The Mosaic bioprosthesis in the aortic position at five years

BACKGROUND AND AIM OF THE STUDY: The study aim was to collect intermediate-term data on the Mosaic bioprosthesis implanted in the aortic position. The device has been in clinical use since February 1994. METHODS: The Mosaic bioprosthesis is a stented porcine aortic valve, which combines a zero pressure differential fixation technique and anti-mineralization treatment with amino oleic acid for improved tissue durability. Between February 1994 and May 1999, 100 patients (49 females, 51 males; mean age at implant 73.4 +/- 7.3 years (range: 31-87 years) underwent aortic valve replacement with the Mosaic prosthesis in our department. Concomitant procedures were performed in 40% of cases. Patients were followed up prospectively at annual intervals; the mean follow up was 2.7 years (total 273.7 patient-years (pt-yr)) and was 100% complete. RESULTS: Total early mortality (within 30 days) was 3.0%; the late mortality rate was 4.4%/pt-yr and included a valve-related mortality rate of 0.7%/pt-yr. The freedom from event rates at five years were 97.3 +/- 1.9% for permanent neurological, 99.0 +/- 1.0% for transient neurological, 95.9 +/- 3.2 for thrombosed prosthesis, 95.6 +/- 2.2% for anti-thromboembolic-related hemorrhage, 100% for primary valvular leak, 96.9 +/- 3.0% for non-structural dysfunction, 100% for endocarditis, and 92.0 +/- 4.9% for explant. The mean systolic gradients were 15.2, 13.1 and 10.1 mmHg for the 21, 23 and 25 mm valve sizes, respectively. CONCLUSION: The clinical and hemodynamic performance of the Mosaic prosthesis was highly satisfactory during the first five years after clinical introduction. Further data will be necessary to confirm long-term durability.     

Hemodynamic assessment of the Medtronic Mosaic bioprosthesis in the aortic position

BACKGROUND AND AIM OF THE STUDY: The Medtronic Mosaic bioprosthesis (MMB) is a newly developed tissue valve which incorporates several features such as a low-profile semi-flexible stent, zero-pressure tissue fixation, and anti-mineralization pretreatment with alpha-amino oleic acid aimed to improve hemodynamics and prevent structural deterioration. METHODS: Between November 1995 to June 1999, 62 patients underwent aortic valve replacement (AVR) with the MMB; 41 of these who reached the one-year follow up interval and who had isolated AVR without any concomitant procedure with size 23 mm and 25 mm MMB were evaluated by serial echocardiography after three, six and 12 months. RESULTS: For size 23 mm valves, mean and peak gradients were 12+/-3 and 21+/-6 mmHg at 3 months, 12+/-3 and 20+/-5 mmHg at 6 months, and 12+/-4 and 20+/-6 mmHg at 12 months. For size 25 mm valves, mean and peak gradients were 13+/-2 and 22+/-4 mmHg at 3 months, 12+/-3 and 21+/-5 mmHg at 6 months, and 12+/-4 and 22+/-6 mmHg at 12 months. In patients with 23 mm MMB, left ventricular mass index (LVMi) was reduced from 181+/-34 g/m2 before surgery to 158+/-32, 150+/-28 and 140+/-25 g/m2 at 3, 6 and 12 months after AVR (p <0.001); in patients with 25 mm MMB, LVMi was reduced from 182+/-28 g/m2 before surgery to 165+/-25, 156+/-24 and 146+/-19 g/m2 at 3, 6 and 12 months after AVR (p <0.001). CONCLUSION: Our results indicate that MMB is associated with low mean and peak gradients and significant reduction in LVMi throughout the postoperative period. Thus, the MMB appears to be an excellent cardiac valve substitute in elderly subjects who require AVR.     

