Safety and effectiveness of introducing a robotic-assisted percutaneous coronary intervention program in a tertiary center: a prospective study.

Background: Robotic-assisted percutaneous coronary intervention (PCI) is a novel technology that permits remote operation of interventional devices. However, little is known about the safety and effectiveness of introducing a robotic PCI program in a hospital already experienced in traditional coronary angioplasty. Methods: Prospective single-arm survey to assess the safety and effectiveness of robotic-assisted PCI in comparison to pre-defined performance goals. The study cohort comprised all consecutive cases treated with robotic PCI since its introduction. The safety primary endpoint was a composite of (I) overall death or (II) non-fatal adverse events related to target vessel complications (stent thrombosis, myocardial infarction, vessel perforation or cardiac tamponade, or repeat invasive treatment) during the index hospitalization. The efficacy primary endpoint was robotic-assisted procedural success, a composite of (I) successful dilatation of the target lesion and (II) successful robotic assistance, defined as absent non-planned manual conversion. Results: A total of 83 patients and 112 lesions were prospectively enrolled. The rate of angiographic success was 99.1%. From these, 97 lesions (86.6%) were treated with only robotic PCI or with hybrid according to the pre-interventional plan. The rates of efficacy and safety primary endpoints were 85.7% and 2.4% respectively (P<0.01 for non-inferior to the pre-defined performance threshold). Conclusions: Introduction of robotic-assisted PCI in a tertiary center was associated with safe and effective results, comparable to pre-defined goals of optimal performance.

Benchmarking as a quality of care improvement tool for patients with ST-elevation myocardial infarction: an NCDR ACTION Registry experience in Latin America.

OBJECTIVE: We aim to examine the effect of benchmarking on quality-of-care metrics in patients presenting with ST-elevation myocardial infarction (STEMI) through the implementation of the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) ACTION Registry. DESIGN: From January 2005 to December 2017, 712 patients underwent primary percutaneous coronary intervention PCI-499 before NCDR ACTION Registry implementation (prior to 2013) and 213 after implementation. SETTING: STEMI. PARTICIPANTS: 712 patients. INTERVENTION(S): Primary PCI. MAIN OUTCOME MEASURE(S): We examined hospital performance for the quality indicators in processes and outcomes of the management of patients presenting with STEMI. Outcome measures include door-to-balloon time (DBT), antiplatelet therapy and anti-ischemic drugs prescribed at discharge from pre-NCDR ACTION Registry to post-implementation. RESULTS: There was improvement in DBT, decreasing from 94 min in 2012 (before NCDR adoption) to reach a median of 47 min in 2017 (Ptrend < 0.001). The percentage of cases with the optimal DBT of < 90 min increased from 55.8% before to 90.1% after the implementation of the NCDR ACTION Registry (Ptrend < 0.001). The rate of aspirin (90.3-100%, P < 0.001), P2Y12 inhibitor (70.1-78.4%, P = 0.02), beta-blocker (76.8-100%, P < 0.001) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (60.1-99.5%, P < 0.001) prescribed at discharge increased from pre-NCDR ACTION Registry to post-implementation. Adjusted mortality before and after NCDR ACTION Registry implementation showed significant change (from 9.04 to 5.92%; P = 0.027). CONCLUSIONS: The introduction of the ACC NCDR ACTION Registry led to incremental gains in the quality in STEMI management through the benchmarking of process of care and clinical outcomes, achieving reduced DBT, improving guideline-directed medication adherence and increasing patient safety, treatment efficacy and survival.

Effect of implementing an acute myocardial infarction guideline on quality indicators.

