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Transcatheter Approach for Critical Pulmonary Stenosis or Pulmonary Atresia with Intact Ventricular Septum in Young Infants Using the Simmons Catheter

Transcatheter Approach for Critical Pulmonary Stenosis or Pulmonary Atresia with Intact... Hindawi Journal of Interventional Cardiology Volume 2020, Article ID 4986815, 7 pages https://doi.org/10.1155/2020/4986815 Research Article Transcatheter Approach for Critical Pulmonary Stenosis or Pulmonary Atresia with Intact Ventricular Septum in Young Infants Using the Simmons Catheter Jian Wang, Jing Sun, Jian Shen, Jianping Yang, Ling Yang, Pengjun Zhao , and Sun Chen Department of Pediatric Cardiology, Xinhua Hospital Affiliated to Medical School, Shanghai Jiaotong University, 1655 Kongjiang Rd, 200092 Shanghai, China Correspondence should be addressed to Pengjun Zhao; pjunzhao@sina.com and Sun Chen; chengsun@hotmail.com Received 3 November 2019; Revised 2 January 2020; Accepted 17 February 2020; Published 15 June 2020 Guest Editor: Yiufai Cheung Copyright © 2020 Jian Wang et al. /is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Objectives and Background. /e conventional process of percutaneous balloon pulmonary valvuloplasty for critical pulmonary stenosis (CPS) and pulmonary atresia with intact ventricular septum (PA/IVS) is challenging because of the difficulty in po- sitioning the catheter stably into the right ventricular outflow tract (RVOT), especially in young infants with a hypertrophic right ventricle. In this study, we introduced a novel transcatheter approach with the Simmons catheter to reach the RVOT and compared its efficacy and safety with those of the approaches using a floating catheter and the Judkins right coronary catheter. Methods and Results. We retrospectively reviewed 52 young infants, 41 of whom had CPS and 11 had PA/IVS, in a single center from June 2009 to October 2017. Patients were divided into three groups according to the type of catheter used to enter through the RVOT. /e unique structure of the Simmons catheter allowed it to be maneuvered directly into the RVOT within a few minutes. Compared with the other two groups, the Simmons catheter group had a significantly shorter fluoroscopy time entering through the RVOT (P< 0.001) and a shorter total X-ray exposure time (P< 0.001). Furthermore, compared with the floating catheter group, the success rate of surgery was much higher in the Simmons catheter group (P< 0.001). Conclusions. /e Simmons catheter is a safe and effective method to enter through the RVOT in infants with CPS or PA/IVS. /erefore, the Simmons catheter could be an alternative catheter when entering through the RVOT in young infants, especially neonates with low birth weight. medical centers [4, 5]. Interventional therapy for PA/IVS 1. Introduction during the neonatal period was reported to have a high Critical pulmonary stenosis (CPS) and pulmonary atresia success rate, with a mid- and long-term survival rate ranging with intact ventricular septum (PA/IVS) are rare and from 81.0 to 92.5% [6, 7]. However, the conventional ap- complex congenital heart defects (CHDs), accounting for proach is to enter into the right ventricular outflow tract approximately 3% of all CHDs [1]. Right ventricular outflow (RVOT) in young infants. /is technique has certain dif- tract obstruction with various degrees of right ventricular ficulties and requires a long fluoroscopy time [8], especially hypoplasia is an important determinant of the management in cases with hypoplastic right ventricle. strategy [2]. /e Simmons catheter was first applied for angiogram in PA/IVS was first managed with percutaneous balloon 1973 and has been widely used in the catheterization of the pulmonary valvuloplasty (PBPV) in 1990 [3]. /is technique left vertebral artery, brachiocephalic arteries, and some is now the predominant treatment for patients with proper visceral arteries [9]. In this study, we introduced a novel anatomy suitable for transcatheter intervention in many application of the Simmons catheter (Terumo , mode: ® 2 Journal of Interventional Cardiology In the floating catheter group, a 5-French floating EA15010M) to maneuver directly into the RVOT to perform pulmonary valvuloplasty in young infants with CPS or PA/ catheter was advanced through the femoral vein to reach the pulmonary valve via clockwise rotation. In the JR catheter IVS. We compared the efficacy and safety of the Simmons catheter with those of the conventional approaches using the group, a 3-French catheter was used to enter through the floating catheter and Judkins right coronary (JR) catheter. RVOT. In the Simmons catheter group, we used a Simmons catheter to maneuver into the RVOT. We chose a Simmons 2. Methods catheter for catheterization when the distal part of the 2.1. Study Subjects. We retrospectively reviewed 52 cases of catheter (Figure 1(d)) was shorter than the diameter of the young infants with CPS or PA/IVS admitted to Xinhua TV. When the TV diameter was shorter or the right ventricle Hospital Affiliated to Shanghai Jiaotong University, School was more severely hypoplastic, a Rosch Left Gastric (RLG) of Medicine, from November 2012 to October 2017. All catheter (Terumo, Japan, Figure 1(c)), which was similar in patients received interventional PBPV therapy. /e inclu- shape but smaller in size, was chosen. Since these catheters sion criteria were as follows: (1) age under 3 months and (2) are similar, the results of both the Simmons and RLG diagnosis using echocardiography as PA/IVS or CPS with catheters were calculated as one group. We used two op- hypoplastic right ventricle (tricuspid valve gradient; TVG erative approaches: the first approach was to advance the >70 mmHg) [10]. Patients with a tricuspid valve (TV) Z- Simmons catheter directly into the right atrium and