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Super-extended (D2plus) lymphadenectomy after chemotherapy has been reported in only a few studies. This retrospective study evaluates survival outcomes in a Western cohort of locally advanced or oligometastatic gastric cancer patients who underwent D2plus lymphadenectomy after neoadjuvant chemotherapy. A total of 97 patients treated between 2010 and 2022 were included. Of these, 62 had clinical stage II/III disease, and 35 had stage IV disease. Most patients (65%) received preoperative DOC/FLOT chemotherapy. The mean number of lymph nodes harvested was 39. Pathological positive nodes in the posterior/para-aortic stations occurred in 17 (17.5%) patients. Lymphovascular invasion, ypN stage, clinical stage, and perineural invasion were predictive factors for positive posterior/para-aortic nodes. Postoperative complications occurred in 21 patients, whereas severe complications (grade III or more) occurred in 9 cases (9.3%). Mortality rate was 1%. Median overall survival (OS) was 59 months (95% CI: 13-106), with a five-year survival rate of 49 ± 6%; the five-year OS after R0 surgery was 60 ± 7%. In patients with positive posterior/para-aortic nodes, the median OS was 15 months (95% CI: 13-18). D2plus lymphadenectomy after chemotherapy for locally advanced or oligometastatic gastric cancer is feasible and associated with low morbidity/mortality rates. The incidence of pathological metastases in posterior/para-aortic nodes is not negligible even after systemic chemotherapy, with poor long-term survival.

Background: Gastroparesis is a digestive syndrome characterized by delayed gastric emptying (GE) and by symptoms that are suggestive of gastroduodenal motor disorders. There are three grades of gastroparesis of increasing severity: (a) mild gastroparesis; (b) compensated gastroparesis; and (c) gastric failure. GE abnormalities are partially related to symptom type and severity, and other mechanisms may be involved., Aim: To investigate enteric dysmotility (ED) in patients with suspected gastroparesis., Methods: Patients with symptoms suggestive of gastroparesis were consecutively included in the study and underwent a 13 C-octanoic acid GE breath test and small bowel manometry (SBM). Clinical features were recorded using predefined, validated questionnaires at entry., Key Results: The study enrolled 88 patients (71 women; mean age: 37.8 ± 14.3 years). Gastric emptying was delayed in 25 patients (28.4%), and 70 patients (79.5%) presented small bowel motor abnormalities including bursts, abnormal activity fronts, inability to respond to meal ingestion, and hypocontractility. Gastric emptying was delayed in 24 of the 70 patients with ED (34.3% vs 5.5% of patients with normal SBM). Enteric dysmotility was detected in 24 of 25 patients (96%) with delayed GE. Patients with and without delayed GE showed similar moderate/severe gastroparesis manifestations, but patients with ED significantly more often had moderate/severe gastroparesis manifestations than patients with normal SBM (grade 1:14% vs 39%, grade 2:62% vs 56%, grade 3:24% vs 5%, respectively)., Conclusions and Inferences: Enteric dysmotility was more frequent than delayed GE in patients with symptoms suggestive of gastroparesis. Gastroparesis severity was associated with small bowel motor abnormalities but not with delayed GE., (© 2019 John Wiley & Sons Ltd.)

Background: The aim of our study was to compare 2 surgical and anesthetic approaches during ventricular assist device implantation., Methods: 68 patients (50.4 ± 17.1 years old) were supported with the HeartWare® HVAD (32 patients) and the Jarvik 2000 VAD (36 patients) between January 2010 and August 2016. Two surgical techniques were applied: a minimally invasive approach with the aid of paravertebral-block (mini-invasive group, 41 patients) and a standard-surgical-approach with the aid of general anesthesia (27 patients)., Results: The minimally invasive approach allowed faster postoperative recovery by significantly reducing the duration of surgery (p<0.05), anesthesia (p<0.05), mechanical ventilation (p<0.05), inotropic support (p<0.05), ICU and in-hospital stay (p<0.05), and time to first mobilization (p<0.05). No case of epidural hematoma was observed. Eleven patients died (16%) at 30 days, 3 in the mini-invasive group (7.3%) and 8 in the invasive group (29.6%)., Conclusions: Minimally invasive approaches play a substantial role in VAD surgery by facilitating faster recovery, which is important for patients at very high risk.

