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1.
Artigo em Inglês | MEDLINE | ID: mdl-31365061

RESUMO

OBJECTIVES: The transcarotid (TC) approach for transcatheter aortic valve implantation (TAVI) is potentially an optimal alternative to the transfemoral (TF) approach. Our goal was to compare the safety and efficacy of TC- and TF-TAVI. METHODS: Patients who underwent TF-TAVI or TC-TAVI in the prospectively collected FRANCE TAVI registry between January 2013 and December 2015 were compared. Propensity score inverse probability weighting methods were employed to minimize the impact of bias related to non-random treatment assignment. RESULTS: Of the 11 033 patients included in the current study, 10 598 (96%) underwent a TF-TAVI and 435 (4.1%) had a TC-TAVI. Patients in the TC-TAVI access group presented with a higher risk profile but were significantly younger. There were no differences in the perioperative and 2-year mortality rates after adjustment [odds ratio (OR) 1.02, 95% confidence interval (CI) 0.62-1.68; P = 0.99 and hazard ratio 1.03, 95% CI 0.7-1.35; P = 0.83). TC-TAVI was associated with a significant risk of stroke (OR 2.42, 95% CI 2.01-2.92; P < 0.001), ST-elevation myocardial infarction (OR 7.32, 95% CI 3.87-13.87; P < 0.001), infections (OR 2.36, 95% CI 2.04-2.71; P < 0.001), bleeding (OR 2.01, 95% CI 1.76-2.29; P < 0.001), renal failure (OR 2.23, 95% CI 1.90-2.60; P < 0.001) and need for dialysis (OR 2.36, 95% CI 2.01-2.76, P < 0.001). Conversely, TC-TAVI was not confirmed as a risk factor for pacemaker implantation after adjustment (OR 1.05, 95% CI 0.96-1.15; P < 0.28) and was a protective factor for vascular complications (OR 0.37, 95% CI 0.32-0.43; P < 0.001). CONCLUSIONS: TC-TAVI is a safe procedure compared to TF-TAVI, although it holds an increased risk of perioperative complications. It should be considered in case of non-femoral peripheral access as the second access choice, to increase the overall safety of TAVI procedures.

2.
Int J Cardiol ; 2019 Aug 19.
Artigo em Inglês | MEDLINE | ID: mdl-31455517

RESUMO

BACKGROUND: Predictors of heart failure (HF) hospitalization after transcatheter aortic valve implantation (TAVI) are not well defined. CAPRI is a score for predicting 1-year post-TAVI cardiovascular and all-cause mortality. The aim of the present study is to assess the prognostic significance of the CAPRI score for HF hospitalization 1 year after TAVI. METHODS AND RESULTS: CAPRI-HF is an ancillary study of the C4CAPRI trial, analyzing 409 consecutive patients treated by TAVI. The primary outcome was hospitalization for HF during the first year post-intervention. The prognostic value of the CAPRI score was assessed by multivariable analysis adjusted for diabetes, atrial fibrillation, vascular route, pacemaker implantation, post-TAVI aortic regurgitation, transfusion and pulmonary artery systolic pressure. A subanalysis focused on patients with low-gradient aortic stenosis (LGAS). At 1 year, HF hospitalization occurred in 78 (19.9%) patients. Patients with HF were more prone to have diabetes, atrial fibrillation, renal dysfunction, lower mean aortic gradient, higher logistic EuroSCORE and higher CAPRI score (p < .05 for all associations). In the multivariable analysis, CAPRI score was the sole predictor of HF: hazard ratio (HR) for each 0.1 CAPRI score increase was 1.065, 95% confidence interval (CI) 1.021-1.110. This was confirmed when adjusted for EuroSCORE: HR 1.066, 95% CI 1.024-1.110. The predictive power of the CAPRI score increased for LGAS: HR 1.098, 95% CI 1.028-1.172. CONCLUSIONS: CAPRI score helps predict HF post-TAVI. Including the score in the decision-making process may help selecting candidates for TAVI and identifying patients who need close monitoring post-procedure.

3.
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.

