Author + information
- Nicolas Van Mieghem1,
- Daniel J. Blackman2,
- David Hildick-Smith3,
- Adam Witkowski4,
- Saib S. Khogali5,
- Marek Grygier6,
- Dominic J. Allocco7 and
- Keith D. Dawkins7
- 1Erasmus Medical Center, Rotterdam, Netherlands
- 2Leeds General Infirmary, Leeds, United Kingdom
- 3Brighton and Sussex University Hospitals, Brighton, United Kingdom
- 4Institute of Cardiology, Warsaw, Poland
- 5New Cross Hospital, Wolverhampton, United Kingdom
- 6Poznan University of Medical Sciences, Poznan, Poland
- 7Boston Scientific Corporation, Marlborough, MA
The RESPOND Post-market Study evaluated clinical outcomes with the repositionable and fully retrievable Lotus Valve used in routine practice for the treatment of calcific aortic stenosis. At 30 days post implantation, patients treated with the Lotus Valve exhibited low rates of mortality (2.2%) and disabling stroke (2.2%). Paravalvular aortic regurgitation (PVL) was absent or at trace levels in 92% of patients, 7.7% of patients had mild PVL, 0.3% of patients exhibited moderate PVL, and no patient had severe PVL. The rate of new permanent pacemaker (PPM) implantation in RESPOND was 30.0%. Since the RESPOND Study completed enrollment, there have been a number of changes to the design of the Lotus Valve, including features designed to reduce the interaction of the valve with the conduction system. Depth GuardTM technology allows for earlier anchoring of the valve during deployment and minimizes interaction of the valve with the left ventricular outflow tract. These features, in combination with modifications to the valve implant technique, may reduce the need for new PPM implantation. The RESPOND Extension Study represents an additional cohort of patients enrolled to assess the clinical and device performance outcomes with Lotus combined with Depth Guard.
The RESPOND Extension Study enrolled patients at 5 European study centers (the Netherlands, United Kingdom, and Poland). The primary endpoint is the rate of all-cause mortality 30 days post procedure. Additional endpoints include: device performance; VARC-2 clinical efficacy and safety composites through 30 days; individual VARC-2 endpoints through 30 days; new conduction disturbances and the need for PPM implantation; grade of pre-discharge PVL. Transthoracic echocardiograms are evaluated by an independent core laboratory.
A total of 50 patients were enrolled in the RESPOND Extension Study (54% female; mean age: 81 years; STS score: 4.4±3.1). All patients received Lotus with Depth Guard, the majority of which (48/50; 96%) were via transfemoral access; 2/50 (4%) were via transaortic access. Successful vascular access, delivery and deployment of the Lotus Valve System, and successful retrieval of the delivery system, were achieved in 100% of patients. Additional procedural details and clinical outcomes at hospital discharge, including safety outcomes, the grade of pre-discharge PVL, and the rate of new PPM implantation, will be available at the time of the meeting.
This report of procedural and discharge data from the RESPOND Extension Study will be the first clinical outcomes reported with the Lotus Valve with Depth Guard and will shed light on the impact of new design features on the incidence of new PPM implantation.