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At least 1,135 records · Page 63Linked to original sources
PubMed2004

Five-year follow up of the ATS mechanical heart valve.

BACKGROUND AND AIM OF THE STUDY: Between January 1, 1997 and December 31, 2001, a total of 342 patients underwent aortic valve replacement (AVR) or mitral valve replacement (MVR) with the ATS Medical prosthesis. The initial three-year phase of this study took place under a United States Food and Drug Administration-approved investigational device exemption study. The study aim was to determine the incidence of valve-related events in up to five years of follow up after valve implantation, and to assess patient disturbance from valve noise. METHODS: Patients were consecutively enrolled to undergo AVR or MVR with the ATS prosthesis. Follow up studies were conducted by patient questionnaire and/or telephone call. Follow up was 96% complete. AVR was conducted in 246 patients (80 with coronary bypass), and MVR in 96 patients (29 with coronary bypass). RESULTS: The overall operative mortality was 2.6% (n = 9; AVR 3.2%, n = 8; MVR 1.0%, n = 1), with two deaths being valve-related (0.6%). In 878 patient-years (pt-yr) of follow up (613 pt-yr for AVR; 265 pt-yr for MVR) there were an additional 22 deaths. Five deaths (0.6%/pt-yr) were valve-related: two were neuroembolic (both MVR), one from endocarditis (AVR), and two from bleeding events (both AVR). Late valve-related complications (>30 days) included 17 episodes of major bleeding (11 AVR, 1.8%/pt-yr; six MVR, 2.3%/pt-yr), five permanent neuroembolic events (four AVR, 0.7%/pt-yr; one MVR, 0.4%/pt-yr); 16 transient neuroembolic events (10 AVR, 1.6%/pt-yr; six MVR, 2.3%/pt-yr); three transient peripheral emboli (two AVR, 0.3%/pt-yr; one MVR, 0.4%/pt-yr); four paravalvular leaks (two AVR, 0.3%/pt-yr; two MVR, 0.8%/pt-yr); and one episode of valve thrombosis (MVR, 0.4%/pt-yr; AVR, 0%/pt-yr). Reoperation was required in two patients: one AVR (paravalvular leak, 0.2%/pt-yr) and one MVR (replacement due to thrombosis, 0.4%/pt-yr). CONCLUSION: These results indicate that intermediate-term results with the ATS mechanical prosthesis continue to be excellent, though further long-term follow up is warranted.

Adult↗
PubMedDate not supplied

The amplatzer [corrected] septal occluder as a standard for therapy of secundum-type [corrected] atrial septal defect.

Atrial septal defect (ASD) accounts for 5-10% of congenital heart malformations. An uncorrected ASD may lead to congestive heart failure, severe pulmonary hypertension, or paradoxical arterial embolism with stroke. Transthoracic echocardiography is often diagnostic in the pediatric population, but transesophageal echocardiography may be required in adults. Closure of an ASD traditionally has been performed surgically, but the most common type (secundum ASD) can now be closed with a percutaneously deployed device. We briefly describe the types of ASDs and their diagnosis. Results of percutaneous closure in 74 children and adults are then presented.

Adult↗
PubMed2004

Medical devices; immunology and microbiology devices; classification of the immunomagnetic circulating cancer cell selection and enumeration system. Final rule.

The Food and Drug Administration (FDA) is classifying the Immunomagnetic Circulating Cancer Cell Selection and Enumeration System device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

Cell Count↗
PubMed2004

Guidance on submitting quality system information.

The Food and Drug Administration's final guidance document on the type of quality system information that should be submitted in some types of premarket submissions was published in February 2003. The final guidance replaces previous draft guidance. This article discusses the final guidance document.

Device Approval↗
PubMed2004

Effects of valve characteristics on the accuracy of the Bernoulli equation: a survey of data submitted to the U.S. FDA.

BACKGROUND AND AIM OF THE STUDY: In 1988, valve manufacturers petitioned the U. S. Food & Drug Administration (FDA) to replace catheter with Doppler ultrasound measurements of pressure gradient (delta P) in clinical studies. Manufactures agreed to submit bench data validating the Bernoulli equation used to calculate delta P = delta P = K(Vd2 - Vp2), where K = constant, Vd = distal Doppler velocity, and Vp = proximal Doppler velocity. Previous studies suggest that K may vary from the idealized 4.0, which could lead to incorrect valve assessment and clinical errors. METHODS: Variation in K-values in marketing application data submitted to the FDA was assessed. Pulse duplicator data included four bileaflet valves, two stented bioprostheses, and seven stentless bioprostheses, sized from 19 to 33 mm. Effects of valve type, valve size, blood-mimicking fluid used, and distal pressure tap position (DPTP) were evaluated via an analysis of variance. RESULTS: K-values varied from 2.50 to 7.40 (n = 90). K was found to be dependent on valve type (p < 0.0001), blood-mimicking fluid (p < 0.0001) and DPTP (p < 0.0001), but not valve size. At DPTP = 30 mm, K = 3.43 +/- 0.56, 5.15 +/- 0.81, and 4.81 +/- 1.02, for bileaflet, stented and stentless valves, respectively. K averaged 10% less using the 100-mm DPTP, due to pressure recovery. Variations due to blood-mimicking fluid were likely related to the fluid density. CONCLUSION: Variations due to DPTP and fluid used are consistent with physical mechanisms of pressure recovery and fluid density. Results from previous studies have suggested that effects of valve type on K are also real. The magnitude of these effects appeared to be +/- 25%. Extrapolation to patients is difficult, but clinicians should be aware that Doppler measurements may vary by similar amounts. Doppler pressure gradients should be interpreted qualitatively and moderated by other diagnostic measures of valve performance.

Analysis of Variance↗