Background: This single-center retrospective study assessed the variation of left ventricular ejection fraction (LVEF) after transapical transcatheter aortic valve implantation and its effect on survival. We also evaluated the effect of sheath diameter on LVEF., Methods: We analyzed data of all consecutive patients who underwent transapical transcatheter aortic valve implantation with the Sapien (Edwards Lifesciences, Irvine, CA) device (and its evolutions) between 2009 and 2015. We analyzed the difference between preoperative LVEF and LVEF at discharge (ΔEF = LVEFpost-op - LVEFpre-op) and considered its interquartile range (±5%) as the cutoff. Patients were divided in three groups: (1) improved LVEF (ΔEF ≥ +5%); (2) unchanged LVEF (ΔEF -5% to +5%), and (3) worsened LVEF (ΔEF ≤ -5%). Survival was evaluated with Kaplan-Meier analysis, and logistic regression multivariable analysis was used to determine independent predictors of LVEF improvement., Results: Data of 122 patients were analyzed. Patients in the three groups were distributed as follows: (group 1) 27 patients (22.1%), (group 2) 69 (56.6%), and (group 3) 26 (21.3%). The mean ΔEF was 12.7% ± 4.7% in group 1 and -10.8% ± 3.9% in group 3. The ΔEF was more likely to improve in patients with preoperative LVEF of less than 0.35 (p = 0.014). There were no significant differences in survival (p = 0.41), rehospitalization (p = 0.472), and New York Heart Association Functional Classification (p = 0.307) among the groups. The use of the smallest available sheath (18F) was not associated with a significant change of ΔEF., Conclusions: LVEF worsened in a small number of patients after transapical transcatheter aortic valve implantation, but this change was not associated with worse postoperative outcomes. Patients with a low LVEF showed better improvement. The progressive reduction of sheath diameter does not have a significant effect on LVEF changes., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter valve-in-valve (VIV) implantation is an alternative option in inoperable or high-risk patients with prosthetic valve dysfunction. Aim of this retrospective multicenter study was to evaluate early and midterm clinical and hemodynamic outcomes of patients undergoing aortic (VIV-A) and mitral VIV (VIV-M)., Methods: We analyzed data of 66 procedures performed in 65 patients who underwent VIV procedures in the VIV-A and VIV-M position at 5 Italian institutions from January 2008 to May 2015. VIV-A and VIV-M were 44 (68%) and 22 (32%), respectively; 1 patient underwent combined mitroaortic VIV. Study devices were both balloon-expandable and self-expandable. Outcomes were defined according to the updated Valve Academic Research Consortium definitions., Results: Overall all-cause 30-day mortality was 6% (4 patients), and it was 4.5% and 9% in VIV-A and VIV-M, respectively (2 patients in each group). Mean follow-up was 14 ± 14 months. Kaplan-Meier survival of the entire cohort at 1, 2, 3, and 4 years was 84.4% ± 4.9%, 80.5% ± 6%, 74.3 ± 8.1%, and 62% ± 13.2%, respectively. Age (hazard ratio: 1.1; 95% confidence interval: 1.0 to 1.3; p = 0.035) and diabetes (hazard ratio: 7.2, 95% confidence interval: 2.1 to 23.7; p = 0.001) were identified as independent predictors of mortality. Degenerated surgical aortic prostheses with an internal diameter (ID) less than 20 mm had significantly higher gradients if compared to prostheses with ID 21 to 23 mm and greater than 23 mm. After VIV-A, a severe stenosis (mean gradient greater than 35 mm Hg) was detected in 3 (6.8%) cases, all with ID less than 20 mm., Conclusions: VIV provides good early and midterm results in high-risk or inoperable patients with mitral or aortic bioprosthesis dysfunction. Age and diabetes are independently associated with mortality. Size of bioprosthesis ID has a significant impact on postoperative gradients., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Aim: To investigate the contribution of anti-platelet therapy and derangements of pre-operative classical coagulation and thromboelastometry parameters to major bleeding post-coronary artery bypass grafting (CABG)., Methods: Two groups of CABG patients were studied: Group A, treated with aspirin alone (n = 50), and Group B treated with aspirin and clopidogrel (n = 50). Both had similar preoperative, clinical, biologic characteristics and operative management. Classic coagulation parameters and rotational thromboelastometry (ROTEM) profiles were determined preoperatively for both groups and the same heparin treatment was administered. ROTEM profiles (INTEM and EXTEM assays) were analyzed, both for traditional parameters, and thrombin generation potential, expressed by area-under-curve (AUC)., Results: There was no significant difference between rates of major bleeding between patients treated with aspirin alone, compared with those treated with aspirin and clopidogrel (12% vs 16%, P = 0.77). In the 14 cases of major bleeding, pre-operative classic coagulation and traditional ROTEM parameters were comparable. Conversely we observed that the AUC in the EXTEM test was significantly lower in bleeders (5030 ± 1115 Ohm*min) than non-bleeders (6568 ± 548 Ohm*min) (P < 0.0001)., Conclusion: We observed that patients with a low AUC value were at a significantly higher risk of bleeding compared to patients with higher AUC, regardless of antiplatelet treatment. This suggests that thrombin generation potential, irrespective of the degree of platelet inhibition, correlates with surgical bleeding.

Objective: Although surgical aortic valve replacement (SAVR) is the treatment of choice for patients with aortic valve stenosis, transcatheter aortic valve replacement (TAVR) and sutureless aortic valve replacement (SU-AVR) have shown good results. The aim of our multicenter, propensity-matched study was to compare the clinical and hemodynamic outcomes of surgical SAVR, transapical TAVR (TA-TAVR), and SU-AVR., Methods: We analyzed data from 566 TA-TAVR, 349 SAVR, and 38 SU-AVR patients treated from January 2009 to March 2012. We used a propensity-matching strategy to compare on-pump (SAVR, SU-AVR) and off-pump (TA-TAVR) surgical techniques. The outcomes were analyzed using multivariate weighted logistic regression or multinomial logistic analysis., Results: In the matched cohorts, the 30-day overall mortality was significantly lower after SAVR than TA-TAVR (7% vs 1.8%, P = .026), with no differences in mortality between SU-AVR and TA-TAVR. Multivariate analysis showed SU-AVR to have a protective effect, although not statistically significant, against aortic regurgitation, pacemaker implantation, and renal replacement therapy compared with TA-TAVR. Compared with TA-TAVR, SAVR demonstrated significant protection against aortic regurgitation (odds ratio, 0.04; P < .001) and a trend toward protection against death, pacemaker implantation, and myocardial infarction. The mean transaortic gradient was 10.3 ± 4.4 mm Hg, 11 ± 3.4 mm Hg, and 16.5 ± 5.8 mm Hg in the TA-TAVR, SU-AVR, and SAVR patients, respectively., Conclusions: SAVR was associated with lower 30-day mortality than TA-TAVR. SAVR was also associated with a lower risk of postoperative aortic regurgitation compared with TA-TAVR. We did not find other significant differences in outcomes among matched patients treated with SAVR, SU-AVR, and TA-TAVR., (Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

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.

Purpose: Spine fusion is the gold standard treatment in degenerative and traumatic spine diseases. The bone regenerative medicine needs (i) in vitro functionally active osteoblasts, and/or (ii) the in vivo induction of the tissue. The bone tissue engineering seems to be a very promising approach for the effectiveness of orthopedic surgical procedures, clinical applications are often hampered by the limited availability of bone allograft or substitutes. New biomaterials have been recently developed for the orthopedic applications. The main characteristics of these scaffolds are the ability to induce the bone tissue formation by generating an appropriate environment for (i) the cell growth and (ii) recruiting precursor bone cells for the proliferation and differentiation. A new prototype of biomaterials known as "bioceramics" may own these features. Bioceramics are bone substitutes mainly composed of calcium and phosphate complex salt derivatives., Methods: In this study, the characteristics bioceramics bone substitutes have been tested with human mesenchymal stem cells obtained from the bone marrow of adult orthopedic patients., Results: These cellular models can be employed to characterize in vitro the behavior of different biomaterials, which are used as bone void fillers or three-dimensional scaffolds., Conclusions: Human mesenchymal stem cells in combination with biomaterials seem to be good alternative to the autologous or allogenic bone fusion in spine surgery. The cellular model used in our study is a useful tool for investigating cytocompatibility and biological features of HA-derived scaffolds.

