Evolução e Estado Atual das Práticas de Implante Transcateter de Válvula Aórtica na América Latina - Estudo WRITTEN LATAM / Recent Developments and Current Status of Transcatheter Aortic Valve Replacement Practice in Latin America - the WRITTEN LATAM Study

Resumo Fundamento: Implante transcateter de valva aórtica (TAVI) é um procedimento adotado em todo o mundo e suas práticas evoluem rapidamente. Variações regionais e temporais são esperadas. Objetivo: Comparar a prática de TAVI na América Latina com aquela no resto do mundo e avaliar suas mudanças na América Latina de 2015 a 2020. Método: A pesquisa foi realizada em centros de TAVI em todo o mundo entre março e setembro de 2015, e novamente nos centros latino-americanos entre julho de 2019 e janeiro de 2020. As seguintes questões foram abordadas: i) informação geral sobre os centros; ii) avaliação pré-TAVI; iii) técnicas do procedimento; iv) conduta pós-TAVI; v) seguimento. As respostas da pesquisa dos centros latino-americanos em 2015 (LATAM15) foram comparadas àquelas dos centros no resto do mundo (WORLD15) e ainda àquelas da pesquisa dos centros latino-americanos de 2020 (LATAM20). Adotou-se o nível de significância de 5% na análise estatística. Resultados: 250 centros participaram da pesquisa em 2015 (LATAM15=29; WORLD15=221) e 46 na avaliação LATAM20. No total, foram 73.707 procedimentos, sendo que os centros WORLD15 realizaram, em média, 6 e 3 vezes mais procedimentos do que os centros LATAM15 e LATAM20, respectivamente. Os centros latino-americanos realizaram menor número de TAVI minimalista do que os do restante do mundo, mas aumentaram significativamente os procedimentos menos invasivos após 5 anos. Quanto à assistência pós-procedimento, observaram-se menor tempo de telemetria e de manutenção do marca-passo temporário, além de menor uso de terapia dupla antiplaquetária nos centros LATAM20. Conclusão: A despeito do volume de procedimentos ainda significativamente menor, muitos aspectos da prática de TAVI nos centros latino-americanos evoluíram recentemente, acompanhando a tendência dos centros dos países desenvolvidos.

Abstract Background: Transcatheter aortic valve replacement (TAVR) is a worldwide adopted procedure with rapidly evolving practices. Regional and temporal variations are expected to be found. Objective: To compare TAVR practice in Latin America with that around the world and to assess its changes in Latin America from 2015 to 2020. Methods: A survey was applied to global TAVR centers between March and September 2015, and again to Latin-American centers between July 2019 and January 2020. The survey consisted of questions addressing: i) center's general information; ii) pre-TAVR evaluation; iii) procedural techniques; iv) post-TAVR management; v) follow-up. Answers from the 2015 survey of Latin-American centers (LATAM15) were compared with those of other centers around the world (WORLD15) and with the 2020 updated Latin-American survey (LATAM20). A 5% level of significance was adopted for statistical analysis. Results: 250 centers participated in the 2015 survey (LATAM15=29; WORLD15=221) and 46 in the LATAM20. Combined centers experience accounted for 73 707 procedures, with WORLD15 centers performing, on average, 6- and 3-times more procedures than LATAM15 and LATAM20 centers, respectively. LATAM centers performed less minimalistic TAVR than WORLD15 centers, but there was a significant increase in less invasive procedures after 5 years in Latin-American centers. For postprocedural care, a lower period of telemetry and maintenance of temporary pacing wire, along with less utilization of dual antiplatelet therapy was observed in LATAM20 centers. Conclusion: Despite still having a much lower number of procedures, many aspects of TAVR practice in Latin-American centers have evolved in recent years, followingthe trend observed in developed country centers.

Dissecção espontânea de artéria coronária: características demográficas e angiográficas do Registro Brasileiro Scalibur / Spontaneous coronary artery dissection: demographic and angiographic characteristics of the Scalibur Brazilian Registry

