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1.
Am J Cardiol ; 2024 Jul 12.
Article in English | MEDLINE | ID: mdl-39004197

ABSTRACT

To compare long-term outcomes of mechanical versus bioprosthetic aortic valve replacement (AVR) in patients under the age of 50, we performed a study-level meta-analysis with reconstructed time-to-event data including studies published by December of 2023. The primary outcome was overall survival. Secondary outcomes included reoperation, major bleeding, and stroke. Five studies met our inclusion criteria with a total of 4245 patients (2311 mechanical, 1934 bioprosthetic). All studies were observational and the mean age of groups across the studies ranged from 38.2 to 43.0 years. The median follow-up time was 11.4 years (IQR, 6.9-15.0). Bioprosthetic AVR was associated with reduced overall survival and higher risk of all-cause death (HR, 1.170 [95% CI, 1.002-1.364], P=0.046), increased risk of reoperation over time (HR, 2.581, [95% CI, 2.102-3.168], P<0.001), decreased risk of major bleeding (HR, 0.500, [95% CI, 0.367-0.682], P<0.001), and decreased risk of stroke (HR, 0.751, [95% CI, 0.565-0.998], P=0.049) compared to mechanical AVR in patients under 50. In conclusion, for patients under the age of 50, bioprosthetic AVR is associated with increased mortality and risk of reoperation compared to mechanical valves. On the other hand, mechanical AVR is associated with an increased risk of major bleeding events and stroke. These aspects should be carefully considered during the selection of valve type in this age group; however, we should keep in mind that the statistically significant differences in the risk of all-cause death and stroke might not be clinically relevant (due to marginal statistical significance).

2.
Molecules ; 29(13)2024 Jun 28.
Article in English | MEDLINE | ID: mdl-38999030

ABSTRACT

Coatings with xenogenic materials, made of detonation nanodiamonds, provide additional strength and increase elasticity. A functionally developed surface of nanodiamonds makes it possible to apply antibiotics. Previous experiments show the stability of such coatings; however, studies on stability in the bloodstream and calcification of the material in natural conditions have yet to be conducted. Tritium-labeled nanodiamonds (negative and positive) were obtained by the tritium activation method and used to develop coatings for a pork aorta to analyze their stability in a pig's bloodstream using a radiotracer technique. A chitosan layer was applied from a solution of carbonic acid under high-pressure conditions to prevent calcification. The obtained materials were used to prepare a porcine conduit, which was surgically stitched inside the pig's aorta for four months. The aorta samples, including nanodiamond-coated and control samples, were analyzed for nanodiamond content and calcium, using the radiotracer and ICP-AES methods. A histological analysis of the materials was also performed. The obtained coatings illustrate a high in vivo stability and low levels of calcification for all types of nanodiamonds. Even though we did not use additional antibiotics in this case, the development of infection was not observed for negatively charged nanodiamonds, opening up prospects for their use in developing coatings.


Subject(s)
Coated Materials, Biocompatible , Nanodiamonds , Tritium , Animals , Nanodiamonds/chemistry , Swine , Coated Materials, Biocompatible/chemistry , Tritium/chemistry , Aorta , Bioprosthesis , Chitosan/chemistry , Heart Valve Prosthesis
3.
Open Heart ; 11(2)2024 Jul 23.
Article in English | MEDLINE | ID: mdl-39043607

