There is an urgent need for new innovations in cardiovascular disease. In a series of presentations at EuroPCR, 20–23 May 2014 (Paris, France), various new technologies were introduced, together with initial clinical data. These included a myocardial access and closure device; innovations in transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve repair (TMVR); an aortic valve remodelling therapy, a novel catheter-guided mitral valve stent; a cinching device enabling percutaneous remodelling of the tricuspid valve; a transcatheter left atrial appendage closure; mitral restriction ring cardiac implant; liquid biopsy system for biomarker sampling; biodegradable nanoparticles loaded with everolimus; a chronic total occlusion (CTO) crossing device; an intra-aortic balloon pump; and new treatment options for heart failure.
The growing epidemic of cardiovascular disease, together with an ageing population represents a substantial clinical challenge that stretches healthcare budgets. There is an urgent need for both interventions focused on prevention and treatment innovations. In two sessions of presentations at EuroPCR on the 20th May 2014 in Paris, companies presented their latest innovations. The aim of these presentations was to introduce novel technological interventions at the early stages of clinical development.
New Valve and Devices
Permaseal Transapical Access and Closure Device
Professor Willard Hennemann of Micro Interventional Devices Inc., Bethlehem, PA, presented Permaseal™, a device designed to facilitate fast, reliable and reproducible myocardial access and closure in percutaneous transcatheter structural heart repair procedures. The device creates a secure, self-sealing access site into the heart using a unique anchor design, featuring a solid core and flexible valve, which minimises tissue damage. Once the procedure is completed and the cannula and guidewire are extracted, the Permaseal webbing constricts around the opening in the heart, providing instantaneous closure while allowing the flexibility to accommodate a beating heart. The device is available in multiple sizes to accommodate different catheters and sheaths. More than 100 successful preclinical cases have taken place, and the Sutureless Transapical Access and Closure Study (STASIS) is ongoing.
Caval-aortic Access to Allow TAVI in Otherwise Ineligible Patients
Dr Adam Greenbaum of the Institute for Structural Heart Disease, Henry Ford Health System, Detroit, discussed the limitations of current devices enabling transcatheter aortic valve implantation (TAVI) procedures: they require large sheaths, making them unsuitable for large sections of the population; and transapical and transarotic access are associated with vascular complications as well as significant morbidity and mortality. Therefore, an alternative access route is needed. The inferior vena cava (IVC) is close to the aorta without significant intervening structures. Successful caval-aortic access, i.e. percutaneous entry into the abdominal aorta from the femoral vein through the adjoining IVC and closure has been demonstrated in pigs,1 more recently in humans.2 The procedure begins with simultaneous IVC and aortagram. The catheter point is taken to the point of the aorta. The sheath can then be inserted and the TAVI procedure can proceed.
To date, the procedure has been performed 28 times. It is particularly useful in patients with contraindications to transfemoral, transapical and transaortic TAVI, including frailty, inadequate vessel size, prior cardiac, thoracic and aortic surgery. Early outcomes appear comparable to transapical delivery. Successful caval-aortic access has been achieved in 100 % of cases to date, with a mean crossing time of 18 minutes. The procedure is safe, with one mortality and major vascular complications reported in five patients. In conclusion, cavalaortic access allows TAVI in those otherwise ineligible. Furthermore, this procedure may have a role in other transcatheter treatments, such as large devices for aortic insufficiency, thoracic endovascular aortic repair (TEVAR) and left ventricular assist devices.
The LeafLex Catheter System
Professor Sharad Shetty of the Royal Perth Hospital, Australia introduced the Leaflex™ (Pi-Cardia, Beit Oved, Israel) catheter system. In a recent European assessment of TAVI utilisation, 86 % of interviewees thought that the medical needs of treating patients with severe aortic stenosis ineligible for conventional surgery remained unmet. Only 55 % of patients received TAVI: the decision not to refer other patients to TAVI were based on budget, reimbursement, hospital capacity and clinical assessment.3 TAVI is a complex, expensive procedure that entails significant complications and has questionable long-term durability. Balloon aortic valvuloplasty (BAV) is an alternative but was not designed to deal with calcium. Its effect is largely due to short-term stretching of the annulus and restenosis is a problem. The LeafLex aortic valve remodelling therapy (Pi-Cardia) is an innovative option, which fractures calcification in the valve by mechanical impact, resulting in a significant increase in aortic valve area (AVA), and does not involve a permanent implant. The device can be employed as a stand-alone procedure, as a bridge to TAVI or surgical aortic valve replacement (SAVR) or may be used in preparation for TAVI. It achieves effective and controlled impact by using two counteracting elements and produces focal fractures at the leaflet’s original folding points, and therefore breaks the calcification without damage to the leaflets. There is no dilation and no overstretching of the annulus and therefore no risk of annular tear.
