Feasibility and Safety of Right and Left Heart Catheterization Via an Antecubital Fossa Vein and the Radial Artery in Patients With Heart Failure
Abstract: Objectives. Heart failure is the leading cause of hospitalization among patients older than 65 years of age. A significant proportion of patients require heart catheterization for diagnostic, therapeutic, and prognostic purposes. To determine the feasibility and safety of full arm-arm catheterization access, we aimed to compare this approach with other established catheterization approaches. Methods and Results. In this retrospective cohort study, a total of 493 consecutive patients with heart failure requiring right and left heart catheterization were studied and analyzed. Subsequently, all patients were divided into three groups based on the catheterization approach used: arm-arm, hybrid femoral-arm, and femoral-femoral access. The three groups did not significantly differ in their baseline clinical, demographic, or risk factor characteristics. The full arm-arm catheterization procedures were significantly longer when compared with hybrid femoral-arm and femoral-femoral approach (73 min vs 68 min vs 67 min, respectively; P=.04), but remarkably provided significantly less fluoroscopy radiation dose (40,337 ± 64,799 cG/cm2 vs 62,270 ± 120,420 cG/cm2 vs 156077 ± 566495 cG/cm2, respectively; P=.04). Procedural complications were rare and occurred in 0.9% of the arm-arm group, 4.8% of the femoral-arm group, and 3.3% of the femoral-femoral group (P=.45). Finally, in arm-arm patients, a significantly earlier ambulation was achieved compared with the others groups (P=.02). Conclusion. Full arm-arm access for bilateral heart catheterization in patients with heart failure proved to be a safe and feasible approach, and was associated with lower radiation burden and early ambulation time when compared with hybrid arm-leg and full femoral catheterization approaches.
J INVASIVE CARDIOL 2017;29(9):301-308. Epub 2017 June 15.
Key words: heart failure, heart catheterization, radial access, femoral access
Heart failure (HF) affects approximately 5 million people in the United States; more than 550,000 new cases of HF are reported each year. Approximately 1%-2% of the adult population in developed countries has HF, with the prevalence rising to ≥10% among the population ≥70 years old.1 Combined right heart catheterization (RHC) and left heart catheterization (LHC) and hemodynamic assessment represent common diagnostic procedures when treating patients with advanced HF.2 Combined heart catheterization is also useful for the evaluation of valvular heart disease (ie, aortic stenosis, mitral stenosis, etc) and intracardiac shunts (ie, atrial septal defect, etc). Finally, a combined heart catheterization is required in selected patients with end-stage HF who are eligible for heart transplantation or implantation of a ventricular assist device as bridge to transplantation or destination therapy.3
The first-ever RHC was performed in 1929 by Werner Forssmann through the antecubital vein using a cut-down technique.4 This approach has been subsequently replaced by proximal venous approaches through femoral, internal jugular, or subclavian veins because of the larger vessel sizes and their greater accessibility. When performed in experienced centers, these approaches are associated with low mortality and morbidity rates.5 Nevertheless, RHC with a femoral vein approach may be associated with several complications, including hematoma, bleeding, delayed discharge due to prolonged bed rest, and infections.5,6
On the other hand, radial artery access is widely recommended as the default approach for LHC, including coronary angiography and percutaneous coronary intervention (PCI). Recent large multicenter trials, such as RIVAL7 and MATRIX,8 along with relevant center-based studies, have demonstrated that radial access reduces the occurrence of adverse clinical and major bleeding events when compared with femoral access9,10 in patients with acute coronary syndromes undergoing complex PCI.
Similarly, since heart catheterization may be required in old and frail patients with HF, it is crucial to avoid complications and to achieve early ambulation and short hospitalization times.
Recently, several studies11-19 reported benefits using the radial artery and either a forearm or antecubital fossa vein, when performing RHC and LHC. However, the majority of these studies had a limited sample size, and above all, none of these studies compared a full arm-arm approach (using the radial artery and either a forearm or antecubital fossa vein) to a hybrid approach (using the radial artery and the femoral vein), or to an entirely femoral approach (using the femoral artery and femoral vein).
In this single-center retrospective cohort study, we aimed to evaluate the impact of radial access vs hybrid and femoral access in patients undergoing RHC and LHC.
