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Background: Cardiopulmonary bypass (CPB) with aortic cross-clamping and cardioplegic arrest remains the method of choice for patients requiring standard myocardial revascularization. Therefore, very high-risk patients presenting with acute coronary syndrome, unstable angina, onset of cardiac decompensation and requiring emergency multiple myocardial revascularization, can have a poor outcome. The on-pump beating heart technique can reduce the mortality and the morbidity in such a selected group of patients and this report describes our clinical experience.Methods: Out of 290 patients operated for CABG from January 2005 to January 2006, 25 (8.6%) selected high-risk patients suffering from life threatening coronary syndrome (mean age 69 +/- 7 years) and requiring emergency multiple myocardial revascularization, underwent on-pump beating heart surgery. The mean pre-operative left ventricle ejection fraction (LVEF) was 27 +/- 8%. The majority of them (88%) suffered of tri-vessel coronary disease and 6 (24%) had a left main stump disease. Nine patients (35%) were on severe cardiac failure and seven among them (28%) received a pre-operative intra-aortic balloon pump. The pre-operative EuroScore rate was equal or above 8 in 18 patients (73%).Results: All patients underwent on-pump-beating heart coronary revascularization. The mean number of graft/patient was 2.9 +/- 0.6 and the internal mammary artery was used in 23 patients (92%). The mean CPB time was 84 +/- 19 minutes. Two patients died during the recovery stay in the intensive care unit, and there were no postoperative myocardial infarctions between the survivors. Eight patients suffered of transitorily renal failure and 1 patient developed a sternal wound infection. The mean hospital stay was 12 +/- 7 days. The follow-up was complete for all 23 patients survived at surgery and the mean follow-up time was 14 +/- 5 months. One patient died during the follow-up for cardiac arrest and 2 patients required an implantable cardiac defibrillator. One year after surgery they all had a standard trans-thoracic echocardiogram showing a mean LVEF rate of 36 +/- 11.8%.Conclusion: Standard on-pump arrested heart coronary surgery has higher mortality and morbidity in emergencies. The on-pump beating heart myocardial revascularization seems to be a valid alternative for the restricted and selected cohort of patients suffering from life threatening coronary syndrome and requiring multiple emergency CABG. [ABSTRACT FROM AUTHOR]

Objective: Thoracic endovascular aortic repair (TEVAR) has been the favored approach for the treatment of type B aortic dissection (TBAD). To obtain an adequate proximal landing zone, coverage of the left subclavian artery (LSA) will often be necessary. The occurrence of possible neurologic complications has continued to be debated. We investigated the management of the LSA in patients with TBAD undergoing endovascular repair., Methods: We searched the PubMed and MEDLINE databases to October 2020 for studies of TEVAR for TBAD. Data on the study design, demographics, endograft details, LSA coverage and revascularization, mortality, complications, and follow-up were extracted and analyzed. The effects of LSA coverage and revascularization on neurologic complications and outcomes were investigated., Results: A total of 26 reports (24 retrospective and 2 prospective) were deemed eligible for our study. A total of 1483 patients (mean age, 56.9 ± 6.2 years) had undergone TEVAR for acute (n = 932; 62.9%), subacute (n = 36; 2.4%), or chronic (n = 515; 34.7%) TBAD, with a success rate of 97.8% and hospital mortality of 4.9%. The LSA origin had been covered for 707 patients (47.7%), and 326 had undergone LSA revascularization (surgical, n = 96; endovascular, n = 170; unspecified or not reported, n = 60). LSA revascularization was concomitant for 68.1% of cases, after TEVAR for 1.8%, and not reported for 30.1%. Of 1146 patients, 10 (0.9%) had experienced left arm claudication, and the overall stroke rate was 3.3% (2.7% for the LSA group and 1% for the uncovered LSA group; P = .0815). Of the patients with stroke and a covered LSA, 1% (2 of 203) had undergone LSA revascularization and 4.8% (5 of 105) had not (P = .0478). Twenty-six patients (1.9%) had developed paraplegia: 0.7% (3 of 433) with a covered LSA, 1.4% (7 of 491) with an uncovered LSA (P = .3508), and not reported for 16 patients. Endoleak was present in 138 patients (13.4%) at a mean follow-up of 32.1 ± 25.6 months., Conclusions: Our review has shown that LSA coverage during endovascular repair for complicated TBAD will does not significantly increase the risk of neurologic complications; however, revascularization of the LSA should be always recommended., (Copyright © 2022. Published by Elsevier Inc.)

