TAVI com próteses balão-expansíveis de nova geração versus auto-expansíveis de nova geração: análise do registro brasileiro de TAVI - RIBAC-NT / TAVI with new generation balloon-expandable prostheses versus new generation self-expandable prostheses: analysis of the Brazilian TAVI registry - RIBAC-NT

INTRODUÇÃO: Não existem estudos comparando os desfechos clínicos do implante de válvula aórtica transcateter (TAVI) com próteses balão-expansíveis (BE) versus auto-expansíveis (AE) de nova geração na realidade brasileira. OBJETIVO: Comparar os resultados clínicos intra-hospitalares de TAVI realizados com próteses BE de nova geração contra próteses AE de nova geração em centros brasileiros participantes do RIBAC-NT. MÉTODOS: Foram utilizados dados de centros ativamente participantes do registro brasileiro de TAVI. Critério de inclusão: todos os procedimentos de TAVI em válvula nativa tricúspide com utilização de próteses de nova geração. Critério de exclusão principal: procedimentos pela via transapical. Os casos foram separados conforme a prótese utilizada em grupo BE (Sapien S3, S3 Ultra e Myval) e AE (Evolut R, Evolut PRO, Acurate Neo, Acurate Neo2 e Portico). Desfecho primário analisado foi morte intra-hospitalar. Desfechos secundários: complicação vascular maior, sangramento maior, sangramento com risco de vida, qualquer acidente vascular encefálico (AVE) e novo implante de marcapasso. RESULTADOS: Ao todo 1703 pacientes de 25 centros foram incluídos na análise, sendo 887 no grupo BE e 819 no grupo AE. A idade média da população foi 80,7±7,2 anos e 48,9% eram mulheres. O grupo AE teve uma maior proporção de pacientes do sexo feminino (53,5% vs. 44,6%, P=<0,001), maior prevalência de doença arterial periférica (16,2% vs. 11%, P=0,002) e de doença pulmonar obstrutiva crônica (16,8% vs. 11,5%, P=0,002), além de Euroscore 2 maior (6,2 vs. 5,5, P=0,03). Tabela 1 estão demonstradas a comparação das características do procedimento entre os grupos. Pacientes do grupo BE realizaram mais procedimentos com anestesia geral, mais por via transfemoral e também com maior proporção de acessos totalmente percutâneos. No grupo AE houve maior necessidade de pré e pós-dilatação e discreta maior incidência de embolização e necessidade de uma segunda prótese, assim como maior incidência de oclusão coronariana. Tabela 2 sumariza o comparativo dos desfechos clínicos. Não houve diferença significativa para a mortalidade intra-hospitalar entre os grupos. Também não se observou diferença entre complicações vasculares, sangramentos, AVE e necessidade de novo marcapasso. Regressão logístico multivariada ajustando para diferenças entre os grupos não indicou diferença de mortalidade entre utilização de prótese BE vs. AE (OR 0,95, P=0,8). Preditores independentes de mortalidade foram sexo feminino (OR 0,49, P=0,009) e Euroscore 2 (OR 1,04, P=0,006). CONCLUSÃO: Em estudo de vida real de pacientes submetidos a TAVI no Brasil, não houve diferença da mortalidade intra-hospitalar entra a utilização de próteses BE de nova geração em comparação a utilização de próteses AE de nova geração.

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

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.

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.

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.

Estreia da terapia de reparo transcateter edge-to-edge nas valvas tricúspide e mitral em um único procedimento na América Latina: relato de caso / First performance of transcatheter edge-to-edge mitral and tricuspid valve repair in a single procedure in Latin America: case report

Apresentamos o caso debutante na América Latina de reparos transcateteres edge- to-edge nas valvas mitral e tricúspide em um único procedimento em paciente de alto risco para cirurgia. A paciente evoluía com insuficiência cardíaca e limitações em suas atividades diárias quando foi submetida ao procedimento, no qual foram realizados os reparos transcateteres das valvas mitral e tricúspide. Aos 6 meses de evolução, estava assintomática e realizando suas atividades diárias. Debatemos as recomendações mais atualizadas sobre a terapia transcateter para coexistência dessas doenças valvares, assim como expomos as lacunas no conhecimento.

