Transcatheter Heart Valve Research Articles

Predictors of permanent pacemaker implantation after transcatheter aortic valve implantation - Results from the SOLVE-TAVI trial

Abstract Background Permanent pacemaker implantation (PPI) is frequently required following transcatheter aortic valve implantation (TAVI). However, the predisposing parameters increasing the likelihood of severe conduction abnormalities are still not fully understood. Purpose To analyze predictors of PPI 30 days after TAVI. Methods The SOLVE-TAVI trial randomized 447 patients to TAVI using either the balloon-expandable Edwards Sapien 3 valve or the self-expanding Medtronic Evolut R valve. Pacemaker rates at 30 days were relatively high, but comparable between both transcatheter heart valve (THV) types (19% vs. 23%). Computed tomography (CT) scans were analyzed semi-automatically to determine aortic annulus size and subannular calcification. The percentage of THV oversizing was calculated using the formula (nominal THV circumference/annular circumference – 1) x 100). Results From all patients treated with either the Sapien 3 or Evolut R valve, 47 patients were excluded because of prior pacemaker implantation. Rates of new PPI at 30 days were similar in patients with and without pre-existing left bundle branch block (7/36 patients vs. 53/342 patients, p=0.48) and right bundle branch block (11/51 patients vs. 48/327 patients, p=0.22), without significant differences according to valve type. Patients with new PPI showed a significantly higher degree of THV oversizing compared to patients without PPI (median 15%, interquartile range [IQR] 9-20% vs. median 12%, IQR 7-17%; p=0.03). Moderate/severe compared to no/mild subannular calcification did not result in higher PPI rates (17/121 patients vs. 40/245 patients; p=65). Conclusion THV oversizing but not pre-existing left and right bundle branch block and subannular calcification is associated with PPI after TAVI.

Myocardial injury after transcatheter aortic valve replacement according to VARC-3 criteria

Abstract Background Periprocedural myocardial injury (PPMI) is frequent in patients undergoing transcatheter aortic valve replacement (TAVR). PPMI after TAVR as defined by Valve Academic Research Consortium-2 (VARC-2) criteria occurs in >50% of the patients and had inconsistent results regarding prognostic significance. However, recent VARC-3 definition is more specific, having increased the troponin threshold from 15-times to 70-times the upper reference limit (URL) to define PPMI. This recent definition of PPMI following TAVR lacks the clinical validation. Objective To determine the incidence, predictors and clinical impact of PPMI following TAVR as defined by recent VARC-3 criteria. Methods We included 1,394 consecutive patients who underwent TAVR with a new generation transcatheter heart valve in two tertiary centers in Canada and Italy, from 2015 to 2022. Patients undergoing a trans-aortic or a trans-apical approach were excluded. High-sensitivity troponin levels were assessed at baseline and within 24 hours after the procedure. PPMI was defined according to VARC-3 criteria as an increase ≥70 times in troponin levels (vs. ≥15 times according to VARC-2 definition). Baseline, procedural and follow-up data were prospectively collected in a dedicated database. Results PPMI was diagnosed in 193 patients (14%) according to the VARC-3 criteria. Female sex and peripheral artery disease were found independent predictors of PPMI in the multivariable analysis (p<0.01 for both). PPMI was associated with a higher risk of mortality at 30-day (HR: 2.76, 95% CI: 1.54-4.95, p=0.001 for all-cause mortality; HR: 9.54, 95%CI: 2.69 to 33.80, p<0.001 for cardiovascular mortality) and 1-year-follow-up (HR: 1.52, 95%CI: 1.02-2.27, p=0.037 for all-cause mortality; HR: 3.04, 95%CI: 1.68-5.50, p<0.001 for cardiovascular mortality). PPMI according to VARC-2 criteria had no impact on mortality (Figure 1). According to restricted cubic splines analysis, the minimal threshold at which high-sensitivity troponin elevation is significantly associated with 1-year all-cause mortality is an 82-fold increase above URL (Figure 2). Conclusions About 1 out of 10 patients undergoing TAVR in the contemporary era had PPMI as defined by recent VARC-3 criteria and it had a negative impact on early and late survival. Baseline factors as female gender and peripheral disease increased the risk. Further studies on the prevention of PPMI post-TAVR and implementing measures to improve outcomes in PPMI patients are warranted.Kaplan-Meier estimates of mortalityRestricted cubic splines analysis

Mid-term outcomes in aortic stenosis patients treated with contemporary balloon expandable and self-expanding valves; does valve size have an impact on outcome?