Objectives: Surgical repair of aortic dissection involving the proximal aortic arch is associated with higher morbidity and mortality, in particular when elderly high-risk patients are concerned. Endovascular treatments for this disease are under evaluation and some reports exist. We investigated the current use of catheter-based treatments for the dissected proximal aortic arch repair., Methods: We searched in PubMed and MEDLINE databases up to the end of June 2020 for studies on endovascular treatment of the dissected proximal aortic arch. Data on demographic, procedure and stent graft (SG) details, access route, mortality with cause of death, complications and follow-up were extracted. A systematic review on the employed technology, procedure and outcome was performed., Results: A total number of 15 articles (13 retrospective reports and 2 case reports) were deemed eligible and were included in the study. In total, 140 patients (mean age: 56.7 years in 106 cases) received endovascular treatments for the dissected proximal aortic arch (unspecific aortic dissection: 14; acute and subacute type A aortic dissection: 88; chronic type A aortic dissection: 23; type B aortic dissection with retrograde type A dissection: 15). The procedure strategy included unspecific thoracic endovascular aorta repair (TEVAR) (n = 8), TEVAR + supra-aortic debranching (n = 2), TEVAR + cervical bypass (n = 8), TEVAR + periscope SG (n = 12), TEVAR + chimney graft (n = 8), TEVAR + branched SG (n = 21) and TEVAR + fenestration (n = 81). Procedural success rate was 95.6% for 116 reported cases. Complications included endoleaks (postoperative: 2; late: 5), stroke (n = 4), late SG-induced new entry (n = 3) and new false lumen formation (n = 1). Hospital mortality was 5% (6 cases) in 13 reports (120 patients). The mean follow-up time was 26.2 ± 29.4 months and 2 patients died during follow-up., Conclusions: As an alternative to surgery for high-risk patients with a dissected proximal aortic arch, the endovascular treatment seems to be promising in highly selected cases. Further studies with long-term results and specifically designed devices are required to standardize this approach., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Determine if shortening the covered section of a self-expanding bidirectional arterial cannula, can enhance retrograde flow and thus reduce the risk of lower limb ischemia., Methods: Outlet pressure vs flow rate was determined for three cannulas types: a 15F self-expanding bidirectional cannula having a covered section of 90 mm, the same cannula but with a shorter covered section of 60 mm, and a Biomedicus cannula as control. The performances of all the cannulas were compared using a computerized flow-bench with calibrated sensors and a centrifugal pump. Water retrograde flow was determined using a tank timer technique. Anterograde and retrograde flow rate versus outlet pressure were determined at six different pump speed., Results: For each of the six pump speed, both bidirectional cannulas, 60-mm covered and 90-mm covered respectively, showed higher performance than Biomedicus cannula control, as demonstrated by higher flow rate and lower pressure. We also observed that for the bidirectional cannula with shorter covered section, i.e. 60 mm coverage, provides enhanced performance as compared to a 90-mm coverage. Finally, the flow rate and the corresponding pressure can be consistently measured by our experimental set-up with low variability., Conclusions: The new configuration of a shorter covered section in a bidirectional self-expanding cannula design, may present an opportunity to overcome lower leg ischemia during extra-corporal life support with long term peripheral cannulation.

