Impact of implant technique following freestyle stentless aortic valve replacement

BACKGROUND: Stentless aortic bioprostheses have excellent hemodynamics and clinical outcomes. The purpose of the present study was to determine whether implant technique of the Freestyle aortic root bioprosthesis impacts clinical outcomes or hemodynamic performance. METHODS: The long-term multicenter study of the Freestyle stentless aortic bioprosthesis includes 500 consecutive patients implanted using the subcoronary and 162 using the full root technique. Clinical outcomes and echocardiographic hemodynamics were compared through 5 years. RESULTS: There were no differences between groups in time to death, valve-related death, or reoperation. The incidence of operative death was higher in the full root than in the subcoronary group (odds ratio 3.97, p = 0.001). Patients in the subcoronary group were more likely to have New York Heart Association functional class III or IV symptoms at 1 year (1.7% versus 0%, p = 0.04) and 5 years postoperatively (4.4% versus 0%, p = 0.02). Mean gradient was lower (p = 0.0004) and effective orifice area larger (p = 0.04) in the full root group. Left ventricular mass index decreased in both groups. The preponderance of patients in both groups had no or trivial aortic regurgitation through 5 years. CONCLUSIONS: Full root implantation of the Freestyle stentless aortic bioprosthesis was associated with higher operative mortality, but somewhat better hemodynamics, functional class, and freedom from aortic regurgitation. Higher operative mortality argues against the empiric replacement of the ascending aorta in the absence of aortic root pathology. In appropriately selected patients, both implant techniques are viable alternatives for valve implantation.     

Efficacy of aortic valve replacement with freestyle stentless valve in patients with aortic valve disease

Stentless porcine aortic bioprosthesis has several potential advantages over conventional stented bioprosthesis. The Medtronic Freestyle aortic bioprosthesis, a stentless design analogous to an aortic allograft, has zero-pressure-fixed leaflets treated with an antimineralization agent, and has been shown to have benefits of superior effective orifice area, excellent flow characteristics and durability. To evaluate the early results for its efficacy in view of post-operative performance. The valve was implanted using the cylinder method, with subcoronary, root-inclusion techniques or full root techniques. No patients experienced any significant valvular regurgitation on echocardiography. The post-operative data of EDVI, ESVI and LVPWD decreased significantly as compared with the pre-operative data while ejection fraction remained unchanged. The average peak pressure gradient was 16.5 mmHg, and the average effective orifice area was 2.45 cm2. In conclusion, Freestyle stentless aortic bioprosthesis showed excellent hemodynamic function. It seems to be suited for the older patient with a small aortic annulus.     

Aortic valve replacement with medtronic freestyle bioprosthesis: operative technique and results

OBJECTIVE: This study evaluates the initial results for safety and efficacy of aortic valve replacement (AVR) using the Medtronic Freestyle Bioprosthesis. METHODS: One hundred three patients underwent AVR with the Medtronic Freestyle Bioprosthesis over a 40-month period. There were 59 male and 44 female patients with a mean age of 74 years (range 36 to 88 years). Valve size ranged from 19 to 27 mm, and all valves were implanted using a freehand subcoronary technique. Anticoagulation with coumadin was only used for atrial fibrillation. Aspirin was given to patients with associated coronary artery disease. Echocardiography to assess transvalvular pressure gradient and effective valve orifice area was performed at discharge, 3 to 6 months, 1 year, and then annually. RESULTS: There were 4 (3.9%) deaths within 30 days of operation and 5 (4.9%) late deaths. Two (1.9%) deaths were valve-related, one from commissural dehiscence and one from bacterial endocarditis. Three (2.9%) deaths, two early and one late, were from other cardiac causes. The remaining deaths were from noncardiac causes. Five (4.9%) patients suffered a thromboembolic event, two had permanent neurological deficits, two had transient neurological events, and one had coronary artery occlusion. Mean transvalvular gradient assessed by echocardiography was low at all time intervals: discharge (12.8 mmHg), 3 to 6 months (11.3 mmHg), 1 year (12.0 mmHg), and 2 years (11.6 mmHg). Mean effective valve orifice area was good at all time intervals: discharge (1.4 cm2), 3 to 6 months (1.5 cm2), 1 year (1.6 cm2), and 2 years (1.6 cm2). Of the 38 patients assessed by echocardiography at 1 year, 33 (87%) had no or trivial valve incompetence and the remainder had mild valve incompetence. CONCLUSIONS: Aortic valve replacement with the Medtronic Freestyle Bioprosthesis has a low incidence of early valve-related mortality and thromboembolism. The bioprosthesis demonstrates good hemodynamic performance even in small diameters and is particularly well suited for older patients and the small aortic root.     

