Late Electrical and Mechanical Remodeling After Atrial Septal Defect Closure in Children: Surgical Versus Percutaneous Approach Biagio Castaldi, MD, Vladimiro L. Vida, MD, PhD, Anna Argiolas, MD, Nicola Maschietto, MD, PhD, Alessia Cerutti, MD, Dario Gregori, MA, PhD, Giovanni Stellin, MD, and Ornella Milanesi, MD Departments of Women’s and Children’s Health and Cardiac, Thoracic and Vascular Sciences, and Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy
Background. Conflicting data were reported about normalization of sizes of right chambers, systolic and diastolic function and prevalence of arrhythmias after ostium secundum atrial septal defect closure. We sought to compare surgical and percutaneous approaches in terms of arrhythmias, right chamber volumes, and function at long-term follow-up. Methods. In all, 107 patients were enrolled, all corrected at pediatric age. Forty-four of them were treated surgically with a right thoracotomy approach and 63 were treated percutaneously. All patients underwent a standard echocardiogram and electrocardiographic Holter examinations. Results. No difference was detected between the two groups regarding right atrial or ventricular volumes. The global right ventricular function assessed by fractional area change was similar between the two groups. However, the longitudinal function and the diastolic function were significantly impaired in the surgical
group (tricuspid annulus peak systolic excursion 23.7 ± 4.5 mm versus 18.7 ± 3.5 mm, p < 0.001; S’ wave 13.7 ± 3.1 cm/s versus 9.8 ± 2.4 cm/s, p < 0.001; E/E’ 4.7 ± 1.7 versus 7.1 ± 2.9, p < 0.001). There was a low incidence of supraventricular couples or runs, but slightly higher in the surgical group (6.8% versus 1.6%), although not statistically significant. No echocardiographic variable related to ventricular or supraventricular arrhythmic events. Conclusions. Either surgical or percutaneous closure of atrial septal defect have a similar efficacy on the volume normalization of the right chamber. Modern surgical techniques have a limited impact on the systolic and diastolic function as well as on the arrhythmic risk; however, the right ventricular longitudinal and diastolic function seems to be better preserved in the percutaneous group. (Ann Thorac Surg 2015;-:-–-) Ó 2015 by The Society of Thoracic Surgeons
O
procedures for ASD closure [4–9] is presently available. However, most of these studies have enrolled only adult patients or patients of very different age groups. Moreover, percutaneous closures of ASD and patent foramen ovale have been often analyzed together [6, 7]. The aim of this study is to evaluate the incidence of long-term arrhythmias and remodeling of the right-side heart chambers in pediatric patients with ASD who were treated surgically (through a right minithoracotomy) or underwent a percutaneous ASD closure.
stium secundum atrial septal defect (ASD) is a relatively frequent congenital heart defect, occurring in approximately 1 in 1,000 live births [1, 2]. If compared with the previous decades, expanded screening programs in neonatology, pediatrics, and sport medicine have allowed early detection of patients with ASD. These patients are usually treated during infancy, when they are still asymptomatic, to prevent ASD-related complications such as irreversible right ventricular (RV) dilation, arrhythmias, and heart failure. As a consequence, the 25-year survival of patients with ASD who undergo correction before the age of 12 is 98%, compared with 99% of healthy patients. This difference in survival rates is directly proportional to age at correction (93% versus 97% when corrected between 12 and 24 years of life; 40% versus 59% when corrected after 41 years of life) [3]. Much information about the efficacy, the safety, and the cost effectiveness of percutaneous and surgical
Patients and Methods Enrollment All patients aged less than 16 years at correction and who had been treated for ostium secundum ASD closure in our unit from 2000 to 2012 were considered eligible for this study. For logistical reasons, only residents in the
Accepted for publication March 10, 2015. Address correspondence to Dr Castaldi, Pediatric Cardiology Unit, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, Padova 3-35128, Italy; e-mail: [email protected].
Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
Drs Castaldi, Maschietto, and Milanesi disclose financial relationships with WL Gore.