Objective: The aim of the present study was to compare the hydrodynamics of 4 different mechanical prostheses fitting the atrioventricular annulus in children., Methods: We tested different inverted aortic prostheses with a prosthesis-annulus relationship in the mitral chamber of the Sheffield pulse duplicator (Department of Medical Physics and Clinical Engineering, Royal Hallamshire Hospital, Sheffield, UK), analyzed by comparing the prosthetic housing diameter and the predicted annulus diameter based on body surface area (0.8 and 1 m(2) corresponding to an annulus diameter of 18.8-20.2 mm). The On-X 19 (On-X Life Technologies, Inc, Austin, Tex), SJM Regent 19 (St Jude Medical Inc, St Paul, Minn), Sorin Overline 18 (Sorin Biomedica, Saluggia, Italy), and Medtronic Advantage Supra 19 (Medtronic Inc, Minneapolis, Minn) valves with a housing diameter of 19 to 20 mm were hydrodynamically compared. The tests were carried out at increasing pulse rate of 72, 80, 100, and 120 beats/min for a stroke volume of 20 and 30 mL. Therefore, cardiac output ranged from 1.44 to 3.6 L/min., Results: Regardless of the pulse rate and stroke volume, the Medtronic Advantage Supra valve showed the highest mean diastolic pressure difference at each cardiac output (P < .05). The mean gradients were significantly lower for the Sorin Overline valve regardless of the cardiac output, stroke volume, and pulse rate (P < .05). The effective orifice areas observed followed exactly the same behavior: the lowest for the Medtronic Advantage Supra valve and the highest for the Sorin Overline valve. The Sorin Overline valve showed the highest closure volumes (P < .05), and the On-X prosthesis showed the highest leakage volumes (P < .05). The Sorin Overline valve had the highest total regurgitant volume (P < .05), and the Medtronic Advantage Supra valve had the lowest total regurgitant volume (P < .05). The On-X valve showed the highest total energy loss regardless of the pulse rate at 20 mL of stroke volume, which was comparable to the SJM Regent and Sorin Overline valves at increased stroke volume. The Medtronic Advantage Supra valve showed the lowest total energy loss regardless of cardiac outputs (P < .05)., Conclusions: This hydrodynamic evaluation model allowed us to compare the efficiency of currently available valve prostheses suitable for atrioventricular replacement in children. Among these prostheses, the Sorin Overline valve showed the best diastolic performance. On the other hand, for total energy loss, the Medtronic Advantage Supra valve demonstrated excellent performance., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: The aim of this study was to describe gender differences in patients operated on for TOF and to define the impact of pregnancy in late post-surgical follow-up in women., Methods: In this research, we studied 145 patients after correction of TOF: 66 male, 79 women, 41 of which reported history of 68 pregnancies, means age 37±10 years, age at operation 7±8 years, mean duration of post-surgical follow-up 30±7 years. Selected variables were compared according to sex and according to history of pregnancy with statistical tests., Results: Men had more severe hemodynamic impairment and a higher number of cardiac reoperations than females. 41% of patients had at least one complication during pregnancy; there were 16 (67%) abortions and 39 (74%) Caesarian delivers; the recurrence of congenital heart defect was 10%. After pregnancy, there was a shift from first to second functional class: unique pregnancy determined no differences in term of morpho-functional ventricular features compared to nulliparous, but they complained fatigue and palpitation and echocardiographyc dysfunction. Left ventricular dysfunction and QRS duration at ECG were independent predictors of ventricular arrhythmias in all patients., Conclusions: There were no gender-specific differences in patients operated on for TOF using ventriculotomy. Pregnancy is an event in these patients at risk for the newborn, in terms of miscarriage, prematurity, and recurrence of birth defects, and for the mother in terms of ventricular dysfunction and electrical instability. At least a single pregnancy does not appear to significantly modify the natural history of post-surgical patients operated on for TOF.

Background and Aim of the Study: Previous studies have shown that the Carpentier-Edwards Magna (CEM) valve is an excellent bioprosthesis in terms of its systolic performance; indeed, it has been described as 'a stented valve with stentless performance'. However, valve performance is not only a matter of gradients; it is also necessary to evaluate the diastolic-phase performance. Previous in-vitro studies have shown that the CEM has an excessive total regurgitant volume. Hence, the study aim was to compare the hydrodynamics of the CEM, with the newly evolved version of this valve, the CEM Ease (CEME)., Methods: The CEM and CEME valves (both 21 mm) were tested in the aortic chamber (23 mm diameter) of the Sheffield pulse duplicator. The tests were carried out at increasing pulse rates (PR; 70-100 beats/min), and at each pulse rate the valve was tested at different stroke volumes (SVs; 45-65 ml). The forward-flow pressure drop, closing leakage volumes and effective orifice area (EOA) were recorded., Results: The CEM and CEME valves showed a comparable systolic-phase performance, there being no significant differences in terms of transvalvular gradient, EOA and stroke work loss, regardless of the PR and SV. In fact, the new CEME exhibited a significantly improved diastolic performance, with the total regurgitant volume being significantly lower, due especially to a reduced leakage volume and, to a lesser extent, a reduced closing volume., Conclusion: The study results indicated that the new CEME valve would maintain the excellent systolic performance of the previous CEM model, but with a significantly improved diastolic performance.

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 and Aim of the Study: In-vivo echocardiographic studies are limited by several confounding factors and technical pitfalls, and consequently the hypothetical differential hydraulic behavior between different prosthetic heart valves has not been identified. However, for surgeons it is essential to know the functional and geometric characteristics of the prostheses to be used. Herein, the in-vitro performance of two new supra-annular bileaflet prostheses--the Medtronic Advantage Supra and Sorin Bicarbon Overline--was compared with that of the 21-mm St. Jude Medical (SJM) Regent valve., Methods: Three high-performance, production-quality prostheses, including the sewing-ring cuffs, were tested in the aortic chamber of a Sheffield pulse duplicator. The sizes of the prostheses which fitted the 21-mm valve holder were: 21 mm Advantage Supra Medtronic; 19 mm SJM Regent, and 18 mm Sorin Bicarbon Overline. The tests were carried out at a fixed pulse rate (70 beats/min), and at increasing cardiac output (CO) of 2, 4, 5, and 7 l/min. Forward-flow pressure drop, total regurgitant volume, closing and leakage volumes, effective orifice area (EOA) and stroke work loss (SWL) were recorded while the valve was operated at each CO., Results: The SJM Regent and Sorin Bicarbon Overline valves each showed, at increasing CO, significantly lower mean and peak gradients. The calculated EOA and SWL were significantly better with the SJM Regent and Sorin Bicarbon Overline prostheses. The Medtronic Advantage Supra valve showed comparable results only while performing at 2 l/min CO. With regards to the regurgitant fraction, lowest values were observed with the Medtronic Advantage Supra valve., Conclusion: This hydrodynamic evaluation model allowed a comparison to be made of the efficiency of recently commercialized bileaflet prostheses, among which the older SJM Regent and the newer Sorin Bicarbon Overline valves demonstrated the best performances.

