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PubMed2003

Ethical framework for the use of sham procedures in clinical trials.

Ethical, professional, and financial considerations support the highest standards in demonstrating the safety and efficacy of new clinical interventions. Professional and regulatory mechanisms implemented to ensure that medical agents undergo a thorough process of systematic testing are lacking in the case of medical procedures. As a result, many procedures, including surgery, are rapidly introduced into the clinical setting without reliable evaluation of their efficacy. In many cases, a randomized, placebo-controlled procedure trial may be necessary to provide this data. We examine the major ethical objections to placebo-controlled procedure trials, including those involving sham surgery, and provide an ethical framework for assessing whether a placebo procedure is ethical to administer in the context of a clinical trial. A placebo-controlled trial of an invasive procedure can be ethically justified if: 1) there is a valuable, clinically relevant question to be answered by the research, 2) the placebo control is methodologically necessary to test the study hypothesis, 3) the risk of the placebo control itself has been minimized, 4) the risk of a placebo control does not exceed a threshold of acceptable research risk, 5) the risk of the placebo control is justified by valuable knowledge to be gained, and 6) the misleading involved in the administration of a placebo control is adequately disclosed and authorized during the informed consent process.

Ethics, Research↗
PubMed2003

Factors predictive of urinary retention after a tension-free vaginal tape procedure for female stress urinary incontinence.

PURPOSE: We performed this study to evaluate factors related to urinary retention after a tension-free vaginal tape (TVT) procedure for female stress urinary incontinence. MATERIALS AND METHODS: We retrospectively analyzed the records of 375 women with a followup of at least 6 months from among patients who underwent the TVT procedure between March 1999 and May 2002 at our institution. We analyzed multiple parameters, including patient characteristics, symptoms and urodynamic studies, using univariate and multivariate regression analyses with respect to postoperative urinary retention, as defined by the need for intermittent catheterization for at least 3 days after the procedure. All patients in the nonretention (343) and retention (32) groups answered a global satisfaction question. RESULTS: In answer to a global satisfaction question 338 of the 375 patients (90.1%) favored the procedure. Univariate analysis demonstrated that patient mean age, parity, peak urinary flow and a history of hysterectomy predicted urinary retention. However, on multivariate analyses the peak urinary flow rate was the only significant independent predictive factor (p = 0.007). While 28 patients (87.5%) in the retention group regained normal voiding without a specific procedure, 4 required tape release or cutting within 3 month of surgery. The global satisfaction question showed a significant difference between the nonretention and retention groups (91.5% vs 75% satisfaction, p = 0.03). CONCLUSIONS: An accurate measurement of the peak urinary flow rate could predict women at risk for postoperative urinary retention that compromises global satisfaction after the highly curative TVT procedure.

Female↗
PubMed2004

Spermatic cord anesthesia block for scrotal procedures in outpatient clinic setting.

PURPOSE: We evaluated the safety and effectiveness of spermatic cord anesthetic block (SCAB) as the only method of anesthesia for bilateral simple orchiectomy in an outpatient clinic setting. MATERIALS AND METHODS: The study included 141 consecutive bilateral simple orchiectomy (BSO) procedures performed at Atlanta Veterans Affairs Medical Center during a 33-month period. All procedures were performed in an outpatient clinic setting using SCAB as the only method of anesthesia. The anesthetic solution consisted of an equal mixture of 1% lidocaine with epinephrine at 1:100,000 and 0.25% bupivacaine. A 10-point visual analog pain scale was used to assess pain/discomfort at baseline, during SCAB instillation and during BSO. Postoperatively overall patient impression/satisfaction with SCAB as a method of anesthesia was determined. RESULTS: Nine of the 141 available cases (6.4%) were excluded from study. The remaining 132 cases were included in data analysis. Mean patient age was 75.4 years (range 44 to 86). A total of 76 patients (57.6%) were receiving luteinizing hormone releasing hormone agonist therapy at the time of the procedure. The mean time needed to perform SCAB and BSO was 3.9 (range 2 to 6) and 33.0 minutes (range 12 to 70), respectively. The average volume of anesthetic solution was 20.1 ml per case (range 10 to 32). The mean pain score was 0.36 (range 0 to 8), 1.96 (range 0 to 8) and 0.33 (range 0 to 5) at baseline, and during SCAB and BSO, respectively. Of the patients 102 (77.3%) underwent a painless procedure (pain score = 0), 29 (21.9%) experienced transient pain that was mild in nature (pain score 4 or less) and only 1 (0.7%) had a pain score of 5. Pain scores were similar in patients who were and were not receiving luteinizing hormone releasing hormone agonists at baseline (p = 0.36), during SCAB instillation (p = 0.89) and during BSO (p = 0.36). The overall impression/satisfaction with SCAB as a method of anesthesia was rated as highly satisfactory by 91.7% of patients and satisfactory by 8.3%. There were no intraoperative adverse events related to SCAB. CONCLUSIONS: SCAB is a simple, safe and highly effective method of anesthesia for scrotal procedures. It allows such procedures to be performed in an outpatient clinic setting, offering convenience and the potential for cost savings.

