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Ugolino Livi

Publications and source records attributed to Ugolino Livi.

At least 19 recordsLinked to original sources

Similar efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic) compared with mycophenolate mofetil (MMF) in de novo heart transplant recipients: results of a 12-month, single-blind, randomized, parallel-group, multicenter study.

BACKGROUND: Enteric-coated mycophenolate sodium (EC-MPS, myfortic) is an advanced formulation that delays the release of mycophenolic acid (MPA). Its efficacy and safety has been proven in several clinical trials in renal transplantation. METHODS: In a single-blind, multicenter trial, a total of 154 de novo heart transplant patients were randomized to either EC-MPS 1,080 mg twice daily or mycophenolate mofetil (MMF) 1,500 mg twice daily. Eligible patients included men or women aged 18 to 65 years, undergoing primary heart transplantation, who were treated with cyclosporine microemulsion and corticosteroids as basic immunosuppression. The primary study objective was to investigate the incidence of biopsy-proven and treated acute rejection, graft loss or death (defined as treatment failure) for EC-MPS vs MMF during the first 6 months of treatment in de novo heart transplant recipients. Secondary objectives included assessment of the overall safety and tolerability of EC-MPS vs MMF in the study population. RESULTS: The primary efficacy variable, treatment failure at 6 months, was similar for both treatments: 52.6% for EC-MPS and 57.9% for MMF (2-sided 95% confidence interval [CI]: -21.0% to 10.4%). At 12 months, treatment failure was 57.7% for EC-MPS and 60.5% for MMF (2-sided 95% CI: -18.4 to 12.7), and death and graft loss rate was 5.1% vs 9.2% for EC-MPS and MMF at 12 months, respectively (2-sided 95% CI: -12.2 to 4.1). The overall safety profile was similar for both groups. Significantly more patients on MMF had two or more study medication dose reductions during the treatment period. CONCLUSIONS: These 6- and 12-month results show that EC-MPS is therapeutically similar to MMF in de novo heart transplant recipients and has a comparable safety profile.

Adolescent↗

Results of aortic valve replacement with a new supra-annular pericardial stented bioprosthesis.

BACKGROUND: The stented Soprano valve (Sorin Biomedica S.pA., Saluggia, Italy) is a pericardial tissue valve designed for a totally supra-annular implant with the aim of improving hemodynamic performance, particularly in patients with a reduced aortic annulus. However, its hemodynamics and early clinical outcome are poorly understood. METHODS: Seventy-seven patients (mean age 76 +/- 5 years, 56% males) underwent aortic valve replacement with the Soprano valve. All patients were monitored with clinical examination and serial echocardiography at 1, 6, and 12 months and yearly afterward. RESULTS: At preoperative echocardiography, average left ventricular outflow tract diameter was 2.1 +/- 0.2 cm. At operation, 35% of patients received a 20-mm valve, 54% a 22-mm valve, and 11% a 24-mm valve. At 6-month follow-up, peak and mean transprosthetic gradients were 18 +/- 8 and 9 +/- 4 mm Hg, respectively; effective orifice area (EOA) and EOA index were 1.84 +/- 0.6 cm2 and 0.9 +/- 0.2 cm2/m2, respectively. Incidence of patient-prosthesis mismatch (ie, EOA index < 0.85 cm2/m2) was 23%, with no case of severe mismatch (ie, EOA index < 0.6 cm2/m2). In addition, left ventricular hypertrophy showed a significant regression (mass index from 214 +/- 98 g to 129 +/- 41 g; p = 0.001), and ejection fraction increased (from 58% +/- 17% to 67% +/- 8%; p = 0.001). Cumulative follow-up was 7.9 months per patient. Thirty-day mortality rate was 2.6% (2 of 77). Cumulative survival at 6, 12, and 24 months was 92% +/- 3.7%, 85% +/- 5.7%, and 85% +/- 5.7%, respectively. Two patients experienced embolic episodes. One case of anticoagulant-related bleeding occurred. CONCLUSIONS: In our series, the Soprano bioprosthesis showed a good hemodynamic performance, low incidence of patient-prosthesis mismatch, and favorable early clinical results.

