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1.
Clin Res Cardiol ; 2022 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-35482101

RESUMO

With growing experience, technical improvements and use of newer generation drug-eluting stents (DES), recent data showed satisfactory acute and long-term results after rotational atherectomy (RA) in calcified coronary lesions. The randomized ROTAXUS and PREPARE-CALC trials compared RA to balloon-based strategies in two different time periods in the DES era. In this manuscript, we assessed the technical evolution in RA practice from a pooled analysis of the RA groups of both trials and established a link to further recent literature. Furthermore, we sought to summarize and analyze the available experience with RA in different patient and lesion subsets, and propose recommendations to improve RA practice. We also illustrated the combination of RA with other methods of lesion preparation. Finally, based on the available evidence, we propose a simple and practical approach to treat severely calcified lesions.

3.
Cardiovasc Revasc Med ; 33: 26-31, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-33451925

RESUMO

BACKGROUND/PURPOSE: In the randomized PREPARE-CALC trial, lesion preparation of calcified lesions with upfront rotational atherectomy (RA) prior to drug-eluting stent (DES) implantation resulted in higher acute success as compared to a provisional modified balloon (MB) strategy. We aimed to investigate the impact of calcified lesion complexity on the treatment effect with either MB or RA. METHODS/MATERIALS: Two hundred patients were randomized to lesion preparation with either MB or RA. The study population was stratified according to lesion complexity into at least one type-C lesion or into exclusively non-type-C lesions. Endpoints were strategy success, need for bail-out RA, acute lumen gain, and late lumen loss (LLL) at 9 months. RESULTS: In total, 143 patients were graded as type-C (45% patients were allocated to MB), whereas 57 patients were graded as non-type-C (61% patients were allocated to MB). In patients with at least one type-C lesion, strategy success with RA was higher than with MB (97% vs 72%, p < 0.001), but superiority of RA was not observed in patients with non-type-C lesions (100% vs 97%, p = 1.00; pinteraction = 0.001). The need for bail-out RA was higher in patients with type-C lesions (n = 15) as compared with non-type-C lesions (n = 1). Acute lumen gain, LLL, and target lesion revascularization at 9 months were not dependent on lesion complexity and upfront lesion preparation strategy. CONCLUSIONS: In patients with calcified non-type-C lesions, the treatment strategy with RA or MB before DES implantation results in comparable success rates, whereas in type-C lesions upfront RA appears to be the superior upfront strategy.


Assuntos
Angioplastia Coronária com Balão , Aterectomia Coronária , Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Calcificação Vascular , Aterectomia Coronária/efeitos adversos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia
4.
J Interv Cardiol ; 2020: 9740938, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33223974

RESUMO

OBJECTIVES: To analyze the impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions. BACKGROUND: The impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions is poorly investigated. METHODS: We performed an as-treated analysis on 47 calcified bifurcation lesions treated with scoring/cutting balloons (SCB) and 68 lesions treated with rotational atherectomy (RA) in the PREPARE-CALC trial. Compromised side branch (SB) as assessed in the final angiogram was the primary outcome measure and was defined as any significant stenosis, dissection, or thrombolysis in myocardial infarction flow <3. RESULTS: True bifurcation lesions were present in 49% vs. 43% of cases in the SCB and RA groups, respectively. After stent implantation, SB balloon dilatation was necessary in around one-third of cases (36% vs. 38%; p = 0.82), and a two-stent technique was performed in 21.3% vs. 25% (p = 0.75). At the end of the procedure, the SB remained compromised in 15 lesions (32%) in the SCB group and 5 lesions (7%) in the RA group (p = 0.001). Large coronary dissections were more frequently observed in the SCB group (13% vs. 2%; p = 0.02). Postprocedural levels of cardiac biomarkers were significantly higher in patients with a compromised SB at the end of the procedure. CONCLUSIONS: In the PREPARE-CALC trial, side branch compromise was more frequently observed after lesion preparation with SCB as compared with RA. Consequently, in calcified bifurcation lesions, an upfront debulking with an RA-based strategy might optimize the result in the side branch.


Assuntos
Angioplastia Coronária com Balão , Aterectomia Coronária , Angiografia Coronária/métodos , Doença da Artéria Coronariana , Vasos Coronários , Complicações Pós-Operatórias , Calcificação Vascular , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/métodos , Angioplastia Coronária com Balão/estatística & dados numéricos , Aterectomia Coronária/efeitos adversos , Aterectomia Coronária/métodos , Aterectomia Coronária/estatística & dados numéricos , Doença da Artéria Coronariana/patologia , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Vasos Coronários/cirurgia , Feminino , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Risco Ajustado/métodos , Calcificação Vascular/diagnóstico , Calcificação Vascular/cirurgia
5.
JACC Cardiovasc Interv ; 13(9): 1071-1082, 2020 05 11.
Artigo em Inglês | MEDLINE | ID: mdl-32305398

RESUMO

OBJECTIVES: The purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years. BACKGROUND: The CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV. METHODS: The CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability. RESULTS: After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm2 vs. 1.9 ± 0.5 cm2; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63). CONCLUSIONS: Five-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202).