Medtronic intact porcine bioprosthesis in the aortic position: 13-year results

BACKGROUND AND AIM OF THE STUDY: The Medtronic Intact porcine bioprosthesis is a second-generation porcine bioprosthesis. This study was designed to evaluate results with this valve implanted in the aortic position at 13 years, notably with regard to the risk of structural valve deterioration (SVD). METHODS: A total of 188 patients (mean age 72.0+/-8.2 years; range: 28-89 years), who underwent aortic valve replacement between June 1987 and December 1990, was reviewed. RESULTS: Operative mortality was 9.0% (n = 17). Mean follow up per patient was 7.2+/-4.2 years (maximum 13.6 years); total follow up was 1,408.4 years. Linearized late mortality rate was 6.8%/patient-year (pt-yr) (n = 96), and the overall survival at 13 years 31.5+/-4.3%. SVD occurred in eight patients (linearized rate 0.57%/pt-yr), and freedom from SVD at 10 and 13 years was respectively 95.8+/-1.9% and 91.0+/-3.3% actuarial, and 97.3+/-1.2% and 95.5+/-1.6% actual. The mean time to onset of SVD was 7.8+/-2.8 years, and was independent of patient age at the time of implantation. Freedom from SVD at 10 and 13 years by age groups was: age < or =60 years, 76.6+/-14.8% and 60.9+/-18.0% actuarial, and 80.0+/-12.6% and 68.6+/-15.1% actual (linearized rate 3.3%/pt-yr); age 61-70 years, 96.3+/-2.6% and 92.4+/-4.5% actuarial, and 96.6+/-2.4% and 94.8+/-2.9% actual (linearized rate 0.37%/pt-yr); and age >70 years, 98.3 1.7% and 95.8+/-3.0% actuarial, and 99.2+/-0.8% and 98.3+/-1.2% actual (linearized rate 0.26%/pt-yr) (p <0.007). CONCLUSION: When implanted in the aortic position, the Medtronic Intact porcine bioprosthesis provides a low rate of SVD at 13 years. The prosthesis can be used in the aortic position in subjects aged over 60 years with a low rate of deterioration, similar to that with other second-generation bioprostheses.     

