Is TAVI superior to surgery in high-risk patients? Insight into the concept of individual risk assessment.

The prevalence of aortic valve stenosis (AS) is growing in developed countries because its prevalence increases with age. A growing number of elderly patients are currently referred to specialized centres to be evaluated for potential therapeutic strategies. Indeed, two techniques are nowadays able to treat high-risk AS patients: TAVI and surgical replacement (AVR). It is the purpose of the present review to summarize current knowledge on safety and efficacy of AVR and TAVI in high-risk patients; to focus on some aspects of recently published guidelines; to emphasize the growing importance of pre-operative individual risk assessment, which is considered the real crucial point for patient selection and trial's comparisons. Indeed, it is worth of noting that currently adopted risk-scores do not show satisfactory performances. Accordingly, it becomes of utmost importance to investigate several baseline but still neglected patients' characteristics (e.g. frailty, functional status, co-morbid conditions, etc.), as well as their pathogenetic relationships with interventional results and follow-up prognosis. All these items are emphasized in the present review. Finally, we have tried to anticipate future scenarios in terms of both ongoing clinical trials and improvements of risk-scores.

Results with expanded donor acceptance criteria in heart transplantation.

OBJECTIVE: Over the past years both donor and recipient profiles have changed in heart transplantation. Satisfactory clinical outcomes of marginal donors in candidates >60 years of age have led us to allocate suboptimal donors to younger recipients as well. Therefore, we retrospectively reviewed our experience. METHODS: Among 199 patients undergoing heart transplantation from January 2000 to February 2010, there were 83 (41%) aged 61-72 years. The other 116 (59%) ranged in age between 18 and 60 years. According to their clinical conditions as heart transplantation candidates, They were classified into 4 groups: younger recipients (n=116) of either optimal donors (n=72; group 1 [G1]) or marginal donors (n=44; group 2 [G2]) and older recipients (n=83) of either marginal grafts (n=70, group 3 [G3]) or optimal grafts (n=13; group 4 [G4]). The gender distribution, cause of end-stage heart failure, preoperative pulmonary hypertension incidence, pretransplantation clinical status, and mean follow-up were not significantly different among the 4 groups. RESULTS: Overall 30-day survival was 90 ± 1% and 10-year rate was 78 ± 9%. Among the groups, 30-day and 10-year actuarial survival rates were, respectively: 94 ± 4% and 87 ± 1% for G1; 86 ± 5% and 84 ± 7% for G2; 88 ± 4% and 71 ± 7% for G3 and were 100% and 82 ± 7% for G4 (P=.7). In comparison among the 4 groups, there was no significant difference regarding freedom from graft failure (P=.3), right ventricular failure (P=.3), acute rejection episodes (P = .2), chronic rejection (P=.2), neoplasia (P=.5), or chronic renal failure (P=.1). Older recipients of marginal donors [G3] had a 4% (n=3) prevalence of permanent pacemaker implant, versus G2: 3% (n=2) among (P=.1). CONCLUSION: Our results suggest that extended donor and recipient criteria do not compromise clinical outcomes after transplantation.

Antithymocyte globulin induction therapy in heart transplantation: prospective randomized study of high vs standard dosage.

BACKGROUND: In cardiac transplantation, high-dose antithymocyte globulin (ATG) induction therapy as short-term rejection prophylaxis has not been used. OBJECTIVE: To evaluate the efficacy and safety of intraoperative use of single high-dose ATG induction therapy after heart transplantation. PATIENTS AND METHODS: Fourteen patients received single high-dose ATG therapy plus shortened standard therapy (group1), and 16 patients received ATG standard therapy (group2). RESULTS: No perioperative deaths were reported. During follow-up, 3 deaths were recorded. Five-year patient survival was 92.8% in groupl vs 85.7% in group2 (P = .34). The mean (SD) number of acute rejection episodes per patient was 2.5 (2.2) in the high-dose ATG group vs 2.7 (2.5) in the standard therapy group (P = .83), with 5-year freedom from acute rejection of 45.5% in group 1 vs 35.6% in group 2 (P = .85). Infections were observed in 6 patients in group1 and in 8 patients in group2 (P = .69). Malignant disease was diagnosed in 1 patient in the high-dose group and 3 patients in the standard therapy group (P = .35). Chronic allograft vasculopathy was recognized in 4 patients (28%) in group1 and 8 (50%) in group2 (P = .05). Five-year actuarial freedom from allograft vasculopathy was 69.2% in the high-dose ATG group vs 50.0%% in the standard therapy group (P = .35). CONCLUSIONS: High-dose ATG for prevention of rejection episodes is safe and efficacious, with a lower rate of early and late complications, in particular, graft vasculopathy.

