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PubMed1976

ICP monitoring: complications and associated factors.

1. Patients with complications when compared with those not developing a complication: a. Were older, 44.4 vs. 34.5 years; b. Were monitored longer, 14.0 vs. 6.5 days; c. Were treated with steroids longer, 18.3 vs. 10.3 days; d. Were hospitalized longer, 35.7 vs. 27.7 days; e. Are twice as likely to die; f. Average age of those dying is older, 46 vs. 30 years; g. Have no clear relationship to antibiotics; h. Do not have a preponderance of single diagnostic category to account for these differences; i. Complications were always controlled with standard therapy; j. An ICP complication was almost never responsible, per se, for death. 2. Over all complication rate was 18%; due to monitoring was 4.5 to 11.5%. 3. Monitoring was responsible for, or contributed to, 25 to 60% of the complications. 4. No complications occurred when monitoring was discontinued within 3 days. 5. Long periods of treatment with steroids increased the risk of a complication developing. 6. Long periods of monitoring were associated with an increased risk of complication. 7. "Individual" factors are partly responsible for the development of a complication, and death. 8. There are two groups of complications: "early" and "late." A. Those most likely to be monitor related occur "late" and account for 35% of the complications. B. Those developing "early" infection account for 65% of the complications and are most likely caused by factors other than monitoring. While there are complications directly attributable to monitoring, the rate is low and they are readily controlled by standard neurosurgical management. While monitoring may increase the morbidity, it does not increase the mortality. We feel that the over-all risk is small and that the returns are great--both in terms of knowledge and patient benefit.

Adult↗

PubMed2002

Complications in postmastectomy breast reconstruction: two-year results of the Michigan Breast Reconstruction Outcome Study.

In this study, the effects of procedure type, timing, and other clinical variables on complication rates in mastectomy reconstruction were prospectively evaluated. Using a prospective cohort design, women undergoing first-time, immediate or delayed breast reconstruction were recruited from 12 centers and 23 plastic surgeons. Complication data for expander/implant, pedicle transverse rectus abdominis musculocutaneous (TRAM) flap, and free TRAM flap procedures were evaluated 2 years after surgery in 326 patients. For each patient, the total number of complications was recorded and the complication data were dichotomized in two ways: (1) total complications and (2) major complications (those requiring reoperation, rehospitalization, or nonperioperative intravenous antibiotic treatment). The effects of procedure type, timing, radiotherapy, chemotherapy, age, smoking, and body mass index on complication rates were analyzed using logistic regression. Immediate reconstructions had significantly higher total as well as major complication rates, compared with delayed procedures (p = 0.011 and 0.005, respectively). Furthermore, higher body mass indexes were associated with significantly higher total and major complication rates (p = 0.005 and p < 0.001, respectively). No significant effects on complication rates were noted for procedure type or for the other independent variables, although there was evidence of trends for higher total and major complication rates in implant patients who received radiotherapy and a trend for higher major complication rates in TRAM flap patients who received chemotherapy. It was concluded that (1) immediate reconstructions were associated with significantly higher complication rates than delayed procedures, and (2) procedure type had no significant effect on complication rates.

Body Mass Index↗

PubMed1995

Administrative databases' complication coding in anterior spinal fusion procedures. What does it mean?

STUDY DESIGN: A review of a cohort of 310 consecutive patients who underwent anterior spinal fusion was performed to evaluate the accuracy of hospital ICD-9-CM complication coding. OBJECTIVES: To better understand the clinical significance of conclusions suggested by studies that rely on electronic administrative databases for their data source. SUMMARY OF BACKGROUND DATA: Despite their availability, there have been no studies to date that have evaluated the accuracy of ICD-9-CM administrative databases as they relate to the actual clinical experience in spinal procedures. METHODS: A physician and a research technician independently reviewed the primary medical records for the occurrence of complications. This data was compared with the hospital-acquired ICD-9-CM coded complications. RESULTS: The physician reviewer identified 152 complications in 119 patients, with 32 different types of complications. The research abstracter identified 175 complications in 130 patients, with 34 different types of complications identified. Hospital ICD-9-CM coding identified 105 complications in 80 patients, including only 11 different ICD-9-CM codes. Overall, 27% of ICD-9-CM complication codes were listed as "unspecified or unclassified complications, reactions, or misadventures," and contained no meaningful clinical information. Cardiac and pulmonary complications were over-estimated and wound infections and genitourinary and gastrointestinal complications were underestimated by ICD-9-CM coding. CONCLUSIONS: Studies of complications of spinal procedures using data derived from hospital ICD-9-CM complication codes may be intrinsically flawed because the data available to researchers from these electronic databases may be inaccurate.

