A new bioabsorbable sleeve for lung staple-line reinforcement (FOREseal™): report of a three-center phase II clinical trial

Objective: To investigate on the feasibility, safety, and effectiveness of a new bioabsorbable material for lung staple-line reinforcement. Methods: This prospective open trial included 66 patients (mean age of 56 ± 17 years) who underwent various types of lung resection using staplers with knitted calcium alginate sleeves for buttressing (FOREseal™, Laboratoires Brothier, Nanterre, France) at three academic centers: 29 lobectomies, 22 emphysema surgeries, 15 wedge resections or lung biopsies. Intraoperative air leakage was assessed at a mean respiratory peak pressure of 30 cmH₂O, and rated as grade 1, 2, or 3. Persistent air leakage in the postoperative course, as well as any relevant event, was assessed daily. The follow-up period was of 6 months. Results: No technical problem linked to the device occurred. Hemostasis of the cutting edges was completed in all patients. Fifty-six percent of the patients had no intraoperative air leak and 27.3% had grade 1 leaks. Mean postoperative air leaks and thoracic drainage times were 1.9 ± 2.3 days and 6 ± 5.3 days, respectively. In-hospital mortality was nil. There was no empyema. Mean hospital stay was 9.1 ± 6.6 days. At follow-up, one patient underwent lung transplantation, and pathology of the explanted specimen showed the absence of device-related foreign-body inflammation. One patient complained from metalloptysis, and another one, with a metastatic invasive aspergillosis, developed an infectious recurrence that required reoperation. Conclusions: FOREseal is an ergonomic, safe, and promising new material instead of nonabsorbable materials and xenomaterials for staple-line reinforcement. A randomized comparative study is now in progress.     

Duct-associated lymphoid tissue (DALT) of minor salivary glands and mucosal immunity.

Minor salivary glands (MSG) play a substantial role in the secretory immunoglobulin A (sIgA)-mediated immunity of the oral cavity. There are two possibilities for the induction of this immunity: (i) an explicitly local antigenic stimulus, or (ii) a remote stimulus as part of the so-called 'common mucosal immune system'. This communication is an attempt to consolidate available evidence in support of both possibilities and to address the former in detail. Although there is strong circumstantial evidence supporting the feasibility of MSG functioning as a part of the common mucosal immune system, direct experimental evidence is yet to emerge. On the other hand, there is increasing structural and physiological evidence in support of MSG serving as a local immunological organ. The purely local response is attributed to the presence of MSG duct-associated lymphoid tissue (DALT), which is comparable to gut- or bronchial-associated lymphoid tissue (GALT or BALT) in origin, tissue organization and function. DALT is accessible to oral antigens by retrograde passage through MSG ducts. Repeated topical antigenic challenging via the oral mucosa may result in the appearance of interacinar plasma cells carrying specific homologous antibodies in MSG. Gut or enteric priming of the same antigen, by passing the oral mucosa by gastric intubation, need not evoke a remote immune response in MSG. Since DALT is more likely to occur in healthy, young growing individuals, who are less likely to undergo bioptic examination of MSG, it has not yet been documented in humans. The physiologically induced DALT is apt to be confused with focal accumulations of lymphoid tissue in pathologically altered MSG, as a consequence of local and some systemic autoimmune diseases. An attempt is made to demarcaate healthy and pathological MSG on the basis of currently available clinical, serological, immunological and genetic evidence.     

Methodik der fortlaufenden Kreislaufanalyse am Hunde

Zusammenfassung Es wird ein für die fortlaufende Blutdruckschreibung an der Karotisschlinge des Hundes entwickeltes Gerät hoher Empfindlichkeit beschrieben, welches bei entlasteter Gefäßwand die Blutdruckänderungen mit automatisch richtiger Wiedergabe der Amplitude durch ein optisches Glasplattenmanometer zur Aufschrift bringt. Die Steuerung des Manometers erfolgt durch eine sich selbsttätig entlastende Membran.Mit 7 Abbildungen     

Variations in length of stay and outcomes for six medical and surgical conditions in Massachusetts and California

