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1.
Cureus ; 16(6): e63068, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-39055479

RESUMEN

Background Aortic valve (AV) repair is a challenging procedure due to its complexity, lower reproducibility, and steep learning curve. To examine its durability and validity, we investigated mid-term outcomes following AV repair without aortic root replacement. Methods Between March 2007 and May 2018, we retrospectively identified 14 patients who underwent AV repair without aortic root replacement at our institution. We investigated their baseline characteristics and postoperative outcomes, including the reoperation rate due to aortic regurgitation (AR) recurrence. Furthermore, we divided them into two groups: those who required reoperation due to AR recurrence (Group R) and those who did not require reoperation (Group F), and statistically compared them. Results The median age was 52.5 years (IQR: 42.0-60.8), with 11 male patients (78.6%). Eight patients (57.1%) had a bicuspid AV. Five cases (35.7%) underwent reoperation due to AR recurrence during a median follow-up period of 5.5 years. There were no significant differences in baseline characteristics between Group R (n=5, 35.7%) and Group F (n=9, 64.3%), including AR etiology, AV repair procedure, and intraoperative AR grade after the final declamp. All cases in Group R had at least mild to moderate AR on the echocardiogram before discharge. Regarding the AR grade before discharge, Group R had a significantly higher grade than Group F (p = 0.013). Conclusions The indication for AV repair for AR might need to be reassessed due to the considerable mid-term reoperation rate. Cases of AV repair with more than mild AR at discharge should be carefully monitored, as they are likely to require future reoperation for AR.

2.
Ann Cardiothorac Surg ; 13(3): 275-282, 2024 May 31.
Artículo en Inglés | MEDLINE | ID: mdl-38841084

RESUMEN

Background: The desire of patients to avoid anticoagulation, together with the potential of valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR), have resulted in the increasing use of bioprosthetic valves for aortic valve replacement (AVR). While patient-prosthesis mismatch (PPM) is known to be an adverse risk after AVR, few studies have addressed the effect of PPM on valve durability. This study evaluates the role of valve size and hemodynamics on long term durability after AVR with a Magna bioprosthesis. Methods: We performed a retrospective, single-center evaluation of patients who underwent a surgical AVR procedure between June 2004 through December 2022 using the Magna bioprosthesis. Perioperative information and long-term follow-up data were sourced from the institution's Society for Thoracic Surgeons Adult Cardiac Surgery Registry and outcomes database. Cumulative incidence of freedom from reintervention were estimated accounting for competing events. Group comparisons used Gray's test. Results: Among 2,100 patients, the mean patient age was 69 years (range, 22-95 years), of whom 98% had native aortic valve disease, 32.5% had concomitant coronary bypass grafting, and 19% had mitral valve surgery. Median follow-up was 5.8 (1.9-9.4) years, during which 116 reinterventions were performed, including 74 explants and 42 VIV procedures. Nine hundred and twenty-eight patients died prior to reintervention. Incidence of all cause reintervention was 1.2%, 4.5%, and 11.7% at 5, 10, and 15 years, respectively. Smaller valve size was associated with worse survival (P<0.001), but not with reintervention. Higher mean gradient at implant was associated with increased late reintervention [sub-distribution hazard ratio: 1.016; 95% confidence interval (CI): 1.005 to 1.028; P=0.0047, n=1,661]. Conclusions: While reintervention rates are low for the Magna prosthesis at 15 years, the analysis is confounded by the competing risk of death. PPM, as reflected physiologically by elevated post-operative valve gradients, portends an increased risk of intervention. Further study is necessary to elucidate the mechanism of early stenosis in patients who progress to reintervention.

