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1.
Circ Cardiovasc Interv ; 12(11): e007938, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31694412

RESUMO

BACKGROUND: No data exist about the characteristics of infective endocarditis (IE) post-transcatheter aortic valve replacement (TAVR) according to transcatheter valve type. We aimed to determine the incidence, clinical characteristics, and outcomes of patients with IE post-TAVR treated with balloon-expandable valve (BEV) versus self-expanding valve (SEV) systems. METHODS: Data from the multicenter Infectious Endocarditis After TAVR International Registry was used to compare IE patients with BEV versus SEV. RESULTS: A total of 245 patients with IE post-TAVR were included (SEV, 47%; BEV, 53%). The timing between TAVR and IE was similar between groups (SEV, 5.5 [1.2-15] months versus BEV, 5.3 [1.7-11.4] months; P=0.89). Enterococcal IE was more frequent in the SEV group (36.5% versus 15.4%; P<0.01), and vegetation location differed according to valve type (stent frame, SEV, 18.6%; BEV, 6.9%; P=0.01; valve leaflet, SEV, 23.9%; BEV, 38.5%; P=0.01). BEV recipients had a higher rate of stroke/systemic embolism (20.0% versus 8.7%, adjusted OR: 2.46, 95% CI: 1.04-5.82, P=0.04). Surgical explant of the transcatheter valve (SEV, 8.7%; BEV, 13.8%; P=0.21), and in-hospital death at the time of IE episode (SEV, 35.6%; BEV, 37.7%; P=0.74) were similar between groups. After a mean follow-up of 13±12 months, 59.1% and 54.6% of the SEV and BEV recipients, respectively, had died (P=0.66). CONCLUSIONS: The characteristics of IE post-TAVR, including microorganism type, vegetation location, and embolic complications but not early or late mortality, differed according to valve type. These results may help to guide the diagnosis and management of IE and inform future research studies in the field.

2.
Circulation ; 2019 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-31736356

RESUMO

Background: No randomized study powered to compare balloon-expandable (BE) with self-expanding (SE) transcatheter heart valve (THV) on individual endpoints after transcatheter aortic valve replacement (TAVR) has been conducted to date. Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry included 12,141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for native aortic stenosis (AS). Long-term mortality status was available in all patients (median 20 months, IQR:14-30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity-score (25 clinical, anatomical and procedural variables) and by date of the procedure (within 3 months). The first co-primary outcome was the occurrence of paravalvular regurgitation (PVR){greater than or equal to}moderate and/or in-hospital mortality. The 2nd co-primary outcome was 2-year all-cause mortality. Results: In matched-propensity analyses, the incidence of the 1st co-primary outcome was higher with SE-THV (19.8%) compared with BE-THV(11.9%; RR=1.68; 95%CI:1.46-1.91; p<0.0001). Each component of the outcome was also higher in SE-THV patients: PVR{greater than or equal to}moderate (15.5% vs. 8.3%; RR=1.90; 95% CI:1.63-2.22; p<0.0001) and in-hospital mortality (5.6% vs 4.2%, RR=1.34; 95%CI:1.07-1.66; p=0.01). During follow-up, all-cause mortality occurred in 899 patients treated with SE-THV (2-year mortality was 29.8%) and in 801 patients treated with BE-THV (2-year mortality 26.6%; HR=1.17; 95% CI:1.06-1.29; p=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. Conclusions: The present study suggests that use of SE-THV was associated with a higher risk of PVR and higher in-hospital and 2-year mortality as compared with BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare head-to-head the latest generation of SE and BE-THV.(Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE-TAVI]; NCT01777828) Clinical Trial Registration: URL: https://clinicaltrials.gov Unique identifier: NCT01777828.

