Rate Of Mechanical Complications Research Articles

MECHANICAL RELIABILITY AND SAFETY OF, AND PATIENT SATISFACTION WITH THE AMBICOR INFLATABLE PENILE PROSTHESIS: RESULTS OF A 2 CENTER STUDY

We reviewed the experience with the 2-piece Ambicor penile prosthesis (American Medical Systems, Minnetonka, Minnesota) at 2 medical centers to investigate its mechanical reliability and complication rates as well as patient and partner satisfaction with the device. From 1995 through 1999, 131 men underwent implantation of an Ambicor penile prosthesis at 2 medical centers. We performed a 3-part study consisting of a retrospective clinical record review, mailed patient and partner questionnaire, and mailed modified patient and partner Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire. Mean followup was 43.4 months (range 12 to 73). All 131 men had a history consistent with an organic etiology of erectile dysfunction, including vascular disease in 62%, radical retropubic prostatectomy in 17%, Peyronie's disease in 15%, neophallus construction in 4% and radical pelvic surgery in 2%. Mean patient age was 56.8 years (range 22 to 76) at implantation. Overall there were complications in 10 cases (7.6%), including infection, hematoma and mechanical failure in 6 (4.6%), 1 (0.7%) and 3 (2.3%), respectively. A total of 112 men (85%) and 91 partners completed the questionnaire. All patient respondents still had an Ambicor prosthesis implanted and 96.4% had erection suitable for coitus. Overall patient and partner satisfaction was 96.4% and 91.2%, respectively. Of the respondents 92.9% of patients and 90.1% of partners would recommend the device to others. Of the 85 men (65%) and 46 partners who completed the modified Erectile Dysfunction Inventory of Treatment Satisfaction survey 90.6% and 82.6%, respectively, were satisfied or very satisfied overall with the penile prosthesis. The Ambicor penile prosthesis is associated with a low complication rate and reliable mechanical function. High satisfaction was reported by patients and partners.

Central line mechanical complication rate in emergency medicine patients.

Central line (CL) placement in the emergency department (ED) is a common practice. Previously published small-scale studies have quoted mechanical complication rates in emergency medicine patients of 10-15%. To determine the mechanical complication rate of central venous catheterization in a large (65,000 visits/year) academic urban ED. This was a retrospective review of all ED-placed CLs over a three-year period from May 1995 to May 1998. Data were collected as part of a monthly quality assurance project and analyzed using Fisher's exact test (significance = p < 0.05). Central lines were defined as subclavian, internal jugular, femoral, and interosseous lines. Mechanical complication was defined as a pneumothorax, hematoma, line misplacement, or hemothorax. There were 22 complications of a total of 643 CLs placed [complication rate 3.4% (95% CI = 1.9% to 4.8%)]. The complication rate for patients with a confirmatory chest x-ray receiving a subclavian or internal jugular CL (excluding all patients who died prior to x-ray evaluation of CL) was 6.2% (22/355) (95% CI = 3.9% to 9.3%). There were 402 (63%) CLs placed during a code with a complication rate of 2.2% (95% CI = 1.0% to 4.2%), 79% (317/402) medical and 21% (85/402) trauma codes. Thirty-seven percent (241) of the CLs were placed on an "elective urgent" basis. Residents placed the majority of CLs (567/643), with a complication rate of 3%. There was no statistically significant difference in complication rates based on level of resident training. The CL mechanical complication rate in the ED at this institution is 3.4%. This is substantially lower than previously reported mechanical complication rates.

Scheduled replacement of central venous catheters is not necessary.

