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1.
Glob Heart ; 16(1): 54, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34381675

RESUMO

Objectives: We aimed to compare the quantitative angiographic aortic regurgitation (AR) into the left ventricular out flow tract (LVOT-AR) of five different types of transcatheter self-expanding valves and to investigate the impact of the learning curve on post-TAVR AR. Background: Quantitative video densitometric aortography is an objective, accurate, and reproducible tool for assessment of AR following TAVR. Methods and results: This retrospective academic core-lab analysis, analyzed 1150 consecutive cine aortograms performed immediately post-TAVR. Quantitative angiographic AR of post-procedural aortography in 181 consecutive patients, who underwent TAVR with the Venus A-valve in a single Chinese center, were compared to the results of Evolut Pro, Evolut R, CoreValve, (Medtronic, Dublin, Ireland) and Acurate Neo (Boston Scientific, Massachusetts, US) transcatheter heart valves (THVs), from a previously published pooled database. Among the 181 aortograms of patients treated with the Venus A-Valve, 113 (62.4%) were analyzable for quantitative assessment of AR. The mean LVOT-AR was 8.9% ± 10.0% with 14.2% of patients having moderate or severe AR in the Venus A-valve group. No significant difference in mean LVOT-AR was observed between Evolut Pro, Evolut R, Acurate Neo, and Venus A-valve. The incidence of LVOT-AR >17%, which correlates with echocardiographic derived ≥ moderate AR, with the Evolut Pro was lower than with the Venus A-valve (5.3% vs. 14.2%, p = 0.034), but was not different from the Evolut R (5.3% vs. 8.8%, p = 0.612), or the Acurate Neo (5.3% vs. 11.3% p = 0.16) systems. A landmark analysis after recruitment of the first half of patients treated with the Venus A valve (N = 56), showed a significantly lower mean LVOT-AR in the second half of the series (11.3% ± 11.9% vs. 6.5% ± 7.1%, p = 0.011). The incidence of LVOT-AR >17% in the latest 57 cases was also numerically lower (7.0% vs. 21.4%, p = 0.857) and compared favorably with the best in class of the self-expanding valves. Conclusion: The Venus A-valve has comparable mean LVOT-AR to other self-expanding valves but has a higher rate of moderate or severe AR than the Evolut Pro THV. However, after completion of a learning phase, results improved and compared favorably with the best in class of the commercially available self-expanding valves. These findings should be confirmed in prospective randomized comparisons of AR between different THVs.


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/epidemiologia , Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , China/epidemiologia , Humanos , Curva de Aprendizado , Estudos Prospectivos , Desenho de Prótese , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
2.
JACC Cardiovasc Interv ; 14(14): 1523-1534, 2021 07 26.
Artigo em Inglês | MEDLINE | ID: mdl-34217623

RESUMO

OBJECTIVES: This study aimed to validate a dedicated software for quantitative videodensitometric angiographic assessment of mitral regurgitation (QMR). BACKGROUND: Quantitative videodensitometric aortography of aortic regurgitation using the time-density principle is a well-documented technique, but the angiographic assessment of mitral regurgitation (MR) remains at best semi-quantitative and operator dependent. METHODS: Fourteen sheep underwent surgical mitral valve replacement using 2 different prostheses. Pre-sacrifice left ventriculograms were used to assess MR fraction (MRF) using QMR and MR volume (MRV). In an independent core lab, the CAAS QMR 0.1 was used for QMR analysis. In vitro MRF and MRV were assessed in a mock circulation at a comparable cardiac output to the in vivo one by thermodilution. The correlations and agreements of in vitro and in vivo MRF, MRV, and interobserver reproducibility for QMR analysis were assessed using the averaged cardiac cycles (CCs). RESULTS: In vivo derived MRF by QMR strongly correlated with in vitro derived MRF, regardless of the number of the CCs analyzed (best correlation: 3 CCs y = 0.446 + 0.994x; R = 0.784; p =0.002). The mean absolute difference between in vitro derived MRF and in vivo derived MRF from 3 CCs was 0.01 ± 4.2% on Bland-Altman analysis. In vitro MRV and in vivo MRV from 3 CCs were very strongly correlated (y = 0.196 + 1.255x; R = 0.839; p < 0.001). The mean absolute difference between in vitro MRV and in vivo MRV from 3 CCs was -1.4 ± 1.9 ml. There were very strong correlations of in vivo MRF between 2 independent analysts, regardless of the number of the CCs. CONCLUSIONS: In vivo MRF using the novel software is feasible, accurate, and highly reproducible. These promising results have led us to initiate the first human feasibility study comprising patients undergoing percutaneous mitral valve edge-to-edge repair.