4.
J Integr Med ; 17(2): 107-114, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30792149

RESUMO

OBJECTIVE: The use of animal models of aortic stenosis (AS) remains essential to further elucidate its pathophysiology and to evaluate new therapeutic strategies. The waved-2 mouse AS model has been proposed; data have indicated that while aortic regurgitation (AR) is effectively induced, development of AS is rare. We aimed to evaluate the effect of high-fat diet (HFD) and vitamin D3 supplementation in this model. METHODS: HFD and subcutaneous vitamin D3 injections were initiated at the age of 6 weeks until the age of 6 (n = 16, 6-month treatment group) and 9 (n = 11, 9-month treatment group) months. Twelve waved-2 mice without supplementation were used as control. Echocardiography was performed at 3, 6 and 9 months. Blood serum analysis (calcium, 1,25(OH)2D3 and cholesterol), histology and immunohistochemistry (CD-31, CD-68 and osteopontin) were evaluated at the end of the experiment (6 or 9 months). RESULTS: Total cholesterol and 1,25(OH)2D3 were significantly increased relative to the control group. HFD and vitamin D3 supplementation did result in improvements to the model, since AS was only detected in 6 (15.3%) mice (2 in the 3 groups) and AR was developed in the remaining animals. Echocardiographic parameters, fibrosis, thickness, inflammation and valvular calcification, were not significantly different between the 6-month treatment and control groups. Similar results were also observed in the 9-month treatment group. CONCLUSION: These results suggest that HFD and vitamin D3 supplementation have no effect in the waved-2 mouse model. This model essentially mimics AR and rarely AS. Further studies are needed to find a reliable animal model of AS.

5.
Arch Cardiovasc Dis ; 112(5): 314-322, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30670363

RESUMO

BACKGROUND: Atrial fibrillation is the most common arrhythmia in adults. A relationship between epicardial adipose tissue and atrial fibrillation has recently been reported. AIM: To evaluate the impact of epicardial fat thickness on the outcome of patients who underwent a first pulmonary vein isolation procedure using a second-generation cryoballoon. METHODS: From February 2012 to February 2017, all patients who underwent a first pulmonary vein isolation procedure using a second-generation cryoballoon at Rouen University Hospital were included. Data were collected retrospectively. Epicardial fat thickness was assessed by cardiac magnetic resonance imaging. The primary endpoint was documented atrial fibrillation recurrence at 4 months. RESULTS: A first pulmonary vein isolation procedure using a second-generation cryoballoon was performed in 288 patients; among them, 231 patients (80.2%) underwent cardiac magnetic resonance imaging. Epicardial fat thickness could be measured accurately in 206 patients (71.5%). Recurrence of atrial fibrillation at 4 months occurred in 32/206 patients (15.5%). In the multivariable analysis, factors predictive of atrial fibrillation recurrence at 4 months were: epicardial fat thickness (hazard ratio 1.96, 95% confidence interval 1.20-3.18; P=0.007), the presence of high left atrium enlargement (hazard ratio 4.63, 95% confidence interval 1.17-18.38; P=0.03) and atrial fibrillation recurrence before hospital discharge (hazard ratio 7.55, 95% confidence interval 2.50-22.81; P<0.001). CONCLUSION: Epicardial fat thickness is a predictive factor for atrial fibrillation recurrence after a first pulmonary vein isolation procedure using a second-generation cryoballoon.


Assuntos
Tecido Adiposo/fisiopatologia , Adiposidade , Fibrilação Atrial/cirurgia , Cateteres Cardíacos , Criocirurgia/instrumentação , Pericárdio/fisiopatologia , Veias Pulmonares/cirurgia , Tecido Adiposo/diagnóstico por imagem , Idoso , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/fisiopatologia , Criocirurgia/efeitos adversos , Desenho de Equipamento , Feminino , Humanos , Imagem por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Pericárdio/diagnóstico por imagem , Veias Pulmonares/fisiopatologia , Recidiva , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
6.
Circ Cardiovasc Interv ; 12(1): e006724, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30630356