Adult↗
PubMed2005

Long-term results of the bulbourethral sling procedure.

PURPOSE: We evaluated the long-term efficacy of the male bulbourethral sling procedure in the treatment of post-radical prostatectomy urinary incontinence. MATERIALS AND METHODS: Between October 1994 and June 2000, 95 patients with post-radical prostatectomy incontinence underwent bulbourethral sling placement with tetrafluoroethylene bolsters at our hospital. Ultimately 71 of these patients responded to our questionnaire and they were classified into 2 groups. Group 1 consisted of 62 patients who had not undergone prior radiation therapy and group 2 consisted of 9 who had undergone radiation therapy before the sling procedure. Patients were asked to respond to questions regarding continence status as well as the validated Incontinence Quality of Life and International Prostate Symptom Score questionnaires. RESULTS: Mean followup from the most recent sling procedure was 4 years (range 0.27 to 6.55). Average patient age at questionnaire response was 74 years. A total of 86 procedures were performed on 71 patients. Of the 71 patients 7 underwent either sling removal or artificial urinary sphincter placement and were excluded from questionnaire analysis. Including retightening procedures 68% of the patients (72% of group 1, 43% of group 2) required 2 or less pads daily. Of the patients 36% (42% of group 1 and 14% of group 2) required 0 pads. CONCLUSIONS: The male bulbourethral sling procedure remains an effective treatment for post-prostatectomy incontinence at 4-year followup.

Aged↗
PubMed2003

High-dose rectal midazolam for pediatric procedures: a randomized trial of sedative efficacy and agitation.

OBJECTIVES: To compare 2 doses of rectal midazolam, used for pediatric emergency department sedation, with regard to sedative efficacy and frequency of paradoxical agitation. METHODS: Children <or=48 months old undergoing cutaneous procedures received midazolam by rectum, randomized in double-blind fashion to standard (0.5 mg/kg, SDM) or high (1 mg/kg, HDM) doses. Behaviors were scored on a 5-point sedation scale before and during procedures. Proportions manifesting successful sedation and postprocedure agitation were compared between the 2 doses. RESULTS: Sixty-five patients (32 SDM, 33 HDM) underwent sedated procedures (repair of lacerations, 97%). Behavior scores improved for both groups following medication administration and at best sedation during procedure. HDM produced better sedation at time of first suture (successful sedation: 70%, SDM vs. 91%, HDM; intergroup difference = 21%; 95% confidence interval [CI] = 2, 41) and at best point during the procedure (72%, SDM vs. 97%, HDM; Delta = 25%; 95% CI = 8, 43). However, sedative efficacy declined such that only 50% and 73% of the SDM and HDM groups, respectively, had successful sedation at the worst point during the procedures. Postprocedure agitation occurred in 17% of patients (6%, SDM vs. 27%, HDM; Delta = 21%; 95% CI = 3, 39). CONCLUSIONS: Rectal midazolam improved sedation scores over preprocedure levels and was more effective with a dose of 1 mg/kg than with 0.5 mg/kg. However, inadequate sedation in 27-50% of patients and prolonged agitation in 27% of patients at higher doses counter the advantages of rectal midazolam.

