ATS
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

This Article
Right arrow Abstract Freely available
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to Personal Folders
Right arrow Download to citation manager
Right arrow Author home page(s):
Thierry A. Folliguet
François Laborde
Marc R. de Leval
Pascal Vouhé
Right arrow Permission Requests
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Le Bret, E.
Right arrow Articles by Vouhé, P.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Le Bret, E.
Right arrow Articles by Vouhé, P.
Related Collections
Right arrow Congenital - acyanotic

Ann Thorac Surg 2001;72:1358-1361
© 2001 The Society of Thoracic Surgeons

Original article: cardiovascular

A new percutaneously adjustable, thoracoscopically implantable, pulmonary artery banding: an experimental study

Emmanuel Le Bret, MDa, Philipp Bonhoeffer, MDb, Thierry A. Folliguet, MDa, Daniel Sidi, MDb, François Laborde, MDa, Marc R. de Leval, MDc, Pascal Vouhé, MDb

a Institut Mutualiste Montsouris, Paris, France
b Hôpital Necker-Enfants Malades, Paris, France
c Great Ormond Street Hospital for Children NHS Trust, London, England, United Kingdom

Accepted for publication May 30, 2001.

Address reprint requests to Dr Le Bret, Departement Cardio-Vasculaire, L’Institut Mutualiste Montsouris, 42 Blvd Jourdan 75014 Paris, France
e-mail: emmanuel.lebret{at}imm.fr


   Abstract
Top
 Abstract
Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Background. In patients who undergo left ventricular retraining, multiple reoperations are often necessary to adjust the pulmonary artery banding. The availability of a percutaneously adjustable band would be very useful.

Methods. Ten lambs (10 to 25 kg) underwent pulmonary artery banding using a new device, 7 by thoracotomy and 3 by thoracoscopy. The possibility of percutaneously adjusting the band was evaluated immediately after operation in 10 animals and at 3 months in 8 animals.

Results. One death occurred on the day of the procedure from displacement of the device and another death was from infection. Immediate hemodynamic studies proved the feasibility of increasing right ventricular afterload in a precise and reversible way. After 3 months the band could still be precisely loosened or tightened in all but 1 animal. Autopsy revealed that all the devices were in the correct position and no fibrosis or adhesions were present around the devices, and there was no residual stenosis noted on the pulmonary artery.

Conclusions. This new device may be a valuable alternative to the repeated pulmonary artery banding needed for ventricular preparation.


   Introduction
Top
 Abstract
 Introduction
Material and methods
 Results
 Comment
 Acknowledgments
 References
 
In children with congenital heart disease and increased pulmonary blood flow, pulmonary artery banding remains a useful palliative procedure when the risk of primary repair is unacceptably high or when a corrective surgical procedure is not feasible. Furthermore, there is a renewed interest for pulmonary artery banding to retrain left ventricles before a staged arterial switch operation in some forms of transposition of the great arteries [1–7]. Optimum constriction can be difficult to obtain by conventional techniques, and the ideal degree of banding may vary with time so that readjustments may become necessary after the initial procedure. In an effort to reach this goal we developed a new device that can be implanted by conventional or thoracoscopic operation, and can be percutaneously adjustable without any reintervention.


   Material and methods
Top
 Abstract
 Introduction
 Material and methods
Results
 Comment
 Acknowledgments
 References
 
Description of the device
The device (NuMED Inc, Hopkinton, NY) consists of a noncompliant polyamide balloon that can be snared around the pulmonary artery. One extremity of the balloon is connected by a catheter to a subcutaneous chamber, similar to those used in clinical practice, and the other is pulled into a sleeve to achieve a circular band (Fig 1). Inflation of the balloon is achieved by injection of saline solution through the subcutaneous chamber. When saline is injected, only the internal diameter of the balloon changes because the outer surface is not compliant; therefore, the balloon cannot compress the neighboring structures and does not require further structural support.



View larger version (146K):
[in this window]
[in a new window]
  		Fig 1. The adjustable pulmonary artery band. The device consists of a noncompliant balloon connected by a catheter to a subcutaneous chamber.

