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Objectives: Transcatheter aortic root repair is still not available because of the technical challenge of coronary perfusion. The use of chimney grafts for coronary ostia can be an option and we tested the flow-through coronary chimney grafts deployed in a 3-dimensional-printed root model as part of a transcatheter aortic root repair system., Methods: A 3-dimensional-printed root was used to test the coronary flow after the deployment of 1 root endograft (28 mm diameter) and two 6-mm diameter 10-cm long coronary chimney grafts. Continuous coronary flows were measured in a bench test at different pressure levels (60, 80 and 100 mmHg) and compared to target coronary flows (250 ml/min at rest for the left and 150 ml/min at rest for the right coronary artery)., Results: The computed tomography scan-based root was modified with two 5-mm diameter coronary conduits to overcome the limits of the original 3-dimensional-printed coronary ostia. The root was placed in the hydrodynamic system: adjusted coronary free flow at 60, 80 and 100 mmHg of pressure was 1913, 2200 and 2480 ml/min for left coronary and 1633, 2026 and 2366 ml/min for right coronary, respectively. After endografts deployment, mean chimney graft flow at 60, 80 and 100 mmHg of pressure was 1053 ml/min (-45%), 1306 ml/min (-41%) and 1502 ml/min (-40%) for the left coronary and 1100 ml/min (-33%), 1460 ml/min (-28%) and 1626 ml/min (-31%) for the right coronary, respectively., Conclusions: In this preliminary study, chimney grafts for transcatheter aortic root repair provided 830% of target flow in the right coronary (-31% of free flow) and 414% of target flow in the left coronary (-42% of free flow) which is more than sufficient for both coronaries in real-life conditions. The potential of this approach should be further explored with specifically designed endografts., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The aim was to evaluate the impact of a bicuspid aortic valve (BAV) on local shear stress and on the pressure profile on the elements of the aortic root (AoR)., Methods: The experiment setup included a BAV with aortic valve stenosis (n = 5 pigs, 67 ± 3.5 kg) and insufficiency (n = 5 pigs, 66.7 ± 4.4 kg). By implanting 6 high-fidelity microsonometric crystals in each AoR, we determined the 3-dimensional (3D) geometry of the AoR. Experimental and geometric data were used to create a 3D time- and pressure-dependent computed fluid dynamic model of the AoR with the BAV., Results: 3D AoR geometry was determined by AoR tilt (α) and rotation angle (β). Both values were maximal at the end of diastole: 24.41 ± 1.70° (α) and 20.90 ± 2.11° (β) for BAV with stenosis and 31.92 ± 11.51° (α) and 20.84 ± 9.80° (β) for BAV with insufficiency and minimal at peak ejection 23.42 ± 1.65° (α), 20.38 ± 1.61° (β) for stenosis and 26.62 ± 7.86° (α), 19.79 ± 8.45° (β) for insufficiency. In insufficiency, low shear stress of 0-0.08 Pa and moderate pressure (60-80 mmHg) were present. In BAV with stenosis, low shear stress of 0-0.5 Pa and moderate pressure (0-20 mmHg) were present at diastole; at peak ejection high shear stress >2 Pa and elevated pressure of >80 mmHg were present., Conclusions: In a BAV with aortic valve stenosis, the haemodynamics are less favourable. The elevated pressure with elevated shear stress may over the long term promote degenerative processes in the leaflets and consequently valve function failure.

Objectives: To treat aortic valve disease and concomitant root disease with transcatheter techniques, 'composite graft' implants are required. Our goal was to assess the suitability of the porcine aortic root for transcatheter root repair tests., Methods: Eight pig hearts explanted from domestic pigs used in experimental surgery were compared to data from the literature on human hearts. The measured diameters included those of the annulus, sinuses of Valsalva, coronary ostia, sinotubular junction, ascending aorta, innominate artery and aortic arch. The measured distances were from the coronary ostia to the nadir of the corresponding annulus; from the innominate artery to the nadir of the corresponding annulus; from the small curvature of the arch to the nadir of the corresponding annulus., Results: The mean weight of the pigs was 89 ± 5.4 kg. The mean aortic annulus diameter was 20 ± 1.2 mm (human: 23.0 ± 2.5 mm), the sinus of Valsalva diameter was 20.5 ± 0.5 mm (human: 31.4 ± 3.4 mm) and the sinotubular junction diameter was 20 ± 0.9 mm (human: 27.2 ± 3.0 mm). The diameter of the mean ascending aorta was 19 ± 0.7 mm (human: 29.3 ± 4 mm); the diameter of the innominate artery was 8.5 ± 0.7 mm, that of the aortic arch was 15 ± 0.7 mm and that of the coronary ostia was 5 ± 0.5 mm (left) and 4.7 ± 0.5 mm (right) (human: 4.8 ± 0.5 mm and 3.7 ± 0.9 mm). The distances from the left and right coronary orifices to the corresponding annuli were 8 ± 1.5 mm and 14 ± 2.4 mm, respectively (human: 14.7 ± 1.3 mm; 15.4 ± 1.7 mm). The distances from the innominate artery to the nadirs of the left and right coronary annuli were 44 ± 4.3 mm and 41 ± 4 mm (human: 80 ± 17 mm). The distance from the curvature of the small arch to the annulus was 35 ± 4.9 mm., Conclusions: The porcine heart can be used as an experimental model to design and test new devices for catheter-based composite repair of the aortic root. Nevertheless, caution is required in using devices with tailored dimensions that must be adapted to the smaller pig's root.