Adolescent↗

PubMed2004

Surgical complications and their management in a series of 300 consecutive pediatric cochlear implantations.

OBJECTIVE: To report the short- and long-term complications encountered in a large number of consecutive children undergoing implantation in a single center. The current study also describes the management and sequelae of each complication. STUDY DESIGN: Prospective study assessing the surgical findings and complications of deaf children undergoing implantation. SETTING: Pediatric tertiary referral center for cochlear implantation. PATIENTS: The present study includes 300 consecutive children undergoing implantation, with a mean age at implantation of 5.1 years, ranging from 1.3 to 16.9 years. Of these children, 196 (65%) had congenital deafness of unknown cause. The commonest known cause was meningitis (73 of 300 [24%]) followed by congenital cytomegalovirus infection (17 of 300 [6%]). Children have been followed up regularly after implantation, typically at yearly intervals after the first year. The mean duration of follow-up at the time of the study was 4 years (range, 0.1-14 yr). RESULTS: There were no major perioperative (within 1 d after surgery) or major early postoperative (within 1 wk after surgery) complications. In the same periods, there were 19 and 15 minor complications, respectively. These complications (e.g., eardrum perforation, hematoma, flap swelling, wound infection, temporary facial weakness) settled with conservative treatment or minor intervention. With regard to the late surgical complications (>1 wk after surgery), there were 7 major (e.g., severe flap infection requiring explantation, cholesteatoma, persistent eardrum perforation) and 14 minor complications (e.g., mild flap infection, flap swelling, hematoma). A number of complications were encountered even 14 years after the original operation, and some of them needed repeated interventions, highlighting the importance of long-term follow-up. However, most of the complications occurred very close to the surgical procedure (<1 yr). CONCLUSION: An overall rate of 2.3% for major surgical complications and an overall rate of 16% for minor surgical complications suggest that cochlear implantation is a relatively safe surgical operation in experienced centers. Most surgical complications are minor and can be managed with conservative treatment or minor surgical intervention. However, meticulous attention to surgical detail, especially handling soft tissues and leaving the posterior canal wall intact, and long-term follow-up are of paramount importance in minimizing the incidence of surgical complications.

Adolescent↗

PubMed2003

Complications of a percutaneous suture-mediated closure device versus manual compression for arteriotomy closure: a case-controlled study.

PURPOSE: To evaluate the incidence and types of complications encountered with use of a percutaneous suture-mediated closure device versus manual compression for arteriotomy closure in a retrospective case-controlled study. MATERIALS AND METHODS: The authors identified 100 consecutive patients, 15 men and 85 women 21-85 years of age (mean, 50 years), between December 2000 and July 2001 in whom the Closer percutaneous suture-mediated closure device was used during 65 uterine artery embolization (UAE) procedures, 11 hepatic chemoembolization procedures, nine diagnostic angiography procedures, seven peripheral vascular interventions, six visceral arterial interventions, and two thrombolysis procedures. An age-, sex-, and procedure-matched control population was identified in which manual compression was performed. Procedure reports and clinical charts were reviewed for the presence of puncture-site complications, as categorized according to Society of Interventional Radiology reporting standards, and for risk factors and comorbid conditions (hypertension, diabetes, stroke, smoking, and coronary artery disease). Follow-up visits and imaging studies were reviewed for patients with complications. RESULTS: In the Closer group, there were seven device failures, four minor complications, and three major complications. Minor complications included two groin hematomas and two cases of persistent pain at the arteriotomy site. Three major complications consisted of two cases of external iliac artery dissection, one with distal embolization, and one case of common femoral artery (CFA) occlusion and distal embolization. All major complications occurred in women undergoing UAE. One patient required thromboendarterectomy and patch angioplasty to repair the CFA occlusion, as well as amputation of a gangrenous toe. In the manual-compression group, there was one minor complication (a groin hematoma) and no major complications. There were significantly more complications in the Closer group than in the manual compression group (P =.02). CONCLUSIONS: Significantly more complications were associated with use of a percutaneous suture-mediated closure device than with manual compression for arteriotomy-site hemostasis. Major complications and associated morbidity may be seen with use of percutaneous suture-mediated closure devices. In particular, an unexpectedly high frequency of device-related complications was demonstrated in young women undergoing UAE.

Adult↗

PubMed2005

Surgical complications in live-donor pediatric and adolescent renal transplantation: study of risk factors.

