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Objectives: This study aimed to analyse risk factors for postoperative stroke, evaluate the underlying mechanisms and report on outcomes of patients suffering a postoperative stroke after total aortic arch replacement using the frozen elephant trunk technique., Methods: Two-hundred and fifty patients underwent total aortic arch replacement via the frozen elephant trunk technique between March 2013 and November 2020 for acute and chronic aortic pathologies. Postoperative strokes were evaluated interdisciplinarily by a cardiac surgeon, neurologist and radiologist, and subclassified to each's cerebral territory. We conducted a logistic regression analysis to identify any predictors for postoperative stroke., Results: Overall in-hospital was mortality 10% (25 patients, 11 with a stroke). A symptomatic postoperative stroke occurred in 42 (16.8%) of our cohort. Eight thereof were non-disabling (3.3%), whereas 34 (13.6%) were disabling strokes. The most frequently affected region was the arteria cerebri media. Embolism was the primary underlying mechanism (n = 31; 73.8%). Mortality in patients with postoperative stroke was 26.2%. Logistic regression analysis revealed age over 75 (odds ratio = 3.25; 95% confidence interval 1.20-8.82; P = 0.021), a bovine arch (odds ratio = 4.96; 95% confidence interval 1.28-19.28; P = 0.021) and an acute preoperative neurological deficit (odds ratio = 19.82; 95% confidence interval 1.09-360.84; P = 0.044) as predictors for postoperative stroke., Conclusions: Stroke after total aortic arch replacement using the frozen elephant trunk technique remains problematic, and most lesions are of embolic origin. Refined organ protection strategies, and sophisticated monitoring are mandatory to reduce the incidence of postoperative stroke, particularly in older patients presenting an acute preoperative neurological deficit or bovine arch., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Background: The impact of transcatheter heart valve (THV) position on the occurrence of paravalvular leakage and permanent pacemaker implantation caused by new-onset conduction disturbances is well described. The purpose of this study was to investigate the influence of the geometry of the thoracic aorta on the implantation depth after TAVI (transcatheter heart valve implantation) using self-expanding valve (SEV) types., Methods: We evaluated three-dimensional geometry of the thoracic aorta based on computed tomography angiography (CTA) in 104 subsequently patients receiving TAVI with SEV devices (Evolut R). Prosthesis position was determined using the fusion imaging method of pre- and post-procedural CTA. An implantation depth of ≥4 mm was defined as the cut-off value for low prosthesis position., Results: The mean implantation depth of the THV in the whole cohort was 4.3 ± 3.0 mm below annulus plane. THV position was low in 66 (63.5%) patients and high in 38 (36.5%) patients. After multivariate adjustment none of the aortic geometry characteristics showed an independent influence on the prosthesis position-neither the Sinus of Valsalva area ( p = 0.335) nor the proximal aortic arch diameter ( p = 0.754) or the distance from annulus to descending aorta ( p = 0.309)., Conclusion: The geometry of the thoracic aorta showed no influence on the positioning of self-expanding TAVI valve types.

Leaflet durability and costs restrict contemporary trans-catheter aortic valve replacement (TAVR) largely to elderly patients in affluent countries. TAVR that are easily deployable, avoid secondary procedures and are also suitable for younger patients and non-calcific aortic regurgitation (AR) would significantly expand their global reach. Recognizing the reduced need for post-implantation pacemakers in balloon-expandable (BE) TAVR and the recent advances with potentially superior leaflet materials, a trans-catheter BE-system was developed that allows tactile, non-occlusive deployment without rapid pacing, direct attachment of both bioprosthetic and polymer leaflets onto a shape-stabilized scallop and anchorage achieved by plastic deformation even in the absence of calcification. Three sizes were developed from nickel-cobalt-chromium MP35N alloy tubes: Small/23 mm, Medium/26 mm and Large/29 mm. Crimp-diameters of valves with both bioprosthetic (sandwich-crosslinked decellularized pericardium) and polymer leaflets (triblock polyurethane combining siloxane and carbonate segments) match those of modern clinically used BE TAVR. Balloon expansion favors the wing-structures of the stent thereby creating supra-annular anchors whose diameter exceeds the outer diameter at the waist level by a quarter. In the pulse duplicator, polymer and bioprosthetic TAVR showed equivalent fluid dynamics with excellent EOA, pressure gradients and regurgitation volumes. Post-deployment fatigue resistance surpassed ISO requirements. The radial force of the helical deployment balloon at different filling pressures resulted in a fully developed anchorage profile of the valves from two thirds of their maximum deployment diameter onwards. By combining a unique balloon-expandable TAVR system that also caters for non-calcific AR with polymer leaflets, a powerful, potentially disruptive technology for heart valve disease has been incorporated into a TAVR that addresses global needs. While fulfilling key prerequisites for expanding the scope of TAVR to the vast number of patients of low- to middle income countries living with rheumatic heart disease the system may eventually also bring hope to patients of high-income countries presently excluded from TAVR for being too young., Competing Interests: “Strait Access Technologies” (SAT) is a start-up company of the University of Cape Town. HA, DB, JSc, HC, DW, and PZ own shares in SAT. JV, RC, and RS are employed by SAT. KP, BB, and MC are former employees and shareholders of SAT. BJ is a former employee of SAT. CS is employed by Auto Tissue Berlin. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Appa, Park, Bezuidenhout, van Breda, de Jongh, de Villiers, Chacko, Scherman, Ofoegbu, Swanevelder, Cousins, Human, Smith, Vogt, Podesser, Schmitz, Conradi, Treede, Schröfel, Fischlein, Grabenwöger, Luo, Coombes, Matskeplishvili, Williams and Zilla.)

Prior studies in patients with transcatheter aortic valve implantation (TAVI) demonstrated an influence of transcatheter heart valve (THV) position on the occurrence of new conductions disturbances (CD) and paravalvular leakage (PVL) post TAVI in balloon-expandable valves (BEV). Purpose of this study was to investigate the THV implantation depth and its influence on the occurrence of CD and PVL in self-expanding valves (SEV). We performed fusion imaging of pre- and post-procedural computed tomography angiography in 104 TAVI-patients (all with Evolut R) to receive a 3-D reconstruction of the THV within the native annulus region. The THV length below the native annulus was measured for assessment of implantation depth. Electrocardiograms pre-discharge were assessed for conduction disturbances (CD), PVL was determined in transthoracic echocardiography. The mean implantation depth of the THV in the whole cohort was 4.3 ± 3.0 mm. Using the best cut-off of ≥ 4 mm in receiver operating characteristic curve analysis (sensitivity 83.3%, specificity 60.0%) patients with lower THV position developed more new CD after TAVI (68.2 vs. 23.7%, P < 0.001). A deep THV position was identified as the only predictor for new CD after TAVI (odds ratio [CI] 1.312[1.119-1.539], P = 0.001). The implantation depth showed no influence on the grade of PVL (r = 0.052, P = 0.598). In patients with TAVI using the Evolut R SEV, a lower THV positioning (≥ 4 mm length below annulus) was a predictor for new conduction disturbances. In contrast, implantation depth was not associated with the extent of PVL. Prostheses positions of self-expanding valves and their influence on the occurrence of new conduction disturbances and the grade of paravalvular leakage after TAVI., (© 2021. The Author(s).)

