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Coil Occlusion Versus Conventional Surgical Closure of Patent Ductus Arteriosus
Coil Occlusion Versus Conventional Surgical Closure of Patent Ductus Arteriosus Tajinder P. Singh,
MD,
W. Robert Morrow, MD, Henry L. Walters, and Mehdi Hakimi, MD
urgical correction of patent ductus arteriosus (PDA) is a low-risk procedure in children. HowS ever, it usually involves left lateral thoracotomy, general anesthesia, and chest tube placement after operation. Since the introduction of transcatheter closure of PDA by Porstmann et al,1 various devices have been used to close the ductus by the transcatheter method.2 – 4 Stainless steel Gianturco coils have been used recently to close the small, restrictive PDA.4,5 Previous studies comparing cost-effectiveness of transcatheter PDA closure with surgery have shown conflicting results.6 – 8 In contrast to an earlier study,6 the transcatheter PDA closure is now often done as an outpatient procedure, the use of general anesthesia is uncommon, and the delivery system needed for the coil delivery is less invasive, resulting in reduced blood loss. In this study, therefore, we sought to compare the clinical and cost-effectiveness of transcatheter coil occlusion of hemodynamically restrictive PDA with conventional surgical closure. jjj In a retrospective cohort study, we evaluated the clinical outcome and cost-effectiveness of 2 treatment strategies for children with an isolated restrictive PDA. The first 25 consecutive pediatric patients ¢6 months of age who underwent cardiac catheterization with the intent to coil occlude a restrictive PDA between March 1994 and September 1995 at our institution constituted the coil group. A restrictive PDA was defined as one with the smallest diameter õ2.5 mm and with a transductal echocardiographic gradient of ú50 mm Hg. Between January 1993 and September 1995, 21 patients ¢6 months of age underwent surgery for a restrictive PDA at our institution. These patients were assigned to the surgery group. Among the 21 patients in the surgery group, 14 had division and 7 had ligation of PDA. Patients were admitted on the day of their planned surgery. Surgery was performed under general anesthesia. After recovery from anesthesia, the patients were admitted to a step-down care bed on the cardiac ward, and transferred to a regular bed 24 to 48 hours later. The chest tube, which was placed intraoperatively, was usually removed within 24 hours. From the Division of Pediatric Cardiology, Department of Pediatrics, the Department of Cardiovascular Surgery, and the Department of Finance, Children’s Hospital of Michigan, Wayne State University School of Medicine, Detroit, Michigan. Dr. Morrow’s address is: Division of Cardiology, Arkansas Children’s Hospital, 800 Marshall Street, Little Rock, Arkansas 72202. Manuscript received August 23, 1996; revised manuscript received and accepted January 2, 1997.
MD,
0002-9149/97/$17.00 PII S0002-9149(97)00104-5
All rights reserved.
1283
Wednesday Apr 09 02:13 PM
MBA,
Patients in the coil group underwent transcatheter coil occlusion procedure as outpatients. The procedure was performed using sedation and local anesthesia. The coil was delivered across the PDA by the retrograde method using a 5Fr JB-1 (Cook Inc., Bloomington, Indiana) catheter.5 Closure of the PDA was confirmed by aortic angiography and/or echocardiography. Additional coils were delivered across the PDA as needed to ensure complete closure. Clinical closure of the PDA was defined as disappearance of the PDA murmur. Complete closure of the PDA was defined as absence of clinical and color Doppler evidence of a residual shunt. After the procedure, patients were observed on the ambulatory medical care ward for 6 hours before discharge. The estimated hospital costs for each patient include cost estimates for use of the operating room or cardiac catheterization laboratory as applicable, other patient care–related costs during hospitalization, and costs for medical supplies (e.g., pharmacy) and laboratory investigations. These estimates include both direct (e.g., disposable medical equipment, medications, other supplies) and indirect (e.g. maintenance, personnel, and so forth) costs and are as reported in Health Care Finance Administration (HCFA) form 25529 for our institution. The cost estimates reported in this form are based on a known ratio of the total costs and the total charges from individual hospital departments (different cost ratios for different departments and, therefore, for use of different services) for our institution. Because of the intrinsic difficulty in estimating the professional costs, the maximum allowable physician charges for the physician’s billed services as designated by Blue Cross and Blue Shield of Michigan for each procedure in individual patients were obtained and used in this analysis.6 These charges were proportionate to the unit times needed during the procedure (for anesthesiologist’s services), bundled charges for the procedure (for surgeon’s services), or unbundled charges for the individual components of the procedure performed, such as right and left heart catheterization angiography, coil placement, and so forth (for cardiologist’s services). All costs were corrected to 1995 dollars using the Consumer Price Index for medical care. The coil and the surgery groups were compared for the closure of PDA, length of hospital stay, and estimated costs per patient. For the 2 patients in the coil group who required a second coil procedure (1 patient) or surgical closure due to failure of the coil procedure (1 patient), the costs of the second procedure were added to the costs of the initial cardiac catheterization. A Mann Whitney U–Wilcoxon rank sum W Test was used to compare the costs for the 2
Q1997 by Excerpta Medica, Inc.