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Valvuloplastia com Balão , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Valvuloplastia com Balão/efeitos adversos , Valvuloplastia com Balão/mortalidade , Feminino , Alemanha , Hemodinâmica , Humanos , Masculino , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Desenho de Prótese , Falha de Prótese , Recuperação de Função Fisiológica , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
6.
Heart Vessels ; 34(12): 1969-1975, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31134380

RESUMO

The objectives of the study were to evaluate the impact of aortic angulation (AA) on success of transcatheter aortic valve replacement (TAVR) with a new generation self-expandable prosthesis (Medtronic Evolut R®). Specific anatomical conditions, such as for example the presence of a horizontal aorta with elevated AA, have seemed to pose a significant challenge for the correct positioning and consequent functioning of self-expandable TAVR prostheses. We assessed 146 patients treated with Evolut R. AA was measured at computed tomography and two groups were identified using as cutoff the mean AA value. Acute outcomes were collected and compared. AA mean value was 49.6 ± 9.4° (AA ≥ 50°: 76 and AA < 50°: 70 patients). Risk profile (Logistic euroSCORE: AA ≥ 50°: 15.7; 75% IQR: 11.1-22.1 vs. AA < 50°: 14.7; 75% IQR: 10.7-24.0; p = 0.8) was equivalent. Perioperative results were similar: valve resheathing (AA ≥ 50°: 21.0% vs. AA < 50°: 24.2%; p = 0.6), recapturing (AA ≥ 50°: 19.7% vs. AA < 50°: 25.7%; p = 0.3), fluoroscopy time (AA ≥ 50°: 11.1 IQR: 8.6-17.0 min. vs. AA < 50°: 11.0 IQR: 8.0-15.7 min.; p = 0.9), and contrast agent use (AA ≥ 50°: 99.0 ± 41.8 ml. vs. AA < 50°: 104.2 ± 38.5 ml.; p = 0.4). At discharge, moderate paravalvular leak was present in 8/76 (10.5%) of the AA ≥ 50° and 6/70 (8.6%) of the AA < 50° (p = 0.7) patients. Severe paravalvular leak, implantation of a second valve, and/or conversion to surgery did not occur. Early safety (AA ≥ 50°: 7.8% vs. AA < 50°: 5.7%; p = 0.6) was similar in the two groups. AA did not affect procedural outcomes and valve performance of the Evolut R prosthesis.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/métodos , Idoso de 80 Anos ou mais , Aorta Torácica/diagnóstico por imagem , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico , Feminino , Seguimentos , Humanos , Masculino , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento
7.
Catheter Cardiovasc Interv ; 93(5): 971-979, 2019 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-30467966

RESUMO

OBJECTIVES: To investigate the impact of the introduction of the next generation self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THVs) on the incidence of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). BACKGROUND: PPM is a risk factor for accelerated degeneration of bioprosthetic aortic valves. Data on PPM after TAVR are derived mainly from studies of older generation THVs. METHODS: PPM was assessed at 30 days post-TAVR with the older generation (Medtronic CoreValve, n = 120 and Edwards Sapien XT, n = 121) and the next generation THVs (Medtronic Evolut R/Pro, n = 136 and Edwards Sapien 3, n = 363). RESULTS: The incidence of any and severe PPM was 15.1% and 0.0% for the older generation THVs, and 42.8% and 12.1% for the next generation THVs. The incidence of moderate and severe PPM was 23.3% and 3.5% in patients who received an Evolut R/Pro vs. 33.1% and 14.7% in those who received a Sapien 3 (P < 0.001). On multivariable analysis, TAVR with the Sapien 3 THV was not associated with PPM, while left ventricular ejection fraction (0.97 [0.95-0.99], P = 0.002), history of myocardial infarction (2.09 [1.00-4.34], P = 0.049), annulus maximum diameter (0.84 [0.77-0.92], P < 0.001), and THV oversizing (0.90 [0.87-0.94], P < 0.001) were independently associated with PPM. In Sapien 3, the risk of any and severe PPM was higher in those with no oversizing (odds ratio: 3.25 [1.23-8.53], P = 0.017 and 5.79[2.33-14.36], P < 0.001). CONCLUSIONS: The incidence of PPM in contemporary TAVR is significant, especially with the next generation BE THV without adequate oversizing.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias/epidemiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Valvuloplastia com Balão , Feminino , Humanos , Incidência , Masculino , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/fisiopatologia , Estudos Prospectivos , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
8.
JACC Cardiovasc Interv ; 11(24): 2507-2518, 2018 12 24.
Artigo em Inglês | MEDLINE | ID: mdl-30503595