INTRODUÇÃO: A dissecção espontânea de artéria coronária (SCAD do inglês spontaneous coronary artery dissection) é uma causa não aterosclerótica de síndrome coronariana aguda que acomete preferencialmente mulheres jovens. De fisiopatologia ainda não completamente conhecida, pode manifestar-se sob a forma de infarto agudo do miocárdio com (IAMCSST) ou sem (IAMSSST) supradesnivelamento do segmento. A SCAD é a principal causa de infarto agudo do miocárdio no ciclo gravídico-puerperal. A descrição demográfica e angiográfica da SCAD de coorte brasileira é pouco explorada. OBJETIVO: Avaliar o perfil demográfico, angiográfico e os gatilhos de SCAD em uma população brasileira. MATERIAL E MÉTODOS: Estudo retrospectivo e prospectivo de pacientes com SCAD envolvendo 22 Hospitais no Brasil. Revisão de base de dados do REDcap no período de 2010-2021. RESULTADOS: Registraram-se 166 pacientes com SCAD, com idade média de 50,15 ± 10,56 anos (29 a 84 anos) com incidência prevalente no gênero feminino (85%). Os pacientes apresentavam nenhum ou poucos fatores de risco para doença arterial coronariana, incluindo hipertensão arterial (25%), história familiar de doença coronariana precoce (22%), dislipidemia mista (16%) e tabagismo ativo (16%). Seis por cento dos casos de SCAD ocorreram no ciclo gravídico puerperal. A maioria dos casos de SCAD manifestou-se como IAMSSST (47%), com IAMCSST (38%) e angina instável (12%) (Tabela). Entre os fatores desencadeantes, presentes em 57,8% dos casos, destacaram-se: estressor emocional (21,08%) e menopausa (18,07%). A displasia fibromuscular, não investigada sistematicamente, foi observada em poucos casos (4,21%), gestação (0,6%), puerpério (10,24%), estressor físico (5,42%), uso de terapia hormonal (3,60%) e doenças psiquiátricas (2,40%). A artéria descendente anterior foi o vaso mais acometido (57%), seguida pela coronária direita (14,45%). Complicações graves mais frequentes foram choque cardiogênico (3,28%) e parada cardiorrespiratória (0,7%). CONCLUSÃO: Nesta grande coorte brasileira, a SCAD acometeu preferencialmente pacientes jovens e mulheres. A frequência de fatores de risco clássicos para doença arterial coronariana foi pouco comum, sendo o gatilho predominante o estressor emocional. Esta entidade deve ser considerada como diagnóstico diferencial na síndrome coronariana aguda, principalmente em mulheres jovens (< 50 anos).

Infective endocarditis following transcatheter aortic valve replacement: comparison of balloon- versus self-expandable valves

BACKGROUND: No data exist about the characteristics of infective endocarditis (IE) post-transcatheter aortic valve replacement (TAVR) according to transcatheter valve type. We aimed to determine the incidence, clinical characteristics, and outcomes of patients with IE post-TAVR treated with balloon-expandable valve (BEV) versus self-expanding valve (SEV) systems. METHODS: Data from the multicenter Infectious Endocarditis After TAVR International Registry was used to compare IE patients with BEV versus SEV. RESULTS: A total of 245 patients with IE post-TAVR were included (SEV, 47%; BEV, 53%). The timing between TAVR and IE was similar between groups (SEV, 5.5 [1.2-15] months versus BEV, 5.3 [1.7-11.4] months; P=0.89). Enterococcal IE was more frequent in the SEV group (36.5% versus 15.4%; P<0.01), and vegetation location differed according to valve type (stent frame, SEV, 18.6%; BEV, 6.9%; P=0.01; valve leaflet, SEV, 23.9%; BEV, 38.5%; P=0.01). BEV recipients had a higher rate of stroke/systemic embolism (20.0% versus 8.7%, adjusted OR: 2.46, 95% CI: 1.04-5.82, P=0.04). Surgical explant of the transcatheter valve (SEV, 8.7%; BEV, 13.8%; P=0.21), and in-hospital death at the time of IE episode (SEV, 35.6%; BEV, 37.7%; P=0.74) were similar between groups. After a mean follow-up of 13±12 months, 59.1% and 54.6% of the SEV and BEV recipients, respectively, had died (P=0.66). CONCLUSIONS: The characteristics of IE post-TAVR, including microorganism type, vegetation location, and embolic complications but not early or late mortality, differed according to valve type. These results may help to guide the diagnosis and management of IE and inform future research studies in the field. (AU)

Determinants of success and hemodynamic impact of balloon postdilatation of self-expanding transcatheter aortic valves

