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3.
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.

4.
J Stroke Cerebrovasc Dis ; 30(9): 105927, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34252826

RESUMO

OBJECTIVES: An assessment of the comparative incidence of fatal or disabling stroke may influence choice of intervention for patients with severe aortic stenosis. We explored whether transcatheter aortic valve implantation (TAVI) is associated with a lower incidence of fatal or disabling stroke, compared to surgical aortic valve replacement (SAVR). MATERIALS & METHODS: We classified stroke into two categories; fatal or disabling, or non-disabling, and completed meta-analyses for each. We explored randomised controlled trials to assess the effect publication year, predicted operative risk, and route of TAVI access. RESULTS: There was no difference between treatment groups per 100 person years of follow up for disabling or non-disabling stroke outcomes. In a stratified analysis by year of publication, there was a lower rate of fatal or disabling stroke with TAVI in trials published after 2015, compared to those published in 2015 or before (p-interaction = 0.01 at 30 days). Higher proportions of transfemoral route access (>90%), more common in recent trials, were associated with a lower rate of fatal or disabling stroke (p-interaction = 0.03 at 30 days). Lower average surgical risk scores were associated with lower rates of fatal or disabling stroke (p = 0.02 at 30 days). CONCLUSION: We found that treatment of aortic stenosis with TAVI compared with SAVR was not associated with an overall reduced risk in fatal or disabling stroke. Subgroup analyses suggested a lower risk of fatal or disabling stroke with TAVI in situations which reflect contemporary practice.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , 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 , Avaliação da Deficiência , Feminino , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Incidência , Masculino , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/mortalidade , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
5.
JACC Cardiovasc Interv ; 14(14): 1523-1534, 2021 Jul 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.

6.
Eur Radiol ; 31(8): 6220-6229, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34156556

RESUMO

OBJECTIVES: We sought to identify the impact of transcatheter aortic valve implantation (TAVI) on changes of fractional flow reserve computed tomography (FFRCT) values and the associated clinical impact. METHODS: A retrospective analysis was done with CT obtained pre-TAVI, prior to hospital discharge and at 1-year follow-up, which provided imaging sources for the calculation of FFRCT values based on an online platform. RESULTS: A total of 190 patients were enrolled. Patients with pre-procedural FFRCT value > 0.80 (i.e., negative) and ≤ 0.80 (i.e., positive) demonstrated a significantly opposite change in the value after TAVI (0.8798 vs. 0.8718, p < 0.001 and 0.7634 vs. 0.8222, p < 0.001, respectively). The history of coronary artery disease (CAD) was identified as an independent predictor for FFRCT changing from negative to positive after TAVI (odds ratio [OR] 2.927, 95% confidence interval [CI] 1.130-7.587, p = 0.027), with lesions more severely stenosed (OR 1.039, 95% CI 1.003-1.076, p = 0.034) and in left anterior descending coronary artery (LAD) (OR 3.939, 95% CI 1.060-14.637, p = 0.041) being prone to change. CONCLUSIONS: TAVI directly brings improvement in FFRCT values in patients with compromised coronary flow. Patients with a history of CAD, especially with lesions more severely stenosed and in LAD, were under risk of FFRCT changing from negative to positive after TAVI. KEY POINTS: •The effect of TAVI on coronary hemodynamics might be influenced by different ischemic severity and coronary territories reflected by FFRCT values. •As different FFRCT variations did not impact outcomes of TAVI patients, AS, but not coronary issues, may be the primary problem to affect, which needs further validation.


Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Substituição da Valva Aórtica Transcateter , Angiografia por Tomografia Computadorizada , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Hemodinâmica , Humanos , Valor Preditivo dos Testes , Estudos Retrospectivos , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X
8.
Int J Cardiol ; 338: 58-62, 2021 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-34090956

RESUMO

BACKGROUND: Horizontal aorta (HA) is an anatomical feature that can pose significant technical challenges for the successful positioning of the bioprosthetic valve during transcatheter aortic valve replacement (TAVR). Physiological range of aortic angle (AA) is unknown; hence there is no cutoff AA for classifying HA. Moreover, patient characteristics predicting HA are under-investigated. METHODS: This was a retrospective analysis of prospective collected data from 16 heart valve centers in Europe. The study utilized a common dataset with a priori agreed-upon definitions and variables. Eligible patients underwent TAVR between 2014 and 2020 and had multidetector computed tomographic imaging data available for determining the AA. The analysis described the distribution of AA and potential predictors of HA. Inter-center variability was also explored. RESULTS: For 4022 patients analyzed, the mean AA ± standard deviation was 49.4° ± 9.4° (median 49°, inter-quartile range [IQR] 12°, range 18-90°). There was no significant difference in mean AA between men and women (49.4° ± 9.1° vs. 49.6° ± 9.3°, respectively; p = 0.53); therefore, 49.4° was accepted as the cutoff value for HA in subsequent analyses. Covariates significantly associated with HA included age (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 1.01-1.04, p < 0.001), body mass index (OR: 1.06, 95% CI: 1.05-1.08, p < 0.01), previous cardiac surgery (OR: 0.58, 95% CI: 0.45-0.75, p < 0.001), and porcelain aorta (OR: 0.66, 95% CI: 0.52-0.85, p = 0.001). Some inter-center variability was observed. CONCLUSIONS: We defined 49.4° as the mean AA, and also associated predictors of HA in a large case series of patients with severe aortic stenosis candidates for TAVR.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Aorta , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Europa (Continente) , Feminino , Humanos , Masculino , Estudos Prospectivos , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
9.
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
10.
JACC Cardiovasc Interv ; 14(11): 1181-1192, 2021 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-33992550

RESUMO

OBJECTIVES: The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited. METHODS: The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared. RESULTS: In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score-matched cohort (91 patients' pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097). CONCLUSIONS: Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274).

11.
Catheter Cardiovasc Interv ; 98(4): 756-764, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33991385

RESUMO

OBJECTIVES: To evaluate outcome and its predictors of bioprosthetic valve fracture (BVF) in patients undergoing valve-in-valve transcatheter aortic valve replacement (VIV-TAVR). BACKGROUND: BVF is feasible and reduces transvalvular gradients in VIV-TAVR-procedures, but follow-up-data and information on factors influencing the outcome are missing. METHODS: The 81 cases of BVF-VIV-TAVR were collected from 14 international centers. RESULTS: Predominantly transcatheter heart valve (THV) was implanted first, followed by BVF. VARC-2 defined device success was 93%, most failures were attributed to residual high gradients. Mean gradients decreased from 37 ± 13 mmHg to 10.8 ± 5.9 mmHg (p < 0.001). BVF reduced the gradient by 16 mmHg. During follow-up (FU, 281 ± 164 days) mean gradient remained stable (10.8 ± 5.9 mmHg at discharge, 12.4 ± 6.3 mmHg at FU, p = ns). In-hospital major adverse events occurred in 3.7%. Event-free survival at 276 ± 237.6 days was 95.4%. The linear mixed model identified balloon-expandable valves (BEV), Mitroflow surgical valve, stenotic surgical bioprostheses and balloon only 1 mm larger than the true internal diameter of the surgical valve as predictors for higher gradients. CONCLUSIONS: BVF is safe and can significantly reduce gradients, which remain stable at FU. BEV, Mitroflow surgical valve, stenotic bioprostheses and balloon larger than the true internal diameter of the surgical valve of only 1 mm are predictors for higher final gradients.