3.
Cardiol Ther ; 13(3): 529-540, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38734999

RESUMEN

INTRODUCTION: The expansion of transcatheter aortic valve implantation (TAVI) to low-risk and younger patients has increased the relevance of the long-term durability of transcatheter heart valves (THV). The present study aims to assess the 10-year durability, hemodynamic performance, and clinical outcomes after TAVI using the CoreValve system. METHODS: An analysis from a prospective registry with predefined clinical and echocardiographic follow-up included 302 patients who underwent TAVI with the CoreValve system between 2007 and 2015. Bioprosthetic valve failure (BVF) was defined as any bioprosthetic valve dysfunction-related death, re-intervention, or severe hemodynamic valve deterioration. RESULTS: At the time of TAVI, the mean age was 80.41 ± 7.01 years, and the Society of Thoracic Surgeons (STS) score was 6.13 ± 5.23%. At latest follow-up (median [IQR]: 5 [2-7] years), cumulative all-cause mortality rates at 3, 5, 7, and 10 years was 23.7%, 40%, 65.8%, and 89.8%, respectively. Mean aortic valve area and transvalvular gradient post-TAVI and at 5, 7, and 10 years were 1.94, 1.87, 1.69, and 1.98 cm2 (p = 0.236) and 8.3, 9.0, 8.2, and 10.1 mmHg (p = 0.796), respectively. Overall, 11 patients had BVF, of whom six had structural valve deterioration (SVD). The 10-year actual and actuarial freedom from BVF was 96.1% and 78.8%, and from SVD was 97.9% and 80.9%, respectively. Three patients developed significant non-SVD due to severe paravalvular leakage, and two patients were diagnosed with infective endocarditis. CONCLUSION: Using an early-generation self-expanding bioprosthesis, we documented durable hemodynamic performance and low rates of BVF and SVD up to 10 years after TAVI.

5.
Circ J ; 2024 May 11.
Artículo en Inglés | MEDLINE | ID: mdl-38735703

RESUMEN

BACKGROUND: Based on the results of a clinical trial in Japan, transcatheter aortic valve replacement (TAVR) for hemodialysis (HD) patients gained approval; however, mid-term TAVR outcomes and transcatheter aortic valve (TAV) durability in HD patients remain unexplored.Methods and Results: We analyzed background, procedural, in-hospital outcome, and follow-up data for 101 HD patients and 494 non-HD patients who underwent TAVR using balloon-expandable valves (SAPIEN XT or SAPIEN 3) retrieved from Osaka University Hospital TAVR database. Periprocedural mortality and TAVR-related complications were comparable between HD and non-HD patients. However, Kaplan-Meier analysis revealed that HD patients had significantly lower survival rates (log-rank test, P<0.001). In addition, HD patients had significantly higher rates of severe structural valve deterioration (SVD) than non-HD patients (Gray test, P=0.038). CONCLUSIONS: TAVR in HD patients had comparable periprocedural mortality but inferior mid-term survival and TAV durability than in non-HD patients. Indications for TAVR in younger HD patients should be carefully determined, considering the possibility of a TAV-in-TAV procedure when early SVD occurs.

6.
Eur J Cardiothorac Surg ; 65(4)2024 Mar 29.
Artículo en Inglés | MEDLINE | ID: mdl-38544298

RESUMEN

Pure aortic regurgitation and dilation of aortic annulus are the most significant risk factors for the failure of pulmonary autograft after the Ross procedure. Aortic annuloplasty has a positive effect on the durability of the autograft. Previously, we described a technique for external annuloplasty with dedicated CORONEO ring. In the present manuscript, we suggest the sizing of annuloplasty based on the diameter of pulmonary autograft annulus.


Asunto(s)
Insuficiencia de la Válvula Aórtica , Estenosis de la Válvula Aórtica , Válvula Pulmonar , Humanos , Autoinjertos , Trasplante Autólogo/efectos adversos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/cirugía , Reoperación/efectos adversos , Válvula Pulmonar/trasplante , Resultado del Tratamiento , Estudios de Seguimiento
7.
Eur Heart J ; 45(13): 1116-1124, 2024 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-38321820