OBJECTIVES.--To determine the extent to which interinstitutional variations in length of stay are explained by differences in patient characteristics and to determine whether patients in hospitals with shorter lengths of stay had worse outcomes. DESIGN.--We reviewed patients' medical records and surveyed patients between 3 and 12 months after hospital discharge using a questionnaire. SETTING.--Six teaching hospitals in California and Massachusetts. PATIENTS.--A cohort of 2484 selected patients who had been hospitalized for acute myocardial infarction or to rule out acute myocardial infarction, coronary artery bypass graft surgery, total hip replacement, cholecystectomy, or transurethral prostatectomy. Between 73% and 84% of the patients with each condition completed a follow-up questionnaire. OUTCOME MEASURES.--In-hospital complications, deaths, length of stay, functional status after hospital discharge, readmission, and patient satisfaction with hospital care were analyzed. RESULTS.--Significant interinstitutional differences in length of stay were noted for all conditions except rule-out acute myocardial infarction. Statistical adjustment for case-mix differences accounted for most of the interinstitutional differences in length of stay for total hip replacement but explained little of the differences in the other conditions. When we controlled statistically for other predictors, length of stay did not have a significant impact on deaths, functional status after hospital discharge, the probability of readmission, or patient satisfaction with hospital care. CONCLUSION.--More research is needed to determine the medical practices that are related to variations in lengths of stay. Routinely available outcome data may help preserve quality in the face of efforts to decrease costs by effecting more standardized practices of care.     

A comparison between fibula and iliac crest in mandibular reconstruction

Nowadays the vascularized free fibula flap and the free iliac crest flap are the methods most frequently used to reconstruct the mandible. This is also the case in our clinic. A retrospective nonrandomized study was performed to compare both flaps. The vascularized fibula free flap and the iliac crest free flap were compared in terms of logistics, flap failure, revisionary surgery, donor site morbidity, and recipient site morbidity. No significant differences in flap failure and revision surgery were found between the fibula group and the iliac crest group. Recipient site and donor site complications (major and minor) were significantly less in the fibula group compared to the iliac crest group. In mandibular reconstruction, the free vascularized fibula flap appears to be superior to the free vascularized iliac crest flap in terms of both recipient site and donor site morbidity.     

P1 blood group antigen expression and epidemic hemolytic uremic syndrome

P1 blood group positivity has been postulated as a host factor which may provide protection against the development of post-enteropathic hemolytic uremic syndrome (HUS). In this study, blood group status in 20 Inuit survivors ofEscherichia coli 0157: H7-associated HUS was compared with age-and sex-matched controls from the same community who had experienced uncomplicated diarrheal illness due to the same pathogen. Of 20 HUS survivors, 6 were P1 antigen positive compared with 8 of the 20 controls (P=0.7). We conclude that P1 antigen positivity was not protective against HUS in this population. Further studies of this condition to clarify the role of host factors in verotoxin-induced endothelial damage are indicated.     

Antimurine antibody formation following OKT3 therapy

OKT3 is an IgG2a murine monoclonal antibody directed against the CD3 antigen receptor of human T lymphocytes. A major concern with OKT3 treatment in solid organ transplant recipients is the development of antimouse antibody, which may preclude retreatment with this agent. We have administered OKT3 on 215 occasions (150 renal, 34 hepatic, 26 cardiac, 5 pancreatic) in 179 patients between April 1982 and December 1988. The mean duration of treatment was 10.5 days (range, 2-22 days). Antimouse antibody data were analyzed on the most recent 133 treatment courses where the antibody status was available pretreatment. Determination of antimouse antibody production was elicited by ELISA technology at days 0, 7, 14, and 28 of OKT3 treatment. Patients were categorized according to the antibody response as follows: (a) absence of antibody; (b) low titer (1:100); or (c) high titer (greater than or equal to 1:1000). Our earlier experience has demonstrated that retreatment with OKT3 is successful in groups a and b. The development of antimurine antibodies was analyzed with regard to the following parameters: (1) The duration of OKT3 treatment; (2) treatment type (prophylactic, primary, or secondary); (3) primary treatment or retreatment; (4) concomitant immunosuppressive regimen (double or triple therapy); (5) dosage of concomitant immunosuppressive drugs; and (6) transplant organ type. The following results were obtained. (1) Duration of treatment had no effect on antibody production (11.0 days in antibody negative and 10.0 days in antibody positive). (2) There was no difference in antibody formation rates for the first treatment of OKT3 when it was used as prophylaxis (26%), primary (19%), or secondary (27%) therapy. (3) Antibody formation rate with first treatment was 29%; with retreatment, patients who were antibody negative following first treatment became positive in 28% of cases, and retreated patients who were low titer positive following first treatment converted to high titer in 57% of cases. (4) Antibody formation was higher in patients receiving double immunosuppressive therapy (36%) than in those receiving triple immunosuppressive therapy (21%) during OKT3 treatment. (5) Concomitant immunosuppression was lower in the antibody-positive group during OKT3 therapy: steroids, 61 mg/day vs. 52 mg/day; azathioprine, 89 mg/day vs. 66 mg/day; CsA, 317 mg/day vs. 186 mg/day. (6) Antibody formation rates were lower in non-renal transplants following first treatment with OKT3 (liver 17%, heart 17%, kidney 28%); this reflects the higher doses of concomitant immunosuppressive therapy used in nonrenal transplants.(ABSTRACT TRUNCATED AT 400 WORDS)