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Journal of Cardiovascular Imaging May 2024Semi-automated software is essential for planning and prosthesis selection prior transcatheter aortic valve replacement (TAVR). Reliable data on the usability of...
BACKGROUND
Semi-automated software is essential for planning and prosthesis selection prior transcatheter aortic valve replacement (TAVR). Reliable data on the usability of software programs for planning a TAVR is missing. The aim of this study was to compare software programs 'Valve Assist 2' (GE Healthcare) and 3mensio 'Structural Heart' (Pie Medical Imaging) regarding usability and accuracy of prosthesis size selection in program-inexperienced users.
METHODS
Thirty-one participants (n = 31) were recruited and divided into program-inexperienced users (beginners) (n = 22) and experts (n = 9). After software training, beginners evaluated 3 patient cases in 129 measurements (n = 129) using either Valve Assist 2 (n = 11) or Structural Heart (n = 11) on 2 test days (T1, T2). System Usability Scale (SUS) and ISONORM 9241/110-S (ISONORM) questionnaire were used after the test. The valve size selected by each beginner was compared with the valve size selected from expert group.
RESULTS
Valve Assist 2 had higher SUS Score: median 78.75 (25th, 75th percentile: 67.50, 85.00) compared to Structural Heart: median 65.00 (25th, 75th percentile: 47.50, 73.75), (p < 0,001, r = 0.557). Also, Valve Assist 2 showed a higher ISONORM score: median 1.05 (25th, 75th percentile: - 0.19, 1.71) compared to Structural Heart with a median 0.05 (25th, 75th percentile: - 0.49, 0.13), (p = 0.036, r = 0.454). Correctly selected valve sizes were stable over time using Valve Assist 2: 72.73% to 69.70% compared to Structural Heart program: 93.94% to 40% (χ (1) = 21.10, p < 0.001, φ = 0.579).
CONCLUSION
The study shows significant better usability scores for Valve Assist 2 compared to 3mensio Structural Heart in program-inexperienced users.
PubMed: 38907292
DOI: 10.1186/s44348-024-00002-9 -
Kidney International Jul 2024
Topics: Humans; Hemosiderosis; Magnetic Resonance Imaging; Kidney Cortex; Male; Female; Heart Valve Prosthesis Implantation; Middle Aged
PubMed: 38906644
DOI: 10.1016/j.kint.2024.01.024 -
Journal of Cardiothoracic Surgery Jun 2024The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement...
BACKGROUND
The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve.
METHODS
MANTRA is an ongoing "umbrella" prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days.
RESULTS
A total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients. The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p < 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p < 0.0001). Mean pressure gradient decreased from 46.2 ± 17.3 mmHg to 10.1 ± 4.7 mmHg at 30-day follow-up. Low or no incidence of moderate-to-severe paravalvular or central leak was reported.
CONCLUSIONS
Preliminary results demonstrate good clinical outcomes and significant improvement of Quality of Life at 30-days, excellent early hemodynamic performance within patient implanted with Perceval PLUS.
TRIAL REGISTRATION
The MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021).
Topics: Humans; Aged; Male; Female; Prospective Studies; Heart Valve Prosthesis; Aortic Valve; Heart Valve Prosthesis Implantation; Treatment Outcome; Aortic Valve Stenosis; Prosthesis Design; Sutureless Surgical Procedures; Quality of Life; Hemodynamics; Aged, 80 and over; Middle Aged
PubMed: 38902742
DOI: 10.1186/s13019-024-02861-1 -
JTCVS Techniques Jun 2024
PubMed: 38899101
DOI: 10.1016/j.xjtc.2024.02.022 -
Journal of Cardiothoracic Surgery Jun 2024Perioperative management and cardiac surgery in pregnant women with anti-phospholipid syndrome combined with heart valve disease have been rarely reported.
BACKGROUND
Perioperative management and cardiac surgery in pregnant women with anti-phospholipid syndrome combined with heart valve disease have been rarely reported.
