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Better anticoagulation control improves survival after valve replacement

Eric G. Butchart, FRCS, FESCaNicola Payne, MPhilbHui-Hua Li, MDbKeith Buchan, FRCSaKayapanda Mandana, MDa,Gary L. Grunkemeier, PhDb

From the Department of Cardiothoracic Surgery,a University Hospital of Wales, Cardiff, United Kingdom, and the Medical Data Research Centre,b Providence Health System, Portland, Ore.

Funding for this study was provided by Medtronic, Inc, Minneapolis, Minn.

Received for publication June 28, 2001. Accepted for publication Sept 26, 2001. Address for reprints: Eric G. Butchart, FRCS, FESC, Department of Cardiothoracic Surgery, University Hospital of Wales, Heath Park, Cardiff CF14 4XN, United Kingdom (E-mail:  Địa chỉ email này đã được bảo vệ từ spam bots, bạn cần kích hoạt Javascript để xem nó. ).

Abstract

Objective: We sought to assess the effect of anticoagulation control on long-term survival after valve replacement with the Medtronic Hall valve (Medtronic, Inc, Minneapolis, Minn).
Methods: Prospective follow-up data, including 82,297 international normalized ratios, were collected for 1476 patients undergoing single valve replacement with the Medtronic Hall valve between 1979 and 1994, with follow-up to the end of 1998. After excluding 204 patients who either died within 30 days or had fewer than 10 international normalized ratios recorded beyond 30 days, there were 10,203 patient years of follow-up for analysis. Anticoagulation variability was measured as the percentage of international normalized ratios outside a target range of 2.0 to 4.0 for each patient.
Results: Linearized rates for late death rose progressively with increasing deciles of anticoagulation variability for both aortic and mitral valve replacement (2.7% and 3.3% per year, respectively, in deciles 1 and 2 up to 9.5% and 14.6% per year, respectively, in deciles 6-10; P < .001). Survival at 15 years after aortic valve replacement was 59% for low anticoagulation variability(deciles 1 and 2), 55% for intermediate anticoagulation variability (decile 3), and 28% for high anticoagulation variability (deciles 4-10); survivals at 15 years after mitral valve replacement were 56%, 42%, and 24%, respectively (P < .001 between low-intermediate anticoagulation variability and high anticoagulation variability for both aortic and mitral valve replacement). On multivariate analysis, significant predictors of reduced survival were anticoagulation variability per 20% increase (hazard ratio, 1.8), diabetes (hazard ratio, 1.6), decade of age (hazard ratio, 1.6), concomitant coronary artery bypass grafting (hazard ratio, 1.5), male sex (hazard ratio, 1.4), hypertension (hazard ratio, 1.4), New York Heart Association class III or IV (hazard ratio, 1.3), and non-sinus rhythm (hazard ratio, 1.2). Patients with low anticoagulation variability who were in sinus rhythm and did not have diabetes, coronary bypass grafting, or hypertension had survivals equal to those of the age- and sex-matched general population at 15years. The incidence of valve-related deaths was significantly higher with high anticoagulation variability compared with the incidence with low-intermediate anticoagulation variability for both aortic (1.4% vs 0.5% per year, P < .001) and mitral valve replacement (1.5% vs 0.5% per year, P < .001). By means of univariate analysis, high anticoagulation variability was significantly associated with New York Heart Association class III or IV at 5 years postoperatively (P < .001) and with age of greater than 60 years at the time of the operation (P = .002).
Conclusions: High anticoagulation variability is the most important independent predictor of reduced survival after valve replacement with a mechanical valve. Better anticoagulation control should improve survival.

Thứ sáu, 09 Tháng 12 2011 19:48

Written by Nguy?n Qu?c Knh

Tm t?t:

B?nh nhn (BN) thay van tim c? h?c c?n u?ng thu?c ch?ng ?ng khng vitamin K su?t ??i ?? duy tr INR ? ?ch ?i?u tr?. M?c tiu: (1)?nh gi m?t s? tr? ngai c?a m hnh qu?n l ch?ng ?ng kinh ?i?n hi?n p d?ng ? n??c ta, (2)T? l? bi?n ch?ng dng thu?c ch?ng ?ng v nguy c? c?a INR khng ??t ?ch ?i?u tr?. ??i t??ng v ph??ng php nghin c?u: Nghin c?u m t? v phn tch, c?t ngang ? 200 BN thay van tim c? h?c.