rotate score<−2.5 were excluded because of the requirement of a the catheter counterclockwise by about 30 . When the pulmonary blood flow increase [4]. /e study was approved catheter tip pointed to the left, the Simmons catheter was by the ethics committee of Xinhua Hospital. Informed sent into the RVOT (Figure 2); the second approach was to consent was obtained from all patients’ parents in the form advance the Simmons catheter directly into the superior of agreement for catheterization and the use of data collected vena cava with its original appearance and then withdraw before and after the procedure. the catheter slowly until the catheter flipped into the RVOT Patients were divided into three groups according to the automatically (Figure 3). /e distal end of the Simmons type of catheter used to enter the RVOT, which were the catheter was located in the RVOT with its tip pointing to- Simmons catheter group (n � 25), the floating catheter group wards the pulmonary valve after the procedure (Figure 4). (n � 11), and the JR catheter group (n � 16). Echocardiog- RVOT angiography was then performed. raphy was reviewed for right ventricular morphology, TV With the Simmons catheter, we found it easy to insert a annulus Z-score, degree of tricuspid valve regurgitation 1.8-F microcatheter and maneuver the distal end of the (TR), pulmonary valve (PV) annulus Z-score, and primary microcatheter close to the center and perpendicular to the diagnosis. Demographic data on catheterization was col- pulmonary valve (Figure 5). Because of the disallowed use of lected, including total fluoroscopy time, fluoroscopy time radiofrequency in China, a Conquest Pro 8–20 wire with a entering into the RVOT, success rate of catheterization, age 0.2 mm tip was used to perforate the atretic pulmonary valve at first intervention, the incidence of complications during in patients with PA/IVS. Most of the time, the Conquest Pro catheterization, and the length of hospital stay. Follow-up 8–20 was replaced with a 0.46 mm microguide wire to es- work included echocardiography and electrocardiogram tablish a femoral vein-ductus-descending aorta-femoral examinations at 1, 3, and 6 months and 1, 2, and 3 years after artery pathway. /e balloon dilation was manipulated by a catheterization, respectively. Regarding the patients who did microballoon with a diameter 1–1.2 times the pulmonary not return for the postoperative examination, we telephoned valve annulus diameter (Figure 6). Finally, the right ventricle them to collect information on reintervention or major pressure was measured, and the right ventricle angiography complications. /erefore, we included the data of reinter- was performed. vention as the major indication for long-term follow-up. 3. Results 2.2. Statistical Analysis. Statistical analysis was performed Patients were divided into three groups: the Simmons with SPSS 19.0 (IBM Corp., Armonk, NY, USA). A chi- catheter group (including 8 cases with the RLG catheter) square test, mono factor analysis of variance, or Kruskal- (n � 25, with 21 cases of CPS and 4 cases of PA/IVS), the Wallis H-test was applied. A P value<0.05 was considered floating catheter group (n � 11, with 8 cases of CPS and 3 statistically significant. cases of PA/IVS), and JR catheter group (n � 16, with 12 cases of CPS and 4 cases of PA/IVS). /e basic characteristics 2.3. Catheterization Procedures. Catheterization for PBPV of patients in the three groups are presented in Table 1. No was performed in all patients under general anesthesia. To significant differences were found between the character- cannulate the femoral artery and vein, 4F and 5F sheaths istics of the three groups. /e TV Z-score was -0.85 ± 0.6 in were used, respectively. Heparin (100 U/kg) was adminis- the floating catheter group, −0.93± 0.7 in the JR catheter tered immediately after cannulation. All 11 cases of PA/IVS group, and −0.90± 0.7 in the Simmons catheter group. /e were membranous atresia, and coronary angiography was PV Z-score was −1.97± 0.7 in the floating catheter group, performed to exclude right ventricle dependent coronary −1.87± 0.7 in the JR catheter group, and −1.94± 1.1 in the circulation. All procedures were carried out by a single chief Simmons catheter group. Although no significant difference physician in our center with several fixed assistants. was found, patients in the Simmons catheter group were Journal of Interventional Cardiology 3 (a) (b) (c) (d) Figure 1: (a) /e morphological structure of the Simmons catheter and its distal part. A close-up view of the (b) Simmons catheter and (c) RLG catheter. (d) /e measurement of the TV. 30° (a) (b) (c) Figure 2: (a) /e Simmons catheter is advanced to the right atrium directly. (b) /e catheter is rotated counterclockwise about 30 . (c) When the distal part of the Simmons catheter points to the left, it will flip into the RVOT. younger (mean age of 32.5± 21.7 days) and had a lower catheter groups than in the floating catheter group weight (3.5± 0.7 kg), including 4 cases of premature infants, (P< 0.001). with the lowest weight at the time of surgery being 1890 g, Complications during the procedure were mainly ar- compared to the other groups. rhythmia, including ventricular premature (n � 3), frequent All 52 infants with the diagnosis of CPS or PA/IVS onset of ventricular tachycardia (n � 2), atrial premature received the transcatheter PBPV therapy. /e utility of the (n � 2), nonsustained ventricular tachycardia (n � 1), and Simmons catheter made it easier and quicker to advance second-degree atrioventricular block (n � 1). /ese com- directly into the RVOT, especially in young infants with low plications were more often observed in cases of long pro- cedures when advancing into the RVOT with constant birth weight. /e outcomes of PBPV in the three groups are presented in Table 2. According to