Methods
Patient selection. The study was conducted in a single tertiary center performing >3000 cardiovascular diagnostic procedures per year. Patient clinical, angiographic, and procedural data (including procedure duration) were prospectively recorded on a dedicated catheterization laboratory database. All consecutive patients undergoing RHC at our hospital between August 2009 and October 2015 were selected from the database. No exclusion criteria were applied. According to the local practice, the majority of these patients also underwent LHC and coronary angiographic study. The decision concerning the selection of both LHC and RHC approach was at the discretion of the individual operator. All patients provided written informed consent for the procedure and were required to fast for 12 hr. The medical records of all patients were retrospectively reviewed for the present study. In particular, all clinical data (creatinine clearance, cardiovascular risk factors and clinical presentation, indications for RHC) were re-checked for consistency, and the occurrence of any complication until hospital discharge was carefully investigated. The procedure time was defined as the time elapsed from entering to exiting the catheterization laboratory. Procedure-related complications included major hematoma (defined as hematoma requiring surgery or transfusion, or associated with hemoglobin decrease ≥3 g/dL), minor hematoma (none of the criteria for major hematoma were fulfilled), vascular complications (including vascular perforation, arteriovenous fistula, pseudoaneurysm, dissection, vascular thrombosis, peripheral embolism, and compartment syndrome), retroperitoneal hematoma, gastrointestinal or genitourinary bleeding, intracranial or eye hemorrhage, hemorrhage (treated surgically or percutaneously), requirement for blood transfusion, requirement for antithrombotic therapy, hypovolemic shock, and cerebral complications (including major stroke, minor stroke or transient ischemic attack [TIA]).
Catheterization procedure. The selection of arterial and venous access sites was left to operator discretion. Yet, according to the local practice of our center, radial artery access was preferred for LHC, with the femoral artery being the main alternative option. The technique for radial artery approach has been reported in detail.20 Briefly, a hydrophilic 5 Fr or 6 Fr Radifocus Introducer II sheath (Terumo Medical) was used and unfractionated heparin was routinely injected directly into the radial artery through the sheath to prevent thrombosis. Direct arterial injection of nitrates was performed in cases of radial spasm only. Coronary angiography was carried out using Judkins curve catheters as standard. Different curve catheters were used in case of inability of the default catheters to engage the coronary ostia. At the end of the procedure, the arterial sheath was removed and hemostasis was achieved using an inflatable wristband (TR Band; Terumo Medical) or a pressure bandage with three elastic sticky straps. Patients were allowed to walk immediately, but were not allowed to use the punctured arm for 4 hr after the procedure.21 The femoral artery approach was performed through an anterior wall puncture of the common femoral artery using Seldinger’s technique. Through a 16 g needle and a 5 Fr non-hydrophilic Pinnacle introducer sheath (Terumo Medical), catheters were inserted and diagnostic coronary angiography and LHC were performed. After the procedure, hemostasis was achieved using manual compression. In most cases, an elastic bandage was applied for 6 hours, and the patients were restricted to bed rest.
Regarding RHC, the femoral vein was the preferred approach by most operators during the study. However, two operators (FB and CT) routinely considered an arm vein as their first approach. In particular, the antecubital fossa vein was selected because it was usually the largest on inspection and/or palpation. Thus, both cephalic orbasilic veins were liberally used, but the basilic veins were favored in the presence of similar vessel size estimation. Arm vein approach was performed with a 6 Fr short radial sheath (10 cm Radifocus Introducer sheath and 10 cm Glidesheath Introducer Sheath [Terumo Medical]) or long radial sheath (25 cm RadifocusII Introducer sheath).
A tourniquet was applied to the upper arm by a nurse in order to evaluate the suitability of the antecubital fossa/forearm vein; if one of the two veins (either cephalic or basilic vein) were prominent, the antecubital fossa/forearm area was cleaned with antiseptic solution. A puncture of the antecubital fossa/forearm vein was performed with a 20 g Insyte intravenous cannula (IV catheter; Becton Dickinson Medical). Subsequently, the tourniquet was removed aseptically. According to Seldinger’s technique, a 6 Fr vein sheath was exchanged with the cannula under local anesthesia with 2% lidocaine infiltration (Figure 1). Once access was gained, a 110 cm, 6 Fr, balloon-tipped, two-lumen, Balloon Wedge Pressure catheter (Arrow International) was advanced via the sheath into the superior vena cava (SVC) up to the right-sided heart and pulmonary artery. Of note, in the case of any resistance to catheter/wire advancement, venography was performed in order to examine the vasculature anatomy by injecting 4 cc of contrast media through the sheath so that guidewires or catheters were safely advanced to gain superior vena cava access (Figure 2; Videos 1-3).
Once the balloon catheter was inflated, right-sided pressures and oxygen saturation were measured. At the conclusion of the procedure, the sheath was removed and compressive bandage gauze and plaster were applied over the wound. Patients were allowed to ambulate immediately after the procedure.