K?t qu?: T? l? ??t ?ch INR ch? 30 - 33 % v th?i gian trong ng??ng ?i?u tr? ch? 36,6%. Bi?n ch?ng ch?y mu 18 - 23,6% v huy?t kh?i 5 - 7,5% v?i 5 b?nh nhn t? vong v 8 b?nh nhn k?t van tim. INR khng ??t ?ch l nguy c? c?a bi?n ch?ng ?ng mu v?i OR 18,46 - 18,76 v p < 0,001. K?t lu?n: INR kh ??t ?ch ?i?u tr? v?i m hnh qu?n l ch?ng ?ng kinh ?i?n v l y?u t? nguy c? cao c?a bi?n ch?ng do ch?ng ?ng.

T? kho: INR, mechanical heart valve, complication, risk

Summary:

Background: Oral anticoagulation in the INR target is essential for pts with mechanical heart valve replacement (MHVR). Objectives: (1)To evaluate the contraints of classic model of anticoagulation management; (2)To identify the rate and the risk factor of the anticoagulation-related complications. Patients and method: observational and analytical, cross-sectional study in 200 pts with MHVR. Results: INR target in 30 - 33% pts and TTR 36,6% . Complication includes 18- 23,6% bleeding and 5 - 7,5% thrombosis, leading to 5 deaths and 8 MHV malfunction. The untargeted INR gives OR 18,46-18,76. Conclusion: The out-of- target range INR is relevant to classic model of anticoagulation management and an important risk factor of complication

Key words: INR, van tim c? h?c, bi?n ch?ng, nguy c?.

I. ??t v?n ??

B?nh nhn sau thay van tim c? h?c ph?i ???c ?i?u tr? ch?ng ?ng su?t ??i  b?ng thu?c khng vitamin K ?? ??t ?ch ch? s? chu?n ha qu?c t? (INR: international normalized ratio) 2,5 - 3,5 nh?m trnh nguy c? huy?t kh?i ho?c ch?y mu. Trn th? gi?i hi?n nay c cc m hnh qu?n l ch?ng ?ng thng qua bc s? gia ?nh, cc phng khm ?ng mu (INR clinics) ho?c b?nh nhn t? ?o INR b?ng my c?m tay v t? ?i?u ch?nh li?u thu?c ch?ng ?ng d??i s? t? v?n t? xa c?a bc s?. M hnh qu?n l ch?ng ?ng kinh ?i?n ???c p d?ng ph? bi?n ? Vi?t nam l b?nh nhn ??n b?nh vi?n ?? xt nghi?m INR v nh?n t? v?n c?a bc s? ?? ?i?u ch?nh li?u thu?c ch?ng ?ng v?i k?t qu? l ch? 21 - 44,8% s? b?nh nhn sau thay van tim c? h?c ??t ???c INR ? ?ch ?i?u tr? [4]. Chng ti ti?n hnh nghin c?u ny v?i m?c tiu:

1) ?nh gi m?t s? tr? ng?i c?a m hnh qu?n l ch?ng ?ng kinh ?i?n hi?n p d?ng ? n??c ta cho b?nh nhn sau thay van tim c? h?c.

2) Xc ??nh t? l? bi?n ch?ng dng thu?c ch?ng ?ng v nguy c? c?a INR khng ??t ?ch ?i?u tr?.

II. ??i t??ng v ph??ng php nghin c?u

2.1. ??i t??ng nghin c?u: 200 b?nh nhn (BN) sau m? thay van tim c? h?c Saint Jude ??n vi?n ?? ti khm ho?c c?p c?u t?i khoa Ph?u thu?t Tim m?ch b?nh vi?n Vi?t ??c v Vi?n Tim m?ch B?ch Mai t? 8/2009 - 8/2011.

2.2. Ph??ng php:

- Nghin c?u m t? v phn tch, c?t ngang.

- Tiu ch ?nh gi: Hi?u bi?t c?a BN v? ch?ng ?ng; tr? ng?i c?a m hnh qu?n l ch?ng ?ng kinh ?i?n; t? l? ??t ?ch v khng ??t ?ch INR 2,5 - 3,5;  th?i gian INR trong ph?m vi ?i?u tr? (TTR); nguy c? bi?n ch?ng ch?y mu c?a INR > 3,5 v nguy c bi?n ch?ng huy?t kh?i c?a INR < 2,5.

- Ti?n hnh: B?nh nhn ??n ti khm ???c bc s? tim m?ch h?i v khm tm

cc bi?n ch?ng dng thu?c ch?ng ?ng, ?o INR t?i labo b?nh vi?n.

