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BACKGROUND: Based on the results of a clinical trial in Japan, transcatheter aortic valve replacement (TAVR) for hemodialysis (HD) patients gained approval; however, mid-term TAVR outcomes and transcatheter aortic valve (TAV) durability in HD patients remain unexplored.MethodsâandâResults: We analyzed background, procedural, in-hospital outcome, and follow-up data for 101 HD patients and 494 non-HD patients who underwent TAVR using balloon-expandable valves (SAPIEN XT or SAPIEN 3) retrieved from Osaka University Hospital TAVR database. Periprocedural mortality and TAVR-related complications were comparable between HD and non-HD patients. However, Kaplan-Meier analysis revealed that HD patients had significantly lower survival rates (log-rank test, P<0.001). In addition, HD patients had significantly higher rates of severe structural valve deterioration (SVD) than non-HD patients (Gray test, P=0.038). CONCLUSIONS: TAVR in HD patients had comparable periprocedural mortality but inferior mid-term survival and TAV durability than in non-HD patients. Indications for TAVR in younger HD patients should be carefully determined, considering the possibility of a TAV-in-TAV procedure when early SVD occurs.
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BACKGROUND: Coronary angioscopy (CAS) has 2 unique abilities: direct visualization of thrombi and plaque color. However, in the recent drug-eluting stent (DES) era, serial CAS findings after DES implantation have not been fully elucidated. We investigated the impact of CAS findings after implantation of a polymer-free biolimus A9-coated stent (PF-BCS) or durable polymer everolimus-eluting stent (DP-EES).MethodsâandâResults: We investigated serial CAS and optical coherence tomography (OCT) findings at 1 and 12 months in 99 patients who underwent PF-BCS or DP-EES implantation. We evaluated factors correlated with angioscopic thrombi and yellow plaque, and the clinical impact of both thrombi and yellow plaque at 12 months (BTY). The BTY group included 17 (22%) patients. The incidence and grade of thrombi and yellow plaque decreased from 1 to 12 months. Although no patients had newly appearing thrombi at 12 months, 2 DP-EES patients had newly appearing yellow plaque at 12 months. Multivariable analysis revealed HbA1c, minimum stent area, and adequate strut coverage were significant factors correlated with 12-month angioscopic thrombi, and DP-EESs were significantly correlated with 12-month yellow plaque. However, BTY was not correlated with clinical events. CONCLUSIONS: The management of diabetes, stent area, and adequate stent coverage are important for intrastent thrombogenicity and polymer-free stents are useful for stabilizing plaque vulnerability.
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BACKGROUND: Little is known about intravascular imaging predictors of cardiac events after drug-eluting stent (DES) implantation in hemodialysis (HD) patients. We aimed to reveal the association between calcified nodules (CN) and target lesion failure (TLF) in HD patients after DES implantation. METHODS: We enrolled 114 HD patients who underwent DES implantation between October 2016 and October 2020. The patients were divided into a CN group (39%, 44 patients) and a non-CN group (61%, 70 patients). The primary endpoint was the incidence of TLF, including cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization. RESULTS: HD duration was longer, and the calcium burden was higher in the CN group than in the non-CN group. Over a median follow-up of 607 days [interquartile range: 349-965 days], the cumulative incidence curve showed that the CN group had a significantly higher incidence of TLF than the non-CN group (31.8% vs. 11.4% within 3 years, p = 0.008).ãOn Fine-Gray sub-distribution hazard model analysis, the CN group was associated with an increased rate of TLF (hazard ratio [HR]: 2.86; 95% confidence interval [CI]: 1.21-6.75, p = 0.016). An in-stent CN was observed in 73% of the lesions with target lesion revascularization in the CN group, whereas no in-stent CN was observed in the non-CN group (p = 0.026). CONCLUSIONS: CN was an independent predictor of TLF in patients undergoing HD. In-stent CN was an important cause of TLF after DES implantation in CN lesions in HD patients; therefore, a different strategy should be considered for treating the lesions.
