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Background: The quality of a myocardial protection of a single-dose del Nido cardioplegia versus multiple dose blood-based cardioplegia on myocardial injury, outcomes and operative times in patients undergoing minimally invasive aortic valve replacement is basically unreported., Methods and Results: Preoperative and post-operative data, as well as technical details from isolated minimally invasive aortic valve replacements, performed using single-dose or multiple-dose cardioplegia were prospectively collected and retrospectively analysed. A total of 110 patients undergoing minimally invasive valve replacements at our institution composed two groups: 55 patients in the blood cardioplegia group (BloCa) and 55 in the del Nido group (DeNiCa). The two-matched groups were comparable in terms of preoperative variables. In the DeNiCa group, there was a statistically significant less need for cardiac defibrillation after aortic cross-clamp release ( p  < 0.001). Moreover, the BloCa group received intraoperatively more blood transfusions ( p  = 0.001) and more insulin administration for higher glucose levels ( p  < 0.001). The BloCa group showed higher intraoperative lactate levels ( p  = 0.01). Need for post-operative inotropic and vasoactive support, Creatine Kinase-MB levels after 6 and 12 h, onset of post-operative atrial fibrillation and length of stay were similar. No deaths occurred in neither groups., Conclusion: Single-dose del Nido cardioplegia in the setting of minimally invasive aortic surgery seems to offer adequate myocardial protection, comparable to multiple dose hematic cardioplegia. It has been documented a lower peri-operative need of defibrillation after cross-clamp release, lactate- and glucose peak values, as well as less blood transfusions compared to blood cardioplegic strategy., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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 SwissTAVI Registry includes all consecutive patients undergoing transcatheter aortic valve implantation (TAVI) and valve-in-valve (VinV) procedures for a failed bioprosthesis in Switzerland. We report the real world, all-comers, 30-day and 1-year outcomes of patients undergoing VinV and standard TAVI procedures., Methods: Prospectively collected data from the 2 groups (VinV and standard TAVI patients) were retrospectively analysed. In an adjusted analysis, in-hospital and 1-year outcomes of VinV patients were compared with those of patients undergoing TAVI for native aortic valve disease in the same registry. A subanalysis of VinV procedures in stenotic or regurgitant bioprosthesis was also performed., Results: Between February 2011 and December 2016, 4599 and 157 consecutive patients underwent TAVI in native aortic valves and VinV procedures in degenerate bioprosthesis, respectively. VinV patients were younger (78 ± 9.1 years vs 82.2 ± 6.3 years; P < 0.001) but at a higher risk for surgery (the logistic EuroSCORE: 28.48 ± 15.3% vs 18.2 ± 13.6%; P < 0.001; the Society of Thoracic Surgery (STS) score: 6.4 ± 5% vs 5.5 ± 4.3%; P = 0.008). Valve predilatation was less frequently performed during VinV procedures (22.9% vs 69.1%; P < 0.001), and the hospital stay was shorter after VinV procedure (8.46 ± 4.2 days vs 9.83 ± 6 days; P = 0.005). VinV patients showed higher predischarge transvalvular mean gradients (14.14 ± 7.9 mmHg vs 8.42 ± 5.0 mmHg; P < 0.001), smaller mean valve surface area (1.54 ± 0.7 cm2 vs 1.83 ± 0.5 cm2; P < 0.001) and a lower risk of moderate/severe paravalvular leak (1.3% vs 5%). Post-procedural kidney injury (1.3% vs 4.8%; P = 0.06) and new pacemakers for conduction abnormalities (3.3% vs 18.5%; P < 0.001) were higher after TAVI. All-cause mortality and cardiovascular mortality at 30 days were similar between the 2 groups (1.9% vs 3.8%; P = 0.242 and 1.9% vs 3.4%; P = 0.321), whereas after 1 year, all-cause mortality was lower for VinV patients (6.8% vs 13%; P = 0.035). The bioprosthetic valve size correlated inversely with postoperative gradients after VinV procedures., Conclusions: VinV aortic procedures showed favourable 30-day and 1-year clinical outcomes compared with TAVI procedures for the native aortic valve disease. Despite higher transvalvular mean gradients following VinV implants, this appears not to impact the early clinical outcomes., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Introduction: Endovascular treatments, such as transcatheter aortic valve implantation (TAVI), carry a risk of embolization due to debris dislodgement during various procedural steps. Although embolic filters are already available and marketed, mechanisms underlying cerebral embolism still need to be elucidated in order to further reduce cerebrovascular events., Methods: We propose an experimental framework with an in silico duplicate allowing release of particles at the level of the aortic valve and their subsequent capture in the supra-aortic branches, simulating embolization under constant inflow and controlled hemodynamic conditions. The effect of a simple flow modulation, consisting of an auxiliary constant flow via the right subclavian artery (RSA), on the amount of particle entering the brachiocephalic trunk was investigated. Preliminary computational fluid dynamics (CFD) simulations were performed in order to assess the minimum retrograde flow-rate from RSA required to deviate particles., Results: Our results show that a constant reversed auxiliary flow of 0.5 L/min from the RSA under a constant inflow of 4 L/min from the ascending aorta is able to protect the brachiocephalic trunk from particle embolisms. Both computational and experimental results also demonstrate that the distribution of the bulk flow dictates the distribution of the particles along the aortic branches. This effect has also shown to be independent of release location and flow rate., Conclusions: The present study confirms that the integration of in vitro experiments and in silico analyses allows designing and benchmarking novel solutions for cerebral embolic protection during TAVI such as the proposed embo-deviation technique based on an auxiliary retrograde flow from the right subclavian artery.

