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Background: The increasing use of biological substitutes for surgical aortic valve replacement (AVR), has led to the development of new bioprostheses with improved hemodynamics and expected durability., Methods: In this observational retrospective two-center cohort study, two innovative bioprostheses, INSPIRIS Resilia and AVALUS were analyzed. We analyzed early and 2.4-year follow-up results in terms of safety, clinical outcome and hemodynamic performance., Results: From November 2017 to February 2021, 148 patients underwent AVR with INSPIRIS Resilia (N.=74) or AVALUS (N.=74) bioprosthesis. The 30-day and mid-term mortality was comparable (1% vs. 3%, P=0.1 and 7% vs. 4%, P=0.4, respectively). Valve-related mortality was observed in one AVALUS patient. Three (4%) patients of the AVALUS group developed prosthetic endocarditis and two of them died after reoperation. No other cases of prosthetic endocarditis were observed. No cases of structural valve degeneration or significant paravalvular leak were detected at follow-up. Median follow-up peak pressure gradient was 21 vs. 23 mmHg (P=0.4) and the mean pressure gradient was 12 vs. 13 mmHg (P=0.9) for Inspiris and AVALUS, respectively. The effective orifice area (EOA) and indexed EOA were 1.5 cm 2 vs. 1.4 cm 2 (P=0.4) and 0.8 vs. 0.7 cm 2 /m 2 (P=0.5), respectively. Indexed left ventricular mass regression was -33 vs. -52 g/m 2 for the Inspiris and AVALUS groups, respectively, (R 2 -adjusted =0.14; P<0.01)., Conclusions: INSPIRIS Resilia and AVALUS bioprostheses were reliable with comparable results in safety, clinical outcome and hemodynamic performance. After statistical adjustment, AVALUS was associated with better left ventricular mass reduction. Long-term follow-up would provide definitive comparative results.

Background: Guidelines for choice of replacement valve-mechanical versus bio-prosthetic, are well established for patients aged <50 and >65 years. We studied the trends and implications of aortic valve replacement (AVR) with mechanical versus bioprosthetic valve in patients aged 50 to 65 years., Methods: STS and cost database of 17 centers for isolated AVR surgery were analyzed by dividing them into bioprosthetic valve (BV) or mechanical valve (MV) groups., Results: From 2002 to 2011, 3,690 patients had AVR, 18.6% with MV and 81.4% with BV. Use of BV for all ages increased from 71.5% in 2002 to 87% in 2011. There were 1127 (30.5%) patients in the age group 50-65 years. Use of BV in this group almost doubled, 39.6% in 2002 to 76.8% in 2011. Mean age of patients in BV group was higher (59.2±4.2 years vs. 56.7±4.3 years, P≤0.0001). Preoperative renal failure, heart failure and chronic obstructive pulmonary disease favored use of BV, whereas preoperative atrial fibrillation favored AVR with MV. Mortality (MV 2.2% vs. BV 2.36%) and other postoperative outcomes between the groups were similar. Cost of valve replacement increased for both groups (MV $26,191 in 2002 to $42,592 in 2011; BV $27,404 in 2002 to $44,257 in 2011)., Conclusions: Use of bioprostheses for AVR has increased; this change is more pronounced in patients aged 50-65 years. Specific preoperative risk factors influence the choice of valve for AVR. Postoperative outcomes between the two groups were similar. Long-term implications of this changing practice, in particular, reoperation for bioprosthetic valve degeneration should be examined.

Aortic valve replacement is the treatment of choice concerning aortic valve disease. Excellent short- and long-term clinical results are reported. Patients referred for aortic valve replacement are getting older and older, so bioprosthetic valves play a more central role worldwide. However, patient comorbidities are also increased more often rendering patients unsuitable for open conventional aortic valve replacement. As a result, transcatheter aortic valve implantation has become the treatment of choice in patients at very high surgical risk. However, the percutaneous technique is related to major disadvantages provided that the diseased native valve is left in place. Its durability is also uncertain. More recently, sutureless Perceval S valve bioprosthesis has gained ground in the field of aortic stenosis therapy filling the gap between conventional aortic valve replacement and transcatheter approach. Excellent hemodynamic and clinical results are reported. Its deployment is performed under direct view and ischemic and overall operative times are significantly decreased. Five-year follow-up results are also optimal. However, the "Achilles' heel" of sutureless technology is increased rates of postoperative permanent pacemaker implantation requirement compared to conventional approach. The incidence of this complication varies in literature. Patient-related factors such as preoperative conduction disorders, older age and short membranous septum are predictors of postoperative pacemaker requirement. However, several technical modifications regarding manufacturer recommendations can be adopted to mitigate this complication. Appropriate annular decalcification, higher guiding sutures placement, reduced balloon pressure and duration and avoiding of oversizing can contribute to prevent from this complication.

