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Transcatheter Aortic Valve Replacement in 2021 and Beyond

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A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Cardiovascular Medicine".

Deadline for manuscript submissions: closed (15 December 2022) | Viewed by 10995

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Special Issue Editors

Dr. Silvia Mas-Peiro

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Guest Editor

Department of Cardiology, Goethe University Hospital Frankfurt, 60590 Frankfurt, Germany
Interests: interventional cardiology; structural heart disease; TAVR; AS physiopathology; AS genomics

Prof. Dr. Stephan Fichtlscherer

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Guest Editor

Department of Cardiology, Goethe University Hospital Frankfurt, 60590 Frankfurt, Germany
Interests: interventional cardiology; interventional therapy of structural heart disease; intensive care medicine

Special Issue Information

Dear Colleagues,

In the last decade, TAVR has brought about a major breakthrough in the treatment of aortic stenosis and has dramatically changed the landscape for this disease in patients not suitable for surgery. In 2020–2021, both clinical trials and real-world studies have confirmed the value of TAVR also in patients at low surgical risk, substantiated the introduction of newly developed devices, refined the identification of prognostic factors, and begun to report favorable outcomes in the very long term.

The use of TAVR continues to grow rapidly, and this raises a number of questions and current unmet needs: accurate patient selection, biomarkers/prognostic factors, role of inflammation, impact of concomitant cardiovascular and non-cardiovascular disorders, quality of life and patient-reported outcomes, personalized device selection, new indications (bicuspid, aortic regurgitation, valve-in-valve), paravalvular leaks, access to coronary ostia, stroke and cerebral embolic protection devices, subclinical valve thrombosis, antithrombotic therapy, valve durability, etc.

This Special Issue aims to collect original articles, reviews, and other contributions on the current state and future developments of TAVR focused on these and other hot topics in the verge of a new era of an even more widespread use of TAVR that will cause an overall dramatic improvement in survival and quality of life for our patients.

Dr. Silvia Mas-Peiro
Prof. Dr. Stephan Fichtlscherer
Guest Editors

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Keywords

Heart valve diseases
Aortic stenosis
Transcatheter aortic valve replacement
TAVR
Interventional
Transcatheter devices
Prognostic factors
Patient selection

Published Papers (7 papers)

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Research

13 pages, 1644 KiB

Open AccessArticle

Value of Post-/Pre-Procedural Aortic Regurgitation Ratio vs. Pre-Procedural Aortic Valve Calcium Score to Predict Moderate to Severe Paravalvular Leak Requiring Post-Dilation after Transcatheter Aortic Valve Implantation

by Roman Uebelacker, Simon S. Martin, Mariuca Vasa-Nicotera and Silvia Mas-Peiro

J. Clin. Med. 2023, 12(24), 7735; https://doi.org/10.3390/jcm12247735 - 17 Dec 2023

Viewed by 638

Abstract

Background and aim: Tools that assist interventionists in selecting patients for post-dilation (PD) are needed. We aimed to assess whether pre-interventional aortic valve calcium (AVC) or the peri-interventional aortic regurgitation (ARI) ratio is a better predictor for a more than mild paravalvular leak (PVL) requiring PD after TAVI. Methods: Patients undergoing TAVI with available data on AVC derived from MSCTs and the ARI ratio derived from peri-interventional hemodynamic curves were studied. The main outcome was moderate-to-severe PVL requiring PD. Results: In 237 patients, more than mild PVL after valve deployment was present in 25.7%. PD was performed in 65 patients. The median (IQR) total AVC was 390.5 (211.5–665.4) mm³. All calcification values were significantly higher in patients who underwent PD. The median (IQR) individual threshold was 600 (550–685) Hus. The overall ARI ratio was 0.78 (0.61–0.96), with values being significantly lower in patients who underwent PD: 0.61 (0.49–0.80) vs. 0.82 (0.69–0.99) (p < 0.001). Both the ARI ratio (OR [95%CI] 0.053 [0.014–0.203]; p < 0.001) and AVC (1.01 [1.000–1.002]; p = 0.015) predicted PD need. ROC curves showed higher discrimination for the ARI ratio (AUC 0.73) than for any calcification parameter (all AUCs ≤ 0.62). Conclusions: The ARI ratio provides interventionists with a powerful predictive tool for PVL requiring PD after TAVI that is beyond the predictive value of pre-procedural valve calcification derived from MSCT. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement in 2021 and Beyond)