We present the first case in Latin America of transcatheter edge-to-edge mitral and tricuspid valve repair in a single procedure, in a patient at high risk for surgery. The patient progressed to heart failure and limitation in her daily living activities when she was submitted to transcatheter mitral and tricuspid valve repair. Six months later, she was asymptomatic and performing her daily living activities. We discuss the most updated recommendations for transcatheter repair when both valvar conditions coexist, and show the knowledge gaps.

Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self-Expanding Valves During Transcatheter Aortic Valve Replacement.

Background No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self-expanding valves. Methods and Results This study included a real-world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1-year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1-year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). Conclusions Repositioning a self-expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1-year mortality, regardless of the type of valve implanted.

Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis Outside Randomized Trials.

BACKGROUND: Recent randomized trials including low-risk patients showed positive results for transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR), but patients with non-tricuspid aortic valve (NTAV), severe coronary artery disease (SevCAD), and those requiring concomitant mitral/tricuspid valve (CMTV) or concomitant ascending aorta replacement (CAAR) interventions were excluded. OBJECTIVES: This study sought to evaluate the presence and impact of the main clinical variables not evaluated in TAVR versus SAVR trials (NTAV, SevCAD, and CMTV or CAAR intervention) in a large series of consecutive low-risk patients with severe aortic stenosis (SAS) undergoing SAVR. METHODS: Single-center study including consecutive patients with SAS and low surgical risk (Society of Thoracic Surgeons score of <4%) undergoing SAVR. Baseline, procedural characteristics, and 30-day outcomes were prospectively collected. RESULTS: Of 6,772 patients with SAS who underwent SAVR between 2000 and 2019, 5,310 (78.4%) exhibited a low surgical risk (mean Society of Thoracic Surgeons score: 1.94 ± 0.87%). Of these, 2,165 patients (40.8%) had at least 1 of the following: NTAV (n = 1,468, 27.6%), SevCAD (n = 307, 5.8%), CMTV (n = 306, 5.8%), and CAAR (n = 560, 10.5%). The 30-day mortality and stroke rates for the overall low-risk SAS cohort were 1.9% and 2.4%, respectively. The mortality rate was similar in the SevCAD (2.6%) and CAAR (2.1%) groups versus the rest of the cohort (odds ratio [OR]: 1.79; 95% confidence interval [CI]: 0.85 to 3.75, and OR: 1.64; 95% CI: 0.88 to 3.05, respectively), lower in the NTAV group (0.9%; OR: 0.42; 95% CI: 0.22 to 0.81), and higher in the CMTV group (5.9%; OR: 2.61; 95% CI: 1.51 to 4.5). CONCLUSIONS: In a real-world setting, close to one-half of the low-risk patients with SAS undergoing SAVR exhibited at least 1 major criterion not evaluated in TAVR versus SAVR randomized trials. Clinical outcomes were better than or similar to those predicted by surgical scores in all groups but those patients requiring CMTV intervention. These results may help determine the impact of implementing the results of TAVR-SAVR trials in real practice and may inform future trials in specific groups.

Similarities and Differences Between Primary Percutaneous Coronary Intervention and Mechanical Thrombectomy.

Acute ischemic stroke is among the leading causes of mortality and disability worldwide. Since 2015, as was the case for primary percutaneous coronary intervention for acute myocardial infarction, catheter-based reperfusion via mechanical thrombectomy (MT) has become the gold-standard treatment for acute ischemic stroke caused by large-vessel occlusion. Despite that, only a fraction of the world's population currently would be able to undergo MT in time, mostly because of the scarcity of 24/7 coverage by neurointerventionalists to deal with this enormous burden. Interventional cardiologists have thus been considered a logical option to aid in combating this vast demand to diminish the burden of acute ischemic stroke. However, despite some seemingly evident similarities between primary percutaneous coronary intervention and MT, for interventional cardiologists to enter this new field, they must be well trained and fully aware of all the clinical, technical, and environmental differences between these two scenarios. The main objective of this state-of-the-art paper is to serve as an introductory and comprehensive guide to familiarize the interventional cardiology community with the most critical technical aspects of MT.

Valve-in-Valve Challenges: How to Avoid Coronary Obstruction.

