Balloon-expandable Transcatheter Aortic Valve Research Articles

Balloon expandable vs. self-expandable transcatheter aortic valve prosthesis short-term results of retrospective study

Transcutaneous aortic valve implantation has been established as an effective method for the treatment of highgrade aortic stenosis in non-operative, high-risk for conventional surgery patients. According to the developed implantation technologies, the prostheses are divided into balloon-expandable valve prostheses (balloon-expandable valves, BEV) and self-expanding valve prostheses (self-expanding prostheses SEV). The two types of devices have different models for implantation, stratum architecture, cusps characteristics, leading to different hemodynamics, frequency of use and performance of normal prosthesis function. The research aims to monitor the short-term results, up to 1 month after discharge, in terms of mortality, the manifestation of heart failure, (para) prosthetic regurgitation, implantation of a pacemaker, and vascular complications. Materials and methods: the article presents a retrospective follow-up of a total of 230 high-risk for conventional cardiac surgery patients with high-grade aortic stenosis treated in a cardiology clinic at UMHAT St. Ekaterina Sofia until 2020, divided into two groups depending on the implanted type of prosthesis. Conclusions: The results obtained based on our experience prove the safety of new prostheses. When choosing between BEV and SEV, the best clinical outcome requires a good knowledge of the strengths and weaknesses of using medical devices with a personalized approach consistent with the clinical and anatomical characteristics of the patient.

Mid-term impact of underfilling and overfilling of the SAPIEN 3 balloon-expandable transcatheter aortic valve implantation on mortality and valve function.

At present, underfilling or overfilling the volume of the balloon-expandable transcatheter heart valve (THV) is generally utilized in transcatheter aortic valve implantation (TAVI). However, no research has assessed the clinical impact of filling volume variations of the current-generation SAPIEN 3 THV. We analyzed the clinical data of 331 patients who underwent TAVI with SAPIEN 3 at our institution. Post-procedural echocardiographic and multidetector computed tomography (MDCT) scan data and 3-year prognoses according to each filling volume were assessed. The procedural outcomes and 3-year mortality rates were comparable among the underfilling, nominal filling, and overfilling groups. For all THV sizes, the THV area evaluated on post-procedural MDCT scan increased stepwise along with an elevated filling volume, thereby covering a wide range of native annulus area. Compared with patients in the nominal filling and overfilling groups, those with 23-mm THVs in the underfilling group had a smaller effective orifice area (EOA) (1.38 [IQR: 1.18-1.56] vs. 1.57 [IQR: 1.41-1.84] vs. 1.58 [IQR: 1.45-1.71] cm2, P = 0.02) and a higher mean transvalvular gradient (13.6 [IQR: 11.0-15.7] vs. 12.1 [IQR: 9.0-14.9] vs. 12.0 [IQR: 8.1-14.8] cm2, P = 0.04). In conclusion, by adjusting the filling volume of SAPIEN 3 using THV with limited sizes, continuously distributed native annulus areas were covered. The underfilling implantation technique had a minimal negative effect on the valve function of 23-mm THVs only. In the entire cohort, the filling volume variations did not affect the mid-term prognosis negatively.

Transcatheter aortic valve-in-valve implantation to treat aortic para-valvular regurgitation after TAVI

