Due to a fairly high percentage (12-13%) of five year revision or secondary hip surgeries DePuy Orthopaedics, Inc. reported based on this year's data from the National Joint Registry (NJR) of England and Wales, the manufacturer announced this week it is voluntarily pulling the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System from the marketplace. DePuy has notified the U.S. Food and Drug Administration (FDA) and other regulatory agencies globally of the voluntary recall. The ASR device is part of a class of large diameter, monoblock hip resurfacing and replacement devices preferred by surgeons for young patients who may benefit from the stability of the device, thus limiting the chance of repeated dislocation. The DePuy ASR™ Hip Resurfacing System was introduced in 2003 and is only approved for use outside the U.S. The ASR™ XL Acetabular System was first launched in 2004 and has been available worldwide. The risk for revision was highest with women utilizing ASR head sizes below 50 mm in diameter. As the numbers suggest, most ASR hip replacement surgeries are successful. However, Depuy is strongly suggesting patients utilizing an ASR device immediately see their implant surgeons for a full evaluation of performance. President of DePuy Orthopaedics David Floyd released this statement: We regret that this recall will be concerning for patients, their family members and surgeons. We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall. DePuy will cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR. Patients and health care professionals with questions related to this recall should visit depuy.com. As of August 27, patients in the U.S. and Canada can contact DePuy by calling 888-627-2677 Monday-Saturday, 8 a.m. to 9 p.m. EST. Patients in other countries can place a collect call to the U.S. at +1 813-287-1651 24 hours a day, seven days a week. It is interesting to note that DePuy decided in 2009 that it would be discontinuing the ASR System because of declining demand and the obvious need to focus on modern replacement and resurfacing emerging technologies.

61.9% of Medicare beneficiaries with ischemic stroke who leave hospital, are either rehospitalized or dead with twelve months, researchers from the University of California-Los Angeles wrote in Stroke: Journal of the American Heart Association. Nearly 15% of ischemic stroke patients die within 30 days of being hospitalized. Medicare beneficiary rehospalization and death rates did not get any better from 2003 to 2006, the authors added, highlighting the need for quality improvement interventions.

The American Heart Association informs that stroke is the second leading cause of hospitalizations among American elderly. 87% of all strokes are ischemic strokes.

There are two main types of stroke:

• Ischemic stroke - a thrombus (blood clot) forms that blocks bloodflow to part of the brain. The clot can form elsewhere in the body, break off and become free-floating (embolus). The embolus eventually makes its way through the bloodstream to the brain, where it can cause an ischemic stroke.
• Hemorrhagic stroke - a blood vessel on the surface of the brain bursts (ruptures) and fills the space between the skull and the brain with blood (subarachnoid hemorrhage). It can also occur if a defective artery in the brain bursts, filling the surrounding tissue with blood (cerebral hemorrhage).

Both types of stroke result from not enough blood flow to the brain and an accumulation of blood that places excessive pressure on the brain.

Gregg C. Fonarow, M.D., study lead author, explained that very few studies have examined the full burden of rehospitalization and death following ischemic stroke. Fonarow and team set out to find out what ischemic stroke mortality and rehospitalization rates were at 30 days and 12 months for Medicare beneficiaries. They also aimed to see whether these rates varied from hospital-to-hospital.

Fonarow said:

"We looked at readmission in addition to mortality because it is expensive to the healthcare system and may represent a potentially preventable, adverse event for patients."

They gathered data from the American Heart Association/American Stroke Association's Get With The Guidelines®-Stroke initiative involving 91,134 Medicaire patients who had been treated at 625 hospitals between April 2003 and December 2006.

Fonarow said:

"The Get With The Guidelines-Stroke database linked to Medicare data provided a very valuable opportunity to analyze outcomes for ischemic stroke patients from all regions of the country and from a broad group of acute care hospitals. Clinical data, coupled with long-term outcome data, was not previously available for Medicare beneficiaries at the national level."

Below are some highlighted results of their findings:

• Nearly 15% of ischemic stroke patients die within 30 days of being admitted to hospital.
• Over 30% of ischemic stroke patients die within 12 months of being admitted to hospital.
• 61.9% of ischemic stroke patients who are discharged from hospital are either re-admitted or die within twelve months
• Death or hospitalization rates among Medicare beneficiaries with acute stroke from 2003 to 2006 did not improve

Fonarow said:

"These findings underscore the need for quality improvement interventions and systems of care that will improve early, intermediate, and long-term outcomes of patients with acute ischemic stroke. Standardizing evidence-based practices that focus on reducing the risks of preventable deaths or readmissions for ischemic stroke patients may be critical.

Most of the variation in outcomes was unexplained by patient and hospital characteristics. This suggests that other factors, including treatment provided, systems of care, care transitions and outpatient follow-up, may explain much of the variation in outcomes."

The study did not include patients enrolled in managed care, uninsured individuals or patients under the age of 65, the authors added. It only included patients in fee-for-service Medicare.