RESUMO

BACKGROUND: Transcatheter aortic valve implantation is increasingly being used in patients at lower risk for surgery. We aimed to assess the distribution of surgical risk score categories in current clinical practice and their relationship with clinical outcomes and the calibration and discrimination power of both the logistic EuroSCORE (logES) and EuroSCORE II. The SOURCE 3 study is a European prospective registry of patients with severe aortic stenosis treated with the commercially available SAPIEN 3 transcatheter heart valve. METHODS AND RESULTS: Out of 1785 patients, 518 patients (low-surgical risk) had a baseline logES <10%, 691 (intermediate-surgical risk) had a logES 10% to 20%, and only 576 patients (high-surgical risk) had a logES ≥20%. Even if low-risk patients were younger compared with the other groups, the mean age was about 80 years old in each risk category. At 1 year, all-cause mortality was 10.3%, 11.4%, and 17.1% in low-, intermediate-, or high-surgical risk patients, respectively, while cardiac mortality was 5.3%, 7.7%, and 11.4%, respectively. Observed mortality rates were substantially lower than that predicted with logES. The observed/predicted mortality ratio was 0.26 in low-surgical risk patients, 0.08 in intermediate-surgical risk patients, and 0.12 in high-surgical risk patients. Similar observations were obtained with EuroSCORE II. CONCLUSIONS: In this real-world setting, two-thirds of SAPIEN 3 transcatheter heart valve treated transcatheter aortic valve implantation patients had a logES <20 but were still considered appropriate transcatheter aortic valve implantation candidates by the heart team, mainly because of older age and less frequently because of conditions not captured by risk scores. logES and EuroSCORE II had poor discrimination and calibration power in this transcatheter aortic valve implantation cohort. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov . Unique identifier: NCT02698956.

7.
Circulation ; 138(23): 2597-2607, 2018 Dec 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.

8.
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.

9.
JACC Cardiovasc Interv ; 11(21): 2195-2203, 2018 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-30409276

RESUMO

OBJECTIVES: This study sought to compare outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) in a catheterization laboratory (cath lab) to those undergoing TAVR in a hybrid operating room (OR). BACKGROUND: TAVR can be performed in a cath lab or in a hybrid OR. Comparisons between these locations are scarce. METHODS: All TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. The primary endpoint of this study was all-cause mortality at 1 year. Secondary endpoints consisted of 30-day complications and 3-year mortality. All analyses were adjusted for baseline and procedural characteristics. RESULTS: A total of 12,121 patients were included in this study, 62% of which underwent TAVR in a cath lab versus 38% in a hybrid OR. Mean age was 82.9 ± 7.2 years, 48.9% of patients were men, and mean Logistic EuroScore was 17.9% ± 12.3%. Both procedure locations showed similar, below 2% rates of intraprocedural complications. After adjusting for baseline and procedural characteristics, major bleeding and infections were significantly higher in the hybrid OR group (bleeding, 6.3% vs. 4.8%; infection, 6.1% vs. 3.5%; p < 0.05). Adjusted mortality rates at 1 and 3 years did not differ significantly between groups (for cath lab vs. hybrid OR, respectively: 1 year: 16.2% vs. 15.8%; p = 0.91; 3 years: 38.4% vs. 36.4%; p = 0.49). CONCLUSIONS: Midterm mortality after TAVR was similar between the cath lab and the hybrid OR. These findings support the performance of TAVR in either location, which has important implications on health care organization and costs.

