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Objectives: The aim of this retrospective multicenter study was to assess how the development of transcatheter aortic valve implantation (TAVI) influenced the characteristics and outcomes of patients undergoing aortic valve procedures., Methods: We reviewed 1395 patients who underwent isolated surgical aortic valve replacement (SAVR) or TAVI in three centres with a high-volume TAVI programme. Patients were divided into two groups: 'Pre-TAVI' (395 patients, 28.3%) and 'Post-TAVI' (1000 patients, 71.7%) operated on before and after the introduction of TAVI into clinical practice. We evaluated age, logistic EuroSCORE I (LES) and hospital mortality according to time periods and the procedure performed, whether SAVR or TAVI., Results: 'Post-TAVI' patients were older (78.2 ± 7.8 vs 76.8 ± 6.7 years; P = 0.002) and with a significantly higher LES (17.8 ± 14.7 vs 9.1 ± 9.2%; P < 0.001) than 'Pre-TAVI' patients. Hospital mortality was not significantly different between groups ('Pre-TAVI' vs 'Post-TAVI': 2 vs 3.4%; P = 0.17). Of the 1000 'Post-TAVI' patients, 605 (60.5%) underwent TAVI and 395 (39.5%), SAVR. Patients undergoing TAVI were older (79.9 ± 7.1 vs 75.5 ± 9.2 years; P < 0.001) and with a higher LES (22.9 ± 15.3 vs 9.7 ± 9.3%; P < 0.001) than 'Post-TAVI' SAVR patients, but their hospital mortality was similar (3.9 vs 2.5%; P = 0.22). LES was similar between 'Pre-TAVI' and 'Post-TAVI' SAVR patients (9.1 ± 9.2 vs 9.7 ± 9.3%; P = 0.26). Furthermore, we did not find significant differences in the overall hospital mortality between SAVR and TAVI patients: 2.3 vs 3.9%, P = 0.08., Conclusions: This analysis shows that the development of TAVI has caused an increase in the preoperative risk profile of patients scheduled for aortic valve procedures (SAVR or TAVI) without increasing hospital mortality.

Background and Aim of the Study: The study aim was to compare the hydrodynamics of the Carpentier-Edwards Magna 21 (CEM) and St. Jude Medical Biocor-Epic-Supra 21 (SJME) valves at increasing stroke volume and pulse rate in two different aortic conduits, namely straight and with sinuses of Valsalva present., Methods: Both valve types were tested in the aortic chamber of the Sheffield pulse duplicator, at rates of 70, 80 and 90 beats/min, and stroke volumes of 50 and 60 ml. The systolic and diastolic performances were each recorded. The leaflet coaptation time, ventricle isovolumetric time and maximum instantaneous flow rate were also recorded., Results: Regardless of the aortic conduit, CEM valves showed a significantly lower gradient than SJME valves (p < 0.05), and a significantly larger effective orifice area (EOA) (p < 0.05); the latter parameter was unaffected for both valves, at an increasing pulse rate (p > 0.05). The maximum transvalvular flow velocity was significantly higher in the straight conduit for both valves (p < 0.05). With regards to diastole, the SJME valve showed the lowest regurgitant volume (p < 0.05). The leaflet coaptation time was significantly shorter for the SJME valve than for the CEM valve (p < 0.05), but when tested in a straight conduit it was shortened significantly for both valves (p < 0.05)., Conclusion: An absence of the sinuses of Valsalva may modify the diastolic and systolic behaviors of the tissue valve leaflets by reducing the time required for leaflet coaptation, and increasing the valve closing volume and maximum transvalvular flow velocity. It is speculated that these hydrodynamic changes may increase the working stress on the valve tissue, leading to possible premature structural valve deterioration.

