Late disruption of a Freestyle stentless bioprosthesis used for repair of sinus of Valsalva aneurysm of noncoronary cusp

We present a case of disruption of the porcine aortic wall of the 27-mm Freestyle stentless bioprosthesis 5 years after the subcoronary implantation to exclude the sinus of Valsalva aneurysm of the noncoronary cusp. At the urgent reoperation, the inflow suture line was found to be intact, and therefore a new stented valve was sutured with the inflow Dacron cuff after removal of ruptured valve. The subcoronary implantation technique creates a cavity between the prosthetic and native aortic walls filled with hematoma. The outflow suture line dehiscence caused blood flow into the cavity, porcine aortic wall rupture, and leaflet destruction.     

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.     

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.     

An improved technique for producing ventricular hypertrophy with a subcoronary valvular aortic stenosis model

Although techniques for producing aortic valve stenosis proximal to the ostia of the coronary arteries have been described in experimental animals, only moderate left ventricular hypertrophy has been obtained. A technique for plicating the noncoronary sinus of Valsalva in puppies is presented that has enabled us to achieve levels of ventricular hypertrophy not previously reported with methods for subcoronary aortic stenosis.     

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.     

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.     

Management of anomalous right coronary arteries encountered during aortic valve surgery.

We experienced three cases with anomalous right coronary arteries during aortic valve surgery. By rotating a Freestyle bioprosthesis by a subcoronary technique, the anomalous artery was secured in one patient. The anomalous artery was injured during the routine aortotomy incision in another patient; a saphenous vein graft was interposed between the ascending aorta and the separated artery. In the third patient, a subannular prosthetic valve was chosen to avoid obstructing the anomalous orifice.     

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 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.     

Stentless aortic root bioprosthesis implantation and coronary artery bypass grafting in a patient with single right coronary artery.

Coronary arteries with anomalous origin from the aorta can be a risk factor during aortic root procedures. We report on the successful management of aortic root surgery in a 76-year-old man with a single coronary ostium. Preoperative computed tomography and angiography revealed an anomalous course of the left main coronary artery from the right sinus of Valsalva. A stentless aortic root bioprosthesis (Prima Plus) was implanted using a modified subcoronary technique. The origin of the left main coronary artery was approximately 2 mm beyond the ostium of the common trunk. Attention to the anatomic relationship of the anomalous coronary arteries to the aorta by clarifying the anatomy of coronary arteries in advance allowed us to safely perform aortic root surgery in a patient with an anomalous origin of the coronary arteries.     

Aortic valve replacement with a freestyle stentless valve using the modified subcoronary technique and hemiarch replacement for bicuspid aortic valve and ascending aortic aneurysma; report of a case

An association between bicuspid aortic valve disease and ascending aortic aneurysma has long been recognized. Root replacement with a composite valve graft for such disease is a well-established technique. But it may involve serious technical difficulties, and may be a more time-consuming procedure than separate valve replacement and graft replacement. We performed an aortic valve replacement with Freestyle stentless valve using the modified subcoronary technique and hemiarch replacement for a 72-year-old man with severe aortic stenosis and ascending aortic aneurysma. Angiographic studies after surgery showed no residual aortic regurgitation (AR) and no deformity of aorta. This technique is an acceptable option for an aortic disease and ascending aneurysma in elderly patients.     

Early experience with the freestyle stentless xenograft

We performed aortic valve replacement with the Freestyle stentless xenograft in 9 patients. There were 6 men and 2 women, whose ages ranged from 44 to 76 years. The modified subcoronary implantation was used in 6 patients and the completely subcoronary implantation was used in 2 patients. The full root replacement was used in 1 patient with bicuspid aortic valve. In a patient who underwent root replacement, postoperative cineangiogram revealed just proximal right coronary artery stenosis. The patient underwent coronary artery bypass grafting to right coronary artery by use of the right internal mammary artery. One in-hospital death occurred on the 46th postoperative day in a patient with severe aortic stenosis and renal failure. 5 patients were investigated by doppler echocardiography at 2 weeks, 3, 6, and 12 months after operation. Peak pressure gradient 1 year after implantation was 11.7 +/- 3.9 mmHg for all valves. No patient had postoperative significant aortic regurgitation.     

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.     

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.     

Aortic root reimplantation for isolated sinus of valsalva aneurysm in the patient with Marfan's syndrome

We describe an isolated extracardiac unruptured acquired aneurysm in the right coronary sinus of Valsalva, which was seen in a 55-year-old woman with Marfan's syndrome. The patient underwent aortic root replacement using a reimplantation technique. Pathologic examination revealed absence of the medial elastic fiber of the aortic wall of the normal sinus of Valsalva. This result supports the preference of entire root replacement instead of patch repair of the affected sinus for the isolated aneurysm in 1 sinus of Valsalva in a patient with Marfan's syndrome.     

Successful repair of unruptured aneurysm of the right sinus of Valsalva

Patch closure of the orifice of an aneurysm is a common operation for sinus of Valsalva aneurysms. Recently, there have been reports of aortic valve-sparing operations for multisinus of Valsalva aneurysms. However, repair would be difficult if only one sinus of Valsalva was dilated. We report a patient with a single unruptured sinus of Valsalva aneurysm successfully treated using the patch repair technique.     

Size and distensibility of the aortic root and aortic valve function after different techniques of the ross procedure

OBJECTIVES: In the Ross procedure, 3 different techniques are used for aortic valve replacement with the pulmonary autograft: freestanding root, inclusion, and subcoronary implantation. The objective of this study was to evaluate echocardiographically the influence of the particular operative technique on dimension, distensibility, and valve function. METHODS: Between February 1990 and August 1998, the Ross procedure was performed in 111 patients (mean age, 48.6 +/- 14.1 years; range, 15.2-70.6 years), with 1 early and 1 late death, 1 autograft replacement, and 1 patient lost to follow-up. The remaining patients underwent the freestanding root (n = 9 patients), inclusion (n = 14 patients), and subcoronary techniques (n = 84 patients). Echocardiography was performed at a mean follow-up of 26 +/- 21.3 months after operation and was compared with the echocardiographic findings of the control subjects (n = 10 subjects). Root sizes were measured at the level of the anulus, sinus, and supra-aortic ridge; the distensibility was calculated as pressure strain elastic modulus and percent change of radius. RESULTS: Size and distensibility of the aortic root were normal, except for a larger diameter at the sinus level in the root technique in comparison to the subcoronary technique (P <.05; maximum diameter, 41.3 +/- 8.6 mm vs 32.6 +/- 4.0 mm). Aortic valve function was comparable among groups with low pressure gradients and most patients with no or trace aortic insufficiency. CONCLUSIONS: The freestanding root, inclusion, and subcoronary techniques in the Ross procedure provide comparable excellent hemodynamics, normal root size, and distensibility, except for the enlarged sinus diameter in the freestanding root. These results may have some impact on the operative procedure and follow-up investigations.     

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.     

A giant unruptured aneurysm of the sinus of Valsalva together with ectasia of the left coronary artery

A sinus of Valsalva aneurysm is defined as a dilatation of the aortic sinuses, between the aortic valve annulus and the sinotubular junction. They are rare and most frequently involve the right coronary sinus. We report a case of an unruptured giant sinus of Valsalva aneurysm in a patient associated with ectasia of the left main stem and left anterior descending coronary artery. The patient was successfully treated with aortic root replacement using a biologic conduit.     

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.