RESUMO

OBJECTIVES: The aim of this study was to compare self-expanding and balloon-expandable transcatheter heart valves (THVs) in large versus small aortic valve annuli. BACKGROUND: The degree of THV oversizing varies according to annular size, and this can modify the hemodynamic performance of self-expanding and balloon-expandable THVs. METHODS: Patients undergoing transcatheter aortic valve replacement in the randomized CHOICE (Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve vs Edwards SAPIEN XT) trial (CoreValve [CV], n = 120; SAPIEN XT [SXT], n = 121) and the nonrandomized CHOICE-Extend registry (Evolut R [ER], n = 100; SAPIEN 3 [S3], n = 334) were compared for THV performance by echocardiography (in all patients) and by cardiac magnetic resonance imaging (MRI) regurgitant fraction (RF) (in a subgroup of patients). Patients were stratified according to aortic valve annular mean diameter into those with large (>23 mm) or small (≤23 mm) annuli. RESULTS: THV percentage oversizing was 19.1 ± 6.4% with the CV, 11.4 ± 7.0% with the SXT, 18.8 ± 4.8% with the ER, and 3.7 ± 5.5% with the S3. Transvalvular mean pressure gradient was lower with the CV and ER than with the SXT and S3 in both the large and small annulus groups. In the randomized CHOICE trial, moderate to severe prosthetic valve regurgitation (PVR) was more with the CV than the SXT in large annuli (15.1% vs. 0.0%; p = 0.002; MRI RF: 10.5 ± 10.2% vs. 4.4 ± 4.5%; p = 0.036) but not in small annuli (0.0% vs. 5.7%; p = 0.50; MRI RF: 4.0 ± 4.1% vs. 4.0 ± 3.4%; p = 0.98). In the CHOICE-Extend registry, moderate to severe PVR occurred in 2 patients, and any PVR was not significantly different between the ER and the S3 in large (41.7% vs. 32.5%; p = 0.24) or small (47.1% vs. 43.8%; p = 0.84) annuli. MRI RF was not different in large annuli (5.0 ± 3.8% vs. 5.0 ± 6.1%; p = 0.99) but was significantly lower with the ER than the S3 in small annuli (2.9 ± 2.3% vs. 4.8 ± 3.7%; p = 0.023). On multivariate analysis, transcatheter aortic valve replacement with the ER in small annuli was associated with a lower rate of prosthesis-patient mismatch than with the S3, with no increased risk for PVR. CONCLUSIONS: Older-generation balloon-expandable THVs were associated with less PVR than self-expanding THVs in patients with large but not small annuli. The next-generation self-expanding THV has improved sealing in patients with large annuli and may have potential advantages in patients with small annuli.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Valvuloplastia com Balão , Bioprótese , Próteses Valvulares Cardíacas , Hemodinâmica , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Ecocardiografia , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Desenho de Prótese , Recuperação de Função Fisiológica , Sistema de Registros , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
9.
Circ Cardiovasc Interv ; 11(10): e007415, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30354632

RESUMO

BACKGROUND: Balloon dilatation or debulking seems to be essential to allow successful stent implantation in calcified coronary lesions. Compared with standard balloon predilatation, debulking using high-speed rotational atherectomy (RA) is associated with higher initial procedural success albeit with higher in-stent late lumen loss at intermediate-term follow-up. Whether modified (scoring or cutting) balloons (MB) could achieve similar procedural success compared with RA is not known. In addition, whether new-generation drug-eluting stents could counterbalance the excessive neointimal proliferation triggered by RA remains to be determined. METHODS AND RESULTS: We randomly assigned patients with documented myocardial ischemia and severely calcified native coronary lesions undergoing percutaneous coronary intervention to a strategy of lesion preparation using MB or RA followed by drug-eluting stent implantation. Stenting was performed using a third-generation sirolimus-eluting stent with a bioabsorbable polymer. The trial had 2 primary end points: strategy success (defined as successful stent delivery and expansion with attainment of <20% in-stent residual stenosis in the presence of TIMI [Thrombolysis in Myocardial Infarction] 3 flow without crossover or stent failure; powered for superiority) and in-stent late lumen loss at 9 months (powered for noninferiority). Two hundred patients were enrolled at 2 centers in Germany (n=100 in each treatment group). The mean age of the study population was 74.9±7.0 years; 76% were men, and 33.5% had diabetes mellitus. Strategy success was significantly more common in the RA group (81% versus 98%; relative risk of failure with an MB- versus RA-based strategy, 9.5; 95% CI, 2.3-39.7; P=0.0001), but mean fluoroscopy time was longer (19.6±13.4 versus 23.9±12.2 minutes; P=0.03). At 9 months, mean in-stent late lumen loss was 0.16±0.39 mm in the MB group and 0.22±0.40 mm in the RA group ( P=0.21, P=0.02 for noninferiority). Target lesion revascularization (7% versus 2%; P=0.17), definite or probable stent thrombosis (0% versus 0%; P=1.00), and target vessel failure (8% versus 6%; P=0.78) were low and not significantly different between the MB and RA groups. CONCLUSIONS: Lesion preparation with upfront RA before drug-eluting stent implantation is feasible in nearly all patients with severely calcified coronary lesions, is more commonly successful as a primary strategy compared with MB, and is not associated with excessive late lumen loss. A strategy of provisional MB remains feasible, safe, and effective as long as bailout RA is readily available and may offer the advantages of compatibility with smaller sized catheters and less irradiation. Both strategies are associated with excellent clinical outcome at 9 months. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02502851.