RESUMEN

BACKGROUND AND AIMS: Transcatheter aortic valve implantation (TAVI) has become a viable treatment option for patients with severe aortic valve stenosis across a broad range of surgical risk. The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize patients at lower surgical risk to TAVI or surgical aortic valve replacement (SAVR). The aim of the present study was to report clinical and bioprosthesis outcomes after 10 years. METHODS: The NOTION trial randomized 280 patients to TAVI with the self-expanding CoreValve (Medtronic Inc.) bioprosthesis (n = 145) or SAVR with a bioprosthesis (n = 135). The primary composite outcome was the risk of all-cause mortality, stroke, or myocardial infarction. Bioprosthetic valve dysfunction (BVD) was classified as structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), clinical valve thrombosis, or endocarditis according to Valve Academic Research Consortium-3 criteria. Severe SVD was defined as (i) a transprosthetic gradient of 30 mmHg or more and an increase in transprosthetic gradient of 20 mmHg or more or (ii) severe new intraprosthetic regurgitation. Bioprosthetic valve failure (BVF) was defined as the composite rate of death from a valve-related cause or an unexplained death following the diagnosis of BVD, aortic valve re-intervention, or severe SVD. RESULTS: Baseline characteristics were similar between TAVI and SAVR: age 79.2 ± 4.9 years and 79.0 ± 4.7 years (P = .7), male 52.6% and 53.8% (P = .8), and Society of Thoracic Surgeons score < 4% of 83.4% and 80.0% (P = .5), respectively. After 10 years, the risk of the composite outcome all-cause mortality, stroke, or myocardial infarction was 65.5% after TAVI and 65.5% after SAVR [hazard ratio (HR) 1.0; 95% confidence interval (CI) 0.7-1.3; P = .9], with no difference for each individual outcome. Severe SVD had occurred in 1.5% and 10.0% (HR 0.2; 95% CI 0.04-0.7; P = .02) after TAVI and SAVR, respectively. The cumulative incidence for severe NSVD was 20.5% and 43.0% (P < .001) and for endocarditis 7.2% and 7.4% (P = 1.0) after TAVI and SAVR, respectively. No patients had clinical valve thrombosis. Bioprosthetic valve failure occurred in 9.7% of TAVI and 13.8% of SAVR patients (HR 0.7; 95% CI 0.4-1.5; P = .4). CONCLUSIONS: In patients with severe AS and lower surgical risk randomized to TAVI or SAVR, the risk of major clinical outcomes was not different 10 years after treatment. The risk of severe bioprosthesis SVD was lower after TAVR compared with SAVR, while the risk of BVF was similar.


Asunto(s)
Estenosis de la Válvula Aórtica , Endocarditis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Infarto del Miocardio , Accidente Cerebrovascular , Trombosis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Resultado del Tratamiento , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Infarto del Miocardio/etiología , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Endocarditis/cirugía , Trombosis/etiología
8.
Catheter Cardiovasc Interv ; 103(1): 209-218, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-37957842

RESUMEN

BACKGROUND: Balloon post-dilation (BPD) is a widely adopted strategy to optimize acute results of TAVI, with a positive impact on both paravalvular leak and mean gradients. On the other hand, the inflation of the balloon inside prosthetic leaflets may damage them increasing the risk of structural valve deterioration (SVD). Furthermore, the impact of BPD on long-term clinical outcomes and valve hemodynamics is yet unknown. AIMS: To evaluate the impact of BPD on valve durability and long-term clinical outcomes in patients undergoing self-expanding transcatheter valve implantation (TAVI). METHODS: Echocardiographic and clinical data from the ClinicalService (a nation-based data repository and medical care project) were analyzed. Patients were divided into two groups, those who underwent BPD after TAVI and those who did not. Coprimary endpoints were all-cause death and SVD. Cumulative incidence functions for SVD were estimated. RESULTS: Among 1835 patients included in the study, 417 (22.7%) underwent BPD and 1418 (77.3%) did not undergo BPD. No statistically significant differences at 6-year follow-up were found between groups in terms of all-cause mortality (HR: 1.05, 95% CI: 0.9-1.22; p = 0.557) and SVD (2.1% vs. 1.4%, p = 0.381). In addition, BPD did not predispose to higher risk of cardiovascular death, myocardial infarction, valve thrombosis, and endocarditis at 6-year follow-up. CONCLUSIONS: BPD following TAVI with a self-expanding prosthesis does not seem to be associated with an increased risk of adverse clinical outcomes or SVD at 6-year follow-up.


Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/etiología , Dilatación , Resultado del Tratamiento , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Diseño de Prótesis
9.
J Thorac Cardiovasc Surg ; 167(1): 101-111.e4, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-37532029

RESUMEN

OBJECTIVE: To characterize residual aortic regurgitation (AR), identify its risk factors, and evaluate outcomes following aortic root replacement with aortic valve reimplantation. METHODS: From 2002 to 2020, 756 patients with a tricuspid aortic valve underwent elective reimplantation for aortic root aneurysm. AR on transthoracic echocardiograms before hospital discharge was graded as mild or greater. Machine learning was used to identify risk factors for residual AR and subsequent aortic valve reoperation. RESULTS: Sixty-five patients (8.6%) had mild (58 [7.7%]) or moderate (7 [0.93%]) residual postoperative AR. They had more severe preoperative AR (38% vs 12%; P < .0001), thickened cusps (7.7% vs 2.2%; P = .008), aortic valve repair (38% vs 23%; P = .004), and multiple returns to cardiopulmonary bypass for additional repair (11% vs 3.3%; P = .003) than those without AR. Predictors of residual AR were severe preoperative AR, smaller aortic root graft, and concomitant cusp repair. At 10 years, patients with versus without residual AR had more moderate or severe AR (48% vs 7.0%; P < .0001) and freedom from reoperation was worse (89% vs 98%; P < .0001). Residual AR was a risk factor for early reoperation. Concomitant coronary bypass, lower body mass index, and lower ejection fraction were risk factors for late reoperation. Ten-year survival was similar among patients with and without residual AR (97% vs 93%; P = .43). CONCLUSIONS: Residual AR after elective reimplantation of a tricuspid aortic valve for aortic root aneurysm is uncommon. Patients with severe preoperative AR and those who undergo valve repair have higher risk for residual AR, which can progress and increase risk of aortic valve reoperation.


Asunto(s)
Aneurisma de la Aorta Torácica , Aneurisma de la Raíz de la Aorta , Insuficiencia de la Válvula Aórtica , Humanos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/etiología , Resultado del Tratamiento , Aneurisma de la Aorta Torácica/cirugía , Reoperación , Reimplantación/efectos adversos , Estudios Retrospectivos
10.
Artículo en Inglés | MEDLINE | ID: mdl-37839657

RESUMEN

OBJECTIVE: Guideline recommendations for mechanical or bioprosthetic valve for mitral valve replacement by age remains controversial. We sought to determine bovine pericardial valve durability by age and risk of reintervention. METHODS: This retrospective study between 2 large university-based cardiac surgery programs examined patients who underwent bioprosthetic mitral valve replacement from 2004 to 2020. Follow-up was obtained through June 2022. Durability outcomes involving structural valve deterioration were compared by age decile. RESULTS: Of 1544 available patients, mean age was 66 ± 13 years and 652 (42%) were aged less than 65 years. Indications for mitral valve replacement were as follows: mitral regurgitation greater than 2+ in 53% (n = 813), mitral stenosis in 44% (n = 650), endocarditis in 18% (n = 277), and reoperation in 39% (n = 602). Concomitant procedures were aortic valve replacement in 28% (n = 426), tricuspid valve in 36% (n = 550), and coronary artery bypass in 19% (n = 290). Thirty-day mortality was 5.4%. In follow-up (clinical: median [interquartile range] 75 [25-129] months), reoperation for endocarditis and new stroke were low (0.30 and 1.06 per 100 patient/years, respectively). The cumulative incidence of mitral valve reintervention for structural valve deterioration among all patients was 6.2% at 10 years and 9.0% at 12 years with no statistical difference in structural valve deterioration in patients aged 40 to 70 years (P = .1). In 90 patients with mitral valve reintervention, 30-day mortality after reintervention was 4.7% (n = 2) for 43 with mitral valve-in-valve and 6.4% (n = 3) for 47 with reoperation. CONCLUSIONS: Bovine pericardial mitral valve replacement is a durable option for younger patients. The opportunity to avoid anticoagulation and the associated risks with mechanical mitral valve replacement may be of benefit to patients. These insights may provide data needed to revise the current guidelines.

