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.

Independent Clinical and Echocardiographic Predictors of Restenosis After Percutaneous Mitral Balloon Commissurotomy in a Large, Consecutive Cohort Followed for 24 Years.

OBJECTIVE: To enlighten preprocedural risk factors of mitral valve restenosis in a large, single-center cohort of patients submitted to percutaneous mitral balloon commissurotomy (PMBC) for the treatment of mitral stenosis (MS) secondary to rheumatic heart disease. METHODS: This is a database analysis of a single-center, high-volume tertiary institution involving all consecutive PMBC procedures performed in the mitral valve (MV). Restenosis was diagnosed when MV area was <1.5 cm² and/or loss of 50% or more of the immediate procedural result aligned with the return/worsened symptoms of heart failure. The primary endpoint was to determine the preprocedural independent predictors of restenosis after PMBC. RESULTS: Among a total of 1921 PMBC procedures, 1794 consecutive patients without previous intervention were treated between 1987 and 2010. Throughout 24 years of follow-up, MV restenosis was observed in 483 cases (26%). Mean age was 36 years and most (87%) were female. Median follow-up duration was 9.03 years (interquartile range, 0.33-23.38). Restenosis population, however, presented a significantly lower age at the procedure time as well as a higher Wilkins-Block score. At multivariate analysis, independent preprocedure predictors of restenosis were left atrium diameter (hazard risk [HR], 1.03; 95% confidence interval [CI], 1.02-1.05; P<.04), preprocedure maximum gradient (HR, 1.02; 95% CI, 1.00-1.03; P=.04), and higher Wilkins-Block score (>8) (HR, 1.38; 95% CI, 1.14-1.67; P<.01). CONCLUSIONS: At long-term follow-up, MV restenosis was observed in a quarter of the population undergoing PMBC. Preprocedure echocardiographic findings, including left atrial diameter, maximum MV gradient, and Wilkins-Block score were found to be the only independent predictors.

Novel Prognostic Score for Immediate and Late Success After Percutaneous Mitral Balloon Commissurotomy in Patients With Mitral Stenosis.

OBJECTIVES: Percutaneous mitral balloon commissurotomy (PMBC) remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis (MS) and suitable anatomy. The objective of this study was to propose a new score for the prediction of immediate and late success. METHODS: This is a single-center, retrospective analysis of all 1582 patients with severe mitral stenosis who underwent PMBC from August 1987 to July 2010. The composite outcome was cardiovascular death, new PMBC, or mitral valve repair surgery up to 24 years of follow-up. RESULTS: Mean patient age was 36.8 ± 12.9 years, most (86.4%) were female, and Wilkins score was between 9-11 in 49.1% of patients. In the multivariate analysis, the predictors of immediate success were age (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.96-0.99; P=.01), left atrium size (OR, 0.96; 95% CI, 0.93-0.99; P=.01), mean preprocedure mitral gradient (OR, 0.93; 95% CI, 0.89-0.96; P<.001), intermediate Wilkins score 9-11 (OR, 0.62; 95% CI, 0.40-0.94; P=.02), and high Wilkins score ≥12 (OR, 0.35; 95% CI, 0.16-0.76; P<.01). For prediction of late events, age (hazard ratio [HR], 0.98; 95% CI, 0.97-0.98; P<.001), New York Heart Association class III-IV (HR, 1.50; 95% CI, 1.18-1.92; P<.001), left atrium size (HR, 1.02; 95% CI, 1.02-0.04; P<.01), and high Wilkins score ≥12 (HR, 2.02; 95% CI, 1.30-3.15; P<.01) were significant. Two nomograms were developed using significant predictors from the model. CONCLUSIONS: In this large population, not only the Wilkins score, but also clinical and hemodynamic features, seem to be relevant in predicting immediate and late success for patients with rheumatic MS who underwent PMBC.

Very Long Term Follow-Up After Percutaneous Balloon Mitral Valvuloplasty.

