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Results of the Valvuloplasty and Angioplasty of Congenital Anomalies Registry
CONGENITAL
American Journal of’ Cardiology
HEART DISEASE
Results of the Valvuloplasty and Angioplasty of Congenital Anomalies Registry Hugh D. Allen, MD, and Charles E. Mullins, MD
I
n 1983, after the initial studies were reported about the use of balloon dilation to treat various congenital cardiac lesions it became apparent that proper, expedient and safe development of the procedures would require coordination and open communication regarding techniques, complications and feasibility for different congenital cardiac lesions. With this goal, pediatric cardiologists from a few concerned institutions formed the Valvuloplasty and Angioplasty of Congenital Anomalies (VACA) group, which was sponsored by Mansfield Scientific,, Inc. The initial membership included: James Lock, MD Children’s Hospital Medical Boston, Massachusetts; Jean Kan, MD, and Robert Johns Hopkins University, Baltimore, Maryland;
Center, White,
Charles Mullins, MD Texas Children’s Hospital and Baylor College of Medicine, Houston,
MD
Texas;
Paul Stanger, MD University of California at San Francisco, San Francisco, California; Michael Tynan, MD Guy’s Hospital, London,
England;
William Rashkind, MD Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania; Zudhi Lababidi, MD University of Missouri, Columbia, Missouri.
This group met in Boston and agreed to develop a data registry. The registry was kept at Johns Hopkins by Dr. Kan. After the initial meeting, the value of opening the registry to all centers performing significant numbers of such procedures so that their data could be From Columbus Children’s Hospital, Ohio State University, Columbus, Ohio, and Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas. Manuscript received November 16, 1989, and accepted November 28,1989.
772
THE AMERICAN
JOURNAL
OF CARDIOLOGY
VOLUME
65
included became apparent. The following centers were added: Sophia Children’s Hospital, Rotterdam, The Netherlands: lzaak Walton Killam Children’s Hospital, Halifax, Nova Scotia; lstituto Dante Passanese de Cardiologia do Estado, Sao Paolo, Brazil; Children’s Hospital National Medical Center, Washington, DC; University of Indiana, Indianapolis, Indiana; University of Iowa Hospitals and Clinic, Iowa City, Iowa; University of Minnesota Hospital and Clinic, Minneapolis, Minnesota; Children’s Memorial Hospital, Chicago, Illinois; Mott Children’s Hospital, University of Michigan, Ann Arbor, Michigan: Rainbow Babies and Children’s Hospital, Cleveland, Ohio; Hospital for Sick Children, Toronto, Canada; University of Nebraska Medical Center, Omaha, Nebraska; University of Alabama, Birmingham, Alabama; Children’s Hospital, Pittsburgh, Pennsylvania; University of Arizona, Tucson, Arizona; Mt. Sinai Medical Center, New York, New York; Mayo Clinic, Rochester, Minnesota; Yale University School of Medicine, New Haven, Connecticut; Cincinnati Children’s Hospital, Cincinnati, Ohio.
Later that year all participating individuals met in a curtained-off portion of a garage in the Dallas’convention center and the registry was underway. To participate, each center agreed to report all their therapeutic catheterization cases on a standardized form (Appendix) to provide data regarding hemodynamic, morbidity and mortality outcomes. Although discussed, there were no guidelines set down by the Registry concerning indications, equipment or technique for the various dilation procedures. The data forms were forwarded to Dr. Kan who processed and analyzed the results. December 1985 was agreed on to be the prearranged date to close the initial prospective data entry. The data were then further analyzed by subgroups according to separate lesions and these form the basis for the texts of the following 6 articles. The group continues to meet to collect and analyze long-term follow-up information.
