Interventional Catheterization
THERAPEUTIC INTERVENTION DURING CARDIAC CATHETERIZATION
(Interventional Cardiac Catheterization)
William Berman, Jr., M.D.
HISTORY
Prior to the mid-1940’s, surgery was not an option for infants and children with
congenital heart disease. Development of cardio-pulmonary bypass in the mid-
50s made intracardiac surgical repairs an option. In 1961, Dr. John Kirklin at the
Mayo clinic performed the first VSD repair in an infant. Accurate pre-operative
diagnosis became essential for optimal surgical results. Beginning in the 1960’s,
prior to modern 2D echocardiography, cardiac catheterization was used in children
to provide accurate anatomic and hemodynamic diagnoses prior to surgery. Until
relatively recently, catheterization was a diagnostic tool, not a treatment modality.
That changed when Dr. William Rashkind at the Children’s Hospital of Philadelphia
performed a balloon atrial septostomy in an infant with transposition of the great
vessels. That procedure ushered in the age of therapeutic, or interventional,
cardiac catheterizations. These are procedures that provide treatment in addition
to invasive diagnosis. In 1982, Dr. Jean Kan at Johns Hopkins Hospital in
Baltimore performed the first balloon pulmonary valveplasty in a child with
pulmonic stenosis. During the intervening 24 years, the field of interventional
cardiac catheterization has grown in scope and complexity. At most institutions
with comprehensive pediatric cardiology practices, including our own, interventional
catheterization procedures outnumber purely diagnostic catheterizations. In many
programs, the number of therapeutic catheterizations approximates or exceeds
the number of cardiac surgical procedures performed in children. I would like to
review the experience of Pediatric Cardiology Associates (PCA) in this area and
indicate the direction of our growth.
Our interventional program began in 1985 when PCA physicians practiced at the
University Hospital. The vast majority of our experience has occurred at
Presbyterian Hospital where we have practiced since 1993. Currently, Drs. Bill
Berman and Brad Raisher perform all our interventional procedures.
PHILOSOPHY
We reserve therapeutic cardiac catheterization for cases
in which the anticipated outcome will be equal to or better,
and the risk will be equal to or less, than surgical
intervention.
OUR DATA
Through 2007, we have performed a total of 1098 interventional cardiac
catheterizations. Early during our experience, 20-30 cases were performed
annually. During the past several years, we have averaged approximately 90
interventional catheterizations per year in a program where approximately 130
pediatric cardiac surgeries are performed annually. Therapeutic catheterizations
now exceed diagnostic procedures performed in the catheterization laboratory.
CASE MIX
Early in our experience, dilatation of stenotic pulmonary and aortic valves with
balloon tipped catheters accounted for the majority of interventions. As the
discipline of interventional catheterization evolved, procedures were developed to
close communications such as the patent ductus arteriosus (PDA) and atrial septal
defect (ASD) with implantable devices passed through a cardiac catheter. More
recently, stents, constructed of expandable metal materials, have been used to
enlarge stenotic vessels including branch pulmonary stenosis and aortic
coarctation. Accordingly, the kinds of lesions treated in the catheterization
laboratory have changed. In 2007, 56% of cases involved implantation of a device
(ASD/PFO device, coil or stent). Whereas no PDA’s were closed at catheterization
prior to the mid-1990’s and no ASD’s were closed prior to the late 1990’s, those
2 procedures alone accounted for over 50% of our interventions in 2007.
AGE MIX
As the spectrum of conditions treated has changed with time, so has the age at
which we treat our patients. During our initial experience, predominantly infants
and children were treated during interventional catheterization. Currently, with the
availability of implantable devices and stents, more adults undergo intervention in
the “pediatric catheterization laboratory”. In 2007, 25% of patients who
underwent an interventional procedure were over 18 years old.
