Akkerbez Adilbekova, MD, Shukhrat Marassulov, MD, PhD, Abay Baigenzhin, MD, PhD, Saken Kozhakhmetov, MD, PhD, Bakhytzhan Nurkeyev, MD, PhD, Amangeldy Kerimkulov, MD,c Saniya Murzabayeva, MD, Rinat Maiorov, MD, and Arailym Kenzhebayeva, MD
ABSTRACT
Objective: The aim of our study was to evaluate the safety and effectiveness of the hybrid method off-pump for closure of isolated ventricular septal defect (VSD) compared with the traditional method of on-pump of children.
Methods: This research was a retrospective cohort study. Data were collected from 500 patients with isolated VSD (or residual VSD after a previous repair) who underwent surgery at the National Scientific Medical Center from May 2016 to December 2020. Patients were operated with 1 of 2 methods of surgery: the traditional method of on-pump or the hybrid method of off-pump. This study assessed the safety and efficacy of the hybrid method by comparing it with the traditional method for the treatment of patients with isolated VSD.
Results: The procedural success rate reached 93.2% in the hybrid method, with a 6.4% conversion rate to the traditional method and 0.4% hospital mortality. The mean operation time was 84 minutes (31; 160 minutes) in the hybrid group (n ¼ 250) and 168 minutes (70; 300 minutes) in the traditional group (n ¼ 250) (P ¼ .000). Hospital mortality was 0.43% in the first group and 1.5% in the second group (P ¼ .000).
Conclusions: The hybrid method of VSD closure is safe and effective in a selected group of patients. The advantages of the hybrid method are improved cosmetics and shorter operation time and overall hospital stay. (JTCVS Techniques 2024;24:137-44)
Currently, there are 3 surgical methods: the traditional method of on-pump, the interventional method, and the hybrid (minimally invasive perventricular device closure) method off-pump.1-3 Moreover, minimally invasive cardiac surgery techniques have some types of incisions, such as inferior median sternotomy and right/left anterior thoracotomy or vertical axillary. Minimally invasive cardiac surgery often leads to less pain, smaller scars, lower risk of bleeding or infection, and faster recovery.4 Each method has advantages and disadvantages. The traditional method of on-pump is considered the “gold standard” treatment; however, post-on-pump neurologic outcomes cannot be ignored, which would have an impact on patients’ quality of life.5,6 The interventional method is the alternative way of treatment.7 Nevertheless, it is a difficult implantation procedure with an unsatisfactory high level of postoperative arrhythmia and vascular complications.8,9 The hybrid method is a minimally invasive ventricular septal defect (VSD) closure on a beating heart. The advantages are shortening the duration of the hospitalization, rehabilitation, no X-ray exposure, and good cosmetic effects. However, there are cons, where mentioned, of the development of arrhythmia and, dislocation of the occluder after implantation.10-13 The aim of our study was to evaluate the safety and effectiveness of the hybrid method off-pump for treating isolated VSD compared with the traditional method of on-pump. We present the following article in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology reporting checklist.
ABSTRACT Objective: The aim of our study was to evaluate the safety and effectiveness of the hybrid method off-pump for closure of isolated ventricular septal defect (VSD) compared with the traditional method of on-pump of children. Methods: This research was a retrospective cohort study. Data were collected from 500 patients with isolated VSD (or residual VSD after a previous repair) who underwent surgery at the National Scientific Medical Center from May 2016 to December 2020. Patients were operated with 1 of 2 methods of surgery: the traditional method of on-pump or the hybrid method of off-pump. This study assessed the safety and efficacy of the hybrid method by comparing it with the traditional method for the treatment of patients with isolated VSD. Results: The procedural success rate reached 93.2% in the hybrid method, with a 6.4% conversion rate to the traditional method and 0.4% hospital mortality. The mean operation time was 84 minutes (31; 160 minutes) in the hybrid group (n ¼ 250) and 168 minutes (70; 300 minutes) in the traditional group (n ¼ 250) (P ¼ .000). Hospital mortality was 0.43% in the first group and 1.5% in the second group (P ¼ .000). Conclusions: The hybrid method of VSD closure is safe and effective in a selected group of patients. The advantages of the hybrid method are improved cosmetics and shorter operation time and overall hospital stay. (JTCVS Techniques 2024;24:137-44)
METHODS
Patient Population