Emergency use of wearable left ventricular assist devices in patients not eligible for heart transplantation.

BACKGROUND: We reviewed our experience concerning the clinical outcomes of emergency implantation of left ventricular assist devices (LVAD) in patients not eligible for heart transplantation (HTX). PATIENTS AND METHODS: Between January 1998 and September 2006, 62 patients were referred for emergency HTX including 35 (55%) who received cardiac allografts; 9 (14%) died on the waiting list. The other 18 subjects (31%) did not meet listing criteria due to pulmonary hypertension with massive transpulmonary gradients (TPG), severe diabetes, or another factor; 7 patients had wearable LVAD implants and the remaining 11 who had contraindications both to HTX and to LVAD implantation remained on medical therapy. RESULTS: Twelve month actuarial survivals were 47% in LVAD G1 vs 1% in medical therapy G2 (P< .005). Four G1 patients died either due to cerebrovascular vascular episodes or to thromboembolic events. The beneficial use of LVAD in 3 patients led to consistent improvement in hemodynamic performance allowing listing for HTX. Two of them have been successfully transplanted; 1 is still waiting. Due to refractory heart failure, 90% of G2 died within the first months after evaluation. CONCLUSION: Our limited experience indicated that emergency use of LVAD ensued a satisfactory outcome allowing better actuarial survival.

Heart transplantation in older candidates.

UNLABELLED: Over the last few years significant changes have occurred in both donor and recipient profiles for heart transplantation (HTX). New therapeutic approaches to chronic heart failure have created a novel class of patients aged between 61 and 70 years. Although they are older than the conventional upper limit, they may undergo HTX using marginal donors. We retrospectively reviewed the outcomes of suboptimal donor implants in older recipients to examine negative prognostic factor. METHODS: Among 272 patients who underwent HTX at our institution from May 1994 to December 2005, 75 (26.5%) were 61 to 72 years (group 1). The remaining 197 (73.5%) denoted as group 2 ranged in age from 18 to 60 years. The Sex distribution, cause of end-stage heart failure, preoperative pulmonary hypertension, pre-HTX clinical status and mean follow-up did not show any significant difference between the two groups. However, group 1 patients had their organs retrieved from marginal donors (89%) vs group 2 (29%; P < .005). They were deceased mainly due to cerebrovascular events, (namely, 82% vs 27%, respectively, P < .005). RESULTS: All analyzed variables-actuarial survival, perioperative mortality, 12-month acute rejection freedom, 100-month chronic rejection freedom, infection freedom, neoplasia freedom, chronic renal failure freedom-did not show any significant difference. CONCLUSION: Advances in chronic heart failure medical therapy have generated a new class of HTX candidates aged between 61 and 70 years who benefitted from transplantation of organs retrieved from suboptimal donors.

Donor organ preservation in high-risk cardiac transplantation.