Background: A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE neo bioprosthetic aortic valve., Methods and Results: This single-arm post-market study had a planned enrolment of 200 subjects; enrolment was terminated early due to declining TA-TAVR procedures at participating centers. Final enrolment was 107 patients (mean age: 79.3 years; 54.2% female; mean STS score at baseline: 6.2%). The mortality rate in the intent-to-treat population was 11.2% at 30 days (primary endpoint) and 25.6% at 12 months. The VARC-2 composite endpoint for 30-day safety occurred in 24.3% of patients. Six patients (5.6%) received a permanent pacemaker within 30 days. Site-reported echocardiographic data showed early improvements in mean aortic valve gradient (baseline: 38.8 [SD 13.1] mmHg, discharge: 6.7 [SD 3.7] mmHg) and effective orifice area (baseline: 0.7 [SD 0.2] cm 2 , discharge: 1.9 [SD 0.6] cm 2 ), and the discharge rate of paravalvular regurgitation was low (74.7% none/trace, 24.2% mild, 1.1% severe)., Conclusions: TA-TAVR with the ACURATE neo valve system yields acceptable clinical outcomes, providing an alternative for patients with aortic stenosis who are not candidates for TF-TAVR., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ‘AH and MH report proctoring for Boston Scientific and consulting on the CRC board for the ongoing ACURATE IDE study; MD and DH report proctoring for Boston Scientific; LC reports being an advisory board member for Boston Scientific; DJA is an employee and shareholder of Boston Scientific; all other authors report no conflicts of interest.’., (© 2021 The Authors. Published by Elsevier B.V.)

Objectives: The goal of this study was to evaluate outcomes of aortic arch replacement using the frozen elephant trunk (FET) technique after previous proximal and/or distal open or endovascular thoracic aortic repair., Methods: Sixty-three patients [median age: 63 (55-74) years; 65% men] were operated on for acute or chronic aortic dissection after previous proximal and/or distal open or endovascular thoracic aortic repair. Intraoperative details, clinical outcome and follow-up results were evaluated., Results: The median time between the index and the FET procedure was 81 (40-113) months. Fifty-eight (92%) patients had already undergone proximal aortic surgery; supracoronary ascending aortic replacement was the most frequent index procedure [n = 25 (40%)]. Distal aortic interventions had been done in 8 (13%) patients including endovascular thoracic aortic repair in 6 patients (10%). In-hospital mortality was 3% (n = 2). Postoperative strokes occurred in 5 patients (8%); of those, 1 stroke was dissection-related (2%). Subsequent aortic reinterventions after the FET procedure had to be done in 33% (n = 21)., Conclusions: Outcomes of aortic arch replacement using the FET technique after previous proximal and/or distal open or endovascular thoracic aortic repair are associated with low mortality and morbidity. Still, postoperative stroke remains an issue. After the successful accomplishments, the approach serves as an ideal platform for the secondary surgical or endovascular downstream aortic procedures, which are frequently needed., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Low prosthesis position after transcatheter aortic valve implantation (TAVI) is associated with higher rates of new onset conduction disturbances and permanent pacemaker implantations. Purpose of this study was to investigate possible predictors of a low prosthesis position of the SAPIEN 3 (Edwards Lifesciences, Irvine, California, USA) valve type using fusion imaging of pre- and post-procedural computed tomography angiography (CTA)., Methods: CTA fusion imaging was performed in 120 TAVI-patients with 3D-reconstruction of the transcatheter heart valve (THV) position within the device landing zone. A low implantation position was defined according to the manufacturer's recommendations as > 30% of the prosthesis below the native annulus plane., Results: A low THV position was found in 17 patients (14%). Patients with low THV position had less calcification of the annulus region and a smaller annulus size compared to patients with a normal or high THV position (P = 0.003 and 0.041, respectively). The only independent predictor of a low THV position in multivariate logistic regression analysis was the extent of calcification of the cusp region (odds ratio [CI] 0.842 [0.727-0.976], P = 0.022)., Conclusions: Fusion imaging of pre-and post-procedural CTA identified reduced calcification of the cusp region as an independent predictor of a low THV position of the SAPIEN 3. This should be considered when planning the TAVI procedure. Correlation of cusp region calcification and prosthesis position after TAVI.

Aims: Early leaflet thrombosis (LT) is a well-described phenomenon after transcatheter aortic valve implantation (TAVI) with an incidence around 15%. Data about predictors of LT are scarce. The purpose of the study was to investigate the influence of prosthesis-related factors on the occurrence of LT., Materials and Results: Fusion imaging of pre- and post-procedural computed tomography angiography was performed in 55 TAVI patients with LT and 140 selected patients as control groups (85 patients in an unmatched and 55 in a matched control) to obtain a 3D reconstruction of the transcatheter heart valve (THV) within the native annulus region. All patients received a balloon-expandable Sapien 3 THV. The THV length above and below the native annulus was measured within the fused images to assess the implantation depth. The deployed THV area was quantified on three heights (left ventricular outflow tract end, stent centre, and aortic end) to determine the average expansion of the prosthesis as percent of the nominal area. We also calculated the extent of prosthesis waist in percent of maximum area. After multivariate adjustment, the extent of THV waist [odds ratio (OR) per 10% (confidence interval, CI) 0.636 (0.526-0.769), P < 0.001] as prosthesis-related factor and previous oral anticoagulation [OR (CI) 0.070 (0.020-0.251), P < 0.001] had significant, independent influence on the occurrence of LT. The implantation depth showed no influence on LT manifestation (P = 0.704)., Conclusion: Besides the absence of previous oral anticoagulation, a less pronounced waist of the implanted THV was a prosthesis-position-related independent predictor of LT after TAVI using the Sapien 3., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Aims: Patients with postoperative delirium (POD) after transcatheter aortic valve replacement (TAVR) are ventilated and hospitalized longer and suffer increased in-hospital mortality. This study hypothesized that a minimalistic approach with conscious sedation during transfemoral aortic valve replacement (TF-AVR) protects against delirium, time of mechanical ventilation, and increased length of stay in intensive care unit (ICU) compared to intubation anaesthesia., Methods and Results: 308 patients which underwent TF-AVR in our centre between 01/2013 and 08/2017 were retrospectively evaluated regarding postoperative delirium, time of mechanical ventilation, and days in ICU. TF-AVR was performed with intubation anaesthesia in 245 patients and with conscious sedation in 63. The operative risk estimated by the logEUROScore was similar in both groups (intubation: 13.28 +/-9.06%, conscious sedation: 12.24 +/-6.77%, p = 0.395). In the conscious sedation group procedure duration was shorter (0.61 +/-0.91h vs. 1.75 +/-0.96h, p<0.001). The risk for intraprocedural complications was not influenced by the anaesthesia method (OR conscious sedation instead of intubation 1.66, p = 0.117), but days on ICU (-2.21 days, p<0.0001) and minutes of mechanical ventilation (-531.2 min, p < 0.0001) were reduced. Furthermore, the risk of POD was decreased when TF-AVR was performed under conscious sedation (6.35% vs. 18.18%, OR 0.29, p = 0.021)., Conclusions: Time of mechanical ventilation, risk of POD, and days on ICU were substantially reduced in patients who underwent TF-AVR under conscious sedation. Our data suggest that TF-AVR with conscious sedation is safe with a beneficial postoperative course in clinical practice, and should be considered the favoured approach., Competing Interests: The authors have declared that no competing interests exist.

