Aortic valvuloplasty (AoVP) is the therapeutic procedure

Transcription

1 Valvular Heart Disease Aortic Valvuloplasty in Pediatric Patients Substantially Postpones the Need for Aortic Valve Surgery A Single-Center Experience of 188 Patients After up to 17.5 Years of Follow-Up Sohrab Fratz, MD; Hans Peter Gildein, MD; Gunter Balling, MD; Walter Sebening, MD; Thomas Genz, MD; Andreas Eicken, MD; John Hess, MD Background Aortic valvuloplasty (AoVP) is an established procedure regarded as a valid alternative for surgical management of congenital aortic valve stenosis. However, its long-term efficacy in preventing or postponing aortic valve surgery remains uncertain for the individual patient. Therefore, the aim of this study was to study the long-term results of AoVP in pediatric patients and its efficacy in preventing or postponing aortic valve surgery. Methods and Results We reviewed up to 17.5 years of follow-up data of all 188 patients who received AoVP at the Deutsches Herzzentrum München. The patients were divided into those 1 month of age (group 1 month; n 68) and those 1 month of age (group 1 month; n 1) at the time of AoVP. After the first and second AoVP, moderate and severe aortic regurgitation developed in 9% and 14%, respectively, of the patients in group 1 month and in 19% and 9%, respectively, of the patients in group 1 month. Survival after 1 years free from aortic valve surgery was 59% (95% confidence interval, 45 to 73) in group 1 month and 7% (95% confidence interval, 59 to 81) in group 1 month. Conclusions This study shows that the long-term results of AoVP of congenital aortic valve stenosis in pediatric patients and its efficacy in preventing or postponing aortic valve surgery are very good. About two thirds of the patients are free from aortic valve surgery 1 years after AoVP. (Circulation. 8;117:11-16.) Key Words: aortic valve stenosis balloon catheterization pediatrics valvuloplasty Aortic valvuloplasty (AoVP) is the therapeutic procedure of choice in most centers for the treatment of congenital aortic valve stenosis in pediatric patients, 1, even though no randomized controlled trials have been conducted to allow a valid comparison of aortic valve surgery (surgical valvotomy, Ross operation, mechanical aortic valve replacement) and AoVP. Only comparative nonrandomized controlled trials have compared surgical valvotomy and AoVP. 3,4 The immediate (in the catheterization laboratory) and short-term (before discharge) results of AoVP have been well studied Clinical Perspective p 16 Additionally, long-term studies have well described the rapid progressive or recurrent gradient across the aortic valve and progressive aortic regurgitation after AoVP Therefore, it is assumed that many patients require subsequent AoVP and/or aortic valve surgery after successful AoVP.,16 However, the long-term efficacy of AoVP in preventing or postponing aortic valve surgery remains uncertain for the individual patient. Therefore, the aim of this study was to determine the long-term results of AoVP of congenital aortic valve stenosis in pediatric patients and its efficacy in preventing or postponing aortic valve surgery. The long-term results of AoVP were determined by reviewing up to 17.5 years of follow-up data of all 188 patients who received AoVP at the Deutsches Herzzentrum München between January 1986 and July 4. Methods Starting in January 1986, AoVP has been used in our institution as the only method of treatment of pediatric aortic valve stenosis. The indication for AoVP was based on a modification of the method of Hossack et al. 17 In brief, the indication for AoVP was a Doppler peak instantaneous gradient of 75 mm Hg or a smaller gradient with signs of left ventricular strain on the ECG, syncope, angina pectoris, fatigue on exercise, cardiogenic shock, low cardiac output, severe left ventricular dysfunction, or duct-dependent circulation. In 1998, the Norwood operation was introduced in our institution for treatment of hypoplastic left heart syndrome. To determine which patients would be offered a Norwood operation, criteria according to Rhodes et al 18 were used. Received January 4, 7; accepted December 7, 7. From the Department of Pediatric Cardiology and Congenital Heart Disease, Deutsches Herzzentrum München, Klinik an der Technischen Universität München, Munich, Germany. Correspondence to Sohrab Fratz, MD, Department of Pediatric Cardiology and Congenital Heart Disease, Deutsches Herzzentrum München, Klinik an der Technischen Universität München, Lazarettstrasse 36, 8636 Munich, Germany. fratz@dhm.mhn.de 8 American Heart Association, Inc. Circulation is available at DOI: /CIRCULATIONAHA

