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Objectives: Sutureless aortic valve replacement (AVR) has been associated with excellent hemodynamic and clinical outcomes, but less is known on the outcomes of the patients operated on for complex surgery. We aimed to evaluate the early outcomes and 1-year follow-up of patients undergoing AVR with a self expandable sutureless valve and concomitant procedures. Methods: Two European centers participated in the study, with a total number of self expandable aortic valve prosthesis implants equal to 682 (time frame May 2010 - May 2014). Of them, 168 (mean age 76.7 ± 6.4 years, female gender 93 (55.4%)) have been operated on for concomitant procedures.. Minimally invasive approach was chosen for 30 (17.9%) patients (14 ministernotomies and 16 right anterior minithoracotomies). 12 (7.1%), 45 (26.8%), 96 (57.1%) and 15 (8.9%) patients received 21 mm, 23 mm, 25 mm and 27 mm size prostheses, respectively. Common implantation technique was implemented in all the patients; coronary artery bypass grafting (if any) and mitral valve repair/replacement (if any) were performed prior to aortotomy and aortic valve replacement. Results: Overall surgical mortality was 7 (4.2%). Cardiopulmonary bypass time and aortic cross-clamp time were 136.3 ± 48 (median and interquartile range: 92 (71–114 minute)) and 94.3 ± 33 (74 (52–98)) min, respectively. Median assisted ventilation time was 10 (range 3–380) h. Revision for bleeding was necessary in 11 (6.5%) patients. 2 (1.2%) patients developed permanent neurological deficit following stroke. In 3 (1.8%) patients transient ischemic attack was observed. In 5 (3.0%) patients acute renal failure developed postoperatively. Permanent pacemaker implant due to advanced atrioventricular block was required in 16 (9.5%). 6/161 (3.7%) patients died during follow-up (mean duration 14 ± 11 months). Mean transprosthetic gradient averaged 13.6 ± 5.4 mm Hg. Conclusion: Good early outcomes, comparable to those of tissue valve prostheses, can be achieved in patients, undergoing sutureless AVR and associated procedures. Shortening the operative times, the self expandable sutureless prosthesis amplifies the armamentarium of aortic valve prostheses and represents a useful tool for associated and complex procedures.

Background Annular stabilization is important during bicuspid aortic valve (BAV) repair to obtain the best long-term results. This report describes the early outcomes of a novel bicuspid annuloplasty ring for this purpose. Methods Under regulatory supervision (NCT02071849), a geometric bicuspid annuloplasty ring was used during valve repair in 16 patients. Three patients had Sievers type 0 valves, 11 had Sievers type 1, and 2 had Sievers type 2. Thirteen patients had left-/right-coronary cusp fusion, 1 had right-/noncoronary cusp fusion, and 2 had both. Moderate to severe aortic insufficiency (AI) was present in 13 of 16 patients, and 3 had mild AI with aortic aneurysms. Ascending aortic aneurysms, root aneurysms, or both were replaced in 7 of 16 patients. The Dacron-covered titanium ring had circular base geometry and two outwardly flaring subcommissural posts positioned opposite on the circumference. The ring was implanted into the annulus beneath the valve, and then leaflet repair was performed. Results Immediate postrepair echocardiograms showed grade 0 residual AI in all patients, with good cusp mobility and effective height, and satisfactory gradients. There were no in-hospital or late mortalities. Two patients experienced leaflet tears from long annular suture tails, requiring late valve replacement. After implementation of a lateral suture fixation technique, no more failures occurred. At a mean follow-up time of 9 months, the remaining 14 patients were in New York Heart Association class I, with predominant grade 0 AI. Conclusions As a technique for BAV repair, internal ring annuloplasty produces major annular remodeling and stabilization. Annular reduction and reshaping to a 50/50% symmetric circular geometry facilitates leaflet repair and enhances cusp coaptation. Geometric ring annuloplasty could have useful applications in BAV repair.

OBJECTIVES: The aim of this study was to analyse early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) through a ministernotomy with a sutureless bioprosthesis implantation compared with a full sternotomy with implantation of a stented bioprosthesis. METHODS: Patients who underwent primary isolated non-emergent AVR at six European centres were included in the study. Of these, 182 (32%) underwent a ministernotomy with a sutureless bioprosthesis (ministernotomy sutureless group) and 383 (68%) a full sternotomy with a stented bioprosthesis (full sternotomy stented group). Propensity score matching was used to reduce selection bias. RESULTS: In the overall cohort, 30-day mortality was 1.6 and 2.1%, and 2-year survival was 92 and 92% in the ministernotomy sutureless group and in the full sternotomy stented group, respectively. Propensity score matching resulted in 171 pairs with similar characteristics and operative risk. Aortic cross-clamp (40 vs 65 min, P < 0.001) and cardiopulmonary bypass time (69 vs 87 min, P < 0.001) were shorter in the ministernotomy sutureless group. Patients undergoing ministernotomy received less packed red blood cells but the risk for postoperative permanent pacemaker implantation was higher. There were no differences regarding 30-day mortality or 2-year survival between the two groups. CONCLUSIONS: AVR through a ministernotomy with implantation of a sutureless bioprosthesis was associated with shorter aortic cross-clamp and cardiopulmonary bypass time and less transfusion of packed red blood cells, but a higher risk for postoperative permanent pacemaker implantation compared with a full sternotomy with a stented bioprosthesis.