Objectives: Our goal was to report our results of late surgical conversion after endovascular aneurysm repair (EVAR)., Methods: Variables analysed included baseline data, preinterventional anatomy, type of endovascular intervention, indications for conversion, operative technique, postoperative complications and follow-up survival rate., Results: Between April 2011 and May 2018, 16 patients with late complications after EVAR underwent open surgical conversion at our institution. The mean age was 73.6 [standard deviation (SD) 8.9] years. There were 3 (18.8%) female patients. In 15 patients, the indication for primary EVAR was abdominal aortic aneurysm, and in 1 patient, chronic abdominal aortic dissection. Five patients underwent secondary EVAR service interventions for endoleak treatment between the index EVAR and the final secondary surgical conversion. Thirteen patients underwent surgery in an elective setting and 3 patients underwent emergency surgery. The mean time from EVAR to open surgical conversion was 6.31 (SD 4.0) years (range 1.2-16.0 years). The most common indication for conversion was endoleak formation (n = 12, 75%), followed by 3 cases of aortic rupture (1 patient with primary type 1 endoleak) and 2 cases of stent graft infection-1 with and 1 without an aortoduodenal fistula. One patient died during emergency open surgery of cardiopulmonary instability. Three patients developed postoperative renal dysfunction with recovery of their renal function before discharge. The in-hospital mortality rate was 12.5%. The median follow-up was 16.5 months (interquartile range 21 months). Freedom from death and aortic reintervention was 100%, respectively. After careful review of the index computed tomography scans for EVAR, the majority of failures could have been anticipated due to trade-offs with regard to length, diameter, morphology, shape and angulation of the proximal and/or distal landing zone., Conclusions: Despite being a challenging operation, late surgical conversion after EVAR yields excellent results with regard to outcome and freedom from the need for further aortic interventions. An anticipative strategy adhering to current recommendations for using or refraining from using EVAR in patients with anatomical challenges will help reduce the need for secondary surgical conversions and keep them to minimum., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: To evaluate the outcomes of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) in a real-world setting through a patient-level meta-analysis., Methods: The meta-analysis included patients of three European multicenter, prospective, observational registry studies that compared outcomes after Edwards SAPIEN 3 or XT TAVI with (n = 339) or without (n = 355) BAV. Unadjusted and adjusted pooled odds ratios (with 95% confidence intervals) were calculated for procedural and 30-day outcomes., Results: Median procedural time was shorter in the non-BAV group than in the BAV group (73 versus 93 min, p = 0.001), as was median fluoroscopy time (7 versus 11 min, p = 0.001). Post-delivery balloon dilation (15.5% versus 22.4%, p = 0.02) and catecholamine use (9.0% vs. 17.9%; p = 0.016) was required less often in the non-BAV group than in the BAV group with the difference becoming insignificant after multiple adjustment. There was a reduced risk for periprocedural atrioventricular block during the intervention (1.4% versus 4.1%, p = 0.035) which was non-significant after adjustment. The rate of moderate/severe paravalvular regurgitation post-TAVI was 0.6% in the no-BAV group versus 2.7% in the BAV group. There were no between-group differences in the risk of death, stroke or other adverse clinical outcomes at day 30., Conclusions: This patient-level meta-analysis of real-world data indicates that TAVI performed without BAV is advantageous as it has an adequate device success rate, reduced procedure time and no adverse effects on short-term clinical outcomes.

The last 15 years have overwhelmed the surgical community with a range of approaches in treating pathologies involving the aortic arch of which some are here to stay. The ones to stay are-in the authors' opinion-refined classical surgical approaches such as the frozen elephant trunk technique, near-orthotopic combined vascular and endovascular approaches such as subclavian to carotid transposition/bypass and double transposition, and finally, near-orthotopic advanced endovascular solutions such as the double-endovascular repair using fenestrated and/or branched solutions which will be the main focus of this article., Competing Interests: Conflict of interestMartin Czerny and Bartosz Rylski are consultants to Terumo Aortic.No need for ethics or consent as this is a review article., (© Indian Association of Cardiovascular-Thoracic Surgeons 2019.)

Objectives: To minimize the complications with thoracic endovascular aortic repair (TEVAR), a new stent graft with no bare ends was developed, namely the Relay non-bare stent (NBS). We hypothesized that the new features of the NBS graft would enable highly accurate deployment and fewer complications. The aim of this study was to analyse the quality of the Relay NBS with respect to its landing precision., Methods: Relying on computed tomography angiographs, we evaluated the distance between the stent graft and the target vessel in the proximal landing zone (before and after the intervention as well as the mid-term results). Seventy-eight patients with thoracic aortic pathologies were included. Median computed tomography angiograph follow-up was 16 months., Results: The stent graft was deployable ≤5 mm from the target vessel in 64 (82%) patients; in 14 (18%) of them, the distance to the target vessel was >5 mm. According to the last follow-up computed tomography angiograph, in 35 (55%) patients, the distance to the target vessel was ≤5 mm and in 29 (45%) patients, it was >5 mm. There was no endoleak type Ia immediately after TEVAR or during the follow-up period. A substantial bird beak phenomenon was observed in 3 (4%) and 7 (11%) patients immediately after TEVAR and during the follow-up period, respectively. One patient had a retrograde dissection type A., Conclusions: The Relay NBS graft can be deployed accurately in the aortic arch in most patients. Retrograde aortic dissection type A seldom occurs after TEVAR using the Relay NBS graft. The distance between the NBS graft and the intended target vessel increases during the follow-up period., (© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

End-stage renal disease (ESRD) affects approximately 2% to 4% of patients with severe aortic stenosis. It is because these patients have been excluded from clinical trials, the impact of transcatheter aortic valve implantation (TAVI) in this patient group has not been thoroughly investigated. Between April 2008 and March 2015, 2,000 patients (dialysis group, n = 56 [2.8%]) were consecutively enrolled when diagnosed with severe aortic stenosis and eligible to undergo TAVI. Procedural and longer-term outcomes were analyzed and adjusted for differences in baseline characteristics. Patients on dialysis had a higher periprocedural mortality (10.7% vs 1.7%; adjusted odds ratio [adjOR] 5.65, 95% confidence interval [CI] 1.91 to 16.67; p = 0.002) and a lower Valve Academic Research Consortium (VARC)-II (VARC) defined device success (adjOR 0.34, 95% CI 0.15 to 0.79; p = 0.012). At 30 days, there was an increased rate of all-cause mortality (21.4 vs 4.8%; adjOR 4.90, 95% CI 1.96 to 12.26; p = 0.001), cardiovascular (adjOR 3.67, 95% CI 1.43 to 9.41; p = 0.007) and noncardiovascular mortality (adjOR 6.28, 95% CI 1.36 to 9.41; p = 0.019), myocardial infarction (adjOR 9.39, 95% CI 1.84 to 48.03; p = 0.007), bleeding (adjOR 2.48, 95% CI 1.06 to 5.83; p = 0.036) as well as the VARC-II defined early safety combined end point (adjOR 2.97, 95% CI 1.28 to 6.90; p = 0.012) associated with dialysis. Dialysis was associated with poor survival at one (57.1% vs 84.2%) and 3 years (26.8% vs 66.9%) with or without the consideration of the first 72 hours (p <0.001; adjusted p <0.001). Although, in the multivariable regression analysis, reduced ejection fraction, peripheral arterial disease, pulmonary hypertension (PH), frailty and dialysis were associated with 1-year mortality, only PH (>60 mm Hg) remained significant in an analysis restricted to the dialysis patients (adjusted hazard ratio 2.68; 95% CI 1.18 to 5.88; p = 0.018). PH had a sensitivity of 45.8%, a specificity of 81.3%, and a positive predictive value of 64.7%. In conclusion, dialysis is an independent predictor of mortality in patients who underwent TAVI. Long-term mortality in dialysis patients appears to be largely determined by the kidney disease and/or dialysis itself whereas VARC-II defined complications are largely unaffected. An increased short-term mortality still calls for (pre-) procedural optimization., (Copyright © 2018. Published by Elsevier Inc.)