Coronary obstruction is a rare but life-threatening complication in patients undergoing transcatheter aortic valve replacement (TAVR). Aortic valve-in-valve (VIV) procedures to treat failed surgical bioprosthesis is associated with ~6-fold higher risk for coronary obstruction in certain situations. The primary mechanism consists in the occlusion of the coronary ostium by the dislodged leaflet from the bioprosthesis after deployment of the transcatheter heart valve (THV), which most commonly occurs during the index procedure, but in up to 1/3 of cases a delayed presentation ensues. The clinical presentation consists of severe hypotension and ECG changes in most of the patients, with very high mortality rates. Therefore, pre-procedural multi-slice computed tomography is crucial for identifying high-risk features, such as low coronary heights, shallow sinuses of Valsalva, and short virtual THV to coronary ostial distance (VTC). Also, some models of surgical bioprosthesis present an increased risk for this dreadful complication. Preemptive protective strategies with coronary wiring, with or without placement of an undeployed stent, could mitigate the risks associated with this complication in high-risk patients, even though studies are lacking. This review aims to take a clinical perspective on the challenges in avoiding this complication during VIV procedures.

Potential of transcatheter aortic valve replacement to improve post-procedure renal function.

BACKGROUND: Baseline comorbidities including renal dysfunction are frequently found in patients treated with transcatheter aortic valve replacement (TAVR) and may increase the risks of acute kidney injury (AKI), although some of them may actually improve renal function. We aimed to evaluate the potential of TAVR to acutely improve post-procedure renal function. METHODS: This is a prospective single-center registry of consecutive patients with severe symptomatic aortic stenosis treated by transfemoral TAVR. Creatinine levels were determined at baseline and daily until hospital discharge. AKI was defined according to VARC-2 criteria. Patients who had improvement of creatinine levels >25% were classified as having TAVR induced renal function improvement (TIRFI). RESULTS: A total of 69 patients undergoing TAVR were included, with a mean age of 83.0±7.4 years, being 24.6% diabetics, with a median STS score of 9.2 (5.1-21.6). Using the VARC-2 criteria, the majority of patients (64.6%) did not have renal impairment, while AKI was detected in 35.4% of the patients. Importantly, in those with prior severe renal dysfunction (clearance <30mL/min/1.73m2) or diabetes, AKI reached up to 50% and 56.3% of the patients, respectively. Conversely, acute kidney recovery (TIRFI) occurred in 12 patients (18.5%) being >50% in 1 patient (1.5%), and at hospital discharge the majority of the patients (88.6%) left the hospital in their original or better renal function categories. CONCLUSION: Despite multiple comorbidities in a selected TAVR-population and the use of contrast media, TAVR did not impair renal function in a majority of patients, with a significant proportion of them rather having acute renal function improvement.

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 TAVR with balloon aortic valve predilatation (BAVP) in reducing procedural complications, but there are few data to support this 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 similar between groups (BAVP=81.2% versus direct-TAVR=78.1%; P=0.3). No differences in clinical outcomes at 30 days and 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, TAVR with 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 in both 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 propensity score matching analysis, all-cause mortality and stroke remained similar. By multivariable analysis, BAVP and the use of CoreValve were independent predictors of new onset persistent left bundle branch block. CONCLUSIONS: The 2 TAVR strategies, with or without BAVP, provided similar clinical and echocardiographic outcomes over a midterm follow-up although BAVP was associated with a higher rate of new onset persistent left bundle branch block, particularly in patients receiving a CoreValve.

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...

Does Ad Hoc Coronary Intervention Reduce Radiation Exposure? – Analysis of 568 Patients / Intervenção Coronariana Ad Hoc Reduz a Exposição Radiológica? - Análise em 568 Pacientes

Background:Advantages and disadvantages of ad hoc percutaneous coronary intervention have been described. However little is known about the radiation exposure of that procedure as compared with the staged intervention.Objective:To compare the radiation dose of the ad hoc percutaneous coronary intervention with that of the staged procedureMethods:The dose-area product and total Kerma were measured, and the doses of the diagnostic and therapeutic procedures were added. In addition, total fluoroscopic time and number of acquisitions were evaluated.Results:A total of 568 consecutive patients were treated with ad hoc percutaneous coronary intervention (n = 320) or staged percutaneous coronary intervention (n = 248). On admission, the ad hoc group had less hypertension (74.1% vs 81.9%; p = 0.035), dyslipidemia (57.8% vs. 67.7%; p = 0.02) and three-vessel disease (38.8% vs. 50.4%; p = 0.015). The ad hoc group was exposed to significantly lower radiation doses, even after baseline characteristic adjustment between both groups. The ad hoc group was exposed to a total dose-area product of 119.7 ± 70.7 Gycm2, while the staged group, to 139.2 ± 75.3 Gycm2 (p < 0.001).Conclusion:Ad hoc percutaneous coronary intervention reduced radiation exposure as compared with diagnostic and therapeutic procedures performed at two separate times.

