Clinical practice guideline for transcatheter versus surgical valve replacement in patients with severe aortic stenosis in Latin America

In elderly (75 years or older) patients living in Latin America with severe symptomatic aortic stenosis candidates for transfemoral approach, the panel suggests the use of transcatheter aortic valve implant (TAVI) over surgical aortic valve replacement (SAVR). This is a conditional recommendation, based on moderate certainty in the evidence. This recommendation does not apply to patients in which there is a standard of care, like TAVI for patients at very high risk for cardiac surgery or inoperable patients, or SAVR for non-elderly patients (eg, under 65 years old) at low risk for cardiac surgery. The suggested age threshold of 75 years old is based on judgement of limited available literature and should be used as a guide rather than a determinant threshold. The conditional nature of this recommendation means that the majority of patients in this situation would want a transfemoral TAVI over SAVR, but some may prefer SAVR. For clinicians, this means that they must be familiar with the evidence supporting this recommendation and help each patient to arrive at a management decision integrating a multidisciplinary team discussion (Heart Team), patient's values and preferences through shared decision-making, and available resources. Policymakers will require substantial debate and the involvement of various stakeholders to implement this recommendation.

Clinical practice guideline for transcatheter versus surgical valve replacement in patients with severe aortic stenosis in Latin America.

In elderly (75 years or older) patients living in Latin America with severe symptomatic aortic stenosis candidates for transfemoral approach, the panel suggests the use of transcatheter aortic valve implant (TAVI) over surgical aortic valve replacement (SAVR). This is a conditional recommendation, based on moderate certainty in the evidence (⨁⨁⨁Ο).This recommendation does not apply to patients in which there is a standard of care, like TAVI for patients at very high risk for cardiac surgery or inoperable patients, or SAVR for non-elderly patients (eg, under 65 years old) at low risk for cardiac surgery. The suggested age threshold of 75 years old is based on judgement of limited available literature and should be used as a guide rather than a determinant threshold.The conditional nature of this recommendation means that the majority of patients in this situation would want a transfemoral TAVI over SAVR, but some may prefer SAVR. For clinicians, this means that they must be familiar with the evidence supporting this recommendation and help each patient to arrive at a management decision integrating a multidisciplinary team discussion (Heart Team), patient's values and preferences through shared decision-making, and available resources. Policymakers will require substantial debate and the involvement of various stakeholders to implement this recommendation.

Autologous blood salvage in cardiac surgery: clinical evaluation, efficacy and levels of residual heparin

ABSTRACT Objective: Intraoperative blood salvage (cell saver technique) in cardiac surgery is universally used in surgical procedures with a marked risk of blood loss. The primary objectives of this study were to determine the concentration of residual heparin in the final product that is reinfused into the patient in the operating room and to evaluate the efficacy and safety of the cell saver technique. Method: Twelve patients undergoing elective cardiac surgery were enrolled in this study. Using the XTRA Autotransfusion System, blood samples were collected from the cardiotomy reservoir, both prior to blood processing (pre-sample) and after it, directly from the bag with processed product (post-sample). Hematocrit and hemoglobin levels, the protein, albumin and residual heparin concentrations, hemolysis index, and the platelet, erythrocyte and leukocyte counts were measured. Results: Hematocrit and hemoglobin levels and red blood cell counts were higher in post-processing samples, with a mean variation of 54.78%, 19.81 g/dl and 6.84 × 106/mm3, respectively (p < 0.001). The mean hematocrit of the processed bag was 63.49 g/dl (range: 57.2-67.5). The residual heparin levels were ≤0.1 IU/ml in all post-treatment analyses (p = 0.003). No related adverse events were observed. Conclusion: The reduced residual heparin values (≤0.1 IU/ml) in processed blood found in this study are extremely important, as they are consistent with the American Association of Blood Banks guidelines, which establish target values below 0.5 IU/ml. The procedure was effective, safe and compliant with legal requirements and the available international literature.

