Cardiovascular Intervention Program
First human use
Transcaval access for transcatheter aortic valve replacement TAVR
Intentional right atrial exit to access the otherwise empty pericardial space
Transcatheter mitral valve cerclage annuloplasty
July 2015 (Dr June-Hong Kim, Pusan National University Yangsan Hospital, Korea)
Transcatheter bidirectional superior cavo-pulmonary bypass (Glenn Shunt)
December 2016 (Dr Kanishka Ratnayaka, UCSD Rady Childrens Hospital, San Diego)
LAMPOON (Intentional Laceration of the Anterior Mitral leaflet to Prevent left ventricular Outflow ObstructioN during transcatheter mitral valve replacement TMVR)
Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction
July 2017 (Dr Danny Dvir, University of Washington, Seattle)
MRI catheterization using a passive commercial nitinol guidewire in patients
August 2017 (Dr Toby Rogers and Dr Adrienne Campbell, NHLBI, Bethesda)
Closure of transcaval access ports using Transmural Systems’ dedicated Transcaval Closure Device, developed at NHLBI
We also have a significant effort towards using MRI to guide radiation-free heart catheterization (see below).
“Transcaval” access is an alternative to standard transfemoral artery access for transcatheter aortic valve replacement (“TAVR”) and other non-surgical procedures that require large-bore catheter access. It has been performed in over 500 patients so far.
Transcaval TAVR involves introducing a sheath (catheter) from the femoral vein across the inferior vena cava into the abdominal aorta. After TAVR the hole is closed with an occluder device. The safety and success of transcaval TAVR relies on the counter-intuitive observation that bleeding from the hole in the abdominal aorta is tolerated as long as there is simultaneous decompression into the matching hole in the nearby vena cava.
Transcaval TAVR was developed at the NHLBI Cardiovascular Intervention Program and applied to patient care in collaboration with Dr. Adam Greenbaum at Henry Ford Hospital. We have introduced the technique to over 70 hospitals on 3 continents using 5 different TAVR valves. It has proven lifesaving in patients who have no other good access options for aortic valve disease, and increasingly it is the preferred approach when transfemoral artery access is not suitable.
1. Aortic access from the
vena cava for large caliber transcatheter cardiovascular interventions:
pre-clinical validation. Halabi M, Ratnayaka K, Faranesh AZ, Chen MY,
Schenke WH, Lederman RJ. J Am Coll Cardiol. 2013 Apr 23;61(16):1745-6.
Pubmed ID 23500317
• This is the first description of the technique as conceived and performed in animals.
2. Caval-aortic access to
allow transcatheter aortic valve replacement in otherwise ineligible
patients: initial human experience. Greenbaum AB, O'Neill WW, Paone G,
Guerrero ME, Wyman JF, Cooper RL, Lederman RJ. J Am Coll Cardiol. 2014 Jul
1;63(25 Pt A):2795-804. Pubmed ID 24814495.
• This details how the procedure was first performed the patients, including the first 19.
3. How to perform transcaval access and closure for transcatheter aortic valve implantation, Lederman RJ, Babalarios VC, Greenbaum AB. Catheter Cardiovasc Interv, 2015;86:1242. Pubmed ID 26356244
4. Anatomic Suitability
for Transcaval Access Based on Computed Tomography. Lederman RJ, Greenbaum
AB, Rogers T, Khan JM, Fusari M, Chen MY. JACC Cardiovasc Interv,
2017;10(1):1. Pubmed ID 28057275
• This teaches how to plan a transcaval procedure based on CT.
5. Transcaval Access and
Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation.
Greenbaum AB, Babaliaros VC, Chen MY, Stine AM, Rogers T, O'Neill WW, Paone
G, Thourani VH, Muhammad KI, Leonardi RA, Ramee S, Troendle JF, Lederman RJ.
J Am Coll Cardiol, 2017;69(5):511. Pubmed ID 27989885
• These are the results of an independently-adjudicated multicenter investigation of the transcaval technique using Amplatzer closure devices.
6. Lecture: Transcaval Access Technique Step-by-Step, CRT 2015 Conference, February 2015. Video posted for download here.
7. Lecture: Transcaval case example, SCAI Conference, May 2015. Video posted here.
8. Live transcaval case transmission, TCT conference, October 2016. Video posted here.
Physician training courses about the transcaval technique are periodically held by our luminary partners, Dr Adam Greenbaum at Henry Ford Hospital (Detroit), Dr Vasilis Babaliaros at Emory University (Atlanta), Dr Toby Rogers at Medstar Washington Hospital Center (Washington DC). Physician proctorship is offered by at least one valve manufacturer (Edwards Lifesciences).
Our NHLBI laboratory is collaborating with Transmural Systems (Andover MA) to co-develop purpose-built closure devices for transcaval TAVR. Testing in patients is planned in early 2018.
About half of patients are turned away from non-surgical catheter-based mitral valve implantation procedures today, out of concern that the valve implant will block blood outflow from the left ventricle. Dr Jaffar Khan in our NHLBI laboratory, in collaboration with Dr Vasilis Babaliaros at Emory University Atlanta and Dr Adam Greenbaum at Henry Ford Hospital Detroit have developed the LAMPOON technique in animals and applied it to a small number of patients.
This procedure resembles a technique that otherwise requires open heart surgery.
We have begun a prospective multicenter trial of the LAMPOON technique. More information can be found on clinicaltrials.gov.