/ 2w21 0976 Mp
Nickolas A. Vitale,
EL–AJC (v. 79, no. 9 ’97)
0976
1283
jjj The results of this study demonstrate that transcatheter coil ocSurgery Group (n Å 21) Coil Group (n Å 25) clusion of restrictive PDA is clinically effective with marginally Age (mos) 25 (6–103) 21 (6–114) Weight (kg) 12.9 (5.7–26.5) 10.4 (5.2–30.6) lower success (clinical closure 92% Clinical closure 100% 92% vs 100%) compared with surgery, Complete closure 80% but at significantly lower costs. The Cath. lab. OR costs $2,791 ($1,428–$4,295) $1,259 ($986–$4,273) cost-effectiveness of transcatheter Professional costs $2,458 ($2,314–$2,790) $2,415 ($1,756–$4,542) procedure to close the PDA has Hospital services costs* $3,941 ($2,412–$5,398) $1,260 ($728–$7,748) Total costs $9,104 ($7,492–$11,839) $4,897 ($3,470–$16,563) been previously reported using estimated costs6 or billed charges.7,8 *Cardiac catheterization laboratory costs not included; p õ0.001 for all cost comparisons. Values are expressed as median (range). The use of charges to represent Cath. lab. catheterization laboratory; OR Å operating room. costs to the medical system has been criticized owing to the influence of market forces, historical patterns, and regulatory pressures.10 The esTABLE II Effect of Experience on PDA Closure and Costs of Transcatheter Coil timated costs reported in this study Procedure represent the provider’s perspective Coil Group (1–12) Coil Group (13–24) p Value of costs incurred per patient to close Cath. lab. costs $1,302 ($1,170–$2,093) $1,206 ($1,097–$1,437) 0.02 the PDA. Estimated professional Professional costs $2,415 ($2,415–$2,415) $2,108 ($2,092–$2,399) õ0.001 costs from the perspective of a sinHospital services $1,293 ($1,180–$1,891) $1,172 ($938–$1,517) 0.005 gle third party payer were added to costs* generate estimated total costs for efTotal costs $5,093 ($4,847–$5,852) $4,538 ($4,215–$4,976) õ0.001 fective closure.6 Complete closure 67% 100% — In a comparison of surgical clo*Cardiac catheterization laboratory costs not included. sure with PDA occlusion with the Values are expressed as median (range). Cath. lab. Å catheterization laboratory; PDA Å patent ductus arteriosus. Rashkind device, Gray et al6 reported lower costs for the more effective surgical procedure. The groups and the length of hospital stay. Statistical sig- higher costs for the transcatheter closure in their study resulted from the additional cost of the Rashnificance was defined as a 2-tailed p value õ0.05. The patient characteristics, the success rate for the kind device and longer duration of the procedure, 2 groups of patients, and comparison of estimated with higher costs for the cardiac catheterization labcosts are shown in Table I. Surgery resulted in clin- oratory and higher professional fee. The participaical closure of the PDA in all patients with disap- tion of an anesthesiologist in 30% of these procepearance of the PDA murmur. A successful implan- dures, the need for transfusion in 14% of these tation of coil(s) across the PDA was achieved in 23 patients, and the cost of the Rashkind occluder depatients (92%). The PDA murmur disappeared in all vice all contributed to increased costs for the transthese 23 patients. However, 4 patients in this group catheter procedure. The lower cost for the coil strathad a trivial residual shunt (clinically silent ductus) egy in our study resulted from lower costs for the by Doppler echocardiography. In 1 of these 4 pa- use of the cardiac catheterization laboratory comtients, the PDA murmur reappeared 6 months after pared with the costs for the operating room, inexthe procedure. This patient underwent a second coil pensive nature of the device used (Gianturco coils), procedure resulting in complete closure of the PDA. and lower costs for the hospital services due to the The hospital service costs per patient were signifi- outpatient nature of the coil procedure. Three patients in the coil group have a clinically cantly lower for the coil group. In addition, the lower costs for the use of cardiac catheterization laboratory silent residual PDA, the clinical significance of compared with operating room and lower physician which