BackgroundPara-valvular regurgitation (PVR) after transcatheter aortic valve (TAV) implantation is associated with increased mortality. Redo-TAVI may be applied to treat PVR, yet with unknown efficacy. We thought to assess redo-TAVI efficacy in reducing PVR using the Redo-TAVI registry (45 centers; 600 TAV-in-TAV cases). MethodsPatients were excluded if redo-TAVI was done urgently (N = 253), for isolated TAV stenosis (N = 107) or if regurgitation location at presentation remained undetermined (N = 123). The study group of patients with PVR (N = 70) were compared against patients with intra-valvular regurgitation (IVR) (N = 41). Echocardiographic examinations of 67 (60%) patients were reassessed in a core-lab for data accuracy validation. ResultsCore-lab examination validated the jet location in 66 (98.5%) patients. At 30 days, the rate of residual AR ≥ moderate was 7 (10%) in the PVR cohort vs. 1 (2.4%) in the IVR cohort, p = 0.137. The rate of procedural success was 53 (75.7%) vs. 33 (80.5%), p = 0.561; procedural safety 51 (72.8%) vs. 31 (75.6%), p = 0.727; and mortality 2 (2.9%) vs. 1 (2.4%), p = 0.896 at 30 days and 7 (18.6%) vs. 2 (11.5%), p = 0.671 at 1 year, respectively. Of patients with residual PVR ≥ moderate at 30 days, 5/7 occurred after implanting balloon-expandable in self-expanding TAV and 2/7 after balloon-expandable in balloon-expandable TAV. ConclusionsThis study puts in perspective redo-TAVI efficacy and limitations to treat PVR after TAVI. Patient selection for this and other therapies for PVR needs further investigation.

Comparison of performance of self-expanding and balloon-expandable transcatheter aortic valves

ObjectiveTo evaluate the flow dynamics of self-expanding and balloon-expandable transcatheter aortic valves pertaining to turbulence and pressure recovery. Transcatheter aortic valves are characterized by different designs that have different valve performance and outcomes. MethodsAssessment of transcatheter aortic valves was performed using self-expanding devices (26-mm Evolut [Medtronic], 23-mm Allegra [New Valve Technologies], and small Acurate neo [Boston Scientific]) and a balloon-expandable device (23-mm Sapien 3 [Edwards Lifesciences]). Particle image velocimetry assessed the flow downstream. A Millar catheter was used for pressure recovery calculation. Velocity, Reynolds shear stresses, viscous shear stress, and pressure gradients were calculated. ResultsThe maximal velocity at peak systole obtained with the Evolut R, Sapien 3, Acurate neo, and Allegra was 2.12 ± 0.19 m/sec, 2.41 ± 0.06 m/sec, 2.99 ± 0.10 m/sec, and 2.45 ± 0.08 m/sec, respectively (P < .001). Leaflet oscillations with the flow were clear with the Evolut R and Acurate neo. The Allegra shows the minimal range of Reynolds shear stress magnitudes (up to 320 Pa), and Sapien 3 the maximal (up to 650 Pa). The Evolut had the smallest viscous shear stress magnitude range (up to 3.5 Pa), and the Sapien 3 the largest (up to 6.2 Pa). The largest pressure drop at the vena contracta occurred with the Acurate neo transcatheter aortic valve with a pressure gradient of 13.96 ± 1.35 mm Hg. In the recovery zone, the smallest pressure gradient was obtained with the Allegra (3.32 ± 0.94 mm Hg). ConclusionsFlow dynamics downstream of different transcatheter aortic valves vary significantly depending on the valve type, despite not having a general trend depending on whether or not valves are self-expanding or balloon-expandable. Deployment design did not have an influence on flow dynamics.

The prognostic value of left ventricular dimensions at the time of transcatheter aortic valve replacement: A propensity‐matched analysis

In the clinical practice a noteworthy proportion of severe symptomatic aortic stenosis patients presents with low-flow low-gradients features, these having reported a less favorable prognosis even when surgically or transcatheter treated. We retrospectively analyzed the prospectively collected data on 1051 consecutive patients undergone balloon-expandable transcatheter aortic valve replacement at our Institution from January 2008 to January 2020. We divided the population according with a mean aortic gradient (MAG) < or ≥40 mmHg and we performed a propensity-matched analysis based on the Society of Thoracic Surgery Score and age, obtaining two homogeneous groups of 314 patients each (Groups A and B, respectively). We then analyzed the outcomes of the two groups by implementing adjusted Cox models adjusted for significant clinical differences between the two groups, such as sex, ejection fraction, comorbidities and other variables not included in the propensity-matched analysis. The only variable associated with both cardiovascular and all-cause events was an ejection fraction ≤35%. Finally, a sensitivity analysis found that an ejection fraction ≤35% was associated with an increase cardiovascular and all-cause mortality only in patients with an indexed end-diastolic volume >97 ml/m2 (p = .0438 and .3363, respectively). In our series a MAG <40 mmHg was not found to be per se an independent risk factor for cardiac and all-cause mortality after transcatheter aortic valve replacement. The ejection fraction was found to be an independent risk factor only in the context of enlarged left ventricular dimensions.