Abstract Background No data currently exists comparing the performance of the contemporary iterations of balloon-expandable (BE) Edwards SAPIEN 3/Ultra and the self-expanding (SE) Medtronic Evolut PRO/R34 valves. In addition, no direct head to head comparisons of the aforementioned devices have been performed in patients with small annuli with the exception of small registries. Purpose Aim of the study was the head-to-head comparison of these transcatheter heart valves (THV) with emphasis on patients with small aortic annulus. Methods In this retrospective registry, peri-procedural outcomes and mid-term all-cause mortality were analyzed. Results 1673 patients (917 SE vs. 756 BE) were followed-up for a median of 15 months. Baseline demographics were similar apart from worse left ventricle systolic function amongst SE patients and more extensive coronary artery disease amongst BE patients. 194 patients died (11.6%) during follow-up. SE and BE groups showed similar survival at one (92.6 vs. 90.6%) and three-years (80.3% vs. 85.2%), plog-rank=0.136. Compared to the BE group, patients treated with SE device had lower peak (16.3±8mmHg SE vs. 21.9±8mmHg BE, p=0.001) and mean (8.8±5mmHg SE vs. 11.5±5mmHg BE, p=0.001) gradients at discharge. Conversely, the BE group demonstrated lower rates of at least moderate paravalvular regurgitation (PVR) post-operatively (5.6% vs. 0.7% for SE and BE valves respectively, p<0.001). In patients treated with small THV (≤26 for SE and ≤23mm for BE; N=284 for SE and N=260 for BE) survival was higher amongst patients treated with SE valves at both 1 (96.7% SE vs. 92.1% BE) and 3-years (91.8% SE vs. 82.2% BE), plog-rank=0.042. Conclusions Real-world comparison of the latest generation SE and BE devices demonstrated similar survival up to 3 years follow-up. Among patients with small aortic annulus, those treated with SE valves seem to demonstrate improved survival rates.36months survival rates

Anatomical characteristics of aortic valve diseases: Implications for transcatheter aortic valve replacement

BackgroundThe etiology of aortic stenosis (AS) significantly impacts transcatheter heart valve (THV) implantation, with rheumatic etiology posing challenges. The concept of valve anchoring during transcatheter aortic valve replacement (TAVR) for patients with aortic regurgitation (AR) remains unclear. ObjectiveThis study aims to investigate the clinical and CT anatomical characteristics of various aortic valve diseases. MethodsA retrospective analysis was conducted on consecutive patients who underwent CT for severe aortic diseases between April 2019 and February 2023. CT analysis was performed in eight anatomical landmarks: left ventricular outflow tract (LVOT), aortic annulus, sinus of Valsalva (SOV), sinotubular junction (STJ), ascending aorta (AAO), coronary height, aortic angle, and aortic valve calcification volume. Results121 patients with severe aortic valve disease were included, divided into AS (71 cases, 59%) and AR (50 cases, 41%) groups. In patients with AR, the absolute diameters of the annulus, LVOT, SOV, STJ, and AAO, as well as the heights of SOV and STJ and the cardiac angle, are larger than those in patients with AS (all P < 0.05). In normalized aortic root dimensions, the AR group had a higher SOV and STJ diameter-to-annulus ratio than the AS group (STJ-SOV-annulus: 1.51–1.44–1.00 vs 1.33–1.28–1.00). The bicuspid and rheumatic AS groups had smaller sinuses (STJ-SOV-annulus:1.27–1.35–1.00, 1.17–1.30–1.00, respectively), necessitating the downsizing of the THV. For 74% of AR patients, the sinotubular junction could not be used as a second anchoring zone, and anchoring relied primarily on the annulus. ConclusionsPatients with rheumatic etiology require smaller valves, and anchoring in AR patients depends on the valve annulus. These structural characteristics will influence TAVR selection.