The aim of this study was to compare the immediate outcome of patients undergoing transcatheter (TAVI) versus surgical aortic valve replacement with the sutureless Perceval bioprosthesis (SU-AVR). This is a retrospective multicenter analysis of 773 patients who underwent either TAVI (394 patients, mean age, 80.8 ± 5.5 years, mean EuroSCORE II 5.6 ± 4.9 %) or SU-AVR (379 patients, 77.4 ± 5.4 years, mean EuroSCORE II 4.0 ± 3.9 %) with or without concomitant myocardial revascularization. Data on SU-AVRs were provided by six European institutions (Belgium, Finland, Germany, Italy and Sweden) and data on TAVIs were provided by a single institution (Catania, Italy). In-hospital mortality was 2.6 % after SU-AVR and 5.3 % after TAVI (p = 0.057). TAVI was associated with a significantly high rate of mild (44.0 vs. 2.1 %) and moderate-severe paravalvular regurgitation (14.1 vs. 0.3 %, p < 0.0001) as well as the need for permanent pacemaker implantation (17.3 vs. 9.8 %, p = 0.003) compared with SU-AVR. The analysis of patients within the 25th and 75th percentiles interval of EuroSCORE II, i.e., 2.1-5.8 %, confirmed the findings of the overall series. One-to-one propensity score-matched analysis resulted in 144 pairs with similar baseline characteristics and operative risk. Among these matched pairs, in-hospital mortality (6.9 vs. 1.4 %, p = 0.035) was significantly higher after TAVI. SU-AVR with the Perceval prosthesis in intermediate-risk patients is associated with excellent immediate survival and is a valid alternative to TAVI in these patients.

In the last years, an increasing proportion of high-risk patients undergo surgical aortic valve replacement. In order to reduce the risk associated with cross-clamp time or cardioplegic ischemic time, sutureless aortic prostheses have been developed. These bioprosthetic valves are not hand sewn, and this technological advance translates into reduced implantation times, thus improving outcome of patients referred for aortic valve replacement. At present, three sutureless bioprostheses are available on the market: 3f Enable (Medtronic Inc., Minneapolis, Minnesota, USA), Perceval (Sorin Group, Saluggia, Italy) and Intuity (Edwards Lifesciences, Irvine, California, USA). This article provides an overview of the available literature on sutureless aortic valves with the aim to better define current role and future perspectives of sutureless aortic bioprostheses for the treatment of aortic valve stenosis.

Surgery for aortic-valve endocarditis is still challenging, particularly in combination with destruction of the annulus. Freedom Solo (Solo) is a bovine stentless prosthesis for aortic valve replacement. It is implanted supra-annularly into the aortic wall with a single suture line, without requiring an 'intact' annulus. Thirteen patients received a Solo for endocarditis with annular destruction. Our results showed a low reinfection rate and no patient-prosthesis mismatch. Our contribution intends to show the feasibility of implantation also in case of complicated anatomical conditions, such as destruction of the annulus.

Sutureless aortic valve replacement (SU-AVR) has emerged as an innovative alternative for treatment of aortic stenosis. By avoiding the placement of sutures, this approach aims to reduce cross-clamp and cardiopulmonary bypass (CPB) duration and thereby improve surgical outcomes and facilitate a minimally invasive approach suitable for higher risk patients. The present systematic review and meta-analysis aims to assess the safety and efficacy of SU-AVR approach in the current literature.Electronic searches were performed using six databases from their inception to January 2014. Relevant studies utilizing sutureless valves for aortic valve implantation were identified. Data were extracted and analyzed according to predefined clinical endpoints.Twelve studies were identified for inclusion of qualitative and quantitative analyses, all of which were observational reports. The minimally invasive approach was used in 40.4% of included patients, while 22.8% underwent concomitant coronary bypass surgery. Pooled cross-clamp and CPB duration for isolated AVR was 56.7 and 46.5 minutes, respectively. Pooled 30-day and 1-year mortality rates were 2.1% and 4.9%, respectively, while the incidences of strokes (1.5%), valve degenerations (0.4%) and paravalvular leaks (PVL) (3.0%) were acceptable.The evaluation of current observational evidence suggests that sutureless aortic valve implantation is a safe procedure associated with shorter cross-clamp and CPB duration, and comparable complication rates to the conventional approach in the short-term.