Flow dynamics in the sinus and downstream of third and fourth generation balloon expandable transcatheter aortic valves

ObjectiveThe early success of transcatheter aortic valve (TAV) replacement (TAVR) has fueled further innovations in the field leading to the emergence multiple iterations of TAV designs. Whether these newer designs are associated with similar hemodynamic outcomes remains unknown. Recently, the SAPIEN 3 Ultra valve received FDA approval for use in patients with published clinical outcomes. The aim of this study is (1) to evaluate and compare the flow dynamics downstream of the SAPIEN 3 Ultra and a SAPIEN 3 (2) and to evaluate and compare the resulting sinus hemodynamics and washout characteristics for a complete hemodynamic characterization. MethodsThe hemodynamic assessment was performed in a pulse duplicating system and particle image velocimetry was used to assess the flow dynamics. Pressure gradient (ΔP), effective orifice area (EOA), leakage fraction (LF), velocity in the flow downstream and the sinus, viscous shear stress (VSS) downstream and adjacent to the leaflet in the sinus, and sinus washout were calculated. ResultsEOA for the SAPIEN 3 Ultra was 1.81 ± 0.05 cm2 and 1.86 ± 0.05 cm2 with the SAPIEN 3, ΔP with the SAPIEN 3 Ultra was 10.56 ± 0.62 mmHg and 14.73 ± 0.79 mmHg with the SAPIEN 3, and LF with the SAPIEN 3 Ultra was 10.4 ± 0.5% and 9.7 ± 0.4% with the SAPIEN 3 (p<0.05). The instantaneous VSS for both valves ≤15 Pa, which is not sufficient to induce hemolysis, but may lead to platelet activation. RSS — an indicator of blood damage — exceeded 100 Pa at peak systole with both TAVs. The sinus velocity at peak systole was 0.24 ± 0.08 m/s with the SAPIEN 3 Ultra and 0.22 ± 0.10 m/s with the SAPIEN 3. VSS range reached 3.9 Pa with the SAPIEN 3 Ultra and 4.0 Pa with the SAPIEN 3. Complete sinus washout was achieved in ∼1.5 and ∼2.4 cardiac cycles for the SAPIEN 3 Ultra and SAPIEN 3, respectively. ConclusionCompared to its predecessor, the hemodynamic performance and sinus hemodynamics of SAPIEN 3 Ultra are comparable.

Comparison of Post-Procedural and 30-day Post-Implantation Transcatheter Aortic Valve Replacement Gradients with and without pre-implantation Balloon Valvuloplasty: A Real-World Analysis of Early Results using a Novel Balloon Expandable Transcatheter Aortic Valve