Background: Radiological exposure associated with transcatheter aortic valve implantation (TAVI) is unknown and might impact on broadening indications to lower risk patients. Radiological exposure of TAVI patients and its predictors are herein reported., Methods: Radiological exposure derived from exams/procedures performed within 30 days preceding/following TAVI were acquired and converted into effective-dose. Total effective-dose was defined as the sum of each single dose derived from diagnostic/therapeutic sources. Univariable and multivariable analyses were performed to recognize correlates of exposure., Results: Seventy-five patients aged 82.6 ± 6.0 years with a median Euroscore II 3.6 [IQR 1.93-6.65] were analysed. Median total effective-dose was 41.39 mSv [IQR 27.93-60.88], with TAVI accounting for 47% of it. Age (coefficient -0.031, 95% CI -0.060 to -0.002; P = 0.031) and previous history of cerebrovascular accidents (CVA; coefficient -0.545; 95% CI -1.039 to -0.010; P = 0.046) resulted as inversely correlated to total effective-dose (log-transformed), whereas left ventricular ejection fraction (LVEF) less than 50% (coefficient 0.430, 95% CI 0.031-0.828; P = 0.035) was directly associated., Conclusion: Multiple radiological sources are responsible for the observed exposure, with TAVI being the prominent source. Age is inversely related to the radiological exposure.

Background: Transcatheter mitral valve replacement (TMVR) may mature to become a therapeutic option for high-risk patients with severe mitral regurgitation (MR), particularly in patients at high or prohibitive surgical risk. MR patients with preexisting aortic valve prosthesis have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anchoring mechanism and the aortic prosthesis. We describe the procedural and short-term outcomes of transapical TMVR with the Tiara valve in patients experiencing severe symptomatic MR with previous aortic valve replacement (AVR)., Methods and Results: Twelve consecutive high surgical risk patients (11 men; mean age, 75±6 years) with aortic valve prosthesis and severe MR underwent TMVR with Tiara valve. Aortic valves were mechanical in 5 and biological in 7 patients, while 1 patient had previously undergone implantation of a transcatheter valve within a failed bioprosthetic surgical valve. Six patients (50%) had undergone redo surgical aortic valve replacement. Clinical characteristics of the group include prior mitral valve repair in 2, prior coronary bypass grafting surgery in 5, chronic atrial fibrillation in 7, renal failure in 9, and pacemaker/cardiac resynchronization device in 9 patients. Mean Society of Thoracic Surgery score and EuroSCORE II were 10.5±4.4 and 12.4±3.7, respectively. Mean baseline left ventricular ejection fraction was 35.5±5.3% (range, 30%-45%). The Tiara valve was implanted uneventfully in all patients. Device migration or left ventricular outflow tract obstruction was not observed. No patient required conversion to open heart surgery or periprocedural hemodynamic support. Procedural success was 100% with no death, MI, stroke, major bleeding, or access site complications at 30 days. MR was eliminated in all 12 patients immediately after implantation., Conclusions: Transapical mitral valve replacement with the Tiara valve in high-risk patients with severe MR and aortic valve prostheses is technically feasible and can be performed safely.

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.