Femoral vein approach was performed with a 6 Fr or 7 Fr sheath. Skin in the femoral area was shaved and sterilized before starting the procedure. According to Seldinger’s technique, the sheath was inserted in the femoral vein under local anesthesia with 2% lidocaine infiltration. Next, a 110 cm, 6 Fr or 7 Fr, balloon-tipped, two-lumen Balloon Wedge Pressure catheter was advanced via the sheath into the inferior vena cava (IVC) and subsequently into the right heart for hemodynamic evaluation. After the procedure, the vein sheath was removed and direct manual compression was applied to the puncture site. Duration of manual compression was decided by the operator (generally, our laboratory’s standard duration was 10 min). Subsequently, a compressive bandage was applied for 2-4 hr to achieve venous hemostasis. During this time, the patients were required to have bed rest.
Statistical analysis. For the purpose of statistical analysis, patients were stratified into three groups depending on the heart catheterization approach: (1) femoral-femoral group (catheterization performed through femoral artery and femoral vein); (2) femoral-arm (hybrid) group (catheterization performed through radial artery and femoral vein); and (3) arm-arm group (catheterization performed through radial artery and arm vein). The differences in baseline anthropometric and clinical characteristics, cardiovascular risk factors, procedural variables, clinical presentation, clinical indications and complication rates were analyzed. For this reason, the comparison of means among observed groups was utilized by using the one-way analysis of variance (ANOVA) statistical test. All data analyses were performed using IBM SPSS for Windows, version 23.0 (IBM Corporation). Data were presented as frequencies and percentages of patients within a particular category of interest. All reported P-values in this study were 2-tailed and values <.05 were considered statistically significant.
Results
Characteristics of the study population. A total of 493 patients were consecutively included in the study. The main clinical characteristics are reported in Table 1. Briefly, 311 patients (63%) were female and mean age was 62 ± 14 years. In terms of cardiovascular risk factors, 149 patients (30%) had history of arterial hypertension, 111 patients (23%) had dyslipidemia, and 37 patients (7%) had family history of cardiovascular disease (Table 1).
The five most frequent clinical indications for heart catheterization in examined population were, in descending order: pulmonary hypertension (33.46%), mitral insufficiency (28%), mitral stenosis (17.24%), tricuspid insufficiency (9.73%), and congenital heart disease (9.12%). Constrictive pericarditis and hypertrophic cardiomyopathy guided the indication to the catheterization in 0.81% and 0.60% of cases, respectively (Table 1).
The study population was stratified according to catheterization access into the femoral-femoral group (n = 91 patients), the arm-arm group (n = 111), and the femoral-arm (hybrid) group (n = 125). As shown in Tables 2 and 3, all clinical characteristics except for age were similar across the three access groups.
Procedure conduction and complication according to catheterization access. Examining procedural variables, statistically significant differences among the groups were found in procedure duration (P=.04) and received fluoroscopy dose (P=.04). According to these data, arm-arm catheterization approach was significantly longer in procedure duration (73 ± 27 min) when compared with femoral-femoral access (67 ± 27 min) and femoral-arm catheterization access (68 ± 27 min).
However, in terms of fluoroscopy dose received, the arm-arm approach provided significantly less radiation exposure for the patient (40,337 cG/cm2) vs other catheterization approaches. The femoral-femoral approach yielded the highest fluoroscopy dose burden (156,077 ± 566,495 cG/cm2), followed by the femoral-arm (hybrid) catheterization approach (62,270 ± 120,420 cG/cm2) (Table 3). Finally, there were no significant differences among the groups with respect to fluoroscopy time.
Access failure or need to change the sheaths and/or introducers did not differ among groups. Table 3 reports the complication rates observed in the three access groups. Of note, complications were rare and not significantly different across study groups. Yet, the occurrence of complications was numerically lower in the arm-arm group. As expected, in patients in which the arm-arm approach was utilized, a significantly earlier ambulation was achieved compared with the others groups (P=.02) (Table 3).
In terms of specific complications, the femoral-arm group had the highest complication rate (4.80%; 6 total, comprising 3 pseudoaneurysms, 2 minor hematomas, and 1 arteriovenous fistula). Two complications occurred in the arm-arm catheterization group (1 minor hematoma and 1 vascular obstruction. The femoral-femoral group had 3 complications (1 retroperitoneal hematoma, 1 minor hematoma, and 1 peripheral embolism). No mortality cases occurred in any group (Table 4).
