- Email: [email protected]
Comparison of hospital charges for closure of patent ductus arteriosus by surgery and by transcatheter coil occlusion
decreasing. However, the striking difference in the reported incidence from 53% to 85% down to 13.6% in this study, and the low incidence of subsequent postpericardiotomy syndrome (2.3% ) are compelling evidence that there has been a true decrease in the occurrence of such effusions.
This study documents a decreasein the incidence of postoperativepericardial effusiousfollowing open heart surgery in children from 53% to 85% in published reports to 13.6% in this study. The incidence of postpericardiotomy syndrome has also decreased from a reported 25% to 30% to 2.3% in this study. These tidings may reflect improvement in surgical and myocardial protection techniques. Acknowledgment: We express our gratitude to James Pollock, RDMS, and Joellyn Gurczynski, ASCVT, for their assistance with performing the echocardiographic studies.
3. Ikaheimo MJ, Huikuri HV, Airaksinen J, Korhonen UR, Linnaluoto MK, Tarkka MR, Takkunen JT. Pericardial effusion after cardiac surgery: incidence, relation to the type of surgery, antitbrombotic therapy, and early coronary bypass graft patency. Am Heart J 1988;116:97-102. 4. Angelini GD, Penny WJ, El-Ghamary F, West RR, Butchart EG, Armistead SH, Breckemidge IM, Henderson AH. The incidence and significance of early pericardial effusion after open heart surgery. Eur J Cardiothorac Surg 1987;1:165-168. 5. Stevenson LW, Child JS, Laks H, Kern L. Incidence and significance of early pericardial effusions after cardiac surgery. Am J Cardiol 1984;54: 848-851. 6. Borkon MA, Schaff HV, Gardner TJ, Merrill WH, Brawley RK, Donahoo JS, Watkins L Jr, Weiss JL, Gott VL. Diagnosis and managementof postoperative pericardial effosions and late cardiac tamponadefollowing open heart surgery. Ann Thorac Surg 1981;31:512-519. 7. Weitzman LB, Tinker WP, Konzon I, Cohen ML, Glassman E, Spencer FC. The incidence and natural history of pericardial effusion after cardiac surgery-an echocardiographic study. Circulation 1984;69:506511. 8. Solem JO, Kugelberg J, Stahl E, Olim C. Late cardiac tamponadefollowing open heart surgery: diagnosis and treatment. Stand .I Thorac Cardiovasc Surg 1986;20:129-131. 9. Clapp SK, Garson A Jr, Gutgesell HP, Cooley DA, McNamara DG. Postoperative pericardial effusion and its relation to postpericardiotomy syndrome. Pediatrics 1980;66:585-588. 10. Beland MJ, Paquet M, Gibbons JE, Tchervenkov CI, Dobell ARC. Per-
cardial effusion after cardiac surgery in children and effects of aspirin for prevention. Am J Cardiol 1990;65:1238-1241. 11. Engle MA, Ehlers KH, O’Loughlin JE, Lindlay LA, Fried R. The postpericardiotomy syndrome: iatrogenic illness with immunologic and virologic com1. Engle MA, Zabriskie JB, Senterfit LB, Gay WA Jr, O’Loughlin JE Jr, Ehlers ponents. Cardiovasc Clin 1981;11:381-391. KH. Viral illness and the postpericardiotomy syndrome: a prospective study in 12. Nomura Y, Haraguchi YT, Oku S, Noda T, Miyata K, UmebayashiY, Taira children. Circtdation 1980;62:1151- 1158. A. Relationship between the degree of injury at operation and the change in 2. Dmsin LM, Engle MA, Hagstim JWC, SchwartzMS. The postpericardiotomy antimyosin antibody titer in the postpericardiotomy syndrome.Pediatr Cardiol syndrome:a six-year epidemiologicstudy.N Engl J Med 1965;272:597-602. 1994;15:116-120.
Comparison of Hospital Charges for Closure of Patent Ductus Arteriosus by Surgery and by Transcatheter Coil Occlusion Raymond
T. Fedderly, Edward
MD, Robert H. Beekman III, MD, Ralph S. Mosca, L. Bove, MD, and Thomas R. Lloyd, MD
r
anscatbeter occlusion by Gianturco coils is a recently described alternative”’ to traditional surgical closure of patent ductus arteriosus (PDA). It is clear that economic considerations are important in the adoption of novel medical treatments, joining the more traditional issues of efficacy, safety, and patient acceptance. A recent multi-institutional study of resource utilization for the Rashkind PDA Oc.eluder@ concluded that surgical closure of isolated PDA was more effective and less costly than transcatheter closure.3 This study compares contemporaneous hospital charges at a single institution for closure of PDA by surgery and by transcatheter occlusion using Gianturco coils. ... All patients who underwent elective closure of a PDA at C.S. Mott Children’s Hospital between July 1992 and November 1993 were identified by From the Division of Pediatric Cardiology, Department of Pediatrics, C.S. Mott Children’s Hospital, The University of Michigan Medical Center, Ann Arbor, Michigan 48 109-0204. Dr. Fedderly’s address is: Children’s Hospital of Wisconsin, Department of Pediatric Cardiology, 9000 West Wisconsin Avenue, Milwaukee, Wisconsin 53226-35 18. Manuscript received July 2 1, 1995; revised manuscript received and accepted November 8, 1995.