Background: The aim was to evaluate the impact of aortic root (AoR) annuloplasty on 3D AoR deformation., Methods: In experimental setup, Yacoub procedure and Yacoub with annuloplasty were performed. Results were compared to native AoR. In each AoR modality, six microsonometric (2 mm, 200 Hz) crystals were implanted at the sinotubular junction (STJ) and at the AoR base (AoB). 3D deformation of the AoR was determined by AoR tilt (α) and rotation (β) angle changes., Results: Tilt angle in Yacoub AoR with annuloplasty and in Yacoub AoR was maximal at ejection, 26.71 ± 0.18° and 24.91 ± 0.13°, respectively, and minimal at diastole, 25.34 ± 0.15° and 21.90 ± 0.15°, respectively. Rotation angle in Yacoub AoR with and without annuloplasty was maximal at ejection, 27.04 ± 0.25° and 23.53 ± 0.54°, respectively, and minimal at diastole, 24.84 ± 0.14° and 21.62 ± 0.16°, respectively. In native AoR, tilt angle and rotation were minimal at ejection, 14.34 ± 0.81° and 18.1 ± 3.20°, respectively, and maximal at diastole, 18.78 ± 0.84° and 21.23 ± 021°, respectively. AoB and STJ had maximal expansion at ejection; 2.59 ± 2.40% and 6.05 ± 0.66 for Yacoub and 3.75 ± 0.66% and 3.08 ± 0.24% for Yacoub with annuloplasty. In native AoR, the expansion at ejection for AoB was 7.13 ± 2.68% and for STJ was 16.42 ± 0.63%., Conclusions: AoB annuloplasty reduces AoB deformation and has an impact on STJ dynamics. In both the Yacoub AoR modalities, during ejection, the AoR takes on more of a cone-like geometry, whereas in native AoR, it is of a cylinder-like shape., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: In this study, the effect of aortic valve (AV) pathology on local hemodynamic conditions was evaluated as a potential trigger for the onset of acute type A and B aortic dissection., Methods: A time- and pressure-related four-dimensional (4-D) computed fluid dynamic model of the aorta was established. In an experimental setup, AV stenosis and AV insufficiency were created. 4-D pressure-related geometry of the aortic root (AR) with valve insufficiency and valve stenosis were determined by high-fidelity (200 Hz) microsonometric crystals. Flow and pressure were obtained at the left ventricle, ascending aorta, and aortic arch., Results: Expansion of the AR in AV insufficiency was higher with expansion in AV stenosis, at peak ejection, and at the end of systole. In AV insufficiency, there was low shear stress (0 to 0.6 Pa), turbulent flow, and high pressure (80 to 95 mm Hg) at the anterior wall of the ascending aorta, at the proximal aortic arch, and at the aortic isthmus. In stenosis, high shear stress (>2 Pa) and high pressure (>95 mm Hg) were found at the ascending aorta and at the bifurcation of the brachiocephalic trunk., Conclusions: In AV insufficiency, low shear stresses and turbulent flow regions were documented at the traditional levels of entry tears for acute type A and B dissection. In AV stenosis, high shear stress with elevated pressure at the ascending aorta may be a trigger element for vessel dilatation, aneurysm formation, and intimal tear, which is typical for type A aortic dissection., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: To compare the outcome and the 1-year hemodynamic results of the rapid-deployment Intuity valve versus the Perimount Magna bioprosthesis in matched populations., Methods: Between March 2014 and May 2015, 32 patients underwent aortic valve replacement with the Intuity valve (Intuity-group). These patients were compared to a matched population of Perimount valves implanted during the same period of time (Perimount-group). Clinical data were compared and echocardiographic 1-year follow-up was performed., Results: There were more female patients in the Intuity-group (47% vs 22%, p = 0.035); mean age was 78 ± 5.6 and 72.5 ± 6 years in the Intuity-group and Perimount-group (p < 0.001); coronary disease was more common in the Intuity-group (65% vs 25%, p = 0.005). Other characteristics were similar. Implants were 100% successful. Mean cross-clamp (50.3 ± 25 vs 53 ± 22 min, p = 0.004), cardiopulmonary bypass (68 ± 27 vs 72 ± 31.8 min; p = 0.006), and surgical times (156.8 ± 54 vs 165 ± 40 min; p = 0.018) were shorter with the Intuity despite more concomitant procedures. Mean valve size was 23.7 mm (Intuity-group) and 24.1 mm (Perimount-group); hospital mortality was zero (Intuity-group) and 3% (Perimount-group); new pacemaker implants were 6% (Intuity) and 3% (Perimount) (p = 0.55) and hospital stay was equivalent. Mean gradients were: 9.9 ± 3.4 (Intuity) versus 12.5 ± 3.8 mmHg (Perimount) (p = 0.022) at discharge and 9 ± 4 mmHg (Intuity) versus 14 ± 4 mmHg (Perimount) (p = 0.02) at follow-up. At discharge, one Intuity valve had 3+ aortic insufficiency (AI) which was unchanged at 1 year and will require an intervention. Another patient had 1 + AI which progressed to 2+ at 1 year. There were no paravalvular leaks in the Perimount valves at discharge and follow-up., Conclusion: Intuity valves showed lower gradients compared to Perimount valves with the same mean size. Paravalvular leaks identified at the time of implantation in Intuity valves need to be addressed at the time of surgery., (© 2017 Wiley Periodicals, Inc.)