the Kruskal-Wallis stimulation of the myocardial tissue. /ere was a trend H-test, the fluoroscopy time entering the RVOT in the towards lower complication rates in the Simmons catheter Simmons catheter group was significantly lower than in the group (n � 2, 8.0%) than in the floating catheter group (n � 4, other two groups (P< 0.001). In addition, the total fluo- 36.3%) and JR catheter groups (n � 3, 18.8%), but it did not roscopy time of the entire catheterization procedure was achieve statistical significance (P � 0.120). /e floating significantly lower in the Simmons catheter group than in catheter group had seven cases of failed procedure; one the other groups (P< 0.001). /e success rate of catheteri- failure of PA/IVS was due to an extremely low birth weight zation was significantly higher in the Simmons and JR and inability to perforate the pulmonary valve, and two 4 Journal of Interventional Cardiology (a) (b) (c) Figure 3: (a) /e Simmons catheter is advanced directly into the superior vena cava with its original appearance. (b) /e catheter is withdrawn slowly and sent over the TV with an adjusted angle. (c) /e catheter will flip into the RVOT automatically. of the right ventricle and lay the foundation for biventricular correction [13]. In the process of interventional therapy for CPS and PA/ IVS, one of the challenges is to stably position the catheter into the RVOT with a small and hypertrophic right ventricle. /is usually requires a long fluoroscopy time and complex procedures. At our clinical center, we have previously ap- plied the conventional floating catheter in patients with CPS and PA/IVS to reach the RVOT. /e acute angle between the RVOTand the infundibular tract, especially in young infants with a hypertrophic or even hypoplastic right ventricle, resulted in many hours spent trying to reach the RVOT. At other clinical centers, the JR catheter is also widely used to maneuver to the atretic pulmonary valve [5, 14]. However, in our experience, using a JR catheter in young infants also required a long fluoroscopy time, and the stiffness of the Figure 4: /e Simmons catheter was maneuvered directly into the distal part of the catheter could lead to tissue injury, which RVOT (anteroposterior view). was in accordance with previous studies [8]. In our study, we introduced a novel application of the failures of CPS were due to the long procedure of advancing Simmons catheter to reach the RVOT in patients with CPS into RVOTand the frequent onset of ventricular tachycardia or PA/IVS, especially young infants with a hypoplastic right during that period. /e other four cases of CPS also failed ventricle. We choose a Simmons catheter for catheterization due to the inability to maneuver the floating catheter into the when the diameter of the TV was over 1.3 times that of the RVOT after a long period of attempts. distal part of the catheter (Figure 1). When the TV diameter was smaller, we chose the Rosch Left Gastric catheter, which is similar in appearance to the Simmons catheter but has a 4. Discussion smaller profile. Using the Simmons catheter to advance into the RVOT CPS and PA/IVS are rare CHDs; however, they are also the in patients with CPS and PA/IVS has several advantages, most common types of cyanotic CHD during the neonatal especially in young infants with low birth weight. /e ad- period [11]. /e variability in malformation necessitates vantages were mainly embodied in its short procedure time, individualized therapeutic pathways for both CPS and PA/ low incidence of complications during catheterization, and IVS; the therapeutic pathway decided is in accordance with user-friendliness. /e average fluoroscopy time of entering the morphology of the right ventricle and associated ab- into the RVOT was significantly reduced, from around normalities [12]. An interventional approach is essential in 10–20 mins in the floating and JR catheter groups to only most cases as a first stage procedure to stimulate the growth Journal of Interventional Cardiology 5 (a) (b) Figure 5: (a) Angiography of the atretic pulmonary valve with the Simmons catheter (lateral view). (b) Angiography with a microcatheter to confirm its position at the center of the pulmonary valve. (a) (b) Figure 6: (a). Perforation was performed with the Conquest Pro, and the femoral vein-ductus-femoral artery pathway was built with a snare to trap the microguide wire; (b) balloon dilation was manipulated with a microballoon of a diameter 1–1.2 times that of the pulmonary valve annulus. Table 1: Basic patient characteristics in the Simmons catheter, floating catheter, and JR catheter groups. Floating catheter (n � 11) JR catheter (n � 16) Simmons catheter P value Gender: Male 6 8 14 0.934 Female 5 8 11 Age (days) 43.6± 28.6 31.2± 20.8 32.5± 21.7 0.289 Diagnosis: PA/IVS 3 3 4 0.658 CPS 8 13 21 Gestational age (weeks) 38.4± 2.7 38.0± 2.6 37.8± 2.8 0.538 Weight at initial procedure (kg) 3.7± 0.6 3.7± 0.6 3.5± 0.7 0.511 TV Z-score −0.85± 0.6 −0.92± 0.7 −0.90± 0.7 0.912 PV Z-score −1.97± 0.7 −1.88± 0.8 −1.94± 1.1 0.897 ∗ # PA/IVS: pulmonary atresia with intact ventricular septum, CPS: critical pulmonary stenosis, TV: tricuspid valve, PV: pulmonary valve. Simmons Catheter group: including 8 cases of the RLG catheter. 6 Journal of Interventional Cardiology Table 2: Catheterization outcomes of PBPV in the three groups. Floating catheter (n � 11) JR catheter (n � 16)> Simmons catheter (n � 25) P Value Fluoroscopy time of entering RVOT (s) 1300.7± 679.9 130.3± 81.0 46.1± 19.9 <0.001 Total fluoroscopy time (min) 38.2± 14.1 19.9± 10.5 14.5± 4.0 <0.001 HLOS (days) 12.0± 8.9 11.0± 5.1 12.4± 11.4 0.693 Complications (%) 4(36.3) 3(18.8) 2(8.0) 0.120 Success rate of catheterization Success/All (%) Reintervention rate (%) 4(36.3) 3(18.8) 6(24.0) 0.582 ∗ # PBPV: percutaneous balloon pulmonary valvuloplasty, RVOT: right ventricular outflow tract, HLOS: hospital length of stay. Simmons Catheter group: including 8 cases of the RLG catheter. 