0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2015.03.017
2
CASTALDI ET AL LONG-TERM FOLLOW-UP AFTER ASD CLOSURE
Veneto Region were involved. The presence of comorbidities such as more than mild valvulopathies, other septal defects, anomalous venous return, pneumologic diseases, bronchodysplasia, hepatic or renal failure, and genetic syndromes were considered exclusion criteria for participation. The patients were divided into two groups: in the first group were included patients treated with percutaneous device implantation (PG group); in the second were those treated surgically (SG group), by using a minimally invasive approach by means of a right anterior minithoracotomy [10]. Seventy-two patients were eligible to be enrolled in the first group; among them, 2 were lost to follow-up and 6 refused to give consent to the study. Sixty patients were eligible for the second group; however, 6 of them were lost to follow-up and 10 refused to give consent to participate in the study. The percutaneous procedure was performed as the first-choice treatment of patients with a single defect or with a multiple fenestration defect because, in these patients, with ASD diameter less than 20 mm and adequate rims (with the exception of the aortic rim), ASD could be closed by a single device. Among patients enrolled in the second group, the surgical procedure was preferred for the following reasons: too large ASD in 10 patients, multiple ASD defects in 12, deficient rims in 12, and parental choice in 10. The Clinical Investigation Committee of the University Hospital of Padua approved the study in accordance with the institutional guidelines for retrospective record review.
Percutaneous Closure Percutaneous closure procedures for each device have been already described [11–13]. Devices used for ASD closure were the Amplatzer Septal Occluder (St. Jude Medical, Plymouth, MN) and Helex or Gore Septal Occluder (WL Gore & Associates, Flagstaff, AZ).
Surgical Technique We made a 2 cm to 4 cm semilunar incision in the sulcus of the right breast (6 cm to 8 cm away from the nipple area) by entering the chest in the fourth intercostal space. In prepubertal children, the incision is kept very low under the right nipple, especially in female patients, with the aim to avoid any possible future interference with breast development. Subcutaneous fat and mammary gland were gently dissected from the fascia up to the fourth intercostal space, where the chest cavity was entered. The incision of the intercostal space was approximately 1 cm longer than the skin incision at each side. Video-assisted optical technology by means of a 5mm 0-degree optical scope, inserted through a separate 5-mm incision in the fourth intercostal space, was often used to implement surgical vision. In patients weighing more than 18 kg who underwent a peripheral cannulation, the superior vena cava was usually occluded with a cross clamp, inserted through a 5-mm separate lateral incision (later utilized for inserting a chest drain).
Ann Thorac Surg 2015;-:-–-
According to our minimally invasive surgical technique, direct aortic and bicaval cannulation was used in patients with body weight less than 18 kg. Since 2006, we have used for patients with higher weight a peripheral arterial and venous cannulation to establish the cardiopulmonary bypass; that has been achieved by means of percutaneous cannulation of the superior vena cava through the right jugular vein, followed by surgical isolation and cannulation of the femoral vessels. The intracardiac repair was then carried out on induced ventricular fibrillation.
Follow-Up Study All eligible patients were contacted and invited to undergo a clinical and instrumental evaluation, including a two-dimensional echocardiogram and 24-hour Holter electrocardiographic monitoring. Demographic, procedural, and clinical data were then collected (device size, stretched diameter, periprocedural complications, palpitations occurrence, and so forth).
Echocardiography The echocardiographic study was performed using a Philips iE33 echo machine and a S5-1 probe (Philips Healthcare, Andover, MA). The right and left ventricular function was evaluated by following the recommendations of the American Society of Echocardiography [14– 16]. In particular, pulsed wave Doppler interrogation of left ventricular inflow was performed in apical 4-chamber view; early diastolic velocity (E) and late diastolic velocity (A) were obtained by positioning a 3-mm sample volume between the mitral or tricuspid leaflet tips during diastole. The E/A ratio was used as a pattern of mitral and tricuspid inflow. Pulsed wave tissue Doppler imaging was performed in apical 4-chamber view to sample both the systolic excursion velocity (S’) and the early and late diastolic excursion velocities (E’ and A’, respectively) of mitral and tricuspid annulus. The fractional area change, the tricuspid annulus peak systolic excursion, and the S’ wave of tricuspid annulus by tissue Doppler were analyzed to rate the RV systolic function. Systolic longitudinal RV dysfunction occurred when the tricuspid annulus peak systolic excursion was 16 mm or less or the S’ wave of the tricuspid annulus was 9 cm/s or less, or both. The E/A ratio and the E/E’ ratio were used to rate the RV diastolic function. The right atrium and the left atrium areas were calculated to assess the occurrence of the right atrial enlargement. An E/A ratio less than 0.8 or greater than 2.5 or an E/E’ ratio 8 or greater were considered as cutoff values to assess RV diastolic dysfunction. The right atrium and the left atrium areas were calculated to evaluate the occurrence of right atrial enlargement.
