Transcatheter Heart Valve Size Research Articles

Performance of balloon-expandable transcatheter bioprostheses in inoperable patients with pure aortic regurgitation of a native valve: The BE-PANTHEON international project

BackgroundThe off-label utilization of transcatheter heart valve (THV) devices for the treatment of inoperable or high-surgical risk patients with pure native aortic valve regurgitation (NAVR) has demonstrated suboptimal outcomes, both with self- and balloon-expandable (BE) devices. The aim of this study is to compare the use of different BE scaffolds in treating pure NAVR. MethodsConsecutive patients with pure severe NAVR who were deemed to be at high-risk and were treated with last-generation BE-THVs among seventeen Centers in Europe and US. Technical and device success rates were the primary objectives. ResultsBetween February 2018 and July 2023, among 144 patients, 41 (28 %) received a MyVal device and 103 (72 %) were treated with a Sapien THV. Patients treated with a MyVal THV had an extra-large annulus more frequently compared to the Sapien group (49%vs.20 %, p < 0.001).Technical and device success rates were 90 % and 81 %, respectively, p > 0.1. The rate of THV migration/embolization (MyVal 4.9%vs. Sapien 11 %, p = 0.4) and second valve needed (4.9%vs.7.8 %, p = 0.7) were numerically lower in the MyVal group, whereas the rate of at least moderate paravalvular leak (15%vs.7.8 %, p = 0.2) and permanent pacemaker implantation (25%vs.18 %, p = 0.16) were numerically higher in the Myval group. ConclusionsOff-label use of BE devices for pure NAVR represents a potential alternative in high-risk patients in the absence of dedicated devices. However, BE in NAVR is associated with suboptimal outcomes. The availability of larger THV sizes may introduce transcatheter aortic valve replacement as an effective treatment for patients traditionally deemed unsuitable. Non-standard abbreviations and acronymsAR = aortic regurgitation, BE = balloon-expandable, NAVR = native aortic valve regurgitation, PM = pacemaker, TAVR = transcatheter aortic valve replacement, THV = transcatheter heart valve, TVEM = transcatheter valve embolization and migration, VARC-3 = Valve Academic Research Consortium 3.

Outcomes and treatment strategy of transcatheter aortic valve replacement with balloon-expandable valve in borderline-size annulus

BackgroundCandidates for transcatheter aortic valve replacement (TAVR) occasionally have a “borderline-size” aortic annulus between 2 transcatheter heart valve sizes, based on the manufacturer's sizing chart. Data on TAVR outcomes in such patients are limited. MethodsWe retrospectively reviewed 1816 patients who underwent transfemoral-TAVR with balloon-expandable valve (BEV) at our institution between 2016 and 2020. We divided patients into borderline and non-borderline groups based on computed tomography-derived annular measurements and compared outcomes. Furthermore, we analyzed procedural characteristics and compared outcomes between the smaller- and larger-valve strategies in patients with borderline-size annulus. ResultsDuring a median follow-up of 23.3 months, there was no significant difference between the borderline (n = 310, 17.0 %) and non-borderline (n = 1506) groups in mortality (17.3 % vs. 19.5 %; hazard ratio [HR] = 0.86 [95% CI = 0.62–1.20], p = 0.39), major adverse cardiac/cerebrovascular events (MACCE: death/myocardial infarction/stroke, 21.2 % vs. 21.5 %; HR = 0.97 [0.71–1.32], p = 0.85), paravalvular leak (PVL: mild 21.8 % vs. 20.6 %, p = 0.81; moderate 0 % vs. 1.2 %; p = 0.37), or mean gradient (12.9 ± 5.8 vs. 12.6 ± 5.2 mmHg, p = 0.69) at 1 year. There was no significant difference between the larger-(n = 113) and smaller-valve(n = 197) subgroups in mortality (23.7 % vs. 15.2 %; HR = 1.57 [0.89–2.77], p = 0.12), MACCE (28.1 % vs. 18.4 %; HR = 1.52 [0.91–2.54], p = 0.11), mild PVL (13.3 % vs. 25.9 %; p = 0.12), or mean gradient (12.3 ± 4.5 vs. 13.6 ± 5.3 mmHg, p = 0.16); however, the rate of permanent pacemaker implantation (PPI) was higher in the larger-valve subgroup (15.9 % vs. 2.6 %, p < 0.001). ConclusionBorderline-size annulus is not associated with higher risk of adverse outcomes after BEV-TAVR. However, the larger-valve strategy for borderline-size annulus is associated with higher PPI risk, suggesting a greater risk of injury to the conduction system.