Objectives: Type A aortic dissection requires immediate surgical repair. Despite improvements in surgery and anaesthesia, there is still a considerable risk when high-risk patients are concerned. Less invasive endovascular treatments are under evaluation. We investigated the current status of catheter-based treatment for type A aortic dissection with the entry tear located in the ascending aorta., Methods: A PubMed search was supplemented by searching through bibliographies and key articles. Demographics, risk score, stent graft detail, access route, mortality, cause of death, complications, reinterventions and follow-up data were extracted and analysed., Results: Thirty-one articles (7 retrospective reports; 24 case reports/series) were included in the study. In total, 104 patients (mean age 71 ± 14 years) received endovascular treatment for acute (63) or chronic (41) type A dissection. A history of a major cardiac or aortic operation was present in 29 patients. The mean EuroSCORE II was 30 ± 20 in 4 reports. A total of 114 stent grafts were implanted: 'off-the-shelf', 65/114; custom made, 12/114; and modified, 7/114. Hospital complications included intraprocedural conversion to open surgery (2/104), stroke (2/104), coronary stenting (2/104), early endoleak (9/104) and repeat aortic endovascular treatment for endoleak (5/104). Hospital mortality was 10% (intraoperative death 2/104). Mean duration of follow-up time was 21 ± 21 months (range 1-81 months); follow-up data were available for 86 patients: 10 patients died of non-aortic-related causes; reintervention for aortic disease (endovascular repair or open surgery) was performed in 8 patients., Conclusions: Catheter-based ascending aorta repair for type A aortic dissection with the entry tear in the ascending aorta can be considered in carefully selected high-risk patients. Further analysis and specifically designed devices are required., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

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: Given the similarities between coronary ostia and renal arteries, chimney grafts (CG) for kidney perfusion during abdominal endovascular aneurysm repair (EVAR) can be considered for coronary perfusion in future transcatheter aortic root repair (TARR) techniques. We analysed the results of renal CG and compared anatomic and technical details with root and coronary anthropometric data., Methods: Current status of kidney perfusion with CG was reviewed from literature. Anatomic details, technical data, CG performance and clinical outcome were collected and analysed. Anatomic details of aortic landing zone and renal arteries were compared with human anthropometric data of aortic root, ascending aorta and coronary ostia., Results: Seventeen articles reported 430 patients (mean age:74.5 ± 2.9 years) treated with renal CG. Mean length and diameter of proximal landing zone were 2.0 ± 2.0 mm and 26.4 ± 4.3 mm, respectively (anthropometric correspondence: ascending aorta diameter of 29.3 mm). Aortic endograft mean diameter was 26.4 ± 7.3 mm with reported oversize of 19.5 ± 6.0%. In total, 590 renal arteries were treated (left:325; right:265; bilateral:139 cases). Mean left and right renal artery diameters were 5.7 ± 0.6 mm and 5.8 ± 0.7 mm, respectively (anthropometric correspondence: coronary ostia diameters of 4.8 mm (left) and 3.7 mm (right)) with reported CG oversize of 19.75 ± 6% (left) and 18.1 ± 5.1% (right). Mean follow-up time was 16.5 ± 8.5 months, CG occlusion rate was 3.2% and endoleak I or II was reported in 83 patients (19.3%), requiring 7 procedures., Conclusions: CG provides satisfactory results in patients with suitable renal artery diameter. Based on aortic root and coronary anthropometric data, CG can be considered in future TARR technologies for coronary perfusion but further tests for flow evaluations are mandatory.