Objective: The Hancock II (HII) is a second-generation porcine bioprosthesis introduced into clinical use in 1982. This study aimed to evaluate very long-term outcomes for the HII valve in a large patient population., Methods: Between May 1983 and November 1993, 517 consecutive patients (pts) (309 male, mean age: 64+/-9 years) underwent valve replacement (VR) surgery with HII, with 302 (58.4%) in the aortic VR (AVR) and 215 (41.6%) in the mitral VR (MVR) position, respectively. At implant, 106 pts (20.5%) were <60 years of age (G1), while 411 (79.5%) were > or =60 years of age (G2). The 25-year follow-up was complete for all pts at a median of 12 years (range: 0-25)., Results: Long-term death occurred in 208 AVR and in 165 MVR pts. Survival at 15 and 20 years was 39.5% and 23.3% in AVR pts and 39.0% and 15.8% in MVR pts. At 25 years the survival of MVR pts was 13.7% (four pts at risk). Late freedom from re-operation was 85.5% and 79.3% at 15 and 20 years in the AVR pts and 73.3% and 52.8% in the MVR pts, respectively. In the AVR population, 20-year freedom from re-operation was 52.2% in G1 pts and 86.8% in G2 pts (p<0.0001), while in the MVR population it was 41.4% in G1 pts and 61.9% in G2 pts (p=0.201), respectively., Conclusions: These results confirm the excellent long-term performance of the HII bioprosthesis., (Copyright 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

Background and Aim of the Study: The most effective method for decellularization of the intact porcine aortic root remains controversial. Additionally, the hydrodynamic effect that such treatment may have on aortic roots has never been previously investigated. The study aim was to compare the in-vitro hydrodynamic performances of intact porcine aortic roots, both before and after decellularization treatment., Methods: Fifteen fresh porcine aortic roots were tested in the aortic chamber of the Sheffield pulse duplicator (SPD). For study purposes, the roots were first sutured to a silicone aortic root and then hydrodynamically tested. After in-vitro testing, the fresh porcine aortic roots, while still fixed within the silicone root, were decellularized according to various protocols (TRI-COL, TRI-DOC, sodium dodecyl sulfate (SDS) 0.03%, and SDS 0.1%). After decellularization, the valve roots were re-tested, adopting identical testing conditions. Forward flow pressure drop, closing leakage volumes, effective orifice area (EOA), and stroke work loss were each monitored. Three roots, used as a control group, were tested in identical fashion before and after storage (without decellularization) for comparative purposes., Results: The TRI-COL- and TRI-DOC-treated porcine aortic roots showed significantly lower transvalvular gradients, lower stroke work loss, lower valve resistance, and higher EOA than fresh intact porcine roots. In contrast, SDS 0.1%-treated porcine aortic roots showed opposing results, with the transvalvular gradients, stroke work loss and valve resistance each higher, and the EOA lower, than pre-treatment values. SDS 0.03% treatment had no significant effect on the hydrodynamic performance. After decellularization in all treatment groups, the diastolic parameters, total regurgitant volume and valve closing volume were each non-significantly increased. The aortic roots used as a control group showed similar results before and after storage., Conclusion: Based on these results using the SPD, all treatments except for SDS 0.03% modified the systolic and diastolic functions of intact porcine aortic roots.