Objectives: This study describes a real-world experience of implanting a novel balloon expandable transcatheter aortic valve replacement (TAVR) compared to devices commonly used in clinical practice. As a secondary objective, the effect of balloon angioplasty (BAV) before TAVR on the transvalvular gradient 1 and 30 days after implantation was evaluated. Background: For most commercial TAVR valves, the 30-day average mean aortic valve gradients have been reported. Our experience with the Lotus Valve System had indicated higher immediate post-implant gradients than those in the literature. We sought to evaluate both these valves, comparing them to other valves. Methods: We analyzed discharge and 30-day echocardiograms of Lotus valves from 7/5/2019 to 8/27/2020. In response to higher-than-expected post-implant gradients, patients from 11/4/19 to 8/27/20 underwent BAV before the valve implantation, whereas patients from 7/5/19 to 10/18/19 did not (no-BAV). We compared these samples to each other and to a random sampling of TAVR valves implanted by the same interventionalist. Results: At discharge, 27 patients received Lotus valves. The average mean aortic valve gradient was 16.7 mmHg (SD = 5.5 mmHg) for the no-BAV and 14.7 mmHg (SD = 3.7 mmHg) for the BAV (P = 0.177) cohorts. No-BAV Lotus valve mean gradients were significantly higher (P &lt; 0.001) than those of the Sapien valve (M = 12 mmHg, SD = 4.3) and CoreValve (M = 9.18 mmHg, SD = 3.96). At the 30-day assessment, the mean gradients in the no-BAV and BAV groups were similar to those in the literature (M = 11 mmHg SD 3.5; M = 12 mmHg, SD 4.1 (P = 0.287)) and those of other valves. Conclusions: The Lotus valve demonstrated higher post-implantation gradients than other valves. This effect was not attenuated by BAV. These elevated gradients were not significant at the 30-day follow-up.

Anatomical Features of Native Aortic Valves Associated with Coronary Obstruction during Balloon-expandable Transcatheter Aortic Valve Replacement

Anatomical Features of Native Aortic Valves Associated with Coronary Obstruction during Balloon-expandable Transcatheter Aortic Valve Replacement

Neosinus and Sinus Flow After Self-Expanding and Balloon-Expandable Transcatheter Aortic Valve Replacement.

The aim of this study was to evaluate flow dynamics in the aortic sinus and the neosinus (NS) after transcatheter heart valve (THV) implantation in valve-in-valve (ViV). Leaflet thrombosis may occur on THVs and affect performance and durability. Differences in flow dynamics may affect the risk for leaflet thrombosis. Hemodynamic assessment following THV implantation in a surgical aortic valve was performed in a left heart simulator under pulsatile physiological conditions. Assessment was performed using a 23-mm polymeric surgical aortic valve (not diseased) and multiple THV platforms, including self-expanding devices (26-mm Evolut, 23-mm Allegra, small ACURATE neo) and a balloon-expandable device (23-mm SAPIEN 3). Particle image velocimetry was performed to assess flow in the sinus and NS. Sinus and NS washout, shear stress, and velocity were calculated. Sinus and NS washout was fastest and approximately 1 cardiac cycle for each with the Evolut, ACURATE neo, and Allegra compared with the SAPIEN 3, with washout in 2 and 3 cardiac cycles, respectively. The Allegra showed the largest shear stress distribution in the sinus, followed by the SAPIEN 3. In the NS, all 4 valves showed equal likelihoods of occurrence of shear stress<1 Pa, but the Allegra showed the highest likelihoods of occurrence for shear stress >1 Pa. The velocities in the sinus and NS were 0.05, 0.078, 0.080, and 0.075m/s for Evolut, SAPIEN 3, ACURATE neo, and Allegra ViV, respectively. Sinus and NS flow dynamics differ substantially among THVs after ViV. Self-expanding supra-annular valves seem to have faster washouts compared with an equivalent-size balloon-expandable THV.

Novel Pressure-Regulated Deployment Strategy for Improving the Safety and Efficacy of Balloon-Expandable Transcatheter Aortic Valves.