Abstract 12293: Subclinical Leaflet Thrombus on Transcatheter Heart Valve in Patients With Severe Aortic Stenosis and Atrial Fibrillation

Background: Subclinical leaflet thrombosis is one of transcatheter heart valve (THV) failure that should be avoided after transcatheter aortic valve implantation (TAVI). Although the effectiveness of direct oral anticoagulants (DOACs) on subclinical leaflet thrombosis has been demonstrated, there is insufficiently established evidence for post-TAVI antithrombotic therapy. The aim of this study was to clarify the formation process of subclinical leaflet thrombosis on THV and thrombogenicity during the perioperative period of TAVI. Methods: This multicenter, prospective, single-arm interventional study enrolled 26 patients with atrial fibrillation treated with edoxaban and severe aortic valve stenosis who underwent TAVI between September 2018 and September 2022. After exclusion, 24 patients were finally analyzed. We investigated changes in maximal leaflet thickness detected by contrast-enhanced computed tomography between 1 week and 3 months after TAVI and measured the thrombogenicity by Total Thrombus-formation Analysis System (T-TAS) and flow stagnation volume by computational fluid dynamics (CFD). Results: Of all, subclinical leaflet thrombosis was observed in 16.7% at 1 week, but decreased to 5.9% at 3 months after TAVI. There was no significant difference in maximum leaflet thickness between 1 week and 3 months, however, patients with subclinical leaflet thrombosis at 1 week had a significantly greater difference in that thickness compared to those without thrombosis. Thrombogenicity assessed by T-TAS and platelet count decreased markedly at 1 week and tended to improve at 3 months. Simple liner regression analysis showed that stagnation volume was positively associated with an increase in maximum leaflet thickness, and low-dose edoxaban was associated with a high risk of increased leaflet thickness at chronic phase. Conclusions: This study showed that course of leaflet thrombus formation in neo-sinus of THV and dynamic fluctuation of thrombogenicity in the acute phase after TAVI. These findings were merely hypotheses generation and thus necessitate future hypothesis testing with large sample sizes.

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.

Abstract 17322: Closing the Loop: Use of Amplatzer PFO Occluder Device in Case of LVAD-Associated Aortic Insufficiency

Description of Case: A 72-year-old woman with destination therapy Heartmate 3 left ventricular assist device (LVAD) presented with NYHA Class III symptoms. Review of her echocardiograms since LVAD implantation revealed progressive central aortic insufficiency (AI) with subsequent LV dilatation, managed with reduction in LVAD speed. Patient declined surgical aortic valve replacement and/or repair. After a multidisciplinary discussion, the patient opted to pursue percutaneous aortic valve closure. Cardiac CT demonstrated no aortic valve thrombus and identified appropriate anatomy for closure with an 18x25 mm Amplatzer PFO Occluder device (Graphic 1). Preoperative TEE revealed LV ejection fraction of 15% with moderate to severe AI and fibrosis of the aortic valve commissures with no aortic valve movement. The aortic valve was closed with the Amplatzer PFO Occluder with an 18mm disk that sat on the LV side of the aortic valve within the AV annulus and the 25mm disk sitting on the aortic side of the aortic valve within the sinus of Valsalva. TEE and intracardiac echocardiography demonstrated excellent device placement with two residual trace AI jets at the non-left and left-right commissure. Following LVAD speed increase, the degree of AI remained unchanged and she was discharged with improved symptoms. Discussion: Moderate-severe AI develops in about 15-25% of patients within 1 year of LVAD implantation. There are previous reports of LVAD-associated AI closure with an Amplatzer cribiform device. We describe the first known use of the Amplatzer PFO Occluder device for the management of LVAD-associated AI. While transcatheter aortic valve replacement (TAVR) is an attractive option to treat LVAD-associated AI, securing the transcatheter heart valve in the absence of calcifications remains a challenge.

Recent progress in functional modification and crosslinking of bioprosthetic heart valves.