Redo-TAVR Feasibility After SAPIEN 3 Stratified by Implant Depth and Commissural Alignment: A CT Simulation Study.

Redo-transcatheter aortic valve replacement (TAVR) can pin the index transcatheter heart valve leaflets open leading to sinus sequestration and restricting coronary access. The impact of initial implant depth and commissural alignment on redo-TAVR feasibility is unclear. We sought to determine the feasibility of redo-TAVR and coronary access after SAPIEN 3 (S3) TAVR stratified by implant depth and commissural alignment. Consecutive patients with native valve aortic stenosis were evaluated using multidetector computed tomography. S3 TAVR simulations were done at 3 implant depths, sizing per manufacturer recommendation and assuming nominal expansion in all cases. Redo-TAVR was deemed unfeasible based on valve-to-sinotubular junction distance and valve-to-sinus height <2 mm, while the neoskirt plane of the S3 transcatheter heart valve estimated coronary access feasibility. Overall, 1900 patients (mean age, 80.2±8 years; STS-PROM [Society of Thoracic Surgeons Predicted Risk of Operative Mortality], 3.4%) were included. Redo-TAVR feasibility reduced significantly at shallower initial S3 implant depths (2.3% at 80:20 versus 27.5% at 100:0, P<0.001). Larger S3 sizes reduced redo-TAVR feasibility, but only in patients with a 100:0 implant (P<0.001). Commissural alignment would render redo-TAVR feasible in all patients, assuming the utilization of leaflet modification techniques to reduce the neoskirt height. Coronary access following TAV-in-TAV was affected by both index S3 implant depth and size. This study highlights the critical impact of implant depth, commissural alignment, and transcatheter heart valve size in predicting redo-TAVR feasibility. These findings highlight the necessity for individualized preprocedural planning, considering both immediate results and long-term prospects for reintervention as TAVR is increasingly utilized in younger patients with aortic stenosis.

Patient-specific computer modelling to predict anatomical risk factors preventing post transcatheter aortic valve implantation coronary re-access in bicuspid aortic valve; a modelling study

Abstract Background Post Transcatheter aortic valve implantation (TAVI) coronary re-access is predicted to become more common as TAVI expands into lower risk cohorts. The use of a self-expanding valve (SEV) has been recognised as an independent predictor for unsuccessful coronary cannulation. Other predictors include reduced transcatheter heart valve (THV) to coronary distance and small sino-tubular junction. Despite this however a patient cohort remains in which the use of a SEV is preferable due to anatomical complexity or extensive calcification. Purpose Using patient-specific computer modelling, we aimed to assess how the deployment of different sized THVs and at different depths affected the distance from valve to coronary and valve to sino-tubular junction in bicuspid aortic valve cases. Methods In this modelling study we have used pre-procedural, CT-derived, patient-specific finite element analysis computer models to predict the eventual valve result. We studied two anatomical measures for both right and left coronary sinuses. The distance from coronary ostium to nearest structure, either THV or displaced native leaflet – Sinus of Valsalva (SoV) free space. The second distance was from the STJ to THV – STJ free space. THVs were modelled at both high and medium implant positions. THV size was based upon annular dimensions. Where the annular dimensions fell near an anatomical grey-zone, a second size THV was modelled. For each patient and measure, a mean of all distances was calculated, in addition to both minimum and maximum distances. Results The free space SOV left main coronary artery (LMCA) mean was 6.39 mm (4.87-7.91 mm). The difference between maximum and minimum was 0.9461 mm (0.54–1.36 mm), p&amp;lt;0.01. The largest patient-specific difference between minimum and maximum was 2.41 mm, using the same THV size but at different depths. The free space SOV right coronary artery (RCA) mean was 5.73 mm (4.17-7.30 mm). The difference between maximum and minimum was 0.789 mm (0.49-1.09 mm), p&amp;lt;0.01. The STJ free space LMCA mean was 4.3 mm (2.35–6.27 mm), The difference between maximum and minimum was 0.99 mm (0.63-1.35 mm), p&amp;lt;0.01. The STJ free space RCA mean was 3.76 mm (2.2-5.32 mm).The difference between maximum and minimum was 1.18 mm (0.9-1.56 mm), p&amp;lt;0.01. The largest patient-specific difference between minimum and maximum was 2.02 mm, using the same valve size but at different depths. Data presented as mean (95% confidence intervals), n=16 patients/48 models. Conclusions This modelling study has indicated a significant difference in all four measured parameters when different THVs are modelled at different depths. Note some of the largest differences are seen with the same size THV but at a different depth. We would highlight the small mean effect size seen across the results, however in cases where the difference is &amp;gt;2mm, this could have an effect on coronary re-access and warrants further investigation.