This research was a retrospective cohort study. Data were collected from 500 patients with isolated VSD (or residual VSD after a previous repair) who underwent surgery at the National Scientific Medical Center in Astana, Kazakhstan from May 2016 to December 2020. Patients were operated via 2 methods of surgery: the traditional method of on-pump and the hybrid method of off-pump. This study assessed the safety and efficacy of the hybrid method by comparing it with the traditional method for the treatment of isolated VSDs. The study protocol was approved by the Ethics Committee of National Scientific Medical Center, Astana, Kazakhstan (protocol number: 081/CR-75; assigned number: 053/ST-63) and carried out in accordance with the principles set out in the Declaration of Helsinki 1964
Study Methods
Surgery was indicated if patients (aged 0-3 years) had a VSD of>4 mm, were older than 3 years, VSD of>3 mm with a pulmonary/systemic blood flow of>1.5, and/or signs of heart failure.14,15 Children who had a VSD of >4 mm between the ages of 0 and 3 years and shunts greater than 1.5:1 generally have mild-to-moderate elevations of pulmonary artery pressure and resistance. They can be monitored until they are up to 5 years of age to maximize the chance of spontaneous closure. If failing the latter, surgical treatment may be performed.16 Inclusion criteria for both methods included (1) patients with congenital isolated VSD (perimembranous, muscular, atrioventricular conal type [inlet], and subarterial [outlet]); (2) patients with residual VSD postsurgical correction of a congenital VSD; and (3) clinical signs: symptoms of heart failure, recurrent respiratory infection, developmental delay, or history of bacterial endocarditis.17 Echocardiographic inclusion criteria for hybrid method included (1) distance to the pulmonary valve>2 mm; (2) no prolapse of the aortic valve into the defect18; (3) subaortic rim (distance from the defect to the aortic valve) of >2 mm; (4) distance to the tricuspid valve >2 mm; (5) defect size from 4 to 12 mm; and (6) for perimembranous defects, the ratio of the size of the VSD and the weight of the patient was taken into account: (a) 6 mm with a weight of 4 to 8 kg; (b) 8 mm with a weight of 9 to 12 kg; and (c) 10 mm greater than 13 kg.19 Exclusion criteria for the hybrid method included (1) large, nonrestrictive VSDs with indistinct margins or high pulmonary hypertension and bidirectional shunting; (2) prolapse of the aortic valve leaflet into the defect; (3) infective endocarditis; (4) concomitant anomalies requiring correction using cardiopulmonary bypass; (5) the presence of cardiac arrhythmias (in particular, AV block); (6) aortic dextraposition; (7) aortic valve regurgitation (more than mild); (8) tricuspid valve regurgitation (more than mild); and (9) aneurysm of the interventricular septum.18-21
The Traditional VSD Closure of On-Pump
All patients in the traditional method group were operated on through median sternotomy incision under general anesthesia. The standard cardiopulmonary bypass (on pump) was with bicaval cannulation and under normothermia. Then cold blood cardioplegia was used for myocardial protection in all operations. The majority of VSDs were performed through a right transatrial access, by using a porous polytetrafluoroethylene patch “Ecoflon” with a continuous running 6/0 polypropylene suture. Transesophageal echocardiography (TEE) was used in all circumstances to evaluate the residual shunts and the competency of the tricuspid and aortic valves
The Hybrid VSD Closure Off-Pump
After general anesthesia, all patients were placed in a supine position (Video 1). The operation was performed entirely under TEE guidance. Before the operation, the location and size of the VSDs were carefully assessed by TEE. Different types of occluders (symmetric, asymmetric, eccentric, and muscular) may be chosen based on the specific characteristics of the VSD as determined by the TEE. A 2- to 4-cm inferior median sternotomy or vertical axillary incision was done and a pericardiotomy was made. After the pericardium was opened and the free wall of the right ventricle was exposed, the puncture site was identified under continuous TEE control. A purse string suture was placed around the chosen location. Then, that place was punctured by a trocar. The 0.035-inch guidewire was introduced into the right ventricle and then through the defect to the left ventricle by the trocar. After the trocar was removed, the delivery sheath was introduced along the guidewire to the left ventricle. After the inner sheath of the delivery sheath and the guidewire were removed, the occluder was deployed through the loading sheath under TEE. Finally, The TEE was used to detect residual shunt and valve dysfunction (especially for the aortic valve). If, after evaluation with TEE, there were signs such as atrioventricular block, residual shunt greater than 2 mm, and new aortic or tricuspid regurgitation, patients were converted to traditional treatment on-pump