Preclinical experience involved more than 200 experiments using a reconstructed aortic valve model. The first-in-human study recruited 15 patients in Europe and Australia and is currently ongoing. The safety endpoints are major adverse cardiovascular and cerebral events (MACCE) at 30 days. Efficacy endpoints include successful device introduction, positioning, operating and withdrawal, and improvement in effective orifice area (EOA) post procedure. In summary, this unique impact procedure has demonstrated good outcomes without generating aortic regurgitation (AR) and without leaflet injury in a reconstructed valve model. The first-in-human study has shown encouraging preliminary results, and will be reported later this year.
- Halabi M, Ratnayaka K, Faranesh AZ, et al., Aortic access from the vena cava for large caliber transcatheter cardiovascular interventions: pre-clinical validation, J Am Coll Cardiol, 2013;61:1745–6.
- Greenbaum AB, O’Neill WW, Paone G, et al., Caval-aortic access to allow transcatheter aortic valve replacement in patients otherwise ineligible: initial human experience, J Am Coll Cardiol, 2014;63(25 Pt A):2795–804.
- Remigi D, Brasseur P, Toal K, et al., TCT-834 qualitative assessment on TAVI utilization: a European perspective, J Am Coll Cardiol, 2012;60:17 S.
- Neuhold S, Huelsmann M, Pernicka E, et al., Impact of tricuspid regurgitation on survival in patients with chronic heart failure: unexpected findings of a long-term observational study, Eur Heart J, 2013;34:844–52.
- Agricola E, Stella S, Gullace M, et al., Impact of functional tricuspid regurgitation on heart failure and death in patients with functional mitral regurgitation and left ventricular dysfunction, Eur J Heart Fail, 2012;14:902–8.
- Sugimoto T, Okada M, Ozaki N, et al., Long-term evaluation of treatment for functional tricuspid regurgitation with regurgitant volume: characteristic differences based on primary cardiac lesion, J Thorac Cardiovasc Surg, 1999;117:463–71.
- Ghanta RK, Chen R, Narayanasamy N, et al., Suture bicuspidization of the tricuspid valve versus ring annuloplasty for repair of functional tricuspid regurgitation: midterm results of 237 consecutive patients, J Thorac Cardiovasc Surg, 2007;133:117–26.
- Navia JL, Nowicki ER, Blackstone EH, et al., Surgical management of secondary tricuspid valve regurgitation: annulus, commissure, or leaflet procedure?, J Thorac Cardiovasc Surg, 2010;139:1473-82 e5.
- Hetzer R, Komoda T, Delmo Walter EM, How to do the double orifice valve technique to treat tricuspid valve incompetence, Eur J Cardiothorac Surg, 2013;43:641–2.
- Lam YY, A new left atrial appendage occluder (Lifetech LAmbre Device) for stroke prevention in atrial fibrillation, Cardiovasc Revasc Med, 2013;14:134–6.
- Lam YY, Yan BP, Doshi SK, et al., Preclinical evaluation of a new left atrial appendage occluder (Lifetech LAmbre device) in a canine model, Int J Cardiol, 2013;168:3996–4001.
- Milewski K, Afari ME, Tellez A, et al., Evaluation of efficacy and dose response of different paclitaxel-coated balloon formulations in a novel swine model of iliofemoral in-stent restenosis, JACC Cardiovasc Interv, 2012;5:1081–8.
- Wu Y, Shen L, Wang Q, et al., Comparison of acute recoil between bioabsorbable poly-L-lactic acid XINSORB stent and metallic stent in porcine model, J Biomed Biotechnol, 2012;2012:413956.
- Zeller T, Kambara AM, Moreira SM, et al., Recanalization of femoropopliteal chronic total occlusions using the ENABLER-P Balloon Catheter System, J Endovasc Ther, 2012;19:131-9.
- Ritzema J, Troughton R, Melton I, et al., Physician-directed patient self-management of left atrial pressure in advanced chronic heart failure, Circulation, 2010;121:1086-95.
- Troost E, Delcroix M, Gewillig M, et al., A modified technique of stent fenestration of the interatrial septum improves patients with pulmonary hypertension, Catheter Cardiovasc Interv, 2009;73:173–9.
- Seib PM, Faulkner SC, Erickson CC, et al., Blade and balloon atrial septostomy for left heart decompression in patients with severe ventricular dysfunction on extracorporeal membrane oxygenation, Catheter Cardiovasc Interv, 1999;46:179–86.
- Gossett JG, Rocchini AP, Lloyd TR, et al., Catheter-based decompression of the left atrium in patients with hypoplastic left heart syndrome and restrictive atrial septum is safe and effective, Catheter Cardiovasc Interv, 2006;67:619–24.
- Keren G, Nitzan Y, Abraham W, et al., An interatrial shunt device reduces left atrial pressure, improves haemodynamics and prevents adverse remodeling in an ovine heart failure mode EuroIntervention, 2013; May 2013; EuroPCR abstracts 2013;164.
- Wechsler AS, Sadowski J, Kapelak B, et al., Durability of epicardial ventricular restoration without ventriculotomy, Eur J Cardiothorac Surg, 2013;44:e189–92, discussion e92.