Transcatheter Aortic Valve Implantation and Morbidity and Mortality-Related Factors: a 5-Year Experience in Brazil / Implante de Válvula Aórtica por Cateter e Seus Fatores de Morbimortalidade em Experiência de 5 Anos no Brasil

Abstract Background: Transcatheter aortic valve implantation has become an option for high-surgical-risk patients with aortic valve disease. Objective: To evaluate the in-hospital and one-year follow-up outcomes of transcatheter aortic valve implantation. Methods: Prospective cohort study of transcatheter aortic valve implantation cases from July 2009 to February 2015. Analysis of clinical and procedural variables, correlating them with in-hospital and one-year mortality. Results: A total of 136 patients with a mean age of 83 years (80-87) underwent heart valve implantation; of these, 49% were women, 131 (96.3%) had aortic stenosis, one (0.7%) had aortic regurgitation and four (2.9%) had prosthetic valve dysfunction. NYHA functional class was III or IV in 129 cases (94.8%). The baseline orifice area was 0.67 ± 0.17 cm2 and the mean left ventricular-aortic pressure gradient was 47.3±18.2 mmHg, with an STS score of 9.3% (4.8%-22.3%). The prostheses implanted were self-expanding in 97% of cases. Perioperative mortality was 1.5%; 30-day mortality, 5.9%; in-hospital mortality, 8.1%; and one-year mortality, 15.5%. Blood transfusion (relative risk of 54; p = 0.0003) and pulmonary arterial hypertension (relative risk of 5.3; p = 0.036) were predictive of in-hospital mortality. Peak C-reactive protein (relative risk of 1.8; p = 0.013) and blood transfusion (relative risk of 8.3; p = 0.0009) were predictive of 1-year mortality. At 30 days, 97% of patients were in NYHA functional class I/II; at one year, this figure reached 96%. Conclusion: Transcatheter aortic valve implantation was performed with a high success rate and low mortality. Blood transfusion was associated with higher in-hospital and one-year mortality. Peak C-reactive protein was associated with one-year mortality.

Resumo Fundamento: O implante de válvula aórtica por cateter tornou-se uma opção para pacientes com doença valvar aórtica de elevado risco cirúrgico. Objetivo: Avaliar os resultados dos seguimentos intra-hospitalar e de até 1 ano do implante de válvula aórtica por cateter. Métodos: Estudo de coorte prospectiva de casos de implante de válvula aórtica por cateter entre julho de 2009 e fevereiro de 2015. Análise de variáveis clínicas e do procedimento, correlacionando com mortalidade intra-hospitalar e de 1 ano. Resultados: Foram submetidos ao implante 136 pacientes, com média de idade de 83 (80-87) anos, sendo 49% mulheres, 131 (96,3%) deles com estenose aórtica, um (0,7%) com insuficiência aórtica e quatro (2,9%) com disfunção de prótese. A classe funcional da NYHA foi III ou IV em 129 (94,8%) casos. A área valvar inicial foi 0,67 ± 0,17 cm2 e o gradiente ventrículo esquerdo-aorta médio de 47,3 ± 18,2 mmHg, com STS de 9,3% (4,8%-22,3%). As próteses implantadas eram autoexpansíveis em 97% dos casos. A mortalidade peroperatória em 1,5% dos casos; em 30 dias em 5,9%; intra-hospitalar em 8,1%; e após 1 ano em 15,5% dos casos. A hemotransfusão (risco relativo de 54; p = 0,0003) e a hipertensão arterial pulmonar (risco relativo de 5,3; p = 0,036) foram preditoras de mortalidade hospitalar; e a proteína C-reativa pico (risco relativo de 1,8; p = 0,013) e a hemotransfusão (risco relativo de 8,3; p = 0,0009) de mortalidade em 1 ano. Aos 30 dias, 97% dos pacientes estavam em classe NYHA I/II e, em 1 ano, o número chegou a 96%. Conclusão: O implante de válvula aórtica por cateter foi realizado com alto índice de sucesso e baixa mortalidade. A hemotransfusão associou-se com maior mortalidade hospitalar e de 1 ano. Proteína C-reativa pico se associou com a mortalidade de 1 ano.

