Abstract
Background
Trans-radial access is increasingly common for cardiac catheterisation. Benefits include reduced bleeding complications, length of hospital stay and costs.
Aims
To determine the feasibility of implementing a nurse-led ultrasound programme to measure radial artery diameter before and after cardiac catheterisation; to determine radial artery occlusion (RAO) rates, risk factors for RAO and predictors of radial artery (RA) diameter.
Method
A prospective observational cohort study design for 100 consecutive patients undergoing cardiac catheterisation, using RA access. Pre- and post-procedural RA diameter were measured using ultrasound, by specialist nurses trained to do so. Logistic regression analyses were performed to determine risk factors for RAO and predictors of RA diameter with results reported as odds ratios (OR) and 95% confidence intervals (CI).
Results
There were no adverse events, supporting the feasibility of nurse led ultrasound programmes. A 4% (n = 4) rate of occlusion was observed. Haemostasis device application time of greater than 190 min was a predictor of RAO (OR 3.12, 95% CI 0.31–31). Male gender and height were predictors for a RA diameter of >2.2 mm.
Conclusions
Nurses can lead the assessment of RA occlusion using ultrasound to enhance planning and care, including monitoring compression times to reduce RAO.
Introduction
Trans-radial access (TRA) for cardiac catheterisation has become an increasingly used method of arterial access in many centres throughout the world (Fech et al., 2012; Masoudi et al., 2017; Santos et al., 2012). This has been driven by the well-described benefits of TRA compared with trans-femoral access, particularly in patients undergoing percutaneous coronary intervention (PCI) (Dharma et al., 2017). The main benefits of TRA are the reduction of adverse bleeding events, vascular complications, decreased length of stay, improved patient comfort and cost savings compared to a trans-femoral approach (Amin et al., 2017; Jolly et al., 2011; Koutouzis et al., 2016). Given these benefits, the European Society of Cardiology has recommended TRA as the preferred access site for PCI (Roffi et al., 2016).
Radial artery occlusion (RAO) following cardiac catheterisation and PCI occur in c. 5–30% of patients (Beyer et al., 2013). Such complications can have a significant impact on patients undergoing this procedure (Uhlemann et al., 2012). A major clinical implication of RAO is that the radial artery (RA) will be unable to be used for further procedures (Pancholy et al., 2012). Major contributors to RAO after cardiac catheterisation include anticoagulation use, compression device application time and reduced arterial-sheath size in comparison to the patient’s RA diameter (Saito et al., 1999).
A nurse-led approach to ultrasound is widely described among other specialities, including renal, urology and peripheral cannula teams (Giles et al., 2015; Moore, 2013; Oliveira and Lawrence, 2016). There is evidence of the benefit of nurse-led ultrasound initiatives in improving patient care, reducing complications, reducing hospital costs and promoting patient comfort (Baumann et al., 2008; Steinwandel et al., 2017). From a cardiology nursing perspective, a nurse-led approach to the performance of ultrasound examination of arterial access has not been reported within the literature.
Aims
This paper describes a single centre experience using a prospective observational cohort study design of a nursing-led model with four main aims: (a) to determine the feasibility of implementing a nursing-led ultrasound programme to measure RA diameter before and after cardiac catheterisation; (b) to determine RAO rates; (c) to determine risk factors for RAO; and (d) to determine predictors of RA diameter.
This study involved training specialist nurses to perform basic ultrasound measurements and quantify the RA diameter in the pre- and post-procedure phases of cardiac catheterisation.
Materials and methods
The study was conducted from 30 November 2016 to 21 December 2016. Ethical approval was obtained from the institutional human research ethics committees (AU201702-05). Verbal consent was obtained from all patients. The investigation conforms with the principles outlined in the Declaration of Helsinki (Rickham, 1964).
Participants
Consecutive adult patients who underwent a cardiac catheterisation or PCI (n = 100) during the study period, using a RA approach in a regional tertiary referral centre; patients were not randomised.