Clinical and hemodynamic results of the mosaic bioprosthesis in aortic position

INTRODUCTION: Aim of the study was to evaluate the hemodynamic and clinical performance of the Mosaic bioprosthesis in the aortic position. PATIENTS AND METHODS: The Mosaic bioprosthesis is a stented porcine heart valve for implantation in the aortic and mitral position, which combines zero pressure and root pressure fixation with glutaraldehyde, antimineralization treatment with alpha amino oleic acid (AOA) and a low profile stent, to optimize hemodynamic function and to minimize mechanical wear and thus to achieve longer tissue durability. Included in a multicenter study, 100 patients (49 females) underwent isolated aortic valve replacement with the Mosaic bioprosthesis between February 1994 and May 1999. Average age at implant was 73.4 +/- 7.3 years (range 31.3-86.8 years). Preoperative and operative clinical data are shown in Tables 1 and 2. Patients were followed-up within the first 30 postoperative days, after six months and at annual intervals, including transthoracic echocardiography and documentation of any adverse events. Mean follow-up was 3.8 years (range 0.1-7.1 years), total 383.1 patient-years. Follow-up is 100% complete. RESULTS: One year after implantation of the bioprosthesis, mean systolic pressure gradient was 15.3 +/- 6.7 mmHg (21), 14.5 +/- 5.7 mmHg (23), 12.7 +/- 4.1 mmHg (25) and 13.0 +/- 4.8 mmHg (27); effective orifice area (EOA) was 1.4 +/- 0.4 cm2 (21), 1.7 +/- 0.4 cm2 (23), 1.8 +/- 0.4 cm2 (25) and 2.6 +/- 0.4 cm2 (27) (Table 3). One year postoperative, nine patients (10.8%) showed mild aortic regurgitation and one patient (1.2%) moderate. Left ventricular mass index decreased significantly for all sizes within the first postoperative year from 159.7 +/- 56.8 g/m2 to 137.3 +/- 40.8 g/m2. Separating the patients with regard to valve size, only the 21-group (154.1 +/- 51.2 g/m2 to 129.1 +/- 34.6 g/m2) and the 27-group (237.7 +/- 59.2 g/m2 to 146.7 +/- 20.6 g/m2) showed significant results. Freedom from event rates at seven years were 96.8 +/- 1.8% for thromboembolic events, 97.2 +/- 2.0% for thrombosed bioprosthesis, 96.6 +/- 2.6% for structural valve deterioration, 98.2% +/- 1.8% for nonstructural dysfunction, 95.9% +/- 2.0% for antithromboembolic hemorrhage, 98.9 +/- 1.1% for endocarditis and 93.9 +/- 3.2% for reoperation and explant (see Table 4). Early mortality (within 30 days) was 3.0%; late mortality was 4.6%/patient-year, including a valve-related mortality of 0.6%/patient-year. Of the patients, 96.5% showed an improvement of at least one NYHA class when comparing preoperative and one year status. DISCUSSION: The hemodynamic performance and the frequency of adverse events of the Mosaic bioprosthesis in the aortic position were very satisfactory within the first seven postoperative years with excellent results, comparable to studies about other established bioprostheses and similar to the findings in other Mosaic series. Only the number of cases of antithromboembolic hemorrhage was noticeably high. One reason might be the high percentage of patients under continuous anti-coagulant therapy: Six months postoperative, still 52.2% of the patients received phenprocoumon, 6.7% acetylsalicylic acid. Concerning hemodynamics, patient-prosthesis mismatch appeared to be a common problem, especially in small valve sizes. Separating the sample in groups with EOA index < or = 0.75 cm2/m2 and EOA index > 0.75 cm2/m2 after one year, 51.6% in the 21-group had an EOA index < or = 0.75 cm2/m2, whereas it was 19.4% (23), 18.8% (25) and 0% (27) in the larger size groups. Generally, further data have to be collected to determine durability of the biological tissue, as the critical period has just started with the seventh year of the clinical trial. CONCLUSION: The Mosaic bioprosthesis proved to be a reliable and well-functioning device for aortic valve replacement, especially in larger sizes.     

Echocardiographic assessment and preliminary clinical results after aortic valve replacement with the Medtronic Mosaic bioprosthesis

BACKGROUND AND AIM OF THE STUDY: The study aim was to examine prospectively the clinical performance and durability of the Medtronic Mosaic bioprosthesis, a stented porcine aortic valve that combines improvements in tissue preservation, notably net zero differential pressure fixation of the leaflets, with antimineralization treatment using 2-amino-oleic acid (AOA). METHODS: A total of 158 Mosaic valves was implanted; 152 in patients aged over 70 years, and six in patients aged <70 years with contraindications to anticoagulant therapy. Mean age was 73.7 years. All valves were implanted in the supraannular position. Thirty-two patients (20%) required concomitant procedures, including coronary revascularization, ascending aorta replacement and/or mitral annuloplasty. Postoperative anticoagulation (heparin) was prescribed for ten days, followed by antiplatelet therapy. No long-term oral anticoagulants were prescribed, except in some patients with atrial fibrillation. The follow up included routine clinical and blood work-up, and echocardiography at six months and one year after surgery. RESULTS: There were seven early (0-30 days) and five late deaths (>30 days). One death was caused by a hemorrhagic stroke at three months in a patient without anticoagulant or antiplatelet therapy. No thromboembolic complications or structural valve deterioration were observed during follow up. At two years, freedom from endocarditis and reoperation was each 99.6%. NYHA class was excellent, with 98% of patients in class I or II at one year. Patient survival was 92% at two years. Hemodynamically, the valve was performing well, with mean systolic gradients of 13.6, 13.2, 12.6 and 9.6 mmHg for the 21, 23, 25 and 27 mm valves, respectively. There was no evidence of structural valve deterioration. CONCLUSION: Long-term evaluations are mandatory to confirm the durability of any new bioprosthetic valve. Satisfactory early clinical and hemodynamic results with the new Mosaic bioprosthesis warrant its continued implantation in the aortic position for patients over the age of 70 years.     