UNLABELLED: To report the surgical complications among our pediatric and adolescent renal transplants and to analyze the different factors that may influence the occurrence of such complications. METHODS: A total of 250 pediatric and adolescent renal transplants were included in this study. Of these patients, there were 154 boys and 96 girls with a mean age of 15.4+/-3.7 yr (range 5-20 yr). All patients received their kidneys from living donors. Four patients underwent renal retransplantation. Surgical complications were reported and their incidence was correlated with several pretransplant, technical and post-transplant risk factors by both univariate and multivariate analyses. The impact of surgical complications on graft and patient survival was computed using the Kaplan-Meier technique. RESULTS: Among the 250 patients, 35 surgical complications were encountered in 33 patients. These complications included urinary leakage in 10 patients, ureteric stricture in 11 patients, complicated lymphocele in eight patients, hematoma necessitating surgical exploration in two patients, wound dehiscence in one patient, stone of the graft ureter in one patient and renal artery stenosis in two patients. The incidence of urological complications (ureteral stenosis, urinary leakage and stone disease) was 8.8% and vascular complications 0.8%. Small ureteric leakage (four patients) was treated by endourologic techniques, whereas leaks associated with ureteral necrosis required open revision. Endourologic treatment was attempted in early and mild cases of ureteric obstruction. In late and severe cases, surgery was performed. On univariate analysis, the factors that significantly affected the incidence of surgical complications were recipient's age, lower urinary tract abnormalities, the type of primary urinary recontinuity, the time to diuresis, and height and weight of the patients. On multivariate analysis, the type of primary urinary continuity was the only factor that sustained statistical significance. Neither patient nor graft survival was affected by the occurrence of surgical complications. CONCLUSION: Primary urinary continuity is the only risk factor that affects the incidence of surgical complications among pediatric and adolescent live donor renal transplants, with the extravesical technique of Lich-Gregoir providing the best results. Surgical complications in pediatric and adolescent renal transplantation can be minimized if basic principles of careful transplant techniques are used. Prompt identification and treatment of any complication is paramount to graft and patient survival.

Adolescent↗

PubMed1996

Risk of pulmonary complications after elective abdominal surgery.

STUDY OBJECTIVE: Intra-abdominal operations are relatively high risk for pulmonary complications. Previous research has more intensely investigated cardiac operative risk, but recent work suggests that significant pulmonary complications may be more common than cardiac complications and associated with longer length of stay. This study identified risk indicators for pulmonary complications after elective abdominal operations. DESIGN: Nested case-control. SETTING: University affiliated Veterans Affairs hospital. PATIENTS: We used a computerized registry of all 2,291 patients undergoing elective abdominal operations from 1982 to 1991. Ascertainment and verification of pulmonary and cardiac complications were systematic and explicit. Charts of all 116 patients identified by the registry as having complications and 412 (19%) randomly selected from 2,175 remaining patients were reviewed to verify complications, using explicit criteria and independent abstraction of preoperative and postoperative components of charts. From 528 validated subjects (23% of the cohort), 82 cases and 82 control subjects were closely matched by operation type and age, +/- 10 years. MEASUREMENTS AND RESULTS: The primary outcome measure was postoperative pulmonary complications. Among 82 cases with pulmonary complications, 27 (33%) also had cardiac complications. Preoperative variables independently associated with pulmonary complications by multivariable analysis (p < or = 0.05) included the following: Charlson comorbidity index (per point odds ratio [OR], 1.6; 95% confidence interval [CI], 1.004 to 2.6), Goldman cardiac risk index (per point OR, 2.04; 95% CI, 1.17 to 3.6), abnormal chest radiograph (OR, 3.2; 95% CI, 1.07 to 9.4), and abnormal findings on lung examination (OR, 5.8; 95% CI, 1.04 to 32). Equal proportions of cases and control subjects had preoperative diagnostic spirometry. No component of spirometry predicted complications, including severity of obstructive lung disease. CONCLUSIONS: For pulmonary operative risk, abnormal results of lung examination and chest radiography plus cardiac and overall comorbidity were important. Spirometry was not helpful. Because 33% of cases had both cardiac and pulmonary complications, future studies should prospectively examine comparative incidence, outcomes, and predictors of both type of complications.

Abdomen↗

PubMed1996

Perioperative complications of anterior procedures on the spine.

