A Novel Percutaneous Technique for Left Ventricular Assist Device Deactivation Using a Left Atrial Appendage Occluder in the Outflow Cannula.

Reverse cardiac remodeling may occur in some left ventricular assist device (LVAD) recipients. Although considered the standard therapy, surgical device explantation with repeat sternotomy might be undesirable or very high risk. On the other hand, there are few data reporting minimally invasive percutaneous LVAD deactivation. We describe a case of a man with LVAD malfunction due to driveline fracture and left ventricular (LV) function recovery who had a Heart Mate II deactivated with a percutaneous technique using a left atrial appendage occluder (LAAO) positioned inside the outflow cannula. To the best of our knowledge, this the first report of LVAD deactivation with the fully recapturable LAAO device. We propose that the use of a LAA occluder to obstruct HM II outflow cannula is feasible and safe.

Performance of Prediction Models for Contrast-Induced Acute Kidney Injury after Transcutaneous Aortic Valve Replacement.

BACKGROUND: Acute kidney injury (AKI) has shown to adversely affect outcomes in patients undergoing transcutaneous aortic valve replacement (TAVR), and its correct risk estimation may interfere in procedural planning and strategies. The aim of the study was to test and compare 6 scores in predicting AKI after TAVR. METHODS: We tested 6 scores (the contrast material limit score, volume-to-creatinine clearance ratio, ACEF, CR4EATME3AD3, Mehran model A, and Mehran model B) in a total of 559 consecutive patients included in the Brazilian TAVR registry. RESULTS: All scores had a poor accuracy and calibration to predict the occurrence of AKI grade 1 or 2. All scores improved the accuracy of AKI risk prediction when stratified for AKI grade 2/3 and AKI grade 3 for all scores. The CR4EATME3AD3 was the best predictor of AKI stage 2/3 (AUC: 0.62; OR: 1.12; 95% CI 1.01-1.26; p = 0.04) and AKI stage 3 (AUC: 0.64; OR: 1.16; 95% CI 1.02-1.32; p = 0.02). Mehran models A and B were both good models for AKI stage 3 (AUC: 0.63; OR: 1.10; 95% CI 1.01-1.22; p = 0.05; and AUC: 0.62; OR: 1.10; 95% CI 1.00-1.21; p = 0.05, respectively). CONCLUSIONS: None of the current models demonstrated validity in detecting AKI when its lower grades were evaluated. CR4EATME3AD3 was the best score in predicting moderate to severe AKI after TAVR. These findings suggest that contrast-induced AKI may not be the only factor related to kidney injury after TAVR.

Improvement of renal function after transcatheter aortic valve replacement in patients with chronic kidney disease.

BACKGROUND: Chronic kidney disease is commonly found in patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) and has marked impact in their prognosis. It has been shown however that TAVR may improve renal function by alleviating the hemodynamic barrier imposed by AS. Nevertheless, the predictors of and clinical consequences of renal function improvement are not well established. Our aim was to assess the predictors of improvement of renal function after TAVR. METHODS: The present work is an analysis of the Brazilian Registry of TAVR, a national non-randomized prospective study with 22 Brazilian centers. Patients with baseline renal dysfunction (estimated glomerular filtration rate [eGFR] < 60mL/min/1.73m2) were stratified according to renal function after TAVR: increase >10% in eGFR were classified as TAVR induced renal function improvement (TIRFI); decrease > 10% in eGFR were classified as acute kidney injury (AKI) and stable renal function (neither criteria). RESULTS: A total of 819 consecutive patients with symptomatic severe AS were included. Of these, baseline renal dysfunction (estimated glomerular filtration rate [eGFR] < 60mL/min/1.73m2) was present in 577 (70%) patients. Considering variance in renal function between baseline and at discharge after TAVR procedure, TIRFI was seen in 197 (34.1%) patients, AKI in 203 (35.2%), and stable renal function in 177 (30.7%). The independent predictors of TIRFI were: absence of coronary artery disease (OR: 0.69; 95% CI 0.48-0.98; P = 0.039) and lower baseline eGFR (OR: 0.98; 95% CI 0.97-1.00; P = 0.039). There was no significant difference in 30-day and 1-year all-cause mortality between patients with stable renal function or TIRFI. Nonetheless, individuals that had AKI after TAVR presented higher mortality compared with TIRFI and stable renal function groups (29.3% vs. 15.4% vs. 9.5%, respectively; p < 0.001). CONCLUSIONS: TIRFI was frequently found among baseline impaired renal function individuals but was not associated with improved 1-year outcomes.