Valvular heart disease (VHD), clinically manifested as stenosis and regurgitation of native heart valve, is one of the most prevalent cardiovascular diseases with high mortality. Heart valve replacement surgery has been recognized as golden standard for the treatment of VHD. Owing to the clinical application of transcatheter heart valve replacement technic and the excellent hemodynamic performance of bioprosthetic heart valves (BHVs), implantation of BHVs has been increasing over recent years and gradually became the preferred choice for the treatment of VHD. However, BHVs might fail within 10-15 years due to structural valvular degeneration (SVD), which was greatly associated with drawbacks of glutaraldehyde crosslinked BHVs, including cytotoxicity, calcification, component degradation, mechanical failure, thrombosis and immune response. To prolong the service life of BHVs, much effort has been devoted to overcoming the drawbacks of BHVs and reducing the risk of SVD. In this review, we summarized and analyzed the research and progress on: (i) modification strategies based on glutaraldehyde crosslinked BHVs and (ii) nonglutaraldehyde crosslinking strategies for BHVs.

Redo-TAVI with SAPIEN 3 in SAPIEN XT or SAPIEN 3 - impact of pre- and post-dilatation on final THV expansion.

When a balloon-expandable transcatheter heart valve (THV) is chosen to treat a failed balloon-expandable THV, there is a risk of underexpansion with a potential impact on performance. We aimed to assess the impact of pre- and post-dilatation on the expansion of balloon-expandable THVs after redo-transcatheter aortic valve implantation (TAVI). Redo-TAVI was performed on the bench with a 23 mm SAPIEN 3 (S3) implanted within a 23 mm SAPIEN XT (SXT) or a 23 mm S3, both of which served as the "failed" THVs. Pre- and/or post-dilatation was performed using a 23 mm non-compliant TRUE balloon. Expansion of the index and redo-THVs were assessed before and after pre-/post-dilatation using microcomputed tomography (micro-CT), and THV hydrodynamic testing was conducted. Without pre- or post-dilatation, the S3 was underexpanded, for all combinations, particularly in the mid-portion of the THV (18.6 mm and 19.7 mm representing 81% and 86% of the nominal diameter inside the SXT and S3, respectively). Pre- and post-dilatation had an additive effect on diameter expansion of the redo-THV, which remained constrained in most combinations. The only combination to achieve nominal expansion was the S3 in S3 when both pre- and post-dilatation were performed. The S3 remained underexpanded inside the SXT despite pre- and post-dilatation (93% in the mid-portion). Improved redo-THV expansion was accompanied by 2.7 mm (12%) overexpansion of the index THV. While all samples had acceptable hydrodynamic performance, the underexpanded samples had worse leaflet pinwheeling. When performing redo-TAVI with a 23 mm S3 inside a 23 mm SXT or S3, only the S3 in S3 with the use of pre- and post-dilatation reached full expansion. This underlines the importance of CT assessment of THV expansion and the role of pre-/post-dilatation.

Challenges and Future Directions in Redo Aortic Valve Reintervention After Transcatheter Aortic Valve Replacement Failure.

Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Reintervention for failed transcatheter heart valves will likely increase in the future as younger patients are expected to outlive the initial bioprosthesis. While redo-TAVR has emerged as an attractive and less invasive alternative to surgical explantation (TAVR-explant) to treat transcatheter heart valve failure, it may not be feasible in all patients due to the risk of coronary obstruction and impaired coronary access. Conversely, TAVR-explant can be offered to most patients who are surgical candidates, but the reported outcomes have shown high mortality and morbidity. This review provides the latest evidence, current challenges, and future directions on redo-TAVR and TAVR-explant for transcatheter heart valve failure, to guide aortic valve reintervention and facilitate patients' lifetime management of aortic stenosis.

Redo Transcatheter Aortic Valve Implantation in the Lotus Mechanically Expanded Transcatheter Heart Valve: Bench-Top Analysis, Clinical Experience, and Procedural Guidance.