We reviewed the operative and hospital records of 447 patients in order to determine the rates of perioperative complications associated with an anterior procedure on the thoracic, thoracolumbar, or lumbar spine. The anterior procedures were performed to treat spinal deformity or for débridement or decompression of the spinal canal. The diagnostic groups that we studied included idiopathic scoliosis in adolescents or young adults (100 patients), scoliosis in mature adults (sixty-three patients), kyphosis (sixty-one patients), neuromuscular scoliosis (sixty patients), fracture (forty-seven patients), a revision procedure (thirty-nine patients), congenital scoliosis (thirty-six patients), tumor (nineteen patients), vertebral osteomyelitis or discitis (eight patients), and miscellaneous (fourteen patients). Complications occurred in 140 (31 per cent) of the 447 patients and were classified as major or minor. Forty-seven patients (11 per cent) had at least one major complication and 109 (24 per cent) had at least one minor complication. Two patients died, both from pulmonary complications after the operation. The most common type of major complication was pulmonary; the most common type of minor complication was genito-urinary. The adolescent or young adult patients who had idiopathic scoliosis had the lowest rate of complications, and the patients who had neuromuscular scoliosis had the highest. An age of more than sixty years at the time of the operation was associated with a higher risk of complications. The duration of the procedures involving a thoracic approach was shorter than that of those involving a thoracolumbar or lumbar approach; however, the rate of complications was not significantly different among the three approaches. Vertebrectomies took longer to perform and were associated with a greater estimated blood loss than discectomies; however, there was no significant difference in the rate of complications between the two types of procedures. The patients who had a fracture or a tumor lost more blood than those from the other diagnostic groups. Blood loss increased as the duration of the operation increased for all procedures. Combined anterior and posterior procedures performed during the same anesthesia session were associated with a higher rate of major complications than were procedures that were staged. A logistical regression analysis showed that the variables that increased the risk of a major complication were an estimated blood loss of more than 520 milliliters and an anterior and posterior procedure performed sequentially under the same anesthesia session. This analysis also demonstrated that the diagnosis of idiopathic scoliosis in adolescents or young adults was associated with a reduced risk of major complications. Compared with other major operations, an anterior procedure on the thoracic, thoracolumbar, or lumbar spine performed for the indications mentioned in this study is relatively safe.

Adolescent↗

PubMed2001

Management and outcome of complications after laparoscopic antireflux operations.

HYPOTHESIS: Perioperative complications of laparoscopic antireflux operations are infrequent and treatable and do not cause permanent disability. DESIGN: Retrospective review of all patients with laparoscopic antireflux operations for the management and outcome of all complications. SETTING: University medical center. PATIENTS: All 538 patients who underwent operation from January 20, 1993, through December 28, 1999. MAIN OUTCOME MEASURES: Complications were defined as any major or minor deviation from the standard postoperative clinical pathway. Minor complications did not require invasive treatment and were not expected to result in permanent disability. Major complications required invasive treatment or could result in permanent disability. The frequency of complications was also stratified into those that occurred during primary antireflux procedures and those that occurred during reoperations for previously failed procedures. RESULTS: Ninety-two complications occurred in 538 operations (17.1%). Sixty-eight patients (12.6%) experienced minor complications. Postoperative ileus was the most common complication (n = 37 [6.9%]), followed by pneumothorax (n = 13 [2.4%]) and urinary retention (n = 10 [1.9%]). Major complications were present in only 24 patients (4.5%) and occurred significantly more frequently after reoperations. Of these, dysphagia was the most frequent complication observed (n = 11 [2.0%]), followed by perforated viscus (n = 4 [0.7%]). Two patients (0.4%) died. All but 4 major complications resulted in full recovery. CONCLUSIONS: Major complications in laparoscopic antireflux surgery are rare, their treatment is straightforward, and permanent disability is uncommon. Complications occur twice as often during reoperations, highlighting the difficulty in performing these procedures. Although primary laparoscopic antireflux operations are performed by many general surgeons routinely, reoperations should be performed by a team experienced in laparoscopic esophageal surgery.

Adult↗

PubMed2000

Predictors of skeletal complications in patients with metastatic breast carcinoma.