30 s in the Simmons catheter group (1300.7± 679.9 s vs. Shanghai Jiaotong University, School of Medicine, and also 130.3± 81.0 s vs. 46.1± 19.9 s, P< 0.001). Furthermore, the in accordance with the 1964 Helsinki declaration and its total fluoroscopy time dropped significantly in the Simmons later amendments or comparable ethical standards. catheter group from 30 mins to approximately 15 mins (38.2± 14.1 mins vs. 19.9± 10.5 mins vs. 14.5± 4.0 mins, Conflicts of Interest P< 0.001). Although not statistically significant, there was a All authors declare no conflicts of interest. trend towards lower complication rates in the Simmons catheter group than in the other groups (36.3% vs. 18.8% vs. 8.0%, P � 0.120). In most cases, the complications of ar- Authors’ Contributions rhythmia during the procedure were caused by constant Jian Wang and Jing Sun contributed equally to this research. stimulation of the RVOT. /e application of the Simmons catheter greatly minimized the probability of stimulation for Acknowledgments arrhythmia by significantly reducing the procedure time to enter into the RVOT. In addition, Simmons catheters are /e authors want to appreciate MS. Shen Luyang who user-friendly during surgeries, with two approaches de- drafted the illustration of the catheterization procedure of scribed in the Methods section above, providing more op- Simmons Catheter. /is study was supported by the tions for surgeons. Shanghai Science and Technology Commission (18441902600). 4.1. Limitations. Our study has several limitations. First, this was a single-center study with limited sample size. Second, References patients were not randomly assigned to each group, causing [1] C. Ferencz, J. D. Rubin, R. J. Mccarter et al., “Congenital heart a potential for selection bias. /ird, the procedures were disease: prevalence at livebirth,” American Journal of Epide- performed by one chief physician; thereby, the accumulation miology, vol. 121, no. 1, pp. 31–36, 1985. of experience might affect the procedural time and outcome [2] Y. H. Choi, J. W. Seo, J. Y. Choi, Y. S. Yun, S. H. Kim, and in all groups. Further clinical trials are required to test these H. J. Lee, “Morphology of tricuspid valve in pulmonary atresia results at different centers. with intact ventricular septum,” Pediatric Cardiology, vol. 19, no. 5, pp. 381–389, 1998. 5. Conclusions [3] S. A. Qureshi, E. Rosenthal, M. Tynan, R. Anjos, and E. J. Baker, “Transcatheter laser-assisted balloon pulmonary In this study, we introduced a novel application of the valve dilation in pulmonic valve atresia,” 5e American Simmons catheter in patients with CPS and PA/IVS, es- Journal of Cardiology, vol. 67, no. 5, pp. 428–431, 1991. pecially young infants with low birth weight and hypoplastic [4] M. Alwi, “Management algorithm in pulmonary atresia with right ventricle. /is catheter structure permitted a rapid intact ventricular septum,” Catheterization and Cardiovas- cular Interventions, vol. 67, no. 5, pp. 679–686, 2006. approach to the RVOTand significantly reduced fluoroscopy [5] M. Marasini, P. F. Gorrieri, G. Tuo et al., “Long-term results of time and thus increased the success rate of the intervention. catheter-based treatment of pulmonary atresia and intact ventricular septum,” Heart, vol. 95, no. 18, pp. 1520–1524, Data Availability [6] G. Agnoletti, J. F. Piechaud, P. Bonhoeffer et al., “Perforation All data generated or analyzed during this study are included of the atretic pulmonary valve,” Journal of the American in this article. College of Cardiology, vol. 41, no. 8, pp. 1399–1403, 2003. [7] H. Chubb, E. Pesonen, S. Sivasubramanian et al., “Long-term Ethical Approval outcome following catheter valvotomy for pulmonary atresia with intact ventricular septum,” Journal of the American All procedures performed in studies involving human College of Cardiology, vol. 59, no. 16, pp. 1468–1476, 2012. participants were in accordance with the ethical standards of [8] S. Bondanza, M. Derchi, G. Tuo, L. Zannini, and M. Marasini, the Ethics Committee of Xinhua Hospital Affiliated to “Use of a telescopic system for transcatheter radiofrequency Journal of Interventional Cardiology 7 perforation and balloon valvotomy in infants with pulmonary atresia and intact ventricular septum,” Cardiology in the Young, vol. 23, no. 2, pp. 203–208, 2013. [9] D. C. Smith and C. R. Simmons, “/e quick aortic turn: a rapid method for reformation of the Simmons sidewinder catheter,” Radiology, vol. 155, no. 1, pp. 247-248, 1985. [10] J. P. Kovalchin, T. J. Forbes, M. R. Nihill, and T. Geva, “Echocardiographic determinants of clinical course in infants with critical and severe pulmonary valve stenosis,” Journal of the American College of Cardiology, vol. 29, no. 5, pp. 1095– 1101, 1997. [11] R. M. Freedom, “/e morphologic variations of pulmonary atresia with intact ventricular septum: guidelines for surgical intervention,” Pediatric Cardiology, vol. 4, no. 3, pp. 183–188, [12] P. E. Daubeney, “Pulmonary atresia with intact ventricular septum: range of morphology in a population-based study,” Journal of the American College of Cardiology, vol. 39, no. 10, pp. 1670–1679, 2002. [13] S. A. Qureshi, “Catheterization in neonates with pulmonary atresia with intact ventricular septum,” Catheterization and Cardiovascular Interventions, vol. 67, no. 6, pp. 924–931, 2006. [14] J. Alcibar, “Guided transcatheter valvulotomy in pulmonary atresia with intact ventricular septum,” Revista Española de Cardiolog´ıa, vol. 56, no. 8, pp. 822–825, 2003. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Interventional Cardiology Hindawi Publishing Corporation

Transcatheter Approach for Critical Pulmonary Stenosis or Pulmonary Atresia with Intact Ventricular Septum in Young Infants Using the Simmons Catheter

