Evolving strategies for preserving the pulmonary valve during early repair of tetralogy

of Fallot: mid-term results

Alvise Guariento, MD

Pediatric and Congenital Cardiac Surgery Unit University of Padua Medical School

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 ofFallot: data from theSociety 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

themost frequent approach

Many institutions have adopted, since many

years, atrans-atrial approach (TA) which

has become with time their preferred

standard procedure

• Commonly in any technique, when the use ofTAP is necessary

- PVR with chronic volume overload

- Progressive RV dilation and dysfunction

- Impaired functional capacity

Background

Development of different

PV preservation

techniques

Surgical history of repair (University of Padua)Evolution of our surgical policy

• Since 80’s: “Classic” transventricular

repair in infants

• Since 1991: Early transatrial one-stage

repair (6 3 months of age)

• Since 2007: Further evolution: PV

preservation

Our PV preservation technique

(since 2007 in selected patients)

• Intra-operative PV balloon dilatation 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 valveduring early repair of Tetralogy of Fallot. Catheter Cardiovasc Interv. 2012 Nov 15;80(6):915-21.

** Vida VL, Guariento A, Castaldi B, Sambugaro M, Padalino MA, Milanesi O, Stellin G Evolving strategies for preserving thepulmonary valve during early repair of tetralogy of Fallot: mid-term results. Jour ThoracCardiovasc Surg 2013 (IN PRESS)

PV Z-score: -3.6

4 mm6 mm

10 mm

At 2D: 5.5 mm

Z-score= -3.6

8- 10 mm

“In-series” PV balloon dilatation

Additional PV plasty

Additional PV plasty after balloon dilation

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

1) PV leaflets repair 2) PV leaflets “de-lamination” *3) PV leaflets re-suspension

PV plasty:

Aim of the study

To assesseffectiveness, early and mid-termresults of the PVpreservation technique by balloon dilation in pts with TOFmainly focusing on:

1) PV function and growth2) RV function

Controls: patients treated with a standard TA repair (with TAP) during thesame time interval

PatientsJune 2007 – December 2012

69 PATIENTS

+

Reason for PV preservation failure:

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

30Control TA repair

39 PV preservation attempts

- PTFE cusp (n=23)- CorMatrix cusp (n=10)

- Autologous pericardium cusp (n=1)- Pulmonaty homograft cusp (n=1)

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) 0.41Median PV annulus at 2D, mm (range) 6.8 (5.5-8.8) 6 (4-9.5) 0.02Median PV Z-score on 2D, n (%) -2.95 (-0.95 - -4.06) -3.35 (-1.54 - -5.62) 0.03Coronary artery anomalies, n (%) 1 (2.9%) 4 (11.4%) 0.36Median preop trans-cut. O2 sat, n (%) 94 (80-100) 90 (80-100) 0.03Median preop RVOT grad, mmHg (range) 67 (40-87) 70 (55-93) 0.12Median CPB time, min (range) 125 (93-200) 158 (104-237) 0.0001Median 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 temporary junc.tachycardia, n (%) 6 (17.6%) 1 (2.9%) 0.04Postop. LOS, n (%) 3 (8.8%) 3 (8.6%) 0.99Median ICU stay, days (range) 3 (1-8) 3 (1-12) 0.46Median hospitalization, days (range) 10 (7-43) 10.5 (7-31) 0.7

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(pts with FU >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-value 0,018)

Echocardiographic evaluation (at discharge)

NEW DILATATION TECHNIQUE

Grade 1: MILD

Grade 2: MODERATE

Grade 3: SEVERE

«CLASSIC» TAP TECHNIQUE

Pulmonary insufficiency

(p-value < 0,0001)

Echocardiographic evaluation (at follow-up)

NEW DILATATION TECHNIQUE

Grade 1: MILD

Grade 2: MODERATE

Grade 3: SEVERE

«CLASSIC» TAP TECHNIQUE

Pulmonary insufficiencyFOLLOW-UP:

432 days(range 189 – 1940)

(p-value < 0,0001)

p=0.00355% (42-70) 50% (40-63)

PV dilatation group Standard TA group

Echocardiographic evaluation at follow-upRV 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.

Limitations

- Retrospective evaluation

- Mid-termfollow-up

- RV function assessment by 2D echo

- Still on a learning curve phase

Conclusions

• PV function can be preservedby balloon

dilatation during early TOF repair.

• Middle term results of valve-sparing

techniques are encouraging.

Conclusions

Preservation of PVanatomical and functional integrity, together

with a transatrial/transpulmonary early repair, seems to be an

encouraging approach for better preserving the:

RIGHT VENTRICULAR FUNCTION

IN THE LONG TERM

THANKS FOR YOUR ATTENTION

Anatomical Theatre – Palazzo Bo - Padova Galileo Galilei’s chair– Palazzo Bo - Padova

PVR and RV function at follow-upLinear regression analyis

PV anatomy

PV dilation group(n=34)

Standars TA group(n=35)

p value

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

0.001Bicuspid (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)

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

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

“In -series” PV balloon dilationn=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 plastyn=4 pts

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

Complex PV plastyn=14 pts

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

p=0.01

E-E2)(PV Z-score -3 - -3.5)PV leaflet’s de-laminationand re-suspension plasty

Our current PV preservationsurgical protocol

A-C) common pathway including“protective” commissurotomy andballoon dilation of the pulmonary valveannulus.

D-D1)(PV Z-score≥ -3)Additional PV plasty, forrepairing accidental leaflet’stears during balloon dilation,and leaflet’s re-suspension.

F)(PV Z-score -3.5 - -4)Additional PV leaflets’spatch augmentation andre-suspension plasty.