Evolut PRO Research Articles

Current and future transcatheter aortic valve replacement valves.

This review analyzes currently available commercial transcatheter aortic valve replacement (TAVR) valves as well as valves in investigational status and those in preclinical testing. The design features and clinical outcomes of the Edwards SAPIEN S3 and Medtronic Evolut PRO+ are described and compared with highlight clinical circumstances where one may be favoured over the other. Multiple randomized and nonrandomized trials have compared commercial and investigational TAVR valves. The results of these are summarized and discussed within this review with a focus on how the SAPIEN S3 and Evolut PRO+ both compare to each other as well as various valves in different investigational stages. TAVR is an innovative and ground-breaking technology that will forever have revolutionized the management of aortic stenosis. Though the technology and valves themselves have come a long way, further developments are necessary if we are to continue to expand its indications and achieve a safer perioperative experience with more durable valves.

Paravalvular leakage of transcatheter aortic valve replacements depending on aortic annulus calcification

Abstract Paravalvular leakage (PVL) has a crucial impact on clinical outcomes of transcateheter aortic valve replacements (TAVR), especially the mortality increases dramatically with high-grade PVL. Furthermore, the calcification of the aortic annulus has a decisive influence on the PVL of TAVR. Therefore, we developed a technical model of a calcified aortic annulus and used it for the investigation of PVL in steady-state back-flow conditions. We investigated an Evolut PRO (Medtronic, Minneapolis, MN, USA), implanted the TAVR at different depths in the aortic annulus model ranging between 0 mm and -6 mm and characterized PVL in steady-state retrograde flow from 0 mmHg up to a maximum achievable pressure. The used test bench and detailed test method was described in previous studies. The aortic annulus model exhibits three elevations symmetrically distributed around the circumference. Depending on the degree of calcification the elevations reached 1 mm to 3 mm into the lumen. For the Evolut PRO bioprosthesis, a decreasing PVL was measured with increasing implantation depth. At an implantation depth of 0 mm (inflow of TAVR and annulus model at same height) maximum PVL was measured. Minimum PVL was measured at a height of -6 mm. Furthermore, even a small calcification of 1 mm led to a large increase in PVL. This trend continued with increasing height of the calcification. The maximum regurgitation of (2,025.21 ± 12.47) ml (n = 3 measurements) was measured at a pressure of 6 mmHg in the annulus model with 3 mm calcification. A test method to quantify PVL depending on annular calcification was successfully developed. Additionally, the influence of implantation depth on PVL was characterized. Due to the technical operating principle of the test bench, only a limited increase in pressure was possible when large PVL occurred. In this respect, the test bench must be optimized in the future.

Redo‐transcatheter aortic valve replacement with the supra‐annular, self‐expandable Evolut platform: Insights from the Transcatheter valve Therapy Registry

AbstractObjectivesTo assess the safety profile of redo‐TAVR procedures from patients in the transcatheter valve therapy (TVT) Registry.BackgroundThe use of transcatheter aortic valves (TAV) to treat previously implanted failing TAVS (TAV‐in‐TAV) has been an increasingly important topic as indications for TAVR move to younger and lower‐risk patients, but data on the safety and efficacy of redo‐TAVR is limited.MethodsPatients undergoing redo‐TAVR procedures using the Evolut R, Evolut PRO or Evolut PRO+ valve in the TVT Registry between April 2015 and March 2020 were included. In‐hospital, 30‐day and 1‐year outcomes were analyzed.ResultsRedo‐TAVR was performed in 292 patients (213 patients received the Evolut R valve and 79 received the Evolut PRO or PRO+ valve). Device success was achieved in 94.5%. In‐hospital mortality was 2.1%, stroke occurred in 2.7%, and 77.2% of patients were discharged home. There were no cases of coronary compression/obstruction or myocardial infarction that occurred in index hospitalization. Mean gradient at 30‐days was 11.9 ± 6.9 mmHg, and 73.1% had none/trace total aortic regurgitation.ConclusionsResults from the TVT Registry demonstrate good short‐term outcomes after redo‐TAVR with the supra‐annular, self‐expandable Evolut platform. Long‐term follow‐up is necessary to further expand understanding this complex scenario.

Transcatheter Aortic Valve Replacement With Self-Expandable Supra-Annular Valves for Degenerated Surgical Bioprostheses: Insights From Transcatheter Valve Therapy Registry.