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Copyright © 2020 Jian Wang et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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10.1155/2020/4986815
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Abstract

Hindawi Journal of Interventional Cardiology Volume 2020, Article ID 4986815, 7 pages https://doi.org/10.1155/2020/4986815 Research Article Transcatheter Approach for Critical Pulmonary Stenosis or Pulmonary Atresia with Intact Ventricular Septum in Young Infants Using the Simmons Catheter Jian Wang, Jing Sun, Jian Shen, Jianping Yang, Ling Yang, Pengjun Zhao , and Sun Chen Department of Pediatric Cardiology, Xinhua Hospital Affiliated to Medical School, Shanghai Jiaotong University, 1655 Kongjiang Rd, 200092 Shanghai, China Correspondence should be addressed to Pengjun Zhao; pjunzhao@sina.com and Sun Chen; chengsun@hotmail.com Received 3 November 2019; Revised 2 January 2020; Accepted 17 February 2020; Published 15 June 2020 Guest Editor: Yiufai Cheung Copyright © 2020 Jian Wang et al. /is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Objectives and Background. /e conventional process of percutaneous balloon pulmonary valvuloplasty for critical pulmonary stenosis (CPS) and pulmonary atresia with intact ventricular septum (PA/IVS) is challenging because of the difficulty in po- sitioning the catheter stably into the right ventricular outflow tract (RVOT), especially in young infants with a hypertrophic right ventricle. In this study, we introduced a novel transcatheter approach with the Simmons catheter to reach the RVOT and compared its efficacy and safety with those of the approaches using a floating catheter and the Judkins right coronary catheter. Methods and Results. We retrospectively reviewed 52 young infants, 41 of whom had CPS and 11 had PA/IVS, in a single center from June 2009 to October 2017. Patients were divided into three groups according to the type of catheter used to enter through the RVOT. /e unique structure of the Simmons catheter allowed it to be maneuvered directly into the RVOT within a few minutes. Compared with the other two groups, the Simmons catheter group had a significantly shorter fluoroscopy time entering through the RVOT (P< 0.001) and a shorter total X-ray exposure time (P< 0.001). Furthermore, compared with the floating catheter group, the success rate of surgery was much higher in the Simmons catheter group (P< 0.001). Conclusions. /e Simmons catheter is a safe and effective method to enter through the RVOT in infants with CPS or PA/IVS. /erefore, the Simmons catheter could be an alternative catheter when entering through the RVOT in young infants, especially neonates with low birth weight. medical centers [4, 5]. Interventional therapy for PA/IVS 1. Introduction during the neonatal period was reported to have a high Critical pulmonary stenosis (CPS) and pulmonary atresia success rate, with a mid- and long-term survival rate ranging with intact ventricular septum (PA/IVS) are rare and from 81.0 to 92.5% [6, 7]. However, the conventional ap- complex congenital heart defects (CHDs), accounting for proach is to enter into the right ventricular outflow tract approximately 3% of all CHDs [1]. Right ventricular outflow (RVOT) in young infants. /is technique has certain dif- tract obstruction with various degrees of right ventricular ficulties and requires a long fluoroscopy time [8], especially hypoplasia is an important determinant of the management in cases with hypoplastic right ventricle. strategy [2]. /e Simmons catheter was first applied for angiogram in PA/IVS was first managed with percutaneous balloon 1973 and has been widely used in the catheterization of the pulmonary valvuloplasty (PBPV) in 1990 [3]. /is technique left vertebral artery, brachiocephalic arteries, and some is now the predominant treatment for patients with proper visceral arteries [9]. In this study, we introduced a novel anatomy suitable for transcatheter intervention in many application of the Simmons catheter (Terumo , mode: ® 2 Journal of Interventional Cardiology In the floating catheter group, a 5-French floating EA15010M) to maneuver directly into the RVOT to perform pulmonary valvuloplasty in young infants with CPS or PA/ catheter was advanced through the femoral vein to reach the pulmonary valve via clockwise rotation. In the JR catheter IVS. We compared the efficacy and safety of the Simmons catheter with those of the conventional approaches using the group, a 3-French catheter was used to enter through the floating catheter and Judkins right coronary (JR) catheter. RVOT. In the Simmons catheter group, we used a Simmons catheter to maneuver into the RVOT. We chose a Simmons 2. Methods catheter for catheterization when the distal part of the 2.1. Study Subjects. We retrospectively reviewed 52 cases of catheter (Figure 1(d)) was shorter than the diameter of the young infants with CPS or PA/IVS admitted to Xinhua TV. When the TV diameter was shorter or the right ventricle Hospital Affiliated to Shanghai Jiaotong University, School was more severely hypoplastic, a Rosch Left Gastric (RLG) of Medicine, from November 2012 to October 2017. All catheter (Terumo, Japan, Figure 1(c)), which was similar in patients received interventional PBPV therapy. /e inclu- shape but smaller in size, was chosen. Since these catheters sion criteria were as follows: (1) age under 3 months and (2) are similar, the results of both the Simmons and RLG diagnosis using echocardiography as PA/IVS or CPS with catheters were calculated as one group. We used two op- hypoplastic right ventricle (tricuspid valve gradient; TVG erative approaches: the first approach was to advance the >70 mmHg) [10]. Patients with a tricuspid valve (TV) Z- Simmons catheter directly into the