Pressure-regulated deployment for balloon-expandable TAVI is safe, effective and results in superior valve haemodynamics regardless of prosthesis size

Abstract Background A novel pressure-regulated deployment method for balloon-expandable transcatheter heart valves (THVs) has been developed(1) to improve clinical outcomes by regulating maximal annular wall tension during prosthesis expansion – to both optimise prosthesis-annulus apposition and diminish annular injury. The previous feasibility study(1) showed that THV deployment at wall tensions between 3-3.5 MPa may be associated with reduced paravalvular-leak (PVL) severity and avoidance of annular rupture. Objective To prospectively evaluate the safety and efficacy of the pressure-regulated THV deployment strategy. Methods 341 consecutive patients with severe native aortic stenosis and moderate-severe surgical risk who underwent TAVI with Sapien 3 THVs using a pressure-regulated deployment strategy were included. Target (maximal) deployment pressure was adjusted according to valve size: 5 atm for 29mm, 5.5 atm for 26mm and 6.25 atm for 23mm THVs. Key procedural and clinical outcomes were recorded and analysed using uni- and multi-variate analyses. Results The average patient age was 82.1±6.9 years and 28.2% were female (see attached table). 29.3% had moderate-severe subannular calcification and 14.5% had estimated ≥20% THV oversizing based on TAVI CT. 112 patients (32.8%) were considered at high-risk of annular rupture(2). Post-dilatation rate was 8.2% and was independently associated only with the degree of THV oversizing (OR 3.5, p=0.007, for ≤5% oversizing). On TTE prior to discharge, 85.6% had none/trivial PVL and 14.4% had mild PVL with no observed moderate/severe PVL. Mild PVL was independently associated with age (OR 1.07, p=0.02, per year) and degree of THV oversizing (OR 2.4, p=0.02, for ≤5% oversizing). Resulting THV mean gradient on TTE was 9.7±3.5mmHg overall, with similar results between 23mm (10.5±3.2mmHg) and 26/29mm valves (9.6±3.5mmHg, p=0.2). New PPM rate was 9.6% and was independently associated only with pre-existing RBBB (OR 13.5, p&amp;lt;0.001). New LBBB rate was 11.2% was independently associated only with low THV implantation depth (OR 4.3, p=0.009, for ≤60% of THV length above native aortic annulus). There were no cases of aortic/annular rupture. Conclusions The pressure-regulated strategy for balloon-expandable THV deployment is associated with an excellent safety and efficacy outcomes profile. Notably, there was no significant difference in valve haemodynamics and degree of PVL post-implantation between the smaller (23mm) and larger (26/29mm) THV sizes. These findings suggest that standardisation of THV deployment pressure to achieve target wall tension results in improved haemodynamics, particularly in small-sized valves.Main Table (Truncated)PVL and MG according to THV size

Abstract 15025: Impact of Type of Transcatheter Heart Valve and Anatomic Features on Complexity of Percutaneous Coronary Intervention in Patients After Transcatheter Aortic Valve Replacement