Objective: The study objective was to screen patients with acute type A aortic dissection for anatomic feasibility of ascending aortic endovascular treatment with a valve-carrying conduit., Methods: High-quality computed tomography scans of 167 patients were available for screening. Aortic dimensions were measured using multiplanar reconstruction in the plane perpendicular to the manually corrected aortic center line. The simulated stent-graft 10-mm-long landing zones were measured starting at the sinotubular junction (proximal landing zone) and ending at the brachiocephalic trunk (distal landing zone). Exclusion criterion was an entry within the aortic root or the landing zone., Results: In 113 patients (68%), the entry was in a coverable zone in the ascending aorta with sufficient proximal and distal landing zone or in more distal aortic segments. In these patients, the median distance between the proximal and distal landing zone was 89.1 (first quartile: 80.0 mm; third quartile: 101.2 mm) and the median diameter difference was 5.0 mm (2.0; 10.1) (12.3 [4.9; 23.0] %). The diameter difference was less than 2 mm in 32 patients (28%), between 6 mm and 10 mm in 20 patients (18%), between 10 mm and 14 mm in 11 patients (10%), and 14 mm or greater in 10 patients (9%)., Conclusions: Two thirds of all patients who present with type A dissections are potential candidates for treatment with endovascular valve-carrying conduits, but most patients would require tapered stent-grafts., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Use of transcatheter aortic valve implantation (TAVI) to treat severe aortic stenosis (AS) has gained popularity, accompanied by an evolution of patient and clinical factors. We aimed to characterise changes and evaluate their impact on outcomes., Setting: In this single-centre, German TAVIK registry patients undergoing TAVI between 2008 and 2015 were documented prospectively., Participants/interventions: 2000 consecutive patients with AS undergoing TAVI were divided in four cohorts. 500 patients underwent TAVI in each of the following time bins: April 2008 to July 2010 (cohort I), July 2010 to April 2013 (cohort II), April 2012 to October 2013 (cohort III) and October 2013 to March 2015 (cohort IV)., Results: The mean age was 81.8 years, without significant variation across cohorts. Compared with cohort I, prior MI (5.4%vs11.0%; p<0.001) and New York Heart Association class IV (10.0%vs3.6%; p<0.001) were less common in cohort IV. Across cohorts, there was a fall in EuroSCORE (24.3%-18.7%), frailty (48.4%-17.0%) and use of transapical access (43.6%-29.0%), while transfemoral access increased (56.4%-71.0%; p<0.001 for each). Periprocedurally, there was a fall in moderate/severe aortic regurgitation (3.2%-0.0%) and rate of unplanned cardiopulmonary bypass (4.0%-1.0%; both p<0.001). A similar trend applied to 30-day rate of major vascular complications (5.2%-1.8%; p=0.006), life-threatening bleeding (7.0%-3.0%; p<0.001) and cardiovascular mortality (4.4%-1.8%; p=0.020). One-year post-TAVI, mortality and stroke rates did not differ., Conclusions: Evolution of TAVI between 2008 and 2015 saw a trend towards its usage in lower risk patients and rapid progression towards improved safety. Evaluation and refinement should now continue to further lessen stroke and pacemaker rates., Competing Interests: Competing interests: GS and HS are proctors and Peter Bramlage consultant for Edwards Lifesciences., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Transcatheter aortic valve implantation (TAVI) in patients with low coronary heights is generally denied but is not impossible. Information about these high-risk procedures is sparse., Methods: Since May 2008, data of more than 3000 patients who had TAVI were prospectively collected in the institutional TAVI Karlsruhe registry. Characteristics, peri- and postoperative outcome of patients with low coronary heights of ≤7 mm were analysed according to the Valve Academic Research Consortium-2., Results: Eighty-six patients with an average coronary height of 6.4 ± 1.1 mm (mean age 81.0 ± 5.3 years, logistic EuroSCORE I 19.6 ± 13.3%) were treated. TAVI was performed in 72 transfemoral (83.7%) and 14 transapical (16.3%) cases using 44 CoreValve/Evolut R (51.2%), 21 Sapien XT/S3 (24.4%), 14 ACURATE (16.3%), 5 Lotus (5.8%) and 2 Portico (2.3%) prostheses. Ten procedures were valve-in-valve (VinV) TAVI (VinV, 11.6%). The 72-h, 30-day, 1-year and follow-up (3.0 ± 1.6 years) mortality rates were 2.3%, 8.0%, 10.5% and 26.7%, respectively. Within 30 days, 4 cardiac deaths and 3 non-cardiac deaths occurred (4.7% and 3.5%). Three coronary obstructions (3.5%) occurred-2 during VinV TAVI. One patient was connected to extracorporeal circulation that could not be weaned later due to an unsuccessful percutaneous coronary intervention. Another patient, the only conversion (1.2%), required delayed surgical valve replacement. The third patient died of right heart failure after aortic dissection. The procedural success rate was 95.3%. VinV procedures were associated with increased follow-up deaths (P < 0.001; hazard ratio 7.96)., Conclusions: Coronary-related complications in TAVI procedures in patients with coronary heights ≤7 mm occurred less frequently, but once they occurred, they were serious. These TAVI procedures are feasible, with a high procedural success rate, but meticulous preoperative planning should be mandatory. In VinV procedures, the follow-up mortality rate is increased; therefore, we do not recommend these procedures.

