technique. METHODS: Our study population included 212 patients who underwent cardiac surgery procedure and presented at least one of the increased risk factor for sternal dehiscence. Fifty-six patients (26.4%) received a reinforced sternal closure technique (RC group), 156 patients (73.6%) received a conventional sternal closure (CC group). RESULTS: The cumulative incidence of sternal refixation, in this selected population, was 5.6% with a statistically significant difference in favour of the RC group. The results of this study clearly show that the appropriate utilisation and selection of one of the several techniques of reinforced sternal closures can be effective in the reduction of sternal dehiscence in high risk patients. CONCLUSIONS: A reinforced technique should therefore be utilised in all patients undergoing cardiac surgery, presenting one or more risk factors for increased incidence of sternal dehiscence.     

Wound closure technique and acute wound complications in gastric surgery for morbid obesity: a prospective randomized trial

BACKGROUND: During the past 10 years, numerous clinical studies have supported the use of continuous monofilament fascial closure after laparotomy. Because of the increased incidence of surgical-site infections and other acute wound complications in the morbidly obese, these patients are well suited for a study of technical factors that may affect the frequency of these wound complications. STUDY DESIGN: A prospective, randomized study of the midline fascial closure technique in gastric bariatric operations was conducted between 1991 and 1998 in 331 consecutive morbidly obese patients. At the time of closure of the upper midline laparotomy wound, the patients were randomized into two groups: Group I patients (n = 172) underwent continuous fascial closure and group II patients (n = 159) underwent interrupted fascial closure. All patients received prophylactic antibiotics in a similar fashion. Wounds were monitored for 30 days postoperatively, and acute wound complications were classified as superficial or deep. Superficial complications included superficial surgical-site infections, seromas, and hematomas. In all superficial complications, the fascia remained uninvolved and intact. Deep wound complications included deep surgical-site infections and fascial dehiscence. RESULTS: A total of 49 acute wound complications occurred (15%). There were 22 superficial (7%) and 27 deep (8%) wound complications in the 331 in the patients studied. Group I patients experienced fewer total wound complications than group II patients (18 versus 31; p=0.021). Group I patients also experienced fewer deep wound complications than group II (5 versus 22; p = 0.003). CONCLUSIONS: Continuous fascial closure reduces major acute wound complications in morbidly obese patients undergoing gastric operations for obesity.     

Gelatin sheet incorporating basic fibroblast growth factor enhances sternal healing after harvesting bilateral internal thoracic arteries

OBJECTIVE: We previously reported that a gelatin sheet incorporating basic fibroblast growth factor accelerated sternal healing after bilateral internal thoracic artery removal in normal and diabetic rats. The aim of this study was to evaluate the effects of this therapeutic modality on sternal healing in a large-animal model before performing a clinical trial. METHODS: After median sternotomy and bilateral internal thoracic artery removal in a pedicled fashion, 14 beagle dogs received either a gelatin sheet incorporating basic fibroblast growth factor (100 mug per sheet) on the posterior table of the sternum (FGF group, n = 7) or did not receive a gelatin sheet (control, n = 7). We compared sternal healing 4 weeks after surgical intervention between the groups. RESULTS: Scintigraphic images obtained by using technetium 99 methylene diphosphonate bone scanning were assessed visually, and the impulse rate was quantified 30 and 60 minutes after injection of technetium 99 methylene diphosphonate to evaluate the sternal perfusion. Sternal uptake was significantly increased in the FGF group (30 minutes: 221% +/- 30% vs 180% +/- 36%; 60 minutes: 267% +/- 26% vs 197% +/- 42%; P <.01). Apparent sternal dehiscence, as assessed radiographically, was observed only in the control animals. Histologically, complete healing of the sternum with marked angiogenesis was observed in the FGF group, whereas poor healing with limited angiogenesis was seen in the control animals. Both bone mineral content (134 +/- 49 vs 52 +/- 32 mg, P <.01) and bone mineral density (133 +/- 53 vs 66 +/- 32 mg/mm(2), P <.05) along the incision line of the sternum, as assessed by means of dual-energy x-ray absorptometry, were higher in the FGF group. CONCLUSIONS: A gelatin sheet incorporating basic fibroblast growth factor enhances sternal perfusion and accelerates sternal bone healing in large animals.23     

