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Biomedical subjects

J F Cardella

Publications and source records attributed to J F Cardella.

50 records · Page 3Linked to original sources

Percutaneous nephrostolithotomy: application to staghorn calculi.

Twenty-five renal staghorn stones measuring at least 5 cm in diameter were removed percutaneously from 24 patients. Twelve patients required multiple access tracts for complete stone removal. Estimated blood loss more than 1000 ml occurred in 16 patients and temperature greater than 38.5 degrees C in 19 patients. All stones were successfully removed, with only two patients having definite residual fragments. Percutaneous nephrostolithotomy may be successfully applied to large staghorn stones. The relative roles of percutaneous therapy and extracorporeal lithotripsy remain to be determined.

Adult↗

Interventional radiologic placement of peripherally inserted central catheters.

PURPOSE: This study examines the difference in success between bedside insertions of peripherally inserted central catheters (PICCs) performed by clinicians and fluoroscopically assisted insertions by cardiovascular/interventional (CV/I) radiologists. PATIENTS AND MATERIALS: Four hundred four PICCs were inserted in 305 patients, with a mean age of 48 years (range, 8-78 years), who required intermediate and long-term central venous access. One hundred fifty patients underwent bedside insertion, and 155 patients underwent fluoroscopically assisted insertion. Dual- and single-lumen PICC devices were used depending on venous access needs. RESULTS: Central venous access with the PICC device was achieved in 111 (74%) of 150 bedside insertions and in 153 (98.7%) of 155 fluoroscopic insertions. Average PICC dwell time was 72.7 days (range, 2-307 days). Of the 305 patients, 244 (73.4%) completed planned therapy with a single catheter, 54 patients (17.7%) required two PICCs at the same site, 15 patients (4.9%) required three or more PICCs at the same site, and 12 patients (4.0%) required PICC replacement to a different site to complete therapy. Complications with bedside insertions included upper extremity thrombophlebitis (n = 4), entry site infection (n = 6), and PICC shear with migration (n = 2), while complications with fluoroscopic insertions included entry site infection (n = 2). CONCLUSION: Because of the far greater placement success achieved by CV/I radiologists, all PICCs are now inserted fluoroscopically. The devices complete favorably with surgically placed central catheters with regard to service interval, morbidity, and cost. Use of fluoroscopic techniques enables placement of these devices in virtually all patients, even those with seemingly no peripheral veins.

Adolescent↗

Recombinant tissue plasminogen activator for the treatment of lower extremity peripheral vascular occlusive disease.

PURPOSE: Regional thrombolysis in the recanalization of peripheral vascular occlusive disease is an increasingly accepted therapeutic modality. Efficacy and complication rate are major issues in thrombolytic therapy. This prospective study was undertaken to determine if locally delivered recombinant tissue plasminogen activator (r-TPA) is safe and effective in clot lysis at non-weight-adjusted doses. PATIENTS AND METHODS: Twenty patients (undergoing 21 infusions) from two centers underwent fibrinolytic therapy with use of r-TPA, at a dose rate of 2 mg/h. The mean duration of arterial occlusion was 27.2 days (range, 1-117 days). Concomitant intravenous heparin anticoagulation was administered to all patients. A coaxial infusion delivery system was employed. Hematologic parameters and angiographic follow-up were evaluated at 4-hour intervals during thrombolytic infusion. The chosen maximum r-TPA dose of 40 mg could be extended at investigator discretion. RESULTS: Complete clot lysis was achieved in 18 of 21 (85.7%) infusions at a mean total dose of 38.9 mg (range, 8-84 mg). The mean infusion duration was 19.7 hours. In 16 of 19 (84.2%) infusions, in which the nadir fibrinogen level was recorded, it remained greater than 65% of baseline. Three of 21 (14.3%) infusions resulted in three major bleeding complications, one of which resulted in death. CONCLUSION: In this two-center trial, catheter-directed r-TPA infusion at 2 mg/h is effective for clot lysis. When combined with concomitant heparin administration, this treatment may result in an unacceptably high frequency of bleeding complications.

Adult↗

Development of a model angiography informed consent form based on a multiinstitutional survey of current forms.

PURPOSE: To develop an informative consent form for angiography that can be read and understood by a patient with an eighth-grade level of education. MATERIALS AND METHODS: Consent forms from 125 medical centers were evaluated with RightWriter 4.0 software. The readability index, a measure of educational grade level needed to understand a document, was determined for each form. Features of forms and discussion of complications were evaluated. A model consent form was developed. RESULTS: Analysis of 27 consent forms revealed a mean readability index of 14.2; to adequately understand the documents, an average of 2.2 years of college were required. Alternatives to the procedure were listed in 14 forms (52%). All consent forms listed potential complications, but only 15 (56%) identified specific numeric risks, and attempts to classify complications according to severity were made in only five (18%). CONCLUSION: An angiography consent form has been developed that can be understood with an eight-grade level of education. It should allow patients to more easily understand the procedure and its risks, benefits, and alternatives. It remains the obligation of the physician to tailor the discussion for each procedure to meet the needs of each patient.

Academic Medical Centers↗

Evaluation of a second-generation tantalum biliary stent in a canine model.