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Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Humanos , Doença da Artéria Coronariana/terapia , Sirolimo , Resultado do Tratamento , Intervenção Coronária Percutânea/efeitos adversos , Diálise RenalRESUMO
BACKGROUND: The use of hybrid operating rooms (HOR) for transcatheter aortic valve implantation (TAVI) has increased, so radiation exposure during procedures that use X-ray fluoroscopy is a fundamental problem not only for patients but also for surgeons and interventional cardiologists, increasing the risk of cataracts among operators. We investigated the efficacy of leaded glasses and protective sheets for ocular radiation protection.MethodsâandâResults: Between January 2020 and February 2021 we enrolled 54 TAVI procedures using the transfemoral approach. The subjects were divided into a curtain protection group (Group C, n=20), glass protection group (Group G, n=17), and sheet protection group (Group S, n=17). The cumulative dose (CD) of the operators showed a decreasing trend in Group S compared with the other two groups. The CD normalized by dose area product (CD/DAP) of the operators was significantly reduced in Group S compared with Group C. However, Group G showed no significant difference compared with Group C. Regarding the distribution of CD/DAP, Group S had a significantly lower distribution than that in groups C and G. CONCLUSIONS: Protective sheets provide more stable radiation protection than conventional curtains or leaded glasses.
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Estenose da Valva Aórtica , Exposição à Radiação , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/cirurgia , Doses de Radiação , Fatores de Risco , Exposição à Radiação/efeitos adversos , Exposição à Radiação/prevenção & controle , Fluoroscopia/efeitos adversos , Valva Aórtica/cirurgia , Resultado do TratamentoRESUMO
BACKGROUND: A polymer-free biolimus A9-coated stent (PF-BCS) may achieve better arterial healing than a durable polymer drug-eluting stent owing to its polymer-free feature.MethodsâandâResults: This multicenter, prospective, observational study enrolled 105 patients (132 lesions) who underwent PF-BCS (51 patients, 71 lesions) or durable polymer everolimus-eluting stent (DP-EES, 54 patients, 61 lesions) implantation. Serial coronary angioscopy (CAS) and optical coherence tomography (OCT) examinations were performed at 1 and 12 months, and the serial vessel responses were compared between PF-BCS and DP-EES. The primary outcome measure was the incidence of subclinical intrastent thrombus on CAS. The secondary outcome measures were: adequate strut coverage (≥40 µm) on OCT and maximum yellow color grade on CAS. The incidence of thrombus was high at 1 month (100% vs. 93%, P=0.091), but decreased at 12 months (18% vs. 25%, P=0.56), without a significant difference between PF-BCS and DP-EES. The adequate strut coverage rate was significantly higher (84±14% vs. 69±22%, P<0.001) and yellow color was significantly less intense (P=0.012) at 12 months in PF-BCS than in DP-EES; however, they were not significantly different at 1 month (adequate strut coverage: 47±21% vs. 50±17%, P=0.40; yellow color: P=0.99). CONCLUSIONS: Although the thrombogenicity of PF-BCS was similar to that of DP-EES, the adequate coverage and plaque stabilization rates of PF-BCS were superior to those of DP-EES at 12 months.