Autologous blood salvage in cardiac surgery: clinical evaluation, efficacy and levels of residual heparin.

OBJECTIVE: Intraoperative blood salvage (cell saver technique) in cardiac surgery is universally used in surgical procedures with a marked risk of blood loss. The primary objectives of this study were to determine the concentration of residual heparin in the final product that is reinfused into the patient in the operating room and to evaluate the efficacy and safety of the cell saver technique. METHOD: Twelve patients undergoing elective cardiac surgery were enrolled in this study. Using the XTRA Autotransfusion System, blood samples were collected from the cardiotomy reservoir, both prior to blood processing (pre-sample) and after it, directly from the bag with processed product (post-sample). Hematocrit and hemoglobin levels, the protein, albumin and residual heparin concentrations, hemolysis index, and the platelet, erythrocyte and leukocyte counts were measured. RESULTS: Hematocrit and hemoglobin levels and red blood cell counts were higher in post-processing samples, with a mean variation of 54.78%, 19.81g/dl and 6.84×106/mm3, respectively (p<0.001). The mean hematocrit of the processed bag was 63.49 g/dl (range: 57.2-67.5). The residual heparin levels were ≤0.1IU/ml in all post-treatment analyses (p=0.003). No related adverse events were observed. CONCLUSION: The reduced residual heparin values (≤0.1IU/ml) in processed blood found in this study are extremely important, as they are consistent with the American Association of Blood Banks guidelines, which establish target values below 0.5IU/ml. The procedure was effective, safe and compliant with legal requirements and the available international literature.

Avaliação de refluxos paraprotéticos por meio da ecocardiografia transesofágica tridimensional com Doppler colorido / Evaluation of paravalvular leaks through color Doppler three-dimensional transesophageal echocardiography

Fundamento: Os refluxos paraprotéticos são complicações comuns após cirurgia de troca valvar. A quantificação da gravidade, a localização e a morfologia dos refluxos paraprotéticos podem ser demonstradas por meio da ecocardiografia transesofágica tridimensional. Objetivo: Avaliar a correlação entre gravidade da regurgitação paravalvar, avaliada pela ecocardiografia tradicional bidimensional, usando a largura da vena contracta, e as medidas derivadas da avaliação pela ecocardiografia transesofágica tridimensional (comprimento, largura e área); avaliar o sucesso terapêutico da oclusão de refluxos paraprotéticos, guiada por ecocardiografia transesofágica tridimensional, e a correlação entre as medidas desta e as dos dispositivos para oclusão percutânea. Método: Estudo retrospectivo de 11 pacientes consecutivamente submetidos ao tratamento percutâneo de refluxos paraprotéticos entre 2014 e 2015, avaliados por meio de ecocardiografia transtorácica e ecocardiografia transesofágica tridimensional, no pré-operatório e no intraoperatório. Resultados: De um total de 20 refluxos paraprotéticos, 18 apresentaram sucesso técnico imediato. Não houve correlação entre as medidas da vena contracta bidimensional e as derivadas da ecocardiografia transesofágica tridimensional. Houve correlação forte entre o comprimento do defeito pela ecocardiografia transesofágica tridimensional e o comprimento do dispositivo para oclusão percutânea (rho = 0,929; p < 0,001), além de correlação moderada entre a área do defeito e a do dispositivo para oclusão percutânea (rho = 0,682; p = 0,002). Não houve correlação entre a largura do dispositivo para oclusão percutânea e a do defeito medida pela ecocardiografia transesofágica tridimensional (rho = 0,440; p = 0,067). Conclusão: Não houve correlação entre a medida da vena contracta bidimensional e as medidas derivadas da ecocardiografia transesofágica tridimensional. A escolha dos dispositivos para oclusão percutânea baseada nas medidas da ecocardiografia transesofágica tridimensional apresentou alta taxa de sucesso imediato, com ótima correlação entre o comprimento dos defeitos e dos dispositivos para oclusão percutânea. A correlação entre as áreas foi boa e não houve correlação entre as larguras

