After a unanimous panel vote, the Berlin Heart Excor Pediatric VAD is expected to receive humanitarian device exemption (HDE) from the FDA. This technology--a bridge-to-transplant, pneumatic blood pumping ventricular assist device intended for use in children with isolated left ventricular or biventricular dysfunction--is currently the only option for patients with severe heart failure (HF) who are awaiting transplant. The Berlin Heart can provide children with extended time before a needed heart transplant, thereby decreasing mortality rate and increasing survival rate.
In the device's trial, 48 patients age 16 or younger received either the Excor or extracorporeal membrane oxygenation (ECMO), the standard of care at present for pediatric patients awaiting a heart transplant. While ECMO patients demonstrated between 66 and 75 percent survival rates depending on cohort (as determined by body surface area), Excor patients showed survival rates between 86 and 92 percents. These dramatic differences between groups led panelists to vote in favor of the Berlin Heart VAD despite significant adverse event rates among these patients: adverse events such as bleeding incidents or infections occurred in 85 percent of study patients overall, and nearly 30 percent suffered a stroke.
Nevertheless, when compared to current therapy, FDA members agreed that these risks were worth the added benefit to survival. Devices such as the Berlin Heart Excor--the only option of their kind--can significantly improve pediatric cardiology treatment, given that the average wait for a heart transplant can exceed four months and the current ECMO survival timeframe is only two weeks. While further, targeted studies are needed for this technology, panelists are hopeful for its potential to impact pediatric survival and mortality.
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.
Pediatric MAS - How far will it go?
As discussed in this space before, pediatric imaging patients can present unique operational and clinical challenges. Questions arise concerning a variety of issues, including but not limited to, the following:
- Administration of anesthesia
- Increased concerns about radiation dose
- Increased concerns about radiologist specialty experience
- Use of conscious sedation
Concerns regarding imaging--both pediatric and adult--have reached federal levels in the past year. For instance, in February 2010, the U.S. Food and Drug Administration (FDA) announced the launching of a campaign to reduce unnecessary radiation exposure from three types of procedures--computed tomography (CT), nuclear medicine studies, and fluoroscopy. An FDA director indicated that the amount of radiation Americans are exposed to for medical imaging purposes has drastically increased over the past two decades. Using data from a March 2009 report by the National Council on Radiation Protection and Measurements (NCRP), the FDA cites the three aforementioned modalities as accounting for 26 percent of total imaging procedures involving radiation, yet contribute 89 percent of the annual exposure that patients have from medical imaging.
To attack the imaging conundrum, the FDA proposes a three-pronged approach:
- Safe use of imaging devices through the development of quality-assurance practices
- Informed clinical decision-making, such as built-in alerts and "appropriate use criteria" for test orders
- Increased individual patient awareness of exposure through medical imaging cards and dose registries
The Advisory Board's Imaging Performance Partnership recently held a webconference outlining issues and challenges within the pediatric imaging space. With the assistance of imaging leaders at several institutions, researchers outlined major areas of concern, such as radiation dosage, sedation practices, and staffing structures.
During the session, participants from various children's hospitals discussed various technologies and techniques used in their respective organizations which aim to greatly reduce radiation exposure in pediatric patients, including but not limited to, the following:
- Bismuth shields for breast imaging: A 2003 study showed a 28 percent reduction in radiation dose with the use of Bismuth shields with no statistically significant decrease in imaging quality
- Pulse Fluoroscopy techniques utilizing GE products
Technology Insights staff follow imaging technologies closely and maintain an extensive knowledge regarding the various products currently available on the market. For additional information on how Technology Insights can assist with your imaging needs, please e-mail TechInsightsRequest@advisory.com.