Redo transcatheter aortic valve implantation (TAVI) is increasing as patients outlive their transcatheter heart valves (THVs) and present with bioprosthetic valve failure. The Lotus mechanically expanded THV has unique design characteristics, which have specific implications for Redo TAVI. The design features of the Lotus valve and their relevance to Redo TAVI were reviewed. Bench-top analysis of Redo TAVI was performed using different contemporary THVs. Procedural and outcome data were obtained from 10 patients who had undergone Redo TAVI for Lotus bioprosthetic valve failure in 5 centers. Recommendations for performing Redo TAVI in Lotus are made, based on these findings. The Lotus leaflets extend from the frame inflow, with a Neoskirt of only 13 mm, hence a low risk of coronary obstruction during Redo TAVI. The Lotus frame posts prevent full apposition of the Redo prosthesis in the upper part of the frame, while implantation of the Redo THV above the Lotus inflow leads to inadequate apposition of the Lotus leaflets. Inflow-to-inflow positioning is therefore recommended for effective sealing and leaflet pinning. The Lotus locking mechanism prevents overexpansion of the frame, limiting Redo THV oversizing. Redo TAVI was favorable with SAPIEN 3, Evolut, and Navitor THVs on bench-top analysis but not with ACURATE Neo 2 due to the upper crowns and short stent preventing inflow-to-inflow deployment. Case review demonstrated satisfactory outcomes in 10 patients treated with Evolut (n=6), SAPIEN 3 (n=3), and Portico (n=1) valves, with no mortality, major morbidity, or coronary obstruction. Three patients had residual mean gradient ≥20 mm Hg, including 2 of 3 SAPIEN cases. Guidance on procedural planning, valve choice, sizing, and positioning is provided. Redo TAVI in Lotus requires an understanding of unique design characteristics, and adherence to key procedural recommendations, but can be safely and effectively performed with most contemporary valve types.

Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry

BackgroundMitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. ObjectivesThis study aimed to determine whether device position and asymmetry are associated with these outcomes. MethodsPatients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. ResultsA total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). ConclusionsValve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.

Implantation depth of balloon-expandable transcatheter heart valves and risks for permanent pacemaker implantation and midterm adverse events.

Permanent pacemaker implantation (PPI) remains a relevant complication after transcatheter aortic valve implantation (TAVI) and its impact on outcome remains controversial. This study aimed to analyze the effects of implantation depth on PPI at 30 days and assess its impact on outcome with the balloon-expandable Sapien 3 (S3) prosthesis. Between 2014 and 2018, 849 patients without previous pacemaker undergoing transfemoral TAVI with the S3 were included. Prosthesis implantation depth was measured and divided into Quintiles. An ordinal logistic regression was used to assess its association with PPI, while a multivariate logistic regression was performed to identify predictors of PPI. Survival analyses were performed with the Kaplan-Meier method and a multivariable Cox regression was performed to ascertain the impact of PPI on mortality. Overall, incidence of PPI at 30 days was 9.7%. Implantation depth decreased consistently from a median of 6.7 mm [5.55-8.00] in 2014 to 2.7 mm [2.30-3.50] in 2018 (p < 0.001). When considering Quintiles of implantation depth, incidence of PPI was significantly higher in upper Quintiles and risk for PPI was significantly lower for the 1. Quintile compared to the 5. Quintile (OR: 0.34, 95% CI: [0.16-0.73]; p = 0.003). In the adjusted multivariable logistic regression implantation depth persisted ad independent predictor of PPI at 30 days. Patients requiring PPI at 30 days displayed significantly higher mortality at 4 years compared to patients without PPI (49.5% vs. 40.0%; log-rank = 0.022). In a multivariate analysis, increased logistic EuroScore, diabetes mellitus, and history of atrial fibrillation, were independent predictors of all-cause mortality at 2 years. Higher prosthesis implantation relative to the virtual aortic annulus was significantly associated with reduced risk for PPI at 30 days. Patients with PPI at 30 days exhibited higher mortality during follow-up, however, only logistic EuroScore, diabetes mellitus, and history of atrial fibrillation were identified as independent predictors of mortality at 2 years.

Single center experience with the balloon-expandable Myval transcatheter aortic valve system with the first 100 patients: 30-day and 1-year follow-up.

