Aortic root replacement with the freestyle stentless porcine aortic root bioprosthesis

Background. Stentless porcine prosthetic valves offer several advantages over traditional valves. Among these are superior hemodynamics, laminar flow patterns, lack of need for anticoagulation and perhaps improved durability.

Methods. One hundred and twelve patients were operated on from September 17, 1992 to April 13, 1998 as part of a multi-center worldwide investigation. All patients received a total aortic root replacement. Patients were evaluated postoperatively at discharge, 3 to 6 months, and yearly by clinical exam and color flow Doppler echocardiography.

Results. There were 4 deaths either in the hospital or within 30 days after surgery for an operative mortality of 3.6%. No patients experienced structural valve deterioration, non-structural valve deterioration, paravalvular leak, unacceptable hemodynamic performance, or postoperative endocarditis. The linearized rates for survival and thromboembolic complications at 5 years were 82.8% and 90.5% respectively. Excellent hemodynamic function is demonstrated by very low gradients, large EOA, and an exceedingly low incidence of any aortic regurgitation.

Conclusions. The Medtronic Freestyle aortic root bioprosthesis can be used safely to replace the aortic root for aortic valve and aortic root pathology. Root replacement allows optimal hemodynamic performance with no significant aortic regurgitation. Early and intermediate results are encouraging, but further follow-up is needed to determine valve durability.     

Eight-year results after aortic valve replacement with the Freestyle stentless bioprosthesis

OBJECTIVES: We sought to describe the hemodynamic and clinical outcomes for the Freestyle aortic root bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in a large multicenter cohort prospectively followed for 8 years. METHODS: A total of 700 patients (651 [93%] >60 years of age) at 8 centers in North America were followed prospectively after aortic valve replacement with the Freestyle stentless bioprosthesis; the implant technique was subcoronary in 500, total root in 162, and root inclusion in 38. Follow-up was 3395 patient-years (4.9 +/- 2.3 years per patient). Clinical and echocardiographic follow-up was prospectively obtained at yearly intervals. RESULTS: For the subcoronary, total root, and root inclusion groups, actuarial freedom from valve-related death was 96.8% (SE 3.0%), 92.3% (SE 7.7%), and 90.9% (SE 11.2%), respectively, and freedom from structural deterioration was 98.6% (SE 2.0%), 100.0% (SE 0.0%), and 100.0% (SE 0.0%), respectively. Hemodynamics remained excellent at 6 years. Freedom from moderate or more aortic regurgitation was 86.0% (SE 5.1%), 98.7% (SE 3.9%), and 97.3% (SE 6.6%), respectively. Gradients were slightly lower (P =.0009), and the effective orifice area (P =.02) and freedom from aortic regurgitation were slightly higher (P =.03) with total root than subcoronary implantation. CONCLUSIONS: The Freestyle stentless aortic root bioprosthesis is a versatile option for aortic valve replacement. Measures of clinical outcomes and prosthesis durability remain excellent in multicenter follow-up through 8 years in a population predominantly older than 60 years at the time of the operation.     

Aortic valve replacement with a stentless porcine aortic root bioprosthesis

From April, 1999 to November, 1999, 8 patients underwent the aortic valve replacement using Medtronic Freestyle aortic root bioprosthesis. Mean age was 67.8 years old. Aortic valve etiology was as follows, AS: 1 case, AR: 2 cases, ASR: 3 cases, IE: 1 case, mechanical valve malfunction due to subvalvular pannus: 1 case. The implanted valve size was 25: 2 cases, 23: 3 cases, 21: 1 cases, 19: 2 cases. Surgical technique was subcoronary: 7 cases, full-root: 1 case. Post-op 2D-echo revealed tribial aortic valve incompetence in two cases because of size discrepancy between the aortic annulus and the ascending aorta. Pacemaker implantation was needed in 1 case because of the complete A-V block. In comparison with 5 cases of aortic valve replacement with Hancock II performed in same period, there were no significant differences about the implanted valve size and mean systolic pressure gradient, but the effective orifice area in Freestyle cases was significantly larger than Hancock II cases.     

Primary tissue failure of the freestyle stentless aortic root bioprosthesis

We present a case of early tissue failure of the Medtronic Freestyle stentless bioprosthesis used in the aortic position which led to reoperation 27 months after implantation. Almost one half of the left coronary cusp of the prosthetic valve had torn away along the annulus. The tear started from the left-non coronary commissure and reached the midpoint of the base of the left coronary cusp. The prosthetic valve was easily excised and replaced with a new mechanical valve. There was no sign of calcification or vegetation in the excised valve. The cause of the valve dysfunction was thought to be primary tissue failure. Long-term function of the Freestyle stentless valve should be carefully followed up.     