Holter Electrocardiography The 24-hour Holter registration was performed using a Cardioline 400h device (Cardioline SPA, Trento, Italy). The postprocessing analysis was further completed through dedicated software (Cardioline CubeHolter version 5.1). Supraventricular extrasystolic beats (SVEB)
Ann Thorac Surg 2015;-:-–-
3
CASTALDI ET AL LONG-TERM FOLLOW-UP AFTER ASD CLOSURE
and ventricular extrasystolic beats (VEB) were classified according to the Lown classification. The SVEB classification is as follows: class 0, no SVEB; class I, 10 or fewer SVEB per hour; class II, more than 10 SVEB per hour; class III, polymorphic SVEB; class IV, supraventricular couples; class V, atrial tachycardia, atrial fibrillation, or atrial flutter; and class VI, multifocal atrial tachycardia. The VEB classification is as follows: class 0, no VEB; class I, 30 or fewer VEB per hour, monomorphic; class II, greater than 30 VEB per hour, monomorphic; class III, polymorphic VEB; class IV, couples or monomorphic runs; class V, R on T VEB.
Statistical Analysis Continuous variables are expressed with interquartile range as a measure of variability. The impact of surgery on RV diastolic dysfunction, RV longitudinal systolic dysfunction, and residual RV dilation have been evaluated by using a set of three logistic models, always adjusted for age, body surface area, and preoperative dilation, regardless of their statistical significance. Model fit was considered significantly improved on the basis of the Akaike information criterion. Cross-validation and bootstrap (1,000 runs) techniques were applied. Somer’s concordance index Dxy (the closer the absolute value is to 1, the better it is) was obtained for the purposes of goodness-of-fit evaluation and adjusted for optimism by using bootstrap (1,000 runs). The statistical significance was set at p less than 0.05. The R system statistical package [17] and Harrell’s rms libraries were used for analysis (FEJ Harrell, Regression Modeling Strategies, 2013).
Results Patients’ general characteristics are summarized in Table 1. All patients in the first group were treated by using a single device—an Amplatzer septal occluder device in 51 (interquartile range, 12/16/18 mm) and a Gore device in the remaining 12 patients (15 mm in 1, 20 mm in 4, 25 mm in 4, and 30 mm in 3). All surgical enrolled patients were approached by means of a right
Fig 1. Histogram showing the frequency of the two approaches over the time (years 2000 to 2012). The blue bars indicate the surgical procedures and the red bars, percutaneous closure.
thoracotomy, the defect was closed, either by using a patch in 39% or by direct suture in 61%. The frequency of both approaches over the time is shown in Figure 1. The ASD diameter was larger in the surgical group (interquartile range, 9/11/14 mm versus 11.5/ 15.5/18 mm, respectively; p < 0.001). However, the grading of RV enlargement was similar between the two groups (p ¼ 0.726; Table 1). At intervention, the two groups had similar age (PG 5, 7, and 11 years versus SG 5, 7.5, and 12 years; p ¼ 0.448), weight (PG 40/54/64.5 kg and SG 45/60/68.2 kg, p ¼ 0.283), and height (150/160/170 cm and 152.2/165/ 172.5 cm, p ¼ 0.236) at evaluation. The surgical group had a longer follow-up (PG 4/5/8 and SG 5/8.5/11 years, p < 0.001). No residual shunts were detected during follow-up. The systolic function of the left ventricle was normal and similar in both groups (Table 2). The RV fractional area change was normal and comparable between groups (PG 0.37/0.42/0.46 and SG 0.34/0.41/ 0.47, p ¼ 0.571); however, the RV longitudinal function assessed by tricuspid annulus peak systolic excursion and by tissue Doppler (S’ wave) was considerably reduced in the surgical group as compared with the device group (20.4/23.0/26.0 versus 16.0/18.3/20.7 mm
Table 1. Patient Characteristics Characteristics
Device Group
Surgical Group
Combined
p Value
Female Age at intervention, years Follow-up length, years Defect size, mm, median Right ventricular dilation Mild Moderate Severe Weight, kg Height, cm Body surface area, m2
74.6 (47) 5.0/7.0/11.0 4.0/5.0/8.0 9.0/11.00/14.0