Assuntos
Insuficiência da Valva Aórtica , Insuficiência da Valva Mitral , Animais , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/cirurgia , Humanos , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Próteses e Implantes , Reprodutibilidade dos Testes , Ovinos , Resultado do Tratamento
3.
Int J Cardiol ; 338: 168-173, 2021 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-34147554

RESUMO

BACKGROUND: Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, particularly paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture. We sought to investigate the frequency of operator selection of intermediate-size balloon-expandable Myval THVs (Meril Life Sciences Pvt. Ltd., India) for TAVI in a real-world dataset. METHODS: In this retrospective survey of patients treated with TAVI using the Myval THV, 20, 23, 26, and 29 mm are conventional-size THVs, 21.5, 24.5 and 27.5 mm are intermediate-size THVs, and 30.5 and 32 mm are extra-large THVs. Operator size selection for implantation was based on multislice computed tomography (MSCT) derived aortic-root dimensions. RESULTS: A total of 1115 patients underwent Myval THV implantation in 27 countries worldwide. The Myval intermediate-size THVs were used in 468 (42.0%) patients. MSCT data were available in 562 patients. There was no statistical difference between the Intermediate/Upsized and Appropriately sized groups or Intermediate/Downsized and Appropriately sized groups in terms of different variables measured with MSCT except for annular dimensions and degree of calcification. CONCLUSIONS: Intermediate-size Myval balloon-expandable THVs are used in nearly half of all cases in contemporary real-world TAVI practice, addressing the unmet need of TAVI operators for a more calibrated THV choice. Our hypothesis should be tested in randomized prospective studies currently initiated in Europe, including clinical outcomes of patients treated with both conventional- and intermediate-size THVs.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Europa (Continente) , Humanos , Índia , Estudos Prospectivos , Desenho de Prótese , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
4.
Ir J Med Sci ; 2021 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-33895965

RESUMO

INTRODUCTION: General practice has a key role in diagnosing patients with valvular heart disease (VHD) and referring them to appropriate services. METHODS: An anonymous survey was conducted to assess the knowledge and clinical practice behaviour of Irish general practitioners (GPs) in relation to VHD. In addition to demographic data, the survey captured information in the following domains: knowledge of VHD prevalence, knowledge of contemporary VHD treatments, barriers to diagnosis, and referral patterns. To augment responses, a monetary prize (donated to charity) was offered and the survey was also disseminated using social media and by the Irish College of General Practitioners. RESULTS: Valid survey responses were received from 197 GPs. The sample was well-balanced by gender, number of years in practice, and practice setting. A small proportion of GPs (16.8%) used a stethoscope to examine for VHD in all patients over 60 years, a figure that rose to 22.3% in patients over 75. Approximately half of participants (48%) felt confident in their ability to detect and diagnose VHD using a stethoscope, and 74% felt lack of access to echocardiography was a major barrier to making a VHD diagnosis. There was a high level of awareness among GPs of minimally invasive nonsurgical interventions now available for VHD treatment. DISCUSSION: Irish GPs displayed good understanding of contemporary VHD treatment options but reported low confidence and inconsistent practices in evaluating patients for VHD. Improved access to echocardiography might help address these deficiencies, but reorganisation of services will be required in a resource-limited public health service.