AIM: To evaluate safety and efficacy of blood cardioplegia in a retrospective selected (but not randomized) donor/recipient population as standard organ preservation technique in high-risk heart transplants (HTX). MATERIALS AND METHODS: The rationale of different strategies was based on both donor and recipient evaluations. Unstable donors with a long history of well-known risk factors and/or long-distance retrieval were given blood cardioplegia, particularly for HTX candidates in poor preoperative clinical condition. Organ protection was performed by administration of St Thomas II crystalloid cardioplegia in 74 patients (group 1) while 58 others (group 2) received blood cardioplegia. RESULTS: Groups I versus II shows comparable results for immediate postoperative mortality rates (4% vs 7%, P =.4), high doses of inotropic drug support (48% vs 20%, P =.08), and the need for postoperative mechanical assistance devices (9% vs 4.5%, P =.4). In contrast statistically significant differences were observed for occurrence of acute right ventricular failure (50% vs 5%; P =.004), atrioventricular conduction disturbances (63% vs 10%, P =.003), spontaneous sinus rhythm recovery (18% vs 64% P =.0038) and reperfusion interval (RI) (time between removal of aortic cross-clamp and discontinuation of extracorporeal circulation (ECC)) exceeding 30 minutes (70% vs 21%, P =.0004). Higher peak creatine kinase MB mean value (176 +/- 23 vs 90 +/- 19, P =.06) indicated more severe ischemic damage among G1 patients. CONCLUSION: This study suggests that high-risk heart transplant candidates benefit from blood cardioplegia, due to the reduced incidence of both right ventricular failure and severe cardiac arrhythmia. Potential limitations to this novel technique may be linked to the higher expenses due to the need for a perfusion technician. Improved myocardial protection can be seen even in a longitudinal study on chronic rejection: this form of allograft protection may preserve the matrix and the endothelium.

Lethal systemic dissemination from a cutaneous infection due to Curvularia lunata in a heart transplant recipient.

A 69-year-old male heart transplant recipient, being treated with Cell Cept, FK 506 and methylprednisolone had multiple deep brown skin nodules and nodes, on the upper right arm. Skin biopsy and culture detected a strain of Curvularia lunata. The infection disseminated to the whole skin surface, oral mucosa, upper third of the oesophagus and to the lungs. Therapy with antibiotics and antifungal drugs was ineffective. The patient died of sepsis. We did not find any other case of systemic dissemination from a skin infection due to C. lunata among heart transplant recipients. We feel that heart transplant recipients need adequate education to prevent situations that would put them at risk for infection and to seek medical advice immediately for an early diagnosis and an effective therapy.

Modified ultrafiltration reduces morbidity after adult cardiac operations: a prospective, randomized clinical trial.

BACKGROUND: Extracorporeal circulation contributes to morbidity after open-heart surgery by causing a systemic inflammatory reaction. Modified ultrafiltration is a technique able to remove the fluid overload and inflammatory mediators associated with use of cardiopulmonary bypass. It has been shown to reduce morbidity after cardiac operations in children, but the impact on adult cardiac procedures is unknown. METHODS AND RESULTS: Five hundred seventy-three consecutive adult patients were prospectively randomized to either ultrafiltration after cardiopulmonary bypass (treatment) or to no ultrafiltration (control). Parsonnet score was used to assess the severity of the patients' clinical conditions. Analysis was done with Student's t test or Mann-Whitney U test for continuous variables and Fisher's exact test or Pearson's chi(2) for discrete variables. Hospital mortality was 2.5% (7 of 284) in the treatment group versus 3.8% (11 of 289) in the control group (P=0.357). Hospital morbidity was lower in treated patients (66 of 284 [23.2%] versus 117 of 289 [40.5%], P=0.0001). Cardiac morbidity was similar (26 of 284 [9.1%] versus 35 of 289 [12.1%], P=0.251), whereas significantly lower rates of respiratory (20 of 284 [7.0%] versus 36 of 289 [12.5%], P=0.029), neurological (5 of 284 [1.8%] versus 14 of 289 [4.8%], P=0.039), and gastrointestinal (0 of 284 versus 4 of 289 [1.4%], P=0.044) complications were found in treated patients. Transfusion requirements were also lower in treated patients (1.66+/-2.6 versus 2.25+/-3.8 U/patient, P=0.039). Duration of intensive care (39.9+/-49.2 versus 46.3+/-72.8 hours, P=0.218) and hospital stay (7.6+/-3.5 versus 7.9+/-4.4 days, P=0.372) were comparable. CONCLUSIONS: Modified ultrafiltration after cardiopulmonary bypass is associated with a lower prevalence of early morbidity and lower blood transfusion requirements. The impact on length of hospital stay needs further analysis. Routine application of modified ultrafiltration after adult cardiac operations is warranted.