BACKGROUND: The high rate of incidence of skeletal complications in women with metastatic breast carcinoma appears to contribute significantly to their morbidity. Although recent trials have demonstrated the efficacy of bisphosphonates in preventing skeletal complications in selected patients, to the authors' knowledge the incidence rate of skeletal complications in an unselected population of women with metastatic breast carcinoma is unknown. The current study was designed to examine the incidence rate of skeletal complications in a large unselected group of women with metastatic breast carcinoma to determine predictors of these complications. METHODS: All women (n = 718) diagnosed with metastatic breast carcinoma between 1981-1991 at the study institution were studied retrospectively. RESULTS: Greater than 50% of the women developed skeletal complications; among these women, 51% had > 1 complication. Approximately 80% of those with bone-limited disease at the time of diagnosis developed complications, as did 60% of those with bone and visceral disease and 21% of those with no bone disease. By univariate analysis, the site of initial metastatic disease, abnormal alkaline phosphatase, and a disease free interval of < 3 years were predictive of skeletal complications. Multivariate analysis revealed that bone involvement at the time of diagnosis was predictive of subsequent skeletal complications. CONCLUSIONS: In this large retrospective study with extensive follow-up, skeletal complications were extremely common and repetitive, although complications predated patient death by >/= 1 year in the group of women presenting with any bone disease. The presence of bone disease at the time of initial presentation was predictive of skeletal complications. In this group of patients, the authors were unable to identify a subgroup with a low rate of skeletal complications.

Bone Diseases↗

PubMed1999

Stoma complications: the Cook County Hospital experience.

PURPOSE: A retrospective analysis of enteric stomas performed at Cook County Hospital was undertaken to evaluate stoma complications per stoma type and configuration and operating service. In addition, we attempted to identify factors predictive of increased enteric stoma complications. METHODS: From 1976 to 1995, data cards on 1,616 patients with stomas were compiled by Cook County Hospital enteric stomal therapists. Data card information included age, gender, weight, early and late stoma complications, emergency status, operating service, type and configuration of the stoma, and whether the patient was seen preoperatively by an enteric stomal therapist. Data were then analyzed using a logistic regression model to identify those variables that influenced the rate of complications. RESULTS: There were 553 (34 percent) patients with complications. Among the total complications, 448 (28 percent) occurred early (<1 month postoperative), and 105 (6 percent) occurred late (>1 month). The most common early complications were skin irritation (12 percent), pain associated with poor stoma location (7 percent), and partial necrosis (5 percent). The most common late complications were skin irritation (6 percent), prolapse (2 percent), and stenosis (2 percent). The enteric stoma with the most complications was the loop ileostomy (75 percent). The enteric stoma with the least complications was the end transverse colostomy (6 percent). The general surgery service had the most complications (47 percent), followed by gynecology (44 percent), surgical oncology (37 percent), colorectal (32 percent), pediatric surgery (29 percent), and trauma (25 percent). Age, operating service, enteric stoma type and configuration, and preoperative enteric stomal therapist marking were found to be variables that influenced stoma complications. CONCLUSIONS: Complications from enteric stoma construction are common. Preoperative enteric stoma site marking, especially in older patients, and avoiding the ileostomy, particularly in the loop configuration, can help minimize complications.

Adolescent↗

PubMed1995

Time course and incidence of late complications in patients treated with radiation therapy for FIGO stage IB carcinoma of the uterine cervix.

PURPOSE: To determine the time course and incidence of late complications from radiation therapy in patients treated with radiation for FIGO Stage IB carcinoma of the uterine cervix, and to evaluate patient and tumor factors associated with an increased probability of treatment complications. METHODS AND MATERIALS: The medical records of 1784 patients with FIGO Stage IB cervical carcinoma who were treated with initial radiation therapy between 1960 and 1989 were retrospectively reviewed. Follow-up was obtained from clinic visits and correspondence with patients and their physicians. Treatment complications were graded retrospectively. Complication rates were calculated actuarially; patients who died of disease or intercurrent illness without experiencing a major complication were censored at the time of death. There were 1241, 924, 548, and 274 patients followed for more than 5, 10, 15, and 20 years, respectively. RESULTS: Of patients treated for Stage IB cervical carcinoma, 7.7% and 9.3% had experienced major (> or = Grade 3) complications at 3 and 5 years, respectively. After 5 years, there was a small but continuous risk of approximately 0.34% per year, resulting in an overall actuarial risk of having had major complications of 14.4% at 20 years. The risk of developing major urinary tract complications was approximately 0.7% per year for the first 3 years of follow-up, decreasing to about 0.25% per year for at least 25 years. In contrast, the risk of developing rectal complications was about 1% per year during the first 2 years, with a subsequent sharp decline to about 0.06% per year between Years 2 and 25. The risk of fistula formation was approximately doubled in the 234 patients who underwent adjuvant extrafascial hysterectomy (5.3 vs. 2.6% at 20 years; p = 0.04) and in the 111 patients who had pretreatment laparotomy (5.2 vs. 2.9%; p = 0.007). The risk of developing small bowel obstruction was increased in patients who underwent pretreatment laparotomy (14.5 vs. 3.7% at 10 years; p < 0.0001) and in patients who weighed < 120 pounds (8.2 vs. 3.6%; p = 0.004), but was not increased in patients who underwent adjuvant hysterectomy. A significantly greater risk of gastrointestinal complications was observed in black and non-Hispanic white patients than in Hispanic women (p = 0.01), even though there was no difference in the rate of developing urinary tract complications (p = 1.0). There was no correlation between the actuarial risk of developing major complications and the patients' age at the time of treatment, but the cumulative risk was greater for patients who were treated at a young age because these patients were more likely to survive to be exposed to a very long period of risk. CONCLUSIONS: Using techniques described by Fletcher and Delclos, the risk of major complications from aggressive irradiation for Stage IB carcinoma of the cervix is low and does not warrant compromises in the intensity of treatment that might decrease the high cure rates achieved in such patients. The long time course of some late complications also suggests that continued surveillance of survivors, by physicians experienced in the diagnosis and management of the sequelae of the curative radiation treatment of cervical cancer, is important.