Objectives: Transapical valve implantation is traditionally performed through a left antero-lateral mini-thoracotomy. A self-expandable apical closure device has recently been developed for full-percutaneous transapical valve implantation. We performed haemodynamics stress-tests on an animal model to evaluate the sealing properties., Methods: Under general anaesthesia 5 pigs (mean weight: 67 ± 6 Kg) received full heparinization (100 IU/Kg; activated clotting time >250 s and, through inferior mini-sternotomies, 21-Fr introducer sheaths for transapical aortic valve implantation (outer diameter: 25-Fr) were placed over-the-wire in the apexes. Delivery-catheters carrying folded occluders (SAFEX TM final design) were inserted in the introducer sheaths and plugs were then deployed under fluoroscopic guidance. Phase 1: after protamine injection, apical bleeding was monitored for 1 h with standard haemodynamics condition. Phase 2: we induced systemic hypertension with adrenaline infusion to test the sealing properties under stress. Animals were sacrificed after Phase 2 and hearts were removed and inspected., Results: Five plugs were successfully introduced and deployed in 5 pig hearts. Plugs provided good apical sealing in each animal and a mean of 7 ± 4 ml of blood lost per animal was collected during Phase 1: haemodynamics remained stable and no plug dislodgement was detected (mean blood pressure: 52 ± 9 mmHg). During Phase 2, mean systolic and diastolic peak levels reached 268 ± 24 mmHg and 175 ± 17 mmHg, respectively, without plug dislodgment or bleeding. Post-mortem inspection showed good plug deployment and fixation without myocardial damage., Conclusions: The new apical occluder seals large-sized apical access sites in animal models also during induced systemic hypertension. This pilot study is a further step towards full-percutaneous transapical valve procedures in the clinical setting., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The aim was to evaluate the impact of the aortic valve reimplantation (David) and of the aortic root (AoR) remodelling (Yacoub) on the AoR haemodynamics., Methods: In an experimental setup where the clinical scenario of Yacoub, ( n =  5, domestic pig) and of David ( n =  5, domestic pig) procedure was performed in each AoR, six high-fidelity (200 Hz) sonomicrometric crystals were implanted. Crystals were positioned at three commissures with their projection at the root base. In post-measurement processing 3D deformation of both AoR was determined and used for computed fluid dynamic modelling in order to evaluate pressure, velocity and shear stress profiles., Results: In David AoR: high pressure (> 150 mmHg) and low to moderate shear stress (0-30 Pa) were found from the period of isovolemic contraction to the closure of the aortic valve. At mid diastole pressure augmentation (> 120 mmHg) a low shear stress (0-10 Pa) was registered at the leaflets, three commissures, and intervalvular triangles. In Yacoub AoR: high pressure (110-130 mmHg) with moderate low shear stress (0-30 Pa) was only registered at isovolemic contraction., Conclusions: The results show that haemodynamic conditions following a David procedure have a less favourable pattern as compared to a Yacoub AoR. In David AoR, high pressure and low shear stress are present during 2/3 of the cardiac cycle, whereas in Yacoub root, these conditions are present only for a short period of isovolemic contraction., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The aim was to determine 3-dimensional (3D) geometrical deformation of the aortic root (AoR) following the David procedure in order to evaluate local haemodynamical conditions of individual AoR elements., Methods: In the experimental set-up, the David procedure was performed on 10 domestic pigs. Data were compared with the measurements obtained in 10 native AoRs. In each AoR, six high-resolution ultrasonometric crystals (200 Hz) were implanted, being positioned at each commissure and at the AoR base. 3D geometrical deformation of the AoR, torsion and tilt angle was determined. Computed fluid dynamics (CFD) simulation analysis was used to evaluate local pressure, flow and shear stress., Results: In David AoRs, the tilt angle was maximal at a peak ejection of 25.9 ± 1.49° and minimal at the end of isovolemic contraction at 23.5 ± 0.80°. David root rotation was maximal at a peak ejection of 27.93 ± 1.54° and minimal at the end of the isovolemic contraction at 25.7 ± 1.32°. In the native AoR, the opposite was observed. Here, the tilt and rotation angle were maximal at the end of isovolemic contraction (17.25 ± 0.68° and 19.71 ± 0.73°) and decreased to its minimal values at peak ejections (14.1 ± 0.62° and 16.33 ± 0.47°). In David AoR, high pressure (>140 mmHg) combined with low-to-moderate shear stress (0-40 Pa) was found at the leaflet body from the beginning of isovolemic contraction till the opening of the aortic valve. Similar high pressure (>140 mmHg) and shear stress (0-40 Pa) were found in the period from aortic valve closure till the beginning of the isovolemic contraction. In native AoRs, high pressure (>95 mmHg) was conjoined with low-to-moderate shear stress (0-30 Pa) at the leaflets and was registered at the end of isovolemic contraction., Conclusions: The David AoR is haemodynamically less favourable when compared with the native AoR. During almost two-thirds of the time period of the cardiac cycle, AoR elements are exposed to high pressure and low shear stress. In contrast, in native AoRs, similar conditions were present only during the short period of isovolemic contraction., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The aim was to define the 3-dimensional (3D) geometrical changes of the aortic root and to determine the local shear stress profile of aortic root elements during the cardiac cycle., Methods: Six sonomicrometric crystals (200 Hz) were implanted into the aortic root of five pigs at the commissures and at the aortic root base (AoB). 3D aortic root deformation including volume, torsion and tilt angle were determined. Geometrical data with measured local flow and pressure conditions was used for computed fluid dynamics modelling of the aortic root., Results: Compared with end-diastole, the sinotubular junction and AoB have maximal expansion at peak ejection: 16.42 ± 6.36 and 7.60 ± 2.52%, and minimal at isovolaemic relaxation: 2.87 ± 1.62 and 1.85 ± 1.79%. Aortic root tilt and rotation angle were maximal at the end of diastole: 17.7 ± 8.8 and 21.2 ± 2.09°, and decreased to 15.24 ± 8.14 and 18.3 ± 0.1.94° at peak ejection. High shear stress >20 Pa was registered at peak ejection at coaptations, and during diastole at the superior two-thirds of the leaflets and intervalvular triangles (IVTs). The leaflet body, inferior one-third of the IVTs and valve nadir were exposed to moderate shear stress (8-16 Pa) during the cardiac cycle., Conclusions: Aortic root geometry demonstrates precise 3D changes of tilt and rotation angle. Reduction of angles during ejection results in a straight cylinder with low shear stress that facilitates the ejection; the increase during diastole results in a tilted frustum with elevated shear stress. Findings can be used for comparative analysis of native and synthetic structures with individual compliance., (© The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Rapid deployment aortic valve replacement (RDAVR) with the use of rapid deployment valve systems represents a smart alternative to the use of standard aortic bioprosthesis for aortic valve replacement. Nevertheless, its use is still debatable in patients with pure aortic valve regurgitation or true bicuspid aortic valve because of the risk of postoperative paravalvular leak. To address this issue, an optimal annulus-valve size match seems to be the ideal surgical strategy. This article describes a new technique developed to stabilize the aortic annulus and prevent paravalvular leak after RDAVR. To confirm the feasibility, this technique was performed in six patients with severe symptomatic aortic stenosis who were scheduled to undergo aortic valve replacement at our center. All patients survived surgery and were discharged from the hospital. There were no new intracardiac conduction system disturbances observed, and a permanent pacemaker implantation was not required in any of the patients. The intraoperative and postoperative echocardiogram confirmed successful positioning of the valve, and no paravalvular leak was observed. In this preliminary experience, RDAVR through a full sternotomy or an upper hemisternotomy approach with the use of aortic annulus stabilization technique was safe, and no leak was observed. Future studies on large series of patients are necessary to confirm the safety and effectiveness of this technique in preventing paravalvular leak in patients with true bicuspid aortic valves or pure aortic regurgitation.