776
THE AMERICAN
JOURNAL
OF CARDIOLOGY@
VOL.
77
MD,
review of cardiac catheterization and surgical records. To reduce confounding by charges of treating coexisting cardiac disease or neonatal conditions, patients aged <6 months at the time of ductus closure and patients with significant associated heart disease were excluded. Hospital bills for the remaining 44 patients were reviewed and total hospital charges ascertained. These charges included room rates and nursing care, operating room or catheterization laboratory charges, anesthesia supplies and recovery room charges, pharmacy, clinical laboratory, and radiology charges, and miscellaneous charges. Professional fees (i.e., cardiologists, surgeons, anesthesiologists, radiologists) were not included. Patients were assigned to coil occlusion or to surgery based on the preference of the referring physician or of the patient or family. Patients in the coil occlusion group were divided into 3 subgroups based on the clinical protocol in use at the time of their coil procedure. Patients in the original coil protocol had coils implanted under general anesthesia, and were observed overnight as hospital inpatients after their procedures. Right-sided cardiac catheterization was performed before coil implantation, and repeated APRll
1, 1996
immediately after implantation. Most TAME I Patient Population and Hospital Charges had transesophageal echocardioHospital Charges Number of Age grams recorded during the proce(mean + SE) Patient Group Patients (median, range) p Value p Value dure, and all had follow-up transNS* thoracic echocardiograms and chest 11 3 yr (7 mo-7 yr) Surgery NS’ All coil protocols 33 4 yr (9 mo-61 yr) roentgenograms before discharge. $5,747t 384 15 5 yr (l-30 yr) Original Patients in the intermediate coil pro$4,457?453 Intermediate 10 2 yr (9 mo-13 yr) tocol had coils implanted using loyr] $3,282 2 335 Current a 7yr(l-61 cal anesthesia and sedation, and * Comparison of surgery with all coil products. were observed overnight as inpaf Comparison among coil occlusion subgroups. tients after their procedures. Right heart catheterization was performed in this group as well. Most patients had transthoracic echocardiograms recorded during the procedure, and all had transthoracic echocardiograms and chest roentgenograms recorded before discharge. Because no instances of coil-induced left pulmonary artery stenosis were observed under the original and intermediate protocols, and because we had found angiographic estimation of ductal shunt size to be more useful than oximetry, ’ patients in the current coil protocol did not undergo right heart catheterization routinely. Coils were implanted under local anesthesia and sedation, 25 50 0 75 100 and patients were discharged after 4 PDA Coil Failure Rate (%) to 6 hours of outpatient observation. Echocardiography was not rouFIGURE 1. Hospital charges for patent ductus arteriosus (PDA) closure analysis. Estinely performed, but a chest roenttimated hospital charges for PDA closure by a coil strategy fsdid kne] plotted against the failure rate of coil occlusion. If coil occlusion were always successful genogram was recorded before dis(failure mte = O%), the charges for closure would be the charges for coil occlusion charge. alone ($3,282), and if coil occlusion were never successful, the charges for closure The hospital charge for closing a would be the charges for coil occlusion + the charges for su ($3 282 + PDA by surgical or coil occlusion $11,670 = $14,952). For comparison, the /&zond das he%Zshoklheestimated charges for the surgical strategy ($11,670). The hospital charges for the strategies was calculated using the coil stra ore less those for surgery at coil failure mks ~72%. The circle following assumptions: ( 1) surgery *in strategy line marks the observed coil failure rate of 1196, mr preon the coi is 100% effective for ductal closure; dicted charges for closure at $4,566. The hatched areas outline the 95% confi(2) all patients who do not achieve dence limits of this estimate (5% to 2T%), with their predicted charges for closure by the coil strategy ($3,866 to $5,733). complete closure by coil occlusion will subsequently undergo surgical closure; and (3) the hospital charges for surgical and January 1995, and the rate of persistent ductal shuntcoil occlusion procedures are approximated by the ing from an actuarial analysis of the first 50 patients.4 observed hospital charges for surgical closure and Comparisons between groups were made using the current coil protocol, respectively. Under these analysis of variance. A p value <0.05 was chosen to assumptions, the hospital charges for closure by sur- represent statistical significance, and Bonfetroni’s gical strategy are equal to the surgical charges, and correction was used for multiple comparisons. the hospital charges for closure by coil occlusion Of the 44 patients included in this study, 11 unstrategy are equal to the sum of the coil occlusion derwent surgical closure and 33 underwent transcharge and the product of the surgical charge and the catheter coil occlusion. There were 15 patients in the failure rate of coil occlusion. For coil occlusion, suc- original coil protocol, 10 in the intermediate coil process was defined as complete closure, as documented tocol, and 8 in the current (outpatient) coil protocol. by color flow Doppler echocardiography. The failure Of the 33 patients, 27 had no residual shunt after 1 rate of coil occlusion includes patients in whom coils catheterization, 2 went on to surgical ligation, and 3 were not successfully implanted and those in whom of the remaining 4 patients had a successful second ductal shunting persists despite coil placement. The catheterization. Mean hospital charges for all 33 coil rate of unsuccessful implantation was determined by occlusion procedures were 4 1% of the mean hospital review of the 72 PDA coil occlusion procedures per- charge for surgical closure (p = 0.0003, Table I). formed at C.S. Mott Children’s Hospital through Within the coil occlusion group, hospital charges varBRIEF REPORTS 777