ABSTRACT

OBJECTIVE: To compare long-term cardiovascular (CV) outcomes between men and women with aortic stenosis (AS) undergoing aortic valve replacement (AVR) by the type of valve implant. METHODS: The study population consisted of 14 123 non-selected patients with AS undergoing first-time AVR and included in the Swedish Web system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) registry during 2008-2016. Comparisons were made between men and women and type of valve implant (ie, surgical implantation with a mechanical (mSAVR) (n=1 966) or biological valve (bioSAVR) (n=9 801)) or by a transcatheter approach (TAVR) (n=2 356). Outcomes included all-cause mortality, ischaemic stroke, major bleeding, thromboembolic events, heart failure and myocardial infarction, continuously adjusted for significant comorbidities and medical treatment. RESULTS: In the mSAVR cohort, there were no significant sex differences in any CV events. In the bioSAVR cohort, a higher risk of death (HR: 1.14; 95% CI: 1.04 to 1.26, p=0.007) and major bleeding (HR: 1.41; 95% CI: 1.18 to 1.69, p<0.001) was observed in men. In the TAVR cohort, men suffered a higher risk of death (HR: 1.24; 95% CI: 1.07 to 1.45, p=0.005), major bleeding (HR: 1.35; 95% CI: 1.00 to 1.82, p=0.022) and thromboembolism (HR: 1.35, 95% CI: 1.00 to 1.82, p=0.047). CONCLUSION: No significant long-term difference in CV events was noted between men and women undergoing AVR with a mechanical aortic valve. In both the bioSAVR and TAVR cohort, mortality was higher in men who also had an increased incidence of several other CV events.


Subject(s)
Aortic Valve Stenosis , Aortic Valve , Heart Valve Prosthesis Implantation , Registries , Humans , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Male , Female , Sweden/epidemiology , Aged , Sex Factors , Aged, 80 and over , Risk Factors , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Treatment Outcome , Risk Assessment/methods , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Transcatheter Aortic Valve Replacement/mortality , Heart Valve Prosthesis , Time Factors , Follow-Up Studies , Prognosis , Postoperative Complications/epidemiology , Postoperative Complications/mortality , Incidence , Survival Rate/trends , Retrospective Studies
4.
Circ Cardiovasc Interv ; : e013782, 2024 Jul 22.
Article in English | MEDLINE | ID: mdl-39034924

ABSTRACT

BACKGROUND: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. METHODS: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. RESULTS: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. CONCLUSIONS: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801.

5.
Korean J Anesthesiol ; 2024 Jul 23.
Article in English | MEDLINE | ID: mdl-39039823

ABSTRACT

Background: Minimalist transcatheter aortic valve replacement (TAVR) under monitored anesthesia care (MAC) emphasizes early recovery. Remimazolam is a novel benzodiazepine with a short recovery time. This study hypothesized that remimazolam is non-inferior to dexmedetomidine in terms of recovery after TAVR. Methods: In this retrospective observational study, remimazolam was compared to dexmedetomidine in patients who underwent TAVR under MAC at a tertiary academic hospital between July 2020 and July 2022. The primary outcome was timely recovery after TAVR, defined as discharge from the intensive care unit within the first day following the procedure. Propensity score matching was used to compare timely recovery between remimazolam and dexmedetomidine, applying a non-inferiority margin of -10%. Results: The study included 464 patients, of whom 218 received remimazolam and 246 received dexmedetomidine. After propensity score matching, 164 patients in each group were included in the analysis. Regarding timely recovery after TAVR, remimazolam was non-inferior to dexmedetomidine (152 of 164 [92.7%] in the remimazolam group versus 153 of 164 [93.3%] in the dexmedetomidine group, risk difference [95% CI]: -0.6% [-6.7% to 5.5%]). The use of remimazolam was associated with fewer postoperative vasopressors/inotropes (21 of 164 [12.8%] vs. 39 of 164 [23.8%]) and temporary pacemakers (TPMs) (76 of 164 [46.3%] vs. 108 of 164 [65.9%]) compared to dexmedetomidine. Conclusions: In patients undergoing TAVR under MAC, remimazolam was non-inferior to dexmedetomidine in terms of timely recovery. Remimazolam may be associated with better postoperative recovery profiles, including a lesser need for vasopressors/inotropes and TPMs.

