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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 -
Frontiers in Cardiovascular Medicine 2024In recent years, the use of artificial intelligence (AI) models to generate individualised risk assessments and predict patient outcomes post-Transcatheter Aortic Valve...
OBJECTIVES
In recent years, the use of artificial intelligence (AI) models to generate individualised risk assessments and predict patient outcomes post-Transcatheter Aortic Valve Implantation (TAVI) has been a topic of increasing relevance in literature. This study aims to evaluate the predictive accuracy of AI algorithms in forecasting post-TAVI mortality as compared to traditional risk scores.
METHODS
Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses for Systematic Reviews (PRISMA) standard, a systematic review was carried out. We searched four databases in total-PubMed, Medline, Embase, and Cochrane-from 19 June 2023-24 June, 2023.
RESULTS
From 2,239 identified records, 1,504 duplicates were removed, 735 manuscripts were screened, and 10 studies were included in our review. Our pooled analysis of 5 studies and 9,398 patients revealed a significantly higher mean area under curve (AUC) associated with AI mortality predictions than traditional score predictions (MD: -0.16, CI: -0.22 to -0.10, < 0.00001). Subgroup analyses of 30-day mortality (MD: -0.08, CI: -0.13 to -0.03, = 0.001) and 1-year mortality (MD: -0.18, CI: -0.27 to -0.10, < 0.0001) also showed significantly higher mean AUC with AI predictions than traditional score predictions. Pooled mean AUC of all 10 studies and 22,933 patients was 0.79 [0.73, 0.85].
CONCLUSION
AI models have a higher predictive accuracy as compared to traditional risk scores in predicting post-TAVI mortality. Overall, this review demonstrates the potential of AI in achieving personalised risk assessment in TAVI patients.
REGISTRATION AND PROTOCOL
This systematic review and meta-analysis was registered under the International Prospective Register of Systematic Reviews (PROSPERO), under the registration name "All-Cause Mortality in Transcatheter Aortic Valve Replacement Assessed by Artificial Intelligence" and registration number CRD42023437705. A review protocol was not prepared. There were no amendments to the information provided at registration.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/, PROSPERO (CRD42023437705).
PubMed: 38883982
DOI: 10.3389/fcvm.2024.1343210 -
ARYA Atherosclerosis 2023Valvular heart disease presents a significant and escalating global health challenge. Prosthetic valve thrombosis (PVT) following surgical valve replacement is a primary...
INTRODUCTION
Valvular heart disease presents a significant and escalating global health challenge. Prosthetic valve thrombosis (PVT) following surgical valve replacement is a primary cause of valve failure. The aim of this study was to ascertain the outcomes and complications of fibrinolytic therapy in patients diagnosed with PVT.
METHOD
This cross-sectional study enrolled 81 patients diagnosed with PVT who underwent fibrinolytic therapy between 2008 and 2018. Streptokinase was administered to 87.6% of patients, while 12.4% received reteplase. All demographic and clinical data were gathered from the patients' medical records. The incidence of successful recovery and complications were assessed.
RESULTS
The records of 81 patients (43.2% male, mean age: 51.6 ± 13.9 years) were examined. The findings revealed that 59% and 35% of the patients had mitral and aortic PVT, respectively. While 12% of the patients experienced drug complications, 90% achieved successful recovery. Stroke and severe hemorrhage were complications frequently reported by the patients treated with streptokinase (8% and 4% respectively). The patients treated with reteplase demonstrated a 100% recovery rate. Conversely, 89% of the patients treated with streptokinase achieved successful recovery, and 7% of the patients experienced a partial recovery.
CONCLUSION
Fibrinolytic agents can serve as an effective treatment with an excellent success rate for managing PVT in patients post-surgical valve replacement.
PubMed: 38882648
DOI: 10.48305/arya.2023.26569.2804 -
Indian Heart Journal Jun 2024Left-sided mechanical prosthetic heart valve thrombosis (PVT) occurs because of suboptimal anticoagulation and is common in low-resource settings. Urgent surgery and...
BACKGROUND
Left-sided mechanical prosthetic heart valve thrombosis (PVT) occurs because of suboptimal anticoagulation and is common in low-resource settings. Urgent surgery and fibrinolytic therapy (FT) are the two treatment options available for this condition. Urgent surgery is a high-risk procedure but results in successful restoration of valve function more often and is the treatment of choice in developed countries. In low-resource countries, FT is used as the default treatment strategy, though it is associated with lower success rates and a higher rate of bleeding and embolic complications. There are no randomized trials comparing the two modalities.