2 1 Circulation March 4, 8 group < 1 mo 1st AoVP: 68 (1%) 5 ( -8) days 1 (1%) 4.5 (.1 -.) yrs nd AoVP: 7 (1%).7 ( ) mo 14 (1%) 8.8 ( ) yrs Figure 1. Number, percentage, age, and interventions of group 1 month and group 1 month at the time of AoVP. surgery: 1 (1%) 1. yrs 9 (13%) 1. (.1-1.9) yrs 7 (6%) 11.4 ( ) yrs (17%) 13.5 (.7-3.) yrs In most cases, percutaneous access for AoVP was retrograde via the femoral artery. Until 1994, percutaneous access was retrograde via the brachial artery. Percutaneous access was antegrade via the foramen ovale and mitral valve in only a few cases. The most important reason for the different percutaneous access was the evolution of catheters and balloons throughout the study period. The charts of all consecutive patients who received an AoVP at our institution were reviewed. Patients with previous cardiac intervention or surgery and patients with significant cardiac malformations other than associated coarctation of the aorta were excluded. Up to July 4, 188 consecutive patients were treated by AoVP without having a previous cardiac intervention or surgery. All 188 patients were included in this study. All patients were divided into groups: a group of patients 1 month of age (group 1 month) and a group of patients 1 month of age (group 1 month) at the time of their first AoVP. Pressure Gradient The systolic pressure peak-to-peak gradients across the aortic valve before and immediately after the first and, if applicable, second AoVP were evaluated. Box plots were used to display the data graphically. The box of the box plots marks the 5th (first quartile) to 75th (third quartile) percentiles; the bold line within the box marks the median. The whiskers above and below the box represent the largest and smallest data points that are 1.5 box lengths (interquartile range) away from the end of the box. Open circles highlight data points 1.5 box lengths away (outliers). Aortic Regurgitation Aortic regurgitation before and after the first and, if applicable, second AoVP was evaluated. Aortic regurgitation was assessed echocardiographically as trivial, mild (regurgitation without a reverse diastolic flow in the aortic arch), moderate (reverse diastolic flow in the aortic arch but not in the abdominal aorta), or severe (reverse diastolic flow in the abdominal aorta). 19 If applicable, aortic regurgitation shortly before subsequent aortic valve surgery also was evaluated. LVEDd, LVEF, and LVFS Left ventricular dimension at end diastole (LVEDd), left ventricular ejection fraction (LVEF), and left ventricular shortening fraction (LVFS) at the last follow-up were evaluated in all surviving patients without subsequent aortic valve surgery who were not lost to follow-up. LVEDd was measured by echocardiography as previously described. LVEDd was expressed as normal or SD above the mean of the normal population as determined by Kampmann et al. LVEDd was expressed in relation to body weight in newborn infants weighing to 4 kg because an increase in body weight does not lead to a concomitant increase in body surface area at that stage of life. LVEDd was expressed in relation to body surface area 1 in older children and adults. LVEF and LVFS were measured by echocardiography as previously described. LVEF and LVFS were expressed as normal, larger than, or smaller than the 95% prediction interval limits determined by Henry et al. 3 LVEDd, LVEF, and LVFS were obtained from archived medical records. Survival Analyses End points were defined as second AoVP, subsequent aortic valve surgery, and death. Median and limits of the age of the groups were calculated at the time of the first AoVP and at the end points. If the last follow-up was before 3, the patient, the parents of the patient, or the local pediatrician of the patient was contacted to ascertain that no end point had been reached. All patients, the parents of the patients, or the local pediatricians of the patients were able to be contacted. Three Kaplan Meier survival analyses were carried out for both groups as previously described. 