The authors propose a novel pressure-regulated method for balloon-expandable transcatheter heart valve (THV) deployment, aimed at optimizing prosthesis-annulus apposition while preventing significant tissue injury. The optimal method for balloon-expandable THV deployment remains debated. Current protocols are volume dependent, relying on under- and overfilling of the deployment apparatus. During deployment, the annular wall tension exerted by the expanding prosthesis is determined by maximal THV diameter and balloon pressure (Laplace's law). Three hundred thirty consecutive patients with severe native aortic stenosis who underwent TAVR with SAPIEN 3 THVs were included. One hundred and six patients were considered at high risk for annular rupture. THVs were deployed until reaching a predetermined balloon pressure. Postdilatation was performed to reduce mild or greater angiographic paravalvular regurgitation (PVR). Using a biomechanical model, annular wall stress was estimated for each case and assessed against rates of postdilatation, mild or greater PVR on transthoracic echocardiography, new permanent pacemaker placement or left bundle branch block, and annular rupture. Patients with wall stress >3 MPa had reduced postdilatation rate (P< 0.001) and reduced final PVR (P=0.014). Annular rupture occurred in 2 of 3 high-risk patients with wall stress >3.5 MPa (3.69 and 3.84 MPa); no rupture occurred in 95 high-risk patients with wall stress≤3.5 MPa. We defined a single target deployment pressure per THV size to ensure deployment within target wall stress levels of 3 to 3.5 MPa: 6.25 atm for 23-mm THVs, 5.5 atm for 26-mm THVs, and 5 atm for 29-mm THVs. Patients within this target range (n=136) had a 10.0% postdilatation rate, 12.7% mild PVR, and no moderate to severe PVR. The relationship between balloon filling volume and associated pressure and wall stress was inconsistent. Pressure-regulated THV deployment is a simple, reproducible, safe, and effective method, regardless of high-risk anatomical complexities.

Self-expanding and balloon-expandable transfemoral transcatheter aortic valve replacement: in-hospital outcomes in Germany

Abstract Background The impact of valve type used in transfemoral transcatheter aortic valve replacement (TF-TAVR) on outcomes is currently under discussion. Purpose We examine the in-hospital outcomes of balloon-expandable (BE) and self-expanding (SE) valves in a complete national cohort in Germany in 2018. Methods All 17,295 patients receiving TF-TAVR with BE (N=9,882) or SE (N=7,413) valves in Germany in 2018 were identified. Outcomes were analyzed for the endpoints in-hospital mortality, major bleeding, stroke, acute kidney injury, postoperative delirium, mechanical ventilation &amp;gt;48h, length of hospital stay, and reimbursement. Since there was no randomization of patients to the two treatment options, logistic or linear regression models were carried out using 22 baseline patient characteristics and center-specific variables as potential confounders. Propensity score methods served as sensitivity analysis. Results Both valve types differed significantly in baseline characteristics with higher EuroSCORE (p&amp;lt;0.001), age (p&amp;lt;0.001) and rate of female sex (p&amp;lt;0.001) in patients treated with SE valves. After risk adjustment, there were no marked differences in outcomes for in-hospital mortality (risk adjusted odds ratio (aOR) for SE instead of BE: 0.94 [95% CI 0.76; 1.17], p=0.617), major bleeding (aOR 0.91 [0.73; 1.14], p=0.400), stroke (aOR 1.13 [0.88; 1.46], p=0.347), acute kidney injury (aOR 0.97 [0.85; 1.10], p=0.621), postoperative delirium (aOR 1.09 [0.96; 1.24], p=0.184), mechanical ventilation &amp;gt;48h (aOR 0.98 [0.77; 1.25], p=0.893), length of hospital stay (risk adjusted difference in days of hospitalization: −0.05 [−0.34; 0.25], p=0.762) and reimbursement (−€72 [−€291; €147], p=0.519). Similar results were found using propensity score methods. Conclusion Outcomes in contemporary TF-TAVR procedures are broadly equivalent regardless of the valve type used. Major complications rarely occur in both types of valve. Funding Acknowledgement Type of funding sources: None. Self- vs balloon-expanding TF-TAVR

Novel pressure-regulated deployment strategy for improving the safety and efficacy of balloon-expandable transcatheter aortic valves