Assuntos
Angioplastia Coronária com Balão , Aterectomia Coronária , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Calcificação Vascular/terapia , Implantes Absorvíveis , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Aterectomia Coronária/efeitos adversos , Aterectomia Coronária/mortalidade , Fármacos Cardiovasculares/administração & dosagem , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/etiologia , Trombose Coronária/etiologia , Feminino , Alemanha , Humanos , Masculino , Neointima , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Fatores de Risco , Índice de Gravidade de Doença , Sirolimo/administração & dosagem , Fatores de Tempo , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/mortalidade
10.
EuroIntervention ; 14(4): e390-e396, 2018 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-29741488

RESUMO

AIMS: Long-term results of transcatheter aortic valve implantation (TAVI), in particular the incidence of bioprosthetic valve failure (BVF), are uncertain. This study presents data derived from a long-term, structured follow-up programme of the self-expanding CoreValve device utilising standardised definitions and core lab adjudication of valve performance. METHODS AND RESULTS: The study prospectively included all 152 patients who had undergone TAVI with the self-expanding CoreValve up to December 2011 at the Heart Center, Bad Segeberg, Germany. Late BVF (>30 days) was defined as either: 1) severe structural valve deterioration (transprosthetic mean pressure gradient ≥40 mmHg and/or ≥20 mmHg rise from baseline OR severe intraprosthetic aortic regurgitation), OR 2) bioprosthetic valve dysfunction leading to death or reintervention. Echocardiographic follow-up at 6.3±1.0 years (range: 5.0-8.9 years) was 88% complete (60 out of 68 survivors beyond five years) and all echocardiograms were analysed by an independent core laboratory. The all-cause mortality rate at 1, 2, 5, 6, 7 and 8 years was 14%, 20%, 50%, 60%, 65%, and 73%, respectively. Among survivors beyond five years, effective orifice area was 1.60±0.46 cm2, and transvalvular mean pressure gradient was 6.7±3.1 mmHg; no cases showed evidence of structural valve deterioration. Five patients (3.3%) had undergone redo TAVI (n=4) or surgery (n=1) 0.6 to 5.2 years after the index procedure, all due to paravalvular leakage. The estimated rate of BVF at eight years was 7.9% for the actuarial and 4.5% for the actual analysis. CONCLUSIONS: Long-term follow-up up to 8.9 years after TAVI documents favourable performance of the self-expanding CoreValve with low rates of BVF.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica , Alemanha , Hemodinâmica , Humanos , Estudos Prospectivos , Desenho de Prótese , Resultado do Tratamento
11.
Cardiol Ther ; 7(1): 79-87, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29633088

RESUMO

INTRODUCTION: For patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), proper antithrombotic therapy is equivocal. Current guidelines recommend triple therapy, which carries a high risk of bleeding. Recent large trials suggest that dual therapy (DT) with novel oral anticoagulant (NOAC) plus P2Y12 inhibitor can be an appropriate alternative, but real-world data for this alternative are scarce and the optimal duration of DT has not yet been established. METHODS: This analysis was performed in a single-center prospective cohort. We investigated 216 PCI patients with indication for anticoagulation due to AF. After PCI patients received DT with reduced doses NOAC plus P2Y12 inhibitor for 6 months, which was followed by standard dose NOAC monotherapy. Efficacy endpoints were defined as cardiac death, myocardial infarction (MI), stent thrombosis (ST), and stroke. Safety endpoints were bleeding events as defined by Bleeding Academic Consortium (BARC). RESULTS: Baseline characteristics of our study population were described by a CHA2DS2-VASc score of greater than 4 and a HAS-BLED score of greater than 3. After a mean follow-up of 18.7 months, efficacy events occurred in 12 patients (5.6%). We observed three (1.4%) cardiac deaths, two (0.9%) MIs, six (2.8%) strokes, and one (0.5%) definite ST. After switching from DT to NOAC monotherapy after 6.3 ± 1.7 months, there was no rebound of ischemic events. Bleeding events occurred in 34 patients (15.7%) mainly under DT, while bleeding was less during NOAC monotherapy. CONCLUSIONS: In this long-term study of high-risk and real-world AF-patients with PCI, DT with NOAC and P2Y12 inhibitor (6 months) followed by NOAC monotherapy was safe and effective.

