Journal of Clinical Medicine

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13 pages, 2191 KiB

Open AccessArticle

Comparison in Short-Term Safety and Efficacy between New-Generation WATCHMAN FLX and Conventional WATCHMAN 2.5 for Percutaneous Left Atrial Appendage Closure

by Nobuyuki Fukuda, Teruhiko Imamura, Shuhei Tanaka, Naoya Kataoka, Ryuichi Ushijima, Hiroshi Ueno and Koichiro Kinugawa

J. Clin. Med. 2022, 11(6), 1618; https://doi.org/10.3390/jcm11061618 - 15 Mar 2022

Cited by 9 | Viewed by 4134

Abstract

Background: Percutaneous left atrial appendage closure using the WATCHMAN system, to prevent thrombosis and minimize anti-coagulant use in patients with non-valvular atrial fibrillation, has recently been introduced. The safety and efficacy of new-generation WATCHMAN FLX, as compared to conventional WATCHMAN 2.5, remain unknown. [...] Read more.

Background: Percutaneous left atrial appendage closure using the WATCHMAN system, to prevent thrombosis and minimize anti-coagulant use in patients with non-valvular atrial fibrillation, has recently been introduced. The safety and efficacy of new-generation WATCHMAN FLX, as compared to conventional WATCHMAN 2.5, remain unknown. Methods: Consecutive patients who received percutaneous left atrial appendage closure using the WATCHMAN system in our institute, between June 2020 and December 2021, were retrospectively analyzed. Safety and efficacy during the 45-day observational period were compared between the two devices. Results: A total of 93 patients (73.0 ± 7.3 years old, 63 men) who received WATCHMAN FLX (n = 44) or WATCHMAN 2.5 (n = 49) were included. The device implant success rate was 100% in the FLX device group and 98% in the 2.5 device group. There were no procedure-related complications in the FLX group, and one non-relevant pericardial effusion in the 2.5 device group. During the 45-day observational period, there were no procedure-related adverse events. No patients in the FLX group had a peri-device leak >3 mm, whereas two patients in the 2.5 device group had a peri-device leak >3 mm. Anti-coagulants could be terminated in most of the patients (85% versus 88%; p = 0.68). Conclusions: Percutaneous left atrial appendage closure using new-generation WATCHMAN FLX seemed to be as safe and effective as conventional WATCHMAN 2.5 during the short-term observational period. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement: Recent Insights, Current Challenges, and Future Prospects)

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14 pages, 1516 KiB

Open AccessArticle

Clinical Comparison of a Novel Balloon-Expandable Versus a Self-Expanding Transcatheter Heart Valve for the Treatment of Patients with Severe Aortic Valve Stenosis: The EVAL Registry

by Monica Barki, Alfonso Ielasi, Andrea Buono, Gabriele Maliandi, Mariano Pellicano, Marta Bande, Francesco Casilli, Francesca Messina, Giuseppe Uccello, Daniele Briguglia, Massimo Medda, Maurizio Tespili and Francesco Donatelli

J. Clin. Med. 2022, 11(4), 959; https://doi.org/10.3390/jcm11040959 - 12 Feb 2022

Cited by 17 | Viewed by 3537

Abstract

Background: Transcatheter aortic valve replacement (TAVR) is an effective treatment option for patients with severe, symptomatic AS, regardless of the transcatheter heart valve (THV) implanted. Prior studies demonstrated a higher device success with lower paravalvular leak (PVL) using the balloon-expandable (BE) Sapien/XT THV [...] Read more.