 
Implantation of the pulmonary artery banding device
An experimental study was performed to evaluate short-term and midterm effectiveness of this balloon band. Ten lambs ranging from 10 to 25 kg were premedicated by 150 mg of Acepromazine (Calmivet; Vetoquinol SA, Lure, France) 30 minutes before operation. Anesthesia was induced with propofol (Diprivan, Zeneca, Rueil, France) (8 mg/kg) and maintained with a mixture of isoflurane (Forène; Abbot, Rungis, France) (1% to 2%) and oxygen. Animals were ventilated through a single lumen tube at 10 mL/kg with a volume-cycled ventilator at 20 breaths per minute and FiO2 60%. Continuous electrocardiographic tracing was monitored. Anesthetized animals were positioned on the right side as for a left lateral thoracotomy.

Millar catheters were placed into the left carotid artery and through the jugular vein to continuously record the arterial and the right ventricular pressures. Both catheters were connected to a software IOX (EMKA, Paris, France). In 7 lambs a conventional left lateral thoracotomy through the fourth intercostal space was performed. The pericardium was opened anterior and parallel to the left phrenic nerve. The balloon band was wrapped around the main pulmonary trunk without constricting the vessel. The subcutaneous chamber was then placed and fixed before skin closure.

In 3 animals, the pulmonary artery banding was performed by a videothoracoscopic approach. Three entry ports (5 mm) were necessary for the surgical instruments: one into the seventh intercostal space on the axillary line for the camera, and the two others into the fourth and fifth intercostal space 2 cm in front of the scapula. The camera was first inserted. Then the pulmonary trunk was identified through the pericardium, and the two other ports were placed near the parietal pleura over the pulmonary artery. The pericardium was grasped with an instrument and then opened and partially resected with scissors. The pulmonary artery trunk was separated from the aorta, first with an electrocautery hook and then with a right angled dissector. The device was then wrapped around the trunk (Fig 2). The pericardium was left open, and a chest tube was introduced under visual control through the first port.



View larger version (76K):
[in this window]
[in a new window]
  		Fig 2. Adjustable pulmonary artery banding by thoracoscopy. The balloon is snared around the pulmonary artery (PA) and the inflation of the balloon is achieved by injection through the subcutaneous chamber.

 
Adjustment of the pulmonary artery banding
The degree of pulmonary constriction was adjusted by injecting or removing saline from the balloon through the subcutaneous chamber under constant monitoring of the systemic arterial, right ventricular, and pulmonary arterial pressures distal to the band. All measurements were made on the anesthetized animal with the chest closed. At the end of the procedure, the balloon was inflated to obtain a systolic right ventricular pressure 10 mm Hg higher than the base line value.

Three-month evaluation
After 3 months, animals were reanesthetized for repeat evaluation. Millar catheters were repositioned in the same way as the first experiment. A right ventricular angiogram was performed to access the position of the band before the animals were sacrificed.

Animals received humane care in compliance with the European regulations for animal experimentation. The protocol was reviewed and approved by the Ethical Committee, Centre d’Etude et de Recherche Appliquée (CERA), Paris, France [8].


   Results
Top
 Abstract
 Introduction
 Material and methods
 Results
Comment
 Acknowledgments
 References
 
Early operative mortality results
No complications were noted during the procedure in the thoracoscopic group. One death occurred in the thoracotomy group soon after extubation of the animal. The postmortem examination revealed that the balloon had moved and was pulling and obstructing the pulmonary trunk because of poor fixation of the catheter.

Early hemodynamic results
Figure 3 shows the variations of the mean systemic pressure, the mean pulmonary pressure distal to the band, and the systolic right ventricular pressure during inflation. At the beginning of inflation, the systemic pressure remained stable during an increase of right ventricular pressure. With an increase in right ventricular pressure of 50%, the systemic pressure and the pulmonary pressure remained constant. More than this level of obstruction, first the systemic pressure and then the right ventricular pressure fell, followed by rapid cardiac failure.



View larger version (26K):
[in this window]
[in a new window]
  		Fig 3. Evolution of the mean systemic pressure, mean pulmonary artery pressure, and systolic right ventricular pressure during inflation of the balloon.

 
At this step, deflation of the balloon was achieved and the band was immediately released. The hemodynamic data returned to normal values within a few seconds. Figure 4 shows the evolution changes in right ventricular and systemic pressures during balloon deflation.



View larger version (18K):
[in this window]
[in a new window]
  		Fig 4. Evolution of the mean arterial pressure and systolic right ventricular pressure during deflation of the balloon.

 
Three-month morbidity results
There were two septic complications. One was a superficial infection that responded to local treatment, but the other was a systemic infection followed by death of the animal 1 month later.

