22 May 2013, Paris, France: The Lotus Valve, a second-generation transcatheter aortic valve implantation (TAVI) device, was successfully implanted in all of the first 60 patients in results from REPRISE II reported at EuroPCR 2013, which showed good device performance and low mortality at 30 days.
“First generation TAVI devices provide significant clinical benefit, but there are opportunities for improvement,” explained lead author Ian Meredith, Director of MonashHeart, Southern Health and Professor of Medicine, Monash University, Melbourne, Australia. He suggested that these include controlled deployment, simple, precise and atraumatic aortic/ventricular repositioning, no or trivial paravalvular leakage and lower complication rate.
The Lotus Valve System has been designed to address these issues. The valve is pre-attached to the delivery system, which has a simple handle design, and functions early in deployment for controlled, precise positioning. It is fully retrievable and can be repositioned and has an adaptive seal designed to minimise paravalvular leak.
REPRISE II prospectively evaluated the safety and performance of the Lotus Valve System for TAVI in symptomatic patients with severe calcific aortic stenosis considered high risk for surgical valve replacement. Reporting results for the first 60 patients, Meredith told the conference, “Successful valve implantation was achieved in all patients.” The primary endpoint for device performance – mean aortic valve pressure gradient at 30 days compared to a performance goal of 18mmHg – was met. Mean aortic gradient decreased from 47.5+17.2mmHg before the procedure to 11.3+5.2mmHg at 30 days. At the same time effective orifice area increased from 0.6+0.2mmHg to 1.7+0.4mmHg.
“Results showed successful valve implantation in all 60 patients, meeting the primary device performance endpoint,” Meredith said. “Importantly, the rate of moderate or greater aortic regurgitation decreased from 18% at the baseline study to 1.9% (one patient) at thirty-day follow up. More than 80% had either no or trivial aortic regurgitation at 30 days,” he reported. He pointed out that the very low rate of moderate or greater aortic regurgitation was ten-folder lower than seen in previous trials with other systems, describing this as ‘a monumental improvement.’ The mortality rate was low – 1.7% at 30 days.
“Valve repositioning and retrieval was performed successfully in all cases when required. And there was no embolisation, ectopic valve deployment or TAV-in-TAV,” he added. Patients suffered negligible aortic regurgitation, while other clinical event rates were consistent with those reported for other valves. “These findings suggest the Lotus Valve may be a valuable addition to the armamentarium for the treatment of severe aortic stenosis,” he concluded.
Commenting on the implications of the study findings, Stephan Windecker, Professor and Chief of Cardiology, Swiss Cardiovascular Center and Clinical Trials Unit Bern, Bern University Hospital, Switzerland, said, “An important factor is that this is a truly repositional device. And it is exciting that the rate of moderate to severe aortic regurgitation is so low.”
23 May 2013, Paris, France: Routinely measuring fractional flow reserve (FFR) using pressure wire assessment during coronary angiography for diagnosis of chest pain leads to significant changes in the management of one in four patients, according to results from a study reported at EuroPCR 2013.
The RIPCORD (Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain) study was designed to assess whether routine assessment of FFR in all the main coronary branches would significantly change the management strategy derived from diagnostic angiography alone.
“Angiographic assessment of chest pain is flawed because it doesn’t assess the functional significance of coronary artery disease,” said the lead author of the study Nick Curzen, Professor of Interventional Cardiology, University Hospital Southampton NHS Foundation Trust and Faculty of Medicine, University of Southampton, Southampton, UK.
He explained that ischaemia is the most important determinant of clinical outcome in coronary artery disease. FFR provides an accurate and reproducible method for detection of ischaemia by measuring the pressure drop across a lesion and previous studies have shown better clinical outcomes of FFR-guided treatment compared to angiography alone. “But, despite this, most patients with chest pain are assessed by angiogram alone,” he told the conference.
RIPCORD recruited 200 patients being investigated for chest pain at 10 UK centres. They all underwent diagnostic coronary angiography carried out by one cardiologist who used the results to develop a treatment plan (plan 1) giving recommendations for medical treatment, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or to request more information.
The first cardiologist then left the room and each patient in the study had FFR measured in all patent vessels of stentable (>2.25mm) diameter by a second cardiologist. The FFR results were shown to the first cardiologist, who used them to develop a second treatment plan (plan 2) for that patient. The primary endpoint of the study was the difference between plan 1 and plan 2 for each patient.
“Routine use of FFR at diagnostic coronary angiography resulted in a significant change in management in 26% of patients,” Curzen reported. FFR led to a change in the judgement of whether a coronary artery had a ‘significant’ lesion in 64 patients (32%) compared to angiogram alone. “These results have potentially important implications for clinical practice,” he concluded. “Management of patients with stable angina alone is flawed and would be improved by routine use of FFR at the diagnostic stage.” He suggested that RIPCORD has provided proof of principle and that a large-scale randomised trial comparing angiographic- with FFR-guided assessment and management of patients with stable angina undergoing diagnostic angiography is now warranted.