remains unknown. The known risk of endocharges resulted in significantly lower total costs carditis in patients with a silent PDA is limited to a single reported case.11 Experimental studies also sup(Table I). Because the coil group represented our initial ex- port a negligible risk for endocarditis in the presence perience with this technique, we divided the 24 pro- of a trivial residual PDA shunt.12 Controversy exists cedures in 23 patients, during which the coil was regarding the appropriateness of ductal closure by successfully implanted (2 procedures in 1 patient), any method in patients with a silent PDA.13 We have into 2 equal groups to determine any effect of ex- been conservative in our approach, however, and perience, and compared the first 12 of the 24 pro- have continued to advise endocarditis prophylaxis cedures with the second 12 for PDA closure and the for these patients. total costs (Table II). The ‘‘learning curve’’ resulted In conclusion, of the 2 strategies for closure of in an improved rate of complete PDA closure and, importantly, decreased total cost per procedure for hemodynamically restrictive PDAs, transcatheter coil occlusion is marginally less effective but signifthe second group of coil procedures. TABLE I Patient Characteristics, Success Rate, and Estimated Costs in Surgical and Coil Groups
1284
THE AMERICAN JOURNAL OF CARDIOLOGYT
/ 2w21 0976 Mp
1284
VOL. 79
Wednesday Apr 09 02:13 PM
MAY 1, 1997
EL–AJC (v. 79, no. 9 ’97)
0976
icantly more cost-effective than conventional surgery. With improvement in technique and device design and with appropriate case selection, there should be further reduction in costs and residual shunts with this strategy.
1. Porstmann W, Wierny L. Warnke H, Gerstberger G, Romaniuk PA. Catheter
closure of patent ductus arteriosus: long term results of 208 cases treated without thoracotomy. Radiol Clin North Am 1971;9:203–218. 2. Rashkind WJ, Mullins CE, Hellenbrand WE, Tait MA. Nonsurgical closure of patent ductus arteriosus: clinical application of the Rashkind PDA occluder system. Circulation 1987;75:583–592. 3. Rao PS, Sideris EB, Haddad J, Rey C, Hausdorf G, Wilson AD, Smith PA, Chopra PS. Transcatheter occlusion of patent ductus arteriosus with adjustable buttoned device: initial clinical experience. Circulation 1993;88:1119–1126. 4. Lloyd TR, Fedderly R, Mendelsohn AM, Sandhu SK, Beekman RH. Transcatheter occlusion of patent ductus arteriosus with Gianturco coils. Circulation 1993;88(part 1):1412–1420. 5. Moore JW, George L, Kirkpatrick SE, Mathewson JW, Spicer RL, Uzrak K, Rothman A, Cambier PA, Slack MC, Kirby WC. Percutaneous closure of the
small patent ductus arteriosus using occluding spring coils. J Am Coll Cardiol 1994;23:759–765. 6. Gray DT, Fyler DC, Walker AM, Weinstein MC, Chalmers TC, for the patent ductus arteriosus closure comparative study group. Clinical outcomes and costs of transcatheter as compared with surgical closure of patent ductus arteriosus. N Engl J Med 1993;329:1517–1523. 7. Fedderly RT, Beekman RH, Mosca RS, Bove EL, Lloyd TR. Comparison of hospital charges for closure of patent ductus arteriosus by surgery and by transcatheter coil occlusion. Am J Cardiol 1996;77:776–779. 8. Human DG, McIntyre L, Gniewick A, Hanna BD. Technology assessment of nonsurgical closure of patent ductus arteriosus: an evaluation of the clinical effectiveness and costs of a new medical device. Pediatrics 1995;96:703–706. 9. Hospital and Hospital Health Care Complex. Form HCFA-2552-92 Cost Report. Instructions for Completion. In: Medicare and Medicaid Guide, no. 725, Dec 15, 1992. 10. Gray DT. Cost-effectiveness analysis of interventions for congenital heart disease. J Interven Cardiol 1995;579–597. 11. Balzer DT, Spray TL, McMullin D, Cottingham W, Canter CE. Endocarditis associated with a clinically silent patent ductus arteriosus. Am Heart J 1993;125:1192–1193. 12. Latson LA, McManus BM, Doer C, Kilzer K, Cheatham JP. Endocarditis risk of the USCI PDA umbrella for transcatheter closure of patent ductus arteriosus. Circulation 1994;90:2525–2528. 13. Lloyd TR, Beekman RH. Clinically silent patent ductus arteriosus. Am Heart J 1994;127:1664–1665.