Bicuspid aortic valve disease and pulmonary autograft root dilatation after the Ross procedure: a clinicopathologic study.

OBJECTIVE: Bicuspid aortic valve disease has been associated with histologic abnormalities of the aortic root. Recent reports have suggested similar alterations may exist in the pulmonary artery of patients with bicuspid aortic valve. The present study was undertaken to define the histologic condition of the aortic and pulmonary artery root in bicuspid aortic valve disease and the relationship with pulmonary autograft root dilatation after the Ross procedure. METHODS: In 17 patients undergoing aortic root replacement with the pulmonary autograft, biopsy specimens of the aortic root and pulmonary artery trunk were collected. Clinical and histologic findings of patients with bicuspid aortic valves were compared with those with tricuspid aortic valves. RESULTS: There were 9 patients (8 male, 1 female) with bicuspid aortic valve (group 1) and 8 (all male) with tricuspid aortic valve (group 2). Mean age was comparable (24.4 +/- 9.8 vs 23.6 +/- 10.8 years, P =.9). Aortic insufficiency as an indication for operation was more common in group 1 (9/9 vs 5/8, P =.007), whereas preoperative aortic root dilatation was equally prevalent (4/9 vs 1/8, P =.1). Prior aortic valve repair had been performed in 2 patients (1/9 vs 1/8, P =.9). Prevalence of cystic medionecrosis of the aortic wall was similar in the 2 groups (4/9 vs 3/8, P =.6). Cystic medionecrosis of the pulmonary artery trunk was found only in 1 patient with tricuspid aortic valve (0/9 vs 1/8, P =.3). During a mean follow-up of 26.5 +/- 12.2 months (32.1 +/- 12.7 vs 20.1 +/- 7.4 months, P =.04), prevalence of pulmonary autograft root dilatation (greater than 4.0 cm) was equally represented in patients with native bicuspid or tricuspid aortic valve (3/9 vs 2/8, P =.6). CONCLUSIONS: Histologic abnormalities of the pulmonary artery root are rare and equally prevalent in young patients with bicuspid and tricuspid aortic valves. On the contrary, root dilatation is relatively common late after autograft root replacement but appears unrelated to bicuspid aortic valve disease or to pre-existing degenerative changes of the pulmonary artery root.

Over twenty-year follow-up of the standard Hancock porcine bioprosthesis implanted in the mitral position.

BACKGROUND: To define the long-term results of 331 standard Hancock porcine bioprostheses implanted in the mitral position between 1973 and 1980. METHODS: Of 331 patients (225 male patients, 68%), mean age 49+/-10 years (range 14 to 69 years), 88% were in New York Heart Association functional class III or IV and 77% were in atrial fibrillation. Follow-up time extended more than 20 years (mean 13.9 years, range 0.3 to 24.7 years) for a total of 4,601 patient-years. RESULTS: Overall operative mortality was 6.3%. At 5, 10, 15, and 20 years, the actuarial survival rate of patients were 71%+/-2%, 46%+/-3%, 30%+/-3%, and 22%+/-2%, respectively. Actuarial estimates of freedom from structural valve deterioration were 95%+/-1%, 67%+/-3%, 32%+/-3%, and 14%+/-3%; from reoperation were 96%+/-1%, 72%+/-3%, 36%+/-4%, and 18%+/-4%; from thromboembolism were 89%+/-2%, 82%+/-3%, 74%+/-4%, and 51%+/-2%; and from anticoagulant-related hemorrhage were 98%+/-1%, 96%+/-1%, 91%+/-1%, and 86%+/-4%. Estimates of freedom from all valve-related mortality at 5, 10, 15, and 20 years were 89%+/-2%, 76%+/-3%, 64%+/-4%, and 48%+/-4%. Multivariate analysis showed younger age to be a significant risk factor for reoperation. Age at operation did not correlate with structural valve deterioration. CONCLUSIONS: The long-term results with the standard Hancock bioprosthesis implanted in the mitral position appear satisfactory, particularly up to 15 years from implantation. Protection from stroke, anticoagulant hemorrhage, and endocarditis was good.

Long-term results after aortic valve replacement with the Biocor PSB stentless xenograft in the elderly.

