Arq Bras CardiolArquivos Brasileiros de CardiologiaArq. Bras. Cardiol.0066-782X1678-4170Sociedade Brasileira de CardiologiatcqJtqYQHQV7vWH5ZdvJJGbS0066-782X201500050000800008S0066-782X201500505001710.5935/abc.20150017Original ArticlesPredictors of Conversion from Radial Into Femoral Access in Cardiac
CatheterizationCarvalhoMaria SaloméCaléRitaGonçalvesPedro de AraújoVinhasHugoRaposoLuísTelesRuiMartinsCristinaGabrielHenrique MesquitaPereiraHelderAlmeidaManuelHospital de Santa CruzPortugalHospital de Santa Cruz - PortugalHospital Garcia de OrtaAlmadaPortugalHospital Garcia de Orta, Almada -
PortugalHospital Garcia de OrtaMailing Address: Maria Salomé Leal de Carvalho, Hospital
de Santa Cruz – Lisboa - Postal Code 2754 - Portugal. Email:
mariasalomecarvalho@gmail.com
Author contributions
Conception and design of the research: Carvalho MS, Calé R. Acquisition of data:
Carvalho MS, Calé R, Gonçalves PA, Vinhas H, Raposo L, Teles R, Martins C, Gabriel
HM, Pereira H, Almeida M. Analysis and interpretation of the data: Carvalho MS,
Calé R, Almeida M. Statistical analysis: Carvalho MS, Calé R. Writing of the
manuscript: Carvalho MS, Calé R. Critical revision of the manuscript for
intellectual content: Gonçalves PA, Almeida M.
Potential Conflict of Interest
No potential conflict of interest relevant to this article was reported.
170320150520151045401408080920141111201424112014This is an Open Access article distributed under the terms of the Creative
Commons Attribution Non-Commercial License which permits unrestricted
non-commercial use, distribution, and reproduction in any medium, provided the
original work is properly cited.Background:
Fewer bleeding complications and early ambulation make radial access a privileged
route for cardiac catheterization. However, transradial (TR) approach is not
always successful, requiring its conversion into femoral access.
Objectives:
To evaluate the rate of conversion from radial into femoral access in cardiac
catheterization and to identify its predictors.
Methods:
Prospective dual-center registry, including 7632 consecutive patients undergoing
catheterization via the radial access between Jan/2009 and Oct/2012. We evaluated
the incidence of conversion into femoral access and its predictors by logistic
regression analysis.
Results:
The patients’ mean age was 66 ± 11 years, and 32% were women. A total of 2969
procedures (38.4%) were percutaneous coronary interventions (PCI), and the most
used first intention arterial access was the right radial artery (97.6%). Radial
access failure rate was 5.8%. Independent predictors of conversion from radial
into femoral access were the use of short introducer sheaths (OR 3.047, CI:
2.380-3.902; p < 0.001), PCI (OR 1.729, CI: 1.375-2.173; p < 0.001), female
sex (OR 1.569, CI: 1.234-1.996; p < 0.001), multivessel disease (OR 1.457, CI:
1.167-1.819; p = 0.001), body surface area (BSA) ≤ 1.938 (OR 1.448, CI:
1.120-1.871; p = 0.005) and age > 66 years (OR 1.354, CI: 1.088-1.684; p =
0.007).
Conclusion:
Transradial approach for cardiac catheterization has a high success rate and the
need for its conversion into femoral access in this cohort was low. Female sex,
older age, smaller BSA, the use of short introducer sheaths, multivessel disease
and PCI were independent predictors of conversion into femoral access.
For the last decades, transfemoral approach in cardiac catheterization has been the
preferred access for invasive cardiac procedures. However, recent evidence favors
transradial approach in several observational and randomized trials. It has been shown
that radial artery access decreases vascular complications with fewer access site
bleeding complications, early patient ambulation, shorter length of hospital stay and
lower hospital costs1-8. Recently, the large RIFLE study, on patients with
ST elevation myocardial infarction (STEMI), has reported a statistically significant
benefit from radial approach on cardiac mortality9. Despite its proven clinical benefit, many interventional cardiologists
perceive that the decrease in vascular complications is balanced by technical
difficulties and a longer learning curve, which might explain why the transradial
approach is still underemployed5,10. On the other hand, when radial access fails, the
most common alternative route is the femoral one11,12.
In this study, we aimed to evaluate the rate of conversion from radial into femoral
access in cardiac catheterization and to identify its clinical, demographic and
procedural predictors.
MethodsStudy design and patient population
In a prospective registry of 14750 consecutive patients from two centres, who
underwent cardiac catheterization for diagnostic or interventional coronary
procedures, between January 2009 and October 2012, we selected for the purpose of
this analysis all consecutive patients in whom the first intention was to use the
radial artery (n = 7664). Of these patients, we excluded those in whom the radial
access failed, and the alternative choice was the contralateral radial (n = 26), the
humeral (n = 4) and the cubital artery (n = 2) (Figure
1).
Patient selection and study design.
Baseline characteristics, indication for and type of the procedure performed,
procedural devices, details of coronary intervention, need for access site crossover
and chosen alternative access were prospectively recorded.
