奇特拉心脏瓣膜：一项多中心临床研究的结果。

Sankarkumar R, Bhuvaneshwar G S, Magotra R, Muralidharan S, Rajan R S, Saha D, Subba Rao K S, Valiathan M S, Radhakrishna S, Ramani A V

Dept. of CVTS, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India.

J Heart Valve Dis. 2001 Sep;10(5):619-27.

BACKGROUND AND AIM OF THE STUDY

The Chitra tilting disc valve was developed in India to meet the need for a low-cost cardiac valve. The valve has an integrally machined cobalt-based alloy cage, an ultra-high molecular-weight polyethylene disc, and a polyester suture ring. An important feature of this valve is its soft closing sound, by virtue of a plastic occluder.

METHODS

Between December 1990 and January 1995, 306 patients underwent isolated aortic (AVR, n = 101) or mitral valve replacement (MVR, n = 205) at six institutions in India. The early mortality rate was 6.9% (seven after AVR; 14 after MVR). A total of 285 survivors was followed up until September 1998; total follow up was 1212 patient-years (pt-yr) (AVR, 445 pt-yr; MVR, 767 pt-yr).

RESULTS

There were 52 late deaths (4.3%/pt-yr; AVR 2.2%/pt-yr; MVR 5.5%/pt-yr). Thirty-five deaths were valve-related (23 were due to unknown causes). One AVR patient (0.2%/pt-yr) and 12 MVR patients (1.6%/pt-yr) developed valve thrombosis, and embolic episodes occurred in 25 patients (seven after AVR, 1.6%/pt-yr; 18 after MVR, 2.4%/pt-yr). Bleeding events and infectious endocarditis occurred infrequently (AVR 0.9 and 0.7%/pt-yr; MVR 0.4 and 0.5%/pt-yr, respectively). There was no incidence of paravalvular leak or structural dysfunction of the valve. Actuarial survival rates at seven years were 82.4+/-4.0% for AVR and 65.2+/-5.0% for MVR. During the same interval, thrombus-free and embolism-free survival after AVR and MVR occurred in 98.9+/-1.1% and 94.1+/-1.9%, and 92.3+/-2.8% and 82.1+/-5.7% of patients, respectively. Freedom from all valve-related mortality and morbidity at seven years was 81.5+/-4.1% after AVR, and 64.2+/-5.1% after MVR.

CONCLUSION

The Chitra valve appears to be safe and to have performance comparable with that of other currently used tilting disc valves. This valve costs substantially less than other valves, and is therefore within reach of a larger subset of Indian patients.

研究背景与目的

Chitra倾斜碟瓣是在印度研发的，旨在满足对低成本心脏瓣膜的需求。该瓣膜有一个整体加工的钴基合金瓣笼、一个超高分子量聚乙烯瓣叶和一个聚酯缝合环。此瓣膜的一个重要特征是借助塑料封堵器实现柔和的关闭声音。

方法

1990年12月至1995年1月期间，印度六家机构的306例患者接受了单纯主动脉瓣置换术（AVR，n = 101）或二尖瓣置换术（MVR，n = 205）。早期死亡率为6.9%（AVR后7例；MVR后14例）。共有285名幸存者随访至1998年9月；总随访时间为1212患者年（pt-yr）（AVR，445 pt-yr；MVR，767 pt-yr）。

结果

有52例晚期死亡（4.3%/pt-yr；AVR为2.2%/pt-yr；MVR为5.5%/pt-yr）。35例死亡与瓣膜相关（23例原因不明）。1例AVR患者（0.2%/pt-yr）和12例MVR患者（1.6%/pt-yr）发生瓣膜血栓形成，25例患者发生栓塞事件（AVR后7例，1.6%/pt-yr；MVR后18例，2.4%/pt-yr）。出血事件和感染性心内膜炎发生率较低（AVR分别为0.9%和？？0.7%/pt-yr；MVR分别为0.4%和0.5%/pt-yr）。未发生瓣周漏或瓣膜结构功能障碍。AVR术后7年的精算生存率为82.4±4.0%，MVR术后为65.2±5.0%。在同一时间段内，AVR和MVR术后无血栓和无栓塞生存率分别为98.9±1.1%和94.1±1.9%，以及92.3±2.8%和82.1±5.7%。AVR术后七年无所有瓣膜相关死亡率和发病率的比例为81.5±4.1%，MVR术后为64.2±5.1%。