\PPENDIX
ssential data must be filled in or data ULMONARY VALVE STENOSIS Prevalvuloplasty: RV pressure RVO pressure PA pressure Art. pressure/ l/minim2 Cardiac output mm Anulus dimension mm Balloon dimension Diameter cm Length Catheter Fr. psi atn Inflation pressure Postvalvuloplasty: RVO pressure Cardiac output lalloon rupture' -yes long. lomplications -..2es (Describe on back)
Registry # Record #
non-day-year Birth Date --- Procedure Date --- Diagnosis: i 2 ')
4CA REGISTRY onfidential Information: Institution Operator Phone #
__ circ. __
no no
!OARCTATION OF AORTA no Operated yes Date of previous surgery Previous surgery: end-to-end anaatomosis -subclavian flap synthetic patch interposition - conduit Preangioplasty: Proximal pressure Distal pressure -IIs7Ik mm Proximal Ao dimension mm Distal Ao dimension Coarct dimension "f l/minim Cardiac output mm Balloon dimension Diameter cm Length Catheter Fr.atm Inflation pressure psi Postangioplasty: Proximal pressure Distal pressure -III?: Coarct dimension mm2 l/min/n Cardiac output no Balloon rupture yes long. circ. no Complications yes (describe on back)
form will be returned for completion. AORTIC VALVE STENOSIS Prevalvuloplasty: LV pressure Ao pressure 74 -Cardiac output l/min/m2 Anulus dimension Diameter mm Length mm Catheter Fr. Inflation pressure psi Postvalvuloplasty: LV pressure / Ao pressure / Cardiac output l/min/n2 Balloon Rupture no yes no Complications yes (Describe .back)
atm
PERIPHERAL PULMONARY ARTERY STENOSIS Vessel dilated L R Previous surgery no yes Surgical date --- Surgical procedure: Tetralogy of Fallot Systemic to pulmonary shunt Reimplantation of pulmonary artery Preangioplasty: Lung scan: Q-RPA % Q-LPA Proximal PA pressure Distal PA pressure LxIj % Dimensicn of vessel proximal mm Dimension of vessel distal mm Dimension of stenosis mm l/min/m' Cardiac output Balloon dimension Diameter nm Length cm Catheter Fr. Inflation pressure psi atm Postangioplasty: Proximal PA pressure Distal PA pressure i mm Dimension of stenosis Cardiac output l/nin/m2 Lung scan: Q-RPA % Q-LPA % Balloon rupture no yes long. circ. no Complications yes (Describe on back
THE AMERICAN
JOURNAL
OF CARDIOLOGY
MARCH
15, 1990
773
1ISCELLANEOUS Structure dilated: Superior baffle Inferior baffle Blalock-Taussig shunt Core-tex shunt Atria1 septal communication Other Pceangioplasty: Proximal pressure Distal pressure 2 l/min/m" Cardiac output Dimension proximal to stenosis mm mm Dimension distal to stenosis Dimension of stenosis mm Balloon dimension Diameter cm Length Catheter E'r. Inflation
pressure
psi
atm
Postangioplasty: Proximal pressure Distal pressure Cardiac output Dimension of stenosis Criteria 4
VACA Registry c/o Jean S. Kan Division of Pediatric Cardiology Brady 5 The Johns Hopkins Hospital 600 North Wolfe Street Baltimore, Maryland ZlZOjj
l/min/m' mm
of effectiveness:
OMPLICATIONS: e.g. bleeding, femoral vessel thrombosis, death
774
Send Form to:
THE AMERICAN
JOURNAL
vessel valve
OF CARDIOLOGY
requiring repair, persistant regurgitation, perforation,
VOLUME
65
arrhythmia, neurologic
event,
American Journal of’ Cardiology
HEART DISEASE
Results of the Valvuloplasty and Angioplasty of Congenital Anomalies Registry Hugh D. Allen, MD, and Charles E. Mullins, MD
I
n 1983, after the initial studies were reported about the use of balloon dilation to treat various congenital cardiac lesions it became apparent that proper, expedient and safe development of the procedures would require coordination and open communication regarding techniques, complications and feasibility for different congenital cardiac lesions. With this goal, pediatric cardiologists from a few concerned institutions formed the Valvuloplasty and Angioplasty of Congenital Anomalies (VACA) group, which was sponsored by Mansfield Scientific,, Inc. The initial membership included: James Lock, MD Children’s Hospital Medical Boston, Massachusetts; Jean Kan, MD, and Robert Johns Hopkins University, Baltimore, Maryland;
Center, White,
Charles Mullins, MD Texas Children’s Hospital and Baylor College of Medicine, Houston,
MD
Texas;
Paul Stanger, MD University of California at San Francisco, San Francisco, California; Michael Tynan, MD Guy’s Hospital, London,
England;
William Rashkind, MD Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania; Zudhi Lababidi, MD University of Missouri, Columbia, Missouri.
This group met in Boston and agreed to develop a data registry. The registry was kept at Johns Hopkins by Dr. Kan. After the initial meeting, the value of opening the registry to all centers performing significant numbers of such procedures so that their data could be From Columbus Children’s Hospital, Ohio State University, Columbus, Ohio, and Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas. Manuscript received November 16, 1989, and accepted November 28,1989.
772
THE AMERICAN
JOURNAL
OF CARDIOLOGY
VOLUME
65
included became apparent. The following centers were added: Sophia Children’s Hospital, Rotterdam, The Netherlands: lzaak Walton Killam Children’s Hospital, Halifax, Nova Scotia; lstituto Dante Passanese de Cardiologia do Estado, Sao Paolo, Brazil; Children’s Hospital National Medical Center, Washington, DC; University of Indiana, Indianapolis, Indiana; University of Iowa Hospitals and Clinic, Iowa City, Iowa; University of Minnesota Hospital and Clinic, Minneapolis, Minnesota; Children’s Memorial Hospital, Chicago, Illinois; Mott Children’s Hospital, University of Michigan, Ann Arbor, Michigan: Rainbow Babies and Children’s Hospital, Cleveland, Ohio; Hospital for Sick Children, Toronto, Canada; University of Nebraska Medical Center, Omaha, Nebraska; University of Alabama, Birmingham, Alabama; Children’s Hospital, Pittsburgh, Pennsylvania; University of Arizona, Tucson, Arizona; Mt. Sinai Medical Center, New York, New York; Mayo Clinic, Rochester, Minnesota; Yale University School of Medicine, New Haven, Connecticut; Cincinnati Children’s Hospital, Cincinnati, Ohio.