OBJECTIVES: To explore the rate, the determinants of success, and the hemodynamic impact of balloon postdilatation (BPD) of self-expanding transcatheter heart valves (SE-THVs) Background: BPD is commonly used to optimize valve expansion and reduce paravalvular leakage (PVL) after transcatheter aortic valve implantation (TAVI) without clearly knowing its hemodynamic benefits. METHODS: Patients (n 5 307) who received a SE-THV were stratified according to whether a BPD was performed or not. Patients who received BPD were stratified according to the severity of PVL remaining after BPD into two groups: Successful BPD ( mild PVL 1 BPD) and Failed BPD (moderate-severe PVL 1 BPD). RESULTS: BPD was performed in 121 patients (39.4%) and was successful in 106 patients (87.6% of attempts). A ratio of the postdilatation balloon diameter to the annulus diameter 0.95 was an independent predictor of BPD failure (OR: 10.72 [2.02-56.76], P 5 .005). Peak transvalvular pressure gradient (PG) was lower in the Successful BPD group (14[12-22] mm Hg) than in the Failed BPD group (18[16-23] mm Hg, P 5 .029), and did not rise in either group during follow-up (median [IQR], 364[161-739] days). CONCLUSION: BPD was performed in 39% of patients who received a SE-THV, and was successful in the majority of attempts. BPD failure was more likely in patients with a small postdilatation balloon-to-annulus diameter ratio. Effective BPD improved THV hemodynamic performance, and this was maintained in the intermediate-term post-TAVI.

The Role of Quantitative Aortographic Assessment of Aortic Regurgitation by Videodensitometry in the Guidance of Transcatheter Aortic Valve Implantation / Papel da Avaliação Aortográfica Quantitativa da Regurgitação Aórtica por Videodensitometria na Orientação do Implante da Valva Aórtica Transcateter

Abstract Background: Balloon post-dilatation (BPD) is often needed for optimizing transcatheter heart valve (THV) implantation, since paravalvular leak (PVL) after transcatheter aortic valve implantation is associated with poor outcome and mortality. Quantitative assessment of PVL severity before and after BPD is mandatory to properly assess PVL, thus improving implantation results and outcomes. Objective: To investigate a quantitative angiographic assessment of aortic regurgitation (AR) by videodensitometry before and after BPD. Methods: Videodensitometric-AR assessments (VD-AR) before and after BPD were analysed in 61 cases. Results: VD-AR decreased significantly from 24.0[18.0-30.5]% to 12.0[5.5-19.0]% (p < 0.001, a two-tailed p < 0.05 defined the statistical significance). The relative delta of VD-AR after BPD ranged from -100% (improvement) to +40% (deterioration) and its median value was -46.2%. The frequency of improvement, no change, and deterioration were 70% (n = 43), 25% (n = 15) and 5% (n = 3), respectively. Significant AR (VD-AR > 17%) was observed in 47 patients (77%) before and in 19 patients (31%) after BPD. Conclusions: VD-AR after THV implantation provides a quantitative assessment of post-TAVI regurgitation and can help in the decision-making process on performing BPD and in determining its efficacy.

Resumo Fundamento: A pós-dilatação com balão (PDB) é normalmente necessária para otimização do implante da válvula cardíaca transcateter (THV), uma vez que o "escape" ou leak paravalvar (PVL) após implante de valva aórtica transcateter está associada com desfecho ruim e mortalidade. A avaliação quantitativa da gravidade do PVL antes e após a PDB é mandatória para se avaliar adequadamente o PVL e, assim, melhorar os resultados e os desfechos do implante. Objetivo: Investigar uma avalição angiográfica quantitativa da regurgitação aórtica (RA) por videodensitometria (VD-RA) antes e após a PDB. Métodos: Resultados da VD-RA antes e após a PDB foram analisados em 61 casos. Resultados Houve diminuição significativa da VD-RA de 24,0(18,0-30,5)% para 12,0(5,5-19,0)% (p < 0,001; p < 0,05 bilateral foi definido como significância estatística). O delta relativo de VD-RA após a PDB variou de -100% (melhora) a +40% (piora) e o valor mediano foi -46,2%. As frequências de melhora, ausência de mudança, e piora foram 70% (n = 43), 25% (n = 15) e 5% (n = 3), respectivamente. Observou-se RA significativo (VD-RA > 17%) em 47 pacientes (77%) antes e em 19 pacientes (31%) após a PDB. Conclusões: A VD-RA após o implante de THV possibilita a avaliação quantitativa da regurgitação pós-TAVI, e pode auxiliar na tomada de decisão quanto à realização ou não da PDB, bem como na avaliação de sua eficácia.

Angiographic assessment of aortic regurgitation by video-densitometry in the setting of TAVI: echocardiographic and clinical correlates