Inclusion and exclusion criteria
All patients undergoing cardiac catheterisation or PCI procedures using a RA approach were eligible for inclusion. Patients with ST-segment myocardial infarction (STEMI) were excluded as were patients where a trans-femoral approach was used for the procedure (n = 26). Included within this group were (n = 7) patients who had a crossover arterial access from radial to femoral access. In addition, STEMI were excluded (n = 19).
Research design
The study was performed using a prospective observational cohort study design.
Study setting
The tertiary referral hospital used in this study is located in regional NSW Australia. The referral base has an approximate area of 131,785 km2 with a population of 950,000 people on the east coast of Australia. The cardiac catheterisation laboratory is staffed by senior interventional cardiologists, fellows and training resident staff, in addition to nursing, radiography and cardiac technical staff. This cardiac catheterisation laboratory performs approximately 2200 cardiac catheterisations and PCIs each year, in addition to treating approximately 400 patients with STEMI each year (Khan et al., 2016).
Protocol and procedures
RAO was defined as the absence of flow using doppler after undergoing invasive assessment and treatment. RA diameter was examined to define sheath to artery ratio.
Prior to commencement of the study routine ultrasound to quantify measurements of the RA prior to a procedure were not current practice in this group of patients. To undertake this study the following protocol using a standardised approach was conceived and developed by a clinical nurse specialist (TW) and reviewed by a professor of cardiology (AB). Four senior nursing staff employed as clinical nurse specialists were selected to undergo training in ultrasound measurements limited to RA diameter and flow dynamics. Staff were selected based on having more than five years cardiac catheterisation experience and post graduate qualifications in cardiac nursing. Initial training of the technique to be used by the specialist nurses was undertaken by a professor of cardiology with extensive experience in this area. Further training involved a review of current literature, training in the recording of information to ensure standardisation of data collection, and a didactic educational presentation. The specialist nurses were accredited to undertake the procedure when examination of the RA diameter and patency were accurately recorded against a known RA assessment result. To ensure accuracy of performance of the ultrasound, inter-observer reliability assessments were undertaken during this training period, assessed using ‘percentage of agreement’. All trained specialist nurses achieved the required 90–95% to establish inter-observer reliability (Burns, 2014). Once inter-observer reliability was achieved on 20 patients, the trained nurse specialist commenced independently measuring and recording the RA diameter. Patency flow images were recorded immediately before the procedure and after haemostatic device removal post procedure. Images that indicated RAO were reviewed by the interventional cardiologist on duty during the training period.
Trained specialist nurses who performed the ultrasound were rostered in the pre-procedure and recovery areas of the catheterisation laboratory to avoid any disruptions to workflow. Prior to cardiac catheterisation all patients had an ultrasound performed to the RA using the Sonosite S-ICU machine using a 10 hertz probe (Sonosite Inc, Bothell USA) by the trained nurses. Longitudinal and cross-sectional images were obtained for each patient. An arm board was used on each patient for bracing hand extension to ensure consistent angle of measurement. The diameter of the RA was obtained by measuring 1 cm proximal to the styloid process and then measuring the internal diameter of the RA. Calliper measurements were performed and images were stored. The longitudinal view was then obtained and doppler flow was assessed to determine artery flow post procedure recorded in this view to the mid-forearm. RA measurements were recorded in millimetres.
RA access was obtained by the attending proceduralist, which included senior interventional cardiologists, interventional fellows and training cardiologists. Lidocaine 1% was administered prior to RA sheath insertion. Patients routinely received intra-arterial glyceryl trinitrate and heparin with varying doses depending on the proceduralist’s preference. The arterial sheaths were removed from all patients immediately post procedure. Haemostasis was achieved using a commerically available radial haemastasis device.
Ultrasound measurements were repeated following haemostasis device removal undertaken by the same trained nurses who took the pre-procedure measurements. No adverse events related to the ultrasound procedure were recorded in this group of patients. Ultrasound equipment is easily accessible in most cardiac catheterisation environments. The training and supervision of nurses allowed easy adoption of this low risk, non-invasive adjunct to patient care.