Aged↗

Heart failure and severe pulmonary hypertension caused by distal detachment of the valve conduit 16 years after the Cabrol composite graft procedure.

We report the case of a patient who underwent Cabrol composite graft procedure for ascending aorta aneurysm and aortic regurgitation. Sixteen years later he developed progressive dyspnea and a left-to-right shunt caused by distal detachment of the valve conduit with persistence of the perigraft space-right atrial fistula visualized with echocardiography. Our case shows that late manifestations of surgical complications of the Cabrol procedure may occur and transesophageal echocardiography may allow a comprehensive assessment in these patients. However, because surgical management of ascending aorta aneurysms has changed in the last decades a detailed knowledge of the surgical technique used is mandatory for adequate interpretation of transesophageal echocardiographic results.

Aged↗

Occurrence of post-transplant lymphoproliferative disorders among over thousand adult recipients: any role for hepatitis C infection?

BACKGROUND: Post-transplant lymphoproliferative disorders represent an increasingly important complication of organ transplantation. Although the majority of the post-transplant lymphoproliferative disorder are etiologically related to Epstein-Barr virus infection other factors may play a role. Hepatitis C virus may induce clonal expansion of B-lymphocytes and has been associated with extrahepatic lymphoproliferative disorders. OBJECTIVES: In this study, we have evaluated: (i) the prevalence of post-transplant lymphoproliferative disorder; (ii) presence of Epstein-Barr virus in post-transplant lymphoproliferative disorder tissue; and (iii) the potential association between post-transplant lymphoproliferative disorder development and hepatitis C virus infection in a large cohort of adult solid organ transplant recipients. METHODS: The study involved 1011 liver, heart and kidney-transplanted patients. Different immunosuppression therapy was recorded from all patients, all were screened for hepatitis C virus infection. When post-transplant lymphoproliferative disorder developed, Epstein-Barr virus encoded RNA by in-situ hybridization and EBNA-1 and gp220 by polymerase chain reaction was assessed in tissue samples. RESULTS: The overall prevalence of post-transplant lymphoproliferative disorder was 1.4% (2.5% in heart, 0.9% in liver and 0.8% in kidney-transplanted patients) and significantly higher in hepatitis C virus positive than in hepatitis C virus negative patients (3.6 % vs 1.2 %; P=0.04). Epstein-Barr virus was present in 10 (77%) out of 13 tumors tested. Two out of three Epstein-Barr virus-negative post-transplant lymphoproliferative disorder developed in hepatitis C virus-positive patients. Thirteen out of 15 (86%) post-transplant lymphoproliferative disorder patients had undergone antithymocyte globulin/OKT3 induction therapy. CONCLUSIONS: Epstein-Barr virus, induction immunosuppression, rejection therapy and also hepatitis C virus infection may play a role in the multifactorial pathogenesis of post-transplant lymphoproliferative disorder.

Adult↗

Clinical and hemodynamic implications of supra-annular implant of biological aortic valves.

The use of stented bioprostheses in elderly patients with degenerative aortic stenosis, despite being desirable, raises concerns about the harmful effects of residual obstruction to left ventricular outflow. To overcome this limitation new stented and stentless bioprostheses have been designed for supra-annular implant. However, the actual hemodynamic advantage of supra-annular implant over the intra-annular one remains incompletely understood. This review focuses on the geometry of biological valve prostheses designed for supra-annular implant and its implications for the echocardiographic assessment of valve hemodynamics. Available data about the hemodynamic performance of these valves implanted in the supra-annular position in comparison with the usual intra-annular implant are also reviewed. Other issues related to biological heart valve performance, such as biomaterials, tissue mechanics, durability, and clinical outcome are not addressed in this review.

Aorta↗

Stented bioprosthetic valve hemodynamics: is the supra-annular implant better than the intra-annular?