A 46-year-old man presenting with fever, peripheral edema, and chest pain was admitted to the emergency department. Electrocardiogram showed sinus tachycardia and first-degree atrioventricular block. Transesophageal echocardiogram showed infective endocarditis in bicuspid aortic valve, complicated with severe aortic regurgitation, ring abscess, and sinus-of-Valsalva aneurysm extending to mitroaortic fibrous continuity. The patient, who was unaware of his bicuspid aortic valve condition, reported having undergone an orthodontic procedure complicated with dental abscess 1 month prior, which was treated with combined clavulanate-amoxicillin antibiotic therapy. Blood cultures were positive for Bacteroides fragilis resistant to metronidazole. Intravenous antibiotic therapy was undertaken, with rapid resolution of fever. He eventually underwent successful aortic homograft implantation and mitral valve repair with residual first-degree atrioventricular block.

Objective: We have analyzed, in a clinical multicenter study, the effect of cardiac surgery in adults with congenital heart disease in Italy., Methods: We collected clinical data from 856 patients aged 19 years or older who underwent surgical intervention from January 1, 2000, to December 31, 2004. Patients were divided into 3 surgical groups: group 1, palliation (3.1%); group 2, repair (69.7%); and group 3, reoperation (27.4%)., Results: Preoperatively, 34.6% of patients were in New York Heart Association class I, 48.4% were in class II, 14.2% were in class III, and 2.8% were in class IV. Sinus rhythm was present in 83%. There were 1179 procedures performed in 856 patients (1.37 procedures per patient), with a hospital mortality of 3.1%. Overall mean intensive care unit stay was 2.3 days (range, 1-102 days). Major complications were reported in 247 (28.8%) patients, and postoperative arrhythmias were the most frequent. At a mean follow-up of 22 months (range, 1 month-5.5 years; completeness, 87%), late death occurred in 5 (0.5%) patients. New York Heart Association class was I in 79.3%, II in 17.6%, and III in 2.9%, and only 1 (0.11%) patient was in class IV. Overall survival estimates are 82.6%, 98.9%, and 91.8% at 5 years for groups 1, 2, and 3, respectively. Freedom from adverse events at 5 years is 91% for acyanotic patients versus 63.9% for preoperative cyanotic patients (P < .0001)., Conclusions: Surgical intervention for congenital heart disease in adults is a safe and low-risk treatment. However, patients presenting with preoperative cyanosis show a higher incidence of late adverse events and complications.

Objective: Calcification is the main cause of structural valve deterioration; however, other causes of failure have been identified, and among them, dehiscence of a commissure from the stent has been reported in several models of porcine valves. The aim of this study was to analyze the rate and mode of occurrence of this complication in first- and second-generation porcine bioprosthetic explants., Methods: Among 586 porcine xenografts explanted and analyzed at the Institute of Pathological Anatomy of the University of Padua, 17 (2.9%) have been replaced for incompetence because of commissural dehiscence. All these explants were in the mitral position, with the exception of a Carpentier-Edwards supra-annular aortic valve prosthesis., Results: Dehiscence was observed in 9 (1.9%) of 455 Hancock standard explants, in 1 (3.2%) of 31 Hancock II, in 3 (8.6%, 2 standard and 1 supra-annular) of 35 Carpentier-Edwards, in 1 (2.4%) of 42 Bioimplants, and in 3 (50%) of 6 Xenotech after a mean time function of 157 +/- 50, 156, 96 +/- 29, 143, and 130 +/- 8 months, respectively. Dehiscence was the sole cause of incompetence in 6 cases. An impending commissural dehiscence caused by blood creeping was observed in one case. This might be an explanation for the dehiscence other than excessive trimming of the aortic wall., Conclusions: Commissural dehiscence is an uncommon and peculiar mode of failure of porcine valves implanted in the mitral position and was observed earlier and more frequently with Carpentier-Edwards porcine explants (P < .05). We speculate that pericardial strip protection of the suture between the Dacron fabric and porcine aortic wall, as used in the Biocor porcine valve, might prevent this complication.

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.

Background: We analyzed the intermediate experience, survival, and prosthetic complications of patients who received the Biocor valve, a new-generation porcine valve, in the mitral position., Methods: At the University of Padua, between May 1992 and January 2004, 154 consecutive patients (102 female and 52 male patients; mean age, 72.3 +/- 6 years; age range, 37-86 years) received 158 mitral Biocor prostheses (Biocor Industria e Pesguisa Ltda, Belo Horizonte, Brazil). Thirty-five percent of the patients had previous mitral operations, 24% had coronary artery bypass grafting, and 34.6% had other procedures. Median preoperative New York Heart Association class was III. Echocardiography was performed in 75% of the long-term survivors. Follow-up included 609.4 patient-years and was 100% complete, with a median time of 4 patient-years (range, 0.02-11.3 years). At 8 years, 20 (14%) of 142 operative survivors were still at risk., Results: Early mortality was 13.6%. According to univariate analysis, New York Heart Association class III to IV, ejection fraction of less than 40%, urgency, male sex, and coronary artery bypass grafting were significant perioperative risk factors. Eight- and 10-year actuarial survival was 51.1% +/- 5.6% (40 deaths). Eight-year actuarial freedom from valve-related death, thromboembolism, anticoagulant-related hemorrhage, endocarditis, paravalvular leak, and valve-related complications were 85.2% +/- 5%, 85.7% +/- 4.4%, 92.6% +/- 3.7%, 94.1% +/- 3%, 91.8% +/- 3%, and 70.2% +/- 5.7%, respectively. Freedom from structural valve deterioration was 100%. Actual freedom from reoperation was 93.2% +/- 2.2%. By Doppler echocardiography, the peak and mean transprosthetic gradients were 15 +/- 5 mm Hg and 6.3 +/- 3 mm Hg, respectively (mean follow-up, 4.2 +/- 2.7 years)., Conclusion: At intermediate follow-up, the Biocor prosthesis in the mitral position showed excellent results in terms of valve durability when compared with other second-generation tissue valves.

