Midterm results after aortic valve replacement with the autologous tissue cardiac valve.

OBJECTIVE: To assess midterm results after aortic valve replacement (AVR) with an autologous tissue cardiac valve (ATCV). This new technique was developed to construct a tissue prosthesis for AVR using the patients pericardium, harvested at the time of operation with negligible effect on operating time. METHODS: Briefly, glutaraldehyde tanned pericardium is mounted on a stent requiring no suturing. Between March 1994 and December 1996, 87 patients, 44/43 M/F and aged 70 +/- 6 years had AVR for aortic stenosis (80%), aortic insufficiency (6%) and combined lesions (14%), one patient suffered from endocarditis. Additional coronary artery bypass was done in 25%, aortic root enlargement in 7%. Aortic cross clamp and cardiopulmonary bypass times were 69 +/- 21 and 93 +/- 29 min. All patients were followed by clinical examination and color flow Doppler echocardiography in 3-12 months interval. Follow up was 99% complete. RESULTS: There were five perioperative deaths (6%), none of them valve related. Eighty-one patients were followed up to a period of 52 months (mean interval 37.5 +/- 1.3 months), one patient was lost for follow up. Overall survival was 86, 81, 79 and 71% at 12, 24, 36 and 48 months, respectively. There were 14 late deaths with eight (10%) valve related (four cerebral deaths, four sudden deaths). Sixteen patients (20%) had to be re-operated due to severe valve incompetence. Freedom from reoperation was 98, 97, 90 and 63% at 12, 24, 36, and 48 months, respectively. Valve incompetence occurred suddenly, without previous signs in the follow-up examinations. Selection and preparation of the pericardium, the way of fixation of the tissue--brief immersion in glutaraldehyde--and engineering problems might be responsible for this disastrous outcome. CONCLUSION: Due to these results we must state, that the ATCV did not fulfill our expectations and presently we can not recommend it as an aortic valve substitute.

Aortic valve replacement: is the stentless xenograft an alternative to the homograft? Midterm results.

BACKGROUND: This study was performed to assess the midterm clinical results after aortic valve replacement (AVR) with stentless xenograft (SX) compared with cryopreserved aortic or pulmonary homografts (HX). METHODS: In 139 patients (<60 years) undergoing elective AVR, 59 HX and 80 SX were inserted. All patients were followed clinically and by color flow Doppler echocardiography for 45+/-12 months (range 31-58 months). RESULTS: There were 5 in-hospital deaths (3.5%): 4 HX and 1 SX (p = NS). The mean gradient was 6+/-2 mm Hg in HX versus 13+/-6 mm Hg in SX (p<0.001) and remained unchanged during follow-up. Actuarial survival (HX 77%, SX 80%), freedom from endocarditis (HX 91%, SX 99%), freedom from thromboembolic events (HX 98%, SX 90%), and freedom from reoperation (HX 98%, SX 100%) were comparable between groups after 58 months. CONCLUSIONS: Despite slightly higher transvalvular gradients, the stentless aortic valve achieved excellent midterm results, when compared with homografts.

Treatment of left ventricular hypertrophy in hypertensive patients with a combination of verapamil and captopril--a multicenter study.

UNLABELLED: The regression of left ventricular hypertrophy in hypertensive patients was evaluated in a multicenter study with a combination therapy of verapamil 120 mg and captopril 25 mg given once or twice daily. The degree of left ventricular hypertrophy was assessed using echocardiography, while hypertension was evaluated by means of twice daily blood pressure self-measurements and ambulatory blood pressure monitoring. RESULTS: An overall of 61 patients was evaluated. Left ventricular mass had decreased by 13.5% during the 6-month treatment period. This reduction neither correlated with the baseline left ventricular mass nor with the extent of blood pressure decrease. CONCLUSION: The combination therapy-verapamil 120 mg plus captopril 25 mg--is well tolerated by hypertensive patients with left ventricular hypertrophy and produced a decrease of left ventricular mass that is independent of the extent of blood pressure decrease.

Autologous tissue cardiac valve for aortic valve replacement: technical aspects and early results.

BACKGROUND: The known complications of heterograft bioprostheses and homograft valves have renewed the interest in the use of autologous material. A new technique to construct a tissue prosthesis for aortic valve replacement using the patient's pericardium harvested at the time of operation was developed. The glutaraldehyde-tanned pericardium is mounted on a stent requiring no suturing. Intraoperative testing assures adequate valve function. METHODS: The autologous tissue cardiac valve was implanted in 50 patients in the aortic position between March 1994 and May 1995. Echocardiograms were performed in all patients before hospital discharge, at 3 months (41 patients), and at the end of first postoperative year (12 patients). The mean age was 69.8 +/- 5 years (range, 58 to 82 years). Eighty-four percent of patients presented with aortic stenosis and 16% had a combined lesion. Additional cardiac procedures were performed in 21 patients. RESULTS: Aortic cross-clamp time was 72 +/- 19 minutes, and bypass time was 97 +/- 28 minutes. There were three in-hospital deaths, and 2 patients died within the first postoperative year. Predischarge echocardiography demonstrated excellent hemodynamics, with a mean gradient of 20 +/- 8 mm Hg and no or trivial aortic insufficiency in 45 patients. One patient had moderate aortic insufficiency. At first follow-up 36 patients (90%) were in New York Heart Association class I and 4 patients were in class II. Echocardiography showed no evidence of valve failure or degeneration (mean gradient, 17 +/- 5mm Hg; aortic insufficiency = grade 0 [trivial] in 35 patients, grade II in 3 patients, and grade III in 1 patient). Similarly, no degeneration or valve failure with increasing aortic insufficiency was seen in the patients studied at the end of the first postoperative year. CONCLUSIONS: These results demonstrate that an autologous tissue cardiac valve can be manufactured in the operating room without significant additional operating time. Intraoperative testing minimizes the risk of primary failure with aortic insufficiency. Short-term results are encouraging with good hemodynamic performance of the valve and no signs of degeneration. However, long-term durability needs to be demonstrated.

Aortic valve replacement: is the stentless xenograft an alternative to the homograft? Early results of a randomized study.

From November 1992 to October 1993 we randomized 101 patients over 60 years of age undergoing elective aortic valve replacement, with or without concomitant coronary artery bypass grafting, to receive either a cryopreserved aortic or pulmonary homograft (n = 38) or a stentless porcine aortic valve xenograft (Edwards Prima 2500) (n = 63). The majority of all valves (92%) were inserted freehand in the subcoronary position. Six homografts (16%) were implanted as a free-root replacement and two xenografts (3%) were used as a mini root. There were four in-hospital deaths (4%), three in the homograft group and one in the xenograft group (homograft, 7.9% versus xenograft, 1.6%; p = not significant). Forty-one patients were followed at 3- to 6-month intervals for 9 +/- 2 months (3 to 14 months) and valve pathology was assessed routinely by means of color flow Doppler echocardiography. Two patients in the homograft group developed new aortic insufficiency grade II; all others remained with trivial or no valve incompetence. The mean gradient remained unchanged to immediate postoperative measurements (homograft, 5 +/- 1 mm Hg versus xenograft, 11 +/- 4 mm Hg; p < 0.001). Despite a slightly higher transvalvular gradient, xenografts achieved excellent initial results when compared to homografts. Ease of implantation and freedom from thromboembolism indicate that xenografts can be an acceptable alternative to homografts, particularly in older patients with small aortic annuli. Long-term studies assessing the durability of the xenograft are necessary for final evaluation.