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial

Resumo Introdução e objetivos: Stents Coated with the Biodegradable Polymer on their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions (Destiny Trial) é um estudo randomizado de não inferioridade que comparou o stent farmacológico eluído com Sirolimus Inspiron® (SES) ao controle o stent Biomatrix® Flex eluído com biolimus (BES). Relatórios dentro do primeiro ano mostraram resultados semelhantes para ambos os stents, em seguimento clínico, angiográfico e também em análise de tomografia de coerência ótica e ultrassom intracoronário. A presente análise tem como objetivo comparar o desempenho clínico desses dois stents farmacológicos com polímeros biodegradáveis após cinco anos do procedimento índice. Métodos: Foram randomizados 170 pacientes (194 lesões) em uma proporção de 2:1 para trata mento com SES ou BES, respetivamente. O desfecho primário para o presente estudo foi a taxa em cinco anos de eventos cardíacos adversos maiores combinados, definida como morte cardíaca, infarto do miocárdio ou revascularização da lesão-alvo. Resultados: Em cinco anos, o desfecho primário ocorreu em 12,5% e 17,9% para o grupo SES e BES, respectivamente (p=0,4). Não houve trombose de stent definitiva ou provável entre os pacientes tratados com o novo SES durante os cinco anos de seguimento e ausência de trombose de stent após o primeiro ano no grupo BES. Conclusões: O novo stent Inspiron® apresentou uma boa e semelhante performance clínica no seguimento em longo prazo, quando comparado com o controle o stent de última geração Biomatrix® Flex.

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial.

INTRODUCTION AND OBJECTIVES: The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. METHODS: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. RESULTS: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. CONCLUSIONS: The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.

Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a new-generation, self-expandable system.

OBJECTIVES: The aim of the study was to evaluate mid- to late clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) with Acurate neo™ (Boston Scientific, Boston, MA). BACKGROUND: TAVR is an established treatment for aortic stenosis (AS). Few data exist on mid- to long-term outcomes and durability after new-generation valves. METHODS: All consecutive patients (n = 104) who underwent Acurate neo™ implantation from 2012 to 2018 were included. Follow-up was systematically performed at 1, 6, 12, and 24 months and yearly thereafter. Outcomes were reported according to VARC-2, and structural valve deterioration (SVD) or bioprosthetic valve failure defined accordingly to new definitions. RESULTS: Mean age was 82 ± 5.4 years, 56.7% were female and the Society of Thoracic Surgeons score for mortality was 5.9 ± 4%. Patients were followed for a median of 3 years (1,092 days; IQR 1.5-4 years), and the maximum follow-up was 7 years. All-cause mortality values at 1 and 5 years were 8.5% and 40.5%, respectively. No relevant changes in mean gradient and orifice area occurred (7.9 ± 3.8 mmHg and 1.9 ± 0.3 cm2 at 1 year; 6.6 ± 2.1 mmHg and 1.8 ± 0.3 cm2 at 5 years), and there was a significant rate of paravalvular leaks resolution at 1, 2, and 3 years (p = .004; p < .001; p < .001, respectively). None of the patients had leaflet thrombosis or endocarditis. One patient developed SVD at 84 months. CONCLUSIONS: Acurate neo™ was associated with sustained echocardiographic results. Reassuring mid- to long-term outcomes was observed in this cohort of elderly patients with severe AS.

Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a newgeneration, self-expandable system / Desfechos clínicos e ecocardiográficos de médio a longo prazo após a substituição da válvula aórtica transcateter com uma nova geração, sistema auto-expansível

Abstract Objectives: The aim of the study was to evaluate mid- to late clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) with A curate neo™ (Boston Scientific, Boston, MA). Background: TAVR is an established treatment for aortic stenosis (AS). Few data exist on mid- to long-term outcomes and durability after new-generation valves. Methods: All consecutive patients (n = 104) who underwent A curate neo™ implantation from 2012 to 2018 were included. Follow-up was systematically performed at 1, 6, 12, and 24 months and yearly thereafter. Outcomes were reported according to VARC-2, and structural valve deterioration (SVD) or bioprosthetic valve failure defined accordingly to new definitions. Results: Mean age was 82 ± 5.4 years, 56.7% were female and the Society of Thoracic Surgeons score for mortality was 5.9 ± 4%. Patients were followed for a median of 3 years (1,092 days; IQR 1.5­4 years), and the maximum follow-up was 7 years. All-cause mortality values at 1 and 5 years were 8.5% and 40.5%, respectively. No relevant changes in mean gradient and orifice area occurred (7.9 ± 3.8 mmHg and 1.9 ± 0.3 cm2 at 1 year; 6.6 ± 2.1 mmHg and 1.8 ± 0.3 cm2 at 5 years), and there was a significant rate of paravalvular leaks resolution at 1, 2, and 3 years (p = .004; p < .001; p < .001, respectively). None of the patients had leaflet thrombosis or endocarditis. One patient developed SVD at 84 months. Conclusions: A curate neo™ was associated with sustained echocardiographic results. Reassuring mid- to long-term outcomes was observed in this cohort of elderly patients with severe AS.

Ablação septal por radiofrequencia em pacientes com miocardiopatia hipertrofica obstrutiva: primeira serie nacional / Radiofrequency septal ablation in patients with obstructive hypertrophic cardiomyopathy: first national series

INTRODUÇÃO: A Cardiomiopatia Hipertrófica (CMH) está associada a obstrução da via de saída (VSVE) em 40% dos casos e a obstrução medioventricular (MV) em 8-10 % dos casos. Quando há obstrução significativa (gradiente maior que 50mmHg em repouso ou após manobra provocativa) e sintomas graves refratários ao tratamento medicamentoso, considera-se o alívio da obstrução, seja através da cirurgia (miectomia septal) procedimento considerado "padrão ouro", seja através de intervenção percutânea (alcoolização). Este último associado à evolução satisfatória, com resultados semelhantes à cirurgia a longo prazo, porém também à criação de área de fibrose e maior prevalência de arritmias. Recentemente, têm sido publicados artigos sobre os resultados de um novo procedimento intervencionista, a ablação septal por radiofrequência, guiado por mapeamento eletroanatômico, com resultados favoráveis, com alivio da obstrução e pouca fibrose secundária. Descrevemos nossa experiência pioneira com ablação septal com radiofrequência utilizando ecocardiograma transesofágico como método guia, substituindo o mapeamento eletroanatômico. Utilizamos o procedimento para alívio do gradiente de VSVE e MV CASUÍSTICA: total de 12 pacientes (p) 75% do sexo feminino, idade média de 56 + 15 anos, frequência cardíaca inferior a 60bpm. Os sintomas foram principalmente dispneia aos esforços e síncopes de repetição. 10 p (83%) tinham obstrução de VSVE) e 2p (17%) tinham obstrução MV. A via de acesso foi retroaórtico- Foram utilizados cateteres de 8 mm não irrigados. A redução do gradiente provocado 35,2% em três meses e 62,3% em um ano (de inicial 96,83 mmHg ± 28,30 para 62,72 ± 20mmHg em três meses para 36,41 mmHg ± 16,81 em um ano). A redução do gradiente de repouso foi de 52,9% em três meses e 69,7% em um ano (de inicial de 73,58 mmHg ± 29,51 para 34,63 ± 13,78mmHg em três meses para 22,25 mmHg ± 13,83 ao final de um ano). Não ocorreu bloqueio atrioventricular, não foi necessário implantes de marcapassos ou outros dispositivos, nem outras complicações graves. COMENTÁRIOS E CONCLUSÕES: A ablação septal guiada por ecocardiograma transesofágico foi segura e eficaz para redução do gradiente tanto de VSVE como MV. Deve ser considerada uma alternativa terapêutica para tratamento da CMH obstrutiva. Destacamos o papel deste método intervindo no gradiente MV, condição extremamente desafiadora pelo fato da cirurgia e a alcoolização terem limitações significativas neste quadro.