OBJECTIVE: To evaluate the compliance rates to quality of care indicators along the implementation of an acute myocardial infarction clinical practice guideline. METHODS: A clinical guideline for acute myocardial infarction was introduced on March 1st, 2005. Patients admitted for acute myocardial infarction from March 1st, 2005 to December 31st, 2012 (n=1,431) were compared to patients admitted for acute myocardial infarction before the implementation of the protocol (n=306). Compliance rates to quality of care indicators (ASA prescription on hospital admission and discharge, betablockers on discharge and door-to-balloon time) as well as the length of hospital stay and in-hospital mortality were compared before and after the implementation of the clinical guideline. RESULTS: The rates of ASA prescription on admission, on discharge and of betablockers were higher after guideline implementation: 99.6% versus 95.8% (p<0.001); 99.1% versus 95.8% (p<0.001); and 95.9% versus 81.7% (p<0.001), respectively. ASA prescription rate increased over time, reaching 100% from 2009 to 2012. Door-to-balloon time after versus before implementation was of 86(32) minutes versus 93(51) (p=0.20). The length of hospital stay after the implementation versus before was of 6(6) days versus 6(4) days (p=0.34). In-hospital mortality was 7.6% (before the implementation), 8.7% between 2005 and 2008, and 5.3% between 2009 and 2012, (p=0.04). CONCLUSION: The implementation of an acute myocardial infarction clinical practice guideline was associated with an increase in compliance to quality of care indicators.

Efeito da implementação de um protocolo assistencial de infarto agudo do miocárdio sobre os indicadores de qualidade / Effect of implementing an acute myocardial infarction guideline on quality indicators

OBJETIVO: Avaliar a adesão aos indicadores de qualidade assistencial ao longo da implementação de um protocolo assistencial de infarto agudo do miocárdio. MÉTODOS: Em 1º de março de 2005 foi implementado o protocolo assistencial de infarto agudo do miocárdio. Foram selecionados pacientes admitidos de 1ºde março de 2005 a 31 de dezembro de 2012 (n=1.431). Para comparação, utilizamos os dados de pacientes admitidos por infarto na fase pré-protocolo (n=306). Comparamos a taxa de adesão aos indicadores (taxa de prescrição de AAS na admissão hospitalar e na alta hospitalar, betabloqueador na alta e tempo porta-balão) entre as fases pré e pós-implementação do protocolo, além de tempo de permanência hospitalar e mortalidade intra-hospitalar nas diferentes fases. RESULTADOS: As taxas de prescrição de AAS na admissão e na alta hospitalar, e de betabloqueador foram maiores na fase pós versus a pré-implementação do protocolo: 99,6% versus 95,8% (p<0,001); 99,1% versus 95,8% (p<0,001) e 95,9% versus 81,7% (p<0,001), respectivamente. A taxa de prescrição de AAS aumentou ao longo da implementação do protocolo, atingindo 100% de 2009 a 2012. O tempo porta-balão pós versus pré foi de 86(32) minutos versus 93(51), respectivamente (p=0,20). O tempo de permanência hospitalar foi semelhante na fase pré versus pós-protocolo: 6(6) dias versus 6(4) dias (p=0,34). A mortalidade intra-hospitalar foi de 7,6% no pré-protocolo, 8,7% entre 2005 e 2008 e 5,3% entre 2009 e 2012 (p=0,04). CONCLUSÃO: A implementação do protocolo assistencial refletiu-se na maior adesão aos indicadores de qualidade.

OBJECTIVE: To evaluate the compliance rates to quality of care indicators along the implementation of an acute myocardial infarction clinical practice guideline. METHODS: A clinical guideline for acute myocardial infarction was introduced on March 1st, 2005. Patients admitted for acute myocardial infarction from March 1st, 2005 to December 31st, 2012 (n=1,431) were compared to patients admitted for acute myocardial infarction before the implementation of the protocol (n=306). Compliance rates to quality of care indicators (ASA prescription on hospital admission and discharge, betablockers on discharge and door-to-balloon time) as well as the length of hospital stay and in-hospital mortality were compared before and after the implementation of the clinical guideline. RESULTS: The rates of ASA prescription on admission, on discharge and of betablockers were higher after guideline implementation: 99.6% versus 95.8% (p<0.001); 99.1% versus 95.8% (p<0.001); and 95.9% versus 81.7% (p<0.001), respectively. ASA prescription rate increased over time, reaching 100% from 2009 to 2012. Door-to-balloon time after versus before implementation was of 86(32) minutes versus 93(51) (p=0.20). The length of hospital stay after the implementation versus before was of 6(6) days versus 6(4) days (p=0.34). In-hospital mortality was 7.6% (before the implementation), 8.7% between 2005 and 2008, and 5.3% between 2009 and 2012, (p=0.04). CONCLUSION: The implementation of an acute myocardial infarction clinical practice guideline was associated with an increase in compliance to quality of care indicators.