Background: Paravalvular leaks are a common complication after valve replacement surgery. Quantification of the severity, location and morphology of paravalvular leaks can be obtained by three-dimensional transesophageal echocardiography. Objective: To evaluate the correlation between the severity of paravalvular regurgitation by vena contracta measurement using bidimensional echocardiography, and measurements derived from three-dimensional transesophageal echocardiography (length, width and area). To evaluate the therapeutic success of three-dimensional transesophageal echocardiography-guided paravalvular leaks occlusion and the correlation between three-dimensional transesophageal echocardiography measurements and dimensions of devices for percutaneous occlusion. Method: Retrospective study of 11 patients consecutively submitted to percutaneous paravalvular leaks treatment between 2014 and 2015, using transthoracic echocardiography and between three-dimensional transesophageal echocardiography in the preoperative and intraoperative periods. Results: Out of a total of 20 paravalvular leaks, 18 showed immediate technical success. There was no correlation between the measurements of the bidimensional vena contracta and the measures derived from the three-dimensional transesophageal echocardiography. There was a strong correlation between the defect length measured by the three-dimensional transesophageal echocardiography and the device for percutaneous occlusion length (rho = 0.929; p < 0.001); and moderate between the defect area and the device for percutaneous occlusion area (rho = 0.682,p = 0.002). There was no correlation between the device for percutaneous occlusion width and the defect width measured by three-dimensional transesophageal echocardiography (rho = 0.440; p = 0.067). Conclusion: There was no correlation between the measurement of the bidimensional vena contracta and the measures derived from the three-dimensional transesophageal echocardiography. The choice of devices for percutaneous occlusion based on three-dimensional transesophageal echocardiography measurements showed a high success rate, with an excellent correlation between defect length and devices for percutaneous occlusion length. The correlation between the areas was good, and there was no correlation between the widths

Prognostic value of renal function in patients with aortic stenosis treated with transcatheter aortic valve replacement.

OBJECTIVES: The objectives of the present study were to analyze the variation of renal function after transcatheter aortic valve replacement (TAVR) focused on acute kidney injury (AKI) and its impact on short- and mid-term mortality. BACKGROUND: Changes on renal function after TAVR and their impact on clinical outcomes are incompletely understood until now. METHODS: At two tertiary centers 221 consecutive patients were submitted to TAVR. Kidney injury was defined according to VARC-2 criteria. Patients were classified according to the presence (group 1) or absence (group 2) of AKI. Creatinine values were collected daily until seventh day after procedure, 1 month, 6 months, and then 1 year after TAVR. RESULTS: At baseline, groups were similar, except for EuroSCORE II (8.66% vs. 7.34%, P = 0.02) and glomerular filtration rate (GFR) (39.59 vs. 48.49 mL/min.1.73 m2 , P = 0.002). Overall 30 day-mortality and 1-year mortality were 6.3% and 14.0%, respectively. Both 30-day mortality (23.1% vs. 1.2%, P < 0.001) and 1-year mortality (44.2% vs. 4.7%, P < 0.001) were higher in group 1. After multivariable-adjusted models, the only independent predictor for AKI after TAVR was baseline GFR (HR: 1.37, 95% CI: 1.08-1.77, P = 0.01). The independent risk factors for 1-year mortality were AKI (HR: 15.66, 95% CI: 6.07-44.63, P < 0.001), COPD (HR: 3.14, 95% CI: 1.05-9.40, P = 0.04) and aortic regurgitation grade postprocedure ≥ 2 (P = 0.05) also after multivariate analysis. CONCLUSIONS: In this TAVR cohort, baseline GFR was the only independent predictor of AKI, which negatively impacted on 30-day and 1-year mortality. © 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. 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.