ied significantly (p = 0.0008) depending on the protocol used, with the mean charge for the original coil protocol being 75% higher than the current coil protocol. The current (outpatient) coil protocol charge is 28% of the mean surgical charge (Table I). Figure 1 shows our hospital charges for PDA closure analysis. Hospital charges for the surgical strategy were estimated at $11,670 (the observed hospital charges in the surgical group), and hospital charges for the coil strategy were estimated as the observed hospital charges for the current coil protocol ($3,282) + $11,670 (coil failure rate). Our estimated coil failure.rate is based on observation of 8 failures in 72 procedures ( 11%, 95% confidence limits 5% to 21%). Of these 8 coil failures, 4 were patients in whom coils were not successfully implanted, and 4 were patients with persistent residual shunts by Doppler echocardiography following coil implantation. Our model therefore estimates the hospital charges for PDA closure by coil occlusion at $4,566 (95% confidence limits $3,866 to $5,733). The hospital charges for the coil occlusion strategy would be less than those for surgery, unless the coil failure rate was ~72%. ... We have shown that hospital charges for percutaneous coil occlusion of PDA are significantly and substantially lower than for surgical closure for contemporary patients at our institution. We have also shown that hospital charges for PDA coil occlusion have been reduced even further as the coil occlusion protocol has evolved. Importantly, we have shown that the advantage in hospital charges of coil occlusion over surgical closure of PDA persists after correcting for the failure rate of coil occlusion. We did not include professional charges in our analysis because our institution does not have a central billing office for professional fees, and complete ascertainment of all professional charges could not be assured. Charges relating to follow-up visits were also neglected in our analysis. We did so primarily because we do not yet know the most appropriate follow-up regimen for patients who have undergone coil occlusion of PDA. We currently recommend 2 or 3 visits over the first 12 months after the procedure, usually with echocardiography. This regimen is a more intensive one than the regimen we recommend after surgical closure, because coil occlusion remains an innovative treatment; as experience accumulates, a less costly follow-up regimen will likely emerge. On the other hand, echocardiographic studies in some surgical series suggest that surgically treated patients may deserve more follow-up than is usually recommended.5 The savings of the current outpatient coil protocol compared with the original inpatient protocol are encouraging. We have performed 3 1 outpatient PDA coil occlusion procedures with no morbidity related to early discharge. Sedation and local anesthesia have allowed adequate patient cooperation for coil occlusion, and neither echocardiographic guidance nor routine right heart catheter778
THE AMERICAN JOURNAL OF CARDIOLOGY@
VOL. 77
ization has proved to be necessary. We no longer believe that routine echocardiography is clinically valuable early after coil occlusion because of the documented high rate of spontaneous closure of minor residual shunts.4 The accuracy of our hospital charges for PDA closure analysis depends on the accuracy of our assumptions, which generally favor surgical closure. Our first assumption, that surgery is always effective, is belied by the fact that 3 of our coil occlusion patients had previously undergone surgical ductus ligation at other institutions. Although outstanding results have been achieved with surgical closure of PDA,6 unsuspected residual shunting has been detected in up to 22% of patients when Doppler echocardiography was performed at follow-up.’ Our second assumption, that patients with failed coil occlusion would all be treated surgically, is also biased against the coil occlusion alternative. ‘Although surgery was performed in 4 patients who did not have successful coil implantation, experience and newer technical refinements 7,8would probably have allowed subsequent successful coil occlusion in some of these patients. Of the 4 patients with persistent residual shunts after coil implantation, 3 have had successful second coil occlusion procedures, and the fourth awaits a second coil procedure (i.e., none has required surgery). Our third assumption, that hospital charges estimate the costs of the procedures, is also subject to several limitations. First, we did not include professional fees (which would favor coil occlusion) or follow-up visits (which would favor surgery). Second, we did not include nonmedical costs incurred by patients and their families during their ductus closure procedures, such as lodging and meals, child care for siblings, time off work during hospitalization, and postdischarge recovery. Because coil occlusion is an outpatient procedure, and we encourage patients to resume their usual activities within 1 to 2 days after coil occlusion, this factor also favors coil occlusion. Considering these issues, our estimate of the savings to patients, families, and health insurance carriers achieved by the coil occlusion strategy is probably conservative. We conclude that hospital charges for coil occlusion of PDA were significantly less than for surgical closure in contemporaneously treated patients at a single institution. The expected hospital charges for closure by a coil occlusion strategy, including the charges for surgical closure in patients with failed coil occlusion, were less than the hospital charges for a surgical closure strategy under any reasonable estimate of the efficacy of coil occlusion of PDA. 1. Lloyd TR, Fedderly R, Mend&&n AM, Sandhu SK, B&man RH. Transcatheter occlusion of patent ductus arteriosus with Gianturco coils. Circulation 1993;88(part 1):1412-1420. 2. Moore JW, George L, Kirkpatrick SE, Mathewson JW, Spicer RL, Uzark K, Rothman A, Cambier PA, Slack MC, Kirby WC. Percutaneous closure of the small patent ductus arteriosus using occluding spring coils. J Am Co0 Cardiol 1994;23:159-165.