6.
Tex Heart Inst J ; 51(2)2024 Jul 19.
Article in English | MEDLINE | ID: mdl-39028801

ABSTRACT

BACKGROUND: Various techniques have been proposed for the preservation of the subvalvular apparatus (SVA) in mitral valve replacement. This study aimed to compare the midterm results of posterior leaflet preservation with the results of selective preservation of the SVA involving artificial chordae implantation in terms of left ventricular performance in patients undergoing mitral valve replacement. METHODS: In total, 127 patients were included in this study. Patients were allocated to 1 of 2 groups according to the techniques used to preserve the SVA. Patients in group 1 underwent posterior leaflet preservation: The anterior leaflet was completely resected, and the posterior leaflet was preserved. In group 2, which comprised patients with severe leaflet extension and subvalvular fusion, the mitral valve was excised completely and substituted with artificial chordae. All relevant preoperative, intraoperative, and postoperative data were recorded. RESULTS: Mean (SD) ages in groups 1 and 2 were 63.1 (9.65) and 57.1 (12.3) years, respectively (P = .003). Mean (SD) follow-up time was 59.97 (23.63) months (range, 6-99 months). Left ventricular end-diastolic diameter decreased significantly after artificial chordae implantation (P < .001), while the decrease after posterior leaflet preservation was not statistically significant (P = .20). In both groups, there were statistically significant reductions (P < .001) in left ventricular end-systolic diameter and left atrium diameter in the postoperative period compared with respective preoperative levels. During follow-up, left ventricular ejection fraction was found to have increased beyond the preoperative levels in both groups, but the differences were not statistically significant (P > .05). CONCLUSION: Results of echocardiographic observations regarding the preservation of the SVA via artificial chordae implantation for mitral valve disease in this sample were satisfactory. Findings suggest that artificial chordae implantation should be considered when posterior leaflet preservation is not suitable.


Subject(s)
Chordae Tendineae , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve Insufficiency , Mitral Valve , Ventricular Function, Left , Humans , Female , Male , Middle Aged , Mitral Valve/surgery , Mitral Valve/diagnostic imaging , Chordae Tendineae/surgery , Chordae Tendineae/physiopathology , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/adverse effects , Treatment Outcome , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/physiopathology , Time Factors , Ventricular Function, Left/physiology , Retrospective Studies , Aged , Prosthesis Design , Follow-Up Studies
7.
Am J Cardiol ; 2024 Jul 10.
Article in English | MEDLINE | ID: mdl-38996898

ABSTRACT

Recommendations for prosthesis type in older patients who underwent surgical aortic valve replacement (SAVR) are established, albeit undervalidated. The purpose of this study is to compare outcomes after bioprosthetic versus mechanical SAVR across various age groups. This was a retrospective study using an institutional SAVR database. All patients who underwent isolated SAVR were compared across valve types and age strata (<65 years, 65 to 75 years, >75 years). Patients who underwent concomitant operations, aortic root interventions, or previous aortic valve replacement were excluded. Objective survival and aortic valve reinterventions were compared. Kaplan-Meier survival estimation and multivariate regression were performed. A total of 1,847 patients underwent SAVR from 2010 to 2023. A total of 1,452 patients (78.6%) received bioprosthetic valves, whereas 395 (21.4%) received mechanical valves. Of those who received bioprosthetic valves, 349 (24.0%) were aged <65 years, 627 (43.2%) were 65 to 75 years, and 476 (32.8%%) were older than 75 years. For patients who received mechanical valves, 308 (78.0%) were aged <65 years, 84 (21.3%) were between 65 and 75 years, and 3 (0.7%) were >75 years. The median follow-up in the total cohort was 6.2 (2.6 to 8.9) years. No statistically significant differences were observed in early-term Kaplan-Meier survival estimates between SAVR valve types in all age groups. However, the cumulative incidence estimates of aortic valve reintervention were significantly higher in patients aged under 65 years who received bioprosthetic than those who received mechanical valves, with 5-year reintervention rates of 5.8% and 3.1%, respectively (p = 0.002). On competing risk analysis for valve reintervention, bioprosthetic valves were significantly associated with an increased hazard of aortic valve reintervention (hazard ratio 3.35, 95% confidence interval 1.73 to 6.49, p <0.001). In conclusion, SAVR with bioprosthetic valves (particularly, in patients aged <65 years) was comparable in survival to mechanical valve SAVR but significantly associated with increased valve reintervention rates.