Written informed consent was obtained from all patients as per protocol.
Transradial technique
During the study period, in the two institutions involved in this study, there were
nine invasive cardiologists with high experience (> 100 procedures/year) in radial
artery catheterization and three fellows in training. The choice of the arterial
access was left at each operator's discretion. Either Allen's test or
oximetry/plethysmography (Barbeau test) was used, as per protocol, in all patients to
access the radial artery patency and adequacy of dual hand blood supply13,14.
Using a dedicated arm board, with the patient's wrist slightly hyperextended, the
right or left radial artery was cannulated with a short 20-gauge needle after
administration of 2 to 3 mL of local anaesthetic. A straight 0.025-inch guide wire
was then advanced into the radial arterial lumen through the needle, and a specific
transradial 5F or 6F hydrophilic introducer sheath (Terumo Medical Corporation,
Elkton, MD) was placed into the radial artery. Both long (25-cm) and short introducer
(10-cm) sheaths were used at the operator's discretion.
Following sheath insertion, whenever radial spasm was suspected, verapamil (2 mg)
and/or isosorbide dinitrate (2 mg) were administered.
An initial intra-arterial bolus of 5000 U of unfractionated heparin was administered
to all patients. Monitoring of coagulation with activated clotting time (ACT) was
used routinely during percutaneous coronary intervention (PCI) in the centers
included in this registry. In case of ad hoc PCI, additional bolus of unfractionated
heparin was given to achieve an ACT > 250 seconds. The use of additional
glycoprotein IIb/IIIa inhibitors was left to the operator's discretion. The radial
sheath was removed immediately in the catheter laboratory following completion of
procedure, and hemostasis was achieved by application of an adjustable plastic clamp
on the radial artery (TR BandTM, Terumo Co., Tokyo, Japan). The clamp was
gradually released over 2 to 3 hours, while monitoring for access site bleeding or
hematoma, and removed after satisfactory access site hemostasis had been
achieved.
As per our routine, all patients undergoing elective or ad hoc PCI were preloaded
with clopidogrel before the procedure (75 mg in the case of chronic treatment with
clopidogrel > 10 days, or 600 mg, if not).
Definitions and statistical analysis
Procedural success was defined as successful completion of the coronary procedure
(diagnostic or interventional) via the initial radial access.
Categorical variables are expressed as absolute values and percentages, and
continuous variables, as mean ± SD or median (interquartile range). Continuous
variables were tested for normal distribution using the Kolmogorov-Smirnov's test and
for equality of variances using the Levene's test.
Baseline and procedural characteristics were compared using Fisher exact test or
Chi-square test for categorical variables and Student t test for
continuous variables. Multivariate analysis regression was used to determine the
independent predictors of conversion from radial into femoral access. The independent
variables for entry into the multivariate model were selected according to their
significance in univariate testing (included those with p < 0.1 in univariate
analysis). The final model was built by forward stepwise variable selection with
entry and exit criteria at the p = 0.05 and p = 0.1 levels, respectively. The
goodness of fit of the model was evaluated by calculating the Hosmer-Lemeshow
statistic.
A significance level of 0.05 with two-sided test was used, and all analyses were done
with the Statistical Pack for Social Sciences (SPSS) software,
version 19.
Results
A total of 7632 patients were included in the study. The baseline clinical and
procedural characteristics are described in Table
1. The mean age of the study population was 66 ± 11 years, and 32% were women.
About one third were diabetic, 73.3% had hypertension, 62.7% had hypercholesterolemia
and 41.9% had smoking habits. The incidence of prior PCI was 22.2%, whereas 1.7% had had
prior coronary artery bypass grafting. Of the total, 2969 procedures (38.4%) were PCIs
and the right radial access was the first choice in most patients (97.6%).
Conversion from initial radial access into femoral access occurred in 5.8% of all
patients. Univariate predictors of conversion from radial into femoral access are
described in Table 1. Comparing with the
successful transradial access group, the transradial access failure group patients were
significantly older (mean age of 69 ± 12 years vs. 65 ± 11 years, p < 0.001), more
likely to be women (46.7% vs. 30.7%, p <0.001), to have chronic kidney disease (7.0%
vs. 4.0%, p=0.002) and a smaller body surface area (mean BSA of 1.82 ± 0.18 vs. 1.87 ±
0.19, p < 0.001). Conversion into femoral access was also more frequent when the
procedure was a PCI (7.4% vs. 4.8% in diagnostic procedures, p < 0.001), in patients
with multivessel disease (8.8% vs. 5.2%, p = 0.001) and when shorter introducers were
used (8.0% vs. 3.6% with long introducers, p < 0.001). Smoking was associated with
lower radial access failure (4.2% vs. 7.0% in non-smokers, p < 0.001), as well as the
use of 6F introducers compared to 4F or 5F (5.5 % vs. 7.6%, p = 0.009). All patients who
had an intra-aortic balloon pump needed the conversion into femoral access (2.7% vs.
0.0%, p < 0.001).