BackgroundTranscatheter aortic valve replacement with supra‐annular transcatheter heart valves has been adopted in patients with degenerated surgical aortic valves. The next generation self‐expanding Evolut PRO valve has not been evaluated in patients with surgical valve failure.Methods and ResultsPatients undergoing transcatheter aortic valve replacement in degenerated surgical aortic valve procedures using the Evolut R or Evolut PRO transcatheter heart valves in the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry between April 2015 and June 2019 were evaluated. Transcatheter valve performance was evaluated by clinical site echocardiography. In‐hospital, 30‐day, and 1‐year clinical outcomes were based on the Society of Thoracic Surgeons‐American College of Cardiology‐Transcatheter Valve Therapy registry definitions. Transcatheter aortic valve replacement in degenerated surgical aortic valve was performed in 5897 patients (5061 [85.8%] patients received the Evolut R valve and 836 [14.2%] received the Evolut PRO valve). Thirty‐day transcatheter heart valves hemodynamic performance was excellent in both groups (mean gradient: Evolut PRO: 13.8±7.5 mm Hg; Evolut R: 14.5±8.1 mm Hg), while paravalvular regurgitation was significantly different between valve types (P=0.02). Clinical events were low at 30 days (Evolut PRO: for the all‐cause mortality, 2.8%, any stroke was 1.8%, new pacemaker implantation, 3.0%: Evolut R:all‐cause mortality, 2.5%, any stroke was 2.2%, new pacemaker implantation, 5.3%) and 1 year (Evolut PRO: all‐cause mortality, 9.2%; any stroke, 3.1%; Evolut R: all‐cause mortality, 9.8%; any stroke, 2.9%).ConclusionsTranscatheter aortic valve replacement in degenerated surgical aortic valve with self‐expandable supra‐annular transcatheter heart valves is associated with excellent clinical outcomes and valve hemodynamics. Additional reductions in residual paravalvular regurgitation were obtained with the next generation Evolut PRO.

Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement

BackgroundNo study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self‐expanding valves.Methods and ResultsThis study included a real‐world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1‐year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1‐year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05).ConclusionsRepositioning a self‐expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1‐year mortality, regardless of the type of valve implanted.

A successful transcatheter aortic valve implantation in an extremely tortuous S-shaped aorta due to chest deformation.

A 65-year-old woman was admitted to the hospital for interventional treatment of aortic stenosis. Echocardiography confirmed severe aortic stenosis and a normal left ventricular ejection fraction (60%). Computed tomography demonstrated an extremely tortuous, S-shaped descending aorta and a significant scoliosis with chest wall deformation (Figs. 1A, B). Considering the complex anatomy, the Heart Team qualified the patient for transcatheter aortic valve implantation (TAVI), despite the low peri-operative risk (1.54% in the EuroScore II). Transcatheter aortic valve implantation was performed in a standard manner, under local anesthesia, from the right femoral artery. Once the Confida Brecker Curve guidewire was placed in the aortic arch, the valve was predilated with 20 mm balloon. A 26 mm Evolut PRO valve (Medtronic Inc., Minneapolis, Minnesota) was slowly advanced into the aorta, which was techni cally challenging (Fig. 1C, Suppl. Video 1). The valve was correctly aligned and deployed under rapid pacing (120/min). Aortogram at the end of the procedure showed no evidence of aortic injury or paravalvular leak (Fig. 1D). Procedural success was confirmed by control transthoracic echocardiography. The indications for transfemoral TAVI are expanding. The final decision considering the type of procedure should be made by the Heart Team, based on an individual’s evaluation. Despite the low risk of mortality following surgery, the patient suffered from the extreme chest wall deformation which made successful sternotomy and latter rehabilitation improbable. Given the flexibility of second generation TAVI delivery systems, it is possible to safely perform the procedure even in a severely tortuous anatomy, which was initially considered a contraindication for TAVI.

Towards patient-specific prediction of conduction abnormalities induced by transcatheter aortic valve implantation: a combined mechanistic modelling and machine learning approach.

