Percutaneous Pulmonary Valve Replacement

First Ever Case in South Asia

Professor Dr. Nurun Nahar Fatema
Paediatric Cardiologist and interventionist
CMH Dhaka.

Introduction

Percutaneous  pulmonary valve implantation(PPVI) was introduced in 2000 by  Prof Philip  Bonhoeffer  of USA to treat  stenosis  and regurgitation in a prosthetic conduit  (artificial tube ) in the right ventricular outflow tract (RVOT). Melody  percutaneous  valve effectively relieves stenosis (narrowing)  and is very capable of treating regurgitant (loose) conduits. This conduits are placed initially in RVOT to treat some complex congenital diseases like Tetralogy  of  Fallot  (ToF), Truncus  Arteriosus ,  Pulmonary Atresia, Double Outlet Right Ventricle with Pulmonary Stenosis (PS) and  Transposition of Great Arteries (TGA) with PS or post Ross operation  like situation to allow unobstructed  forward flow  of blood from right ventricle to pulmonary artery.

Therapy indication

MELODY transcatheter pulmonary valve is intended to-

– Extend RVOT conduit life

– Relieve conduit stenosis without inducing  regurgitation

– Restore and maintain pulmonary valve competence

Device Rationale

• Helps reduce the total number of surgeries over the patient’s lifetime by postponding time to surgery while restoring pulmonic function
• Encourages earlier intervention, providing better outcomes for patients while avoiding surgical complications
• Indicated in patients implanted with failed conduits.

Medtronic MelodyTM Transcatheter Pulmonary Valve

• 18 mm modified contegra® Bovine Jugular Vein Valve
• nuMed Platinum Iridium stent

–28mm length

–Crimped down to 6 mm, re-expanded 18mm upto 22mm

Medtronic “Ensemble”

• Proprietary NuMed Balloon-In-Balloon delivery system:

– Two balloons:

One expands to make sure the stent in place

The other expands to make sure that valve is inflated

• Sheath covering of valve during delivery
• Three balloon delivery size: 18,20,22 mm
• Catheter size: 22 Fr
• One valve size only

 Selection Criteria

• SELECTION CRITERIA:
• Objective evidence of conduit dysfunction

–Moderate or severe regurgitation

–Right ventricular outflow obstruction

• Weight ≥ 25 kg
• Conduit originally ≥ 16 mm
• Conduit currently ≤ 22 mm
• Favorable RV-PA conduit morphology

–Amenable to stent anchorage

–Sizing balloon (waist) diameter ≥ 14mm and ≤ 20 mm.

EXCLUSION CRITERIA Pregnancy Active endocarditis Unsuitable anatomy No venous access Professor Dr. Nurun Nahar Fatema

Patient selection

Patient’s profile

1st diagnosis

ECHO before 1st surgery

Angiogram before 1st surgery

He had his first surgery (ICR)on 27th July 2007 in Narayana Hridayalaya , Bengalore, India which was a trans-atrial repair.

After 1st surgery

Patient was symptomatic in the form of exertional dysponea.

ECHO after 1st surgery

Angiogram after 1st surgery

First Clip

Second Clip

2nd Surgery

• So redo surgery was performed in 2009 and an orthotropic conduit was placed between right ventricular (RV) out flow tract and pulmonary artery on 22nd January 2009.
• After 2nd surgery he again developed easy fatigability after 6 months

ECHO after 2nd surgery(15/12/12)

Angiogram after 2nd surgery

Angiogram after 2nd surgery

Pulmonary valve replacement

Finally in 25th December 2012, first ever case of pulmonary valve replacement in South Asia was performed in catheterization laboratory of CMH Dhaka with technical support from a Saudi cardiac team.

Preparation for transcatheter pulmonary valve replacement

Rinsing Melody® Pulmonary Valve

• Using aseptic technique, prepare 4 sterile bowl

–1 empty bowl will be used as a “Discard bowl”

–3 bowls will be filled with 500 ml isotonic saline to be used for rinsing.

• Remove Melody® by grasping the serial number tag with atraumatic forceps and lifting it from the jar.

Rinsing Melody® Pulmonary Valve

• Transfer the Melody® TPV to 1st rinse bowl after emptying out any residual fluid from the storage jar.
• Wash Melody® TPV with rinse solution by alternately emptying and filling the valve, by inverting and swirling, and filling and emptying valve for two minutes.
• Transfer Melody® to 2nd and 3rd rinse bowl respectively and repeat above wash procedure for a minimum of 2 minutes.
• Leave the TPV in the 3rd rinse bowl until needed for implantation

Crimping and loading of Melody® TPV

• BLUE to BLUE and

WHITE TO WHITE !!

• The distal end of Melody® can be identified by the blue suture
• White suture has been used at the proximal end (in flow)
• The valve must be properly oriented on the catheter with placement of the blue suture towards blue tip of the delivery system and the white suture to white shaft of the delivery system.

Crimping and loading of Melody® TPV

• Ensure valve leaflets are fully open prior to beginning the crimping procedure.
• Reduce the size of valve while crimping.
• It is recommended to use 3 ml syringe for crimping to an intermediate size prior to final crimping onto the balloon catheter
• Carefully slide the sheath over the crimped valve

Procedure

Place: Cath Lab, CMH Dhaka, Bangladesh. Date: 25 Dec 2012 Brig Gen Nurun Nahar Fatema and Dr. Mansur Al Jofan

Step 1

1. Standard hemodynamic evaluation (pressure measurement: RA, RV, PA, AO)
2. RV angiography for better evaluation of RVOT
3. PA angiogram for better evaluation of main PA/ pulmonary branches anatomy/PR Assessment.
4. Aortogram after balloon inflation in RVOT for coronary assessment.

Step 1- artogram

Step 2

• Varify that the patient meets the morphological criteria:
• RVOT dimentions  ≥ 16 mm and ≤ 22mm

Step 4

• Pre-dilatation & coronary angio: RVOT balloon inflation and simultaneous coronary angiography in AP and lateral projection:

–To evaluate conduit distensibility

–Potential compression of coronary arteries

Step 5

• Pre stenting

Step 6

• Melody TPV implant

Step 7

• Post dilatation with HIGH PRESSURE BALLON not required .

Follow up

Follow up echo after 1 year

• Functioning Melody valve
• No residual PS
• No residual PR

Conclusion

Percutaneous pulmonary valve implantation (PPVI) is a new treatment option in patient with RVOT conduit regurgitation and stenosis. Early result following PPVI have shown a significant reduction in right ventricular pressure and RVOT gradient. The most common complication is stent fracture or PR in the context of endocarditis. We got excellent result in our first case. We have performed our 2nd case in 1st Jan 2014 . So PPVI has the potential to become the standard procedure in the treatment of dysfunctional conduit and will be easy to procure if price is considered for the developing countries.