- X? l s? li?u b?ng SPSS 11.5, tm t? l? % v t? su?t chnh OR. TTR (time in therapeutic range) l t? l? % s? l?n INR ??t ?ch / s? l?n xt nghi?m INR.

III. K?t qu?

1. ??c ?i?m b?nh nhn:

200 b?nh nhn,  tu?i trung bnh 46,7 10,5  v?i cn n?ng trung bnh 55,6 4,3 kg v 53% nam, 47% n?. Van c? h?c g?m 40% van hai l, 21,8% van ??ng m?ch ch?, 38,2% van hai l km van ??ng m?ch ch?.

2. Hi?u bi?t c?a b?nh nhn v? ?ch INR:

-         72,7% BN cho l c?n v 27,3% BN cho l khng c?n xt nghi?m ?ng mu khi dng ch?ng ?ng u?ng.

-         61,8% BN bi?t v 21,8% BN khng bi?t c?n ?i?u ch?nh li?u thu?c ch?ng ?ng u?ng theo gi tr? INR.

-         32,7% BN khng bi?t v 67,3% (135 BN) bi?t c ph?m vi ?ch ?i?u tr? INR nh?ng trong ? c 89% (120 BN) bi?t ?ng ?ch INR 2,5 - 3,5.

N?i xt nghi?m INR

- B?nh vi?n trung ??ng (H n?i)

- B?nh vi?n ? t?nh

C ng??i thn ?i km

Kho?ng cch ??n b?nh vi?n (km)

Th?i gian ?i (gi?)

Th?i gian ch? k?t qu? INR (gi?)

Th?i gian ch? t? v?n bc s? (gi?)

Chi ph VN? cho 1 l?n ?i th? INR

B?nh nhn khng hi lng

Nh?n xt: ?a s? BN ph?i ??n b?nh vi?n trung ??ng ? H n?i ?? xt nghi?m INR, t?n km th?i gian, s?c l?c v chi ph ?i l?i cho b?n thn v ng??i thn.

Bi?n ch?ng ch?ng ?ng

T?i nh

Khi ??n vi?n

Ch?y mu:

47/200 BN (23,6%)

36/200 BN (18%)

Chn r?ng ho?c m?i

Tiu ha

D??i da

Rong kinh

Xu?t huy?t no

25/47 BN (53%)

10 BN (21,3%)

10 BN

2 BN

21/36 BN (58%)

4 BN

6 BN

3 BN

2 BN (2 t? vong)

Huy?t kh?i:

10/200 BN (5 %)

15 BN (7,5%)

M?ch no

M?ch chi

M?ch m?c treo ru?t

K?t van tim

5 BN

5 BN

1 (t? vong)

4 BN (m? c?p c?u)

2 (2 t? vong)

8 (m? c?p c?u)

Nh?n xt: T? l? bi?n ch?ng dng thu?c ch?ng ?ng kh cao; 17 BN ph?i nh?p vi?n c?p c?u (m? l?y mu c?c ? van tim c? h?c ho?c ? chi) v?i 5 BN t? vong. Nh?ng t? l? ny c l? th?p h?n th?c t? v nhi?u BN khng ??n vi?n.

INR

??t ?ch 2,5 - 3,5

60 BN (30%)

66 BN (33%)

< 2,5

82 BN (41%)

72 BN (36%)

> 3,5

58 BN (29%)

62 BN (31%)

TTR

36,6%

Nh?n xt: Ch? 30 - 33% b?nh nhn c INR ??t ?ich ?i?u tr? v? TTR 36,6%.

Khng ??t ?ch

55 BN

85 BN

??t ?ch 2,5- 3,5

2 BN

58 BN

T?i nh: OR = 18,76 (CI 95%: 4,25 - 115,84 v p < 0,001).

Khi ??n vi?n: OR = 18,46 (CI 95%: 4,17 - 113,97 v p < 0,001).

Nh?n xt: INR khng ??t ?ch ?i?u tr? l y?u t? nguy c? r?t cao c?a bi?n ch?ng do dng thu?c ch?ng ?ng.

IV. Bn lu?n

Cc b?nh nhn trong nghin c?u ny c tu?i trung bnh 46,7 10,5 nn th?i gian dng thu?c ch?ng ?ng ko di su?t ??i.

Vi?c h??ng d?n dng thu?c ch?ng ?ng ch?a ???c t?t v?i 27,3% b?nh nhn cho l khng c?n xt nghi?m ?ng mu v 21,8% b?nh nhn khng bi?t c?n ?i?u ch?nh li?u thu?c ch?ng ?ng u?ng theo gi tr? INR. Ch? c 67,3% s? b?nh nhn th?c ???c ph?m vi ?ch ?i?u tr? INR nh?ng 10% trong ? hi?u sai gi tr? ?ch INR. Trong m?t nghin c?u t?i b?nh vi?nVi?t ??c, trong s? 180 b?nh nhn th 40% khng bi?t ?ch INR c?n ??t [4].