Administration, Rectal↗
PubMed2004

The educational experience of pediatric emergency medicine fellows in the use and application of procedural sedation/analgesia.

OBJECTIVES: The purpose of this study is to describe the clinical and educational experience provided to the pediatric emergency medicine (PEM) fellows in procedural sedation/analgesia during their course of training. METHODS: A nonanonymous survey was completed by the program director of each Accreditation Council for Graduate Medical Education (ACGME)-accredited PEM fellowship program listed in the 2001 to 2002 Graduate Medical Education Directory. Information relating to program demographics, agents available for use in the emergency department (ED), and the educational opportunities offered to trainees was sought. RESULTS: Each of the 32 ACGME-accredited programs completed the survey. Thirty programs report using procedural sedation and analgesia (PSA) to facilitate the completion of nonpainful and 32 programs to facilitate the completion of painful procedures in the ED. Twenty-nine programs (92%) permit their fellows to provide PSA independently after meeting credentialing criteria at their institution. Formal didactic sessions, direct supervision of procedures, and dedicated journal clubs were the 3 most frequently cited educational methods reported. The educational method chosen was not predicted by the ED type, the size of the training program, or by the volume of patients evaluated in the ED. Twelve program directors report their belief that a minimum number of procedures should be completed prior to completion of the training program. CONCLUSION: There is wide variation in the educational methods used by PEM fellowship training programs in procedural sedation/analgesia.

Analgesia↗
PubMed2006

Parental presence during invasive procedures and resuscitation: attitudes of health care professionals in Turkey.

OBJECTIVES: An agreement among physician, nurse, and family on the issue and a solution developed by all will improve the quality of work. The aims of this study were to determine health care professionals' (physicians and nurses) attitude toward parental presence during invasive procedures and toward parental participation in this decision and to investigate the difference between the approach of physicians and nurses. METHODS: This study was performed on the physicians and nurses of the Medical Faculty of the Department of Pediatrics of Ege University between December 2003 and March 2004. The questionnaire delivered was completed by 49 (94%) of 52 nurses and 51 (89%) of 57 physicians. RESULTS: Parental presence during blood sampling, simple wound repair/suture, lumbar puncture, and bone marrow aspiration/biopsy was approved by 72.5%, 27.5%, 66.7%, and 82.4% of the physicians and 53.1%, 57.1%, 81.6%, and 85.7% of the nurses, respectively. None of the health care professionals preferred parents to attend during any kind of resuscitation. Attitudes of the nurses and physicians were found to be similar between the 2 groups except for simple wound repair. Major determinants of the decision about the agreement for parental presence were procedural invasiveness for physicians (reported by 82.5%) and level of sedation for nurses (reported by 75.5%). The mean ages of both groups of health care professionals who did not approve parental presence during invasive procedures were lower than that of the ones who approved for all procedures. CONCLUSION: The physicians and nurses in the study population tended to prefer parents not to be present during procedures as the level of invasiveness increased. An agreement between the attitudes of physicians and nurses toward parental presence during invasive procedures is essential for improving quality of service, especially in the dynamic environment of the emergency department.

Adult↗
PubMed2004

Use of dermal regeneration template in contracture release procedures: a multicenter evaluation.