OBJECTIVES: The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV). BACKGROUND: PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy. METHODS: All consecutive patients who underwent successful PBMV between 1987 and 2010 were included. The primary endpoint was the composite of all-cause mortality, need for mitral surgery, or repeat PBMV up to 23 years. RESULTS: Among all 1,582 consecutive patients undergoing PBMV, acute success was achieved in 90.9% (n = 1,438). Independent predictors of acute success included left atrial size (odds ratio: 0.96; 95% confidence interval [CI]: 0.93 to 0.99; p = 0.045), Wilkins score ≤8 (odds ratio: 1.66; 95% CI: 0.48 to 0.93; p = 0.02) and age (odds ratio: 0.97; 95% CI: 0.96 to 0.99; p = 0.006). Very long term follow-up (median 8.3 years, mean 15.6 years) was obtained in 79.1% of successful cases. The incidence of the primary endpoint was 19.1% (95% CI: 17.0% to 21.1%). The rates of overall mortality, need for mitral valve surgery, or repeat PBMV were 0.6% (95% CI: 0.3% to 1.2%), 8.3% (95% CI: 7.0% to 9.9%), and 10.0% (95% CI: 8.5% to 11.7%), respectively. On multivariate analysis, New York Heart Association functional class III or IV (hazard ratio: 1.62; 95% CI: 1.26 to 2.09; p < 0.001), higher age (hazard ratio: 0.97; 95% CI: 0.96 to 0.98; p = 0.028), and mitral valve area ≤1.75 cm2 after the procedure (hazard ratio: 1.67; 95% CI: 1.28 to 2.11; p = 0.028) were independent predictors of the primary endpoint. CONCLUSIONS: In very long term follow-up, more than 75% of patients exhibited sustained results. Prediction of late favorable results is multifactorial and strongly determined by age, previous symptoms and post-procedural mitral valve area.

Fibrinolytic therapy for thrombosis in cardiac valvular prosthesis short and long term results.

OBJECTIVE: To assess the short- and long-term results of the use of streptokinase (SK) for the treatment of thromboses in cardiac valvular prostheses. METHODS: Seventeen patients with cardiac prosthetic thrombosis diagnosed by clinical, echocardiographic, and radioscopic findings underwent fibrinolytic treatment with a streptokinase bolus of 250,000 U followed by 100.000 U/hour. Short- and long-term results were assessed by radioscopy and echocardiography. RESULTS: Of the 17 patients, 12 had mechanical double-disk prostheses (4 aortic, 6 mitral, 2 tricuspid), 4 had single-disk prostheses (2 aortic, 1 mitral, and 1 tricuspid), and 1 had a tricuspid bioprosthesis. The success rate was 64.8%, the partial success rate was 17.6%, and the nonsuccess rate was 17.6%. All patients with a double-disk prosthesis responded, completely or partially, to the treatment. None of the patients with a single-disk prosthesis had complete resolution of the thrombosis. The time of streptokinase infusion ranged from 6 to 80 hours (mean of 56 h). The mortality rate due to the use of streptokinase was 5.8% and was secondary to cerebral bleeding. During streptokinase infusion, 3 (17.6%) embolic episodes occurred as follows: 1 cerebral, 1 peripheral, and 1 coronary. The rethrombosis index was 33% in a mean follow-up of 42 months. CONCLUSION: The use of fibrinolytic agents was effective and relatively safe in patients with primary thrombosis of a double-disk prosthesis. A fatal hemorrhagic complication occurred in 1 (5.8%) patient, and embolic complications occurred in 3 (17.6%) patients. In a mean 42-month follow-up, 67% of the patients were free from rethrombosis.

Consequences of the prolonged waiting time for patient candidates for heart surgery.

OBJECTIVE: To assess mortality and the psychological repercussions of the prolonged waiting time for candidates for heart surgery. METHODS: From July 1999 to May 2000, using a standardized questionnaire, we carried out standardized interviews and semi-structured psychological interviews with 484 patients with coronary heart disease, 121 patients with valvular heart diseases, and 100 patients with congenital heart diseases. RESULTS: The coefficients of mortality (deaths per 100 patients/year) were as follows: patients with coronary heart disease, 5.6; patients with valvular heart diseases, 12.8; and patients with congenital heart diseases, 3.1 (p<0.0001). The survival curve was lower in patients with valvular heart diseases than in patients with coronary heart disease and congenital heart diseases (p<0.001). The accumulated probability of not undergoing surgery was higher in patients with valvular heart diseases than in the other patients (p<0.001), and, among the patients with valvular heart diseases, this probability was higher in females than in males (p<0.01). Several patients experienced intense anxiety and attributed their adaptive problems in the scope of love, professional, and social lives, to not undergoing surgery. CONCLUSION: Mortality was high, and even higher among the patients with valvular heart diseases, with negative psychological and social repercussions.