Objectives: We assessed the safety and efficacy of a novel low-profile, 22-Fr transapical delivery system together with the ACURATE neo™ resheathable transcatheter heart valve., Methods: This prospective, single-arm, multicentre study enrolled 60 patients with severe symptomatic aortic stenosis and high surgical risk ineligible for transfemoral access. Primary end points were 6-month mortality and procedural success., Results: The mean age of patients was 79.8 ± 4.7 years, and the patients had severe comorbidities including coronary artery disease (71.7%), diabetes (38.3%), atrial fibrillation (30.0%) and chronic obstructive pulmonary disease (21.7%); logistic EuroSCORE-I, -II and the Society of Thoracic Surgeons (STS) scores were 20.9 ± 8.9%, 6.1 ± 5.0% and 4.3 ± 2.9%, respectively. A non-rib spreading approach using soft tissue retractors only was used in 88.3% of patients (n = 53). Resheathing and repositioning of transcatheter heart valve were performed in 6.7% of cases (n = 4); the device implantation time was 3 ± 2 min. Apical access site complications occurred in 1.7% (n = 1). Procedural success was 98.3% (n = 59), and procedural success in the absence of major adverse cardiac and cerebrovascular events at 30 days was 90.0% (n = 54). At 30 days, cardiovascular and overall mortality were 8.3% (n = 5), stroke rate was 1.7% (n = 1), and 17.2% of patients (n = 10) received a permanent pacemaker implant. No paravalvular leakage ≥2+ was observed, and the mean transvalvular gradient was 5.9 ± 2.7 mmHg. At 6 months, survival was 84.3% with sustained haemodynamic results., Conclusions: This study indicates safety and efficacy of transapical aortic valve implantation using a novel low-profile delivery system. High procedural success, short implantation times and a low rate of apical access site complications underline the favourable safety profile and ease of use., Clinical Trial Registration: ClinicalTrials.gov: NCT02950428.

Background: The study sought to report our results of surgical treatment of native and prosthetic aortic infection with xenopericardial tube grafts from the ascending aorta to beyond the bifurcation., Methods: Within a 28-month period, 20 patients were treated with a bovine self-made pericardial tube graft to replace infected vascular grafts (after conventional surgical aortic replacement or endovascular stent graft implantation) or to treat a contaminated surgical site. An integrated standardized therapeutic concept was applied in all patients, consisting of complete removal of the infected prosthetic material, extensive debridement, and orthotopic vascular reconstruction with self-made tube grafts constructed from a bovine pericardial patch., Results: Four patients died perioperatively (20%) due to sepsis, pulmonary failure, or sudden circulatory arrest. The mean follow-up was 18 months (first quartile 2, third quartile 17 months). Interval computed tomography scans revealed 100% freedom from proven aortic reinfection, but reinfection cannot be ruled out in 4 patients who died of unknown causes during follow-up or because of ongoing sepsis. Three patients required aortic reintervention for a suture-line aneurysm, for graft occlusion, and for the development of a neoaortointestinal fistulation, respectively., Conclusions: Patients with infectious aortic disease present in a frail state and the initial and the late mortality is substantial. Yet, surgical treatment of native and prosthetic aortic infection with xenopericardial tube grafts shows promising short-term results with regard to durability and freedom from reinfection in any aortic segment. Further studies are needed to learn of the long-term behavior of these grafts., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

We aimed to compare the outcomes of transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in an elderly but nonfrail, minimally co-morbid population. Although data comparing these 2 procedures in intermediate- and low-risk patients are mounting, no distinction has been made between co-morbidity and age/gender as driving forces for surgical risk. Patients undergoing isolated TAVI or SAVR between May 2008 and March 2015 were documented. Data for 225 patients (TAVI 132, SAVR 93) aged ≥75 and <86 years and fulfilling minimal-risk criteria were analyzed. Patients who underwent TAVI were older (80.7 vs 77.4 years, p <0.0001) and had a higher mean Society of Thoracic Surgeons score (2.16% vs 1.72%, p <0.0001). Mild prosthetic valve regurgitation (odds ratio [OR] 4.9, 95% confidence interval [CI] 3.34 to 7.20) was more likely after TAVI, as were renal complications (predominantly stage I acute kidney injury; OR 2.86, 95% CI 1.79 to 4.55) and new pacemaker implantation (OR 3.33, 95% CI 1.76 to 6.26) at 30 days; however, life-threatening bleeding (OR 0.58, 95% CI 0.36 to 0.93) and reintervention for bleeding (OR 0.03, 95% CI 0.01 to 0.13) were less likely. Survival was comparable between groups at 30 days (99.2% vs 100%, p = 1.0) and 1 year (96.2% vs 96.8%, OR 0.85, 95% CI 0.20 to 3.63, p = 0.823), but it was poorer for patients who underwent TAVI at 2 years (OR 0.31, 95% CI 0.16 to 0.61). In conclusion, the short-term outcomes of TAVI in elderly, low-risk, minimally co-morbid patients appear to be similar to those of SAVR, with access-specific complications. Although these results point toward the potential for more liberal use of TAVI in minimal-risk patients, poorer midterm survival remains a concern, requiring further exploration., (Copyright © 2018. Published by Elsevier Inc.)

Objectives: Our goal was to assess the results after orthotopic branched endovascular aortic arch repair using a new double-branch endoprosthesis in patients with thoracic aortic disease affecting the aortic arch who cannot undergo classical surgery., Methods: Within a 4-year period, 15 patients with thoracic aortic disease affecting the aortic arch were treated with the Bolton Relay plus double-branch endoprosthesis (Bolton Medical, Sunrise, FL, USA). We assessed clinical outcome, occurrence of endoleaks and the need for secondary interventions. The median logistic EuroSCORE I level was 13.6 (4.2; 22.8)., Results: The in-hospital mortality rate was 6.7%. A disabling stroke was observed in 1 (6.7%) patient, whereas non-disabling strokes occurred in 2 (13.3%) patients. Type I and III endoleaks occurred in 6.7%. The median follow-up period was 263 (1st quartile 84; 2nd quartile 564) days. Four patients died during the follow-up period. Aortic-related survival was 100%., Conclusions: Orthotopic branched endovascular aortic arch repair using the Bolton Relay Plus double-branch endoprosthesis is a safe and feasible technique enriching the armamentarium to treat patients with thoracic aortic disease who cannot undergo classical surgery. Aortic-related survival is excellent, and the occurrence of disabling stroke and endoleaks warranting treatment is low. Further studies are needed to assess the long-term durability of this new method.

Outcome after classical surgical repair of acute Type A aortic dissection has steadily improved over the years and several modifications in cannulation and perfusion added to this achievement. However, subgroups remain where results of classical surgical repair still have room for improvement, particularly patients with severe preoperative malperfusion as well as elderly patients with a limited physiological reserve. So far, only small case series or case reports have been published on the endovascular treatment of dissected ascending aortas. However, a tube alone is not sufficient to fix the entire complex underlying problem in the vast majority of patients with acute Type A aortic dissection. In addition, these published reports are either due to a favorable anatomy or due to very localized disease processes, which are the exception and not the rule. The concept of an endovascular valve-carrying conduit may significantly increase the number of patients suitable for endovascular therapy and it may soon be common practice., Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare.