Objectives: The aim of this study was to analyze the 8-year experience, survival, prosthetic complications, and hemodynamics of patients who received the Biocor valve, a new-generation tissue valve, in the aortic position., Methods: From May 1992 through May 2001, 257 consecutive patients (129 women and 128 men; mean age, 75 +/- 6 years; age range, 45-91 years) received 258 aortic Biocor porcine prostheses. One female patient who received 2 Biocor valves in the aortic position during 2 consecutive operations was entered twice in the statistical analysis. Twelve (4.6%) patients had previous aortic valve operations. Preoperatively, 82 (32%) patients were in New York Heart Association functional class III or IV. Associated surgical procedures included coronary artery bypass grafting in 56 (21.7%) patients, aortic annular enlargement or aortoplasty in 20 (8%) patients, and others in 8 (3%) patients. Echocardiography was performed in the majority of long-term survivors (91.6%). Follow-up included 1215 patient-years and was 100% complete, with a median time of 5 patient-years (range, 0.4-10.5 years)., Results: There were 16 (6.2%) early deaths. According to a univariate analysis, New York Heart Association functional class III or IV, concomitant procedures, ejection fractions of less than 40%, and urgent operations were identified as significant perioperative risk factors. At follow-up, 75 patients died; 8-year actuarial Kaplan-Meier survival was 48% +/- 5%. At 8 years, the actuarial freedom from valve-related death was 92% +/- 2.6%, the freedom from thromboembolism was 93% +/- 2%, the freedom from anticoagulant-related hemorrhage was 95% +/- 2%, the freedom from endocarditis was 99% +/- 0.6%, the freedom from paravalvular leak was 96% +/- 1.5%, the freedom from all valve-related complications was 78% +/- 4.5%, and the freedom from structural valve deterioration was 95% +/- 3.7%. At 8 years, the actuarial freedom from structural valve deterioration was 89% +/- 10% and 95.8% +/- 4% in patients younger and older than 65 years, respectively. At 10 years, in patients older than 65 years, the actual freedom from structural valve deterioration was 97.9% +/- 2.1%, and the freedom from reoperation was 97% +/- 1.3%. New York Heart Association status was I or II in 90% of patients at the end of follow-up. The mean echocardiographic follow-up time was 4.6 +/- 2 years. By using Doppler echocardiography, the peak and mean transprosthetic gradients were determined to be 30.8 +/- 9.3 mm Hg and 16.6 +/- 5.3 mm Hg, respectively. Mean mass/volume ratio and left ventricular end-diastolic volume were 1.37 +/- 0.17 g/mL and 63.4 +/- 22.6 mL/m(2), respectively. The majority of patients showed a persistent left ventricular hypertrophy., Conclusion: The Biocor is an effective bioprosthesis with a low incidence of valve-related complications comparable with that of other second-generation bioprostheses. This stented porcine prosthesis provides satisfactory results in terms of hemodynamics, valve durability, and freedom from reoperation.

Background: Tricuspid valve replacement (TVR) is an uncommon procedure. The use of biological vs mechanical prostheses in TVR has pros and cons. Therefore, we debate the choice between the different types of valves by means of a meta-analysis of studies of the last decade., Methods: The heading "tricuspid valve replacement and (bio* or mec*)" was used to retrieve studies from Medline, Current Contents, and Embase. Eight out of 11 studies met the preset strict criteria: intra-institutional comparison of results of biological or mechanical TVR. Survival of hospital-discharged patients was recalculated to reduce the effect of unbalanced perioperative risk factors on overall survival. Hazard ratio was obtained from actuarial survival graphics comparison and at-risk groups, according to the method described by Parmar. If missing, the number of patients at risk was approximated assuming constant and noninformative censoring. Hazard pooling was done according to study heterogeneity. Bioprostheses were assumed as the gold standard and mechanical prostheses assumed as the challenging device. Therefore, a hazard more than 1 pointed to a higher risk of mechanical prostheses. Our 1998 study was updated for this analysis., Results: In this study, 1,160 prostheses and 6,046 follow-up years were analyzed. The pooled survival hazard ratio of mechanical prostheses versus bioprostheses was 1.07 (0.84 to 1.35, p = 0.60). The pooled freedom from reoperation hazard ratio was 1.24 (0.67 to 2.31, p = 0.67). Pooled survival differences were trivial, favoring mechanical prostheses at 1 (-0.04%) and 15 years (-1.1%) and favoring bioprostheses (+1.8%) at 10 years., Conclusions: There is not a gold standard in tricuspid prostheses replacement. Prosthetic choice is left to the surgeon's clinical judgment, taking into consideration each patient's characteristics and needs.

Congenital heart diseases are currently treated in the pediatric age. However, a conspicuous number of patients requires treatment in the adult age. This study has been undertaken by members of the European Congenital Heart Surgeons Association with the aim of evaluating the impact of cardiac surgery in this particular age group. We have collected data from 1,247 patients who underwent 1,287 operations during a 5-year period between January 1, 1997 and December 31, 2001. Patients were divided into three groups: (1) palliative procedures (4.4%), operation performed to improve patients' clinical status without restoring normal anatomy or physiology; (2) repair (79.3%), operation performed to achieve an anatomic or physiologic repair with separation of the pulmonary from the systemic circulation (included in this group are also Fontan-type repair and one and a half ventricle repair); (3) reoperation (16.3%), all the reoperations performed after repair (either anatomic or physiologic). Hospital mortality (within 30 days) was 2.4% (range, 0% to 15.3% in different centers). Kaplan-Meier estimates shows a 94% survival at 4 years, which is higher for repair (95%) as compared with reoperations (92%) or palliations (88%). Surgery for congenital heart disease in the adult age is a safe, beneficial, and low-risk treatment that modifies patients' natural history by improving their clinical status.

Objectives: We sought to assess the risk of sudden death (SD) in both male and female athletes age 12 to 35 years., Background: Little is known about the risk of SD in adolescents and young adults engaged in sports., Methods: We did a 21-year prospective cohort study of all young people of the Veneto Region of Italy. From 1979 to 1999, the total population of adolescents and young adults averaged 1,386,600 (692,100 males and 694,500 females), of which 112,790 (90,690 males and 22,100 females) were competitive athletes. An analysis by gender of risk of SD and underlying pathologic substrates was performed in the athletic and non-athletic populations., Results: There were 300 cases of SD, producing an overall cohort incidence rate of 1 in 100,000 persons per year. Fifty-five SDs occurred among athletes (2.3 in 100,000 per year) and 245 among non-athletes (0.9 in 100,000 per year), with an estimated relative risk (RR) of 2.5 (95% confidence interval [CI] 1.8 to 3.4; p < 0.0001). The RR of SD among athletes versus non-athletes was 1.95 (CI 1.3 to 2.6; p = 0.0001) for males and 2.00 (CI 0.6 to 4.9; p = 0.15) for females. The higher risk of SD in athletes was strongly related to underlying cardiovascular diseases such as congenital coronary artery anomaly (RR 79, CI 10 to 3,564; p < 0.0001), arrhythmogenic right ventricular cardiomyopathy (RR 5.4, CI 2.5 to 11.2; p < 0.0001), and premature coronary artery disease (RR 2.6, CI 1.2 to 5.1; p = 0.008)., Conclusions: Sports activity in adolescents and young adults was associated with an increased risk of SD, both in males and females. Sports, per se, was not a cause of the enhanced mortality, but it triggered SD in those athletes who were affected by cardiovascular conditions predisposing to life-threatening ventricular arrhythmias during physical exercise.