Long-term results of aortic valve replacement with Edwards Prima Plus stentless bioprosthesis: eleven years' follow up

BACKGROUND AND AIM OF THE STUDY: The Edwards Lifesciences Prima Plus stentless valve (ELSV) is a bioprosthesis manufactured from a porcine aortic root. The study aim was to evaluate late clinical outcomes after aortic valve replacement (AVR) with ELSV implanted as a miniroot in patients with aortic valve disease. METHODS: Between 1993 and 2004, 318 patients (232 males, 86 females; mean age 69 +/- 9 years; range: 37-83 years) underwent AVR with the ELSV. Preoperatively, 102 patients (32%), 162 (51%) and 54 (17%) were in NYHA classes I/II, III and IV, respectively. Aortic stenosis, aortic regurgitation and combined lesions were present in 124 patients (39%), 114 (36%) and 41 (13%), respectively. Twenty patients (6%) were referred for an acute aortic dissection, 20 (6%) for an aortic root aneurysm, and 139 (44%) had an associated aneurysmal dilatation of the ascending aorta. The ascending aorta was replaced in 159 patients (50%); aortic arch replacement was required in 10 (3%). Coronary artery bypass graft was performed in 86 patients (27%). The follow up was based on clinical data. RESULTS: Operative mortality was 5% (n = 17). There were 49 late deaths (5.2%/pt-yr). Valve-related mortality occurred in 10 patients (1%/pt-yr). Actuarial survival at five and 10 years was 78% and 33%, respectively. Actuarial freedom from valve reoperation and structural valve deterioration at 10 years were 100% and 64%. Actuarial freedom from embolic events and endocarditis at 10 years were 84% and 81%, respectively. CONCLUSION: The ELSV, when implanted as a miniroot, provided good early and long-term results in terms of survival and freedom from major complications.     

Eight-year results of Freestyle stentless bioprosthesis in the aortic position: a single-center study of 500 patients

BACKGROUND AND AIM OF THE STUDY: Stentless bioprostheses may be the future valve of choice for aortic valve replacement (AVR). The study aim was to investigate mid-term clinical outcome after AVR with the Medtronic Freestyle valve. METHODS: Between April 1997 and November 2004, a total of 500 patients (241 females, 259 males) was implanted with a Freestyle bioprosthesis for AVR, without population selection, by a single surgical team at the authors' institutions. Mean patient age was 74.5 +/- 9.6 years (range: 26-91 years); 34 patients (7%) were aged < 60 years, 121 (24%) were aged > 80 years, and 205 (41%) were in NYHA classes III or IV. The surgical procedure used included a modified subcoronary technique in 482 cases and complete root replacement in 18, conducted with mini-extracorporeal circulation. Concomitant procedures included coronary artery bypass grafting in 123 patients (25%), mitral valve repair/replacement in five, and maze in two. Follow up was 98% complete; the mean follow up was 31.3 months (range: 4-95 months). RESULTS: The mean cardiopulmonary bypass time was 98 +/- 26 min, and total aortic cross-clamp time 77 +/- 19 min. Operative mortality was 5.2% (n = 26), and no patients aged under 60 years died. At eight years, freedom from structural valve deterioration was 100% (0% in the young population), freedom from endocarditis 97.2%, freedom from reoperation 97%, and overall survival 83%. Most of the late deaths (n = 56) were of non-cardiac origin, and occurred in older patients. After one year, the mean aortic echocardiographic gradient was 11.5 +/- 1.1 mmHg, and was improved compared to that at discharge. No significant aortic insufficiency occurred. CONCLUSION: Use of the Freestyle stentless bioprosthesis for AVR resulted in excellent short-term survival in the octogenarian population, and excellent mid-term results in the younger population. In time, experience will indicate whether the Freestyle should be considered as the bioprosthesis of choice for patients of all ages.     