12.
EuroIntervention ; 2021 05 25.
Artigo em Inglês | MEDLINE | ID: mdl-34031022

RESUMO

BACKGROUND: Bioprosthetic valve fracture (BVF) is a technique to reduce gradients in valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) procedures. Outcome of VIV-TAVI with BVF has not been compared with VIV-TAVI without BVF. AIMS: To evaluate the outcome of VIV-TAVI with BVF compared to VIV-TAVI without BVF. METHODS: In total, 81 cases of BVF-VIV-TAVI (BVF-group) from 14 centres were compared to 79 cases of VIV-TAVI without BVF (control-group). RESULTS: VARC-2 defined device success was 93% in the BVF- and 68.4% in the control-group (p<0.001). The mean transvalvular gradient decreased from 37 ± 13mmHg to 10.8 ± 5.9mmHg (p<0.001) in the BVF- and from 35 ± 16mmHg to 15.8 ± 6.8mmHg (p<0.001) in the control-group with a significantly higher final gradient in control (p<0.001). The transvalvular gradients did not significantly change over time. In-hospital major adverse events occurred in 3.7% in BVF- and 7.6% in control-group (p=0.325). A linear mixed model identified BVF, self-expanding transcatheter heart valves (THVs) and other surgical aortic valve (SAV) types other than Mitroflow as predictors for lower transvalvular gradients. CONCLUSIONS: Compared to VIV-TAVI alone, VIV-TAVI with BVF resulted in a significantly lower transvalvular gradient acutely and at follow-up. Independent predictors for lower gradients were the use of self-expanding THVs and the treatment of SAVs other than Mitroflow, irrespective of BVF-performance. BVF significantly reduced the gradient independently from transcatheter or surgical valve type.

13.
Glob Heart ; 16(1): 20, 2021 03 19.
Artigo em Inglês | MEDLINE | ID: mdl-33833944

RESUMO

Objectives: The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloon-expandable valves. Background: Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI. Methods: This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database. Results: The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246). Conclusion: The Myval THV, in comparison with other BEV's analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.

14.
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.

15.
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
17.
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
18.
JACC Cardiovasc Interv ; 14(2): 198-207, 2021 01 25.
Artigo em Inglês | MEDLINE | ID: mdl-33478637

RESUMO

OBJECTIVES: This study sought to evaluate the incidence and causes of percutaneous coronary intervention (PCI) at different time periods following transcatheter aortic valve replacement (TAVR). BACKGROUND: Coronary artery disease (CAD) and aortic stenosis frequently coexist, but the optimal management of CAD following TAVR remains incompletely elucidated. METHODS: Patients undergoing unplanned PCI after TAVR were retrospectively included in an international multicenter registry. RESULTS: Between July 2008 and March 2019, a total of 133 patients (0.9%; from a total cohort of 15,325) underwent unplanned PCI after TAVR (36.1% after balloon-expandable bioprosthesis, 63.9% after self-expandable bioprosthesis). The median time to PCI was 191 days (interquartile range: 59 to 480 days). The daily incidence of PCI was highest during the first week after TAVR and then declined over time. Overall, the majority of patients underwent PCI due to an acute coronary syndrome, and specifically 32.3% had non-ST-segment elevation myocardial infarction, 15.4% had unstable angina, 9.8% had ST-segment elevation myocardial infarction, and 2.2% had cardiac arrest. However, chronic coronary syndromes are the main indication beyond 2 years. PCI success was reported in almost all cases (96.6%), with no significant differences between patients treated with balloon-expandable and self-expandable bioprostheses (100% vs. 94.9%; p = 0.150). CONCLUSIONS: Unplanned PCI after TAVR is rare, with an incidence declining over time after TAVR. The main indication to PCI is acute coronary syndrome in the first 2 years after TAVR, and thereafter chronic coronary syndromes become prevalent. Unplanned PCIs are frequently successfully performed after TAVR, with no apparent differences between balloon-expandable and self-expandable bioprostheses. (Revascularization After Transcatheter Aortic Valve Implantation [REVIVAL]; NCT03283501).


Assuntos
Estenose da Valva Aórtica , Intervenção Coronária Percutânea , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Humanos , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
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