12.
J Thromb Thrombolysis ; 44(2): 161-168, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28597206

RESUMO

The thick struts of bioresorbable vascular scaffolds (BRS) are associated with changes in wall shear stress and contribute to neointimal proliferation. We aimed to evaluate the relationship between the BRS strut distribution and the neointimal proliferation. 50 lesions underwent optical coherence tomography, 12 months after BRS implantation. Scaffold area and neointimal thickness were evaluated in each cross-sectional area (CSA). Scaffold eccentricity was defined as follows: (maximum diameter - minimum diameter) × 100/maximum diameter. CSAs of BRS were divided into four quadrants. The maximal neointimal thickness (Maximal-NIT), Minimal-NIT and the number of struts in each quadrant were measured. The number of struts were classified as 1, 2, 3 and ≥ 4. Furthermore, the mean-NIT acquired in each quadrant was divided by the average-NIT of all struts in the same CSA, which was defined as the unevenness score. In addition, Maximal-NIT minus Minimal-NIT was divided by the average-NIT of all struts in the same CSA, which was defined as heterogenicity of neointimal proliferation. There was a significant difference in the association between the number of struts and not only the unevenness score (no. of strut = 1 (N = 440), unevenness score 1.04 ± 0.34; 2 (N = 696), 0.98 ± 0.27; 3 (N = 994), 0.96 ± 0.23; ≥4 (N = 1202), 1.04 ± 0.22, P < 0.01) but also Maximal-NIT and Minimal-NIT. Furthermore, a significant correlation was observed between scaffold eccentricity in each CSA and the heterogeneity of neointimal proliferation in the same CSA (N = 892, R = 0.38, p = 0.01). Crowding of struts is associated with increased neointimal proliferation after BRS implantation. The scaffold eccentricity causes heterogeneity of neointimal proliferation.


Assuntos
Implantes Absorvíveis , Stents Farmacológicos/normas , Everolimo/administração & dosagem , Neointima/tratamento farmacológico , Idoso , Proliferação de Células , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neointima/diagnóstico por imagem , Neointima/patologia , Tomografia de Coerência Óptica/métodos
13.
Cardiol J ; 24(6): 649-659, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28497845

RESUMO

BACKGROUND: The choice of optimal antithrombotic regimen after transcatheter aortic valve replace-ment (TAVR) remains a matter of debate. The objective of this study was to compare both efficacy and safety outcomes based on the type of antithrombotic therapy prescribed after TAVR Methods: This is a retrospective analysis of 514 consecutive patients treated with either dual antiplate¬let therapy (DAPT) (n = 315; 61.3%) or oral anticoagulation (OAC) plus clopidogrel (n = 199; 38.7%) for a minimum of 3 months after TAVR followed by antiplatelet monotherapy or OAC only, respectively. Patients had pre-defined clinical and echocardiographic follow-ups at 30 days, 6 and 12 months. The key efficacy endpoint was a composite of all-cause death, myocardial infarction, stroke and valve throm¬bosis at 1 year. The key safety endpoint was the occurrence of life-threatening/major bleeding at 1 year. RESULTS: Baseline characteristics did not differ between both groups, except for a higher incidence of atrial fibrillation in the OAC group. No significant differences in both efficacy and safety endpoints were observed at 30 days and 6 months. At 1 year, the key efficacy endpoint occurred in 21.5% of the DAPT group compared to 19.7% of the OAC group (p = 0.61). The key safety endpoint occurred in 25.1% and 27.8%, respectively (p = 0.53). However, after 1 year valve thrombosis was reported in 8 (2.5%) patients in the DAPT group but not in the OAC group (p = 0.02). CONCLUSIONS: OAC after TAVR seems to reduce the risk of clinical valve thrombosis without a statisti-cally significant increase in bleeding complications.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Aspirina/administração & dosagem , Clopidogrel/administração & dosagem , Terapia Trombolítica/métodos , Trombose/prevenção & controle , Substituição da Valva Aórtica Transcateter/métodos , Administração Oral , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico , Quimioterapia Combinada , Ecocardiografia , Feminino , Seguimentos , Humanos , Masculino , Inibidores da Agregação Plaquetária/administração & dosagem , Sistema de Registros , Estudos Retrospectivos , Trombose/etiologia , Resultado do Tratamento
14.
J Cardiol ; 70(5): 454-460, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28476635

RESUMO

BACKGROUND: Incomplete stent apposition (ISA) can be divided into acute and late forms. Late ISA may be due to persistent ISA or late-acquired ISA (LAISA). This study evaluated the natural course of ISA after bioresorbable vascular scaffold (BRS) implantation using optical coherence tomography (OCT). METHODS: Thirty-two patients (45 BRS) were assessed immediately after BRS implantation and 1 year thereafter using OCT. Acute ISA identified after BRS implantation but absent at follow-up was defined as resolved; otherwise, it was considered persistent. LAISA was defined as newly developed ISA that was identified at follow-up despite complete apposition immediately after BRS implantation. Intra-BRS fibrin-like material (IBF) was identified as an irregular intraluminal mass. ISA percentage was expressed as follows: (number of ISA/total number of BRS struts)×100. RESULTS: Among 45 BRS and 15,894 analyzed BRS struts, 34 and 882 had acute ISA post-procedure, respectively. At follow-up, 92 of 15,364 analyzed struts exhibited late ISA (64 persistent ISA and 28 LAISA). In 15 of 28 struts with LAISA, LAISA occurred at the sites adjacent to post-interventional dissection. Uncovered struts were more frequently observed in late ISA compared to apposed struts (3.7±4.8 vs. 0.58±2.2%, p=0.09). IBF was significantly more common in BRS with late ISA (62.5 vs. 8.1%, p=0.02). Receiver-operating characteristic curve analysis identified a cut-off value of 280µm for acute ISA distance predicting persistent ISA. CONCLUSION: Resolution of acute ISA after BRS is common. The occurrence of LAISA may be infrequent and may be a nidus of stent thrombosis.


