Last week, the American College of Cardiovascular Administrators (ACCA) held its annual meeting in Chicago, IL. While sessions on physician integration and health reform served to kick off the meeting, several sessions on transcatheter valve devices provided a look into current experience and future potential--both good and bad--for this still investigational field. On the heels of ACC, where clinical results of the hotly anticipated PARTNER trial were released, much of the discussion at ACCA focused on future reimbursement and profitability for these procedures.
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Leaders in the medical device industry, hospital executives, physicians, and consultants gathered in the Grand Hyatt in Washington DC today at InHealth's 2011 Health Technology Summit. The purpose of the meeting was to discuss the macroeconomic climate in health care and how its pressures will determine the future of clinical technology innovation. Many of discussion points centered on the balance between value and volume. This balance, while rooted in the shifting payment methodologies in the delivery system, also emerged as a dynamic within the medical device industry. Academics, analysts, and industry reps emphasized that the 'new normal' in health care would make the demonstration of value pervasive through all aspects of the delivery system.
Dr. David M. Cutler, the Otto Eckstein Professor of Applied Economics at Harvard University, started of the day with a keynote address that introduced medical technology innovation within the context of the health care system this country has built across the past few decades. He began recalling the story of a heart attack suffered by President Dwight Eisenhower. The President suffered a heart attack while in office in 1955, and after the event was on bed rest for six weeks to recuperate. In the decades following the President Eisenhower's attack, the advances in clinical technology has enabled revascularization (through angioplasty and stenting, as well as coronary artery bypass grafting), such that patients suffering a heart attack recover faster, live longer, and have overall better outcomes. Dr. Cutler emphasized that though the cost of treating a heart attack has climbed dramatically, there is a clear, demonstrable benefit in health and longevity. Today, Dr. Cutler articulated, the advancements made in technology have lead to increasing complexities and, in correlation, the overuse of care. For that reason, the challenge for healthcare is to coordinate that complexity more effectively.
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This past week, an ambulatory surgical center in San Francisco performed the city's first outpatient, robotically-assisted knee replacement. The surgeon, Dr. Kevin Stone, used MAKO Surgical's RIO robotic system to perform a partial knee replacement. The MAKO robot system (which we've covered on the Pipeline previously here, and here), is fitting nicely into this overall story of outpatient joint replacement.
A topic of heated discussion in orthopedics research, outpatient total joint replacement is still a long way off from widespread adoption. At this time, only a small number of physicians are performing total joint replacement (TJR) surgeries on an outpatient basis, and these procedures are thereby taking place on an extremely limited scale. Only a small percentage of patients are potential candidates for a hospital stay below 24 hours, and instead of trying to segment out those patients, most institutions are focused on shortening length of stay (LOS) for all joint replacement patients.
Where outpatient joint replacement may make more sense is in the minimally invasive, bone sparing procedures used on younger patients, the exact same cases for which MAKO is being adopted. The technical challenges and need for precision in partial knee replacement make a strong case for robotic assistance, and has thereby generated great excitement for MAKO's platform (Just last week MAKO announced the establishment of 11 new sites from Health Management Associates, Inc.). MAKO, however, has yet to be widely adopted. The current install base is approximately 70 sites in the country, and with limited clinical data to affirm the robot's value proposition, many remain skeptical of the steep investment it takes to acquire the technology.
These limitations will likely continue to make both robotic and outpatient joint replacement a niche practice at the national level. Advances in these areas, however, would be troubling to hospitals for whom orthopedic surgery is a strong source of revenue. If outpatient TJR could be performed on a large scale, this change would have far-reaching implications for hospitals, which might see increased competition from ambulatory surgery centers and physician private practices. For now, this does not appear to be much of a risk.
A recent study from The Journal of Bone and Joint Surgery (JBJS) examines the long-term success of oxidized zirconium compared to cobalt chrome material in femoral implants. Oxidized zirconium, often referenced as Smith & Nephew's Zirconium trade name, has been marketed as an ultra-wear-resistant material for use in hip and knee implants. In this randomized controlled trial a sampling of 40 patients underwent bilateral total knee replacement with one femoral implant made of cobalt chrome and the opposite knee femoral component composed of oxidized zirconium. At five-year follow-up radiographic outcomes, Knee Society scores and WOMAC scores for the two types of implants were comparable. Interestingly there did seem to be some variation in patient preference; 38% of patients preferred the cobalt chrome knee while 18% preferred the oxidized zirconium knee. The remaining 44% had no preference.