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Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Trombose , Implantes Absorvíveis , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/patologia , Doença da Artéria Coronariana/terapia , Stents Farmacológicos/efeitos adversos , Everolimo , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Polímeros , Estudos Prospectivos , Desenho de Prótese , Sirolimo/análogos & derivados , Resultado do TratamentoRESUMO
BACKGROUND: Transcatheter mitral valve repair with the MitraClip system has been established in selected high-risk patients. The MitraClip procedure results in a relatively large iatrogenic atrial septal defect (iASD). This study aimed to investigate the prevalence and clinical course of iASD requiring transcatheter closure following the MitraClip procedure.MethodsâandâResults: This study was conducted at all 59 institutions that perform transcatheter mitral valve repair with the MitraClip system in Japan. The data of patients on whom transcatheter iASD closure was performed were collected. Of the 2,722 patients who underwent the MitraClip procedure, 30 (1%) required transcatheter iASD closure. The maximum iASD size was 9±4 mm (range, 3-18 mm). The common clinical course of transcatheter iASD closure was hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt. Of the 30 patients, 22 (73%) required transcatheter closure within 24 h following the MitraClip procedure, including 12 with hypoxemia and 5 with right-sided heart failure complicated with cardiogenic shock. Of the 5 patients, 2 required mechanical circulatory support devices. Twenty-one patients immediately underwent transcatheter iASD closure, and hemodynamic deteriorations were resolved; however, 1 patient died without having undergone transcatheter closure. CONCLUSIONS: Transcatheter iASD closure was required in 1% of patients who underwent the MitraClip procedure. Many of these patients immediately underwent transcatheter iASD closure because of hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt.
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Insuficiência Cardíaca , Comunicação Interatrial , Insuficiência da Valva Mitral , Humanos , Valva Mitral/cirurgia , Cateterismo Cardíaco/efeitos adversos , Doença Iatrogênica , Comunicação Interatrial/cirurgia , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/complicações , Hipóxia , Resultado do TratamentoRESUMO
BACKGROUND: Patients undergoing maintenance hemodialysis (HD) with severe aortic stenosis are at a high risk for bioprosthetic valve dysfunction after transcatheter aortic valve implantation (TAVI). Currently, preoperative factors that predict the occurrence of valve dysfunction after TAVI on HD patients remain to be elucidated. The aim of this study is to analyze the association between preoperative clinical factors and valve stenosis after TAVI on HD patients. METHODS: Twenty-four of HD patients who underwent TAVI at our institution between April 2012 and January 2016 were analyzed. The mean aortic transvalvular pressure gradient (MPG) and effective orifice area index (EOAi) were assessed by serial echocardiography. Associations between preoperative clinical factors and time-series changes in MPG were examined using mixed-effects linear regression model for repeated measures. RESULTS: Three patients developed severe structural valve deterioration with calcific valve stenosis requiring reoperation. A multivariate linear mixed-effects model showed that lower serum magnesium (sMg) levels were associated with the increase of MPG after TAVI (beta-coefficient = 0.019, p = 0.03). No correlation was observed with serum calcium, phosphorus, or intact parathyroid hormone. Time-series changes of MPG and EOAi had significant difference between lower and higher sMg group. All 3 of the patients who underwent reoperation showed lower preoperative sMgs. CONCLUSION: Among bone-mineral metabolism markers, preoperative hypomagnesemia was associated with the increase of MPG after TAVI, suggesting that hypomagnesemia could predict post-TAVI valve dysfunction in HD patients. Further studies with larger sample sizes are warranted.
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Substituição da Valva Aórtica Transcateter , Constrição Patológica , Humanos , Magnésio , Período Pós-Operatório , Diálise Renal/efeitos adversos , Substituição da Valva Aórtica Transcateter/efeitos adversosRESUMO
Recently developed coronary angiography with intraprocedural 320-row computed tomography can be performed in a catheterization laboratory (XACT) by injecting contrast medium from a place close to the coronary arteries, thereby requiring a minimal amount of contrast medium. However, its clinical application has not yet been established. This study aimed to evaluate the diagnostic accuracy of XACT angiography with a minimal volume of contrast medium in patients with suspected coronary artery disease (CAD). A total of 167 coronary segments were analyzed in 14 patients (9 males, median age 70 years) with suspected CAD by XACT angiography with 7.5 ml of contrast medium and invasive coronary angiography (ICA) with standard techniques. The segmental-based diagnostic accuracy of XACT angiography in detecting stenosis of ≥ 50% and ≥ 75% and visualized by ICA was good (sensitivity: 74% and 62%, specificity: 99% and 99%, positive predictive value: 93% and 80%, and negative predictive value: 97% and 97%, respectively). These results suggest that XACT angiography with a very low amount of contrast medium may have strong clinical utility for screening coronary arteries in patients with renal dysfunction or undergoing clinical procedures such as pacemaker implantation.