Although half of intensivists routinely replace their central venous catheters (CVCs), this practice is not supported by data from randomized control studies or by pathophysiology of CVC infection. The daily risk of CVC infection is considered to be a constant; the risk of catheter infection is directly related to the duration of catheter insertion. Consequently, the routine change of the catheter is able to decrease the number of infections per catheter but not to modify the number of infections per day of catheter insertion. This assertion is supported by evidence-based medicine: scheduled replacement every 3 or 7 days has not been shown to alter the infectious risks of CVCs in randomized studies or a meta-analysis. Moreover, routine replacement at a new site exposes the patient to an increased risk of mechanical complications. The overall rate of mechanical complications per catheter inserted is approximately 3%. Guidewire exchange of the catheters may reduce the risk of mechanical complications, but unfortunately is associated with a higher rate of catheter colonization and catheter-related bacteremia. Routine replacement of CVCs is not necessary.

Peripherally inserted central catheters in patients with AIDS are associated with a low infection rate.

We reviewed the medical records of all human immunodeficiency virus (HIV)-infected patients who had a peripherally inserted central catheter (PICC) placed during a 1-year period. Ninety-seven PICCs were inserted in 66 patients for 8337 catheter-days. Eighty of 97 catheters were used primarily to treat cytomegalovirus disease. The mean time to any complication was 150 days. The total complication rate was 6.1 per 1000 catheter-days. The total infection rate was 1. 3 per 1000 catheter-days, and the serious infection rate was 0.8 per 1000 catheter-days. The mean time to a serious infection was 310 days. The noninfectious complication rate was 4.6 per 1000 catheter-days. PICCs were associated with a low infection rate and a moderate mechanical complication rate, which compare favorably with historical rates seen in AIDS patients with other types of central venous access devices. PICCs are a reasonable alternative to other central venous access devices in patients with HIV or AIDS.

Multi-purpose silastic dual-lumen central venous catheters for both collection and transplantation of hematopoietic progenitor cells.

Autologous peripheral blood progenitor cell (PBPC) transplantation frequently requires sequential placement and use of two separate central venous catheters: (1) a short-term, large-bore, stiff device inserted for leukapheresis, and after removal of that device, (2) a long-term, multi-lumen, flexible, Silastic catheter for administration of high-dose chemotherapy, re-infusion of hematopoietic cells, and intensive supportive care. We reviewed our recent experience with two dual-lumen, large-bore, Silastic multi-purpose ('hybrid') catheters, each of which can be used as a single device for both leukapheresis and long-term supportive care throughout the transplant process. Quinton-Raaf PermCath and Bard-Hickman hemodialysis/apheresis dual-lumen catheters were used as the sole venous access device in 112 consecutive patients who underwent autologous PBPC collection and transplantation. The catheter exit site was monitored three times a week, and lumen patency was assessed using clinical and radiologic techniques. Catheters were removed prematurely for persistent thrombus, positive blood cultures despite appropriate antibiotics, or mechanical dysfunction. There were no intra-operative or immediate post-operative complications relating to insertion. Thirty-two patients experienced catheter occlusion necessitating urokinase instillation. Persistent occlusive problems were noted in 16 patients, and in 10 patients the catheter had to be removed. Two exit site infections and 17 bacteremias occurred. Catheters had to be removed for persistent infection in two subjects and for mechanical problems in five others. Cost analysis comparing the hybrid catheters alone vs conventional devices revealed a charge of $4230 in patients with hybrid catheters vs. $7530 in those requiring a temporary non-Silastic dialysis catheter in addition to a flexible, long-term Silastic catheter. Hybrid, Silastic, dual-lumen, large-bore central venous catheters are safe, cost-effective and convenient multi-purpose venous access devices that may be used in the setting of autologous PBPC collection and transplantation. The rate of thrombotic, infectious and mechanical complications appears comparable to other central venous access devices.