Discussion
HF is the leading cause of hospitalization in the population of patients older than 65 years of age in the developed countries.22 HF has a prevalence of nearly 6 million in the United States and more than 23 million worldwide and is associated with high morbidity, mortality, and health-care cost expenditures.23,24 A significant disability and morbidity are common in patients with HF, with the trend of progression over time and unfavorable prognosis:25,26 HF should be regarded as a clinical syndrome with challenging clinical and therapeutic decisions that have to be made by clinicians relying on patient history, physical examination, and appropriate procedures.
In this regard, heart catheterization is fundamental in HF patients with or without signs of pulmonary hypertension who are symptomatic despite optimal therapy or have an unclear hemodynamic status and, importantly, may be candidates for mechanical circulatory support (eg, left ventricular assist device) or heart transplantation.1,27,28
However, since heart catheterization may be an extremely problematic procedure in frail and vulnerable patients with advanced HF, it is crucial to ascertain which heart catheterization access strategy provides an optimal safety and reproducibility profile. For this reason, we wanted to compare and characterize the three most common catheterization approaches in a large, consecutive cohort of HF patients at our tertiary center.
Our results revealed for the first time in a large cohort of consecutive patients that full arm-arm approach entailing radial artery for LHC and superficial arm vein (cephalic or basilica vein) for RHC is a feasible alternative to full femoral and hybrid arm-leg catheterization. Moreover, we found that full arm-arm approach imposed a significantly lower radiation burden on the patient. Previously, Yang et al reported that transforearm (arm-arm) approach for bilateral heart catheterization was a safe and feasible alternative to transfemoral approach (femoral-femoral) in different clinical scenarios, while transfemoral approach was preferred for aortic stenosis, mitral stenosis, or atrial septal defect.14 Although slightly longer in procedural duration compared to other catheterization approaches, full arm-arm access also exhibited the lowest number of complications among the observed groups.14 However, no comparisons were made by the authors between full upper-limb approach and hybrid access catheterization, and they did not stratify patients according to presence of HF. Several studies recently reported the safety of hemodynamic assessment performed by upper-limb approach,13,16 and no differences were found in terms of cerebrovascular events; this was also confirmed by our study. In a prospective study, Williams et al demonstrated that bilateral heart catheterization using a full arm-arm approach was safe, with significantly reduced procedural time and screening time, as well as less fluoroscopy time when compared with full femoral access.16 Likewise, findings reported by Gilchrist et al showed that use of forearm for central venous access to right heart appeared safer than the use of femoral conduits.11
Although previous reports showed significantly more access-site complications in patients undergoing transfemoral procedures, we were not able to confirm this finding, even though the femoral-femoral access group in our study had 3 cases of access failure, compared with none in the other groups. Importantly, our results showed that the arm-arm approach significantly decreased time to ambulation, suggesting that a remarkable reduction of hospitalization time can be achieved when applying this strategy systematically in patients with HF. Moreover, shortened time to ambulation and hospitalization has the potential to reduce direct and indirect costs and may contribute to improve patient satisfaction and quality of life.29
Conclusion
This is the first study to date that compared the safety and feasibility of full arm-arm access to femoral-femoral and hybrid femoral-arm approach in a population of HF patients who required simultaneous bilateral heart catheterization. Our results showed that full catheterization access from the upper limb is a safe and feasible alternative to other catheterization approaches when accessing the heart bilaterally. Moreover, this access provided significantly less radiation burden to patients and was associated with the lowest number of complications and shortest time to ambulation.
Heart catheterization performed from the arm should definitely assume an important role in the modern catheterization laboratory, especially in patients with HF undergoing several catheterization procedures. Should we “forgo the groin” altogether?30 Further multicenter, prospective, randomized studies are needed before assuming this approach as a standard strategy in patients with HF.
Study limitations. Our study was a single-center retrospective analysis, based on the data obtained from our registry. Another potential limitation in our study was a sample size that was potentially insufficient to detect some differences among the groups.
Acknowledgments. The authors would like to thank the Coronary Care Unit staff of the “Policlinico A. Gemelli” Catholic University of the Sacred Heart for its invaluable help, support, and patience.
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*Joint first authors.
From the 1Department of Cardiovascular Medicine, Catholic University of the Sacred Heart, Rome, Italy; and the 2Department of Pathophysiology, University of Split School of Medicine, Split, Croatia.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.
Manuscript submitted February 9, 2017 and accepted February 17, 2017.
Address for correspondence: Domenico D’Amario, MD, PhD, Largo A. Gemelli, 8, 00168 Roma, Italy. Email: domenico.damario@gmail.com