right atrium and rotate score<−2.5 were excluded because of the requirement of a the catheter counterclockwise by about 30 . When the pulmonary blood flow increase [4]. /e study was approved catheter tip pointed to the left, the Simmons catheter was by the ethics committee of Xinhua Hospital. Informed sent into the RVOT (Figure 2); the second approach was to consent was obtained from all patients’ parents in the form advance the Simmons catheter directly into the superior of agreement for catheterization and the use of data collected vena cava with its original appearance and then withdraw before and after the procedure. the catheter slowly until the catheter flipped into the RVOT Patients were divided into three groups according to the automatically (Figure 3). /e distal end of the Simmons type of catheter used to enter the RVOT, which were the catheter was located in the RVOT with its tip pointing to- Simmons catheter group (n � 25), the floating catheter group wards the pulmonary valve after the procedure (Figure 4). (n � 11), and the JR catheter group (n � 16). Echocardiog- RVOT angiography was then performed. raphy was reviewed for right ventricular morphology, TV With the Simmons catheter, we found it easy to insert a annulus Z-score, degree of tricuspid valve regurgitation 1.8-F microcatheter and maneuver the distal end of the (TR), pulmonary valve (PV) annulus Z-score, and primary microcatheter close to the center and perpendicular to the diagnosis. Demographic data on catheterization was col- pulmonary valve (Figure 5). Because of the disallowed use of lected, including total fluoroscopy time, fluoroscopy time radiofrequency in China, a Conquest Pro 8–20 wire with a entering into the RVOT, success rate of catheterization, age 0.2 mm tip was used to perforate the atretic pulmonary valve at first intervention, the incidence of complications during in patients with PA/IVS. Most of the time, the Conquest Pro catheterization, and the length of hospital stay. Follow-up 8–20 was replaced with a 0.46 mm microguide wire to es- work included echocardiography and electrocardiogram tablish a femoral vein-ductus-descending aorta-femoral examinations at 1, 3, and 6 months and 1, 2, and 3 years after artery pathway. /e balloon dilation was manipulated by a catheterization, respectively. Regarding the patients who did microballoon with a diameter 1–1.2 times the pulmonary not return for the postoperative examination, we telephoned valve annulus diameter (Figure 6). Finally, the right ventricle them to collect information on reintervention or major pressure was measured, and the right ventricle angiography complications. /erefore, we included the data of reinter- was performed. vention as the major indication for long-term follow-up. 3. Results 2.2. Statistical Analysis. Statistical analysis was performed Patients were divided into three groups: the Simmons with SPSS 19.0 (IBM Corp., Armonk, NY, USA). A chi- catheter group (including 8 cases with the RLG catheter) square test, mono factor analysis of variance, or Kruskal- (n � 25, with 21 cases of CPS and 4 cases of PA/IVS), the Wallis H-test was applied. A P value<0.05 was considered floating catheter group (n � 11, with 8 cases of CPS and 3 statistically significant. cases of PA/IVS), and JR catheter group (n � 16, with 12 cases of CPS and 4 cases of PA/IVS). /e basic characteristics 2.3. Catheterization Procedures. Catheterization for PBPV of patients in the three groups are presented in Table 1. No was performed in all patients under general anesthesia. To significant differences were found between the character- cannulate the femoral artery and vein, 4F and 5F sheaths istics of the three groups. /e TV Z-score was -0.85 ± 0.6 in were used, respectively. Heparin (100 U/kg) was adminis- the floating catheter group, −0.93± 0.7 in the JR catheter tered immediately after cannulation. All 11 cases of PA/IVS group, and −0.90± 0.7 in the Simmons catheter group. /e were membranous atresia, and coronary angiography was PV Z-score was −1.97± 0.7 in the floating catheter group, performed to exclude right ventricle dependent coronary −1.87± 0.7 in the JR catheter group, and −1.94± 1.1 in the circulation. All procedures were carried out by a single chief Simmons catheter group. Although no significant difference physician in our center with several fixed assistants. was found, patients in the Simmons catheter group were Journal of Interventional Cardiology 3 (a) (b) (c) (d) Figure 1: (a) /e morphological structure of the Simmons catheter and its distal part. A close-up view of the (b) Simmons catheter and (c) RLG catheter. (d) /e measurement of the TV. 30° (a) (b) (c) Figure 2: (a) /e Simmons catheter is advanced to the right atrium directly. (b) /e catheter is rotated counterclockwise about 30 . (c) When the distal part of the Simmons catheter points to the left, it will flip into the RVOT. younger (mean age of 32.5± 21.7 days) and had a lower catheter groups than in the floating catheter group weight (3.5± 0.7 kg), including 4 cases of premature infants, (P< 0.001). with the lowest weight at the time of surgery being 1890 g, Complications during the procedure were mainly ar- compared to the other groups. rhythmia, including ventricular premature (n � 3), frequent All 52 infants with the diagnosis of CPS or PA/IVS onset of ventricular tachycardia (n � 2), atrial premature received the transcatheter PBPV therapy. /e utility of the (n � 2), nonsustained ventricular tachycardia (n � 1), and Simmons catheter made it easier and quicker to advance second-degree atrioventricular block (n � 1). /ese com- directly into the RVOT, especially in young infants with low plications were more often observed in cases of long pro- cedures when advancing into the RVOT with constant birth weight. /e outcomes of PBPV in the three groups are presented in