79.5 (35) 5.0/7.5/12.0 5.0/8.5/11.0 11.7/15.5/18.0
76.6 (82) 5.0/7.0/11.0 4.0/7.0/10.0 10.0/12.0/16.0
0.552 0.448
Background. Conflicting data were reported about normalization of sizes of right chambers, systolic and diastolic function and prevalence of arrhythmias after ostium secundum atrial septal defect closure. We sought to compare surgical and percutaneous approaches in terms of arrhythmias, right chamber volumes, and function at long-term follow-up. Methods. In all, 107 patients were enrolled, all corrected at pediatric age. Forty-four of them were treated surgically with a right thoracotomy approach and 63 were treated percutaneously. All patients underwent a standard echocardiogram and electrocardiographic Holter examinations. Results. No difference was detected between the two groups regarding right atrial or ventricular volumes. The global right ventricular function assessed by fractional area change was similar between the two groups. However, the longitudinal function and the diastolic function were significantly impaired in the surgical
group (tricuspid annulus peak systolic excursion 23.7 ± 4.5 mm versus 18.7 ± 3.5 mm, p < 0.001; S’ wave 13.7 ± 3.1 cm/s versus 9.8 ± 2.4 cm/s, p < 0.001; E/E’ 4.7 ± 1.7 versus 7.1 ± 2.9, p < 0.001). There was a low incidence of supraventricular couples or runs, but slightly higher in the surgical group (6.8% versus 1.6%), although not statistically significant. No echocardiographic variable related to ventricular or supraventricular arrhythmic events. Conclusions. Either surgical or percutaneous closure of atrial septal defect have a similar efficacy on the volume normalization of the right chamber. Modern surgical techniques have a limited impact on the systolic and diastolic function as well as on the arrhythmic risk; however, the right ventricular longitudinal and diastolic function seems to be better preserved in the percutaneous group. (Ann Thorac Surg 2015;-:-–-) Ó 2015 by The Society of Thoracic Surgeons
O
procedures for ASD closure [4–9] is presently available. However, most of these studies have enrolled only adult patients or patients of very different age groups. Moreover, percutaneous closures of ASD and patent foramen ovale have been often analyzed together [6, 7]. The aim of this study is to evaluate the incidence of long-term arrhythmias and remodeling of the right-side heart chambers in pediatric patients with ASD who were treated surgically (through a right minithoracotomy) or underwent a percutaneous ASD closure.
stium secundum atrial septal defect (ASD) is a relatively frequent congenital heart defect, occurring in approximately 1 in 1,000 live births [1, 2]. If compared with the previous decades, expanded screening programs in neonatology, pediatrics, and sport medicine have allowed early detection of patients with ASD. These patients are usually treated during infancy, when they are still asymptomatic, to prevent ASD-related complications such as irreversible right ventricular (RV) dilation, arrhythmias, and heart failure. As a consequence, the 25-year survival of patients with ASD who undergo correction before the age of 12 is 98%, compared with 99% of healthy patients. This difference in survival rates is directly proportional to age at correction (93% versus 97% when corrected between 12 and 24 years of life; 40% versus 59% when corrected after 41 years of life) [3]. Much information about the efficacy, the safety, and the cost effectiveness of percutaneous and surgical
Patients and Methods Enrollment All patients aged less than 16 years at correction and who had been treated for ostium secundum ASD closure in our unit from 2000 to 2012 were considered eligible for this study. For logistical reasons, only residents in the
Accepted for publication March 10, 2015. Address correspondence to Dr Castaldi, Pediatric Cardiology Unit, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, Padova 3-35128, Italy; e-mail: [email protected].
Ó 2015 by The Society of Thoracic Surgeons Published by Elsevier
Drs Castaldi, Maschietto, and Milanesi disclose financial relationships with WL Gore.