Three-month band location results
The position of the band was explored in all animals by angiography before sacrifice. The band was in the correct position without distortion of the pulmonary bifurcation in all animals.

Ability to inflate and deflate after 3 months
In all lambs but 1, it was possible to adjust the degree of pulmonary constriction after 3 months and obtain complete deflation with no residual gradient. In 1 lamb, it was not possible to inflate the balloon because of partial disconnection of the subcutaneous chamber from the catheter.

Site of implantation after 3 months
During autopsy after 3 months, there were no adhesions present around the balloon, and dissection of the device for removal was easily performed. There was no residual stenosis on the pulmonary artery from fibrosis. No differences were noted between animals operated by thoracoscopy or by thoracotomy.


   Comment
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
Acknowledgments
 References
 
Since the original description of pulmonary artery banding by Muller and Dammann [9] in 1952, the indications for this intervention have changed progressively from simple cases of left to right shunt at the ventricular level to more complex conditions, particularly for left ventricular retraining. There are three conditions in which left ventricular retraining can be useful: (1) late presentation of transposition of the great arteries (after 2 months of age) in preparation for a switch operation; (2) congenitally corrected transposition of the great arteries with intact ventricular septum before a double switch procedure; and (3) conversion of an atrial switch (Mustard or Senning) into an arterial switch for late right ventricular failure. Usually difficulty in achieving optimal left ventricular overload with conventional banding is related to poorly tolerated, sudden hemodynamic changes. Furthermore, preparatory banding can produce with time a variable response partly related to age but, perhaps more importantly, to the level of ventricular dysfunction. The experience with arterial switch operation after left ventricular retraining in adults or adolescents shows that several operations are usually required before adequate left ventricular preparation was achieved [10]. Therefore, the need for an adjustable band has long been recognized, and several investigators have developed a variety of adjustable pulmonary artery bands [11–16] but few of them have found clinical acceptance.

The present experimental study shows that this new device is simple and safe. It can be snared around the pulmonary trunk even by a thoracoscopic approach. The outflow tract obstruction of the right ventricle can be very precisely adjusted without any reintervention, just by adding or removing a small volume of saline from the subcutaneous chamber. It can be loosened immediately in case of poor tolerance.

The midterm results after 3 months showed that fibrosis and adhesions were absent around the band and that there was no residual stenosis of the pulmonary artery. In addition, the band had not moved and was still well positioned without compressing the pulmonary branches.

A few problems were pointed out during this study. One death occurred just after extubation. The cause of death was directly related to the device, which had moved during awakening of the animal and was pulling the pulmonary trunk, creating a complete obstruction of the right ventricular outflow tract. This accident did not occur again after two modifications in the procedure were made: (1) the sleeves were designed shorter and more flexible, and (2) the sleeves were fixed to the intercostal muscle in order to maintain a constant distance from the pulmonary artery.

Two infections were noted at the beginning of the studies. In both animals the device had been sterilized by immersion into a Glutaraldehyde (Phagocide D; Phagogene, Carros, France) solution and probably the sterilization or rinsing was not adequate. Subsequent sterilizations were done using STERRAD (Sterrad 100S; Johnson and Johnson Medical, Issy les Moulineaux, France) and no more infections were noted.

In 1 lamb, it was not possible after 3 months to obtain control of the obstruction by injection through the chamber because of a leak in the connection between the chamber and the catheter. This part of the device was reinforced and the connection is now secure.

After these modifications, the device appears simple and safe for adjustable pulmonary artery banding. Use of thoracoscopy was not the real aim of this study, but this technique in a patient without a previous operation may produce fewer adhesions and make dissection for the switch operation easier.

In conclusion, this new device for pulmonary artery banding is easily implantable even by thoracoscopy, and precise bidirectional percutaneous adjustment can be performed up to 3 months after implantation. Long-term evaluation is necessary and potential clinical applications must be better defined.


   Acknowledgments
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
References
 
This work was supported by a grant from the Fondation de l’Avenir pour la recherche médical appliquée. Special thanks to N. Borenstein, P. Daniel, A. G. Orange, and H. Flaouter from the Centre d’Etude et de Recherche Appliquée (CERA).