M hnh qu?n l ch?ng ?ng kinh ?i?n l b?nh nhn ??n b?nh vi?n ?? xt nghi?m INR v nh?n t? v?n tr?c ti?p c?a bc s? t? ra c nhi?u tr? ng?i do ?a s? (74,5%) ph?i ??n cc b?nh vi?n trung ??ng ? H n?i v?n ? qu t?i, ph?i ng??i thn ?i km (36,4%), m?t nhi?u th?i gian (?i l?i xa, ch? k?t qu? xt nghi?m v ch? bc s? t? v?n) nn 25% s? b?nh nhn khng hi lng v? m hnh ny. M?t khc, c l? v nhi?u tr? ng?i m b?nh nhn khng th??ng xuyn xt nghi?m nn t? l? ??t ?ch INR r?t th?p (30 - 33% s? b?nh nhn) v?i TTR ch? ??t 36,6%.  Ansel J, Hirsh I et al th?y TTR t? l? ngh?ch v?i t?n xu?t bi?n ch?ng ch?ng ?ng v TTR l 55 - 60% n?u do bc s? gia ?nh x? tr, 60 - 65 % n?u do INR clinics v ??t t?i 70% n?u do b?nh nhn t? theo di INR v t? ?i?u ch?nh thu?c ch?ng ?ng [1]. Heneglian th?y r?ng 85% s? b?nh nhn ??t ?ch n?u theo di INR m?i tu?n so v?i ch? 50% ??t ?ch n?u theo di INR m?i thng [3].

Chng ti g?p t? l? bi?n ch?ng kh cao (18  - 23,6% ch?y mu v 5 - 7,5% huy?t kh?i, trong ? c 5 BN t? vong v 8 BN k?t van tim c? h?c) so v?i m?t s? tc gi? n??c ngoi l ch?y mu chi?m 4,9% [2] ??n 15,4% [5] c l? h? p d?ng m hnh INR clinics. N?m 2006, chng ti ? m? c?p c?u d??i tu?n hon ngoi c? th? cho 8 BN k?t van tim c? h?c nh?ng 1 BN ? t? vong sau m? [6]. 54% s? BN huy?t kh?i van tim c INR < 2,5 v 10,9% ch?y mu (c tr??ng h?p ??t t? v ch?y mu no) c INR > 3,5 [1].

Chng ti nh?n th?y INR khng ??t ?ch ?i?u tr? l y?u t? nguy c? cao c?a bi?n ch?ng (ch?y mu, huy?t kh?i) khi dng thu?c ch?ng ?ng khng vitamin K (OR 18,46 - 18,76 v p < 0,001).

V. K?t lu?n

M hnh qu?n l ch?ng ?ng kinh ?i?n kh ??t ???c ?ch ?i?u tr? INR v   ? c?ng l y?u t? nguy c? cao c?a bi?n ch?ng do dng thu?c ch?ng ?ng khng vitamin K.

1. Ansell J, Hirsh J, Roller L et al (2005), "The pharmacology and management of the vitamin K antagonists", Chest, 126: 2045-2335.

2. Butchart E.G, Payne N, Li H.H et al (2002), "Better anticoagulation control improves survival after valve replacement", J Thorac Cardiovasc Surg, 123, pp 715-723.

3. Heneglian C, Coelle P et al (2006), "Self-monitoring of oral anticoagulation: a systematic review and meta-analysis", Lancet, 367, pp 404-411.

4. H? Th? Thin Nga (2009), "Theo di ?i?u tr? khng vitamin K ? b?nh nhn sau m? thay van tim c? h?c t?i b?nh vi?n Vi?t ??c", Y h?c Vi?t nam, t?p 355, s? 2, trang 72 - 76.

5. Koertke H, Minami K, Boethig D et al (2003), "INR self-management permits lower anticoagulation levels after mechanical heart valve replacement", Circulation, 108, suppl II, pp 75-78.

6. Nguy?n Qu?c Knh, L Ng?c Thnh (2006), "B??c ??u nghin c?u ??c ?i?m lm sng, ch?n ?on v x? tr t?c ngh?n van tim c? h?c do huy?t kh?i", Y h?c Vi?t nam, t?p 323, s? 6.

gigigi

2013-09-12 191209

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