Implante valvular aórtico transarterial: experiencia en Chile / Transcatheter aortic valve implantation: Experience in 17 patients

Background: Transcatheter aortic valve implantation (TAVI) is taking a leading role in the management of patients with severe aortic stenosis. Valve replacement surgery prolongs survival and is the technique of choice considering its historical background and long experience worldwide. Recently however, TAVI has positioned itself as the only standard therapy for symptomatic patients who are not candidates for surgery. Aim: To report the experience with this new technique comparing our results with those reported in the literature. Material and Methods: Between May 2010 and December 2011,17patients aged 81 ± 7.3 years (58.8% men with an Euro SCORE 29 ± 22.4%) underwent a TAVI. Results: The median transvalvular gradient was 54 ± 15.7 mmHg. All patients received a CoreValveTM. Technical success was 100%, with a post implant gradient of 6.29 ± 3.3 mmHg. Residual aortic regurgita-tion was observed in 94%, none greater than grade II. There were no complications at the vascular access site. One patient developed cardiac tamponade during the procedure. Permanent pacemaker implantation was required in 35.2%. Hospital mortality rate was 5.8%, a figure that remained unchanged at 30 days offollow-up. Conclusions: In high-risk patients with aortic stenosis, TAVI has a high success rate and a low rate of complications. Besides an appropriate patient selection, a trained multidisciplinary team and technical conditions to solve possible complications of the procedure are required.

Valvuloplastia aórtica por cateter balão na estenose aórtica degenerativa: impacto terapêutico em pacientes em condição clínica in extremis / Balloon aortic valvuloplasty in degenerative aortic stenosis: therapeutic impact on patients in extremis

INTRODUÇÃO: A valvuloplastia aórtica por cateter balão (VAB) é utilizada como estratégia paliativa em pacientes inelegíveis tanto para troca valvar cirúrgica quanto para implante valvar aórtico transcateter, ou como ponte para essas modalidades de tratamento. Não se sabe o impacto terapêutico da VAB quando realizada como medida de salvamento para pacientes em condições clínicas extremas (in extremis). MÉTODOS: Foram analisados pacientes com estenose aórtica grave de etiologia degenerativa submetidos à VAB entre julho de 2008 e janeiro de 2013. Os pacientes foram divididos entre o grupo in extremis (definido pela presença de duas ou mais das seguintes disfunções orgânicas: ventilação mecânica, instabilidade hemodinâmica, terapia renal dialítica, coagulopatia ou disfunção hepática graves) e o grupo controle, que incluiu os demais pacientes. RESULTADOS: Um total de 19 pacientes realizaram VAB no período. A condição clínica in extremis esteve presente em 42,1%. Os pacientes do grupo in extremis tiveram EUROSCORE II mais elevado (41,1 ± 24,7 vs. 15,9 ± 14,0; P = 0,01) e fração de ejeção do VE mais baixa que o grupo controle (33,9 ± 17,3% vs. 49,0 ± 12,5%; P = 0,04). Nenhum paciente do grupo in extremis sobreviveu ao período intra-hospitalar, enquanto que, no grupo controle, a mortalidade foi de 27,3% (P < 0,01). CONCLUSÕES: Para o tratamento de pacientes com estenose aórtica grave de etiologia degenerativa, a VAB tem resultado desfavorável quando indicada para pacientes com duas ou mais disfunções orgânicas, ou seja, em condição clínica in extremis.

BACKGROUND: Balloon aortic valvuloplasty (BAV) is used as a palliative strategy in patients who are not eligible for valve replacement surgery, transcatheter aortic valve implantation, or as a bridge to these treatment modalities. The impact of BAV as a salvage procedure for patients in extreme clinical conditions (in extremis) is unknown. METHODS: Patients with severe degenerative aortic stenosis undergoing BAV between July 2008 and January 2013 were evaluated. Patients were divided into the in-extremis group (defined by the presence of two or more of the following organ dysfunctions: mechanical ventilation, hemodynamic instability, dialysis, coagulopathy or severe hepatic dysfunction) and the control group, which included the remaining patients. RESULTS: A total of 19 patients underwent BAV. The clinical condition in-extremis was present in 42.1% of them. Patients from the in-extremis group had a higher EUROSCORE II (41.1 ± 24.7 vs. 15.9 ± 14.0; P = 0.001) and LV ejection fraction lower than the control group (33.9 ± 17.3% vs. 49.0 ± 12.5; P = 0.04). None of the patients in the in-extremis group survived past the hospitalization period, whereas the control group mortality was 27.3% (P < 0.01). CONCLUSIONS: BAV has an unfavorable result in patients with severe degenerative aortic stenosis with two or more organ dysfunctions, that is, patients in extremis.