The Ionescu-Shiley bioprosthesis in the aortic position. Medium to long-term evaluation

From August 1977 through October 1984, 241 patients underwent aortic valve replacement with the Ionescu-Shiley prosthesis. The average age was 50.8 years (range 15 to 78). Aortic valve replacement was performed alone in 121 patients (50.2%) and with associated surgery in 120 (49.8%). Cumulative duration of follow-up was 1,260.08 patient-years, with a mean follow-up of 5.32 years per patient. Five patients were lost to follow-up. There were 26 hospital deaths and 15 late deaths (1.19% per patient-year). The expected 10.5 year actuarial survival rate was 82 +/- 2.9%. Twelve thromboembolic episodes occurred in 7 patients (7 central and 5 peripheral). The linearized thromboembolic rate was 0.95% per patient-year: 0.32% for patients with isolated aortic valve replacement and 0.63% for patients with concomitant surgery. Freedom from thromboembolic events at 10.5 years was 78 +/- 12%. Structural valve failure was found in 24 patients (1.9% per patient-year) with an actuarial rate of freedom for primary tissue failure of 72.6 +/- 6.1% at 10.5 years. Reoperation was required in 39 cases (3.09% per patient-year) due to primary tissue failure (n:24), paravalvular leak (n:7), infective endocarditis (n:6) and valve thrombosis (n:2). In conclusion, this pericardial bioprosthesis has demonstrated an adequate performance at mid and long-term follow-up, but somehow less satisfactory than previously reported.     

Echocardiogram of the porcine aortic bioprosthesis in the mitral position

Echocardiography was performed in 10 consecutive patients who had a clinically normally functioning porcine aortic bioprosthesis in the mitral position. Strong well defined echoes were recorded from the anterior and posterior aspects of the xenograft stent. The maximal separation of the anterior and posterior stent echoes approximated the diameter of the stent at its base. The maximal excursion of the anterior stent was 5 to 10 mm (mean 7.5) with a mean systolic slope of 15 to 35 mm/sec (mean 22.2) and diastolic slope of 11 to 59 mm/sec (mean 21.5). In all 10 patients it was possible to record an anterior xenograft leaflet with anterior movement at the onset of diastole and posterior movement at the onset of systole and with appropriately steep (more than 200 mm/sec) slopes. The diastolic (E-F) slope of the anterior leaflet in 9 of the 10 patients ranged from 9 to 38 mm/sec (mean 19). In 6 of the 10 patients a posterior xenograft leaflet with a movement pattern symmetric with that of the anterior leaflet was recorded. In two patients, the central aortic leaflet was recorded with little diastolic displacement. These two patients also had mild aortic regurgitation, which was associated with diastolic shudder of the the xenograft leaflets.Echocardiography was also performed in one patient who was later shown to have a 10 cm³ thrombus on the ventricular surface of a xenograft valve. The echocardiogram in this patient revealed the following abnormalities: (1) excessive anterior stent movement and systolic slope suggesting paravalvular leak in the presence of abnormal cinefluoroscopic valve tilt, and (2) multiple dense nonhomogeneous echoes between the anterior and posterior aspects of the valve stent, with an early diastolic clear space behind the anterior stent and abnormal echoes behind the posterior stent during systole. Echocardiography therefore appears to be useful in evaluating the porcine aortic bioprosthesis in the mitral position.     