Aortic Valve Prolapse and Aortic Regurgitation Associated With Subpulmonic Ventricular Septal Defect Kan Tohyama,
MD,
Gengi Satomi,
n subpulmonic ventricular septal defect (VSD), the incidence of associated aortic valve prolapse and Iaortic regurgitation is high. Surgical intervention 1–4
may be necessary due to the development of aortic regurgitation.5 The introduction of echocardiography in recent years has made it possible to diagnose the presence and location of VSD and aortic valve deformity noninvasively, even in infancy and early childhood.6 – 9 We have studied the natural development of aortic valve prolapse in subpulmonic VSD, with particular reference to the hemodynamic factors related to the early development of aortic regurgitation. jjj We reviewed the records of 315 patients with subpulmonic VSD who had been studied at our institution from 1987 to 1992. Patients with complications of cardiac malformations other than VSD were excluded from the study. Patient ages ranged from 20 days to 35 years. In patients with a clinical diagnosis of subpulmonic VSD, echocardiographic examination had been indicated (1) on the first visit, (2) every 6 months to 1 year to 2 years thereafter, and (3) or when diastolic murmur or bounding pulse occurred.
From the Department of Pediatric Cardiology, The Heart Institute of Japan, Tokyo Women’s Medical College, Tokyo, Japan. This study was supported by grants from the Japan Research Promotion Society for Cardiovascular Disease, the Ministry of Health and Welfare, and a grant from Takeda Science Foundation, Tokyo, Japan. Dr. Tohyama’s address is: Department of Pediatrics, Doai Memorial Hospital, 2-1-11 Yokoami-cho, Sumida-ku, Tokyo 130, Japan. Manuscript received July 24, 1996; revised manuscript received and accepted December 31, 1996.
MD,
and Kazuo Momma,
A Toshiba Medical model SSH-140A (Tokyo, Japan), Aloka model SSD-870 (Tokyo, Japan), or ACUSON model X280A (Mountain View, California) echocardiograph was used for the examination. The patients were examined for the location of VSD and for the presence or absence of prolapse of the aortic valve and aortic regurgitation. A transducer of either 5, 3.75, or 3 MHz was used, depending on the patient’s build and the kind of echocardiograph used. For diagnosis of the location of the defect, the shortaxis cross section at the origin of the aorta and the 4-chamber cross section was used, combined with an image of the defect of the ventricular septum from the echocardiogram and the site of the shunted flow from the color Doppler echocardiogram. For diagnosis of prolapse of the right coronary cusp of the aortic valve, the long-axis cross section of the origin of the aorta was used, referring to the delineation of the projection with a distinct inflection point from the natural curve of the sinus of Valsalva (Figure 1). The degree of aortic regurgitation was rated as moderate for regurgitation reaching the tip of the mitral valve, mild for that not reaching the tip of the mitral valve, and slight for slight regurgitation under the aortic valve. Following echocardiographic diagnosis of subpulmonic VSD and aortic valve deformity, 56 patients underwent cardiac catheterization and selective angiocardiography. The pulmonary-to-systemic flow ratio (Qp/Qs) and left-to-right shunt ratio were calculated. Aortic regurgitation was graded according to Sellers10; grade 1 corresponds to mild regurgitation, and grades 2 and 3 to moderate regurgitation. Results were compared by means of Student’s t test with a p value õ0.05 considered to be significant.
Q1997 by Excerpta Medica, Inc.