3.
Arch Cardiovasc Dis ; 112(8-9): 512-522, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31474571

RESUMO

BACKGROUND: Despite the worldwide development of transcatheter aortic valve implantation (TAVI) over the last decade, strategies that take patient characteristics into account to guide the choice of transcatheter heart valve have not been evaluated. AIM: To evaluate the immediate results of TAVI using a tailored choice of balloon-expandable or self-expanding transcatheter heart valve, according to each patient's clinical and anatomical characteristics. METHODS: This single-centre observational study included all patients treated with TAVI from 2012 to 2017. The 30-day results were reported according to Valve Academic Research Consortium-2 criteria. A total of 502 patients were included (mean age, 81±9 years; 52% men; mean EuroSCORE II, 7.0±6.5%). Three main variables guided the choice of transcatheter heart valve: the anatomy of the iliofemoral arteries and of the aortic root, and the general condition of the patient. RESULTS: A SAPIEN™ balloon-expandable transcatheter heart valve was used in 275 patients (55%) and a CoreValve™ self-expanding transcatheter heart valve in 227 patients (45%). The approach was transfemoral in 427 patients (85%), and only 29 patients (6%) required transthoracic access. At 30-day follow-up, the rates of adverse events were as follows: mortality, 3.2%; stroke, 3.0%; major bleeding, 5.9%; and major vascular complications, 6.0%. Rates of complications at 30 days were similar in the SAPIEN™ and CoreValve™ groups, except for a higher rate of pacemaker implantation in the latter group (29.5% vs. 14.5%; P<0.001). CONCLUSION: The choice of balloon-expandable or self-expanding transcatheter heart valve tailored to the patient's clinical and anatomical characteristics allows for maximal use of the transfemoral approach, and is associated with low 30-day rates of major complications and mortality.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Valvuloplastia com Balão , Próteses Valvulares Cardíacas , Desenho de Prótese , 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 , Tomada de Decisão Clínica , Feminino , Humanos , Masculino , Seleção de Pacientes , Complicações Pós-Operatórias/etiologia , Recuperação de Função Fisiológica , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
4.
Eur J Heart Fail ; 2019 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-31476260

RESUMO

AIMS: The MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone. We report the 24-month outcome from this trial. METHODS AND RESULTS: At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm2 or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n = 152) or medical treatment alone (control group, n = 152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group [hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.77-1.34]. All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (HR 1.02, 95% CI 0.70-1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (HR 0.97, 95% CI 0.72-1.30). CONCLUSIONS: In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at 2 years compared with medical treatment alone.

5.
J Am Heart Assoc ; 8(13): e012031, 2019 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-31256703

RESUMO

Background Percutaneous mitral commissurotomy ( PMC ) was the first available transcatheter technique for treatment of mitral valve diseases. Experience has led to extending the indications to patients with less favorable characteristics. We aimed to analyze (1) the temporal trends in characteristic and outcomes of patients undergoing PMC in a single center over 30 years and (2) the predictive factors of poor immediate results of PMC . Methods and Results From 1987 to 2016, 1 full year for each decade was analyzed: 1987, 1996, 2006, and 2016. Poor immediate results of PMC were defined as a mitral valve area <1.5 cm2 or MR (mitral regurgitation) grade >2. Mitral anatomy was assessed using the Cormier classification and the fluoroscopic extent of calcification. Six hundred three patients were included: 111, 202, 205, and 85, respectively. Mean age increased >10 years over time ( P<0.0001). Mitral anatomy was less favorable over the years: the presence of calcification increased from 25% of patients at the beginning of PMC to >40% during the past decade ( P<0.0001) with a 3-fold increase in severe mitral calcification. Consistently, the proportion of good immediate results decreased over time ( P<0.05) but remained at 76% in 2016. Multivariate analysis showed 3 predictive factors of poor immediate results: smaller baseline mitral valve area ( P<0.0001), pre- PMC MR grade 2 ( P<0.01), and the presence or amount of calcification ( P<0.001). Conclusions This clinic's patients became significantly older with more frequent and severe calcification in the past decade. Predictive factors of poor immediate results were related to valve anatomy, including calcification. Despite challenges raised by severe calcification, PMC was still successful in >3 out of 4 patients in recent years.

