Dr Malik at CSI-Frankfurt in June 2018

CSI is the premiere structural heart meeting. Dr Malik was presenting at the meeting on Paravalvular leak and PFO closure.

Dr Malik performs TAVI, PFO closure, ASD closure, LAA closure and closes paravalvular leaks.

He was also learning. The tricuspid valve is a new frontier in intervention. More women are affected than men. The leak is usually due to annular dilatation- the leaflets are probably OK, but the ring of the valve stretches. There is no validated technology, but here is an update on what is out there:


All challenging – either treating the leaflets (bringing them together), or reducing the annulus size with pulling the ring down or together, or replacing the valve.

Thus, cardiologists are mimicking what surgeons are doing, with increasing success.

Step 1 is to develop these techniques in very sick patients.

Step 2 is to consider doing the treatment earlier before the right ventricle is irreparably damaged.

Tricuspid technology-the technical bit:

  1. Abbott-MitraClip
    • It is a transfemoral procedure
    • The TV area is larger than Mitral, and has three cusps.
    • Tip1-to misalign the loading by 90 degrees,
    • Tip2-In functional TR, grab anteroseptal and then posteroseptal commissures.
    • Study of 64 cases- European-42% needed 2-4 clips. 89% transfemoral- in hospital death 5%
    • TIP3- gap between leaflets >8mm makes it difficult, but XTR clip will help.
    • TRILUMINATE study- 85 patients in this study being collected. Using a dedicated delivery system-will come out this year.often 2 clips
    • Total in world is 600 cases, challenges in imaging (TOE) and technique.
    • Currently there is no reimbursement in Europe
  2. 4Tech TriCinch Coil
    • Transvenous device- with anchor and stent
    • Use ICE to puncture into pericardium-in anterior-posterior annulus. Inflate with CO2 600cc  via puncture in right atrial appendage.  Image RCA as the RCA is close by. Then tension the system-Stent is placed in the IVC
    • If there is previous cardiac surgery, this will not work-there is no pericardial space.
    • Very early days with this technology
  3. Trialign
    • Reproduces the surgical technique (K procedure) to make it the three leaflet tricuspid valve a bileaflet valve
    • It is a transjugular procedure- RF wire used to puncture at commissure. Two pledgets placed-then brought togather
    • May need more pledgets- in a line or series.
    • Requires repeated RF ablation- and a careful watch of the right coronary artery
    • SCOUT-1 trial- 25 patients
  4. HeartStitch Jade-suture
    • Mimics an annuloplasty
    • Used in PFO closure already-performing quite well
    • Transjugular procedure is planned
    • So far, it has not yet been done percutaneously- but may well work.
    • The theory is similar to Trialign
    • Less force than other annulus procedures
  5. Traipta
    • Tranatrial pericardial access, then deploying the device, then avoiding the right coronary artery, then sealing any holes!
    • RAA used with balloon and wire pushed into pericardium. (0.014 wire used.) a microcatheter is pushed into the pericardium. If this catheter has a balloon on it, it wont fall back.
    • A big loop is taken over the heart- tightens the AV groove.
    • Need to check that the coronaries are OK
    • The device is a mesh- flattens out with tension.
    • Not yet used in man-Tricuspid will reduce in size more than mitral ring as right heart is lower pressure
  6. PASTA
    • Mimics Hetzer surgical approach to get a double orifice valve
    • Pledgeted transannular sutures-on mid anterior annulus and septal crossing.
    • RCA wire left in to mark this
    • Agiliis , confienza wire, 20W burn 1 sec, Flexible catheter through the valve- electrosurgery to puncture from RV to RA.
    • Cor-Knot to bring the sutures togather
    • Dual puncture allows a larger force to be applied- but in man- the sutures have pulled through in all 3 cases.
  7. Trisol medical
    • This is a new tricuspid valve-single piece of pericardium-acts like a sail- bileaflet valve.
    • Reduced radial force on conduction tissue
    • Large TV closing volume.
    • 30F delivery system and retrievable
    • Not yet in man
  8. Cardiac Implant- complete ring-DaVingi-TR
    • Fabric band with 10 stakes
    • Heal for 3 months, and then tension it.
    • In RCA is protected.
    • One trigger fires all 10 stakes into the annulus- stabilised with  a balloon. Do in diastole to hold it steady
    • Tethers left under the skin in the jugular area- to be caught up 90 days later. The tethers do NOT hold it in place. Tissue growth does the holding.
    • 4  patients  have been done.
    • Bit like Cardioband, Milliped, but the Cardioband is an incomplete ring.
    • It could hit the AV node with a tether –but it has not been a problem to date.
  9. TricValve
    • Bicaval valves (CAVI)-implanting in the inferior vena cava and the superior vena cava
    • Avoid the tricuspid valve itself as it is huge and a free area that is not as supported.
    • CT scan to define the sizes
    • Self expanding IVC up to 43mm, SVC up to 38mm
    • IVC valve sits in the Right atrium- like a chimney
    • 40 cases done- IVC-CAVI only in most. Most were off label use of  Edwards Sapien and pre-stenting
    • PPM leads are not a contraindication.
  10. Tricuspid Valve in Valve (TVIV)
    • No rapid pacing is needed
    • Lundeqvist wire- in LPA, Tricky to cross valve- inflate a small amount
    • If very large RV, then put safari in RV apex- with steerable catheter to get it there.-again no rapid pacing needed.
    • Conscious sedation-no TOE needed- usually done with ICE (intracardiac echo)
    • Used melody valve or the Edwards Sapien valve
    • 284 ViV and 22 valve in ring brought togather in a registry.
      1. Acute results were good. Post implant TR was mild TR in 16%, moderate or more in 1%. Only 2 patients with gradient >10mmHg.
      2. 10% had tricuspid valve reintervention
      3. Both Melody and sapien valve performed similarly
      4. Endocarditis in 1.5% per year
      5. Valve patients had 8 with thrombus-these were managed with anticoagulation.
  1. NaviGate valve
    • Very sick patients- torrential or massive TR
    • Low profile, short height, annular winglets, multiple sizes.
    • Surgical trans-atrial approach with CT scan planning to find the right rib space to use.
    • Guide by TOE and fluoroscopy-to maintain central position
    • Self expanding valve- LV area 1stand then pulling up to annulus to release the atrial rim.
    • 27 patients overall. 30 day mortality 9%
  2. Unified Caval Valve-Cavalve
    • Stent from SVC to IVC-valve in RA on the stent- gaps in the stent
    • Would be impossible to pace after this.
    • Pacing leads would be jailed.
    • The RA is still pressurised, but venous pressure is reduced.
  3. All other techniques
    • Forma-a space occupying device in TV orifice.- anchored in RV apex with a hook- done via axillary vein.-20-24 F sheath
      1. 18 patients in a study and the latest data from this shows good outcomes.
      2. This does leave a lot of kit in the heart
    • Millipede IRIS-transfemoral delivery experience from mitral side- now in tricuspid.
      1. i.2 tricuspid cases-complete ring placed and then   tensioned.
    • Cardioband-incomplete ring placed- used in mitral valve and CE marked for this
      1. TRI-repair done- 1stCE marked device for the tricuspid valve
    • Pascal device
Posted on 29 June 2018
Author: LCC

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