0002-9149/97/$17.00 PII S0002-9149(97)00105-7
All rights reserved.
/ 2w21 0976 Mp
1285
MD
Wednesday Apr 09 02:13 PM
EL–AJC (v. 79, no. 9 ’97)
0977
1285
MD,
W. Robert Morrow, MD, Henry L. Walters, and Mehdi Hakimi, MD
urgical correction of patent ductus arteriosus (PDA) is a low-risk procedure in children. HowS ever, it usually involves left lateral thoracotomy, general anesthesia, and chest tube placement after operation. Since the introduction of transcatheter closure of PDA by Porstmann et al,1 various devices have been used to close the ductus by the transcatheter method.2 – 4 Stainless steel Gianturco coils have been used recently to close the small, restrictive PDA.4,5 Previous studies comparing cost-effectiveness of transcatheter PDA closure with surgery have shown conflicting results.6 – 8 In contrast to an earlier study,6 the transcatheter PDA closure is now often done as an outpatient procedure, the use of general anesthesia is uncommon, and the delivery system needed for the coil delivery is less invasive, resulting in reduced blood loss. In this study, therefore, we sought to compare the clinical and cost-effectiveness of transcatheter coil occlusion of hemodynamically restrictive PDA with conventional surgical closure. jjj In a retrospective cohort study, we evaluated the clinical outcome and cost-effectiveness of 2 treatment strategies for children with an isolated restrictive PDA. The first 25 consecutive pediatric patients ¢6 months of age who underwent cardiac catheterization with the intent to coil occlude a restrictive PDA between March 1994 and September 1995 at our institution constituted the coil group. A restrictive PDA was defined as one with the smallest diameter õ2.5 mm and with a transductal echocardiographic gradient of ú50 mm Hg. Between January 1993 and September 1995, 21 patients ¢6 months of age underwent surgery for a restrictive PDA at our institution. These patients were assigned to the surgery group. Among the 21 patients in the surgery group, 14 had division and 7 had ligation of PDA. Patients were admitted on the day of their planned surgery. Surgery was performed under general anesthesia. After recovery from anesthesia, the patients were admitted to a step-down care bed on the cardiac ward, and transferred to a regular bed 24 to 48 hours later. The chest tube, which was placed intraoperatively, was usually removed within 24 hours. From the Division of Pediatric Cardiology, Department of Pediatrics, the Department of Cardiovascular Surgery, and the Department of Finance, Children’s Hospital of Michigan, Wayne State University School of Medicine, Detroit, Michigan. Dr. Morrow’s address is: Division of Cardiology, Arkansas Children’s Hospital, 800 Marshall Street, Little Rock, Arkansas 72202. Manuscript received August 23, 1996; revised manuscript received and accepted January 2, 1997.
MD,
0002-9149/97/$17.00 PII S0002-9149(97)00104-5
All rights reserved.
1283
Wednesday Apr 09 02:13 PM
MBA,
Patients in the coil group underwent transcatheter coil occlusion procedure as outpatients. The procedure was performed using sedation and local anesthesia. The coil was delivered across the PDA by the retrograde method using a 5Fr JB-1 (Cook Inc., Bloomington, Indiana) catheter.5 Closure of the PDA was confirmed by aortic angiography and/or echocardiography. Additional coils were delivered across the PDA as needed to ensure complete closure. Clinical closure of the PDA was defined as disappearance of the PDA murmur. Complete closure of the PDA was defined as absence of clinical and color Doppler evidence of a residual shunt. After the procedure, patients were observed on the ambulatory medical care ward for 6 hours before discharge. The estimated hospital costs for each patient include cost estimates for use of the operating room or cardiac catheterization laboratory as applicable, other patient care–related costs during hospitalization, and costs for medical supplies (e.g., pharmacy) and laboratory investigations. These estimates include both direct (e.g., disposable medical equipment, medications, other supplies) and indirect (e.g. maintenance, personnel, and so forth) costs and are as reported in Health Care Finance Administration (HCFA) form 25529 for our institution. The cost estimates reported in this form are based on a known ratio of the total costs and the total charges from individual hospital departments (different cost ratios for different departments and, therefore, for use of different services) for our institution. Because of the intrinsic difficulty in estimating the professional costs, the maximum allowable physician charges for the physician’s billed services as designated by Blue Cross and Blue Shield of Michigan for each procedure in individual patients were obtained and used in this analysis.6 These charges were proportionate to the unit times needed during the procedure (for anesthesiologist’s services), bundled charges for the procedure (for surgeon’s services), or unbundled charges for the individual components of the procedure performed, such as right and left heart catheterization angiography, coil placement, and so forth (for cardiologist’s services). All costs were corrected to 1995 dollars using the Consumer Price Index for medical care. The coil and the surgery groups were compared for the closure of PDA, length of hospital stay, and estimated costs per patient. For the 2 patients in the coil group who required a second coil procedure (1 patient) or surgical closure due to failure of the coil procedure (1 patient), the costs of the second procedure were added to the costs of the initial cardiac catheterization. A Mann Whitney U–Wilcoxon rank sum W Test was used to compare the costs for the 2
Q1997 by Excerpta Medica, Inc.