We sought to investigate a new angiographic method for aortic regurgitation (AR) severity assessment in the setting of transcatheter aortic valve implantation (TAVI). AR after TAVI is common but challenging to quantitate, especially in the cath-lab. In 228 patients, AR was quantitated before and after TAVI by echocardiography and by video-densitometric analysis of aortograms. Contrast time– density curves for the aortic root (the reference region) and the left ventricular outflow tract, LVOT were generated. LVOT-AR was calculated as the area under the curve of the LVOT as a fraction of the area under the curve of the reference region. LVOT-AR was 0.10 6 0.08, 0.13 6 0.10 and 0.28 6 0.14 in none-trace, mild and moderate-severe post-TAVI AR as defined by echocardiography (P 0.17 corresponded to moderate-severe AR on echocardiography (area under the curve 5 0.84). At follow-up (median, 496 days), patients with LVOT-AR 0.17 showed a significant reduction of LV mass index (LVMi; 121 [95–148] vs. 140 [112– 169] g/m2 , P 5 0.009) and the prevalence of LV hypertrophy (LVH; 64 vs. 88%, P 5 0.001) compared to baseline. In patients with LVOT-AR > 0.17, LVMi (149 [121–178] vs. 166 [144–188] g/m2 , P 5 0.14) and the prevalence of LVH (74 vs. 87%, P 5 0.23) did not show a significant change. Compared to patients with LVOT-AR 0.17, those with LVOT-AR > 0.17 had an increased 30-day (16.4% vs. 7.1%, P 5 0.035) and one year mortality (32.9 vs. 14.2%, log rank P value 5 0.001; HR: 2.690 [1.461–4.953], P 5 0.001). LVOT-AR > 0.17 corresponds to greater than mild AR as defined by echocardiography and predicts impaired LV reverse remodeling and increased early and midterm mortality after TAVI.

Prevalence, predictors, and prognostic implications of residual impairment of functional capacity after transcatheter aortic valve implantation

Background Patients with degenerative aortic stenosis(AS) referred for transcatheter aortic valve implantation(TAVI) typically have advanced cardiac and vascular adverse remodeling and multiple comorbidities and,therefore, might not recover a normal functional capacity after valve replacement. We sought to investigate the prevalence, the predictors, and the prognostic impact of residual impairment of functional capacity after TAVI. Methods and results Out of 790 patients undergoing TAVI with impaired functional capacity (NYHA II–IV) at baseline, NYHA functional class improved in 592 (86.5%) andremained unchanged/worsened in 92 (13.5%) at follow-up[median (IQR): 419 (208–807) days] after TAVI. Normal functional capacity (NYHA I) was recovered in 65.5%(n = 448) of patients, while the rest had variable degrees of residual impairment. On multivariable regression analysis,atrial fibrillation [odds ratio-OR, 2.08 (1.21–3.58), p = 0.008],low-flow–low-gradient AS [OR, 1.97 (1.09–3.57),p = 0.026], chronic obstructive pulmonary disease [OR, 1.92(1.19–3.12), p = 0.008], and lower hemoglobin at baseline[OR, 1.11 (1.01–1.21) for each g% decrement, p = 0.036]were independently associated with residual impairment offunctional capacity. All-cause and cardiac mortality weresignificantly higher in those with residual impairment of functional capacity than in those in NYHA I class [hazard ratioHR:2.37 (95% CI: 1.51–3.72), p/0.001 and 2.16 (95% CI:1.08–4.35), p = 0.030, respectively]. Even mild residual functional impairment (NYHA II) was associated with a higherall-cause [HR: 2.02 (95% CI: 1.10–3.72), p = 0.023] andcardiac [HR: 2.08 (95% CI: 1.42–3.07), p/0.001] mortality. Conclusion Residual impairment of functional capacity iscommon after TAVI and is independently associated with increased mortality. Predictors of residual impairment of functional status are predominantly patient-rather than procedure-related.

The interaction of de novo and pre-existing aortic regurgitation after TAVI: insights from a new quantitative aortographic technique

AIMS: The aim of this study was to evaluate the intermediate-term clinical impact of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using a novel quantitative angiographic method taking into account the influence of pre-existing AR.METHODS AND RESULTS:AR after TAVI was quantified in 338 patients (age 82 [78-86] years; 55% male) and the influence on intermediate-term all-cause mortality was evaluated. In 228 aortograms, AR was quantitated using a dedicated videodensitometric method focused in the left ventricular outflow tract (LVOT-AR). Patients with LVOT-AR >0.17 had a significantly increased all-cause mortality at three years, compared with patients who had LVOT-AR ≤0.17 (adjusted hazard ratio [HR]: 1.73, 95% confidence interval [CI]: 1.05-2.86, p=0.032). Taking the influence of pre-existing AR into account, patients with post-procedural LVOT-AR >0.17 and ≤mild pre-existing AR had a significantly increased mortality at two years, compared to patients with LVOT-AR >0.17 and >mild pre-existing AR (HR: 2.55, 95% CI: 1.16-5.58, p=0.029). In those with >mild pre-existing AR (n=70), post-TAVI LVOT-AR >0.17 was not associated with increased mortality (HR: 0.77, 95% CI: 0.31-1.91, p=0.578).CONCLUSIONS:AR after TAVI could be quantitated utilising LVOT-AR. The cut-point of >0.17 indicates a significant AR pertaining to increased intermediate-term mortality, especially in those with no significant pre-existing AR...