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 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.     

Clinical and Hemodynamic Comparison of the Medtronic Freestyle and Toronto SPV Stentless Valves

The excellent hemodynamics of stentless valves have been observed by numerous investigators. With the recent release of the Toronto SPV (stentless porcine valve) and the Medtronic Freestyle stentless valves in North America, it is appropriate to now compare the clinical and hemodynamic performance of these devices. We analyzed the results of 995 patients who underwent aortic valve replacement (AVR) with either of the two valves; in all cases a subcoronary implant technique was used. There were important differences in the preoperative characteristics for the two groups: Medtronic Freestyle patients were notably older than the Toronto SPV patients (70.7+/-8.6 vs 61.8+/-11.1 years, p < 0.001) and were markedly more symptomatic (p < 0.0001). In the Toronto SPV group, most patients had New York Heart Association (NYHA) Class II (41.5%) or Class III (44.7%) symptoms preoperatively, while in the Freestyle group, 61.5% were in Class III and 12.5% were in Class IV. There were no notable differences in mortality or morbidity for the two groups. Both devices demonstrated a meaningful decrease in mean gradient and a corresponding increase in effective orifice area (EOA). Furthermore, the indexed EOA (EOA/body surface area [BSA]) was > 1cm2/m2 for all valves indicating there was no patient-prosthetic mismatch. There was a meaningful decrease in left ventricular (LV) mass as well as LV mass index (LVMI) for both devices up to 3 years postoperatively. Our data indicate that there were no differences in clinical outcome or hemodynamic performance of these two valves. Both devices offer excellent results with normalization of LV function.     

Aortic Valve Replacement with Stentless Porcine Bioprostheses

The implantation of stentless porcine valves (SPVs) is technically more demanding than implantation of stented bioprosthetic valves. Implantation of the Toronto SPV bioprosthesis requires an,understanding of the relationships between the leaflets and the aortic annulus and sinotubular junction. In addition to proper alignment of the three commissures within the aortic root, the diameter of sinotubular junction should not exceed the external diameter of the porcine aortic valve after completion of the operation. The Medtronic Freestyle porcine aortic root bioprosthesis can be used for subcoronary implantation as well as for aortic root replacement. Degenerative calcification of a tricuspid aortic valve is the most common cause of aortic valve disease in older patients. Implantation of stentless valves in the subcoronary position is usually feasible because the geometry of the aortic root is well maintained in these patients. The bicuspid aortic valve is the second most common cause of aortic valve disease in older patients and the most common in younger patients. These patients frequently have dilated aortic root, and the Medtronic Freestyle bioprosthesis is ideal for implantation using the root inclusion technique. Stentless porcine bioprostheses are minimally obstructive and associated with low mean systolic gradients. In addition, they have better hemodynamic performance during exercise than stented bioprostheses. For these reasons, patient-prosthesis mismatch has not been described with stentless valves. Left ventricular function after aortic valve replacement appears to be better with stentless than with stented bioprostheses. Comparative, nonrandomized studies of aortic valve replacement with stented and stentless valves suggest that the risk of cardiac death is reduced with stentless valves and the rates of valve-related complications also appear to be lower. What remains unknown is whether stentless valves are more durable than stented ones.     

Aortic valve replacement with the freestyle stentless bioprosthesis with respect to spacial orientation of patient coronary ostia

OBJECTIVE: This study evaluates our results for safety and efficacy of aortic valve replacement using the Freestyle bioprosthesis (Medtronic, Inc, Minneapolis, Minn) with a new modified subcoronary implantation technique. This technique takes into account the spacial orientation of the stentless bioprosthesis in the aortic root with respect to the patient's coronary ostia rather than the native commissures. METHODS: Fifty-two consecutive patients with predominant aortic valve stenosis underwent aortic valve replacement with a Freestyle bioprosthesis by means of the described modified subcoronary technique over a 15-month period. Fifty of them were followed up by means of echocardiography at discharge, 6 months, and 1 year. There were 19 men and 31 women, with a mean age of 76 +/- 7 years (range, 58-87 years). Valve size ranged from 21 to 27 mm. RESULTS: Patients with bicuspid aortic valves had a significantly larger angle between both coronary ostia than patients with tricuspid aortic valves (P =.0001). The peak and mean systolic gradients decreased significantly during the first postoperative year for each valve size (P 相似文献   

Eight-year results of aortic root replacement with the freestyle stentless porcine aortic root bioprosthesis

Background. Stentless porcine aortic 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 four patients were operated on from September 17, 1992, to October 31, 1997, as part of a multicenter worldwide investigation of the Medtronic Freestyle stentless porcine bioprosthesis. All patients received a total aortic root replacement. The patients were evaluated postoperatively at discharge, at 3 to 6 months, and yearly by clinical examination and color flow Doppler echocardiography.