After multivariable adjustment (Figure 2),
independent predictors of conversion from radial access into femoral access were female
sex (OR 1.569, CI: 1.234-1.996, p < 0.001), age > 66 years (OR 1.354, CI:
1.088-1.684, p = 0.007), BSA ≤ 1.938 (OR 1.448, CI: 1.120-1.871, p = 0.005), multivessel
disease (OR 1.457, CI: 1.167-1.819, p = 0.001), the use of short introducer sheaths (OR
3.047, CI: 2.380 3.902, p < 0.001) and PCI (OR 1.729, CI: 1.375-2.173).
Predictors of conversion from radial access into femoral access. PCI:
percutaneos coronart interventions; BSA: body surface area; CI: confidence
interval.
Discussion
In this study, we sought to identify possible predictors of conversion from radial into
femoral access in cardiac catheterization.
Our main findings were: (1) a very low radial access failure (5.8%) in contemporary
practice by intermediate (60-100 procedures/year) and high (> 100 procedures/year)
volume transradial operators with standard radial sheaths and catheters; (2) the most
common alternative access was the femoral artery; (3) independent predictors of radial
access failure were the use of short introducers, PCI, female sex, multivessel disease,
lower BSA and older age; and (4) both a smoking history and the use of larger sheaths
(≥ 6F) were associated with radial access success.
Several aspects make radial access a privileged route. It is feasible, being superficial
and easy to puncture and to compress, causing fewer complications at the vascular access
site compared to femoral access. Likewise, it offers superior comfort for the patient in
the post-procedural period, with earlier ambulation and higher cost-effectiveness15. Recent studies have shown a mortality benefit in
STEMI patients1,9. Nevertheless, potential procedural difficulties still intimidate
some operators and radial access success is highly dependent on the operator's
experience and skills.
Failure can be due to inability to gain radial artery access or inability to
successfully engage the coronary arteries, owing to radial spasm, anatomic variations or
severe tortuosity in the radial, brachial, or subclavian arteries11,16-18.
Over the years, as expected, the use of radial access had a gradual increase: 25% in
2009 to 76% in 2012 (Figure 3A). Focusing on
radial access failure rates, one could anticipate a decrease with greater experience.
Nonetheless, failure rate was higher in the last years and this could be explained by
the fact that higher operator experience could have been offset by a widespread use of
the technique, even in less favorable situations to the transradial approach (Figure 3B).
Radial access use over the years.
Radial access failure over the years.
Procedural failure lessens with experience, and ultimately occurs with a frequency of
less than 5%19-21. Our higher failure (5.8%) could be partly justified by the fact
that we have fellows-in-training. Moreover, in the acute coronary syndrome setting, as
in the RIVAL trial1, a higher radial access
failure rate has been reported (about 7%). After a systematic review of 23 randomized
studies published up to 2007, comparing radial with femoral access in diagnostic and/or
therapeutic coronary procedures, Jolly et al.3
reported a transradial approach failure rate of 5.9%. Our radial access failure rate
(5.8%) was similar, although we must consider that, in that meta-analysis, 85.3% of the
procedures were PCIs, whereas in our population, the percentage is substantially lower
(38.4%). In line with this remark, a non randomized study performed in 200912, including 2100 patients undergoing PCI in the
acute coronary syndrome setting, reported a radial access failure rate of 4.6%.
Comparing with the Brazilian experience, the study by Andrade et al.21 showed a very low failure rate (2.5%), but with a
substantially reduced use of the radial access (< 15%), which implies a highly
selected population in which this approach was used and may justify the high success
rate.
The choice of the catheterization approach (femoral, radial or brachial) is usually a
function of the operator, institution, and patient preference. Despite some advantages
related to radial access, femoral approach is still widely used since many operators
were initially trained in this access and it has also several advantages, such as
allowing the use of larger sheaths (useful for procedures in need of higher catheter
support and/or bulkier devices). In addition, the femoral access has been associated
with less radiation time and contrast22-26.
We found that the use of short introducers was linked to radial access failure. This
could be explained by a potential selection bias (center preference concerning
introducer choice) or by the fact that long sheaths, once inserted, provide protection
to almost the entire length of the radial artery from further manipulation.
Nevertheless, in a previous study, no association was found between sheath length and
radial artery spasm27. We also found that the
need for PCI and the presence of multivessel disease were associated with radial access
failure, which are surrogates for a more challenging procedure, with more catheter
manipulation and exchanges, which would probably be more difficult in transradial
approach, and this was also found in other studies28-30.
Female sex, as well as shorter BSA and older age, were found to be independent
predictors of transradial cardiac catheterization failure. This is likely related to
smaller size of radial artery, increased subclavian tortuosity, small aortic roots and
short ascending aortas, preventing steady guide catheter coronary cannulation during the
procedure, as previously described by other authors1,11,19.
One interesting finding in our results was the association between smoking history and a
lower radial access failure. In line with the smoking paradox for coronary artery
disease this could also be explained by the younger age of smoking patients submitted to
catheterization (in our study, the mean age of the smoking patients was 61 ± 11 vs. 69 ±
11 years, p < 0.001) and this has also been found in other studies31. Nevertheless, smoking remained an independent
predictor of radial access success after multivariate analysis.
