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1.
Catheter Cardiovasc Interv ; 97(7): 1462-1469, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-33443813

RESUMO

OBJECTIVES: We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality. BACKGROUND: Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate. We hypothesized that this is related to effect modifiers, in particular the left ventricular ejection fraction (LVEF). METHODS: This multicentre study derived its data from prospective registries. To adjust for confounders, we used propensity-score based, stabilized inverse probability weighted Cox regression models. RESULTS: In total, 5,910 patients underwent TAVI via TF (N = 4,072), DA (N = 524), and TA (N = 1,314) access. Compared to TF, 30-day mortality was increased among DA (HR 1.87, 95%CI 1.26-2.78, p = .002) and TA (HR 3.34, 95%CI 2.28-4.89, p < .001) cases. Compared to TF, 5-year mortality was increased among TA cases (HR 1.50, 95%CI 1.24-1.83, p < .001). None of the variables showed a significant interaction between the approaches and mortality. An impaired LVEF (≤35%) increased mortality in all approaches. CONCLUSIONS: The surgical intra-thoracic TA and DA TAVI are both associated with a higher 30-day mortality than TF TAVI. TA TAVI is associated with a higher 5-year mortality than TF TAVI. The DA approach may therefore have some advantages over the TA approach when TF access is not feasible.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Humanos , Estudos Prospectivos , Volume Sistólico , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Função Ventricular Esquerda
2.
JAMA ; 326(22): 2277-2286, 2021 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-34905030

RESUMO

Importance: Patent foramen ovale (PFO)-associated strokes comprise approximately 10% of ischemic strokes in adults aged 18 to 60 years. While device closure decreases stroke recurrence risk overall, the best treatment for any individual is often unclear. Objective: To evaluate heterogeneity of treatment effect of PFO closure on stroke recurrence based on previously developed scoring systems. Design, Setting, and Participants: Investigators for the Systematic, Collaborative, PFO Closure Evaluation (SCOPE) Consortium pooled individual patient data from all 6 randomized clinical trials that compared PFO closure plus medical therapy vs medical therapy alone in patients with PFO-associated stroke, and included a total of 3740 participants. The trials were conducted worldwide from 2000 to 2017. Exposures: PFO closure plus medical therapy vs medical therapy alone. Subgroup analyses used the Risk of Paradoxical Embolism (RoPE) Score (a 10-point scoring system in which higher scores reflect younger age and the absence of vascular risk factors) and the PFO-Associated Stroke Causal Likelihood (PASCAL) Classification System, which combines the RoPE Score with high-risk PFO features (either an atrial septal aneurysm or a large-sized shunt) to classify patients into 3 categories of causal relatedness: unlikely, possible, and probable. Main Outcomes and Measures: Ischemic stroke. Results: Over a median follow-up of 57 months (IQR, 24-64), 121 outcomes occurred in 3740 patients. The annualized incidence of stroke with medical therapy was 1.09% (95% CI, 0.88%-1.36%) and with device closure was 0.47% (95% CI, 0.35%-0.65%) (adjusted hazard ratio [HR], 0.41 [95% CI, 0.28-0.60]). The subgroup analyses showed statistically significant interaction effects. Patients with low vs high RoPE Score had HRs of 0.61 (95% CI, 0.37-1.00) and 0.21 (95% CI, 0.11-0.42), respectively (P for interaction = .02). Patients classified as unlikely, possible, and probable using the PASCAL Classification System had HRs of 1.14 (95% CI, 0.53-2.46), 0.38 (95% CI, 0.22-0.65), and 0.10 (95% CI, 0.03-0.35), respectively (P for interaction = .003). The 2-year absolute risk reduction was -0.7% (95% CI, -4.0% to 2.6%), 2.1% (95% CI, 0.6%-3.6%), and 2.1% (95% CI, 0.9%-3.4%) in the unlikely, possible, and probable PASCAL categories, respectively. Device-associated adverse events were generally higher among patients classified as unlikely; the absolute risk increases in atrial fibrillation beyond day 45 after randomization with a device were 4.41% (95% CI, 1.02% to 7.80%), 1.53% (95% CI, 0.33% to 2.72%), and 0.65% (95% CI, -0.41% to 1.71%) in the unlikely, possible, and probable PASCAL categories, respectively. Conclusions and Relevance: Among patients aged 18 to 60 years with PFO-associated stroke, risk reduction for recurrent stroke with device closure varied across groups classified by their probabilities that the stroke was causally related to the PFO. Application of this classification system has the potential to guide individualized decision-making.