Integra dermal regeneration template (Integra Life Sciences, Plainsboro, N.J.) is an effective treatment for full-thickness burns. It can also be useful in contracture release procedures; however, the clinical utility of a dermal regeneration template in contracture release procedures has not been adequately characterized. In this multicenter investigation, the outcomes of release procedures incorporating a dermal regeneration template for 89 consecutive patients, who underwent a total of 127 contracture releases, were retrospectively evaluated. The procedures involved the application of Integra, which includes a temporary silicone epidermal substitute and an artificial dermal layer. After formation of a neodermis, the silicone layer is removed and replaced with an epidermal autograft. Data on patient and contracture site history, treatment methods, physician assessments of range of motion or function, patient satisfaction, recurrence, and adverse events were collected with a standardized questionnaire. Release procedures for the study patients involved the neck, axilla, trunk, elbow, knee, hand, and other anatomical sites. The mean postoperative follow-up period was 11.4 months. At 76 percent of the release sites, range of motion or function was rated as good (significant improvement in range of motion or function) or excellent (maximal range of motion or function possible) by physicians. Responding patients expressed satisfaction with the overall results of treatment at 82 percent of the sites. No recurrence of contracture at 75 percent of the sites was observed during follow-up monitoring. Patient age and prior surgical treatment at the site did not significantly affect the results of treatment. However, outcomes were superior at mature sites, i.e., those for which more than 12 months had elapsed since the original injury. Postoperative complications rarely necessitated regrafting. These results indicate that a dermal regeneration template provides a useful alternative technique for contracture release procedures. The study data indicate that this approach leads to favorable functional outcomes and a high rate of patient satisfaction. This modality also seems to be versatile, because a range of anatomical sites are amenable to treatment with a dermal regeneration template, regardless of prior surgical treatment, and both pediatric and adult patients respond well to this form of therapy. Furthermore, Integra confers functional and cosmetic benefits similar to those of full-thickness grafts but without comparable potential for donor-site morbidity.

Adolescent↗
PubMed2004

Development of less invasive surgical procedures for thoracic esophageal cancer.

In order to minimize the invasiveness of the operative procedure for thoracic esophageal cancer, several procedures have been introduced since January 1997. They included: (i) perioperative use of steroids; (ii) muscle-sparing thoracotomy without costectomy; (iii) preparation of the gastric tube with preservation of sufficient blood supply; (iv) reconstruction of the alimentary tract via posterior-mediastinal route; and (v) formation of anastomosis between the remaining esophagus and the gastric tube at a location between the gastroepiploic arteries of the gastric greater curvature. Twenty-one patients who did not receive preoperative chemoradiotherapy underwent the newly developed procedure, and were compared with those receiving the original procedure. Hospital mortality was zero, and postoperative systemic inflammatory response syndrome was suppressed. The mean postoperative hospital stay was 21.5 days, and the actuarial 3-year survival rate was 76.2%. From the comparison with those receiving the original procedure, it can be concluded that the newly developed procedures were effective in minimizing surgical invasiveness and were sufficiently curative in terms of cancer treatment.

Anastomosis, Surgical↗
PubMed2005

Safe and effective sedation and analgesia for bone marrow aspiration procedures in children with alfentanil, remifentanil and combinations with midazolam.

BACKGROUND: Invasive procedures such as bone marrow aspiration in children may be painful and cause anxiety. We investigated the efficacy and safety of remifentanil (R) alfentanil (A), remifentanil-midazolam (RM), and alfentanil-midazolam (AM) combinations in providing analgesia and sedation for bone marrow aspiration. METHODS: Eighty children undergoing a diagnostic bone marrow aspiration whose ages ranged from 5-16 years (mean 9.20 +/- 3.00 years) were enrolled in this study. The patients were randomly assigned to one of 4 treatment groups. Vital signs, sedation and pain scores, somatic responses (sweating and tears) were recorded before, during bone marrow aspiration and after 5 and 15 min of the procedure. RESULTS: There were no statistical differences between sedation and the CHEOPS scores of the four groups during and after the procedures. The VAS scores were significantly higher for group A compared with groups R and RM during the procedure (P < 0.008). There were no differences between the VAS scores in group AM compared with groups R and RM (P > 0.008). There were also no statistical differences among the VAS scores of four groups after the procedure (P > 0.008). All patients had adequate sedation and analgesia. None of the patients in the study had deep sedation, hypotension, bradycardia, hypoxemia, or respiratory depression. CONCLUSIONS: Remifentanil, alfentanil, remifentanil-midazolam, and alfentanil-midazolam combinations are effective in children and can be used safely in bone marrow aspiration which is a brief but painful procedure performed in the pediatric patient group.

Adolescent↗
PubMed2006

Leigh syndrome: anesthetic management in complicated endoscopic procedures.