Transcatheter mitral valve replacement with the Tiara valve can be performed in inoperable patients with severe functional regurgitation. Risk of left ventricular outflow tract obstruction can be prevented using preoperative 3D imaging and 3D-printed models. However, in the case of mono-disk mechanical prostheses previously implanted in aortic position (Bjork-Shiley), there is an additional risk of mechanical interference leading to reduced leaflet motion and aortic valve dysfunction. Hereafter, we describe the case of a patient with a 27-mm mono-disk mechanical aortic valve implanted in 1978, a EuroSCORE II of 18%, and a Society of Thoracic Surgeon score (mortality) of 16% who successfully underwent a transapical Tiara valve implantation., (Copyright © 2018 Elsevier Inc. All rights reserved.)

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.

Objective: The aim of this study was to compare outcomes after rapid-deployment aortic valve replacement (RDAVR) and conventional aortic valve replacement (AVR) from two studies., Methods: Patients who underwent RDAVR (INTUITY valve) in the prospective, 5-year, single-arm multicenter TRITON study, or conventional AVR (Perimount Magna Ease valve) in the prospective Perimount Magna Ease postmarket study, were propensity score matched and compared for procedural, hemodynamic, safety, and clinical outcomes., Results: Matched RDAVR (n = 106) and conventional AVR (n = 106) patients had similar baseline characteristics (mean ± SD age, 72.8 ± 7.6 vs 72.5 ± 7.4 years; male 59.4% vs 61.3%) and procedures (concomitant procedures: 41.5% vs 50.9%). Mean ± SD aortic cross-clamp time was significantly shorter in RDAVR than AVR patients (51.8 ± 20.9 vs 73.9 ± 33.2 minutes; P < 0.001), as was mean cardiopulmonary bypass time (82.8 ± 34.2 vs 102.4 ± 41.7 minutes; P < 0.001). At 1 year, RDAVR patients showed significantly lower mean ± SD and peak aortic valve gradients (9.0 ± 3.4 and 17.0 ± 6.2 mm Hg, respectively) than conventional AVR patients (13.4 ± 5.5 and 24.2 ± 10.8 mm Hg, respectively; all P < 0.001). Patient-prosthesis mismatch was significantly less common with RDAVR than with AVR [overall: 16/66 (24.2%) vs 46/76 (60.5%); P = 0.007; severe: 2/66 (3.0%) vs 13/76 (17.1%)]. There were no significant differences between the RDAVR and AVR groups regarding 30-day safety endpoints. Survival rates in the RDAVR and conventional AVR groups were, respectively, 99.1% and 100.0% at 30 days, 97.1% and 95.1% at 1 year, and 93.3% and 94.1% at 3 years (P = nonsignificant)., Conclusions: In this retrospective study with matched populations, the RDAVR with the INTUITY valve system provided superior procedural and hemodynamic outcomes than a standard bioprosthesis without compromising safety.

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.)

Objective: We aimed to analyse the incidence of prosthesis-patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event., Methods: A total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls)., Results: Moderate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta -0.023; 95% CI -0.032 to -0.014; P<0.001), a stented (vs a stentless) surgical bioprosthesis (unstandardised beta -0.11; 95% CI -0.161 to -0.071; P<0.001), higher BMI (unstandardised beta -0.01; 95% CI -0.013 to -0.007; P<0.001) and implantation of a SAPIEN/SAPIEN XT/SAPIEN 3 transcatheter device (unstandardised beta -0.064; 95% CI -0.095 to -0.032; P<0.001). Neither severe PPM nor elevated gradients had an association with VARC II-defined outcomes or 1-year survival (90.9% severe vs 91.5% moderate vs 89.3% none, P=0.44)., Conclusions: Severe PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation., Competing Interests: Competing interests: DD is a consultant for Edwards Lifesciences, Medtronic and Abbott. SB is a proctor and consultant for Medtronic and a proctor for Boston Scientific and JenaValve. RL is a member of the Medtronic advisory board. SG is a consultant for Edwards Lifesciences, Medtronic, Surmodics, Osprey Medical and Boston Scientific and also repots research grants from Edwards Lifesciences and VA Office of Research and Development. EF reports consulting and proctoring for Edwards Lifesciences. DH is a member of the Medtronic advisory board. TZ reports lecture fees from Edwards Lifesciences and Medtronic. MJR is a consultant for Medtronic, Abbott and Boston Scientific. SW reports institutional research grants from Amgen, Abbott, Boston Scientific, Biotronik and St. Jude Medical. NMvM reports research grant support from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, Claret and Essential Medical. NB has received research grants from Edwards Lifesciences and speaker honoraria from Edwards Lifesciences, Medtronic and Abbott. AC is part of the speakers bureau for Edwards Lifesciences, Medtronic and Abbott, and also reports proctoring for Medtronic. J-MS reports research grants and speaker honoraria from Medtronic, Edwards Lifesciences, Boston Scientific, and Abbott. No other conflicts of interest were reported., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Trans-carotid access for trans-catheter aortic valve replacement is a valid alternative in patients with aortic valve dysfunction, severe peripheral vascular disease, and high-risk for surgery. However, in the event of the need for a bailout valve-in-valve procedure, the safety of this access site is uncertain. We report a patient with aortic regurgitation, previous coronary surgery, peripheral vascular disease, and impaired ventricular function who underwent a CoreValve Evolut-R (Medtronic Inc, Minneapolis, MN) implantation through the left carotid artery followed by a successful valve-in-valve procedure with a 26-mm Edwards Sapien3 valve (Edwards Lifesciences, Irvine, CA) through the same carotid access site., (© 2018 Wiley Periodicals, Inc.)