The mitro-aortic disease in high-risk patients is a challenge for the cardiac surgeon because minimally invasive techniques are difficult to apply. We report the first case in the literature of a 78-year-old woman affected by severe rheumatic steno-insufficiency of aortic and mitral valves at high surgical risk. The patient was successfully treated by mitral valve replacement with a biological prosthesis and concomitant aortic valve replacement with a sutureless prosthesis.

The study aim was to report the results of a single-center cohort of patients who underwent aortic valve replacement (AVR) with a sutureless prosthesis in case of cardiac reoperation (REDO).Between March 2010 and December 2011, a total of 83 patients underwent AVR with the Perceval S sutureless aortic bioprosthesis (Sorin Biomedica Cardio Srl, Saluggia, Italy) at the authors' institution. Thirteen of these patients (six males, seven females; mean age 75.2 +/- 5.6 years) had previously undergone cardiac surgery and represented the study population. Preoperative, periprocedural and echocardiographic parameters, as well as clinical outcomes, were analyzed for all patients.The primary procedure was AVR, using a bioprosthesis in six patients (46%) and coronary artery bypass grafting in seven (54%). The logistic EuroSCORE was 19.4 +/- 10.7%. Surgery was always performed via a full sternotomy; the mean implanted valve size was 23.6 +/- 1.3 mm (the previous valve size was 23.2 +/- 3.2 mm; p = 0.66). The mean cross-clamp time was 44 +/- 16 min, and the mean intensive care unit stay was 3.3 +/- 2.3 days. No intraoperative or in-hospital deaths occurred, and all patients were alive at a mean follow up of 8.5 months. Two postoperative events included transient ischemic attack in one patient, and the need for pacemaker implantation in one patient. On echocardiographic evaluation, no patient showed signs of paraprosthetic leak. The mean transvalvular gradient was 10.3 +/- 1.5 mmHg.Use of the Perceval S sutureless AVR offers a fast and safe procedure, even in high-risk REDO surgery, providing a good hemodynamic performance with excellent clinical recovery, demonstrated at a follow up of six months. Although the sample size was limited, the results were encouraging and support the use of sutureless valves in the frame of REDO surgery for aortic valve disease.

Background The application of negative pressure wound therapy (NPWT) in patients with deep wound infection after cardiac surgery has steadily increased worldwide. Following NPWT, in patients with concomitant sternal diastasis, preparation of the substernal structures for the sternal wires application is mandatory, with increased risk of severe complications, such as laceration of the right ventricle. The aim of this study is to present an innovative technique for sternal closure after NPWT, using the ASCS® System (ASCS atraumatic Sternum Closure System; KS Handelsvertretung Produktinovation, Bad Homburg, Germany). Methods Between January 2009 and August 2012, 88 patients (mean age 64.2 ± 12.4 years) with deep wound infection and sternal diastasis received NPWT; 16 of these patients (18.2%) underwent sternal closure after NPWT with ASCS®. Results In all 16 cases, neither sub-sternal dissection nor placement of trans- or peristernal wires was necessary. No damage to the aortocoronary bypass and ventricular rupture occurred. Minimal post-operative bleeding from Redon drains (mean 40 ± 10 ml) was present. At follow-up, deep wound infection and sternal diastasis did not occur. Conclusions The ASCS® System combined with NPWT in patients with postoperative deep wound infection and sternal diastasis is a feasible and safe procedure. Because preparation of the substernal structures is not necessary, this device might prevent the occurrence of severe complications. Our experience, however, is limited and larger case series are necessary to fully evaluate this new and innovative technique.

OBJECTIVES: Left ventricular (LV) hypertrophy in aortic stenosis (AS) is considered a compensatory response helping maintain systolic function, but constitutes a risk factor for cardiac morbidity and mortality. The aim of this study was to assess the degree of LV mass regression after sutureless implantation of the Perceval S aortic valve bioprosthesis (Sorin Group, Saluggia, Italy). METHODS: Between March 2010 and July 2012, 78 patients with symptomatic AS underwent isolated aortic valve replacement (AVR) with the Perceval bioprosthesis. Mean age was 77.1 ± 5.3 years, 46 patients were female (59%) and mean logistic EuroSCORE was 11 ± 7.5%. Echocardiography was performed preoperatively, at discharge, and at follow-up (mean 13.5 ± 7.3 months). LV mass was calculated using the Devereux formula and indexed to body surface area. RESULTS: There was 1 in-hospital non-cardiac death and 3 late deaths. LV mass index decreased from 148.4 ± 46 g/m 2 at baseline to 119.7 ± 38.5 g/m 2 at follow-up (P= 0.002). No significant changes were observed in LV hypertrophy and/or relative wall thickness >0.42 as well as in LV ejection fraction. Mean aortic gradient decreased from 49.5 ± 15.8 mmHg at baseline to 11.6 ± 5.1 mmHg at discharge and 8.3 ± 4.4 mmHg at follow-up (P< 0.001), resulting in significant clinical improvement. No moderate or severe paravalvular leakage was observed at discharge and at follow-up. CONCLUSIONS: In AS patients, isolated AVR with the Perceval sutureless bioprosthesis is associated with significant LV mass regression at 1-year follow-up. However, longer-term follow-up is necessary to confirm these findings.