Introduction: Approximately half of the patients with severe aortic valve stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) present with concomitant coronary artery disease (CAD). Percutaneous coronary intervention (PCI) after TAVR is gaining increasing importance. Consequently, we investigated the factors that influence PCI procedures in patients following TAVR. Methods: We included consecutive 633 patients with severe aortic stenosis who underwent TAVR at our institution from 2016-2022. The primary endpoint was the time from puncture to initial coronary angiography. Results: The median age was 84 (81 - 87) years old, 39% were male, and 173 (27.3%) had concomitant coronary artery disease. Of these, 39 (22.2%) were treated conservatively, 22 (12.5%) underwent coronary artery bypass and TAVR, 64 (36.5%) underwent PCI before TAVR, and 46 (26.2%) underwent PCI after TAVR. The success rate of PCI after TAVR was 100% for both types of valves. The median initial angiography time from puncture was 16.2 minutes (10.6 - 29.1), significantly longer in the Self-expandable valve (SEV) group [22.0 minutes (14.1 - 59.2)] compared to the Balloon-expandable (BEV) group [14.9 minutes (8.1 - 21.1)] (p = 0.026). PCI to the right coronary artery [29.0 min (17.2 - 49.5)] took significantly longer than PCI to the left coronary artery [14.0 min (8.0 - 18.1)] (p = 0.001). Conversely, there was no significant association with CT measurements such as aortic angle, annulus area, coronary height, or valve size, and transcatheter heart valve size (p &gt; 0.05). Factors that predicted difficulty in engaging coronary arteries (&gt;30 min from puncture to first contrast) were SEV [odds ratio 6.4, 95% confidence interval (1.2 - 38.2), p = 0.024], RCA [odds ratio 6.0, 95% confidence interval (1.3 - 33.4), p = 0.020]. Conclusions: Despite the high completion rate of PCI after TAVR, the use of SEV and the approach to the right coronary artery can pose challenges.

Ongoing Experience With Patient-Specific Computer Simulation of Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve

BackgroundTranscatheter aortic valve replacement (TAVR) is increasingly being used to treat younger, lower-risk patients with bicuspid aortic valve (BAV). Patient-specific computer simulation may identify patients at risk for developing paravalvular regurgitation (PVR) and major conduction disturbance. Only limited prospective experience of this technology exist. We wished to describe our ongoing experience with patient-specific computer simulation. MethodsPatients who were referred for consideration of TAVR with a self-expanding transcatheter heart valve (THV) and had BAV identified on pre-procedural cardiac computed tomography imaging underwent patient-specific computer simulation. The computer simulations were reviewed by the Heart Team and used to guide surgical or transcatheter treatment approaches and to aid in THV sizing and positioning. Clinical outcomes were recorded. ResultsBetween May 2019 and May 2021, 16 patients with BAV were referred for consideration of TAVR with a self-expanding THV. Sievers Type 1 morphology was present in 15 patients and Type 0 in the remaining patient. Two patients were predicted to develop moderate-to-severe PVR with a TAVR procedure and these patients underwent successful surgical aortic valve replacement. In the remaining 14 patients, computer simulation was used to optimize THV sizing and positioning to minimise PVR and conduction disturbance. One patient with a low valve implantation depth developed moderate PVR and this complication was correctly predicted by the computer simulations. No patient required insertion of a new permanent pacemaker. ConclusionPatient-specific computer simulation may be used to guide the most appropriate treatment modality for patients with BAV. The usage of computer simulation to guide THV sizing and positioning was associated with favourable clinical outcomes.