/ 2w21 0976 Mp
Nickolas A. Vitale,
EL–AJC (v. 79, no. 9 ’97)
0976
1283
jjj The results of this study demonstrate that transcatheter coil ocSurgery Group (n Å 21) Coil Group (n Å 25) clusion of restrictive PDA is clinically effective with marginally Age (mos) 25 (6–103) 21 (6–114) Weight (kg) 12.9 (5.7–26.5) 10.4 (5.2–30.6) lower success (clinical closure 92% Clinical closure 100% 92% vs 100%) compared with surgery, Complete closure 80% but at significantly lower costs. The Cath. lab. OR costs $2,791 ($1,428–$4,295) $1,259 ($986–$4,273) cost-effectiveness of transcatheter Professional costs $2,458 ($2,314–$2,790) $2,415 ($1,756–$4,542) procedure to close the PDA has Hospital services costs* $3,941 ($2,412–$5,398) $1,260 ($728–$7,748) Total costs $9,104 ($7,492–$11,839) $4,897 ($3,470–$16,563) been previously reported using estimated costs6 or billed charges.7,8 *Cardiac catheterization laboratory costs not included; p õ0.001 for all cost comparisons. Values are expressed as median (range). The use of charges to represent Cath. lab. catheterization laboratory; OR Å operating room. costs to the medical system has been criticized owing to the influence of market forces, historical patterns, and regulatory pressures.10 The esTABLE II Effect of Experience on PDA Closure and Costs of Transcatheter Coil timated costs reported in this study Procedure represent the provider’s perspective Coil Group (1–12) Coil Group (13–24) p Value of costs incurred per patient to close Cath. lab. costs $1,302 ($1,170–$2,093) $1,206 ($1,097–$1,437) 0.02 the PDA. Estimated professional Professional costs $2,415 ($2,415–$2,415) $2,108 ($2,092–$2,399) õ0.001 costs from the perspective of a sinHospital services $1,293 ($1,180–$1,891) $1,172 ($938–$1,517) 0.005 gle third party payer were added to costs* generate estimated total costs for efTotal costs $5,093 ($4,847–$5,852) $4,538 ($4,215–$4,976) õ0.001 fective closure.6 Complete closure 67% 100% — In a comparison of surgical clo*Cardiac catheterization laboratory costs not included. sure with PDA occlusion with the Values are expressed as median (range). Cath. lab. Å catheterization laboratory; PDA Å patent ductus arteriosus. Rashkind device, Gray et al6 reported lower costs for the more effective surgical procedure. The groups and the length of hospital stay. Statistical sig- higher costs for the transcatheter closure in their study resulted from the additional cost of the Rashnificance was defined as a 2-tailed p value õ0.05. The patient characteristics, the success rate for the kind device and longer duration of the procedure, 2 groups of patients, and comparison of estimated with higher costs for the cardiac catheterization labcosts are shown in Table I. Surgery resulted in clin- oratory and higher professional fee. The participaical closure of the PDA in all patients with disap- tion of an anesthesiologist in 30% of these procepearance of the PDA murmur. A successful implan- dures, the need for transfusion in 14% of these tation of coil(s) across the PDA was achieved in 23 patients, and the cost of the Rashkind occluder depatients (92%). The PDA murmur disappeared in all vice all contributed to increased costs for the transthese 23 patients. However, 4 patients in this group catheter procedure. The lower cost for the coil strathad a trivial residual shunt (clinically silent ductus) egy in our study resulted from lower costs for the by Doppler echocardiography. In 1 of these 4 pa- use of the cardiac catheterization laboratory comtients, the PDA murmur reappeared 6 months after pared with the costs for the operating room, inexthe procedure. This patient underwent a second coil pensive nature of the device used (Gianturco coils), procedure resulting in complete closure of the PDA. and lower costs for the hospital services due to the The hospital service costs per patient were signifi- outpatient nature of the coil procedure. Three patients in the coil group have a clinically cantly lower for the coil group. In addition, the lower costs for the use of cardiac catheterization laboratory silent residual PDA, the clinical significance of compared with operating room and lower physician which