Primary tissue failure of the freestyle stentless aortic root bioprosthesis

We present a case of early tissue failure of the Medtronic Freestyle stentless bioprosthesis used in the aortic position which led to reoperation 27 months after implantation. Almost one half of the left coronary cusp of the prosthetic valve had torn away along the annulus. The tear started from the left-non coronary commissure and reached the midpoint of the base of the left coronary cusp. The prosthetic valve was easily excised and replaced with a new mechanical valve. There was no sign of calcification or vegetation in the excised valve. The cause of the valve dysfunction was thought to be primary tissue failure. Long-term function of the Freestyle stentless valve should be carefully followed up.     

Aortic valve replacement with stentless porcine aortic bioprosthesis

Twenty-nine patients were entered in a clinical trial on aortic valve replacement with a stentless glutaraldehyde-fixed porcine aortic valve. This bioprosthesis is secured to the aortic root by the same technique used for aortic valve replacement with aortic valve homografts. The functional results obtained from this operation have been most satisfactory. To assess the hemodynamic benefit of eliminating the stent of a porcine aortic valve, we matched 22 patients with a stentless porcine bioprosthesis for age, sex, body surface area, valve lesion, and bioprosthesis size to 22 patients who had aortic valve replacement with a Hancock II bioprosthesis. Mean and peak systolic gradients across the aortic bioprosthesis and effective aortic valve areas were obtained by Doppler studies. Gradients across the stentless bioprosthesis were significantly lower than gradients across the Hancock II valve for every bioprosthesis size. Effective aortic valve areas of the stentless bioprosthesis were significantly larger than the valve areas of the Hancock II valve. Our data demonstrate that the hemodynamic characteristics of a glutaraldehyde-fixed porcine aortic bioprosthesis are greatly improved when the aortic root is used as a stent for the valve. This technique of implantation is expected to enhance the durability of the bioprosthesis, because the aortic root may dampen the mechanical stress to which the leaflets are subjected during the cardiac cycle.     

Outcome and follow-up of aortic valve replacement with the freestyle stentless bioprosthesis

BACKGROUND: The aim of this study was to determine the morbidity, mortality, and hemodynamics after implantation of the Freestyle stentless bioprosthesis in the aortic position. METHODS: A total of 280 patients were operated on from June 1993 to July 1999 as part of a multicenter investigation. Factors influencing hospital mortality and long-term survival were assessed by logistic regression and Cox proportional hazards analysis. Patients were evaluated postoperatively at discharge, at 3 to 6 months, and yearly by clinical examination and color flow Doppler echocardiography. RESULTS: Hospital mortality in this group was relatively high (9.6%). Logistic regression analysis showed that cross-clamp time, age, myocardial infarction, diabetes, left ventricular hypertrophy, coronary artery disease, New York Heart Association class III or IV and female gender were the independent predictive factors. According to the Kaplan-Meier method, the 4-year survival for hospital survivors was 94%. In the multivariate Cox proportional hazard analysis, only coronary artery disease proved to be prognostic. During follow-up, 11 patients developed paravalvular leakage due to prosthetic dehiscence at the side of the noncoronary cusp. Performance of the prosthesis as assessed by echocardiography was excellent. Mean gradient decreased significantly between discharge and follow-up at 3 to 6 months. At 1-year follow-up trivial regurgitation was found in 6 patients (3%) and mild regurgitation in 4 (2%). Regurgitation did not increase with time. The effective orifice area increased significantly from discharge to follow-up at 3 to 6 months. CONCLUSIONS: Hospital mortality after implantation of a stentless bioprosthesis was higher compared to conventional prosthesis. A high incidence of prosthesis dehiscence at the proximal suture line was found, which was probably due to technique. Hemodynamic performance up to 3 years showed low transvalvular gradients. There is echocardiographic evidence for reduction of left ventricular hypertrophy and improvement of left ventricular function.     

Successful aortic root replacement for prosthetic valve endocarditis using the freestyle stentless bioprosthesis: report of two cases

We report two cases of prosthetic valve endocarditis which were successfully treated with aortic root replacement using the freestyle stentless bioprosthesis. Prosthetic valve endocarditis occurred in two patients after aortic valve replacement and modified Bentall operation, respectively. The aortic annulus was severely damaged and left ventriculo-aortic discontinuity was found in both cases. We used the freestyle stentless bioprosthesis, which fits well to the destroyed aortic annulus with left ventriculo-aortic discontinuity, because of its flexibility. Postoperative echocardiography revealed excellent hemodynamic results in both cases. Although the long-term results obtained with the freestyle stentless bioprosthesis, such as resistance to bacterial infection, have not been reported, this prosthesis appears to be very useful for treatment of prosthetic valve endocarditis. We expect that this prosthesis might be a option for PVE as an alternative to a homograft.     