Assuntos
Stents Farmacológicos , Everolimo/administração & dosagem , Idoso , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Trombose , Tomografia de Coerência Óptica/métodos
15.
JACC Cardiovasc Interv ; 10(7): 686-697, 2017 04 10.
Artigo em Inglês | MEDLINE | ID: mdl-28385406

RESUMO

OBJECTIVES: The aim of this study was to determine the incidence, characteristics, and treatment outcomes of patients diagnosed with clinical transcatheter heart valve thrombosis. BACKGROUND: Limited data exists on clinical or manifest transcatheter heart valve thrombosis. Prior studies have focused on subclinical thrombosis. METHODS: A retrospective analysis was conducted of prospectively collected data from a single-center registry that included 642 consecutive patients who underwent transcatheter aortic valve replacement between 2007 and 2015 (305 patients had self-expanding valves; balloon-expandable, n = 281; mechanically expanding, n = 56). Long-term oral anticoagulation (OAC) was indicated in 261 patients, while 377 patients received dual-antiplatelet therapy post-procedure. All patients underwent scheduled clinical and echocardiographic follow-up. RESULTS: The overall incidence of clinical valve thrombosis was 2.8% (n = 18). No patient on OAC developed thrombosis. Of the detected thrombosis cases, 13 patients had balloon-expandable, 3 had self-expanding, and 2 had mechanically expanding valves. Thrombosis occurred significantly more often with balloon-expandable valves (odds ratio: 3.45; 95% confidence interval: 1.22 to 9.81; p = 0.01) and following valve-in-valve procedures (odds ratio: 5.93; 95% confidence interval: 2.01 to 17.51; p = 0.005). Median time to diagnosis of valve thrombosis was 181 days. The median N-terminal pro-brain natriuretic peptide level was 1,318 pg/ml (interquartile range: 606 to 1,676 pg/ml). The mean transvalvular gradient and valve area were 34 ± 14 mm Hg and 1.0 ± 0.46 cm2, respectively. Computed tomography showed hypoattenuating areas with reduced leaflet motion. Initiation of OAC resulted in significant reduction of transvalvular gradient and clinical improvement. No deaths were related to valve thrombosis. CONCLUSIONS: Clinical transcatheter heart valve thrombosis is more common than previously considered, characterized by imaging abnormalities and increased gradients and N-terminal pro-brain natriuretic peptide levels. It occurred more commonly after balloon-expandable transcatheter aortic valve replacement and valve-in-valve procedures. OAC appeared to be effective in the prevention and treatment of valve thrombosis. Randomized control trials are needed to define optimal antithrombotic therapy after transcatheter aortic valve replacement.


Assuntos
Valva Aórtica/cirurgia , Bioprótese , Doenças das Valvas Cardíacas/epidemiologia , Próteses Valvulares Cardíacas , Trombose/epidemiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Valvuloplastia com Balão , Biomarcadores/sangue , Angiografia por Tomografia Computadorizada , Esquema de Medicação , Quimioterapia Combinada , Ecocardiografia Transesofagiana , Feminino , Alemanha/epidemiologia , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/tratamento farmacológico , Humanos , Incidência , Masculino , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Inibidores da Agregação Plaquetária/administração & dosagem , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Trombose/diagnóstico por imagem , Trombose/tratamento farmacológico , Fatores de Tempo , Resultado do Tratamento
16.
EuroIntervention ; 12(13): 1667-1673, 2017 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-28106001