Abstract Background The optimal method for balloon-expandable transcatheter heart valve (THV) deployment remains unknown. Current implantation protocols are volume-dependent and rely on ad-hoc filling of the deployment apparatus without accounting for annular wall tension during prosthesis expansion, predisposing patients to inconsistent clinical outcomes. During THV deployment, the annular wall tension exerted by the expanding prosthesis is determined by prosthesis diameter and balloon pressure (Laplace's Law). Objective We proposed and tested a novel method for balloon-expandable THV deployment, aimed at controlling balloon pressure and the resulting annular wall tension to allow optimal prosthesis-annulus apposition while preventing significant tissue injury. Methods 330 consecutive patients with severe native aortic stenosis who underwent balloon-expandable THV implantation between 2015–2020 were included. 106 patients were considered high-risk for annular rupture. THVs were deployed until reaching a pre-determined balloon pressure; 4–4.5atm in earlier cases to establish experience and safety, later increasing to 5–6.5atm in most cases. Post-dilatation was performed to reduce &amp;gt;mild angiographic regurgitation (PVR). Using a biomechanical model, annular wall stress (tension) was estimated for each case and assessed against recorded rates of post-dilatation, ≥mild paravalvular regurgitation (PVR) on TTE, new PPM or LBBB and annular rupture. Results Patients with wall stress &amp;gt;3MPa (n=184) had reduced post-dilatation rate (p&amp;lt;0.001) and final PVR (≥mild, p=0.014). Annular rupture occurred in 2/3 high-risk cases with wall stress &amp;gt;3.5MPa; no rupture occurred in 102 high-risk cases with wall stress ≤3.5MPa. Based on these results, we defined target deployment wall stress levels (3–3.5MPa) and associated deployment pressure per THV size. Patients within this target range (n=136) had 8.1% new PPM, 12.5% new LBBB, 12.7% mild PVR with no cases of ≥moderate PVR. Importantly, there was an inconsistent relationship between deployment balloon volume and resulting annular wall stress. Conclusion Pressure-regulated THV deployment is a simple, easily reproducible, safe and effective method, regardless of high-risk anatomical complexities. Funding Acknowledgement Type of funding sources: None. Annular wall stress and PVRModel, stress vs volume and new strategy

Late-Phase Delayed Coronary Obstruction Caused by Protruding Calcified Aortic Valve Leaflet After Balloon-Expandable Transcatheter Aortic Valve Replacement

Late-Phase Delayed Coronary Obstruction Caused by Protruding Calcified Aortic Valve Leaflet After Balloon-Expandable Transcatheter Aortic Valve Replacement

One-year outcomes of the pivotal clinical trial of a balloon-expandable transcatheter aortic valve implantation in Japanese dialysis patients

BackgroundDialysis patients with aortic stenosis are generally considered as being at extreme or high surgical risk. Herein, the first clinical trial was conducted to investigate clinical safety and effectiveness of transcatheter aortic valve replacement (TAVR) using the balloon-expandable transcatheter aortic valve (SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) in Japanese dialysis patients. MethodsThe clinical trial is a single arm, prospective, open, non-randomized, Japanese multicenter study. The primary purpose of this trial is to evaluate the efficacy and safety of TAVR using SAPIEN 3 in 28 Japanese dialysis patients. ResultsMean age was 79.2 years and 67.9% were male (Mean STS score was 14.3%). Transfemoral and transapical approaches were performed in 25 (89.3%) and 3 patients (10.7%), respectively. All bioprostheses were successfully implanted. Median intensive care unit stay and hospital stay after TAVR were 1.4 days and 6.3 days, respectively. In-hospital mortality was 3.6% and freedom from all-cause mortality at 1 year was 89.3%. Disabling stroke and life-threatening bleeding at 1 year was 7.7% and 8.5%, respectively. There was no structural valve deterioration during follow-up. New York Heart Association functional status, six-minute walk test, and EuroQOL visual analogue scale score significantly improved through 1 year compared with baseline. ConclusionsTAVR using SAPIEN 3 is safe and effective for the treatment of Japanese dialysis patients with symptomatic severe aortic valve stenosis.

