The Take Home: SCAI

Issue: July/August 2012

Source: SCAI; reprinted with permission

This year’s Society for Cardiovascular Angiography and Interventions Scientific Sessions in Las Vegas brought together a record number of more than 1,500 attendees, including specialists in congenital/pediatric, coronary, structural and endovascular interventions, who discussed the latest advances, newest techniques and emerging innovations in their respective fields. Among them were Thomas Tu, MD, FSCAI, director of the cardiac catheterization lab, Louisville Cardiology Group, Baptist Hospital East, Louisville, and Dennis W. Kim, MD, PhD, FSCAI, assistant professor, Emory University School of Medicine, Atlanta, who shared with Cardiology Today Intervention their highlights from the meeting.

Thomas Tu, MD, FSCAI

PRECISE

At SCAI 2012, Giora Weisz, MD, presented the results of PRECISE, a pivotal trial of the CorPath system (Corindus). This system consists of a robotically driven cassette into which a coronary guidewire and angioplasty catheters can be loaded. The operator can manipulate these devices remotely, in this case from a shielded cockpit in the cath lab.

Thomas Tu

In this multicenter trial, 164 patients with relatively simple coronary lesions underwent angioplasty using the robotic system. In all but two cases, PCI was successfully completed using the device. The other two cases required manual assistance from the operator. There were no device-related complications, and clinical success was achieved in 97.6% of patients. Four patients had peri-procedural non-Q wave MI, but there were no major adverse events at the 30-day follow-up. The reduction in radiation exposure to the operator was 95% compared with the standard technique.

This trial may represent the first step in replacing the manual skills required for performing angioplasty. In addition to reducing occupational health risks, there is also the potential for a more precise interventional technique because the operator can concentrate on the images without simultaneously having to perform the hands-on manipulation.

Catheter DCM

Tim Henry, MD, of the Minneapolis Heart Institute, presented the results of the Catheter DCM phase 2a trial of ixmyelocel-T therapy. In this trial of 22 patients with Class III-IV chronic HF with ejection fraction less than 30% and who were failing medical management, randomization was performed 2:1 between treatment and standard therapy. Treatment consisted of bone marrow harvest and culture for 12 days in an automated system (Aastrom Biosciences) to stimulate growth of macrophages and mesenchymal cells. These cells were then injected into the myocardium using the Myostar catheter (Cordis) and NOGA mapping (Cordis).

There were no differences between the two groups in procedural complications or arrhythmias. At 1 year, the treated group had improvements in HF class, 6-minute walking distance and ejection fraction. The patients with ischemic cardiomyopathy seemed to have the most improvement.

Although this is a small trial and early-stage research, it represents a step forward in the use of stem cell therapy for HF. Its presentation at the SCAI meeting should stimulate interest among interventional cardiologists for the treatment of congestive HF and cardiomyopathy.

MOBILITY

Michael Jaff, DO, presented the results of the MOBILITY trial, in which patients with complex iliac lesions were treated with either balloon-expandable or self-expanding stents. The major adverse event rate was 6.1% for the Absolute Pro (Abbott Vascular) and 5.4% for the Herculink Elite (Abbott Vascular), both well below the objective performance goal of 19.5%. Restenosis rates were only 8.4% and 9%, respectively, despite moderate-to-severe calcification in 90% of patients. The clinical improvement in walking distance and reduction of claudication were substantial for both stents.

The results of this trial support stenting as first-line therapy for iliac disease, without reservation due to lesion complexity.

Impact of AUC

Publication of the appropriate use criteria (AUC) for diagnostic catheterization during SCAI 2012 added fuel to the ongoing debate about the role of these criteria in quality improvement. AUC supporters cited regional variation in the use of these procedures and health care costs as evidence that the AUC are needed. They pointed to the AUC as a way for interventionalists to demonstrate that they are making sound judgments based on scientific evidence.

AUC critics cited concerns that the criteria are easily misinterpreted and can be misused to restrict reimbursement for necessary procedures. Even the terms appropriate and inappropriate could be inherently misleading, as they were adopted from the Delphi method used for decision-making in global warfare, not health care.

All sides agreed that the AUC are just one form of quality assessment and are not meant to be the final word in determining physician practice. During a SCAI 2012 keynote lecture, Ralph Brindis, MD, MPH, described the AUC as in its “awkward adolescence” and warned that if interventionalists don’t come to the table to work on quality improvement and cost containment, they will find themselves on the menu. SCAI is on the forefront of these efforts, Brindis said, with its quality improvement tools and quality of care initiatives.