Background: Transcatheter aortic valve replacement (TAVR) is an effective treatment option for patients with severe, symptomatic AS, regardless of the transcatheter heart valve (THV) implanted. Prior studies demonstrated a higher device success with lower paravalvular leak (PVL) using the balloon-expandable (BE) Sapien/XT THV vs. a self-expanding (SE) THV. However, few data are available on the performance of a novel BE THV. Purpose: to compare early clinical performance and safety of the newly available BE Myval THV (Myval, Meril Life Sciences Pvt. Ltd., India) vs. the commonly used SE (Evolut R, Medtronic) THV. Methods: A single-center, retrospective cohort analysis was performed with 166 consecutive patients undergoing TAVR from March 2019 to March 2021 for severe symptomatic AS treated with either the novel BE Myval or the SE Evolut R (ER) bioprosthesis. The primary endpoint was device success at day 30 according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included 30-day all-cause mortality, cardiovascular mortality, more than mild PVL, permanent pacemaker implantation (PPI) rates and a composite of all-cause mortality and disabling stroke at 6 months. Results: Among the 166 included patients, 108 patients received the SE ER THV and 58 patients were treated with the BE Myval THV. At baseline, the two groups showed comparable demographic characteristics. The primary composite endpoint of early device success occurred in 55 patients (94.8%) in the BE Myval group and in 90 patients (83.3%) in the SE ER group (OR 3.667, 95% CI 1.094–12.14; p = 0.048). At day 30, the BE Myval THV group exhibited a significantly lower incidence of more than mild PVL (BE Myval 3.45% vs. SE ER 14.8%, OR 0.2, 95% CI 0.05–0.8; p = 0.0338), along with a lower rate of PPI (BE Myval 11% vs. SE ER 24.2%, OR 0.38, 95% CI 0.15–0.99; p = 0.0535). At the 6-month follow-up, the incidence of all-cause mortality and disabling stroke did not significantly differ between the two groups, while the incidence of PPI (BE Myval 11% vs. SE ER 27.5%, OR 0.32, CI 95% 0.1273–0.8; p = 0.02) and ≥moderate PVL (BE Myval 6.9% vs. SE ER 19.8%, OR 0.31, 95% CI 0.1–0.94; p = 0.0396) was significantly lower in the BE Myval group. Conclusions: In patients with severe symptomatic AS undergoing TAVR, the novel Myval BE THV provided a comparable performance to the well-known ER SE THV, and it was associated with a lower rate of PPI and ≥moderate PVL within 30 days and 6 months after the procedure. Randomized, head-to-head comparison trials are needed to confirm our results. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement: Recent Insights, Current Challenges, and Future Prospects)

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9 pages, 1753 KiB

Open AccessArticle

Paravalvular Aortic Regurgitation Severity Assessed by Quantitative Aortography: ACURATE neo2 versus ACURATE neo Transcatheter Aortic Valve Implantation

by Andreas Rück, Won-Keun Kim, Hideyuki Kawashima, Mahmoud Abdelshafy, Ahmed Elkoumy, Hesham Elzomor, Rutao Wang, Christopher U. Meduri, Dinos Verouhis, Nawzad Saleh, Yoshinobu Onuma, Darren Mylotte, Patrick W. Serruys and Osama Soliman

J. Clin. Med. 2021, 10(20), 4627; https://doi.org/10.3390/jcm10204627 - 9 Oct 2021

Cited by 17 | Viewed by 2893

Abstract

The new-generation ACURATE neo2 system was commercially released in September 2020. In this study, we sought to compare the aortic regurgitation (AR) severity of the ACURATE neo2 versus the ACURATE neo transcatheter heart valve, using quantitative videodensitometric angiography (qAR). This is [...] Read more.

The new-generation ACURATE neo2 system was commercially released in September 2020. In this study, we sought to compare the aortic regurgitation (AR) severity of the ACURATE neo2 versus the ACURATE neo transcatheter heart valve, using quantitative videodensitometric angiography (qAR). This is a retrospective, Corelab analysis of final post-transcatheter aortic valve implantation (TAVI) aortograms of patients treated with the ACURATE neo2 and ACURATE neo systems. The ACURATE neo2 cohort comprised consecutive patients treated between September 2020 and January 2021 at two centers. The ACURATE neo cohort included consecutive patients treated before September 2020. Our primary objective was to compare AR severity on qAR following TAVI with ACURATE neo2 and ACURATE neo. Out of 401 aortograms, 228 (56.9%) were analyzable, with 120 in the ACURATE neo2 cohort, and 108 in the ACURATE neo cohort. The mean AR fraction was 4.4 ± 4.8% in the neo2 cohort, and 9.9 ± 8.2% in the neo cohort (p < 0.001). Furthermore, moderate or severe AR (qAR > 17%) was detected in 2 aortograms (1.7%) in the neo2 cohort and 15 aortograms (13.9%) in the neo cohort (p < 0.001). Quantitative aortography shows a lower rate of moderate or severe paravalvular AR in what is the first European experience of the new-generation, self-expanding ACURATE neo2 when compared to the first-generation ACURATE neo. Moreover, aortographic data need to be correlated and compared to Core Laboratory-adjudicated 30-day echocardiographic data. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement: Recent Insights, Current Challenges, and Future Prospects)

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13 pages, 1116 KiB

Open AccessArticle

The Prognosis of Baseline Mitral Regurgitation in Patients with Transcatheter Aortic Valve Implantation

by Juqian Zhang, Arnaud Bisson, Jad Boumhidi, Julien Herbert, Christophe Saint Etienne, Anne Bernard, Gregory Y.H. Lip and Laurent Fauchier

J. Clin. Med. 2021, 10(17), 3974; https://doi.org/10.3390/jcm10173974 - 2 Sep 2021

Cited by 3 | Viewed by 2016

Abstract

Mitral regurgitation (MR) is the most common valvular lesion in transcatheter aortic valve implantation (TAVI) recipients. This study aims to assess the long-term prognostic impact of baseline MR in TAVI patients. Methods: Adult patients who underwent TAVI were identified in the French National [...] Read more.