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Angiografia por Tomografia Computadorizada , Meios de Contraste/administração & dosagem , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Estenose Coronária/diagnóstico por imagem , Iohexol/administração & dosagem , Tomografia Computadorizada Multidetectores , Idoso , Doença da Artéria Coronariana/fisiopatologia , Estenose Coronária/fisiopatologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Reprodutibilidade dos Testes , Índice de Gravidade de DoençaAssuntos
Falso Aneurisma , Aneurisma Cardíaco , Infarto do Miocárdio , Humanos , Angiografia por Tomografia Computadorizada , Falso Aneurisma/diagnóstico por imagem , Infarto do Miocárdio/diagnóstico por imagem , Coração , Ventrículos do Coração/diagnóstico por imagem , Angiografia Coronária , Aneurisma Cardíaco/diagnóstico por imagemRESUMO
BACKGROUND: Little is known about late outcomes after transcatheter aortic valve replacement (TAVR) in dialysis patients.MethodsâandâResults:We enrolled 25 dialysis patients (mean age 76.5 years; mean STS score 14.7%; men 60.0%) with aortic valve stenosis undergoing TAVR at our institute. Cardiovascular mortality and stroke were defined according to the VARC-2 criteria, and major adverse cardiac and cerebrovascular events (MACCE) were investigated. Twenty-three patients (92.0%) were discharged, and the median hospital stay after TAVR was 9 days (IQR, 7.5-11 days). Mortality at 30 days was not observed. The overall survival rate at 1 and 3 years were 80.0% and 55.7%, respectively (follow-up period, 879±493 days; range, 40-1,826 days). At 1 and 3 years, rates of freedom from cardiovascular mortality, disabling stroke, and MACCE were 100% and 83.0%, 91.2% and 84.7%, and 69.8% and 39.9%, respectively. Three patients required redo-TAVR for valve dysfunction at 23, 36, and 38 months after the first TAVR, respectively (The rate of freedom from severe structural valve deterioration at 1 and 3 years was 100% and 85.9%, respectively). CONCLUSIONS: Satisfactory in-hospital outcomes were achieved in dialysis patients after TAVR. Various problems, however, such as complications particular to dialysis patients and valve durability, remained at midterm follow-up. Further studies are recommended to solve these problems, and prudent preoperative assessments should be mandatory.
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Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Taxa de Sobrevida , Fatores de TempoRESUMO
A 70-year-old man with dyspnea was admitted to our department and received standard therapy for recurrent heart failure. He was diagnosed with polycystic kidney disease (PKD) in his thirties and received hemodialysis for 4 years before undergoing renal transplantation at age 45. Although his left ventricular ejection fraction (LVEF) was preserved in his 50s, LVEF decreased progressively from 61% to 24%, while left ventricular diastolic dimension (LVDd) increased from 54 mm to 65 mm between 63 and 69 years of age. Right ventricular endomyocardial biopsy demonstrated myocardial disarray and interstitial fibrosis. Genetic analysis identified a heterozygous frameshift mutation in PKD1, which encodes polycystin-1, a major causative gene of PKD. We detected PKD1 protein expression in myocardial tissue by immunostaining. Recent epidemiological studies and animal models have clarified the pathological correlation between ventricular contractile dysfunction and PKD1 function. Here, we present a case of old-age onset progressive cardiac contractile dysfunction with a PKD1 gene mutation.