Finally, the association between larger sheaths (≥ 6F) and radial access
success might be due to selection bias, because the operator would select smaller
diameter sheaths for patients in which he would anticipate a more difficult radial
access procedure, such as smaller and older patients, in line with International
recommendations27.
Study limitations
The present study is a registry from two high-volume centers, with bias in the
selection of patients for radial access. The procedures were performed by different
operators, with variable degrees of experience, and it was not possible to evaluate
the impact of the operator's experience on failure rate.
Our results reflect radial access learning curve, since, in the first 2 years, less
than 50% of the procedures were performed via radial access, and thus, predictors of
radial access failure in more experienced centers/operators might be different.
Conclusions
Transradial approach for cardiac catheterization was associated with a high success
rate. The predictors of conversion into femoral access were female sex, older age,
smaller BSA, multivessel disease, PCI and the use of short introducers.
These findings could contribute to improve patient selection and increase radial access
success.
Study Association
This study is not associated with any thesis or dissertation work.
Sources of Funding
There were no external funding sources for this study.
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eventsAm J Cardiol2011151081013821386Fatores Preditivos da Conversão de Acesso Radial em Femoral no
Cateterismo CardíacoCarvalhoMaria SaloméCaléRitaGonçalvesPedro de AraújoVinhasHugoRaposoLuísTelesRuiMartinsCristinaGabrielHenrique MesquitaPereiraHelderAlmeidaManuelHospital de Santa CruzLisboaPortugalHospital de Santa Cruz, Lisboa -
PortugalHospital Garcia de OrtaAlmadaPortugalHospital Garcia de Orta, Almada -
PortugalCorrespondência: Maria Salomé Leal de Carvalho, Hospital
de Santa Cruz – Lisboa - CEP 2754 - Portugal. Email:
mariasalomecarvalho@gmail.com
Contribuição dos autores
Concepção e desenho da pesquisa: Carvalho MS, Calé R. Obtenção de dados: Carvalho
MS, Calé R, Gonçalves PA, Vinhas H, Raposo L, Teles R, Martins C, Gabriel HM,
Pereira H, Almeida M. Análise e interpretação dos dados: Carvalho MS, Calé R,
Almeida M. Análise estatística: Carvalho MS, Calé R. Redação do manuscrito:
Carvalho MS, Calé R. Revisão crítica do manuscrito quanto ao conteúdo intelectual
importante: Gonçalves PA, Almeida M.
Potencial conflito de interesse
Declaro não haver conflito de interesses pertinentes.
Fundamento:
Menos complicações hemorrágicas e deambulação precoce fazem do acesso radial uma
via privilegiada para cateterismo cardíaco. Entretanto, a abordagem transradial
(TR) nem sempre é bem-sucedida, sendo necessária a sua conversão em acesso
femoral.
Objetivo:
Avaliar a taxa de conversão do acesso radial em femoral no cateterismo cardíaco e
identificar seus fatores preditivos.
Métodos:
Registro prospectivo de dois centros, incluindo 7.632 pacientes consecutivos
submetidos a cateterização via acesso radial entre janeiro de 2009 e outubro de
2012. Avaliou-se a incidência de conversão em acesso femoral e seus fatores
preditivos através de análise de regressão logística.
Resultados:
A idade média dos pacientes foi de 66 ± 11 anos, sendo 32% deles mulheres. Houve
2.969 (38.4%) intervenções coronarianas percutâneas (ICP),sendo a artéria radial
direita a primeira escolha mais usada (97,6%). A taxa de insucesso do acesso
radial foi de 5,8%. Fatores preditivos independentes da conversão do acesso radial
em femoral foram o uso de bainhas introdutoras curtas (OR 3,047; IC: 2,380-3,902;
p < 0,001), ICP (OR 1,729; IC: 1,375-2,173; p < 0,001), sexo feminino (OR
1,569;IC: 1,234-1,996; p < 0,001), doença multiarterial (OR 1,457; IC:
1,167-1,819; p = 0,001), área de superfície corporal(ASC) ≤ 1,938 (OR 1,448; IC:
1,120-1,871; p = 0,005) e idade > 66 anos (OR 1,354; IC: 1,088-1,684; p =
0,007).
Conclusão:
A abordagem transradial para cateterismo cardíaco tem alta taxa de sucesso e a
necessidade de sua conversão em acesso femoral nesta coorte foi baixa. Os fatores
preditivos independentes de sua conversão em acesso femoral foram: sexo feminino;
idade mais avançada; menor ASC; uso de bainhas introdutoras curtas; doença
multiarterial; e ICP.