BACKGROUND: Leigh's syndrome, a disorder of infancy and childhood, is characterized by gray matter degeneration and focal brainstem necrosis. It presents with special clinical features such as developmental delay, nervous system dysfunction, respiratory abnormalities, and hypertrophic cardiomyopathy that can be a real challenge to the anesthesiologist. Anesthesia or sedation has rarely been reported in patients with Leigh disease. We report our experience in sedating five children with Leigh syndrome in seven procedures undertaken in the endoscopy suite (outside the operating room). METHODS: Five children with Leigh disease, three girls and two boys, have been referred to us for percutaneous endoscopic gastrostomy (PEG) insertion and or replacement (a total of seven procedures). The average age was 2.6 years with a range of 4 months to 6 years. Informed consent was obtained from the patient's parents or guardian. An anesthesia machine, scavenging system, O(2) source and routine monitoring were available. Sedation was accomplished with propofol intravenous (i.v.) (0.5-1 mg x kg(-1)) maintained with a propofol infusion (50-100 microg x kg(-1) x min(-1)). The spontaneously breathing patients received oxygen through an oxygen facemask during the procedure and afterwards recovery was managed in the gastroenterology unit. RESULTS: All the children underwent the procedure without complications. One patient developed transient desaturation (SpO(2) 80%) for a few seconds. Body temperature, heart rate, arterial blood pressure, O(2) saturation and endtidal CO(2) were stable during the endoscopies. No special post-procedure management was required; the patients woke up at the end of the endoscopy and were able to drink and eat as usual. CONCLUSIONS: This rare mitochondrial disease presents unique management problems to the anesthesiologist when using general anesthesia. Our patients were managed appropriately before endoscopy and underwent the procedure under deep sedation. No complications occurred. We concluded that deep sedation in the endoscopy suite was safe in this small series of patients with this rare disease.

Anesthetics, Intravenous↗
PubMedDate not supplied

Evaluation of the impact of a paediatric procedural sedation credentialing programme on quality of care.

OBJECTIVES: The aim of the present study is to describe changes in documentation, risk assessment and patient care resulting from implementation of a credentialing process for medical and nursing staff in paediatric procedural sedation (PPS) in two EDs - one an urban mixed ED and the other a specialist paediatric ED. METHODS: Chart review of 100 patients undergoing PPS prior to and 100 patients following introduction of the PPS programme. Information was extracted from medical records and sedation checklists. Demographics, drugs used, procedure performed and elements of the pre-procedural, intra-procedural and post-procedural care were compared pre- and post implementation of the PPS programme. RESULTS: Significant improvements in the post-implementation period compared with pre-implementation were seen in: frequency of documentation of informed consent (87 vs 15%, P < 0.0001); evidence of performance of a pre-procedural risk assessment (87 vs 1%, P < 0.0001); and appropriate recording of vital signs (58 vs 27%, P < 0.0001). Improvements were also noted in documentation of weight, allergies, fasting status and recording of drug orders. There were no adverse events recorded in the pre-programme period and 6 recorded in the post-programme period. CONCLUSION: The implementation of a PPS credentialing programme into these two EDs resulted in significant improvements in risk assessment, monitoring and documentation of important information related to safe PPS. These improvements should result in improved quality and safety of PPS.

Child↗
PubMed2001

Intravenous ketamine plus midazolam is superior to intranasal midazolam for emergency paediatric procedural sedation.

OBJECTIVES: This study compared intranasal midazolam (INM) with a combination of intravenous ketamine and intravenous midazolam (IVKM) for sedation of children requiring minor procedures in the emergency department. METHOD: A single blinded randomised clinical trial was conducted in the emergency department of a major urban paediatric hospital. Subjects requiring sedation for minor procedures were randomised to receive either INM (0.4 mg/kg) or intravenous ketamine (1 mg/kg) plus intravenous midazolam (0.1 mg/kg). Physiological variables and two independent measures of sedation (Sedation Score and Visual Analogue Sedation Scale) were recorded before sedation and at regular intervals during the procedure and recovery period. Times to adequate level of sedation and to discharge were compared. RESULTS: Fifty three patients were enrolled over a 10 month period. Sedation was sufficient to complete the procedures in all children receiving IVKM and in 24 of the 26 receiving INM. Onset of sedation was an average of 5.3 minutes quicker with IVKM than with INM (95%CI 3.2, 7.4 minutes, p<0.001). Children given INM were discharged an average of 19 minutes earlier than those given IVKM (95%CI 4, 33 minutes, p=0.02). Mean Sedation Scores and Visual Analogue Sedation Scale scores for the 30 minutes after drug administration were significantly better in children given IVKM compared with INM (2.4 and 1.8 versus 3.5 and 3.8, respectively). Both doctors and parents were more satisfied with sedation by intravenous ketamine and midazolam. CONCLUSIONS: Intravenous ketamine plus midazolam used in an appropriate setting by experienced personnel provides an excellent means of achieving sedation suitable for most non-painful minor procedures for children in the emergency department. This combination is superior to INM in terms of speed of onset and consistency of effect. INM delivered via aerosol spray has a more variable effect but may still be adequate for the completion of many of these procedures.