Hemodynamic evaluation of the Carpentier-Edwards porcine bioprosthesis and the Hancock pericardial bioprosthesis in aortic position

Forty-four asymptomatic patients were catheterised at Boucicaut Hospital 9.5 months after aortic valve replacement to assess the haemodynamic performances of 21 Hancock pericardial (HP) and 23 porcine Carpentier-Edwards (CE) (standard model) bioprostheses, implanted in the aortic position. Left heart catheterisation was performed from a femoral approach; the simultaneous gradient was measured by planimetry and the functional valve surface area calculated at rest and after exercise. The resting calculated surface area of the HP was greater than that of the CE bioprostheses (equation: see text). The transvalvular pressure gradient was lower in the HP than in the CE group (7.8 +/- 4 vs 15.3 cf243 6 mmHg; p less than 0.005). After exercise (15 patients) the calculated surface area increased with the increased transvalvular blood flow in both groups but at each flow rate the calculated valve surface area was greater in the HP group. The haemodynamic performance of the CE bioprosthesis is inferior to that of the HP bioprosthesis, especially in the smaller models. However, the CE bioprosthesis would seem to be mechanically more reliable in the long term than the HP bioprosthesis has since been withdrawn from the market.     

Two years' clinical experience with a quadrileaflet stentless bioprosthesis in the mitral position

BACKGROUND AND AIMS OF THE STUDY: Currently available bioprosthetic mitral valves do not provide sufficient durability. A new stentless pericardial prosthesis was designed for better hemodynamic performance and reduction of stress load compared with current stented bioprostheses. METHODS: Between September 1997 and August 1999, the Quadrileaflet mitral valve (QMV) was implanted in 17 patients at our institution. Four patients had minimally invasive mitral valve replacement. Mean patient age was 62.2 +/- 16.3 years; preoperative NYHA class was 3.06 +/- 0.2; ejection fraction was 64.1 +/- 14.7%. Echocardiography was performed pre-, intra- and postoperatively, and at 3-6, 12 and 24 months follow up. RESULTS: Fifteen patients had an uneventful intra- and postoperative course. Two patients died, one from acute left heart failure at 6 h after surgery, and one on the first postoperative day after resuscitation for ventricular fibrillation. A small-sized prosthesis was implanted in four patients, medium-sized in eight and large-sized in five. The mean duration of cardiopulmonary bypass was 138.3 +/- 37.0 min; mean cross-clamp time was 91.3 +/- 26.3 min. Postoperative control echocardiography showed a mean valve orifice area of 2.5 +/- 0.4 cm2, transvalvular velocity (Vmax) was 1.6 +/- 0.4 m/s, and mean pressure gradient 3.6 +/- 2.0 mmHg. Echocardiographic evaluation after 3, 6 and 12 months showed no significant difference compared with the intraoperative data. Three patients had a minor mitral regurgitation (grade I-II). At 12 months all patients were in NYHA class I or II. CONCLUSION: The implantation technique of the QMV is more demanding, but the prosthesis is a promising alternative to conventional biological mitral valve replacement. Further follow up is needed to confirm these favorable mid-term results.     

Hemodynamic evaluation of the Carpentier-Edwards bioprosthesis in the aortic position.

The Carpentier-Edwards bioprosthesis is a glutaraldehyde-fixed porcine xenograft with a fully flexible thin-walled stent. Cardiac catheterization studies were performed in 17 patients to evaluate use of this valve in the aortic position. Hemodynamic studies established a mean peak gradient across the prosthesis of 19 mm Hg (range 5 to 65). The mean effective orifice area was calculated to be 1.6 cm2 (range 0.8 to 3.3). All patients demonstrated an improvement in functional class after operation. Mean left ventricular ejection fraction increased from 51 +/- 16 to 68 +/- 9 percent (P less than 0.004) in eight patients operated on for aortic stenosis, but was not significantly changed in patients operated on for aortic insufficiency. Hemodynamic comparison of the Carpentier-Edwards bioprosthesis with the standard Hancock xenograft showed similar effective orifice areas for the 23 and 25 mm diameter valves. In two patients studied the 21 mm Carpentier valve demonstrated a greater effective orifice area than that previously reported for the standard Hancock xenograft. The Carpentier-Edwards bioprosthesis affords both clinical and hemodynamic improvement when used in the aortic position and may allow improved effective orifice area when used in the smaller aortic root.     