Although commonly reported as single-centre experiences, redo aortic valve replacement (RAVR) has overall acceptable results. Nevertheless, trans-catheter aortic valve replacement has recently questioned the efficacy of RAVR.Early-to-mid-term results and determinants of mortality in 711 cases of RAVR from seven European institutions were assessed in the entire population and in selected high-risk subgroups [elderly75 years, urgent/emergent procedures, preoperative New York Heart Association (NYHA) functional Class IV and endocarditis].Hospital mortality was 5.1%, major re-entry cardiovascular complications (MRCVCs) 4.9%, low cardiac output syndrome (LCOS) 15.3%, stroke 6.6%, acute respiratory failure (ARF) 10.6%, acute renal insufficiency (ARI) 19.3% and need for continuous renal replacement therapy (CRRT) 7.2%, transfusions 66.9% and for permanent pacemaker (PMK) 12.7%. Mid-term survival, freedom from acute heart failure (AHF), reinterventions, stroke and thrombo-embolisms were 77.2 ± 2.7, 84.4 ± 2.6, 97.2 ± 0.8, 97.2 ± 0.9 and 96.3 ± 1.2%, respectively; 87.5% of patients were in NYHA functional Class I-II. Preoperative left ventricular ejection fraction of30% [odds ratio (OR) 8.7, 95% confidence interval (CI) 2.1-35.6], MRCVCs (OR 20.9, 95% CI 5.6-78.3), cardiopulmonary bypass time (OR 1.1, 95% CI 1.0-1.1), perioperative LCOS (OR 17.2, 95% CI 5.1-57.4) and ARI (OR 5.1, 95% CI 1.5-18.1) predicted hospital death. Endocarditis (OR 7.5, 95% CI 2.9-19.1), preoperative NYHA functional Class IV (OR 4.7, 95% CI 1.0-24.0), combined RAVR + mitral surgery (OR 5.1, 95% CI 1.5-17.3) and AHF at follow-up (OR 2.8, 95% CI 1.3-6.0) predicted late death at the Cox proportional hazard regression model. Elderly75 years had similar hospital mortality (P = 0.06) and major morbidity, except for a higher need for PMK (P = 0.03), as well as comparable mid-term survival (P = 0.89), freedom from AHF (P = 0.81), reinterventions (P = 0.63), stroke (P = 0.21) and thrombo-embolisms (P = 0.09). Urgent/emergent indication resulted in higher hospital death, LCOS, transfusions, MRCVCs, intra-aortic balloon pumping (IABP), stroke, prolonged (48 h) ventilation, pneumonia, ARI, CRRT, lower mid-term survival and freedom from AHF (P ≤ 0.03). Preoperative NYHA functional Class IV correlated with higher LCOS, IABP, prolonged ventilation, pneumonia, ARF, ARI, CRRT and MRCVCs and lower mid-term survival, freedom from AHF, reinterventions and stroke (P ≤ 0.02). Endocarditis demonstrated higher hospital mortality, MRCVCs, LCOS, IABP, stroke, ARF, prolonged intubation, pneumonia, ARI, CRRT, transfusions and PMK and lower mid-term survival and freedom from AHF and reinterventions (P ≤ 0.04).RAVR achieves overall satisfactory results. Baseline risk factors and perioperative complications strongly affect outcomes and mandate improvements in perioperative management. New emerging strategies might be considered in selected high-risk cases.

Mechanical circulatory support is a therapy for patients with end stage cardiac insufficiency. The thromboembolic events are feared complications during support, due to the surface thrombogenicity of the implanted device. Activated blood platelets play a major role in this context. Consequently the platelet morphology of patients was investigated.Platelets of eight patients were observed by means of scanning electron microscopy during the period of support with the Novacor left ventricular assist system N100. Blood was collected preoperatively and daily during the first week as well as weekly during the first 3 months. Samples were fixed with cacodylic-acid buffered glutaraldehyde. Platelet alterations were classified as non-activated, activated and aggregated, based on the so-called 'shape change' morphology. In addition, blood coagulation parameters were evaluated (e.g. activated partial thromboplastin time, prothrombin time, antithrombin III).Preoperatively, 15.0 +/- 4.6% (overall mean values) of activated platelets were found. Within the first postoperative week, the mean level of activated platelets increased to 32.8 +/- 8.0% (P0.05). Comparing short- (30 days; n = 4) vs. long-period (30 days; n = 4) support, a significant difference of activated platelets was evaluated (24.3 +/- 3.3% vs. 34.8 +/- 3.4%, P = 0.004). A correlation was found between the values of activated clotting time and activated platelets. Specific platelet deformations and damages appeared during support, which could not be found preoperatively.The platelet morphology showed alterations in all patients probably most strongly induced by the surface activation of the implanted device. These observations should be taken into consideration in management of postoperative anticoagulation therapy.

