Transcatheter Heart Valve Implantation Research Articles

Coronary access after repeat transcatheter aortic valve replacement in patients of small body size: A simulation study

BackgroundCoronary artery access after repeat transcatheter aortic valve replacement (TAV-in-TAV) is reportedly more difficult because leaflet displacement of the first transcatheter heart valve (THV) impairs coronary cannulation; however, its effects in small patients are unknown. This study aimed to simulate coronary accessibility after TAV-in-TAV in patients of small body size. MethodsWe retrospectively analyzed computed tomography scans after initial THV implantation and classified patients by THV and coronary artery location, valve-to-aorta distance, and valve-to-coronary distance. Risks were compared between the SAPIEN and CoreValve/Evolut series, among THV generations, and between bicuspid and tricuspid aortic valves in the CoreValve/Evolut series. ResultsA total of 254 patients (SAPIEN series, n = 164; CoreValve/Evolut series, n = 90) were enrolled. The average body surface area of the patients was 1.44 m2. Patients were classified as “feasible” (26%), “theoretically feasible with low risk” (19.7%), “theoretically feasible with high risk” (8.7%), or “unfeasible” (45.8%). The “unfeasible” rate was significantly higher in the CoreValve/Evolut series than in the SAPIEN series (78.9% vs 26.2%; P < .001). A significantly higher “unfeasible” rate was identified in the current model of SAPIEN (SAPIEN, 8.3%; SAPIENXT, 1.8%; SAPIEN3, 48.2%; P < .001), but not in the CoreValve/Evolut series (CoreValve, 83.3%; Evolut R, 80.0%; Evolut PRO, 71.4%; P = .587). Patients with a bicuspid aortic valve had a lower “unfeasible” rate compared to those with a tricuspid aortic valve (60.0% vs 86.2%; P = .014). ConclusionsPatients of small body size may have a high probability of “unfeasible” coronary access after TAV-in-TAV, especially when treated with current high-frame devices, suggesting the need for careful strategic planning for initial THV implantation.

Hybrid Approach Using the Cusp-Overlap Technique for Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve

BackgroundThe cusp-overlap (CO) technique has recently been advocated and is being increasingly adopted for self-expandable transcatheter heart valve (THV) implantation. ObjectivesThe aim of this study was to evaluate the feasibility, implantation depth, and outcomes of the CO technique for the balloon-expandable SAPIEN 3 THV. MethodsThe CO technique was used in consecutive patients undergoing balloon-expandable THV implantation at one center between April 2021 and March 2022. Optimal fluoroscopic angles were determined from preprocedural computed tomography and confirmed on predeployment angiography. The THV radiolucent line was positioned 2 to 4 mm below the noncoronary cusp in the CO view, and positioning was confirmed in the 3-cusp view. Postdeployment THV implantation depth was assessed in both views. One-month outcomes were assessed using Valve Academic Research Consortium 3 criteria. ResultsAmong 137 patients eligible for the CO technique, the CO view was not used because of unfavorable ergonomics in 27 patients (26.5%) and hemodynamic instability in 8 patients (7.8%). Among 102 patients, the mean age was 81.1 ± 6.6 years, the mean Society of Thoracic Surgeons score was 3.3% ± 2.2%, and 64.7% were men. The mean measured THV implantation depth was 3.0 ± 1.4 mm in the CO view and 2.5 ± 1.4 mm in the 3-cusp view. At 1-month follow-up, 1 patient (1.0%) had died, 1 (1.0%) had had a stroke, and 7 (6.8%) had undergone permanent pacemaker implantation. ConclusionsThe CO technique is feasible and safe and may facilitate more accurate balloon-expandable THV positioning, especially when deep implantation needs to be avoided. Further studies are required to explore potential reduction in atrioventricular conduction block, pacemakers, or paravalvular regurgitation.

Early results of Pulsta® transcatheter heart valve in patients with enlarged right ventricular outflow tract and severe pulmonary regurgitation due to transannular patch.