Comparison of minimum pressure and patent hemostasis on radial artery occlusion after transradial catheterization

ABSTRACT: Objectives. The aim of this study was to compare two hemostatic techniques, minimum pressure technique and patent hemostasis, on radial artery occlusion (RAO) after trans-radial catheterization. Background. RAO is an infrequent complication of trans-radial procedures. One of the strategies used to reduce this complication is the patent hemostasis technique. Use of minimum pressure in hemostatic wristband, without monitoring patency, might have the same efficacy for preventing RAO. Methods. This is a multicenter study encompassing patients submitted to trans-radial catheterization. After pneumatic wristband application, the band was deflated to the lowest allowable volume while preserving hemostasis. Radial artery patency was subsequently evaluated. The group with no return of plethysmography curve was labeled "minimum pressure," and the group in which the signal returned was labeled "patent hemostasis." RAO was verified by Doppler evaluation within the first 24 hours of the procedure. Results. A total of 1082 patients were enrolled, with mean age of 61.4 ± 10.4 years. The majority (61.0%) were male and 34.5% had diabetes. Patent hemostasis was achieved in only 213 cases (20%). Early RAO occurred in 16 patients (1.8%) in the minimum pressure group and in 4 patients (1.9%) in the patent hemostasis group (P=.97). No major bleeding was observed among the entire cohort. EASY scale for hematoma grade was similar between the cohorts (EASY grades 1-3: 7.0% in the minimum pressure group vs 7.5% in the patent hemostasis group; P=.96). Conclusion. Checking radial patency during hemostatic compression may not be necessary after the procedure when adopting a mild and short hemostatic compression

Comparison of Minimum Pressure and Patent Hemostasis on Radial Artery Occlusion After Transradial Catheterization.

OBJECTIVES: The aim of this study was to compare two hemostatic techniques, minimum pressure technique and patent hemostasis, on radial artery occlusion (RAO) after transradial catheterization. BACKGROUND: RAO is an infrequent complication of transradial procedures. One of the strategies used to reduce this complication is the patent hemostasis technique. Use of minimum pressure in hemostatic wristband, without monitoring patency, might have the same efficacy for preventing RAO. METHODS: This is a multicenter study encompassing patients submitted to transradial catheterization. After pneumatic wristband application, the band was deflated to the lowest allowable volume while preserving hemostasis. Radial artery patency was subsequently evaluated. The group with no return of plethysmographic curve was labeled "minimum pressure," and the group in which the signal returned was labeled "patent hemostasis." RAO was verified by Doppler evaluation within the first 24 hours of the procedure. RESULTS: A total of 1082 patients were enrolled, with mean age of 61.4 ± 10.4 years. The majority (61.0%) were male and 34.5% had diabetes. Patent hemostasis was achieved in only 213 cases (20%). Early RAO occurred in 16 patients (1.8%) in the minimum pressure group and in 4 patients (1.9%) in the patent hemostasis group (P=.97). No major bleeding was observed among the entire cohort. EASY scale for hematoma grade was similar between the cohorts (EASY grades 1-3: 7.0% in the minimum pressure group vs 7.5% in the patent hemostasis group; P=.96). CONCLUSION: Checking radial patency during hemostatic compression may not be necessary after the procedure when adopting a mild and short hemostatic compression.

Análise crítica dos estudos que mudaram a prática clínica recente: doença valvar / Critical analysis of studies that have changed recent clinical practice: valvular heart disease

Nesta breve análise crítica, discutiremos três estudos com potencial de alterar a prática clínica e as principais diretrizes internacionais no que tange à doença valvar. O estudo PARTNER III foi um estudo que randomizou 1000 pacientes de baixo risco cirúrgico entre troca valvar transcateter e cirurgia convencional, com superioridade da técnica transcateter em um desfecho primário combinado de mortalidade de todas as causas, acidente vascular cerebral (AVC) e re-hospitalização em doze meses de seguimento (8,5%vs.15,1%, p = 0,001). Já o estudo Evolut Low Risk randomizou 1468 pacientes entre as duas técnicas, com um desfecho primário de mortalidade ou AVC incapacitante ao final de dois anos de seguimento que atingiu não-inferioridade na comparação Bayesiana (5,3% transcateter vs . 6,7% cirurgia). Finalmente, discutimos também o estudo COAPT, no qual 614 pacientes foram randomizados entre o dispositivo edge-to-edge MitraClip e o tratamento clínico da insuficiência mitral secundária. Nesses pacientes selecionados, a taxa anualizada de hospitalizações por insuficiência cardíaca foi de 35,8% por paciente-ano no grupo MitraClip, comparado com 67,9% no grupo controle (HR 0,53, IC 95% 0,4-0,7).Nas novas diretrizes, pode-se razoavelmente esperar uma indicação I para a troca valvar transcateter em pacientes de baixo risco e uma indicação IIa para a técnica edge-to-edge em pacientes com características semelhantes aos do COAPT. Esses procedimentos devem ser considerados no contexto do Heart Team para que sejam atingidos os melhores resultados