Valvotomia mitral percutânea: quarta dilatação / Percutaneous mitral valvotomy: fourth dilatation

Paciente do sexo feminino, 37 anos, portadora de estenose mitral de etiologia reumática, submetida, com sucesso, a valvotomia mitral percutânea em 1996, 2000 e 2005. Após 41 meses do terceiro procedimento, além de episódios de fibrilação atrial paroxística, voltou a apresentar dispneia aos moderados esforços. O estudo ecocardiográfico demonstrou gradiente transvalvar médio de 8 mmHg, pressão sistólica da artéria pulmonar de 55 mmHg, área valvar mitral de 1 cm² e escore de Wilkins de 10 pontos. Em decorrência da evidência de reestenose clínica e ecocardiográfica, indicou-se novo procedimento percutâneo, realizado sem intercorrências, porém obtendo-se resultado subótimo.

Thirty-seven-year-old female, previously diagnosed with mitral valve stenosis due to rheumatic fever, who had successfully undergone percutaneous mitral valvotomy in 1996, 2000 and 2005. Forty-one months after the thirdprocedure, in addition to episodes of paroxystic atrial fibrillation, the patient had dyspnea after ordinary exertion.Echocardiographic evaluation revealed a mean transvalvular gradient of 8 mmHg, pulmonary artery systolic pressure of 55 mmHg, a mitral valve area of 1 cm², and a Wilkins score of 10 points. With the evidence of clinical and echocardiographicmitral restenosis, a new percutaneous procedure was performed, with no periprocedural complications, however, achieving suboptimal outcome.

Valvotomia mitral percutânea: da primeira à terceira dilatação / Percutaneous mitral ballon valvotomy: from the first to third dilatation

Introdução: As causas de reestenose pós-valvotomia mitral percutânea dependem principalmente das características da população submetida à técnica. O objetivo deste tra balho foi comparar os resultados imediatos e tardios dos pacientes submetidos a dois ou mais procedimentos de valvotomia mitral percutânea (VMP) a um grupo de pacientes submetidos apenas a uma dilatação para o tratamento da estenose mitral grave. Método: Os pacientes foram divididos em dois grupos: o grupo A incluiu 90 pacientes submetidos a uma primeira VMP e que, em decorrência de reestenose ecocardiográfica e clínica, foram encaminhados a uma segunda intervenção, e 9 pacientes que, pelo mesmo motivo, foram submetidos a um terceiro procedimento; e grupo B, composto de 90 pacientes selecionados por amostra aleatória simples submetidos a apenas uma dilatação, todas com sucesso. As variáveis ecocardiográficas analisadas para comparação dos resultados dentro do mesmo grupo e entre os grupos A e B foram a área valvar mitral (AVM), os gradientes diastólicos máximo (GDM) e médio (GDm), o diâmetro do átrio esquerdo e a incidência de reestenose...

Background: The causes for restenosis following percutaneous balloon mitral valvotomy (PBMV) vary according to the population undergoing this technique. The aim of this study was to compare the immediate and long-term results of patients undergoing a second and third PBMV to patients submitted to a single dilatation of the mitral valve for the treatment of severe mitral stenosis. Methods: Patients were divided into two groups: group A with 90 patients who, due to clinical and echocardiographic restenosis, were submitted to more than one procedure, and group B with 90 patients, selected by a random sample who underwent a single successful procedure. The echocardiographic variables analyzed to compare the results in the same group and between groups A and B were mitral valve area (MVA), maximal and mean diastolic gradients, left atrial diameter and incidence and time to restenosis...