Assuntos
Anticoagulantes/uso terapêutico , Forame Oval Patente/cirurgia , Acidente Vascular Cerebral/tratamento farmacológico , Adolescente , Adulto , Feminino , Fibrinolíticos/uso terapêutico , Forame Oval Patente/complicações , Forame Oval Patente/tratamento farmacológico , Humanos , Masculino , Pessoa de Meia-Idade , Números Necessários para Tratar , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Fatores de Risco , Prevenção Secundária , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/etiologia , Adulto Jovem
3.
Hellenic J Cardiol ; 62(3): 206-211, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33484876

RESUMO

BACKGROUND: The Cocoon septal occluder (CSO) is a new generation double disk occluder device for catheter closure of the secundum atrial septal defect (ASD). Initial clinical evaluations with the use of this device have shown quite satisfactory results but large follow-up studies are missing. In this international multicenter study, we present procedural and follow-up data from 4008 patients with secundum ASD who underwent catheter closure with the use of CSO. METHODS: The study cohort consisted of 1853 pediatric and 2155 adult patients with secundum ASD treated with the CSO. Patients were enrolled retrospectively from 11 international centers and were followed for a mean period of 43 months (range 12-84 months), postprocedural. Clinical, electrocardiographic, echocardiographic, procedural, and follow-up data were collected from each collaborating hospital. RESULTS: The CSO was permanently implanted in 3983 patients (99.4%). Echocardiographic evaluation at one month follow-up revealed complete closure in 99.6% of those patients who had a device implanted. Thrombus formation in one adult patient was the only major device related to procedural complication. During the follow-up period, no patient developed cardiac erosions, allergic reactions to nickel, or other major complications. CONCLUSIONS: Implantation of CSO provided satisfactory procedural and follow-up results with high success and no device-related cardiac erosions and nickel allergy.


Assuntos
Comunicação Interatrial , Dispositivo para Oclusão Septal , Adulto , Cateterismo Cardíaco/efeitos adversos , Criança , Ecocardiografia Transesofagiana , Seguimentos , Comunicação Interatrial/diagnóstico por imagem , Comunicação Interatrial/cirurgia , Humanos , Estudos Retrospectivos , Dispositivo para Oclusão Septal/efeitos adversos , Resultado do Tratamento
4.
J Invasive Cardiol ; 32(11): 405-411, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32771997

RESUMO

OBJECTIVE: The aim of this study was to report the 30-day and 1-year outcomes and performance from the Portico Alternative Access study to obtain CE approval of the alternative access delivery system. METHODS: The Portico Alternative Access study is a multicenter, prospective, non-randomized, investigational study (www.clinicaltrials.gov identifier, NCT03056573) describing 45 patients with severe symptomatic aortic valve stenosis (AS) treated with the self-expanding Portico device using subclavian/axillary access. RESULTS: Forty-five subjects (81.7 ± 5.9 years; 57.8% female; Society of Thoracic Surgeons score, 5.4 ± 4.7%) with severe, symptomatic AS had a Portico bioprosthetic aortic valve implantation attempt via axillary/subclavian access. Implantation was successful in 97.8% of subjects. At 30 days, the rate of major vascular complications at the subclavian/axillary access site was 4.4%. All-cause mortality was 2.2% at 30 days and 4.4% at 1 year. CONCLUSION: The Portico transcatheter aortic valve can be safely delivered by axillary or subclavian access with high implant success rate and low complication rates.


Assuntos
Estenose da Valva Aórtica , Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Feminino , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
5.
Can J Cardiol ; 35(9): 1114-1123, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31202537

RESUMO

BACKGROUND: Chronic kidney disease (CKD) has a negative impact on outcomes after transcatheter aortic valve replacement (TAVR). Data on outcomes in renal transplant recipients (RTRs) undergoing TAVR are scarce. We compared the outcomes in RTRs undergoing TAVR with matched patients who have native kidneys and similar kidney function. METHODS: This retrospective cohort study used data from 16 TAVR centres (13,941 patients). The study cohort included 216 patients (72 RTRs and 144 matched controls). RESULTS: The mean estimated glomerular filtration rate (eGFR) was 39.2 ± 23.6 vs 44.5 ± 23.6 mL/min for RTRs and control patients (P = 0.149), with a similar CKD stage distribution. After TAVR, the eGFR declined among RTRs but remained stable for up to 1 year in controls (P = 0.021). Long-term hemodialysis was required in 19 (26.4%) RTRs and 20 (13.8%) controls (hazard ratio [HR] = 2.09 95% confidence interval [CI], 1.03-3.86; P = 0.039) and was most often initiated during the periprocedural period (14 RTRs vs 16 controls; P = 0.039). After a median follow-up of 2.3 years, risk of death (29.2% vs 31.9%) and death/hemodialysis (40.3% vs 36.8%) was similar between the groups. The contrast volume/eGFR ratio was the strongest predictor of hemodialysis initiation (odds ratio [OR] = 1.64; 95% CI, 1.36-1.97 per 1 unit increase; P < 0.001), with a greater effect among RTRs than controls (P for interaction = 0.022). CONCLUSION: s: TAVR appears safe in RTRs with mortality rates similar to matched patients with native kidneys. However, RTRs carry an increased risk of progressive renal impairment and need for hemodialysis initiation after TAVR. Our data highlight the importance of minimizing contrast load during TAVR, particularly in RTRs.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Taxa de Filtração Glomerular/fisiologia , Transplante de Rim , Sistema de Registros , Insuficiência Renal Crônica/complicações , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Causas de Morte/tendências , Feminino , Seguimentos , Saúde Global , Humanos , Masculino , Diálise Renal , Insuficiência Renal Crônica/mortalidade , Insuficiência Renal Crônica/terapia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo
7.
Int J Cardiol ; 177(2): 418-22, 2014 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-25305675