APRll 1, 1996
3. Gray DT, Fyler DC, Walker AM, Weinstein MC, Chalmers TC. Clinical outcomesand costs of transcatheteras comparedwith surgical closure of patent ductus arteriosus. N Engr JMed 1993;329:1517-1523. 4. Shim D, Fedderly RT, Beekman RH, Ludomirsky A, Young ML, Schork A, Lloyd TR. Follow-up after coil occlusion of patent ductus arteriosus (abstr) J Am Co11 Cardiol 1995;331A. 5. So’rensonKE, Kristensen Bo, Hanson OK. Frequency of occurrence of residual ductal flow after surgical ligation by color-flow mapping. Am J Cardiol 1991;67:653-654.
Decrease
6. Mavroudis C, Backer CL, Gevitz M. Forty-six years of patent ductus arteriosus division at Children’s Memorial Hospital of Chicago. Standardsfor comparison. Ann Surg 1994;220:402-409. 7. Sommer RJ, Gutierrez A, Lai WW, ParnessIA. Use of preformed nitinol snareto improve transcathetercoil delivery in occlusion of patent ductus arteriosus. Am J Cardiol 1994;74:836-839. 8. Hijazi ZM, Geggel RL. Results of anterogradetranscatheterclosure of patent ductus arteriosus using single or multiple Gianturco coils. Am J Cardiol 1994:74:925-929.
in Pacemaker Incidence Heart Transplantation
Afler
Orthoto@ic
Christoph Kratochwill, MD, Susanne Schmid, MD, Jeanette Keller-Strametz, MD, Gerhard Kreiner, MD, Martin Grabenweger, MD, Michael Grimm, MD, Giinther Laufer, MD, and Gottfried Heinz, MD
neous sinus cycle length. A corrected SN recovery time of 520 ms was accepted as the upper limit of normal in the denervated transplanted heart.lm3Manported to exhibit some SN abnormality in the post- ifest SN dysfunction was assumed in the absence of operative period.5 Only 4.5% to 21% of these pa- donor atria1 activity (usually some junctional escape tients, however, will require permanent pacemaker mechanism was present) or clinically defined paceplacement for severe symptomatic SN dysfunc- maker dependence on 2 1 postoperative evaluation. tion. 4,6,7-9The aim of the present study was to ( 1) Latent SN dysfunction was defined as a prolonged evaluate the annual incidence of pacemaker place- corrected SN recovery time with or without relative ment over a 6.5-year period in a population syste- sinus bradycardia ( <80 beats/mm) .l” A substantial number of patients were screened matically screened for SN dysfunction, (2) assess any change in the type of SN abnormality, and (3) each year. The incidence of patients with pacemaker find out perioperative and demographic risk factors placement was related to the number of patients for prolonged SN dysfunction necessitating pace- screened, the number of patients exhibiting SN dysmaker placement. function, and the number of heart transplantations ... performed each year. With respect to the year 1993, A total of 185 patients had screening of SN func- the number of patients who underwent transplantation. The mean age was 49 + 10 years, and the donor tion until August 1993 was used in all analyses. Varage was 29 + 9 years. The underlying cardiac pa- ious demographic and perioperative factors were thology was dilated cardiomyopathy in 126, isch- evaluated by a stepwise logistic regression analysis, emit heart disease in 48, and end-stage valvular heart the incidence of pacemaker placement being the dedisease in 10 patients. One patient was included after pendent variable. Univariate analyses were done by successful retransplantation. St. Thomas cardio- Student’s t test and chi-square analysis. A p value plegic solution was used in 37 patients; 144 patients <0.05 was considered significant. underwent transplantation with use of Bretschneider During a 6.5-year study period, there were 131 cardioplegia. University of Wisconsin solution was patients with entirely normal SN function including used in 4 instances. The orthotopic technique of a normal corrected SN recovery time (Figure 1). Lower and Shumway was employed in all patients. Fifty-four patients had impaired SN function that Ischemic time was measured from donor aortic cross was obvious in 30 patients (manifest SN dysfuncclamp to release of the recipient aortic cross clamp. tion) . Twenty-four patients had prolonged corrected All patients had systematic evaluation of SN SN recovery time (latent SN dysfunction). Heart function including determination of SN recovery rates and corrected SN recovery time are shown in time in the first 3 postoperative weeks. SN recovery Figure 1. time was evaluated at pacing cycle lengths of 600 to Twenty-nine patients ( 15.7% of the entire study 300 ms. Temporary epicardial electrodes, placed in population screened and 53.7% of patients with imthe right donor atrium at the end of operation, were paired SN function) underwent pacemaker placeused for bipolar atria1 pacing. Correction (corrected ment for prolonged and symptomatic SN dysfuncSN recovery time) was done by subtracting sponta- tion. Most of the pacemakers were implanted before discharge. Only 3 patients had late pacemaker placeFrom the Department of Cardiology, Deportment of Cardiothoracic ment (Figure 1) . In the 3 latter cases, the severity of Surgery, University of Vienna, Vienna, Austria. Dr. Krotochwill’s adSN dysfunction was rather underestimated; SN dysdress is: Klinik fur lnnere Medizin II, Abteilung Kardiologie, Wahrinfunction had been well evident postoperatively, but ger Gtirtef 18-20, A-l 090 Vienna, Austria. Manuscript received July patients were asymptomatic and restored sinus 28, 1995; revised manuscript received and accepted November rhythm, and thus a pacemaker was not readily im15, 1995. everal groups reported a relatively high incidence of sinus node (SN) dysfunction after orthotopic S heart transplantation.‘-6 Up to 64% have been re-
BRIEF REPORTS
779
This study documents a decreasein the incidence of postoperativepericardial effusiousfollowing open heart surgery in children from 53% to 85% in published reports to 13.6% in this study. The incidence of postpericardiotomy syndrome has also decreased from a reported 25% to 30% to 2.3% in this study. These tidings may reflect improvement in surgical and myocardial protection techniques. Acknowledgment: We express our gratitude to James Pollock, RDMS, and Joellyn Gurczynski, ASCVT, for their assistance with performing the echocardiographic studies.