Background: Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR)., Objectives: This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR., Methods: From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices., Results: A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001)., Conclusions: Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The Transcatheter Valve Therapy (TVT) registry model was recently developed to predict the risk of in-hospital mortality in patients undergoing transcatheter aortic valve replacement. We sought to externally validate the model in an independent data set of consecutively enrolled patients in the Swiss Transcatheter Aortic Valve Implantation registry., Methods and Results: The original prediction model was retrospectively applied to 3491 consecutive patients undergoing transcatheter aortic valve replacement in Switzerland between February 2011 and February 2016. We examined model performance in terms of discrimination (Harrel C index) and calibration (Hosmer-Lemeshow goodness-of-fit test) for prediction of in-hospital and 30-day mortality and compared its predictive accuracy with the Society of Thoracic Surgeons Predicted Risk of Mortality score. Rates of in-hospital and 30-day mortality in the external validation cohort were 2.9% and 3.8%, respectively. The TVT registry model was found to have moderate discrimination (C index, 0.66; 95% confidence interval, 0.60-0.72 and C index, 0.67; 95% confidence interval, 0.62-0.72 for in-hospital and 30-day mortality, respectively) and good calibration. Compared with the Society of Thoracic Surgeons Predicted Risk of Mortality score, the TVT registry model demonstrated improved calibration for in-hospital (slope, 0.83; P =0.23 versus slope, 0.24; P <0.001, respectively) and 30-day (slope, 1.11; P =0.40 versus slope, 0.41; P <0.001, respectively) mortality., Conclusions: In a large, multicenter, non-US cohort of patients with transcatheter aortic valve replacement, the validation of the TVT registry model demonstrated moderate discrimination and good calibration for the prediction of in-hospital and 30-day mortality. As a result, the TVT registry model should be considered an alternative to the Society of Thoracic Surgeons Predicted Risk of Mortality score for decision making and assessment of early outcome in patients eligible for transcatheter aortic valve replacement., (© 2017 American Heart Association, Inc.)