4 For the first survival analysis, adverse events were defined as second AoVP, surgery, or death. For the second survival analysis, adverse events were defined as surgery or death. For the third survival analysis, adverse events were defined as death. Statistical analysis was performed with SPSS version 1..1 (SPSS Inc, Chicago, Ill). The authors had full access to and take full responsibility for the integrity of the data. All authors have read and agree to the manuscript as written. Results Sixty-eight patients (14 female patients) were in group 1 month; 1 patients (34 female patients) were in group 1 month (Figure 1). The age of the patients at the time of their first AoVP was a mean of days (median, 5.5; limits, to 8) in group 1 month and a mean of years (median, 4.5; limits,.1 to ) in group 1 month. The age of the patients at subsequent aortic valve surgery, death, or last follow-up was a mean of years (median,.8 years; limits,. to 17.5) in group 1 month and a mean of years (median, 1.3; limits,.3 to 6.5) in group 1 month. The time between the first AoVP and subsequent aortic valve surgery, death, or last follow-up was a mean of years (median,.8; limits,. to 17.5) in group 1 month and a mean of years (median, 5.7; limits,. to 16.1) in group 1 month. Pressure Gradient The systolic pressure gradient across the aortic valve immediately after the first and second AoVP decreased significantly in both groups (Figure ). For 7 patients in group 1 month (1%) and 14 patients in group 1 month (1%), the systolic pressure gradient across the aortic valve progressed or recurred after the first AoVP before the second AoVP or surgery. Aortic Regurgitation Moderate or severe aortic regurgitation developed after the first AoVP in of 68 patients in group 1 month (9%). Seven of these patients were subsequently treated surgi-

3 Fratz et al AoVP Postpones Aortic Valve Surgery gradient [mmhg] pre (n=68) post (n=64) pre (n=7) post (n=7) 1st AoVP nd AoVP 15 group > 1 mo 1 gradient [mmhg] cally; 1 additional patient is awaiting surgery. Of the remaining 1 patients, 4 died shortly after the first AoVP, and 8 have moderate aortic regurgitation. Of these 8 patients, 5 have normal LVEDd. Two patients have increased LVEDd but normal LVEF and LVFS. One patient was lost to follow-up. Moderate or severe aortic regurgitation developed after the first AoVP in 3 of 1 patients in group 1 month (19%). Of these 3 patients, 11 were subsequently treated surgically. The remaining 1 patients have moderate or severe aortic regurgitation. Only 4 of these patients had LVEDd SD above the mean of the normal population. All 4 patients have normal LVEF and LVFS. Moderate or severe aortic regurgitation developed after the second AoVP in 1 of 7 patients in group 1 month (14%) and in 4 of 14 patients in group 1 month (9%). All 5 patients were subsequently treated surgically. The indication for surgery of the aortic valve was moderate or severe aortic regurgitation in 7 of 1 patients in group 1 month (7%) and in 15 of 7 patients in group 1 month (56%). LVEDd, LVEF, and LVFS LVEDd was available in 3 patients in group 1 month and in 64 patients in group 1 month at follow-up. LVEDd was SD above the mean of the normal population in 9 pre (n=1) post (n=118) pre (n=14) post (n=14) 1st AoVP nd AoVP Figure. Systolic pressure gradients across the aortic valve of patients in group 1 month and group 1 month at the time of the first and second AoVP. Box plots are used to graphically display the data. The box of the box plots marks the 5th (first quartile) to 75th (third quartile) percentiles; the bold line within the box, the median. The whiskers above and below the box represent the largest and smallest data points that are 1.5 box lengths (interquartile range) away from the end of the box;, data points 1.5 box lengths away (outliers). patients (8%) in group 1 month and in 17 patients (7%) in group 1 month. LVEF was available in patients in group 1 month and in 56 patients in group 1 month at follow-up. LVEF was larger than the 95% prediction interval limits 3 in 9 patients (41%) in group 1 month and in patients (36%) in group 1 month. LVEF was smaller than the 95% prediction interval limits 3 in 5 patients (3%) in group 1 month and in none of the patients (%) in group 1 month. LVFS was available in 34 patients in group 1 month and in 64 patients in group 1 month at follow-up. LVFS was larger than the 95% prediction interval limits 3 in 13 patients (38%) in group 1 month and in 1 patients (33%) in group 1 month. LVFS was smaller than the 95% prediction interval limits 3 in patients (6%) in group 1 month and in none of the patients (%) in group 1 month. Survival Analyses Survival free from aortic valve surgery or second AoVP is depicted in Figure 3, and survival free from surgery is depicted in Figure 4. Figure 5 shows survival. Seventeen (5%) of the patients in group 1 month died during follow-up. Because the Norwood operation was introduced in our institution in 1998 for treatment of hypoplastic left heart syndrome, we analyzed the mortality of group 1