Disclosure: Dr. Tu is on the speakers’ bureau for Abbott Vascular.

Dennis W. Kim, MD, PhD, FSCAI

Congenital/Pediatric Intervention

The SCAI 2012 Scientific Sessions provided an important forum for engaging discussion around many of the challenges and opportunities facing congenital and pediatric interventional cardiology. The spectrum of issues in congenital heart diseases is complex and the therapeutic options are increasingly diverse. For this reason, 2012 meeting highlights included forums for lively interactive discussion. Sessions focused on complex case studies and creative ways interventional cardiologists are using a variety of tools to fit “a round peg in a square hole.” Techniques for on-the-table stent modifications, new potential uses for the percutaneous Melody valve and novel stent management of Tetralogy of Fallot during infancy provided that “Aha!” moment for many in the audience. The “Brain-Scratchers” and “I Blew It!” sessions revealed the creative and innovative ways pediatric interventionalists conquer complex situations that arise unexpectedly.

Dennis W. Kim

As there is a dearth of tools designed specifically for use in children, pediatric interventionalists are always looking for ways to use existing tools in new ways. A lively point of discussion was around the use of tools from other medical specialties, such as interventional radiology, and how they can be used and modified for our field. In another session, participants engaged in spirited debate about the merits of using premounted vs. unmounted stents throughout the vascular system. Ultimately, attendees put the question to a vote with both premises found to have significant merit. With the ongoing development of hybrid surgical strategies, the relative advantages and disadvantages of premounted and unmounted stents continue to evolve as the long-term strategy for stent management of vascular obstructions matures.

Growth of Registries

Another hot topic at SCAI 2012 was the expanding use of registries to inform treatment of congenital heart defects. Despite many treatment options for congenital heart disease, it is clear that systematic, prospective multi-institutional evaluations of catheter-based interventional strategies must be established to drive pediatric medical innovations and propel medical progress. As such, sessions highlighting the development and growth of registries were popular at the meeting. Headed by Tom Forbes, MD, the Congenital Cardiovascular Interventional Study Consortium (CCISC) was created to collaboratively investigate transcatheter therapies in children and is comprised of centers throughout the United States, Europe, Asia and South America. By this joint effort, the CCISC reported the largest prospective direct comparison of balloon angioplasty vs. stenting vs. surgery for coarctation of the aorta.

Such prospective comparative studies have been few for pediatric therapies, although they are becoming more common. Future areas of investigation for the CCISC include treatment and management strategies for coronary fistulae, comparative study of transcatheter PDA occlusion, new intraprocedural anticoagulation strategies, bioabsorbable stent technology and risk stratification and complication registries. Perhaps the greatest benefit of the CCISC will be its ability to provide an interactive and “real-time” forum for communication among pediatric interventionalists.

SCAI 2012 participants also welcomed updates on the IMPACT Registry, which assesses the prevalence, demographics, management and outcomes of pediatric and adult patients with congenital heart disease, who are undergoing diagnostic catheterizations and catheter-based interventions. With more than 2 million patients with congenital heart disease in the United States, the IMPACT registry will help to improve outcomes and safety for those undergoing catheterization procedures.

Mullins Keynote Lecture

This year’s Mullins Keynote Lecture was widely attended — and not just by congenital specialists. Julio Palmaz, MD, is considered one of the great pioneers of stent technology, and the Palmaz stent series continues to be one of the workhorses in congenital cath labs around the world.

During his keynote, Palmaz described how the next leaps in stent technology will occur by moving past the gross scaffolding structure of the stent itself to the use of nanotechnological methods to imprint stents with surfaces conducive to more normalized cell attachment and growth. Drug-eluting stents were a logical step in coronary stent technology and have certainly become an important mainstay in managing coronary obstruction. However, the merging of cellular and molecular sciences with stent technology through understanding of the cell-to-cell and cell-to-surface interactions will undoubtedly bring about important new technologies, translating into improved results. Because device therapies in children often need to last for their entire lifetimes, innovations that allow for early intervention with continuing efficacy through the adult years are vitally important.

Disclosure: Dr. Kim reports no relevant financial disclosures.