5.
BMJ Open ; 11(4): e045590, 2021 04 02.
Artigo em Inglês | MEDLINE | ID: mdl-33811055

RESUMO

AIMS: To evaluate temporal trends of acute coronary syndromes (ACS) treated via percutaneous coronary intervention (PCI) throughout the COVID-19 outbreak in a European healthcare system affected but not overwhelmed by COVID-19-related pathology. METHODS AND RESULTS: We performed a retrospective multicentre analysis of the rates of PCI for the treatment of ACS within the period 2 months pre and post the first confirmed COVID-19 case in Ireland, as well as comparing PCI for ST-elevation myocardial infarction (STEMI) with the corresponding period in 2019. During the 2020 COVID-19 period (29 February-30 April 2020), there was a 24% decline in PCI for overall ACS (incidence rate ratio (IRR) 0.76; 95% CI 0.65 to 0.88; p<0.001), including a 29% reduction in PCI for non-ST-elevation ACS (IRR 0.71; 95% CI 0.57 to 0.88; p=0.002) and an 18% reduction in PCI for STEMI (IRR 0.82; 95% CI 0.67 to 1.01; p=0.061), as compared with the 2020 pre-COVID-19 period (1 January-28 February 2020). A 22% (IRR 0.78; 95% CI 0.65 to 0.93; p=0.005) reduction of PCI for STEMI was seen as compared with the 2019 reference period. CONCLUSION: This study demonstrates a significant reduction in PCI procedures for the treatment of ACS since the COVID-19 outbreak in Ireland. The reasons for this decline are still unclear but patients need to be encouraged to seek medical attention when cardiac symptoms appear, in order to avoid incremental cardiac morbidity and mortality due to a reduction in coronary revascularisation for the treatment of ACS.


Assuntos
Síndrome Coronariana Aguda , COVID-19/epidemiologia , Intervenção Coronária Percutânea/estatística & dados numéricos , Síndrome Coronariana Aguda/epidemiologia , Síndrome Coronariana Aguda/cirurgia , Atenção à Saúde , Humanos , Irlanda/epidemiologia , Pandemias , Estudos Retrospectivos , Resultado do Tratamento
6.
JACC Cardiovasc Interv ; 14(5): 531-538, 2021 03 08.
Artigo em Inglês | MEDLINE | ID: mdl-33582086

RESUMO

OBJECTIVES: The aim of this study was to investigate the online assessment feasibility of aortography using videodensitometry in the catheterization laboratory during transcatheter aortic valve replacement (TAVR). BACKGROUND: Quantitative assessment of regurgitation after TAVR through aortography using videodensitometry is simple, reproducible, and validated in vitro, in vivo, in clinical trials, and in "real-world" patients. However, thus far the assessment has been done offline. METHODS: This was a single center, prospective, proof-of-principle, feasibility study. One hundred consecutive patients with aortic stenosis and indications to undergo TAVR were enrolled. All final aortograms were analyzed immediately after acquisition in the catheterization laboratory and were also sent to an independent core laboratory for blinded offline assessment. The primary endpoint of the study was the feasibility of the online assessment of regurgitation (percentage of analyzable cases). The secondary endpoint was the reproducibility of results between the online assessment and the offline analysis by the core laboratory. RESULTS: Patients' mean age was 81 ± 7 years, and 56% were men. The implanted valves were either SAPIEN 3 (97%) or SAPIEN 3 Ultra (3%). The primary endpoint of online feasibility of analysis was 92% (95% confidence interval [CI]: 86% to 97%) which was the same feasibility encountered by the core laboratory (92%; 95% CI: 86% to 97%). Reproducibility assessment showed a high correlation between online and core laboratory evaluations (R2 = 0.87, p < 0.001), with an intraclass correlation coefficient of 0.962 (95% CI: 0.942 to 0.975; p < 0.001). CONCLUSIONS: This study showed high feasibility of online quantitative assessment of regurgitation and high agreement between the online examiner and core laboratory. These results may pave the way for the application of videodensitometry in the catheterization laboratory after TAVR. (Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab [OVAL]; NCT04047082).


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Aortografia , Estudos de Viabilidade , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Reprodutibilidade dos Testes , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
7.
JACC Cardiovasc Interv ; 14(2): 172-181, 2021 01 25.
Artigo em Inglês | MEDLINE | ID: mdl-33478633

RESUMO

OBJECTIVES: The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system. BACKGROUND: The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device. METHODS: A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported. RESULTS: Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 ± 6.9 years and 5.2 ± 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n = 7]) and stroke (3.5% [n = 10]). After TAVR, the mean aortic valve area was 1.9 ± 0.9 cm2, and the mean transvalvular gradient was 11.9 ± 5.7 mm Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients. CONCLUSIONS: Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Europa (Continente) , Humanos , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
8.
Am Heart J ; 232: 23-38, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33160946