Nas últimas décadas, a abordagem transfemoral no cateterismo cardíaco tem sido
preferida para os procedimentos cardíacos invasivos. No entanto, evidência recente em
vários ensaios observacionais e randomizados favoreceu a abordagem transradial. Foi
demonstrado que o acesso através da artéria radial reduz as complicações vasculares
com menos sangramento nos locais de acesso, deambulação mais precoce do paciente,
menor tempo de internação hospitalar e custos hospitalares mais baixos1-8. Recentemente, o grande estudo RIFLE, em pacientes com infarto do
miocárdio com supradesnível do segmento ST, relatou benefício estatisticamente
significativo da abordagem radial na mortalidade cardíaca9. A despeito de seu comprovado benefício clínico, muitos
cardiologistas intervencionistas percebem que a redução nas complicações vasculares é
contrabalançada por dificuldades técnicas e uma mais longa curva de aprendizado, que
podem explicar o motivo pelo qual a abordagem transradial é ainda subutilizada5,10. Por outro lado, quando o acesso radial falha, a alternativa mais comum
é a via femoral11,12.
Este estudo teve por objetivo avaliar a taxa de conversão do acesso radial em femoral
no cateterismo cardíaco, além de identificar seus fatores preditivos clínicos,
demográficos e procedurais.
MétodosDesign do estudo e população de pacientes
De um registro prospectivo de 14.750 pacientes consecutivos, originários de dois
centros e submetidos a cateterismo cardíaco para procedimentos coronarianos
diagnósticos ou intervencionistas entre janeiro de 2009 e outubro de 2012,
selecionamos todos aqueles nos quais a primeira intenção foi usar a artéria radial
(n = 7.664). Desses pacientes, excluíram-se aqueles nos quais o acesso radial
falhou, tendo-se optado pela alternativa da artéria radial contralateral (n = 26),
umeral (n = 4) e cubital (n = 2) (Figura
1).
Seleção dos pacientes e design do estudo.
As características basais, indicação e tipo do procedimento realizado,
dispositivos procedurais, detalhes da intervenção coronariana, necessidade de
cruzamento para outra via de acesso, e acesso alternativo escolhido foram
registrados prospectivamente.
Todos os pacientes assinaram o termo de consentimento livre e esclarecido, segundo
o protocolo.
Técnica transradial
Durante o período estudado, as duas instituições envolvidas neste estudo contavam
com nove cardiologistas intervencionistas com grande experiência (> 100
procedimentos/ano) em cateterização da artéria radial e três outros em
treinamento. A escolha do acesso arterial foi deixada a critério de cada
cardiologista intervencionista. Utilizou-se o teste de Allen ou a
oximetria/pletismografia (teste de Barbeau), segundo o protocolo, em todos os
pacientes para avaliar a permeabilidade da artéria radial e a adequação do duplo
suprimento sanguíneo da mão13,14.
Usando-se um suporte para o braço, com o pulso do paciente em leve hiperextensão,
a artéria radial direita ou esquerda foi canulada com uma pequena agulha de
calibre 20 após a administração de 2 a 3 ml de anestésico local. Um fio-guia reto
de 0,025 polegada foi então introduzido na luz arterial radial através da agulha e
uma bainha introdutora transradial hidrofílica específica de 5F ou 6F (Terumo
Medical Corporation, Elkton, MD) foi inserida na artéria radial. As bainhas
introdutoras tanto longas (25 cm) quanto curtas (10 cm) foram utilizadas a
critério do cardiologista intervencionista.
Após a inserção da bainha, sempre que se suspeitou de espasmo radial, realizou-se
a administração de verapamil (2 mg) e/ou dinitrato de isossorbida (2 mg).
Todos os pacientes receberam um bolus intra-arterial inicial
de5.000 U de heparina não fracionada. Monitoração da coagulação foi realizada
rotineiramente através do tempo de coagulação ativada (TCA) durante a intervenção
coronariana percutânea (ICP) nos centros incluídos neste registro. No caso de ICP
ad hoc, um bolus adicional de heparina não
fracionada foi administrado para se obter um TCA > 250 segundos.O uso adicional
de inibidores da glicoproteína IIb/IIIa foi deixado a critério do cardiologista
intervencionista. A bainha radial foi imediatamente removida no laboratório de
hemodinâmica após o término do procedimento, obtendo-se hemostasia com a aplicação
de um clamp de plástico ajustável na artéria radial (TR
BandTM, TerumoCo., Tóquio, Japão). O clamp foi
liberado gradualmente ao longo de 2 a 3 horas, com monitoração para sangramento ou
hematoma no sítio de punção, tendo sido removido após a obtenção de hemostasia
satisfatória naquele sítio.
Segundo nossa rotina, todos os pacientes submetidos a ICP eletiva ou ad
hoc receberam clopidogrel antes do procedimento (75 mg, em caso de
tratamento crônico com clopidogrel > 10 dias, ou 600 mg, em caso
contrário).
Definições e análise estatística
Definiu-se o sucesso do procedimento coronariano (diagnóstico ou intervencionista)
como a sua realização completa e bem-sucedida através do acesso radial
inicial.
As variáveis categóricas foram expressas em valores absolutos e percentagens, e as
variáveis contínuas, como média ± DP ou mediana (intervalo interquartil). As
variáveis contínuas foram testadas para distribuição normal usando-se o teste de
Kolmogorov-Smirnov e para igualdade de variâncias, usando-se o teste de
Levene.