Objective: We sought to assess the efficiency of 2 different sternal wiring techniques in preventing deep sternal wound infection or sternal instability., Methods: Seven hundred patients were randomized to 2 different groups according to chest-closure techniques. Three hundred fifty patients who underwent a peristernal double crisscross wire closure were included in group X, whereas 350 patients who underwent a standard transsternal closure were included in group T. After sternal closure, the technique for wound suturing was the same for both groups, namely triple-layer sutures up to the intracutaneous skin. All data were prospectively collected and entered in our institute database., Results: The 2 groups of patients were comparable for sex, age, preoperative risk factors, and operative procedures. The overall mortality rate was 4.3% in group X and 4.6% in group T. Postoperative morbidity and mortality were comparable between the 2 groups, unlike for sternal wound complications. None of the patients included in group X had superficial or deep wound complications, whereas in group T 7 (2%) patients presented with a superficial sternal wound infection, 6 (1.7%) presented with a deep chest wound infection with sternal instability requiring re-exploration (P <.05), and 3 presented with a sternal instability caused by sternum disruption without infection. Among patients with deep wound infection and sternal instability, 1 patient died, resulting in a mortality rate of 16.7%., Conclusions: The peristernal double crisscross wiring technique achieved a greater sternal stability, resulting in a lower incidence of wound infection in association with triple-layer closure of suprasternal tissues.

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.

A hydraulic calcium phosphate cement having dicalcium phosphate dihydrate (DCPD) as end-product of the setting reaction was implanted in a cylindrical defect in the diaphysis of sheep for up to 6 months. The composition of the cement was investigated as a function of time. After setting, the cement composition consisted essentially of a mixture of DCPD and beta-tricalcium phosphate (beta-TCP). In the first few weeks of implantation, the edges of the cement samples became depleted in DCPD, suggesting a selective dissolution of DCPD, possibly due to low pH conditions. The cement resorption at this stage was high. After 8 weeks, the resorption rate slowed down. Simultaneously, a change of the color and density of the cement center was observed. These changes were due to the conversion of DCPD into a poorly crystalline apatite. Precipitation started after 6-8 weeks and progressed rapidly. At 9 weeks, the colored central zone reached its maximal size. The fraction of beta-TCP in the cement was constant at all time. Therefore, this study demonstrates that the resorption rate of DCPD cement is more pronounced as long as DCPD is not transformed in vivo.

Background: Survival and prosthetic complications of patients receiving the Hancock II second-generation bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in the aortic, mitral, mitral-aortic, and tricuspid positions were analyzed at 15 years' follow-up., Methods: Between May 1983 and December 1993, 212 patients (104 men and 108 women; mean age, 63 +/- 9 years; age range, 29-81 years) received 66 aortic, 114 mitral, 26 mitral-aortic, and 6 tricuspid Hancock II valves. Thirty-one percent of patients had previous valve operations, 15% had concomitant cardiac procedures, and 87% were in New York Heart Association class III or IV. Follow-up included 1704 patient-years and was 98% complete, with a median of 9 patient-years (range, 0.013-17.4 years). Forty-six patients were at risk at 14 to 15 years, and 30 were at risk after 15 years., Results: One hundred twenty-two (57%) of 212 patients died, 20 of them perioperatively. Fifteen-year actuarial Kaplan-Meier survival was 35.2% +/- 3.8%, and freedom from valve-related mortality was 84% +/- 3.5%, with no difference on the basis of position or age (<65 or >or=65 years). Percentages for freedom from thromboembolism, anticoagulant-related hemorrhage, endocarditis, and paravalvular leak were, respectively, 78.2% +/- 4%, 83.5% +/- 3.6%, 95.7% +/- 2%, and 97.3% +/- 1.4%, with no significant difference between the aortic and mitral positions. Freedom from structural valve deterioration was 71.8% +/- 5.6%: 88.9% +/- 6.2% in the aortic position versus 59.5% +/- 3.9% in the mitral position (P =.01) and 64.3% +/- 3% in the mitral-aortic position. In patients younger than 65 years, actual freedom from structural valve deterioration was less than that seen in older patients (84.5% +/- 3.5% vs 95% +/- 3.0%) and was better in the aortic versus the mitral position (92% +/- 4.5% vs 82% +/- 4.2%)., Conclusion: The Hancock II porcine valve showed excellent 15-year durability. We recommend its use in patients 65 years of age, as well as in younger patients undergoing aortic replacement.

Background and Objectives: The Hancock II bioprosthesis is a second-generation porcine valve xenograft treated with the detergent sodium dodecyl sulphate (T6) to retard calcification. The aim of this investigation was to study the gross and microscopic features in Hancock II explants to assess the structural changes occurring with time., Methods: Among 1382 Hancock II bioprostheses (701 isolated aortic, 421 isolated mitral, 130 double) implanted from 1983 to 1997 in 1252 patients, 22 (16 mitral, 6 aortic) were removed at reoperation until 1999 and were available for pathological investigation: infective endocarditis occurred in 5 and structural deterioration in 8, whereas in the remaining 9 xenografts reoperation was performed for nonstructural valve deterioration (paravalvular leak in 4 and prophylactic replacement in 5). Morphological investigation consisted of gross examination and x-ray, histologic, immunohistochemistry, electron microscopic, and atomic absorption spectroscopic examination., Results: The cause of structural valve deterioration was dystrophic calcification in 4 cases (1 aortic, 3 mitral; range of time graft was in place, 101 to 144 months), non-calcium-related tears in 3 cases (all mitral, range 121 to 163 months), and commissural dehiscence in 1 (aortic, range 156 months). Five of the nonstructural valve deterioration explants (range 42 to 122 months) showed only pinpoint mineralization at the commissures. Mean calcium content in nonstructural deterioration explants was 14.70 +/- 22.33 versus 99.11 +/- 81.52 mg/g in explants with structural valve deterioration. Electron microscopic examination showed early nuclei of mineralization mostly consisting of calcospherulae upon cell debris. Local or diffuse lipid insudation was observed in all but 2 explants and consisted of cholesterol clefts, lipid droplets, and lipid-laden macrophages featuring foam cells. The lipid insudation was the most plausible cause of tearing in 2 explants., Conclusions: These pathologic findings support the clinical results of a delayed occurrence of structural failure of Hancock II bioprostheses and a mitigation of mineralization by the anti-calcification treatment. However, other factors such as lipid insudation may come into play in the long term.