8.
Front Med Technol ; 6: 1399729, 2024.
Article in English | MEDLINE | ID: mdl-39011523

ABSTRACT

Over the last years computer modelling and simulation has emerged as an effective tool to support the total product life cycle of cardiovascular devices, particularly in the device preclinical evaluation and post-market assessment. Computational modelling is particularly relevant for heart valve prostheses, which require an extensive assessment of their hydrodynamic performance and of risks of hemolysis and thromboembolic complications associated with mechanically-induced blood damage. These biomechanical aspects are typically evaluated through a fluid-structure interaction (FSI) approach, which enables valve fluid dynamics evaluation accounting for leaflets movement. In this context, the present narrative review focuses on the computational modelling of bileaflet mechanical aortic valves through FSI approach, aiming to foster and guide the use of simulations in device total product life cycle. The state of the art of FSI simulation of heart valve prostheses is reviewed to highlight the variety of modelling strategies adopted in the literature. Furthermore, the integration of FSI simulations in the total product life cycle of bileaflet aortic valves is discussed, with particular emphasis on the role of simulations in complementing and potentially replacing the experimental tests suggested by international standards. Simulations credibility assessment is also discussed in the light of recently published guidelines, thus paving the way for a broader inclusion of in silico evidence in regulatory submissions. The present narrative review highlights that FSI simulations can be successfully framed within the total product life cycle of bileaflet mechanical aortic valves, emphasizing that credible in silico models evaluating the performance of implantable devices can (at least) partially replace preclinical in vitro experimentation and support post-market biomechanical evaluation, leading to a reduction in both time and cost required for device development.

9.
Cardiol Clin ; 42(3): 373-387, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38910022

ABSTRACT

Self-expanding valves (SEV) and balloon-expandable valves (BEV) for transcatheter aortic valve implantation (TAVI) have their own features. There is a growing interest in long-term outcomes with the adoption of lifetime management in younger patients. To evaluate late outcomes in TAVI with SEV versus BEV, we performed a study-level meta-analysis of reconstructed time-to-event data published by May 31, 2023. We found no statistically significant difference in all-cause death after TAVI with SEV versus BEV. Randomized controlled trials are warranted to validate our results.


Subject(s)
Aortic Valve Stenosis , Aortic Valve , Heart Valve Prosthesis , Prosthesis Design , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Treatment Outcome , Time Factors
10.
Am J Cardiol ; 225: 89-97, 2024 Aug 15.
Article in English | MEDLINE | ID: mdl-38897268

ABSTRACT

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.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Tricuspid Valve , Humans , Tricuspid Valve/surgery , Heart Valve Prosthesis Implantation/methods , Bioprosthesis , Reoperation/statistics & numerical data , Time Factors , Heart Valve Diseases/surgery , Prosthesis Design , Treatment Outcome
11.
J Clin Med ; 13(9)2024 May 02.
Article in English | MEDLINE | ID: mdl-38731212

ABSTRACT

Background: Conflicting data exist on the occurrence and outcome of infective endocarditis (IE) after pulmonary valve implantation. Objectives: This study sought to assess the differences between transcatheter pulmonary valve implantation (TPVI) and surgical pulmonary valve replacement (SPVR). Methods: All patients ≥ 4 years who underwent isolated pulmonary valve replacement between 2005 and 2018 were analyzed based on the data of a major German health insurer (≈9.2 million insured subjects representative of the German population). The primary endpoint was a composite of IE occurrence and all-cause death. Results: Of 461 interventions (cases) in 413 patients (58.4% male, median age 18.9 years [IQR 12.3-33.4]), 34.4% underwent TPVI and 65.5% SPVR. IE was diagnosed in 8.0% of cases during a median follow-up of 3.5 years. Risk for IE and all-cause death was increased in patients with prior IE (p < 0.001), but not associated with age (p = 0.50), sex (p = 0.67) or complexity of disease (p = 0.59). While there was no difference in events over the entire observational time period (p = 0.22), the time dynamics varied between TPVI and SPVR: Within the first year, the risk for IE and all-cause death was lower after TPVI (Hazard Ratio (HR) 95% CI 0.19 (0.06-0.63; p = 0.006) but increased over time and exceeded that of SPVR in the long term (HR 10.07 (95% CI 3.41-29.76; p < 0.001). Conclusions: Patients with TPVI appear to be at lower risk for early but higher risk for late IE, resulting in no significant difference in the overall event rate compared to SPVR. The results highlight the importance of long-term specialized care and preventive measures after both interventions.