11.
Artículo en Inglés | MEDLINE | ID: mdl-37462612

RESUMEN

OBJECTIVES: We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. METHODS: The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed. RESULTS: A total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm2. CONCLUSIONS: The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT03666741.

12.
J Artif Organs ; 2023 Apr 26.
Artículo en Inglés | MEDLINE | ID: mdl-37099052

RESUMEN

The aim of this study was to review long-term clinical outcomes and valve performance after Epic Supra valve implantation in aortic position. From 2011 to 2022, 44 patients (mean age 75 ± 8 years) underwent surgical aortic valve replacement (SAVR) with an Epic Supra valve at our hospital. Survival, incidence of late complications, and echocardiographic date were retrospectively analyzed. During a mean follow-up period of 6.2 ± 3.5 years, the overall survival rate was 91 ± 4% at 2 and 88 ± 5% at 5 years, while rates of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) were 86 ± 5% and 83 ± 6%, respectively. There was one case of reoperation for prosthetic valve endocarditis at 6 years after the initial surgery. Echocardiographic examinations showed 5-year rates of freedom from severe structural valve deterioration (SVD) and moderate SVD of 100 and 92%, respectively. There was no significant increase in mean pressure gradient or decrease in left ventricular ejection fraction from 1 week after surgery to the late follow-up period. Long-term clinical results and durability of the Epic Supra valve in aortic position were satisfactory.

13.
Catheter Cardiovasc Interv ; 101(5): 932-942, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36924015

RESUMEN

BACKGROUND: With expansion of transcatheter aortic valve implantation (TAVI) into younger patients, valve durability is critically important. AIMS: We aimed to evaluate long-term valve function and incidence of severe structural valve deterioration (SVD) among patients ≥ 10-years post-TAVI and with echocardiographic follow-up at least 5-years postprocedure. METHODS: Data on patients who underwent TAVI from 2007 to 2011 were obtained from the UK TAVI registry. Patients with paired echocardiograms postprocedure and ≥5-years post-TAVI were included. Severe SVD was determined according to European task force guidelines. RESULTS: 221 patients (79.4 ± 7.3 years; 53% male) were included with median echocardiographic follow-up 7.0 years (range 5-13 years). Follow-up exceeded 10 years in 43 patients (19.5%). Valve types were the supra-annular self-expanding CoreValve (SEV; n = 143, 67%), balloon-expandable SAPIEN/XT (BEV; n = 67, 31%), Portico (n = 4, 5%) and unknown (n = 7, 3%). There was no difference between postprocedure and follow-up peak gradient in the overall cohort (19.3 vs. 18.4 mmHg; p = NS) or in those with ≥10-years follow-up (21.1 vs. 21.1 mmHg; p = NS). Severe SVD occurred in 13 patients (5.9%; median 7.8-years post-TAVI). Three cases (23.1%) were due to regurgitation and 10 (76.9%) to stenosis. Valve-related reintervention/death occurred in 5 patients (2.3%). Severe SVD was more frequent with BEV than SEV (11.9% vs. 3.5%; p = 0.02), driven by a difference in patients treated with small valves (BEV 28.6% vs. SEV 3.0%; p < 0.01). CONCLUSIONS: Hemodynamic function of transcatheter heart valves remains stable up to more than 10 years post-TAVI. Severe SVD occurred in 5.9%, and valve-related death/reintervention in 2.3%. Severe SVD was more common with BEV than SEV.


Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Femenino , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Sistema de Registros , Reino Unido , Diseño de Prótesis
14.
Cardiovasc Res ; 119(1): 302-315, 2023 03 17.
Artículo en Inglés | MEDLINE | ID: mdl-35020813

RESUMEN

AIMS: Bioprosthetic heart valves (BHVs), made from glutaraldehyde-fixed heterograft materials, are subject to more rapid structural valve degeneration (SVD) in paediatric and young adult patients. Differences in blood biochemistries and propensity for disease accelerate SVD in these patients, which results in multiple re-operations with compounding risks. The goal of this study is to investigate the mechanisms of BHV biomaterial degeneration and present models for studying SVD in young patients and juvenile animal models. METHODS AND RESULTS: We studied SVD in clinical BHV explants from paediatric and young adult patients, juvenile sheep implantation model, rat subcutaneous implants, and an ex vivo serum incubation model. BHV biomaterials were analysed for calcification, collagen microstructure (alignment and crimp), and crosslinking density. Serum markers of calcification and tissue crosslinking were compared between young and adult subjects. We demonstrated that immature subjects were more susceptible to calcification, microstructural changes, and advanced glycation end products formation. In vivo and ex vivo studies comparing immature and mature subjects mirrored SVD in clinical observations. The interaction between host serum and BHV biomaterials leads to significant structural and biochemical changes which impact their functions. CONCLUSIONS: There is an increased risk for accelerated SVD in younger subjects, both experimental animals and patients. Increased calcification, altered collagen microstructure with loss of alignment and increased crimp periods, and increased crosslinking are three main characteristics in BHV explants from young subjects leading to SVD. Together, our studies establish a basis for assessing the increased susceptibility of BHV biomaterials to accelerated SVD in young patients.


Asunto(s)
Bioprótesis , Calcinosis , Prótesis Valvulares Cardíacas , Animales , Ratas , Ovinos , Válvulas Cardíacas , Materiales Biocompatibles , Colágeno
15.
J Mech Behav Biomed Mater ; 135: 105434, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-36116342

RESUMEN

Transcatheter heart valve replacement is becoming a more routine procedure, and this is further supported by positive outcomes from studies involving low-risk patients. Nevertheless, the lack of long-term transcatheter heart valve (TAV) durability is still one of the primary concerns. As a result, more research has been focused on improving durability through various methods such as valve design, computational modeling, and material selection. Recent advancements in polymeric valve fabrication showed that linear low-density polyethylene (LLDPE) could be used as leaflet material for transcatheter heart valves. In this paper, a parametric study of computational simulations showed stress distribution on the leaflets of LLDPE-TAV under diastolic load, and the results were used to improve the stent design. The in silico experiment also tested the effect of shock absorbers in terms of valve durability. The results demonstrated that altering specific stent angles can significantly lower peak stress on the leaflets (13.8 vs. 6.07 MPa). Implementing two layers of shock absorbers further reduces the stress value to 4.28 MPa. The pinwheeling index was assessed, which seems to correlate with peak stress. Overall, the parametric study and the computational method can be used to analyze and improve valve durability.


Asunto(s)
Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica , Simulación por Computador , Humanos , Modelos Cardiovasculares , Polietileno , Diseño de Prótesis , Estrés Mecánico , Reemplazo de la Válvula Aórtica Transcatéter/métodos
16.
JTCVS Open ; 9: 59-69, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36003435

RESUMEN

Background: This study assessed the long-term hemodynamic functional performance of the new Inspiris Resilia aortic valve after accelerated wear testing (AWT). Methods: Three 21-mm and 23-mm Inspiris valves were used for the AWT procedure. After 1 billion cycles (equivalent to 25 years), the valves' hemodynamic performance was compared with that of the corresponding zero-cycled condition. Next, 1 AWT cycled valve of each valve size was selected at random for particle image velocimetry (PIV) and leaflet kinematic tests, and the data were compared with data for an uncycled Inspiris Resilia aortic valve of the same size. PIV was used to quantitatively evaluate flow fields downstream of the valve. Valves were tested according to International Standards Organization 5840-2:2015 protocols. Results: The 21-mm and 23-mm valves met the International Organization for Standardization (ISO) durability performance requirements to 1 billion cycles. The mean effective orifice areas for the 21-mm and 23-mm zero-cycled and 1 billion-cycled valves were 1.89 ± 0.02 cm2 and 1.94 ± 0.01 cm2, respectively (P < .05) and 2.3 ± 0.13 cm2 and 2.40 ± 0.11 cm2, respectively (P < .05). Flow characterization of the control valves and the study valves demonstrated similar flow characteristics. The velocity and shear stress fields were also similar in the control and study valves. Conclusions: The Inspiris Resilia aortic valve demonstrated very good durability and hemodynamic performance after an equivalent of 25 years of simulated in vitro accelerated wear. The study valves exceeded 1 billion cycles of simulated wear, 5 times longer than the standard requirement for a tissue valve as stipulated in ISO 5840-2:2015.