Abstract 12383: Large Field-of-View Intravascular Ultrasound for Peri-Procedural Assessment of Stent Frame Expansion After Transcatheter Heart Valve-in-Valve

Introduction. It is unknown whether large field-of-view intravascular ultrasound (IVUS) can be a valid peri-procedural imaging tool to assess actual expansion of transcatheter heart valve (THV) during valve-in-valve procedures. Hypothesis. To compare % expansion of SAPIEN 3 THV measured with peri-procedural IVUS versus post-procedural cardiac gated contrast multi-slice computer tomography (MSCT). Expansion was defined as actual outer frame area/nominal area x 100%. Methods. Studied were patients with successful valve-in-valve for failed surgical mitral and tricuspid bioprosthetic valves. All underwent peri-procedural IVUS using 10MHz Vision PV035 (Philips North America Corporation, Andover, USA) and post-procedural MSCT (SOMATOM Definition Flash, Dual Source, SIEMENS). IVUS and MSCT (Syngo Via, Siemens, Germany) measurements were off -line and done at 1-mm step along the entire height of SAPIEN 3 THV (height 18, 20 and 22 mm for the Sapien THV 23, 26 and 29 mm, respectively). Results. Five patients (68.8±11.2 years, 3 female) were treated for failed surgical mitral (n=3) and tricuspid (2) bioprosthetic valves using SAPIEN 3 THV size 23mm (n=1), 26mm (n=1), and 29mm (n=3). Mean peri-procedural and pre-discharge residual transvalvular gradient differed substantially (1.9±0.9 vs 7.9±1.1mmHg, p=0.001). In total, 104 corresponding cross-sections of the THVs were measured with both IVUS and MSCT. Actual outer-frame SAPIEN 3 expansion was smaller within the lengths of inflow and mid segment (overlapping the ring) than in the outflow, being substantially smaller than nominal (Fig 1). Overall, there was very good agreement between % expansion of THV stent frame assessed in IVUS and MSCT (93.5%±13.3% vs 96.3%±11.3%; r =0.976 and p&lt;0.001). Conclusions. Peri-procedural use of large field-of-view IVUS offers an accurate insight into actual THV expansion deployed valve-in-valve. Figure 1. % expansion of SAPIEN 3 measured in IVUS and MSCT.

The Manchester experience – a novel technique for supra-annular placement of the Edwards SAPIEN 3 Ultra TVH prosthesis in severe bicuspid aortic valve stenosis

Abstract Background Bicuspid AV disease has been excluded from the seminal trials evaluating transcatheter heart valve (THV) placement in severe aortic stenosis. Although registry data has shown good results overall, case selection likely involves more challenging anatomical subsets being treated either surgically or medically in this very heterogenous condition. Conventional annular placement, as well as high annular placement in tapered anatomies remain the commonest deployment techniques. We reasoned that marked supra-annular placement with the mid-portion of the SAPIEN 3 Ultra (S3U) valve sealing skirt placed at the narrowest opening point at commissural level could be an alternative strategy allowing treatment of additional patient groups. This proposed technique takes advantage of elliptical expansion at commissural level with more circular expansion above and below this point to prevent embolisation, as well as sealing skirt positioning at the narrowest opening point to prevent paravalvular leak. Aims We examined the feasibility of marked supra-annular placement of the balloon-expandable S3U prosthesis with the mid-point of the sealing skirt placed at commissural level in patients with severe bicuspid aortic valve stenosis and relative contra-indications to annular placement. Methods We assessed patients with severe bicuspid aortic stenosis undergoing TAVI at our centre over a 9-month period and identified those with relative contra-indications to conventional annular placement. These included: (i) excessive annular size (ii) severe leaflet and raphe calcification with risk of rupture into the right ventricle (iii) excessive leaflet length with potential leaflet overhang. CT imaging was used to define the narrowest opening location at commissural level, typically 10–15mm supra-annular. The diameter at this level was used to select THV size. Calculations were made to approximate the mid skirt level to this supra-annular position. In most cases this involved supra-annular positioning with the lower THV border 5–8mm supra-annular. This was achieved in most cases by aligning the unexpanded border with the annulus. Results Out of 9 patients with biscupid AV, 4 had relative contra-indications for annular placement. In all 4 cases, excellent valvular expansion with only minimal paravaulvar leak was achieved with placement of the S3U prosthesis at 5–7mm above the annulus and with supra-annular sealing at commissural level. Annular dimensions of 35.5mm and 31.5mm were successfully treated with 29mm and 26mm valves due to significant tapering at commissural level in 2 patients. There were no procedural complications, incidences of AV blocks or valve embolisation. Conclusion As a proof of concept, we have demonstrated excellent outcomes with marked supra-annular TAVI placement in patients with severe bicuspid AV stenosis and anatomy unfavourable for conventional annular placement. This is the first description of this completely novel deployment technique. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Manchester Royal Infirmary

Coronary Access Following Redo TAVR: Impact of THV Design, Implant Technique, and Cell Misalignment.