6.
Open Heart ; 6(1): e001008, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31218003

RESUMO

Background: Patients with severe aortic stenosis (AS) have a reduced life expectancy and quality of life (QoL), owing to advanced age and the presence of multiple comorbidities. Currently, there is no AS-specific QoL measurement tool, which prevents an accurate assessment of how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) was developed in order to address this deficiency. Methods: The present trial protocol was designed to enable validation of the TASQ, which has been produced in five languages (English, French, German, Italian and Spanish) to increase usability. Patients with severe AS who are undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) will be asked to complete the TASQ and, for comparative purposes, the Kansas City Cardiomyopathy Questionnaire and the general health-related QoL Short Form-12 questionnaire. The questionnaires will be completed prior to the intervention, at discharge, as well as at 30 days and 3 months follow-up. A total of 290 patients will be recruited across one Canadian and nine European centres. Overall, the protocol validation aims to include 120 patients undergoing transfemoral TAVI (TF-TAVI), 120 undergoing SAVR and up to 50 being treated medically. The primary objective of the registry is to validate the TASQ in five different languages. The secondary objective is to assess the utility of the TASQ for assessing differences in QoL outcome between patients undergoing TF-TAVI, SAVR or medical management for their AS. Discussion: Validation and roll-out of the TASQ will enable clinicians to capture an accurate assessment of how AS and its management affects the QoL of patients and will help them to determine the most appropriate treatment strategy for individual patients. Trial registration number: NCT03186339.

7.
8.
Int J Cardiol ; 286: 36-42, 2019 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-30967274

RESUMO

OBJECTIVE: In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR), the impact of concomitant mitral stenosis (MS) remains unknown. The aim of this study was to determine the incidence and impact of moderate to severe MS in patients undergoing TAVR. METHODS: The study included 2113 consecutive patients (mean age: 80 ±â€¯9 years, mean STS: 6.4 ±â€¯5.2%) who underwent TAVR in 2 centers. The presence of MS was defined as a mean transmitral gradient ≥ 5 mm Hg on baseline echocardiography in the absence of severe mitral regurgitation. Clinical events were prospectively collected in a dedicated TAVR database. RESULTS: A total of 157 patients (7.4%) had moderate to severe MS (mean gradient: 7.2 ±â€¯2.8 mm Hg; degenerative origin in 88%). Patients with MS were younger, more frequently women, had a higher left ventricular ejection fraction and an increased rate of severe pulmonary hypertension (p < 0.02 for all). Thirty-day mortality was similar in both groups (MS: 3.8%; no MS: 5.5%, adjusted p = 0.34). At a mean follow-up of 3 ±â€¯2 years, there were no differences between groups in mortality (MS: 35%, no MS: 36.2%, adjusted HR: 1.14, 95% CI: 0.86-1.51), or heart failure rehospitalization (MS: 21%, no MS: 21.7%; adjusted HR: 1.16, 95% CI: 0.81-1.67). Patients with MS exhibited a similar functional status at follow-up compared to those with no MS (NYHA I-II in 85% and 88% of patients, respectively, adjusted p = 0.20). CONCLUSIONS: About 7% of patients undergoing TAVR had concomitant moderate to severe MS. The presence of MS had no negative impact on early and mid-term clinical outcomes post-TAVR. These results suggest that TAVR is a valid alternative for treating patients with aortic stenosis in the presence of moderate to severe MS.

9.
Circ Cardiovasc Interv ; 12(4): e007597, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30998397

RESUMO

BACKGROUND: The durability of transcatheter aortic bioprosthetic valves is a crucial issue, but data are scarce, especially beyond 5 years of follow-up. We aimed to assess long-term (7 years) structural valve deterioration (SVD) and bioprosthetic valve failure of transcatheter aortic bioprosthetic valves. METHODS AND RESULTS: Consecutive patients with at least 5-year follow-up available undergoing transcatheter aortic valve implantation from April 2002 to December 2011 in 5 French centers were included. Incidence of SVD and bioprosthetic valve failure were defined according to newly standardized criteria of the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery and reported as cumulative incidence function to account for the competing risk of death. One thousand four hundred three consecutive patients were included with a mean age of 82.6±7.5 years and with a mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 21.3±7.5%. A balloon-expandable valve was used in 83.7% of cases. Survival rates were 83.5% (95% CI, 81.4%-85.5%) and 18.6% (95% CI, 15.3%-21.8%) at 1 and 7 years, respectively. Median duration of follow-up was 3.9 years. Bioprosthetic valve failure occurred in 19 patients with a 7-year cumulative incidence of 1.9% (95% CI, 1.4%-2.4%). SVD occurred in 49 patients (moderate, n=32; severe, n=17) with a 7-year cumulative incidence of moderate and severe SVD of 7.0% (95% CI, 5.6%-8.4%) and 4.2% (95% CI, 2.9%-5.5%), respectively. Five patients had aortic valve reintervention (1.0%; 95% CI, 0.4%-1.6%) including 1 case of surgical aortic valve replacement and 4 redo-transcatheter aortic valve implantation. The incidences of SVD and bioprosthetic valve failure were not significantly different between balloon and self-expandable prostheses. CONCLUSIONS: The long-term assessment of transcatheter aortic bioprosthetic valves durability is limited by the poor survival of our population beyond 5 years. Further studies are warranted, particularly in younger and lower-risk patients.