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10 pages, 440 KiB

Open AccessArticle

Procedural Outcomes of a Self-Expanding Transcatheter Heart Valve in Small Annuli

by Clemens Eckel, Dagmar Sötemann, Won-Keun Kim, Christina Grothusen, Vedat Tiyerili, Guido Dohmen, Matthias Renker, Efstratios Charitos, Christian W. Hamm, Yeong-Hoon Choi, Helge Möllmann and Johannes Blumenstein

J. Clin. Med. 2022, 11(18), 5313; https://doi.org/10.3390/jcm11185313 - 9 Sep 2022

Cited by 2 | Viewed by 1271

Abstract

Background: Self-expanding transcatheter valves (THV) seem superior to balloon-expanding valves in regard to the incidence of prosthesis–patient mismatch (PPM). Data on the occurrence of PPM with the ACURATE neo/neo2 system as a representative of self-expanding prostheses in very small annuli, even below the applicable instructions for use (IFU), are scarce. Methods: Data from 654 patients with severe native aortic stenosis treated with the smallest size ACURATE neo/neo2 valve (size S, 23 mm) at two German high-volume centers from 06/2012 to 12/2021 were evaluated. We compared clinical and hemodynamic outcomes among patients with implantation in adherence to the recommended sizing (on-label n = 529) and below the recommended sizing range (off-label n = 125) and identified predictors for PPM in the overall population. BMI-adjusted PPM was defined according to VARC-3 recommendations. Results: Post-procedure, the mean gradient (10.0 mmHg vs. 9.0 mmHg, p = 0.834) and the rate of paravalvular leakage (PVL) ≥ moderate (3.2% vs. 2.8%, p = 0.770) were similar between on-label and off-label implantations. The rate of moderate to severe PPM (24%) was comparably low in ACURATE neo/neo2 S, with a very low proportion of severe PPM whether implanted off- or on-label (4.9% vs. 3.8%, p = 0.552). Thirty-day all-cause mortality was higher among patients with off-label implantations (6.5% vs. 2.3%, p = 0.036). In the subgroup of these patients, no device-related deaths occurred, and cardiac causes did not differ (each 5). Besides small annulus area and high BMI, a multivariate analysis identified a greater cover index (OR 3.26), deep implantation (OR 2.25) and severe calcification (OR 2.07) as independent predictors of PPM. Conclusions: The ACURATE neo/neo2 S subgroup shows a convincing hemodynamic outcome according to low mean gradient even outside the previous IFUs without a relevant increase in the rate of PVL or PPM. In addition to known factors such as annulus area and BMI, potential predictors for PPM are severe annulus calcification and implantation depth. Nevertheless, the ACURATE neo/neo2 system seems to be a reliable option in patients with very small annuli. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement in 2021 and Beyond)

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12 pages, 867 KiB

Open AccessArticle

Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry

by Helge Mollmann, Axel Linke, Luis Nombela-Franco, Martin Sluka, Juan Francisco Oteo Dominguez, Matteo Montorfano, Won-Keun Kim, Martin Arnold, Mariuca Vasa-Nicotera, Lenard Conradi, Anthony Camuglia, Francesco Bedogni and Ganesh Manoharan

J. Clin. Med. 2022, 11(16), 4839; https://doi.org/10.3390/jcm11164839 - 18 Aug 2022

Cited by 9 | Viewed by 1390

Abstract

A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a Portico™ transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav™ DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico™ THV at 30 days. The study collected ‘standard-of-care’ clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single Portico™ THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm² and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The Portico™ THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico™ THV with either the first-generation DS or FlexNav™ DS. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement in 2021 and Beyond)

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11 pages, 647 KiB

Open AccessArticle

Hemodynamic Performance of Two Current-Generation Transcatheter Heart Valve Prostheses in Severely Calcified Aortic Valve Stenosis

by Max Potratz, Kawa Mohemed, Hazem Omran, Lasha Gortamashvili, Kai Peter Friedrichs, Werner Scholtz, Smita Scholtz, Volker Rudolph, Cornelia Piper, Tomasz Gilis-Januszewski, René Schramm, Nobuyuki Furukawa, Jan Gummert, Sabine Bleiziffer and Tanja Katharina Rudolph

