ACC 2014: Top five things you may have missed

April 03, 2014
By Loren Bonner and Lauren Dubinsky

The American College of Cardiology's 63rd Annual Scientific Session and Expo wrapped up on Monday in Washington, DC. As always, the show was a platform for breaking clinical trial results — those that are sure to have an impact on the industry for years to come. This year there was big news for transcatheter aortic valve replacement (TAVR) and renal denervation — promising procedures we've been hearing about for years. This news, in addition to other observations, made our top five trend list from ACC14. Please feel free to share your observations in the comments section below.

1.) A setback for renal denervation— At ACC14, the results of the much-anticipated SYMPLICITY HTN-3 trial were released, leaving many disappointed and U.S. Food and Drug Administration approval for the technology on the back burner. Renal denervation, which many experts claimed would be a "game-changing" technology, is used to lower blood pressure through a catheter-based device by applying radiofrequency pulses to the renal arteries. But renal denervation did not meet the primary and secondary efficacy goals in patients with severe resistant hypertension in this trial, although it did meet the primary safety endpoints.

The trial was the largest study that investigated the efficacy of renal artery denervation as a treatment for resistant hypertension, and it was also the most thoroughly-designed, since it involved blinding and sham treatment in the control arm.

"There really wasn't any significant benefit here," Dr. Deepak Bhatt of Brigham and Women's Hospital in Boston, Mass. and the study's lead author, said at ACC's Late-Breaking Clinical Sessions Deep Dive on Monday.

But some experts still have hope. "Further down the road, I would hope that the procedure can work," said Dr. Robert Califf of Duke University Medical Center.

Many big device companies have renal denervation technology under investigation and will likely be examining data from this study to determine what to do going forward.

2.) Big news for TAVR— Meanwhile, TAVR received a boost when results from a prospective study on Medtronic's CoreValve System showed that for the first time, high-risk patients with severe aortic stenosis had lower death rates at one year, compared with conventional surgical valve replacement. Many experts, including Dr. Keith Dawkins from Boston Scientific, told DOTmed News that the results are pivotal because they show that TAVR could be "superior to surgery" for certain patients. TAVR involves transporting a prosthetic valve through a catheter in the leg to the heart in patients with aortic stenosis. Medtronic received FDA clearance for CoreValve in early 2014. The only other TAVR device on the market is Edwards Lifesciences' SAPIEN Transcatheter Heart Valve.

3.) Ultrasound: The darling of the cath/angio lab— Ultrasound continues to play a dominant role as the imaging modality of choice in cardiology — especially as cost continues to dominate the conversation. With that, premium cardiology ultrasound systems are getting more sophisticated. Two highlights on display at ACC14 include Siemens' Abdominal Vascular Release of the ACUSON SC2000 ultrasound system, only recently FDA approved, with 64-image channels and new workflow improvements. Also, Esaote's latest ultrasound offering, CrystaLine, which the company says enables high-quality images at deeper tissue levels in the body, ideal for patients who are obese and more difficult to scan.

4.) What about cardiovascular IT? Cardiology departments have started to realize the drawbacks of their siloed information systems and manufacturers are offering them integration solutions.

McKesson showcased their new integrated workflow solution, Qualitative Intelligence Communications System (QICS), which provides critical result management, echo interpretation variability and echo performance variability solutions, and is intended to help hospitals achieve Intersocietal Accreditation Commission accreditation.

"It's a struggle to extract [the information] from the database but QICS gathers all points and allows them to prove it's effective," said Kyle Souligne, product marketing manager for cardiology at McKesson.

GE Healthcare's solution, Centricity Cardio Enterprise, includes Centricity Cardio Workflow. The solution helps hospitals manage the whole cardiology department, including scheduling, procedural data monitoring, report generation, billing, and inventory management.

Don Woodlock, vice president and general manager of GE Healthcare IT, said that it can take 20 to 25 minutes to "put that puzzle together." Using GE's technology, Oklahoma State University Medical Center was able to save 20 minutes per cath lab study. At ACC, GE also showcased an expanded Centricity Cardio Workflow offering, which includes a new Invasive Peripheral Vascular module, in order to help cardiologists assess, document and report on the patient's peripheral vessels.

5.) Dose reduction— Toshiba America Medical Systems showcased its Infinix-i dose monitoring capabilities, including its Dose Tracking System (DTS). The company says that it's the first and only real-time visualization technology on the X-ray market that helps manage dose.

The system enables the clinician to more easily see how much radiation they have distributed in certain areas. Also, after the procedure, a summary dose report can automatically be generated.

"It's easy to manage the skin dose in real-time to avoid risk," said Andrew Kuhls-Gilcrist, clinical sciences manager at Toshiba.

Another feature on the system that helps reduce dose is Spot Fluoroscopy, allowing clinicians to observe a region of anatomy using live "spot" fluoroscopy overlaid onto what they call the Last Image Hold surrounding area.