Fundamento:Uma série de vantagens e desvantagens tem sido descrita para a intervenção coronária percutânea ad hoc, como a realizada ao mesmo tempo que o cateterismo diagnóstico, porém pouco se sabe sobre a exposição radiológica desse procedimento, comparado com a intervenção estadiada, ou seja, em dois momentos.Objetivo:Comparar a dose de radiação utilizada na angioplastia ad hoc com a angioplastia estadiada.Métodos:O produto de dose por área e o Kerma total foram mensurados, somando-se ambas as fases de diagnóstico e terapêutica. Além disso, foram computados o tempo total de fluoroscopia e o número de filmagens.Resultados:Um total de 568 pacientes consecutivos foram tratados com intervenção coronária percutânea ad hoc (n = 320) ou estadiada (n = 248). À admissão, o grupo do ad hoc apresentava menos hipertensão (74,1% vs. 81,9%; p = 0,035), dislipidemia (57,8% vs. 67,7%; p = 0,02) e doença triarterial (38,8% vs. 50,4%; p = 0,015). O grupo ad hoc foi exposto a doses significativamente menores de radiação, mesmo após ajuste para as diferenças basais entre os grupos. O grupo ad hoc foi exposto a uma dose de produto de dose por área total de 119,7 ± 70,7 Gycm2 enquanto que os pacientes estadiados foram expostos a uma dose de 139,2 ± 75,3 Gycm2 (p < 0,001).Conclusão:A intervenção coronária percutânea ad hoc reduziu a exposição radiológica, em comparação com procedimentos diagnósticos e terapêuticos realizados em tempos separados.

Utilização minimizada de contraste na intervenção coronária percutaânea guiada pelo ultrassom intravascular. Seguimento de 1 ano do estudo randomizado MOZART / Minimized contrast use with intravascular ultrasound­guidance percutaneous coronary intervention. One­year follow­up of the MOZART randomized study

Introdução:Recentemente, o estudo MOZART demonstrou que a utilização do ultrassom intracoronário (USIC) para guiar a intervenção coronariana percutânea (ICP) diminui o volume de contraste utilizado no procedimento. Avaliamos a incidência de eventos adversos cardiovasculares tardios desses pacientes. Métodos: Pacientes com risco para nefropatia induzida por contraste (NIC) ou para sobrecarga de volume, e com indicação de ICP, foram randomizados para procedimento guiado pela angiografia ou USIC, e acompanhados por um período de 1 ano. Resultados: Incluídos 83 pacientes nos grupos ICP guiado por angiografia (n = 42) ou USIC (n = 41), sendo que 77,1% eram diabéticos e 44,6% tinham clearance de creatinina < 60mL/min/1,73m2. As características clínicas e angiográficas não mostraram diferenças entre os grupos. A maioria tinha lesões tipo B2/C (89,8%) e uma mediana de dois stents foram usados (intervalo interquartil: 1,0­2,0 stents). O tempo de procedimento da ICP guiada por USIC foi 14 minutos maior do que no grupo guiado por angiografia (p = 0,006). No entanto, os grupos não diferiram em relação ao tempo de fluoroscopia ou à média de aquisições de imagem por procedimento. A NIC ocorreu em 19,0% vs. 7,3% (p = 0,26). No período de seguimento de 1 ano, 12% dos pacientes apresentaram algum evento cardiovascular maior, sendo dois óbitos (um para cada grupo), e não houve diferenças entre os grupos. Conclusões: A estratégia de redução de contraste com a ICP guiada pelo ultrassom intravascular, em pacientes com risco para NIC ou sobrecarga de volume, mostrou­se segura a curto e longo prazos.