10.
11.
Artigo em Inglês | MEDLINE | ID: mdl-30811746

RESUMO

Transcatheter tricuspid valve-in-valve replacement (TTVR) represents an attractive therapeutic option in very high surgical risk patients with degenerated tricuspid bioprostheses. However, the procedural management of these patients might be challenging due to their comorbidities, long lasting heart valve disease and the presence of left-sided mechanical prostheses. Thus, a more "minimally disruptive" procedure would have several potential benefits in such a frail population. We present the cases of four patients admitted for congestive heart failure due to severe degeneration of their tricuspid bioprostheses who were treated with a minimalist TTVR. The protocol combined continuation of the oral anticoagulant treatment with no bridging therapy, the use of a single venous access with local anesthesia, rapid pacing via the stiff right ventricular wire, and transthoracic echocardiographic guidance and assessment, with no need for contrast injection. Our protocol aims at simplifying the TTVR procedure and might be a useful tool to avoid procedural complications and reduce hospital stay.

13.
14.
JACC Cardiovasc Interv ; 12(2): 155-165, 2019 01 28.
Artigo em Inglês | MEDLINE | ID: mdl-30594510

RESUMO

OBJECTIVES: A large, prospective international registry was developed to evaluate the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices. BACKGROUND: TTVI for native tricuspid valve dysfunction has been emerging during the last few years as an alternative therapeutic option to serve a large high-risk population of patients with severe symptomatic tricuspid regurgitation (TR). METHODS: The TriValve Registry included 312 high-risk patients with severe TR (76.4 ± 8.5 years of age; 57% female; EuroSCORE II 9 ± 8%) at 18 centers. Interventions included repair at the level of the leaflets (MitraClip, Abbott Vascular, Santa Clara, California; PASCAL Edwards Lifesciences, Irvine, California), annulus (Cardioband, Edwards Lifesciences; TriCinch, 4tech, Galway, Ireland; Trialign, Mitraling, Tewksbury, Massachusetts), or coaptation (FORMA, Edwards Lifesciences) and replacement (Caval Implants, NaviGate, NaviGate Cardiac Structures, Lake Forest, California). Clinical outcomes were prospectively determined during mid-term follow-up. RESULTS: A total of 108 patients (34.6%) had prior left heart valve intervention (84 surgical and 24 transcatheter, respectively). TR etiology was functional in 93%, and mean annular diameter was 46.9 ± 9 mm. In 75% of patients the regurgitant jet was central (vena contracta 1.1 ± 0.5; effective regurgitant orifice area 0.78 ± 0.6 cm2). Pre-procedural systolic pulmonary artery pressure was 41 ± 14.8 mm Hg. Implanted devices included: MitraClip in 210 cases, Trialign in 18 cases, TriCinch first generation in 14 cases, caval valve implantation in 30 cases, FORMA in 24 cases, Cardioband in 13 cases, NaviGate in 6 cases, and PASCAL in 1. In 64% of the cases, TTVI was performed as a stand-alone procedure. Procedural success (defined as the device successfully implanted and residual TR ≤2+) was 72.8%. Greater coaptation depth (odds ratio: 24.1; p = 0.002) was an independent predictor of reduced device success. Thirty-day mortality was 3.6% and was significantly lower among patients with procedural success (1.9% vs. 6.9%; p = 0.04); Actuarial survival at 1.5 years was 82.8 ± 4% and was significantly higher among patients who had procedural success achieved. CONCLUSIONS: TTVI is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Mid-term survival is favorable in this high-risk population. Greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality.