Wall rupture of Medtronic Freestyle stentless porcine aortic root bioprosthesis

The Medtronic Freestyle stentless bioprosthetic valve provides excellent hemodynamics and long-term durability. However, several studies have reported mid-term structural valve deterioration unique to cases of Freestyle bioprosthesis implantation. According to these reports, the degeneration of the porcine aortic wall causes the dilatation and disruption of the sinus of Valsalva. We encountered a very rare case of an 8 mm-long tear located just above the inflow end of the Dacron cloth. The sudden rupture of the bioprosthetic aortic wall formed a pseudoaneurysm that compressed and almost occluded the pulmonary artery leading to low cardiac output syndrome and shock.     

The freestyle stentless aortic bioprosthesis: more about the subcoronary technique.

Two years after aortic valve replacement with a Freestyle stentless aortic xenograft using the partial scallop inclusion technique, late prosthetic valve endocarditis developed with abscess formation in the space between the porcine and native human aortic wall. The presence of such a periprosthetic dead space exposes the patient to increased postoperative pressure gradients and the risk of superinfection.     

Surgical treatment with the freestyle bioprosthesis and omentopexy for prosthetic valve endocarditis after aortic root replacement

A 60-year-old woman, who had undergone aortic root replacement with composite graft 5 months previously, suffered from anemia and slight fever. Transthoracic echocardiography showed pseudoaneurysm in the aortic root, and blood culture was positive. She was diagnosed with prosthetic valve endocarditis, and surgical intervention was planned. Intraoperatively necrotic tissue and dehiscence of the suture line in the aortic annulus were found. Re-aortic root replacement with Freestyle bioprosthesis and re-hemiarch graft replacement were performed with the omentopexy around the aortic root and the new graft. Antibiotics were administered intravenously for 6 weeks postoperatively. At 7 months after the operation, no prosthetic valve infection had recurred. Although the long-term results of Freestyle bioprosthesis have not been determined, it might be a valuable option for aortic root infection as an alternative to an aortic homograft. In addition, omentopexy might also be effective in the prevention of recurrent prosthetic valve infection.     

Technique of aortic valve replacement with the Edwards stentless aortic bioprosthesis 2500.

Aortic valve replacement with a stentless device ought to result in superior hemodynamic function, because obstructing stents and sewing rims are eliminated. From 15 June 1991 to 15 October 1991, 15 patients underwent aortic valve replacement with the newly designed Edwards stentless aortic bioprosthesis 2500. Patients' ages ranged from 51 to 70 years (mean 61 years). Preoperatively 4 patients presented with aortic regurgitation, 7 with aortic stenosis and 4 with combined lesions; 7 patients were male and 8 female. No additional cardiac or noncardiac diseases were encountered. The operations were performed under normothermic extracorporeal cardiopulmonary bypass and cold cardioplegic cardiac arrest. The implanted valves ranged from 21 mm to 27 mm in diameter. Ten patients received a subcoronary implantation with the lower row of stitches made up of interrupted sutures and the upper row of a continuous suture. In 5 patients the so-called miniroot technique was used, also with lower interrupted sutures and running upper sutures, after adaptation of coronary ostia to the performed openings in the graft. Aortic cross-clamp time ranged between 73 min and 94 min (mean 82 min). There was no operative mortality or morbidity. Postoperative echocardiography showed no signs of aortic valve regurgation in any patient and continuous wave-Doppler measurements showed that resting pressure gradients across the aortic valve were absent or low. Our preliminary experiences with a stentless aortic xenograft valve show that in presence of an increased cross-clamp time an improved hemodynamic function will be obtained. Further studies will be needed, however, to establish the long-term behavior of this device.     

Prosthetic valve endocarditis after aortic valve replacement with freestyle stentless xenograft

A 52-year-old man underwent aortic valve replacement with freestyle stentless xenograft, using subcoronary technique for active infective endocarditis in June, 2001. Eighteen month later he had late prosthetic valve endocarditis associated with aortic annular abscess due to Staphylococcus epidermidis infection. The abscess was debrided and gelatin-resorcin-formalin glue (GRF glue) was injected into the abscess cavity. Abscess cavity was closed with continuous running suture of 3-0 polypropylene stitches. Finally the aortic valve was replaced with ATS mechanical valve (20 mmAP). After administration of vancomycin and gentamicin for 4 weeks, he discharged on 57th postoperative day in good condition. We strongly suggest that GRF glue is essential to close the aortic annular abscess of combined with aortic regurgitation due to active infective endocarditis.     

Aortic root replacement with a freestyle stentless valve for aortitis syndrome with ascending aortic aneurysm and aortic regurgitation.

A 47-year-old woman who had been diagnosed as having aortitis syndrome underwent aortic root replacement for an ascending aortic aneurysm and aortic regurgitation. Because the patient has been treated with steroids for more than 20 years, a Freestyle stentless valve was used to avoid the risk of valve detachment. There were no complications observed during the postoperative course. Although long-term follow-up will be necessary to observe the valve durability, the Freestyle stentless valve seems to be useful for aortic root replacement in patients at high risk of valve detachment due to aortitis syndrome.