Incidência de distúrbios da condução atrioventricular e intraventricular após implante percutâneo da bioprótese valvar aórtica CoreValve / Incidence of atrioventricular and intraventricular conduction disorders after transcatheter aortic valve implantation with the CoreValve bioprosthesis

Introdução: O sistema de condução localizado no septo interventricular encontra-se anatomicamente contíguo ao anel valvar aórtico. Por isso, distúrbios na condução atrioventricular e intraventricular podem decorrer de inflamação, edema e estresse mecânico causados pelas hastes metálicas da bioprótese CoreValve. O objetivo deste estudo foi avaliar a incidência de distúrbios da condução atrioventricular e intraventricular após implante percutâneo da CoreValve. Método: Entre janeiro de 2008 e abril de 2010, 23 pacientes portadores de estenose aórtica foram submetidos a implante da CoreValve. A média de idade foi de 81 ± 8,3 anos, e 12 (52,1%) pacientes eram do sexo masculino. Resultados: Após o implante valvar, constataram-se as seguintes alterações na condução atrioventricular: 3 (13%) bloqueios atrioventriculares totais, 2 (8,7%) bloqueios atrioventriculares de 2º grau e 8 (34,8%) bloqueios atrioventriculares de 1º grau, sendo 4 (17,4%) novos e 4 preexistentes. Assim, distúrbios de condução mais avançados, como bloqueio atrioventricular de 2o grau e/ou bloqueio atrioventricular total ocorreram em 5 (21,7%) pacientes. Em relação aos distúrbios da condução intraventricular pós-implante, foram detectados 14 (60,9%) bloqueios completos de ramo esquerdo, sendo 2 (8,7%) com bloqueio completo de ramo direito e bloqueio completo de ramo esquerdo alternante. Nesta série, 7 (30,4%) pacientes foram submetidos a implante de marca-passo permanente, 6 (26,1%) deles por indicação absoluta. Todos os pacientes que apresentavam bloqueio completo de ramo direito antes do procedimento necessitaram do marca-passo permanente...

Background: There is a close anatomical relationship between the aortic valve annulus and the conduction system.Therefore, atrioventricular and intraventricular conduction disorders may occur as a result of inflammation, edema and mechanical stress caused by the metallic struts of the CoreValvebioprosthesis. The objective of this study was to evaluate the incidence of atrioventricular and intraventricular conduction disorders after percutaneous CoreValve implantation.Method: Between January 2008 and April 2010, 23 patients with aortic stenosis were submitted to CoreValve bioprosthesis implantation. Mean age was 81 ± 8.3 years and 12 (52.1%) patients were male. Results: After valve implantation, the following atrioventricular conduction disorderswere observed: 3 (13%) complete atrioventricular blocks, 2 (8.7%) 2nd degree atrioventricular blocks and 8 (34.8%) 1st degree atrioventricular blocks, of which 4 (17.4%) werenew and 4 were preexisting. Therefore, advanced conduction disorders, such as 2nd degree atrioventricular block and/orcomplete atrioventricular block were observed in 5 (21.7%) patients. As to post-implant intraventricular conductiondisorders, 14 (60.9%) left bundle branch blocks were observed, 2 (8.7%) of them with alternating right bundle branch block and left bundle branch block. In this series, 7 (30.4%) patients received a permanent pacemaker, 6 (26.1%) of them with absolute indication. All of the patients withright bundle branch block before the procedure required permanent pacemaker implantation. Conclusion: Atrioventricular conduction disorders and, specially, left bundle branch block are common after percutaneous implantation of the CoreValve prosthesis. Permanent pacemaker is required in approximately one fourth of the cases. The presence of pre-implant right bundle branch block is related to a greater risk of developing advanced conduction disorders.