0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2015.03.017
2
CASTALDI ET AL LONG-TERM FOLLOW-UP AFTER ASD CLOSURE
Veneto Region were involved. The presence of comorbidities such as more than mild valvulopathies, other septal defects, anomalous venous return, pneumologic diseases, bronchodysplasia, hepatic or renal failure, and genetic syndromes were considered exclusion criteria for participation. The patients were divided into two groups: in the first group were included patients treated with percutaneous device implantation (PG group); in the second were those treated surgically (SG group), by using a minimally invasive approach by means of a right anterior minithoracotomy [10]. Seventy-two patients were eligible to be enrolled in the first group; among them, 2 were lost to follow-up and 6 refused to give consent to the study. Sixty patients were eligible for the second group; however, 6 of them were lost to follow-up and 10 refused to give consent to participate in the study. The percutaneous procedure was performed as the first-choice treatment of patients with a single defect or with a multiple fenestration defect because, in these patients, with ASD diameter less than 20 mm and adequate rims (with the exception of the aortic rim), ASD could be closed by a single device. Among patients enrolled in the second group, the surgical procedure was preferred for the following reasons: too large ASD in 10 patients, multiple ASD defects in 12, deficient rims in 12, and parental choice in 10. The Clinical Investigation Committee of the University Hospital of Padua approved the study in accordance with the institutional guidelines for retrospective record review.
Percutaneous Closure Percutaneous closure procedures for each device have been already described [11–13]. Devices used for ASD closure were the Amplatzer Septal Occluder (St. Jude Medical, Plymouth, MN) and Helex or Gore Septal Occluder (WL Gore & Associates, Flagstaff, AZ).
Surgical Technique We made a 2 cm to 4 cm semilunar incision in the sulcus of the right breast (6 cm to 8 cm away from the nipple area) by entering the chest in the fourth intercostal space. In prepubertal children, the incision is kept very low under the right nipple, especially in female patients, with the aim to avoid any possible future interference with breast development. Subcutaneous fat and mammary gland were gently dissected from the fascia up to the fourth intercostal space, where the chest cavity was entered. The incision of the intercostal space was approximately 1 cm longer than the skin incision at each side. Video-assisted optical technology by means of a 5mm 0-degree optical scope, inserted through a separate 5-mm incision in the fourth intercostal space, was often used to implement surgical vision. In patients weighing more than 18 kg who underwent a peripheral cannulation, the superior vena cava was usually occluded with a cross clamp, inserted through a 5-mm separate lateral incision (later utilized for inserting a chest drain).
Ann Thorac Surg 2015;-:-–-
According to our minimally invasive surgical technique, direct aortic and bicaval cannulation was used in patients with body weight less than 18 kg. Since 2006, we have used for patients with higher weight a peripheral arterial and venous cannulation to establish the cardiopulmonary bypass; that has been achieved by means of percutaneous cannulation of the superior vena cava through the right jugular vein, followed by surgical isolation and cannulation of the femoral vessels. The intracardiac repair was then carried out on induced ventricular fibrillation.
Follow-Up Study All eligible patients were contacted and invited to undergo a clinical and instrumental evaluation, including a two-dimensional echocardiogram and 24-hour Holter electrocardiographic monitoring. Demographic, procedural, and clinical data were then collected (device size, stretched diameter, periprocedural complications, palpitations occurrence, and so forth).
Echocardiography The echocardiographic study was performed using a Philips iE33 echo machine and a S5-1 probe (Philips Healthcare, Andover, MA). The right and left ventricular function was evaluated by following the recommendations of the American Society of Echocardiography [14– 16]. In particular, pulsed wave Doppler interrogation of left ventricular inflow was performed in apical 4-chamber view; early diastolic velocity (E) and late diastolic velocity (A) were obtained by positioning a 3-mm sample volume between the mitral or tricuspid leaflet tips during diastole. The E/A ratio was used as a pattern of mitral and tricuspid inflow. Pulsed wave tissue Doppler imaging was performed in apical 4-chamber view to sample both the systolic excursion velocity (S’) and the early and late diastolic excursion velocities (E’ and A’, respectively) of mitral and tricuspid annulus. The fractional area change, the tricuspid annulus peak systolic excursion, and the S’ wave of tricuspid annulus by tissue Doppler were analyzed to rate the RV systolic function. Systolic longitudinal RV dysfunction occurred when the tricuspid annulus peak systolic excursion was 16 mm or less or the S’ wave of the tricuspid annulus was 9 cm/s or less, or both. The E/A ratio and the E/E’ ratio were used to rate the RV diastolic function. The right atrium and the left atrium areas were calculated to assess the occurrence of the right atrial enlargement. An E/A ratio less than 0.8 or greater than 2.5 or an E/E’ ratio 8 or greater were considered as cutoff values to assess RV diastolic dysfunction. The right atrium and the left atrium areas were calculated to evaluate the occurrence of right atrial enlargement.