12.
J Artif Organs ; 2024 May 20.
Article in English | MEDLINE | ID: mdl-38769278

ABSTRACT

Preclinical testing using animal models is indispensable in cardiovascular research. However, the translation to clinical practice of these animal models is questionable since it is not always clear how representative they are. This systematic review intends to summarize the interspecies differences in the coagulation profile of animal models used in cardiovascular research. It aims to guide future research in choosing the optimal animal species. A literature search of PubMed, Embase, Web of Science (Core Collection) and Cochrane Library was performed using a search string that was well defined and not modified during the study. An overview of the search terms used in each database can be found in the appendix. Articles describing coagulation systems in large animals were included. We identified 30 eligible studies of which 15 were included. Compared to humans, sheep demonstrated a less active external pathway of coagulation. Sheep had a higher platelet count but the platelet activatability and response to biomaterials were lower. Both sheep and pigs displayed no big differences in the internal coagulation system compared to humans. Pigs showed results very similar to those of humans, with the exception of a higher platelet count and stronger platelet aggregation in pigs. Coagulation profiles of different species used for preclinical testing show strong variation. Adequate knowledge of these differences is key in the selection of the appropriate species for preclinical cardiovascular research. Future thrombogenicity research should compare sheep to pig in an identical experimental setup.

13.
Circ Cardiovasc Interv ; 17(7): e013558, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38785079

ABSTRACT

BACKGROUND: Elevated aortic valve gradients are common after transcatheter aortic valve implantation for degenerated surgical aortic valve replacement bioprostheses, but their clinical impact is uncertain. METHODS: A total of 12 122 patients who underwent transcatheter aortic valve implantation-in-surgical aortic valve replacement from November 2011 to December 2019 in the Society of Thoracic Surgery/American College of Cardiology Transvalvular Therapeutics Registry were included. The primary outcome was a composite of 1-year all-cause mortality, stroke, myocardial infarction, or valve reintervention. Secondary outcomes included 1-year all-cause mortality, readmission, and change from baseline 12-question self-administered Kansas City Cardiomyopathy Questionnaire-Overall Summary Score. Due to nonlinearity observed with restricted cubic splines analysis, a Cox regression analysis with aortic valve mean gradient modeled as a spline-continuous variable (with 20 mm Hg as a cutoff) was used to study the 1-year composite outcome and mortality. RESULTS: The composite outcome occurred most frequently in patients with aortic valve mean gradient ≥30 and <10 mm Hg, as compared with those with 10 to 20 and 20 to 30 mm Hg ranges (unadjusted rates, 13.9%, 12.1%, 7.5%, and 6.5%, respectively; P=0.002). When the mean aortic valve gradient was ≥20 mm Hg, higher gradients were associated with greater risk of the 1-year composite outcome (adjusted hazard ratio, 1.02 [1.02-1.03] per mm Hg; P<0.001) and 1-year mortality (adjusted hazard ratio, 1.02 [1.00-1.03] per mm Hg; P=0.007). Whereas when the mean aortic valve gradient was <20 mm Hg, higher gradients were not significantly associated with the composite outcome (adjusted hazard ratio, 0.99 [0.98-1.003] per mm Hg; P=0.12) but were associated with lower 1-year mortality (adjusted hazard ratio, 0.98 [0.97-0.99] per mm Hg; P=0.007). CONCLUSIONS: The relationship between postprocedural aortic valve mean gradient after transcatheter aortic valve implantation-in-surgical aortic valve replacement and clinical outcomes is complex and nonlinear, with relatively greater adverse events occurring at low and high gradient extremes. Further study of factors mediating the relationship between postprocedural gradients and clinical outcomes, including low-flow states, is necessary.