Objecti6e: The main disadvantage of implanted cardiac valve bioprostheses remains primarily tissue failure due to calcification. Coating of bioprostheses with viable autologous endothelial cells may delay or even eliminate tissue calcification and subsequent cardiac dysfunction. Methods: Glutaraldehyde-preserved Hancock bioprostheses (n 5), pretreated with glutamic acid (8%) and cryopreserved allografts (n5) were lined, using endothelial cells harvested from the external jugular vein. Coated specimens were cultivated for 9 days in Medium 199 supplemented with 20% fetal calf serum and basic fibroblast growth factor. Endothelialized grafts were anastomosed into the descending thoracal aorta of adult Chacma baboons. Untreated valve bioprostheses (n4) served as controls. Forty days after implantation the prostheses were examined morphologically and immunohistochemically. Results: After implantation endothelialized prostheses showed a positive Factor VIII related antigen reaction by immunohistochemistry on all valve surfaces. Scanning electron microscopy showed confluently lined leaflets with transplanted endothelial cells and displayed cobblestone morphology on all coated allografts. In contrast, the surface of pretreated xenograft valves revealed uncoated areas with platelet and leucocyte aggregates. No endothelium was observed on the leaflets of untreated controls 40 days after implantation. Conclusion: In vitro endothelialization of cardiac valve bioprostheses with autologous endothelial cells is possible. The newly created endothelium is shear stress resistant and the antithrombotic as well as the antiaggregatory capacity of the transplanted cells were retained. Lining with autologous endothelial cells could improve the durability and clinical outcome of biological valve prostheses. © 1997 Elsevier Science B.V.

The introduction of transcatheter aortic valve implantation (TAVI), coupled with the increasing number of elderly patients requiring cardiac surgery, has given rise to an intense debate on the most appropriate treatment strategy for this high-risk population. The study aim was to compare clinical outcomes in older versus younger patients undergoing minimally invasive aortic valve replacement (AVR).Between March 2010 and July 2012, 66 patients undergoing minimally invasive isolated AVR with the sutureless Perceval S bioprosthesis (Sorin Group, Saluggia, Italy) were allocated to two groups according to ageor = 80 years (group A, n = 25) or80 years (group B, n = 41). In-hospital and follow up data were collected for all patients, including an evaluation of the patients' quality of life, using the SF-36 questionnaire.Mean age and logistic EuroSCORE were statistically different between groups (p0.001 and p = 0.002, respectively). The length of intensive care unit stay was similar in groups A and B (1.9 +/- 0.8 and 2.5 +/- 1.4 days, respectively; p = 0.061). In-hospital mortality occurred in only one patient of group A (1.5%). Postoperative transient cerebral ischemic events occurred with similar frequency in both groups (two in group A and four in group B; p = 0.59). One patient in group A and two patients in group B required pacemaker implantation (1.5 versus 3%; p = 0.68). The mean follow up was 13.9 +/- 7.4 months, during which time three patients died (two in group A, one in group B). All enrolled patients answered the SF-36 questionnaire, and there were no significant differences between groups in all eight domains of the test.Within the setting of minimally invasive isolated AVR, the study results showed that the clinical outcomes and quality of life in patients agedor = 80 years were comparable to those of younger patients. Therefore, advanced age per se does not preclude successful AVR through a minimally invasive approach.

AIM Although minimally invasive aortic valve replacement (MIAVR) has been shown to cause less morbidity than conventional surgery, it has not yet received broad application. The purpose of this study was to evaluate sutureless implantation using the Perceval S aortic valve bioprosthesis (Sorin Group, Saluggia, Italy) via ministernotomy. METHODS Seventy-two patients (43 women, 29 men; mean age 77.4 ± 5.3 years) with isolated aortic valve stenosis (mean gradient of 52 ± 14 mmHg) underwent aortic valve implantation with the sutureless Perceval S bioprosthesis, following cardiopulmonary bypass (CPB), aortic cross-clamping (ACC), cardioplegic arrest and removal of the calcified native valve. The mean logistic EuroSCORE was 9.7 ± 6.2%. RESULTS The prosthetic valve was successfully deployed in all patients. Thirty-day mortality was 1.4% (n = 1). Mean CBP, ACC, and implantation times were 68 ± 18, 40 ± 13 and 8.9 ± 4 min, respectively. Perioperative echocardiography revealed significant paravalvular leakage in one patient. Postoperative mean gradient was 11.6 ± 5.1 mmHg. At a mean follow-up of 13 ± 6.7 months, no significant paravalvular leakage or valvular regurgitation was observed, and no migration or dislodgement of the prosthesis occurred. CONCLUSION This study shows that sutureless implantation of the Perceval S aortic valve bioprosthesis provides a simple and reproducible alternative for MIAVR. As the valve does not need to be sutured, it may also result in reduced ACC and CPB times. This self-anchoring valve may also allow the application of MIAVR to a broader spectrum of patients. This new technology needs a long-term follow-up.