Transcatheter aortic valve implantation for mixed versus pure stenotic aortic valve disease

In addition to patients with pure/predominant aortic stenosis (PAS), real-world transcatheter aortic valve implantation(TAVI) referrals include patients with mixed aortic valve disease (MAVD; severe stenosis+moderate-severe regurgitation). We sought to compare TAVI outcomes in patients with MAVD vs. PAS. Out of 793 consecutive patients undergoing TAVI, 106 (13.4%) had MAVD. Patients with MAVD were younger and had a higher operative risk, a more severe adverse cardiac remodelling, and a worse functional status than patients with PAS. Moderate-severe prosthetic valve regurgitation (PVR) was significantly more frequent in patients with MAVD than in patients with PAS (15.7% vs. 3.6%, p=0.003), even after propensity-score and multivariable adjustments. Moderate-severe PVR was associated with increased one-year mortality in patients with PAS (log-rank p=0.002), but not in patients with MAVD (log-rank p=0.27). Eventually, all-cause and cardiac mortality as well as the functional capacity were similar in the two study groups up to one year. A significant proportion of patients referred for TAVI in a real-world registry has MAVD. Moderate-severe AR at baseline can influence the rate and modify the clinical sequelae of post-TAVI PVR. Eventually, clinical outcomes in patients with MAVD are comparable to those in patients with PAS in the acute and midterm phases, in spite of a baseline higher risk. MAVD should not be considered a contraindication for TAVI.

Direct transcatheter heart valve implantation versus implantation with balloon predilatation: insights from the brazilian transcatheter aortic valve replacement registry

Background—Direct transcatheter aortic valve replacement (TAVR) is regarded as having potential advantages over TAVRwith balloon aortic valve predilatation (BAVP) in reducing procedural complications, but there are few data to supportthis approach. Methods and Results—Patients included in the Brazilian TAVR registry with CoreValve and Sapien-XT prosthesis were compared according to the implantation technique, with or without BAVP. Clinical and echocardiographic data were analyzed in overall population and after propensity score matching. A total of 761 consecutive patients (BAVP=372;direct-TAVR=389) were included. Direct-TAVR was possible in 99% of patients, whereas device success was similarbetween groups (BAVP=81.2% versus direct-TAVR=78.1%; P=0.3). No differences in clinical outcomes at 30 daysand 1 year were observed, including all-cause mortality (7.6% versus 10%; P=0.25 and 18.1% versus 24.5%; P=0.07,respectively) and stroke (2.8% versus 3.8%; P=0.85 and 5.5% versus 6.8%; P=0.56, respectively). Nonetheless, TAVRwith BAVP was associated with a higher rate of new onset persistent left bundle branch block with the CoreValve (47.7%versus 35.1%; P=0.01 at 1 year). Mean gradient and incidence of moderate/severe aortic regurgitation were similar inboth groups at 1 year (11% versus 13.3%; P=0.57 and 9.8±5.5 versus 8.7±4.3; P=0.09, respectively). After propensityscore matching analysis, all-cause mortality and stroke remained similar. By multivariable analysis, BAVP and the use ofCoreValve were independent predictors of new onset persistent left bundle branch block...

Association between transcatheter aortic valve replacement and subsequent infective endocarditis and in-hospital death

IMPORTANCE: Limited data exist on clinical characteristics and outcomes of patients who had infective endocarditis after undergoing transcatheter aortic valve replacement (TAVR). OBJECTIVE: To determine the associated factors, clinical characteristics, and outcomes of patients who had infective endocarditis after TAVR. DESIGN, SETTING, AND PARTICIPANTS: The Infectious Endocarditis after TAVR International Registry included patients with definite infective endocarditis after TAVR from 47 centers from Europe, North America, and South America between June 2005 and October 2015. EXPOSURE: Transcatheter aortic valve replacement for incidence of infective endocarditis and infective endocarditis for in-hospital mortality. MAIN OUTCOMES AND MEASURES: Infective endocarditis and in-hospital mortality after infective endocarditis. RESULTS: A total of 250 cases of infective endocarditis occurred in 20 006 patients after TAVR (incidence, 1.1% per person-year; 95% CI, 1.1%-1.4%; median age, 80 years; 64% men). Median time from TAVR to infective endocarditis was 5.3 months (interquartile range [IQR], 1.5-13.4 months). The characteristics associated with higher risk of progressing to infective endocarditis after TAVR was younger age (78.9 years vs 81.8 years; hazard ratio [HR], 0.97 per year; 95% CI, 0.94-0.99), male sex (62.0% vs 49.7%; HR, 1.69; 95% CI, 1.13-2.52), diabetes mellitus (41.7% vs 30.0%; HR, 1.52; 95% CI, 1.02-2.29), and moderate to severe aortic regurgitation (22.4% vs 14.7%; HR, 2.05; 95% CI, 1.28-3.28). Health care-associated infective endocarditis was present in 52.8% (95% CI, 46.6%-59.0%) of patients...