Terapia fibrinolítica para trombose de próteses valvares cardíacas: resultados imediatos e tardios / Fibrinolytic therapy for thrombosis in cardiac valvular prosthesis short and long term results

OBJECTIVE: To assess the short- and long-term results of the use of streptokinase (SK) for the treatment of thromboses in cardiac valvular prostheses. METHODS: Seventeen patients with cardiac prosthetic thrombosis diagnosed by clinical, echocardiographic, and radioscopic findings underwent fibrinolytic treatment with a streptokinase bolus of 250,000 U followed by 100.000 U/hour. Short- and long-term results were assessed by radioscopy and echocardiography. RESULTS: Of the 17 patients, 12 had mechanical double-disk prostheses (4 aortic, 6 mitral, 2 tricuspid), 4 had single-disk prostheses (2 aortic, 1 mitral, and 1 tricuspid), and 1 had a tricuspid bioprosthesis. The success rate was 64.8 percent, the partial success rate was 17.6 percent, and the nonsuccess rate was 17.6 percent. All patients with a double-disk prosthesis responded, completely or partially, to the treatment. None of the patients with a single-disk prosthesis had complete resolution of the thrombosis. The time of streptokinase infusion ranged from 6 to 80 hours (mean of 56 h). The mortality rate due to the use of streptokinase was 5.8 percent and was secondary to cerebral bleeding. During streptokinase infusion, 3 (17.6 percent) embolic episodes occurred as follows: 1 cerebral, 1 peripheral, and 1 coronary. The rethrombosis index was 33 percent in a mean follow-up of 42 months. CONCLUSION: The use of fibrinolytic agents was effective and relatively safe in patients with primary thrombosis of a double-disk prosthesis. A fatal hemorrhagic complication occurred in 1 (5.8 percent) patient, and embolic complications occurred in 3 (17.6 percent) patients. In a mean 42-month follow-up, 67 percent of the patients were free from rethrombosis

Valvoplastia mitral com duplo cateter-baläo: análise de 200 casos / Percutaneous mitral balloon valvotomy: analysis of 200 cases

Objetivo - Avaliar a valvoplastia mitral por duplo cateter-baläo como técnica alternativa näo cirúrgica para tratamento da estenose mitral reumática. Método - Duzentos pacientes foram submetidos ao procedimento, sendo 86,5% do sexo feminino, com idade média de 35,2 anos. Oitenta e um por cento estavam em classes funcionais III e IV (NYHA), e 4% exibiam ritmo de fibrilaçäo atrial. Quatro por cento foram submetidos à comissurotomia cirurgica prévia e 7% eram gestantes. Utilizou-se a técnica de dilataçäo com duplo cateter-baläo, após punçäo septal esquerda. Resultados - O procedimento foi realizado com sucesso em 89% dos pacientes. A área valvar mitral aumentou de 0,91 ñ 0,27 para 2,10 ñ 0,47 cm*, p < 0,001; ocorreu reduçäo do gradiente transvalvar mitral de 20,86 ñ 6,16 para 4,26 ñ 3,13 mmHg, p < 0,001; as pressöes do átrio esquerdo e do tronco da artéria pulmonar reduziram de 25,90 ñ 7,10 para 12,10 ñ 9,0 mmHg e de 36,47 ñ 12,93 para 24,56 ñ 9,98 mmHg, p < 0,001, respectivamente. Dos 21 casos com insucesso, em 19 ocorreram dificuldades com a técnica transeptal. Em 12, constataram-se graus distintos de derrame pericárdico, dos quais 6 exibiram sinais de tamponamento cardíaco. Os 21 casos foram operados, ocorrendo 1 óbito. O refluxo mitral aparece em 50 casos e aumentou em 8. Quinze destes casos, exibiram descompensaçäo clínica, dos quais 10 foram operados, 3 estäo sob controle clínico e 2 faleceram tardiamente. Conclusäo - A valvoplastia mitral pelo duplo cateter-baläo é técnica segura, com bons resultados, constituindo-se me procedimento terapêutico alternativo näo cirúrgico da estenose mitral