Background: The aim of this study was to retrospectively analyze early and late outcomes of infrainguinal revascularization performed with the Omniflow-II ® (LeMaitre Vascular, Inc., Burlington, MA, USA) biosynthetic vascular graft (BVG) for complex femoro-popliteal obstructive disease., Methods: Over a 10-year period, this BVG was used in 110 patients who underwent infrainguinal femoro-popliteal or femoro-distal bypass. Early (intraoperative and <30 days) results were analyzed in terms of death, thrombosis, amputations and reinterventions. Follow-up results were analyzed in terms of primary and secondary graft patency, and amputation-free survival., Results: We performed 87 (79.1%) above-the-knee bypass, 20 (18.2%) below-the-knee bypass, and 3 (2.7%) tibial artery bypass. In-hospital mortality was not observed. Mean follow-up was 66±37 months (range, 3-150). Estimated primary patency rate at 1, 2 and 5-years of follow-up was 77%±4 (95%CI: 68-84), 73%±5 (95%CI: 63.5-83), and 59%±6 (95%CI: 47-70.5) respectively. Predictors of primary patency loss were the presence of critical limb ischemia (P=0.048; HR: 2.1; 95%CI: 1.01-4.28), and the necessity of below-the-knee bypass (P=0.012; HR: 2.4; 95%CI: 1.22-4.75). Aneurysmal degeneration of the BVG was detected in 4 (3.6%) patients, an infected BVG occurred in 3 (2.7%) patients. The amputation-free survival was 96%±2 (95%CI: 91-99), 93%±3 (95%CI: 86-96), and 76%±5 (95%CI: 66-84) at 1, 2 and 5-years respectively., Conclusions: In our experience, Omniflow-II ® is a valid first-line alternative for infrainguinal revascularization when the ipsilateral autologous saphenous vein is not available. Aneurysmal degeneration was lower than previously reported with alternative BVGs, and the incidence of BVG infection was acceptably low.

Background: The Shelhigh™ SuperStentless (Shelhigh, INC., Union, NJ, USA) is a stentless aortic valve bioprosthesis and aortic root valved conduit. In 2007, this device was recalled by FDA due to malfunction, and subsequently reintegrated by BioIntegral Surgical™ Few data are available over late durability of this device. We performed a long-term follow-up of Shelhigh™ devices implanted at our center., Methods: Between 2002 and 2007, 44 patients underwent aortic valve replacement with a Shelhigh™ device (40 aortic valve bioprosthesis and 4 valved conduit). We performed a clinical and echocardiographic follow-up (9.2 years±4.3). Standardized definitions of valve-related events were adopted., Results: At discharge, maximum and mean aortic gradients averaged 36.1±11.3 and 21.0±6.8 mmHg, respectively. The 30-days mortality was 2.3%. Over the follow-up period, 29 patients died (65.9%); 2 deaths were valve related. Overall survival at 1, 5 and 10 years was 97.7%, 85.8% and 54% respectively. At last echocardiography, average transvalvular gradients had remained globally stable in the population (33.6±12 and 20.4±10.5 mmHg). Eight (19%) structural valve deterioration (SVD) events were reported. Two (5%) non-structural valve dysfunction (NSVD) events occurred (periprosthetic leak). Two (5%) infectious endocarditis events and two (5%) valve thromboses were also deplored. Three (7%) patients required re-operation (2 due to SVD and 1 due to endocarditis)., Conclusions: The immediate hemodynamic performance of the Shelhigh™ aortic bioprostheses was unexpectedly suboptimal. Despite this, hemodynamic performance remained stable over time. Patients survival at follow-up was satisfactory, however, continued surveillance is necessary.

Biologically-engineered matrix - a tissue that is grown in vitro from donor cells, decellularized, and stored prior to use as off-the-shelf allografts - offers a promising alternative to current cardiovascular biomaterials. This perspective reviews preclinical studies and clinical trials of vascular grafts and valves comprising biologically-engineered matrix, with a focus on those based on donor dermal fibroblast remodeling of fibrin gel with the capacity to heal and grow following recellularization, via animation of the matrix. It concludes with a discussion of related key clinical considerations.

Tissue engineering has garnered significant attention for its potential to address the predominant modes of failure of small diameter vascular prostheses, namely mid-graft thrombosis and anastomotic intimal hyperplasia. In this review, we described two main features underpinning the promise of tissue-engineered vascular grafts: the incorporation of an antithrombogenic endothelium, and the generation of a structurally and biomechanically mimetic extracellular matrix. From the early attempts at the in-vitro endothelialization of vascular prostheses in the 1970s through to the ongoing clinical trials of fully tissue-engineered vascular grafts, the historical advancements and unresolved challenges that characterize the current state-of-the-art are summarized in a manner that establishes a guide for the development of an effective vascular prosthesis for small diameter arterial reconstruction. The importance of endothelial cell purity and their arterial specification for the prevention of both diffuse neointimal hyperplasia and the accelerated development of atherosclerotic lesions is delineated. Additionally, the need for an extracellular matrix that recapitulates both the composition and structure of native elastic arteries to facilitate the protracted stability and patency of an engineered vasoactive conduit is described. Finally, the capacity of alternative sources of cells and mechanical conditioning to overcome these technical barriers to the clinical translation of an effective small diameter vascular prosthesis is discussed. In conclusion, this review provides an overview of the historical development of tissue-engineered vascular grafts, highlighting specific areas warranting further research, and commentating on the outlook of a clinically feasible and therapeutically efficacious vascular prosthesis for small diameter arterial reconstruction.

Background: Transcatheter aortic valve replacement (TAVR) in patients with chronic kidney disease (CKD) is challenging due to the high risk of contrast-induced nephropathy (CIN) and acute kidney injury (AKI). AKI dramatically reduces the clinical benefit of TAVR and is one of the strongest predictors of 30-day mortality as well as long-term adverse outcomes after TAVR. The aim of this study was to evaluate a protocol specifically designed to reduce the incidence of contrast-induced nephropathy (CIN) in advanced CKD patients screened for and undergoing TAVR., Methods: Twelve consecutive patients with severe aortic valve stenosis suffering from at least stage 4 CKD underwent both screening with pre-procedural computed tomography scan (CT scan) and bioprosthetic valve implantation without contrast medium. All the TAVR procedures were performed using the CoreValve Evolut R/PRO transcatheter aortic valve (Medtronic Inc, Minneapolis, MN, USA). The annulus and the optimal implantation projection were identified on the non-contrast medium CT scans with the aid of calcifications as a reference. The implant projection was confirmed immediately before the valve implantation by placing two pigtail catheters alternately inside each sinus of Valsalva (SOV)., Results: We enrolled 12 patients: mean age 83.42 4.50 years, number of male 5 (41.7%), mean STS 10.33±6.16, mean EuroScore II 13.75±9.07, mean serum creatinine 2.01±0.63 mg/dL, mean eGFR 23.00±5.69 mL/min/1.7m2. All TAVR procedures were successful, leading to a drop in transaortic mean gradient (mean gradient 33.5±14.09 mmHg; postoperative mean gradient 6.08±mmHg). No patient had more than a mild paravalvular leak. Only two patients underwent permanent pacemaker implantation due to advanced atrioventricular block (AV block). Mean change in eGFR 48 hours after the procedure was 1.3 mL/min. None of the patients developed AKI, according to Valve Academic Research Consortium-2 (VARC-2) definition., Conclusions: In patients with advanced CKD, a strategy of "zero contrast" TAVR, preceded by accurate CT scan analysis and procedural planning, appears to be safe and feasible permitting to preserve renal function. The avoidance of contrast medium during preprocedural analysis and TAVR implantation could reduce the incidence of AKI and consequently could improve outcomes in this complex patient cohort.

