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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 -
Brazilian Journal of Cardiovascular... Oct 2023To assess actual data on the safety, effectiveness, and hemodynamic performance of Bovine Pericardium Organic Valvular Bioprosthesis (BVP). (Clinical Trial)
Clinical Trial Observational Study
OBJECTIVE
To assess actual data on the safety, effectiveness, and hemodynamic performance of Bovine Pericardium Organic Valvular Bioprosthesis (BVP).
METHODS
The BIOPRO Trial is an observational, retrospective, non-comparative, non-randomized, and multicenter study. We collected data from 903 patients with symptomatic, moderate, or severe valve disease who underwent BVP implants in the timeframe from 2013 to 2020 at three Brazilian institutions. Death, valve-related adverse events (AEs), functional recovery, and hemodynamic performance were evaluated at the hospital, at discharge, and six months and one year later. Primary analysis compared late (> 30 days after implant) linearized rates of valve-related AEs, such as thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, and endocarditis, following objective performance criteria (OPC). Analysis was performed to include at least 400 valve-years for each valve position (aortic and mitral) for complete comparisons to OPC. Kaplan-Meier survival and major adverse cardiovascular and cerebrovascular event analyses were also performed.
RESULTS
This retrospective study analyzed follow-up data collected from 903 patients (834.2 late patient-years) who have undergone surgery for 455 isolated aortic valve replacement (50.4%), 382 isolated mitral valve replacement (42.3%), and 66 combined valve replacement or other intervention (7.3%). The linearized rates of valve-related AEs were < 2 × OPC. One-year survival rates were 95.1% and 92.7% for aortic and mitral valve replacement, respectively. This study demonstrated an improvement in the New York Heart Association classification from baseline and hemodynamic performance within an expected range.
CONCLUSION
According to this analysis, BVP meets world standards for safety and clinical efficacy.
Topics: Animals; Cattle; Humans; Aortic Valve; Aortic Valve Stenosis; Bioprosthesis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Hemodynamics; Pericardium; Postoperative Complications; Prosthesis Design; Retrospective Studies; Treatment Outcome
PubMed: 37797247
DOI: 10.21470/1678-9741-2023-0015 -
EuroIntervention : Journal of EuroPCR... Aug 2023Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited.
BACKGROUND
Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited.
AIMS
We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry.
METHODS
A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria.
RESULTS
The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm, and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies.
CONCLUSIONS
BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.
Topics: Humans; Transcatheter Aortic Valve Replacement; Bicuspid Aortic Valve Disease; Aortic Valve; Constriction, Pathologic; Treatment Outcome; Prosthesis Design; Heart Valve Prosthesis; Prospective Studies; Aortic Valve Stenosis; Heart Valve Diseases; Mitral Valve Stenosis; Registries; Death
PubMed: 37203860
DOI: 10.4244/EIJ-D-23-00021 -
EuroIntervention : Journal of EuroPCR... Sep 2023Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large... (Observational Study)
Observational Study
BACKGROUND
Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting.
AIMS
We aimed to evaluate the safety and feasibility of Myval in NCAR.
METHODS
This was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed.
RESULTS
A total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm. The annular area was beyond the recommended range for extra-large sizes in 2.6% of cases, and additional volume was added in 92% (median 4 cc, up to 9 cc). The extra-large sizes were used in 95 patients (84.1%), and the mean oversizing was 17.9±11.0%. The technical success rate was 94.7%; the rate of residual ≥moderate aortic regurgitation was 8.9%, and the pacemaker rate was 22.2%. There were no cases of annular rupture, cardiac tamponade, or aortic dissection, but in 4 patients (3.5%) valve embolisation occurred (1 antegrade and 3 ventricular), all in cases with a tapered left ventricle outflow tract (p=0.007). Thirty-day and 1-year mortality were 5.3% and 9.7%, respectively. Technical success was associated with better survival (97.1% vs 72.7%; p=0.012), and valve embolisation was the main determinant of mortality (p=0.047).
CONCLUSIONS
Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.