Post-procedure conduction abnormalities (CA) remain a common complication of transcatheter aortic valve implantation (TAVI), highlighting the need for personalized prediction models. We used machine learning (ML), integrating statistical and mechanistic modelling to provide a patient-specific estimation of the probability of developing CA after TAVI. The cohort consisted of 151 patients with normal conduction and no pacemaker at baseline who underwent TAVI in nine European centres. Devices included CoreValve, Evolut R, Evolut PRO, and Lotus. Preoperative multi-slice computed tomography was performed. Virtual valve implantation with patient-specific computer modelling and simulation (CM&S) allowed calculation of valve-induced contact pressure on the anatomy. The primary composite outcome was new onset left or right bundle branch block or permanent pacemaker implantation (PPI) before discharge. A supervised ML approach was applied with eight models predicting CA based on anatomical, procedural and mechanistic data. CA occurred in 59% of patients (n = 89), more often after mechanical than first or second generation self-expanding valves (68% vs. 60% vs. 41%). CM&S revealed significantly higher contact pressure and contact pressure index in patients with CA. The best model achieved 83% accuracy (area under the curve 0.84) and sensitivity, specificity, positive predictive value, negative predictive value, and F1-score of 100%, 62%, 76%, 100%, and 82%. ML, integrating statistical and mechanistic modelling, achieved an accurate prediction of CA after TAVI. This study demonstrates the potential of a synergetic approach for personalizing procedure planning, allowing selection of the optimal device and implantation strategy, avoiding new CA and/or PPI.

Quantitative Angiographic Assessment of Aortic Regurgitation After Transcatheter Implantation of the Venus A-valve: Comparison with Other Self-Expanding Valves and Impact of a Learning Curve in a Single Chinese Center.

Objectives:We aimed to compare the quantitative angiographic aortic regurgitation (AR) into the left ventricular out flow tract (LVOT-AR) of five different types of transcatheter self-expanding valves and to investigate the impact of the learning curve on post-TAVR AR.Background:Quantitative video densitometric aortography is an objective, accurate, and reproducible tool for assessment of AR following TAVR.Methods and results:This retrospective academic core-lab analysis, analyzed 1150 consecutive cine aortograms performed immediately post-TAVR. Quantitative angiographic AR of post-procedural aortography in 181 consecutive patients, who underwent TAVR with the Venus A-valve in a single Chinese center, were compared to the results of Evolut Pro, Evolut R, CoreValve, (Medtronic, Dublin, Ireland) and Acurate Neo (Boston Scientific, Massachusetts, US) transcatheter heart valves (THVs), from a previously published pooled database. Among the 181 aortograms of patients treated with the Venus A-Valve, 113 (62.4%) were analyzable for quantitative assessment of AR. The mean LVOT-AR was 8.9% ± 10.0% with 14.2% of patients having moderate or severe AR in the Venus A-valve group. No significant difference in mean LVOT-AR was observed between Evolut Pro, Evolut R, Acurate Neo, and Venus A-valve. The incidence of LVOT-AR >17%, which correlates with echocardiographic derived ≥ moderate AR, with the Evolut Pro was lower than with the Venus A-valve (5.3% vs. 14.2%, p = 0.034), but was not different from the Evolut R (5.3% vs. 8.8%, p = 0.612), or the Acurate Neo (5.3% vs. 11.3% p = 0.16) systems. A landmark analysis after recruitment of the first half of patients treated with the Venus A valve (N = 56), showed a significantly lower mean LVOT-AR in the second half of the series (11.3% ± 11.9% vs. 6.5% ± 7.1%, p = 0.011). The incidence of LVOT-AR >17% in the latest 57 cases was also numerically lower (7.0% vs. 21.4%, p = 0.857) and compared favorably with the best in class of the self-expanding valves.ConclusionThe Venus A-valve has comparable mean LVOT-AR to other self-expanding valves but has a higher rate of moderate or severe AR than the Evolut Pro THV. However, after completion of a learning phase, results improved and compared favorably with the best in class of the commercially available self-expanding valves. These findings should be confirmed in prospective randomized comparisons of AR between different THVs.

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.

The Impact of Aortic Angulation on Contemporary Transcatheter Aortic Valve Replacement Outcomes.