Predictors of permanent pacemaker requirement after transcatheter aortic valve implantation: Insights from a Brazilian Registry

Background: The aimof this study is to evaluate the predictors of permanent pacemaker (PPM) implantation afterTAVI.Methods: Between January 2008 and February 2012, 418 patientswith severe aortic stenosis underwent TAVI andwere enrolled in a Brazilian multicenter registry. After excluding patients who died during the procedure andthose with a previous PPM, 353 patients were included in the analysis.Results: At 30 days, the overall incidence of PPM implantation was 25.2%. Patients requiring PPM weremore likelyto be older (82.73 vs. 81.10 years, p = 0.07), have pre-dilation (68.42% vs. 60.07%, p = 0.15), receive CoreValve(93.68% vs. 82.55%, p = 0.008), and have baseline right bundle branch block (RBBB, 25.26% vs. 6.58%, p b 0.001).On multivariable analysis, CoreValve vs. Sapien XT (OR, 4.24; 95% CI, 1.56–11.49; p = 0.005), baseline RBBB (OR,4.41; 95% CI, 2.20–8.82; p b 0.001), and balloon pre-dilatation (OR, 1.75; 95% CI, 1.02–3.02; p = 0.04) were independentpredictors of PPM implantation.Conclusion: PPM implantation occurred in approximately one-fourth of cases. Pre-existing RBBB, balloon predilatation,and CoreValve use were independent predictors of PPM after TAVI. The type of prosthesis used andpre-balloon dilatation should be considered in TAVI candidates with baseline RBBB.

Stents farmacológicos libertadores de everolimus Xience TM V no tratamento de pacientes com lesões coronárias complexas na prática diária: resultados iniciais do Registro Brasileiro BRAVO / Xience TM V everolimus-eluting stents in the treatment of patients with complex coronary lesions in the daily clinical practice: early results of the Brazilian Registry BRAVO

Introdução: A eficácia e a segurança do stent farmacológico (SF) de segunda geração liberador de everolimus XienceTM V (Abbott Vascular, Santa Clara, Estados Unidos) já foram estabelecidas no tratamento de pacientes selecionados com lesões coronárias. No entanto, o impacto do stent Xience TM V em população da prática clínica com lesóes complexas ainda não está totalmente definido. Métodos: O Registro BRAVO foi um estudo prospectivo, não-randomizado, multicêntrico, que avaliou os resultados clínicos tardios de pacientes minimamente selecionados tratados com o SF Xience TM V na prática diária brasileira. No total, foram incluídos 535 pacientes em 25 centros clínicos entre setembro de 2008 e setembro de 2010. Eventos cardíacos adversos maiores (ECAM) foram definidos como morte cardíaca, infarto agudo do miocárdio (IAM) e revascularização do vaso-alvo (RVA). Resultados: A média de idade dos pacientes era de 62,7 + - 11,1 anos 40 dos quais tinham diabetes, 24,9 apresentavam IAM prévio e 41,9 apresentaram-se com síndrome coronária aguda. Cerca de dois terços dos pacientes tinham lesões tipo B2/C e 46,1 trataram a artéria descendente anterior. Implante de múltiplos stents ocorreu em 13,8 dos casos, e o sucesso angiográfico foi > 99. Na fase intra-hospitalar, a taxa de IAM periprocedimento foi de 1,9. Já no seguimento de 6 meses, as taxas cumulativas de óbito cardíaco, IAM e RVA foram de 1,1, 2,2 e 1,3, respectivamente)taxa de ECAM de 4,3). Com relação à trombose de stent (definida de acordo com os critérios do Academic Research Consortium - ARC), foram reportados 4 casos até 6 meses...

Valvoplastia mitral percutânea em paciente gestante guiada apenas pelo ecocardiograma transesofágico / Percutaneous mitral valvuloplastry in a pregnant woman guided only by the transesophageal echocardiography

A estenose da válvula mitral é a lesão de válvula mais comum durante a gravidez. Apesar de um tratamento clínico eficaz e de uma anatomia valvular favorável, de acordo com o critério de Wilkins e Block [score de Wilkins-Block], a intervenção percutânea em pacientes sintomáticas mostra-se muito importante. Nessas pacientes, recomenda-se evitar ao máximo a exposição aos raios X para proteger o feto dos efeitos deletérios da radiação ionizante. Neste relato de caso, uma paciente de 24 anos, grávida, com grave estenose mitral (área valvular de 0,9 cm²), foi submetida com sucesso a um tratamento percutâneo com ETE-guiado, sem o uso de raios X.