Other measures
Demographic information, cardiovascular disease risk factors and medical management information were obtained by accessing patient’s medical records. The procedural time, procedural characteristics and RA measurements were obtained from both the patient’s medical records and the haemodynamic reporting system within the cardiac catheterisation laboratory. Admission related information was obtained from the hospital’s inpatient tracking systems. Variables were selected according to clinical relevance. Data was stored on a password protected database.
Statistical methods
All statistical analyses were programmed using SAS v9.4 (SAS Institute, Cary, North Carolina, USA). Baseline descriptive statistics are presented by counts and percentages for categorical variables and means (standard deviation) or median (min., max.) for continuous variables. Based on medium effect size and predictor variables and 80% power the required sample size to detect population associations is approximately n = 98 using 0.1 significance level tests.
Logistic regression was performed to determine the factors associated with RAO (yes or no) following cardiac catheterisation. The variables examined in the model selected on clinical relevance were sex (male v. female), age (categorised as >65 years or ≤ 65 years) and obesity (body mass index (BMI) > 25). Procedural data included anticoagulant dosage of Heparin, the dosage of sedation, the number of punctures, sheath to artery ratio of >1, presence of RA spasm, radial diameter <2.2 mm, TR application time of >190 min and procedural length >30 min.
Logistic regression was performed to determine factors associated with RA diameter of 2.2 mm or greater based on the mean diameter of the patient group. Variables examined in this model were sex (male or female), age (> 65 years or ≤ 65 years), BMI > 25 or ≤ 25, current smoker (yes or no), diabetes (yes or no), hypertension (yes or no), dyslipidaemia (yes or no) and systolic blood pressure (greater than 140 mmHg). Height was dichotomised based on the mean height of 1.72 m (≤ 1.72 m or above 1.72 m) and weight was dichotomised based on the mean weight of 88 kg (> 88 kg or ≤ 88 kg).
Results of the logistic regressions are reported as odds ratios (ORs) or adjusted ORs (AORs) with 95% confidence intervals (CI). Statistical significance is set at p < 0.05. Due to the low number of patients with unfavourable procedural outcomes, only age and gender were adjusted for in the regression model.
Results
Characteristics of consecutive patients undergoing trans-radial access for coronary catheterisation or percutaneous coronary intervention (n = 100).
CABG: coronary artery bypass graft; MI: myocardial infarction; PVD: peripheral vascular disease.
Diagnostic cardiac catheterisation was performed more commonly than PCI (57 v. 43%), with right RA (91%) and 6 French sheaths (78%) favoured in the majority of patients. Most patients required a single site of vascular access, with 7% requiring cross-over to femoral artery access who were subsequently excluded from this study. Pre- or intra-procedural sedation (fentanyl and midazolam) was used in 71% of cases, with 29% receiving no sedation, only local anaesthetic. Reassuringly on 94% of occasions, arterial access was achieved on the first puncture. The mean duration of the radial compression device band application was 211 min (SD 76.6 min) which was more than the protocol recommendation of 180 min, with a difference noted depending on patient location following the procedure. Higher acuity areas such as Coronary Care, recorded lower compression times than the less acute cardiology medical wards. Procedural characteristics are outlined in Table 1.
The mean initial RA measure was 2.20 mm. A total of 53 patients had an RA diameter measure of greater than 2.20 mm. There was a mean increase in radial diameter from 2.20 mm in the pre-procedural measurement compared with 2.47 mm in the post-procedural measurement (p = 0.005). On univariate analysis a haemostasis device application time of greater than 190 min increased the odds of development of RAO (OR 3.12, 95% CI 0.31–31.1, p = 0.007) in this group of patients. Due to the small number of patients with RAO, further significant associations were unable to be determined and therefore multivariate analysis was not performed.
Logistic regression was undertaken to determine the predictors of RA diameter of greater than 2.20 mm, adjusting for age and sex. This showed male gender (AOR 4.54, 95% CI 1.76–11.7, p = 0.02) and height of greater than 1.74 m (AOR 2.91, 95% CI 1.29–6.57, p = 0.01) were significant predictors of increased RA diameter in this patient group.
