October 19, 2012 — The 24th Transcatheter Cardiovascular Therapeutics (TCT) conference, sponsored by the Cardiovascular Research Foundation, will take place Oct. 22–26, 2012 in Miami, Fla. This symposium showcases a variety of research studies within the TCT field, and while there have been many developments over the past year, several advancements are of particular importance. In considered those of special interest this year, four topics stand out: the next generation of Drug-Eluting Stents (DESs) and bioresorbable vascular scaffolds, patent foramen ovale (PFO) therapy, transcatheter valve therapy and cardiac imaging technologies.
Looking back, there were many highlights at the 23rd TCT Conference in 2011. Reporting on the first randomized trial to investigate two different access approaches, TCT 2011 emphasized the RIFLE STEACS study. This clinical study was performed in Italy and looked at patients with ST Segment Elevation Myocardial Infarction undergoing primary Percutaneous Coronary Intervention who were randomly assigned to either radial or femoral access approaches. Additionally, there was much excitement over the presentation of outcome data from the PARTNER transcatheter aortic valve replacement (TAVR) trial, the largest TAVR clinical study to date, that suggested transfemoral TAVR could improve both cost and quality of life compared to traditional surgery. This year’s event promises a new look at these procedures and technologies, as well as emphasis on other cardiovascular therapy advancements in 2012.
Coronary and peripheral stenting have revolutionized the field of interventional cardiology and greatly improved clinical outcomes. The next generation of DES is metallic drug-eluting stents with bioresorbable polymers. Companies such as Boston Scientific and Biotronik will be presenting product updates of their next-generation DES stents, Synergy and Orsiro, respectively. Based on their updates, it will be interesting to see if these stents have better clinical performance and safety profiles than traditional stents and can be adopted widely. Bioresorbable Vascular Scaffolds (BVSs), seen as the fourth generation of stents, are composed of biodegradable polymer/metal materials that can release anti-proliferative drugs and provide temporary support to the occluded vessel. Presentation of first clinical results from the 6- and 12-month ABSORB EXTEND trials of Abbott Vascular’s Absorb BVS stent will take place in Tuesday’s Session IV. The ABSORB EXTEND study evaluated the safety and efficacy of the Absorb BVS stent, which is commercially available in Europe and Asia, in approximately 1,000 patients with more complex coronary artery disease. This large-scale study will give insight into whether this novel technology has superior clinical benefits to current treatments, and will have a significant impact on the medical community’s perspective on BVS.
At the top of the list of late-breaking trials to be presented at TCT are two PFO closure trials, RESPECT and PC Trial. These trials compare the PFO closure technique to medical therapy in patients with cryptogenic stroke, prevalent in individuals below the age of 55 years. Patent foramen ovale is a small hole between the left and right atria of the heart that fails to close naturally soon after a baby is born and is present in 25% of the general population. Given the lack of clinical data on the effectiveness of PFO interventions, results of these trials will address this issue and determine an optimal therapy that has yet to be proven.
Several sessions at TCT 2012 will focus on the future of transcatheter heart valve (THV) devices. The Edwards Lifesciences Sapien THV, approved by the FDA in November 2011, currently has first-mover advantage with US market exclusivity. Sapien’s limited-indication US approval has prompted off-label use, and the results of this experience, expected to be positive, will be further discussed by Dr. Wilson Szeto during Wednesday’s THV sessions. One of the biggest complaints with first-generation THV devices has been their large size. With the expectation that smaller devices such as the 18 French Portico developed by St. Jude Medical will soon be approved, Dr. Martyn Thomas’ session assures a closer look at whether these low-profile valves will enable alternative access approaches. Another session to closely watch that day includes a look by Medtronic’s Rhonda Robb at THV trends in Europe, where reduced sales due to EU austerity recently sent Edwards share price plunging on Wall Street. THV sales growth in the EU is reaching a mature phase in some countries, such as Germany, and speakers at TCT will highlight future expectations of THV as more competitors enter the market. Lastly, with the success of aortic THV products, the stage has been set for mitral valve therapy, and Wednesday’s Session III investigating the future and viability of this untapped market is expected to be popular.
In the past year, there have been numerous cardiac imaging developments specifically related to transcatheter procedures. In particular, computed tomography angiography (CTA) and the use of multiple imaging modalities have fueled the growth of this market and are of great interest. GE will be showcasing their new cardiac imaging technology, including their Innova HeartVision, which fuses two-dimensional X-ray images and three-dimensional models from multiple modalities in real time and can be synchronized with echocardiogram gating. Additionally, sessions on Thursday looking at innovative imaging modalities will reveal new data comparing research implications to clinical utility, the results of which are expected to be indicative of real-world feasibility. GE will also be discussing their new hemodynamic recording system, and with Edwards Oct.11th, 2012 acquisition of BMEYE for their advanced hemodynamic monitoring device, discussion of positive growth in this sector will be revealing.
In addition to presenting new and interesting research topics, TCT will be offering for the first time educational track sessions covering new approaches in heart team decision making and collaboration. A heart team is a multidisciplinary team comprised of clinical cardiologists, cardiac surgeons and interventionalists who work together to determine the best revascularization techniques for patients with coronary artery and structural heart disease.
The symposium combines the latest advancements in science and practical learning for physicians to improve patient treatment outcomes and quality of care. Insights from TCT 2012 will shed light on the optimal approaches to treating patients and shape the healthcare industry.
This expert insight was written by Rob Littlefield, MSc, GlobalData's analyst covering cardiovascular devices, and Priya Madhavan, GlobalData's research analyst covering cardiovascular devices. If you would like an analyst comment or to arrange an interview, please contact us on the details below.
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