Black or African American↗

PubMed2005

Central venous catheter-related complications in children with oncological/hematological diseases: an observational study of 418 devices.

BACKGROUND: The use of indwelling central venous catheters (CVCs) has become commonplace in the management of children undergoing anticancer treatment. Several types of CVC are available, while information on complications observed in children is scarce. We describe the experience of two tertiary care centers in Italy that prospectively followed up three types of CVC used at both institutions over a 30-month period. PATIENTS AND METHODS: Between January 2000 and May 2002, double-lumen (DL) or single-lumen (SL) Hickman-Broviac (HB) catheters, and single-lumen pressure-activated safety valve (PASV) catheters were used and prospectively evaluated. Four types of possible complication were defined a priori: mechanical, thrombotic, malfunctioning and infectious. RESULTS: Four hundred and eighteen CVCs (180 SL-HB, 162 DL-HB and 76 PASV) were inserted in 368 children, for a total of 107 012 catheter days at risk of complication. At least one complication occurred while using 169 of the devices (40%): 46% of the DL-HB, 46% of the PASV and 33% of the SL-HB (P=0.02) catheters. Subjects with hematological malignancies or non-malignant diseases had significantly more complications than those with solid tumors (P <0.0001). Overall, 234 complications were documented: 93 infectious [complication rate per 1000 catheter days at risk (CR)=0.87], 84 malfunctioning (CR=0.78), 48 mechanical (CR=0.45) and nine thrombotic (CR=0.08). SL-HB had statistically fewer infectious complications, while PASV had more mechanical complications. In a multivariate regression model, the most significant risk factors for having a CVC complication were hematological disease [relative risk (RR)=3.0; 95% confidence interval (CI) 1.8-4.8] and age <6 years at CVC insertion (RR=2.5; 95% CI 1.5-4.1). As for the type of CVC, compared with SL-HB, the DL-HB catheter had a statistically significant two-fold increased risk of any complication (RR=2.1; 95% CI 1.2-3.6), while the PASV catheter had a borderline RR of 1.8 (95% CI 1.0-3.6). Analysis by tumor type showed a higher risk of any kind of complication in patients with solid malignancies who had received a DL-HB catheter as compared with an SL-HB catheter (RR=7.2; 95% CI 2.8-18.7). CONCLUSIONS: CVCs may cause complications in up to 40% of patients, with type of CVC, underlying disease and patient age being the three main factors that affect the incidence of CVC-related complications. SL-HB catheters have the best performance.

Antineoplastic Agents↗

PubMed1993

Iatrogenic complications in adult intensive care units: a prospective two-center study.