BACKGROUND: This study seeks to define the long-term results after Biocor PSB stentless aortic valve replacement (AVR) in elderly patients, including the effects of No-React treatment. METHODS: We reviewed the outcomes of 106 consecutive patients, aged 70+/-6 years, having Biocor PSB (93 standard, 13 No-React) AVR between October 1992 and October 1996. RESULTS: There were three early deaths (3%) and 15 late deaths (15%), during a mean follow-up of 5.8+/-1.6 years. At 8 years, survival was 82%+/-4% and freedom from cardiac death was 94%+/-3%. Freedom from valve failure was 92%+/-4% at 8 years (No-React: 92%+/-8% at 4 years). Replacement of the xenograft was required in 5 patients. Freedom from reoperation was 91%+/-4% at 8 years (No-React: 92%+/-8% at 4 years). Four bleeding and two embolic events were recorded: overall valve-related event-free survival was 81%+/-7% at 8 years (No-React: 76%+/-12% at 4 years). Age of long-term survivors averaged 77+/-5 years and their New York Heart Association status was 1.3+/-0.6 (versus 2.9+/-0.6 preoperatively, p = 0.01). CONCLUSIONS: Satisfactory freedom from cardiac events and from valve deterioration added to uniform improvement in functional status despite advanced age and high prevalence of comorbid conditions make AVR with the Biocor PSB xenograft a valid long-term therapy for the elderly. No-React treatment does not influence xenograft durability.

G20210A prothrombin gene polymorphism and prothrombin activity in subjects with or without angiographically documented coronary artery disease.

BACKGROUND: G20210A prothrombin mutation has been associated with high prothrombin levels and an increased risk of venous thrombosis. The role of this common polymorphism, as well as that of prothrombin levels, in determining the risk of arterial disease is still somewhat controversial. METHODS AND RESULTS: We determined the prevalence of the G20210A mutation and prothrombin activity in 660 individuals, of whom 436 had angiographically documented severe coronary artery disease (CAD patients) and 224 had normal coronary angiography (CAD-free control subjects). Heterozygosity for the 20210A allele was found in 5.3% of the CAD patients versus 3.1% of the CAD-free subjects (P=0.21). Similarly, no statistically significant difference was found between CAD patients with or without previous myocardial infarction (4.5% versus 5.3%, respectively; P=0.73). The genotype-phenotype correlation study showed a significant influence of the 20210A allele on prothrombin activity, with higher levels in carriers compared with noncarriers (153.2% versus 122.2%, respectively; P<0.001). Prothrombin activity was significantly higher in CAD patients than in CAD-free subjects (132.8% versus 123.3%, respectively; P<0.005). By multiple logistic regression, prothrombin activity in the upper tertile of the control distribution was significantly associated with CAD compared with prothrombin activity in the lower tertile (adjusted odds ratio 1.86, 95% CI 1.01 to 3.4). CONCLUSIONS: In a population with a clear-cut definition of the phenotype, the G20210A prothrombin mutation was not significantly associated, per se, with either angiographically documented CAD or myocardial infarction, whereas it significantly influenced prothrombin activity. In our population, high prothrombin activity itself was independently associated with CAD but not with the presence or absence of previous myocardial infarction.

Aortic insufficiency after surgical repair of acute type a aortic dissection: incidence, indications for reoperation and medical management.

Recurrent aortic insufficiency presents in as many as 20% of patients late after repair of acute type A aortic dissection. This underscores the need for life-long follow up and appropriate management of patients after such surgery. The prevalence of, and risk factors for, recurrent aortic regurgitation, and the indications for and results of medical and surgical treatment are discussed.

Comparison of late outcome after stentless versus stented xenograft aortic valve replacement.

