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1.
Int J Cardiol ; 357: 115-120, 2022 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-35337936

RESUMO

BACKGROUND: Direct comparisons of latest-generation balloon-expandable versus self-expanding transcatheter heart valves (THV) are scarce. To compare outcomes after transcatheter aortic valve replacement (TAVR) with SAPIEN 3 Ultra (Ultra) versus Evolut R or Pro (Evolut) THVs. METHODS: 1612 consecutive patients undergoing TAVR with either Ultra (n = 616) or Evolut (n = 996) were included. After propensity score matching (PSM), 467 and 205 matched pairs were identified in the entire cohort and with latest-generation THVs, respectively. Outcomes were investigated up to 30 days after TAVR. RESULTS: After PSM, baseline characteristics were comparable in the entire cohort (n = 934). Device success (92.7% vs. 87.6%; p = 0.011) and need for permanent pacemaker implantation (PPI) (15.2% vs. 8.4%; p = 0.002) were higher for Evolut compared with Ultra. Elevated gradients (≥20 mm Hg) were less frequent (1.6% vs. 10.4%; p < 0.001), whereas rates of ≥ moderate paravalvular leakage (PVL II+) were more frequent for Evolut compared with Ultra (3.7% vs. 1.3%; p = 0.019). With latest-generation THVs (n = 410), device success was comparable (93.2% vs. 89.8%; p = 0.216), whereas the need for PPI was higher for Evolut Pro compared with Ultra (15.6% vs. 9.8%; p = 0.075). Elevated gradients were less frequent (0% vs. 8%; p < 0.001), whereas rates of PVL II+ were more frequent for Evolut compared with Ultra (5.4% vs. 1.5%; p = 0.028). CONCLUSIONS: Device success rates were high with both THV platforms with low rates of adverse events up to 30 days after TAVR. Compared with Ultra, Evolut was associated with higher pacemaker rates as well as PVL II+, but with less elevated gradients.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Humanos , Desenho de Prótese , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
2.
Cardiovasc Revasc Med ; 36: 99-106, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34099410

RESUMO

INTRODUCTION: Trials investigating aspirin omission in patients taking oral anticoagulation (OAC) after percutaneous coronary intervention (PCI) or acute coronary syndrome (ACS) were not powered to assess rates of major bleeding or ischemic events. METHODS: We performed an updated meta-analysis and network analysis of randomized trials comparing treatment with or without aspirin in patients taking OAC and a P2Y12-inhibitor after PCI or ACS. The primary outcome was TIMI major bleeding. RESULTS: Five trials enrolling 11,542 patients allocated to antithrombotic regimens omitting (n = 5795) or including aspirin (n = 5747) were included. Aspirin omission was associated with a lower risk of TIMI major bleeding (RR = 0.56, 95% CI [0.44-0.71]; P < 0.001) but a trend towards a higher risk of MI (RR = 1.21, 95% CI [0.99-1.47]; P = 0.06), which was significantly higher when only non-vitamin K antagonist OAC (NOAC)-based trials were considered (Pinteraction = 0.02). The risk of stent thrombosis was comparable with both strategies (RR = 1.29, 95% CI [0.87-1.90]; P = 0.20), with a trend towards a higher risk of ST with aspirin omission when only NOAC-based trials were considered (Pinteraction = 0.06). Risks of stroke and death were similar with both strategies. Network meta-analysis ranked dabigatran (low dose) without aspirin as the best strategy for bleeding reduction (P-score = 0.86) and apixaban with aspirin as the best strategy for MI reduction (P-score = 0.66). CONCLUSIONS: In patients taking OAC after PCI or ACS, aspirin omission is associated with a lower risk of TIMI major bleeding, with a numerically increased risk of MI, which is statistically significant when only NOAC-based trials are considered. This supports individualization of the treatment regimen based on patient risk.


Assuntos
Síndrome Coronariana Aguda , Fibrilação Atrial , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/terapia , Anticoagulantes/efeitos adversos , Aspirina/efeitos adversos , Fibrilação Atrial/complicações , Fibrinolíticos/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
4.
Clin Res Cardiol ; 110(12): 1993-2006, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34505192