Prognostic value of renal function in patients with aortic stenosis treated with transcatheter aortic valve replacement

OBJECTIVES: The objectives of the present study were to analyze the variation of renal function after transcatheter aortic valve replacement (TAVR) focused on acute kidney injury (AKI) and its impact on short- and mid-term mortality. BACKGROUND: Changes on renal function after TAVR and their impact on clinical outcomes are incompletely understood until now. METHODS: At two tertiary centers 221 consecutive patients were submitted to TAVR. Kidney injury was defined according to VARC-2 criteria. Patients were classified according to the presence (group 1) or absence (group 2) of AKI. Creatinine values were collected daily until seventh day after procedure, 1 month, 6 months, and then 1 year after TAVR.RESULTS:At baseline, groups were similar, except for EuroSCORE II (8.66% vs. 7.34%, P = 0.02) and glomerular filtration rate (GFR) (39.59 vs. 48.49 mL/min.1.73 m2 , P = 0.002). Overall 30 day-mortality and 1-year mortality were 6.3% and 14.0%, respectively. Both 30-day mortality (23.1% vs. 1.2%, P < 0.001) and 1-year mortality (44.2% vs. 4.7%, P < 0.001) were higher in group 1. After multivariable-adjusted models, the only independent predictor for AKI after TAVR was baseline GFR (HR: 1.37, 95% CI: 1.08-1.77, P = 0.01). The independent risk factors for 1-year mortality were AKI (HR: 15.66, 95% CI: 6.07-44.63, P < 0.001), COPD (HR: 3.14, 95% CI: 1.05-9.40, P = 0.04) and aortic regurgitation grade postprocedure ≥ 2 (P = 0.05) also after multivariate analysis...

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...

Implante transcateter valve-in-valve para disfunção de biopróteses cirúrgicas aórticas / Transcatheter valve-in-valve implantation for surgical aortic bioprosthesis dysfunction

Introdução: Estudos recentes têm demonstrado a eficácia do implante transcateter valve-in-valve para otratamento de disfunção de biopróteses em pacientes de alto risco cirúrgico. Apresentamos nossa experiênciainicial com o implante valve-in-valve.Métodos: Caracterizamos o perfil clínico, ecocardiográfico e do procedimento, e reportamos os resultados de médio prazo de pacientes com disfunção de bioprótese submetidos a implante valve-in-valve em posição aórtica. Resultados: Incluímos sete pacientes do sexo masculino, com idade de 72,6 ± 10,0 anos. O escore STS foi 9,6± 10,5%, e o EuroSCORE logístico foi 22,7 ± 14,7%. Três pacientes apresentavam dupla disfunção; dois tinham insuficiência; e dois exibiam estenose isolada. A via transfemoral foi utilizada em seis casos, e a transapical, em um caso. Os dispositivos implantados incluíram as próteses Sapien XT (n = 5) e CoreValve (n = 2). O sucesso do procedimento foi obtido em seis (85,7%) casos. Após o procedimento, o gradiente médio reduziu-se de 38,2 ± 9,6mmHg para 20,9 ± 5,9 mmHg, e a área valvar elevou-se de 1,2 ± 0,4 cm2 para 1,5 ± 0,5 cm2. Ao final de 1 ano, nãoocorreram óbitos e nem outros desfechos adversos significativos; 80% dos pacientes encontravam-se em classefuncional NYHA I/II. Os gradientes transvalvares e a área valvar permaneceram inalterados nesse período. Conclusões: O procedimento valve-in-valve foi eficaz na maioria dos pacientes de alto risco cirúrgico comdisfunção de bioprótese. Quando realizado em pacientes bem selecionados, resulta em desfechos clínicos e hemodinâmicos satisfatórios.