Topics: Male; Humans; Aged; Aged, 80 and over; Female; Transcatheter Aortic Valve Replacement; Aortic Valve; Aortic Valve Insufficiency; Aortic Valve Stenosis; Heart Valve Prosthesis; Treatment Outcome; Prosthesis Design
PubMed: 37565470
DOI: 10.4244/EIJ-D-23-00344 -
The Journal of International Medical... Nov 2023is a Gram-negative bacillus typically associated with bacteremia in immunocompromised patients. Prosthetic valve endocarditis (PVE) is a serious complication of... (Review)
Review
is a Gram-negative bacillus typically associated with bacteremia in immunocompromised patients. Prosthetic valve endocarditis (PVE) is a serious complication of prosthetic valve surgery, with a high mortality rate if not treated promptly. We present a rare case of PVE caused by . A man in his mid-60s presented to the Emergency Department with a fever and showed elevated C-reactive protein concentrations. He had prosthetic mitral and aortic valve replacement surgery 15 years previously. Gram-negative rods were detected in a blood culture. These rods were identified as using matrix-assisted laser desorption ionization time-of-flight mass spectrometry and confirmed by 16S rRNA sequencing. The patient was treated with gentamicin and imipenem, and underwent valve replacement surgery. was isolated in a left atrial appendage swab obtained during the surgery. Follow-up blood cultures were negative after treatment. However, after a cardiac arrest event, the patient's general condition deteriorated, and he died. To the best of our knowledge, this is the first case of PVE caused by in Korea and the second fatality to date. This case highlights the importance of considering as a potential cause of PVE, even in patients without known risk factors.
Topics: Humans; Male; Aortic Valve; Campylobacter fetus; Endocarditis, Bacterial; Heart Valve Prosthesis; RNA, Ribosomal, 16S; Aged
PubMed: 37987669
DOI: 10.1177/03000605231213264 -
Tricuspid Edge-to-Edge Repair Versus Tricuspid Valve Replacement for Severe Tricuspid Regurgitation.Korean Circulation Journal Nov 2023Tricuspid valve (TV) repair techniques other than annuloplasty remain challenging and frequently end in tricuspid valve replacement (TVR) in complicated cases. However,...
BACKGROUND AND OBJECTIVES
Tricuspid valve (TV) repair techniques other than annuloplasty remain challenging and frequently end in tricuspid valve replacement (TVR) in complicated cases. However, the results of TVR are suboptimal compared with TV repair. This study aimed to evaluate the clinical effectiveness of TV edge-to-edge repair (E2E) compared to TVR for severe tricuspid regurgitation (TR).
METHODS
We retrospectively reviewed 230 patients with severe TR who underwent E2E (n=139) or TVR (n=91) from 2001 to 2020. Clinical and echocardiographic results were analyzed using inverse probability of treatment weighting analysis and propensity score matching.
RESULTS
The two groups showed no significant differences in early mortality and morbidities. During the mean follow-up of 106.2±68.8 months, late severe TR and TV reoperation rates were not significantly different between groups. E2E group, however, showed better outcomes in overall survival (p=0.023), freedom from significant tricuspid stenosis (TS) (trans-tricuspid pressure gradient ≥5 mmHg, p=0.021), and freedom from TV-related events (p<0.001). Matched analysis showed consistent results.
CONCLUSIONS
E2E for severe TR presented more favorable clinical outcomes than TVR. Our study supports that E2E might be a valuable option in severe TR surgery, avoiding TVR.
PubMed: 37973388
DOI: 10.4070/kcj.2023.0108 -
The Annals of Thoracic Surgery Nov 2023Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown in the wake of multiple natural history... (Review)
Review
Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown in the wake of multiple natural history studies showing progressively worse outcomes associated with increasing TR severity, even after adjusting for multiple comorbidities. Historically, isolated tricuspid valve surgery has been associated with high in-hospital mortality rates, leading to the development of transcatheter treatment options. The aim of this first Tricuspid Valve Academic Research Consortium document is to standardize definitions of disease etiology and severity, as well as endpoints for trials that aim to address the gaps in our knowledge related to identification and management of patients with TR. Standardizing endpoints for trials should provide consistency and enable meaningful comparisons between clinical trials. A second Tricuspid Valve Academic Research Consortium document will focus on further defining trial endpoints and will discuss trial design options.