remains unknown. The known risk of endocharges resulted in significantly lower total costs carditis in patients with a silent PDA is limited to a single reported case.11 Experimental studies also sup(Table I). Because the coil group represented our initial ex- port a negligible risk for endocarditis in the presence perience with this technique, we divided the 24 pro- of a trivial residual PDA shunt.12 Controversy exists cedures in 23 patients, during which the coil was regarding the appropriateness of ductal closure by successfully implanted (2 procedures in 1 patient), any method in patients with a silent PDA.13 We have into 2 equal groups to determine any effect of ex- been conservative in our approach, however, and perience, and compared the first 12 of the 24 pro- have continued to advise endocarditis prophylaxis cedures with the second 12 for PDA closure and the for these patients. total costs (Table II). The ‘‘learning curve’’ resulted In conclusion, of the 2 strategies for closure of in an improved rate of complete PDA closure and, importantly, decreased total cost per procedure for hemodynamically restrictive PDAs, transcatheter coil occlusion is marginally less effective but signifthe second group of coil procedures. TABLE I Patient Characteristics, Success Rate, and Estimated Costs in Surgical and Coil Groups
1284
THE AMERICAN JOURNAL OF CARDIOLOGYT
/ 2w21 0976 Mp
1284
VOL. 79
Wednesday Apr 09 02:13 PM
MAY 1, 1997
EL–AJC (v. 79, no. 9 ’97)
0976
icantly more cost-effective than conventional surgery. With improvement in technique and device design and with appropriate case selection, there should be further reduction in costs and residual shunts with this strategy.
1. Porstmann W, Wierny L. Warnke H, Gerstberger G, Romaniuk PA. Catheter
closure of patent ductus arteriosus: long term results of 208 cases treated without thoracotomy. Radiol Clin North Am 1971;9:203–218. 2. Rashkind WJ, Mullins CE, Hellenbrand WE, Tait MA. Nonsurgical closure of patent ductus arteriosus: clinical application of the Rashkind PDA occluder system. Circulation 1987;75:583–592. 3. Rao PS, Sideris EB, Haddad J, Rey C, Hausdorf G, Wilson AD, Smith PA, Chopra PS. Transcatheter occlusion of patent ductus arteriosus with adjustable buttoned device: initial clinical experience. Circulation 1993;88:1119–1126. 4. Lloyd TR, Fedderly R, Mendelsohn AM, Sandhu SK, Beekman RH. Transcatheter occlusion of patent ductus arteriosus with Gianturco coils. Circulation 1993;88(part 1):1412–1420. 5. Moore JW, George L, Kirkpatrick SE, Mathewson JW, Spicer RL, Uzrak K, Rothman A, Cambier PA, Slack MC, Kirby WC. Percutaneous closure of the
small patent ductus arteriosus using occluding spring coils. J Am Coll Cardiol 1994;23:759–765. 6. Gray DT, Fyler DC, Walker AM, Weinstein MC, Chalmers TC, for the patent ductus arteriosus closure comparative study group. Clinical outcomes and costs of transcatheter as compared with surgical closure of patent ductus arteriosus. N Engl J Med 1993;329:1517–1523. 7. Fedderly RT, Beekman RH, Mosca RS, Bove EL, Lloyd TR. Comparison of hospital charges for closure of patent ductus arteriosus by surgery and by transcatheter coil occlusion. Am J Cardiol 1996;77:776–779. 8. Human DG, McIntyre L, Gniewick A, Hanna BD. Technology assessment of nonsurgical closure of patent ductus arteriosus: an evaluation of the clinical effectiveness and costs of a new medical device. Pediatrics 1995;96:703–706. 9. Hospital and Hospital Health Care Complex. Form HCFA-2552-92 Cost Report. Instructions for Completion. In: Medicare and Medicaid Guide, no. 725, Dec 15, 1992. 10. Gray DT. Cost-effectiveness analysis of interventions for congenital heart disease. J Interven Cardiol 1995;579–597. 11. Balzer DT, Spray TL, McMullin D, Cottingham W, Canter CE. Endocarditis associated with a clinically silent patent ductus arteriosus. Am Heart J 1993;125:1192–1193. 12. Latson LA, McManus BM, Doer C, Kilzer K, Cheatham JP. Endocarditis risk of the USCI PDA umbrella for transcatheter closure of patent ductus arteriosus. Circulation 1994;90:2525–2528. 13. Lloyd TR, Beekman RH. Clinically silent patent ductus arteriosus. Am Heart J 1994;127:1664–1665.