3. Ikaheimo MJ, Huikuri HV, Airaksinen J, Korhonen UR, Linnaluoto MK, Tarkka MR, Takkunen JT. Pericardial effusion after cardiac surgery: incidence, relation to the type of surgery, antitbrombotic therapy, and early coronary bypass graft patency. Am Heart J 1988;116:97-102. 4. Angelini GD, Penny WJ, El-Ghamary F, West RR, Butchart EG, Armistead SH, Breckemidge IM, Henderson AH. The incidence and significance of early pericardial effusion after open heart surgery. Eur J Cardiothorac Surg 1987;1:165-168. 5. Stevenson LW, Child JS, Laks H, Kern L. Incidence and significance of early pericardial effusions after cardiac surgery. Am J Cardiol 1984;54: 848-851. 6. Borkon MA, Schaff HV, Gardner TJ, Merrill WH, Brawley RK, Donahoo JS, Watkins L Jr, Weiss JL, Gott VL. Diagnosis and managementof postoperative pericardial effosions and late cardiac tamponadefollowing open heart surgery. Ann Thorac Surg 1981;31:512-519. 7. Weitzman LB, Tinker WP, Konzon I, Cohen ML, Glassman E, Spencer FC. The incidence and natural history of pericardial effusion after cardiac surgery-an echocardiographic study. Circulation 1984;69:506511. 8. Solem JO, Kugelberg J, Stahl E, Olim C. Late cardiac tamponadefollowing open heart surgery: diagnosis and treatment. Stand .I Thorac Cardiovasc Surg 1986;20:129-131. 9. Clapp SK, Garson A Jr, Gutgesell HP, Cooley DA, McNamara DG. Postoperative pericardial effusion and its relation to postpericardiotomy syndrome. Pediatrics 1980;66:585-588. 10. Beland MJ, Paquet M, Gibbons JE, Tchervenkov CI, Dobell ARC. Per-
cardial effusion after cardiac surgery in children and effects of aspirin for prevention. Am J Cardiol 1990;65:1238-1241. 11. Engle MA, Ehlers KH, O’Loughlin JE, Lindlay LA, Fried R. The postpericardiotomy syndrome: iatrogenic illness with immunologic and virologic com1. Engle MA, Zabriskie JB, Senterfit LB, Gay WA Jr, O’Loughlin JE Jr, Ehlers ponents. Cardiovasc Clin 1981;11:381-391. KH. Viral illness and the postpericardiotomy syndrome: a prospective study in 12. Nomura Y, Haraguchi YT, Oku S, Noda T, Miyata K, UmebayashiY, Taira children. Circtdation 1980;62:1151- 1158. A. Relationship between the degree of injury at operation and the change in 2. Dmsin LM, Engle MA, Hagstim JWC, SchwartzMS. The postpericardiotomy antimyosin antibody titer in the postpericardiotomy syndrome.Pediatr Cardiol syndrome:a six-year epidemiologicstudy.N Engl J Med 1965;272:597-602. 1994;15:116-120.
Comparison of Hospital Charges for Closure of Patent Ductus Arteriosus by Surgery and by Transcatheter Coil Occlusion Raymond
T. Fedderly, Edward
MD, Robert H. Beekman III, MD, Ralph S. Mosca, L. Bove, MD, and Thomas R. Lloyd, MD
r
anscatbeter occlusion by Gianturco coils is a recently described alternative”’ to traditional surgical closure of patent ductus arteriosus (PDA). It is clear that economic considerations are important in the adoption of novel medical treatments, joining the more traditional issues of efficacy, safety, and patient acceptance. A recent multi-institutional study of resource utilization for the Rashkind PDA Oc.eluder@ concluded that surgical closure of isolated PDA was more effective and less costly than transcatheter closure.3 This study compares contemporaneous hospital charges at a single institution for closure of PDA by surgery and by transcatheter occlusion using Gianturco coils. ... All patients who underwent elective closure of a PDA at C.S. Mott Children’s Hospital between July 1992 and November 1993 were identified by From the Division of Pediatric Cardiology, Department of Pediatrics, C.S. Mott Children’s Hospital, The University of Michigan Medical Center, Ann Arbor, Michigan 48 109-0204. Dr. Fedderly’s address is: Children’s Hospital of Wisconsin, Department of Pediatric Cardiology, 9000 West Wisconsin Avenue, Milwaukee, Wisconsin 53226-35 18. Manuscript received July 2 1, 1995; revised manuscript received and accepted November 8, 1995.
776
THE AMERICAN
JOURNAL
OF CARDIOLOGY@
VOL.