1. Intentional Laceration of the Anterior Mitral Valve Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement: Pre-Clinical Findings. Khan JM, Rogers T, Schenke WH, Mazal JR, Faranesh AZ, Greenbaum AB, Babaliaros VC, Chen MY, Lederman RJ. JACC Cardiovasc Interv, 2016;9(17):1835. Pubmed ID 27609260
2. Live case demonstration at TCT October 2016. Video posted here.
3. Intentional Laceration of the Anterior Mitral leaflet to Prevent Outflow ObstructioN (LAMPOON) during TMVR: first-in-human experience, Babaliaros VC, Greenbaum AB, Khan JM, Rogers T, Wang DD, Eng MH, O’Neill WW, Paone G, Thourani VH, Lerakis S, Kim DW, Lederman RJ. Journal of the American College of Cardiology Interventions, 2017. Pubmed ID 28427597.
TRAIPTA is a catheter-based repair for secondary tricuspid valve regurgitation, which causes right-sided heart failure and for which there is no satisfactory non-surgical option. TRAIPTA restores tricuspid valve function by installing a simple extracardiac appliance. The TRAIPTA technique uses a catheter to exit the heart, from inside out, to enter the pericardial space surrounding the heart. Once inside the pericardial space, the TRAIPTA device surrounds the valve annulus and introduces circumferential compression to restore tricuspid valve function, while protecting other vital structures from compression. The right atrial exit port is then closed with a simple occluder device. Dr Toby Rogers developed the technique has been demonstrated in animals with tricuspid valve regurgitation but has not yet been tested in patients.
Our NHLBI laboratory has designed and is testing purpose-built devices for TRAIPTA. We have applied for several patents for these devices so that they can be commercialized, and we have reversed tricuspid regurgitation using these prototypes in live animals. NHLBI is collaborating with Cook Medical to test TRAIPTA in patients.
Mitral cerclage annuloplasty is a completely new treatment for secondary (“functional”) mitral valve regurgitation, a common contributor to heart failure. This technique connects natural cavities via a non-anatomic device trajectory. Cerclage establishes circumferential tension around the mitral annulus through a pathway that includes the coronary sinus, a basal septal perforator vein, a short trans-myocardial tunnel through the interventricular septum, and the right ventricle In applying circumferential tension, cerclage is unique among percutaneous mitral regurgitation annuloplasty strategies.
Cerclage has been tested successfully in a small number of patients by Dr June-Hong Kim at Pusan National University Yongsang Hospital in Busan, Korea.
NHLBI is collaborating with Transmural Systems (Andover MA) on a refined catheter system to accomplish mitral cerclage annuloplasty. First human tests are planned for 2018.
· This describes the first human mitral cerclage annuloplasty.
Patients needing TAVR, whether for bioprosthetic or native aortic valve failure, sometimes risk acute coronary obstruction created when the TAVR device pushes the diseased aortic valve leaflets outwards. BASILICA is a simple catheter approach, performed immediately before TAVR, to reduce this risk. BASILICA splits the threatening aortic leaflet using techniques similar to LAMPOON. It has shown promise in a small number of patients. BASILICA may also prove important for patients with bicuspid aortic valve disease (“BiSILICA”), which is more common in Asia.
NHLBI has begun a multi-center prospective investigation of BASILICA (NCT03381989)
Pledget assisted tricuspid annuloplasty (PASTA) is the world’s first transcatheter suturing technique using off-the shelf components. PASTA creates a double orifice tricuspid valve to reduce tricuspid regurgitation (leakage) when the right heart chambers are massively dilated. PASTA employs double-bite suture pledgets, a novel “septal bite” to serve as an intracardiac anchor, and a simple technique to exchange electrosurgical traversing wires for sutures.
Unlike X-ray, which depicts only shadows of the heart, MRI clearly depicts soft tissue and blood spaces. Advances in MRI allow real-time MRI at frame rates of 5-15 per second. Compared with X-ray, these pictures have fewer pixels but more information. MRI catheterization allows radiation-free catheterization, for example in children or in protracted procedures, and allows guidance of newer and more complex non-surgical procedures.
At the NIH Clinical Center, we now perform MRI catheterization as our standard clinical approach. Not only does it avoid radiation entirely, it provides the most accurate measurement of blood flow, and it allows us to study heart function both at rest and after pharmacologic provocation.
NHLBI offers to help you begin the practice and investigation of MRI catheterization at your medical center. We also offer training for fellows with expertise and interest in interventional and image-guided intervention. For information, contact Dr. Robert Lederman.
MRI catheterization is not yet popular because there are not a large number of MRI-safe catheter tools; companies do not wish to invest in the development of MRI-safe catheter tools because MRI catheterization is not yet popular. That is why NHLBI is developing custom MRI-safe catheter tools, along with a team of scientists, engineers, physicists, and clinicians, to “jump-start” the chicken-egg problem with industry, and to bring MRI catheterization into wider clinical practice. NHLBI issues periodic solicitations for Small Business Innovation Research contract to develop MRI-safe catheter devices, and our lab offers to (and often does) collaborate with the contract awardees. These include a MRI safe hemodynamic recording system, a MRI myocardial bioptome, and MRI myocardial injection catheters.
Our laboratory continues to work on a range of pre-clinical applications for MRI catheterization devices. Internally, we have developed unique passive MRI guidewires, and are working to help commercialize it for general use in patients.