The aim of this study was to investigate whether the degree of aortic angulation (AA) affects outcomes after transcatheter aortic valve replacement (TAVR) using newer-generation transcatheter heart valves (THVs). AA≥48° has been reported to adversely influence accurate THV deployment, procedural success, fluoroscopy time, and paravalvular leak (PVL) in patients undergoing TAVR with early generation self-expanding (SE) THVs. A retrospective observational study was conducted among 841 patients across all risk strata who underwent transfemoral TAVR using the balloon-expandable (BE) SAPIEN 3 or the SE CoreValve Evolut PRO from 2015 to 2020. The previously published cutoff of 48° was used to analyze procedural success and in-hospital outcomes according to THV type. Receiver-operating characteristic analysis was performed to investigate the impact of AA on an in-hospital composite outcome (need for >1 THV, more than mild PVL, new permanent pacemaker implantation, stroke, and death). AA≥48° did not influence outcomes in patients with BE THVs. Additionally, AA≥48° did not influence procedural success (99.1% vs. 99.1%; p=0.980), number of THVs used (1.02 vs. 1.04; p=0.484), rates of more than mild PVL (0.4% vs. 0%; p=0.486), new permanent pacemaker implantation (11.8% vs. 17.1%; p=0.178), in-hospital stroke (3.9% vs. 1.8%; p=0.298), or in-hospital death (0.4% vs. 0.9%; p=0.980) in patients with SE THVs. Receiver-operating characteristic analysis demonstrated similar outcomes irrespective of AA, with areas under the curve of 0.5525 for SE THVs and 0.5115 for BE THVs. AA no longer plays a role with new-generation BE or SE THVs in contemporary TAVR practice. AA≥48° did not affect procedural success or in-hospital outcomes and should no longer be a consideration when determining THV selection.

Conduction disturbances after TAVR - a 1-year follow-up

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Transcatheter aortic valve replacement (TAVR) is an established procedure to treat patients (pts) with symptomatic severe aortic stenosis. Although conduction disturbances remain the most frequent complication, there is a lack of consensus on their management, which leads to significant differences in permanent pacemaker (PPM) implantation rates between centers. Purpose To evaluate new conduction disturbances and PPM implantation in pts undergoing TAVR, peri-procedure and up to 1 year. Methods We retrospectively analyzed all pts who underwent TAVR at a tertiary center from October 2014 to November 2019; pts with a previous PPM were excluded (n = 30). Clinical and ECG data were collected at presentation and up to 1 year after implantation, including systematic interrogation of implanted PPM. Results 340 pts underwent TAVR (57% female, mean age 80 ± 8years). CoreValve Evolut R was the most used valve (41% of pts), followed by CoreValve Evolut Pro (21%) and Acurate Neo (13%). Of the 77% pts who were in sinus rhythm pre-TAVR, 79% had normal atrioventricular (AV) conduction and 20% 1st degree AV block (AVB); 60% had no intraventricular (IV) conduction disturbance, 9% left bundle branch block (LBBB), 7% right bundle branch block (RBBB) and 7% RBBB plus fascicular block. After TAVR, 50.9% of pts exhibited new conduction disturbances. Regarding AV conduction, 12.4% of pts developed advanced AVB and 20% of pts without previous disturbances developed 1st degree AVB. Concerning IV conduction, the most frequent disturbance was de novo LBBB (n = 109, 32,2%) which resolved in 56% of cases after 6 months. Among pts with previous RBBB, 42% developed advanced AVB; the presence of previous RBBB was the major risk factor for advanced AVB [OR = 8.5 (95% CI 4.1-17.5; p &amp;lt; 0.001)] and PPM implantation [OR = 5.2 (95% CI 2.7-10.0; p &amp;lt; 0.001)], followed by previous 1st degree AVB [OR = 2.3 (95% CI 1.2-4.4; p = 0.016) for PPM implantation]; previous FA or LBBB were not associated with advanced AVB or PPM implantation. Overall, 19% of pts implanted a PPM post-TAVR (n = 63). The main reason was advanced AVB (60%), followed by LBBB plus 1st degree AVB (22%), isolated LBBB (5%) and alternating bundle branch block (ABBB) (5%). At first PPM evaluation, pts with advanced AVB had a median percentage of ventricular pacing (VP) of 80% (52% had VP &amp;gt;90% and 14% &amp;lt;1%) and one year after-TAVR the median percentage of VP was 83%. Concerning pts with LBBB plus 1st degree AVB, median VP at first assessment was 4% (38% had &amp;lt; 1% of VP). In pts with isolated LBBB or ABBB, median VP at first evaluation was 13% and 11%, respectively. Conclusion LBBB was the most frequent de novo conduction disturbance after TAVR, with more than half of the cases resolving in the first 6 months. RBBB, on the other hand, was the major risk factor for advanced AVB and PPM implantation. Advanced AVB was associated with a high percentage of VP at 1-year follow-up, unlike pts with milder degrees of conduction delay.