J. Clin. Med. 2022, 11(15), 4570; https://doi.org/10.3390/jcm11154570 - 5 Aug 2022

Cited by 3 | Viewed by 1568

Abstract

Background: Treatment of severely calcified aortic valve stenosis is associated with a higher rate of paravalvular leakage (PVL) and permanent pacemaker implantation (PPI). We hypothesized that the self-expanding transcatheter heart valve (THV) prostheses Evolut Pro (EPro) is comparable to the balloon-expandable Sapien 3 (S3) regarding hemodynamics, PPI, and clinical outcome in these patients. Methods: From 2014 to 2019, all patients with very severe calcification of the aortic valve who received an EPro or an S3 THV were included. Propensity score matching was utilized to create two groups of 170 patients. Results: At discharge, there was significant difference in transvalvular gradients (EPro vs. S3) (dPmean 8.1 vs. 11.1 mmHg, p ≤ 0.001) and indexed effective orifice area (EOAi) (1.1 vs. 0.9, p ≤ 0.001), as well as predicted EOAi (1 vs. 0.9, p ≤ 0.001). Moderate patient prosthesis mismatch (PPM) was significantly lower in the EPro group (17.7% vs. 38%, p ≤ 0.001), as well as severe PPM (2.9% vs. 8.8%, p = 0.03). PPI and the PVL rate as well as stroke, bleeding, vascular complication, and 30-day mortality were comparable. Conclusions: In patients with severely calcified aortic valves, both THVs performed similarly in terms of 30-day mortality, PPI rate, and PVL occurrence. However, patient prothesis mismatch was observed more often in the S3 group, which might be due to the intra-annular design. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement in 2021 and Beyond)

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13 pages, 1115 KiB

Open AccessArticle

Multi-Center Comparison of Two Self-Expanding Transcatheter Heart Valves: A Propensity Matched Analysis

by Johannes Blumenstein, Clemens Eckel, Oliver Husser, Won-Keun Kim, Matthias Renker, Yeong-Hoon Choi, Christian W. Hamm, Hani Al-Terki, Dagmar Sötemann, Leon Körbi, Vedat Tiyerili, Christina Grothusen, Luise Gaede, Guido Dohmen and Helge Möllmann

J. Clin. Med. 2022, 11(14), 4228; https://doi.org/10.3390/jcm11144228 - 21 Jul 2022

Cited by 4 | Viewed by 1457

Abstract

Background: During the last years, several transcatheter aortic heart valves entered the clinical market and are commercially available. The prostheses differ regarding several technical and functional aspects. However, little is known regarding head-to-head comparative data of the ACURATE neo and the PORTICO valve prostheses. Objectives: The aim of this study was to compare two self-expanding transcatheter aortic heart valves (THV), the ACURATE neo and the PORTICO, with regard to in-hospital and 30-day outcomes, as well as early device failures. Methods: A total of 1591 consecutive patients with severe native aortic valve stenosis from two centers were included in the analyses and matched by 1:1 nearest neighbor matching to identify one patient treated with PORTICO (n = 344) for each patient treated with ACURATE neo (n = 344). Results: In-hospital complications were comparable between both valves, including any kind of stroke (ACURATE neo = 3.5% vs. PORTICO = 3.8%; p = 1.0), major vascular complications (ACURATE neo = 4.5% vs. PORTICO = 5.4%; p = 0.99) or life-threatening bleeding (ACURATE neo = 1% vs. PORTICO = 2%; p = 0.68). The rate of device failure defined by the VARC-2 criteria were comparable, including elevated gradients and moderate-to-severe paravalvular leakage (ACURATE neo = 7.3% vs. PORTICO = 7.6%; p = 1.0). However, the need for permanent pacemaker implantation (PPI) was significantly more frequent after the use of PORTICO THV (9.5% vs. 18.7%; p = 0.002). Conclusions: In this two-center case-matched comparison, short-term clinical and hemodynamic outcomes showed comparable results between PORTICO and ACURATE neo prostheses. However, PORTICO was associated with a significant higher incidence of PPI. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement in 2021 and Beyond)

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19 pages, 1937 KiB

Open AccessArticle

Comparison of PCWP and LVEDP Measurements in Patients with Severe Aortic Stenosis Undergoing TAVI—Same Same but Different?

by Elke Boxhammer, Moritz Mirna, Laura Bäz, Brunilda Alushi, Marcus Franz, Daniel Kretzschmar, Uta C. Hoppe, Alexander Lauten and Michael Lichtenauer