4 14 Circulation March 4, 8 [%] [%] month before and after Before 1998, 15 patients (%) in group 1 month died. After 1998, patients (3%) in group 1 month died. Therefore, mortality in group 1 month decreased from 38% before 1998% to 7% after Three patients (3%) in group 1 month died during follow-up. The first patient, a 5-year old woman, had a sudden death at home awaiting aortic valve replacement surgery. She had AoVP at the age of 11 years and had endocarditis with subsequent grade 3 aortic regurgitation at the age of 18 years. The second patient, a 9-month old prematurely born male infant with multiple respiratory tract infections, died of sepsis. He had AoVP at the age of months. The third patient, a 4-month old prematurely born female infant, also died of sepsis. She had AoVP at the age of 3 months and coarctation repair at the age of 4 months and died in the postoperative course of sepsis. Discussion This study shows that the long-term results of AoVP of congenital aortic valve stenosis in pediatric patients and its efficacy in preventing or postponing aortic valve surgery are very good. Survival after 1 years free from aortic valve [%] [yrs] Figure 3. Survival after 1 years free from aortic valve surgery or second AoVP was 47% (95% CI, 3 to 6) in group 1 month and 63% (95% CI, 5 to 85) in group 1 month. The tic marks represent the times at which patients were censored; the numbers of patients at risk are displayed above the graph [yrs] Figure 4. Survival after 1 years free from aortic valve surgery was 59% (95% CI, 45 to 73) in group 1 month and 7% (95% CI 59 to 81%) in group 1 month. The tic marks represent the times at which patients were censored; the numbers of patients at risk are displayed above the graph [yrs] Figure 5. Survival after 1 years was 71% (95% CI, 57 to 85) in group 1 month and 98% (95% CI, 96 to 1%) in group 1 month. Note the high rate of early deaths in group 1 month, which are the major cause of the difference between groups in Figures 3 and 4. The tic marks represent the times at which patients were censored; the numbers of patients at risk are displayed above the graph. surgery was 59% (95% confidence interval [CI], 45 to 73) in group 1 month and 7% (95% CI, 59 to 81) in group 1 month (Figure 4). It is important to note that our treatment strategy uses AoVP as an initial palliation for patients with congenital aortic valve stenosis. AoVP as an initial palliation is followed by optional secondary aortic valve surgery. Secondary aortic valve surgery seems to be inevitable for a significant number of patients in the long run. Progressive or recurrent systolic pressure gradient across the aortic valve has previously been identified as an important indication for a second AoVP The systolic pressure gradient across the aortic valve decreased significantly after the first AoVP in both groups (Figure ). However, in our study, only 1% of the patients in both groups had a progressive or recurrent systolic pressure gradient leading to a second AoVP. Aortic regurgitation has previously been identified as the main indication for aortic valve surgery after AoVP In addition, in our study, aortic regurgitation was moderate or severe in 7% of the patients in group 1 month and 56% of the patients in group 1 month shortly before aortic valve surgery after AoVP. However, immediately after the first AoVP, moderate or severe aortic regurgitation developed in only 9% of the patients in group 1 month and 19% of the patients in group 1 month. About half of these patients were subsequently treated surgically. The other half was closely followed echocardiographically to monitor the LVEDd, LVEF, and LVFS. Even after the second AoVP, moderate or severe aortic regurgitation developed in only 14% of the patients in group 1 month and 9% of the patients in group 1 month. All these patients were subsequently treated surgically. It is important to note that during the study period AoVP was carried out by only 3 interventionalists. Therefore, we assume that the avoidance of a learning curve and the consistency of treatment strategy and patient selection throughout the years may have contributed to our low aortic regurgitation rates.