Discussion
This study aimed to determine the clinical feasibility of implementing a nursing-led programme to measure RA diameter before and after coronary intervention procedures, to determine RAO rates, risk factors for RAO and predictors of RA diameter. The results suggest that a nurse-led model of using ultrasound to measure diameter of the RA is feasible with no adverse events associated with the implementation of this programme reported. It offers valuable clinical data to assist in detecting early RAO and enhancing patient care in a cardiology setting.
Nursing-led performance of pre- and post-procedural ultrasound measurement and colour doppler flow utilisation in a cardiac catheterisation environment has not been previously described in the literature to our knowledge. Nursing staff are important elements in the early detection of procedural complications and are a key element in interventional nursing standards (White et al., 2018). This research addresses a previously underreported complication from a nursing perspective, and this innovative approach can be easily adopted in any cardiac catheterisation laboratory, offering a valuable adjunct to clinical care.
The RAO and vascular complication rates were relatively low (4%), which is comparable to previously published data on RAO (Kotowycz et al., 2014; Uhlemann et al., 2012). While the complications related to RAO do not have the prognostic implications of femoral access complications, RAO may result in pain, readmission, the need for surgery and will prevent future RA access (Pancholy et al., 2016). Nursing adoption of any measures that can reduce RAO is timely and important.
The utilisation of ultrasound measurements and colour doppler may translate to a range of clinical benefits. The optimisation of patient selection for RA approach for cardiac catheterisation and PCI, particularly for patients perceived to be at higher risk of RA access failure. Equipment selection may also be guided by ultrasound derived RA diameter prior to attempted arterial access (Chugh et al., 2015). For example, appropriate sheath and catheter size may be more accurately selected, allowing for improved patient-centred procedures and potential reduction in access-site injury. Evidence suggests that ensuring a ratio of the RA internal diameter to external sheath diameter greater than 1 may reduce the incidence of RAO (Saito et al., 1999). Avoidance of vessel trauma may limit the risk of RA spasm and reduce the rate of crossover from TRA to trans-femoral access (Beyer et al., 2013).
The thrombotic mechanism of RAO ensures that both anticoagulation dose and compression time remain important considerations of TRA (Goswami et al., 2016). A Heparin dose of 5000 units maybe protective of RAO while it has been well established that lower doses may be predictive of RAO (Bazemore and Mann, 2005). Arterial occlusion and time to haemostasis remains a pertinent issue for interventional nursing staff delivering post-procedural care (Fech et al., 2012). Increased compression time has been demonstrated to be a significant contributor to RAO resulting in future inability to utilise TRA (Kiemeneij and Boink, 2016). Solutions to reduce haemostasis time include; patent haemostasis which refers to allowing controlled RA bleeding after sheath removal and allowing antegrade blood flow which avoids occlusive compression. This can be confirmed by plethysmography or alternatively if bleeding occurs (Wilson et al., 2017). Our data showed that compliance with the compression time could be improved. It maybe enticing to speculate that our RAO rate could be improved with improved protocol adherence. This would be a useful area of further research by collaborating with other centres.
There is emerging data supporting ulnar artery occlusion (allowing increased flow through the RA via antegrade flow) which has been demonstrated to reduce RAO immediately post procedure (Koutouzis et al., 2016), and at 30 days (Pancholy et al., 2016). This advanced technique can be adopted in those centres seeking to reduce the incidence of RAO. As nursing is predominantly responsible for the care of the TRA site post procedure, increasing nurses’ knowledge of RAO has practical clinical benefits, and maybe an area for further nursing led research. Data collected in this study showed higher compression times in less acute wards. Continued vigilance by cardiology nurses around adherence to, or development of protocols designed to reduce RAO through education, training and research will be a positive step to RAO reduction.