Clinical consequences of consecutive self-expanding transcatheter heart valve iterations.

ObjectiveTo compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs).MethodsClinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database.ResultsTAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31–5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98–6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed.ConclusionsTAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology.Supplementary InformationThe online version of this article (10.1007/s12471-021-01568-5) contains supplementary material, which is available to authorized users.

Impact of Baseline and Newly Acquired Conduction Disorders on Need for Permanent Pacemakers With 3 Consecutive Generations of Self-Expanding Transcatheter Aortic Heart Valves

IntroductionWe aimed to compare conduction dynamics and need for permanent pacemaker implantation (PPI) after CoreValve, Evolut R and PRO (transcatheter aortic valve replacement (TAVR)). MethodsPatients were stratified based on conduction at baseline; Cohort A had normal conduction, Cohort B had conduction abnormalities including atrioventricular (AV)-block, fascicular block or complete bundle branch block. Three different dynamic QRS-patterns were defined: stable QRS-duration, transient QRS-prolongation and persistent QRS-prolongation. We performed multivariable regression analysis to estimate the effect of the three separate transcatheter heart valves (THV's) on need for PPI at 30 days. ResultsTAVR was performed with CoreValve (N = 113), Evolut R (N = 157) or Evolut PRO (N = 92). Conduction dynamics were similar between the different THVs. Overall, Evolut R and PRO showed a tendency towards less PPI compared to CoreValve (17% vs. 19% vs. 27%, P = 0.08), which was driven by a lower PPI rate in Cohort A (6% vs. 11% vs. 25%, P = 0.002). Need for PPI was restricted to patients with persistent QRS-prolongation in Cohort A (26/106) but did not correlate with conduction dynamics in Cohort B. In multivariable logistic regression analysis the use of Evolut R (OR 0.38, 95% CI 0.19–0.78, P = 0.008) and PRO (OR 0.41, 95% CI 0.19–0.91, P-value = 0.028) were independently associated with less need for PPI. ConclusionThe newer generations Evolut R and PRO were associated with less PPI compared to CoreValve. Acquired persistent conduction abnormalities predicted PPI after TAVR only in patients with normal conduction at baseline. Our findings may help identify eligible patients for early discharge after Evolut R/PRO TAVR.

Haemodynamic collapse immediately after transcatheter aortic valve implantation due to dynamic intraventricular gradient: a case report and review of the literature.

BackgroundDynamic intraventricular obstruction after transcatheter aortic valve implantation (TAVI) has been previously reported. There is a risk of haemodynamic collapse in the case of left ventricular outflow tract (LVOT) obstruction due to systolic anterior motion (SAM) of the mitral valve.Case summaryAn 83-year-old woman with aortic stenosis (AS) was referred to our hospital for TAVI. Transthoracic echocardiography revealed a severely calcified aortic valve with a peak velocity of 6.3 m/s across the valve. Acceleration of blood flow (peak velocity 2.6 m/s) at the LVOT due to a septal bulge was also seen. Transfemoral TAVI was performed, and a 29 mm Evolut PRO was implanted under general anaesthesia. After the implantation, a complete atrioventricular block with junctional rhythm developed, and refractory hypotension occurred immediately. Transoesophageal echocardiography revealed LVOT obstruction due to SAM of the mitral valve associated with severe mitral regurgitation (MR), which was not observed preoperatively. Fluid infusion and catecholamine administration were not effective. However, after performing temporary pacing from the right ventricular (RV) apex, the LVOT obstruction and severe MR improved. Her haemodynamics stabilized, and we could complete the procedure. A dual-chamber permanent pacemaker with beta-blocker administration as a longer-term treatment further improved the LVOT obstruction. The patient was finally discharged to a rehabilitation hospital.DiscussionAlertness and recognition of potential LVOT obstruction after TAVI are important. Pacing from the RV apex, as well as dual-chamber pacing, comprise a less invasive and feasible therapeutic option in such cases.