RESUMO

AIMS: The use of large-diameter sheaths carries the risk of significant vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI). In this analysis, we sought to assess the impact of a modified femoral artery puncture technique using digital subtraction angiography (DSA) and road mapping during transfemoral TAVI on periprocedural vascular and bleeding events. METHODS AND RESULTS: This is a retrospective analysis of transfemoral TAVI patients included in a prospective institutional database. The modified femoral artery puncture technique using DSA-derived road mapping guidance was introduced in October 2012. Before the introduction of this technique, vascular puncture was acquired based on an integration of angiographic data, the bony iliofemoral landmarks and a radiopaque object. Consecutive patients who underwent TAVI with the road mapping technique (RM group, n=160) were compared with consecutive patients who underwent TAVI without road mapping (control group, n=160) prior to its introduction. A standardised strategy of periprocedural anticoagulation was adopted in both groups as well as the use of a single suture-based closure device. All endpoints were defined according to the VARC-2 criteria for event definition. The mean age in the RM group was 80±7.7 years compared to 81±5.9 years in the control group (p=0.19), and females were equally distributed between both groups (63.1% vs. 58.1%, p=0.36). The baseline logistic EuroSCORE was 20.7±14.4% vs. 24.9±15.2% in the RM and control group, respectively (p=0.01). Notably, sheath size was significantly larger in the RM compared to the control group due to the more frequent use of the 20 Fr sheath (23.8% vs. 1.8%, p<0.001, respectively) associated with the more frequent implantation of the 29 mm Edwards SAPIEN XT valve in the RM group (43.8% vs. 7%, respectively, p<0.001). Despite the latter finding, both major vascular complications and major bleeding at 30 days were significantly lower in the RM group compared to the control group (4.3% vs. 11.8%, p=0.01, and 14.4% vs. 25.6%, p=0.01). An analysis limited to access site-related complications also revealed lower events in the road map group but did not reach statistical significance (8.1% vs. 13.8%, p=0.1). Other forms of vascular and bleeding complications as well as all-cause mortality were comparable in both groups. CONCLUSIONS: A modified femoral artery puncture technique using DSA and road mapping was associated with a reduction in major vascular and bleeding complications after transfemoral TAVI, and provides a simple and effective strategy for potentially improving patient outcomes.


Assuntos
Estenose da Valva Aórtica/cirurgia , Artéria Femoral , Implante de Prótese de Valva Cardíaca , Hemorragia/etiologia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Angiografia Digital/efeitos adversos , Angiografia Digital/métodos , Cateterismo Cardíaco/métodos , Feminino , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Estudos Retrospectivos , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
17.
Int J Cardiovasc Imaging ; 33(2): 145-152, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27761749

RESUMO

This study investigated the predictors of acute recoil after implantation of everolimus-eluting BRS based on optical coherence tomography (OCT). Thirty-nine patients (56 scaffolds) were enrolled. Acute absolute recoil by quantitative coronary angiography was defined as the difference between the mean diameter of the last inflated balloon (X) and the mean lumen diameter of BRS immediately after balloon deflation (Y). Acute percent recoil was defined as (X - Y) × 100/X. Plaque eccentricity (PE) and plaque composition (PC) were assessed by OCT. PC was classified into two different types: calcific (score = 1), fibrous and lipid (score = 0). Based on the mean acute scaffold recoil value of the present study, scaffolds were divided into two groups: the low acute recoil group (LAR, n = 34) and the high acute recoil group (HAR, n = 22). Acute percent and absolute recoil were 6.4 ± 3.0 % and 0.19 ± 0.11 mm. PE, PC score and scaffold/artery ratio were significantly higher in HAR than in LAR. In multivariate logistic regression analysis, PE > 1.49, PC score (score 1) and scaffold/artery ratio >1.07 were significant positive predictors for the occurrence of acute scaffold recoil (OR 10.7, 95 % CI 2.2-51.4, p < 0.01; OR 5.6, 95 % CI 1.9-22.0, p = 0.04; OR 12.4, 95 % CI 2.6-65.4, p < 0.01, respectively). Acute recoil of BRS is influenced by BRS sizing as well as OCT-derived plaque characteristics.


Assuntos
Implantes Absorvíveis , Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/terapia , Vasos Coronários/efeitos dos fármacos , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Everolimo/administração & dosagem , Tomografia de Coerência Óptica , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Distribuição de Qui-Quadrado , Angiografia Coronária , Everolimo/efeitos adversos , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Polímeros/química , Valor Preditivo dos Testes , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
18.
J Cardiol ; 69(4): 606-612, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-27520757

RESUMO

BACKGROUND: Peri-strut low intensity areas (PLIA) surrounding metallic coronary stent struts on optical coherence tomography (OCT) images have been histologically related to delayed healing and inflammation, and have been associated with neointimal proliferation. The relationship between PLIA and vascular healing response after bioresorbable scaffold (BRS) implantation remains unclear. METHODS: This study includes 38 consecutive patients (50 scaffolds) evaluated using OCT 12 months after BRS implantation. Mean and percent neointimal area were quantified. A PLIA was defined as a peri-strut region with an homogenous lower intensity appearance than the surrounding tissue on OCT images without significant signal attenuation. Cross sections were scored as follows: score 0, no PLIA; score 1, <1 quadrant; score 2, ≥1 but <2 quadrants; score 3, ≥2 quadrants but <3 quadrants; and score 4, ≥3 quadrants. Scaffolds were divided into two groups (PLIA+ and PLIA-) based on the presence or absence of any PLIA in the scaffold segment. RESULTS: The frequency of any PLIA within the scaffold segment was 70.0%. The median PLIA score per scaffold was 0.51 (interquartile range 0-1.07). Using both scaffold- and frame-level analysis, a significant positive correlation was observed between PLIA score and both mean and percent neointimal area. Mean and percent neointimal area were significantly higher in the PLIA+ group than in the PLIA- group (1.95±0.65mm2 vs. 1.51±0.27mm2, p<0.01 and 24.0±7.0% vs. 17.4±3.6%, p<0.01, respectively). CONCLUSION: The presence and extent of PLIA on OCT imaging after BRS implantation appears to be significantly associated with neointimal formation.