Background: Recent studies have demonstrated the efficacy of the transcatheter valve-in-valveimplantation for the treatment of bioprosthesis dysfunction in high-risk surgical patients. This study presents the initial experience with valve-in-valve implantation. Methods: Clinical, echocardiographic, and procedural profiles were characterized, and the mid-term results of patients with surgical bioprosthesis dysfunction submitted to valve-in-valve implantation in theaortic position were reported.Results: Seven male patients were included, aged 72.6 ± 10.0 years. The STS score was 9,6 ± 10,5%, andthe logistic EuroSCORE was 22.7 ± 14.7%. Three patients had combined aortic bioprosthesis failure; two had isolated regurgitation; and two had isolated stenosis. The transfemoral access was used in six cases, and the transapical access in one case. Implanted devices included Sapien XT (n = 5) and CoreValve (n = 2) prostheses. Procedural success was achieved in six (85.7%) cases. After the procedure, the mean gradient decreased from 38.2 ± 9.6 mmHg to 20.9 ± 5.9 mmHg, and the valve area increased from 1.2 ±0.4 cm2 to 1.5 ± 0.5 cm2. After 1 year, there were no deaths and no other significant adverse outcomes; 80% of patients were in NYHA functional class I/II. The transvalvular gradients and valve area remained unchanged in this period.

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 ...

Initial experience of two national centers in transcatheter aortic prosthesis implantation.

BACKGROUND: Transcatheter aortic valve implantation is an effective alternative to surgical treatment of severe aortic stenosis in patients who are inoperable or at high surgical risk. OBJECTIVES: To report the immediate and follow-up clinical and echocardiographic results of the initial experience of transcatheter aortic valve implantation. METHODS: From 2009 June to 2013 February, 112 patients underwent transcatheter aortic valve implantation. RESULTS: Mean age was 82.5 ± 6.5 years, and the logistic EuroSCORE was 23.6 ± 13.5. Procedural success was 84%. After the intervention, a reduction in the mean systolic gradient was observed (pre: 54.7 ± 15.3 vs. post: 11.7 ± 4.0 mmHg; p < 0.01). Cerebrovascular accidents occurred in 3.6%, vascular complications in 19% and permanent pacemaker was required by 13% of the patients. Thirty-day mortality and at follow-up of 16 ± 11 months was 14% and 8.9% respectively. The presence of chronic obstructive pulmonary disease was the only predictor of mortality at 30 days and at follow-up. During follow up, aortic valve area and mean systolic gradient did not change significantly. CONCLUSIONS: Transcatheter aortic valve implantation is an effective and safe procedure for the treatment of aortic stenosis in high-surgical risk or inoperable patients. The presence of chronic obstructive pulmonary disease was the only independent predictor of mortality identified both in the first month post-intervention and at follow-up.

Experiência Inicial de Dois Centros Nacionais no Implante de Prótese Aórtica Transcateter / Initial Experience of Two National Centers in Transcatheter Aortic Prosthesis Implantation

Fundamento: O implante de prótese aórtica transcateter é uma alternativa efetiva para o tratamento cirúrgico para a correção de estenose aórtica grave em pacientes inoperáveis ou de alto risco cirúrgico. Objetivos: Apresentar os resultados clínicos e ecocardiográficos imediatos e no médio prazo da experiência inicial do implante de prótese aórtica transcateter. Métodos: Entre junho de 2009 e fevereiro de 2013, 112 pacientes foram submetidos a implante de prótese aórtica transcateter. Resultados: A idade média foi 82,5 ± 6,5 anos e o Euro SCORE logístico foi 23,6 ± 13,5. O sucesso do procedimento foi de 84%. Após o implante, houve queda do gradiente sistólico médio (pré = 54,7 ± 15,3 mmHg vs. pós = 11,7 ± 4,0 mmHg; p < 0,01). Acidente vascular cerebral ocorreu em 3,6% dos pacientes, complicações vasculares em 19%, e foi necessário o implante de marca-passo definitivo em 13% dos pacientes nos primeiros 30 dias pós-implante. A mortalidade aos 30 dias e no seguimento médio de 16 ± 11 meses foi, respectivamente, de 14 e de 8,9%. A presença de doença pulmonar obstrutiva crônica foi o único preditor de mortalidade em 30 dias e no seguimento. A área valvar aórtica e o gradiente sistólico médio não apresentaram variações significativas durante o seguimento. Conclusões: O implante de prótese aórtica transcateter é um procedimento eficaz e seguro para o tratamento da estenose aórtica em pacientes de alto risco cirúrgico ou inoperáveis. A presença de doença pulmonar obstrutiva crônica foi o único preditor independente de mortalidade identificado, tanto no primeiro mês pós-intervenção quanto no seguimento mais tardio. .