RESUMO

BACKGROUND: The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies. The safety and efficacy of these novel technologies should be investigated in randomized control trials against the contemporary TAVR devices. The objective of the LANDMARK trial is to compare the balloon-expandable Myval transcatheter heart valve (THV) series with contemporary THV (SAPIEN THV and Evolut THV series) series in patients with severe symptomatic native aortic stenosis. METHODS/DESIGN: The LANDMARK trial (ClinicalTrials.govNCT04275726, EudraCT number 2020-000,137-40) is a prospective, randomized, multinational, multicenter, open-label, and noninferiority trial of approximately 768 patients treated with TAVR via the transfemoral approach. Patients will be allocated in a 1:1 randomization to Myval THV series (n = 384) or to contemporary THV (n = 384) (either of SAPIEN THV or Evolut THV series). The primary combined safety and efficacy endpoint is a composite of all-cause mortality, all stroke (disabling and nondisabling), bleeding (life-threatening or disabling), acute kidney injury (stage 2 or 3), major vascular complications, prosthetic valve regurgitation (moderate or severe), and conduction system disturbances (requiring new permanent pacemaker implantation), according to the Valve Academic Research Consortium-2 criteria at 30-day follow-up. All patients will have follow-up to 10 years following TAVR. SUMMARY: The LANDMARK trial is the first randomized head-to-head trial comparing Myval THV series to commercially available THVs in patients indicated for TAVR. We review prior data on head-to-head comparisons of TAVR devices and describe the rationale and design of the LANDMARK trial.


Assuntos
Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias/epidemiologia , Substituição da Valva Aórtica Transcateter , Injúria Renal Aguda/epidemiologia , Insuficiência da Valva Aórtica/epidemiologia , Doença do Sistema de Condução Cardíaco/epidemiologia , Doença do Sistema de Condução Cardíaco/terapia , Estudos de Equivalência como Asunto , Humanos , Mortalidade , Marca-Passo Artificial , Hemorragia Pós-Operatória/epidemiologia , Desenho de Prótese , Falha de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Acidente Vascular Cerebral/epidemiologia
12.
EuroIntervention ; 16(12): e1005-e1013, 2020 12 18.
Artigo em Inglês | MEDLINE | ID: mdl-32928715

RESUMO

AIMS: The aim of this study was to investigate the risk of impaired coronary access and coronary obstruction after redo TAVI. METHODS AND RESULTS: Post-procedure multidetector computed tomography (MDCT) scans of 221 TAVI recipients were analysed. Increased risk of impaired coronary access was defined as a coronary ostium below the TAVI commissures with a valve-to-aorta distance <2 mm at this level. Increased risk was found in 123 (55.6%) cases: the left main was involved in 109 (49.3%), the right coronary in 79 (35.7%), and both were involved in 65 (29.4%) patients. A small sinotubular junction (STJ width OR 0.68, CI: 0.56-0.81, p<0.001; STJ height OR 0.81, CI: 0.69-0.95, p<0.011) and supra-annular devices (OR 19.8, CI: 6.6-58.8, p<0.001) predicted increased risk. Increased risk of coronary obstruction, defined as a coronary ostium below the TAVI commissures with a valve-to-coronary distance <2 mm, was observed in 14.9% of patients; in 17.2% of cases complete sealing of the STJ would occur. CONCLUSIONS: Post-TAVI MDCT suggested an increased potential risk of impaired coronary access in more than half of the patients should redo TAVI be required, predicted by a small STJ and supra-annular device design. Furthermore, 10-20% of patients presented an increased risk of coronary obstruction. While this theoretical study is hypothesis-generating, it raises concerns that need to be further investigated and addressed before TAVI is extended to patients with longer life expectancy.


Assuntos
Estenose da Valva Aórtica , Oclusão Coronária , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Humanos , Tomografia Computadorizada Multidetectores , Desenho de Prótese , Substituição da Valva Aórtica Transcateter/efeitos adversos
14.
Open Heart ; 7(2)2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32763967

RESUMO

BACKGROUND: Optimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA). DESIGN: The PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605). Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA) will be enrolled in the study. Patients will be allocated to a computational simulation arm (experimental) or standard treatment arm (control) using a 1:1 randomisation. For patients randomised to the computational simulation arm, preprocedural planning will be based on the analysis of cardiac computed tomography (CCT)-based patient-specific computational simulations (FEops HEARTguide, Ghent, Belgium) in order to predict optimal device size and position. For patients in the control arm, preprocedural planning will be based on local practice including CCT analysis. The LAA closure procedure and postprocedural antithrombotic therapy will follow local practice in both arms. The primary endpoint of the study is incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT. Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months. CONCLUSION: The objective of the PREDICT-LAA study is to test the hypothesis that a preprocedural planning for LAA closure with the Amplatzer Amulet device based on patient-specific computational simulations can result in a more efficient procedure, optimised procedural outcomes and better clinical outcomes as compared with a standard preprocedural planning. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04180605).