Mitral valve stenosis is the most common valve lesion in pregnancy. In spite of an optimized clinical treatment and a favorable valve anatomy according to Wilkins and Block score, in symptomatic patients, percutaneous intervention is shown to be of great importance. In these patients, avoiding x-ray exposure as much as possible is recommended so as to protect the fetus from the deleterious effects of ionizing radiation. In this case report, a 24-year old pregnant patient with severe mitral stenosis (valve area of 0.9 cm²) was successfully submitted to a TEE-guided percutaneous treatment, without the use of x-ray.

Consenso de especialistas (SBC/SBHCI) sobre o uso de stents farmacológicos: recomendações da sociedade brasileira de cardiologia/sociedade brasileira de hemodinâmica e cardiologia intervencionista ao sistema único de saúde / Expert consensus (SBC/SBHCI) on the use of drug-eluting stents: recommendations of the Brazilian society of interventional cardiology/ Brazilian society of cardiology for the Brazilian public single healthcare system / Expert consensus (SBC/SBHCI) on the use of drug-eluting stents: recommendations of the Brazilian society of interventional cardiology/ Brazilian society of cardiology for the Brazilian public single healthcare system

Os autores revisam a evolução da intervenção coronariana percutânea, a sua crescente aplicação na revascularização miocárdica de pacientes portadores de doença arterial coronariana, seja no Brasil, seja no âmbito mundial. Desde a introdução do método, em 1977, com a utilização isolada do cateter-balão, a constatação de que o mesmo tinha limitações (oclusão aguda e reestenose), a adoção dos stents coronarianos e, mais recentemente, o advento dos stents farmacológicos, idealizados para reduzir ainda mais as taxas de reestenose, possibilitaram o crescimento exponencial da aplicação da intervenção coronariana percutânea (ICP) no Brasil, superando a cirurgia de revascularização e tornando-se o tratamento majoritário para enfermos sintomáticos, acometidos de aterosclerose obstrutiva coronariana. Esta preferência se salienta, a partir do ano 2000, após o início do reembolso dos stents pelo Sistema de Unico de Saúde Brasileiro. Este fato demonstra a importância do Sistema Público de Saúde, quando este incorpora os avanços médicos, e passa a oferecer bons padrões de tratamento cardiovascular a grande número de brasileiros. Destaca-se a complexidade da profilaxia da reestenose intra-stent, por sua ocorrência imprevisível e ubíqua. O controle deste fenômeno melhora a qualidade de vida, reduzindo o retorno da angina do peito, a realização de novos procedimentos de revascularização e a re-internação hospitalar. Os stents farmacológicos lograram êxito sólido e consistente na conquista deste objetivo de forma abrangente, beneficiando todas as apresentações clínicas e angiográficas, em maior ou menor grau. Sua adoção e critérios para sua utilização em outros países são discutidos, assim como a formalização das indicações preconizadas pela Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista, para o seu reembolso pelo SUS. A incorporação de novas tecnologias em saúde é um processo que compreende duas etapas distintas: na primeira, o registro do produto é efetivado na Agência Nacional de Vigilância Sanitária (ANVISA)...

The authors review percutaneous coronary intervention (PCI) evolution and its growing application in myocardial revascularization for patients with coronary heart disease in Brazil and worldwide. PCI was introduced in 1977 using only the catheter balloon. Limitations of this method (acute occlusion and coronary restenosis) led to the adoption of coronary stents and more recently the advent of drug-eluting stents², which were developed to drastically reduce restenosis rates. These developments allowed the exponential growth of percutaneous coronary intervention (PCI) procedures in Brazil which have replaced many bypass surgery procedures and have become the gold standard for the majority of symptomatic patients suffering from coronary artery disease. The preference for this procedure gained new dimensions in 2000 when the Brazilian Public Healthcare System (SUS) began reimbursing for stent procedures. This measure exemplified the importance of the Public Healthcare System's participation in incorporating medical advances and offering a high standard of cardiovascular treatment to a large portion of the Brazilian population. It is emphasized that prevention of in-stent restenosis is complex due to its unpredictable and ubiquitous occurrence. Control of this condition improves quality of life and reduces the recurrence of angina pectoris, the need to perform new revascularization procedures and hospital readmissions. The overall success of the drug-eluting stents has proven to be reliable and consistent in overcoming restenosis and has some beneficial impact for all clinical and angiographic conditions. This paper discusses the adoption and criteria for the use of drug-eluting stents in other countries as well as the recommendations established by the Brazilian Society of Interventional Cardiology for their reimbursement by SUS. The incorporation of new healthcare technology involves two distinct stages. During the first stage, the product is registered with the National Health Surveillance Agency (ANVISA)...