Background: Transcatheter aortic valve implantation is an effective alternative to surgical treatment of severe aortic stenosis in patients who are inoperable or at high surgical risk. Objectives: To report the immediate and follow-up clinical and echocardiographic results of the initial experience of transcatheter aortic valve implantation. Methods: From 2009 June to 2013 February, 112 patients underwent transcatheter aortic valve implantation. Results: Mean age was 82.5 ± 6.5 years, and the logistic EuroSCORE was 23.6 ± 13.5. Procedural success was 84%. After the intervention, a reduction in the mean systolic gradient was observed (pre: 54.7 ± 15.3 vs. post: 11.7 ± 4.0 mmHg; p < 0.01). Cerebrovascular accidents occurred in 3.6%, vascular complications in 19% and permanent pacemaker was required by 13% of the patients. Thirty-day mortality and at follow-up of 16 ± 11 months was 14% and 8.9% respectively. The presence of chronic obstructive pulmonary disease was the only predictor of mortality at 30 days and at follow-up. During follow up, aortic valve area and mean systolic gradient did not change significantly. Conclusions: Transcatheter aortic valve implantation is an effective and safe procedure for the treatment of aortic stenosis in high-surgical risk or inoperable patients. The presence of chronic obstructive pulmonary disease was the only independent predictor of mortality identified both in the first month post-intervention and at follow-up. .

Análise da incidência e preditores clínicos e ecocardiográficos do refluxo paraprotético aórtico após o implante de prótese aórtica transcateter / Analysis of the incidence and clinical and echocardiographic predictors of paravalvular aortic regurgitation after transcatheter aortic valve implantation

INTRODUÇÃO: A incidência de refluxo paraprotético (RPP) parece maior entre os pacientes submetidos a implante de prótese aórtica transcateter e sua potencial associação com aumento da mortalidade tardia tem suscitado preocupação na comunidade científica. Nosso objetivo foi avaliar a incidência e o impacto clínico e estabelecer preditores do RPP em nossa casuística. MÉTODOS: Entre julho de 2009 e fevereiro de 2013, 112 pacientes foram submetidos a implante de prótese aórtica transcateter. O grau do RPP pós-procedimento foi avaliado segundo os critérios do VARC 2. Dividiu-se a população em grupo RPP ausente/RPP discreto e grupo RPP moderado/RPP grave. RESULTADOS: A média da idade foi de 82,5 ± 3,9 anos, 58,9% eram do sexo feminino e o EuroSCORE logístico foi de 23,6 ± 13,4. Houve queda do gradiente sistólico médio (54,7 ± 15,3 mmHg vs. 11,7 ± 4 mmHg; P < 0,01) e ganho da área valvar aórtica (0,66 ± 0,15 cm² vs. 1,8 ± 0,3 cm²; P < 0,01). Ao final do procedimento, 46,4% não apresentaram RPP, e RRP discreto ou moderado foi observado em 42% e 11,6% dos pacientes. Nenhum paciente apresentou RPP grave. A análise multivariada identificou sexo masculino [odds ratio (OR) 5,85, intervalo de confiança (IC] 1,29-26,7; P = 0,022), valvoplastia aórtica percutânea prévia (OR 18,44, IC 2,30-147,85; P = 0,006), fração de ejeção < 35% (OR 4,160, IC 1,014-17,064; P = 0,048) e presença de hipertensão pulmonar grave (OR 7,649, IC 1,86-31,51; P = 0,005) como preditores independentes de RPP moderado/grave. CONCLUSÕES: A incidência de RPP moderado/grave foi baixa e comparável à de outras casuísticas. Sexo masculino, antecedente de valvoplastia aórtica percutânea prévia, presença de hipertensão pulmonar grave e disfunção ventricular esquerda grave foram preditores independentes dessa complicação.