Background: Recently, the MOZART study demonstrated that using intravascular ultrasound (IVUS) for guiding percutaneous coronary intervention (PCI) reduces the volume of contrast used in the procedure. The authors assessed the incidence of late adverse cardiovascular events in these patients. Methods: Patients at risk for contrast­induced nephropathy (CIN) or volume overload were randomized to angiography­guided versus IVUS­guided PCI, and followed­up for a 1­year period. Results: Eighty­three patients were included in the angiography­guided (n = 42) or IVUS­guided (n = 41) groups, of whom 77.1% were diabetics and 44.6% had creatinine clearance < 60mL/min/1.73m2. Clinical and angiographic characteristics did not differ between the groups. Most had type B2/C lesions (89.8%) and a median of two stents were used (interquartile range: 1.0­2.0 stents). The duration of IVUS­guided PCI was 14minutes longer than the angiography­guided PCI group (p = 0.006). However, the groups did not differ regarding fluoroscopy time or mean image acquisitions per procedure. CIN occurred in 19.0% vs. 7.3% (p = 0.26). During the 1­year follow­up, 12% of patients had a major cardiovascular event, with two deaths (one in each group), and no differences were found between groups. Conclusions: The contrast reduction strategy with IVUS­guided PCI in patients at risk for CIN or volume overload was shown to be safe in the short and long term

Implante percutâneo de prótese valvar aórtica ­ experiência com o dispositivo reposicionável LotusTM / Percutaneous aortic valve implantation ­ an experience with the LotusTM repositionable device

Introdução: A válvula aórtica transcateter de segunda geração LotusTM foi desenhada para proporcionar ao intervencionista o controle completo de sua liberação durante o procedimento. O presente estudo apresenta a experiência inicial e os desfechos hospitalares de pacientes tratados com essa prótese no Brasil. Métodos: Registro observacional, retrospectivo, que incluiu pacientes com estenose aórtica grave sintomáticos, considerados de alto risco cirúrgico, tratados em sete centros.Resultados: Receberam o dispositivo 31 pacientes, sendo 61,3% do sexo feminino, com idade de 82,9 ± 6,9 anos e escore STS de 6,5 ± 4,1%. A área valvar aórtica foi de 0,73 ± 0,18 cm2 e o gradiente médio de 51,7 ± 13,9 mmHg. Todos os procedimentos foram realizados pela via transfemoral, e a pré-dilatação foi necessária em 65% dos casos. A taxa de sucesso do procedimento foi de 96,7%. Não houve complicação vascular com necessidade de intervenção cirúrgica e nem casos de acidente vascular cerebral. O gradiente médio após o procedimento foi de 10,5 ± 5,8 mmHg e não foram observadas regurgitações aórticas de graus moderado/importante. A taxa de implante de marca-passo definitivo foi de 38,7%, e a permanência hospitalar de 8,5 ± 4,8 dias. Conclusões: Na experiência inicial com o implante da válvula aórtica LotusTM, os resultados hospitalares demostraram a segurança e a eficácia do dispositivo, além de ausência de regurgitação aórtica relevante

Background: The second-generation LotusTM transcatheter aortic valve was designed to provide the interventional cardiologist with complete control of its release during the procedure. This study presents the initial experience and in-hospital outcomes of patients treated with this prosthesis in Brazil. Methods: This observational and retrospective study included patients with symptomatic severe aortic stenosis considered at high surgical risk, treated in seven centers. Results: The device was used in 31 patients, 61.3% female, aged 82.9 ± 6.9 years, and with STS score of 6.5 ± 4.1%. The aortic valve area was 0.73 ± 0.18 cm2 and the mean gradient was 51.7 ± 13.9 mmHg. All procedures were performed by the transfemoral access route, and pre-dilation was necessary in 65% of cases. The success rate of the procedure was 96.7%. There were no vascular complications requiring surgical intervention nor cases of stroke. The mean gradient after the procedure was 10.5 ± 5.8 mmHg; no cases of moderate to severe aortic regurgitation were observed. The rate of permanent pacemaker implantation was 38.7%, and mean in-hospital length of stay was 8.5 ± 4.8 days. Conclusions: In the initial experience with the use of the LotusTM aortic valve, in-hospital results demonstrated the safety and efficacy of the device; no cases of significant aortic regurgitation were observed

Does Ad Hoc Coronary Intervention Reduce Radiation Exposure? - Analysis of 568 Patients.