Mitral regurgitation (MR) is the most common valvular lesion in transcatheter aortic valve implantation (TAVI) recipients. This study aims to assess the long-term prognostic impact of baseline MR in TAVI patients. Methods: Adult patients who underwent TAVI were identified in the French National Hospital Discharge Database. All-cause and cardiovascular mortality, stroke, and rehospitalization with heart failure (HF) were compared in TAVI patients with and without baseline MR and tricuspid regurgitation (TR), respectively; the associations of MR and TR with the outcomes were assessed by Cox regression. Results: Baseline MR was identified in 8240 TAVI patients. Patients with baseline MR have higher yearly incidence of all-cause mortality (HR: 1.192, 95% confidence interval CI: 1.125–1.263), cardiovascular mortality (HR: 1.313, 95%CI: 1.210–1.425), and rehospitalization for heart failure (HF) (HR: 1.411, 95%CI: 1.340–1.486) compared to those without, except for stroke rate (HR: 0.988, 95%CI: 0.868–1.124). Neither baseline MR nor TR was an independent risk predictor for all-cause mortality or cardiovascular mortality in TAVI patients. Baseline MR was independently associated with rehospitalization for HF in TAVI patients. Conclusions: Baseline MR and TR were associated with increased all-cause and cardiovascular mortality post-TAVI, however, neither of them was independent predictor for all-cause or cardiovascular mortality. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement: Recent Insights, Current Challenges, and Future Prospects)

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8 pages, 1451 KiB

Open AccessArticle

Long-Term Outcome with New Generation Prostheses in Patients Undergoing Transcatheter Aortic Valve Replacement

by Alexander R. Tamm, Martin Geyer, Felix Kreidel, Lea Dausmann, Caroline Jablonski, Omar Hahad, Eberhard Schulz, Thomas Münzel and Ralph Stephan Von Bardeleben

J. Clin. Med. 2021, 10(14), 3102; https://doi.org/10.3390/jcm10143102 - 14 Jul 2021

Cited by 4 | Viewed by 2432

Abstract

The aim of this study was to compare patients with transcatheter aortic valve replacement (TAVR) receiving new generation prostheses SAPIEN 3 (S3, Edwards Lifesc.) and Evolut R (ER, Medtronic Inc.) in terms of periprocedural and long-term outcome. Our retrospective, single-center analysis included 359 [...] Read more.

The aim of this study was to compare patients with transcatheter aortic valve replacement (TAVR) receiving new generation prostheses SAPIEN 3 (S3, Edwards Lifesc.) and Evolut R (ER, Medtronic Inc.) in terms of periprocedural and long-term outcome. Our retrospective, single-center analysis included 359 consecutive patients with severe aortic stenosis who underwent TAVR with S3 or ER from 2014–2016 (mean age 82 ± 7 years, 47% male, mean EuroSCORE II 8.0 ± 8%, mean follow-up 3.8 years). Device Success was equal (S3 93.0% vs. ER 92.4%, p = 0.812). We report a 30-day mortality of 2.8% in the S3 group, and 2.1% in the ER group (p = 0.674). There was no difference in stroke, conversion to open surgery, vascular and bleeding complications or myocardial infarction. While prosthesis mean gradients were higher with S3 (12.0 mmHg vs. 8.2 mmHg, p < 0.001), there was a trend to less paravalvular regurgitation (PVR moderate or severe: 1% vs. 3.6%, p = 0.088). All-cause mortality up to 5 years did not show a difference (mean survival S3 3.5 ± 0.24 years, ER 3.3 ± 0.29 years, p = 0.895). Independent predictors of long-term mortality were impaired LVEF, chronic kidney injury, peripheral artery disease, malignant tumor and periprocedural stroke. New generation TAVR valves offer an excellent implant and outcome success rate. Long-term survival was independent of prostheses choice and mainly attributed to comorbidities and complications. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement: Recent Insights, Current Challenges, and Future Prospects)

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Review

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13 pages, 1087 KiB

Open AccessReview

An Update on New Generation Transcatheter Aortic Valves and Delivery Systems

by Gloria Santangelo, Alfonso Ielasi, Mariano Pellicano, Azeem Latib, Maurizio Tespili and Francesco Donatelli

J. Clin. Med. 2022, 11(3), 499; https://doi.org/10.3390/jcm11030499 - 19 Jan 2022

Cited by 13 | Viewed by 8736

Abstract

Over the last 15 years, the management of aortic valve disease has been changed by transcatheter aortic valve replacement, which has become the standard of care across the entire spectrum of surgical risk. As a result of continuous evolution of this technique, several [...] Read more.