Topics: Humans; Tricuspid Valve Insufficiency; Tricuspid Valve; Heart Valve Prosthesis Implantation; Treatment Outcome; Comorbidity; Cardiac Catheterization; Severity of Illness Index
PubMed: 37804270
DOI: 10.1016/j.athoracsur.2023.09.018 -
Circulation. Cardiovascular... Nov 2023Coronary accessibility following redo-transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study...
BACKGROUND
Coronary accessibility following redo-transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging.
METHODS
A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5.
RESULTS
With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 (<0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 (<0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; <0.001), and the highest at Evolut node 5 (61% versus 32%; <0.001).
CONCLUSIONS
Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283.
Topics: Humans; Aortic Valve; Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Heart Valve Prosthesis; Feasibility Studies; Treatment Outcome; Tomography, X-Ray Computed; Prosthesis Design
PubMed: 37988439
DOI: 10.1161/CIRCINTERVENTIONS.123.013238 -
Journal of Biomechanics Jul 2023With the current advances and expertise in biomedical device technologies, transcatheter heart valves (THVs) have been drawing significant attention. Various studies...
With the current advances and expertise in biomedical device technologies, transcatheter heart valves (THVs) have been drawing significant attention. Various studies have been carried out on their durability and damage by dynamic loading in operational conditions. However, very few numerical investigations have been conducted to understand the effects of leaflet curvature and thickness on the crimping stresses which arise during the surgical preparation processes. In order to contribute to the current state of the art, a full heart valve model was presented, the leaflet curvature and thickness of which were then parameterized so as to understand the stress generation as a result of the crimping procedure during the surgical preparations. The results show that the existence of stresses is inevitable during the crimping procedure, which is a reduction factor for valve durability. Especially, stresses on the leaflets at the suture sites connected with the skirt were deduced to be critical and may result in leaflet ruptures after THV implantation.
Topics: Aortic Valve; Transcatheter Aortic Valve Replacement; Heart Valve Prosthesis; Prosthesis Design
PubMed: 37295168
DOI: 10.1016/j.jbiomech.2023.111663 -
The Journal of Invasive Cardiology Feb 2024The SavvyWire(OpSens Medical) is a support wire for transcatheter aortic valve replacement (TAVR) procedures that, in addition to its dedicated left ventricle (LV)... (Observational Study)
Observational Study
OBJECTIVES
The SavvyWire(OpSens Medical) is a support wire for transcatheter aortic valve replacement (TAVR) procedures that, in addition to its dedicated left ventricle (LV) pacing capabilities, has a distal pressure sensor that measures live transvalvular hemodynamics during the procedure. We aimed to determine the safety, efficacy, and functionality of the SavvyWire during TAVR procedures in an all-comer population.
METHODS
We performed a multicentric, prospective, observational, single-arm, all-comers registry of patients with symptomatic, severe aortic stenosis undergoing TAVR in 3 Canadian centers. Data were collected in a dedicated database, and pre-specified questionnaires were fulfilled by the heart team implanters after each procedure.
RESULTS
A total of 60 patients were included (mean age: 78.6 ± 7.2 years; 51% women; mean Society of Thoracic Surgeons score: 2.2 ± 1.6%). TAVR was performed through a transfemoral approach in 90% of cases, and balloon- and self-expandable valves were used in 73% and 27% of patients, respectively. There were no cases of LV perforation, guidewire deformation, significant loss of capture, or major software malfunction. The rate of successful delivery of the TAVR system was 100%, and effective LV pacing was achieved in 98% of patients. The pre-TAVR mean gradient was 39 ± 14 mm Hg while the final post-TAVR gradient was 8 ± 5 mm Hg; the mean aortic systolic pressure during rapid pacing was 54 ± 12 mm Hg. In 97% of the TAVR procedures, SavvyWire's functionality was reported to be better or similar to other TAVR workhorse support wires.
CONCLUSIONS
SavvyWire was safe, effective, and functional for live transvalvular hemodynamic evaluation and rapid pacing during TAVR procedures. More studies with larger sample sizes and comparison against different wires and gradient measurement methods are warranted.
Topics: Aged; Aged, 80 and over; Female; Humans; Male; Aortic Valve; Aortic Valve Stenosis; Canada; Heart Valve Prosthesis; Hemodynamics; Prospective Studies; Prosthesis Design; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 38335504
DOI: 10.25270/jic/23.00242