BACKGROUND: Advantages and disadvantages of ad hoc percutaneous coronary intervention have been described. However little is known about the radiation exposure of that procedure as compared with the staged intervention. OBJECTIVE: To compare the radiation dose of the ad hoc percutaneous coronary intervention with that of the staged procedureMethods:The dose-area product and total Kerma were measured, and the doses of the diagnostic and therapeutic procedures were added. In addition, total fluoroscopic time and number of acquisitions were evaluated. RESULTS: A total of 568 consecutive patients were treated with ad hoc percutaneous coronary intervention (n = 320) or staged percutaneous coronary intervention (n = 248). On admission, the ad hoc group had less hypertension (74.1% vs 81.9%; p = 0.035), dyslipidemia (57.8% vs. 67.7%; p = 0.02) and three-vessel disease (38.8% vs. 50.4%; p = 0.015). The ad hoc group was exposed to significantly lower radiation doses, even after baseline characteristic adjustment between both groups. The ad hoc group was exposed to a total dose-area product of 119.7 ± 70.7 Gycm2, while the staged group, to 139.2 ± 75.3 Gycm2 (p < 0.001). CONCLUSION: Ad hoc percutaneous coronary intervention reduced radiation exposure as compared with diagnostic and therapeutic procedures performed at two separate times.

Surgical cutdown versus percutaneous access in transfemoral transcatheter aortic valve implantation: Insights from the Brazilian TAVI registry.

OBJECTIVE: To compare the 1-year outcomes of complete percutaneous approach versus surgical vascular approach for transfemoral transcatheter aortic valve implantation (TAVI), among "real-world" patients from the multi-center Brazilian TAVI registry. BACKGROUND: Vascular access still remains a major challenge for TAVI via transfemoral approach. Vascular access through complete percutaneous approaches or through open surgical vascular techniques seems to be acutely similar. However, the long-term outcomes of both techniques remain poorly described. METHODS: The study population comprised all patients treated via transfemoral route in the Brazilian TAVI registry, a "real-world", nation-based, multi-center study. Patients were divided according to the initial vascular access approach (percutaneous vs. surgical) and clinically followed-up for 1 year. The primary endpoint was the incidence of combined adverse events all-cause mortality, life-threatening bleeding, and/or major vascular complication at 1 year. RESULTS: A total of 402 patients from 18 centers comprised the study population (percutaneous approach in 182 patients; surgical cutdown approach 220 patients). The incidence of combined adverse events was not different in the percutaneous and the surgical groups at 30 days (17.6% vs. 16.3%; P = 0.8) and at 1 year (primary endpoint) (30.9% vs. 28.8%; P = 0.8). Also, the study groups overall were comparable regarding the incidence of each individual safety adverse events at 30 days and at 1 year. CONCLUSION: Total percutaneous techniques or surgical cutdown and closure may provide similar safety and effectiveness during the first year of follow-up in patients undergoing transfemoral TAVI.

Denervação simpática renal percutânea / Percutaneous sympathetic renal denervation

A hipertensão arterial sistêmica (HAS) é uma doença de alta prevalência e está comprovadamente relacionada a maior risco de eventos cardiovasculares. Apesar dos grandes avanços no tratamento farmacológico, uma parcela considerável dos pacientes não obtém um controle efetivo da doença, a despeito do uso de múltiplos fármacos e em doses elevadas. A denervação simpática renal percutânea (DSRP) tem se mostrado uma terapia promissora, com elevada segurança e eficácia em estudos preliminares em pacientes com HAS resistente. O papel do sistema nervoso simpático na fisiopatologia da HAS é bem conhecido e constitui o racional para a ablação das fibras simpáticas, por meio da aplicação de radiofrequência por via transluminal nas artérias renais. Nos últimos anos, resultados provenientes de algumas séries de casos, estudos não controlados e um estudo randomizado multicêntrico, com número limitado de pacientes, mostraram queda significativa dos níveis tensionais em curto e médio prazos. Esta revisão teve por objetivo reunir as evidências do uso da DSRP no controle da HAS resistente de maneira crítica, assim como descrever aspectos técnicos do procedimento e perspectivas.

Arterial hypertension is a highly prevalent disease and is associated with increased cardiovascular risk. Despite great advances in drug therapy, a considerable number of patients do not have an effective control of the disease, despite the use of multiple drugs, usually in high doses. Renal sympathetic denervation (RSD) has proved to be a promising therapy, with high safety and efficacy in preliminary studies in patients with resistant hypertension. The role of sympathetic nervous system in the physiopathology of hypertension is well known and is the rationale for the ablation of sympathetic fibers by transluminal delivery of radiofrequency in the renal arteries. In the last few years, results from case series, non-controlled studies and one multicenter randomized trial with a limited number of patients have shown a significant decrease in short and mid-term blood pressure levels. The objective of this review was to gather evidence on the use of RSD in the control of resistant hypertension and describe technical aspects and perspectives of the procedure.