J. Clin. Med. 2022, 11(11), 2978; https://doi.org/10.3390/jcm11112978 - 25 May 2022

Cited by 1 | Viewed by 1706

Abstract

Background: Pulmonary capillary wedge pressure (PCWP) and left ventricular end-diastolic pressure (LVEDP) are often used as equivalents for determination of pulmonary hypertension (PH). PH is a comorbidity in patients with severe aortic valve stenosis (AS) and associated with limited prognosis. The aim of the study was to examine the role of differentiated classification basis of PCWP and LVEDP in patients planning for transcatheter aortic valve implantation (TAVI). Methods: 284 patients with severe AS completed a combined left (LHC) and right heart catheterization (RHC) as part of a TAVI planning procedure. Patients were categorized twice into subtypes of PH according to 2015 European Society of Cardiology (ESC) guidelines—on the one hand with PCWP and on the other hand with LVEDP as classification basis. PCWP-LVEDP relationships were figured out using Kaplan-Meier curves, linear regressions and Bland-Altman analysis. Results: Regarding 1-year mortality, Kaplan-Meier analyses showed similar curves in spite of different classification bases of PH subtypes according to PCWP or LVEDP with exception of pre-capillary PH subtype. PCWP-LVEDP association in the overall cohort was barely present (R = 0.210, R² = 0.044). When focusing analysis on PH patients only a slightly increased linear regression was noted compared to the overall cohort (R = 0.220, R² = 0.048). The strongest regression was observed in patients with creatinine ≥ 132 µmol/L (R = 0.357, R² = 0.127) and in patients with mitral regurgitation ≥ II° (R = 0.326, R² = 0.106). Conclusions: In patients with severe AS, there is a weak association between hemodynamic parameters measured by LHC and RHC. RHC measurements alone are not suitable for risk stratification with respect to one-year mortality. If analysis of hemodynamic parameters is necessary in patients with severe AS scheduled for TAVI, measurement results of LHC and RHC should be combined and LVEDP could serve as a helpful indicator for risk assessment. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement in 2021 and Beyond)

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9 pages, 1506 KiB

Open AccessArticle

Prognostic Implications of a Modified Seattle Heart Failure Model Score Following Transcatheter Aortic Valve Replacement

by Teruhiko Imamura, Nikhil Narang, Hiroshi Onoda, Shuhei Tanaka, Ryuichi Ushijima, Mitsuo Sobajima, Nobuyuki Fukuda, Hiroshi Ueno and Koichiro Kinugawa

J. Clin. Med. 2021, 10(24), 5807; https://doi.org/10.3390/jcm10245807 - 11 Dec 2021

Cited by 1 | Viewed by 2125

Abstract

Background: The Seattle heart failure model (SHFM) score is a well-known risk predictor of mortality in patients with heart failure. We validated this score in patients receiving transcatheter aortic valve replacement (TAVR) and aimed to generate further risk discrimination by adding invasive hemodynamics parameters. Methods: Patients who underwent TAVR at our institute between 2015 and 2020 were included and followed for 2 years from index discharge. Patients were randomly assigned to the derivation cohort or the validation cohort. In the derivation cohort, the original SHFM score was modified by adding baseline hemodynamics parameters to evaluate the primary outcomes: 2-year incidence of mortality or readmission from heart failure. The model performance of the modified SHFM score was evaluated in the validation cohort. Results: A total of 217 patients (median age: 86 (83, 88) years old, 64 (29%) men) were included. From the derivation cohort (N = 108), a novel modified SHFM score was constructed: 6 × (original SHFM score < 88.1%) + 5 × (pulmonary capillary wedge pressure > 14 mmHg) + 4 × (cardiac index < 2.26 L/min/m²), which had an improved discrimination compared with the original model (area under the curve: 0.887 vs. 0.679, p = 0.014). In the validation cohort (N = 109), the modified SHFM score showed accurate predictive discrimination of the 2-year cumulative incidence of the primary endpoint into three groups (a low score group with 0–5 points, 3%; an intermediate score group with 6–10 points, 12%; and a high score group with 11–15 points, 43%, p < 0.001). Conclusion: A modified SHFM score consisting of the original SHFM score and invasive hemodynamics parameters predicted mortality and morbidity following TAVR. Evaluation of the external validity of this score in other cohorts needs further investigation. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement in 2021 and Beyond)

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