RESUMO

BACKGROUND: Bicuspid aortic valve may be associated with increased complications during transcatheter aortic valve implantation (TAVI). AIMS: Compare balloon-expandable transcatheter heart valve (THV) safety and efficacy in severe tricuspid (TAV) and bicuspid (BAV) aortic stenosis. METHODS: Transfemoral TAVI was performed in 743 patients (Jan 2014-June 2019) using the SAPIEN 3 THV. Aortic valve morphology was determined using computed tomography. Valve Academic Research Consortium-2 (VARC-2) derived safety and efficacy endpoints at 1 year were evaluated. RESULTS: BAV patients (n = 78), were younger (77 [72, 81] vs. 81 [78, 85] years, p < 0.001) with lower surgical risk (EuroSCORE II 2.96% vs. 4.51% p < 0.001). Bicuspid valves were more calcified (BAV 1308mm3, TAV 848mm3 p < 0.001) with more asymmetric calcification (BAV 63/78 (81%), TAV 239/665 (36%), p < 0.001). Device success (BAV 94%, TAV 90%, p = 0.45) and major vascular complications (BAV 6%, TAV 9%, p = 0.66) were comparable. At 1 year, there was a trend toward lower combined all-cause mortality and rehospitalization for congestive heart failure in BAV patients (BAV 7%, TAV 13%, p = 0.08) with significantly lower all-cause mortality in this cohort (BAV 1%, TAV 9%, p = 0.020). VARC-2 time-related valve safety (BAV 22%, TAV 20%, p = 0.60) was comparable; however, bioprosthetic valve thrombosis remained more common in BAV patients (BAV 7%, TAV 2%, p = 0.010, Hazard ratio 3.57 [95% confidence interval 1.26, 10.10]). After propensity score matching, only bioprosthetic valve thrombosis remained significantly different. CONCLUSIONS: Safety and efficacy of the SAPIEN 3 balloon-expandable THV in BAV is comparable with TAV. Higher rates of bioprosthetic valve thrombosis require further investigation.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/métodos , Valva Tricúspide/cirurgia , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Feminino , Seguimentos , Humanos , Masculino , Tomografia Computadorizada Multidetectores/métodos , Desenho de Prótese , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
5.
Herz ; 46(5): 429-436, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34427692

RESUMO

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.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Humanos , Estudos Multicêntricos como Assunto , Desenho de Prótese , Fatores de Risco , Resultado do Tratamento
7.
Am J Cardiol ; 139: 71-78, 2021 01 15.
Artigo em Inglês | MEDLINE | ID: mdl-33190811

RESUMO

We aimed to evaluate the efficacy and safety of a low-dose imaging protocol to reduce intraprocedural radiation during transcatheter aortic valve implantation (TAVI). Observational analysis: 802 transfemoral TAVI patients receiving balloon-expandable devices ≥23 mm at a high-volume centre. After propensity score matching, a standard-dose group (SD, n = 333) treated between January 2014 and February 2016 was compared with a low-dose group (LD, n = 333) treated between August 2017 and March 2019 after departmental uptake of a low-dose imaging protocol (reduced field size, high table height, use of "fluoro save," 3.75 frames/second acquisition, increased filtering). Primary end point was dose-area product (DAP). Secondary safety end points were VARC-2 device success and a composite of in-hospital complications. The LD protocol was associated with lower DAP (4.64 [2.93, 8.42] vs 22.73 [12.31, 34.58] Gy⋅cm2, p <0.001) and fluoroscopy time (10.4 [8.1, 13.9] vs 11.5 [9.1, 15.3] minutes, p = 0.001). Contrast use was higher in the LD group (LD 110 [94, 130] vs SD 100 [80, 135] milliliters, p = 0.042). Device success (LD 88.3% vs SD 91.3%, p = 0.25), and the composite end point (LD 8.1% vs SD 11.4%, p = 0.19) were similar. In multivariate analysis, the low-dose protocol was associated with a 19.8 Gy⋅cm2 reduction in procedural DAP (p <0.001). In conclusion, compared with standard imaging, a low-dose protocol for TAVI significantly reduced radiation dose without compromising outcomes.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Fluoroscopia/métodos , Lesões por Radiação/prevenção & controle , Cirurgia Assistida por Computador/métodos , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Relação Dose-Resposta à Radiação , Feminino , Humanos , Masculino , Prognóstico , Estudos Retrospectivos , Fatores de Risco
8.
J Thorac Dis ; 12(11): 6769-6779, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33282378

RESUMO

BACKGROUND: This study compares two latest-generation self-expanding transcatheter heart valves (THV), the supra-annular ACURATE neo (Boston Scientific) and the intra-annular Centera THV (Edwards Lifesciences). METHODS: In this single center observational cohort trial 317 patients treated with the ACURATE neo and 78 patients treated with the Centera TVH were included. The main endpoints were device success and the early safety endpoint at 30 days. RESULTS: Besides higher incidence of diabetes mellitus and higher body mass index in patients treated with the ACURATE neo THV, there were no baseline differences between the groups. Device success was similar in both groups (neo: 91.8% vs. Centera: 93.6%; P=0.598), with numerically higher rates of moderate to severe paravalvular leakage in the ACURATE neo group (4.7% vs. 1.3%; P=0.214). At 30 days all-cause mortality rates were low in both groups (0.3% vs. 0%; P=0.620) and no difference occurred in the early safety at 30 days (19.3% vs. 16.7%; P=0.599). However, all-cause stroke rates were significantly higher in patients treated with the Centera THV (6.4 vs. 1.6%; P=0.015). CONCLUSIONS: The ACURATE neo and the Centera THV show low mortality rates as well as comparable, favorable hemodynamics. The finding of higher stroke rates at 30 days with the repositionable Centera SE-THV needs further assessment.