Objectives: Surgical repair of complete A-V canal defects (CAVCD) is a well established procedure which is currently performed in infancy. The aim of this study is to evaluate surgical results of correction in early infancy in comparison to older age., Methods: From January 1985 to March 2001, 119 consecutive patients (age range 27 days to 83 months, mean 6.7 months) underwent repair of CAVCD in our Institution. Forms with unbalanced ventricles in association with Fallot's tetralogy or heterotaxia were excluded from this series. Fifty-eight patients (49%) underwent correction before 3 months of age (Group A), and 61 patients (51%) after 3 months (Group B). Surgical repair was accomplished with a double patch technique in 100 patients (84%). Associated surgical lesions were treated simultaneously in 48 patients (40%)., Results: There were 11 operative deaths (<30 days) (two in Group A (3.4%) and nine in Group B (15%)) (P = 0.05). The remaining patients were discharged home in good haemodynamic condition. Reoperation for postoperative left A-V incompetence occurred in five patients in Group A and in eight patients in Group B. There were eight late deaths (three in Group A and five in Group B), of which four were non-cardiac related. At a mean follow-up time of 80 months (range 2-184 months) 100 patients are asymptomatic and well, and free from oral medication. Echocardiographic examination showed absent or mild residual left A-V valve incompetence in 91 patients (49 in Group A and 42 in Group B) and moderate left A-V valve incompetence in nine patients (four in Group A and five in Group B). Kaplan-Meier survival estimates at 10 years were 90% for Group A and 75% for Group B. Kaplan-Meier freedom from reoperation at 10 years was 89% for Group A and 84% for Group B., Conclusions: Our data demonstrate that repair of CAVCD under 3 months of age is the ideal approach to this malformation with a lower mortality rate at operation compared to older patients. Logistic analysis showed that an operative age >3 months is, compared to an age < or =3 months, an incremental risk factor for hospital mortality with an odds ratio of 4.8 (95% confidence limit 1-23.5) (P = 0.05). In the long term, freedom from reoperation for left A-V valve incompetence is higher when compared to children repaired at an older age., (Copyright 2002 Elsevier Science B.V.)

We prospectively compared, according to their preoperative clinical profiles, the in-hospital outcomes of patients operated on consecutively (but without randomization) for isolated coronary artery disease with on-pump or off-pump techniques. During 2001, 324 patients underwent coronary artery bypass grafting: 216 patients (mean age, 66.7 +/- 8.9 years; range, 41-85 years) underwent on-pump revascularization, and 108 patients (mean age, 676 +/- 10 years; range, 37-90 years) underwent full-sternotomy off-pump revascularization. The 2 groups were homogeneous with regard to female sex (22.6% vs 26.8%), previous cardiac operation (2.8% vs 4.6%), cardiogenic shock (1.3% vs 1.9%), diabetes (30% vs 33%), and chronic renal failure that required hemodialysis (3% vs 3.5%). Postoperative complications, including bleeding, myocardial infarction, acute renal failure, mediastinitis with sternal dehiscence, cerebrovascular events, and prolonged respiratory assistance were more frequent in on-pump patients (P = 0.004). The total number of grafts and the grafts per patient ratio were significantly higher in on-pump patients (P = 0.0001), whereas the total number of full arterial revascularizations was higher in off-pump patients (P = 0.0001). Off-pump patients showed a significantly shorter intensive care unit stay (P = 0.02), and less need for intra-aortic balloon pump insertion (P = 0.04). In-hospital mortality was 2.8% in on-pump patients and 2.7% in off-pump patients (P = NS). Although the hospital mortality rate was comparable for the 2 techniques, the in-hospital comparison between the 2 groups showed how the avoidance of cardiopulmonary bypass can significantly reduce the cumulative postoperative incidence of complications in patients undergoing coronary artery bypass grafting.

Objectives: Does the use of bilateral internal mammary artery (IMA) grafts provide incremental benefit relative to the use of a single IMA graft?, Methods: Meta-analysis by qualitative and quantitative protocol of the studies published in the literature in the last 15 years. Only eight, out of 149 observational studies found, met our criteria: surgical results of bilateral versus single IMA, patient age range from 20 to 89 years, exclusion of emergency and diabetic patients, study group larger than 100 patients, minimal follow-up time. The final sample size included 16362 patients., Results: Late survival was evaluated at 5 and 10 years. The hazard ratio (HR) was calculated from seven studies, the difference of survival was from six and five studies, respectively. The effect size was summarized using a random effect model, suggested by the results of statistical test for homogeneity of the HR (P < 0.05) and of the survival difference at 5 (P < 0.05) and at 10 years (P < 0.05). The bilateral IMA estimate of combined HR was 0.79 (95% confidence limits, C.L. = 0.66/0.91). The combined difference of survival probability at 5 years was 0.014 (95% C.L. = -0.03/0.06) and at 10 years was 0.07 (95% C.L. = 0.003/0.170)., Conclusion: There is significant evidence in favor of decreasing death risk of bilateral versus single IMA procedure., (Copyright 2002 Elsevier Science B.V.)

Background: Prosthetic cardiac valves have increased life expectancy of patients (pts) with valvular heart disease. Bioprosthetic complications required devices replacements within 10 years of implantation; structural valve deterioration (SVD) has emerged as the major cause of reoperation. We reviewed survival and prosthetic complications of Biocor porcine bioprostheses implanted in mitral, aortic and mitro-aortic position., Methods: Between January 1991 and January 2001 446 pts (192 males; 254 females; mean age 73.4+/-6.7 year, range 40-91) received 258 aortic, 138 mitral and 50 mitro-aortic Biocor porcine valves; of these 83 pts have previous different types of prosthetic devices (15 aortic, 53 mitral and 15 double). Concomitant cardiac procedures, namely myocardial revascularization, were performed in 91/446 pts (20.5%). All explanted bioprostheses (BPS) were available for pathologic investigation. Follow-up included 1319 pt.-years and was 98% complete with a median time of 36 pt.-months., Results: Perioperative mortality was 6.8% (30/446 pts; 12 aortic, 17 mitral and 1 double) and was mostly related to reoperations. At the end of follow-up 18.5% of pts died (77/416), 12 deaths were valve-related with freedom from valve related mortality of 94% at 9 years. Survival was 54% at 9 years. It was 63%, 41% and 62% for aortic, mitral and double valve replacement, respectively. At follow-up 87% of pts. were in NYHA I-II class and 13% were in III-IV class; 55% were in sinus rhythm, 36% in atrial fibrillation and 9% had a pace-maker. Eighty-five percent of pts were anticoagulated. There were 6 thromboembolic and 5 anticoagulant-related haemorrhagic episodes with no significant difference between aortic and mitral position (p=0.7). The event freedom was respectively 92% and 98.5% at 9 years. Prosthetic valve endocarditis (PVE) and non-SVD freedom were 96% and 93% at 9 years. SVD due to tissue degeneration, calcification and cusp's tears affected 2 pts with 94% freedom at 9 years. Overall freedom from all valve-related complications was 80% at 9 years and freedom from reoperation was 92% at 9 years., Conclusions: (1) Our intermediate-term follow-up of the Biocor porcine valve (BPS) showed excellent durability in all positions. (2) The aortic patients and especially the oldest group had better results than the mitral patients (41% vs. 63% 9 years survival, p=0.0004). (3) Higher mitral risk was related to higher prevalence of reoperations. (4) The incidence of anticoagulation-related complications is low in both aortic and mitral position without significant difference (p=0.7). 4) A longer follow-up is required to get more information about SVD timing.