To report our single-center data, regarding the first 100 patients who underwent TAVR procedure with the new balloon-expandable MYVAL system. We report 30-day and 1-year outcomes in low to high-risk TAVR patient population. From November 2019 to July 2021, 100 consecutive patients underwent TAVR procedure. Patient outcome was classified according to the VARC-2 definitions. The device performance was assessed using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. The mean age was 74.7 years, 63 (63%) were male. The mean Euroscore II and STS score were 4.8 ± 4.9 and 5.6 ± 3.9, respectively. Transfemoral access was the most frequent (surgical vs. percutaneous 2% vs. 97%) and in one patient surgical subclavian access was used. VARC-2 outcomes were as follows: device success 99%, STROKE 1%, major and minor vascular complication was 1% and 11%, respectively, the rate of new permanent pacemaker implantation was 30.7%. At discharge, the incidence of grade I, grade II aortic regurgitation was 39% and 1%, respectively, without relevant PVL. In-hospital mortality was only 1%. These results included a high proportion (17%) of patients with bicuspid aortic valves. At 1 year, the all-cause mortality rate was 7% (only two due to cardiac event) and only a single patient had valve-related dysfunction requiring surgical aortic replacement. TAVR procedure with MYVAL transcatheter heart valve system shows excellent 30-day and 1-year outcomes regarding patient survival, technical success, and valve-related adverse events. The limitations of our study comprise a single-center study with retrospective data collection.

Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial

BackgroundThe SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring. ObjectivesThis study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures. MethodsThis prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire. ResultsA total of 121 patients (mean age: 82.2 ± 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary efficacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 ± 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported. ConclusionsThe use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383)

Preventing Coronary Occlusion in an Elderly Severe Aortic Stenosis Patient with Critically Low Coronary Heights – A Case Report

Background: Transcatheter Aortic Valve Replacement (TAVR) is an established treatment for severe, symptomatic Aortic Stenosis (AS). However, the presence of low coronary heights confers a high risk for coronary obstruction during or after TAVR. Case: In this case report, we present our experience with transfemoral-TAVR in an elderly, high-risk (STS score – 12.08%) female severe AS patient with low coronary heights (right: 7.4 mm, left: 8.7 mm). She had lower annulus area (287 mm2) and moderately low valve area (0.7 cm2) as well. Her mean and peak pressure gradients (PGs) were 38 mmHg and 61 mmHg, respectively. Upon the Heart Team’s evaluation, TAVR was recommended and a 20 mm Balloon Expandable (BE) Myval Transcatheter Heart Valve (THV) was selected. No peri-procedural or post-procedural complications were reported and the post-procedural hemodynamics, namely the mean and peak PGs improved to 16 mmHg and 30 mmHg after TAVR, respectively. The patient was discharged in a stable condition after four days of hospital stay. Conclusion: We report the successful implantation of a small-sized BE Myval THV (20 mm) in a patient with low coronary heights. Life-threatening complications including paravalvular leak, coronary obstruction, or annular rupture were well averted; hence, we ascertain that the Myval THV is a suitable device for treating severe AS in difficult anatomies. However, the viability of the novel valve needs to be reaffirmed in larger studies.

Outcomes Following Transcatheter Aortic Valve Replacement for Aortic Stenosis in Patients With Type 0 Bicuspid, Type 1 Bicuspid, and Tricuspid Aortic Valves.

Data concerning the outcomes of transcatheter aortic valve replacement in type 0 bicuspid aortic stenosis (AS) are scarce. The study aims to compare the outcomes of transcatheter aortic valve replacement for AS in patients with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy. We enrolled consecutive patients undergoing transcatheter aortic valve replacement for severe AS between 2012 and 2022 in this single-center retrospective cohort study. The primary outcome was mortality, while secondary outcomes included in-hospital complications such as stroke and pacemaker implantation and transcatheter heart valve hemodynamic performance. The number of patients with AS with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy was 328, 302, and 642, respectively. Self-expanding transcatheter heart valves were used in the majority of patients (n=1160; 91.4%). In the matched population, differences in mortality (30 days: 4.2% versus 1.7% versus 1.7%, Poverall=0.522; 1 year: 10% versus 2.3% versus 6.2%, Poverall=0.099) and all stroke (30 days: 1.0% versus 0.9% versus 0.0%, Poverall=0.765; 1 year: 1.4% versus 1.6% versus 1.3%, Poverall=NS) were nonsignificant, and the incidence of overall in-hospital complications was comparable among groups. Ascending aortic diameter was the single predictor of 1-year mortality in type 0 bicuspid patients (hazard ratio, 1.59 [95% CI, 1.03-2.44]; P=0.035). The proportion of patients with a mean residual gradient ≥20 mm Hg was the highest in those with type 0 bicuspid anatomy, although the need for permanent pacemaker implantation was the lowest in this group. Major clinical outcomes of transcatheter aortic valve replacement for AS in patients with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy are equivalent at short- and mid-term follow-up. These observations merit further exploration in prospective international registries and randomized controlled trials.