Long Term Results of Limb Salvage With the Fabroni Custom Made Endoprosthesis

In 1972 the authors began working on a limb amputation method using custom endoprostheses. Because of the biomechanical characteristics of these prostheses, good long-term results have been achieved. The current study presents the analysis of 27 cases, including 11 total femoral replacements, with a followup between 10 to 24 years (median, 14.4 years), with an overall score of 75% using the International Symposium On Limb Salvage evaluation system. Analyzing this surviving group, the authors realize that proximal humerus and proximal femur prosthesis with total or partial joint replacement have better scores of prosthetic survival, limb function, and patient acceptance and the lowest rates of mechanical complications. However, the replacement involving the knee had more complications and worse scores. The authors conclude that the simplest prosthetic design implanted had the fewest intrinsic prosthetic complications. Reducing the stiffness of a prosthesis and increasing the range of movement of the joint involved decreasing the stress forces between the prosthesis and the bone. This may have contributed to the favorable outcomes reported in the series.

Long-term mechanical reliability of multicomponent inflatable penile prosthesis: comparison of device survival

Objectives. To determine the mechanical reliability of multicomponent inflatable penile prosthesis, comparing five different types of devices, as well as the two-piece versus three-piece as a group. Methods. We followed 83 patients with two-piece and 283 patients with three-piece inflatable penile prostheses for a mean time of 66 months. At a cutoff of 63 months, mechanical complication rates were reviewed and statistically analyzed. Results. Thirty-one device-related complications occurred, and all were secondary to fluid leakage. The Mentor Alpha-1 prosthesis was significantly better than the Mentor Mark-II in terms of mechanical reliability ( P = 0.01). A trend was noted toward the AMS 700 Ultrex inflatable penile prosthesis having fewer mechanical complications than the Mentor Mark-II ( P = 0.06). In addition, a trend toward all three-piece prostheses being more mechanically reliable than the two-piece was noted ( P = 0.08). The Mentor Alpha-1 device had a higher cumulative proportional survival (0.957) than all other devices (0.842 for AMS 700 Ultrex, 0.839 for AMS 700 CX, 0.783 for Mentor GFS, and 0.750 for Mentor Mark-II). Conclusions. As a group, a trend was noted toward the three-piece prosthesis having better mechanical reliability than the two-piece prosthesis. Comparisons between the individual types of prostheses showed that the Mentor Alpha-1 device was significantly more mechanically reliable than the Mentor Mark-II device, and a trend was noted toward the AMS 700 Ultrex device having fewer mechanical complications than the Mentor Mark-II. The Mentor Alpha-1 prosthesis had the highest cumulative proportional survival.

Seldinger technique as an alternative approach for percutaneous insertion of hydrophilic polyurethane central venous catheters in newborns.

The use of hydrophilic central venous catheters, percutaneously inserted by means of the Seldinger technique, was evaluated in this prospective study. Between 1988 and 1991, 138 catheters were inserted in newborns who were admitted to our neonatal intensive care unit. An adequate position of the tip, evaluated radiographically, was achieved in 130 (94.2%) of these insertions. The side effects associated with these 130 catheters and the duration of their use were recorded. Results were compared with those of percutaneously inserted Silastic catheters described in the literature. The rate of adequate catheter placement seems comparable. Because of a high rate of minor mechanical complications, the mean catheter duration was rather short (8.3 days). However, the incidence of serious complications, especially infectious complications, was low.

Femoral arterial catheterization in paediatric burn patients

Despite the obvious drawbacks associated with prolonged arterial cannulation, arterial catheters are frequently required in paediatric burn patients with respiratory failure to facilitate monitoring of oxygenation, ventilation and blood pressure, and to allow for the painless performance of phlebotomy. Burn patients with respiratory failure frequently require prolonged arterial catheterization, often for more than 72 h, and many of their cannulation sites are burned. We report our favourable 3-year experience with 81 femoral arterial catheters in 36 paediatric burn patients. When small diameter pressure monitoring catheters are used, femoral cannulation sites are associated with a low rate of mechanical and infectious complications.