   References
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Yacoub M.H., Arensman F.W., Bernhard A., Heintzen P.E., Lange P.E., Radley-Smith R. Preparation of the left ventricle for anatomical correction of transposition of the great arteries. Pediatr Cardiol 1983;4(Suppl 1):83-92.
  2. Boutin C.H., Jonas R.A., Sanders S.P., Wernovsky G., Mone S.M., Colan S.D. Rapid two-stage arterial switch operation. Acquisition of left ventricular mass after pulmonary artery banding in infants with TGA. Circulation 1994;90:1304-1309.[Abstract/Free Full Text]
  3. Boutin C.H., Wernovsky G., Sanders S.P., Jonas R.A., Castaneda A.R., Colan S.D. Rapid two-stage arterial switch operation. Evaluation of left ventricular systolic mechanics late after an acute pressure overload stimulus in infancy. Circulation 1994;90:1294-1303.[Abstract/Free Full Text]
  4. Ilbawi M.N., Idriss F.S., DeLeon S.Y., et al. Preparation of the left ventricle for anatomical correction in patients with simple transposition of the great arteries. J Thorac Cardiovasc Surg 1987;94:87-94.[Abstract]
  5. Hisatomi K., Sato T., Isomura T., et al. Rapid two-stage arterial switch operation. Eur J Cardiothorac Surg 1995;9:670.[Medline]
  6. Jonas R.A., Giglia T.M., Sanders S.P., et al. Rapid, two stage arterial switch for transposition of the great arteries and intact ventricular septum beyond the neonatal period. Circulation 1989;80(Suppl I):I203-I208.
  7. Mee R.B.B. Severe right ventricular failure after Mustard or Senning operation. Two stage repair: pulmonary artery banding and switch. J Thorac Cardiovasc Surg 1986;92:385-390.[Abstract]
  8. Convention Européenne sur la protection des animaux vertébrés utilisés à des fins expérimentales ou à d’autres fins scientifiques. Journal Officiel des Communautés Européennes. L222/29–37 August 1999:24.
  9. Muller W., Dammann J. The treatment of certain congenital malformations of the heart by the creation of pulmonary stenosis to reduce pulmonary hypertension and excessive pulmonary blood flow: a preliminary report. Surg Gynecol Obstet 1952;95:213-219.[Medline]
  10. Padalino M.A., Stellin G., Brawn W.J., et al. Arterial switch operation after left ventricular retraining in the adult. Ann Thorac Surg 2000;70:1753-1757.[Abstract/Free Full Text]
  11. Muraoka R., Yokota M., Aoshima M., et al. Extrathoracically adjustable pulmonary artery banding. J Thorac Cardiovasc Surg 1983;86:582-586.[Abstract]
  12. Solis E., Heck C., Seward J., Kaye M. Percutaneously adjustable pulmonary artery banding. Ann Thorac Surg 1986;41:65-69.[Abstract]
  13. Vince D., Culham G., Taylor G. The development of a prosthesis for banding of an artery capable of staged dilatation by intraluminal balloon: an experimental investigation. J Thorac Cardiovasc Surg 1987;93:628-635.[Abstract]
  14. Higashidate M., Beppu T., Imai Y., Kurosawa H. Percutaneously adjustable pulmonary artery band. J Thorac Cardiovasc Surg 1989;97:864-869.[Abstract]
  15. Ahmadi A., Rein J., Hellberg K., Bastanier C.H. Percutaneously adjustable pulmonary artery band. Ann Thorac Surg 1995;60:S520-S522.
  16. Schlensak C.H., Sarai K., Gildein H.P., Beyersdorf F. Pulmonary artery banding with a novel percutaneously bidirectionnally adjustable device. Eur J Cardiothorac Surg 1997;12:931-933.[Abstract]



This article has been cited by other articles:


Home page
 J. Thorac. Cardiovasc. Surg.Home page
D. W. Quinn, S. P. McGuirk, C. Metha, P. Nightingale, J. V. de Giovanni, R. Dhillon, P. Miller, O. Stumper, J. G. Wright, D. J. Barron, et al.
The morphologic left ventricle that requires training by means of pulmonary artery banding before the double-switch procedure for congenitally corrected transposition of the great arteries is at risk of late dysfunction.
J. Thorac. Cardiovasc. Surg., May 1, 2008; 135(5): 1137 - 1144.e2.
[Abstract] [Full Text] [PDF]

Home page
 Ann. Thorac. Surg.Home page
S. Talwar, S. K. Choudhary, A. Mathur, B. Airan, R. Singh, R. Juneja, S. S. Kothari, and A. Saxena
Changing Outcomes of Pulmonary Artery Banding With the Percutaneously Adjustable Pulmonary Artery Band
Ann. Thorac. Surg., February 1, 2008; 85(2): 593 - 598.
[Abstract] [Full Text] [PDF]

Home page
 J. Thorac. Cardiovasc. Surg.Home page
A new technique of percutaneously adjustable pulmonary artery banding.
J. Thorac. Cardiovasc. Surg., March 1, 2006; 131(3): 621 - 624.