15.
Am J Cardiol ; 2019 Dec 09.
Artigo em Inglês | MEDLINE | ID: mdl-31889524

RESUMO

This study sought to determine, in patients with new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI), the incidence and factors associated with (i) LBBB recovery and (ii) permanent pacemaker implantation (PPI) at 1-year follow-up. This was a multicenter study including 153 patients (mean age: 81 ± 5 years, 56% of women) with NOP-LBBB post-TAVI (balloon-expandable valve in 112 patients). Delta PR (ΔPR) and delta QRS (ΔQRS) were defined as the difference in PR and QRS length between baseline and hospital discharge ECG, and the relative ΔPR and ΔQRS as absolute ΔPR and ΔQRS divided by baseline PR and QRS length, respectively. The patients had a clinical visit and 12-lead ECG at 1-year follow-up. LBBB recovery was observed in 50 patients (33%), and 14 patients (9%) had advanced conduction disturbances requiring PPI during the follow-up period. No clinical or ECG variables were associated with LBBB recovery, including prosthesis type (self- or balloon-expandable valve, p = 0.563), QRS width at baseline/discharge or absolute/relative ΔQRS (p >0.10 for all). The presence of atrial fibrillation at baseline (0.026), a longer PR interval at discharge (0.009), and a longer absolute and relative ΔPR (p = 0.002 and p = 0.004, respectively) were associated with an increased risk of PPI at 1-year follow-up. In conclusion, NOP-LBBB post-TAVI resolved in one-third of patients at 1-year follow-up, but no clinical or ECG variables were associated with LBBB recovery. Conversely, a nonsinus rhythm at baseline and a longer ΔPR were associated with an increased risk of PPI within the year after TAVI.

16.
Circ Cardiovasc Interv ; 11(11): e006927, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30571207

RESUMO

BACKGROUND: The impact of preexisting left bundle branch block (LBBB) in transcatheter aortic valve replacement (TAVR) recipients is unknown. The aim of this study was to determine the impact of preexisting LBBB on clinical outcomes after TAVR. METHODS AND RESULTS: This multicenter study evaluated 3404 TAVR candidates according to the presence or absence of LBBB on baseline ECG. TAVR complications and causes of death were defined according to Valve Academic Research Consortium-2 definitions. Follow-up outpatient visits or telephone interviews were conducted at 30 days, 12 months, and yearly thereafter. Echocardiography examinations were performed at baseline, at hospital discharge, and at 1-year follow-up. Preexisting LBBB was present in 398 patients (11.7%) and was associated with an increased risk of permanent pacemaker implantation (PPI; 21.1% versus 14.8%; adjusted odds ratio, 1.51; 95% CI, 1.12-2.04) but not death (7.3% versus 5.5%; adjusted odds ratio, 1.33; 95% CI, 0.84-2.12) at 30 days. At a mean follow-up of 22±21 months, there were no differences between patients with and without preexisting LBBB in overall mortality (adjusted hazard ratio, 0.94; 95% CI, 0.75-1.18) and cardiovascular mortality (adjusted hazard ratio, 0.90; 95% CI, 0.68-1.21). In a subanalysis of 2421 patients without PPI at 30 days and with complete follow-up about the PPI, preexisting LBBB was not associated with an increased risk of PPI or sudden cardiac death. Patients with preexisting LBBB had a lower left ventricular ejection fraction (LVEF) at baseline and at 1-year follow-up ( P <0.001 for both), but those with low LVEF exhibited a similar increase in LVEF over time after TAVR compared with patients with no preexisting LBBB ( P=0.327). CONCLUSIONS: Preexisting LBBB significantly increased the risk of early (but not late) PPI after TAVR, without any significant effect on overall mortality or cardiovascular mortality. Preexisting LBBB was associated with lower LVEF pre-TAVR but did not prevent an increase in LVEF post-TAVR similar to patients without LBBB.