77
MD,
review of cardiac catheterization and surgical records. To reduce confounding by charges of treating coexisting cardiac disease or neonatal conditions, patients aged <6 months at the time of ductus closure and patients with significant associated heart disease were excluded. Hospital bills for the remaining 44 patients were reviewed and total hospital charges ascertained. These charges included room rates and nursing care, operating room or catheterization laboratory charges, anesthesia supplies and recovery room charges, pharmacy, clinical laboratory, and radiology charges, and miscellaneous charges. Professional fees (i.e., cardiologists, surgeons, anesthesiologists, radiologists) were not included. Patients were assigned to coil occlusion or to surgery based on the preference of the referring physician or of the patient or family. Patients in the coil occlusion group were divided into 3 subgroups based on the clinical protocol in use at the time of their coil procedure. Patients in the original coil protocol had coils implanted under general anesthesia, and were observed overnight as hospital inpatients after their procedures. Right-sided cardiac catheterization was performed before coil implantation, and repeated APRll
1, 1996
immediately after implantation. Most TAME I Patient Population and Hospital Charges had transesophageal echocardioHospital Charges Number of Age grams recorded during the proce(mean + SE) Patient Group Patients (median, range) p Value p Value dure, and all had follow-up transNS* thoracic echocardiograms and chest 11 3 yr (7 mo-7 yr) Surgery NS’ All coil protocols 33 4 yr (9 mo-61 yr) roentgenograms before discharge. $5,747t 384 15 5 yr (l-30 yr) Original Patients in the intermediate coil pro$4,457?453 Intermediate 10 2 yr (9 mo-13 yr) tocol had coils implanted using loyr] $3,282 2 335 Current a 7yr(l-61 cal anesthesia and sedation, and * Comparison of surgery with all coil products. were observed overnight as inpaf Comparison among coil occlusion subgroups. tients after their procedures. Right heart catheterization was performed in this group as well. Most patients had transthoracic echocardiograms recorded during the procedure, and all had transthoracic echocardiograms and chest roentgenograms recorded before discharge. Because no instances of coil-induced left pulmonary artery stenosis were observed under the original and intermediate protocols, and because we had found angiographic estimation of ductal shunt size to be more useful than oximetry, ’ patients in the current coil protocol did not undergo right heart catheterization routinely. Coils were implanted under local anesthesia and sedation, 25 50 0 75 100 and patients were discharged after 4 PDA Coil Failure Rate (%) to 6 hours of outpatient observation. Echocardiography was not rouFIGURE 1. Hospital charges for patent ductus arteriosus (PDA) closure analysis. Estinely performed, but a chest roenttimated hospital charges for PDA closure by a coil strategy fsdid kne] plotted against the failure rate of coil occlusion. If coil occlusion were always successful genogram was recorded before dis(failure mte = O%), the charges for closure would be the charges for coil occlusion charge. alone ($3,282), and if coil occlusion were never successful, the charges for closure The hospital charge for closing a would be the charges for coil occlusion + the charges for su ($3 282 + PDA by surgical or coil occlusion $11,670 = $14,952). For comparison, the /&zond das he%Zshoklheestimated charges for the surgical strategy ($11,670). The hospital charges for the strategies was calculated using the coil stra ore less those for surgery at coil failure mks ~72%. The circle following assumptions: ( 1) surgery *in strategy line marks the observed coil failure rate of 1196, mr preon the coi is 100% effective for ductal closure; dicted charges for closure at $4,566. The hatched areas outline the 95% confi(2) all patients who do not achieve dence limits of this estimate (5% to 2T%), with their predicted charges for closure by the coil strategy ($3,866 to $5,733). complete closure by coil occlusion will subsequently undergo surgical closure; and (3) the hospital charges for surgical and January 1995, and the rate of persistent ductal shuntcoil occlusion procedures are approximated by the ing from an actuarial analysis of the first 50 patients.4 observed hospital charges for surgical closure and Comparisons between groups were made using the current coil protocol, respectively. Under these analysis of variance. A p value <0.05 was chosen to assumptions, the hospital charges for closure by sur- represent statistical significance, and Bonfetroni’s gical strategy are equal to the surgical charges, and correction was used for multiple comparisons. the hospital charges for closure by coil occlusion Of the 44 patients included in this study, 11 unstrategy are equal to the sum of the coil occlusion derwent surgical closure and 33 underwent transcharge and the product of the surgical charge and the catheter coil occlusion. There were 15 patients in the failure rate of coil occlusion. For coil occlusion, suc- original coil protocol, 10 in the intermediate coil process was defined as complete closure, as documented tocol, and 8 in the current (outpatient) coil protocol. by color flow Doppler echocardiography. The failure Of the 33 patients, 27 had no residual shunt after 1 rate of coil occlusion includes patients in whom coils catheterization, 2 went on to surgical ligation, and 3 were not successfully implanted and those in whom of the remaining 4 patients had a successful second ductal shunting persists despite coil placement. The catheterization. Mean hospital charges for all 33 coil rate of unsuccessful implantation was determined by occlusion procedures were 4 1% of the mean hospital review of the 72 PDA coil occlusion procedures per- charge for surgical closure (p = 0.0003, Table I). formed at C.S. Mott Children’s Hospital through Within the coil occlusion group, hospital charges varBRIEF REPORTS 777