As características basais e procedurais foram comparadas usando-se o teste exato
de Fisher ou o qui-quadrado para variáveis categóricas e o teste t
de Student para variáveis contínuas. Usou-se análise de regressão
multivariada para determinar os fatores preditivos independentes para conversão do
acesso radial em femoral. As variáveis independentes para entrada no modelo
multivariado foram selecionadas de acordo com sua significância na análise
univariada (incluindo-se aquelas com p < 0,1 na análise univariada).
Construiu-se o modelo final de regressão através de seleção forward
stepwise de variáveis com critérios de entrada e saída com níveis de p
= 0,05 e p = 0,1, respectivamente. Avaliou-se a adequação do ajuste do modelo
através do teste de Hosmer-Lemeshow.
Adotou-se o nível de significância de 0,05 com teste bicaudal, e todas as análises
foram realizadas com o programa Statistical Pack for Social Sciences
(SPSS),versão 19.
Resultados
Um total de 7.632 pacientes foi incluído neste estudo. A Tabela 1 apresenta as características basais clínicas e
procedurais. A população do estudo apresentava as seguintes características: idade
média, 66 ± 11 anos;32% de mulheres; um terço, diabética; 73,3%, hipertensa; 62,7%
tinha hipercolesterolemia; e 41,9% era tabagista. A incidência de ICP anterior foi de
22,2%, e 1,7% da amostra tinha sido submetida a revascularização miocárdica
cirúrgica. Do total, 2.969 procedimentos (38,4%) foram ICP, tendo o acesso radial
direito sido a primeira escolha na maioria dos pacientes (97,6%).
Características basais e procedurais
Variáveis
Prevalência
Total n = 7.632
Conversão n = 445
Sucesso do AR n = 7.187
p
Características clínicas
Idade (anos)
66 ± 11
69 ± 12
65 ± 11
< 0,001
Mulheres, n (%)
2.416 (31,7)
208 (46,7)
2.208 (30,7)
< 0,001
Peso (kg)
76 ± 13
74 ± 13
77 ± 13
< 0,001
Altura (cm)
166 ± 9
163 ± 9
166 ± 9
< 0,001
IMC (kg/m2)
28 ± 4
28 ± 4
28 ± 4
0,479
ASC (m2)
1,87 ± 0,19
1,82 ± 0,18
1,87 ± 0,19
< 0,001
DRC (TFG < 60ml/min/1,73 m2), n (%)
316 (4,1)
31 (7,0)
285 (4,0)
0,002
Insuficiência cardíaca, n (%)
343 (4,5)
17 (3,8)
328 (4,6)
0,464
DPOC, n (%)
328 (4,3)
14 (3,1)
314 (4,4)
0,208
Doença arterial periférica, n (%)
389 (5,1)
17 (3,8)
372 (5,2)
0,191
Cirurgia valvular prévia, n (%)
1.053 (13,8)
75 (16,9)
978 (13,6)
0,052
Infarto do miocárdio anterior, n (%)
1.312 (17,2)
88 (19,8)
1.224 (17,0)
0,136
Acidente cerebrovascular prévio, n (%)
442 (5,8)
28 (6,3)
414 (5,7)
0,623
Revascularização miocárdica anterior
ICP prévia, n (%)
1.694 (22,2)
93 (20,9)
1.601 (22,2)
0,510
Cirurgia prévia, n (%)
130 (1,7)
10 (2,2)
120 (1,7)
0,374
Fatores de risco cardíacos
Hipertensão, n (%)
5.593 (73,3)
340 (76,4)
5.253 (73,1)
0,131
Hipercolesterolemia, n (%)
4.782 (62,7)
298 (67,0)
4.484 (62,4)
0,053
Tabagismo, n (%)
3.201 (41,9)
135 (30,3)
3.066 (42,7)
< 0,001
Diabetes mellitus, n (%)
2.317 (30,4)
139 (31,2)
2.178 (30,3)
0,692
Contexto clinico/características procedurais
SCA, n (%)
2.850 (37,3)
184 (41,3)
2.666 (37,1)
0,077
ICP, n (%)
2.970 (38,9)
221 (49,7)
2.749 (38,2)
< 0,001
Doença multiarterial, n (%)
412 (5,4)
39 (8,8)
373 (5,2)
0,001
AR direito, n (%)
7.452 (97,6)
438 (98,4)
7.014 (97,6)
0,261
Calibre ≥ 6F, n (%)
6.666 (87,4)
374 (84,0)
6.292 (88,2)
0,009
Bainhas mais longas, n (%)
3.718 (48,7)
132 (29,7)
3.586 (49,9)
< 0,001
Balão intra-aórtico, n (%)
12 (0,2)
12 (2,7)
0 (0,0)
< 0,001
AR: acesso radial; IMC: índice de massa corporal; ASC: área da
superfície corporal; DRC: doença renal crônica; TFG: taxa de filtração
glomerular; DPOC: doença pulmonar obstrutiva crônica; ICP: intervenção
coronariana percutânea; SCA: síndrome coronariana aguda.