Resultados imediatos e tardios do implante de stents farmacológicos para o tratamento de bifurcações: comparação entre as estratégias de um stent versus dois stents / Immediate and Late Results of Drug-Eluting Stent Implantation for the Treatment of Coronary Bifurcation Lesions: Comparison Between One-Stent and Two-Stent Strategies

Fundamentos: Os stents farmacológicos reduziram a necessidade de nova revascularização nas lesões bifurcadas. Entretanto, o seguimento tardio e a estratégia mais adequada (um stent vs. dois stents) não estão bem estabelecidos. Método: No período de junho de 2002 a dezembro de 2006, 156 pacientes consecutivos com lesões envolvendo bifurcações foram tratados com implante de stents farmacológicos. Comparou-se a taxa de eventos cardíacos adversos maiores (ECAM) combinados ­ óbito, infarto e revascularização do vaso-alvo (RVA) ­ e a incidência de trombose do stent conforme a estratégia (um stent: ramo principal vs. dois stents: ramos principal e lateral). Resultados: A média das idades foi de 64 ± 12 anos, 75,6% eram do sexo masculino e 28,8%, diabéticos. O seguimento médio foi de 2,4 ± 1,3 anos. Utilizou-se a estratégia com um stent em 67,3% dos pacientes. Bifurcações verdadeiras ocorreram em 64,7% dos casos. A estratégia de dois stents foi adotada em 32,7% dos casos (crush: 14,7%; cullote: 3,2%; T-stent: 10,3%; simultaneous kissing stent: 3,8%; V-stent: 0,6%). Kissing balloon final foi utilizado em 85,9% dos casos. A sobrevida livre de ECAM estimada foi de 95% na estratégia com um stent vs. 86% com dois stents (teste do log-rank, p = 0,03). A análise multivariada identificou o uso de dois stents como único preditor independente de ECAM (OR: 2,82; IC 95%: 1,04- 7,68; p = 0,04). A taxa de trombose no emprego de um stent em comparação com dois stents foi de 1,9% vs. 3,9% (p = 0,6)...

Background: Drug-eluting stents (DES) have reduced the need for repeat revascularization in coronary bifurcation lesions. However, late follow-up and the most adequate strategy (one stent vs. two stents) have not been well established. Methods: From June 2002 to December 2006, 156 consecutive patients underwent drug-eluting stent implantation to treat coronary bifurcation lesions. The rates of major adverse cardiac events (MACE) ­ death, myocardial infarction, and target-vessel revascularization (TVR) ­ and stent thrombosis were compared according to the strategy adopted (one-stent: main branch vs. twostents: main branch and side branch). Results: The mean age of the group was 64 ± 12 years; 75.6% of the patients were men and 28.8% were diabetic. The mean follow-up duration was 2.4 ± 1.3 years. The one-stent strategy was used in 67.3% of the patients. 64.7% of the lesions treated were true bifurcations. The two-stent techniques strategy were used in 32.7% of the cases (crush: 14.7%; cullote: 3.2%; T-stenting: 10.3%; simultaneous kissing stent: 3.8%; V-stenting: 0.6%). Final kissing balloon inflation was used in 85.9% of the cases. The combined event-free survivalwas estimated to be 95% with the one-stent strategy vs. 86% with the two-stent strategy (p Log Rank = 0.03). Multivariate analysis identified the two-stent strategy as the only independent predictor of MACE (OR: 2.82; IC 95%: 1.04-7.68; p = 0.04). Stent thrombosis rates using one stent was 1.9% vs. 3.9% using two stents; p = 0.6)...