Objectives: Available apical occluders do not fulfil requirements for full-percutaneous transapical valve procedures with large-sized introducer sheaths. A self-expanding closure device designed for closed-chest transapical valve procedures was tested in an animal model to verify safety, efficacy and thrombogenicity., Methods: Large-sized 21-Fr introducer sheaths (Certitude™ system for Sapien™ valves) were percutaneously placed in the ventricles of nine 3-month old minipigs. To seal the apical access, delivery catheters carrying folded self-expanding plugs were inserted. Then, the plugs were deployed while sheaths were removed. Echocardiograms verified tamponade and cardiac function, drains were not placed and a 3-month long aspirin therapy was administered. After 6 and 9 months, animals were euthanized and organs were analysed for macroembolic lesions search. Histological analysis was also performed., Results: Nine minipigs (weight: 28±3 kg) were used for this study. Eight plugs were successfully deployed in 8 ventricles without cardiac tamponade or ventricular dysfunction (success rate: 88.9%). In a failed procedure (the animal died after 1 month of cardiac tamponade), the outer disc of the apical plug got stuck in the intercostal space and did not correctly deploy. Post-mortem analysis in 8 minipigs at 6 (n = 4) and 9 months (n = 4) confirmed full deployment and good fixation of all plugs with internal surfaces covered by new endocardium. Macroscopic analysis of myocardium and vital organs showed absence of embolic lesions. Histological analysis showed absence of significant inflammatory infiltration and thrombosis., Conclusions: In this animal model, self-expanding closure devices sealed 21-Fr large percutaneous apical accesses without acute tamponade, thrombosis or embolization. Further tests to evaluate full-percutaneous closed-chest apical procedures are required., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Aims of the Study: An extracorporeal membrane oxygenation system (ECMO), as a bridge to either recovery, a ventricular assist device (VAD), or heart or lung transplantation, may be the only lifesaving option for critically ill patients suffering from refractory cardiac, respiratory or combined cardiopulmonary failure. As peripheral hospitals may not offer ECMO treatment, tertiary care centres provide specialised ECMO teams for on-site implantation and subsequent patient transfer on ECMO to the tertiary hospital. This study reports the results of the largest ECMO transportation programme in Switzerland and describes its feasibility and safety., Methods: Patients transported on ECMO by our mobile ECMO team to our tertiary centre between 1 September 2009 and 31 December, 2016 underwent retrospective analysis. Implantation was performed by our specialised ECMO team (primary transport) or by the medical staff of the referring hospital (secondary transport) with subsequent transfer to our institution. Type of ECMO, transport data, patient baseline characteristics, operative variables and postoperative outcomes including complications and mortality were collected from medical records., Results: Fifty-eight patients were included (three patients excluded: one repatriation, two with incomplete medical records). Thirty-five patients (60%) received veno-venous, 22 (38%) veno-arterial and one patient (2%) veno-venoarterial ECMO. Forty-nine (84%) patients underwent primary and nine (16%) secondary transport. Thirty-five (60%) patients were transferred by helicopter and 23 (40%) by ambulance, with median distances of 38.1 (13–225) km and 21 (3-71) km respectively. No clinical or technical complications occurred during transportation. During hospitalisation, three patients had ECMO-associated complications (two compartment syndrome of lower limb, one haemothorax after central ECMO upgrade). Median days on ECMO was 8 (<1–49) and median days in hospital was 17 (<1–122). ECMO weaning was successful in 41 patients (71%), on-transport survival was 100%, 40 patients survived to discharge (69%), and overall survival was 67% (39 patients) at a median follow-up of 58 days (<1–1441). Cumulative survival was significantly affected by cardiogenic shock vs. ARDS (p = 0.001), veno-arterial and veno-venoarterial vs. veno-venous ECMO (p = 0.001) and after secondary vs. primary transport (p <0.001). The ECMO weaning rate was significantly lower after secondary transfer (22%, two patients, both vaECMO) vs. primary transfer (80%, p = 0.002, 39 patients of which 35 (71%) had vvECMO)., Conclusions: The first results of our ECMO transportation programme show its feasibility, safety and efficacy without on-site implant or on-transport complications or mortality. The favourable early survival may justify the large effort with respect to logistics, costs and manpower. With rising awareness, referring centres may increasingly consider this lifesaving option at an early stage, which may further improve outcomes.

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.

Severe ascending aorta disease includes aneurysms, pseudoaneurysms (ascending aorta pseudoaneurysms), penetrating aortic ulcers and Type A aortic dissections. Surgical replacement of the aortic root, ascending aorta or aortic arch is the common treatment for severe ascending aortic disease involving the root, the ascending aorta and/or the arch. Despite good surgical results, there is still a risk for morbidity and mortality following surgery for ascending aorta replacement when elderly patients or patients at high risk for surgery are concerned. Less invasive endovascular treatments for ascending aorta repair are under evaluation, and some reports appeared in the available literature in the last decade. However, clinical series or randomized studies are not yet available, and the use of these techniques is still questionable. In this study, we analysed the outcomes of reported cases of endovascular treatment for ascending aorta disease, excluding Type A aortic dissection. We reviewed reports published until February 2017, and we evaluated the employed technology, the devices, the procedural steps and the outcomes. A total of 26 articles reported 67 patients (mean age 65 ± 17 years) who received endovascular treatment for ascending aorta disease: aneurysms, ascending aorta pseudoaneurysms, penetrating aortic ulcers, intramural haematoma, thrombosis, iatrogenic coarctation and aortic rupture. Complications included endoleak (9 cases), stroke (3 cases), non-ST-elevation myocardial infarction (1 case) and splenic infarction (1 case). Three patients required conversion to open surgery, and 1 patient underwent endovascular reintervention. Early mortality was 2.9%. As an alternative treatment for ascending aorta disease in selected high-risk patients, the endovascular repair will gain popularity, but further analysis is required., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. 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.)