Background: Full aortic root replacement with biological conduit has limited options. This non-randomized cohort study aims to compare mid-term clinical and hemodynamic results of the BioIntegral (BI) composite biological versus the stentless Freestyle (FS) conduits in patients undergoing full aortic root replacement., Methods: From February 2013 to July 2017, 265 patients underwent aortic root replacement at a single institution (202 BI, 65 FS). Preoperative, intraoperative and postoperative parameters, complications including stroke, myocardial infarction (MI), endocarditis and reoperation were studied. Hemodynamic performance of both conduits was analyzed by echocardiography. Target endpoints were 30-day mortality, two-year survival, two-year freedom from major adverse valve-related and cardiovascular events., Results: Wider BI conduits were used (BI 27±2 vs. FS 25±2 mm, P<0.0001). The BI group had shorter cardiopulmonary bypass (BI 165±67 vs. FS 200±78 min, P<0.0001) and cross-clamp (BI 102±36 vs. FS 122±40 min, P=0.001) times. Thirty-day mortality was similar in both groups. There were fewer conduit-related reoperations in the BI group (BI 0% vs. FS 3%, P=0.012) but higher postoperative atrial fibrillation (BI 31% vs. FS 17%, P=0.025). No significant differences were observed for stroke (BI 5% vs. FS 10%, P=0.947), MI (BI 3% vs. FS 4%, P=0.583), or infective endocarditis (BI 0% vs. FS 2%, P=0.077). No significant hemodynamic differences were evident on follow-up echocardiography while an improved overall survival trend was seen in the BI group (P=0.062)., Conclusions: FS and BI provide comparable clinical mid-term results and hemodynamic parameters. Simplified implantation technique providing shorter cardiopulmonary bypass and operation times are advantageous for BI.

Background: Currently, the only commercial pre-assembled aortic valved conduits employ mechanical valves, requiring lifelong anticoagulation. Tissue-valved conduits that require assembly on the operating table are less standardized, require extensive experience for satisfactory results, and are limited in their longevity. The KONECT RESILIA™ Aortic Valved Conduit is a new tissue valved conduit that consists of a Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve stent, the novel RESILIA™ tissue leaflets, and a new DualFit sewing ring pre-assembled to a Terumo GelWeave Valsalva Graft™. RESILIA tissue is a bovine pericardial tissue that may offer superior anti-calcification properties compared to contemporary tissue valves; furthermore, it may be stored dry., Methods: We tested the handling and implantability of this new aortic valved conduit in 8 human cadaver hearts, as well as the valve removal potential without detaching the coronary ostia., Results: The KONECT RESILIA aortic valved conduit's handling and implantability was uniformly satisfactory. The valve inside the conduit could be easily surgically extracted, leaving the conduit and coronary ostia intact., Conclusions: We found this first evaluation of the KONECT RESILIA Aortic Valved Conduit to be that it handled well and was easily implantable and extractable in a human cadaver model.

Background: The Solo Smart pericardial aortic valve has been widely used in Europe as an option for aortic valve replacement (AVR). We are reporting early and midterm clinical outcomes of AVR with the Solo Smart valve in a single North America center., Methods: This is a retrospective study of 270 consecutive patients who had AVR at Mazankowski Alberta Heart Institute from February 2011 to March 2015. Follow-up and echocardiographic data were collected retrospectively from electronic and paper charts. Univariate and multivariate analysis were performed to evaluate the results., Results: The mean age was 71.2±10.0 years, 67.4% were male, and 79.3% had combined procedures. Mean STS Score was 4.18±3.91. Early mortality was 3.7% for the entire group and 0% for isolated AVR group. Mean cross-clamp time for isolated AVR and AVR with concomitant procedure was 70.8±12.7 min and 117.0±45.0 min, respectively. Permanent pacemaker implantation was necessary in 2.2% of patients. Echocardiography demonstrated a reduction in mean gradients from 40.8±17.4 mmHg to 7.6±3.7 mmHg and peak gradient from 72.5±48.8 mmHg to 15.5±7.5 mmHg. The 1-, 3-, and 5-year overall survival was 93.0%, 86.5% and 75.9%, respectively. At 5 years, freedom from valve-related death was 92.4%, freedom from structural valve deterioration and freedom from aortic valve reoperation were 96.4% and 98%, respectively., Conclusions: The Solo Smart valve is safe and has excellent hemodynamic performance. Aortic valve reoperation and rates of valve-related adverse events during midterm follow-up were low.