Assuntos
Valva Aórtica/cirurgia , Bloqueio de Ramo/terapia , Estimulação Cardíaca Artificial , Doenças das Valvas Cardíacas/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Brasil/epidemiologia , Bloqueio de Ramo/diagnóstico , Bloqueio de Ramo/mortalidade , Bloqueio de Ramo/fisiopatologia , Canadá/epidemiologia , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/mortalidade , Ecocardiografia , Eletrocardiografia , Europa (Continente)/epidemiologia , Feminino , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/mortalidade , Doenças das Valvas Cardíacas/fisiopatologia , Humanos , Masculino , Marca-Passo Artificial , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
17.
Circulation ; 138(23): 2597-2607, 2018 12 04.
Artigo em Inglês | MEDLINE | ID: mdl-30571260

RESUMO

BACKGROUND: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. METHODS: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. RESULTS: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). CONCLUSIONS: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.


Assuntos
Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Falha de Equipamento , Feminino , Seguimentos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Hemodinâmica , Humanos , Masculino , Modelos de Riscos Proporcionais , Sistema de Registros , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento
18.
Circ Cardiovasc Interv ; 11(9): e007038, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30354588

RESUMO

BACKGROUND: Data on long-term outcomes after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) are scarce. The objective of this study was to determine the long-term clinical outcomes and structural valve degeneration (SVD) over time in patients undergoing ViV-TAVR. METHODS AND RESULTS: Consecutive patients undergoing ViV-TAVR in 9 centers between 2009 and 2015 were included. Patients were followed yearly, and clinical and echocardiography data were collected prospectively. SVD was defined as subclinical (increase >10 mm Hg in mean transvalvular gradient+decrease >0.3 cm2 in valve area or new-onset mild or moderate aortic regurgitation) and clinically relevant (increase >20 mm Hg in mean transvalvular gradient+decrease >0.6 cm2 in valve area or new-onset moderate-to-severe aortic regurgitation). A total of 116 patients (mean age, 76±11 years; 64.7% male; mean Society of Thoracic Surgeons score, 8.0±5.1%) were included. Balloon- and self-expandable valves were used in 47.9% and 52.1% of patients, respectively, and 30-day mortality was 6.9%. At a median follow-up of 3 years (range, 2-7 years), 30 patients (25.9%) had died, 20 of them (17.2%) from cardiovascular causes. Average mean transvalvular gradients remained stable up to 5-year follow-up ( P=0.92), but clinically relevant SVD occurred in 3/99 patients (3.0%), and 15/99 patients (15.1%) had subclinical SVD. One patient with SVD had redo ViV-TAVR. CONCLUSIONS: About one-fourth of ViV-TAVR recipients had died after a median follow-up of 3 years. Overall valve hemodynamics remained stable over time and clinically relevant SVD was infrequent, but 1 out of 10 patients exhibited some degree of SVD.


Assuntos
Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , 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/mortalidade , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Ecocardiografia Doppler em Cores , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/mortalidade , Hemodinâmica , Humanos , Masculino , Desenho de Prótese , Falha de Prótese , Recuperação de Função Fisiológica , Reoperação , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
19.
JACC Cardiovasc Interv ; 11(17): 1669-1679, 2018 09 10.
Artigo em Inglês | MEDLINE | ID: mdl-30190058

RESUMO

OBJECTIVES: The authors aimed to determine the procedural learning curve and minimum annual institutional volumes associated with optimum clinical outcomes for transcatheter aortic valve replacement (TAVR). BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a complex procedure requiring significant training and experience for successful outcome. Despite increasing use of TAVR across institutions, limited information is available for its learning curve characteristics and minimum annual volumes required to optimize clinical outcomes. METHODS: The study collected data for patients at 16 centers participating in the international TAVR registry since initiation of the respective TAVR program. All cases were chronologically ordered into initial (1 to 75), early (76 to 150), intermediate (151 to 225), high (226 to 300), and very high (>300) experience operators for TAVR learning curve characterization. In addition, participating institutions were stratified by annual TAVR case volume into low-volume (<50), moderate-volume (50 to 100), and high-volume (>100) groups for comparative analysis. Procedural and 30-day clinical outcomes were collected and multivariate regression analysis performed for 30-day mortality and the early safety endpoint. RESULTS: A total of 3,403 patients comprised the study population. On multivariate analysis, all-cause mortality was significantly higher for initial (odds ratio [OR]: 3.83; 95% confidence interval [CI]: 1.93 to 7.60), early (OR: 2.41; 95% CI: 1.51 to 5.03), and intermediate (OR: 2.53; 95% CI: 1.19 to 5.40) experience groups compared with the very high experience operators. In addition, the early safety endpoint was significantly worse for all experience groups compared with the very high experience operators. Low annual volume (<50) TAVR institutions had significantly higher all-cause 30-day mortality (OR: 2.70; 95% CI: 1.44 to 5.07) and worse early safety endpoint (OR: 1.60; 95% CI: 1.17 to 2.17) compared with the moderate- and high-volume groups. There was no difference in patient outcomes between intermediate and high annual volume groups. CONCLUSIONS: TAVR procedures display important learning curve characteristics with both greater procedural safety and a lower mortality when performed by experienced operators. In addition, TAVR performed at low annual volume (<50 procedures) institutions is associated with decreased procedural safety and higher patient mortality. These findings have important implications for operator training and patient care at centers performing TAVR.