As patient preference is a highly subjective measure, especially in a small sample size, this study mainly serves as evidence of non-inferiority and long-term efficacy of oxidized zirconium implants. Since it seems that the premium oxidized zirconium doesn't show a significant improvement over the standard cobalt chrome in vivo, is the premium material worth the higher price it demands in the marketplace? More and more this question is being raised across a variety of devices in orthopedics. More research is needed to help elucidate which premium offerings actually translate to superior clinical outcomes both immediately post-op and in longer-term follow-up studies such as this one.
A new Norwegian study published in Epilepsia found that up to 37.8 percent of children with epilepsy have psychiatric symptoms, compared to 17 percent of controls. The study surveyed 14,699 parents and 36,456 children between the ages of 8 to 13 years in Akershus County, Norway in 2002. The survey assessed psychological co-morbidities using the Strengths and Difficulties Questionnaire to screen 4 behavioral health problem areas, namely emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems. The results demonstrate that the burden of epilepsy makes children more vulnerable to psychological issues and unable to cope with difficulties. The study found that having family income below the poverty line, having a single parent, or having asthma or diabetes, all increased the risk of psychiatric co-morbidities, but having epilepsy was the strongest predictive factor.
Additionally, a sex pattern emerged, where epilepsy was a stronger risk factor in developing psychiatric problems in girls over boys (odds ratio of 4.25 in girls vs. 2.32 in boys). This may be because girls have a more negative attitudes regarding the disease and feel greater pressure to "be like others" during childhood and adolescence. Moreover, among epileptic children with psychological issues, boys reported more peer problems (39.1% in boys vs. 28.3% in girls), while girls reported more emotional problems (39.1% in girls vs. 26.6% in boys).
This study, along with others that demonstrate increased psychological co-morbidities with chronic diseases, delineates the imperative for physicians to screen their patients for psychological problems and help them manage their lifestyle. The resulting effects of psychological co-morbidities are damaging; this study showed that the psychological problems affected family relationships (67.8% of children with epilepsy vs 38% for children without epilepsy), classroom learning (65.7% vs 44.2%), peer relationships (63.6% vs 26.9%), and leisure time activities (46.7% vs 19.1%). Therefore, actively screening for these underrecognized problems will not only help patients clinically, it will also improve learning, family dynamics, and other crucial social factors in development.
Once touted as the future of spine surgery, artificial disc replacement has not gained much traction since it's introduction several years ago. Higher revision rates, poor outcomes, and the fact that the implant procedures were complicated all limited adoption. The initial markets, however, were largely dominated by lumbar discs. Now, with a shift in focus to the cervical market, the future of disc replacement is looking brighter. One recent study highlights the clinical advantages of disc replacement over fusion in the cervical spine.
Published in the official journal of the Spine Arthroplasty Society, this recent study demonstrated the advantages of Synthes' ProDisc-C over anterior cervical discectomy and fusion (ACDF). The randomized trial compared 103 artificial disc patients to 106 ACDF patients. An additional 136 artficial disc patients were also followed, though outside of the initial trial design. In several standard quality metrics--neurologic success, visual analogue scale (VAS) for neck and arm pain, SF-36 score, and patient satisfaction--artificial disc replacement scored better than ACDF.
More interesting, perhaps, was the rate of secondary surgery procedures. These procedures (any re-operation, revision, supplemental fixation, or removal of implant) were tracked at 24 and 48 months. The results show that fusion patients were four times as likely to require an additional surgery; half of those additional surgeries were attributed to adjacent level disease, suggesting that disc replacement may slow the rate of adjacent level disease.
Adjacent level disease remains a major sticking point for traditional spinal fusion. With clinical evidence mounting that cervical disc replacement performs equally or better in quality metrics, and that they may arrest the spread of adjacent level disease, we expect disc replacement to see stronger growth in years to come. This will likely bring new cost concerns to hospitals as they will need to venture into new product categories, as those come up, look to Technology Insights for guidance and support.