Background: Replacement of the tricuspid valve is uncommon. Prostheses specifically designed for this position are not available. Bovine, porcine as well as mechanical valve prostheses are currently used, however, the most suitable prosthesis type has not been defined., Methods: We retrospectively analyzed all consecutive patients who underwent tricuspid valve replacement (TVR) at the Medical University of Vienna from 1996 to 2014. Baseline patient characteristics, prosthesis type, and postoperative outcome data were collected., Results: A total of 58 patients underwent TVR. Forty-one patients (71%) received biological (18 bovine, 23 porcine), and 17 patients (29%) mechanical prostheses. One-year survival (70.2% vs. 76.5%, P=0.18), and freedom from reoperation at one year (86.3% vs. 94.1%, P=0.35) was not significantly different bioprostheses and mechanical valves. Freedom from reoperation rates for bovine versus porcine prostheses (one-year: 88.2% vs. 84.4%, P=0.145) were also not significantly different. However, three bovine prosthesis had to be reoperated due to high-grade central regurgitation without any signs of endocarditis or structural valve degeneration., Conclusions: There is a lack of clinical trials on tricuspid valve replacement and no specific guidelines for the choice of prosthesis. In the current study we have not identified significant differences in mortality between mechanical and biological valves. However, bovine prostheses seem less suitable for the tricuspid position due to the high closing volume with consecutive severe postoperative regurgitation.

Introduction: Life expectancy in young adults undergoing mechanical or bioprosthetic aortic valve replacement (AVR) may be reduced by up to 20 years compared to age matched controls. The Ross procedure is a durable, anticoagulation-sparing alternative. We performed a systematic review and meta-analysis to compare the valve hemodynamics of the Ross procedure versus other AVR., Evidence Acquisition: We searched Cochrane CENTRAL, MEDLINE and EMBASE from inception to February 2017 for randomized controlled trials (RCTs) and observational studies (n≥10 Ross). Independently and in duplicate, we performed title and abstract screening, full-text eligibility assessment, and data collection. We evaluated the risk of bias with the Cochrane and CLARITY tools, and the quality of evidence with the GRADE framework., Evidence Synthesis: We identified 2 RCTs and 13 observational studies that met eligibility criteria (N.=1412). In observational studies, the Ross procedure was associated with a lower mean aortic gradient at discharge (MD -9 mmHg, 95% CI: -13 to -5, P<0.0001, I2=97%) and latest follow-up (MD -5 mmHg, 95% CI: -7 to -3, P<0.0001, I2=92%). There was no significant difference in the incidence of severe aortic regurgitation at latest follow-up (RR 1.3, 95% CI: 0.3 to 5.8, P=0.70, I2=30%). In RCTs, the Ross procedure was associated with a lower mean gradient at latest follow-up (MD -15 mmHg, 95% CI: -32 to 2, P=0.08, I2=99%). The mean pulmonic gradient for the Ross procedure was 18.0 mmHg (95% CI: 16 to 20, P<0.0001) at latest follow-up. The evidence for all outcomes from observational studies was deemed to be of very low quality, while the evidence from RCTs was downgraded for imprecision and moderately serious risk of bias., Conclusions: Compared to conventional AVR, the Ross procedure was associated with better aortic valve hemodynamics. Future studies should evaluate the impact of the Ross procedure on exercise capacity and quality of life.

Background: Aim of this study was to assess the potential differences in respecting the principles of goal-directed perfusion between aortic valve replacement with sutureless vs. conventional stented bioprostheses., Methods: Data from 94 consecutive patients undergoing aortic valve replacement with Perceval sutureless valve, with or without concomitant coronary artery bypass grafting, were compared to a contemporary cohort of 116 patients receiving conventional stented bioprostheses. Propensity score matching was used to reduce selection bias. Flow-dependent estimate of oxygen delivery and carbon dioxide production were compared in accordance to the principles of goal directed perfusion. Hospital outcomes were assessed as well., Results: Propensity score matching resulted in 39 pairs with similar characteristics and operative risk. Cross-clamping time (41.6±20.6 vs. 89.6±48.2; P<0.001) and cardiopulmonary bypass time (66.9±29.4 vs. 121.2±56.6, P<0.001) were shorter in Perceval patients. Flow-dependent parameters were significantly better in Perceval patients (peak VCO2i P=0.010; nadir VO2i P=0.035; nadir DO2i/VCO2i P=0.015; peak RQ P=0.020) and therefore goal-directed perfusion principles were met more frequently (all P<0.001). Peak lactates were higher in controls (P=0.001), as well as number of patients receiving transfusions during CPB (P=0.044). QualyP Score was also higher in controls (P<0.001). Perceval patients experienced reduced postoperative bleeding, had a lower incidence of surgical revisions and transfusions. Duration of ventilation was longer in controls., Conclusions: The use of sutureless valves significantly reduces cardiopulmonary bypass and cross-clamping times and contributes to achieve a goal-directed perfusion. This results in better perfusion quality, with a positive clinical impact.

Aortic valve replacement (AVR) with biological heart valves remains the gold standard for treating operable older patients with symptomatic aortic stenosis. Over the last few years, transcatheter aortic valve implantation (TAVI) has been shown to be superior to medical treatment in high-risk patients with severe aortic stenosis. The transfemoral TAVI route has been also found in randomized controlled trials to be as good as, if not superior to, standard AVR at 5 years in high-risk patients. In intermediate-risk patients, TAVI was found in randomized controlled trials as a non-inferior alternative to surgery, with a different pattern of adverse events associated with each procedure. In retrospective propensity matched analysis, the use of TAVI in patients with an intermediate to high risk profile was associated with a significantly higher incidence of perioperative complications and decreased survival at short and mid-term when compared with conventional surgery and sutureless valve implantation. More data is needed to draw a firm conclusion comparing the two treatments in intermediate-risk patients. Sutureless bioprostheses may represent a viable alternative to standard bioprostheses for intermediate and high-risk patients when having conventional surgery.