Holter Electrocardiography The 24-hour Holter registration was performed using a Cardioline 400h device (Cardioline SPA, Trento, Italy). The postprocessing analysis was further completed through dedicated software (Cardioline CubeHolter version 5.1). Supraventricular extrasystolic beats (SVEB)
Ann Thorac Surg 2015;-:-–-
3
CASTALDI ET AL LONG-TERM FOLLOW-UP AFTER ASD CLOSURE
and ventricular extrasystolic beats (VEB) were classified according to the Lown classification. The SVEB classification is as follows: class 0, no SVEB; class I, 10 or fewer SVEB per hour; class II, more than 10 SVEB per hour; class III, polymorphic SVEB; class IV, supraventricular couples; class V, atrial tachycardia, atrial fibrillation, or atrial flutter; and class VI, multifocal atrial tachycardia. The VEB classification is as follows: class 0, no VEB; class I, 30 or fewer VEB per hour, monomorphic; class II, greater than 30 VEB per hour, monomorphic; class III, polymorphic VEB; class IV, couples or monomorphic runs; class V, R on T VEB.
Statistical Analysis Continuous variables are expressed with interquartile range as a measure of variability. The impact of surgery on RV diastolic dysfunction, RV longitudinal systolic dysfunction, and residual RV dilation have been evaluated by using a set of three logistic models, always adjusted for age, body surface area, and preoperative dilation, regardless of their statistical significance. Model fit was considered significantly improved on the basis of the Akaike information criterion. Cross-validation and bootstrap (1,000 runs) techniques were applied. Somer’s concordance index Dxy (the closer the absolute value is to 1, the better it is) was obtained for the purposes of goodness-of-fit evaluation and adjusted for optimism by using bootstrap (1,000 runs). The statistical significance was set at p less than 0.05. The R system statistical package [17] and Harrell’s rms libraries were used for analysis (FEJ Harrell, Regression Modeling Strategies, 2013).
Results Patients’ general characteristics are summarized in Table 1. All patients in the first group were treated by using a single device—an Amplatzer septal occluder device in 51 (interquartile range, 12/16/18 mm) and a Gore device in the remaining 12 patients (15 mm in 1, 20 mm in 4, 25 mm in 4, and 30 mm in 3). All surgical enrolled patients were approached by means of a right
Fig 1. Histogram showing the frequency of the two approaches over the time (years 2000 to 2012). The blue bars indicate the surgical procedures and the red bars, percutaneous closure.
thoracotomy, the defect was closed, either by using a patch in 39% or by direct suture in 61%. The frequency of both approaches over the time is shown in Figure 1. The ASD diameter was larger in the surgical group (interquartile range, 9/11/14 mm versus 11.5/ 15.5/18 mm, respectively; p < 0.001). However, the grading of RV enlargement was similar between the two groups (p ¼ 0.726; Table 1). At intervention, the two groups had similar age (PG 5, 7, and 11 years versus SG 5, 7.5, and 12 years; p ¼ 0.448), weight (PG 40/54/64.5 kg and SG 45/60/68.2 kg, p ¼ 0.283), and height (150/160/170 cm and 152.2/165/ 172.5 cm, p ¼ 0.236) at evaluation. The surgical group had a longer follow-up (PG 4/5/8 and SG 5/8.5/11 years, p < 0.001). No residual shunts were detected during follow-up. The systolic function of the left ventricle was normal and similar in both groups (Table 2). The RV fractional area change was normal and comparable between groups (PG 0.37/0.42/0.46 and SG 0.34/0.41/ 0.47, p ¼ 0.571); however, the RV longitudinal function assessed by tricuspid annulus peak systolic excursion and by tissue Doppler (S’ wave) was considerably reduced in the surgical group as compared with the device group (20.4/23.0/26.0 versus 16.0/18.3/20.7 mm
Table 1. Patient Characteristics Characteristics
Device Group
Surgical Group
Combined
p Value
Female Age at intervention, years Follow-up length, years Defect size, mm, median Right ventricular dilation Mild Moderate Severe Weight, kg Height, cm Body surface area, m2
74.6 (47) 5.0/7.0/11.0 4.0/5.0/8.0 9.0/11.00/14.0
79.5 (35) 5.0/7.5/12.0 5.0/8.5/11.0 11.7/15.5/18.0
76.6 (82) 5.0/7.0/11.0 4.0/7.0/10.0 10.0/12.0/16.0
0.552 0.448
