Evolving strategies for preserving the

pulmonary valve during early repair of tetralogy

of Fallot: mid-term results

Vladimiro Vida, MD, PhD

Pediatric and Congenital Cardiac Surgery Unit

University of Padua Medical School

Disclosures

Nothing to disclose

Background

Tetralogy of Fallot (TOF) repair has become nowadays a

standard routine practice

Al Habib HF, Jacobs JP, Mavroudis C, et al. Contemporary patterns of management of tetralogy of Fallot: data from the

Society of Thoracic Surgeons Database. Ann Thorac Surg. 2010 Sep;90(3):813-9.

Sarris GEE, Comas JV, Tobota Z, et al. Results of reparative surgery for tetralogy of Fallot: data from the European

Association for Cardio-Thoracic Surgery Congenital Database. Eur J Cardiothorac Surg. 2012 Nov;42(5):766-74.

Stellin G, Milanesi O, Rubino M et al. Repair of tetralogy of Fallot in the first six months of life: transatrial versus

transventricular approach. Ann Thorac Surg 1995;60:588–S591.

Correction via a right ventriculotomy with

RVOT TAP reconstruction remains the

most frequent approach

Many institutions have adopted, since many

years, a trans-atrial approach (TA) which

has become with time their preferred

standard procedure

• Commonly in any technique, when the use of TAP is necessary

- PVR with chronic volume overload

- Progressive RV dilation and dysfunction

- Impaired functional capacity

Background 1

PV cusps augmentation plasty

- limits an immediate PV regurgitation

- improves short-term clinical outcomes

Early PV cusp deterioration is expected

with a progressive PVR, in the long-term.

Development of different

PV preservation

techniques

Our PV preservation technique

(since 2007 in selected patients)

• Intra-operative PV balloon dilation during TA TOF repair

• Initial indication: less severe forms (PV Z score ≥-3)

• Current indication: PV Z-score ≥ 4

Vida VL, Padalino MA, Maschietto N, Biffanti R, Anderson RH, Milanesi O, Stellin G. The balloon dilation of the pulmonary valve

during early repair of Tetralogy of Fallot. Catheter Cardiovasc Interv. 2012 Nov 15;80(6):915-21.

PV Z-score: -3.6

4 mm 6 mm

10 mm

At 2D: 5.5 mm Z-score= -3.6

8- 10 mm

“In-series” PV balloon dilation

Additional PV plasty

Additional PV plasty after balloon dilation

“De-lamination”: to increase the PV leaflet’s coaptation surface

1) PV leaflets repair 1) PV leaflets “de-lamination”

2) PV leaflets resuspension 2) PV leaflets patch augmentation

3) PV leaflets re-suspension

Simple PV plasty Complex PV plasty

Aim of the study

To assess effectiveness, early and mid-term results of the PV

preservation technique by balloon dilation in pts with TOF

mainly focusing on:

1) PV function and growth

2) RV function

Controls: patients treated with a standard TA repair (with TAP) during the

same time interval

Patients June 2007 – December 2012

69 PATIENTS

+

Reason for PV preservation failure:

1) tearing of the hinges of the PV leaflets due to over-sizing of the

balloon catheter (n=3)(early in our experience)

2) very low PV Z-score (<-4)(n=2).

5 Conversions to TA

repair

34 PV preservation

success (49%)

30 Control TA

repair

39 PV preservation

attempts

- PTFE cusp (n=23)

- CorMatrix cusp (n=10)

- Autologous pericardium cusp (n=1)

- Pulmonaty homograft cusp (n=1)

PV anatomy

PV dilation group

(n=34)

Standars TA group

(n=35) p value

Unicuspid (n=4 pts) - 4 (100%)

0.001 Bicuspid (n=59 pts) 28 (47.4%) 30 (52.6%)

Tricuspid (n=6 pts) 6 (100%) -

Median preoperative PV Z-score p value

Unicuspid (n=4 pts) -4.26 (-2.97 - -4.98)

0.0004 Bicuspid (n=59 pts) -3.2 (-0.95 - -5.62)

Tricuspid (n=6 pts) -1.73 (-1.19 - -2.44)

Preoperative variables and results

PV dilation group

(n=34)

Control TA group

(n=35) p value

Age at surgery, days (range) 115 (36-521) 113 (65-454) 0.41

Median PV annulus at 2D, mm (range) 6.8 (5.5-8.8) 6 (4-9.5) 0.02

Median PV Z-score on 2D, n (%) -2.95 (-0.95 - -4.06) -3.35 (-1.54 - -5.62) 0.03

Coronary artery anomalies, n (%) 1 (2.9%) 4 (11.4%) 0.36

Median preop trans-cut. O2 sat, n (%) 94 (80-100) 90 (80-100) 0.03

Median preop RVOT grad, mmHg (range) 67 (40-87) 70 (55-93) 0.12

Median CPB time, min (range) 125 (93-200) 158 (104-237) 0.0001

Median CCT, min (range) 76 (45-118) 75 (48-114) 0.93

RVP/SBP after CPB discontinuation

- 1/3

- 1/2

- ¾

8 (23.5%)

19 (55.9%)

7 (20.6%)

10 (28.6%)

21 (60%)

4 (11.4%)