Background: Stentless aortic valves have been developed to overcome obstructive limitations associated with stented bioprostheses. A new concept of surgical sutureless (SU) bioprosthesis has been developed in the last decade. In this multi-institutional study we sought to compare hemodynamics of different bioprosthesis concept as transcatheter (TAVR), Livanova Perceval S sutureless valve and Freedom Solo Stentless (FS) valve in patients undergoing aortic valve replacement (sAVR)., Methods: From 2010 to 2016, 478 patients underwent sAVR with FS, 518 Perceval S and 367 patients underwent TAVR. After a propensity matched analysis 185 patients in each group were selected. Thirty-day postoperative clinical and echocardiographic parameters were evaluated. Echocardiographic hemodynamic data were also collected at 12 and 24 months., Results: Mean prosthesis diameter was 23.8±1.3 mm for FS, 23.2±2.1 mm for Perceval S and 25.1±2.6 mm for TAVR. In-hospital mortality was 2.0% for FS, 1.9% for Perceval, 5.8% for TAVR (P=0.02). Postoperative FS peak gradients were 15.6±9.1 mmHg (mean 7.6±5.4 mmHg); SU gradients were 18.7±9.1 mmHg (mean 10.9±5.4 mmHg), TAVR peak gradients were 14.7±9.1 mmHg (mean 6.1±5.4 mmHg) P=0.018 (P<0.001). Postoperative effective orifice area (EOA) was 1.94±0.7 cm² for FS, 1.6±0.7 cm² for SU and 1.97±0.7cm² for TAVR (P<0.001). There was no prostheses-patient-mismatch (PPM) in FS group, while 4 cases and 2 cases are reported in SU and TAVR respectively. Postoperative grade 2-3 paravalvular leak (PVL) was present in 4.3% for TAVR and 0.5% in SU valves and no cases in FS. Postoperative permanent pacemaker implant rate was 11.9% for TAVR (1.0%) in FS group and 5.4% in SU valves (P<0.001)., Conclusions: SU patients demonstrated post-operative excellent hemodynamic performance with smaller EROA and higher gradients compared to FS and TAVR. TAVR demonstrated higher mortality and pacemaker rates. Further studies are warrented to validate TAVR indications in this subset of patients.

Background: Sutureless aortic valve prostheses have the potential of shortening surgical time, but if this results in improved clinical outcome remains to be determined. The aim of this study was to compare the outcome of patients undergoing conventional vs. minimally invasive AVR, with either a stented or sutureless bioprosthesis., Methods: From 2007 to 2015, 627 patients underwent elective isolated AVR and were divided into three groups: patients who underwent sutureless-AVR via J sternotomy (group A, N.=206) and patients who underwent stented-AVR via J sternotomy (group B, N.=247) or full-sternotomy (group C, N.=174)., Results: Patients in group A were significantly older than groups B and C (77±5 vs. 74±7 and 70±8 years; P<0.001). Aortic cross-clamp and cardiopulmonary bypass times were shorter in group A than in groups B and C. As expected, aortic cross-clamp time was prolonged in group B as compared to groups A and C (60±18 vs. 36±10 and 54±16 min; P<0.001). After multivariate adjustment, minimally invasive AVR resulted in significantly fewer postoperative complications in terms of drainage bleeding and the need for blood transfusions (385±287 vs. 500±338 mL, P=0.006; and 1.3±2.1 vs. 1.8±2.6 IU, P=0.001, respectively). No differences in postoperative outcomes were observed among groups., Conclusions: The minimally invasive approach confers a protective effect against bleeding complications, but it is time-consuming. The use of sutureless valves is associated with significantly shorter surgical times compared with stented bioprostheses. In addition, no differences in mortality were observed among groups, and patients who received a sutureless valve, though significantly older, showed a better clinical outcome than patients who received a stented valve.

Background: Nowadays, tricuspid valve replacement (TVR) is much less common than aortic or mitral valve replacement, since repair is almost always preferable. Prosthetic tricuspid valves are associated with high mortality and morbidity, mostly due to thrombotic or hemorrhagic events. Nevertheless, there is lack of evidence of which is the optimal type of valve (biological versus mechanical) in tricuspid position., Methods: We analyzed all the patients who underwent TVR in our Institution, from 2005 to 2015. Patient baseline characteristics were recorded (such as functional class, previous cardiac surgery, right ventricular dysfunction or pulmonary hypertension), and a clinical long-term follow-up was conducted. We compared the outcomes between mechanical and biological prostheses: in-hospital mortality, long-term mortality, need for reintervention and adverse events (such as stroke or valve thrombosis)., Results: During the study period 120 tricuspid prosthetic valves were implanted in 111 patients. 81 of them (67.5%) were bioprostheses, and 39 (32.5%) mechanical valves. 73 patients (60.8%) had undergone a previous cardiac surgery (28.4% had previous tricuspid surgery). Most of the patients (87.1%) were in high functional class (grade III-IV of the NYHA classification), and 85% had moderate to severe pulmonary hypertension. Mean logistic EuroSCORE I was 14.80%. Only 37 cases were isolated TVR (30.6%), as most of the cases were TVR concomitant to mitral valve replacement. In-hospital mortality was 21.7%, and during the follow-up (mean follow-up of 7 years) reached 37.5%. Three mechanical tricuspid valves (7.7%) had to be replaced due to thrombosis, while 7 biological valves (8.6%) had to be replaced due to valve deterioration. The incidence of stroke was 7.5%., Conclusions: Tricuspid valve replacement is an infrequent procedure with a high incidence of perioperative morbidity and mortality. Biological or mechanical valves have similar mortality, and a reasonably low incidence of need for reintervention due to thrombosis or valve deterioration.

