May 23, 2011 – An analysis of the benefits to using a fractional flow reserve (FFR)-guided intervention strategy found that the technology can improve patient outcomes while saving significant amounts of money. Full results for the U.K., France and Italy and preliminary results in Switzerland and Belgium were announced at a late breaking trial session last week at EuroPCR.
The analysis, which was funded by an educational research grant from St. Jude Medical, found that within each of the country’s respective health care systems, the FFR-guided approach is cost-saving, meaning that use of FFR improves health outcomes for patients with multivessel coronary artery disease at lower costs when compared to using angiography alone.
The magnitude of health and budget impact strongly depends on assumptions about the cost of cardiovascular care in each country and local clinical conditions. Additionally, in each country, the use of the PressureWire technology improved the quality-adjusted life expectancy for PCI patients.
“In each region where this economic analysis was conducted, the PressureWire was found to both improve clinical outcomes by increasing quality-adjusted life years and reducing the number of cardiac events and save a substantial amount of resources,” said Professor Uwe Siebert, M.D., M.Sc., MPH., Sc.D., from the Health and Life Sciences University of Hall (Austria), who led the research project. “Our research reveals that the magnitude of the health benefits and cost savings from FFR measurement for the European patients and health care payers could be even more significant under an optimal FFR implementation scenario.”
Specifically, in the context of the current healthcare model for each respective country, the analysis found:
In the United Kingdom FFR use:
• Can prevent on average more than 30 avoidable deaths, more than 70 heart attacks and more than 120 major adverse cardiac events (MACE) over two years
• Could save the British healthcare system more than 300,000 euro in 2011 and more than 800,000 euro in 2012
• Potentially reduces treatment cost for PCI per patient by an average of about 600 euro in the U.K.
In France FFR use:
• Can prevent on average nearly 300 avoidable deaths, nearly 700 heart attacks and about 1,200 MACE in France over two years
• Could save the French healthcare system more than 5 million euro in 2011 and more than 11 million euro in 2012
• Potentially reduces treatment cost for PCI per patient by an average of about 900 eEuro in France
In Italy FFR use:
• Can prevent on average more than 120 avoidable deaths, more than 300 heart attacks and more than 520 MACE in Italy over two years
• Could save the Italian healthcare system more than 800,000 euro in 2011 and more than 3 million euro in 2012
• Potentially reduces treatment cost for PCI per patient by an average of about 500 euro in Italy
The study was conducted to determine the incremental cost-effectiveness of FFR-guided vs. angiography-guided PCI in patients with multivessel coronary artery disease in the various health care systems in question from the societal perspective. To do this, original patient-level data from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study were used.
“Results in both the U.S. and now in Europe have demonstrated that FFR both improves patient outcomes and reduces cost to the healthcare system. With healthcare system finances under pressure everywhere, we are proud to offer a technology that relieves European health care systems from financial pressure and that protects and saves the lives of European patients,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division.
The methodology of the data analysis in each country was verified by local physicians.
Preliminary results in Belgium and Switzerland also reveal a trend towards cost-savings. The full report for these countries will be revealed later this year.
FFR measurements indicate the severity of blood flow blockages in the coronary arteries. Using the PressureWire Aeris or PressureWire Certus, this physiological measurement helps physicians to better identify which specific lesion or lesions are responsible for a patient’s ischemia, a deficiency of blood supply to the heart caused by blood restriction. The benefits of FFR were recognized in the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Guidelines with new recommendations for the treatment of coronary artery disease which support measuring FFR in a wide range of patients before performing PCI or recommending surgery.
For more information: www.sjm.com
April 24, 2024 