Comparação dos stents farmacológicos vs. stents convencionais com supradesnivelamento do segmento ST: resultados do registro EINSTEIN / Long-Term Outcomes of Drug-eluting Stents Compared to Bare-metal Stents for Acute STElevation Myocardial Infarction: Results from the EINSTEIN Registry

Fundamentos: Os estudos randomizados que testaram os stents farmacológicos no infarto agudo do miocárdio com supradesnivelamento do seguimento ST (IAMSST) demostraram resultados conflitantes. Além disso, a trombose do stent e o seguimento tardio pouco reportado permanecem como os grandes limitantes à expansão da aplicação desses dispositivos no IAMSST. Objetivo: Comparar as taxas de eventos cardíacos adversos maiores combinados (ECAM) e as taxas de trombose do stent em pacientes não-selecionados tratados com stents convencionais ou farmacológicos no IAMSST e alocados de forma não-randômica. Método: Entre janeiro de 2001 e julho de 2007, 251 pacientes consecutivos com IAMSST foram submetidos a angioplastia primária ou de resgate com implante de stent convencional (n= 112) ou farmacológico (n= 139), no Hospital Israelita Albert Einstein - São Paulo, SP. Investigamos a incidência de ECAM (óbito, infarto do miocárdio e revascularização do vaso-alvo (RVA) e as taxas de [RVA]) e trombose do stent. Resultados: No total, a média das idades foi de 63 + - 13 anos, sendo 77 por cento dos pacientes do sexo masculino . No seguimento mediano de 2,8 anos (1,2-4,4), a incidência de ECAM foi maior nos pacientes tratados com stents convencionais...

Background: Randomized clinical trials comparing drugeluting stents (DES) with bare metal stents (BMS) in the setting of ST-segment elevation myocardial infarction (STEMI) have been showing conflicting results. Additionally, issues regarding stent thrombosis and the lack of long-term clinical outcomes have limited the widespread use of DES in STEMI. Objective: To compare the rates of major adverse cardiac events (MACE) and stent thrombosis in unselected patients who underwent primary or rescue percutaneous coronary intervention with BMS implantation with those treated with DES. Methods: Between January 2001 and July 2007, 251 consecutive patients with STEMI underwent PCI with BMS (n = 112) or DES (n =139). We investigated the incidence of MACE, including death, myocardial infarction and target vessel revascularization (TVR), as well as stent thrombosis rates. Results: Overall, the mean age was 63 ± 13 years-old and 77% were male. The median clinical follow-up was 2.8 years (1.3-4.4). The cumulative incidence of MACE was higher in patients who received BMS as compared with DES (25.2% vs. 10.1%; p < 0.01) driven by a higher incidence of all-cause mortality (17.8% vs. 5.1%; p < 0.01), mainly cardiac death (15.9 vs. 4.3; p < 0.01). TVR was detected in 8 patients (7.5%) with BMS and in 5 patients (3.6%) with DES (p = 0.25). The incidence of stent thrombosis was similar between groups (3.7% vs. 2.2%; p = 0.7). Conclusions: In this observational series, the use of DES in the setting of STEMI showed lower rates of MACE compared to BMS at the long-term follow-up.

Presença das capacidades sensoriais dos recém nascidos segundo a percepçäo das puérperas / Perception of puerperal mothers on their children's sensorial capacities

O estudo ocorreu em uma maternidade de Säo Paulo. Teve como objetivo verificar a presença das capacidades sensoriais dos recém nascidos, segundo a percepçäo das puérperas. A amostra foi constituída por 100 puérperas que atenderam os critérios: ter recebido assistência em alojamento conjunto, alta hospitalar, ter no mínimo 72 horas de paridade, ter realizado parto cesárea, ter um filho vivo. Os dados foram coletados em 1998 e revelaram que as puérperas percebiam nos seus filhos as capacidades auditiva, olfativa, visual, gustativa e tátil. Segundo a percepçäo das puérperas primíras e näo primíparas constatou-se através do teste do x2 que näo houve diferença significante para as capacidades visual, olfativa e tátil, enquanto para as capacidades auditiva e gustativa houve diferença.