A conversão do acesso radial inicial em femoral ocorreu em 5,8% de todos os
pacientes. A Tabela 1 apresenta os fatores
preditivos de conversão do acesso radial em femoral resultantes da análise
univariada. Comparando se com o grupo de acesso transradial bem-sucedido, os
pacientes do grupo de acesso transradial malsucedido eram significativamente mais
velhos (idade média de 69 ± 12 anos vs. 65 ± 11 anos; p < 0,001), apresentavam
maior probabilidade de serem mulheres (46,7% vs. 30,7%; p < 0,001), de terem
doença renal crônica (7,0% vs. 4,0%; p = 0,002) e menor área de superfície corporal
(ASC média de 1,82 ± 0,18 vs. 1,87 ± 0,19; p < 0,001). A conversão em acesso
femoral foi ainda mais freqüente quando o procedimento era uma ICP (7,4% vs. 4,8%
para procedimentos diagnósticos; p < 0,001), em pacientes com doença multiarterial
(8,8% vs. 5,2%; p = 0,001) e quando se utilizaram introdutores curtos (8,0% vs. 3,6%
com introdutores longos; p < 0,001). Tabagismo foi associado a menor taxa de
insucesso do acesso radial (4,2% vs. 7,0% para não fumantes; p < 0,001), assim
como o uso de introdutores 6F em comparação ao de 4F ou 5F (5,5% vs. 7,6%; p =
0,009).Em todos os pacientes com balão intra aórtico houve necessidade de conversão
para acesso femoral (2,7% vs. 0,0%; p < 0,001).
Após ajuste multivariável (Figura 2), os
fatores preditivos independentes de conversão de acesso radial para femoral foram
sexo feminino (OR 1,569; IC: 1,234-1,996; p < 0,001), idade > 66 anos (OR
1,354; IC: 1,088-1,684; p = 0,007), ASC ≤ 1,938 (OR 1,448; IC: 1,120-1,871; p =
0,005), doença multiarterial (OR 1,457; IC: 1,167 1,819; p = 0,001), uso de bainhas
introdutoras curtas (OR 3,047; IC: 2,380-3,902; p < 0,001) e ICP (OR 1,729; IC:
1,375-2,173).
Fatores preditivos da conversão do acesso radial em femoral. ICP:
intervenção coronariana percutânea; ASC: área de superfície corporal; IC:
intervalo de confiança.
Discussão
Neste estudo, procuramos identificar possíveis fatores preditivos da conversão do
acesso radial em femoral no cateterismo cardíaco.
Nossos principais achados foram: (1) taxa de insucesso do acesso radial muito baixa
(5,8%) na prática atual dos cardiologistas intervencionistas transradiais com volume
intermediário (60-100 procedimentos/ano) e alto (> 100 procedimentos/ano) com
bainhas e cateteres radiais padronizados; (2) a artéria femoral foi o acesso
alternativo mais comum; (3) fatores preditivos independentes para o insucesso do
acesso radial foram o uso de bainhas introdutoras curtas, ICP, sexo feminino, doença
multiarterial, menor ASC e idade mais avançada; e (4) tanto uma história de tabagismo
quanto o uso de bainhas maiores (≥6F) foram associadas ao sucesso do acesso
radial.
Vários aspectos tornam o acesso radial uma via privilegiada. É factível, superficial
e fácil para puncionar e comprimir, causando menos complicações no sítio de punção
vascular em comparação ao acesso femoral. Além disso, proporciona maior conforto ao
paciente após o procedimento,com deambulação mais precoce e alta relação de
custo-efetividade15. Estudos recentes
mostraram um benefício em relação à mortalidade em pacientes com infarto do miocárdio
com supradesnível do segmento ST1,9. No entanto,
potenciais dificuldades procedurais ainda intimidam alguns cardiologistas
intervencionistas, sendo o sucesso do acesso radial altamente dependente de sua
experiência e habilidade.
O insucesso pode dever-se à inabilidade em obter acesso à artéria radial ouem
alcançar as artérias coronárias,devido a espasmo radial, variações anatômicas ou
grave tortuosidade das artérias radial, braquial ou subclávia11,16-18.
Como esperado, ao longo dos anos, o uso do acesso radial aumentou gradualmente,
passando de 25% em 2009 para 76% em 2012 (Figura
3A). Com relação às taxas de insucesso do acesso radial, seria possível
prever sua redução com o aumento da experiência. No entanto, a taxa de insucesso foi
mais alta nos últimos anos, o que poderia ser explicado pelo fato de a maior
experiência dos cardiologistas intervencionistas ter sido contrabalançada pelo uso
disseminado da técnica, mesmo em situações menos favoráveis à abordagem transradial
(Figure 3B).
Uso do acesso radial ao longo dos anos.
Insucesso do acesso radial ao longo dos anos.
