6


EuroPCR


August 2013


Device industry awarded for their “relentless commitment to research and daring innovation”


At EuroPCR 2013 (21–24 May, Paris, France), in a break from tradition, the Ethica award was given to the entire cardiovascular device industry for their contribution to the development and success of interventional cardiology


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ach year at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the Ethica award is given to an individual who the PCR boards believe has made a significant contribution to the field of cardiovascular medicine. However, EuroPCR course director William Wijns (co-director, Cardiovascular Centre, OLVZ, Aalst


translated into interventional therapies. But, to be successful, these therapies had to go through a cycle of invention, technical development, miniaturisation, pre-clinical evaluation, clinical evaluation, and trials and surveys in the real world.” According to Wijns, medical technology is the “lifeblood” of interventional cardiology, explaining that the investment of the industry


The awardees have been relent- lessly committed to research and daring innovations, and


these innovations have translated into interventional therapies


Belgium) reported that this year, rather than give the award to an individual, the PCR boards decided instead to give the award to the device industry to recognise their “persistent drive for technological evolution”. He said: “The awardees have been relentlessly committed to research and daring innovations, and these innovations have


was “essential to optimise healthcare delivery for patients”. He added: “Device-based therapies are slowing the pace at which health spending is rising. In many clinical proceedings, less invasive procedures have become equally or more efficacious (and safer) than previous standards of care. At the same time, medical technology has


reduced hospital stays by 56% over the last 20 years. These achievements are great but they are insufficiently publicised. We need to pay more atten- tion to measuring and demonstrating the economic and social benefits of our procedures.” Wijns explained that the PCR boards decided to award the industry this year because interventional medicine was facing “serious challenges” and it was time for “all stakeholders, policymakers, healthcare professionals, institutions, members of the public and industry join forces to make a healthy future possible.” He commented that one serious challenge was that Europe’s ageing population was causing an increase in chronic disease, leading to an “ever rising demand for health services”. Furthermore, Wijns reported, the economic climate was also putting a strain on healthcare resources. He said: “Public spending is under pressure and the number of tax payers contributing to the treasury is shrinking. So, we need to join forces to implement a solution. The good news is that interventional medicine—our sector, our passion—is part of that solution.”


Benefits of iFR/FFR hybrid approach confirmed


Preliminary results from the ADVISE II (Adenosine Vasodilator Independent Stenosis Evaluation II) study, which was presented at EuroPCR (21–24 May, Paris, France), confirm that the use of a hybrid approach combining instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) to assess the severity of coronary stenoses would avoid the use of adenosine in more than 50% of patients interrogated with pressure guidewires


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he ADVISE study, which was presented at the 2011 Transcatheter Cardiovascular Therapeutics (TCT) congress, showed that the use of iFR (which, unlike FFR, does not require the administration of adenosine) to assess coronary stenosis severity yields similar results to FFR (the current standard physiological technique used in the catheterisation laboratory). However, since then, studies have indicated discrepancies in iFR/FFR agreement. ADVISE II study presenter and principal investigator Javier Escaned (Cardiovascular Institute, Hospital Clinico San Carlos, Madrid, Spain) reported that these discrepancies might have resulted from: “Heterogeneous FFR technique, differences in iFR detection algorithm,


and lack of ECG to detect wave-free period” among other factors. Therefore, he commented, a prospective study with “rigorous” methodology was required to establish the clinical value of iFR (ie. ADVISE II) ADVISE II was a


to iFR measurements, and their decision to perform revascularisation was based on an FFR value of ≤0.80. Later, an independent core lab (Cardialysis, The Netherlands) analysed off line the digital ECG and pressure recordings to calculate iFR


hybrid iFR/FFR approach, is that, given the high classification match between both techniques when iFR value is ≤0.85 or ≥0.94, the use of FFR can be restricted to stenoses with iFR in the so-called adenosine zone (0.86 to 0.93), thus facilitating


A hybrid iFR/FFR approach can provide a greater than 90% agreement while saving the use of hyperaemic agent in more than half of patients


prospective, double-blind, multicentre registry, and included patients with one or more >40 diameter coronary stenosis assessed visually, and who had stable angina or acute coronary syndromes. Escaned stated that the investigators were blinded


and to establish the agreement with FFR measurements. The presenter reported: “The primary endpoint was the percentage of stenosis properly classified in terms of haemodynamic severity by iFR values of ≤0.85 and ≥0.94.” The rationale of the


intracoronary diagnosis and reducing the need for adenosine administration. Of the 354 stenoses assessed in the study (in 308 patients), 203 had an iFR value of ≤0.85 or ≥0.94 while 81 had a iFR value within the adenosine zone. Escaned reported that


88.2% of stenoses with an iFR value outside ≤0.85 or ≥0.94 were correctly classified in terms of haemodynamic severity. Overall, the hybrid iFR/FFR approach was found to have a positive predictive value of 91.18% and a negative predictive value of 91.76%. He commented: “The estimated saving from adenosine in a hybrid iFR- FFR approach was 71.5% for stenoses and 69.2% for patients.”


Escaned noted: “These preliminary results show that prior observations made by different research groups can be replicated prospectively and that a hybrid iFR/FFR approach can provide a greater than 90% agreement while saving the use of hyperaemic agent in more than half of patients.”


William Wijns


For Wijns, it is not just industry and interventional cardiologists who have to work together to overcome the current challenges facing healthcare resources. He stated that interventional cardiologists should “reach out and engage with other disciplines”, noting that “only a true multidisciplinary approach can adequately respond to the needs of our elderly patients with multiple comorbidities.”


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