The implications and potential challenges of coronary access after redo transcatheter aortic valve replacement (TAVR) are unknown. The authors sought to evaluate the impact of different transcatheter heart valve (THV) designs, neoskirt height, implant technique, and cell misalignment on coronary access after redo TAVR. Different THV designs (Sapien 3 [Edwards Lifesciences LLC], Evolut Pro [Medtronic], ACURATE neo [Boston Scientific Corporation], and Portico [Abbott Structural Heart]) and sizes were implanted inside Sapien XT (Edwards Lifesciences LLC) and Evolut R (Medtronic) THVs, which were modeled as the "failed" THVs, at different implant depths. Valve combinations underwent micro-computed tomography to determine the neoskirt height and dimensions of the lowest accessible cell for potential coronary access. This was compared with dimensions of 6-F/7-F/8-F coronary guiding catheters. Redo TAVR combinations resulted in a wide range of neoskirt heights (15.4-31.6mm) and a variable diameter of the lowest accessible cell (1.9-21.8mm). An ACURATE neo implanted in a Sapien XT resulted in the largest accessible cells, whereas a Portico implanted in a Sapien XT resulted in the lowest neoskirt heights. The smallest accessible cell was observed in the Evolut Pro-in-Evolut R configuration with higher neoskirt heights. Redo TAVR in a tall frame valve with supra-annular leaflets caused a taller neoskirt height. In Evolut-in-Evolut combinations, misalignment of the cells of the 2 THVs reduced the cell area by 30% to 50% compared with an aligned configuration. This study demonstrates that different redo TAVR combinations are not equivalent in terms of future coronary access. Redo TAVR using a tall frame valve in a failed tall frame valve and misaligned cells may lead to potentially challenging coronary access.

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.

Orifice Areas of Balloon-Expandable Transcatheter Heart Valves: A Three-Dimensional Transesophageal Echocardiographic Study

Accurate expected effective orifice area (EOA) values for balloon-expandable (BE) transcatheter heart valves (THV) are crucial for preventing patient-prosthesis mismatch (PPM) and assessment of THV function. Currently published reference EOAs, however, are based on transthoracic echocardiography (TTE), which may be subject to left ventricular outflow tract diameter underestimation and/or suboptimal THV Doppler interrogation. The objective of this study was to establish reference EOA values for BE THVs on the basis of Doppler and three-dimensional (3D) transesophageal echocardiography (TEE). Two hundred twelve intraprocedural transesophageal echocardiographic examinations performed during BE THV implantation with optimal postimplantation Doppler and 3D imaging were retrospectively reviewed. Continuity equation-derived EOAs were compared with geometric orifice areas by 3D planimetry (GOA3D). Performance indices (i.e., EOA normalized to valve size) and PPM rates were determined. TTE-based EOAs obtained within 30days were also calculated in a subset of 170 patients. The average EOA for all BE THV valves (77% SAPIEN 3) was 2.3±0.5cm2, while the average EOA was 1.6±0.2cm2 for 20-mm, 2.0±0.2cm2, for 23-mm, 2.5±0.3cm2 for 26-mm, and 3.0±0.3cm2 for 29-mm THV size (P<.001). Bland-Altman analysis demonstrated very good agreement between EOA and GOA3D (bias -0.04±0.15cm2). There were strong correlations between annular area and TEE-based EOA (R=0.84) and GOA3D (R=0.87). The mean performance index was 47±5% and was similar for all THV sizes (P=.21). EOAs based on TTE were smaller compared with those based on TEE, while the correlation with annular area (R=0.67) and agreement with GOA3D (bias -0.26±0.43cm2) was not as strong. The overall PPM rate was 2% in the TEE cohort and 12% in the TTE cohort. EOAs for BE THVs based on intraprocedural Doppler and 3D TEE suggest that previously published TTE-based reference values for EOA are underestimated, while PPM rates may be overestimated. Our findings have important clinical implications for preimplantation decision-making and for the evaluation of THV hemodynamics and function during follow-up.