Results. Operative mortality was 3.9%. No patient experienced structural valve deterioration, nonstructural deterioration, perivalvular leak, or unacceptable hemodynamic performance. At 8 years, survival was 59.8%. Freedom from thromboembolic complications was 83.3%. Freedom from postoperative endocarditis was 96.9%. Freedom from reoperation was 100%. Mean systolic gradients did not change over the time period studied. They were 6.4 ± 3.8 mm Hg at 1 year and 6.7 ± 2.6 mm Hg at 8 years. Correspondingly, effective orifice area was 1.9 ± 0.7 cm² at 1 year and 1.8 ± 0.8 cm² at 8 years. The incidence of any aortic insufficiency also did not change over the length of follow-up. At 1 year, 98% of patients had no or trivial aortic insufficiency and 2% had mild aortic insufficiency. At 8 years, 100% of patients evaluated were free of any aortic insufficiency.

Conclusions. The Medtronic Freestyle aortic root bioprosthesis can be used safely to replace the aortic root or aortic valve for aortic valve and aortic root pathology. Total root replacement allows optimal hemodynamic performance with no significant aortic regurgitation. Results up to 8 years show excellent survival and no signs of degeneration. Further follow-up is still needed to determine valve durability.     

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.     

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.     

Medtronic Freestyle Aortic Root Bioprosthesis: Implant Techniques

BACKGROUND: The Medtronic Freestyle aortic root bioprosthesis is a complete porcine aortic root to allow implantation (1) as a subcoronary valve replacement by removing graft sinus aorta, (2) as a cylinder with the sinotubular junction intact within the aorta (root inclusion), or (3) as a complete aortic root replacement. The choice among the three implant techniques depends on surgeon preference or upon the pathology encountered. The advantages and differences among the three implant techniques are examined. METHODS: The Medtronic Freestyle bioprosthesis was implanted in 1163 patients in a Food and Drug administration (FDA) clinical trial between August 1992 and October 1997. There were 21 centers in the international trial using a single data repository. Clinical data was collected prior to and at operation, at 3 to 6 months and annually. The data were compiled and statistical analysis performed at the data center. RESULTS: Patients having subcoronary valve implants were older (80% > 65 years) and aortic occlusion time was about 20 minutes less than the other methods. Patients having aortic root replacement presented with more aortic valve insufficiency (20%). Pathology of the aortic root and ascending aorta requiring repair was 26%, and larger (27 mm) valves were used in 40% of patients. Risk of operation was lowest (5.0%) with subcoronary valve implants and highest (11.7%) with root replacement technique. Thromboembolism was higher, early and late, with root inclusion (3.0, 3.9%/patient per year) and root replacement (3.2, 3.0%/patient per year) than for subcoronary implants (1.8, 1.6%/patient per year). There were more patients taking warfarin at the 4-year point with root inclusion (20%) or root replacement techniques (24%) than among patients having subcoronary implants (14%). Explants of the valve occurred in 2% of patients, none of whom had aortic root replacement. CONCLUSIONS: The Medtronic Freestyle bioprosthesis is an effective and versatile device for replacement of the aortic valve. It offers implant techniques that can treat the aortic root pathology encountered at surgery and allows the operation to proceed according to surgeon preference.     

Relation between size of prosthesis and valve gradient: comparison of two aortic bioprosthesis.