In this short critical review, we will discuss three trials with the potential to alter clinical practice and the main international guidelines regarding valvular heart disease. The PARTNER III trial was a study of 1000 low surgical risk patients randomized between transcatheter aortic valve replacement (TAVR) and conventional surgery, showing the superiority of the transcatheter technique with a combined primary endpoint of all-cause mortality, stroke and rehospitalization over twelve months of follow-up (8.5%vs. 15.1%, p = 0.001). The Evolut Low Risk trial randomized 1468 patients between the two techniques with a primary endpoint of death or incapacitating stroke at the end of two years of follow-up, achieving non-inferiority in a Bayesian comparison (5.3% TAVR vs. 6.7% surgery). Finally, we also will discuss the COAPT study, in which 614 patients were randomized between the edge-to-edge MitraClip device and clinical treatment for secondary mitral regurgitation. Among these selected patients, the annual rate of hospitalizations for heart failure was 35.8% per patient-year in the MitraClip group, compared with 67.9% in the control group (HR 0.53, 95% CI 0.4-0.7). Under the new guidelines, we may reasonably expect a class I indication for transcatheter valvular replacement in low-risk patients and a class IIa indication for the edge-to-edge technique in patients with characteristics similar to those of the COAPT study. These procedures should be considered within the context of the Heart Team so that the best results are achieved

Intravascular imaging comparison of two metallic limus-eluting stents abluminally coated with biodegradable polymers: IVUS and OCT results of the DESTINY trial.

We sought to compare, by means of IVUS and OCT imaging, the performance of a novel sirolimus-eluting drug-eluting stent (DES) with biodegradable polymer (Inspiron™) to the Biomatrix™ DES. From the DESTINY trial, a total of 70 randomized patients (2:1) were enrolled in the IVUS substudy (Inspiron™, n = 46; Biomatrix™: n = 20) while 25 patients were evaluated with OCT (Inspiron™, n = 19; Biomatrix™: n = 06) at 9-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at 9 months. Patients treated with both DES had very little NIH formation at 9 months either by IVUS (% of NIH obstruction of 4.9 ± 4.1 % with Inspiron™ vs. 2.7 ± 2.9 % with Biomatrix™, p = 0.03) or by OCT (neointimal thickness of 144.2 ± 72.5 µm Inspiron™ vs. 115.0 ± 53.9 µm with Biomatrix™, p = 0.45). Regarding OCT strut-level assessment, again both devices showed excellent 9-month performance, with high rates of strut coverage (99.49 ± 1.01 % with Inspiron™ vs. 97.62 ± 2.21 % with Biomatrix™, p < 0.001) and very rare malapposition (0.29 ± 1.06 % with Inspiron™ vs. 0.53 ± 0.82 % with Biomatrix™, p = 0.44). Patients with any uncovered struts were more frequently identified in the Biomatrix™ group (9.78 ± 7.13 vs. 2.29 ± 3.91 %, p < 0.001). In the present study, midterm IVUS and OCT evaluations showed that both new generation DES with biodegradable polymer were effective in terms of suppressing excessive neointimal response, with very high rates of apposed and covered struts, suggesting a consistent and benign healing pattern.

Prospective comparison between three TAVR devices: ACURATE neo vs. CoreValve vs. SAPIEN XT. A single heart team experience in patients with severe aortic stenosis.