One of the recognised complications of TRA is that the RA is prone to spasm causing tight vascular constriction, pain, loss of palpable pulse and transient entrapment of the arterial sheath and/or catheter (Ho et al., 2012). This study group showed a low RA spasm rate. Our study demonstrated high usage of intra-arterial glyceryl trinitrate usage after sheath insertion and high usage of intra-venous sedation. This may be associated with a subsequent quantified increase in RA diameter recorded post-procedurally and maybe linked to a reduced likelihood of RA vasospasm (Boyer et al., 2013). The use of sedation has been shown to reduce pain and anxiety, promote a more positive patient experience and reduce RA spasm (Deftereos et al., 2013). An additional explanation for increased artery diameter recorded post procedure could include the effect of the sheath stretching the RA during the procedure (Dharma et al., 2017).
The benefits of pre-procedure doppler imaging assessment of radial arteries to minimise sheath artery mismatch has been well described (Chugh et al., 2015). In this group of patients, predictors of a higher radial diameter were being tall and being a male. The sheath to artery diameter plays a significant role in radial RAO with a clear association of smaller diameter sheaths producing less RAO (Dahm et al., 2002; Saito et al., 1999). In the era of chronic total occlusion and complex PCI, these procedures may require large access site catheters, and more specialised equipment to aid in the performance of these procedures (Galassi et al., 2014). The ability to accurately measure RA diameter becomes increasingly important to inform radial access (Seto et al., 2010). Specialised cardiac catheterisation nurses who perform ultrasound are well positioned to support this.
There are clearly described benefits of utilising ultrasound guided assistance to aid arterial access compared with palpation (Tang et al., 2014). These benefits centre on reducing multiple punctures and reduction in haematoma rate (Tang et al., 2014). Quantifying pre-procedural measurements of the RA diameter via ultrasound measurement is a useful planning tool (Chugh et al., 2015). Results should be incorporated into standard cardiac catheterisation admission documentation which may inform practice improvements and policy change for cardiac nurses. Further research for nursing may involve testing the long-term impacts that this innovative change in nursing policy has on nursing job satisfaction, the nursing experience of translating this change into practice, and patient outcomes.
Conclusion
A nurse-led approach to ultrasound in interventional cardiology is feasible and offers a range of clinical benefits including pre-procedural planning, allowing early identification of potential complications for patients who undergo RA access for cardiac catheterisation. This first step in establishing the feasibility of this programme will lead to prospective nurse-led trials in both inpatient and outpatient settings to determine efficacy and allow long-term follow up of cardiac catheterisation patients.
Limitations
The limitations of this study include that this is an observational study in a single centre with a small sample size. Patients were not randomised, and the design lacked long-term follow-up and did not include primary PCI so definitive conclusions regarding the implications of ultrasound assessment in emergent cases cannot be made. From this study the feasibility of nursing-led ultrasound measurement pre- and post-cardiac catheterisation procedures has been established, however future research using a randomised controlled trial design is needed to establish efficacy and to build on these findings.
Key points for policy, practice and/or research
A nursing-led routine assessment of patients undergoing cardiac catheterisation is a feasible change in policy for nursing staff as a means of pre-procedure assessment. It can be used to assist in planning for procedures and to assist in identifying potential procedure complications early. It provides useful quantifiable clinical information to optimise clinical care through identification of patients at risk of RAO. In addition, it will aid in early nursing intervention strategies for those patients identified as having a complication. Compression times were shown to be a predictor of RAO in this patient group. Development of guidelines to enable evidence-based practice to ensure safely minimising compression time of haemostatic device maybe an important adjunct to nursing care. Being a tall male was a predictor of increased RA diameter in this patient group.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
Ethics statement
Ethical approval was obtained from the institutional human research ethics committees (AU201702-05). Verbal consent was obtained from all patients. The investigation conforms with the principles outlined in the Declaration of Helsinki (Rickham, 1964).
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Hunter Medical Research Institute ‘Building Research and Interdisciplinary Collaborations Nursing and Midwifery Research and Innovation Grant’ funded by the University of Newcastle School of Nursing & Midwifery (grant number -HMRI 16-59). Funding source: BRICS.