OBJECTIVES: A prospective randomized multicentre trial was performed to analyse the efficacy of a vest (Posthorax support vest®) to prevent sternal wound infection after cardiac surgery, and to identify risk factors. METHODS: From September 2007 to March 2010, 2539 patients undergoing cardiac surgery via median sternotomy were prospectively randomized into those who received a Posthorax® vest and those who did not. Patients were instructed to wear the vest postoperatively for 24 h a day for at least 6 weeks; the duration of follow-up was 90 days. Patients who did not use the vest within a period of 72 h postoperatively were regarded as study dropouts. Statistical calculations were based on an intention-to-treat (ITT) analysis. Further evaluations comprised all subgroups of patients. RESULTS: Complete data were available for 2539 patients (age 67 ± 11years, 45% female). Of these, 1351 were randomized to receive a vest, while 1188 received no vest. No significant differences were observed between groups regarding age, gender, diabetes, body mass index, chronic obstructive pulmonary disease (COPD), renal failure, the logistic EuroSCORE and the indication for surgery. The frequency of deep wound complications (dWC: mediastinitis and sternal dehiscence) was significantly lower in vest (n= 14; 1.04%) vs non-vest (n= 27; 2.27%) patients (ITT, P< 0.01), but superficial complications did not differ between groups. Subanalysis of vest patients revealed that only 933 (Group A) wore the vest according to the protocol, while 202 (Group BR) refused to wear the vest (non-compliance) and 216 (Group BN) did not use the vest for other reasons. All dWC occurred in Groups BR (n= 7) and BN (n= 7), although these groups had the same preoperative risk profile as Group A. Postoperatively, Group BN had a prolonged intubation time, a longer stay in the intensive care unit, greater use of intra-aortic balloon pump, higher frequency of COPD and a larger percentage of patients who required prolonged surgery. CONCLUSION: Consistent use of the Posthorax® vest prevented deep sternal wounds. The anticipated risk factors for wound complications did not prove to be relevant, whereas intra- and postoperative complications appear to be very significant.

Thirty years ago the Smeloff-Cutter double-caged ball prosthesis was developed for aortic valve replacement. Between 1967 and 1977 a total of 46 patients admitted to the University Hospital Munich underwent an isolated aortic valve replacement with the Smeloff-Cutter prosthesis. Postoperatively all patients received anticoagulation treatment with phenprocoumon (Marcumar). A retrospective follow-up of 95.6% of patients, representing 842 patient years, was completed. The corresponding actuarial survival rates after 10, 20, and 25 years were 69.1%, 47.4%, and 31.4%. The actuarial freedom rates from either valve-related complications, reoperations, or death were 72.9%, 47.4%, and 20.3%. Thromboembolism occurred in 1.41% per patient year, bleeding in 1.90%. The rates of valvular dysfunction, reoperation, and endocarditis were 1.16%, 1.16%, and 0.2% per patient-year. Today, of the surviving patients 81% are in NYHA Class I or II, 19% in NYHA Class III. No surviving patient deteriorated over the reported time in his or her functional NYHA classification. After 25 years the Smeloff-Cutter valve has proved to be a reliable prosthesis for aortic valve replacement and-together with the Starr-Edwards prosthesis-it has set a standard in longterm durability by which all other valve designs will have to be measured.

Susceptibility to endocarditis after transcatheter aortic valve implantation (TAVI) has not yet been described. We report the first case of acute aortic prosthetic valve endocarditis in a patient undergoing transapical TAVI, successfully treated with surgery. In November 2009, an 83-year-old woman underwent TAVI (23 mm Edwards Sapien) with an uneventful postoperative course. After 6 months, her blood cultures tested positive for Enterococcus faecalis and a prosthetic aortic valve endocarditis was diagnosed following the identification of a large mobile vegetation with subvalvular abscess. The abscess cavity was closed with a pericardial patch, and the prosthetic aortic valve was replaced with a 23 mm Mitroflow aortic bioprosthesis, using a standard surgical procedure with cardiopulmonary bypass.