Home page
 Ann. Thorac. Surg.Home page
E. Le Bret, J. M. Lupoglazoff, N. Borenstein, G. Fromont, F. Laborde, J. Bachet, and P. Vouhe
Cardiac "Fitness" Training: An Experimental Comparative Study of Three Methods of Pulmonary Artery Banding for Ventricular Training
Ann. Thorac. Surg., January 1, 2005; 79(1): 198 - 203.
[Abstract] [Full Text] [PDF]

Home page
 CirculationHome page
D. Bonnet, A. F. Corno, D. Sidi, N. Sekarski, M. Beghetti, I. Schulze-Neick, M. Fasnacht, E. Le Bret, A. Kalangos, P. R. Vouhe, et al.
Early Clinical Results of the Telemetric Adjustable Pulmonary Artery Banding FloWatch-PAB
Circulation, September 14, 2004; 110(11_suppl_1): II-158 - II-163.
[Abstract] [Full Text] [PDF]

Home page
 J Am Coll CardiolHome page
N. Sekarski, P. Fridez, A. F. Corno, L. K. von Segesser, and E. J. Meijboom
Doppler-guided regulation of a telemetrically operated adjustable pulmonary banding system
J. Am. Coll. Cardiol., September 1, 2004; 44(5): 1087 - 1094.
[Abstract] [Full Text] [PDF]

Home page
 J. Thorac. Cardiovasc. Surg.Home page
A. F. Corno, D. Bonnet, N. Sekarski, D. Sidi, P. Vouhe, and L. K. von Segesser
Remote control of pulmonary blood flow: initial clinical experience
J. Thorac. Cardiovasc. Surg., December 1, 2003; 126(6): 1775 - 1780.
[Abstract] [Full Text] [PDF]

Home page
 Eur. J. Cardiothorac. Surg.Home page
A. F. Corno, N. Sekarski, M.-A. Bernath, M. Payot, P. Tozzi, and L. K. von Segesser
Pulmonary artery banding: long-term telemetric adjustment
Eur. J. Cardiothorac. Surg., March 1, 2003; 23(3): 317 - 322.
[Abstract] [Full Text] [PDF]

Home page
 J. Thorac. Cardiovasc. Surg.Home page
B. P. J. Leeuwenburgh, P. H. Schoof, P. Steendijk, J. Baan, W. J. Mooi, and W. A. Helbing
Chronic and adjustable pulmonary artery banding
J. Thorac. Cardiovasc. Surg., February 1, 2003; 125(2): 231 - 237.
[Abstract] [Full Text] [PDF]

Home page
 Ann. Thorac. Surg.Home page
H. Takayama, A. Sekiguchi, M. Chikada, M. Noma, A. Ishizawa, and S. Takamoto
Mortality of pulmonary artery banding in the current era: recent mortality of PA banding
Ann. Thorac. Surg., October 1, 2002; 74(4): 1219 - 1224.
[Abstract] [Full Text] [PDF]

Home page
 ICVTSHome page
A. F. Corno, P. Fridez, L. K. von Segesser, and N. Stergiopulos
A new implantable device for telemetric control of pulmonary blood flow
Interactive CardioVascular and Thoracic Surgery, September 1, 2002; 1(1): 46 - 49.
[Abstract] [Full Text] [PDF]

This Article
Right arrow Abstract Freely available
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to Personal Folders
Right arrow Download to citation manager
Right arrow Author home page(s):
Thierry A. Folliguet
François Laborde
Marc R. de Leval
Pascal Vouhé
Right arrow Permission Requests
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Le Bret, E.
Right arrow Articles by Vouhé, P.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Le Bret, E.
Right arrow Articles by Vouhé, P.
Related Collections
Right arrow Congenital - acyanotic

HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
ANN THORAC SURG ASIAN CARDIOVASC THORAC ANN EUR J CARDIOTHORAC SURG
J THORAC CARDIOVASC SURG ICVTS ALL CTSNet JOURNALS