The International Apheresis Registry: Results of 1983 Second Pilot

Results of the second pilot of the International Apheresis Registry for 1983 involving 37 centers on four continents are presented. This report is a follow-up of the initial pilot reported previously and includes the results of 37 additional centers reporting on 659 patients for a total of 5,780 treatments. The results were collected through a single-page questionnaire. Information gathered included patient demographics, medical history, treatment specifics (type, methodology, access type, anticoagulants, drugs), side effects, response, and payment provider. The data are grouped by regions (East, Europe, and North America). Analysis of the data identifies the regional differences in apheresis usage and treatment specifics, suggesting that an international view of apheresis is more representative of this therapeutic modality than national results, which are highly dependent on the local economics and available technology.     

Partial Left Ventriculectomy: The 2nd International Registry Report 2000

BACKGROUND: Partial left ventriculectomy (PLV) has been performed without standardized inclusion or exclusion criteria. METHODS: An international registry of PLV was expanded, updated, and refined to include 287 nonischemic cases voluntarily reported from 48 hospitals in 11 countries. RESULTS: Gender, age, ventricular dimension, etiology, ethnology, myocardial mass, operative variation, presence or absence of mitral regurgitation, and transplant indication had no effects on event-free survival, which was defined as absence of death or ventricular failure that required a ventricular assist device or listing for transplantation. Preoperative patient conditions, such as duration of symptoms (> 9 vs < 3 years; p = 0.001), New York Heart Association (NYHA) class (Class IV vs < Class IV; p = 0.002), depressed contractility (fractional shortening [FS] < 5% vs > 12%; p = 0.001), and refractory decompensation that required emergency procedure (p < 0.001) were associated with reduced event-free survival. Five or more cases in each hospital led to significantly better outcomes than the initial four cases. Rescue procedures for 14 patients nonsignificantly improved patient survival (2-year survival 52%) over event-free survival (2-year survival 48%; p = 0.49), with improved NYHA class among survivors (3.6 to 1.8; p < 0.001). Outcome was better in 1999 than in all series before 1999 (p = 0.02) most likely due to patient selection, which was refined to avoid known risk factors such as reduced proportion of patients in NYHA Class IV, FS < 5%, and hospitals with experience in 10 or less cases. A combination of these risk factors could have stratified 17 high-risk patients with 0% 1-year survival and 26 low-risk patients with 75% 2-year event-free survival. CONCLUSION: Avoidance of risk factors appears to improve survival and might help stratify high- or low-risk patients. Although less symptomatic patients with preserved contractility had better results after PLV, change of indication requires prospective randomized comparison with medical therapies or other approaches.     

International Breast Implant Registry: A User Report

The International Breast Implant Registry (IBIR) was founded in 2002 under the auspices of the International Plastic, Reconstructive, and Aesthetic Surgery Foundation (IPRAF), the International Confederation for Plastic, Reconstructive, and Aesthetic Surgery (IPRAS), and the European and International Committee for Quality Assurance, Medical Technologies, and Devices in Plastic (EQUAM) on the basis of continuous discussion about the safety and compatibility of different breast implants. The IBIR aims to integrate and replace the already existing national breast implant registries. It also is assumed that the European Parliament, the Food and Drug Administration, and international organizations of plastic and aesthetic surgeons will postulate obligatory international breast implant registration. Currently, IBIR is in a pilot phase with the goal of understanding data collection issues and concerns in various countries whereby the data entered to date will be completely available in the final version. A well-established global registry represents an important tool of quality assurance. By publishing their experiences in applying the registry, the authors aim to encourage more plastic and aesthetic surgeons to submit their cases to the registry and thus enhance its value as a successful and powerful device.     

IRODaT: The International Online Registry for Organ Donation and Transplantation 2007

Objective

IRODaT, an international registry for organ donation and transplantation, presents preliminary data reports on global trends on a regular basis and at various times of the year. The purpose of this report was not only to present statistics, but also to make organ donation effectiveness rates a useful tool to reveal similarities between various countries on an international level.

Materials and Methods

The IRODaT database produced this report for 2007 thanks to early reporting performed by professionals in coordination and transplant services from 49 countries. The countries were grouped as follows: countries with >200 total donors countries with 50 to 200 donors, and countries with <50 donors.

Results

The percentages of deceased and living donors according to the total number of donors from the 49 countries showed that countries performing >200 effective donation procedures yearly in 2007 showed a clear positive trend when compared for number of living donors, donors per million inhabitants, and number of transplantable organs per donor.

Conclusions

The results obtained through this new presentation of the IRODaT provide a quick, clear, and illustrative view of organ donation activity in various countries.     

Pediatric drug regulation: International perspectives

There was a time when the predominant approach to exposing children to new drugs was to protect children from research. This has evolved over the past several decades into protecting children through research. To encourage pediatric studies and approval of pediatric medicines, governments have provided financial incentives as well as obligations/requirements for pharmaceutical companies to carry out pediatric studies in certain circumstances. The unique considerations for children have been acknowledged by the various governments and drug regulatory agencies through international dialogue and cooperation among patient and patient care representatives, regulatory agencies, and academic, clinical and manufacturing stakeholders. We describe pediatric drug regulation in five of the largest international drug regulatory agencies and additionally discuss efforts at international cooperation and discussion in pediatric drug regulation.