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 goal was to show the technical details, feasibility and clinical results of balloon-expandable stent valve implantation in the aortic position during conventional redo open-heart surgery in selected obese patients with a small aortic prosthesis and severe patient-prosthesis mismatch., Methods: Two symptomatic overweight patients (body mass index of 31 and 38), each with a small aortic prosthesis (a 4-year-old, 21-mm Hancock II biological valve and a 29-year-old, 23-mm Duromedic mechanical valve), increased transvalvular gradients (59/31 and 74/44 mmHg) and a reduced indexed effective orifice area (0.50 and 0.43 cm 2 /m 2 ) underwent implantation of two 26-mm balloon-expandable Sapien 3 valves during standard on-pump redo valve surgery., Results: Using full re-sternotomy, cardiopulmonary bypass and cardioplegic arrest, the two balloon-expandable stent valves were implanted under direct view using a standard aortotomy, after prosthesis removal and without annulus enlargement. Aortic cross-clamp times were 162 and 126 min; cardiopulmonary bypass times were 178 and 180 min; total surgical times were 360 and 318 min. At discharge, echocardiograms showed transvalvular peak and mean gradients of 13/9 and 23/13 mmHg and indexed effective orifice areas of 0.64 and 1.08 cm 2 /m 2 . The 3-month echocardiographic follow-up showed transvalvular peak and mean gradients of 18/9 and 19/11 mmHg and indexed effective orifice areas of 0.78 cm 2 /m 2 and 0.84 cm 2 /m 2 , with improved symptoms (New York Heart Association class 1)., Conclusions: Implantation of a balloon-expandable stent valve during redo aortic valve surgery is feasible in selected cases and prevents patient-prosthesis mismatch in obese patients without need for aortic annulus enlargement. Moreover, in the case of stent valve degeneration, this approach permits additional valve-in-valve procedures with large stent valves and prevents re-redo surgery., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Introduction: Redo surgery still is the treatment of choice for degenerated bioprosthesis. However, as far as elderly patients with concomitant comorbidities are concerned, the standard reoperation carries additional operative risks and, therefore, minimally invasive procedures must be prioritized., Areas Covered: During the last ten years, transcatheter procedures in native valves have become a standard technique in several centers with excellent procedural and mid-term results. Similarly, implantation of transcatheter stent-valves within degenerated aortic and mitral bioprosthesis, the 'valve-in-valve' procedure (V-in-V), represents a valid alternative to redo surgery in patients with high-risk surgical profiles. New challenges for V-in-V are the transcatheter stent-valve deployment in hostile targets (stented bioprosthesis with externally mounted leaflets, stentless valves, small bioprostheses), and avoid complications as delayed atrial embolization of mitral implantation and V-in-V thrombosis. Moreover a continuous ameliorated design of the devices on the market and new transcatheter stent-valves are recently developed in order to improve the outcome and safety of V-in-V treatment. Expert commentary: We reviewed the clinical outcomes and the procedural details of published transcatheter aortic and mitral valve-in-valve series focusing, in particular, on data from the Valve-in-Valve International Data registry (VIVID), and we provide a practical guide for valve sizing and stent-valve positioning.

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.)

Background: New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation., Methods and Results: In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P<0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no significant differences for disabling stroke (S3 1.3% versus XT 3.1%, P=0.29) and all-cause mortality (S3 3.3% versus XT 4.5%, P=0.27)., Conclusions: The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01368250., (© 2015 American Heart Association, Inc.)

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.)

Urgent reoperative transapical aortic valve-in-valve has never been proposed as a treatment option in case of a failed transcatheter aortic valve implantation (TAVI) or in case of worsening of an existing paravalvular leak, if this complication occurs right after, or a few days after, the primary transapical aortic valve implantation. Experienced surgeons should argue that after a transapical TAVI, the apex is damaged and fragile, with a high risk of irreparable ventricular tears and life-threatening bleeding if a second transapical procedure is scheduled during the acute phase. Nevertheless, if the patient is inoperable and the vascular status, including the ascending aorta, limits alternative accesses, the urgent reoperative transapical valve-in-valve becomes an alternative. We illustrate, for the first time ever, our experience with an 81-year old female patient who underwent a transapical (TA) TAVI with a Sapien XT 23 mm. The day after the procedure, the patient haemodynamically worsened in combination with a worsening of a known (grade 1-2) paravalvular leak. Thus, on postoperative day two, an urgent transapical valve-in-valve was performed, and a second Sapien XT 23 mm was placed, with an excellent haemodynamic result and absence of leak. The redo apical access did not appear very complicated and the postoperative recovery was uneventful., (© The Author 2013. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Importance: Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed., Objective: To determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves., Design, Setting, and Participants: Correlates for survival were evaluated using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 [SD, 9.8] years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8% [interquartile range, 7.7%-16%]). Surgical valves were classified as small (≤21 mm; 29.7%), intermediate (>21 and <25 mm; 39.3%), and large (≥25 mm; 31%). Implanted devices included both balloon- and self-expandable valves., Main Outcomes and Measures: Survival, stroke, and New York Heart Association functional class., Results: Modes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation and combined groups, respectively; P = .005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83.2% (95% CI, 80.8%-84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%-83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%-96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%-91%; 18 deaths; 66 survivors) (P = .01). Similarly, patients with small valves had worse 1-year survival (74.8% [95% CI, 66.2%-83.4%]; 27 deaths; 57 survivors) vs with intermediate-sized valves (81.8%; 95% CI, 75.3%-88.3%; 26 deaths; 92 survivors) and with large valves (93.3%; 95% CI, 85.7%-96.7%; 7 deaths; 73 survivors) (P = .001). Factors associated with mortality within 1 year included having small surgical bioprosthesis (≤21 mm; hazard ratio, 2.04; 95% CI, 1.14-3.67; P = .02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33-7.08; P = .008)., Conclusions and Relevance: In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis.

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.

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.

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.