OBJECTIVES: a) To evaluate the frequency, types, severity, and morbidity of iatrogenic complications; b) determine associated factors that favor iatrogenic complications; and c) suggest new or more efficient protective measures that may be taken to improve patient safety. DESIGN: Prospective, observational study. SETTING: Two ICUs in France. PATIENTS AND METHODS: The study included 382 patients (age > or = 15 yrs; 400 consecutive admissions). Patients were monitored by two physicians in each ICU to assess all iatrogenic complications occurring during their ICU stay, with the exception of adverse effects of drugs. An iatrogenic complication was defined as an adverse event that was independent of the patient's underlying disease. RESULTS: We observed 316 iatrogenic complications in 124 (31%) of the 400 admissions. Of these iatrogenic complications, 107 (in 53 [13%] of the 400 admissions) complications were major, three leading to death. Severe hypotension, respiratory distress, pneumothorax, and cardiac arrest represented 78% of the major iatrogenic complications. Fifty-nine percent of the major iatrogenic complications had clearly identified associated factors. Human errors accounted for 67% of these factors. Patients > 65 yrs (adjusted odds ratio = 2.6, 95% confidence interval: 1.4 to 4.9) and those patients admitted with two or more organ failures (adjusted odds ratio = 4.8, 95% confidence interval: 2.5 to 9.2) were more likely to develop major iatrogenic complications. High or excessive nursing workload also led to an increased risk of major iatrogenic complications. Persistent morbidity, secondary to iatrogenic complications at the time of discharge, was present in five survivors. The risk of ICU death was about two-fold higher for the patients with major iatrogenic complications than in the remaining patients after adjusting for the Organ System Failure Score and the prognosis of the disease (relative risk = 1.92, 95% confidence interval: 1.28 to 2.56). CONCLUSIONS: Major iatrogenic complications were frequent, associated with increased morbidity and mortality rates, related to high or excessive nursing workload, and were often secondary to human errors. To improve patient safety in our ICUs, preventive measures should be targeted primarily on the elderly and the most severely ill patients. Special attention should be given to improving the organization of workload and training, and promoting wider use of noninvasive monitoring.

Adult↗

PubMed1999

Complications related to permanent pacemaker therapy.

This study evaluates complications related to permanent endocardial pacing in the era of modern pacemaker therapy. There is only limited information available about the complications related to modern cardiac pacing. Most of the existing data are based on the 1970s and are no longer valid for current practice. The recent reports on pacemaker complications are focused on some specific complication or are restricted to early complications. Thus, there are no reports available providing a comprehensive view of complications related to modern cardiac pacing. Four hundred forty-six patients, who received permanent endocardial pacemakers between January 1990 and December 1995 at Kuopio University Hospital, were reviewed retrospectively using patient records. Attention was paid to the occurrence of any complication during the implantation or follow-up. An early complication was detected in 6.7%, and 4.9% of patients were treated invasively due to the early complication. Late complication developed in 7.2% and reoperation was required in 6.3% of the patients. Complications related to the implantation procedure occurred in 3.1%. Inadequate capture or sensing was observed in 7.4% of the patients. Pacemaker infection was detected in 1.8% and erosion in 0.9% of the patients. An AV block developed in 3.6% (1.6%/year) patients who received an AAI(R)-pacemaker due to sick sinus syndrome. There was no mortality attributable to pacemaker therapy. A great majority (68%) of the complications occurred within the first 3 months after the implantation. Complications associated to modern permanent endocardial pacemaker therapy are not infrequent. Eleven percent of patients needed an invasive procedure due to an early or late complication.

Adolescent↗

PubMed1995

Bleeding complications with the chimeric antibody to platelet glycoprotein IIb/IIIa integrin in patients undergoing percutaneous coronary intervention. EPIC Investigators.

BACKGROUND: The potential for novel antiplatelet and antithrombin agents to contribute to periprocedural bleeding complications of percutaneous coronary revascularization is poorly defined. In the Evaluation of c7E3 Fab in Preventing Ischemic Complications of High-Risk Angioplasty (EPIC) trial, the periprocedural use of aspirin, heparin, and a chimeric antibody to the platelet glycoprotein IIb/IIIa integrin c7E3 Fab in 2099 patients significantly reduced postprocedural ischemic complications and 6-month clinical restenosis but was associated with increased procedural bleeding complications. We review these complications and describe clinical and procedural variables associated with increased bleeding complications in the EPIC trial. METHODS AND RESULTS: Patients with high-risk clinical or lesion morphological characteristics were randomized to receive placebo bolus plus placebo infusion, c7E3 Fab bolus plus placebo infusion, or c7E3 Fab bolus plus c7E3 Fab infusion. Patients received periprocedural aspirin and intravenous heparin continued for a minimum of 12 hours after the procedure. Outcomes reflecting bleeding complications were measured: transfusions, decreased hemoglobin, and an index including both parameters. Major bleeding complications unrelated to bypass surgery occurred in 3.3%, 8.6%, and 10.6%, and blood product transfusions were used in 7.5%, 14.0%, and 16.8% of patients treated with placebo, bolus c7E3 Fab, and bolus plus infusion c7E3 Fab, respectively (both P < .001). Most major bleeding complications occurred at the femoral access site, regardless of treatment. Intracranial hemorrhage (0.3%) and death (0.09%) attributable to major bleeding complications were rare. Multivariable regression analyses identified several variables significantly and independently related to major bleeding complications or greater blood loss, including greater age, female sex, lower weight, c7E3 Fab therapy, and duration and complexity of the index procedure. Major bleeding complications and blood loss in patients receiving bolus plus infusion were not significantly greater than in those receiving bolus alone (P = .38 and P = .14, respectively). CONCLUSIONS: Bleeding complications unrelated to bypass surgery were two to three times more frequent in patients receiving c7E3 Fab than in those receiving placebo, but most were transient and well tolerated. Risk-factor analysis and modification of concomitant antithrombotic and antiplatelet treatment strategies may aid in reducing bleeding complications and enhancing clinical benefit in patients receiving c7E3 Fab during percutaneous coronary revascularization.