Objectives: Age-related degenerative heart-valve disease is a health issue in the present era. Octogenarians are frequently affected by concomitant diseases and, with the present lack of resources, the risk/benefit of valvular replacement therapy poses serious medical, economical and political challenge. We analysed the long-term survival of 346 octogenarians who underwent 352 operations between 1 January 1987 and 1 January 2009 and we compared it with the survival of the general population, matched for age, sex and operative year., Methods: The total follow-up was of 1352 years, maximum 15.7 years and was nearly complete except for a single foreigner. Heart diseases, concomitant pathologies, complications and actuarial survival of this study group were compared with 4649 younger counterparts, who received 5416 operations during the same time frame. Octogenarians were sorted by age, sex and operative year and the expected survival was calculated by applying US survival rate and added to the Kaplan-Meier plot for visual comparison., Results: A total of 279 aortic, 38 mitral and 35 mitro-aortic valves were replaced or repaired using 357 bioprostheses, 18 mechanical prostheses, 12 reparative operations and 24 re-operations. A total of 75% of patients were younger than 84 years, 95% were younger than 87 years and 99% younger than 90 years. Sex prevalence was 215 female versus 131 male. Operative (30 days) mortality was 5.5% and overall survival was 84.3% at 1 year, 65.4% at 5 years, 27.3% at 10 years and 5.4% at 15 years. The expected survival of the age-, sex-, operative year-matched population was 26.9% at 10 years and 7.9% at 15 years. Female operative mortality was 5.9% and survival was respectively 86.3%, 70.2%, 27.5% and 9.1%, male mortality was 4.5% and survival was respectively 81%, 56.7%, 28.8% and 0% (p=0.16). Expected female survival was 30% at 10 years and 10% at 15 years versus 22% and 5.6%, respectively, in males. Six octogenarians underwent re-operation, with one death., Conclusions: Despite the highest prevalence of concomitant diseases and the requirement of additional resources for the detection and neutralisation of risk factors, heart-valve operations in octogenarians offer excellent results that compare favourably with the expected survival of the age-, sex- and operative year-matched population, particularly after primary operations., (Copyright 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

The aims of the present study were to compare hydrodynamics of three pericardial and two porcine valves while performing at different stroke volume (SV) and increasing pulse rate (PR). Carpentier-Edwards Magna-21 (CEM), Sorin Soprano-20 (SS), Mitroflow-23 (MF), SJM-Biocor-Epic-Supra-21 (SJME), and Medtronic Mosaic Ultra-23 (MMU) were tested in the aortic chamber (23-mm in diameter) of the Sheffield-Pulse-Duplicator. The tests were carried out at increasing pulse-rate and at each pulse-rate the valve was tested at different SV. CEM and MF showed significantly lower gradients than porcine valves and SS. Transvalvular gradients were unrelated to PR showing a constant value with increasing PR. While SJME valve showed the lowest regurgitant volume, on the contrary CEM showed the highest. At increasing SV, effective-orifice-area (EOA) observed with CEM was significantly larger than with the other tested valves, even though at SV 60 ml MF was comparable and at SV 65 ml significantly better. SS, SJME and MMU showed comparable EOAs with bigger area at increasing PR. The latter relation was reversed for CEM and MF. Our results show that CEM and MF have shown significantly better in-vitro hydrodynamics in comparison with their porcine counterpart and SS. Nevertheless, at increasing pulse rate, porcine tissue valves and SS may guarantee higher EOA values.

Background: TRI Technologies (TT) valves evidenced a propensity to structural failure, consisting in fracture of the pivoting system, leading to leaflet escape. At our institution, between 2000 and 2002, 36 TT valves were implanted in 34 patients. Here we report the final results of the Tritech survey program., Methods: In February 2002, the first valve-related death occurred. After the event, patients were enrolled in the TT valve survey program and strictly followed up. The option of a reintervention was advised to each patient and weighed against the redo operative risk. The prophylactic TT valve replacement program took place in two time frames, dependent on each patient's personal choice: between September 2002 and October 2003 (first phase), and between September 2004 and October 2004 (second phase). Overall, 22 (10 women, 12 men) patients underwent reoperation. Mean time interval between TT valve implantation and replacement was 23 +/- 11 months. Patients' mean age was 59 +/- 11 years (median age, 64 years)., Results: All recipients adhering to the program successfully underwent reoperation. Operative mortality was 0%., Conclusions: We believe that the timing of the second surgery was fundamental for the favorable outcome of each patient and the absence of operative mortality. We are convinced that the tailored programming of the reintervention, together with the strong motivation of each patient, contributed in minimizing the risks related to surgery. The circumscribed cohort of patients involved was compatible with a tailored therapeutic plan. We strongly advise prophylactic reoperation of recipients of TT valves.