There is controversy over the use of the Ross procedure with regard to the sub-coronary and root replacement technique and its long-term durability. A systematic review of the literature may provide insight into the outcomes of these two surgical subvariants. A systematic review of reports between 1967 and February 2013 on sub-coronary and root replacement Ross procedures was undertaken. Twenty-four articles were included and divided into (i) sub-coronary technique and (ii) root replacement technique. The 10-year survival rate for a mixed-patient population in the sub-coronary procedure was 87.3% with a 95% confidence interval (CI) of 79.7-93.4 and 89.1% (95% CI, 85.3-92.1) in the root replacement technique category. For adults, it was 94 vs 95.3% (CI, 88.9-98.1) and in the paediatric series it was 90 vs 92.7% (CI, 86.9-96.0), respectively. Freedom from reoperation at 10 years was, in the mixed population, 83.3% (95% CI, 69.9-93.4) and 93.3% (95% CI, 89.4-95.9) for sub-coronary versus root replacement technique, respectively. In adults, it was 98 vs 91.2% (95% CI, 82.4-295.8), and in the paediatric series 93.3 vs 92.0% (95% CI, 86.1-96.5) for sub-coronary versus root replacement technique, respectively. The Ross procedure arguably has satisfactory results over 5 and 10 years for both adults and children. The results do not support the advantages of the sub-coronary technique over the root replacement technique. Root replacement was of benefit to patients undergoing reoperations on neoaorta and for long-term survival in mixed series., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Concomitant aortic and mitral valve replacement or concomitant aortic valve replacement and mitral repair can be a challenge for the cardiac surgeon: in particular, because of their structure and design, two bioprosthetic heart valves or an aortic valve prosthesis and a rigid mitral ring can interfere at the level of the mitroaortic junction. Therefore, when a mitral bioprosthesis or a rigid mitral ring is already in place and a surgical aortic valve replacement becomes necessary, or when older high-risk patients require concomitant mitral and aortic procedures, the new 'fast-implantable' aortic valve system (Intuity valve, Edwards Lifesciences, Irvine, CA, USA) can represent a smart alternative to standard aortic bioprosthesis. Unfortunately, this is still controversial (risk of interference). However, transcatheter aortic valve replacements have been performed in patients with previously implanted mitral valves or mitral rings. Interestingly, we learned that there is no interference (or not significant interference) among the standard valve and the stent valve. Consequently, we can assume that a fast-implantable valve can also be safely placed next to a biological mitral valve or next to a rigid mitral ring without risks of distortion, malpositioning, high gradient or paravalvular leak. This paper describes two cases: a concomitant Intuity aortic valve and bioprosthetic mitral valve implantation and a concomitant Intuity aortic valve and mitral ring implantation., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Transcatheter aortic valve replacement (TAVR) provides good results in selected high-risk patients. However, it is unclear whether this procedure carries advantages in extreme-risk profile patients with logistic EuroSCORE above 35%., Methods: From January 2009 to July 2011, of a total number of 92 transcatheter aortic valve procedures performed, 40 'extreme-risk' patients underwent transapical TAVR (TA-TAVR) (EuroSCORE above 35%). Variables were analysed as risk factors for hospital and mid-term mortality, and a 2-year follow-up (FU) was obtained., Results: The mean age was: 81 ± 10 years. Twelve patients (30%) had chronic pulmonary disease, 32 (80%) severe peripheral vascular disease, 14 (35%) previous cardiac surgery, 19 (48%) chronic renal failure (2 in dialysis), 7 (17%) previous stroke (1 with disabilities), 3 (7%) a porcelain aorta and 12 (30%) were urgent cases. Mean left ventricle ejection fraction (LVEF) was 49 ± 13%, and mean logistic EuroSCORE was 48 ± 11%. Forty stent-valves were successfully implanted with six Grade-1 and one Grade-2 paravalvular leakages (success rate: 100%). Hospital mortality was 20% (8 patients). Causes of death following the valve academic research consortium (VARC) definitions were: life-threatening haemorrhage (1), myocardial infarction (1), sudden death (1), multiorgan failure (2), stroke (1) and severe respiratory dysfunction (2). Major complications (VARC definitions) were: myocardial infarction for left coronary ostium occlusion (1), life-threatening bleeding (2), stroke (2) and acute kidney injury with dialysis (2). Predictors for hospital mortality were: conversion to sternotomy, life-threatening haemorrhage, postoperative dialysis and long intensive care unit (ICU) stay. Variables associated with hospital mortality were: conversion to sternotomy (P = 0.03), life-threatening bleeding (P = 0.02), acute kidney injury with dialysis (P = 0.03) and prolonged ICU stay (P = 0.02). Mean FU time was 24 months: actuarial survival estimates for all-cause mortality at 6 months, 1 year, 18 months and 2 years were 68, 57, 54 and 54%, respectively. Patients still alive at FU were in good clinical condition, New York Heart Association (NYHA) class 1-2 and were never rehospitalized for cardiac decompensation., Conclusions: TA-TAVR in extreme-risk patients carries a moderate risk of hospital mortality. Severe comorbidities and presence of residual paravalvular leakages affect the mid-term survival, whereas surviving patients have an acceptable quality of life without rehospitalizations for cardiac decompensation.

Background and Aim of the Study: Transapical transcatheter aortic valve replacement (TAVR) is a new minimally invasive technique with a known risk of unexpected intra-procedural complications. Nevertheless, the clinical results are good and the limited amount of procedural adverse events confirms the usefulness of a synergistic surgical/anesthesiological management in case of unexpected emergencies., Methods: A review was made of the authors' four-year database and other available literature to identify major and minor intra-procedural complications occurring during transapical TAVR procedures. All implants were performed under general anesthesia with a balloon-expandable Edwards Sapien stent-valve, and followed international guidelines on indications and techniques., Results: Procedural success rates ranged between 94% and 100%. Life-threatening apical bleeding occurred very rarely (0-5%), and its incidence decreased after the first series of implants. Stent-valve embolization was also rare, with a global incidence ranging from 0-2%, with evidence of improvement after the learning curve. Rates of valve malpositioning ranged from 0% to < 3%, whereas the risk of coronary obstruction ranged from 0% to 3.5%. Aortic root rupture and dissection were dramatic events reported in 0-2% of transapical cases. Stent-valve malfunction was rarely reported (1-2%), whereas the valve-in-valve bailout procedure for malpositioning, malfunctioning or severe paravalvular leak was reported in about 1.0-3.5% of cases. Sudden hemodynamic management and bailout procedures such as valve-in-valve rescue or cannulation for cardiopulmonary bypass were more effective when planned during the preoperative phase., Conclusion: Despite attempts to avoid pitfalls, complications during transapical aortic valve procedures still occur. Preoperative strategic planning, including hemodynamic status management, alternative cannulation sites and bailout procedures, are highly recommended, particularly during the learning curve of this technique.

Objectives: Guidelines proposed bioprosthesis implantation for aortic valve disease if the patients were at least 65 years old at the time of surgery, with a trend towards even younger patients in recent years. Considering the adverse effects of lifetime anticoagulation, new biological valves (less prone to degeneration) and new technologies may lead patients and surgeons to different choices. Therefore, it is interesting to analyse the results of aortic bioprosthetic valve replacement in patients aged <65 years at the time of surgery., Methods: From January 2000 to December 2010, 84 patients aged <65 years at the time of surgery had undergone an aortic bio-prosthetic valve replacement. A mid-term follow-up [(FU) mean FU time: 54.4 ± 39.2 months] was done in August 2011 in all patients (FU completeness: 100%). Results were compared with patients who had a mechanical prosthetic aortic valve replacement during the same period., Results: The reoperation rate for structural valve degeneration (SVD) of bioprostheses was 6% and occurred exclusively among patients <56 years. Contraindications for anticoagulation determined the choice of a bioprosthesis among 83% of these patients. The personal preference to avoid anticoagulation was the leading cause in 68% of the older patients (56-65 years). Neurological complications occurred more frequently in the mechanical control group., Conclusions: Reoperations for SVD after bioprosthesis implantation occurred exclusively among younger patients (<56 years), not suitable for systemic anticoagulation. Previous studies, together with our experience, are in favour of an age limit between 56 and 60 years, taking into consideration alternative transcatheter approaches to SVD treatment.

Objectives: Little is known about the stent deformability required for optimal stented heart valve bioprosthesis design. Therefore, two bioprosthetic valves with known good long-term clinical results were tested. The strain in the radial direction of the stent posts of these valves was compared with contemporary bioprosthetic valves and a native porcine aortic root., Methods: Medtronic Intact and Carpentier-Edwards Standard (CES), and four contemporary bioprostheses, including one self-expanding prosthesis, were tested with three sonomicrometry probes per valve fixed at commissure attachment points. The mean values from 2400 data points from three measurements of the interprobe distances were used to calculate the radius of the circle circumscribed around the three probes. Changes in the radius of the aortic root at pressures 70-90 and 120-140 mmHg (pressure during diastole and systole) and that of the stent posts at 70-90 and 0-10 mmHg (transvalvular pressure gradient during diastole and systole) were compared., Results: An increase in radius by 7.3 ± 2.6, 8.7 ± 0.0 and 3.9 ± 0.0% for the porcine aortic root, CES and Intact valves, respectively, was observed during transition from diastolic to systolic pressure and less for contemporary bioprostheses-mean 2.5 ± 0.9%, lowest 1.2 ± 0.0., Conclusions: The results indicate that the radial deformability of bioprosthetic valve stent posts can be as low as 1.2% for xenoaortic and 3.0% for xenopericardial prostheses with no compromise of valve durability. Although these results suggest that valve stent post-deformability might not be of critical importance, a concrete answer to the question of the significance of stent deformability for valve durability can be obtained only by acquiring long-term follow-up results for valve prostheses with rigid stents.