5 Fratz et al AoVP Postpones Aortic Valve Surgery 15 It is known that a significant number of patients after both AoVP and aortic valve surgery 5 9 inevitably require aortic valve replacement for progressive aortic regurgitation at some point. However, no studies exist that allow a valid comparison of AoVP and aortic valve surgery. Throughout the literature, the indication for intervention and reintervention varies significantly. All studies comparing AoVP and aortic valve surgery are retrospective and nonrandomized, consist of different age groups, and use different techniques during different periods of time. Nevertheless, AoVP and aortic valve surgery seem comparable in terms of immediate gradient relief, procedural mortality, and longer-term survival. 3,4,9 14,16,5 3 Therefore, both AoVP and aortic valve surgery should be seen as palliative procedures. However, if a treatment strategy is adopted that uses AoVP as the initial palliation instead of initial aortic valve surgery, patients may benefit from at least 1 fewer open heart surgery in their life, thus lowering the risk of reoperation resulting from scar tissue and decreasing the risk of the neurodevelopmental consequences of cardiopulmonary bypass. 33 An important limitation of our study is that we do not have precise anatomic data on each valve treated. Therefore, we cannot correlate outcome with specific types of valve abnormalities. For example, the interventional cardiologist often is confronted with the problem of a severely abnormal stenotic aortic valve, usually bicuspid, unicuspid, or with a rudimentary third cusp. AoVP in these types of valves distributes circumferential force unevenly and may therefore disrupt the cusps unevenly. Hence, some of these valves were subjectively judged as not suitable for AoVP and were not included in this study. Therefore, we cannot determine which anatomic configurations are likely to lead to early failure. However, bicuspid valves are known to be a risk factor for both aortic regurgitation and subsequent reintervention. 14 Therefore, it is possible that surgery would offer a greater benefit in selected subsets of patients. However, even though some have attempted to repair these valves surgically, 34,35 it seems that these valves require valve replacement early regardless of the approach. 36 Therefore, the high reintervention rate in this type of aortic valve may suggest an even stronger argument for AoVP as the initial palliation for patients with congenital aortic valve stenosis because it avoids the risk of reoperation in a patient in whom reintervention is almost certain. Another limitation of our study is that the outcome was most likely influenced by patient selection. The reason is that some patients with abnormal valves were subjectively judged as not suitable for AoVP and therefore not included in this study. However, we are fairly sure that patient selection was relatively consistent because a single interventionalist (W.S.) carried out 9% of the cases. Conclusions This study shows that the long-term results of AoVP of congenital aortic valve stenosis in pediatric patients and its efficacy in preventing or postponing aortic valve surgery are very good. About two thirds of the patients are free from aortic valve surgery 1 years after AoVP. None. Disclosures References 1. Lababidi Z. Aortic balloon valvuloplasty. Am Heart J. 1983;16: Thomson JD. Management of valvar aortic stenosis in children. Heart. 4;9: Justo RN, McCrindle BW, Benson LN, Williams WG, Freedom RM, Smallhorn JF. Aortic valve regurgitation after surgical versus percutaneous balloon valvotomy for congenital aortic valve stenosis. 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6 16 Circulation March 4, 8 NH, Tajik AJ. Recommendations for quantitation of the left ventricle by two-dimensional echocardiography: American Society of Echocardiography Committee on Standards, Subcommittee on Quantitation of Two- Dimensional Echocardiograms. J Am Soc Echocardiogr. 