O insucesso do procedimento diminui com o aumento da experiência, atingindo,por fim,
uma taxa inferior a 5%1921. Nossa taxa de insucesso mais alta (5,8%)
poderia ser parcialmente justificada pelo fato de termos profissionais em
treinamento. Além disso, no contexto da síndrome coronariana aguda, como no estudo
RIVAL1, relatou-se uma mais alta taxa de
insucesso do acesso radial (cerca de 7%). Após revisão sistemática de23 estudos
randomizados publicados até 2007, comparando os acessos radial e femoral nos
procedimentos coronarianos diagnósticos e/ou terapêuticos, Jolly e cols.3 relataram uma taxa de insucesso para a
abordagem transradial de 5,9%. A nossa taxa de insucesso para o acesso radial (5,8%)
foi similar, embora se deva considerar que, naquela meta-análise, 85,3% dos
procedimentos foram ICP, enquanto na nossa população, a porcentagem foi
substancialmente mais baixa (38,4%). Em concordância com essa observação, um estudo
não randomizado realizado em 200912, incluindo
2.100 pacientes submetidos a ICP no contexto de síndrome coronariana aguda, relatou
uma taxa de insucesso para o acesso radial de 4,6%.
Comparando-se com a experiência brasileira, o estudo de Andrade e cols.21 mostrou uma taxa de insucesso muito baixa
(2,5%), mas com o uso substancialmente reduzido do acesso radial (< 15%), o que
implica em uma população bastante selecionada, na qual tal abordagem foi usada,
podendo justificar a alta taxa de sucesso.
A via de acesso para o cateterismo (femoral, radial ou braquial) em geral decorre da
escolha do cardiologista intervencionista, da instituição e da preferência do
paciente. A despeito de algumas vantagens relacionadas ao acesso radial, a abordagem
femoral é ainda amplamente utilizada, pois muitos cardiologistas intervencionistas
foram inicialmente treinados nesse tipo de acesso, que também apresenta muitas
vantagens, como proporcionar o uso de bainhas maiores (úteis para procedimentos que
requeiram maior suporte de cateter e/ou dispositivos mais volumosos). Além disso, o
acesso femoral foi associado com menor tempo de radiação e menos contraste22-26.
Observamos que o uso de bainhas introdutoras curtas esteve ligado a insucesso do
acesso radial. Isso poderia ser explicado por um possível viés de seleção
(preferência do centro quanto à escolha da bainha introdutora) ou pelo fato de que
bainhas longas, uma vez inseridas, proporcionam proteção para quase toda a extensão
da artéria radial para manipulação adicional. No entanto, em um estudo prévio, não se
observou associação entre comprimento da bainha e espasmo da artéria radial27. Observamos ainda que o insucesso do acesso
radial associou-se à necessidade de ICP e à presença de doença multiarterial, que são
indicadores de um procedimento mais desafiador, com maior manipulação e troca de
cateter, conferindo maior dificuldade à abordagem transradial, tendo isso sido
relatado em outros estudos28-30.
Sexo feminino, assim como menor ASC e idade mais avançada, foram identificados como
fatores preditivos independentes para o insucesso do cateterismo cardíaco
transradial. Isso pode estar relacionado ao menor tamanho da artéria radial, aumento
da tortuosidade da subclávia, raízes aórticas pequenas e aortas ascendentes curtas,
que impedem uma canulação coronária estável durante o procedimento, como já descrito
por outros autores1,11,19.
Um achado interessante deste estudo foi a associação entre história de tabagismo e
baixa taxa de insucesso para o acesso radial. Considerando-se o paradoxo do tabagismo
para doença arterial coronariana, isso poderia ser explicado pela idade mais jovem
dos pacientes tabagistas submetidos ao cateterismo (no nosso estudo, a idade média
dos pacientes tabagistas foi de 61±11 vs. 69±11 anos; p < 0,001), o que também foi
relatado em outros estudos31. No entanto, o
tabagismo permaneceu como um fator preditivo independente para o sucesso do acesso
radial após análise multivariada.
Por fim, a associação entre bainhas maiores (≥ 6F) e sucesso do acesso radial pode
dever-se a viés de seleção, pois o cardiologista intervencionista escolheria bainhas
com diâmetros menores para pacientes para os quais antevisse um procedimento com
acesso radial mais difícil, como nos casos de indivíduos menores e mais idosos, em
concordância com as recomendações internacionais27.
Limitações do estudo
O presente estudo é um registro de dois centros de grande volume, com viés na
seleção de pacientes para acesso radial. Os procedimentos foram realizados por
diferentes cardiologistas intervencionistas, com variados graus de experiência,
não tendo sido possível avaliar o impacto da experiência do cardiologista
intervencionista na taxa de insucesso.
Nossos resultados refletem uma curva de aprendizado para o acesso radial, uma vez
que, nos primeiros dois anos,menos de 50% dos procedimentos foram realizados por
esse acesso. Consequentemente, deve haver uma diferença quanto aos fatores
preditivos de insucesso do acesso radial em centros e para cardiologistas
intervencionistas com maior experiência.
Conclusões
A abordagem transradial para cateterismo cardíaco associou-se com alta taxa de
sucesso. Os fatores preditivos de conversão em acesso femoral foram sexo feminino,
idade mais avançada, menor ASC, doença multiarterial, ICPe uso de bainhas
introdutoras curtas.
Esses achados poderiam contribuir para melhorar a seleção de pacientes e aumentar o
sucesso do acesso radial.
Fontes de financiamento
O presente estudo não teve fontes de financiamento externas.
Vinculação acadêmica
Não há vinculação deste estudo a programas de pós‑graduação.