Failure modes of the Carpentier-Edwards pericardial bioprosthesis in the aortic position

BACKGROUND AND AIM OF THE STUDY: Modes of failure of the Perimount bioprostheses have not been characterized. Thus, the study aim was to classify their failure modes, to compare their rates of occurrence, and to relate these to patient age. METHODS: Between September 1981 and July 1985, a total of 478 patients received Carpentier-Edwards Perimount aortic valve prostheses as part of a premarket approval cohort. During yearly follow up over 19 years, 95 prostheses were explanted, 70 (74%) for reasons of structural valve deterioration (SVD). Preoperative diagnostic studies, echocardiograms, operative notes and pathology reports were reviewed to classify the primary modes of failure. Hazard function methodology established mode-specific occurrence rates and how these were modulated by patient age at implant. RESULTS: The pathophysiology of SVD was pure regurgitation in 23 cases, pure stenosis in 18, mixed in 20, and uncertain in nine. Primary modes of failure were calcification (n = 27; 39%), non-calcific degeneration (n = 21; 30%), fibrosis (n = 5; 7.1%), dehiscence (n = 4; 5.7%), a combination of these (n = 10; 14%), or unknown (n = 3; 4.3%). The failure rate for each mode accelerated with time, was highest and almost equal for calcification and degeneration, and was slower and almost equal for fibrosis and dehiscence. Except for dehiscence, failure modes were age-dependent (p < 0.05), and this was most prominent for degeneration and calcification. CONCLUSION: Perimount bioprostheses rarely fail from design-related causes; rather, they fail at almost equal rates from calcific and non-calcific degeneration, both of which occur late and are age-dependent. Further investigation into improved methods for fixation and anti-calcification in preparing these valves is warranted.     

Long-term results with the Biocor-SJM stentless porcine aortic bioprosthesis

BACKGROUND AND AIM OF THE STUDY: The study aim was to update the clinical analysis of hemodynamic performance, structural failure and survival in patients undergoing aortic valve replacement (AVR) with a composite aortic, aldehyde tanned, stentless porcine bioprosthesis. METHODS: Between January 1990 and March 2001, 247 patients underwent AVR with aortic stentless valves. Patient demographic and clinical analysis included age, sex, valve lesion, valve size, pre- and postoperative NYHA class, hospital morbidity, mortality, operative data and duration of hospitalization. RESULTS: Mean patient age was 47.3 years; 71% of patients were males, and 45% had aortic insufficiency. The incidence of rheumatic heart disease requiring surgery was 41.7%. In 23% of patients surgery was indicated due to aortic stented bioprosthetic dysfunction. Preoperatively, 81% of patients were in NYHA classes III and IV. Mean follow up was 5.9+/-2.8 years (range: 1 month to 11.4 years); total follow up was 1,392 patient-years (98% complete). The valve size used was < or =25 mm in 75.3% of patients. The mean intensive care unit stay was 2.6 days; mean hospital stay was 10.7 days. Hospital mortality was 4.0% and late death 6.1%. There were no valve-related deaths. Postoperatively, the mean aortic effective orifice area (EOA) was 1.71 cm2, the mean peak transvalvular gradient 17.1 mmHg, and the mean transvalvular gradient 9.0 mmHg; the left ventricular mass index (g/m2) was 174 and 117 before and after surgery respectively. The rate of leaflet tissue degeneration was 0.9%, and seen as mild by echocardiographic follow up. Actuarial survival at almost 12 years was 91%, and freedom from reoperations was approximately 99%. CONCLUSION: Patients with aortic stentless valves have hemodynamic benefits seen as larger aortic EOA, low transvalvular gradients, satisfactory left ventricular remodeling with significant reduction of left ventricular mass, low complication rate, low reoperation rate, lower leaflet tissue degeneration rate, and no valve-related mortality. A longer follow up is required to confirm these benefits.     