Administration, Intranasal↗
PubMed2002

Cost analysis of adjunct hypnosis with sedation during outpatient interventional radiologic procedures.

PURPOSE: To compare the cost of standard intravenous conscious sedation with that of sedation with adjunct self-hypnotic relaxation during outpatient interventional radiologic procedures. MATERIALS AND METHODS: Data were reviewed from a prospective randomized study in which patients undergoing vascular and renal interventional procedures underwent either standard sedation (n = 79) or sedation with adjunct hypnosis (n = 82). These data were used to construct a decision analysis model to compare the cost of standard sedation with the cost of sedation with adjunct hypnosis. Multiple sensitivity analyses were performed to assess the applicability of these results to other institutions with different cost structures with respect to the following variables: cost of the hypnosis provider, cost of room time for interventional radiologic procedure, hours of observation after the procedure, and frequency and cost of complications associated with over- or undersedation. RESULTS: According to data from this experience, the cost associated with standard sedation during a procedure was $638, compared with $300 for sedation with adjunct hypnosis, which resulted in a savings of $338 per case with hypnosis. Although hypnosis was known to reduce room time, hypnosis remained more cost-effective even if it added an additional 58.2 minutes to the room time. CONCLUSION: Use of adjunct hypnosis with sedation reduces cost during interventional radiologic procedures.

Adolescent↗
PubMed2003

A novel denervation procedure for idiopathic cervical dystonia.

BACKGROUND: For idiopathic cervical dystonia, the treatment of choice is botulinum toxin injection or surgical denervation. There are two major procedures of surgical denervation: intradural ventral rhizotomy and extradural peripheral neurotomy (Bertrand procedure). The Bertrand procedure is always accompanied by popstoperative sensory loss in the C2 region. METHODS: The authors have modified these procedures to minimize the complications. Our method is unilateral intradural ventral rhizotomy of C1 and C2, extradural denervation of the C3-C6 posterior rami and contralateral peripheral sectioning of the branches of the accessory nerve to the sternocleidomastoid muscle. Forty-four patients underwent this modified operation ('Taira's' method: group A) and the results were compared with those in a matched control group of 38 patients who underwent the traditional Bertrand's procedure (Bertrand's method: group B). RESULTS: Three patients in group A showed a sensory deficit in the C2 area, while all of the patients in group B had C2 sensory disturbance. Pre- and postoperative rating scores did not differ between the two groups. The intraoperative blood loss was significantly smaller in group A. CONCLUSION: Compared with the traditional Bertrand's operation, our procedure carries a much lower incidence of complications and a significant decrease of intraoperative blood loss.

Female↗
PubMed1995

Comparison of cardiopulmonary adaptation during exercise in children after the atriopulmonary and total cavopulmonary connection Fontan procedures.

