Medical innovation isn't the same as it was five years ago. It isn't the same as it was one year ago. Cutting-edge advances in nanotechnology and molecular and genomic medicine seem to occur on a monthly basis. In fact, just last week, the first self-replicating synthetic cell was created. How do we make sense of news like this? What does it mean (or does it mean anything) for hospitals?
Such a dizzying pace of innovation isn't helped by the pressures of reform legislation. Hospitals are struggling to understand the potential impact of comparative effectiveness, episodic bundling, the Acute Care Episode (ACE) demonstration project, and the medical excise tax and how these products of the Patient Protection and Affordable Care Act will affect the future of their medical enterprise. The passing of reform legislation has awoken hospitals to major problems with the way they plan for clinical service line growth, as well as with the way they acquire and deploy new clinical technologies. Hospitals find themselves pressured by physicians and consumers to provide care in innovative ways and, in increasingly competitive markets, hospitals have realized that they are unprepared to make principled and deliberate decisions about which service lines to grow, which to defend, and where partnership and divestment strategies make sense. While innovation has changed over the past few years, the dollars involved and the high stakes have not. Moving forward, hospitals cannot afford to get it wrong - scarce dollars, reputations, and political capital hang in the balance at the prospect of poor investment decisions.
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In what has been reported as the most anticipated session of the conference, Dr. Martyn Thomas-a lead physician in the world of transcatheter aortic valve implantation (TAVI)-presented updated data from the European SOURCE registry at EuroPCR this week. This presentation, focused primarily on one-year data for patients enrolled in cohort 1 of the SOURCE registry (those who underwent transapical delivery), showed that survival rates for the two delivery methods are showing closer results than seen in previous studies.
Specifically, patients undergoing transapical delivery now show 12-month survival rates of 72% in comparison to transfemoral patients that have 12-month survival rates of 81.1%. This is greatly improved over previous comparisons that used the early studies REVIVE, REVIVAL, TRAVERCE, and PARTNER EU in which transapical performed at an abysmal 58% versus transfemoral at 74.9%.
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Last week at the American Heart Association's (AHA) annual Scientific Sessions on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke, Dr. Peter Groeneveld from the Philadelphia VA Medical Center provided insight into the impact of advanced cardiovascular technologies and rising health care costs.
In a retrospective analysis of Medicare claims data from 2003 and 2006 (abstract here on page 17), Dr. Groeneveld and colleagues found that the rising use of drug eluting stents (DES) and Implantable Cardioverter Defibrillators (ICDs) was associated with significant cost increases for patient with coronary artery disease (CAD) and congestive heart failure (CHF). The researches found that the cost increase of treating Medicare CAD patients with DES was nearly $5 billion dollars (approximately 89 percent of total growth) and the increase of treating Medicare CHF patients with ICDs was nearly $900 million (approximately 29 percent of total growth).
Though both were adding large dollars to Medicare cost, ICDs increased in direct proportion to the number of devices used. DES, on the other hand, added substantial cost beyond that of the stents themselves. In a subsequent interview with TCTMD, Dr. Groeneveld explained how medicine changes with new technologies, and that changes associated with DES included rises in imaging exams, diagnostic cardiac catheterizations, physician referrals, subspecialist evaluations, and elective hospitalizations; all adding more cost to these patients.
Some physicians, however, question the cost impact, and point to the fact that DES, by potentially avoiding restenosis or open-heart procedures, may reduce cost. At the same time, they argue, cost may not be an appropriate metric for technology that saves lives and improves quality of life.
Still, cost remains a major concern, both for providers and for payers alike. This study, which was sponsored by the NIH and AHRQ, underscores the importance of the cost issue to the federal government. We at TI are well aware of the importance of the issue for hospitals, and often work with our members to identify cost savings opportunities. Though these technologies are increasingly important in providing care to cardiovascular patients, smart utilization and standardization can help reduce their impact to the budget without compromising clinical care.
While many pediatric surgery programs are still playing catch up with the trend toward laparoscopic surgery, a variety of techniques are evolving that could seemingly make laparoscopy obsolete down the road. These techniques make 'stealth' incisions through the umbilicus or axillary to make scars virtually unrecognizable while other techniques use natural orifices, eliminating scarring altogether. A new technique, Single-incision pediatric endoscopic surgery (SIPES) has been developed as an application of single incision surgery to infant patients. A new study slated to be published next month (but e-published this April) details this technique in pyloromyotomy.
This push is being driven by the desire from parents of pediatric patients to ekunubate scarring on their children due to the potential for scars to grow into adulthood.
How far will this force push pediatric surgeons in the field of MAS? Should we expect the least invasive methods to one day be used for all procedures? In pediatric surgery, the answer is likely 'no', or at least not for a long time. Conceptually, natural orifice transluminal endoscopic surgery (NOTES) is the least invasive MAS method, as surgeons can access the abdomen without making a single external incision.
