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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 -
JACC. Cardiovascular Interventions Jun 2024
PubMed: 38904606
DOI: 10.1016/j.jcin.2024.05.010 -
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 -
Zhonghua Yi Xue Za Zhi Jun 2024To explore the risk factors for progression to chronic kidney disease (CKD) in patients with cardiac valve replacement surgery-associated acute kidney injury (AKI). A...
To explore the risk factors for progression to chronic kidney disease (CKD) in patients with cardiac valve replacement surgery-associated acute kidney injury (AKI). A retrospective, nested case-control study was conducted at Fuwai Central China Cardiovascular Hospital. The study subjects were patients who underwent cardiac valve replacement surgery from January 1, 2018 to December 31, 2020, with a baseline estimated glomerular filtration rate (eGFR)>60 ml·min·(1.73 m) and postoperative complication of AKI. The patients were followed up for 90 days after discharge from hospital. The endpoint event was defined as progression to CKD 90 days after the occurrence of cardiac valve replacement surgery-associated AKI. The patients were divided into CKD group and non-CKD group based on whether they experienced endpoint event. The baseline clinical data were compared between the two groups. The measurement data with non-normal distribution was represented as (,). Logistic regression model was used to analyze the risk factors of endpoint event. The receiver-operating characteristic (ROC) curve was drawn to evaluate the performance for predicting CKD in cardiac valve replacement surgery-associated AKI patients. A total of 149 cardiac valve replacement surgery-associated AKI patients (86 males and 63 females) were included in the study, aged (59.0±10.2) years. There were 27 patients (18.1%) who progressed to new-onset CKD 90 days after the occurrence of cardiac valve replacement surgery-associated AKI. Compared with non-CKD group, patients in CKD group had older age [66 (58, 70) vs 59 (53, 64) years], lower baseline eGFR [76.3 (65.8, 98.5) vs 92.7 (78.5, 101.6) ml·min·(1.73 m)], higher proportion of preoperative hypertension [51.9% (14/27) vs 27.9% (34/122)] and serum creatinine at discharge [136 (101, 165) vs 86 (65, 104) μmol/L], and the differences were statistically significant (all <0.05). The multivariate logistic regression analysis results revealed that older age (=1.063, 95%: 1.001-1.129, =0.047), preoperative hypertension (=3.070, 95%: 1.105-8.532, =0.031) and higher serum creatinine at discharge (=1.026, 95%:1.013-1.038, <0.001) were risk factors for progression to CKD in patients with cardiac valve replacement surgery-associated AKI. The clinical risk model including age, preoperative hypertension, preoperative baseline eGFR, and serum creatinine at discharge produced a moderate performance for predicting progression to CKD in patients with cardiac valve replacement surgery-associated AKI [the area under the curve (AUC)=0.865, 95% 0.790-0.940, <0.001]. Older age, preoperative hypertension and higher serum creatinine at discharge are risk factors for progression to CKD in patients with cardiac valve replacement surgery-associated AKI.
Topics: Humans; Male; Female; Acute Kidney Injury; Risk Factors; Renal Insufficiency, Chronic; Middle Aged; Disease Progression; Case-Control Studies; Retrospective Studies; Heart Valve Prosthesis Implantation; Logistic Models; Aged; Glomerular Filtration Rate
PubMed: 38901978
DOI: 10.3760/cma.j.cn112137-20231219-01422 -
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 -
The American Journal of Cardiology Jun 2024Tricuspid valve replacement (TVR) with mechanical versus tissue valves remains a controversial subject. To evaluate the long-term effects of types of valves on...
Tricuspid valve replacement (TVR) with mechanical versus tissue valves remains a controversial subject. To evaluate the long-term effects of types of valves on patient-relevant outcomes, we performed a systematic review with meta-analysis of reconstructed time-to-event data of studies published by March 15, 2024 (according to referred the Reporting Items for Systematic Reviews and Meta-analyses guidelines). A total of 21 studies met our eligibility criteria and included 7,166 patients (mechanical: 2,495 patients, 34.8%). Patients who underwent mechanical TVR had a lower risk of death than those who received a tissue valve (hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.70 to 0.84, p <0.001). Mechanical TVR was associated with lifetime gain, as evidenced by the restricted mean survival time, which was 2.2 years longer in patients who underwent TVR with mechanical valves (12.4 vs 10.2 years, p <0.001). Our landmark analysis for reoperations revealed the following: from the time point 0 to 7 years, we found no difference in the risk of reoperation between mechanical and tissues valves (HR 0.98, 95% CI 0.60 to 1.61, p = 0.946); however, from the time point 7 years onward, we found that mechanical TVR had a lower risk of reoperation in the follow-up (HR 0.24, 95% CI 0.08 to 0.72, p = 0.001). The meta-regression analysis demonstrated a modulating effect of atrial fibrillation on the association between mechanical valves and mortality; the HRs for all-cause death tended to decrease in the presence of populations with a larger proportion of atrial fibrillation (p = 0.018). In conclusion, our results suggest that TVR with mechanical valves, whenever considered clinically reasonable and accepted by patients as an option, can offer a better long-term survival and lower risk of reoperation in the long run.
PubMed: 38897268
DOI: 10.1016/j.amjcard.2024.06.010 -
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