Later that year all participating individuals met in a curtained-off portion of a garage in the Dallas’convention center and the registry was underway. To participate, each center agreed to report all their therapeutic catheterization cases on a standardized form (Appendix) to provide data regarding hemodynamic, morbidity and mortality outcomes. Although discussed, there were no guidelines set down by the Registry concerning indications, equipment or technique for the various dilation procedures. The data forms were forwarded to Dr. Kan who processed and analyzed the results. December 1985 was agreed on to be the prearranged date to close the initial prospective data entry. The data were then further analyzed by subgroups according to separate lesions and these form the basis for the texts of the following 6 articles. The group continues to meet to collect and analyze long-term follow-up information.
\PPENDIX
ssential data must be filled in or data ULMONARY VALVE STENOSIS Prevalvuloplasty: RV pressure RVO pressure PA pressure Art. pressure/ l/minim2 Cardiac output mm Anulus dimension mm Balloon dimension Diameter cm Length Catheter Fr. psi atn Inflation pressure Postvalvuloplasty: RVO pressure Cardiac output lalloon rupture' -yes long. lomplications -..2es (Describe on back)
Registry # Record #
non-day-year Birth Date --- Procedure Date --- Diagnosis: i 2 ')
4CA REGISTRY onfidential Information: Institution Operator Phone #
__ circ. __
no no
!OARCTATION OF AORTA no Operated yes Date of previous surgery Previous surgery: end-to-end anaatomosis -subclavian flap synthetic patch interposition - conduit Preangioplasty: Proximal pressure Distal pressure -IIs7Ik mm Proximal Ao dimension mm Distal Ao dimension Coarct dimension "f l/minim Cardiac output mm Balloon dimension Diameter cm Length Catheter Fr.atm Inflation pressure psi Postangioplasty: Proximal pressure Distal pressure -III?: Coarct dimension mm2 l/min/n Cardiac output no Balloon rupture yes long. circ. no Complications yes (describe on back)
form will be returned for completion. AORTIC VALVE STENOSIS Prevalvuloplasty: LV pressure Ao pressure 74 -Cardiac output l/min/m2 Anulus dimension Diameter mm Length mm Catheter Fr. Inflation pressure psi Postvalvuloplasty: LV pressure / Ao pressure / Cardiac output l/min/n2 Balloon Rupture no yes no Complications yes (Describe .back)
atm
PERIPHERAL PULMONARY ARTERY STENOSIS Vessel dilated L R Previous surgery no yes Surgical date --- Surgical procedure: Tetralogy of Fallot Systemic to pulmonary shunt Reimplantation of pulmonary artery Preangioplasty: Lung scan: Q-RPA % Q-LPA Proximal PA pressure Distal PA pressure LxIj % Dimensicn of vessel proximal mm Dimension of vessel distal mm Dimension of stenosis mm l/min/m' Cardiac output Balloon dimension Diameter nm Length cm Catheter Fr. Inflation pressure psi atm Postangioplasty: Proximal PA pressure Distal PA pressure i mm Dimension of stenosis Cardiac output l/nin/m2 Lung scan: Q-RPA % Q-LPA % Balloon rupture no yes long. circ. no Complications yes (Describe on back
THE AMERICAN
JOURNAL
OF CARDIOLOGY
MARCH
15, 1990
773
1ISCELLANEOUS Structure dilated: Superior baffle Inferior baffle Blalock-Taussig shunt Core-tex shunt Atria1 septal communication Other Pceangioplasty: Proximal pressure Distal pressure 2 l/min/m" Cardiac output Dimension proximal to stenosis mm mm Dimension distal to stenosis Dimension of stenosis mm Balloon dimension Diameter cm Length Catheter E'r. Inflation
pressure
psi
atm
Postangioplasty: Proximal pressure Distal pressure Cardiac output Dimension of stenosis Criteria 4
VACA Registry c/o Jean S. Kan Division of Pediatric Cardiology Brady 5 The Johns Hopkins Hospital 600 North Wolfe Street Baltimore, Maryland ZlZOjj
l/min/m' mm
of effectiveness:
OMPLICATIONS: e.g. bleeding, femoral vessel thrombosis, death
774
Send Form to:
THE AMERICAN
JOURNAL
vessel valve
OF CARDIOLOGY
requiring repair, persistant regurgitation, perforation,
VOLUME
65
arrhythmia, neurologic
event,