The purpose of this study is to assess the feasibility, effectivity, and safety of a novel self-expandable valve system, Pulsta® transcatheter heart valve in patients with tetralogy of fallot and severe pulmonary regurgitation after transannular patch repair. Severe pulmonary regurgitation after tetralogy of fallot repair is a life-threatening problem and should be treated by pulmonary valve implantation. Although percutaneous pulmonary valve implantation has been ever increasingly used for this purpose, available balloon-expandable valves have limitations and cannot be used by most patients. Pulsta® transcatheter heart valve is a new self-expandable valve system and offers a new solution to be used in patients with different types of native right ventricular outflow tract geometry. Ten patients with severe regurgitation after tetralogy of fallot repair with a transannular patch have been enrolled in the study according to echocardiographic examination. MRI was used in asymptomatic patients to delineate the indication and the right ventricular outflow tract geometry. Pulsta® transcatheter heart valve implantation was performed in ten patients, and preprocedural, procedure, and 6 months follow-up findings of the patients were evaluated. Pulsta® pulmonary valve implantation was performed in ten patients successfully without any severe complications. Valve functions were perfect in six of ten patients, while the others had insignificant regurgitation by echocardiographic examination at the end of 6 months follow-up. This study showed that Pulsta® transcatheter heart valve is a feasible, effective, and safe method in the treatment of severe pulmonary regurgitation due to transannular patch repair in patients with tetralogy of fallot.

Transcatheter Aortic Valve Replacement Through a Single Femoral Access: A Multicenter Experience.

During the past few years, physicians have optimized transcatheter aortic valve replacement and its periprocedural management, with the minimalist approach becoming popular. We aimed to further simplify the procedure using a single femoral access (the "all-in-one" technique). Here, we report a multicenter experience with TAVR with Acurate neo/neo2 transcatheter heart valves (Boston Scientific) through a single, large-bore, femoral sheath. Patients underwent TAVR with the Acurate neo or neo2 through a single femoral access at 4 centers. The large sheath was used for both the delivery catheter and the pigtail used to visualize the aortic root. A total of 157 patients (59% women) with a mean age of 82 ± 6 years underwent TAVR with the Acurate neo (n = 100) or the Acurate neo2 (n = 57). The procedure was successfully performed through a single large sheath in all patients. Median duration of hospitalization stay was 2 days (interquartile range, 1-3 days). On echocardiography before discharge, the mean gradient was 7 ± 3 mm Hg and 7 patients (4.4%) had more than mild paravalvular leak. At 30 days, a major vascular complication had occurred in 2 patients (1.3%), 2 patients (1.3%) had suffered a stroke, and only 4 patients (2.5%) had required new permanent pacemaker implantation. A total of 3 patients (1.9%) had died. An all-in-one access technique allows safe implantation of Acurate neo and neo2 transcatheter heart valves, with low rates of periprocedural complications and favorable short-term outcomes.

Quantification of Commissural Alignment of Balloon-Expandable THV on Fluoroscopy: A Comparison Study With Post-TAVR CT

BackgroundCoronary access may be challenging following transcatheter aortic valve replacement (TAVR) in the setting of transcatheter heart valve (THV) commissural misalignment. ObjectivesThe authors aimed to quantify the degree of commissural alignment following balloon-expandable THV implantation using a fluoroscopy-based trigonometric approach and assess its correlation with post-TAVR computed tomography (CT). MethodsTwenty patients who had undergone both TAVR with the balloon-expandable SAPIEN 3 THV and post-TAVR CT were included in the analysis. Optimized, predeployment 3-cusp angiographic view and postdeployment angiographic view using identical fluoroscopic projections were required. The distance between the most central posterior commissural strut and the THV centerline was assessed. Commissural alignment was calculated by means of a trigonometrical approach using an arcsine function, assuming circular deployment of the THV. Commissural alignment was stratified using a 4-tier scale: aligned (0° to 15°); mildly misaligned (15° to 30°); moderately misaligned (30° to 45°), and severely misaligned (45° to 60°). ResultsSeven patients (35.0%) were misclassified by 1 tier, and no patient was misclassified by 2 or more tiers, with strong agreement between CT and fluoroscopy (weighted Cohen’s kappa coefficient = 0.724). Correlation of the commissural offset angle determined from fluoroscopy and CT was excellent (r = 0.986; 95% CI: 0.965 to 0.995). Bland-Altman analysis demonstrated a strong agreement between both modalities with a mean difference of 0.5° (95% limits of agreement: −12.7° to 13.7°). ConclusionsThe degree of commissural alignment of the balloon-expandable THV can be reliably assessed and quantified on postdeployment fluoroscopy using a standardized 3-cusp view and trigonometry-based analysis.