CASE PRESENTATION
We describe a case of transcatheter mitral valve-in-valve replacement in a pregnant woman with bioprosthetic valve failure and anti-phospholipid syndrome at 18 weeks' gestation. The patient underwent a cesarean section delivery at 34 weeks of gestation, resulting in the birth of a healthy baby.
CONCLUSIONS
Transapical mitral valve-in-valve surgery resulted in safe maternal and infant outcomes in a pregnant woman with anti-phospholipid syndrome combined with mitral bioprosthetic valve failure. The success of this procedure underscored the importance of multidisciplinary teamwork.
Topics: Humans; Female; Pregnancy; Antiphospholipid Syndrome; Mitral Valve; Adult; Heart Valve Prosthesis Implantation; Pregnancy Complications, Cardiovascular; Bioprosthesis; Heart Valve Prosthesis; Cesarean Section; Cardiac Catheterization; Mitral Valve Insufficiency; Prosthesis Failure
PubMed: 38898495
DOI: 10.1186/s13019-024-02702-1 -
Journal of Clinical Medicine May 2024Postoperative cardiovascular complications (either in a hospital or within 30 days after the operation) are among the most common problems with non-cardiac surgeries... (Review)
Review
Postoperative cardiovascular complications (either in a hospital or within 30 days after the operation) are among the most common problems with non-cardiac surgeries (NCSs). Pre-existing cardiac comorbidities add significant risk to the development of such complications. Valvular heart disease (VHD), a rather frequent cardiac comorbidity (especially in the elderly population), can pose serious life-threatening peri-/postoperative complications. Being familiar with the recommended perioperative management of patients with VHD or an implanted prosthetic heart valve who are scheduled for NCS is of great importance in daily clinical practice. Although recently published guidelines by the European Society of Cardiology (ESC) and the American College of Cardiology and American Heart Association (ACC/AHA) for the management of VHD and perioperative management of patients undergoing NCS addresses the mentioned problem, a comprehensive review of the guidelines that provides an easy-to-use summary of the recommendations and their similarities and differences is missing in the published literature. In this review article, we summarize all of the relevant important information based on the latest data published in both guidelines needed for practical decision-making in the perioperative management of patients with VHD or after valvular repair (with prosthetic heart valve) who are scheduled for NCS.
PubMed: 38892948
DOI: 10.3390/jcm13113240 -
Journal of Clinical Medicine May 2024The primary objective of this study was to evaluate the initial experience in Germany with the Meril Myval™ (MM) transcatheter heart valve (THV) system for the...
The primary objective of this study was to evaluate the initial experience in Germany with the Meril Myval™ (MM) transcatheter heart valve (THV) system for the treatment of severe symptomatic aortic valve stenosis. The MM THV is a novel balloon-expandable valve with an expanded sizing matrix. Contemporary patients undergoing TAVI with the established Edwards Sapien™ (ES) THV served as the comparator group. : Between 1st March and 31 August 2020 a total of 134 patients (33% female, 80.1 ± 6.7 years; EuroScore II 4.7 ± 4.8) underwent TAVI with an MM (95% transfemoral) for severe aortic stenosis at six German tertiary care centers. Correct positioning of the THV was achieved in 98.5% (n = 132). Mean aortic gradients (MPG) were reduced from 42 ± 14 mmHg to 11 ± 5 mmHg. Mild postprocedural paravalvular leak (PVL) was observed in 62% (n = 82) patients, whereas only one patient had more than mild PVL. New permanent pacemaker implantation (PPI) was indicated in 15 patients (11%). Major vascular complications occurred in 6.7% (n = 9) patients. The in-hospital combined incidence of all-cause death and stroke was 4.5% (n = 6). In the comparator group that included 268 patients, the 30-day incidences of PPI, major vascular complications, and the composite of all-cause death and stroke were 16%, 1.9%, and 7.1%, respectively; MPGs were reduced from 44 ± 15 mmHg to 12.8 ± 4.6 mmHg and the more than mild PVL occurred in 0.7%. The MM is a promising novel THV system, with performance comparable to the established ES THVs. These findings await confirmation by ongoing randomized trials.