Subject(s)
Aortic Valve Stenosis , Aortic Valve , Bioprosthesis , Heart Valve Prosthesis , Prosthesis Failure , Registries , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Transcatheter Aortic Valve Replacement/instrumentation , Female , Male , Aged , Aged, 80 and over , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Risk Factors , Treatment Outcome , Time Factors , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Risk Assessment , Prosthesis Design , Hemodynamics , United States , Retrospective Studies
14.
Article in English | MEDLINE | ID: mdl-38688452

ABSTRACT

OBJECTIVES: Randomized controlled trials comparing transcatheter aortic valve implantation with surgical aortic valve replacement demonstrate conflicting evidence, particularly in low-risk patients. We aim to reevaluate the evidence using trial sequential analysis, balancing type I and II errors, and compare with conventional meta-analysis. METHODS: Databases were searched for randomized controlled trials, which were divided into higher-risk and lower-risk randomized controlled trials according to a pragmatic risk classification. Primary outcomes were death and a composite end point of death or disabling stroke assessed at 1 year and maximum follow-up. Conventional meta-analysis and trial sequential analysis were performed, and the required information size was calculated considering a type I error of 5% and a power of 90%. RESULTS: Eight randomized controlled trials (n = 5274 higher-risk and 3661 lower-risk patients) were included. Higher-risk trials showed no significant reduction in death at 1 year with transcatheter aortic valve implantation (relative risk, 0.93, 95% CI, 0.81-1.08, P = .345). Lower-risk trials suggested lower death risk on conventional meta-analysis (relative risk, 0.67, 95% CI, 0.47-0.96, P = .031), but trial sequential analysis indicated potential spurious evidence (P = .116), necessitating more data for conclusive benefit (required information size = 5944 [59.8%]). For death or disabling stroke at 1 year, higher-risk trials lacked evidence (relative risk, 0.90, 95% CI, 0.79-1.02, P = .108). In lower-risk trials, transcatheter aortic valve implantation indicated lower risk in conventional meta-analysis (relative risk, 0.68, 95% CI, 0.50-0.93, P = .014), but trial sequential analysis suggested potential spurious evidence (P = .053), necessitating more data for conclusive benefit (required information size = 5122 [69.4%]). Follow-up results provided inconclusive evidence for both primary outcomes across risk categories. CONCLUSIONS: Conventional meta-analysis methods may have prematurely declared an early reduction of negative outcomes after transcatheter aortic valve implantation when compared with surgical aortic valve replacement.

15.
Indian J Thorac Cardiovasc Surg ; 40(3): 300-310, 2024 May.
Article in English | MEDLINE | ID: mdl-38681712

ABSTRACT

Purpose: To study the effect of rosuvastatin 40 mg (initiated 7 days prior to surgery) in patients undergoing valve replacement (VR) for rheumatic mitral valve disease on left ventricular (LV) strain and biomarker release kinetics. Methods: In this randomized study, cardiac biomarkers viz. troponin I (TnI), Creatine kinase MB (CK-MB), N-terminal pro B-type natriuretic peptide (NTPBNP) were measured before surgery; and 8, 24 and 48 h postoperatively. Global LV (circumferential, global circumferential strain (GCS); longitudinal, GLS; radial, global radial strain (GRS)) strains were measured preoperatively; and 48 h and 30 days postoperatively. Results: Following VR, Global Longitudinal Strain (GLS), Global Circumferential Strain (GCS) and Global Radial Strain (GRS) declined at 48 h in both statin loaded (SL) and non loaded (NL) groups. The %decline in strain was significantly lower in SL group (% change in GLS 35.8% vs 38.8%, GCS 34% vs 44.1%, GRS 45.7% vs 52.6%; p < 0.001).All strain values improved at 30 days with higher improvement in SL group (GLS -15.92 ± 2.00% vs -12.6 ± 1.66%, GCS -15.12 ± 2.93% vs -13.04 ± 2.44%; GRS 22.12 ± 6.85% vs 19.32 ± 6.48%). While TnI, CKMB, NTPBNP increased following surgery, values at 8, 24 and 48 h were lower in the SL vs. NL group. Mean change (baseline to peak biomarker value) was also significantly lower in SL group.The SL group had shorter hospital and Intensive Care Unit (ICU) stay. On Receiver Operating Characteristic Curve (ROC) analysis, baseline GCS ≤ 14% best predicted postoperative 30 day Left Ventricular Ejection Fraction (LVEF) ≤ 50%. Conclusion: Pre-operative high dose rosuvastatin was "cardioprotective" with favorable effect on LV global strain and release kinetics of biomarkers. These cut-offs (described for the first time for rheumatic VR) can be used as prognostic predictors.