New Orleans, LA--On Tuesday, April 5th at the American College of Cardiology's (ACC's) annual scientific session, results of several major, late-breaking clinical trials, including the MAGELLAN trial and OSCAR study, were presented. The highlights of both studies are summarized below.
MAGELLAN: Rivaroxaban Compared with Enoxaparin for the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients
Background and Purpose: Evidence supports that pharmacologic thromboprophylaxis has clear clinical benefits in acutely ill medical patients, and oral rivaroxaban is effective and safe for the prevention of venous thromboembolism (VTE). As such, this study sought to compare the safety and efficacy of thromboprophylaxis with rivaroxaban 10 mg at two discrete follow-up intervals: first, for up to 14 days; second, for up to 39 days, with acutely ill patients who required hospitalization receiving subcutaneous enoxaparin 40 mg dose for up to 14 days.
Design: In this multinational, multicenter, randomized, double-blind, controlled trial of 8,101 patients, patients were randomized to either rivaroxaban or enoxaparin, followed for 90 days, and received lower limb venous ultrasound on days 10 and 35.
Endpoints: The primary efficacy endpoint was a composite of DVT, fatal VTE, and pulmonary embolism; the primary safety endpoint was a composite of major bleeding events and medically-relevant non-major bleeding events.
Results: Bleeding events were significantly lower in the enoxaparin cohort compared to the rivaroxaban group at 10 and 35 days. At 10 days, clinically-relevant bleeding occurred at rates of 1.2 versus 2.8 percent (p<0.0001) in the enoxaparin and rivaroxaban groups, respectively; at 35 days, this trend continued, with the enoxaparin group experiencing clinically-relevant bleeding at a rate of 1.4 percent versus 4.1 percent in the rivaroxaban cohort (p<0.0001).
Conclusions: Rivaroxaban demonstrated no clear clinical benefit over enoxaparin in this large, diverse patient population, where bleeding events were significantly higher for those in the cohort that received rivaroxaban.
Olmesartan and Calcium Antagonists Randomized (OSCAR) Study
Background/Purpose: Hypertension, a condition that increases an individual's risk for cardiovascular disease and events, is often treated with angiotensin II receptor blockers (ARBs). However, studies to date have not compared the protective merits of ARBs in higher doses with ARBs plus calcium channel blockers (CCBs) in patients with uncontrolled hypertension. As such, this study sought to do precisely this.
Design/Methods: This multicenter, controlled, prospective, randomized study consisted of 1164 hypertensive Japanese patients, 65 to 84 years of age, who were randomized to two arms and followed over three years. The study consisted of 134 Japanese institutions, and its two arms included:
- High-dose ARB monotherapy (n=578)
- ARB + CCB combination therapy, the control (n=586)
Endpoints: The study's primary endpoint consisted of fatal and non-fatal cardiovascular, coronary, and vascular events as well as diabetic complications, renal dysfunction, and all-cause mortality over 36 months. Its secondary endpoint included each cardiovascular event's incidence, blood pressure changes, and other adverse events, also over 36 months.
Results: The primary composite endpoint rate (PCER) for the high-dose ARB and ARB plus CCB groups was not significant (P=0.1717). Among patients with cardiovascular disease, the PCER was higher for high-dose ARB than for ARB + CCB (P=0.0261), while for those without cardiovascular disease (+ type 2 DM), the PCER was lower for high-dose ARB than for ARB + CCB (P=0.1445).
Conclusions: Although no difference in cardiovascular events and non-cardiovascular deaths existed between high-dose ARB and ARB + CCB groups, in patients with cardiovascular disease, the primary endpoint rate was lower in the ARB + CCB cohort.
According to new International Diabetes Federation (IDF) regulations (click here for full press release), bariatric surgery should be considered as an option for the treatment of diabetes, even in patients who are only moderately overweight. This ruling is a departure from American Diabetes Association (ADA) guidelines which state that surgery should only be considered a treatment option for morbidly obese diabetes patients. In addition to disagreement from the ADA, some clinicians are wary of the IDF recommendation and believe that the long term outcomes of bariatric surgery warrant further study. Still, on the heels of the recent FDA decision to expand eligibility criteria for laparoscopic gastric banding procedures to less obese patients, this decision reflects the ever-growing acceptance of bariatric surgery among both physicians and patients to treat a broadening range of patients and conditions.