Transapical aortic valve replacement is an established technique performed in high-risk patients with symptomatic aortic valve stenosis and vascular disease contraindicating trans-vascular and trans-aortic procedures. The presence of a left ventricular apical diverticulum is a rare event and the treatment depends on dimensions and estimated risk of embolisation, rupture, or onset of ventricular arrhythmias. The diagnosis is based on standard cardiac imaging and symptoms are very rare. In this case report we illustrate our experience with a 81 years old female patient suffering from symptomatic aortic valve stenosis, respiratory disease, chronic renal failure and severe peripheral vascular disease (logistic euroscore: 42%), who successfully underwent a transapical 23 mm balloon-expandable stent-valve implantation through an apical diverticulum of the left ventricle. Intra-luminal thrombi were absent and during the same procedure were able to treat the valve disease and to successfully exclude the apical diverticulum without complications and through a mini thoracotomy. To the best of our knowledge, this is the first time that a transapical procedure is successfully performed through an apical diverticulum.

Intraoperative cardiac imaging plays a key role during transcatheter aortic valve replacement. In recent years, new techniques and new tools for improved image quality and virtual navigation have been proposed, in order to simplify and standardize stent valve positioning and implantation. But routine performance of the new techniques may require major economic investments or specific knowledge and skills and, for this reason, they may not be accessible to the majority of cardiac centres involved in transcatheter valve replacement projects. Additionally, they still require injections of contrast medium to obtain computed images. Therefore, we have developed and describe here a very simple and intuitive method of positioning balloon-expandable stent valves, which represents the evolution of the 'dumbbell' technique for echocardiography-guided transcatheter valve replacement without angiography. This method, based on the partial inflation of the balloon catheter during positioning, traps the crimped valve in the aortic valve orifice and, consequently, very near to the ideal landing zone. It does not require specific echocardiographic knowledge; it does not require angiographies that increase the risk of postoperative kidney failure in elderly patients, and it can be also performed in centres not equipped with a hybrid operating room.

Transapical aortic valve replacement through an apical aneurysm is traditionally contraindicated because of the risk of severe systemic embolization when thrombi are present. However, a chronic fibrotic aneurysm without apical thrombi carries a low risk of distal embolization and can be safely employed for a transapical transcatheter aortic valve replacement in case of absence of an alternative access site (severe vascular disease, small vascular sizes and diseased calcified aorta). We illustrate our experience with a 73-year-old patient suffering from symptomatic aortic valve stenosis, coronary artery disease with occluded left anterior descending artery, left ventricular apical aneurysm and severe peripheral vascular disease, who successfully underwent a transapical 26 mm Sapien™ XT stent-valve implantation through the fibrotic thin akinetic apical wall.

Quadricuspid aortic valve (QAV) is a rare congenital anomaly associated with aortic valve insufficiency and significant morbidity, and requires the replacement or, rarely, the repair of the malfunctioning heart valve. A QAV associated with an ascending aorta aneurysm is an extremely rare anatomic combination with a hypothetical, but not clear, shared embryological etiology. To date, only two cases of type B QAV with ascending aorta aneurysm have been reported. Herein is described the first ever case of a 38-year-old male suffering from severe symptomatic aortic valve regurgitation due to a type A QAV, associated with an ascending aorta aneurism, who underwent a successful combined replacement of the aortic valve and ascending aorta.

Transapical aortic valve implantation is indicated in high-risk patients with aortic stenosis and peripheral vascular disease requiring aortic valve replacement. Minimally invasive direct coronary artery bypass grafting is also a valid, minimally invasive option for myocardial revascularization in patients with critical stenosis on the anterior descending coronary artery. Both procedures are performed through a left minithoracotomy, without cardiopulmonary bypass, aortic cross-clamping, and cardioplegic arrest. We describe a successful combined transapical aortic valve implantation and minimally invasive direct coronary bypass in a high-risk patient with left anterior descending coronary artery occlusion and severe aortic valve stenosis., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to investigate the feasibility of transventricular-transseptal approach (TVSA) for extrapleural trans-catheter aortic valved stent implantation via a subxyphoidian access., Methods: In five porcine experiments (52.3 ± 10.9 kg) the right ventricle was exposed via subxyphoidian access. Under the guidance of intracardiac echocardiography (ICE) and fluoroscopy, the transseptal access from right ventricle to left ventricle was created progressively by puncture and dilation with dilators (8F-26F). Valved stents built in-house from commercial tanned pericardium and self-expandable Nitinol stents were loaded into a cartridge. A delivery sheath was then introduced from the right ventricle into the left ventricle and then into the ascending aorta. The cartridge was connected and the valved stent was deployed in the aortic position. Then, the ventricular septal access was sealed with an Amplatzer septal occluder device and the right ventricular access was closed by tying prepared purse-string suture directly. Thirty minutes after the whole procedure, the animals were sacrificed for macroscopic evaluation of the position of valved stent and septal closure device., Result: Procedural success of TVSA was 100% at the first attempt. Mean procedure time was 49 ± 4 min. Progressive dilatation of the transseptal access resulted in a measurable ventricular septal defect (VSD) after dilator sizes 18F and more. All valved stents were delivered at the target site over the native aortic valve with good acute valve function and no paravalvular leaks. During the procedure, premature beats (5/5) and supraventriclar tachycardias (5/5) were observed, but no atrial-ventricular block (0/5) occurred. Heart rate before (after) was 90 ± 3 beats min⁻¹ (100 ± 2 beatsmin⁻¹: p < 0.05), whereas blood pressure was 60 ± 1 mm Hg (55 ± 2 mm Hg (p < 0.05)). Total blood loss was 280 ± 10 ml. The Amplatzer septal occluder devices were fully deployed and the ventricular septal accesses were sealed successfully, without detectable residual shunt., Conclusion: Trans-catheter implantation of aortic valved stent via extrapleural transventricular-transseptal access is technically feasible and has the potential for a simplified procedure under local anaesthesia., (Copyright © 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

Transcatheter aortic valve therapies are the newest established techniques for the treatment of high risk patients affected by severe symptomatic aortic valve stenosis. The transapical approach requires a left anterolateral mini-thoracotomy, whereas the transfemoral method requires an adequate peripheral vascular access and can be performed fully percutaneously. Alternatively, the trans-subclavian access has been recently proposed as a third promising approach. Depending on the technique, the fine stent-valve positioning can be performed with or without contrast injections. The transapical echo-guided stent-valve implantation without angiography (the Lausanne technique) relies entirely on transoesophageal echocardiogramme imaging for the fine stent-valve positioning and it has been proved that this technique prevents the onset of postoperative contrast-related acute kidney failure. Recent published reports have shown good hospital outcomes and short-term results after transcatheter aortic valve implantation, but there are no proven advantages in using the transfemoral or the transapical technique. In particular, the transapical series have a higher mean logistic Euroscore of 27-35%, a procedural success rate above 95% and a mean 30-day mortality between 7.5 and 17.5%, whereas the transfemoral results show a lower logistic Euroscore of 23-25.5%, a procedural success rate above 90% and a 30-day mortality of 7-10.8%. Nevertheless, further clinical trials and long-term results are mandatory to confirm this positive trend. Future perspectives in transcatheter aortic valve therapies would be the development of intravascular devices for the ablation of the diseased valve leaflets and the launch of new stent-valves with improved haemodynamic, different sizes and smaller delivery systems.