Assuntos
Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/terapia , Cateterismo Cardíaco/instrumentação , Modelagem Computacional Específica para o Paciente , Terapia Assistida por Computador , Tomografia Computadorizada por Raios X , Apêndice Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico por imagem , Função do Átrio Esquerdo , Canadá , Cateterismo Cardíaco/efeitos adversos , Europa (Continente) , Frequência Cardíaca , Humanos , Estudos Multicêntricos como Assunto , Valor Preditivo dos Testes , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
15.
Interv Cardiol ; 15: e09, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32714445

RESUMO

Acute coronary artery obstruction is a rare but life-threatening complication of transcatheter aortic valve implantation. In patients at risk of coronary artery obstruction, pre-emptive coronary artery protection with a coronary wire, balloon or stent provides a bailout treatment option. The authors describe the steps involved in performing chimney stenting and summarise the short- and long-term outcome data associated with this technique.

16.
JACC Cardiovasc Interv ; 13(6): 751-761, 2020 03 23.
Artigo em Inglês | MEDLINE | ID: mdl-32192695

RESUMO

OBJECTIVES: The aim of this study was to determine the safety and efficacy of chimney stenting, a bailout technique to treat coronary artery occlusion (CAO). BACKGROUND: CAO during transcatheter aortic valve replacement (TAVR) is a rare but often fatal complication. METHODS: In the international Chimney Registry, patient and procedural characteristics and data on outcomes are retrospectively collected from patients who underwent chimney stenting during TAVR. RESULTS: To date, 16 centers have contributed 60 cases among 12,800 TAVR procedures (0.5%). Chimney stenting was performed for 2 reasons: 1) due to the development of an established CAO (n = 25 [41.6%]); or 2) due to an impending CAO (n = 35 [58.3%]). The majority of cases (92.9%) had 1 or more classical risk factors for CAO. Upfront coronary protection was performed in 44 patients (73.3%). Procedural and in-hospital mortality occurred in 1 and 2 patients, respectively. Myocardial infarction (52.0% vs. 0.0%; p < 0.01), cardiogenic shock (52.0% vs. 2.9%; p < 0.01), and resuscitation (44.0% vs. 2.9%; p < 0.01) all occurred more frequently in patients with established CAO compared with those with impending CAO. The absence of upfront coronary protection was the sole independent risk factor for the combined endpoint of death, cardiogenic shock, or myocardial infarction. During a median follow-up time of 612 days (interquartile range: 405 to 842 days), 2 cases of stent failure were reported (1 in-stent restenosis, 1 possible late stent thrombosis) after 157 and 374 days. CONCLUSIONS: Chimney stenting appears to be an acceptable bailout technique for CAO, with higher event rates among those with established CAO and among those without upfront coronary protection.


Assuntos
Valva Aórtica/cirurgia , Oclusão Coronária/terapia , Próteses Valvulares Cardíacas , Intervenção Coronária Percutânea/instrumentação , Stents , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/etiologia , Oclusão Coronária/mortalidade , Reestenose Coronária/etiologia , Trombose Coronária/etiologia , Europa (Continente) , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Oriente Médio , América do Norte , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
17.
CJC Open ; 2(1): 34-37, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32159135

RESUMO

Two successful cases of percutaneous transfemoral transcatheter aortic valve replacement (TAVR) in patients with previous aortobifemoral bypass graft surgery are presented. Both cases demonstrate feasibility of this strategy after careful preprocedural planning and suggest transfemoral TAVR can also be considered for patients when alternative access and/or general anaesthesia is excluded.