BACKGROUND AND AIM OF THE STUDY: The use of stented bioprostheses for aortic valve replacement (AVR) in elderly patients with a small aortic annulus may result in unsatisfactory hemodynamic performance of the prosthesis. To overcome this limitation, new bioprostheses have been designed for complete supra-annular implantation, but the actual hemodynamic advantage of the supra-annular implant over the intra-annular has not been fully investigated. Accordingly, the hemodynamic performance of the same stented bioprosthesis (except for sewing ring design) implanted in the supra-annular and conventional intra-annular seating was compared. METHODS: Twenty-two patients received an intra-annular implant, and 38 a supra-annular implant. Age (74 +/- 5 versus 76 +/- 5 years, p = 0.54), gender (55% versus 50% males, p = 0.79) and body surface area (1.74 +/- 0.2 versus 1.81 +/- 0.2 m2, p = 0.13) were similar in both subgroups, who underwent echocardiography at 8 +/- 2 and 6 +/- 2 months after surgery, respectively (p = 0.09). RESULTS: The two patient subgroups had similar preoperative left ventricular outflow tract diameters (2.06 +/- 0.2 and 2.1 +/- 0.2 cm; p = 0.62), average size of implanted prosthesis (21.0 and 21.3 mm; p = 0.44) and mean transprosthetic flow rate (246 +/- 70 and 218 +/- 58 ml/s; p = 0.12). Mean (8 +/- 3 and 19 +/- 8 mmHg, p < 0.0001), and peak (17 +/- 6 and 40 +/- 13 mmHg; p < 0.0001) transprosthetic gradients were lower, and mean effective orifice area (EOA) (1.78 +/- 0.4 and 1.45 +/- 0.5 cm2, p = 0.006) was higher in patients with supra-annular implants than in those with intraannular. The incidence of patient-prosthesis mismatch (EOA index < 0.85 cm2/m2) decreased from 50% to 34% (p < 0.0001), with no case of severe mismatch using the supra-annular implant. During follow up, a left ventricular mass reduction occurred in patients with supra-annular implants (from 225 +/- 110 to 173 +/- 59 g/m2; p < 0.03), but not in patients with intra-annular implants (173 +/- 62 and 186 +/- 64 g/m2; p = 0.87) CONCLUSION: The study results showed that, compared to intra-annular implantation, supra-annular implantation of bioprosthetic stented valves in the aortic position was associated with a significantly better hemodynamic performance of the prosthesis and significant regression of left ventricular hypertrophy.

Aged↗

One-year clinical experience with the Acorn CorCap cardiac support device: results of a limited market release safety study in Italy and Sweden.

BACKGROUND: The Acorn CorCap cardiac support device (CSD) is a mesh-like device intended to provide end-diastolic support and reduce ventricular wall stress. Animal studies with the CorCap CSD have demonstrated beneficial reverse remodeling, and preliminary safety studies in patients with heart failure have shown that the device is safe and associated with improved left ventricular (LV) structure and function. The objective of the current study was to further evaluate the safety and efficacy of the CorCap CSD in patients with advanced heart failure. METHODS: Twenty-four patients with dilated cardiomyopathy, severe LV dysfunction, and advanced heart failure (NYHA class II-IV) were enrolled at four centers in Italy and Sweden. All patients underwent CorCap CSD implantation either alone (n = 3) or in combination with mitral valve repair/replacement (n = 13), coronary artery bypass surgery (n = 6), combined mitral valve repair/coronary artery bypass surgery (n = 1) or aneurysmectomy (n = 1). RESULTS: The LV end-diastolic diameter decreased from 69.3 +/- 7.2 to 60.1 +/- 9.0 mm at 3 months, 60.9 +/- 9.6 mm at 6 months, and 58.9 +/- 8.0 mm at 12 months (all p < 0.05). A trend toward an improved LV ejection fraction (28.8 +/- 10.5% at baseline and 32.4 +/- 12.7, 33.1 +/- 10.8, and 33.8 +/- 13.9% at 3, 6 and 12 months respectively) was also noted. The NYHA functional class, 6-min walking distance, and quality of life as measured using Uniscale were all improved. There were no differences in response among the patients submitted to the different types of concomitant surgery. CONCLUSIONS: In agreement with earlier safety studies, even the present investigation demonstrated improvements in cardiac structure and function as well as in patient functional status after Cor Cap CSD implantation. Randomized controlled trials are in progress.

