At first blush, a study recently published in the New England Journal of Medicine provides slightly contrarian findings about the benefits of using surgery for treatment of early stage prostate cancer in men under 65. There has been a great deal of discussion about the perceived over-treatment of prostate cancer in the US, specifically focusing on the use of surgery and robotic surgery for patients who could potentially be well-served by watchful waiting.
This new study, performed by the University Hospital in Uppsala, Sweden, indicates that there was a significant reduction in the rate of death from prostate cancer in the study group that received radical prostatectomy, as compared to the group that received active surveillance. With other recent studies suggesting questionable benefits of surgery over watchful waiting for management of patients with early stage disease, there is still a lack of consensus on the appropriate way to balance the use of these treatment approaches.
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The controversy surrounding metal-on-metal hips, whose bearing surfaces can cause a dangerous accumulation of metal ions in vitro as the implant wears over time, has already lead to a public health warning by the FDA. Today, in one of the "broadest use of the agency's authority to conduct studies of devices after approval for sale," the FDA has ordered 21 manufacturers of metal-on-metal total hip replacement systems to conduct post-market surveillance studies of their devices to assess metal toxicity risks.
The vendors have thirty days to submit plans for a post-market study which the FDA is recommending be an eight-year surveillance study that looks at adverse events in patients with metal-on-metal hips. Levels of chromium and cobalt in patients' blood at baseline and each year post-implant for up to eight years have been suggested as basic data that will be needed. The data request, however, does not end there. Vendors should also be investigating revision risks, demographic groups that have especially high levels of blood toxicity, as well as cardiac, neurological, and immunosuppressive events that could be correlated to the ionisation of the blood caused by these implants.
With these escalating concerns and increasing physician and patient resistance to these types of implants, it may be only a matter of time before metal-on-metal hips fall completely out of favor among the orthopedic community. At the same time, these concerns have been around for awhile and metal on metal continue to account for roughly a quarter of the 260,000 hip replacements performed each year. But, as the concerns continue to mount, an impact will certainly be felt.
For industry, the impact will fall disproportionately on DePuy, whose hip business has already suffered from a major recall announced last year. For providers, being increasingly careful on utilization of these implants and following closely the development of this story will be imperative.
On Friday, May 6, the United States Food and Drug Administration (FDA) approved expanding indications for use of Abbott Vascular's carotid artery stent--the RX Acculink CarotidStent System--to include patients at standard surgical risk for carotid endarterectomy (CEA). Previously, Abbott's stent system, which is used together with either its Accunet or Emboshield embolic protection devices, was approved exclusively for use in patients at high surgical risk and requiring carotid revascularization. Patients considered high surgical risk were required to have a reference vessel diameter between 4.0 and 9.0 millimeters at the target lesion. In addition, patients had to meet one of these requirements:
- Neurologic symptoms with > 50 percent stenosis of the common or internal carotid artery (symptomatic)
- No neurologic symptoms but > 80 percent stenosis of the common or internal carotid artery (highly symptomatic)
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San Francisco - Results released from a sub-study of the Multicenter Automatic Defibrillator Implantation (MADIT-CRT) Trial demonstrated that heart failure patients with NYHA class I or II and ejection fraction of less than 30% who receive CRT-D are at lower risk of receiving a shock from their ICD. These results are especially encouraging, given that ICD shocks have been associated with increased mortality as well as psychological morbidity.
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San Francisco, CA--Wednesday's sessions of the Heart Rhythm Society (HRS) meeting included a review of innovations in cardiovascular rhythm devices (CRM). To a standing room only crowd, five presenters reviewed pipeline devices currently in development in the CRM space. Presentations include advancements in both lead and generator technology, such as multi-electrode and epicardial leads and subcutaneous, intravascular, and leadless devices. Currently, none of these pipeline devices are approved in the US, and many have only undergone animal or limited human trials. Nonetheless, these innovations represent interesting advancements in the future of CRM.
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San Francisco - According to a study presented today at Heart Rhythm 2011, the Heart Rhythm Society's 32nd Annual Scientific Sessions, a new subcutaneous implantable cardioverter defibrillator (S-ICD) accurately detected and successfully converted all episodes of ventricular fibrillation (VF) in 100% of observed patients. These promising results came out of a 98-patient, multi-center, Netherlands-based study—the largest S-ICD patient cohort study to date.