Recent experience with major sternal wound complications

During a recent 1-year period, 31 patients sustained a major sternal wound infection and sternal dehiscence developed in 6 patients. Multiple potential risk factors were tabulated in these patients and in a control group selected from 1,521 patients undergoing sternotomy during the same time period. The overall infection rate was 2.1%, and the mortality rate in the patients with sternal infection or dehiscence was 16.2%. Chronic obstructive pulmonary disease, prolonged intensive care unit stay, respiratory failure, connective tissue disease, and male sex were significantly higher in the group with sternal infection or dehiscence (p less than 0.05). Advanced age and low cardiac output episodes were more frequent in this group, but only approached statistical significance. Although several risk factors may have been interrelated, male sex and the presence of pulmonary disease were statistically independent predictors of sternal wound infection. Risk factors may be helpful in identifying high-risk patients for additional prophylactic measures.     

Postoperative sternal dehiscence in obese patients: incidence and prevention

Background

Obesity has been identified as the single most important risk factor for postoperative sternal infection in coronary bypass surgery patients. It is also a major risk factor for sternal dehiscence, with or without infection, for any type of cardiac operation. We assessed whether prophylactic measures could prevent this complication.

Methods

Two studies were conducted. In study A, 3,158 heart surgery patients were analyzed at 3 cardiac units. Obesity was defined as body mass index (BMI) more than 30. Group I (1,253 obese [39.7%]) was compared with group II (1,905 nonobese [60.3%]). Sternal closure was done at the surgeon's preference: (a) plain wires through and through the bone; (b) peristernal figure-of-eight wires; or (c) peristernal method, using stainless-steel cables. In study B, 123 obese patients were prospectively divided into 2 subgroups. Group B-1 (54 patients) underwent lateral prophylactic sternal reinforcement before placement of peristernal wires. Group B-2 (69 patients) had standard sternal closure, as in study A.

Results

In study A, group I had 81 dehiscences (6.46%); 78 also suffered deep sternal infection and mediastinitis (96%). Despite treatment, dehiscence recurred in 13, and mortality was 38.4%. In group II nonobese patients, 31 dehisced (1.6%, p = 0.000), with no mortality. In study B, group B-1 (54) had 0% dehiscence versus group B-2 (69) with 6 dehiscences (8.7%).

Conclusions

In our study, the rate of obesity is high (∼ 40%). Sternal dehiscence is real when the BMI is more than 30 (6.46%), and has high morbidity and mortality. Prophylactic sternal reinforcement seems to prevent this complication.     

Renal function with cyclosporine C2 monitoring, enteric-coated mycophenolate sodium and basiliximab: a 12-month randomized trial in renal transplant recipients

BACKGROUND: Cyclosporine exposure, as estimated by the area under the curve (AUC), predicts outcomes in renal transplantation. Cyclosporine concentration at two h post-dose (C(2)) has been shown to be the most reliable, single-point surrogate marker for AUC. The objective of this study was to measure renal function beyond month 2 post-transplant using two different C(2) maintenance targets in combination with enteric-coated mycophenolate sodium (EC-MPS), corticosteroids, and basiliximab induction. METHODS: In this open-label, multicenter trial, renal transplant recipients entered one of two randomized groups at day 61 post-transplant: group A (higher-C(2) range) or group B (lower-C(2) range). RESULTS: Patients (164) were recruited, and 141 patients were entered the randomized groups (group A, n = 66; group B, n = 75). At 12 months, the mean calculated creatinine clearance was significantly greater in group B than in group A (79.2 vs. 71.0 mL/min, p < 0.05). Biopsy-proven acute rejection occurred in 14.7% patients in group B and in 24.2% patients in group A (n.s.). During the 12-month trial, 17.7% patients discontinued EC-MPS because of adverse events. Group B (44.0%) had fewer serious adverse events when compared with group A (62.1%; p = 0.04). Overall patient and graft survival were 99.4% and 95.7% respectively. Among 99 high-risk patients (i.e., African-American race, previous transplant, PRA >35% or >4 HLA mismatches), mean creatinine clearance at 12 months was 65.6 mL/min and biopsy-proven rejection occurred in 20.2% patients. CONCLUSIONS: Low cyclosporine C(2) levels are associated with improved renal function compared with higher C(2) levels when used in conjunction with EC-MPS, steroids and basiliximab induction. EC-MPS with low cyclosporine C(2) levels, corticosteroids and basiliximab provides excellent renal function with good efficacy even in high-risk patients.     