The long-term outcomes of 292 patients having stented xenograft aortic valve replacement (AVR) (group 1) and 376 having stentless AVR (group 2) were compared. Patients in group 1 were older (75 +/- 9 years v 70 +/- 6 years, P =.01), had more advanced cardiac disease (New York Heart Association [NYHA] classification III-IV: 85% v 75%, P =.03), and more associated procedures (53% v 41%, P =.01). Early mortality was higher in Group 1 (6.2% v 2.6%, P =.02), primarily due to cardiac cause (5.4% v 1.5%, P =.009). During follow-up (37 +/- 30 months v 43 +/- 35 months, P = not significant [ns]), 66 late deaths were recorded (12% v 9%, P = ns). At 8 years, survival (70% +/- 5% v 81% +/- 3%, P =.01) freedom from cardiac death (85% +/- 1% v 92% +/- 3%, P =.02) and prosthesis-related death (79% +/- 5% v 95% +/- 2%, P =.004) was higher in Group 2, but freedom from structural deterioration was similar (92% +/- 5% v 93% +/- 3%, P = ns). Late functional status was equally satisfactory (NYHA classification I-II: 89% v 90%, P = ns). Stentless AVR may confer selective survival advantages. Because freedom from valve failure is similar to stented xenografts, extension of stentless AVR to patients without anatomic contraindications appears justified.

Long-term results with the Xenomedica porcine bioprosthesis in the mitral position.

BACKGROUND AND AIM OF THE STUDY: The study aim was to evaluate our clinical experience with the Xenomedica heart valve prosthesis, a low-pressure glutaraldehyde-preserved porcine aortic valve with low-profile mounting. METHODS: Between January 1983 and July 1990, 242 consecutive patients (75 men, 167 women; mean age 59.8+/-8.0 years; range: 32-77 years) underwent mitral valve replacement with the Xenomedica prosthesis. Preoperatively, patients were in NYHA classes III (66%) and IV (26%); 94 patients (39%) had undergone previous cardiac surgery and 201 (83%) had chronic atrial fibrillation. Etiology was rheumatic in 51%, myxomatous in 7%, ischemic in 1%, endocarditis in 2%, and due to dysfunction of a previously implanted device in 39%. In total, 115 (47%) patients underwent an associated procedure. Mean follow up was 142+/-24 months (range: 2-181 months); total follow up was 2,627 patient-years. RESULTS: Early mortality was 8.2% (14 patients with low-output syndrome, three with multi-organ failure, one with stroke and two with major bleeding, 2). Late mortality was 45% (3.8%/pt-year) (84 cardiac deaths, 38 being valve-related). Actuarial survival at 5, 10 and 15 years was 69+/-3%, 52+/-3% and 38+/-4%, respectively. Actuarial estimates of freedom from structural valve deterioration (SVD) at 5, 10 and 15 years were 93+/-2%, 64+/-4%, and 25+/-9%; in almost all cases SVD occurred in progressive fashion. At 5, 10 and 15 years, estimates of freedom from thromboembolism were respectively 90+/-2%, 83+/-3% and 83+/-3%, for anticoagulant-related hemorrhage 96+/-1%, 88+/-3% and 88+/-3%, for endocarditis 96+/-1%, 94+/-2% and 94+/-2%, and for reoperation 93+/-2%, 67+/-4% and 54+/-6%. Estimates of freedom from all valve-related mortality at 5, 10 and 15 years were 87+/-2%, 80+/-3% and 75+/-4%. Multivariate analysis (Cox model) showed younger age to be a significant risk factor for reoperation. CONCLUSION: Long-term results with the Xenomedica device implanted in the mitral position appear in line with those achieved for other first-generation bioprostheses. However, incidence of primary tissue failure within 10 years was unsatisfactory. Although sudden dysfunction of the device never occurred, close monitoring of survivors is warranted.

Evaluation of valve-related complications in patients with Sorin Bicarbon prosthesis: a seven-year experience.