Background: Transcatheter aortic valve implantation is indicated in high-risk patients with aortic stenosis. We compared the clinical outcome of 180 consecutive patients who underwent transapical (TA) and transfemoral (TF) procedures in a single centre., Methods: Ninety consecutive TA (TA-group) and 90 consecutive TF (TF-group) were performed from 2009 to 2014. Clinical variables were prospectively collected and retrospectively analysed for hospital outcomes and to identify risk factors for hospital mortality, vascular complications and stroke., Results: Mean age was 80 ± 8.5 and 83 ± 8.4 years, in the TA and TF-group, respectively. TA-group presented higher prevalence of comorbidities: more vascular disease (79% vs 22%, p < 0.001), chronic pulmonary disease (32% vs 10%, p < 0.001), previous vascular surgery (14% vs 4%, p = 0.039), coronary disease (60% vs 40%, p = 0.007), and previous cardiac surgery (28% vs 17%, p = 0.073). Logistic Euroscore was 36 ± 15% in the TA-group and 25 ± 14% in the TF-group (p < 0.001), but hospital mortality was similar (TA:9%, TF:10%, p = 0.799). Access-related vascular complications occurred more often in transfemoral patients (TA:3%, TF:11%, p = 0.081) while major bleeding (TA:3%, TF:4%, p = 1) and stroke (TA:2%, TF:3%, p = 1) were equally distributed. Postoperative renal failure and dialysis were associated with impaired neurological outcome (p = 0.035 and p = 0.020, respectively). Mild to severe paravalvular leak was more prevalent in transfemoral patients (TA:5%, TF:25%, p < 0.001)., Conclusions: In our experience, the TA and TF-group presented different risk profiles but mortality rate and adverse neurological outcome had a similar incidence. The transfemoral approach carried more vascular complications and paravalvular leaks but last-generation devices will improve this outcome.

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.)

The recruitment of bone marrow (BM)-derived progenitor cells to the lung is related to pulmonary remodelling and the pathogenesis of pulmonary hypertension (PH). Although sildenafil is a known target in PH treatment, the underlying molecular mechanism is still elusive. To test the hypothesis that the therapeutic effect of sildenafil is linked to the reduced recruitment of BM-derived progenitor cells, we induced pulmonary remodelling in rats by two-week exposure to chronic hypoxia (CH, 10% oxygen), a trigger of BM-derived progenitor cells. Rats were treated with either placebo (saline) or sildenafil (1.4 mg/kg/day ip) during CH. Control rats were kept in room air (21% oxygen) with no treatment. As expected, sildenafil attenuated the CH-induced increase in right ventricular systolic pressure and right ventricular hypertrophy. However, sildenafil suppressed the CH-induced increase in c-kit + cells in the adventitia of pulmonary arteries. Moreover, sildenafil reduced the number of c-kit + cells that colocalize with tyrosine kinase receptor 2 (VEGF-R2) and CD68 (a marker for macrophages), indicating a positive effect on moderating hypoxia-induced smooth muscle cell proliferation and inflammation without affecting the pulmonary levels of hypoxia-inducible factor (HIF)-1α. Furthermore, sildenafil depressed the number of CXCR4 + cells. Collectively, these findings indicate that the improvement in pulmonary haemodynamic by sildenafil is linked to decreased recruitment of BM-derived c-kit + cells in the pulmonary tissue. The attenuation of the recruitment of BM-derived c-kit + cells by sildenafil may provide novel therapeutic insights into the control of pulmonary remodelling., (© 2016 The Authors. Journal of Cellular and Molecular Medicine published by John Wiley & Sons Ltd and Foundation for Cellular and Molecular Medicine.)

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.)

Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety., (© 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.)