BACKGROUND: The incidence of paravalvular aortic regurgitation (PAR) seems higher among patients submitted to transcatheter aortic valve implantation and its potential association with an increased late mortality has raised concerns in the scientific community. Our objective was to evaluate the incidence and clinical impact of PAR and establish PAR predictors in our patient population. METHODS: Between July/2009 and February/2013, 112 patients were submitted to transcatheter aortic valve implantation. The degree of PAR after the procedure was assessed according to the VARC 2 criteria. The population was divided into no/mild PAR group and moderate/severe PAR group. RESULTS: Mean age was 82.5 ± 3.9 years, 58.9% were female and the logistic EuroSCORE was 23.6 ± 13.4. There was a decrease in the mean systolic gradient (54.7 ± 15.3 mmHg vs 11.7 ± 4 mmHg; P < 0.01) and a gain in the aortic valve area (0.66 ± 0.15 cm² vs 1.8 ± 0.3 cm²; P < 0.01). At the end of the procedure 46.4% did not have PAR, and mild or moderate PAR was observed in 42% and 11.6% of the patients. No patient presented severe PAR. Multivariate analysis identified male gender [odds ratio (OR) 5.85, confidence interval (CI] 1.29-26.7; P = 0.022), previous percutaneous aortic val­vuloplasty (OR 18.44, CI 2.30-147.85; P = 0.006), ejection fraction < 35% (OR 4.160, CI 1.014-17.064; P = 0.048) and the presence of severe pulmonary hypertension (OR 7.649, CI 1.86-31.51; P = 0.005) as independent predictors of moderate/severe PAR. CONCLUSIONS: The incidence of moderate/severe PAR was low and comparable to other studies. Male gender, history of prior percutaneous aortic valvuloplasty, presence of severe pulmonary hypertension and severe left ventricular dysfunction were independent predictors of this complication.

Transcatheter aortic valve replacement in elderly patients.

Aortic stenosis is the most common native valve disease, affecting up to 5% of the elderly population. Surgical aortic valve replacement reduces symptoms and improves survival, and is the definitive therapy in patients with symptomatic severe aortic stenosis. However, despite the good results of classic surgery, risk is markedly increased in elderly patients with co-morbidities. Transcatheter aortic valve replacement (TAVR) allows implantation of a prosthetic heart valve within the diseased native aortic valve without the need for open heart surgery and cardiopulmonary bypass, offering a new therapeutic option to elderly patients considered at high surgical risk or with contraindications to surgery. To date, several multicenter registries and a randomized trial have confirmed the safety and efficacy of TAVR in those patients. In this chapter, we review the background and clinical applications of TAVR in elderly patients.

Transcatheter aortic valve replacement in elderly patients

Aortic stenosis is the most common native valve disease, affecting up to 5% of the elderly population. Surgical aortic valve replacementreduces symptoms and improves survival, and is the definitive therapy in patients with symptomatic severe aortic stenosis. However, despitethe good results of classic surgery, risk is markedly increased in elderly patients with co-morbidities. Transcatheter aortic valve replacement(TAVR) allows implantation of a prosthetic heart valve within the diseased native aortic valve without the need for open heart surgery andcardiopulmonary bypass, offering a new therapeutic option to elderly patients considered at high surgical risk or with contraindications tosurgery. To date, several multicenter registries and a randomized trial have confirmed the safety and efficacy of TAVR in those patients. Inthis chapter, we review the background and clinical applications of TAVR in elderly patients.