16.
Circulation ; 149(22): e1223-e1238, 2024 May 28.
Article in English | MEDLINE | ID: mdl-38660790

ABSTRACT

Tricuspid valve disease is an often underrecognized clinical problem that is associated with significant morbidity and mortality. Unfortunately, patients will often present late in their disease course with severe right-sided heart failure, pulmonary hypertension, and life-limiting symptoms that have few durable treatment options. Traditionally, the only treatment for tricuspid valve disease has been medical therapy or surgery; however, there have been increasing interest and success with the use of transcatheter tricuspid valve therapies over the past several years to treat patients with previously limited therapeutic options. The tricuspid valve is complex anatomically, lying adjacent to important anatomic structures such as the right coronary artery and the atrioventricular node, and is the passageway for permanent pacemaker leads into the right ventricle. In addition, the mechanism of tricuspid pathology varies widely between patients, which can be due to primary, secondary, or a combination of causes, meaning that it is not possible for 1 type of device to be suitable for treatment of all cases of tricuspid valve disease. To best visualize the pathology, several modalities of advanced cardiac imaging are often required, including transthoracic echocardiography, transesophageal echocardiography, cardiac computed tomography, and cardiac magnetic resonance imaging, to best visualize the pathology. This detailed imaging provides important information for choosing the ideal transcatheter treatment options for patients with tricuspid valve disease, taking into account the need for the lifetime management of the patient. This review highlights the important background, anatomic considerations, therapeutic options, and future directions with regard to treatment of tricuspid valve disease.


Subject(s)
American Heart Association , Tricuspid Valve , Humans , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/pathology , United States , Heart Valve Diseases/therapy , Heart Valve Diseases/diagnostic imaging , Tricuspid Valve Insufficiency/diagnostic imaging , Tricuspid Valve Insufficiency/therapy , Heart Valve Prosthesis Implantation
17.
Circ Cardiovasc Imaging ; 17(4): e016435, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38626096

ABSTRACT

Heart valve replacement has steadily increased over the past decades due to improved surgical mortality, an aging population, and the increasing use of transcatheter valve technology. With these developments, prosthetic valve complications, including prosthetic valve endocarditis, are increasingly encountered. In this review, we aim to characterize the manifestations of prosthetic valve endocarditis using representative case studies from our institution to highlight the advances and contributions of modern multimodality imaging techniques.


Subject(s)
Endocarditis, Bacterial , Endocarditis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Prosthesis-Related Infections , Humans , Aged , Endocarditis, Bacterial/diagnostic imaging , Endocarditis, Bacterial/therapy , Heart Valve Prosthesis/adverse effects , Endocarditis/diagnostic imaging , Endocarditis/etiology , Heart Valve Prosthesis Implantation/adverse effects , Multimodal Imaging , Prosthesis-Related Infections/diagnostic imaging , Prosthesis-Related Infections/therapy
18.
JACC Cardiovasc Interv ; 17(8): 1032-1044, 2024 Apr 22.
Article in English | MEDLINE | ID: mdl-38456883

ABSTRACT

BACKGROUND: The fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported. OBJECTIVES: The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR). METHODS: Patients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes. RESULTS: 10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve area (2.1 ± 0.7 cm2 vs 1.9 ± 0.6 cm2; P < 0.0001) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001). CONCLUSIONS: S3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.