ied significantly (p = 0.0008) depending on the protocol used, with the mean charge for the original coil protocol being 75% higher than the current coil protocol. The current (outpatient) coil protocol charge is 28% of the mean surgical charge (Table I). Figure 1 shows our hospital charges for PDA closure analysis. Hospital charges for the surgical strategy were estimated at $11,670 (the observed hospital charges in the surgical group), and hospital charges for the coil strategy were estimated as the observed hospital charges for the current coil protocol ($3,282) + $11,670 (coil failure rate). Our estimated coil failure.rate is based on observation of 8 failures in 72 procedures ( 11%, 95% confidence limits 5% to 21%). Of these 8 coil failures, 4 were patients in whom coils were not successfully implanted, and 4 were patients with persistent residual shunts by Doppler echocardiography following coil implantation. Our model therefore estimates the hospital charges for PDA closure by coil occlusion at $4,566 (95% confidence limits $3,866 to $5,733). The hospital charges for the coil occlusion strategy would be less than those for surgery, unless the coil failure rate was ~72%. ... We have shown that hospital charges for percutaneous coil occlusion of PDA are significantly and substantially lower than for surgical closure for contemporary patients at our institution. We have also shown that hospital charges for PDA coil occlusion have been reduced even further as the coil occlusion protocol has evolved. Importantly, we have shown that the advantage in hospital charges of coil occlusion over surgical closure of PDA persists after correcting for the failure rate of coil occlusion. We did not include professional charges in our analysis because our institution does not have a central billing office for professional fees, and complete ascertainment of all professional charges could not be assured. Charges relating to follow-up visits were also neglected in our analysis. We did so primarily because we do not yet know the most appropriate follow-up regimen for patients who have undergone coil occlusion of PDA. We currently recommend 2 or 3 visits over the first 12 months after the procedure, usually with echocardiography. This regimen is a more intensive one than the regimen we recommend after surgical closure, because coil occlusion remains an innovative treatment; as experience accumulates, a less costly follow-up regimen will likely emerge. On the other hand, echocardiographic studies in some surgical series suggest that surgically treated patients may deserve more follow-up than is usually recommended.5 The savings of the current outpatient coil protocol compared with the original inpatient protocol are encouraging. We have performed 3 1 outpatient PDA coil occlusion procedures with no morbidity related to early discharge. Sedation and local anesthesia have allowed adequate patient cooperation for coil occlusion, and neither echocardiographic guidance nor routine right heart catheter778
THE AMERICAN JOURNAL OF CARDIOLOGY@
VOL. 77
ization has proved to be necessary. We no longer believe that routine echocardiography is clinically valuable early after coil occlusion because of the documented high rate of spontaneous closure of minor residual shunts.4 The accuracy of our hospital charges for PDA closure analysis depends on the accuracy of our assumptions, which generally favor surgical closure. Our first assumption, that surgery is always effective, is belied by the fact that 3 of our coil occlusion patients had previously undergone surgical ductus ligation at other institutions. Although outstanding results have been achieved with surgical closure of PDA,6 unsuspected residual shunting has been detected in up to 22% of patients when Doppler echocardiography was performed at follow-up.’ Our second assumption, that patients with failed coil occlusion would all be treated surgically, is also biased against the coil occlusion alternative. ‘Although surgery was performed in 4 patients who did not have successful coil implantation, experience and newer technical refinements 7,8would probably have allowed subsequent successful coil occlusion in some of these patients. Of the 4 patients with persistent residual shunts after coil implantation, 3 have had successful second coil occlusion procedures, and the fourth awaits a second coil procedure (i.e., none has required surgery). Our third assumption, that hospital charges estimate the costs of the procedures, is also subject to several limitations. First, we did not include professional fees (which would favor coil occlusion) or follow-up visits (which would favor surgery). Second, we did not include nonmedical costs incurred by patients and their families during their ductus closure procedures, such as lodging and meals, child care for siblings, time off work during hospitalization, and postdischarge recovery. Because coil occlusion is an outpatient procedure, and we encourage patients to resume their usual activities within 1 to 2 days after coil occlusion, this factor also favors coil occlusion. Considering these issues, our estimate of the savings to patients, families, and health insurance carriers achieved by the coil occlusion strategy is probably conservative. We conclude that hospital charges for coil occlusion of PDA were significantly less than for surgical closure in contemporaneously treated patients at a single institution. The expected hospital charges for closure by a coil occlusion strategy, including the charges for surgical closure in patients with failed coil occlusion, were less than the hospital charges for a surgical closure strategy under any reasonable estimate of the efficacy of coil occlusion of PDA. 1. Lloyd TR, Fedderly R, Mend&&n AM, Sandhu SK, B&man RH. Transcatheter occlusion of patent ductus arteriosus with Gianturco coils. Circulation 1993;88(part 1):1412-1420. 2. Moore JW, George L, Kirkpatrick SE, Mathewson JW, Spicer RL, Uzark K, Rothman A, Cambier PA, Slack MC, Kirby WC. Percutaneous closure of the small patent ductus arteriosus using occluding spring coils. J Am Co0 Cardiol 1994;23:159-165.