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.

Efficacy of larger valve sizing with underfilling in balloon-expandable transcatheter aortic valve replacement.

To investigate the efficacy and safety of larger valve sizing beyond the commercially recommended annular range in transcatheter aortic valve replacement (TAVR) with balloon-expandable transcatheter heart valve(THVs). The clinical implications of larger balloon-expandable THVimplantation with underfilling are poorly evaluated. This retrospective study included 692 consecutive patients who underwent TAVR with SAPIEN3. A total of 271 patients who underwent SAPIEN 3 implantation were analyzed based on three border zones (Zone 1: 300-345 mm2 , 23vs. 20 mm; Zone 2: 400-430 mm2 , 26vs. 23 mm; Zone 3: 500-546 mm2 , 29vs. 26 mm). The primary endpoint was the effective orifice area (EOA) assessed by echocardiography at 1 year, and secondary endpoints were a 30-day mortality rate, procedural complications during TAVR, and a composite of death from any cause and heart failure requiring rehospitalization at 1 year. At 1-year follow-up, the EOA in the larger valve groups was greater than that in the recommended valve group in each zone (Zone 1: 1.45 ± 0.03vs. 1.06 ± 0.06 cm2 , p < 0.001; Zone 2: 1.83 ± 0.05vs. 1.41 ± 0.05 cm2 , p < 0.001; Zone 3: 1.93 ± 0.07vs. 1.69 ± 0.07 cm2 , p = 0.02). No significant difference in the secondary endpoint was observed in any of the zones. Implantation of the out-of-range larger SAPIEN 3 THVs with underfilling was associated with greater EOA at the 1-year follow-up and feasible in the selected patients.

Mitral Valve Infective Endocarditis after Trans-Catheter Aortic Valve Implantation

Scarce data exist on mitral valve (MV) infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). This multicenter study included a total of 579 patients with a diagnosis of definite IE after TAVI from the IE after TAVI International Registry and aimed to evaluate the incidence, characteristics, management, and outcomes of MV-IE after TAVI. A total of 86 patients (14.9%) had MV-IE. These patients were compared with 284 patients (49.1%) with involvement of the transcatheter heart valve (THV) only. Two factors were found to be associated with MV-IE: the use of self-expanding valves (adjusted odds ratio 2.49, 95% confidence interval [CI] 1.23 to 5.07, p=0.012), and the presence of an aortic regurgitation ≥2 at discharge (adjusted odds ratio 3.33; 95% CI 1.43 to 7.73, p<0.01). There were no differences in IE timing and causative microorganisms between groups, but surgical management was significantly lower in patients with MV-IE (6.0%, vs 21.6% in patients with THV-IE, p=0.001). All-cause mortality rates at 2-year follow-up were high and similar between patients with MV-IE (51.4%, 95% CI 39.8 to 64.1) and patients with THV-IE (51.5%, 95%CI 45.4 to 58.0) (log-rank p=0.295). The factors independently associated with increased mortality risk in patients with MV-IE were the occurrence of heart failure (adjusted p<0.001) and septic shock (adjusted p<0.01) during the index hospitalization. One of 6 IE episodes after TAVI is localized on the MV. The implantation of a self-expanding THV and the presence of an aortic regurgitation ≥2 at discharge were associated with MV-IE. Patients with MV-IE were rarely operated on and had a poor prognosis at 2-year follow-up.

Patient-Specific Computer Simulation to Predict Conduction Disturbance With Current-Generation Self-Expanding Transcatheter Heart Valves