Influência do diabete melito nos resultados imediatos do implante de stent coronário: uma análise dos dados da Central Nacional de Intervenções Cardiovasculares (CENIC) / Influence of Diabetes Mellitus on immediate results of coronary stent: National Center for Cardiovascular Interventions (CENIC) data analysis

OBJETIVO: Avaliar a influência do diabete melito (DM) nos resultados imediatos do implante de stent coronário (SC), de acordo com o quadro clínico de apresentação. MÉTODOS: Entre janeiro/1997 e dezembro/2003, segundo a Central Nacional de Intervenções Cardiovasculares (CENIC), 11.874 pacientes diabéticos foram submetidos a implante de SC: 7.386 (62,3 por cento) com insuficiência coronária crônica (ICO), 3.142 (26,4 por cento), em síndrome isquêmica instável sem elevação ST (SIASEST) e 1.346 (11,3 por cento), com infarto agudo do miocárdio (IAM) com supradesnivelamento de ST. Estes grupos foram comparados com 48.103 não-diabéticos: 30.980 (64,5 por cento) com ICO, 10.938 (22,7 por cento) em SIASEST e 6.185 (12,8 por cento) com IAM. RESULTADOS: Os diabéticos apresentaram características clínicas e angiográficas de maior risco. Os diabéticos com ICO apresentaram taxa de eventos adversos semelhantes aos não-diabéticos (0,98 por cento x 0,91 por cento, p=0,5971), porém, os diabéticos em SIASEST e IAM apresentaram maior incidência de eventos: 2,76 por cento x 1,46 por cento (p<0,0001) e 7,87 por cento x 4,1 por cento (p<0,0001), respectivamente. A análise multivariada mostrou o DM como preditor independente de risco para eventos adversos maiores na SIASEST (OR: 1,92 IC: 1,46-2,52 p<0,0001) e no IAM (OR: 2,0 IC: 1,57-2,54 p<=0,0001) e não na ICO (OR: 1,08 IC: 0,83-1,42 p=0,5470). CONCLUSÃO: Os pacientes diabéticos portadores de ICO apresentaram evolução hospitalar semelhante aos não diabéticos, porém, os com SIASEST e IAM demonstraram maior taxa de eventos cardíacos adversos comparados com a população não-diabética.

Artéria coronária única submetida a angioplastia com implante de Stent / Single coronary artery: angioplasty with stent implantation

Relatamos caso de rara anomalia de artéria coronária direita saindo do terço médio da artéria descendente anterior com lesão obstrutiva ateromatosa proximal, imediatamente antes da emergência da coronária direita. O paciente foi submetido a angioplastia com implante de Stent na descendente anterior com sucesso. Há relatos de apenas 7 casos desta anomalia de distribuição na literatura, porém nenhum com tratamento de revascularização percutânea.

Resultados imediatos e seguimento de pacientes uniarteriais versus multiarteriais com idade inferior a 50 anos submetidos a implante de stent coronariano / Comparison of immediate results and follow-up of patients with single-vessel and multivessel coronary artery disease younger than 50 years of age undergoing coronary stent implantation

OBJECTIVE: To assess the in-hospital results and clinical follow-up of young patients (< 50 years) with multivessel coronary artery disease undergoing stent implantation in native coronary arteries and to compare their results with those of patients with single-vessel coronary artery disease. METHODS: We retrospectively studied 462 patients undergoing coronary stent implantation. Patients were divided into 2 groups: group I (G-I) - 388 (84 percent) patients with single-vessel coronary artery disease; and group II (G-II) - 74 (16 percent) patients with multivessel coronary artery disease. RESULTS: The mean age of the patients was 45±4.9 years, and the clinical findings at presentation and demographic data were similar in both groups. The rate of clinical success was 95 percent in G-I and 95.8 percent in G-II (P=0.96), with no difference in regard to in-hospital evolution between the groups. Death, acute myocardial infarction, and the need for myocardial revascularization during clinical follow-up occurred in 10.1 percent and 11.2 percent (P=0.92) in G-I and G-II, respectively. By the end of 24 months, the actuarial analysis showed an event-free survival of 84.6 percent in G-I and 81.1 percent in G-II (P=0.57). CONCLUSION: Percutaneous treatment with coronary stent implantation in young patients with multivessel disease may be safe with a high rate of clinical success, a low incidence of in-hospital complications, and a favorable evolution in clinical follow-up