Bortolotti U, Milano A, Mazzaro E, Thiene G, Talenti E, Casarotto D
Department of Cardiovascular Surgery, University of Padova Medical School, Italy.
J Am Coll Cardiol. 1994 Sep;24(3):676-82. doi: 10.1016/0735-1097(94)90014-0.
This study aimed to assess the clinical performance and durability of a new generation of porcine valve, the Hancock II bioprosthesis, at intermediate-term follow-up.
Standard porcine bioprostheses undergo progressive structural deterioration, mainly due to cusp and commissural calcification, affecting durability and requiring reoperation. The Hancock II bioprosthesis, which is currently undergoing clinical investigation, is made from a porcine aortic valve treated with a calcium-retarding agent (sodium dodecyl sulfate [T6]), which should delay onset of calcification and increase durability.
From May 1983 to December 1992, we used the Hancock II bioprothesis in aortic (59 patients), mitral (101 patients) and mitral-aortic (25 patients), valve replacement procedures. Postoperative follow-up ranged from 0.1 to 8.7 years (mean [+/- SD] 4.5 +/- 2.6 years) and was 100% complete. Freedom from major postoperative events was calculated at 7 years for patients with aortic valve replacement and at 8 years for those with mitral and mitral-aortic valve replacement.
The actuarial survival rate was 48 +/- 10%, 76 +/- 3% and 63 +/- 6%; freedom from valve-related mortality was 91 +/- 4%, 94 +/- 2% and 89 +/- 6%; freedom from thromboembolism was 80 +/- 11%, 90 +/- 2% and 79 +/- 7%; and freedom from reoperation was 100%, 97 +/- 1% and 89 +/- 6% after aortic, mitral and mitral-aortic valve replacement, respectively. No structural valve deterioration occurred.
At intermediate-term follow-up the Hancock II bioprosthesis showed excellent durability in all positions. However, the effectiveness of anticalcification treatment must be assessed with longer follow-up studies.
本研究旨在评估新一代猪瓣膜——汉考克二代生物瓣膜在中期随访时的临床性能和耐用性。
标准猪生物瓣膜会逐渐发生结构退化，主要是由于瓣叶和瓣环钙化，影响耐用性并需要再次手术。目前正在进行临床研究的汉考克二代生物瓣膜由经钙阻滞剂（十二烷基硫酸钠[T6]）处理的猪主动脉瓣制成，这应能延迟钙化的发生并提高耐用性。
1983年5月至1992年12月，我们在主动脉瓣置换（59例患者）、二尖瓣置换（101例患者）以及二尖瓣-主动脉瓣置换（25例患者）手术中使用了汉考克二代生物瓣膜。术后随访时间为0.1至8.7年（平均[±标准差]4.5±2.6年），且随访率为100%。计算主动脉瓣置换患者7年时、二尖瓣和二尖瓣-主动脉瓣置换患者8年时无主要术后事件发生的情况。
精算生存率分别为48±10%、76±3%和63±6%；无瓣膜相关死亡率分别为91±4%、94±2%和89±6%；无血栓栓塞发生率分别为80±11%、90±2%和79±7%；主动脉瓣、二尖瓣和二尖瓣-主动脉瓣置换术后再次手术率分别为100%、97±1%和89±6%。未发生瓣膜结构退化。
在中期随访中，汉考克二代生物瓣膜在所有位置均显示出出色的耐用性。然而，抗钙化治疗的有效性必须通过更长时间的随访研究来评估。