Objective: We performed a multi-institutional study to compare the long-term structural valve deterioration of isolated Hancock Standard versus Hancock II bioprostheses., Methods: From 1983 to 2002, 714 Hancock Standard and 1293 Hancock II bioprostheses were implanted at hospitals of the Venetian territory (Padova, Treviso, and Venice). Follow-up on January 1, 2003, included 14,749 patient-years with a median of 12 years and was 96% complete: 115 Hancock Standard and 53 Hancock II bioprostheses were at risk at 15 years. The 2 series were nonconcomitant, and many covariates differed (Table 1). Survival was analyzed with Cox analysis, and durability was analyzed with Weibull analysis. Balancing analysis with the logistic propensity score model was performed., Results: Perioperative mortality was 6% in Hancock II and 12% in Hancock Standard operations. The overall unadjusted 15-year survival was identical (39.7% +/- 2.3% vs 39.9% +/- 2.4%, respectively), but age-adjusted survival at 15 years was 46% versus 25% (P < .001). Late survival was unrelated to the prosthetic model, whereas it was adversely affected by older age, previous operations, aortic regurgitation, male sex, higher New York Heart Association class, atrial fibrillation, and coronary artery bypass grafting. In Hancock II patients aged 65 years and older, the cumulative hazard of structural valve deterioration at 15 years was 6%, versus 17.5% in Hancock Standard patients. In younger patients, it was 18% and 37%, respectively. Analysis of 541 propensity-balanced patients showed a hazard ratio of the Hancock Standard prosthesis of 2 and a risk reduction of older age of approximately 10% every 10 years., Conclusion: After balancing risk factors and calibrating age effects, Hancock II propensity-matched bioprostheses showed similar survival but definitely increased durability.

Objectives: The purpose of this multi-institutional study was to review the 15-year outcome of patients who received isolated aortic or mitral valve replacement with the Hancock II bioprosthesis., Methods: From 1983 through 2002, 1274 patients underwent 1293 isolated valve replacements, 809 aortic valve replacements and 484 mitral valve replacements, at hospitals in the Venetian area (Padova, Treviso, and Venice). Mean age was 68 +/- 8 years in patients undergoing aortic valve replacement and 66 +/- 9 years in patients undergoing mitral valve replacement; 52% of patients undergoing aortic valve replacement and 63% of patients undergoing mitral valve replacement were in New York Heart Association class III or greater. Coronary artery disease was present in 32% of patients who had undergone aortic valve replacement and 18% of patients who had undergone mitral valve replacement. Follow-up included 8520 patient-years, with a median of 12 years, and was 97% complete., Results: Overall 15-year survival was 39.7% +/- 2.4%, similar in both the aortic and mitral positions. Multivariable analysis of late survival showed the incremental risk of male sex, higher New York Heart Association class, coronary artery disease, and mitral position. Freedom from embolism was higher in the aortic position (81% +/- 2.9% in aortic vs 72% +/- 4.7% in mitral valve replacements). Freedom from endocarditis was similar in the aortic and mitral position (95% +/- 1.2% vs 94% +/- 1.7%). Freedom from reoperation (82% +/- 3.7% vs 71% +/- 5.0%) and from valve-related morbidity-mortality (52% +/- 3.6% vs 36% +/- 4.4%) was higher in patients who had undergone AVR. Actual freedom from structural valve deterioration for patients 60 years and older who had undergone aortic valve replacement was 96.5% +/- 1.3% versus 88% +/- 3.2% for patients who had undergone mitral valve replacement and 70% +/- 7.5% versus 77.5% +/- 5.3%, respectively, in younger patients. Multivariable Weibull analysis showed structural valve deterioration related to younger age and preoperative valve incompetence and inversely related to coronary artery disease., Conclusion: Optimal 15-year durability can be expected in male patients 60 years and older who have undergone aortic valve replacement and in male patients 65 years and older who have undergone mitral valve replacement, extending safely the age limits for the use of this valve.