Subject(s)
Aortic Valve Stenosis , Aortic Valve , Balloon Valvuloplasty , Heart Valve Prosthesis , Prosthesis Design , Recovery of Function , Registries , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Female , Humans , Male , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/physiopathology , Balloon Valvuloplasty/adverse effects , Hemodynamics , Postoperative Complications/etiology , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Treatment Outcome , United States
19.
J Infect Public Health ; 17(4): 712-718, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38484416

ABSTRACT

BACKGROUND: Infective endocarditis continues to be a significant concern and may be undergoing an epidemiological transition. METHODS: Were studied 1804 consecutive episodes of infective endocarditis between 1978 and 2022. The mean age was 48 ( ± 19), and 1162 (64%) patients were male. Temporal trends in demographic data, comorbidities, predisposing conditions, microorganisms, complications and in-hospital death have been studied over the decades (1978-1988, 1989-1999, 2000-2010 and 2011-2022). The outcomes and clinical characteristics were modeled using nonlinear cubic spline functions. FINDINGS: Valve surgery was performed in 50% of the patients and overall in-hospital mortality was 30%. From the first to the fourth decade studied, the average age of patients increased from 29 to 57 years (p < 0.001), with significant declines in the occurrence of rheumatic valvular heart disease (15% to 6%; p < 0.001) and streptococcal infections (46% to 33%; p < 0.001). Healthcare-associated infections have increased (9% to 21%; p < 0.001), as have prosthetic valve endocarditis (26% to 53%; p < 0.001), coagulase-negative staphylococcal infections (4% to 11%; p < 0.001), and related-complications (heart failure, embolic events, and perivalvular abscess; p < 0.001). These changes were associated with a decline in adjusted in-hospital mortality from 34% to 25% (p = 0.019). INTERPRETATION: In the 44 years studied, there was an increase in the mean age of patients, healthcare-related, prosthetic valve, coagulase-negative staphylococci/MRSA infections, and related complications. Notably, these epidemiological changes were associated with a decline in the adjusted in-hospital mortality.


Subject(s)
Endocarditis, Bacterial , Endocarditis , Heart Valve Prosthesis , Prosthesis-Related Infections , Staphylococcal Infections , Humans , Male , Adult , Middle Aged , Female , Endocarditis, Bacterial/surgery , Hospital Mortality , Coagulase , Heart Valve Prosthesis/adverse effects , Prosthesis-Related Infections/epidemiology , Endocarditis/epidemiology , Staphylococcus , Staphylococcal Infections/complications
20.
J Am Heart Assoc ; 13(7): e033176, 2024 Apr 02.
Article in English | MEDLINE | ID: mdl-38533939

ABSTRACT

BACKGROUND: It remains controversial whether prosthesis-patient mismatch (PPM) impacts long-term outcomes after surgical aortic valve replacement. We aimed to evaluate the association of PPM with mortality, rehospitalizations, and aortic valve reinterventions. METHODS AND RESULTS: We performed a systematic review with meta-analysis of reconstructed time-to-event data of studies published by March 2023 (according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Sixty-five studies met our eligibility criteria and included 122 989 patients (any PPM: 68 332 patients, 55.6%). At 25 years of follow-up, the survival rates were 11.8% and 20.6% in patients with and without any PPM, respectively (hazard ratio [HR], 1.16 [95% CI, 1.13-1.18], P<0.001). At 20 years of follow-up, the survival rates were 19.5%, 12.1%, and 8.8% in patients with no, moderate, and severe PPM, respectively (moderate versus no PPM: HR, 1.09 [95% CI, 1.06-1.11], P<0.001; severe versus no PPM: HR, 1.29 [95% CI, 1.24-1.35], P<0.001). PPM was associated with higher risk of cardiac death, heart failure-related hospitalizations, and aortic valve reinterventions over time (P<0.001). Statistically significant associations between PPM and worse survival were observed regardless of valve type (bioprosthetic versus mechanical valves), contemporary PPM definitions unadjusted and adjusted for body mass index, and PPM quantification method (in vitro, in vivo, Doppler echocardiography). Our meta-regression analysis revealed that populations with more women tend to have higher HRs for all-cause death associated with PPM. CONCLUSIONS: The results of the present study suggest that any degree of PPM is associated with poorer long-term outcomes following surgical aortic valve replacement and provide support for implementation of preventive strategies to avoid PPM after surgical aortic valve replacement.

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