APRll 1, 1996
3. Gray DT, Fyler DC, Walker AM, Weinstein MC, Chalmers TC. Clinical outcomesand costs of transcatheteras comparedwith surgical closure of patent ductus arteriosus. N Engr JMed 1993;329:1517-1523. 4. Shim D, Fedderly RT, Beekman RH, Ludomirsky A, Young ML, Schork A, Lloyd TR. Follow-up after coil occlusion of patent ductus arteriosus (abstr) J Am Co11 Cardiol 1995;331A. 5. So’rensonKE, Kristensen Bo, Hanson OK. Frequency of occurrence of residual ductal flow after surgical ligation by color-flow mapping. Am J Cardiol 1991;67:653-654.
Decrease
6. Mavroudis C, Backer CL, Gevitz M. Forty-six years of patent ductus arteriosus division at Children’s Memorial Hospital of Chicago. Standardsfor comparison. Ann Surg 1994;220:402-409. 7. Sommer RJ, Gutierrez A, Lai WW, ParnessIA. Use of preformed nitinol snareto improve transcathetercoil delivery in occlusion of patent ductus arteriosus. Am J Cardiol 1994;74:836-839. 8. Hijazi ZM, Geggel RL. Results of anterogradetranscatheterclosure of patent ductus arteriosus using single or multiple Gianturco coils. Am J Cardiol 1994:74:925-929.
in Pacemaker Incidence Heart Transplantation
Afler
Orthoto@ic
Christoph Kratochwill, MD, Susanne Schmid, MD, Jeanette Keller-Strametz, MD, Gerhard Kreiner, MD, Martin Grabenweger, MD, Michael Grimm, MD, Giinther Laufer, MD, and Gottfried Heinz, MD
neous sinus cycle length. A corrected SN recovery time of 520 ms was accepted as the upper limit of normal in the denervated transplanted heart.lm3Manported to exhibit some SN abnormality in the post- ifest SN dysfunction was assumed in the absence of operative period.5 Only 4.5% to 21% of these pa- donor atria1 activity (usually some junctional escape tients, however, will require permanent pacemaker mechanism was present) or clinically defined paceplacement for severe symptomatic SN dysfunc- maker dependence on 2 1 postoperative evaluation. tion. 4,6,7-9The aim of the present study was to ( 1) Latent SN dysfunction was defined as a prolonged evaluate the annual incidence of pacemaker place- corrected SN recovery time with or without relative ment over a 6.5-year period in a population syste- sinus bradycardia ( <80 beats/mm) .l” A substantial number of patients were screened matically screened for SN dysfunction, (2) assess any change in the type of SN abnormality, and (3) each year. The incidence of patients with pacemaker find out perioperative and demographic risk factors placement was related to the number of patients for prolonged SN dysfunction necessitating pace- screened, the number of patients exhibiting SN dysmaker placement. function, and the number of heart transplantations ... performed each year. With respect to the year 1993, A total of 185 patients had screening of SN func- the number of patients who underwent transplantation. The mean age was 49 + 10 years, and the donor tion until August 1993 was used in all analyses. Varage was 29 + 9 years. The underlying cardiac pa- ious demographic and perioperative factors were thology was dilated cardiomyopathy in 126, isch- evaluated by a stepwise logistic regression analysis, emit heart disease in 48, and end-stage valvular heart the incidence of pacemaker placement being the dedisease in 10 patients. One patient was included after pendent variable. Univariate analyses were done by successful retransplantation. St. Thomas cardio- Student’s t test and chi-square analysis. A p value plegic solution was used in 37 patients; 144 patients <0.05 was considered significant. underwent transplantation with use of Bretschneider During a 6.5-year study period, there were 131 cardioplegia. University of Wisconsin solution was patients with entirely normal SN function including used in 4 instances. The orthotopic technique of a normal corrected SN recovery time (Figure 1). Lower and Shumway was employed in all patients. Fifty-four patients had impaired SN function that Ischemic time was measured from donor aortic cross was obvious in 30 patients (manifest SN dysfuncclamp to release of the recipient aortic cross clamp. tion) . Twenty-four patients had prolonged corrected All patients had systematic evaluation of SN SN recovery time (latent SN dysfunction). Heart function including determination of SN recovery rates and corrected SN recovery time are shown in time in the first 3 postoperative weeks. SN recovery Figure 1. time was evaluated at pacing cycle lengths of 600 to Twenty-nine patients ( 15.7% of the entire study 300 ms. Temporary epicardial electrodes, placed in population screened and 53.7% of patients with imthe right donor atrium at the end of operation, were paired SN function) underwent pacemaker placeused for bipolar atria1 pacing. Correction (corrected ment for prolonged and symptomatic SN dysfuncSN recovery time) was done by subtracting sponta- tion. Most of the pacemakers were implanted before discharge. Only 3 patients had late pacemaker placeFrom the Department of Cardiology, Deportment of Cardiothoracic ment (Figure 1) . In the 3 latter cases, the severity of Surgery, University of Vienna, Vienna, Austria. Dr. Krotochwill’s adSN dysfunction was rather underestimated; SN dysdress is: Klinik fur lnnere Medizin II, Abteilung Kardiologie, Wahrinfunction had been well evident postoperatively, but ger Gtirtef 18-20, A-l 090 Vienna, Austria. Manuscript received July patients were asymptomatic and restored sinus 28, 1995; revised manuscript received and accepted November rhythm, and thus a pacemaker was not readily im15, 1995. everal groups reported a relatively high incidence of sinus node (SN) dysfunction after orthotopic S heart transplantation.‘-6 Up to 64% have been re-
BRIEF REPORTS
779