Adult↗

Natural leukocyte interferon alfa for the treatment of chronic viral hepatitis in heart transplant recipients.

BACKGROUND: A more rapid and aggressive course of hepatitis B virus (HBV)-related and hepatitis C virus (HCV)-related infection in organ transplant recipients has been described. Interferon alfa is the most accepted drug for treating HBV and HCV chronic infections. However, the use of interferon alfa-N3 has been contraindicated in heart transplant (HTx) recipients because of the hypothesized greater risk of triggering acute cellular rejection. The aim of this clinical pilot study was to evaluate tolerability, safety, and efficacy of natural leukocyte interferon alfa in the treatment of chronic HBV and HCV in HTx recipients. METHODS: Seven HTx recipients were enrolled in the study: two with HBV, four with HCV, and one with combined HBV-HCV chronic infection. The patients had a mean follow-up after heart transplantation of 8.5+/-3 years, before starting interferon alfa-N3 treatment at a dose of 6 MU three times per week, intramuscularly for 12 months. RESULTS: All patients completed the treatment with no major side effects. No unexpected episodes of acute cellular rejection were observed during the treatment. Mean aminotransferase serum levels were significantly lower than before transplantation at 3 (P<0.03), 6 (P<0.02), and 12 (P<0.02) months of treatment and at the 12-month follow-up (P<0.02). A complete and sustained response was achieved in all subjects with HBV-related chronic hepatitis, whereas sustained virologic response was observed in one of four HCV patients. CONCLUSIONS: The preliminary data emerging from our study indicate that natural leukocyte interferon alfa-N3 can be safely administered in HTx recipients with chronic HBV or HCV viral hepatitis. Further studies with larger numbers of patients are needed to assess the efficacy of interferon alfa-N3 on HCV virologic response.

Adult↗

A long-term experience with the Cabrol root replacement technique for the management of ascending aortic aneurysms and dissections.

BACKGROUND: Little information exists regarding the long-term results of the Cabrol technique. This study aimed at exploring, over a 16-year period, the results of aortic root replacements employing this procedure. METHODS: Between 1986 and 2002 forty-five patients (mean age 58.7 +/- 13.8 years old, 84.4% male) underwent a Cabrol procedure. Aortic dissection was the most frequent cause of aortic disease in this series (n = 17), followed by annuloaortic ectasia (n = 10), atherosclerotic aneurysm (n = 5) and poststenotic dilatation (n = 5). Six patients (13.4%) had undergone a previous aortic operation, 8 (17.7%) had a Marfan syndrome and five (11.1%) underwent concomitant arch replacement. Mean clinical follow-up was 87.3 +/- 24.3 months. Twenty-eight patients (93.3% of survivors) had a transesophageal echocardiography (TEE) performed at a mean of 64 +/- 32 months postoperatively. RESULTS: Early mortality was 20%. It was 9.1% for patients with an ascending aortic aneurysm and 41.2% for dissections (p = 0.026). Independent multivariate predictors of early mortality were: aortic dissection (p = 0.009), emergency operation (p < 0.001), operative year (p = 0.02), cross-clamp time (p = 0.001), and CPB duration (p < 0.001). Actuarial survival was 0.77 +/- 0.06, 0.72 +/- 0.06, 0.59 +/- 0.04 and 0.59 +/- 0.04 at 1, 5, 10, and 16 years, respectively. Multivariate analysis revealed age (p = 0.007), cross-clamp time (p = 0.0006) and CPB duration (p = 0.009) as strong predictors of poor late survival. A periprosthetic jet with significant valve regurgitation was detected by TEE in 3 patients. In one of them, an infected periprosthetic space-right ventricular fistula was demonstrated requiring reoperation. Altogether, freedom from reoperation and endocarditis at 16 years was 0.97 +/- 0.02 and 0.94 +/- 0.03, respectively. CONCLUSIONS: The Cabrol technique demonstrated a nonnegligible incidence of early and long-term complications. It should be rarely used and only when a "button" technique is not feasible.