BackgroundPatient-specific computer simulation may predict the development of conduction disturbance following transcatheter aortic valve replacement (TAVR). Validation of the computer simulations with current-generation devices has not been undertaken. MethodsA retrospective study was performed on patients who had undergone TAVR with a current-generation self-expanding transcatheter heart valve (THV). Preprocedural computed tomography imaging was used to create finite element models of the aortic root. Procedural contrast angiography was reviewed, and finite element analysis performed using a matching THV device size and implantation depth. A region of interest corresponding to the atrioventricular bundle and proximal left bundle branch was identified. The percentage of this area (contact pressure index [CPI]) and maximum contact pressure (CPMax) exerted by THV were recorded. Postprocedural electrocardiograms were reviewed, and major conduction disturbance was defined as the development of persistent left bundle branch block or high-degree atrioventricular block. ResultsA total of 80 patients were included in the study. THVs were 23- to 29-mm Evolut PRO (n = 53) and 34-mm Evolut R (n = 27). Major conduction disturbance occurred in 27 patients (33.8%). CPI (28.3 ± 15.8 vs. 15.6 ± 11.2%; p < 0.001) and CPMax (0.51 ± 0.20 vs. 0.36 ± 0.24 MPa; p = 0.008) were higher in patients who developed major conduction disturbance. CPI (area under the receiver operating characteristic curve [AUC], 0.74; 95% CI, 0.63-0.86; p < 0.001) and CPMax (AUC, 0.69; 95% CI, 0.57-0.81; p = 0.006) demonstrated a discriminatory power to predict the development of major conduction disturbance. ConclusionsPatient-specific computer simulation may identify patients at risk for conduction disturbance after TAVR with current-generation self-expanding THVs.

Membranous septum morphology and risk of conduction abnormalities after transcatheter aortic valve implantation.

There are limited data on the association of membranous septum (MS) morphology and transcatheter heart valve (THV) implantation depth, and the development of new conduction abnormalities (CA) after transcatheter aortic valve implantation (TAVI). The aim of this study was to describe the morphology of the MS and predict the risk of new CA after TAVI based on the MS morphology and THV implantation depth. Based on preprocedural CT scans, the MS depth was measured for every 25% of the entire MS width in 272 TAVI patients without preprocedural bundle branch block (BBB) or pacemaker. Post-procedural CT scans for THV implantation depth assessment were available in 130 of these patients. The MS depth was a median of 2.5 mm (IQR 1.4-3.8) deeper at the posterior edge when compared to the anterior edge of the MS. New CA developed in 7.1% of patients in whom the THV did not cross the lower MS border at its anterior edge (3.6% with new BBB and high degree CA, respectively), in 18.8% of patients (15.6% with new BBB and 3.1% with new high-degree CA) where the THV overlapped the lower MS border by <2.5 mm and in 47.1% of patients (24.3% with new BBB and 22.9% with new high-degree CA) with THV overlap of the lower MS border by ≥2.5 mm. The difference of the MS depth and THV implantation depth measured at the anterior edge of the MS predicted new CA after TAVI.

The Wattson temporary pacing guidewire for transcatheter heart valve implantation.

Transcatheter aortic valve implantationand implantation of other transcatheter heart valves, generally requires insertion of a temporary venous pacemaker. Implantation of a temporary venous pacemaker adds complexity, time and risk to the procedure. Guidewire modification to allow pacing is increasingly popular, however it requires technical expertise and provides unipolar pacing resulting in high thresholds and potential capture loss. The Wattson temporary pacing guidewire is a novel device which offers guidewire support for valve delivery and concomitant bipolar pacing. It may offer a safe and effective solution to guidewire pacing for transcatheter aortic valve implantation and other transcatheter heart valve implantations. Herein, we review the literature surrounding left ventricular guidewire pacing along with the features and clinical data of the Wattson wire.

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.

Repeat transcatheter aortic valve implantation and implications for transcatheter heart valve performance: insights from bench testing.

THV implantation within failed surgical valves is well established. However, the implications of THV implantation within failed THVs are poorly understood. This study aimed to assess the impact of different transcatheter heart valve (THV) designs and implant positioning strategies on hydrodynamic performance after redo transcatheter aortic valve implantation (TAVI). THVs of varying design (SAPIEN 3, Evolut PRO, ACURATE neo, ALLEGRA, and Portico) and size were implanted inside SAPIEN XT and Evolut R THVs. Hydrodynamic function as per International Organization for Standardization (ISO) specifications was evaluated using a pulse duplicator, and multi-modality imaging was performed. The majority of tested THV-in-THV combinations resulted in stable anchoring of the new implant. However, some combinations resulted in unstable anchoring with the potential for dislodgement or embolisation. Hydrodynamic function was favourable for all tested THV designs implanted in the intra-annular SAPIEN XT THV. SAPIEN 3 implantation within an Evolut THV with supra-annular leaflets must be appropriately sized to ensure adequate anchoring. Avoidance of an intra-annular deployment mitigated leaflet overhang of the Evolut leaflets and optimised hydrodynamic performance. This study demonstrates that most THV designs and implantation strategies can result in favourable hydrodynamic performance following redo TAVI. Whether the leaflets of a failed THV are intra- or supra-annular may have important implications for the positioning of a redo-THV implant. Certain THV designs or implantation positions may be more desirable when performing redo TAVI.