Aspire porcine bioprosthesis: ten years' experience

BACKGROUND AND AIM OF THE STUDY: Clinical results of this multicenter study of the Aspire porcine valve were reported previously at eight years; the present report provides an update of valve performance to 10 years postoperatively. METHODS: A total of 749 patients (60% males; mean age 73+/-7 years) underwent implantation with the Aspire (Tissuemed) porcine bioprosthesis between 1991 and 2002, at three institutions. Follow up was complete for 98% of the cohort. The mean follow up period was 51.6+/-39.6 months (range: 0-181 months); total follow up was 3,159 patient-years (pt-yr). RESULTS: There were 617 aortic valve replacements (AVR), 96 mitral valve replacements (MVR) and 32 double valve replacements. There were 62 deaths (8.3%), one of which was valve-related. The late mortality rate was 9.3% per pt-yr (1.2%/pt-yr valve-related). Actuarial freedom from complications at 10 years was: thromboembolism 76+/-4% (2.6%/pt-yr); hemorrhage 73+/-4% (2.8%/pt-yr); structural valve deterioration (SVD) 96+/-2% (0.2%/pt-yr); non-structural deterioration 99+/-1% (0.1%/pt-y); prosthetic valve endocarditis 97+/-1% (0.3%/pt-yr); and reoperation 97+/-1% (0.4%/pt-yr). In patients aged >70 years, the 10-year actuarial freedom from SVD was 98+/-2% for AVR and 93+/-7% for MVR. Preoperative atrial fibrillation (AF) was a significant predictor of late mortality (p <0.001), thromboembolism (p = 0.05) and hemorrhage (p = 0.01). CONCLUSION: The Aspire porcine bioprostheses is a reliable choice for a tissue valve, for both the aortic and mitral positions, especially in patients aged >70 years. In elderly patients the presence of AF is a significant predictor of early and late mortality and morbidity.     

Hemodynamic evaluation of the Sorin Soprano bioprosthesis in the completely supra-annular aortic position

BACKGROUND AND AIM OF THE STUDY: The study aim was to evaluate the clinical and hemodynamic performance of the Sorin Soprano bioprosthesis in the aortic position. METHODS: Rest and stress echocardiography were performed at six months after surgery in 57 patients who underwent aortic valve replacement with the stented Soprano bioprosthesis. The exercise protocol included workloads of 25, 50, 75 and 100 W, each of 2 min duration. RESULTS: Thirty-day mortality was 1.8% (n = 1). Due to malperfusion of the coronary arteries, two Soprano prostheses had to be replaced by a different prosthesis, and one patient received coronary artery bypass grafts. One patient developed bacterial endocarditis of his prosthesis at seven months postoperatively and died as a result of a fulminant sepsis. There were no other prosthesis-related adverse events. Mean pressure gradients (MPG) ranged from 7.8 to 15.9 mmHg, effective orifice areas (EOA) from 1.25 to 2.98 cm2, EOA index (EOAI) from 0.79 to 1.43 cm2/m2, and EOA fraction from 34 to 45%. Stress echocardiography showed no significant increase in MPG up to 50 W, and MPGs did not exceed 35 mmHg at 75 and 100 W. CONCLUSION: Initial hemodynamic results showed low MPGs during rest and exercise. The EOAI was large due to completely supra-annular placement of the Soprano valve. The difficulty of complete supraannular placement is that the prosthesis is positioned relatively high, especially in narrow aortic roots, and this may handicap coronary artery perfusion. Patient selection with suitable aortic root anatomy is crucial to achieve the benefit of completely supra-annular implantation without coronary ostium deterioration.