PURPOSE: To evaluate the safety and feasibility of use of a balloon-expandable tantalum (Tantaflex) stent in the biliary tree in a canine model. MATERIALS AND METHODS: In this prospective, randomized trial, 10 tantalum stents were placed in eight dogs (two telescoping stents in two dogs), and six Wallstents were placed in six dogs as controls. Stents were deployed into the common bile duct via a cholecystostomy at laparotomy under fluoroscopic and cholangiographic guidance. Two dogs from each stent group were killed at 4, 12, and 26 weeks; the two dogs with telescoping stents were killed at 12 weeks. Premortem patency was confirmed cholangiographically. Postmortem stent explants were inspected grossly, and tissues were examined histologically. Bacteriologic evaluation of bile was performed. RESULTS: All 14 dogs survived until they were scheduled to be killed without clinical complication or evidence of jaundice. Patency was demonstrated at terminal cholangiography in 12 of 14 dogs and at explantation in 13 of 14 dogs. One Wallstent placed across the ampulla in a dog killed at 26 weeks became obstructed. In another dog, the presence of a cholelith in the cystic duct precluded filling of the common bile duct from the cholecystotomy. Only mild inflammatory changes were present in the bile ducts. CONCLUSION: The tantalum stent can be used safely and effectively in the common bile duct in normal dogs. Performance of a clinical trial in humans is supported finding of this study.

Ampulla of Vater↗

Cumulative experience with 1,273 peripherally inserted central catheters at a single institution.

PURPOSE: To compare bedside insertion of peripherally inserted central catheters (PICCs) by specially-trained nurses with insertion by cardiovascular and interventional radiologists. MATERIALS AND METHODS: Nurses performed 327 bedside insertions with a palpatory, through-the-needle technique in 301 patients. Radiologists performed 542 insertions with a venographic-fluoroscopic direct puncture and sheath technique in 354 patients. RESULTS: A total of 869 PICCs were inserted in 655 patients. Compared with the first interval of the study (reported previously), bedside technical success improved from 74% to 82.6%, technical success decreased from 98.6% to 98.2%, and the service interval for a given PICC decreased from 72.7 to 28.1 days (because PICCs were used instead of peripheral intravenous lines). Rates of thrombophlebitis and infection remained low. Device failure continued to be a problem. About 25% of patients needed insertion of more than one PICC to complete therapy. CONCLUSION: Bedside insertion by specially trained nurses is less costly than insertion by radiologists, but radiologists are needed for difficult initial insertions, PICC salvage, and PICC exchange.

Catheterization↗

Experimental nonsurgical transcervical sterilization with a custom-designed platinum microcoil.

PURPOSE: Investigation of a technique for nonsurgical female sterilization. MATERIALS AND METHODS: A custom designed platinum microcoil with Dacron fibers was placed unilaterally into a fallopian tube and uterine horn of 10 rabbits after transcervical selective tubal catheterization with use of fluoroscopic guidance. The contralateral uterus and fallopian tube served as controls. After the rabbits were bred, pregnancy was determined by palpation and confirmed at autopsy. Postmortem histopathologic evaluation of uteri and fallopian tubes was performed. RESULTS: Nine of the 10 rabbits became pregnant. None of the animals had embryos on the microcoil side. Nine rabbits had a total of 45 embryos on the control side. One animal failed to become pregnant on either side. The microcoil remained in good position in all 10 rabbits. There was a microcoil-associated, mild inflammatory tissue response in the uteri and fallopian tubes. CONCLUSION: A platinum occlusion microcoil placed in a utero-tubal location has potential as a means for nonsurgical female sterilization.

Animals↗

Experience with 100 consecutive central venous access arm ports placed by interventional radiologists.

PURPOSE: This study reports the authors' experience with long-term follow-up of 100 consecutive peripherally inserted, subcutaneous arm ports for central venous access. MATERIALS AND METHODS: One hundred patients with subcutaneous arm ports inserted by interventional radiologists were retrospectively studied. Data were collected from the patients' medical records and from telephone canvassing. Using each insertion period as an observation, the complication rates per 100 catheter days were determined with 95% confidence intervals (CIs). RESULTS: One hundred subcutaneously implanted ports were placed in 98 patients; three devices (three patients) were lost to follow-up, leaving 97 devices in 95 patients. Total exposure time was 23,842 days (mean, 246 days; range, 2-865 days). Seven infectious and two noninfectious complications occurred with seven (7.2%) devices in six patients (6.3%), yielding 0.038 complications per 100 catheter days at risk (95% CI; 0.011-0.069) and 0.029 infections per 100 catheter days at risk (95% CI; 0.008-0.058). A successful clinical outcome was defined as a functional port at removal, time of death, or at study closure (minimum of 6 months of follow-up), which was not removed because of a complication. This successful outcome was achieved in 91 ports (93.8%). Procedural-related complications, defined as those occurring up to 30 days after insertion, occurred in only one port (thrombophlebitis and catheter tip infection-day 9). All other patients received several months of service from their port. Fifteen devices were placed in 13 patients with HIV for 3,486 days, with a total complication rate of 0.11 per 100 catheter days (95% CI; 0.0-0.28), all of which were infections. Devices in HIV-positive patients were associated with higher total complication (20% vs 4.9%) and infection rates (20% vs 3.7%) than devices in patients without HIV infection. This gives a relative risk 8.17 x (P = .04) greater for infectious complications for devices placed in HIV-infected individuals. CONCLUSIONS: Subcutaneous arm ports placed by interventional radiologists are effective for central venous access with excellent functionality (93.8% achieved a successful long-term outcome) and a very low procedural complication rate. Although infections were more frequent in HIV-infected individuals, these devices are associated with a very low incidence of both immediate and long-term complications, including infection, for all patients.

Adolescent↗