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Mutação da Fase de Leitura/genética , Cardiopatias/fisiopatologia , Miocárdio/metabolismo , Doenças Renais Policísticas/complicações , Doenças Renais Policísticas/genética , Idoso , Ecocardiografia , Fibrose/patologia , Cardiopatias/etiologia , Cardiopatias/genética , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/genética , Humanos , Transplante de Rim , Masculino , Contração Miocárdica/genética , Miocárdio/patologia , Doenças Renais Policísticas/terapia , Volume Sistólico/fisiologia , Canais de Cátion TRPPRESUMO
Mitraclip is an alternative therapeutic option for severe functional mitral regurgitation (MR) with reduced ejection fraction, especially in patients with high surgical risk. Although the Mitraclip was reported as an effective therapy in patients who fulfilled the anatomical criteria of the EVEREST trial, it is still uninvestigated whether the therapy is also feasible and beneficial in patients outside the indication criteria of the EVEREST II trial. Among them, MR with a large coaptation gap is considered as a challenging anatomy, because the gap makes it difficult to grasp both leaflets with a standard Mitraclip procedure. As two techniques to grasp such a large coaptation gap were reported, there was no report concerning the effectiveness of extracorporeal membrane oxygenation (ECMO) during Mitraclip implantation. Here we present a first case of successful Mitraclip implantation in a patient with a large coaptation gap with the support of ECMO. © 2016 Wiley Periodicals, Inc.
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Oxigenação por Membrana Extracorpórea , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Ecocardiografia Doppler em Cores , Ecocardiografia Tridimensional , Ecocardiografia Transesofagiana , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/fisiopatologia , Desenho de Prótese , Volume Sistólico , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
Trans-catheter aortic valve implantation (TAVI) in patients with high surgical risk is an alternative therapeutic option for severe aortic stenosis. Although second generation TAVI devices are available now, this therapy still cannot overcome all serious complications. Among them, coronary obstruction is a life threatening complication, however, there is no report concerning the complication in patients with anomalous coronary arteries. Here we present a case with coronary obstruction of an anomalous left main coronary that occurred after implantation of the mechanical expanding Lotus valve (Boston Scientific Inc.). © 2016 Wiley Periodicals, Inc.
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Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Estenose Coronária/etiologia , Anomalias dos Vasos Coronários/complicações , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Angiografia por Tomografia Computadorizada , Angiografia Coronária/métodos , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/terapia , Anomalias dos Vasos Coronários/diagnóstico por imagem , Feminino , Humanos , Tomografia Computadorizada Multidetectores , Intervenção Coronária Percutânea/instrumentação , Desenho de Prótese , Índice de Gravidade de Doença , Stents , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of this study was to evaluate safety, feasibility, and efficacy of transaxillary TAVI using a novel self-expandable transcatheter heart valve (THV) via a direct percutaneous technique. METHODS: The analysis comprises 12 consecutive patients with severe aortic stenosis treated with the ACURATE Neo™ THV (Symetis) by direct percutaneous transaxillary access. RESULTS: Patients presented with a mean age of 79.9 ± 6.2 years and high calculated surgical risk (logEuroSCORE I: 19.55 ± 15.00%; STS PROM score: 5.42 ± 3.25%). Transaxillary TAVI was performed in 11/12 via the left and in 1/12 via the right-sided axillary artery. Device success was achieved in all patients (12/12). Mortality rate at 30 days was 0% (0/12). No major and one minor access site complication (1/12) occurred. No major or life-threatening access site-related bleeding resulted. None of the patients suffered from postprocedural stroke/transient ischemic attack. There was no need for a permanent pacemaker. Mean effective orifice area post implantation was 2.1 ± 0.29 cm2 and mean aortic gradient 6.2 ± 1.5 mm Hg. In none of the patients, greater than moderate aortic regurgitation or paravalvular leakage was detected at discharge (0/12). CONCLUSIONS: Our study suggests that the implantation of the second-generation self-expandable ACURATE Neo™ via a transaxillary access is technically feasible and safe and yields excellent short-term clinical results. © 2017 Wiley Periodicals, Inc.