TCT-275 First-in-Man Transfemoral Stent-in-Valve Implantation as Bail-Out for Failed Transcatheter Heart Valve Implantation: Proof of Concept

TCT-275 First-in-Man Transfemoral Stent-in-Valve Implantation as Bail-Out for Failed Transcatheter Heart Valve Implantation: Proof of Concept

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

Impact of Annular Oversizing on Paravalvular Regurgitation and ValveHemodynamics: New Insights From PARTNER 3.

This study sought to investigate the impact of computed tomography (CT)-based area and perimeter oversizing on the incidence of paravalvular regurgitation (PVR) and valve hemodynamics in patients treated with the SAPIEN 3 transcatheter heart valve (THV). The incremental value of considering annular perimeter or left ventricular outflow tract measurements and the impact of THV oversizing on valve hemodynamics are not well defined. The PARTNER 3 (Placement of Aortic Transcatheter Valves 3) trial included 495 low-surgical-risk patients with severe aortic stenosis who underwent THV implantation. THV sizing was based on annular area assessed by CT. Area- and perimeter-based oversizing was determined using systolic annular CT dimensions and nominal dimensions of the implanted THV. PVR, effective orifice area, and mean gradient were assessed on 30-day transthoracic echocardiography. Of 485 patients with available CT and echocardiography data, mean oversizing was 7.9 ± 8.7% for the annulus area and 2.1 ± 4.1% for the perimeter. A very low incidence of≥moderate PVR (0.6%) was observed, including patients with minimal annular oversizing. Incidence of≥mild PVR and need for procedural post-dilatation were inversely related to the degree of oversizing. For patients with annular dimensions suitable for 2 THV sizes, the larger THV with both area and perimeter oversizing was associated with the lowest incidence of≥mild PVR (12.0% vs 43.4%; P<0.0001). Left ventricular outflow tract area oversizing was not associated with PVR. THV prosthesis size, rather than degree of oversizing, had greatest impact on effective orifice area and mean gradient. In low-surgical-risk patients, a low incidence of≥moderate PVR was observed, including patients with minimal THV oversizing. The degree of prosthesis oversizing had the greatest impact on reducing mild PVR and incidence of post-dilatation, without impacting valve hemodynamics. In selected patients with annular dimensions in between 2 valve sizes, the larger THV device oversized to both the annular area and perimeter reduced PVR and optimized THV hemodynamics.

Surgical Techniques for Removal and Replacement of Chronically Implanted TAVR Prosthesis: Step by Step

Transcatheter aortic valve replacement has substantially grown in volume over the years, and increasingly is being used in patients with longer life expectancy, including younger patients. With increasing implantation of transcatheter heart valves (THV) the need for explantation of these devices with replacement of the aortic valve will also go up. Bioprosthetic valve endocarditis, along with paravalvular leaks and structural valve degeneration will be the leading causes requiring THV explantation and redo-aortic valve replacement (AVR). Given the cascade of trials in different populations and the rapid development cycle for THV, the patients, design and composition of the bioprostheses being explanted will vary considerably. However, many of the preoperative considerations, imaging and technical considerations in patients with a failed THV will be the same. Here, we highlight the technical steps to achieve a safe THV explantation and redo-AVR.

La técnica de superposición de cúspides en TAVI con dispositivo autoexpandible optimiza la profundidad del implante y reduce la necesidad de marcapasos permanente