11.
JACC Cardiovasc Interv ; 11(19): 1956-1965, 2018 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-30219324

RESUMO

OBJECTIVES: This study sought to describe the current practices and compare outcomes according to the use of balloon aortic valvuloplasty (BAV) or not during transcatheter aortic valve replacement (TAVR). BACKGROUND: Since its development, aortic valve pre-dilatation has been an essential step of TAVR procedures. However, the feasibility of TAVR without systematic BAV has been described. METHODS: TAVR performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (Registry of Aortic Valve Bioprostheses Established by Catheter) registry. We compared outcomes according to BAV during the TAVR procedure. RESULTS: A total of 5,784 patients have been included in our analysis, corresponding to 2,579 (44.6%) with BAV avoidance and 3,205 (55.4%) patients with BAV performed. We observed a progressive decline in the use of BAV over time (78% of procedures in 2013 and 49% in the last trimester of 2015). Avoidance of BAV was associated with similar device implantation success (97.3% vs. 97.6%; p = 0.40). TAVR procedures without BAV were quicker (fluoroscopy 17.2 ± 9.1 vs. 18.5 ± 8.8 min; p < 0.01) and used lower amounts of contrast (131.5 ± 61.6 vs. 141.6 ± 61.5; p < 0.01) and radiation (608.9 ± 576.3 vs. 667.0 ± 631.3; p < 0.01). The rates of moderate to severe aortic regurgitation were lower with avoidance of BAV (8.3% vs. 12.2%; p < 0.01) and tamponade rates (1.5% vs. 2.3%; p = 0.04). CONCLUSIONS: We confirmed that TAVR without BAV is frequently performed in France with good procedural results. This procedure is associated with procedural simplification and lower rates of residual aortic regurgitation.

12.
J Invasive Cardiol ; 30(8): 301-309, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-30068785

RESUMO

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is now the standard treatment for severe aortic stenosis in high-risk symptomatic patients, and its indications are expanding to lower-risk patients. OBJECTIVES: The objective of this study was to analyze the state of TAVI in Spain vs other European and non-European countries. METHODS: Using an online questionnaire, we analyzed the routine practice of 250 TAVI centers worldwide. The questionnaire included 59 questions on patient selection, technical aspects of the procedure, and postprocedural management. The centers were divided into Spain (n = 41), rest of Europe (n = 105), and rest of the world (n = 104). RESULTS: The cumulative number of procedures (74; range, 40-122) and those performed in the last year (16.5; range, 15-29.5) in Spain, were significantly lower than the rest of Europe (P<.01) and the rest of the world (P<.01). The patient risk profile was higher, with an under-use of functional tests compared to the rest of the world. While the use of computed tomography to analyze the aortic annulus was lower in Spain (P<.001), general anesthesia and transesophageal echocardiography were more frequently used in Spain than in the rest of Europe (P<.001 for both). Dual-antiplatelet therapy is the most common post-TAVI antithrombotic therapy in the absence of an indication for anticoagulation, although its duration is longer in Spain (6 months) compared to European centers (3 months). CONCLUSIONS: Routine TAVI practice in Spain differed in some key aspects of preprocedural, intraprocedural, and postprocedural management. Future studies will help to unify strategies and assess their impact on clinical results.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Seleção de Pacientes , Substituição da Valva Aórtica Transcateter/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Ecocardiografia Transesofagiana , Europa (Continente) , Feminino , Humanos , Masculino , Fatores de Risco , Espanha , Estados Unidos
13.
EuroIntervention ; 14(AB): AB64-AB73, 2018 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-30158097

RESUMO

Aortic bioprostheses are increasingly used both for surgery, as an alternative to mechanical valves, and for transcatheter implantation in patients with severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) has been widely adopted for the treatment of severe symptomatic aortic stenosis in elderly (>75 years) patients who are at risk for surgery and who have favourable transfemoral access. It is already under evaluation in low-risk patients. The aim of this review is to present an update on definitions and to assess the various forms of transcatheter heart valve failure and their management: structural valve deterioration, non-structural deterioration, thrombosis and endocarditis.