Infectious and Mechanical Complications of Central Venous Catheters Placed by Percutaneous Venipuncture and over Guidewires

OBJECTIVE To compare the frequency of infectious and mechanical complications of central venous and pulmonary artery catheters placed by initial venipuncture vs. over a guidewire at existing sites. HYPOTHESIS Exchange of central venous catheters and pulmonary artery catheters over a guidewire as opposed to fresh venipuncture reduces mechanical complications without increasing risk of infection. DESIGN Chart audit. PATIENTS Medical, surgical, and coronary ICU patients requiring invasive monitoring or central venous access. INTERVENTIONS Patients requiring prolonged catheterization underwent periodic exchange of catheters over a guidewire. Rates of catheter-related infections and mechanical complications were determined for central venous catheters placed by initial venipuncture and those catheters placed by guidewire exchange. MEASUREMENTS AND MAIN RESULTS Over a 12-month period, 939 catheters were inserted in 454 patients. Of these 939 catheters, 534 were placed by guidewire exchange. Use of a guidewire was associated with a decreased frequency of pneumothorax and hemothorax compared with initial venipuncture (0/405 [0%] vs. 7/534 [1.3%], respectively; p < .05) but not with increased risk of infection (9/405 [2.2%] vs. 14/534 [2.6%], respectively; NS). Guidewire-facilitated replacement of multiple consecutive catheters at the same site did not increase the risk of catheter-related infection. Catheters placed via internal jugular veins were more likely to become infected than catheters placed via subclavian veins (17/477 [3.6%] vs. 3/430 [0.7%], respectively; p < .01). CONCLUSIONS When prolonged central venous or pulmonary artery catheterization is necessary, periodic catheter replacement over a guidewire is associated with fewer mechanical complications than initial venipuncture. Periodic catheter replacement over a guidewire is also associated with no increase in risk of infection.

Atypical thrombotic and septic complications of totally implantable venous access devices in patients with cystic fibrosis.

The use of vascular access systems in patients with cystic fibrosis (CF) is well accepted, with lower overall complications and maintenance costs than percutaneous silastic catheters. We report our 6 year experience with 22 infusaports in 15 CF patients. Our patients had indwelling catheters for an average of 539 days per catheter (range, 14-2,224 days). These infusaports were used for home antibiotic therapy, blood sampling, and total parenteral nutrition. The overall complication rate was relatively low, 1 in every 1,483 catheter days. Infectious complications were extremely infrequent at a rate of 1 in 5,929 catheter days. The rate of mechanical complications was 1 in 1,976 catheter days. However, superior vena caval syndrome or deep venous thrombosis was associated with 3 of 22 catheters (13.6%). Due to this high incidence of major thrombotic events with the attendant risk of pulmonary embolism, all patients with CF using infusaports and without evidence of liver disease or bleeding problems receive aspirin prophylaxis.

A Controlled Trial of Scheduled Replacement of Central Venous and Pulmonary-Artery Catheters

The incidence of infection increases with the prolonged use of central vascular catheters, but it is unclear whether changing catheters every three days, as some recommend, will reduce the rate of infection, It is also unclear whether it is safer to change a catheter over a guide wire or insert it at a new site. We conducted a controlled trial in adult patients in intensive care units who required central venous or pulmonary-artery catheters for more than three days. Patients were assigned randomly to undergo one of four methods of catheter exchange: replacement every three days either by insertion at a new site (group 1) or by exchange over a guide wire (group 2), or replacement when clinically indicated either by insertion at a new site (group 3) or by exchange over a guide wire (group 4). Of the 160 patients, 5 percent had catheter-related bloodstream infections, 16 percent had catheters that became colonized, and 9 percent had major mechanical complications. The incidence rates (per 1000 days of catheter use) of bloodstream infection were 3 in group 1, 6 in group 2, 2 in group 3, and 3 in group 4; the incidence rates of mechanical complications were 14, 4, 8, and 3, respectively. Patients randomly assigned to guide-wire-assisted exchange were more likely to have bloodstream infection after the first three days of catheterization (6 percent vs. 0, P = 0.06). Insertions at new sites were associated with more mechanical complications (5 percent vs. 1 percent, P = 0.005). Routine replacement of central vascular catheters every three days does not prevent infection. Exchanging catheters with the use of a guide wire increases the risk of bloodstream infection, but replacement involving insertion of catheters at new sites increases the risk of mechanical complications.