Transcatheter stent-valve implantation in stenosed congenital bicuspid aortic valves is under debate. Heavily calcified elliptic bicuspid valves represent a contraindication to catheter-based valve therapies because of a risk of stent-valve displacement, distortion, or malfunctioning after the implantation. In this case report we illustrate our experience with a patient suffering from stenosed congenital bicuspid aortic valve who successfully underwent a transapical 26-mm Edwards Sapien stent-valve (Edwards Lifesciences Inc, Irvine, CA) implantation. Postoperative distortion, malfunctioning, and paravalvular leaks were not detected., (Copyright 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: We reviewed our surgery registry, to identify predictive risk factors for operative results, and to analyse the long-term survival outcome in octogenarians operated for primary isolated aortic valve replacement (AVR)., Methods: A total of 124 consecutive octogenarians underwent open AVR from January 1990 to December 2005. Combined procedures and redo surgery were excluded. Selected variables were studied as risk factors for hospital mortality and early neurological events. A follow-up (FU; mean FU time: 77 months) was obtained (90% complete), and Kaplan-Meier plots were used to determine survival rates., Results: The mean age was 82+/-2.2 (range: 80-90 years; 63% females). Of the group, four patients (3%) required urgent procedures, 10 (8%) had a previous myocardial infarction, six (5%) had a previous coronary angioplasty and stenting, 13 patients (10%) suffered from angina and 59 (48%) were in the New York Heart Association (NYHA) class III-IV. We identified 114 (92%) degenerative stenosis, six (5%) post-rheumatic stenosis and four (3%) active endocarditis. The predicted mortality calculated by logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 12.6+/-5.7%, and the observed hospital mortality was 5.6%. Causes of death included severe cardiac failure (four patients), multi-organ failure (two) and sepsis (one). Complications were transitory neurological events in three patients (2%), short-term haemodialysis in three (2%), atrial fibrillation in 60 (48%) and six patients were re-operated for bleeding. Atrio-ventricular block, myocardial infarction or permanent stroke was not detected. The age at surgery and the postoperative renal failure were predictors for hospital mortality (p value <0.05), whereas we did not find predictors for neurological events. The mean FU time was 77 months (6.5 years) and the mean age of surviving patients was 87+/-4 years (81-95 years). The actuarial survival estimates at 5 and 10 years were 88% and 50%, respectively., Conclusions: Our experience shows good short-term results after primary isolated standard AVR in patients more than 80 years of age. The FU suggests that aortic valve surgery in octogenarians guarantees satisfactory long-term survival rates and a good quality of life, free from cardiac re-operations. In the era of catheter-based aortic valve implantation, open-heart surgery for AVR remains the standard of care for healthy octogenarians., (Copyright 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

The transapical transcatheter aortic valve implantation (TA-TAVI) in degenerated aortic bioprosthesis is an emerging therapy for surgically non-amenable patients. However, the presence of different types of aortic bioprostheses (stented and stentless), available in different sizes (19-27 mm), can be at the origin of important mismatches between the malfunctioning, degenerated aortic valves and the inner stent-valves implanted through transapical accesses (23 and 26 mm Edwards Sapien transcatheter stent-valves). We report an emergency TA-TAVI treatment of a severely regurgitant degenerated 23 mm Mitroflow aortic bioprosthesis (Sorin Group, Milano, Italy) implanted seven years earlier in an 80-year-old lady, and we reviewed the current available literature about transapical 'valve-in-valve' procedures to analyze the hemodynamic results and the ideal 'prosthesis-to-prosthesis' match.

Background: Cardiac computed tomographic scans, coronary angiograms, and aortographies are routinely performed in transcatheter heart valve therapies. Consequently, all patients are exposed to multiple contrast injections with a following risk of nephrotoxicity and postoperative renal failure. The transapical aortic valve implantation without angiography can prevent contrast-related complications., Methods: Between November 2008 and November 2009, 30 consecutive high-risk patients (16 female, 53.3%) underwent transapical aortic valve implantation without angiography. The landmarks identification, the stent-valve positioning, and the postoperative control were routinely performed under transesophageal echocardiogram and fluoroscopic visualization without contrast injections., Results: Mean age was 80.1 +/- 8.7 years. Mean valve gradient, aortic orifice area, and ejection fraction were 60.3 +/- 20.9 mm Hg, 0.7 +/- 0.16 cm(2), and 0.526 +/- 0.128, respectively. Risk factors were pulmonary hypertension (60%), peripheral vascular disease (70%), chronic pulmonary disease (50%), previous cardiac surgery (13.3%), and chronic renal insufficiency (40%) (mean blood creatinine and urea levels: 96.8 +/- 54 microg/dL and 8.45 +/- 5.15 mmol/L). Average European System for Cardiac Operative Risk Evaluation was 32.2 +/- 13.3%. Valve deployment in the ideal landing zone was 96.7% successful and valve embolization occurred once. Thirty-day mortality was 10% (3 patients). Causes of death were the following: intraoperative ventricular rupture (conversion to sternotomy), right ventricular failure, and bilateral pneumonia. Stroke occurred in one patient at postoperative day 9. Renal failure (postoperative mean blood creatinine and urea levels: 91.1 +/- 66.8 microg/dL and 7.27 +/- 3.45 mmol/L), myocardial infarction, and atrioventricular block were not detected., Conclusions: Transapical aortic valve implantation without angiography requires a short learning curve and can be performed routinely by experienced teams. Our report confirms that this procedure is feasible and safe, and provides good results with low incidence of postoperative renal disorders., (2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The trans-apical aortic valve implantation (TA-AVI) is an established technique for high-risk patients requiring aortic valve replacement. Traditionally, preoperative (computed tomography (CT) scan, coronary angiogram) and intra-operative imaging (fluoroscopy) for stent-valve positioning and implantation require contrast medium injections. To preserve the renal function in elderly patients suffering from chronic renal insufficiency, a fully echo-guided trans-catheter valve implantation seems to be a reasonable alternative. We report the first successful TA-AVI procedure performed solely under trans-oesophageal echocardiogram control, in the absence of contrast medium injections.

