ESC Congress 2015: St. Jude, HeartFlow tout FFR-guided PCI

The European Society of Cardiology Congress conference wrapped up this week in London. Here’s a roundup of news from the overseas meeting of interventional cardiologists, dominated by data on fractional flow reserve technology.

FFR: St. Jude touts 5 year data showing long-term benefits

St. Jude Medical (NYSE:STJ) released 5-year data from a trial comparing the use of fractional flow reserve-guided percutaneous coronary interventions using its Medical PressureWire against angiography-guided PCIs alone.

The data comes from a 5-year follow up of the Fame trial, which had 12-month results published in the New England Journal of Medicine.

Data from the follow-up showed that patients who received FFR-guided PCI resulted in a 27% relative reduction of cardiac mortality versus angiography alone.

“Original 12 month results from the FAME trial and the study’s 2 year follow-up data demonstrated clearly that PCI guided by fractional flow reserve results in a significant reduction in major adverse cardiac events for patients undergoing PCI. Now, the study’s 5 year follow up data have given us a critical look at the impact of FFR guidance over time. We’ve proven that the benefits are sustained and can dramatically impact the long-term wellbeing and clinical outcomes of patients as compared to only using angiography to guide intervention,” principal investigator Nico Pijls of Eindhoven, Denmark’s Catharina Hospital said in prepared remarks.

At the 5-year mark, patients who were treated with the FFR-guided PCI showed decreased levels of adverse events, as well as a reduction of costs associated with health care.

“The 5-year data from the FAME study build upon our understanding of applying FFR to guide the care of patients battling coronary artery disease, and this study has continued to demonstrate that St. Jude Medical’s PressureWire technology can improve patient outcomes and the clinical benefits of PCI, while reducing costs for the health care system. FFR technology provides physicians with the insight they need to make improved clinical decisions for their patients,” chief medical officer Dr. Mark Carlson said in prepared remarks.

Original data from the study showed a 28% reduction in cardiac events at 12 months, and a 34% reduction in risk of death or heart attack at 2 years.

HeartFlow presented data from the Platform trial of its FFRct analysis that showed a significant reduction in unnecessary invasive coronary angiography after evaluation with the device.

The 580-patient trial reported that among patients who had a planned ICA, 73% showed no significant blockage or obstruction. To compare, only 12% of patients who were evaluated with HeartWare’s FFRct platform who went on to have an ICA procedure found no blockage or obstruction.

In 61% of patients, the FFRct test resulted in the cancellation of a planned invasive test, according to the study. Despite that difference, both ICA only and FFRct evaluated patients had similar rates of revascularization at 31.6% and 28.5%, respectively.

“In the current state of affairs, the way we are practicing in the U.S. today, the number of patients going to the cath lab that don’t have any obstructive disease is well over 50%,” HeartFlow CEO John Stevens told MassDevice.com.

Carmat touts feasibility data for artificial heart

Artificial heart developer Carmat (FRA:CXT) released preliminary data on a study of its artificial heart device designed as an alternative for patients suffering from end-stage heart failure.

Carmat’s C-TAH is an implantable, electro-hydraulically actuated pulsatile biventricular pump with all compenents other than batteries contained in a single device that is implanted in the pericardial sac after excision of the native ventricles, according to the company.

Interim results from the study, which was published in an article in The Lancet medical journal in July, reported no hemolysis or thromoembolic events in the 2 patients who were implanted with the C-TAH.

“Before proof of concept, we already have substantial confidence in the confirmation of the advantages of the Carmat heart. Its acquired hemocompatibility and the pulsatile way it operates make it possible to minimize the formation of blood clots, which are the main problem other ventricular assist devices face,” co-founder Alain Carpentier said in prepared remarks.

From the data collected in the study, investigators revealed that a thromboresistant layer had developed around the bioprosthesis in the 1st patient.

“These interim results are a vindication of our development efforts, and give us reason to be confident regarding the pursuance of our trials on a broader patient population in order to ascertain in a statistically significant manner the advantages of the Carmat artificial heart in the treatment of end-stage heart failure,” CEO Marcello Conviti said in a press release.

 

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