BACKGROUND AND AIM OF THE STUDY: The study aim was to evaluate the medium-term results of aortic valve replacement (AVR), mitral valve replacement (MVR) and double valve replacement (DVR) with the Sorin Bicarbon prosthesis. METHODS: A total of 990 patients (568 men, 422 women; mean age 60+/-10 years; range: 20-86 years) was reviewed who received 1,108 Sorin Bicarbon prostheses between 1992 and 1998 at three institutions. AVR was performed in 541 patients (55%), MVR in 330 (33%) and DVR in 119 (12%). Concomitant procedures, mainly coronary artery grafting, were performed in 222 patients (22%). Follow up was 98% complete; total cumulative follow up was 3,091 patient-years. RESULTS: Hospital mortality was 3.7% (n = 37). There were 49 late deaths; actuarial survival at seven years was 88+/-2% after AVR, 86+/-5% after MVR, and 78+/-8% after DVR. At last follow up, 915 survivors were in NYHA functional class I or II. At seven years, actuarial freedom from valve-related deaths, valve thrombosis, embolism and bleeding respectively was 96+/-1%, 99+/-1%, 93+/-2% and 91+/-3% after AVR; 97+/-2%, 97+/-3%, 90+/-3% and 86+/-7% after MVR; and 92+/-6%, 98+/-1%, 64+/-2% and 82+/-2% after DVR. Reoperation was required in 20 patients (due to valve thrombosis in six, endocarditis in five and periprosthetic leak in nine). At seven years, actuarial freedom from reoperation was 97+/-1%, 96+/-2% and 84+/-9% after AVR, MVR and DVR, respectively; actuarial freedom from endocarditis was 99+/-1%, 99+/-1% and 95+/-5%. Nine patients experienced a nonstructural valve dysfunction (all periprosthetic leak), while no cases of structural failure were observed. CONCLUSION: The Sorin Bicarbon prosthesis has shown good medium-term results with regard to clinical improvement, and low incidence of valve-related complications. Thus, it appears to be a reliable valve substitute when the use of a mechanical prosthesis is indicated.

Experience with stentless aortic xenografts.

BACKGROUND AND AIM OF THE STUDY: The study aim was to define the long-term results after aortic valve replacement (AVR) with freehand stentless xenografts. METHODS: A retrospective analysis was performed of 376 consecutive patients (195 males, 181 females; mean age 70 +/- 7 years; range: 26-87 years) who underwent stentless AVR between October 1992 and April 2000. In total, 164 patients received Toronto SPV, 106 Biocor PSB, 101 Cryolife-O'Brien, and five other valves. Indication for surgery was valve stenosis (n = 246), regurgitation (n = 50), mixed lesion (n = 75) and prosthetic valve failure (n = 5). Mean preoperative NYHA functional class was 2.9 +/- 0.6 (range: 2-4). Associated procedures were required in 153 patients (41%), including coronary artery bypass grafting (n = 97), mitral operation (n = 26), ascending aortic replacement (n = 17) and 'other' (n = 13). Mean valve size was 25 +/- 3 mm (range: 21-29 mm), mean aortic cross-clamp time was 96 +/- 23 min (range: 42-186 min), and mean cardiopulmonary bypass time 128 +/- 34 min (range: 65-363 min). RESULTS: Ten patients (2.7%) died in hospital, due to cardiac causes (n = 6), cerebrovascular accident (n = 3) and multiorgan failure (n = 1). During a mean follow up of 40 +/- 20 months (range: 1-90 months) there were 33 late deaths. Survival was 96 +/- 1%, 83 +/- 3% and 80 +/- 4% and valve-related event-free survival 97 +/- 1%, 87 +/- 2% and 82 +/- 6% at one, five and seven years, respectively. Valve failure occurred in 21 (6%) patients (10 structural, nine non-structural, two endocarditis): freedom from structural valve deterioration was 99 +/- 1%, 95 +/- 2% and 92 +/- 4% at one, five and seven years. Reoperation on the xenograft was required in 17 (5%) patients, giving a freedom from reoperation of 99 +/- 1%, 94 +/- 2% and 90 +/- 4% at one, five and seven years. Freedom from valve failure and reoperation were significantly lower with Cryolife-O'Brien valves, but freedom from structural valve failure was similar. The average NYHA class was improved at follow up (1.4 +/- 0.7 versus 2.9 +/- 0.6 preoperatively, p = 0.01). CONCLUSION: Long-term survival and freedom from valve-related adverse events after stentless AVR in an elderly population were satisfactory. Freedom from structural deterioration was excellent and comparable for all xenograft models, while non-structural deterioration may have been more common with one valve model. Despite the advanced patient age, functional improvement late after operation may be expected.