Over the last 15 years, the management of aortic valve disease has been changed by transcatheter aortic valve replacement, which has become the standard of care across the entire spectrum of surgical risk. As a result of continuous evolution of this technique, several next-generation transcatheter heart valves (THVs) have been developed to minimize procedural complications and improve patient outcomes. This review aims to provide an update on the new generation THVs and delivery systems. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement: Recent Insights, Current Challenges, and Future Prospects)

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14 pages, 3617 KiB

Open AccessReview

Trans-Catheter Valve-in-Valve Implantation for the Treatment of Aortic Bioprosthetic Valve Failure

by Andrea Buono, Diego Maffeo, Giovanni Troise, Francesco Donatelli, Maurizio Tespili and Alfonso Ielasi

J. Clin. Med. 2022, 11(2), 344; https://doi.org/10.3390/jcm11020344 - 11 Jan 2022

Cited by 3 | Viewed by 2351

Abstract

Aortic valve-in-valve (ViV) procedure is a valid treatment option for patients affected by bioprosthetic heart valve (BHV) degeneration. However, ViV implantation is technically more challenging compared to native trans-catheter aortic valve replacement (TAVR). A deep knowledge of the mechanism and features of the [...] Read more.

Aortic valve-in-valve (ViV) procedure is a valid treatment option for patients affected by bioprosthetic heart valve (BHV) degeneration. However, ViV implantation is technically more challenging compared to native trans-catheter aortic valve replacement (TAVR). A deep knowledge of the mechanism and features of the failed BHV is pivotal to plan an adequate procedure. Multimodal imaging is fundamental in the diagnostic and pre-procedural phases. The main challenges associated with ViV TAVR consist of a higher risk of coronary obstruction, severe post-procedural patient-prosthesis mismatch, and a difficult coronary re-access. In this review, we describe the principles of ViV TAVR. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement: Recent Insights, Current Challenges, and Future Prospects)

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17 pages, 683 KiB

Open AccessReview

The Pandora’s Box of Frailty Assessments: Which Is the Best for Clinical Purposes in TAVI Patients? A Critical Review

by Omar Baritello, Annett Salzwedel, Simon H. Sündermann, Josef Niebauer and Heinz Völler

J. Clin. Med. 2021, 10(19), 4506; https://doi.org/10.3390/jcm10194506 - 29 Sep 2021

Cited by 6 | Viewed by 2721

Abstract

Frailty assessment is recommended before elective transcatheter aortic valve implantation (TAVI) to determine post-interventional prognosis. Several studies have investigated frailty in TAVI-patients using numerous assessments; however, it remains unclear which is the most appropriate tool for clinical practice. Therefore, we evaluate which frailty [...] Read more.

Frailty assessment is recommended before elective transcatheter aortic valve implantation (TAVI) to determine post-interventional prognosis. Several studies have investigated frailty in TAVI-patients using numerous assessments; however, it remains unclear which is the most appropriate tool for clinical practice. Therefore, we evaluate which frailty assessment is mainly used and meaningful for ≤30-day and ≥1-year prognosis in TAVI patients. Randomized controlled or observational studies (prospective/retrospective) investigating all-cause mortality in older (≥70 years) TAVI patients were identified (PubMed; May 2020). In total, 79 studies investigating frailty with 49 different assessments were included. As single markers of frailty, mostly gait speed (23 studies) and serum albumin (16 studies) were used. Higher risk of 1-year mortality was predicted by slower gait speed (highest Hazard Ratios (HR): 14.71; 95% confidence interval (CI) 6.50–33.30) and lower serum albumin level (highest HR: 3.12; 95% CI 1.80–5.42). Composite indices (five items; seven studies) were associated with 30-day (highest Odds Ratio (OR): 15.30; 95% CI 2.71–86.10) and 1-year mortality (highest OR: 2.75; 95% CI 1.55–4.87). In conclusion, single markers of frailty, in particular gait speed, were widely used to predict 1-year mortality. Composite indices were appropriate, as well as a comprehensive assessment of frailty. Full article

(This article belongs to the Special Issue Transcatheter Aortic Valve Replacement: Recent Insights, Current Challenges, and Future Prospects)

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