Aortic Dissection↗

A short-term experience with the Tirone David I valve sparing operation for the treatment of aneurysms of the ascending aorta and aortic root.

AIM: The aim of this report is to summarize our experience with the Tirone David I technique over a 4-year period. METHODS: Since 1997 15 patients were operated on using this surgical procedure. Of the patients, nine were male (60%) and six (40%) female. Ages ranged from 23 to 75 years (mean 62.1+/-17.2 years). The underlying disease was chronic aneurysm of the ascending aorta or root in 13 (86.6%) and chronic dissection in two (13.4%). Four patients (26.6%) had skeletal manifestations of Marfan's syndrome. Additional cardiac procedures were performed in two patients (13.4%). Mean follow-up time was 26.6+/-11.2 months (range 7-50 months). RESULTS: There were no early deaths. Postoperative non-fatal complications occurred in two (13.3%) patients. There was no valve-related late death occurring 6 months after operation. Actuarial survival was 0.94+/-0.07 at 4 years; 4-year freedom from reoperation was 0.91+/-0.07. The probability of needing reoperation was 8+/-0.9%. There were no instances of infective endocarditis or thromboembolic complications. At the end of the follow-up period, trivial or no aortic regurgitation was demonstrated in 57.1%, mild in 42.9% and no patient had an insufficiency graded >/=moderate. Echocardiography showed early postoperative reduction in left ventricular end-systolic and end-diastolic dimensions, which was maintained at follow-up controls. CONCLUSIONS: The Tirone David I procedure showed good early results, which encourage further use of this type of repair. However, further larger studies and long-term results are necessary for a definite judgment on this operative method.

Adult↗

Long-term decrease in subjective perceived efficacy of immunosuppressive treatment after heart transplantation.

BACKGROUND: Mild, long-term non-compliance with immunosuppressive treatment after organ transplantation is common, and can result in early mortality. One possible source of non-compliance is the belief that the treatment is ineffective or unnecessary. This study investigates patients perception of the efficacy of their immunosuppressive treatment in a sample of heart transplant patients. METHODS: A questionnaire was given to 67 heart transplant recipients. The first part of the questionnaire addressed health-related behavior and attitude toward the immunosuppressive medication, using self-report questions. In the second part of the questionnaire, participants evaluated the perceived risk of rejection associated with non-compliant behaviors described in 8 scenarios. RESULTS: The data from the self-report questions showed a mild level of behavioral non-compliance, increasing over time, and a mild level of medication non-compliance. One third of the medication non-compliant patients chose the inefficacy or non-necessity of the treatment as a main cause of non-compliance. The second part of the questionnaire showed that subjective perceived efficacy of the immunosuppressive treatment decreased over time. CONCLUSIONS: Medication non-compliance is fostered by many factors. One of these is the belief that the treatment is ineffective or unnecessary. This belief increases over time, and could be the result of a non-clinical selective-attention bias.

Female↗

Long-term results of Bentall composite aortic root replacement for ascending aortic aneurysms and dissections.

