NHLBI Cardiovascular Intervention Program (Lederman Lab) Projects and Collaborations Pages

Transcaval access to the aorta for transcatheter aortic valve replacement

Summary

“Transcaval” access is a new non-surgical approach to transcatheter aortic valve replacement (“TAVR”) that enables TAVR in patients without other good options.    It has been performed in over 150 patients to date.

Transcaval TAVR involves introducing a large introducer sheath (catheter) from the femoral vein across the inferior vena cava into the abdominal aorta.  After TAVR the hole is closed with a nitinol occluder device intended to close congenital heart defects.   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 Henry Ford Hospital.  It has proven lifesaving in patients who have no other good access options for aortic valve disease.   

Through a close and ongoing collaboration with Drs Adam Greenbaum and William O’Neill at Henry Ford Hospital, we continue to refine transcaval TAVR and to teach other physicians how to perform the technique.   We are sponsoring a multi-center IDE protocol (see below).  We also have organized a safety and quality surveillance program to make sure any unintended consequences or side effects of transcaval TAVI are identified and shared among physicians who are using the technique in the care of their patients.  We also are developing special medical devices intended to make the technique safer and more effective (see below).

Manuscripts and Presentations about transcaval TAVR

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. Transcaval Retrograde Transcatheter Aortic Valve Replacement for Patients With No Other Access: First-in-Man Experience With CoreValve.  Martinez-Clark PO, Singh V, Cadena JA, Cucalon Reyes AM, Gallegos C, Dager A, Greenbaum A, O'Neill WW.  JACC Cardiovasc Interv. 2014 Sep;7(9):1075-7.  Pubmed ID     25129663
   • This is short description of subsequent transcaval TAVR performed in a small number of patients in Cali Columbia.
4. How to plan transcaval access using computed tomography: a new approach to large transcatheter implants, with pictorial examples.  Lederman RJ, Chen MY, Rogers T, Wang DD, Paone G, Guerrero ME, O’Neill WW, Greenbaum AB, JACC Imaging; 2014;7(11):1167.  Pubmed ID 25459598
   • This teaches how to prepare a CT-based treatment plan.
5. Transcaval access for TAVR across a polyester aortic graft.  Lederman RJ, O'Neill WW, Greenbaum AB, Catheter Cardiovasc Interv, 2014.  Pubmed ID 25510917. 
   • Case report details the technique with attention to crossing graft material.
6. Live Case Demonstration, Scottsdale Interventional Forum, March, 2014. Posted here.
7. Live Case Demonstration, CSI Congress, Frankfurt, Germany, June 27, 2014.
8. Live Case Demonstration, Transcatheter Therapeutics Conference (TCT 2014), Washington DC, September 13, 2014.
9. Lecture: Transcaval Retrograde TAVR in Selected Patients, Technique and Outcomes, Transcatheter Therapeutics Conference (TCT 2014), Washington DC, September 16, 2014. Posted here.
10. Lecture: Transcaval Access Technique Step-by-Step, CRT 2015 Conference, Washington DC, February 21, 2015.  Video posted for download here.
11. 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

Teaching physicians how to perform transcaval access

We teach physicians how to perform transcaval TAVR.  The technique is easy to learn for experienced structural heart interventional physicians and surgeons, but there is significant “art” that is best taught on-site.  

Dr Adam Greenbaum (agreenb1@hfhs.org) of Henry Ford Hospital in Detroit is willing to invite physicians to observe the transcaval technique at his hospital, and he is willing to travel to proctor your first few cases.
Dr Robert Lederman (lederman@nih.gov) of NHLBI is willing teach and proctor the technique.

NHLBI offers to perform analysis of baseline contrast-enhanced abdomen and pelvic CT scan to guide the conduct of transcaval TAVR.   Click HERE to view a sample report.  Click HERE for instructions on how to send CT scans for consultation.

The NHLBI Transcaval TAVR IDE Protocol: An FDA approved multicenter study of transcaval TAVR for de novo aortic valve stenosis or for bioprosthetic aortic valve failure in patient with no other good access options

NHLBI is conducting a US multicenter IDE (investigational device exemption) protocol in order to study outcomes and complications of transcaval TAVR in patients who have no good access options.   The lead site is Henry Ford Hospital in Detroit MI, the Principal investigator is Dr Adam Greenbaum, and the study sponsor is Dr Robert Lederman.   Details of the trial (NCT02280824) are available from clinicaltrials.gov. 

Sites that have performed Transcaval TAVR

The following medical centers are known to have performed transcaval TAVR as of February 2016.

Patient Inquiries

If you are a patient and you believe you would benefit from transcaval TAVR, please have your physician contact one of the physicians performing the technique.

You can also learn about how to participate in this procedure as a patient from clinicaltrials.gov

Inventing Medical Devices Designed to Improve Transcaval TAVR Our NHLBI laboratory has designed and is testing purpose-built closure devices for transcaval TAVR.  We have applied for several patents for these devices so that they can be commercialized, and we have tested several promising prototypes in live animals and in human cadavers.  NHLBI has issued a solicitation for Small Business Innovation Research contract proposals to develop these or other devices to improve the safety and effectiveness of the transcaval technique.  We offer close collaboration to the contractor and to perform the first human testing.