REPRESENTATIVE CASES IN 2007
Pulm. valve, conduit, RV outflow stenosis 7
Peripheral pulmonary stenosis 10
Aortic valve stenosis and coarctation 8 4
Atrial septal defect/patent foramen ovale 22/3
Patent ductus arteriosus/coil embolization 18/2
FURTURE DIRECTIONS
THE PATENT FORAMEN OVALE (PFO)
Currently, trans-catheter closure of the PFO is restricted by the FDA to a very
narrow spectrum of patients, namely individuals who sustain a paradoxical
embolus, have a patent foramen ovale with right to left shunting on trans-
esophageal echocardiographic study, and who sustain a subsequent embolic
episode or episodes while on anticoagulation with coumadin or aspirin and
clopidogrel. At this time, a single occult embolic stroke or myocardial infarction,
even with a confirmed PFO and right to left atrial level shunting, does not qualify a
patient to receive a trans-catheter closure device (even though surgery is an
option). Controlled trials are under way to test the safety and efficacy of the
trans-catheter approach, compared to historical surgical controls and patients
undergoing systemic anticoagulation with coumadin. Moreover, the PFO
increasingly is implicated in other conditions, most notably migraine headaches and
decompression illness. We anticipate our adult caseload will increase if and when
the trans-catheter closure device is approved for a broader spectrum of subjects.
VALVEPLASTIES AND STENT IMPLANTATIONS
Major recent advances have occurred in the equipment available to the pediatric
interventionalist. Catheters, sheaths and balloon dilatation devices have all been
downsized for application in neonates and small infants. Some investigators have
applied these devices to the fetal setting, where narrowed vessels or valves are
addressed in utero. Constraints that once existed related to vessel damage and
size limitation no longer are a major concern. These equipment options broaden
our scope of practice in the interventional laboratory.
HYBRID INTERVENTIONS
Currently, trans-catheter devices are being tested in selected centers for VSD
closure, palliation of infants with hypoplastic left heart, and completion of the
Fontan procedure for treatment of patients with a single functional ventricle. In
some centers, especially Chicago Children’s Hospital, Miami Children’s Hospital, and
Columbus Children’s Hospital, the practicality of hybrid procedures involving both
surgery and therapeutic catheterization is being tested. One such procedure is the
trans-cardiac closure of large muscular VSD’s, using an open chest approach
without cardiopulmonary bypass. Initial results are very impressive. The
cooperative efforts of surgeons and interventionalists during a single case is both
sensible and exciting as a future direction of the discipline.
TRANS-CATHETER VALVE REPLACEMENT
Dr. Philip Bonhoffer, initially from Germany but now working in London, has led the
development and implementation of tissue valves placed in the pulmonary position
by a trans-catheter approach. The valves, which are large venous valves obtained
from cows, are mounted inside expandable stents. The system has been refined
to the point that a clinical trial is underway in Great Britain to test the valves’
safety, effectiveness and durability. Again, initial results are promising.
BENEFITS OF INTERVENTIONAL CATHETERIZATION IN CHILDREN
The main benefit of interventional catheterization is that it obviates the need for
cardiac surgery in many instances. Of the 1100 interventional catheterizations
performed by our physicians, surgery was avoided entirely in an estimated 2/3 of
patients. The cost of an interventional catheterization is 1/3 to 1/2 that of
surgery. The vast majority of patients go home the same day, without the need
for hospitalization. While the overall mortality/morbidity risks are probably only
slightly less than for surgery, interventions are nearly painless, leave no scars and
don't require blood transfusions. To insure the highest quality and best
outcomes, the American Heart Association, the American College of Cardiology and
the Society of Cardiac Angiography and Interventions (SCAI) have stated (in
separate guidelines) that interventional procedures in infants and children must be
performed only at facilities where pediatric cardiology surgical back-up is
immediately available, and the volume of cases is high enough to permit
consistency and excellence. At Presbyterian Hospital, we meet or exceed all
published guidelines for a catheter-based interventional program.
(Interventional Cardiac Catheterization)
William Berman, Jr., M.D.