Aged↗

PubMed1996

Complications after acute stroke.

BACKGROUND AND PURPOSE: We sought to observe the type, timing, and frequency of complications occurring in hospitalized patients after an acute stroke. METHODS: In a single hospital, we prospectively identified a consecutive cohort of patients who were either admitted after an acute stroke or who suffered a stroke while already an inpatient (n=613). We retrieved the case notes for 607 (99%) of these strokes, and a single observer, using predefined diagnostic criteria, reviewed the notes and recorded the type, timing, and frequency of complications that occurred during the inpatient period. We also measured the reliability of complication identification from case note review by comparing two observers on a sample of records. RESULTS: Complications were recorded after 360 strokes (59%); the most common individual complications were falls (complicating 22% of all strokes), skin breaks (18%), and urinary tract (16%) or chest (12%) infections. Miscellaneous "other" complications complicated 32% of strokes. Seizures and chest infections occurred early, whereas depression and painful shoulder were later problems. Complications were more common in older patients, who were more disabled before their stroke and had suffered more severe strokes. We demonstrated moderate to good agreement between the two observers for most complications. CONCLUSIONS: Complications after acute stroke are common, confirming that stroke rehabilitation requires active and knowledgeable medical input. Knowing the nature and timing of complications, together with the identification of high-risk patients, may be useful to those planning stroke services. The differences in our results and those previously reported, most notably for skin breaks, are probably due to the different methods used, in particular patient selection and diagnostic criteria for complications. Although complications may be useful as a measure of outcome in comparative studies (eg, therapeutic trials and audit), the methodological difficulties in accurately and reliably measuring them must be addressed.

Accidental Falls↗

PubMed1999

[Hemorrhagic complications from anticoagulant treatment: analysis of predictive risk factors].

UNLABELLED: Anticoagulant therapy has shown its efficacy in the prevention of thromboembolic complications but it is not devoid of bleeding complications. Although the thromboembolic risk of some cardiac diseases may be extrapolated from well-organized clinical trials, the risk of bleeding complications should be determined in the context of the environment in which it is carried out. OBJECTIVE: To determine the complications of the patients in anticoagulant therapy, in our environment, and to analyse the of risk factors. PATIENTS AND METHODS: We have studied the complications suffered by 300 patients who underwent anticoagulation for cardiac diseases, between March-94 and March-96 retrospectively. We have classified the complications in two groups: a) Fatal or intracranial with sequelae. b) Those requiring hospitalization and/or transfusion. Univariate and multivariant analyses were conducted to identify predictors of complications, including the following factors: age, sex, diabetes, hypertension, length of therapy, distance from our Center to their place of residence, INR (> 3 vs 2 to 3) and number of drugs associated with Acenocoumarol (> or = 3 vs 2 or less). RESULTS: During the follow-up 24 patients died due to non haemorrhagic complications; 3 left the treatment on their cardiologist recommendation; 2 moved their place of residence and 1 was lost in the follow-up. Of 270 remaining 3 (0.55/100 patients-year) had complications of group a and 21 (3.88/100 patients-year) of grub b. INR > 3 and multiple medications were shown as predictors of complications when including some of the complications considered. CONCLUSIONS: 1) During two years of follow-up 1.1% (0.55/100 patients-year) of patients in anticaogulant therapy had bleeding complications resulting in death or neurological sequelae. 2) When including some of the complications considered the percentage rises to 4.44/100 patients-years. 3) Although there were no differences statistically significant, INR > 3 and polymedication have been found as predictors risk factor. 4) Patients with INR of 2 to 3 and non polymedicated presented a low risk of bleeding complications (1.66/100 patients-year).

Adolescent↗