Assuntos
Implantes Absorvíveis , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Neointima/diagnóstico por imagem , Tomografia de Coerência Óptica , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Estudos Transversais , Everolimo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
19.
Int J Cardiovasc Imaging ; 33(2): 169-175, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27757563

RESUMO

Heterogeneity of neointimal thickness is observed after drug-eluting stents implantation in bifurcation lesions (BL). We evaluated the vascular response of everolimus-eluting bioresorbable scaffold (BRS) struts deployed at BL using optical coherence tomography (OCT). 50 patients (64 scaffolds) underwent follow-up OCT after BRS implantation. Cross-sectional areas of each BL with a side branch more than 1.5 mm were analyzed using OCT every 200 µm. All images were divided into three regions according to shear stress: the 1/2 circumference of the vessel opposite to the ostium (OO), the vessel wall adjacent to the ostium (AO) and the side-branch ostium (SO). The %uncovered strut and the averaged neointimal thickness (NIT) were calculated. Overall, there were significant differences in both NIT and %uncovered strut among the three regions (OO, 119.2 ± 68.5 µm vs. AO, 94.2 ± 35.7 µm vs. SO, 80.5 ± 41.4 µm, p = 0.03; OO, 0.4 %vs. AO, 1.4 %vs. SO, 4.8 %, p = 0.02). Scaffolds were divided into two groups: a large-ratio side-branch group (LRSB; n = 32) and a small-ratio side-branch group (SRSB; n = 32), based on the median value of the ratio of the diameter of side branch ostium (Ds) to that of the main branch (Dm). In the LRSB alone, there were significant differences in both NIT and %uncovered strut among the three regions (OO, 128.0 ± 61.1 µm vs. AO, 97.3 ± 34.3 µm vs. SO, 75.9 ± 39.4 µm, p < 0.01; OO, 0.3 % vs. AO, 2.3 % vs. SO, 8.7 %, p < 0.01). After BRS implantation in BL, neointimal response was pronounced at the vessel wall opposite to the side branch ostium, especially in those with large side branches.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Vasos Coronários/efeitos dos fármacos , Vasos Coronários/diagnóstico por imagem , Everolimo/administração & dosagem , Neointima , Intervenção Coronária Percutânea/instrumentação , Tomografia de Coerência Óptica , Idoso , Fármacos Cardiovasculares/efeitos adversos , Everolimo/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Desenho de Prótese , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Cicatrização
20.
EuroIntervention ; 12(10): 1298-1304, 2016 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-27866140

RESUMO

AIMS: In the current study we assess the impact of two different access-site suture-mediated closure devices (SMCD), ProGlide and Prostar, on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI), as well as on long-term mortality. METHODS AND RESULTS: From 2008 to 2013, 1,022 patients underwent transfemoral TAVI in two German centres using ProGlide (n=506) and Prostar (n=516) SMCD to close the access site. The primary outcome was the incidence of peri-TAVI major vascular complications according to Valve Academic Research Consortium-2 (VARC-2) definitions. Secondary outcomes were the incidence of bleeding complications and mortality. Compared to the Prostar SMCD group, patients in the ProGlide SMCD group less frequently experienced VARC-2 major vascular complications (7.5% vs. 15.9%, p<0.001), closure device failure (0.8% vs. 2.3%, p=0.04), any bleeding (BARC: 36.8% vs. 53.9%, p<0.001; VARC-2: 30.8% vs. 34.9%, p=0.59). Furthermore, one-year mortality was significantly lower in the ProGlide SMCD group, 14.8% vs. 19.5% in the Prostar SMCD group, log-rank p=0.04. However, VARC-2 major vascular complications but not ProGlide use were identified as an independent predictor of one-year mortality (adjusted odds ratio 1.54, 95% CI: 1.01-2.34 and 1.01, 95% CI: 0.65-1.55, respectively). CONCLUSIONS: In this analysis, the use of ProGlide SMCD was associated with a reduced risk of vascular and bleeding complications following TAVI compared to Prostar SMCD usage. However, major vascular complications but not ProGlide use did independently predict long-term mortality.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Cateterismo Cardíaco/instrumentação , Implante de Prótese de Valva Cardíaca/instrumentação , Técnicas Hemostáticas/instrumentação , Substituição da Valva Aórtica Transcateter/instrumentação , Adulto , Idoso , Idoso de 80 Anos ou mais , Implante de Prótese de Valva Cardíaca/métodos , Hemorragia/complicações , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
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