HISTORY
Prior to the mid-1940’s, surgery was not an option for infants and children with
congenital heart disease. Development of cardio-pulmonary bypass in the mid-
50s made intracardiac surgical repairs an option. In 1961, Dr. John Kirklin at the
Mayo clinic performed the first VSD repair in an infant. Accurate pre-operative
diagnosis became essential for optimal surgical results. Beginning in the 1960’s,
prior to modern 2D echocardiography, cardiac catheterization was used in children
to provide accurate anatomic and hemodynamic diagnoses prior to surgery. Until
relatively recently, catheterization was a diagnostic tool, not a treatment modality.
That changed when Dr. William Rashkind at the Children’s Hospital of Philadelphia
performed a balloon atrial septostomy in an infant with transposition of the great
vessels. That procedure ushered in the age of therapeutic, or interventional,
cardiac catheterizations. These are procedures that provide treatment in addition
to invasive diagnosis. In 1982, Dr. Jean Kan at Johns Hopkins Hospital in
Baltimore performed the first balloon pulmonary valveplasty in a child with
pulmonic stenosis. During the intervening 24 years, the field of interventional
cardiac catheterization has grown in scope and complexity. At most institutions
with comprehensive pediatric cardiology practices, including our own, interventional
catheterization procedures outnumber purely diagnostic catheterizations. In many
programs, the number of therapeutic catheterizations approximates or exceeds
the number of cardiac surgical procedures performed in children. I would like to
review the experience of Pediatric Cardiology Associates (PCA) in this area and
indicate the direction of our growth.
Our interventional program began in 1985 when PCA physicians practiced at the
University Hospital. The vast majority of our experience has occurred at
Presbyterian Hospital where we have practiced since 1993. Currently, Drs. Bill
Berman and Brad Raisher perform all our interventional procedures.
PHILOSOPHY
We reserve therapeutic cardiac catheterization for cases
in which the anticipated outcome will be equal to or better,
and the risk will be equal to or less, than surgical
intervention.
OUR DATA
Through 2007, we have performed a total of 1098 interventional cardiac
catheterizations. Early during our experience, 20-30 cases were performed
annually. During the past several years, we have averaged approximately 90
interventional catheterizations per year in a program where approximately 130
pediatric cardiac surgeries are performed annually. Therapeutic catheterizations
now exceed diagnostic procedures performed in the catheterization laboratory.
CASE MIX
Early in our experience, dilatation of stenotic pulmonary and aortic valves with
balloon tipped catheters accounted for the majority of interventions. As the
discipline of interventional catheterization evolved, procedures were developed to
close communications such as the patent ductus arteriosus (PDA) and atrial septal
defect (ASD) with implantable devices passed through a cardiac catheter. More
recently, stents, constructed of expandable metal materials, have been used to
enlarge stenotic vessels including branch pulmonary stenosis and aortic
coarctation. Accordingly, the kinds of lesions treated in the catheterization
laboratory have changed. In 2007, 56% of cases involved implantation of a device
(ASD/PFO device, coil or stent). Whereas no PDA’s were closed at catheterization
prior to the mid-1990’s and no ASD’s were closed prior to the late 1990’s, those
2 procedures alone accounted for over 50% of our interventions in 2007.
AGE MIX
As the spectrum of conditions treated has changed with time, so has the age at
which we treat our patients. During our initial experience, predominantly infants
and children were treated during interventional catheterization. Currently, with the
availability of implantable devices and stents, more adults undergo intervention in
the “pediatric catheterization laboratory”. In 2007, 25% of patients who
underwent an interventional procedure were over 18 years old.
