Cardiovascular Intervention Treatments and Devices

We create new catheter based treatments and devices for structural heart disease and introduce them into medical practice.

We are a multidisciplinary team of cardiologists (adult and pediatric), imaging scientists, and catheter engineers. We have close collaborations with luminary cardiologists across the USA and the world.

We have a growing list of techniques and devices that we have invented and helped to use in humans for the first time. Many more are in advanced development.

We also have a significant effort towards using MRI to guide radiation-free heart catheterization (see below).

TAVR: Transcaval access to the aorta for transcatheter aortic valve replacement

Summary

“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 1000 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 130 hospitals on 5 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.

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. 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.

9. Live transcaval case transmission, PCR London Valve conference, September 2018. Video download from here.

Physician training for transcaval access

Physician training courses about the transcaval technique are periodically held by our luminary partners, Dr Adam Greenbaum and Dr Vasilis Babaliaros at Emory University (Atlanta), Dr Toby Rogers at Medstar Washington Hospital Center (Washington DC). Physician proctorship is offered by at least two valve manufacturer (Edwards Lifesciences and Medtronic).

Inventing medical devices to enhance transcaval closure

Our NHLBI laboratory is collaborating with Transmural Systems (Andover MA) to co-develop purpose-built closure devices for transcaval TAVR. The device appears safe and effective in an early feasibility study.

1.      Dedicated closure device for transcaval access closure: from concept to first-in-human testing. Rogers T, Greenbaum AB, Babaliaros VC, Stine AM, Khan JM, Schenke WH, Eng MH, Paone G, Leshnower BG, Satler LF, Waksman R, Chen MY, Lederman RJ, JACC Cardiovasc Interv, 2019;12:2198. Pubmed ID 31629746

LAMPOON: Catheter-based splitting of the anterior mitral valve leaflet to prevent LV outflow tract obstruction during transcatheter mitral valve replacement

Summary

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 completed a multicenter trial of the LAMPOON technique. 

Manuscripts and Presentations about LAMPOON

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. JACC Cardiovasc Interv, 2017. Pubmed ID 28427597.

4.     Anterior Leaflet Laceration to Prevent Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement [LAMPOON Trial], Khan JM, Babaliaros VC, Greenbaum AB, Foerst JR, Yazdani S, McCabe JM, Paone G, Eng MH, Leshnower BG, Gleason PT, Chen MY, Wang DD, Tian X, Stine, AM, Rogers T, Lederman RJ JACC, 2019;73:2521. Pubmed ID 31118146

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. Dr Toby Rogers developed 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.
   • 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 is collaborating with Cook Medical 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 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.

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
2. This describes cerclage as conceived and performed in animals.
3. Mitral Loop Cerclage Annuloplasty for Secondary Mitral Regurgitation. First Human Results. Park YH, Chon MK, Lederman RJ, Sung SC, Je H, Choo KS, Lee SH, Shin ES, Kim JS, Lee SY, Chon KJ, Kim JH. J Am Coll Cardiol Cardiovascular Interventions. 2017;10(6):597-610. Pubmed ID 28335897

· This describes the first human mitral cerclage annuloplasty.

BASILICA: Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction

Summary

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. 

Clinical Protocol

NHLBI has begun a multi-center prospective investigation of BASILICA (NCT03381989)

Manuscripts and Presentations about BASILICA

1. Khan JM*, Dvir D*, Greenbaum AB, Babaliaros VC, Rogers T, Aldea G, Reisman M, Mackensen GB, Eng MH, Paone G, Wang DD, Guyton RA, Devireddy CM, Schenke WH, Lederman RJ, “Transcatheter laceration of aortic leaflets to prevent coronary obstruction during transcatheter aortic valve implantation: concept to first-in-human” aka BASILICA, Journal of the American College of Cardiology Cardiovascular Interventions, 2018;11(7):677–89. (Pubmed ID 29622147)
2. A BASILICA procedure was demonstrated by Drs Adam Greenbaum and Danny Dvir at the 2017 Transcatheter Therapeutics conference in Denver, broadcast from Henry Ford Hospital in Detroit. Video posted here.
3. TCTMD news story about BASILICA here.
4. NIH press release about BASILICA here.

PASTA

Summary

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. 

Manuscripts about PASTA

1. Khan JM, Rogers T, Schenke WH, Greenbaum AB, Babaliaros VC, Paone G, Ramasawmy R, Chen MY, Herzka DA, Lederman RJ, “Transcatheter Pledget-Assisted Suture Tricuspid Annuloplasty (PASTA),” Catheterization and Cardiovascular Interventions, 2018 Feb 6. (Pubmed ID 29405564)

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 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. MRI catheterization in cardiopulmonary disease. Rogers T, Ratnayaka K, Lederman RJ. Chest. 2014 Jan;145(1):30-6. Pubmed ID 24394821
2. CMR fluoroscopy right heart catheterization for cardiac output and pulmonary vascular resistance: results in 102 patients. Rogers T, Ratnayaka K, Khan JM, Stine AM, Schenke WH, Grant LP, Mazal JR, Grant EK, Campbell-Washburn A, Hansen MS, Ramasawmy R, Herzka DA, Xue H, Faranesh AZ, Kellman P, Lederman RJ, Journal of Cardiovascular Magnetic Resonance, 2017;19:54. Pubmed ID 2875064
3. Radiation-Free MRI Diagnostic Heart Catheterization in Children. Ratnayaka K, Kanter JP, Faranesh AZ, Grant EK, Olivieri LJ, Cross RR, Cronin I, Hamann KS, Campbell-Washburn AE, O’Brien KJ, Rogers T, Hansen MS, Lederman RJ, Journal of Cardiovascular Magnetic Resonance, 2017 Sep 6;19(1):65. Pubmed ID 28874164
4. More information about iCMR is available at https://icmr.nhlbi.nih.gov

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 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.

NHLBI Cardiovascular Intervention Structural Heart Image Data Repository

Representative cardiovascular medical images (such as CT) are posted from patients with specific conditions of interest to researchers worldwide. These can be downloaded and used freely from this link.