Commenting on the implications of the study findings, Kari Niemela, Medical Director and founder of the Heart Center Co., Tampere University Hospital, Tampere, Finland, said, “The RIPCORD trial demonstrated that routine measurement of FFR in patients with stable angina pectoris changes treatment plan in one out of four patients as compared to visual evaluation with coronary angiography alone.” He added, “As the number of patients in this highly interesting multicentre trial was relatively small (200 patients), a large-scale randomised controlled trial including a health economic assessment of both diagnostic options for routine use is justified.”
23 May 2013, Paris, France: A new investigational device - the Helio System (TF-FA) - being developed for use with the Sapien XT Transcatheter Heart Valve was successfully deployed in all four patients in a small, first-in-human feasibility study of its use in high-risk aortic insufficiency reported at EuroPCR 2013.
The HELIO dock system acts as an anchor to help stabilise the SAPIEN XT valve for patients with aortic insufficiency. The native leaflets in the heart are captured between the transcatheter heart valve and the dock. “This is an innovative, minimally invasive approach to treat aortic insufficiency,” said the lead author of the study, Sanjeevan Pasupati, specialist in coronary and structural heart disease intervention, Waikato Hospital, Hamilton, New Zealand. He explained that currently available valves anchor to calcified valves. “What makes aortic insufficiency different from aortic stenosis – for which transcatheter aortic valve implantation (TAVI) is established – is the lack of calcium in the aortic leaflets and annulus, making it challenging to anchor the transcatheter heart valve. We need a system to anchor the valve in these patients.”
The prospective trial using the transfemoral or transapical approach was designed as a clinical evaluation of the safety and initial performance of the new system in high-risk aortic insufficiency. Four patients (mean age 70+10 years) were recruited at Dr Pasupati’s centre between August 2011 and June 2012. Their mean logistic EuroSCORE was 8.6+1.3 and mean left ejection fraction was 57%+16%. The mean native annulus diameter was 25.4+1.1mm and the mean gradient was 20.1+8.8mmHg. They were followed-up at hospital discharge and at 30 days, six months and 12 months and will continue to be followed-up annually out to five years.
Pasupati reported that there were no in-hospital deaths. One patient had a stroke/TIA and one suffered minor vascular complication. One patient, who had pre-existing renal impairment, had an acute kidney injury. “The primary endpoint of freedom from all-cause mortality at 30 days was 100%,” he told the conference, adding that all four patients were alive at one year. He added, “Successful delivery and deployment of the HELIO System and retrieval of the delivery systems resulting in improved aortic insufficiency in the earliest evaluable echocardiogram post-implant was achieved in all four patients.” Aortic insufficiency improved from moderate to severe before the procedure to trivial at 30 days. Two patients followed up at 12 months had no aortic insufficiency at this time point.
Commenting on the implications of the study findings, Professor Stephan Windecker, Professor and Chief of Cardiology, Swiss Cardiovascular Center and Clinical Trials Unit Bern, Bern University Hospital, Switzerland, said, “The field of transcutaneous aortic valve implantation is expanding in indications from its well established use in aortic stenosis to other causes of aortic regurgitation. The larger annulus size in patients with aortic insufficiency without stenosis means we need facilitating techniques to use devices previously used in aortic stenosis. In this study it is encouraging to treat patients with aortic regurgitation for which we have not previously had suitable devices.”
23 May 2013, Paris, France: Transcatheter aortic valve implantation (TAVI) is effective and safe in Asian patients, according to early experience based on first results from a multicentre Asian registry reported at EuroPCR 2013.
“TAVI has become a treatment option for selected patients with symptomatic severe aortic stenosis. But current data are virtually all from North American or European centres,” Paul Chiam, senior consultant cardiologist at the National Heart Center, Singapore, told the conference. He explained that it is unknown whether the smaller average physique in Asian patients may affect outcomes after TAVI.
To answer this question, Chiam and colleagues started an investigator-driven registry, collecting data on clinical outcomes from patients undergoing TAVI at 14 centres across Asia. These centres are in China, Hong Kong, Malaysia, the Philippines, Singapore, South Korea, Taiwan and Thailand. Patient demographics, clinical characteristics, procedural and 30-day outcomes were recorded and analysed for 253 patients undergoing TAVI between February 2009 and August 2012.
“Procedural success was reported for 97% of Asian patients undergoing TAVI,” said Chiam. Major vascular complications occurred in only 4% of patients by 30 days after their procedure. The 30-day mortality was very low (3%), as was the stroke rate (1.6%). Mean NYHA class at 30 days was 1.4+0.6 and 9% of patients required a permanent pacemaker at this time point. There were no difference in clinical outcomes between the two devices except for significantly more patients requiring a pacemaker after undergoing TAVI with a CoreValve device compared to those where a Sapien device was used (15.7% vs 0.9%, p<0.0001).
Commenting on the implications of the study findings, Chiam concluded, “Early experience suggests that TAVI appears feasible and safe in a physically smaller Asian population, with low stroke and mortality rates and without an increase in vascular complications.”