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Nanomaterial-based cancer therapies have been cited as having potentially higher potency and effectiveness than traditional protein-based therapies, as well as the possibility of facilitating simultaneous imaging and therapy, or theranostics. While the first-generation of nanomaterial-based medicines has already been introduced into clinical use, the field continues to grow as novel uses of nanomaterials for cancer therapy are uncovered. Recently, nanoscientists at Memorial Sloan-Kettering Cancer Center published a paper that reviews research efforts to date as well as recent breakthroughs in using nanomaterials as potential multifunctional therapeutic agents in cancer treatments, making a significant new contribution to the growing body of literature on this topic. The researchers at MSKCC feel that the field of clinical nanomaterials is on the rise, given the large amount of research funding (more than a billion dollars was dedicated to nanomaterial research efforts at US government agencies over the past decade) that has been allocated to this effort in recent years, as well as the agents' novel properties, size, and shape that could potentially be harnessed to improve cancer therapies.
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The Subcutaneous ICD (S-ICD), which had notable exposure at last year's HRS sessions, has returned to the spotlight this year in Denver with a simultaneous presentation and publication of the latest clinical data.
The device, developed by Cameron Health, uses entirely subcutaneous leads rather than transvenous leads to deliver life-saving shocks to patients experiencing potentially fatal ventricular tachycardias. Because the leads do not enter the vasculature, they are easier to replace or repair and thereby carry significantly less risk of lead-related issues than traditional ICDs. Their ability to detect arrhythmias, however, has always been a concern among physicians. The data presented this week may provide a little more confidence in the technology.
A few different sets of data were presented, some on lead placement, and others on long-term outcomes of patients implanted with an S-ICD. A small prospective trial that followed 55 patients for about 10 months was the most significant in terms of providing insight into the clinical use of the technology. In those patients, 100 percent of induced VF episodes were successfully detected during controlled electrophysiologic testing. In the ten months after implantation, the S-ICD had detected and successfully treated 12 episodes of spontaneous VT that occurred in three patients. The data was presented by Dr. Gust Bardy of the Seattle Institute for Cardiac Research, who is also a cofounder of Cameron Health; it was also published online May 12, 2010 in the New England Journal of Medicine to coincide with the presentation at HRS.
The S-ICD could establish a niche in device therapy for primary prevention patients that require no pacing support. The ease of implant and lower risk of lead issues could help overcome common concerns related to ICD therapy, but the higher energy output needed to deliver a life-saving shock will likely cause physicians to hesitate using the device.
The device is still likely a few years away from commercial release in the United States. The S-ICD's pivotal trial enrolled it's first U.S. patient earlier this month, and will ultimately look at roughly 330 subjects at up to 35 sites in the U.S., Europe and New Zealand.
Here in Denver, where the Heart Rhyhm Society (HRS) - the premier association for cardiac electrophysiologists - is holding its annual scientific sessions, fierce debate continues about the impact of this year's passage of health reform legislation. The opening plenary session assembled a distinguished panel of policy experts (former Senator Tom Daschle, NPR/Fox News Correspondent Juan Williams, and Health Affairs Editor-in-Chief Susan Dentzer) and physicians (Drs. Harlan Krumholz and Richard Fogel) to discuss the future of health care in light of the passage of the Patient Protection and Affordable Care Act. Richard Fogel, as a practicing electrophysiologist and CEO of The Care Group, a large physician group, received a favorable reaction from the crowd of heart rhythm professionals as he outlined his major concerns about health form legislation. These concerns broadly fell into three major categories.
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Though Americans widely use body mass index (BMI) to determine obesity, an article published in the May issue of Obstetrics and Gynecology suggests that this standard fails to identify many women considered obese by the Geneva, Switzerland-based World Health Organization (WHO)--which qualifies women with body fat of 35 percent or higher as obese. Using a sample of over 800 women between the ages of 16 and 33 years, approximately 37 percent were considered obese (over 30kg/m2) using BMI standards compared to over 63 percent using the WHO standard. Further, the study revealed notable differences in percent body fat for a given BMI across different ethnicities, with white and Hispanic women maintaining almost 3 percent more body fat on average than black women for any BMI.
As such, researchers suggest that the Bethesda, Maryland-based (NIH)-recommended BMI threshold of 30 kg/m2 is too high and that many women below the cutoff may benefit from weight-loss counseling. Additionally, the study recommends accounting for race/ethnicity within BMI cutoffs to counteract body fat percentage discrepancies. Resultantly, health care providers should consider early testing for obesity-related conditions--such as diabetes and cardiovascular disease--in overweight patients, even if they are not deemed obese by BMI standards. This need is particularly acute in reproductive age women who are more likely to be obese than their male counterparts but often do not receive necessary testing and treatment for obesity-related conditions.
Click here to view USA Today coverage of the article.