Introduction and objectivesThis study aimed to determine the safety and efficacy of modifying the classic implantation technique for aortic transcatheter heart valve (THV) implantation to a cusp-overlap-projection (COP) technique to achieve a higher implantation depth and to reduce the burden of new permanent pacemaker implantation (PPMI) at 30 days. Aortic self-expanding THV carries an elevated risk for PPMI. A higher implantation depth minimizes the damage in the conduction system and may reduce PPMI rates. MethodsFrom March 2017, 226 patients were consecutively included: 113 patients were treated using the COP implantation technique compared with the previous 113 consecutive patients treated using the classic technique. In all patients, implantation depth was assessed by 3 methods (noncoronary cusp to the THV, mean of the noncoronary cusp and the left coronary cusp to the THV, and the deepest edge from the left coronary cusp and the noncoronary cusp to the THV). ResultsThe COP group had a lower implantation depth than the group treated with the classic technique (4.8 mm± 2.2 vs 5.7 mm± 3.1; P=.011; 5.8 mm± 3.1 vs 6.5 mm± 2.4; P=.095; 7.1 mm± 2.8 vs 7.4 mm±3.2; P=.392). Forty patients (17.7%) required a new PPMI after the 30-day follow-up but this requirement was significantly lower in the COP group (12.4% vs 23%, P=.036). The COP implantation technique consistently protected against the main event (OR, 0.45; 95%CI, 0.21-0.97; P=.043), with similar procedural success rates and complications. ConclusionsThe COP implantation technique is a simple modification of the implantation protocol and provides a higher implantation depth of self-expanding-THV with lower conduction disturbances and PPMI rates.

Cusp-overlapping TAVI technique with a self-expanding device optimizes implantation depth and reduces permanent pacemaker requirement

Introduction and objectivesThis study aimed to determine the safety and efficacy of modifying the classic implantation technique for aortic transcatheter heart valve (THV) implantation to a cusp-overlap-projection (COP) technique to achieve a higher implantation depth and to reduce the burden of new permanent pacemaker implantation (PPMI) at 30 days. Aortic self-expanding THV carries an elevated risk for PPMI. A higher implantation depth minimizes the damage in the conduction system and may reduce PPMI rates. MethodsFrom March 2017, 226 patients were consecutively included: 113 patients were treated using the COP implantation technique compared with the previous 113 consecutive patients treated using the classic technique. In all patients, implantation depth was assessed by 3 methods (noncoronary cusp to the THV, mean of the noncoronary cusp and the left coronary cusp to the THV, and the deepest edge from the left coronary cusp and the noncoronary cusp to the THV). ResultsThe COP group had a lower implantation depth than the group treated with the classic technique (4.8 mm± 2.2 vs 5.7 mm± 3.1; P=.011; 5.8 mm± 3.1 vs 6.5 mm± 2.4; P=.095; 7.1 mm± 2.8 vs 7.4 mm±3.2; P=.392). Forty patients (17.7%) required a new PPMI after the 30-day follow-up but this requirement was significantly lower in the COP group (12.4% vs 23%, P=.036). The COP implantation technique consistently protected against the main event (OR, 0.45; 95%CI, 0.21-0.97; P=.043), with similar procedural success rates and complications. ConclusionsThe COP implantation technique is a simple modification of the implantation protocol and provides a higher implantation depth of self-expanding-THV with lower conduction disturbances and PPMI rates.

Transcatheter Heart Valve Implantation in Bicuspid Patients with Self-Expanding Device.

Bicuspid aortic valve (BAV) patients are conventionally not treated by transcathether aortic valve implantation (TAVI) because of anatomic constraint with unfavorable outcome. Patient-specific numerical simulation of TAVI in BAV may predict important clinical insights to assess the conformability of the transcathether heart valves (THV) implanted on the aortic root of members of this challenging patient population. We aimed to develop a computational approach and virtually simulate TAVI in a group of n.6 stenotic BAV patients using the self-expanding Evolut Pro THV. Specifically, the structural mechanics were evaluated by a finite-element model to estimate the deformed THV configuration in the oval bicuspid anatomy. Then, a fluid–solid interaction analysis based on the smoothed-particle hydrodynamics (SPH) technique was adopted to quantify the blood-flow patterns as well as the regions at high risk of paravalvular leakage (PVL). Simulations demonstrated a slight asymmetric and elliptical expansion of the THV stent frame in the BAV anatomy. The contact pressure between the luminal aortic root surface and the THV stent frame was determined to quantify the device anchoring force at the level of the aortic annulus and mid-ascending aorta. At late diastole, PVL was found in the gap between the aortic wall and THV stent frame. Though the modeling framework was not validated by clinical data, this study could be considered a further step towards the use of numerical simulations for the assessment of TAVI in BAV, aiming at understanding patients not suitable for device implantation on an anatomic basis.