0.56

ICU complications, n (%) 11 (32.4%) 8 (22.9%) 0.54

Postop junc.tachycardia, n (%) 6 (17.6%) 1 (2.9%) 0.04

Postop. LOS, n (%) 3 (8.8%) 3 (8.6%) 0.99

Median ICU stay, days (range) 3 (1-8) 3 (1-12) 0.46

Median hospitalization, days (range) 10 (7-43) 10.5 (7-31) 0.7

“In-series” PV balloon dilation n=15 / 35 patients (44%)

PV Z-score -2.29 (-0.95 - -3.74) -3.56 (-2.28 - -4.06)

Single BD

n=20 pts

“In-series” BD

n= 15 pts

p=0.002

Simple PV plasty

n=4 pts

Additional PV plasty after balloon dilation (n=18 pts, 53%)

Complex PV plasty

n=14 pts

PV Z-score -2.34 (-1.52 - -2.78) -3.5 (-2.28 - -4.06)

p=0.01

Echocardiographic evaluation at discharge

PV dilation group

(n=34)

Standars TA group

(n=35) p value

Degree of TR, n (%)

Grade 1 (mild)

Grade 2 (moderate)

Grade 3 (severe)

30 (91.2%) 3 (8.8%)

-

33 (94.3%) 2 (5.7%)

-

0.48

Median RVOT gradient, mmHg (range) 29 (18 – 50) 25 (12 – 50) 0.18

RVOT gradient grade, n (%)

Grade 1 (<20 mmHg)

Grade 2 (20 – 40 mmHg)

Grade 3 (>40 mmHg)

1 (2.9%) 30 (88.2%)

3 (8.8%)

7 (20%) 26 (77.1%)

1 (2.9%)

0.07

Degree of PVR*, n (%)

Grade 1 (none-mild)

Grade 2 (moderate)

Grade 3 (severe)

30 (88.2%) 4 (11.8%)

-

14 (40%) 9 (25.7%) 12 (34.3%)

0.0001

* Grothoff M, Spors B, Abdul-Khaliq H, Gutberlet M: Evaluation of postoperative pulmonary regurgitation after surgical repair of

tetralogy of Fallot: Comparison between doppler echocardiography and mr velocity mapping. Pediatr Radiol. 2008; 38: 186-191

Follow-up

PV dilation group

(n=34)

Standars TA group

(n=35) p value

Follow-up time, days (range)

432 (189 – 1940)

711 (189 – 1492)

0.08

Reoperations, n (%)

1* (2.9%)

1** (2.8%)

0.9

Both with a residual peak RVOT gradient

> 50 mmHg

Both required additional RVOT muscle

bandle resection, TAP + PTFE PV cusp

interposition

Echocardiographic evaluation at follow-up (>6 months)

PV dilation group

(n=30)

Standars TA group

(n=32) p value

Degree of TR, n (%)

Grade 1 (mild)

Grade 2 (moderate)

Grade 3 (severe)

30 (100%)

-

-

32 (100%)

-

-

0.99

Median RVOT gradient, mmHg (range) 23.5 (8 – 40) 22 (7 – 45) 0.85

RVOT gradient grade, n (%)

Grade 1 (<20 mmHg)

Grade 2 (20 – 40 mmHg)

Grade 3 (>40 mmHg)

18 (60%)

12 (40%)

-

18 (56%)

12 (38%)

2 (6%)

0.37

PV Z-score, n (range) -0.1 (-0.3 - +0.7) - -

Degree of PVR, n (%)

Grade 1 (none-mild)

Grade 2 (moderate)

Grade 3 (severe)

24 (80%)

6 (20%)

-

8 (25%)

11 (35%)

13 (40%)

<0.0001

p=0.003

55% (42-70) 50% (40-63)

PV dilation group Standard TA group

Echocardiographic evaluation at follow-up RV fraction of area change

Horton KD, Meece RW, Hill JC: Assessment of the right ventricle by echocardiography: A primer for

cardiac sonographers. J Am Soc Echocardiogr. 2009; 22: 776-792.

Anavekar NS, Gerson D, Skali H, Kwong RY, Yucel EK, Solomon SD: Twodimensional assessment of right

ventricular function: An echocardiographic-mri correlative study. Echocardiography. 2007; 24: 452-456.

PVR and RV function at follow-up Linear regression analyis

Limitations

-Retrospective evaluation

-Mid-term follow-up

- RV function assessment by 2D echo

- Still on a learning curve phase

Conclusions

The PV function can be preserved by balloon dilation during early TA TOF repair

and this contributes to better preserve RV function.

We have recently further expanded the applicability of such a technique to patients

with an increasingly smaller PV annulus (PV Z-score ≥ 4)(being the in-series balloon

dilation and a more aggressive PV plasty strategy important key points).

In case the total valve preservation cannot be achieved the conversion to standard TA

repair can be easily performed.

E-E2)(PV Z-score -3 - -3.5)

PV leaflet’s de-lamination

and re-suspension plasty

Our current PV preservation

surgical protocol

A-C) common pathway including

“protective” commissurotomy and

balloon dilation of the pulmonary valve

annulus.

D-D1)(PV Z-score -3)

Additional PV plasty, for

repairing accidental leaflet’s

tears during balloon dilation,

and leaflet’s re-suspension.

F)(PV Z-score -3.5 - -4)

Additional PV leaflets’s

patch augmentation and

re-suspension plasty.