14.
J Am Coll Cardiol ; 2018 Aug 22.
Artigo em Inglês | MEDLINE | ID: mdl-30153483

RESUMO

BACKGROUND: The optimal anti-thrombotic treatment after transcatheter aortic valve replacement (TAVR) remains a matter of debate. Dual antiplatelet therapy (DAPT) is recommended but single antiplatelet therapy or oral anticoagulation (OAC) are frequently used according to the patient profile. Whether this may impact clinical outcome is unknown. METHOD: and objectives: FRANCE-TAVI is a prospective multicenter nation-wide French registry. Our objectives were to identify independent correlates of long-term all-cause mortality and early bioprosthetic valve dysfunction (BVD, defined as increased prosthetic gradient ≥10 mmHg or new gradient ≥20 mmHg). RESULTS: Of 12,804 patients included between January 1, 2013 and December 31, 2015, 11,469 (age 82.8±0.07 years old [mean±SE], logistic Euroscore 17.8±0.1%, mean duration follow-up was 495±3.5 days) were alive at discharge with known antithrombotic treatment and were analyzed for mortality. 2555 had at least 2 echocardiographic evaluations and were eligible of BVD assessment. One third of patients had a history of atrial fibrillation and the same proportion had OAC at discharge (n=3836). Neither aspirin nor clopidogrel were independently associated with mortality. Male gender (adj HR 1.63 [1.44-1.84], p<0.001), history of atrial fibrillation (adj. HR 1.41 [1.23-1.62], p<0.001) and chronic renal failure (adj. HR 1.37 [1.23-1.53], p<0.001) were the strongest independent correlates of mortality. Anticoagulation at discharge (adj. OR 0.54 [0.35-0.82], p=0.005) and a non-femoral approach (adj. OR 0.53 [0.28-1.02], p=0.049) were independently associated with lower rates of BVD, while chronic renal failure (adj. OR 1.46 [1.03-2.08], p=0.034) and prosthesis size ≤23mm (adj. OR 3.43 [2.41-4.89], p<0.001) yielded higher risk of BVD. CONCLUSIONS: Gender, renal failure and atrial fibrillation, impacted the most mortality at 3-year follow-up. In contrast anticoagulation (mostly given for atrial fibrillation) decreased the risk of BVD after TAVR.

15.
16.
Pacing Clin Electrophysiol ; 41(9): 1178-1184, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29931693

RESUMO

BACKGROUND: One of the most frequent complications of transcatheter aortic valve implantation (TAVI) is the occurrence of atrioventricular (AV) conduction disorders secondary to AV node or His bundle injury leading to permanent pacemaker implantation (PPI). The objective was to quantify the rate of ventricular pacing (VP), according to post-TAVI indication for PPI using recorded pacemaker memory. METHODS: From October 2009 to January 2017' all patients who had PPI following TAVI performed at Rouen University Hospital were included. Indications for PPI were: ≥ 1 episode of complete atrioventricular block (CAVB) or 2:1 atrioventricular block, and new-onset persistent left bundle branch block (NOP-LBBB) with either prolonged PR interval (> 200 ms) or HV interval (>70 ms). The primary endpoint was VP percentage at the first pacemaker interrogation (a VP percentage ≥ 1% was considered as significant). RESULTS: Out of 936 TAVI patients (Sapien-3' n = 379 [Edwards Lifesciences, Irvine, CA, USA]; Sapien-XT' n = 513; CoreValve' n = 44, Medtronic, Minneapolis, MN, USA), 87 (9.3%) had PPI. Eighty of these 87 patients were followed-up and analyzed. At the first pacemaker interrogation, a significant VP percentage was observed in 60/80 followed-up patients (75%), in 46/51 patients (90.2%) implanted for CAVB, and 12/23 patients (52.2%) implanted for NOP-LBBB associated with either prolonged PR or HV interval. No clinical predictive factor of significant VP percentage was found. CONCLUSION: In the post-TAVI period, our data support PPI in patients with CAVB even if paroxysmal. Our data also suggest PPI may be considered in patients with NOP-LBBB associated with either prolonged PR or HV interval.

17.
EuroIntervention ; 14(3): e343-e351, 2018 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-29790479

RESUMO

AIMS: The aim of this study was to establish the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster) by comparison with an everolimus-eluting stent with permanent polymer (PP-EES; XIENCE). METHODS AND RESULTS: CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) is a large-scale, prospective, multicentre, randomised single-blind, controlled, non-inferiority trial conducted at 58 study sites globally, including Europe, Japan and Korea, powered to prove non-inferiority for freedom from target lesion failure (TLF: cardiac death, target vessel-related myocardial infarction [MI] and target lesion revascularisation) at nine months. Patients requiring a percutaneous coronary intervention (PCI) were randomised (1:1) to BP-SES (n=551) or PP-EES (n=550). Freedom from TLF at five years was 90.0% in the BP-SES and 91.1% in the PP-EES group (p=0.54). The patient-oriented composite endpoint (all death, any MI, any revascularisation) was 24.1 and 25.6% (p=0.57) with BP-SES and PP-EES, respectively. The very late stent thrombosis rate from one to five years was especially low at 0.2% in both arms. CONCLUSIONS: This randomised clinical trial showed that the BP-SES stent was non-inferior to the benchmark PP-EES stent for TLF. Safety and efficacy measures were comparable up to five-year follow-up after PCI.

