Limited long-term durability of the Cryolife O'Brien stentless porcine xenograft valve.

BACKGROUND: Despite the fact that early and midterm hemodynamic and clinical results of the Cryolife O'Brien (CLOB) stentless valve have been reported to be favorable, the long-term durability and clinical results of this valve are largely unknown. Accordingly, we analyzed 10-year outcomes after aortic valve replacement with this valve. METHODS AND RESULTS: From January 1994 to September 2004, 185 patients (67, 73, and 75 years, 25th, 50th, and 75th quartiles, respectively; 38% older than 75 years; 56% females) underwent aortic valve replacement with the CLOB valve. Sixty-eight percent of patients were in NYHA class 3 to 4. Standard EuroSCORE was 7.1+/-2.7. Pure aortic stenosis accounted for 42% (n=79), and pure insufficiency for 12% of cases (n=22). Concomitant surgery: 28% coronary artery bypass (n=51), 11% mitral valve replacement/annuloplasty (n=21), and 2% ascending aorta replacement (n=3). Sixty-one percent of patients received a 23-mm valve or smaller size. Follow-up was 100% completed, and cumulative follow-up was 65 months/patient. The 30-day mortality was 5.4% (none were valve related). Actuarial survival at 5 and 10 years were 68% and 40%, respectively. Actuarial freedom from structural valve deterioration was 91% at 5 years and dropped to 44% at 10 years. Actuarial freedom from reoperation was 94% at 5 years and declined to 57% at 10 years. CONCLUSIONS: In a population with a high prevalence of elderly females with small aortic root, the CLOB valve demonstrated satisfactory clinical results till 8-years. Afterward, a significant increase in hazard for structural valve deterioration and reoperation occurred in late follow-up.

Stent-grafting of the thoracic aorta: feasibility and early results in acute and chronic lesions.

BACKGROUND AND AIMS: Conventional surgery of the thoracic aorta is frequently associated with significant mortality and morbidity. Here we present treatment of surgical pathologies of the thoracic aorta using a less invasive endovascular approach. METHODS: From January 2000 to May 2004, 51 patients (mean age 62.7 +/- 12.8 years, 36 men) underwent endovascular repair of thoracic aortic lesions in our institution. All patients underwent computed tomography scan at discharge, 6 and 12 months and annually thereafter. Clinical follow-up was carried out by outpatient clinic visit or by telephone contact with the patients or their referring physicians. Mean follow-up was 15.8 months. RESULTS: The 30-day mortality rate was 3.8%, one death in the group of chronic (1.9%) and one in the group of acute lesion (1.9%). The survival rate in the follow-up period was 92.4% at 6 months. Computed tomography angiography confirmed exclusion of the lesion in 25 out of 27 chronic patients, whereas type I and II endoleaks were detected in two patients treated with a secondary procedure. In addition, two patients with an acute type B aortic dissection presented with early endoleaks. The overall rate of complications was 10%. No other endoleaks or deaths were observed at later follow-up. CONCLUSIONS: The early and mid-term results of endovascular stent-grafting for the treatment of chronic and acute thoracic aortic diseases showed a good outcome and low rate of complications. Stent-grafting of the thoracic aorta is still an investigational procedure that needs further validation.

Successful treatment of polymicrobial multivalve infective endocarditis. Multivalve infective endocarditis.

A 57-year-old man presented with triple valve infective endocarditis. There were vegetations on the tricuspid, mitral, and aortic valve. He had multiple complications such as pulmonary abscess, severe anaemia, and congestive heart failure. His general condition was extremely poor. Intensive medical therapy, such as blood transfusion, mechanical ventilation, and inotropic support, allowed him to tolerate surgery. Triple valve replacement was successfully performed without major complication. Vegetation cultures grew Streptococcus bovis and Enterecoccus faecalis. At 1 year follow-up, the patient is alive in NYHA functional class I.

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.

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.

Patient-prosthesis mismatch after small-size stentless aortic valve replacement.

OBJECTIVE: The aim of this study was to determine the occurrence of patient-prosthesis mismatch (P-PM) after aortic valve replacement (AVR) with a small-size Cryolife O'Brien (CLOB) bioprosthesis and to evaluate its clinical and hemodynamic implications. METHODS: Sixty-two patients (mean age 70.9 +/- 5.2 years, 77.8% females), receiving a labeled 21-23 mm CLOB between 1993 and 2000, were retrospectively studied. Effective orifice area (EOA) was calculated by the continuity equation and then indexed to the patient's body surface area (BSA) to obtain the indexed EOA (EOAI). Based on previous observations a mismatch was defined as EOAI or= 0.8 cm/m2 showed an earlier concentric remodeling up to 1 year; no difference was demonstrated at later studies between groups. Survival and clinical status results were not affected by an EOAI

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.

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.

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.

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.

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.