Assuntos
Competência Clínica/normas , Hospitais com Alto Volume de Atendimentos/normas , Hospitais com Baixo Volume de Atendimentos/normas , Curva de Aprendizado , /normas , Cirurgiões/normas , Substituição da Valva Aórtica Transcateter/normas , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Segurança do Paciente/normas , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Carga de Trabalho/normas
20.
JACC Cardiovasc Interv ; 11(15): 1495-1505, 2018 08 13.
Artigo em Inglês | MEDLINE | ID: mdl-30031719

RESUMO

OBJECTIVES: The authors sought to determine: 1) the global arrhythmic burden; 2) the rate of arrhythmias leading to a treatment change; and 3) the incidence of high-degree atrioventricular block (HAVB) at 12-month follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). BACKGROUND: Controversial data exist on the occurrence of significant arrhythmias in patients with LBBB post-TAVR. METHODS: This was a multicenter prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR with the balloon-expandable SAPIEN XT/3 valve (n = 53), or the self-expanding CoreValve/Evolut R system (n = 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted at 4 (3 to 6) days post-TAVR, and patients had continuous electrocardiogram monitoring for 12 months. All arrhythmic events were adjudicated in a central electrocardiography core lab. Primary endpoints were the incidence of arrhythmias leading to a treatment change, and the incidence of HAVB at 12-month follow-up. RESULTS: A total of 1,553 new arrhythmic events were detected in 44 patients (1,443 episodes of tachyarrhythmia in 26 patients [atrial fibrillation/flutter/atrial tachycardia: 1,427, ventricular tachycardia 16]; 110 episodes of bradyarrhythmia in 21 patients [HAVB 54, severe bradycardia 56]). All arrhythmic events were silent in 34 patients (77%), the arrhythmic event led to a treatment change in 19 patients (18%), and 11 patients (11%) required pacemaker or implantable cardioverter-defibrillator implantation (due to HAVB, severe bradycardia, or ventricular tachycardia episodes in 9, 1, and 1 patient, respectively). A total of 12 patients died at 1-year follow-up, 1 from sudden death. CONCLUSIONS: A high incidence of arrhythmic events was observed at 1-year follow-up in close to one-half of the patients with LBBB post-TAVR. Significant bradyarrhythmias occurred in one-fifth of the patients, and PPM was required in nearly one-half of them. These data support the use of a cardiac monitoring device for close follow-up and expediting the initiation of treatment in this challenging group of patients. (Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation [MARE study]: NCT02153307).


Assuntos
Estenose da Valva Aórtica/cirurgia , Arritmias Cardíacas/diagnóstico , Bloqueio de Ramo/diagnóstico , Eletrocardiografia Ambulatorial , Substituição da Valva Aórtica Transcateter/efeitos adversos , Potenciais de Ação , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/epidemiologia , Arritmias Cardíacas/epidemiologia , Arritmias Cardíacas/fisiopatologia , Arritmias Cardíacas/terapia , Bloqueio de Ramo/epidemiologia , Bloqueio de Ramo/fisiopatologia , Bloqueio de Ramo/terapia , Canadá/epidemiologia , Europa (Continente)/epidemiologia , Feminino , Frequência Cardíaca , Humanos , Incidência , Masculino , Valor Preditivo dos Testes , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
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