18.
Artigo em Inglês | MEDLINE | ID: mdl-29778857

RESUMO

OBJECTIVES: The aim of this study was to develop a new scoring system based on thoracic aortic calcification (TAC) to predict 1-year cardiovascular and all-cause mortality. BACKGROUND: A calcified aorta is often associated with poor prognosis after transcatheter aortic valve replacement (TAVR). A risk score encompassing aortic calcification may be valuable in identifying poor TAVR responders. METHODS: The C4CAPRI (4 Cities for Assessing CAlcification PRognostic Impact) multicenter study included a training cohort (1,425 patients treated using TAVR between 2010 and 2014) and a contemporary test cohort (311 patients treated in 2015). TAC was measured by computed tomography pre-TAVR. CAPRI risk scores were based on the linear predictors of Cox models including TAC in addition to comorbidities and demographic, atherosclerotic disease and cardiac function factors. CAPRI scores were constructed and tested in 2 independent cohorts. RESULTS: Cardiovascular and all-cause mortality at 1 year was 13.0% and 17.9%, respectively, in the training cohort and 8.2% and 11.8% in the test cohort. The inclusion of TAC in the model improved prediction: 1-cm3 increase in TAC was associated with a 6% increase in cardiovascular mortality and a 4% increase in all-cause mortality. The predicted and observed survival probabilities were highly correlated (slopes >0.9 for both cardiovascular and all-cause mortality). The model's predictive power was fair (AUC 68% [95% confidence interval [CI]: 64-72]) for both cardiovascular and all-cause mortality. The model performed similarly in the training and test cohorts. CONCLUSIONS: The CAPRI score, which combines the TAC variable with classical prognostic factors, is predictive of 1-year cardiovascular and all-cause mortality. Its predictive performance was confirmed in an independent contemporary cohort. CAPRI scores are highly relevant to current practice and strengthen the evidence base for decision making in valvular interventions. Its routine use may help prevent futile procedures.

19.
EuroIntervention ; 14(4): e397-e404, 2018 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-29688174

RESUMO

AIMS: Transcatheter valve-in-valve implantation (VinV) is established for the treatment of degenerated surgical bioprostheses in patients at high operative risk. Our aim was to report on the first large assessment of VinV with next-generation balloon-expandable transcatheter heart valves. METHODS AND RESULTS: After SAPIEN XT or SAPIEN 3 VinV, 514 patients were analysed using an inverse probability of treatment weighting. Standardised clinical and haemodynamic outcomes were compared, and core laboratory evaluation of implantation depth was performed. Thirty-day all-cause mortality was 0.6% and 3.5% for SAPIEN 3 and SAPIEN XT (p=0.077). Residual transprosthetic gradient ≥20 mmHg was observed in 38.3% (SAPIEN 3) and 35.7% (SAPIEN XT) of patients (p=0.627) with increased rates in small bioprostheses (≤21 mm true ID). In SAPIEN 3 VinV, low implantation depth >20% THV stent frame length was associated with a higher rate of elevated transaortic gradients (p=0.048). Similarly, an implantation depth >5 mm was linked to more pacemaker implantations (p=0.01). Overall, a trend towards higher pacemaker implantation rates was observed after SAPIEN 3 VinV (6% vs. 2.5% in SAPIEN XT, p=0.071). CONCLUSIONS: Transcatheter aortic VinV with the balloon-expandable SAPIEN XT or SAPIEN 3 was similarly safe and effective. However, residual stenosis remains a concern, particularly in smaller bioprostheses and with increasing implantation depth.

20.
J Am Coll Cardiol ; 71(17): 1841-1853, 2018 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-29699609

RESUMO

BACKGROUND: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures. OBJECTIVES: The goal of this study was to evaluate 1-year outcomes in this registry. METHODS: This study was a multicenter retrospective review of clinical outcomes. RESULTS: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm2, mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation. CONCLUSIONS: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.

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