Background: The most appropriate approach for high-risk patients with degenerated bioprostheses remains a matter of debate. The aim of the study was to evaluate the clinical and hemodynamic outcome of redo patients undergoing transcatheter aortic valve-in-valve implantation (VinV-TAVI) and sutureless aortic valve replacement (AVR), with assessment of patient-prosthesis mismatch (PPM) in the perioperative and follow-up period., Methods: From 2010, 343 patients underwent TAVI and 220 patients underwent sutureless AVR at our institution. Among these, 14 patients had prior bioprosthetic AVR and indication for reintervention because of valve degeneration. Patients from the TAVI group (N.=6) underwent VinV-TAVI, and patients from the sutureless group (N.=8) underwent redo AVR., Results: Mean age was 78.8±3 years in the sutureless group and 80.2±2.3 in the VinV-TAVI group. Logistic EuroSCORE was 36.4±24.1% and 33.8±13.8% in the sutureless and VinV-TAVI group, respectively. There was no in-hospital death. No patient was lost to follow-up (21±13 months, range 6 to 42). Quality of life measured with the EQ-5D questionnaire improved by 65% in the sutureless group and by 67% in the VinV-TAVI group. At follow-up echocardiographic evaluation, no paravalvular leak or intraprosthetic regurgitation was observed in either group. The mean iEOA was 0.96±0.08 vs. 0.71±0.15 cm2/m2 in the sutureless vs. VinV-TAVI group., Conclusions: In patients undergoing redo aortic valve surgery for degenerated bioprostheses, both VinV-TAVI and sutureless AVR are effective in terms of clinical outcome. As regards echocardiographic evaluation, no leak was observed in either group and no cases of severe PPM were recorded in the sutureless group.

Bioresorbable vascular scaffolds (BRS) are novel devices designed to provide transient vessel support to drug-delivery capability without the potential long-term limitations of metallic drug-eluting stents. The technology, heralded as the latest revolution in the field of percutaneous coronary intervention, could overcome many of the long-term safety concerns associated with metallic stents and possibly even convey a further clinical benefit. However, despite its theoretical advantages, the safety and efficacy of the first generation BRS remain unclear in all-comer patient populations. Invasive imaging modalities and methodologies were developed to guide BRS implantation and monitor the interaction between the scaffold and the vessel at long-term follow-up. These tools are helpful to avoid some of the pitfalls associated with BRS implantation and may improve the clinical outcome of these devices. The present review aims to report the most recent data regarding multi-imaging modalities as guidance and follow-up of coronary interventions involving the use of BRS.

The transcatheter valve-in-valve (VIV) procedure for failed aortic bioprostheses is recognized as an alternative treatment to conventional surgery in high-risk patients. This less invasive option has now been applied to failed mitral bioprostheses (VIV) or failed repairs i.e. valve-in-ring (VIR). In this emerging field, to get an optimal result, a good understanding of the design features of the failed surgical heart valve/ring, the transcatheter heart valve being used and their compatibility, is of paramount importance. Although similar in many ways to the aortic counterpart, a mitral VIV/VIR procedure can pose certain different challenges such as delayed migration and left ventricular outflow tract obstruction. This review describes the features of bioprostheses, rings and THVs relevant to a VIV/VIR procedure, and also provides guidance regarding sizing, positioning and how to avoid some of the major complications therefore improving the chances of a successful outcome.

Aim: The Crown PRT (The Phospholipid Reduction Treatment) is a new stent bovine bioprosthesis for aortic valve replacement (AVR). Aim of this paper is to report the postoperative clinical and hemodynamic results after ninety consecutive implants., Methods: After receiving CE mark in July 2014, two European university centers implanted the new Crown PRT (Sorin Group, Burnaby, Canada) for the first time. Up to now, ninety patients underwent aortic valve replacement, in isolated or combined procedures, for aortic stenosis or insufficiency. Intraoperative transesophageal echocardiogram was used to assess the prosthesis's function. In hospital outcomes and echocardiographic parameters were recorded., Results: Age and Log Euroscore were 71.8±7.9 years and 10.2%±4.5 respectively. In-hospital mortality for isolated AVR was 0%; one patient died after a multiple procedure (overall 30-days mortality 1.1%). No adverse device effects were recorded. Intensive Care Unit stay was 2±5.8 days. At discharge, echocardiogram showed no paravalvular leaks and normal postoperative gradients., Conclusion: Our starting results showed that the Crown PRT is safe and reliable, with excellent hemodynamic performance. Further clinical results with a larger population and long term follow-up are needed to assess the versatility and the durability of this new device.

Transcatheter aortic valve implantation (TAVI) has become an accepted alternative treatment option for high-risk or inoperable patients with symptomatic severe aortic stenosis. The future challenge for TAVI devices is to ensure results in terms of safety and efficacy that may justify an eligibility extension for this procedure to patients at intermediate and low risk for surgery. The ideal aortic valve prosthesis should be durable, with optimal hemodynamic performance and able to reduce the current major complications of TAVI procedure, in particular vascular complications (not infrequent with the transfemoral access route), paravalvular leaks, stroke and atrioventricular block requiring a permanent pacemaker. The SAPIEN 3™ (S3) (Edwards Lifesciences, Irvine, CA, USA) is the last Edwards family's transcatheter heart valves and incorporates a number of new and enhanced features intended to reduce the risk of vascular injury and paravalvular regurgitation, and to facilitate rapid and accurate positioning and implantation. The first data on S3 (SAPIEN3 trial) were presented at the EuroPCR 2014 and confirmed the advantage of the S3 compared with the previous Edwards valves (SAPIEN and SAPIEN XT) in terms of prevention of vascular complications and of moderate-severe paravalvular leaks, but showed an increase in the need of a permanent pacemaker post-TAVR. The S3 is certainly a promising evolution of transcatheter valves which may effectively reduce the risk of vascular complications and paravalvular leak. However, the S3 seems to be related to an increased risk of atrioventricular block, even if this complication could be due to the need to implant the valve in a higher position compared to previous models.