PubMed: 38892875
DOI: 10.3390/jcm13113163 -
EuroIntervention : Journal of EuroPCR... Jun 2024Coronary access (CA) is a major concern in redo-transcatheter aortic valve implantation (TAVI) for failing supra-annular self-expanding transcatheter aortic valves...
BACKGROUND
Coronary access (CA) is a major concern in redo-transcatheter aortic valve implantation (TAVI) for failing supra-annular self-expanding transcatheter aortic valves (TAVs).
AIMS
This ex vivo study evaluated the benefit of leaflet splitting (LS) on subsequent CA after redo-TAVI in anatomies deemed at high risk of unfeasible CA.
METHODS
Ex vivo, patient-specific models were printed three-dimensionally. Index TAVI was performed using ACURATE neo2 or Evolut PRO (TAV-1) at the standard implant depth and with different degrees of commissural misalignment (CMA). Redo-TAVI was performed using the balloon-expandable SAPIEN 3 Ultra (TAV-2) at different implant depths with commissural alignment. Selective CA was attempted for each configuration before and after LS in a pulsatile flow simulator. The leaflet splay area was assessed on the bench.
RESULTS
In matched comparisons of 128 coronary cannulations across 64 redo-TAVI configurations, the overall feasibility of CA significantly increased after LS (60.9% vs 18.7%; p<0.001). The effect of LS varied according to the sinotubular junction height, TAV-1 design, TAV-1 CMA, and TAV-2 implant depth, given TAV-2 alignment. LS enabled CA for up to CMA 45° with the ACURATE neo2 TAV-1 and up to CMA 30° with the Evolut PRO TAV-1. The combination of LS and a low TAV-2 implant provided the highest feasibility of CA after redo-TAVI. The leaflet splay area ranged from 25.60 mm2 to 37.86 mm2 depending on the TAV-1 platform and TAV-2 implant depth.
CONCLUSIONS
In high-risk anatomies, LS significantly improves CA feasibility after redo-TAVI for degenerated supra-annular self-expanding platforms. Decisions on redo-TAVI feasibility should be carefully individualised, taking into account the expected benefit of LS on CA for each scenario.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve; Heart Valve Prosthesis; Prosthesis Design; Printing, Three-Dimensional; Aortic Valve Stenosis; Coronary Vessels; Prosthesis Failure; Reoperation
PubMed: 38887883
DOI: 10.4244/EIJ-D-24-00107 -
EuroIntervention : Journal of EuroPCR... Jun 2024
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Heart Valve Prosthesis; Aortic Valve; Male; Female; Aged; Treatment Outcome; Aged, 80 and over; Prosthesis Design
PubMed: 38887882
DOI: 10.4244/EIJ-D-23-01018 -
Current Cardiology Reports Jun 2024Patients with severe tricuspid regurgitation (TR) are at risk for significant morbidity and mortality. Transcatheter tricuspid valve interventions (TTVI) may offer... (Review)
Review
PURPOSE OF REVIEW
Patients with severe tricuspid regurgitation (TR) are at risk for significant morbidity and mortality. Transcatheter tricuspid valve interventions (TTVI) may offer patients less invasive treatment alternatives to surgery. This review evaluates the most common class of device currently used worldwide to treat TR, tricuspid transcatheter edge-to-edge repair (T-TEER) and orthotopic transcatheter tricuspid valve replacement (TTVR), both of which are now approved in the USA and Europe.
RECENT FINDINGS
The first pivotal randomized clinical trial, TRILUMINATE, demonstrated that T-TEER can safely reduce TR and is associated with improved health status outcomes. However, results of this trial have raised questions about whether this device can provide sufficient TR reduction to impact clinical outcomes. Orthotopic TTVR has recently gained attention with initial data suggesting near-complete TR elimination. The current review examines the technical features and anatomic limitations of the most commonly used devices for T-TEER and orthotopic TTVR, discusses the current clinical data for these devices, and offers a theoretical construct for device selection.
Topics: Humans; Tricuspid Valve Insufficiency; Cardiac Catheterization; Tricuspid Valve; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 38884853
DOI: 10.1007/s11886-024-02051-4