OBJECTIVES: The outcome of patients undergoing aortic valve replacement (AVR) may be affected by the influence of prosthesis-patient mismatch on left ventricular mass regression. However, due to the discrepancies in labeled valve size, size of sizer and actual valve dimension, it is difficult to compare different valve types. In order to perform an objective comparison, this study was designed to compare the hemodynamics of the Edwards Lifescience pericardial (ELP) and the Medtronic Mosaic porcine (MM) bioprosthesis between patients receiving the same valve size and between patients with the same aortic annulus diameter. METHODS: This prospective, randomized study was performed on 81 hospital survivors out of 86 patients undergoing AVR with either the ELP (n=39) or the MM (n=42) bioprosthesis. Intra-operative randomization was performed after the surgeon had excised the aortic valve, measured the size of the aortic annulus with three different sizers (ELP, MM and a set of metric sizers), and decided which size he would implant for either of the valve types. All valves were implanted in supra-annular position with the same implantation technique. Echocardiographic follow-up was performed early postoperatively and 6 months thereafter. RESULTS: In 12 (31%) of the patients receiving the ELP-valve, as compared to 3 (7.1%) of the patients receiving the MM-valve, the labeled valve size was smaller than the aortic annulus diameter (P<0.05). Early postoperatively, mean (17.4+/-3.1 vs 20.3+/-3.6 mmHg) and peak gradients (30.1+/-4.8 vs 37.6+/-9.6 mmHg) for the 21 mm ELP-valve were lower than for the 21 mm MM-valve (P<0.05). All other hemodynamic parameters did not show significant differences at any time point. When the same aortic annulus diameter was taken as a reference, there were no significant hemodynamic differences between either valve type at any time point, regardless of the valve size implanted. CONCLUSIONS: This study demonstrates that the hemodynamic performance of the ELP and the MM bioprosthesis are comparable when the same aortic annulus diameter is taken as a reference. The significant variabilities between different valve types with regard to labeled valve size, valve-sizer size and actual valve size have to be taken into account, when hemodynamic comparisons are performed.     

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.     

Early experience of aortic valve replacement with the Freestyle stentless aortic bioprosthesis in elderly patients.

OBJECTIVES: Stentless bioprostheses have been gaining popularity in recent years as hemodynamically superior alternatives to conventional stented bioprostheses. METHODS: Between July 1996 and November 1998, 13 patients with aortic valve disease, 7 males and 6 females with a mean age (+/- SD) of 68 +/- 5 years, underwent an aortic valve replacement using the Medtronic Freestyle aortic bioprosthesis. The predominant lesions were stenosis in 8 patients and regurgitation in 5, while 2 patients had endocarditis. The operation was performed by a subcoronary technique in 9, root-inclusion technique in 3, and full root technique in 1 patient. RESULTS: Throughout the follow-up periods (with average follow-up period of 20.6 months), there was no hospital mortality, though there was one late death of unknown cause. The New York Heart Association class improved in all patients. The peak transvalvular gradient decreased from 18.4 +/- 9.8 to 12.6 +/- 9.6 mmHg, and the effective valve orifice area increased from 2.30 +/- 0.96 to 2.59 +/- 1.05 cm2 between the 1-month and the 6-month follow-up examinations. In patients with aortic regurgitation, the left ventricular end-diastolic/end-systolic volume index significantly decreased from 147 +/- 36/62 +/- 19 to 73 +/- 26/33 +/- 14 ml/m2 at 1 month after the operation. The left ventricular mass index also significantly decreased from 189 +/- 26 to 143 +/- 30 g/m2 in patients with aortic regurgitation and from 171 +/- 28 to 144 +/- 30 g/m2 in those with aortic stenosis. CONCLUSIONS: Although long-term follow-up is required for further evaluation, the early results appeared to indicate that the Freestyle aortic bioprosthesis was suitable for elderly patients requiring aortic valve replacement.     

Stentless aortic root bioprosthesis (freestyle) to patients of bicuspid aortic valve with abnormal positioning of the coronary ostia]

Stentless aortic root bioprosthesis (Freestyle) was implanted to two patients of bicuspid aortic valve stenosis with anatomically abnormal positioning of the coronary ostia. In a patient of LR type bicuspid valve, the left coronary artery was located at 180 degrees against the right coronary ostium. To match the Valsalva sinus of the patient with bioprosthesis, the left half of the native annulus, 23 mm in the diameter, was plicated corresponding to the one third of the Freestyle inflow, 21 mm in the diameter. In the other patient of AP type bicuspid valve, both coronary ostia were closely positioned at 90 degrees. To keep both ostia in the sinus of bioprosthesis, careful trimming and suturing were required in the narrow part of both ostia. Their postoperative courses were uneventful and no regurgitation has been observed in either case.     

Successful implantation of self-expanding valve for a failed stentless prosthesis

Valve-in-valve transcatheter aortic valve implantation is currently used for failed bioprosthesis. The use of a transcatheter prosthesis in a regurgitant noncalcified root implanted Medtronic Freestyle prosthesis is particularly challenging. We present a successful transaxillary valve-in-valve implantation of a self-expandable transcatheter aortic valve prosthesis in a failed Freestyle bioprothesis implanted eleven years earlier. Tips and tricks are discussed.     