Successful percutaneous balloon aortic valvuloplasty for worsening paravalvular leakage detected oneweek after the balloon expandable transcatheter aortic valve replacement.

Successful percutaneous balloon aortic valvuloplasty for worsening paravalvular leakage detected oneweek after the balloon expandable transcatheter aortic valve replacement.

Six-Month Biological Response and Functionality of Balloon-Expandable Transcatheter Aortic Valve (Myval) in Aortic Banding Model

BackgroundLong-term evaluation of transcatheter heart valves (THV) in the pre-clinical setting and clinical translation of outcomes was limited.AimWe evaluate biocompatibility and durability of a balloon expandable THV system (Myval, Meril Lifesciences) at 6-month follow-up in the novel ovine aortic banding model.MethodsA surgical ascending aortic banding model was created in 11 sheep. Two weeks later, 11 Myval THV systems (20 and 23 mm) were introduced and implanted via carotid approach for a 6 month follow-up. Transthoracic echocardiography was performed at 30, 90, and 180 days. Subsequently, the animals were sacrificed and the valves with surrounding tissue harvested for pathological and radiographic evaluation.ResultsAll valves were implanted successfully. There were 2 procedure-related deaths. One sheep died prematurely on day 133 due to endocarditis and one on day 74 due to leaflet immobility caused by tight banding. Both these were not related to the device.At 6 months all valves that completed follow-up (n = 7) were functional, with no significant regurgitation, calcification, thrombi, or vegetation. At terminal follow-up mean pressure gradient was 21.9{plus minus}11 mm Hg, Vmax = 3.3{plus minus}1 m/s and ejection fraction of 53.3 {plus minus} 6%. In pathology, implant cusps were covered with endothelialized and fibrocellular neointima, whereas the conduits were fully integrated without inflammatory reaction. There were no signs of thrombus or calcifications.ConclusionsIn this novel aortic banding model, Myval THV showed optimal deployment and good hemodynamic performance at 6 months. There were no device related degenerations and healing was very advanced.

A Completely Endovascular Solution for Transcatheter Aortic Valve Implantation Embolisation and Inversion into the Aortic Arch

IntroductionTranscatheter aortic valve implantation (TAVI) has evolved into the preferred alternative to surgical valve replacement for severe aortic valve stenosis with high surgical risk. With expanding indications, life threatening complications including transcatheter aortic valve embolisation and inversion (TAVEI), in which the valve dislodges, inverts, and migrates caudally, may increase concomitantly.ReportAn 80 year old male with severe aortic valve stenosis underwent balloon expandable transcatheter aortic valve implantation (TAVI). Valve embolisation into the aortic arch inverted the bioprothesis, excluding the option of fixation in the descending aorta. Through-valve thoracic endovascular aortic repair (TEVAR) was performed after bifemoral snaring using a through-and-through wire technique and pulling the valve into the descending aorta.DiscussionTAVI is emerging as the preferred treatment for severe aortic valve stenosis and comes with unique procedural complications, such as life threatening transcatheter aortic valve embolisation and inversion (TAVEI). Although some authors prefer treating embolisation of a non-inverted balloon expandable valve into the aorta by using the valvuloplasty balloon to pull the valve distally and fixing it in the descending aorta, this risks further expansion of the valve and consequently fixing it in an undesirable position and is not possible if the valve inverts. Downstream placement of the valve by snaring with a guiding catheter covering/protecting a through-and-through wire technique, combined with through-valve TEVAR, provides a new bail out strategy for this serious complication and may reduce TAVEI associated mortality and morbidity.

