Abstract
Since the first implanted in September 1997, the use of On-X prosthetic heart valve has been increasing around in the world. This study was designed to assess the feasibility, safety, and the postoperative hemodynamics with this new valve in clinical setting. Material and Method: The current study was carried out on 52 patients undergoing aortic valve replacement with this prosthesis between April 1999 to August 2002 at Chonnam National University Hospital to evaluate the surgical results. 52％ of the patients were male and the average age at implant was 50$\pm$13 years. The study followed the guidelines of the AATS/STS. Preoperatively, 32(61.5％) patients were in NYHA functional class III or IV and 2 patients had previous aortic valve surgery. Concomitant cardiac surgery was performed in 71.1％. The implanted valve sizes were 19 mm in 13 patients, 21 mm in 26, 23 mm in 10 and 25 mm in 3, respectively. Mean follow-up was 16.6$\pm$10.5 months (1∼39 months). Echocardiographic assessment was performed pre- and immediate postoperatively, as well as 3, 6, 12 months after surgery, evaluating pressure loss and regression of left ventricular hypertrophy. Result: Mean cardiopulmonary bypass time was 191$\pm$94.7 minutes with an aortic cross-clamp time of 142$\pm$51.7 minutes. There was no early and late mortality, Freedom from adverse events at 1 year in the study were as follows: thromboembolism, 95.6$\pm$6％; bleeding events, 90.2$\pm$4％; paravalvular leakage 92.3$\pm$4％; and overall valve-related morbidity at 1 year was 76.6$\pm$3％. There were no cases of valve thrombosis, prosthetic valve endocarditis and structural or non-structural failure. Left ventricular function at 12 months after surgery (EF=62.7$\pm$9.8％) revealed a statistically significant improvement compared to preoperative investigation (EF=55.8$\pm$15.9％, p=0.006). Left ventricular mass index was 247.3$\pm$122.3 g/$m^2$ on preoperative echocardiographic study, but regressed to 155.5$\pm$58.2 g/$m^2$ at postoperative 1 year (p=0.002). Over the follow-up period a further decrease of peak transvalvular gradients was observed in all patients: 62.5$\pm$38.0 mmHg on preoperative assessment, 18.2$\pm$6.8 mmHg at immediate postoperative period (p < 0.0001), 7.6$\pm$5.09 mmHg (p<0.0001) at 6 month, 18.0$\pm$10.8 mmHg (p<0.0001) at 1 year. Conclusion: The On-X prosthetic heart valve performs satisfactorily in the first 1 year period. Clinical outcome by examining NYHA functional classification revealed especially good results. Effective regression of left ventricular hypertrophy and statistically significant decrease of transvalvular gradient were observed over the first year, but longer-term follow-up of this patient group is needed to establish the expected rates for late valve-related events as well as the long-term clinical efficacy of this valve.
On-X 기계판막은 1997년 처음으로 사용된 이후 전 세계적으로 사용빈도가 증가하고 있다. 본 연구는 이 새로운 기계판막에 대한 유용성과 안전성, 그리고 술 후 혈역학적 변화에 대해 알아보고자 시행되었다. 대상 및 방법: 1999년 4월부터 2002년 8월까지 전남대학교병원 흉부외과에서 On-X 판막을 사용하여 대동맥판막 치환술을 시행했던 52명의 환자를 대상으로 분석하였다. 환자 중 52%가 남자였으며 평균연령은 50$\pm$13세였다. 연구는 판막수술 후 결과보고에 대한 AATS/STS 지침에 따라 분석하였다. 술 전 뉴욕 심장병학회의 기능분류상 class III 이상의 환자가 32명(61.5%)이였으며, 2명의 환자는 이전에 대동맥판막 수술을 받았던 환자였다. 71.1%의 환자에서 동반된 질환에 의해 대동맥판막 치환술과 함께 동반 수술을 시행하였고, 이식된 판막의 크기는 19 mm 13명, 21 mm 26명, 23 mm 10명과 25 mm 3명이었다 평균 외래 추적관찰 기간은 16.6$\pm$10.5 (1∼39)개월이었다. 수술 전과 수술 직후 그리고 3, 6, 12개월에 심초음파를 반복 시행하여 술 후 혈역학적 변화양상을 분석하였다. 결과: 평균 체외순환시간과 대동맥 차단시간은 각각 191$\pm$94.7분과 142$\pm$51.7분이었다. 술 후 조기 및 만기 사망은 없었다. 술 후 12개월간 event-free rate는 혈전색전증 95.6$\pm$6%; 출혈성 합병증 90.2$\pm$4%: 판막 주위누출 92.3$\pm$4%이었으며 전체적인 event-free rate는 76.6$\pm$3%이었다. 수술 후 판막혈전이나 심내막염, 구조적 판막부전은 발생하지 않았다. 술 후 12개월의 평균심박출량은 62.7$\pm$9.8%로 수술 전(55.8$\pm$15.9%)에 비해 의미 있는 증가를 보였다(p=0.006). 좌심실 체적지수와 최대 판막압력차는 수술 전에 247.3$\pm$122.3 g/$\textrm{cm}^2$, 62.5$\pm$38.0 mmHg을 보였으나 술 후 12개월에 각각 155.5$\pm$58.2 g/$\textrm{cm}^2$(p=0.002), 18.0$\pm$10.8 mmHg (p<0.0001)로 감소하는 소견을 보였다. 결론: On-X 기계판막을 이용한 대동맥판막 치환술은 임상적 및 혈역학적으로 만족스러운 조기 결과를 보여주었다. 그러나 대상 환자들에 대한 장기간의 외래 추적관찰과 함께 기존 판막과의 비교가 이루어짐으로써 이 새로운 판막에 대한 유용성과 안정성이 확립될 수 있을 것으로 생각한다.