Table 2. According to the Kruskal-Wallis stimulation of the myocardial tissue. /ere was a trend H-test, the fluoroscopy time entering the RVOT in the towards lower complication rates in the Simmons catheter Simmons catheter group was significantly lower than in the group (n � 2, 8.0%) than in the floating catheter group (n � 4, other two groups (P< 0.001). In addition, the total fluo- 36.3%) and JR catheter groups (n � 3, 18.8%), but it did not roscopy time of the entire catheterization procedure was achieve statistical significance (P � 0.120). /e floating significantly lower in the Simmons catheter group than in catheter group had seven cases of failed procedure; one the other groups (P< 0.001). /e success rate of catheteri- failure of PA/IVS was due to an extremely low birth weight zation was significantly higher in the Simmons and JR and inability to perforate the pulmonary valve, and two 4 Journal of Interventional Cardiology (a) (b) (c) Figure 3: (a) /e Simmons catheter is advanced directly into the superior vena cava with its original appearance. (b) /e catheter is withdrawn slowly and sent over the TV with an adjusted angle. (c) /e catheter will flip into the RVOT automatically. of the right ventricle and lay the foundation for biventricular correction [13]. In the process of interventional therapy for CPS and PA/ IVS, one of the challenges is to stably position the catheter into the RVOT with a small and hypertrophic right ventricle. /is usually requires a long fluoroscopy time and complex procedures. At our clinical center, we have previously ap- plied the conventional floating catheter in patients with CPS and PA/IVS to reach the RVOT. /e acute angle between the RVOTand the infundibular tract, especially in young infants with a hypertrophic or even hypoplastic right ventricle, resulted in many hours spent trying to reach the RVOT. At other clinical centers, the JR catheter is also widely used to maneuver to the atretic pulmonary valve [5, 14]. However, in our experience, using a JR catheter in young infants also required a long fluoroscopy time, and the stiffness of the Figure 4: /e Simmons catheter was maneuvered directly into the distal part of the catheter could lead to tissue injury, which RVOT (anteroposterior view). was in accordance with previous studies [8]. In our study, we introduced a novel application of the failures of CPS were due to the long procedure of advancing Simmons catheter to reach the RVOT in patients with CPS into RVOTand the frequent onset of ventricular tachycardia or PA/IVS, especially young infants with a hypoplastic right during that period. /e other four cases of CPS also failed ventricle. We choose a Simmons catheter for catheterization due to the inability to maneuver the floating catheter into the when the diameter of the TV was over 1.3 times that of the RVOT after a long period of attempts. distal part of the catheter (Figure 1). When the TV diameter was smaller, we chose the Rosch Left Gastric catheter, which is similar in appearance to the Simmons catheter but has a 4. Discussion smaller profile. Using the Simmons catheter to advance into the RVOT CPS and PA/IVS are rare CHDs; however, they are also the in patients with CPS and PA/IVS has several advantages, most common types of cyanotic CHD during the neonatal especially in young infants with low birth weight. /e ad- period [11]. /e variability in malformation necessitates vantages were mainly embodied in its short procedure time, individualized therapeutic pathways for both CPS and PA/ low incidence of complications during catheterization, and IVS; the therapeutic pathway decided is in accordance with user-friendliness. /e average fluoroscopy time of entering the morphology of the right ventricle and associated ab- into the RVOT was significantly reduced, from around normalities [12]. An interventional approach is essential in 10–20 mins in the floating and JR catheter groups to only most cases as a first stage procedure to stimulate the growth Journal of Interventional Cardiology 5 (a) (b) Figure 5: (a) Angiography of the atretic pulmonary valve with the Simmons catheter (lateral view). (b) Angiography with a microcatheter to confirm its position at the center of the pulmonary valve. (a) (b) Figure 6: (a). Perforation was performed with the Conquest Pro, and the femoral vein-ductus-femoral artery pathway was built with a snare to trap the microguide wire; (b) balloon dilation was manipulated with a microballoon of a diameter 1–1.2 times that of the pulmonary valve annulus. Table 1: Basic patient characteristics in the Simmons catheter, floating catheter, and JR catheter groups. Floating catheter (n � 11) JR catheter (n � 16) Simmons catheter P value Gender: Male 6 8 14 0.934 Female 5 8 11 Age (days) 43.6± 28.6 31.2± 20.8 32.5± 21.7 0.289 Diagnosis: PA/IVS 3 3 4 0.658 CPS 8 13 21 Gestational age (weeks) 38.4± 2.7 38.0± 2.6 37.8± 2.8 0.538 Weight at initial procedure (kg) 3.7± 0.6 3.7± 0.6 3.5± 0.7 0.511 TV Z-score −0.85± 0.6 −0.92± 0.7 −0.90± 0.7 0.912 PV Z-score −1.97± 0.7 −1.88± 0.8 −1.94± 1.1 0.897 ∗ # PA/IVS: pulmonary atresia with intact ventricular septum, CPS: critical pulmonary stenosis, TV: tricuspid valve, PV: pulmonary valve. Simmons Catheter group: including 8 cases of the RLG catheter. 6 Journal of Interventional Cardiology Table 2: Catheterization outcomes of PBPV in the three groups. Floating catheter (n � 11) JR catheter (n � 16)> Simmons catheter (n � 25) P Value Fluoroscopy time of entering RVOT (s) 1300.7± 679.9 130.3± 81.0 46.1± 19.9 <0.001 Total fluoroscopy time (min) 38.2± 14.1 19.9± 10.5 14.5± 4.0 <0.001 HLOS (days) 12.0± 8.9 11.0± 5.1 12.4± 11.4 0.693 Complications (%) 4(36.3) 3(18.8) 2(8.0) 0.120 Success rate of catheterization Success/All (%) Reintervention rate (%) 4(36.3) 3(18.8) 6(24.0) 0.582 ∗ # PBPV: percutaneous balloon pulmonary valvuloplasty, RVOT: right ventricular outflow tract, HLOS: hospital length of stay. Simmons Catheter group: including 8 cases of the RLG catheter. 