Surgical aortic valve replacement (S-AVR) after previous cardiac surgery is expected to be associated with a high rate of adverse events. The aim of this study was to estimate the rate and identify the determinants of postoperative stroke in these patients. This is a multicenter study including 741 patients who underwent S-AVR after previous cardiac surgery. Forty-eight patients (6.5%; after isolated AVR, 6.0%) suffered stroke and 10 of them died during the in-hospital stay (20.8%). At multivariate analysis, women (10.2% vs 4.4%, odds ratio [OR] 2.57, 95% confidence interval [CI] 1.36 to 4.86), emergency procedure (15.1% vs 4.8%, OR 2.63, 95% CI 1.12 to 5.78), perioperative use of intra-aortic balloon pump (22.9% vs 5.3%, OR 2.67, 95% CI 1.15 to 6.19), cardiopulmonary bypass time of >210 minutes (15.7% vs 5.0%, OR 2.31, 95% CI 1.13 to 4.71), blood products transfusion (9.3% vs 0.8%, OR 7.75, 95% CI 1.83 to 32.93), and reexploration for bleeding (24.0% vs 5.2%, OR 4.84, 95% CI 2.18 to 10.77) were independent predictors of postoperative stroke. These findings were confirmed by a regression model including CHA 2 DS 2 -VASc score of ≥2, which itself was predictive of stroke (8.2% vs 1.6%, OR 4.52, 95% CI 1.34 to 15.28). Survival at 3 years in patients with postoperative stroke was 51.9%, whereas it was 85.0% in control patients (adjusted analysis: relative risk 2.97 and 1.86 to 4.72, respectively). In conclusion, the risk of postoperative stroke after S-AVR in patients with previous cardiac surgery is high and has an impact on the immediate and late mortality. Excessive bleeding requiring blood transfusion and/or reexploration, prolonged cardiopulmonary bypass time, and use of intra-aortic balloon pump were associated with an extremely high rate of stroke.

Sutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year.From February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%.One-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up.The Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population.

Recently, small case series have described successful off-label use of transcatheter aortic valve implantation (TAVI) in patients with degenerated bioprosthetic valves in mitral position. We here report the case of a 78-year-old female patient who underwent TAVI for severe aortic stenosis and transapical valve-in-valve implantation for degenerated mitral bioprosthesis. There was no evidence of intraprosthetic regurgitation and/or paraprosthetic leaks on control angiography and transesophageal echocardiography. The postoperative course was uneventful. Following accurate patient selection and evaluation by an experienced multidisciplinary team, the transcatheter approach for double valve implantation in aortic and mitral position may represent a viable treatment option for those high-risk patients who otherwise would be inoperable.

The Perceval S bioprosthesis (21 and 23 mm) was approved for clinical use in December 2010 and it is now routinely used. This bioprosthesis is suggested for the treatment of patients undergoing minimally-invasive surgery for reasons of safety and reduction in implantation time. Here we describe the use of the Perceval bioprosthesis in patients undergoing minimally invasive cardiac surgery.

Background Sutureless aortic bioprostheses bear the potential of easy implantation, reduced ischemic time, and surgical trauma in aortic valve replacement. We herein show our clinical and echocardiographic results after a 1-year experience with a new sutureless bioprosthesis. Methods The Perceval S (Sorin Biomedica Cardio Srl, Saluggia, Italy) is a pericardial aortic prosthesis assembled within a super-elastic alloy frame. It is implanted intra-annularly, without the need of suture. As part of a premarketing multicenter study (Cavalier Trial), since March 2010, 83 patients were screened for implantation in our center. Results The patients received a size S (4), M (38), or L (41) prosthesis, either as isolated (57) or combined procedures (26). Fifty-one patients (61.5%) received a "J" sternotomy. Mean logistic European system for cardiac operative risk evaluation was 10. ± 7.5%, mean aortic cross-clamp time was 43.8 ± 20.8 minutes (36 ± 12.7 minutes for isolated procedures). Mean implantation time was 8 ± 3.8 minutes (range 4 to 28 minutes). In-hospital mortality was 2.4% (1 patient for multiorgan failure and 1 for liver insufficiency); mean hospital stay was 11.5 ± 4.4 days (range 2 to 28 days). We recorded 5 pacemaker implantations (6%). At follow-up, we had 2 deaths (1 patient for congestive heart failure and 1 for gastrointestinal bleeding). At 1 year, mean New York Heart Association functional class was 1.0 ± 0.6. Mean transprosthetic gradients were 13.4 ± 2.8, 12.6 ± 2.3, and 10.8 ± 1.3 mm Hg postoperatively, at 6 months, and at 1 year, respectively. Conclusions The Perceval S shows satisfactory clinical and hemodynamic results. Due to its simple implantation technique, it represents an alternative especially for minimally invasive surgery. Operative trauma can be minimized by short aortic cross-clamp time.

The barrier functions of myocardial precapillary arteriolar and postcapillary venular walls (PCA or PCV, respectively) are of considerable scientific and clinical interest (regulation of blood flow and recruitment of immune defense). Using enzyme histochemistry combined with confocal microscopy, we reexamined the cell architecture of human PCA and PVC and reconstructed appropriate in vitro models for studies of their barrier functions. Contrary to current opinion, the PCA endothelial tube is encompassed not by smooth muscle cells but rather by a concentric layer of pericytes cocooned in a thick, microparticle-containing extracellular matrix (ECM) that contributes substantially to the tightness of the arteriolar wall. This core tube extends upstream into the larger arterioles, there additionally enwrapped by smooth muscle. PCV consist of an inner layer of large, contractile endothelial cells encompassed by a fragile, wide-meshed pericyte network with a weakly developed ECM. Pure pericyte and endothelial cell preparations were isolated from PCA and PCV and grown in sandwich cultures. These in vitro models of the PCA and PCV walls exhibited typical histological and functional features. In both plasma-like (PLM) and serum-containing (SCM) media, the PCA model (including ECM) maintained its low hydraulic conductivity ( LP = 3.24 ± 0.52·10−8cm·s−1·cmH2O−1) and a high selectivity index for transmural passage of albumin (SIAlb = 0.95 ± 0.02). In contrast, LP and SIAlb in the PCV model (almost no ECM) were 2.55 ± 0.32·10−7cm·s−1·cmH2O−1 and 0.88 ± 0.03, respectively, in PLM, and 1.39 ± 0.10·10−6cm·s−1·cmH2O−1 and 0.49 ± 0.04 in SCM. With the use of these models, systematic, detailed studies on the regulation of microvascular barrier properties now appear to be feasible.