The Vitacuff and Intravascular Catheter—Related Infection-Reply

In Reply. — We would agree that guide-wire changes are widely used, but we are unable to find randomized, controlled trials demonstrating the precise rate of infectious or mechanical complications associated with their use. We excluded guide-wire changes from our study because previous data suggested a lack of protection from use of the Vitacuff in such cases, presumably because the cuff has no effect on a previously colonized subcutaneous catheter tract.1 We acknowledge that some patients have contraindications to new sticks such as coagulopathy or widespread cutaneous burns. In such instances, one leaves the first catheter in place longer and uses a guide-wire change when necessary. Our data and those of Maki et al1suggest that the first catheter placed in such patients would be less likely to require changing for infectious complications if placed with a Vitacuff. The average catheter life in our study was 4 to

Low catheter sepsis rate in a hospital-wide nutrition support service

Four hundred and seventy-nine catheters were inserted into 471 patients over a 6 year period for the administration of total parenteral nutrition. Catheter insertion was carried out only by surgical members of the nutrition support service. Complications were recorded prospectively and stored, with all other details of treatment, on a microcomputer. The mechanical complication rate was 6.4% of catheters used and the incidence of catheter related sepsis (CRS) 2.9%. Catheters which grew organisms, but were not associated with CRS, occurred in 3.7% of catheters used. Catheter care was performed by nurses throughout the hospital under the supervision of the nutrition nurse. The results of our work indicate that restriction of catheter care to specialised nurses is unnecessary providing there is staff education and support. In addition, the value of routine catheter tip culture in patients, not suspected of having infection, is questionable.

Urinary Tract Infections and Asymptomatic Bacteriuria after Vaginal Plastic Surgery: A Comparison of Suprapubic and Transurethral Catheters

In a prospective randomized study comprising 90 women undergoing vaginal plastic surgery, suprapubic and transurethral catheter drainage of the bladder were compared regarding urinary tract infection and asymptomatic bacteriuria. No statistically significant differences were found. The mean duration of catheterization was 4.9 days for suprapubic vs 3.3 days for transurethral catheter patients. Postoperative urinary tract infection was diagnosed in 23.7% of patients with suprapubic and in 27.5% of patients with transurethral catheters. Asymptomatic bacteriuria at catheter removal was found in 21.0% of suprapubic and in 12.5% of transurethral catheter patients. More mechanical complications were seen with SPCs than with TUCs. It is concluded that the two methods involve similar risks of infectious complications but that SPCs have a higher rate of mechanical complications.

COMPARATIVE STUDY OF THE INFECTION RATES OF BROVIAC/HICKMAN CATHETERS (BHC) AND TOTALLY IMPLANTABLE VENOUS DEVICES (IVD) IN PEDIATRIC ONCOLOGY PATIENTS

We reviewed the records of 30 patients with 37 venous access catheters who were prospectively identified at time of placement to compare complications of BHC (Broviac or Hickman, n=20) and IVD (Mediport or Infusaport, n=17). Choice of catheter type (BHC or IVD) was fay parental discretion. The groups were comparable with respect to age [BHC: mean 5.4y(0.3y-19.0y); IVD: 6.2y(0.7y-19.0y)], sex, diagnoses, days in place (mean=164d, BHC group; 154d IVD group), percent time neutropenic, percent inpatient days, and percent days accessed (BHC: 30% vs IVD: 28% of days). There were 10 catheter-associated infections in the BHC group (3282 days at risk), 3 local and 7 with bacteremia; 4 required catheter removal. There were 9 catheter-associated infections in the IVD group during 2618 days at risk (5 local, 4 with bacteremia); only 1 required catheter removal. All infections requiring catheter removal occurred in patients < 2 years of age. Pathogens included S. epidermidis (8), S. aureus (3), enterococcus (2), E. coli (1), and C. albicans (1). Noninfectious complications occurred in 14 BHC (5 resulting in catheter removal) and 11 IVD (5 resulting in catheter removal). Overall infection rate per 100 catheter days was 0.34 and 0.30 for the IVD and BHC groups respectively. Mechanical complication rate per 100 catheter days was 0.42 for both groups. Thus the incidence of infectious and noninfectious complications was comparable for both types of catheters.