30 s in the Simmons catheter group (1300.7± 679.9 s vs. Shanghai Jiaotong University, School of Medicine, and also 130.3± 81.0 s vs. 46.1± 19.9 s, P< 0.001). Furthermore, the in accordance with the 1964 Helsinki declaration and its total fluoroscopy time dropped significantly in the Simmons later amendments or comparable ethical standards. catheter group from 30 mins to approximately 15 mins (38.2± 14.1 mins vs. 19.9± 10.5 mins vs. 14.5± 4.0 mins, Conflicts of Interest P< 0.001). Although not statistically significant, there was a All authors declare no conflicts of interest. trend towards lower complication rates in the Simmons catheter group than in the other groups (36.3% vs. 18.8% vs. 8.0%, P � 0.120). In most cases, the complications of ar- Authors’ Contributions rhythmia during the procedure were caused by constant Jian Wang and Jing Sun contributed equally to this research. stimulation of the RVOT. /e application of the Simmons catheter greatly minimized the probability of stimulation for Acknowledgments arrhythmia by significantly reducing the procedure time to enter into the RVOT. In addition, Simmons catheters are /e authors want to appreciate MS. Shen Luyang who user-friendly during surgeries, with two approaches de- drafted the illustration of the catheterization procedure of scribed in the Methods section above, providing more op- Simmons Catheter. /is study was supported by the tions for surgeons. Shanghai Science and Technology Commission (18441902600). 4.1. Limitations. Our study has several limitations. First, this was a single-center study with limited sample size. Second, References patients were not randomly assigned to each group, causing [1] C. Ferencz, J. D. Rubin, R. J. Mccarter et al., “Congenital heart a potential for selection bias. /ird, the procedures were disease: prevalence at livebirth,” American Journal of Epide- performed by one chief physician; thereby, the accumulation miology, vol. 121, no. 1, pp. 31–36, 1985. of experience might affect the procedural time and outcome [2] Y. H. Choi, J. W. Seo, J. Y. Choi, Y. S. Yun, S. H. Kim, and in all groups. Further clinical trials are required to test these H. J. Lee, “Morphology of tricuspid valve in pulmonary atresia results at different centers. with intact ventricular septum,” Pediatric Cardiology, vol. 19, no. 5, pp. 381–389, 1998. 5. Conclusions [3] S. A. Qureshi, E. Rosenthal, M. Tynan, R. Anjos, and E. J. Baker, “Transcatheter laser-assisted balloon pulmonary In this study, we introduced a novel application of the valve dilation in pulmonic valve atresia,” 5e American Simmons catheter in patients with CPS and PA/IVS, es- Journal of Cardiology, vol. 67, no. 5, pp. 428–431, 1991. pecially young infants with low birth weight and hypoplastic [4] M. Alwi, “Management algorithm in pulmonary atresia with right ventricle. /is catheter structure permitted a rapid intact ventricular septum,” Catheterization and Cardiovas- cular Interventions, vol. 67, no. 5, pp. 679–686, 2006. approach to the RVOTand significantly reduced fluoroscopy [5] M. Marasini, P. F. Gorrieri, G. Tuo et al., “Long-term results of time and thus increased the success rate of the intervention. catheter-based treatment of pulmonary atresia and intact ventricular septum,” Heart, vol. 95, no. 18, pp. 1520–1524, Data Availability [6] G. Agnoletti, J. F. Piechaud, P. Bonhoeffer et al., “Perforation All data generated or analyzed during this study are included of the atretic pulmonary valve,” Journal of the American in this article. College of Cardiology, vol. 41, no. 8, pp. 1399–1403, 2003. [7] H. Chubb, E. Pesonen, S. Sivasubramanian et al., “Long-term Ethical Approval outcome following catheter valvotomy for pulmonary atresia with intact ventricular septum,” Journal of the American All procedures performed in studies involving human College of Cardiology, vol. 59, no. 16, pp. 1468–1476, 2012. participants were in accordance with the ethical standards of [8] S. Bondanza, M. Derchi, G. Tuo, L. Zannini, and M. Marasini, the Ethics Committee of Xinhua Hospital Affiliated to “Use of a telescopic system for transcatheter radiofrequency Journal of Interventional Cardiology 7 perforation and balloon valvotomy in infants with pulmonary atresia and intact ventricular septum,” Cardiology in the Young, vol. 23, no. 2, pp. 203–208, 2013. [9] D. C. Smith and C. R. Simmons, “/e quick aortic turn: a rapid method for reformation of the Simmons sidewinder catheter,” Radiology, vol. 155, no. 1, pp. 247-248, 1985. [10] J. P. Kovalchin, T. J. Forbes, M. R. Nihill, and T. Geva, “Echocardiographic determinants of clinical course in infants with critical and severe pulmonary valve stenosis,” Journal of the American College of Cardiology, vol. 29, no. 5, pp. 1095– 1101, 1997. [11] R. M. Freedom, “/e morphologic variations of pulmonary atresia with intact ventricular septum: guidelines for surgical intervention,” Pediatric Cardiology, vol. 4, no. 3, pp. 183–188, [12] P. E. Daubeney, “Pulmonary atresia with intact ventricular septum: range of morphology in a population-based study,” Journal of the American College of Cardiology, vol. 39, no. 10, pp. 1670–1679, 2002. [13] S. A. Qureshi, “Catheterization in neonates with pulmonary atresia with intact ventricular septum,” Catheterization and Cardiovascular Interventions, vol. 67, no. 6, pp. 924–931, 2006. [14] J. Alcibar, “Guided transcatheter valvulotomy in pulmonary atresia with intact ventricular septum,” Revista Española de Cardiolog´ıa, vol. 56, no. 8, pp. 822–825, 2003.

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Journal of Interventional CardiologyHindawi Publishing Corporation

Published: Jun 15, 2020

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