METHODS
We performed a single center randomized controlled trial comparing urgent surgery (valve replacement or thrombectomy) with FT (low-dose, slow infusion tissue plasminogen activator, tPA) in patients with symptomatic left-sided PVT. The primary outcome was the occurrence of a complete clinical response, defined as discharge from hospital with completely restored valve function, in the absence of stroke, major bleeding or non-CNS systemic embolism. Outcome assessment was done by investigators blinded to treatment allocation. The principal safety outcome was the occurrence of a composite of in-hospital death, non-fatal stroke, non-fatal major bleed or non-CNS systemic embolism. Outcomes will be assessed both in the intention-to-treat, and in the as-treated population. We will also report outcomes at one year of follow-up. The trial has completed recruitment.
CONCLUSION
This is the first randomized trial to compare urgent surgery with FT for the treatment of left-sided PVT. The results will provide evidence to help clinicians make treatment choices for these patients. (Clinical trial registration: CTRI/2017/10/010159).
PubMed: 38879396
DOI: 10.1016/j.ihj.2024.06.013 -
Journal of Infection and Chemotherapy :... Jun 2024Infective endocarditis (IE) caused by MRSA (methicillin-resistant Staphylococcus aureus) is associated with a high mortality rate. This study aimed to elucidate the...
BACKGROUND
Infective endocarditis (IE) caused by MRSA (methicillin-resistant Staphylococcus aureus) is associated with a high mortality rate. This study aimed to elucidate the characteristics of patients with MRSA-IE in Japan and identify the factors associated with prognosis.
METHODS
This retrospective study included patients with a confirmed diagnosis of IE caused by MRSA, between January 2015 and April 2019.
RESULTS
A total of 65 patients from 19 centers were included, with a mean age of 67 years and 26 % were female. Fifty percent of the patients with IE were had nosocomial infections and 25 % had prosthetic valve involvement. The most common comorbidities were hemodialysis (20 %) and diabetes (20 %). Congestive heart failure was present in 86 % of patients (NYHA class I, II: 48 %; III, IV: 38 %). The 30-day and in-hospital mortality rates were 29 % and 46 %, respectively. Multi-organ failure was the primary cause of death, accounting for 43 % of all causes of death. Prognostic factors for in-hospital mortality were age, disseminated intravascular coagulation, daptomycin and/or linezolid as initial antibiotic therapy, and surgery. Surgical treatment was associated with a lower mortality rate (odds ratio [OR], 0.026; 95 % confidence interval [CI], 0.002-0.382; p = 0.008 for 30-day mortality and OR, 0.130; 95 % CI; 0.029-0.584; p = 0.008 for in-hospital mortality).
CONCLUSION
Mortality due to MRSA-IE remains high. Surgical treatment is a significant prognostic predictor of MRSA-IE.
PubMed: 38876203
DOI: 10.1016/j.jiac.2024.06.002 -
Frontiers in Cardiovascular Medicine 2024The Dafodil™-1 trial was designed to evaluate the clinical safety and performance of Dafodil™ pericardial bioprosthesis for replacing diseased native or prosthetic...
BACKGROUND
The Dafodil™-1 trial was designed to evaluate the clinical safety and performance of Dafodil™ pericardial bioprosthesis for replacing diseased native or prosthetic aortic or mitral valves in patients with advanced valvular heart disease (VHD).
METHODS
The Dafodil™-1 trial was a prospective, multicenter, first-in-human clinical trial. Patients were enrolled if they had advanced VHD requiring aortic valve replacement (AVR) or mitral valve replacement (MVR) with or without concomitant valve surgery and having surgical risk scores <4%. Major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI), and stroke; and hemodynamics were analyzed.
RESULTS
A total of 136 patients (aortic: 67 and mitral: 69) were enrolled in the trial (with mean age-AVR group: 60.2 ± 8.3 years and MVR group: 49.7 ± 14.4 years). A total of 134 patients (aortic: 66 and mitral: 68) completed the 3-year follow-up (total 300 per 100 patient-years of follow-up). The AVR group demonstrated a significant reduction in the mean pressure gradients from 51.2 ± 24.1 mmHg at baseline to 11.1 ± 6.0 mmHg at the 3-year follow-up ( < 0.0001). The mean effective orifice area (EOA) improved from baseline (0.9 ± 0.6 cm) to 3-year follow-up (1.8 ± 0.4 cm) ( < 0.0001). In the MVR group, the mean indexed EOA (iEOA) increased significantly from baseline (0.7 ± 0.4 cm/m) to 3-year follow-up (1.1 ± 0.4 cm/m) ( < 0.001). There was significant improvement in New York Heart Association functional class and mean SF-12 scores in both groups. At 3-year follow-up, the MACE incidence was 2.3% per 100 patient-years (1.3% strokes per 100 patient-years and 1.3% deaths per 100 patient-years) for AVR group and 4.7% per 100 patient-years (0.6% strokes per 100 patient-years and 4.0% deaths per 100 patient-years) for MVR group. No cases of MI, structural valve deterioration and prosthetic valve endocarditis were reported. The AVR and MVR groups achieved 89.6% and 79.7% MACE-free survival, respectively at 3-year follow-up.
