Peratrial Balloon Pulmonary Valvuloplasty Of Severe Pulmonary Stenosis-Initial Clinical Trial

Background:Percutaneous balloon pulmonaty valvuloplasty(PBPV)is well established and studied in children,adolescents,and adults.However,performing PBPV is difficult in patients with severe pulmonary stenosis(PS)due to the long pathway(femoral vein to pulmonary valve)which makes the appropriate positioning of the balloon across the pulmonary valve(PV)difficult,the fatal ventricular arrhythmia which caused by a long guidewire,and hemodynamic instability that occurred during performing PBPV.We performed transthoracic peratrial balloon pulmonary valvuloplasty(PaBPV)on patients to overcome these difficulties.Our aim is to evaluate the feasibility,safety,efficacy,and clinical outcome of this new approachMethods:Between February 2012 and August 2019,37 patients(mean age,5.8 ±11.8 years;age range,0.014-46 years:mean weight,16.3±20.3 kg;weight range,3.5-80 kg)with PS underwent PaBPV in our hospital.The procedures were performed through a right mini-thoracotomy(Group-A)and lower median mini-sternotomy(Group-B)without fluoroscopy and cardiopulmonary bypass.A parasternal or submammary skin incision(2 to 2.5 cm in length)was made in the right 4th intercostal space then exposed with a mini retractor.A specially designed metal hollow probe was inserted through the purse-string sutures placed on the right atrium wall.Under transesophageal echocardiographic(TEE)guidance,the probe was advanced firstly through the tricuspid valve,then stenosed pulmonary valve into the main pulmonary artery,and thereafter the balloon valvuloplasty performed after adjusting the balloon in an appropriate position.Results:All patients left the hospital with smiling faces after a successful operation.Before the balloon dilatation,the peak systolic gradient(PSG)was 80.3±19.9 mm Hg.Immediately after balloon dilatation,the peak systolic gradient across the pulmonary valve decreased from 80.3±19.9 mm Hg to 17.9 ± 8.0 mm Hg.The mean intracardiac manipulation time was 28.6± 9.4 minutes;range.12-54 minutes.After the balloon dilatation,tricuspid insufficiency was significantly reduced Patients with immediate postintervention PSG>30 mm Hg were more likely to need a second PaBPVConclusions:PaBPV appeared as a feasible,safe,and effective treatment option for those patients who had severe pulmonary stenosis.Therefore,it can be inferred an acceptable alternative to surgical repair in all age groups of patients.Although a few percentages of patients required a second intervention,especially those with poor immediate results,follow-up results are encouraging.Therefore,long-term follow-up is necessary after PaBPV.