Purpose - To study the immediate clinical, echocardiographic and hemodynamic results Of 200 patients who underwent percutaneous mitral balloon valvotomy (PMV) with double balloon technique. Methods - Two hundred patients were submitted to PVM for treatment of congestive heart failure secondary to severe mitral stenosis, between August 1987 to July 1991. Their mean age was 35.2 years, and 86.5% were female patients: 81% of them was in functional class, New York Heart Association (NYHAJ III or IV; 4% was in atrial fibrilation and 4% had previous surgical commissurotomy. Results - PMV was successfully performed in 89% of the patients. The mitral valve area, by pressure half time method, increased from 0.91 ± 0.27 to 2.10 ± 0.47 cm2, p < 0.001; the mean mitral gradient decreased from 20,86 ± 6.16 to 4.26 ± 3.13 mmHg, p < 0.001; the left atrium and mean pulmonary artery pressure decreased from 22.3 ± 7.1 to 11.9 ± 8.3 and 36.47 ± 12.93 to 24.56 ± 9.98 mmHg, p < 0.001, respectively. Complications related to transeptal technique occurred in 12 patients, which resulted in cardiac tamponade in 5 and death in 1. In 19 patients the punction of the atrial septum could not be performed. Mitral regurgitation (MR) immediately after PMV appeared 1 + or more grade in 50 patients, increased in 8 patients and remained unchanged in 11 patients. Ten patients needed mitral valve replacement in the first 48h after PMV, for treatment of severe MR. Conclusion - PMV prod uces excellent immediate results and can be considered an alternative to surgery for the relief of mitral stenosis

Conseqüências do prolongamento do tempo de espera em pacientes candidatos à cirurgia cardiáca / Consequences of the prolonged waiting Time for patients candidates for heart surgery

OBJECTIVE - To assess mortality and the psychological repercussions of the prolonged waiting time for candidates for heart surgery. METHODS - From July 1999 to May 2000, using a standardized questionnaire, we carried out standardized interviews and semi-structured psychological interviews with 484 patients with coronary heart disease, 121 patients with valvular heart diseases, and 100 patients with congenital heart diseases. RESULTS - The coefficients of mortality (deaths per 100 patients/year) were as follows: patients with coronary heart disease, 5.6; patients with valvular heart diseases, 12.8; and patients with congenital heart diseases, 3.1 (p<0.0001). The survival curve was lower in patients with valvular heart diseases than in patients with coronary heart disease and congenital heart diseases (p<0.001). The accumulated probability of not undergoing surgery was higher in patients with valvular heart diseases than in the other patients (p<0.001), and, among the patients with valvular heart diseases, this probability was higher in females than in males (p<0.01). Several patients experienced intense anxiety and attributed their adaptive problems in the scope of love, professional, and social lives, to not undergoing surgery. CONCLUSION - Mortality was high, and even higher among the patients with valvular heart diseases, with negative psychological and social repercussions

Sensibilidade e especificidade do hormônio natriurético do tipo B para identificar doentes com insuficiência mitral grave sintomáticos e assintomáticos / Sensitivity and specificity of B-type natriuretic peptide for identifying symptomatic and asymptomatic patients with severe mitral regurgitation

OBJETIVO: Verificar a sensibilidade e a especificidade do hormônio natriurético do tipo B (BNP) para identificar pacientes ambulatoriais, com insuficiência mitral crônica grave, sintomáticos e assintomáticos. MÉTODOS: Um grupo de pacientes com insuficiência mitral foi examinado e submetido à eletrocardiografia, telerradiografia de tórax, coletas de sangue venoso e ecocardiograma transtorácico. Por meio da análise de variáveis ecocardiográficas, 62 pacientes apresentavam refluxo mitral discreto e moderado (G I) e 34 refluxo mitral grave (G II). A capacidade discriminante do BNP em detectar pacientes com insuficiência mitral grave foi avaliada pela construção de curvas ROC. RESULTADOS: Entre os 96 doentes, 71 (73 por cento) eram mulheres e as idades variaram entre 15 e 63 (média de 31,7) anos. Os valores de BNP variaram de 0,00 pg/ml a 193 pg/ml. Os doentes do G I tiveram um valor médio de BNP de 18,10 ± 0,74 pg/ml e os do G II de 50,54 ± 1,46 pg/ml, (p=0,001). O valor de corte para identificar insuficiência mitral grave foi de 15,40 pg/ml, para o melhor balanço entre a sensibilidade e a especificidade, respectivamente de 0,73 e 0,74. O valor de corte para identificar pacientes sintomáticos e com insuficiência mitral grave foi de 28,40 pg/ml, para o melhor balanço entre a sensibilidade e a especificidade, respectivamente de 0,78 e 0,83. CONCLUSÃO: Os valores de BNP capazes de indentificar doentes com insuficiência mitral grave assintomáticos e sintomáticos são menores do que os 100 pg/ml considerados para o diagnóstico de insuficiência cardíaca.