Objectives: To assess safety and efficacy of transapical transcatheter aortic valve implantation (TA-TAVI) in the absence of predilation using balloon aortic valvuloplasty (BAV). Predilation of the stenosed valve using BAV is a routine step in TA-TAVI; however, evidence supporting its clinical value is lacking, and several studies have linked it with higher complication rates., Methods: A prospective, two-armed, multicentre registry (EASE-IT TA) to gather data on patients undergoing TA-TAVI with or without BAV, using the Edwards SAPIEN 3 valve was designed. The primary evaluation criterion was a composite of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, acute kidney injury and pacemaker implantation [per Valve Academic Research Consortium-2 (VARC-2)] within 30 days after TAVI., Results: A total of 198 subjects underwent TA-TAVI, 61 with and 137 without BAV. Patient characteristics were comparable at baseline (mean ± SD: age 80.3 ± 5.7 years; logistic EuroSCORE 20.2 ± 12.6). Similar reductions in peak and mean transvalvular gradients were observed post-procedurally. There was a significant reduction of fluoroscopy time without BAV (4.7 vs 7.9 min; P = 0.039) and significantly decreased odds of catecholamine administration (17.5% vs 32.8%; P = 0.017). A decreased odds of the primary evaluation criterion in patients without BAV after 30 days (adjusted odds ratio 0.71; 95% confidence interval 0.34-1.82) and the same composite end-point after 6 months (adjusted odds ratio 0.74; 95% confidence interval 0.37-1.47) were not significant even after multivariable adjustment., Conclusions: TA-TAVI without BAV appears to be at least equal to its conventional counterpart in terms of efficacy and may offer advantages in terms of safety. Thus, there appears to be little justification for maintaining the BAV step in TA-TAVI for many patients.

Objectives: The aim of this study was to investigate whether balloon-expandable and self-expandable transcatheter heart valves (THVs) differ in terms of the incidence of early subclinical leaflet thrombosis (LT)., Methods: Electrocardiographic-gated cardiac dual-source computed tomography angiography was performed at a median of 5 days after transcatheter aortic valve implantation and assessed for evidence of LT., Results: Of the 629 consecutive patients, 538 (86%) received a balloon-expandable THV and 91 (14%) a self-expandable THV. LT was documented in 77 (14%) patients with a balloon-expandable valve and in 16 (18%) with a self-expandable valve (P = 0.42). Similarly, LT was not significantly related to THV size (P = 0.62). Corresponding to a lower rate of atrial fibrillation in the group with LT [25 (27%) vs 222 (41%), P = 0.01], anticoagulation at the time of computed tomography angiography was less frequent in this group [21 (23%) vs 183 (34%), P = 0.03]. Among the other potentially relevant covariables, there was no significant difference in the clinical baseline and the procedural characteristics between patients with and without LT (age 82 ± 6 years vs 82 ± 6 years, P = 0.51; ejection fraction 49 ± 10% vs 50 ± 10%, P = 0.47). In multivariate logistic regression analysis, including potentially relevant covariables, valve type was not significantly associated with LT (P = 0.36). In the univariate and multivariate analyses, only the lack of anticoagulation at the time of computed tomography angiography was predictive of thrombus formation [0.563 (0.335-0.944), P = 0.03; 0.576 (0.343-0.970), P = 0.04]., Conclusions: In this large retrospective study of 629 patients, the type and the size of THV was not predictive of early LT.

Aims: Life-threatening complications occur during transcatheter aortic valve implantation (TAVI) which can require emergent cardiac surgery (ECS). Risks and outcomes of patients needing ECS during or immediately after TAVI are still unclear., Methods and Results: Incidence, risk factors, management, and outcomes of patients requiring ECS during transfemoral (TF)-TAVI were analysed from a contemporary real-world multicentre registry. Between 2013 and 2016, 27 760 patients underwent TF-TAVI in 79 centres. Of these, 212 (0.76%) patients required ECS (age 82.4 ± 6.3 years, 67.5% females, logistic EuroSCORE: 17.1%, STS-score 5.8%). The risk of ECS declined from 2013 (1.07%) to 2014 (0.70%) but remained stable since. Annual TF-TAVI numbers have more than doubled from 2013 to 2016. Leading causes for ECS were left ventricular perforation by the guidewire (28.3%) and annular rupture (21.2%). Immediate procedural mortality (<72 h) of TF-TAVI patients requiring ECS was 34.6%. Overall in-hospital mortality was 46.0%, and highest in case of annular rupture (62%). Independent predictors of in-hospital mortality following ECS were age > 85 years [odds ratio (OR) 1.87, 95% confidence interval (95% CI) (1.02-3.45), P = 0.044], annular rupture [OR 1.96, 95% CI (0.94-4.10), P = 0.060], and immediate ECS [OR 3.12, 95% CI (1.07-9.11), P = 0.037]. One year of survival of the 114 patients surviving the in-hospital period was only 40.4%., Conclusion: Between 2014 and 2016, the need for ECS remained stable around 0.7%. Left ventricular guidewire perforation and annular rupture were the most frequent causes, accounting for almost half of ECS cases. Half of the patients could be salvaged by ECS-nevertheless, 1 year of all-cause mortality was high even in those ECS patients surviving the in-hospital period., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)

" The major goal of surgery for acute type A aortic dissection is to have an alive patient. " This motto still remains the most important directive. However, also depending onto the extent of the underlying pathology and consecutively depending onto the extent of primary surgery, there is and will be need for additional classical surgical or interventional treatment sooner or later during follow-up in a substantial number of patients having had surgery for acute type A aortic dissection. This article shall guide the interested reader through the underlying mechanisms as well as treatment options in patients with chronic type B "residual" after type A repair and shall finally suggest preventive strategies to reduce the occurrence of this pathology to a minimum., Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare.

Background: Previous studies into the effect of a reduced left ventricular ejection fraction (EF) on the short- and long-term prognosis of patients undergoing transcatheter aortic valve implantation (TAVI) have reported conflicting findings. We analysed data from the Karlsruhe TAVI registry with the aim of addressing this question., Methods and Results: Patients with aortic stenosis undergoing TAVI were divided into sub-groups according to EF: severely reduced (<30%; n = 109), reduced (≥30 and ≤40%; n = 201), and mid-range/preserved (>40%; n = 1690). VARC complications at 30 days for the population with severely reduced EF did not differ in comparison to the patients with mid-range/preserved EF. Patients with severely reduced EF had a significantly lower survival at 48 h (91.7 vs. 99.0%; p < 0.001), at 30 days (84.4 vs. 95.8%; p < 0.001) and at 1 year (66.1 vs. 85.0%, p < 0.001) compared to those with mid-range/preserved EF. The risk of death increased with age, peripheral arterial disease, poor self-care and chronic renal failure in patients with severely reduced EF., Conclusions: Mortality post-TAVI was higher for patients with a reduced EF, although the excess comorbidity burden likely contributed to this. A reduced EF should not be considered a contraindication for TAVI per se, but the additional presence of comorbidity indicates increased risk for these patients.