Impact of sigmoid septum on periprocedural outcomes following transcatheter aortic valve implantation using current-generation valves.

The role of sigmoid septum (SS) observed using preprocedural transthoracic echocardiography (TTE) in patients undergoing transcatheter aortic valve implantation (TAVI) remains unknown. This study aimed to compare clinical outcomes of TAVI using the current-generation transcatheter heart valves in patients with and without SS. We divided 140 consecutive patients, excluding four patients who underwent pacemaker implantation before TAVI, into two groups (those with and without SS) and compared the periprocedural outcomes, including new pacemaker implantation, within 30days post-TAVI. Thirty-five patients (25%; 32 female patients) had SS before TAVI. The body surface area and aortic annulus area measured using computed tomography were significantly smaller in patients with SS than in those without SS (1.40 m2 vs. 1.48 m2, P = 0.03; and 372 mm2 vs. 409 mm2, P < 0.01; respectively). Device success was achieved in all patients with SS. Postprocedural TTE on 30days post-TAVI showed no significant differences in the valvular hemodynamics between patients with and without SS. No severe prosthesis-patient mismatch was noted on TTE, although the transcatheter heart valve size tended to be smaller in patients with SS. Within 30days of the TAVI, three (8.6%) and eight (7.6%) patients with and without SS, respectively, had new pacemaker implantation (P = 0.86). The presence of SS was not associated with periprocedural outcomes following TAVI in patients without pre-existing pacemakers. No specific assessment or treatment strategy is required for the TAVI in patients with SS using the current-generation devices.

Patient-Specific Computer Simulation to Optimize Transcatheter Heart Valve Sizing and Positioning in Bicuspid Aortic Valve

ABSTRACT Background Outcomes of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) might be improved through better transcatheter heart valve (THV) sizing and positioning. Patient-specific computer simulation may be used to identify an optimal THV size and implant depth that minimizes paravalvular regurgitation. We sought to examine whether the usage of optimal THV sizing and positioning would be associated with improved clinical outcomes. Methods A multi-center retrospective study was performed on patients who had undergone TAVR in BAV. Finite element models of the aortic root were created and then finite element analysis was performed using different THV sizes and implant depths. Computational fluid dynamics was undertaken. Patients were classified as having optimal THV sizing and positioning if the predicted paravalvular regurgitation of the computer simulation corresponding to the implanted THV size and implant depth was within 5 mL/sec of the best possible computer simulation, and non-optimal if not. Clinical outcomes were compared between the two patient groups. Results A total of 50 patients were included in the study. Paravalvular regurgitation severity was higher in patients where non-optimal THV sizing and positioning was used (P < 0.001). At 2 years, the Kaplan-Meier estimate of the rate of death from any cause was higher in the group where non-optimal THV sizing and positioning was used (34.5% vs. 9.1%; hazard ratio, 6.23; 95% confidence interval, 1.04 to 37.44; P = 0.02 by log-rank test). Conclusion Computer simulation suggests that the usage of optimal THV sizing and positioning might improve clinical outcomes of TAVR in BAV. Abbreviations: AUC: area under the receiver operating characteristic curve; BAV: bicuspid aortic valve; BAVi: bicuspid aortic valve imaging; CI: confidence interval; CPI: contact pressure index; CT: computed tomography; TAVR: transcatheter aortic valve replacement; THV: transcatheter heart valve

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.