There is an ever-growing trend towards less-invasive procedures in all fields of medicine. We designed an animal study to prove the concept that trans-apical aortic valve replacement from an incision within the umbilicus through a single channel for instruments is feasible, which would be a major leap towards no-scar cardiac surgery. In three adult pigs, after creating a single 3-cm incision at a place where the human umbilicus would be, we introduced a 30F sheath through a tunnel created by an endoscopic vein-harvesting device up to the cardiac apex, through it and up to the left ventricle simulating the approach for trans-apical aortic valve replacement. We used a standard Amplatz nitinol occluder to seal the defect in ventricle wall later. The animals were followed up for 1h. Blood loss was minimal, and no tamponade occurred in any of the animals. In addition, we performed a test with water column static pressure to evaluate the impact of preclotting on the sealing properties of the occluders: 1 min flow-through was 2860+/-176 ml for the standard occluders and 348+/-56 ml for preclotted occluders (p<0.001).

Objective: Balloon-expandable stent valves require flow reduction during implantation (rapid pacing). The present study was designed to compare a self-expanding stent valve with annular fixation versus a balloon-expandable stent valve., Methods: Implantation of a new self-expanding stent valve with annular fixation (Symetis, Lausanne, Switzerland) was assessed versus balloon-expandable stent valve, in a modified Dynatek Dalta pulse duplicator (sealed port access to the ventricle for transapical route simulation), interfaced with a computer for digital readout, carrying a 25 mm porcine aortic valve. The cardiovascular simulator was programmed to mimic an elderly woman with aortic stenosis: 120/85 mmHg aortic pressure, 60 strokes/min (66.5 ml), 35% systole (2.8 l/min)., Results: A total of 450 cardiac cycles was analysed. Stepwise expansion of the self-expanding stent valve with annular fixation (balloon-expandable stent valve) resulted in systolic ventricular increase from 120 to 121 mmHg (126 to 830+/-76 mmHg)*, and left ventricular outflow obstruction with mean transvalvular gradient of 11+/-1.5 mmHg (366+/-202 mmHg)*, systolic aortic pressure dropped distal to the valve from 121 to 64.5+/-2 mmHg (123 to 55+/-30 mmHg) N.S., and output collapsed to 1.9+/-0.06 l/min (0.71+/-0.37 l/min* (before complete obstruction)). No valve migration occurred in either group. (*=p<0.05)., Conclusions: Implantation of this new self-expanding stent valve with annular fixation has little impact on haemodynamics and has the potential for working heart implantation in vivo. Flow reduction (rapid pacing) is not necessary.

Trans-apical aortic valve replacement (AVR) is a new and rapidly growing therapy. However, there are only few training opportunities. The objective of our work is to build an appropriate artificial model of the heart that can replace the use of animals for surgical training in trans-apical AVR procedures. To reduce the necessity for fluoroscopy, we pursued the goal of building a translucent model of the heart that has nature-like dimensions. A simplified 3D model of a human heart with its aortic root was created in silico using the SolidWorks Computer-Aided Design (CAD) program. This heart model was printed using a rapid prototyping system developed by the Fab@Home project and dip-coated two times with dispersion silicone. The translucency of the heart model allows the perception of the deployment area of the valved-stent without using heavy imaging support. The final model was then placed in a human manikin for surgical training on trans-apical AVR procedure. Trans-apical AVR with all the necessary steps (puncture, wiring, catheterization, ballooning etc.) can be realized repeatedly in this setting.

The aim of this study was to provide an insight into normative values of the ascending aorta in regards to novel endovascular procedures using ECG-gated multi-detector CT angiography. Seventy-seven adult patients without ascending aortic abnormalities were evaluated. Measurements at relevant levels of the aortic root and ascending aorta were obtained. Diameter variations of the ascending aorta during cardiac cycle were also considered. Mean diameters (mm) were as follows: LV outflow tract 20.3 +/- 3.4, coronary sinus 34.2 +/- 4.1, sino-tubular junction 29.7 +/- 3.4 and mid ascending aorta 32.7 +/- 3.8 with coefficients of variation (CV) ranging from 12 to 17%. Mean distances (mm) were: from the plane passing through the proximal insertions of the aortic valve cusps to the right brachio-cephalic artery (BCA) 92.6 +/- 11.8, from the plane passing through the proximal insertions of the aortic valve cusps to the proximal coronary ostium 12.1 +/- 3.7, and between both coronary ostia 7.2 +/- 3.1, minimal arc of the ascending aorta from left coronary ostium to right BCA 52.9 +/- 9.5, and the fibrous continuity between the aortic valve and the anterior leaflet of the mitral valve 14.6 +/- 3.3, CV 13-43%. Mean aortic valve area was 582.0 +/- 131.9 mm(2). The variation of the antero-posterior and transverse diameters of the ascending aorta during the cardiac cycle were 8.4% and 7.3%, respectively. Results showed large inter-individual variations in diameters and distances but with limited intra-individual variations during the cardiac cycle. A personalized approach for planning endovascular devices must be considered.

Aims: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development., Methods and Results: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation., Conclusion: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.

Objectives: The off-pump trans left ventricular approach provides an alternative option for insertion of stented aortic valves of any size for endovascular replacement. One of the key steps in this procedure is the repair of the ventricle after catheter withdrawal. This study evaluates the reliability of a new device for sutureless and quick repair of the left ventricle access., Methods: The Amplatz-nitinol occluder consists of two square heads that squeeze the ventricle wall between them thus sealing the ventricular defect. In four adult pigs weighing 55 kg, left thoracoscopy was performed to open the pericardium and visualise the cardiac apex. Following a heparin injection (100 U/kg) under ICUS and fluoroscopic control, we inserted a 30 F sheath into the epigastric area through the cardiac apex up into the left ventricle thus simulating the approach for an off-pump aortic valve replacement. The sheath was then removed and the ventricle closed with the occluder. Animals were followed-up for three hours; the haemodynamics and pericardial bleeding were recorded. The animals were then sacrificed and the gross anatomy of the heart was examined., Results: The device was successfully deployed in four animals in less than one minute. ACT was above 200 seconds in all cases. All animals survived the procedure with a mean arterial pressure of 50 +/- 15 mm Hg. Bleeding during deployment was 80 +/- 20 ml and over a 3 hour period was 800 +/- 20 ml. Examination of the gross anatomy examination demonstrated the correct positioning of the device., Conclusions: The occluder is easy to use and the procedure is feasible and reproducible. However, the occluder design requires technical improvements in order to reduce bleeding before it can be used clinically.

Objective: Off-pump trans left ventricular approach provides more precise deployment of stented aortic valve of any size with respect to the endovascular replacement. One of the key steps of this procedure is the ventricle repair after catheter withdrawing. We designed an animal study to compare the consistency of a sutureless repair of the left ventricle access using nitinol occluder with and without pericardial cuff on the ventricular side., Methods: Material description: The Amplatz-nitinol occluder consists of two square heads squeezing ventricle wall in between them, sealing the defect. To improve its sealing property, a pericardial patch was sutured to the ventricular head of the occluder. Animal study setup: In adult pigs, a 30F sheath was inserted into the epigastric area through the cardiac apex, up to the left ventricle, simulating the approach for off-pump aortic valve replacement. The sheath was then removed and the ventricle closed with standard occluder in half of the animals, and cuffed occluder in the other half. Animals were followed-up for 3h, collecting haemodynamics data and pericardial bleeding., Results: Device was successfully deployed in 12 animals in less than 1min. In the group where the standard occluder was used, bleeding during the deployment was 80+/-20ml and after the deployment was 800+/-20ml over 3h. In the group where the cuffed occluder was used, bleeding during the deployment was 85+/-20ml and after the deployment was 100+/-5ml over 3h. In the cuffed group, bleeding was significantly lower than the standard group, p-value being <0.001., Conclusions: The occluder is easy to use and the pericardial cuff dramatically increases its efficacy as demonstrated by a significant reduction of blood loss. The cuffed occluder opens the way for endoscopic, off-pump, transventricular aortic valve replacement.