Self‐expanding transcatheter aortic valve infolding: Current evidence, diagnosis, and management

Prosthetic valve infolding is a rare but severe complication of transcatheter aortic valve implantation (TAVI) with self-expanding valves. However, currently available clinical data are limited and fragmented. This report aims to provide a comprehensive overview of this complication focusing on predisposing factors, clinical presentation, diagnostic findings, treatment and clinical outcomes. A systematic review of the literature was performed to identify cases of infolding occurring during TAVI with self-expanding valves published until August 2020. These data were pooled with all the retrospectively identified infolding cases occurred at San Raffaele Scientific Institute between December 2014 and August 2020. A total of 34 cases were included. Among patients with available data, 38% received a first-generation CoreValve, and 62% a second-generation Evolut R (82%) or Evolut PRO (18%). Infolding occurred mostly with ≥29-mm valves (94%). Predisposing factors included resheathing of a second-generation valve (82%), heavy calcification of the native valve (65%), lack of predilatation (16%), Sievers type-1 bicuspid aortic valve (11%), and improper valve loading (5%). Infolding resulted in severe PVL causing hemodynamic instability (29%) or cardiac arrest (12%). Postdilatation was the treatment strategy in 68%, while prosthesis replacement with a new device in 23% of cases. Device success rate was 82%. Death and stroke occurred in 3% and 12% of cases. Prosthetic valve infolding is typically observed after resheathing of a large-size self-expanding TAVI. When infolding is timely diagnosed, prosthesis removal and replacement should be pursued. Further studies are required to precisely define predisposing factors to prevent this complication.

Self-Expandable Transcatheter Aortic Valve Frame Infolding: An Increasingly Recognized Complication.

Clinicians should be aware of the rare complication of frame infolding during deployment of a self-expanding transcatheter valve.Multimodality cardiac imaging is important to optimize transcatheter valve deployment.

Optimal Oversizing Index Depending on Valve Type and Leakage-Proof Function for Preventing Paravalvular Leakage after Transcatheter Aortic Valve Implantation.

Paravalvular leak (PVL) is an important complication of transcatheter aortic valve implantation (TAVI) and is associated with poor prognosis. We aimed to identify the risk factors for PVL after TAVI including patient (calcium amount or location), device (leakage-proof or not), and procedural (oversizing index (OI)) factors. The primary outcome was mild or greater PVL at 1-month follow-up echocardiography. Overall, 238 patients who underwent TAVI using eight types of valves (Edwards Sapien, Sapien XT, Sapien 3, CoreValve, Evolut R, Evolut PRO, Lotus, and Lotus Edge) were included. The incidence of significant PVL (≥mild PVL) was 24.4%. Although patient factors (calcification of valve) were not predictors of PVL, valve without leakage-proof function (Edwards Sapien, Sapien XT, and CoreValve) was a significant predictor of PVL (adjusted odds ratio, 3.194, 95% CI, 1.620–6.299). Furthermore, OI has a significant protective role against PVL (PVL increased by 45% when OI decreased by 5%). The best cutoff value of OI to predict the absence of PVL was ≥17.6% for the Evolut system and ≥10.2% for the Sapien system. The predictors of PVL after TAVI included factors from the device (valve without leakage-proof function) and procedure (under-sizing). In patients with a high risk of PVL, the procedure should be optimized using valves with leakage-proof function and adequate OI.

Risk of Coronary Obstruction and Feasibility of Coronary Access After Repeat Transcatheter Aortic Valve Replacement With the Self-Expanding Evolut Valve: A Computed Tomography Simulation Study.

The supra-annular leaflet position and tall stent frame of the self-expanding Evolut PRO or Evolut PRO+ transcatheter heart valves (THVs) may cause coronary occlusion during transcatheter aortic valve replacement (TAVR)-in-TAVR and present challenges for future coronary access. We sought to evaluate the risk of TAVR-in-TAVR with Evolut PRO or Evolut PRO+ THVs and the feasibility of future coronary access. The CoreValve Evolut PRO Prospective Registry (EPROMPT; NCT03423459) prospectively enrolled patients with symptomatic severe aortic stenosis to undergo TAVR using a commercially available latest generation self-expanding THV at 2 centers in the United States. Computed tomography was performed 30 days after TAVR, which we used to simulate TAVR-in-TAVR with a second Evolut PRO or Evolut PRO+ THV and evaluate for risk of coronary obstruction and feasibility of future coronary access. Eighty-one patients enrolled with interpretable computed tomography are reported herein. Computed tomography simulation predicted sinus of Valsalva sequestration and resultant coronary obstruction during future TAVR-in-TAVR in up to 23% of patients. Computed tomography simulation predicted that the position of the pinned THV leaflets would hinder future coronary access in up to 78% of patients after TAVR-in-TAVR. Further THV design improvements and leaflet modification strategies are needed to mitigate the risk of coronary obstruction during TAVR-in-TAVR with self-expanding THVs and to facilitate future coronary access. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03423459.