Prospective,randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: Five-year follow-up

Background contextThe CHARITÉ artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITÉ disc or any other artificial disc has been published to date.PurposeThe purpose of this study was to compare the safety and effectiveness at the five-year follow-up time point of lumbar total disc replacement using the CHARITÉ artificial disc (DePuy Spine, Raynham, MA) with that of anterior lumbar interbody fusion (ALIF) with BAK cages and iliac crest autograft, for the treatment of single-level degenerative disc disease from L4 to S1, unresponsive to nonoperative treatment.Study design/settingRandomized controlled trial—five-year follow-up.Patient sampleNinety CHARITÉ patients and 43 BAK patients.Outcome measuresSelf-reported measures: visual analog scale (VAS); validated Oswestry disability index (ODI version 1.0); Short-Form 36 Questionnaire, and patient satisfaction. Physiologic measures: radiographic range of motion, disc height, and segmental translation. Functional measures: work status.MethodsOf the 375 subjects enrolled in the CHARITÉ IDE trial, 277 were eligible for the five-year study and 160 patients thereof completed the five-year follow-up. The completers included 133 randomized patients. Overall success was defined as improvement≥15 pts in ODI vs. baseline, no device failure, absence of major complications, and maintenance or improvement of neurological status. Additional clinical outcomes included an ODI questionnaire as well as VAS, SF-36, and patient satisfaction surveys. Work status was tracked for all patients. Safety assessments included occurrence and severity of adverse events and device failures. Radiographic analyses such as index- and adjacent-level range of motion, segmental translation, disc height, and longitudinal ossification were also carried out.ResultsOverall success was 57.8% in the CHARITÉ group vs. 51.2% in the BAK group (Blackwelder's test: p=0.0359, Δ=0.10). In addition, mean changes from baseline for ODI (CHARITÉ: ?24.0 pts vs. BAK: ?27.5 pts), VAS pain scores (CHARITÉ: ?38.7 vs. BAK: ?40.0), and SF-36 questionnaires (SF-36 Physical Component Scores [PCS]: CHARITÉ: 12.6 pts vs. BAK: 12.3 pts) were similar across groups. In patient satisfaction surveys, 78% of CHARITÉ patients were satisfied vs. 72% of BAK patients. A total of 65.6% patients in the CHARITÉ group vs. 46.5% patients in the BAK group were employed full-time. This difference was statistically significant (p=0.0403). Long-term disability was recorded for 8.0% of CHARITÉ patients and 20.9% of BAK patients, a difference that was also statistically significant (p=0.0441). Additional index-level surgery was performed in 7.7% of CHARITÉ patients and 16.3% of BAK patients.Radiographic findings included operative and adjacent-level range of motion (ROM), intervertebral disc height and segmental translation. At the five-year follow-up, the mean ROM at the index level was 6.0° for CHARITÉ patients and 1.0° for BAK patients. Changes in disc height were also similar for both CHARITÉ and BAK patients (0.7 mm for both groups, p=0.9827). Segmental translation was 0.4 and 0.8 mm in patients implanted with CHARITÉ at L4–L5 vs. L5–S1, respectively, and 0.1 mm in BAK patients.ConclusionsThe results of this five-year, prospective, randomized multicenter study are consistent with the two-year reports of noninferiority of CHARITÉ artificial disc vs. ALIF with BAK and iliac crest autograft. No statistical differences were found in clinical outcomes between groups. In addition, CHARITÉ patients reached a statistically greater rate of part- and full-time employment and a statistically lower rate of long-term disability, compared with BAK patients. Radiographically, the ROMs at index- and adjacent levels were not statistically different from those observed at two-years postsurgery.