Background: In vivo comparison of the performance of heart valve prostheses is confounded by several factors, such as different nominal size, patients' characteristics and hemodynamics, surgical techniques, and study design. The aim of this study was to compare the in vitro hydrodynamic performances of 5 different tissue valves that would fit a 21-mm-diameter valve holder of the Sheffield pulse duplicator., Methods: Three samples of 5 supra-annular production-quality tissue valves, including the sewing ring cuffs, were tested in the aortic chamber of the Sheffield pulse duplicator. The prostheses fitting a 21-mm valve holder, which is comparable with a 21-mm aortic annulus, were as follows: 20-mm Sorin Soprano, 21-mm Carpentier-Edwards Magna, 21-mm SJM-Biocor-Epic-Supra, 21-mm Medtronic Mosaic, and 23-mm Mitroflow. The tests were carried out at a fixed pulse rate (70 beats/min) and at increasing cardiac outputs of 2, 4, 5, and 7 L/min. Each valve was tested 10 times for each different cardiac output. This resulted in a total of 40 tests for each valve and 120 tests for each valve model. Forward flow pressure decrease, effective orifice area, stroke work loss, and total regurgitant, closing, and leakage volumes were recorded while the valve operated under each cardiac output., Results: Pericardial valves showed significantly lower transvalvular gradients than porcine valves, unlike the SJM-Biocor-Epic-Supra valve at 2 L/min of cardiac output. Although the Carpentier-Edwards Magna valve provided the best performance at 2 and 4 L/min, the Mitroflow valve exhibited the lowest mean and peak gradients at 5 to 7 L/min. Total regurgitant and leakage volumes were higher for the Carpentier-Edwards Magna valve and lower for the SJM-Biocor-Epic-Supra and Mitroflow valves. Between 2 and 4 L/min, the calculated effective orifice area and stroke work loss were better for the Carpentier-Edwards Magna valve, whereas between 5 and 7 L/min, they were significantly superior with the Mitroflow prosthesis. Among the porcine bioprostheses, the SJM-Biocor-Epic-Supra valve showed significantly better results when compared with the Medtronic Mosaic valve at each cardiac output., Conclusion: Assuming that the valve holder is comparable with a defined aortic annulus of 21 mm in which a spread of supra-annular tissue valves could be fitted, this hydrodynamic evaluation model allows comparison of the efficiency of currently available bioprostheses with a definite tissue annulus diameter. Pericardial valves exhibited the best performances, and the Mitroflow valve showed the lowest gradients and stroke work loss at increasing cardiac output.

Background and Aim of the Study: The choice of aortic valve substitutes remains controversial. Malfunction and systemic valve complications affect the results of mechanical and tissue valves. Two devices--the Sorin Monocast (tilting disk) valve and the Hancock Standard valve were compared, the study aim being to determine whether the valve model is a marker or a causal influence of poor outcome after aortic valve replacement (AVR)., Methods: Between January 1970 and January 1984, patients aged < 70 years and operated on for aortic valve disease were selected. A total of 379 patients received either Sorin (group S) valves (n = 213; median age 51 years) or Hancock Standard (group HcK) valves (n = 192; median age 50 years) (p = NS). Total follow up was 2,471 patient-years (pt-yr) for group S and 2,368 pt-yr for group HcK. Follow up was 98% complete; median duration was 15 pt-yr for group S and 13.2 pt-yr for group HcK. Propensity matching for available patient intrinsic and operative risk factors was ultimately used to investigate whether biological or mechanical valve models impact upon outcome after aortic valve surgery. Patient survival was analyzed according to the 'intention to treat' principle., Results: The 30-day mortality was 7.5% for group S and 10.9% for group HcK (p = NS). The 19-year Kaplan-Meier freedom from valve-related mortality was 84% (group S) and 82% (group HcK) (p = NS), while overall survival was 42% (group S) and 35% (group HcK) (p = NS). Structural valve deterioration (SVD) was the major cause of reoperation in the HcK group. The 19-year freedom from all valve-related complications was 43% (group S) versus 19% (group HcK) (p = 0.0001). By propensity score, 61% of the valve replacements (247/405) were perfectly matched for available risk factors, with an equal distribution of risk covariates. When SVD and reoperation due to SVD were excluded, survival and freedom from all valve-related complications of the matched patients were identical between the prostheses under comparison., Conclusion: In this relatively young population, the Sorin valve showed a significantly lower valve-related complication rate than the Hancock Standard valve. The latter valve showed a significantly increasing rate of reoperation due to SVD, and thereby a relative inadequacy for use in younger patients. When analyzed according to an 'intention to treat' principle, the 19-year survival and freedom from valve-related complications of patients with the same propensity score for selection of either valve type were similar.