Aortic Valve Prolapse and Aortic Regurgitation Associated With Subpulmonic Ventricular Septal Defect Kan Tohyama,
MD,
Gengi Satomi,
n subpulmonic ventricular septal defect (VSD), the incidence of associated aortic valve prolapse and Iaortic regurgitation is high. Surgical intervention 1–4
may be necessary due to the development of aortic regurgitation.5 The introduction of echocardiography in recent years has made it possible to diagnose the presence and location of VSD and aortic valve deformity noninvasively, even in infancy and early childhood.6 – 9 We have studied the natural development of aortic valve prolapse in subpulmonic VSD, with particular reference to the hemodynamic factors related to the early development of aortic regurgitation. jjj We reviewed the records of 315 patients with subpulmonic VSD who had been studied at our institution from 1987 to 1992. Patients with complications of cardiac malformations other than VSD were excluded from the study. Patient ages ranged from 20 days to 35 years. In patients with a clinical diagnosis of subpulmonic VSD, echocardiographic examination had been indicated (1) on the first visit, (2) every 6 months to 1 year to 2 years thereafter, and (3) or when diastolic murmur or bounding pulse occurred.
From the Department of Pediatric Cardiology, The Heart Institute of Japan, Tokyo Women’s Medical College, Tokyo, Japan. This study was supported by grants from the Japan Research Promotion Society for Cardiovascular Disease, the Ministry of Health and Welfare, and a grant from Takeda Science Foundation, Tokyo, Japan. Dr. Tohyama’s address is: Department of Pediatrics, Doai Memorial Hospital, 2-1-11 Yokoami-cho, Sumida-ku, Tokyo 130, Japan. Manuscript received July 24, 1996; revised manuscript received and accepted December 31, 1996.
MD,
and Kazuo Momma,
A Toshiba Medical model SSH-140A (Tokyo, Japan), Aloka model SSD-870 (Tokyo, Japan), or ACUSON model X280A (Mountain View, California) echocardiograph was used for the examination. The patients were examined for the location of VSD and for the presence or absence of prolapse of the aortic valve and aortic regurgitation. A transducer of either 5, 3.75, or 3 MHz was used, depending on the patient’s build and the kind of echocardiograph used. For diagnosis of the location of the defect, the shortaxis cross section at the origin of the aorta and the 4-chamber cross section was used, combined with an image of the defect of the ventricular septum from the echocardiogram and the site of the shunted flow from the color Doppler echocardiogram. For diagnosis of prolapse of the right coronary cusp of the aortic valve, the long-axis cross section of the origin of the aorta was used, referring to the delineation of the projection with a distinct inflection point from the natural curve of the sinus of Valsalva (Figure 1). The degree of aortic regurgitation was rated as moderate for regurgitation reaching the tip of the mitral valve, mild for that not reaching the tip of the mitral valve, and slight for slight regurgitation under the aortic valve. Following echocardiographic diagnosis of subpulmonic VSD and aortic valve deformity, 56 patients underwent cardiac catheterization and selective angiocardiography. The pulmonary-to-systemic flow ratio (Qp/Qs) and left-to-right shunt ratio were calculated. Aortic regurgitation was graded according to Sellers10; grade 1 corresponds to mild regurgitation, and grades 2 and 3 to moderate regurgitation. Results were compared by means of Student’s t test with a p value õ0.05 considered to be significant.
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