1989;: Henry WL, Ware J, Gardin JM, Hepner SI, McKay J, Weiner M. Echocardiographic measurements in normal subjects: growth-related changes that occur between infancy and early adulthood. Circulation. 1978;57: Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53: Kugelmeier J, Egloff L, Real F, Rothlin M, Turina M, Senning A. Congenital aortic stenosis: early and late results of aortic valvulotomy. Thorac Cardiovasc Surg. 198;3: Hsieh KS, Keane JF, Nadas AS, Bernhard WF, Castaneda AR. Long-term follow-up of valvotomy before 1968 for congenital aortic stenosis. Am J Cardiol. 1986;58: Keane JF, Driscoll DJ, Gersony WM, Hayes CJ, Kidd L, O Fallon WM, Pieroni DR, Wolfe RR, Weidman WH. Second natural history study of congenital heart defects: results of treatment of patients with aortic valvar stenosis. Circulation. 1993;87(suppl):I-16 I Alexiou C, Chen Q, Langley SM, Salmon AP, Keeton BR, Haw MP, Monro JL. Is there still a place for open surgical valvotomy in the management of aortic stenosis in children? The view from Southampton. Eur J Cardiothorac Surg. 1;: Detter C, Fischlein T, Feldmeier C, Nollert G, Reichart B. Aortic valvotomy for congenital valvular aortic stenosis: a 37-year experience. Ann Thorac Surg. 1;71: McCrindle BW. Independent predictors of immediate results of percutaneous balloon aortic valvotomy in childre Valvuloplasty and Angioplasty of Congenital Anomalies (VACA) Registry Investigators. Am J Cardiol. 1996;77: Jindal RC, Saxena A, Juneja R, Kothari SS, Shrivastava S. Long-term results of balloon aortic valvulotomy for congenital aortic stenosis in children and adolescents. J Heart Valve Dis. ;9: Lambert V, Obreja D, Losay J, Touchot-Kone A, Piot JD, Serraf A, Lacour-Gayet F, Planche C. Long-term results after valvotomy for congenital aortic valvar stenosis in children. Cardiol Young. ;1: Bellinger DC, Jonas RA, Rappaport LA, Wypij D, Wernovsky G, Kuban KC, Barnes PD, Holmes GL, Hickey PR, Strand RD. Developmental and neurologic status of children after heart surgery with hypothermic circulatory arrest or low-flow cardiopulmonary bypass. N Engl J Med. 1995; 33: Fraser CD Jr, Wang N, Mee RB, Lytle BW, McCarthy PM, Sapp SK, Rosenkranz ER, Cosgrove DM 3rd. Repair of insufficient bicuspid aortic valves. Ann Thorac Surg. 1994;58: Tolan MJ, Daubeney PE, Slavik Z, Keeton BR, Salmon AP, Monro JL. Aortic valve repair of congenital stenosis with bovine pericardium. Ann Thorac Surg. 1997;63: van Son JA, Reddy VM, Black MD, Rajasinghe H, Haas GS, Hanley FL. Morphologic determinants favoring surgical aortic valvuloplasty versus pulmonary autograft aortic valve replacement in children. J Thorac Cardiovasc Surg. 1996;111: CLINICAL PERSPECTIVE Aortic valvuloplasty (AoVP) of congenital aortic valve stenosis is an established procedure regarded as a valid alternative for surgical management. However, its long-term efficacy in preventing or postponing aortic valve surgery remains uncertain for the individual patient. Therefore, the aim of this study was to examine the long-term results of AoVP in pediatric patients and its efficacy in preventing or postponing aortic valve surgery. This study reviewed up to 17.5 years of follow-up data of all 188 patients who received AoVP at the Deutsches Herzzentrum München in Munich, Germany. The patients were divided into those 1 month of age (group 1 month; n 68) and those 1 month of age (group 1 month; n 1) at the time of AoVP. After the first and second AoVP, moderate and severe aortic regurgitation developed in 9% and 14%, respectively, of the patients in group 1 month and in 19% and 9%, respectively, of the patients in group 1 month. Survival after 1 years free from aortic valve surgery was 59% (95% confidence interval, 45 to 73) in group 1 month and 7% (95% confidence interval, 59 to 81) in group 1 month. This study shows that the long-term results of AoVP of congenital aortic valve stenosis in pediatric patients and its efficacy in preventing or postponing aortic valve surgery are very good. About two thirds of the patients are free from aortic valve surgery 1 years after AoVP.