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

Correlation between fluoroscopy and tomographic aortic-root measurements in the decision of the transcatheter heart valve size in patients undergoing transcatheter aortic valve implantation

Abstract Introduction and hypothesis Transcatheter aortic valve implantation (TAVI) has become the standard treatment in intermediate and high-risk patients with high degree aortic stenosis (AS).(1–2) These has been also extended to low-risk and younger patients.(3–5) Besides the use of computed-tomography (CT) as diagnostic method to measure the aortic anatomy for transcatheter heart valve (THV) size decision and the radiation exposure (RE) during TAVI, younger patients are more exposed to radiation and contrast media (CM) complications due to a potentially second procedure.(6) Reducing RE and CM using only angiography aortic measurement could reduce the risk of RE and CM related complications without compromising the efficacy of the THV. We hypothesize that angiographic aortic root (AR) measure has good correlation with CT measure without compromising safety and efficacy of the THV. Methods Observational analysis: 1250 transfemoral TAVI patients with balloon or self-expandable valves were included. Aortic root CT measurement was done in all patients. AR measurement using Follow the right cup rule (7) was additionally done in 505 patients. Correlation between CT only (Group I n=745) versus CT and AR measurement (Group II n=505) was done. An inter and intraobserver validation analysis was done. Primary endpoint was VARC-2 device success. Secondary safety endpoints were composite of in-hospital and 30-days complications. Results Really good intra (0.86, p&amp;lt;0.001) and interobserver (0.81, p&amp;lt;0.001) correlation between CT (mean aortic diameter, distance between non (NC-HP) and left cusp hinge points (LC-HP) distance) and angiographic (LC-HP distance) measurements was observed. CT and AR measurement had a very good correlation between the two groups (CT mean aortic diameter vs CT NC-HP and LC-HP distance, 0.724 p&amp;lt;0.001; CT NC-HP and LC-HP distance vs angiographic NC-HP and LC-HP distance manual calibration 0.808 p&amp;lt;0.001; angiographic NC-HP and LC-HP distance manual calibration vs angiographic NC-HP and LC-HP distance automatic calibration 0.930 p&amp;lt;0.001). No differences in primary endpoint were observed between groups (device success Group I 98% vs Group II 99%, p 0.18). In-hospital complications were similar between two groups except in major bleeding (13% vs 19%, p 0.004), major vascular (10.9% vs 16.6%, p 0.004) and minor vascular (14% vs 21%, p 0.001) between group I and II respectively. Valve safety (86% vs 77%, p&amp;lt;0.001, OR 0.89, 95% CI 0.85–0.95) and clinical efficacy (84% vs 60.8%, p&amp;lt;0.001, OR 0.72, 95% CI 0.67–0.77) at 30 days were more common in group II. No difference in valve dysfunction was observed (Group I 10.3% vs Group II 7.3%, p 0.042, OR 1.41, 95% CI 0.97–2.05). Conclusions Compared to CT, AR measurement is a good option selecting THV size. No differences regarding device success and in-hospital and 30 days follow-up complications were observed. AR measurement could replace CT in specific cases. Funding Acknowledgement Type of funding sources: None. Angiographic and CT measurementsEndpoints

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.

Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis: A Practical Operative Overview.

The bicuspid aortic valve (BAV) represents a complex anatomic scenario for transcatheter aortic valve replacement (TAVR) because of its unique technical challenges. As TAVR is moving towards younger and lower-risk populations, the proportion of BAV patients undergoing TAVR is expected to rise. Initial experiences of TAVR with first-generation transcatheter heart valves in high surgical risk patients with BAV stenosis showed higher rates of device failure and periprocedural complications as compared to tricuspid anatomy. The subsequent advances in imaging techniques and understanding of BAV anatomy, new iterations of transcatheter heart valves, and growing operators' experience yielded better outcomes. However, in the lack of randomized trials and rigorous evidence, the field of TAVR in BAV has been driven by empirical observations, with wide variability in transcatheter heart valve sizing and implantation techniques across different centers and operators. Thus, in this review article, we provide a fully illustrated overview of operative periprocedural steps for TAVR in BAV stenosis, though recognizing that it still remains anecdotal.

Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement: VIVID Registry

BackgroundPermanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). ObjectivesThe goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. MethodsData were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. ResultsA total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). ConclusionsIn a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.