19.
Eur Heart J Qual Care Clin Outcomes ; 6(1): 32-40, 2020 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-31124556

RESUMO

AIMS: The coronary sinus Reducer is a percutaneous device proven to improve angina symptoms in refractory angina (RA). We evaluated its potential cost-effectiveness and impact on the healthcare resource use. METHODS AND RESULTS: Angina-related healthcare resource usage and quality-of-life data were collected for 215 consecutive RA patients undergoing Reducer implantation in Belgium, the Netherlands, and Italy. Costs were assessed from each country's healthcare system perspective. Data from the date of RA diagnosis to Reducer implantation [Standard-of-Care (SoC)-period] and from Reducer implantation to follow-up (Reducer-period) were compared: during Reducer-period, a significant reduction in angina-driven hospitalizations, outpatient visits, coronary angiograms, and percutaneous coronary interventions per patient-year was observed, translating into significantly reduced costs per patient-year. To assess cost-effectiveness, costs and utilities of 1-year SoC were compared with those of 1-year Reducer-period. Assumptions on Reducer efficacy duration were further explored with modelled projections. Reducer was associated with higher quality-adjusted life years (QALYs: 0.665 vs. 0.580, P < 0.001) and incremental costs, yielding incremental cost-effectiveness ratios (ICERs) of 53 197, 34 948, 63 146 €/QALY gained in Belgium, the Netherlands, and Italy, respectively. Under both the assumptions of 2 and 3 years Reducer effect duration with a 30%-year efficacy decrease, the device yielded ICERs in the range of 1977-20 796 €/QALY gained. CONCLUSION: In patients with RA, Reducer device decreases healthcare resource use and related costs. In a limited 1-year timeframe, Reducer is consistently cost-effective according to a range of cost-effectiveness thresholds. Under the explored assumptions, the device yields cost-effectiveness ratios suggesting high value from all the considered perspectives.


Assuntos
Angina Pectoris/terapia , Seio Coronário/fisiopatologia , Atenção à Saúde/economia , Eletrodos Implantados/economia , Aceitação pelo Paciente de Cuidados de Saúde , Qualidade de Vida , Idoso , Angina Pectoris/economia , Angina Pectoris/fisiopatologia , Análise Custo-Benefício , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Estudos Retrospectivos , Resultado do Tratamento
20.
Catheter Cardiovasc Interv ; 95(3): E96-E99, 2020 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-31250526

RESUMO

Thoracic endovascular aortic repair (TEVAR) is performed with large-bore delivery systems. Small-size access vessels may be a contraindication for TEVAR, particularly in case of severe calcifications. In this case report, we describe the first-in-man use of intravascular lithotripsy to enable transfemoral delivery of TEVAR stent grafts in a patient with severely calcified iliac arteries. A 69-year-old female with multiple sclerosis and thoracic aortic aneurysm (TAA) was referred for percutaneous TEVAR. Both common iliac arteries were severely calcified with circumferential calcifications and a minimum diameter below 5.5 mm. In order to enable percutaneous delivery of 20 French Valiant Navion stent grafts (Medtronic), the circumferential calcified plaques were treated by use of a Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.). Subsequently, the aortic stent grafts were safely and successfully passed through the iliofemoral artery and the TAA was excluded by TEVAR. Final angiography showed normal flow in the iliofemoral artery without any signs of perforation or overt dissection. This case report demonstrates successful application of intravascular lithotripsy in calcified iliofemoral arteries enabling percutaneous transfemoral TEVAR. If confirmed in future cases and trials, indications for transfemoral TEVAR may further expand toward patients with severely calcified peripheral arterial disease.


Assuntos
Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular , Cateterismo Periférico , Procedimentos Endovasculares , Artéria Femoral , Artéria Ilíaca , Litotripsia , Doença Arterial Periférica/terapia , Calcificação Vascular/terapia , Idoso , Aneurisma da Aorta Torácica/complicações , Aneurisma da Aorta Torácica/diagnóstico por imagem , Prótese Vascular , Implante de Prótese Vascular/instrumentação , Procedimentos Endovasculares/instrumentação , Feminino , Artéria Femoral/diagnóstico por imagem , Humanos , Artéria Ilíaca/diagnóstico por imagem , Doença Arterial Periférica/complicações , Doença Arterial Periférica/diagnóstico por imagem , Punções , Índice de Gravidade de Doença , Stents , Resultado do Tratamento , Calcificação Vascular/complicações , Calcificação Vascular/diagnóstico por imagem
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