Self-expanding and balloon-expandable valves in low risk TAVR patients

BackgroundRecent randomized studies have broadened the indication of transcatheter aortic valve replacement (TAVR) to also include low-surgical-risk patients. However, the data on self-expanding (SE) and balloon-expandable (BE) valves in low-risk patients remain sparse. MethodsThe current study is a post hoc analysis of combined data from both LRT 1.0 and 2.0 trials comparing BE and SE transcatheter heart valves. ResultsA total of 294 patients received a BE valve, and 102 patients received an SE valve. The 30-day clinical outcomes were similar across both groups except for stroke (4.9% vs. 0.7%, p = 0.014) and permanent pacemaker implantation (17.8% vs. 5.8%, p < 0.001), which were higher in the SE cohort than the BE cohort. No difference was observed in terms of paravalvular leak (≥moderate) between the groups (0% vs. 1.5%, p = 0.577). SE patients had higher aortic valve area (1.92 ± 0.43 mm2 vs. 1.69 ± 0.45 mm2, p < 0.001) and lower mean gradient (8.93 ± 3.53 mmHg vs. 13.41 ± 4.73 mmHg, p < 0.001) than BE patients. In addition, the rate of subclinical leaflet thrombosis was significantly lower in SE patients (5.6% vs. 13.8%, p = 0.038). ConclusionIn this non-randomized study assessing SE and BE valves in low-risk TAVR patients, SE valves are associated with better hemodynamics and lesser leaflet thrombosis, with increased rates of stroke and permanent pacemaker implantation at 30 days; however, this could be due to certain patient-dependent factors not fully evaluated in this study. The long-term implications of these outcomes on structural valve durability remain to be further investigated. Clinical Trial RegistryLRT 1.0: NCT02628899LRT 2.0: NCT03557242

Parametric analysis of transcatheter aortic valve replacement in transcatheter aortic valve replacement: evaluation of coronary flow obstruction.

Transcatheter aortic valve replacement (TAVR) is increasingly being considered for use in younger patients having longer life expectancy than those who were initially treated. The TAVR-in-TAVR procedure represents an appealing strategy to treat failed transcatheter heart valves (THV) likely occurring in young patients. However, the permanent displacement of first THV can potentially compromise the coronary access and ultimately inhibit the blood flow circulation. The objective of this study was to use finite-element analysis (FEA) to quantify coronary flow in a patient who underwent TAVR-in-TAVR. A parametric investigation was carried out to determine the impact of both the implantation depth and device size on coronary flow for several deployment configurations. The FEAs consisted of first delivering the SAPIEN 3 Ultra THV and then positioning the Evolut PRO device. Findings indicates that high implantation depth and device undersize of the second THV could significantly reduce coronary flow to 20% of its estimated level before TAVR. Additionally, a positive correlation was observed between coronary flow and the valve-to-coronary distance (R = 0.86 and p = 0.032 for the left coronary artery, and R = 0.93 and p = 0.014 for the right coronary artery). This study demonstrated that computational modeling can provide valuable insights to improve the pre-procedural planning of TAVR-in-TAVR.

Self-Expandable Transcatheter Heart Valve Embolization Caused by Sledding Phenomenon With a Pigtail Catheter

Self-Expandable Transcatheter Heart Valve Embolization Caused by Sledding Phenomenon With a Pigtail Catheter