BACKGROUND: There are several potential physiological differences between the atriopulmonary (AP) and the total cavopulmonary connection (TCPC) Fontan circulations. Studies suggest that the TCPC reduces energy loss due to turbulence and may have more dependence on respiratory movement for pulmonary blood flow. We compared cardiopulmonary physiology during rest and exercise in patients who had undergone the AP Fontan procedure with those who had undergone the TCPC Fontan procedure. METHODS AND RESULTS: Forty-three children were studied more than 6 months after undergoing a Fontan procedure (23 AP and 20 TCPC); 106 healthy children were also studied as a control group. Measurements of effective pulmonary blood flow, stroke volume, arteriovenous oxygen difference, minute ventilation, heart rate, and oxygen and carbon dioxide consumption were made with an Innovision quadrupole mass spectrometer. Data from the control group allowed calculation of z scores for the Fontan groups matched for age, sex, pubertal stage, and body surface area. Maximal exercise performance was equal in the two Fontan groups, but it was below normal. However, adaptation to exercise was different in the Fontan groups. After 9 minutes of exercise, pulmonary blood flow rose less in the AP group than in the TCPC group (P < .01), and the stroke volume in the AP group also tended to be lower (P = .057) and their arteriovenous oxygen difference was significantly greater (P < .01). Although minute ventilation per unit of carbon dioxide production was similar in the Fontan groups at this level of exercise, children in the TCPC group breathed faster by approximately 10 breaths per minute (P < .005). CONCLUSIONS: At submaximal exercise, children who had undergone the TCPC Fontan procedure had pulmonary hemodynamics superior to those of children who had undergone the AP procedure, largely because of respiratory adaptation that permitted blood to be "sucked" into the lungs. To achieve the same maximal exercise performance, children who had undergone the AP procedure had a superior metabolic adaptation to exercise stress.

Adaptation, Physiological↗
PubMed2002

Intracerebral hemorrhages associated with neurointerventional procedures using a combination of antithrombotic agents including abciximab.

BACKGROUND: We report the occurrence of fatal intracerebral hemorrhage associated with using a combination of antithrombotic agents, including abciximab, in patients undergoing neurointerventional procedures. SUMMARY OF REPORT: Seven patients (average age 60, range 46 to 73 years) developed fatal intracerebral hemorrhages associated with neurointerventional procedures and the use of intravenous abciximab. The procedures included angioplasty and stent placement in the cervical internal carotid artery (n=4), angioplasty of the intracranial internal carotid artery (n=1), and angioplasty of the middle cerebral artery (n=2). Clinical deterioration was observed within 1 hour of the procedure in 5 patients and 7 and 8 hours after the procedure, respectively, in the remaining 2 patients. All patients had received heparin and clopidogrel; 6 had also received aspirin. CONCLUSIONS: Intracerebral hemorrhages can occur after neurointerventional procedures in patients with recent cerebral ischemic events, particularly when aggressive antithrombotic treatment is used.

Abciximab↗
PubMed2005

Long-term evaluation of the Roux-Elmslie-Trillat procedure for patellar instability: a 26-year follow-up.

BACKGROUND: Few published articles exist reporting the long-term evaluation of the Roux-Elmslie-Trillat procedure. PURPOSE: To assess the long-term effect of the Roux-Elmslie-Trillat procedure in preventing recurrent subluxation and dislocation of the patella. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Eighteen patients who underwent the Roux-Elmslie-Trillat procedure for dislocation or subluxation of the patella were identified from a group previously evaluated at a mean follow-up of 3 years. The prevalence of recurrent subluxation or dislocation at a mean follow-up of 26 years was compared with the prevalence reported at the mean follow-up of 3 years. Although not the focus of this study, Cox functional scores were obtained from the smaller group and compared with the results at the 3-year follow-up. RESULTS: Seven percent (95% confidence interval, 0.00-0.32) of the patients had recurrent subluxation at 26 years compared with 7% (95% confidence interval, 0.03-0.13) of the study population reported at 3 years (P = 1.00). Fifty-four percent (95% confidence interval, 0.27-0.79) rated their affected knee as good or excellent at 26 years compared with 73% (95% confidence interval, 0.64-0.81) of the larger study population reported at 3 years (P = .14). CONCLUSION: The prevalence of recurrent subluxation and dislocation in patients with patellofemoral malalignment who underwent the Roux-Elmslie-Trillat procedure for dislocation or subluxation of the patella is similar at 3 and 26 years after the procedure. The long-term functional status of the affected knee in patients who underwent the Roux-Elmslie-Trillat procedure declined.

Adolescent↗