TRAIPTA: Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty to treat secondary tricuspid valve regurgitation

Summary 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. The technique has been demonstrated in animals with tricuspid valve regurgitation but has not yet been tested in patients.

Manuscripts and Presentations related to TRAIPTA

1. Trans-auricular intra-pericardial tricuspid annuloplasty.  Rogers T, Ratnayaka K, Sonmez M, Franson DN, Schenke WH, Mazal JR, Kocaturk O, Chen MY, Faranesh AZ, Lederman RJ, JACC Cardiovascular Interventions 2015 Mar;8(3):483-91.  Pubmed ID: 25703872.   Available for download here.
   • This describes the technique of TRAIPTA as initially tested in animals, including improvement of secondary tricuspid valve regurgitation.
2. Intentional right atrial exit for microcatheter infusion of pericardial carbon dioxide or iodinated contrast to facilitate sub-xiphoid access. Rogers T, Ratnayaka K, Schenke WH, Faranesh AZ, Mazal JR, O'Neill WW, Greenbaum AB, Lederman RJ. Catheter Cardiovasc Interv. 2014 Oct 14. doi: 10.1002/ccd.25698.  Pubmed ID:  25315516.
   • This tests the safety of intentional right atrial exit, which is an important first step in TRAIPTA.

Inventing Medical Devices Designed to Perform TRAIPTA Tricuspid Annuloplasty

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 has initiated a collaboration with a large medical device manufacturer to test TRAIPTA in patients.

Transcatheter Mitral Cerclage Annuloplasty to Treat Secondary Mitral Valve Regurgitation.

Summary 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 not yet been tested in patients but we continue to refine the devices and the technique.  We seek a commercial partner (see below).   A parallel effort is being led by our former fellow, Dr June-Hong Kim of Pusan National University in Pusan, Korea.

Manuscripts and Presentations about Mitral Cerclage Annuloplasty

1. Mitral cerclage annuloplasty, a novel transcatheter treatment for secondary mitral valve regurgitation: initial results in swine. Kim JH, Kocaturk O, Ozturk C, Faranesh AZ, Sonmez M, Sampath S, Saikus CE, Kim AH, Raman VK, Derbyshire JA, Schenke WH, Wright VJ, Berry C, McVeigh ER, Lederman RJ.  J Am Coll Cardiol. 2009 Aug 11;54(7):638-51.  Pubmed ID  19660696

• This is the first description of cerclage as conceived and performed in animals.

Inventing Medical Devices Designed to Perform Mitral Valve Cerclage Annuloplasty Our NHLBI laboratory has designed and is testing purpose-built devices to perform mitral valve cerclage annuloplasty.  We have applied for, and received, several patents for these devices to impart commercial value, and we have tested several promising prototypes in live animals.  NHLBI has issued a solicitation for Small Business Innovation Research contract proposals to develop these or other devices to apply cerclage to help patients with mitral valve regurgitation who are not suitable for surgical treatment.   We offer close collaboration to the contractor and to perform the first human testing.

MRI Catheterization

Why MRI Catheterization? 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. Routine MRI Catheterization in Patients 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.

Bringing MRI Catheterization to Practice in Children

The NHLBI intramural program recently installed a MRI Catheterization system at Childrens National Medical Center in Washington DC.  The technical leader of the program is Dr. Michael Hansen, and the clinical leader is Dr. Kanishka Ratnayaka.  The program has several clinical objectives:

1. Bring NHLBI engineering expertise in rapid MRI to enhance diagnostic cardiac MRI in children.  This may allow the power of cardiac MRI to be applied to children without general anesthesia.
2. Combine MRI-derived roadmaps with live X-ray to enhance interventional pediatric catheterization, in a technique called “X-ray Fused with MRI (XFM),” especially in complex procedures.
3. Radiation-free catheterization in patients.

Bringing MRI Catheterization to Practice at Your Medical Center 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.

Recent publications about MRI catheterization

1. Real-time MRI-guided right heart catheterization in adults using passive catheters.  Ratnayaka K, Faranesh AZ, Hansen MS, Stine AM, Halabi M, Barbash IM, Schenke WH, Wright VJ, Grant LP, Kellman P, Kocaturk O, Lederman RJ.  Eur Heart J. 2013 Feb;34(5):380-9. Pubmed ID    22855740
2. MRI catheterization in cardiopulmonary disease. Rogers T, Ratnayaka K, Lederman RJ.  Chest. 2014 Jan;145(1):30-6. Pubmed ID     24394821

Inventing and Cultivating Development of Medical Devices for MRI Catheterization

Inventing and Cultivating Development of Medical Devices for MRI Catheterization 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 contracts 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 MRI-safe “active” antenna-guidewires and a unique passive MRI guidewires, and are working towards testing both in patients.