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Estenose da Valva Aórtica/cirurgia , Artéria Axilar , Cateterismo Periférico/métodos , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Artéria Axilar/diagnóstico por imagem , Cateterismo Periférico/efeitos adversos , Angiografia por Tomografia Computadorizada , Angiografia Coronária/métodos , Bases de Dados Factuais , Ecocardiografia Transesofagiana , Estudos de Viabilidade , Feminino , Humanos , Masculino , Tomografia Computadorizada Multidetectores , Desenho de Prótese , Falha de Prótese , Punções , Estudos Retrospectivos , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do TratamentoRESUMO
BACKGROUND: Dual antiplatelet therapy (DAPT) is commonly used after transcatheter aortic valve implantation (TAVI); however, the supporting evidence is limited. To determine if aspirin alone is a better alternative to DAPT, we compared the outcomes of patients treated with DAPT or aspirin alone after TAVI.MethodsâandâResults:We analyzed a total of 144 consecutive patients (92 females, mean age 83±6 years) who underwent implantation of a balloon-expandable transcatheter valve (SAPIEN or SAPIEN XT, Edwards Lifesciences). Patients were divided into DAPT (n=66) or aspirin-alone treatment groups (n=78). At 1 year after TAVI, the composite endpoint, which consisted of all-cause death, myocardial infarction, stroke, and major or life-threatening bleeding complications, occurred significantly less frequently (Kaplan-Meier analysis) in the aspirin-alone group (15.4%) than in the DAPT group (30.3%; P=0.031). Valve function assessed by echocardiography was similar between the 2 treatment groups with respect to effective orifice area (1.78±0.43 cm2in DAPT vs. 1.91±0.46 cm2in aspirin-alone group; P=0.13) and transvalvular pressure gradient (11.1±3.5 mmHg in DAPT vs. 10.3±4.1 mmHg in aspirin-alone group; P=0.31). CONCLUSIONS: Treatment with aspirin alone after TAVI had greater safety benefits and was associated with similar valve function as DAPT. These results suggest that treatment with aspirin alone is an acceptable regimen for TAVI patients.
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Estenose da Valva Aórtica , Valva Aórtica/cirurgia , Aspirina/administração & dosagem , Bioprótese , Próteses Valvulares Cardíacas , Inibidores da Agregação Plaquetária/administração & dosagem , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/terapia , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Masculino , Taxa de SobrevidaRESUMO
BACKGROUND: Feasibility and early results of transfemoral aortic valve implantation using the ACURATE neo/TF(TM)self-expanding stent are reported. METHODS AND RESULTS: The study group of 15 patients (mean age 83.3±6.0) was enrolled with a mean EuroSCORE and STS score of 21.9±11.6% and 7.5±3.1%, respectively. Clinical and echocardiographic evaluations were performed at baseline, discharge, 30 days and 6 months. The primary endpoint was all-cause mortality at 30 days. Transcatheter aortic valve implantation (TAVI) using the ACURATE neo/TF device was successful in 14 patients; 1 patient underwent valve-in-valve implantation because the prosthetic valve embolized during withdrawal of the delivery system. Conversion to surgery, coronary obstruction, peri-operative stroke, and pacemaker implantation did not occur at 30 days. Mean transvalvular gradients at discharge significantly decreased from 44.2±10.5 mmHg (preprocedural) to 7.7±3.1 mmHg (P<0.0001) and effective orifice area significantly increased from 0.77±0.12 to 1.69±0.25 cm(2)(P<0.0001). None or trace paravalvular leak was revealed in 50.0%, and no patient exhibited moderate or higher paravalvular leak. The overall mortality at 30 days and 6 months was 0% and 6.7%, respectively. CONCLUSIONS: A new self-expanding TF TAVI device, ACURATE neo/TF, is safe and effective in the treatment of severe aortic stenosis in elderly patients at high risk for surgery.