17.
Arch Cardiovasc Dis ; 115(6-7): 369-376, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35715323

RESUMEN

BACKGROUND: Transcatheter aortic valve replacement is an established treatment for high- or intermediate-risk patients with symptomatic aortic valve stenosis. As more low-risk patients are being treated, transcatheter heart valve durability is gaining importance. Data on structural valve deterioration beyond 8 years after transcatheter aortic valve replacement is limited. AIM: To evaluate the outcomes of transcatheter aortic valve replacement in high-risk patients with a follow-up of ≥10 years, focusing on survival and structural valve deterioration, according to the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery definitions. METHODS: Only patients with a follow-up of ≥ 10 years were included in this study (n=510). Using serial echocardiographic data, the cumulative incidences of structural valve deterioration and bioprosthetic valve failure were analysed. Receiver operating characteristic analysis was used for predictor assessment. RESULTS: Mean age was 79.6±6.7 years, with a mean logistic EuroSCORE of 19.8±12.7%. Immediate procedural mortality was 2.9%, and 30-day mortality was 7.8%. Kaplan-Meier-estimated survival at 10 years was 10.3±1.5%. At 10 years, the cumulative incidences of severe and moderate structural valve deterioration were 4.3% and 13%, respectively, for the total population. The cumulative incidence of bioprosthetic valve failure at 10 years was 9.0%. There was a significant difference in the rates of structural valve deterioration and bioprosthetic valve failure depending on valve type: structural valve deterioration, SAPIEN 8.9% vs CoreValve 2.2% at 10 years (P=0.001); bioprosthetic valve failure, SAPIEN 13.9% vs CoreValve 6.7% at 10 years (P=0.021). CONCLUSIONS: Structural valve deterioration and bioprosthetic valve failure of early transcatheter heart valves was low at 10 years. The identified differences between valve types must be validated using current-generation devices in younger patients.


Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Falla de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , Bioprótesis , Ecocardiografía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Tasa de Supervivencia
20.
Herz ; 46(5): 429-436, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34427692

RESUMEN

As we approach 20 years of clinical experience with transcatheter aortic valve replacement (TAVR), a vast portfolio of high-quality clinical data has accumulated, confirming the safety and efficacy of TAVR across the entire spectrum of surgical risk. Although many aspects of this innovative therapy have been thoroughly studied, several challenges remain. As TAVR is expanding to include younger low-risk patients, with longer life expectancy, one major unsolved issue is represented by transcatheter heart valve (THV) durability, since robust THV durability data are currently limited to approximately 5-6 years. Additionally, steric interactions between THV components and coronary ostia may render coronary access particularly difficult, and thus personalized decisions regarding THV type and implanting techniques are of paramount importance to secure future coronary access. Since bicuspid aortic valve (BAV) stenosis may be associated with unfavorable anatomic factors, it has represented an exclusion criterion in major randomized TAVR trials. Albeit promising data are available from multicenter registries, results of specifically designed randomized trials are eagerly needed to inform use of TAVR for BAV stenosis. Although valve-in-valve (ViV) TAVR has emerged as an effective treatment option for degenerated aortic bioprostheses, ViV procedures are associated with specific risks, which mandated the development of specific techniques aimed at reducing the occurrence of periprocedural adverse events. Despite the transfemoral approach represents the access of choice for TAVR, a significant proportion of patients have significant peripheral artery disease and alternative vascular access routes have been increasingly evaluated with encouraging data regarding their safety and feasibility.


Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Humanos , Estudios Multicéntricos como Asunto , Diseño de Prótesis , Factores de Riesgo , Resultado del Tratamiento
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