RESUMO

Despite its simplicity, device closure of atrial septal defects is still associated with rare but potentially lethal complications. In this prospective non-randomized multicenter study we investigated the safety and efficacy of the Cocoon septal occluder (CSO) for closure of atrial septal defects (ASDs) in 92 patients. Median age of the patients was 10.5 years (range 3-61 years) and median weight was 25 kg (range 13-65 kg). The device is an improved new generation double disc design made of Nitinol wire mesh that is coated with platinum using NanoFusion technology. The discs are connected by a waist with diameter ranging from 6mm to 40 mm with 2mm increments. All patients completed a 3-month follow-up. Mean ASD diameter was 21 ± 7 mm (range 10-35 mm), while the mean device diameter was 24 ± 8 mm (range 14-40 mm). The CSO was permanently implanted in all 92 patients. Complete echocardiographic closure of the defect immediately after the procedure or at the one month follow-up, was observed in all 92 patients (100%). No device-related complications were observed during the procedure or at short-term follow-up (range 3-12 months). Our preliminary results indicate that CSO is a promising device for transcatheter closure of ASDs. Further studies are required to document its efficacy, safety and long-term results in a larger patient population.


Assuntos
Cateterismo Cardíaco/instrumentação , Comunicação Interatrial/epidemiologia , Comunicação Interatrial/cirurgia , Dispositivo para Oclusão Septal/estatística & dados numéricos , Adolescente , Adulto , Cateterismo Cardíaco/métodos , Criança , Pré-Escolar , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Comunicação Interatrial/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem
8.
J Thorac Cardiovasc Surg ; 146(5): 1047-54; discussion 1054, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23998786

RESUMO

OBJECTIVE: Transcatheter valve-in-valve implantation has emerged as an option, in addition to reoperative surgical aortic valve replacement, to treat failed biologic heart valve substitutes. However, the clinical experience with this approach is still limited. We report the comprehensive experience of transcatheter valve-in-valve implantation in the Nordic countries from May 2008 to January 2012. METHODS: A total of 45 transcatheter aortic valve-in-valve implantations were performed during the study period in 11 centers. The mean age of the patients was 80.6 years (range, 61-91), 26 were male and 19 were female, and the mean EuroSCORE, EuroSCORE II, and Society of Thoracic Surgeons score was 35.4, 16.3, and 14.6, respectively. The type of failure was stenosis and combined in 58% (mean and peak aortic valve gradient, 77 and 45 mm Hg, respectively) and regurgitation in 42% of cases. The SAPIEN/XT (Edwards LifeSciences, Irvine, Calif) and CoreValve (Medtronic Inc, Minneapolis, Minn) system was used in 33 and 12 cases, respectively. The access route was transapical in 25, transfemoral in 17, transaortic in 2, and subclavian in 1 case. The mean follow-up was 14.4 months. The periprocedural and postoperative outcomes were assessed using the Valve Academic Research Consortium criteria. RESULTS: No intraprocedural mortality occurred. The technical success rate was 95.6% (1 second valve implantation, 1 conversion to open surgery). The all-cause 30-day mortality was 4.4% (1 cardiac-related and 1 aspiration pneumonia). The major complications within 30 days included stroke in 2.2%, periprocedural myocardial infarction in 4.4%, and major vascular complication in 2.2% of patients. At 1 month, all but 1 patient had either no or mild paravalvular leakage, with a mean and peak valve gradient of 17 mm Hg (range, 4-38) and 30 mm Hg (range, 7-68), respectively. The mean gradient was greater than 20 mm Hg in 17% of patients and remained unchanged at 12 months. The 1-year survival was 88.1%. CONCLUSIONS: Transcatheter valve-in-valve implantation is widely performed, albeit in small numbers, in most centers in the Nordic countries. The short-term results were excellent in this high-risk patient population, demonstrating a low incidence of device- or procedure-related complications. However, a considerable number of patients were left with suboptimal systolic valve performance with unknown long-term effects, warranting close surveillance after transcatheter valve-in-valve implantation.


Assuntos
Insuficiência da Valva Aórtica/terapia , Estenose da Valva Aórtica/terapia , Valva Aórtica/cirurgia , Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Idoso , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/etiologia , Estenose da Valva Aórtica/mortalidade , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Feminino , Finlândia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Falha de Prótese , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Países Escandinavos e Nórdicos , Fatores de Tempo , Resultado do Tratamento
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