Objectives: To assess outcomes for patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement but with less than high risk., Background: While there is abundant data for high risk patients there is insufficient data for reduced risk., Methods: Patients undergoing TAVI or SAVR between 2007 and 2012 in Karlsruhe were considered. They were assessed by cardiac computed tomography, transoesophageal echocardiogram, and logistic EuroSCORE I (ES) and groups compared using Propensity Score Matching., Results: The mean ES was 10.1±2.8 in the TAVI group (n = 419) and 5.7 ± 3.2 in the SAVR group (n = 722; P < 0.0001). Mean survival probability over 3 years was higher in patients undergoing surgery (P < 0.0001). A total of 432 patients were considered for the matched-pairs analysis based on propensity scores (216 in each group). Major vascular complications (10.6% vs. 0.0%; P < 0.0001), new pacemaker implantation (13.9% vs. 4.6%; P < 0.001) and moderate aortic insufficiency (3.2% vs. 0.5%; P = 0.03) were more frequent in patients undergoing TAVI. Major (20.8% vs. 4.2%; P < 0.0001) and life-threatening (14.5% vs. 2.3%; P < 0.0001) bleeding complications were more frequent in those undergoing surgery. Survival probability over 3 years in the propensity matched cohort was comparable between both groups (P = 0.16)., Conclusions: In this large, single center, real world dataset there was no difference in mortality between patients undergoing TAVI or SAVR during a 3-year follow-up but there was a TAVI related increase in major vascular complications, new pacemaker implantation and aortic insufficiency and a SAVR related increased bleeding risk., (© 2015 Wiley Periodicals, Inc.)

Objectives: The novel ACURATE TA™ transcatheter aortic valve (Symetis, Ecublens, Switzerland) is composed of a self-expanding nitinol stent covered by an anti-paravalvular leak skirt designed for transapical implantation. Since Conformite Europeenne (CE)-mark approval, the first 250 patients implanted with the newly approved device have been included in this post-market, multicentre registry., Methods: The registry was conducted at 17 sites in Germany, Italy, Switzerland and Argentina to treat 250 high-risk elderly patients. This all-comers population presented preoperatively with a mean aortic gradient of 43.2 ± 17.4 mmHg, mean age of 80.9 ± 6.3 years, mean society of thoracic surgeons risk score of 8.0 ± 5.9% and mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 22.3 ± 12.7%. The majority of patients (93%) were in New York Heart Association (NYHA) class III/IV. All patients were treated within a multidisciplinary Heart Team., Results: The procedural success rate was 98% (n = 245) with two valve-in-valve procedures and three conversions to conventional surgery. The 30-day mortality rate was 6.8%. Postimplant echocardiography revealed a relevant paravalvular leak (moderate 2+) in 2.3% of patients, with all other patients demonstrating either none/trace or a 1+ leak. The 30-day stroke rate was 2.8% and the mean transvalvular gradient was 12.4 ± 5.8 mmHg. A new pacemaker implantation was required in 10.0% of patients and 85% of patients returning for the follow-up presented in NYHA class I/II., Conclusions: The short-term result of the registry shows a safety and efficacy profile comparable, if not improved in some aspects, with previously approved transcatheter aortic valve implantation devices. These 'real-world' data highlight an excellent functional outcome, especially in regard to a low rate of relevant paravalvular leak., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Compared with surgical aortic valve replacement, transcatheter aortic valve implantation (TAVI) is associated with a higher risk of developing a new conduction disorder that necessitates permanent pacemaker implantation (PM). The most frequently observed conduction disorder is left bundle branch block (LBBB), which impairs left ventricular function., Objectives: The primary objective of this study was to assess the incidence and prognostic significance of persistent new-onset LBBB following TAVI. Factors predictive of persistent new-onset LBBB were also explored., Methods: This study included a total of 793 patients who underwent TAVI between May 2008 and April 2012. Patients were divided into two groups: those with persistent new-onset LBBB and those without persistent new-onset LBBB. Follow-up was conducted within 1-year of TAVI., Results: Persistent new-onset LBBB was observed in 31.1 % (n = 197) out of 634 eligible patients. At 30 days and 1-year post-TAVI, the all-cause mortality rate was higher in patients with persistent new-onset LBBB (6.1 %, n = 12 and 20.8 %, n = 41, respectively) than in patients without new-onset LBBB (3.3 %, n = 10 and 13.0 %, n = 57, respectively; p = 0.014 and p = 0.010 for the two time points). Multivariate regression analyses revealed, that persistent new-onset LBBB was an independent predictor of all-cause mortality at 1 year (HR 1.84, 95 %CI 1.35-2.02). PM implantation was observed slightly more frequently in patients with persistent new-onset LBBB (14.2 %) than in those without (9.4 %; HR 1.60, 95 %CI 0.96-2.67). Risk factors for pacemaker (PM) were baseline RBBB (HR 6.23, 95 %CI 3.76-10.33), chronic atrial fibrillation (HR 1.75, 95 %CI 1.10-2.56) and the Medtronic CoreValve implantation (HR 2.40, 95 %CI 1.55-3.75). At 1-year follow-up, the mean survival of patients with PM (81.2 %) was slightly lower, but not significantly different from that of patients without PM (85.0 %; p = 0.377). Upon multivariable logistic binary regression analysis Medtronic CoreValve was associated with an increase rate of persistent new-onset LBBB (HR 2.52, 95 %CI 1.67-3.80) and PM implantation. Mortality during 1 year of follow-up, however, was neither increased in the total population (p = 0.232), nor in a subgroup of those with LBBB in a comparison of Medtronic CoreValve and Edwards SAPIEN., Conclusion: This study demonstrated that persistent new-onset LBBB was associated with increased mortality in patients undergoing TAVI. Compared with the Edwards SAPIEN valve, implantation of the Medtronic CoreValve resulted in a higher rate of both persistent new-onset LBBB and PM but not death.

The new balloon-expandable Edwards SAPIEN 3 THV has significant design improvements requiring adjustments in the implantation technique as compared to the previous generation SAPIEN XT. Basically, the new valve requires less oversizing due to the outer skirt, which, if positioned underneath the annulus, can reduce the occurrence and severity of paravalvular leak (PVL). As with any transcatheter vale, a thorough assessment of the device-landing-zone, the surrounding structures, and the distribution of calcifications is of vast importance. Once the SAPIEN 3 valve is positioned with the initial orientation of the middle balloon marker at the level of the leaflet hinge points, the outer skirt will remain under the annulus, despite the foreshortening of the lower inflow portion of the valve. If there is an incomplete apposition, the outer skirt can conform to the anatomy, close the gaps, and reduce the risk of PVL. When calcifications are located on the edges of the annulus, PVL is common with the SAPIEN XT THV but dramatically reduced with the SAPIEN 3 THV. If the calcification extends from the annulus into the entire LVOT, there is always an incomplete apposition of the either valve frame; however, the resulting PVL is reduced by the outer skirt of the SAPIEN 3. In 165 consecutive SAPIEN 3 patients, 89.7% (n = 145) had none or a trace PVL and there were no patients with moderate or severe PVL. The new generation SAPIEN 3 valve allows more challenging anatomies to be treated, requires less oversizing, and can reduce PVL., (© 2014 The Authors. Journal of Interventional Cardiology Published by Wiley Periodicals, Inc.)