REPRESENTATIVE CASES IN 2007
Pulm. valve, conduit, RV outflow stenosis 7
Peripheral pulmonary stenosis 10
Aortic valve stenosis and coarctation 8 4
Atrial septal defect/patent foramen ovale 22/3
Patent ductus arteriosus/coil embolization 18/2
FURTURE DIRECTIONS
THE PATENT FORAMEN OVALE (PFO)
Currently, trans-catheter closure of the PFO is restricted by the FDA to a very
narrow spectrum of patients, namely individuals who sustain a paradoxical
embolus, have a patent foramen ovale with right to left shunting on trans-
esophageal echocardiographic study, and who sustain a subsequent embolic
episode or episodes while on anticoagulation with coumadin or aspirin and
clopidogrel. At this time, a single occult embolic stroke or myocardial infarction,
even with a confirmed PFO and right to left atrial level shunting, does not qualify a
patient to receive a trans-catheter closure device (even though surgery is an
option). Controlled trials are under way to test the safety and efficacy of the
trans-catheter approach, compared to historical surgical controls and patients
undergoing systemic anticoagulation with coumadin. Moreover, the PFO
increasingly is implicated in other conditions, most notably migraine headaches and
decompression illness. We anticipate our adult caseload will increase if and when
the trans-catheter closure device is approved for a broader spectrum of subjects.
VALVEPLASTIES AND STENT IMPLANTATIONS
Major recent advances have occurred in the equipment available to the pediatric
interventionalist. Catheters, sheaths and balloon dilatation devices have all been
downsized for application in neonates and small infants. Some investigators have
applied these devices to the fetal setting, where narrowed vessels or valves are
addressed in utero. Constraints that once existed related to vessel damage and
size limitation no longer are a major concern. These equipment options broaden
our scope of practice in the interventional laboratory.
HYBRID INTERVENTIONS
Currently, trans-catheter devices are being tested in selected centers for VSD
closure, palliation of infants with hypoplastic left heart, and completion of the
Fontan procedure for treatment of patients with a single functional ventricle. In
some centers, especially Chicago Children’s Hospital, Miami Children’s Hospital, and
Columbus Children’s Hospital, the practicality of hybrid procedures involving both
surgery and therapeutic catheterization is being tested. One such procedure is the
trans-cardiac closure of large muscular VSD’s, using an open chest approach
without cardiopulmonary bypass. Initial results are very impressive. The
cooperative efforts of surgeons and interventionalists during a single case is both
sensible and exciting as a future direction of the discipline.
TRANS-CATHETER VALVE REPLACEMENT
Dr. Philip Bonhoffer, initially from Germany but now working in London, has led the
development and implementation of tissue valves placed in the pulmonary position
by a trans-catheter approach. The valves, which are large venous valves obtained
from cows, are mounted inside expandable stents. The system has been refined
to the point that a clinical trial is underway in Great Britain to test the valves’
safety, effectiveness and durability. Again, initial results are promising.
BENEFITS OF INTERVENTIONAL CATHETERIZATION IN CHILDREN
The main benefit of interventional catheterization is that it obviates the need for
cardiac surgery in many instances. Of the 1100 interventional catheterizations
performed by our physicians, surgery was avoided entirely in an estimated 2/3 of
patients. The cost of an interventional catheterization is 1/3 to 1/2 that of
surgery. The vast majority of patients go home the same day, without the need
for hospitalization. While the overall mortality/morbidity risks are probably only
slightly less than for surgery, interventions are nearly painless, leave no scars and
don't require blood transfusions. To insure the highest quality and best
outcomes, the American Heart Association, the American College of Cardiology and
the Society of Cardiac Angiography and Interventions (SCAI) have stated (in
separate guidelines) that interventional procedures in infants and children must be
performed only at facilities where pediatric cardiology surgical back-up is
immediately available, and the volume of cases is high enough to permit
consistency and excellence. At Presbyterian Hospital, we meet or exceed all
published guidelines for a catheter-based interventional program.
| AMPLATZER® PDA Occluder |
| Atrial septal dilatation |
| AMPLATZER® ASD Occluder |
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| Partially deployed |
| Fully deployed and released from delivery cable |
| PEDIATRIX CARDIOLOGY ASSOCIATES OF NEW MEXICO |