A 77-year-old woman was found accidentally to be in atrial fibrillation. Two-dimensional echocardiography revealed the presence of a mass attached to the anterior papillary muscle of the mitral valve. She was mildly symptomatic for dyspnea and asthenia. The patient was successfully operated on to excise the left ventricular mass and preserve the mitral valve apparatus. Morphological examination of the excised tissue led to a diagnosis of papillary fibroelastoma. Surgical treatment must be considered when such a tumor is diagnosed, even though asymptomatic, and especially if left-sided because of the high risk of systemic embolization.

Objective: Mechanical valvular prostheses have the advantage of longevity but carry a risk of thrombosis which is dependant on valve design, materials and host-related interface. While pannus is common to both biologic and mechanical valves, acute prosthetic thrombosis is mostly a complication of mechanical valves; therefore we investigated to find rates and risk of these obstructive complications., Methods: Between 1/1/70 and 31/12/97, 2680 patients received at least one mechanical prosthesis in the aortic or mitral or tricuspid position and a total of 3014 operations were performed. Follow-up included 18523 years and was 98% complete. Incidence rates, Kaplan-Meier estimates, modeling of the hazard and multivariate analysis in the hazard domain were used in the analysis., Results: Overall survival was 76%, 64%, 51%, 38.5% and 29% at 5, 10, 15, 20 and 25 years, respectively. It was significantly better in aortic than in mitral than in double prosthesis. 290 patients received a single reoperation, 37 a second, six a third and one a fourth reoperation. Two-hundred and fifty-one of these reoperations were exclusively due to malfunction of mechanical prosthesis, nine to malfunction of both mechanic and biologic prostheses. Most frequent reoperative indications was dehiscence (133), pannus (48) and thrombosis (29). The linearized rate of reoperations for pannus was 0.24%/patient per year, for valvular thrombosis 0.15%/patient per year. The shape of the thrombotic hazard was constant (at random) and the relative risk 12 times higher for tricuspid prosthesis, seven times higher for mitral prosthesis. Multivariate analysis controlling for prosthetic position, age, sex and prosthetic size, showed a 67% risk reduction with larger prosthesis (>27 mm), a 69% risk reduction with the Sorin tilting disk prosthesis and an 83% risk reduction with the bileaflet prosthesis. Pannus hazard shows a delayed exponential rise and was two times higher in tricuspid and three times higher in mitral position. Multivariate analysis showed a 50% risk reduction with larger prosthesis, an 11 times higher hazard of old (caged-disk, caged ball) prosthesis and a three times higher hazard of Lillehei-Kaster prosthesis. Reoperation for thrombosis has a 62% perioperative (30 days) survival compared to 92% survival of pannus reoperation., Conclusions: Mechanical valves have a low incidence of reoperation, mostly for prosthetic dehiscence. Pannus development is the next frequent complication increasing with time since implant, therefore in this series it was related to old valvular models and tilting disk prosthesis, with longer follow-up. Acute thrombosis occurs significantly earlier than pannus formation. Despite shorter follow-up we are therefore confident that bileaflet prostheses are less prone to this complication and pannus is a rare early etiologic factor. Thrombosis has very high operative risk as compared to pannus, justifying the present trend to thrombolysate selected cases.

Objective: To validate the accuracy of the prognostic significance of non-invasive clinical diagnostic indices as predictors of sustained ventricular tachycardia (sVT) or fibrillation (VF) in patients undergoing repair for tetralogy of Fallot., Methods: One way analysis of variance and pairwise comparison of the values with the Bonferroni correction, logistic multivariate analysis, and ordinal logistic analysis were used to study quantitative electrocardiographic and echocardiographic variables in 66 patients who had undergone surgery for tetralogy of Fallot by ventriculotomy at a mean (SD) age of 11.8 (9.5) years. The mean (SD) period of follow up was 16.1 (5.7) years after surgery., Results: Four groups of patients were identified by ECG and 24 hour Holter monitoring: 19 (28.7%) without ventricular arrhythmias, 34 (51.5%) with minor ventricular arrhythmias, seven (10.6%) with non-sustained ventricular tachycardia (nsVT), and six (9.0%) with sVT or VF. One way analysis indicated significant differences in QT dispersion (QTd) and end diastolic volume of the right ventricle (EDVRV) among the groups. Univariate logistic analysis showed EDVRV, QTd, and QRS duration to be significantly associated with sVT or VF. Stepwise multivariate analysis and ordinal logistic analysis showed QTd to be preferable to QRS duration as an indicator, because it was unrelated to EDVRV, and was capable of separating different probability curves for nsVT as opposed to sVT or VF., Conclusions: Stratification of patients undergoing corrective surgery for tetralogy of Fallot and at risk of life threatening arrhythmias is possible by simple and inexpensive means, which provide sensitive and specific indices.

We studied 38 patients (mean age 32 +/- 14 years) with arrhythmogenic right ventricular cardiomyopathy (ARVC) to evaluate the clinical significance of histologic features on endomyocardial biopsy specimens as related to signal-averaged electrocardiography (SAECG), spontaneous ventricular arrhythmias, and hemodynamic features. Fifteen patients presented with ventricular tachycardia or fibrillation (sustained ventricular arrhythmias), 23 with other minor arrhythmias. SAECG variables and right ventricular ejection fraction (RVEF) were statistically correlated with the extent of myocardial fibrosis on biopsy in ARVC. An increased percentage of fibrous tissue (> or = 30%) was a significant univariate predictor of late potentials (p = 0.004) and reduced RVEF (p = 0.02). The 18 patients with late potentials had an increased percentage of fibrous tissue (p = 0.01), a reduced RVEF (p = 0.0004), and a higher risk for sustained ventricular arrhythmias (p = 0.05) than the 20 patients without late potentials. RVEF was the most powerful predictor of late potentials (p = 0.004) at multivariate analysis. Moreover, RVEF < or = 50% was associated with an increased risk for development of sustained ventricular arrhythmias (p = 0.02). A SAECG parameter, namely the root-mean-square voltage of the terminal 40 ms at 25 Hz, was an independent predictive factor for the occurrence of sustained ventricular arrhythmias (p = 0.02). Although fibrous tissue may contribute to delayed myocardial activation in ARVC, a reduced RVEF plays an essential role for spontaneous manifestation of sustained ventricular arrhythmias.