CONCLUSIONS
The Dafodil™-1 trial demonstrated satisfactory outcomes of clinical safety, hemodynamic performance, and quality-of-life metrics. Additionally, no incidence of structural valve deterioration and very low rates of valve thrombosis during the 3-year follow-up period of Dafodil™-1 first-in-human trial indicated acceptable valve durability up to three years and similar outcomes are warranted for longer follow-ups as a primary goal.
CLINICAL TRIAL REGISTRATION NUMBER
https://www.ctri.nic.in/Clinicaltrials/showallp.php?mid1=18377&EncHid=&userName=CTRI/2017/07/009008, CTRI/2017/07/009008.
PubMed: 38873269
DOI: 10.3389/fcvm.2024.1393762 -
BMC Cardiovascular Disorders Jun 2024Studies of transcatheter pulmonary valve replacement (TPVR) with the Melody valve have demonstrated good clinical and hemodynamic outcomes. Our study analyzes the...
BACKGROUND
Studies of transcatheter pulmonary valve replacement (TPVR) with the Melody valve have demonstrated good clinical and hemodynamic outcomes. Our study analyzes the midterm clinical and hemodynamic outcomes for patients who underwent Melody valve implantation in Southeast Asia.
METHODS
Patients with circumferential conduits or bioprosthetic valves and experiencing post-operative right ventricular outflow tract (RVOT) dysfunction were recruited for Melody TPVR.
RESULTS
Our cohort (n = 14) was evenly divided between pediatric and adult patients. The median age was 19 years (8-38 years), a male-to-female ratio of 6:1 with a median follow-up period of 48 months (16-79 months), and the smallest patient was an 8-year-old boy weighing 18 kg. All TPVR procedures were uneventful and successful with no immediate mortality or conduit rupture. The primary implant indication was combined stenosis and regurgitation. The average conduit diameter was 21 ± 2.3 mm. Concomitant pre-stenting was done in 71.4% of the patients without Melody valve stent fractures (MSFs). Implanted valve size included 22-mm (64.3%), 20-mm (14.3%), and 18-mm (21.4%). After TPVR, the mean gradient across the RVOT was significantly reduced from 41 mmHg (10-48 mmHg) to 16 mmHg (6-35 mmHg) at discharge, p < 0.01. Late follow-up infective endocarditis (IE) was diagnosed in 2 patients (14.3%). Overall freedom from IE was 86% at 79 months follow-up. Three patients (21.4%) developed progressive RVOT gradients.
CONCLUSION
For patients in Southeast Asia with RVOT dysfunction, Melody TPVR outcomes are similar to those reported for patients in the US in terms of hemodynamic and clinical improvements. A pre-stenting strategy was adopted and no MSFs were observed. Post-implantation residual stenosis and progressive stenosis of the RVOT require long term monitoring and reintervention. Lastly, IE remained a concern despite vigorous prevention and peri-procedural bacterial endocarditis prophylaxis.
Topics: Humans; Male; Child; Heart Valve Prosthesis; Female; Heart Valve Prosthesis Implantation; Adolescent; Pulmonary Valve; Treatment Outcome; Hemodynamics; Young Adult; Prosthesis Design; Cardiac Catheterization; Time Factors; Adult; Recovery of Function; Pulmonary Valve Insufficiency; Bioprosthesis; Pulmonary Valve Stenosis; Retrospective Studies; Risk Factors; Asia, Southeastern
PubMed: 38872098
DOI: 10.1186/s12872-024-03919-7 -
MMW Fortschritte Der Medizin Jun 2024
Review
Topics: Humans; Middle Aged; Endocarditis, Bacterial; Male; Fatal Outcome; Aortic Valve; Heart Valve Prosthesis Implantation; Diagnosis, Differential; Malpractice; Prosthesis-Related Infections; Autopsy
PubMed: 38871909
DOI: 10.1007/s15006-024-3958-4