The main disadvantage of implanted xenograft valves used in cardiac surgery is their poor clinical long-term result, due to early tissue degeneration. In order to improve the performance of such glutaraldehyde fixed bioprostheses, a biological coating with viable endothelial cells was suggested. Therefore, glutaraldehyde preserved bovine pericard patches, as well as commercially available xenograft valves, were lined using human venous endothelial cells or microvascular cells from the subcutaneous fat tissue. Before cells were transplanted into their new environment, grafts were treated with an amino acid solution in order to neutralize the cytotoxic effect of free aldehydes, and precoated with fibronectinheparin and basic fibroblast growth factor (bFGF) or endothelial cell growth supplement (ECGS) in order to enhance cell proliferation. Coated specimens were kept in culture conditions for a further seven days. Proliferation of transplanted cells was verified by an increase of activation following 3H-thymidine incorporation, while the maintained metabolic cell activity was demonstrated via Prostacycline (PGI2) measurement. Morphology was evaluated by means of scanning electron microscopy (SEM). As evaluated by the β-Counter, 7 ng/ml bFGF (288,727 ± 39,668 counts on day 4) substantially enhanced cell proliferation after seeding, opposed to the stimulation with 30,000 ng/ml ECGS (91,924 ± 1129 counts on day 4), (p2 release of transplanted cells was stimulated with 25 μM Na arachidonic acid by the factor 2.6 ± 0.3 and inhibited with 5 mM acetylsalecylic acid by the factor 0.7 + 0.2 on day 4 when compared with the basic level. After seven days of cultivation, SEM observation revealed that specimens stimulated with bFGF showed areas of confluent coated leaflets with an even distribution of cell layer. We therefore conclude that proliferation of transplanted cells is most favorable when stimulated with bFGF and that a special treatment of GA preserved cardiac valve bioprostheses allows a vital biological coating with human endothelial cells.

Examination results concerning immunological reactions in cryopreserved allograft valves during the early postoperative course are so far not available. Cytoimmunological monitoring (CIM) is a well established method to prove rejection reaction after allograft transplantation and was used in this study. Allograft valves were harvested from patients who underwent heart transplantation, and did not require sterilizing in antibiotic solutions. The valves were dissected, conserved and subsequently frozen to -40 degrees C and stored in a freezing system at -196 degrees C. During the first 3 weeks following allograft implantation, CIM was performed daily. An activation index (AI) was determined from the cytological evaluation of the mononuclear concentrate in the peripheral blood. An increase of the AI > 1 was defined as an immunological reaction. As control we performed 98 CIM examinations in eight patients who underwent bioprosthetic valve replacement in the aortic position. Echocardiography (TTE and TEE) was used postoperatively as function control. Out of 16 patients who underwent cryopreserved aortic valve implantation in the aortic position, 336 CIM-results were obtained. An immunological reaction could be detected in all patients, starting on the 5th day on average. Comparing ABO-compatible (group I, n = 9) with ABO-incompatible (group II, n = 7) allografts, the AI-maximum in group I was 1.4 with a mean duration of 1.5 days. Group II was characterized by more intensive immunoreactions (mean = 2.3) which proved to be even more prolonged (mean = 3.3 days, P < 0.05). Nevertheless it became apparent that all observed immunological events were completely reversible without the need for immunosuppressive drugs.(ABSTRACT TRUNCATED AT 250 WORDS)

Results: During this time period, we operated upon 7470 patients through a median sternotomy. 268 patients (3.6%) received tracheostomy due to prolonged or expected prolonged assisted ventilation within 14 days (mean 8.1±2.64) after median sternotomy. In 240 patients (91.4%), tracheostomy was performed percutaneously with no major complication (bleeding, tracheal injury). 23 patients (8.6%) who were not suited for the percutaneous approach (anatomical reasons) underwent surgical tracheostomy in the OR. Deep sternal wound infection developed in 3 patient (1.1%), but the identified microbes (staph. aureus) were different to those cultured from the trachea, excluding cross-contamination. Survivors (219/268, 81.7%) were successfully weaned after 19.2±11.5 days (3–81).