Managing graft infections is a challenge in vascular surgery. The incidence of vascular graft infections varies between 2% and 6%. The number of patients treated by means of implantation of artificial prostheses is constantly growing. The treatment of vascular graft infections remains controversial. This article discusses in-situ repair and the role of extra-anatomic routes. Homografts present the lowest rate of reinfection with acceptable rates of degradation and aneurysm formation. Silvergrafts and synthetic grafts coated with antimicrobials show similar early and late mortality rates, but higher reinfection rates. The outcome extra-anatomic bypass surgery seems to be improved in actual series compared with historical results but their disadvantages (limited patency, higher rate of amputations as well as high rates of reintervention combined with higher early mortality) are obvious.

Aim: The aim of this paper was to develop a new self-expandable aortic valved stent following the shape of the sinus of Valsalva, which can be deployed above native leaflets for aortic regurgitation, and study it's effect on coronary artery flow when orthotopic implantation in and above native leaflets., Methods: New self-expandable aortic valved stent consist of nitinol stent and bovine pericardium, and was designed following the shape of the sinus of Valsalva, the bovine pericardium was tailed as native leaflet. Thirty-six swine hearts were divided into three equal groups of twelve. In Group A (N.=12), the new self-expandable aortic valved stents deployed in native leaflets. In Group B (N.=12), the new self-expandable aortic valved stents deployed above native leaflets. In Group C (N.=12), the cylinder-like valved stents deployed only in native leaflets. The measurements of each coronary flow rate and endoscopic inspections were repeated post-implantation., Results: In Group A and C, valve implantation in native leaflets resulted in a significant decrease in both left and right coronary flows. In Group B, no significant change in either right or left coronary flow was found after new self-expandable aortic valved stent placement. Endoscopic inspections showed that in group A and C the native leaflets sandwiched between valved stent and aortic wall, whereas, in group B the native leaflets were under the artificial leaflets., Conclusion: Two kinds of stents deployed in native leaflets affect left and right coronary flows significantly. No significant effect was found when the new self-expandable aortic valved stent deployed above native leaflets. This new self-expandable aortic valved stent can be deployed above the native leaflets, which avoids the obstruction of native leaflets on coronary flow.

Arterial prosthetic graft infection is one of the most challenging issues in vascular surgery. We report a case of an infected descending thoracic aorta endograft, presenting itself several years after placement, with hemoptysis and back pain as referred symptoms. The patient was successfully treated by removing the thoracic aorta and replacing the infected endografts with a cryopreserved aortic allograft, running from the left subclavian artery to the aortic diaphragmatic hiatus.

Aim: Aim of this study was to elucidate if postoperative neurocognitive function after biological aortic valve replacement (AVR) can be influenced by temperature management during cardiopulmonary bypass (CPB)., Methods: In this prospective randomized study, we measured the effect of mild hypothermic (32 °C, N.=30) vs. normothermic (37 °C, N.=30) CPB on neurocognitive function. All patients underwent elective isolated biological AVR (mean age 67 ± 8 years, mean additional EuroSCORE 5.6 ± 2.4). Neurocognitive function was objectively measured by means of objective P300 auditory-evoked potentials before surgery, one week and four months after surgery. Clinical data and outcome were monitored., Results: P300 evoked potentials were comparable between patients operated with mild hypothermic (370 ± 30 ms) and normothermic CPB (373 ± 32 ms) before surgery (P=0.85). P300 peak latencies were prolonged (=impaired) in patients operated with normothermic (402 ± 29, P<0.0001) as well as with mild hypothermic CPB (405 ± 30 ms, P<0.0001) one week after surgery. Even four months after surgery, still impairment of P300 peak latencies could be documented in either patients operated with normothermic (394 ± 28 ms) and mild hypothermic CPB (400 ± 33 ms,) in repeated measures analysis of variance (P=0.042). Group comparison revealed no difference between patients operated with normothermic and mild hypothermic CPB at one week (P=0.54) and four months (P=0.67) after surgery. Clinical data as well as postoperative adverse events were comparable between the two groups., Conclusion: Normothermic temperature management during CPB is non-inferior to hypothermic in means of neuroprotection. Since patients after biological aortic valve replacement show a subclinical but measurable cognitive deficit up to four months after surgery, other factors have to be addressed to add further benefit to the extremely good results of open biological AVR.

Aim: The aim of the study was to evaluate the early and late results of aortic replacement using cryopreserved homografts and autologous deep veins for infected infrarenal prosthetic reconstructions and the influence of type of bacteria on the mortality., Methods: Thirty-three patients were treated from 30 March 1994 to 01 September 2008 for aorto-femoral or iliaco-femoral graft infections with homografts (HG:19) or autologous deep veins (DV:14). The diagnosis was based on physical signs, bacteriological tests and computed tomography(CT) scans. We obtain cryopreserved homografts from our non-profit vessel bank, deep veins were harvested before the arterial reconstruction. Patients were followed by clinical examination and ultrasound., Results: The infections occurred 47.78 ± 20 months after the primary operations; 45% of the infections were caused by Gram-negative bacteria. Treatment indications included seven aortoduodenal fistula (21.2%) and six septic para-anastomotic bleedings (18.2%). There were six in-hospital deaths (18.2%). All the deceased patients had Gram-negative bacteria in cultures and pluribacterial infections. No patient died with single staphylococcus, streptococcus or MRSA infection. At three years freedom from reinfection was 100% in DV group and 82% (CI:0.56-0.92) in the homograft group. Survival after three years was 71% (CI:0.48-0.88) in HG group and 79% (CI:0.49-0.94) in DV group. The difference is not significant., Conclusion: For infrarenal graft infection homograft replacement or deep vein implantation is durable method and eradicate late reinfection. The in-hospital mortality is significantly higher in patients with aortoduodenal fistulas with Gram-negative organisms regardless of the conduit used for aortic replacement.