Prior to the study's observation period, S-ICDs were implanted according to international guidelines and then tested for efficacy. Following implantation, patients were observed for an average follow-up period of nine months, during which all patients were free from heart-failure related hospitalizations as well as sudden cardiac death. Investigators found the S-ICD systems to accurately detect and successfully convert all episodes of induced VF. A primary prevention indication was present in 62 patients (63%) and 41% had ischemic cardiomyopathy. Although over-sensing caused inappropriate therapy in 8 patients, after the devices were reprogrammed, no additional incidents of inappropriate therapy occurred.
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Welcome to the last day of ACOG and the end of our conference coverage. We are sad to see the end to what has been an informative session but are looking forward to sharing what we've learned with our members.
Today's early presentation on obstetrics and quality tracking raised many issues that remain top-of-mind to both administrators and physicians. As more and more payment mechanisms are tied to quality, it behooves physicians to take a greater role in determining which measures will be tracked. Some institutions have begun to experiment with bundling obstetrics services creating incentives to reduce overall episodic costs.
Recently, many providers have focused on lowering rates of caesarean section to reduce overall cost related to both the delivery and any additional neonatal care. While C-section rates can be instructive regarding the overall facility's practices, this does not take into account maternal and child risk factors that can drive this rate up. Discussions at today's meeting focused on re-working our quality metrics to focus on process, rather than outcomes (e.g. C-section rate).
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The developments at ACOG continue as new technology and procedures are highlighted in both clinical sessions and on the vendor floor. Today, uterine fibroids took center stage as several clinical sessions discussed their current and future treatment.
Uterine fibroids affect 25% of women of reproductive age with up to 70% of women experiencing non-symptomatic fibroids. While some of these may be treated using various prescription drugs or other courses of therapy, many patients will require more intensive surgical procedures. As with much of the surgical field, there has been a concerted push towards minimally invasive surgery and treating uterine fibroids is no exception. There will always be a place for surgical resection and hysterectomy procedures, but some newer techniques look to both better preserve organs and minimize pain and discomfort. Below are a few technologies to watch on uterine fibroid treatment:
MFgFUS: MR-guided focused ultrasound uses a standard, diagnostic MRI to visualize fibroids and then ablates these lesions using high intensity ultrasound transducers. MRgFUS is primarily in use in academic medical centers due to its long procedure time (up to four hours in some cases) taking away valuable MRI time. Other indications for MRgFUS systems, such as use in cancer treatment, are not yet FDA approved and are currently undergoing clinical trials. InSightec remains the only US vendor available for MRgFUS though Philips has another product currently undergoing clinical trials.
LUAO: Laparoscopic uterine artery occlusion provides a low-risk surgical alternative to UFE and hysterectomy. In this procedure, the uterine arteries are blocked using clips or bipolar coagulation preventing blood flow to the fibroids. LUAO preserves uterine fertility though the effect on abortion on pre-term labor remains unknown. While promising, LUAO requires advanced laparoscopic skill that may not be attainable for all physicians.
VizAblate: Not yet FDA approved, Gynesonics' VizAblate system uses an intrauterine ultrasound scope to visualize the fibroids and then an RF-ablation system to destroy the fibroids. This can be performed without general or regional anesthesia and takes less than 20 minutes in most cases making its use in offices likely. VizAblate was recently approved for use in Europe and clinical trials remain underway.
HIFU: High-focused ultrasound (also not FDA approved) works similar to MRgFUS in that high intensity ultrasound waves are used to ablate the fibroids. Instead of MRI guidance, handheld ultrasound is used to visualize fibroids. HIFU could gain traction as MRI units will no longer need to be tied up performing MRgFUS procedures and could allow in-office use.
HALT: Not yet submitted to the FDA for approval, this system uses laparoscopic ultrasound guidance to visualize the fibroid prior to treatment using RF ablation. As the ultrasound probe is next to the uterus, it is possible that visualization will improve, particularly for larger patients. The HALT system is able to treat fibroids irrespective of location and can be performed as an outpatient procedure.
Each of these fibroid treatments is still in the early stages of development and additional studies will be needed to show long-term efficacy and comparative performance with current techniques. However, the diversification of the uterine fibroid market continues making the choice for physicians that much more complicated. Many of the aforementioned procedures will be located in non-hospital settings freeing up valuable OR time but also presenting a threat to hospital volumes. We will continue to monitor these and other fibroid technologies to keep you up to date on the latest developments.
Hope you are enjoying this glimpse of ACOG and stay tuned for tomorrow's reporting as we continue coverage.