STUDY OBJECTIVES: The aim of this study was to evaluate the early and long-term outcomes in patients undergoing aortic root replacement (ARR) with the Bentall procedure. DESIGN: Retrospective study. SETTING: Cardiothoracic surgery unit. PATIENTS AND METHODS: Between January 1986 and January 2002, 72 patients (mean age 58.3 +/- 12.4 years, 81.9% males) underwent ARR by means of a Bentall operation. Annuloaortic ectasia was the most frequent cause of aortic disease in this series of patients (31 patients; 43.1%), followed by type A dissection (19 patients; 26.3%), atherosclerotic aneurysm (18 patients; 25.1%), and poststenotic dilatation (4 patients; 5.5%). Nine patients (12.5%) had Marfan syndrome, and 10 patients (13.8%) underwent a concomitant replacement of the aortic arch. Follow-up ranged from 2 to 192 months (mean [+/- SD], 86.6 +/- 23.8 months). RESULTS: The mean 30-day mortality rate was 5.5 +/- 2%. The mean early mortality rate was 21 +/- 4% and 0% (p < 0.001), respectively, in patients with and without dissecting aortic aneurysms. There were two late deaths that were due to a pulmonary neoplasm and a cerebrovascular accident. The mean 16-year survival rate was 91.7 +/- 3.2%. The mean hazard of freedom from death was constant beyond 3 years (8.5 +/- 3.5%). No patient required reoperation. Furthermore, the long-term clinical follow-up was marked by a complete absence of endocarditis, anticoagulant-related hemorrhage, valve thrombosis, and prosthesis failure. Finally, patients showed a significant improvement in mean New York Heart Association functional status (1.3 +/- 0.1; p < 0.001 [postoperatively vs preoperatively]). CONCLUSIONS: In our experience, the late results of the Bentall operation were satisfactory. Our findings confirm that this technique still represents the procedure of choice for ARR with coronary reimplantation.

Actuarial Analysis↗

Sixteen-year results of composite aortic root replacement for non-dissecting chronic aortic aneurysms.

BACKGROUND: The aim of this study was to evaluate the early and long-term outcomes in patients undergoing a Bentall procedure or its button modification for chronic aortic aneurysms with aortic valve incompetence. METHODS: Between January 1986 and January 2002, 65 patients (84% males, mean age 58.9 +/- 11 years) underwent aortic root replacement with a Bentall or a button-Bentall operation. Annuloaortic ectasia was the most frequent cause of aortic disease in this series (n = 37, 56.9%), followed by atherosclerotic aneurysms (n = 22, 33.9%), and post-stenotic dilation (n = 5, 7.7%). One patient (1.5%) underwent redo aortic root replacement,3 (4.6%) had a Marfan syndrome, and 6 (9.2%) underwent a concomitant replacement of the aortic arch. The duration of follow-up ranged from 2 to 192 months (mean 89.6 +/- 21.8 months). RESULTS: The 30-day mortality was 0%. Early non-fatal complications comprised: bleeding requiring surgical re-exploration (n = 1, 1.5%), low output syndrome (n = 1, 1.5%), acute renal insufficiency (n = 1, 1.5%), transient ischemic attack (n = 2, 3.1%), stroke (n = 1, 1.5%), and pulmonary insufficiency (n = 1, 1.5%). There was a late death due to a pulmonary neoplasm. The 16-year actuarial survival was 97 +/- 2% (hazard 0.02 +/- 0.02). No patient required reoperation. Furthermore, the long-term clinical follow-up was characterized by the complete absence of endocarditis, anticoagulant-related hemorrhage, valve thrombosis, and prosthetic failure. Finally, the NYHA functional status was significantly improved (1.1 +/- 0.50, p < 0.001 vs preoperatively). CONCLUSIONS: The late results of the Bentall and button-Bentall procedures were excellent. Our findings confirm that these techniques still constitute the gold standard in the surgical treatment of combined valve and ascending aorta pathologies.

Aged↗

Frontal cerebral blood flow is impaired in patients with heart transplantation.

Patients with cardiovascular disease have cognitive function disturbances that are still evident after heart transplantation (HT). The aim of this study was to evaluate cerebral function in transplant patients and to assess whether cyclosporine therapy was responsible for cerebral abnormalities 1 year after transplantation. Six HT patients, eight liver transplant (LT) patients, and ten age-matched healthy controls underwent regional cerebral blood flow (rCBF) assessment by the (99m)Tc-hexamethyl-propylene-amineoxime ((99m)Tc-HM-PAO) single-photon emission computed tomography (SPECT) technique. The rCBF was correlated with cyclosporine blood levels. rCBF in HT and LT patients was similar to that of controls in all regions assayed, except for the frontal inferior region of HT patients, where it was significantly lower than in controls. No correlations between rCBF and cyclosporine blood levels were found in either HT or LT patients. In conclusion, the cerebral abnormalities seen in patients after HT but not after LT may be due to long-standing cerebral hypoperfusion resulting from severe heart disease, whereas cyclosporine does not account for such functional alterations.