Tissue-engineered heart valves (TEHVs) promise to be the ideal heart valve replacement: they have the potential to grow and repair within the host, to minimise inflammatory and immunological responses and to limit thromboembolism. Viable cells included in TEHVs can theoretically adapt to a growing and changing environment exactly as a native biological structure. This could be extremely important in case of paediatric applications, where reoperations are frequently required to replace failed valve substitutes or to accommodate the growth of the patient. At present time the biological matrix from allogenic or xenogenic decellularized valves represents an appropriate valve scaffold in TEHVs, showing theoretically an ability to grow and repair within the host. Viable cells included in extracellular valve matrix can theoretically adapt to a growing and changing environment like the native biological structure. The aim of this paper is to present a review concerning the use of homograft and allograft valves as an ideal substrate for cardiac engineered tissue valves that represent an exciting possibility for in situ regeneration and repair of heart valves.

Several limitations inherent to the implantation of a metallic device, such as the occurrence of in-stent re-stenosis, in an arterial lumen intuitively explain the interest for developing bio-absorbable stents. Two main types of bio-absorbable stents currently exist: polymer stents and metallic stents. To date, no studies with bio-absorbable stents have been conducted in the superficial femoral artery (SFA). Because of their strut thickness and lack of radial force, polymer stents are no good candidates for endovascular use. Absorbable metal stents (AMS) do have the potential to perform well for artery treatment, although current evidence from in-human coronary and infrapopliteal studies yield unsatisfactory results. Drastic technological improvements are mandatory before AMS can be considered for every day practice. Yet, it is our belief that further development of other metal and non-metal bio-absorbable stents, with or without drug-coating, may lead to the creation of the ultimate SFA stent.

Aim: Postoperative renal dysfunction after aortic valve replacement is a serious complication. To minimize its occurrence, risk factors have to be identified, and if possible eliminated., Methods: Of 1000 consecutive patients, who underwent AVR, a file study was performed chi(2)nd logistic regression analysis were performed to study the effect of 24 preoperative, 7 peroperative and 7 postoperative factors on the occurrence of 30-day postoperative worsening of renal function., Results: Fifty-three patients had a 30-day postoperative decrease of renal function. Nine of these patients died, which is significantly more than the mortality without this complication (P<0.0001). In those nine patients, another complication (postoperative heart failure, thromboembolism or respiratory failure) was present. Thirteen factors were significant in an univariate analysis: preoperative renal dysfunction (P<0.001), age>80 (P<0.001), atrial fibrillation (P<0.001) , preoperative pulmonary edema (P=0.001), conduction defect (P=0.002), diabetes (P=0.006), myocardial infarction (P=0.006), postoperative heart failure (P=0.007), cross clamp time >75 min (P=0.015), previous coronary artery bypass grafting (CABG) (P=0.018), concomitant CABG (P=0.031), ejection fraction <50% (P=0.033) and CVA (P=0.035). Four factors were identified as independent predictors in a multivariate analysis: renal dysfunction (P<0.001, Odds ratio [OR] 5.5; 95% confidence interval [CI] 2.9-10.4), preoperative atrial fibrillation (P=0.010, OR=2.3, 95% CI=1.2-4.2), age>80 (P=0.014, OR=2.2, 95% CI=1.2-4.1) and myocardial infarction (P=0.022, OR=2.2, 95% CI=1.1-4.4)., Conclusions: Few factors are liable for therapeutic intervention, especially in elderly and patients with comorbidity. In patients with risk factors, shortening of cross clamping time or installation of minimal extracorporeal circulation might be beneficial.

Aim: Despite continuous development of anticalcification treatment for bioprosthetic valves, calcification remains one major cause of structural failure. The aim of this study is to investigate changes in hemodynamic performance and leaflet kinematics in progressively calcified pericardial and porcine aortic valve prostheses., Methods: Five pericardial (Edwards Perimount Magna) and 5 porcine (Medtronic Mosaic Ultra) aortic valve prostheses (Ø23 mm) were exposed to a high concentration Calcium-phosphate fluid in an in vitro pulse duplicator (300 cycles/minute) for 6 weeks. The prostheses were removed weekly and tested in an artificial circulation system (70 beats/min, Cardiac Output 5 l/min). All prostheses underwent X-ray, computed tomography (CT)-Scan and photographic examination for evaluation of progressive calcification. Leaflet kinematics were visualized with a high-speed camera., Results: Pericardial valves demonstrated faster degeneration with significantly larger radiographic areas of leaflet calcification (16.5+/-4.3% versus 5.6%+/-2.0%) and also significantly higher Ca-uptake (170+/-71 microg/mg versus 103+/-49 microg/mg) after 6 weeks. Despite degeneration systolic function remained superior for pericardial valves (mean effective orifice area [EOA] 1.52+/-0.05 versus 1.28+/-0.11 cm2, P<0.01), but leaflet kinematics showed longer closing times (135+/-11 msec versus 85+/-9 msec after 6 weeks) accompanied by higher regurgitant flow (7.8+/-1.12 mL versus 1.2+/-0.28 mL, P<0.001)., Conclusion: In vitro pericardial valves calcified faster and more severe than porcine valves leading to impaired diastolic function with prolongation of closing times and higher closing volume. Systolic function remained almost undisturbed by the calcification process. As a consequence in clinical settings, follow-up examinations for structural valve deterioration in porcine valves should focus on systolic performance, in pericardial valves on diastolic function.