For breast cancer patients, detecting and diagnosing their condition is traditionally a lengthy process requiring multiple imaging scans. A source of frustration and anxiety for women, this process can take several weeks from initial mammogram to final diagnosis.
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In the United States, we see nearly 800,000 strokes each year—amounting to a new or recurrent stroke occuring every 40 seconds. Fortunately, with notable improvements in care, many more people are surviving strokes than in the past. Stroke survival, however, brings its own set of demands on the health care delivery system, with many patients needing extensive support from physicians, therapists, and family members.
Current efforts around developing certified Comprehensive Stroke Centers (written about earlier this week on The Pipeline) are focused on enhancing acute and post-acute care for stroke, but with much of the health care dialogue centered on population care management, a focus on stroke prevention may become a more realistic goal for the delivery system.
An article published last week in BMJ Open suggests that the possibility of reducing the incidence of stroke can be realized through improved management of known risk factors. While the study arrives at its conclusion in a weak manner, the story is compelling.
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At the end of September, the Joint Commission released proposed requirements for certification as a Comprehensive Stroke Center. These new requirements build off of the exisiting certification program for Primary Stroke Centers (PSCs), which was launched in 2003 and has seen impressive growth since its inception.
To date, more than 800 hospitals nationwide have achieved this distinction, which signals a dedication to providing evidenced-based care for stroke patients in an efficient and high-quality manner. The Comprehensive Stroke Center program will certify hospitals that can provide advanced therapies for acute stroke patients, but can also provide enhanced long-term management of these patients. Assuming the final rules closely resemble the current proposed guidelines, it's possible that not many hospitals will be able to meet the extensive requirements. Few hospitals should be engaged in providing advanced stroke services, especially considering the intensity of resources needed and the complexity of care required.
The Joint Commission developed the proposed requirements along with The American Heart Association (AHA) and the American Stroke Association (ASA). Similar to PSC certification, the proposed requirements follow the Brain Attack Coalition’s recommendations—in this case the “Recommendations for Comprehensive Stroke Centers” that were first published in 2005—and provide detailed specifications on the capabilities, technology, physicians, and services needed to be considered a comprehensive program by the joint commission. A detailed account of the requirements can be found on the Joint Commission's website, but here we'd like to highlight some of the key aspects needed.
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GAITHERSBURG, MD. – On Thursday, October 13, 2011, the U.S. Food and Drug Administration’s (FDA’s) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted unanimously (11-0) to recommend approval of Cook Medical’s Zilver PTX drug-eluting stent—a self-expanding, Paclitaxel-coated, nitinol stent that employs the same delivery system as Cook’s Zilver vascular bare-metal stent (BMS).
A first-in-class device, the Zilver PTX was determined to be both safe and effective for the treatment of symptomatic peripheral arterial disease (PAD) in the superficial femoral artery (SFA) based on data from two Cook-sponsored studies—a randomized controlled trial (RCT) of 479 patients and a single-arm study (SAS) of 787 patients.
This landslide vote in favor of recommending the device for approval did not come without considerable debate. Panelists spent the day carefully reviewing data from both studies. First, Cook presented data from its RCT, which included 479 patients with an average age of 68 years, from Germany, Japan, and the United States; these patients had up to two stenotic or occluded above-the-knee (ATK) femoropopliteal arterial lesions of less than or equal to 14 centimeters in length and were randomized to either Zilver PTX (240 patients) or percutaneous transluminal angioplasty (238 patients). Of the 238 patients randomized to angioplasty, 120 were deemed to have suboptimal procedural outcomes and were therefore randomized a second time to either Zilver PTX (64 patients) or Zilver BMS (56 patients). Patients began antiplatelet therapy either before or during the procedure and continued this treatment—clopidogrel for all but Japanese patients, who received ticlopidine—for 60 days following the procedure; aspirin was taken indefinitely.
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After returning from the 53rd annual American Society for Radiation Oncology (ASTRO) meeting, I wanted to share some of the main themes from the conference this year. We’ll provide a more detailed take on these during our ASTRO roundup webconference on Wednesday, Nov. 9, so please also join us if your schedule permits. Registration details can be found here.
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A Danish medical device company, FBC Device ApS, recently received a U.S. patent for an interbody fusion device that allows patient-customized alignment. The device allows for spine surgeons to work with the patient’s anatomy and insert the two-piece implant, which provides natural spine alignment to individual patients. Founder and CEO of FBC Device ApS, Finn Christensen, has dubbed the device “Natural Balance,” as it allows for relative movement between the two pieces of the implant and enables the patient’s body to naturally align itself to the optimal fusion position.
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Gynecologic surgery and urogynecology are some of the highest revenue areas within the women’s health service line, making them a target for growth among administrators.
Da Vinci’s robotic surgery system has become a key topic of discussion among administrators seeking to differentiate these programs, despite its limited clinical evidence base. Comparing robotic surgery to standard laparoscopic procedures is necessary for many organizations, as the cost of these systems is prohibitively high in some cases. Also, physician training can be costly and time-consuming as laparoscopic techniques are challenging to many physicians. Understanding which procedures most benefit from robotic techniques can help focus training programs and service offerings.
Repair for pelvic organ prolapse—the slipping of the pelvic organs due to weak muscles and walls—will affect 7% of women by the time they are 80, leading to approximately 300,000 surgeries per year. As population demographics shift with an aging population, an increasing number of women will require surgery for prolapsed pelvic organs, outpacing many other gynecologic cases.
Sacrocolpopexy is an operation in which the vagina is suspended from a synthetic mesh bridge to ensure proper alignment of the pelvic organs. With the advent of robotic surgery, some physicians believe that these cases will now be easier to perform due to the steeper learning curve associated with laparoscopic sacrocolpopexy–the current standard of care. However, there has yet to be a consensus among gynecologists as to whether or not robotic surgery systems improve patient’s quality of life and truly assist physicians.
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On September 29, 2011, the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) released updated guidelines for the management and treatment of peripheral artery disease (PAD), a condition that affects approximately eight million Americans, 20% of whom are 65 years of age or older. Updated for the first time since their initial release in 2005, these guidelines aim to provide cardiologists, vascular medicine specialists and surgeons, interventional radiologists, pulmonologists, and primary care physicians (PCPs) with a road map for effective management and treatment of PAD patients, many of whom are asymptomatic.
To provide this road map, members of ACCF, AHA, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of Vascular Medicine, and Society for Vascular Surgery reviewed recent, evidence-based clinical trials and other data to develop these updated recommendations. Specifically, findings of the Reduction of Atherothrombosis for Continued Health (REACH) registry showed high rates of hospitalization for PAD patients; hospitalization rates for asymptomatic and symptomatic patients in the study were 23% and 31%, respectively.
Moreover, both asymptomatic and symptomatic PAD patients enrolled in the study were associated with high hospitalization costs: While asymptomatic individuals had an average two-year hospitalization cost of $7,445, symptomatic patients displayed an average two-year hospitalization cost of $11,693.
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