Hemodynamic function of the standard St. Jude bileaflet disc valve has no clinical impact 10 years after aortic valve replacement

OBJECTIVES: Size mismatch and impaired left ventricular function have been shown to determine the hemodynamic function of the standard St. Jude bileaflet disc valve early after aortic valve replacement (AVR). We aimed to analyse St. Jude valve hemodynamic function and its clinical impact in the survivors of a prospective series 10 years after AVR for aortic stenosis. DESIGN: Forty-three survivors aged 32-90 years from a prospective series attended a follow-up study with Doppler echo and radionuclide cardiography 10 years after AVR for aortic stenosis. Six patients with significant left sided valve regurgitation were excluded from further analysis: they had significantly lower St. Jude valve gradient and left ventricular ejection fraction (LVEF) and larger mass index (LVMi) than 37 without. RESULTS: In the 37 patients without left sided valve regurgitation peak and mean gradients were inversely related to St. Jude valve geometric orifice area (GOA) indexed for either body surface area or left ventricular end-diastolic dimension (LVEDD). The gradients correlated directly with LVEDD but not with LVEF or LVMi. Eleven patients with hypertension had higher peak gradients (31+/-13 versus 22+/-8 mmHg, p<0.05), lower LVEF, and higher LVEDD and LVMi than 26 without. Peak gradient was greater than 35 mmHg in five hypertensive patients with normal LVEF but lesser than 30 mmHg in six with impaired LVEF. Supranormal LVEF and severe size mismatch identified the remaining patients (N=3) with peak gradient above 35 mmHg. In a multilinear regression analysis GOA indexed for LVEDD, hypertension, and LVEF were independently related to peak gradient. CONCLUSION: High gradients of the standard St. Jude bileaflet disc valve 10 years after AVR was primarily related to systemic hypertension and mismatch between valve and left ventricular cavity size. Hypertension and left sided valve regurgitation, but not St. Jude valve gradient or size mismatch, were the dominant determinants of left ventricular hypertrophy and impaired function.     

The Freestyle Stentless Bioprosthesis in more than 1000 Patients: A Single-Center Experience over 10 Years

Abstract   Background and Aim: Early and mid-term clinical outcomes after aortic valve replacement (AVR) with stentless bioprostheses in a large cohort of patients are presented. Methods: Between April 1996 and November 2005, 1014 patients underwent AVR with the stentless Medtronic Freestyle bioprosthesis, with 168 using the full-root technique. The mean age was 73 ± 3 (range: 20 to 90) years. Follow-up included 2953 patient-years and was 95% complete for adverse events. Results: Operative mortality was 3.4% (N = 34). Overall survival was 46 ± 9% at nine years and similar to age- and gender-matched German general population. Freedom from prosthetic valve endocarditis, major bleeding, neurological events, and reoperation after nine years was 97 ± 6%, 92 ± 7%, 70 ± 16%, and 92 ± 9%, respectively. Freedom from structural valve deterioration was 97 ± 5% at 9 years. During the learning phase, mean transprosthetic gradients of 23.5 ± 3.0 mmHg and 24.8 ± 3.1 mmHg were observed for valve sizes 21 and 23 mm, respectively, 10 days after subcoronary implantation in 1997, which could be lowered to 16 ± 2.1 mmHg and 14.9 ± 0.9 mmHg in 2005, respectively, with increasing experience of the surgeons. During the follow-up period, mean gradients dropped on average by 15 mmHg in patients presenting higher gradients at discharge. Conclusions: The Freestyle stentless bioprosthesis showed encouraging midterm durability with low rates of valve-related morbidity, and can be safely implanted without increased operative risk even during the learning phase. Special training of the surgeons is recommended to achieve optimal hemodynamic performance.     

Perforation of the Valsalva sinus after implantation of Medtronic Freestyle aortic bioprosthesis

We report on structural valve deterioration in patients with the Medtronic Freestyle aortic bioprosthesis (Medtronic, Inc, Minneapolis, MN), including spontaneous perforation of the Valsalva sinus. These occurred in four prosthesis in 3 patients using the modified subcoronary method or full root technique. One patient died of ruptured pseudoaneurysm and the others survived reoperation well. Careful follow-up is required after Freestyle bioprosthesis implantation.