Novel Pressure-Regulated Deployment Strategy for Improving the Safety and Efficacy of Balloon-Expandable Transcatheter Aortic Valves

The optimal method for balloon-expandable transcatheter heart valve (THV) deployment remains unknown. Current implantation protocols are volume-dependent and rely on ad-hoc filling of the deployment apparatus without accounting for annular wall tension during prosthesis expansion, predisposing patients to inconsistent clinical outcomes.

Short-and-Long-Term Outcomes after Coronary Rotational Atherectomy in Patients Treated with Trans-Catheter Aortic Valve Implantation.

Background. Coronary artery disease (CAD) is a common finding among patients undergoing trans-catheter aortic valve implantation (TAVI), who often present severely calcified coronary lesions. Evidence is scarce about the use of rotational atherectomy (RA) in this setting, in particular regarding long-term outcome. Methods. RA was performed on severely calcified coronary lesions concomitant with TAVI in a consecutive series of patients treated between 2010 and 2020. Immediate and long-term clinical outcomes are reported. Results. A concomitant CAD (coronary stenosis visually > 50%) was observed in 402/845 (47.6%) consecutive patients undergoing TAVI at the University Hospital of Verona. Angioplasty was performed in 104 patients (12.3%). Among these, 19 patients (18.3%, 20 coronary arteries), were treated with RA after TAVI: 10 after implantation of a balloon-expandable trans-catheter valve and 9 after a self-expandable valve. All procedures were successful. Hypotension occurred in 3 patients (15.8%), with rapid recovery after the procedure; CI-AKI (contrast-induced acute kidney injury) in 3 patients (15.8%), of which two recovered within discharge. At a median follow-up of 21.5 months (Q1–3: 6–36) event free survival was 83.3%. Only one patient suffered a target vessel failure >2 years after RA. Neither stroke nor peri-procedural infarctions were detected. Conclusions. RA concomitant with TAVI was feasible and safe in patients treated with implantation of either self-expandable, or balloon-expandable trans-catheter aortic valves. Long-term clinical events related to the coronary procedure were extremely infrequent and the survival rate at median follow-up of 21.5 months was 83.3%.

Early commercial experience with a newly designed balloon-expandable transcatheter heart valve: 30-day outcomes and implications of preprocedural computed tomography.

We herein report a single-centre experience with the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve implantation (TAVI) system. Between March 2019 and January 2020, a total of 79 consecutive patients received transfemoral TAVI using the SAPIEN 3 Ultra device. Data were retrospectively analysed according to updated Valve Academic Research Consortium-2 definitions. Detailed analysis of multislice computed tomography data was conducted to identify potential predictors for permanent pacemaker (PPM) implantation and residual paravalvular leakage (PVL) post TAVI. Device success and early safety were 97.5% (77/79) and 94.9% (75/79) with resulting transvalvular peak/mean pressure gradients of 21.1 ± 8.2/10.9 ± 4.4 and PVL >mild in 0/79 patients (0%). Mild PVL was seen in 18.9% (15/79) of cases. Thirty-day mortality was 2.5% (2/79). The Valve Academic Research Consortium-2 adjudicated clinical end points disabling stroke, acute kidney injury and myocardial infarction occurred in 1.3% (1/79), 5.1% (4/79) and 0% (0/79) of patients. Postprocedural PPM implantation was necessary in 7.6% (6/79) of patients. Multislice computed tomography analysis revealed significantly higher calcium amounts of the right coronary cusp in patients in need for postprocedural PPM implantation and a higher eccentricity index in patients with postinterventional mild PVL. First experience with this newly designed balloon-expandable-transcatheter heart valve demonstrates adequate 30-day outcomes and haemodynamic results with low mortality, low rates of PPM implantation and no residual PVL >mild. The herein-presented multislice computed tomography values with an elevated risk for PPM implantation and residual mild PVL may help to further improve outcomes with this particular transcatheter heart valve in TAVI procedures.