Objective: This study was undertaken to quantify the relationship between prosthesis size adjusted for patient size (prosthesis-patient size) and long-term survival after aortic valve replacement., Methods: Data from nine representative sources on 13,258 aortic valve replacements provided 69,780 patient-years of follow-up (mean 5.3 +/- 4.7 years), with reliable survival estimates to 15 years. Prostheses included 5757 stented porcine xenografts, 3198 stented bovine pericardial xenografts, 3583 mechanical valves, and 720 allografts. Manufacturers' labeled prosthesis size was 19 mm or smaller in 1109 patients. Expressions of prosthesis-patient size assessed were indexed internal prosthesis orifice area (in centimeters squared per square meter of body surface area) and standardized internal prosthesis orifice size (Z, the number of SDs from mean normal native aortic valve size). Multivariable hazard domain analysis with balancing score and risk factor adjustment quantified the association of prosthesis-patient size with survival., Results: Prosthesis-patient size down to at least 1.1 cm(2)/m(2) or -3 Z did not adversely affect intermediate- or long-term survival (P >.2). However, 30-day mortality increased 1% to 2% when indexed orifice area fell below 1.2 cm(2)/m(2) (P =.002) or standardized orifice size fell below -2.5 Z (P =.0003). The increased early risk affected fewer than 1% of patients receiving bioprostheses but about 25% of those receiving mechanical devices., Conclusions: Aortic prosthesis-patient size down to 1.1 cm(2)/m(2) or -3 Z did not reduce intermediate- or long-term survival after aortic valve replacement. However, patient-prosthesis size under 1.2 cm(2)/m(2) or -2.5 Z was associated with a 1% to 2% increase in 30-day mortality. Prosthesis-patient sizes this small or smaller were rarely implanted in patients receiving bioprostheses.

Up to the end of 1982, reoperation for dehiscence of an aortic prosthesis was necessary in 5% of patients operated on for primary aortic valve replacement in the previous decade at the University of Padova Cardiac Surgery Center. This complication occurred early (median time to diagnosis 4 months) and was associated with an elevated 30-day operative mortality (27%, 70% CL 19-37%). This is probably (P = 0.09) related to preoperative heart failure. The follow-up of the traced surviving patients (92%) indicates a continuing poor prognosis with a 6-year survival rate of only 13.5% (70% CL 5.0-30%). All the events were cardiac related and directly or indirectly connected with the persistence or recurrence of dehiscence that was observed in 72% of the cases. In the face of these results, a retrospective study has been performed to identify, on the basis of the available data, the subsets of patients more prone to develop this complication. Our results suggest that a significant increased risk (P less than 0.001) can be identified in patients presenting with bacterial endocarditis (12.2% rate), in patients with concomitant aneurysm of the ascending aorta (10.9%) and in patients with degenerative regurgitation or severe calcifications of their native valve, with rates of 7.0 and 6.0 respectively. In these situations particular care is required to avoid undue stress on the annular tissue. We also suggest the use of buttressed interrupted sutures.