9.
JACC Cardiovasc Interv ; 13(22): 2631-2638, 2020 11 23.
Artigo em Inglês | MEDLINE | ID: mdl-33129822

RESUMO

OBJECTIVES: The aim of this study was to compare outcomes after transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra (Ultra) and SAPIEN 3 (S3) transcatheter heart valves (THVs). BACKGROUND: The latest generation balloon-expandable Ultra THV incorporates new technical features and might improve outcomes following TAVR. METHODS: This registry included all consecutive patients who underwent TAVR with either the Ultra or S3 between January 2014 and January 2020. One-to-one propensity score matching was performed to account for differences in baseline characteristics. In-hospital and 30-day Valve Academic Research Consortium-2-defined outcomes were investigated. RESULTS: A total of 310 patients (n = 155 Ultra, n = 155 S3) were included. There were no significant differences in baseline characteristics after propensity score matching. Procedures were significantly more often performed under conscious sedation with Ultra compared with S3 (97.4% vs. 71.6%; p < 0.001). Pre-dilatation was more frequent with S3 compared with Ultra (85.2% vs. 42.6%; p < 0.001). In-hospital outcomes, including device success (91.6% vs. 95.5%; p = 0.165), major vascular complications (12.3% vs. 11.0%; p = 0.723), and new pacemaker implantation (5.8% vs. 4.5%; p = 0.608), were comparable between S3 and Ultra patients, respectively. Post-procedural mean transprosthetic gradients (13.2 ± 5.7 mm Hg vs. 13.1 ± 4.7 mm Hg; p = 0.829) and rate of moderate or greater paravalvular leakage (PVL) (1.3% vs. 2.7%; p = 0.414) were comparable, whereas mild PVL was more frequent with S3 compared with Ultra (43.0% vs. 18.7%; p < 0.001). CONCLUSIONS: Device success rates were high with both balloon-expandable THVs, with overall low rates of adverse events up to 30 days after TAVR. Despite a lower frequency of pre-dilatation, significant reduction of mild PVL confirms improved annular sealing properties of the novel Ultra THV.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Humanos , Desenho de Prótese , Resultado do Tratamento
10.
Am J Cardiol ; 127: 99-104, 2020 07 15.
Artigo em Inglês | MEDLINE | ID: mdl-32386815

RESUMO

Transfemoral Transcatheter Aortic Valve Implantation (tf-TAVI) has become an established therapy-option for patients with symptomatic severe aortic stenosis. Conscious sedation (CS) has proven to be an alternative to general anesthesia . So far, the outcome of patients undergoing unplanned periprocedural conversion from CS to general anesthesia has not been investigated. All patients undergoing transfemoral transcatheter aortic valve implantation in CS between 2014 and 2019 were included. The primary end point was early safety at 30 days according to Valve Academic Research Consortium-2 criteria. The reasons for conversion and length of ICU-/ hospital stay were further analyzed. Of 1,058 included patients 35 (3.3%) required a conversion. The end point was documented in 13 (37%) of the converted and 110 (11%) of nonconverted patients (p < 0.001). The causes were: unrest in 11/35 patients, procedural complications in 10/35 patients, respiratory distress in 8/35, and cardiovascular decompensation in 6 patients (17.1%). Compared with the group without conversion (Median (interquartile range ), 4 [4-5] days), length of hospital stay was longest in the group with procedural complications (6 [1-11] days) followed by cardiovascular decompensation (5 [4-7] days). In conclusion, the conversion rate to general anesthesia was low in a large cohort of unselected transcatheter aortic valve implantation patients. Additionally, hospital stay was longer dependent on the reason for conversion.


Assuntos
Anestesia Geral/métodos , Estenose da Valva Aórtica/cirurgia , Cateterismo Periférico/métodos , Sedação Consciente/métodos , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Feminino , Artéria Femoral , Seguimentos , Alemanha/epidemiologia , Mortalidade Hospitalar/tendências , Humanos , Tempo de Internação/tendências , Masculino , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
13.
Clin Res Cardiol ; 108(10): 1069-1073, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31267238

RESUMO

Implantation of bioprosthetic surgical valves has been a common procedure in elderly patients with severe aortic stenosis due to patients´ preferences avoiding anticoagulation therapy. However, this valve presents sometime certain deterioration degree (i.e., dysfunction due to stenosis or regurgitation) or even paravalvular leak. Transcatheter heart valve implantation is a good alternative in high-risk patients. The valve-in-valve procedure has been shown to be a safe and effective procedure. However, the presence of the fixed sewing ring of the surgical bioprosthesis can hamper appropriate expansion of the THV. For this reason, the use of cracking balloon seems to be a safe alternative to increase the effective orifice area. We present a case of a patient with a degenerated previous implanted biological valve and paravalvular leak. We used the treatment strategy of valve-in-valve with post-dilatation with high-pressure balloon, in a way to treat both, the degenerated valve and the paravalvular leak. The use of a single percutaneous procedure was enough and safe to treat both problems without further complications.


Assuntos
Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/diagnóstico , Ecocardiografia , Humanos , Masculino , Desenho de Prótese , Falha de Prótese , Reoperação
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