Background: Transapical transcatheter aortic valve implantation is generally perceived to be associated with increased morbidity compared with transfemoral transcatheter aortic valve implantation. We aimed to compare access-related complications and survival using propensity score matching., Methods and Results: Prospective, single-center registry of 1000 consecutive patients undergoing transapical and transfemoral transcatheter aortic valve implantation between May 2008 and April 2012. Transapical was performed in 413 patients and transfemoral in 587 patients. Patients with transapical access were less often women and less had pulmonary hypertension. Further they had more peripheral arterial disease, coronary artery disease, carotid stenosis, and recurrent surgery and a higher logistic EuroSCORE I (24.3% ± 16.2% for transapical versus 22.2% ± 16.2% for transfemoral; P < 0.01). After building 2 propensity score-matched groups of 354 patients each with either access route (total 708 patients), baseline characteristics were comparable. In this analysis, there was no significant difference in 30 day mortality (5.9% transapical versus 8.5% transfemoral; P = 0.19), the rate of myocardial infarction (2.5% transapical versus 2.0% transfemoral; P = 0.61), stroke (2.0% transapical versus 2.3% transfemoral; P = 0.79), bleeding complications, pacemaker implantation rates, or moderate aortic insufficiency. Stage 1 renal complications were more common in transapical patients (odds ratio, 2.81; 95% confidence interval, 1.93-4.09), whereas major vascular complications were less common (odds ratio, 0.14; 95% confidence interval, 0.06-0.29). Survival probability over the long term was not statistically different (hazard ratio, 0.89; 95% confidence interval, 0.72-1.10; log-rank Test, P = 0.27)., Conclusions: The data demonstrate that in an experienced multidisciplinary heart team, either access route can be performed with comparable results., (© 2014 American Heart Association, Inc.)

Background: In patients with severe calcific aortic stenosis, balloon aortic valvuloplasty (BAV) is routinely performed in order to pre-dilate the stenosed aortic valve prior to transcatheter aortic valve implantation (TAVI). Although pre-dilation is considered to be essential for the preparation of the valve landing zone, there is no clear evidence to support its clinical value. In contrast, BAV has been suggested to be linked to several complications. Notably, while preliminary evidence has supported the feasibility and safety of TAVI without pre-dilation, larger studies directly comparing the benefit/risk profile of TAVI in the presence and absence of pre-dilation are required., Methods/design: Therefore, a prospective, two-armed, multicenter registry (EASE-IT) was designed to obtain essential data concerning procedural success rates, adverse events, and mortality in a large cohort of patients undergoing transapical (TA)-TAVI using the Edwards SAPIEN 3 balloon expandable heart valves with and without pre-ballooning., Discussion: Data provided by EASE-IT will be used to assess the relevance of BAV during the TAVI procedure and to investigate associations between patient characteristics and outcomes. Therefore, results obtained from the EASE-IT registry could contribute to reduced rates of TAVI-associated morbidity and mortality in patients with severe, calcific aortic stenosis., Trial Registration: ClinicalTrials.gov Identifier: NCT02127580.

Background: Aortic rupture of the device landing zone is a rare complication of transcatheter aortic valve implantation (TAVI) and it is associated with significant mortality., Methods: This study reports on the experience of a single-center in a case series of more than 1,000 implants. We explored patient and procedural characteristics aiming at identifying variables that increase the risk for aortic root rupture., Results: Among a total of 1,000 TAVI procedures, six patients (0.6 %) had a rupture of the device landing zone. Five of these patients received the balloon-expandable Edwards SAPIEN valve (5/813; 0.62 %) of which four had a supraannular and one a subannular rupture. One patient received the self-expanding Medtronic CoreValve (1/199; 0.5 %; p = n.s. vs. SAPIEN) and had an annular rupture. Factors that were associated with aortic rupture were: (1) the relative size of the valve compared with the aortic annulus and its geometric form; (2) the need for post-dilation of the new valve because of paravalvular leakage; and (3) the location and severity of calcification. We determined, to avoid aortic rupture, caution may be necessary in the presence of the following conditions: (1) flat sinuses of Valsalva and severe calcifications of either the body or the free edge of the aortic cusps (supraannular rupture); (2) an ellipsoid annulus and bulky calcifications on either the base of the cusps or the rim of the annulus (annular rupture); and (3) a narrow left-ventricular outflow tract (LVOT) and bulky calcification of the LVOT (subannular rupture). After considering these precautions, we observed no case of aortic root rupture in the following 600 cases., Conclusion: The data indicate that to reduce the frequency of aortic rupture, a careful pre-procedural planning appears essential to avoid this serious and potentially deleterious complication.

Unlabelled: Transcatheter aortic valve replacement (TAVI), though a preferred treatment option in the elderly population carrying increased risks for open heart surgery, may result in prognosis-limiting moderate or severe aortic regurgitation. Here, we report a series of 11 patients from 3 German TAVI centers, suffering from moderate- to high-grade aortic regurgitation after CoreValve implantation, who were subsequently treated by Edwards Sapien XT implantation., Methods: The patients were 79.5 ± 4.2 years of age and presented between November 2009 and February 2013 with a symptomatic high-grade aortic stenosis (mean maximum gradient 57 ± 22 mmHg) and EuroSCORE of 16 ± 7%. Initial implantation of a Medtronic CoreValve resulted in moderate-to-severe aortic regurgitation (grade 2.64 ± 0.37) although postdilatation was attempted in eight cases and snare repositioning was attempted in one case., Results: All 11 patients were treated by a Sapien XT (Edwards) valve implanted into the initially deployed CoreValve: four via transfemoral, one via transaortical and six via transapical approaches. Successful implantation was possible in all 11 patients resulting in a reduction of aortic regurgitation to mean grade 0.23 ± 0.39. Two patients required permanent pacemaker. After 30 days, ten patients were alive, whereas one patient succumbed to pneumonia complicating advanced chronic obstructive pulmonary disease., Conclusion: In the instance of moderate or severe aortic regurgitation after TAVI of a CoreValve, transfemoral or transapical Sapien XT valve-in-valve deployment is an excellent option to reduce residual regurgitation to none or mild.

Background: This prospective study examines the impact of EuroSCORE and transfemoral (TF) or transapical (TA) delivery approach on mortality at 30 days and 1 year in patients with severe aortic stenosis implanted with either the Edwards SAPIEN Transcatheter Heart Valve (THV) or Medtronic CoreValve., Methods and Results: TAVI was successfully performed in 293 (97.7%) of 300 patients (TF: 174, TA: 126, mean EuroSCORE 24.0). The mortality at 30 days and after 1 year was 6.0% and 17.3%. Mortality depends significantly on the logistic EuroSCORE with a 30-day odds ratio (OR) of 1.92 (95% CI 1.41 to 2.62, P < 0.001) and after 1 year of 1.67 (95% CI 1.34 to 2.08, P < 0.001). Mortality in patients with a logistic EuroSCORE <15 (n = 113) or ≥15 (n = 187) at 30 days was 0.9% versus 9.1% and after 1 year 7.1% versus 23.5% demonstrating significantly less mortality (P < 0.001) in patients with lower logistic EuroSCOREs. In this specific setup of our center there was no significant difference (P = 0.553) in mortality regarding the technical approach for TA (4.0% and 15.9%) and for TF (7.5% and 18.4%). Severe cardiac complications occurred in 20 patients (6.7%) with a 30-day mortality of 45.0%., Conclusion: The mortality in patients undergoing TAVI correlates significantly with the logistic EuroSCORE. Patients with a logistic EuroSCORE <15 can be implanted, with a low 30-day mortality and good long-term outcome over 1 year., (©2012, Wiley Periodicals, Inc.)