234 The role of preprocedural assessment of aortic valve calcium volume for the optimization of percutaneous aortic bioprosthesis implantation (TAVI)

Abstract Aims Paravalvular leaks (PVL) and conduction disorders requiring permanent pacemaker implantation (PPI) in patients with severe Aortic Valvular Stenosis (SA) undergoing percutaneous aortic valve prosthesis (TAVI) still have a significant and unacceptable incidence for patients at medium and low surgical risk, who represent, with increasing scientific evidence, the prevalent population. The appearance of these complications seems to be related to clinical, anatomical and procedural factors, which influence the decision-making process of the type and size of bioprosthesis to be implanted. Particular attention has been paid to the role of the volume of calcium present at the native aortic valve (VCA) as a predictor of these complications, in order to optimize the percutaneous procedure. The VCA can be quantified using algorithms derived from Multilayer Computed Computed Axial Tomography (MSCT), an examination that has become a pivotal element in the evaluation of the patient's eligibility for TAVI.The aim of our study was to document the pre-procedural added value of VCA in terms of possible containment of adverse events and how much it may affect the choice of the type of bioprosthesis to be implanted. Methods and results 111 patients underwent TAVIs at the Interventional Cardiology Unit of the AOU S. Giovanni di Dio and Ruggi D'Aragona, between 2017 and 2020, subsequently divided into 2 groups: group A (self-expandable bioprosthesis, Medtronic Evolut R or Evolut Pro) and group B (balloon expandable bioprosthesis, Edward Sapien 3).The clinical, electrocardiographic, echocardiographic and anatomical parameters of the enrolled patients were analyzed, and the VCA in the preprocedural phase was quantified for each of them, using an algorithm extracted from the MSCT reading software, OsiriX (OsiriX-MD v.2.8.2 64-bit). A univariate logistic regression analysis was performed for the risk of developing the composite event of significant PVL and IPP.In Group B, no significant variables were found, while in Group A, the VCA (OR: 1.001; 95% CI, 1.000-1.002; p &amp;lt; 0.043) and incomplete left branch block (OR: 5.781; 95% CI, 0.013-32.988; p &amp;lt; 0.048) were significant. Subsequently, these two variables were tested in a multivariate regression model according to which only the VCA emerged as an independent predictor for the composite event (OR: 1.001; 95% CI, 1.000-1.002; p &amp;lt; 0.039). Conclusion VCA is significantly associated with the risk of moderate to severe PVL and rhythm disturbances requiring PPI, in the group of patients in whom a self-expandable bioprosthesis was implanted, unlike patients who received a balloon-expandable bioprosthesis where this association is not significant.

Numerical models for assessing the risk of leaflet thrombosis post-transcatheter aortic valve-in-valve implantation.

Leaflet thrombosis has been suggested as the reason for the reduced leaflet motion in cases of hypoattenuated leaflet thickening of bioprosthetic aortic valves. This work aimed to estimate the risk of leaflet thrombosis in two post-valve-in-valve (ViV) configurations, using five different numerical approaches. Realistic ViV configurations were calculated by modelling the deployments of the latest version of transcatheter aortic valve devices (Medtronic Evolut PRO, Edwards SAPIEN 3) in the surgical Sorin Mitroflow. Computational fluid dynamics simulations of blood flow followed the dry models. Lagrangian and Eulerian measures of near-wall stagnation were implemented by particle and concentration tracking, respectively, to estimate the thrombogenicity and to predict the risk locations. Most of the numerical approaches indicate a higher leaflet thrombosis risk in the Edwards SAPIEN 3 device because of its intra-annular implantation. The Eulerian approaches estimated high-risk locations in agreement with the wall sheer stress (WSS) separation points. On the other hand, the Lagrangian approaches predicted high-risk locations at the proximal regions of the leaflets matching the low WSS magnitude regions of both transcatheter aortic valve implantation models and reported clinical and experimental data. The proposed methods can help optimizing future designs of transcatheter aortic valves with minimal thrombotic risks.