OBJECTIVE: We sought to compare the new transcatheter aortic valve replacement (TAVR) device ACURATE neo (ACT) with the already established CoreValve (MCV) and SAPIEN XT (SXT) for the treatment of severe aortic stenosis (AS). BACKGROUND: Very few data on TAVR devices are available beyond MCV and SAPIEN and there is no previous study comparing ACT with MCV and SXT. METHODS: We prospectively evaluated consecutive patients who underwent transfemoral TAVR for the treatment of severe AS. Clinical outcomes were reported following Valve Academic Research Consortium 2 (VARC-2) criteria. RESULTS: A total of 162 patients (ACT n = 49, MCV n = 56, SXT n = 57), were included. MCV group had higher valve embolization/migration rates (ACT none; MCV 9%; SXT 2%; P = 0.034) causing lower device success rates (ACT 98%; MCV 86%; SXT 95%; P = 0.043). At 30 days, there was no significant difference in all-cause mortality (P = 0.22), cardiovascular mortality (P = 0.20), periprocedural myocardial infarction (P = 0.40), stroke (P = 0.64), major vascular complications (P = 0.48), life-threatening bleeding (P = 0.29), acute kidney injury stage 2/3 (P = 0.69), or VARC-2 composite early safety endpoints (P = 0.21). MCV group had higher rates of new permanent pacemaker implantation (ACT 6%; MCV 25%; SXT 11%; P = 0.013). Follow-up echocardiography showed no significant difference in aortic valve mean pressure gradient (P = 0.73) or moderate/severe aortic regurgitation (P = 0.19) between groups. CONCLUSIONS: In a "real world" registry, ACT compared favorably against the well-studied SXT and MCV devices in both safety and efficacy. MCV implantation was associated with lower device success rates and higher rates of new permanent pacemaker implantation. © 2016 Wiley Periodicals, Inc.

Prospective comparison between three TAVR devices: ACURATE neo vs. CoreValve vs. SAPIEN XT. A single heart team experience in patients with severe aortic stenosis

OBJECTIVE: We sought to compare the new transcatheter aortic valve replacement (TAVR) device ACURATE neo (ACT) with the already established CoreValve (MCV) and SAPIEN XT (SXT) for the treatment of severe aortic stenosis (AS). BACKGROUND: Very few data on TAVR devices are available beyond MCV and SAPIEN and there is no previous study comparing ACT with MCV and SXT. METHODS: We prospectively evaluated consecutive patients who underwent transfemoral TAVR for the treatment of severe AS. Clinical outcomes were reported following Valve Academic Research Consortium 2 (VARC-2) criteria.RESULTS:A total of 162 patients (ACT n = 49, MCV n = 56, SXT n = 57), were included. MCV group had higher valve embolization/migration rates (ACT none; MCV 9%; SXT 2%; P = 0.034) causing lower device success rates (ACT 98%; MCV 86%; SXT 95%; P = 0.043). At 30 days, there was no significant difference in all-cause mortality (P = 0.22), cardiovascular mortality (P = 0.20), periprocedural myocardial infarction (P = 0.40), stroke (P = 0.64), major vascular complications (P = 0.48), life-threatening bleeding (P = 0.29), acute kidney injury stage 2/3 (P = 0.69), or VARC-2 composite early safety endpoints (P = 0.21). MCV group had higher rates of new permanent pacemaker implantation (ACT 6%; MCV 25%; SXT 11%; P = 0.013). Follow-up echocardiography showed no significant difference in aortic valve mean pressure gradient (P = 0.73) or moderate/severe aortic regurgitation (P = 0.19) between groups...

Intravascular imaging comparison of two metallic limus-eluting stents abluminally coated with biodegradable polymers: IVUS and OCT results of the DESTINY trial

We sought to compare, by means of IVUS and OCT imaging, the performance of a novel sirolimus-eluting drug-eluting stent (DES) with biodegradable polymer (Inspiron™) to the Biomatrix™ DES. From the DESTINY trial, a total of 70 randomized patients (2:1) were enrolled in the IVUS substudy (Inspiron™, n = 46; Biomatrix™: n = 20) while 25 patients were evaluated with OCT (Inspiron™, n = 19; Biomatrix™: n = 06) at 9-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at 9 months. Patients treated with both DES had very little NIH formation at 9 months either by IVUS (% of NIH obstruction of 4.9 ± 4.1 % with Inspiron™ vs. 2.7 ± 2.9 % with Biomatrix™, p = 0.03) or by OCT (neointimal thickness of 144.2 ± 72.5 µm Inspiron™ vs. 115.0 ± 53.9 µm with Biomatrix™, p = 0.45). Regarding OCT strut-level assessment, again both devices showed excellent 9-month performance, with high rates of strut coverage (99.49 ± 1.01 % with Inspiron™ vs. 97.62 ± 2.21 % with Biomatrix™, p < 0.001) and very rare malapposition (0.29 ± 1.06 % with Inspiron™ vs. 0.53 ± 0.82 % with Biomatrix™, p = 0.44). Patients with any uncovered struts were more frequently identified in the Biomatrix™ group (9.78 ± 7.13 vs. 2.29 ± 3.91 %, p < 0.001)...

Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

AIMS: To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. METHODS: This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. RESULTS: After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. CONCLUSIONS: The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.

Impacto da Curva de Aprendizado na Seleção de Pacientes e nos Resultados Clínicos do Implante por Cateter de Prótese Aórtica / Impact of Transcatheter Aortic Valve Implantation Learning Curve on Patient Selection and Clinical Outcomes

Introdução: O implante por cateter de prótese aórtica (TAVI, do inglês transcatheter aortic valve implantation) constitui tratamento alternativo para pacientes com estenose aórtica de alto risco cirúrgico ou inoperáveis. Para adquirir competência, o grupo multidisciplinar deve receber treinamento específico e acumular experiência na execução do TAVI. Contudo, sua curva de aprendizado não está bem estabelecida. Nosso objetivo foi analisar o impacto da curva de aprendizado na seleção de pacientes, nos aspectos técnicos e nos resultados clínicos do TAVI. Métodos: Estudo observacional e prospectivo dos primeiros 150 pacientes submetidos a TAVI por via femoral, entre janeiro de 2009 e dezembro de 2013 divididos em tercis (n = 50) de acordo com a data do procedimento. Os desfechos foram definidos conforme os critérios Valve Academic Research Consortium-2 (VARC-2). Resultados: A idade foi de 82,5 ± 6,7 anos, sendo 44% homens e 75% em classe NYHA III/IV. O EuroSCORE (24,2 ± 13% vs. 21,2 ± 10,8% vs. 23,4 ± 14,3%) e o STS Score (5,9 ± 2,9% vs. 6,7 ± 4,3% vs. 5,8 ± 3,1%) foram similares entre os grupos. Observou-se redução gradativa nos tempos do procedimento (107,2 ± 48,1 minutos vs. 90,3 ± 42,2 minutos vs. 76,6 ± 37,7 minutos; p < 0,01) e de fluoroscopia (31,3 ± 9,6 minutos vs. 25,4 ± 8,7 minutos vs. 17,2 ± 6,2 minutos; p = 0,01), e no ...

Background: Transcatheter aortic valve implantation (TAVI) is an alternative treatment for high-risk or inoperable patients with aortic stenosis. The multidisciplinary team must undergo specific training and accumulate experience to achieve optimal results. However, its learning curve is not well established. Our objective was to investigate the impact of learning curve on patient selection, technical aspects and clinical outcomes of TAVI. Methods: Observational, prospective analysis of the first 150 patients undergoing transfemoral TAVI between January 2009 and December 2013. Patients were divided into tertiles (n = 50), according to the procedure date. Outcomes were defined according to Valve Academic Research Consortium-2 (VARC-2) criteria. Results: Mean age was 82.5 ± 6.7 years, 44% were male and 75% were in NYHA class III/IV. EuroS-CORE (24.2 ± 13% vs. 21.2 ± 10.8% vs. 23.4 ± 14.3%) and STS Score (5.9 ± 2.9% vs. 6.7 ± 4.3% vs. 5.8 ± 3.1%) were similar between groups. A gradual decrease was observed in procedure times (107.2 ± 48.1 minutes vs. 90.3 ± 42.2 minutes vs. 76.6 ± 37.7 minutes; p < 0.01), fluoroscopy times (31.3 ± 9,6 minutes vs. 25.4 ± 8.7 minutes vs. 17.2 ± 6.2 minutes; p = 0.01) and contrast volume (145.5 ± 70.9 mL vs. 123.2 ± 87.8 mL vs. 101.1 ± 50 mL; p = 0.01). Mortality decreased gradually (20% vs. 10% vs. 4%; p = 0,047), and lower bleeding and moderate-to-severe aortic regurgitation were ...