Adult↗

Usefulness of the Cryolife O'Brien stentless suprannular aortic valve to prevent prosthesis-patient mismatch in the small aortic root.

OBJECTIVES: This study evaluated the occurrence of prosthesis-patient mismatch (PPM) after Cryolife O'Brien (CLOB) suprannular stentless valve replacement in patients with a small aortic root and its repercussions on the patient's hemodynamic status and left ventricular mass regression. BACKGROUND: The correct management of the small aortic annulus is still controversial. Small aortic prostheses can lead to a PPM, which results in high gradients with important repercussions on the hemodynamic status. METHODS: Seventy-two patients (mean age: 72.5 +/- 6.2 years, 73.6% women) with a small aortic root (< or =21 mm intraoperatively measured aortic annulus) had a CLOB valve implanted in the aortic position between November 1993 and July 2001 at our institution. Mean prosthesis size was 22.0 +/- 0.8 mm. Patients underwent echocardiography preoperatively, at discharge, six months, one year and yearly thereafter. RESULTS: The incidence of PPM at discharge was 22.2% (16/72); 18.7% were severe (effective orifice area index [EOAI] < or =0.65 cm/m(2)), 43.7% were moderate (EOAI = 0.66 to 0.75 cm/m(2)) and 37.6% were mild (0.76 to 0.85 cm/m(2)). At multivariable analysis, gender (p < 0.001), age (p = 0.015), body surface area (p < 0.001) and patient's annulus index (p < 0.001) were significant factors influencing the occurrence of "transient" PPM. At one year the incidence of PPM was 0%. CONCLUSIONS; Suprannular CLOB valve yielded excellent hemodynamic results in patients with small aortic roots. This study demonstrates that PPM can be completely avoided when using the CLOB valve. The superior hemodynamics of this stentless valve are likely to be related to its suprannular design.

Aged↗

Preliminary experience with the St. Jude Medical Regent mechanical heart valve in the aortic position: early in vivo hemodynamic results.

BACKGROUND: The St. Jude Medical Regent is a new generation mechanical aortic valve. METHODS: Between March 2000 and July 2001, this valve was implanted in the aortic position in 40 patients (21 men; mean age 59.1 +/- 9.0 years). Preoperatively, 24 patients (60%) were in New York Heart Association functional class III or IV. Eighteen patients (45%) underwent associated procedures. Mean valve size was 21.4 +/- 2.4 mm. The mean duration of follow-up was 8.5 +/- 4.5 months (range, 1 to 16 months). RESULTS: There were no operative deaths. Early complications included one reoperation for bleeding and one transient low output syndrome. Valve replacement was followed by a significant reduction in mean and peak transaortic gradients over time (p < 0.001) and analysis of variance failed to demonstrate statistical differences between valve size over time (p = not significant). A significant reduction in left ventricular hypertrophy occurred over time (p = 0.01) in all valve sizes (p = not significant between groups): baseline left ventricular mass index was 194 g/cm2; it reduced by 22 g/cm2 (p = 0.006) at discharge. Left ventricular mass index decreased from 172 +/- 55 g/cm2 to 156 +/- 44 g/cm2 (p = 0.03) from discharge to 2 months. Further reductions were not significant. Relative wall thickness decreased from 0.57 +/- 0.13 preoperatively to 0.42 +/- 0.06 at discharge (p = 0.001), and again at 2 months (-0.2; p = not significant), and at 1 year (-0.02; p = not significant). CONCLUSIONS: The early experience with the St. Jude Medical Regent valve has been satisfactory.

Adult↗