Balloon-expandable transcatheter aortic valve implantation with or without pre-dilation - results of a meta-analysis of 3 multicenter registries.

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.

Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI).

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.

A comparison of transcatheter aortic valve implantation and surgical aortic valve replacement in 1,141 patients with severe symptomatic aortic stenosis and less than high risk.

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.

How to adapt the implantation technique for the new SAPIEN 3 transcatheter heart valve design.

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.

Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve - rationale and design of a multicenter registry (EASE-IT).

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.

Acute and late outcomes of Transcatheter Aortic Valve Implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in patients at high- and low-surgical risk.

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.

Impact of the Aortic Geometry on TAVI Prosthesis Positioning Using Self-Expanding Valves.

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.

Massive cardiopulmonary cement embolism with cardiac perforation after vertebroplasty: a case series.

Background: The prevalence of cement embolism after percutaneous vertebroplasty ranges from 2.1 to 26%, in literature. Even if most cases remain asymptomatic, intracardiac cement embolism becomes symptomatic in up to 8.3% of the cases. Case summary: We report a case series of two cases with massive cardiopulmonary cement embolism, which lead to perforation of the right ventricle and needed cardiothoracic surgery. Discussion: As this entity affects different fields of medical specialties and may lead to fatal outcome, we believe that the efforts of better understanding its development, avoidance, detection, and treatment need to be intensified. For this purpose, systematic and interdisciplinary studies to follow up patients after vertebroplasty are needed.

Risk factors for stroke after total aortic arch replacement using the frozen elephant trunk technique.

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 Technological Basis of a Balloon-Expandable TAVR System: Non-occlusive Deployment, Anchorage in the Absence of Calcification and Polymer Leaflets.

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.

Implantation depth and its influence on complications after TAVI with self-expanding valves.

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.

Predictors for low TAVI-prosthesis position assessed by fusion imaging of pre- and post-procedural CT angiography.

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.

The frozen elephant trunk technique for aortic dissection is safe after previous aortic repair.

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.

Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study.

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] cm2, discharge: 1.9 [SD 0.6] cm2), 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.

Influence of prosthesis-related factors on the occurrence of early leaflet thrombosis after transcatheter aortic valve implantation.

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.

A logistic regression analysis comparing minimalistic approach and intubation anaesthesia in patients undergoing transfemoral transcatheter aortic valve replacement.

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.

Accuracy of deployment of the Relay non-bare stent graft in the aortic arch.

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.

Anatomic feasibility of an endovascular valve-carrying conduit for the treatment of type A aortic dissection.

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.

Impact of Dialysis on the Prognosis of Patients Undergoing Transcatheter Aortic Valve Implantation.

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.

Endovascular aortic arch repair using a double-branched approach.

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.