Le cathétérisme veineux central en hématologie pédiatrique

Central venous catheters (CVC) have proven to be a reliable route of the administration of chemotherapy, saline, blood cells and nutritional support in patients with malignant haematological disease [1, 6, 9, 13, 18]. However, infection remained one of the most important causes of morbidity associated with this procedure. The aims of this study were a) to evaluate the efficacy of laminar air flow to prevent CVC infections, b) to study morbidity associated with polyethylene (PE) and silicone (S) catheters, and c) to evaluate the part played by increasing staff practice. 177 CVC were inserted in 170 children during a period of 20 months. Ages ranged from 5 months to 15 years (mean : 7 years). All the S CVC were tunnelled whereas, because of their rigidity, none of the PE CVC were. At the time of their removal, bacteriological samples from the CVC skin exit site, blood drawn through the catheter and the tips of these CVC were cultured. During the first period (one year), three groups of CVC were studied : in group 1, 37 S CVC in patients placed in a non-sterile ward; in group 2, 40 S CVC in children nursed under laminar air flow; in group 3, 60 PE CVC in patients of a non-sterile ward. During the second period (8 months), 40 new S CVC were inserted in children nursed in non-sterile wards, but after nursing staff training (group 4). Results showed that during the first period there was on overall rate of mechanical accidents of 13.8 % (haematoma, CVC migration), with one CVC infection (3.3 %) in group 1, no complications in group 2 (laminar air flow), and eight CVC infections (16.3 %) in group 3 (PE CVC). During the second period (group 4), whilst the rate of mechanical complications fell significantly (5 % vs 29 %), there was no decrease in the infection rate.

Parenteral nutrition complications in a voluntary hospital.

A prospective study analyzing the complications in 307 patients who had specialized nutrition support administered by their private practitioners was performed and compared to other series in which a nutrition support service exclusively provided such care of patients. The mechanical complication rate of 4.6%, septic complication rate of 2.9%, and metabolic complication rate of 4.2% compared favorably with the reported literature. A new category of complications, the judgmental complication, is described and was 12.7% in the reported series. The Saint Barnabas Medical Center experience suggests that individual practitioners can satisfactorily administer intravenous specialized nutrition support if in fact an involved nutrition support service functions administratively and supportively in the background.

Impotence: The Surgical Approach

Techniques are now available to restore erectile potency. Several prosthetic devices have been developed that afford a high degree of reliability. The inflatable prosthesis is cosmetically superior, but it is associated with the highest mechanical complication rate. Penile revascularization is a technique with great potential, but the methodology at this point requires further development. Surgeons involved with the treatment of impotency must acquire both the surgical skills required by the operative techniques as well as a philosophical approach to the psychological aspects involved in such therapy. Restoration of penile rigidity can, for some men, mean a new lease on life, but in the improperly selected patient a surgical success may be associated with utter patient dissatisfaction.

Improved Mechanical Survival With Revised Modelinflatable Penile Prosthesis Using Rear-tip Extenders

During an 18-month period 102 men with erectile impotence received a revised model inflatable penile prosthesis with rear-tip extenders. In this group there was 1 mechanical failure of the cylinder (1 per cent) compared to 5 mechanical failures of the cylinders (8 per cent) in a group of 63 men who did not receive the rear-tip extenders in the last 18 months. The group that received rear-tip extenders had a total mechanical complication rate of 4 per cent compared to 13 per cent in the group that did not receive the rear-tip extenders.