Objective: This study validates the off-pump antegrade trans-ventricular route for ultrasound-guided direct access aortic valve replacement. Direct access aortic valve replacement using a transthoracic and valved stent-based approach offers numerous advantages over the remote access percutaneous approach and may one day provide an alternative treatment modality for aortic valve disease., Methods: Valved stents were implanted off-pump in 17 pigs (72.10+/-8.4 kg) via the direct access transapical approach using a left-sided mini-thoracotomy and continuous ultrasonic and fluoroscopic guidance. Acute valved stent function was studied with intravascular and two-dimensional intracardiac ultrasound. The invasive valve gradient was assessed with pull-back pressure catheter. All valved stents were tested in vitro before insertion. Macroscopic analysis was performed at necropsy., Results: In 11 of the 17 pigs, valved stents were delivered to the target site over the native aortic valve leaflets without interference of coronary blood flow and with good acute valve function. Three valved stents were deployed supra-annularly, two of those occluded the right coronary orifice and one the left coronary orifice, leading to fatal outcomes. Three valved stents dislodged into the left ventricle, one because of size-mismatch and two because of failure to unfold correctly. In 11 properly sized and deployed valved stents, two showed a moderate and one a severe paravalvular leak., Conclusions: Seventeen pigs underwent direct access valve replacement of the aortic valve with deployment of a valved stent into the native aorta. Eleven valves observed for an average 5-h period showed satisfactory, postimplantation valve function.

Objectives: This study validates the off-pump antegrade transventricular route for ultrasound-guided direct-access aortic valved stent implantation., Background: Direct-access aortic valved stent implantation offers numerous advantages over the remote-access percutaneous approach and may one day provide an alternative to surgical aortic valve replacement., Methods: Valved stents were implanted off-pump in 12 pigs (68.5.0 +/- 7.3 kg) via direct-access transapical approach using a left-sided mini-thoracotomy and continuous ultrasonic and fluoroscopic guidance. Acute valved stent function was studied with intravascular and intracardiac ultrasound. All valved stents were tested in vitro before insertion. Macroscopic analysis was performed at necropsy., Results: In 8 of 12 pigs, valved stents were delivered to the target site over the native aortic valve leaflets without interference of coronary blood flow and with good acute valve function. Two valved stents were deployed and supra-annularly occluded the coronary orifice, leading to fatal outcome. Two valved stents dislodged into the left ventricle, one because of size mismatch and one that failed to unfold correctly., Conclusions: Twelve pigs underwent deployment of a valved stent in the aortic position. Six valves observed for an average 4.5-h period showed satisfactory postimplantation valve function.

Purpose: To validate the use of simultaneous intracardiac and intravascular ultrasound (IVUS) guidance for periprocedural dimension assessment, Residual-Coronary/Sinus-Stent Index (RCSSI) estimation, target site identification, deployment monitoring, and quality control of off-pump aortic Valved Stent implantation., Methods: Five pigs (56+/-5 kg) underwent off-pump orthotopic aortic valve implantation using a custom-made self-expanding Valved Stent. Intracardiac ultrasound (AcuNav) was introduced via the right femoral vein. After left-sided thoracotomy, pursestring sutures were placed on the left ventricular apex. Following heparinization, a guidewire was inserted through the apex and advanced over the aortic valve under fluoroscopy. A wire-guided IVUS catheter transducer (6-F, 12.5-MHz) was inserted and the aortic target site identified. IVUS probe location was tracked with AcuNav, and measures of the aortic root were taken by both. After removal of the IVUS, the Valved Stent delivery system was introduced over the guidewire under fluoroscopy and AcuNav monitoring; the Valved Stent was deployed over the native valves. In vivo assessment included leaflet motion, planimetric valve orifice and RCSSI (stent to aortic wall distance/coronary diameter) calculations, coronary blood flow characteristics, transvalvular gradient, regurgitation, and paravalvular leaking in combination with continuous cardiac output measures. Macroscopic analysis was performed at necropsy., Results: IVUS dimensions of the aortic root were equal to AcuNav and necropsy dimensions. Both tools showed good valvular function, with full valvular opening and closing in 3 of 5 valves. At necropsy, the 3 aortic Valved Stents were safely anchored. One Valved Stent was placed supra-annularly; 2 dislodged into the left ventricle because of size mismatch. One Valved Stent showed a moderate to severe paravalvular leak., Conclusions: Simultaneous intracardiac and intravascular ultrasound-guided off-pump orthotopic aortic Valved Stent implantation via left sided thoracotomy is feasible in an animal model. IVUS and intracardiac ultrasound allow adequate aortic dimension assessment and Valved Stent delivery monitoring, as well as postimplantation coronary flow evaluation.

Objective: The aim of the present study is to evaluate a new self-expanding valved stent design for minimal invasive aortic valve implantation and its interference with coronary flow., Methods: An equine pericardial valve mounted onto a self-expanding nitinol stent (3F Therapeutics trade mark, CA, USA), outer diameter 23 mm, was evaluated (A) in vitro in a dynamic pulsatile mock loop and (B) in vivo in six calves (75+/-2.5 kg). In four animals valve stents were implanted on-pump and in two animals off-pump after induction of ventricular fibrillation. Target site for deployment was the orthotopic aorta, over the native valves. In vivo assessment was performed with intracardiac (AcuNav) and intravascular ultrasound including leaflet motion, planimetric valve orifice and residual-coronary\sinus-stent-index (RCSSI, distance stent to aortic wall/coronary diameter) calculations, coronary blood flow characteristics, transvalvular gradient, regurgitation and paravalvular leaking, in combination with continuous cardiac output measures. Macroscopic analysis was performed at necropsy., Results: Two-dimensional intracardiac ultrasound showed good leaflet motion, with full valvular opening and closing in five of six valves. Planimetric valve orifice was 1.75+/-0.4 cm(2). There were no signs of coronary flow impairment with an RCSSI of 1.8+/-1.2. The implanted valved stents showed a low transvalvular gradient of 5.3+/-3.9 mmHg (mean, peak-to-peak) on invasive measurements and 4.7+/-2.5 mmHg in two-dimensional intracardiac sonography. One of six valves showed mild to moderate regurgitation and one of six valves a minor to moderate paravalvular leak due to size mismatch., Conclusions: This new self-expanding valved stent design allows for on- and off-pump aortic valve implantation in the orthotopic aorta, over the native valves without interference of the coronary blood flow and excellent acute valve function in properly sized devices.