Author + information
- Received July 5, 2017
- Revision received August 3, 2017
- Accepted August 22, 2017
- Published online November 20, 2017.
- Abdulla A. Damluji, MD, MPHa,b,
- Daniel W. Nelson, MDc,
- Marco Valgimigli, MD, PhDd,
- Stephan Windecker, MDd,
- Robert A. Byrne, MB, BCh, PhDe,
- Fernando Cohen, MDf,
- Tejas Patel, MDg,
- Emmanouil S. Brilakis, MD, PhDh,
- Subhash Banerjee, MDi,
- Jorge Mayol, MDj,
- Warren J. Cantor, MDk,
- Carlos E. Alfonso, MDl,
- Sunil V. Rao, MDm,
- Mauro Moscucci, MD, MBAb and
- Mauricio G. Cohen, MDl,∗ ()
- aSinai Hospital of Baltimore, LifeBridge Health Cardiovascular Institute, Baltimore, Maryland
- bDivision of Cardiology, Johns Hopkins University, Baltimore, Maryland
- cDepartment of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin
- dSwiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland
- eDeutsches Herzzentrum München, Technische Universität München and DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
- fHospital Italiano de Buenos Aires, Buenos Aires, Argentina
- gApex Heart Institute, Ahmedabad, India
- hMinneapolis Heart Institute, Minneapolis, Minnesota
- iDivision of Cardiology, Department of Medicine, University of Texas Southwestern Medical, Dallas, Texas
- jCentro Cardiológico Americano, Sanatorio Americano, Montevideo, Uruguay
- kSouthlake Regional Health Centre, University of Toronto, Toronto, Canada
- lCardiovascular Division, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida
- mDuke Clinical Research Institute, Durham, North Carolina
- ↵∗Address for correspondence:
Dr. Mauricio G. Cohen, University of Miami, Miller School of Medicine, 1400 N.W. 12th Avenue, Suite 1179, Miami, Florida 33136.
Objectives The aim of this study was to examine the current practice and use of transfemoral approach (TFA) for coronary angiography and intervention.
Background Wide variability exists in TFA techniques for coronary procedures.
Methods The authors developed a survey instrument that was distributed via e-mail lists from professional societies to interventional cardiologists from 88 countries between March and December 2016.
Results Of 987 operators, 18% were femoralists, 38% radialists, 42% both, and 2% neither. Access using femoral pulse palpation alone was preferred by 60% of operators, fluoroscopy guidance by 11%, and a combination of palpation, fluoroscopy, or ultrasound by 27%. Only 11% used micropuncture in >90% of their cases. Performing femoral angiography immediately after access was preferred by 23% and at the end of the procedure by 47%, and not done at all by 31% of operators. Hemostasis by manual compression was preferred by 50%, collagen plug vascular closure device by 31%, and suture-based vascular closure device by 11% of operators. Judkins left and right catheters were preferred for diagnostic angiography of the left (99%) and right (94%) coronary arteries. Extra backup curves (XB or EBU) were most commonly preferred for percutaneous coronary intervention of the left anterior descending (80%) and left circumflex (80%), whereas the Judkins right catheter was preferred for percutaneous coronary intervention of the right coronary artery (86%).
Conclusions There is significant variability in preferences for femoral access technique. Even though recommended best practices advocate for fluoroscopic and ultrasound guidance, most operators use palpation alone. Femoral angiography is also not consistently used despite guideline recommendations. The lack of adoption of imaging guidance for vascular access deserves further investigation.
Transfemoral access (TFA) was first used for invasive hemodynamic assessment by Stephen Hales in the mid-18th century when he measured the blood pressure of a horse by inserting a brass rod in the femoral artery and observed the column of blood rising in a 9-foot glass tube (1). When Sones introduced his technique for coronary angiography in 1958, brachial artery cutdown was the predominant access site (2). Subsequently, vascular access for coronary angiography was modified to a percutaneous approach using TFA in 1967 by Judkins (3). Since then, and despite the increasing advocacy and use of transradial procedures, TFA remains the predominant access site for angiography and percutaneous coronary intervention (PCI) in the United States (4,5).
In 2016, the Society for Coronary Angiography and Interventions (SCAI) published a consensus statement on best practices in the cardiac catheterization laboratory, which was endorsed by multiple international societies of cardiovascular intervention. In that document, recommendations regarding access management, prevention of infection and bleeding, hemostasis and sheath removal, appropriate monitoring, and post-procedure care were discussed (6). The variability in TFA practice and adherence to these recommendations in the United States and worldwide has not been studied. In order to better understand the current operator preferences for TFA, technique, and target areas for improvements in quality of care, we conducted the i-FACTS (International Femoral Access Practices Survey). We also examined preferences on choice of diagnostic and interventional catheters, selection of antithrombotic therapies, methods to achieve hemostasis, and perceptions about complications encountered in clinical practice after TFA.
We created a structured, closed-ended questionnaire composed of 42 items, which covered the following topics: 1) demographic and procedural volume of responders; 2) patients’ characteristics for TFA selection; 3) technical aspects of access site puncture; 4) technical aspects of diagnostic angiography and intervention; 5) antithrombotic regimens for PCI; 6) hemostasis; and 7) post-procedure care.
We used an Internet-based software (Qualtrics, Provo, Utah) to generate and distribute the survey. In order to assess the feasibility to complete the survey within 10 min, we sent the online link to 10 pre-selected academic interventional cardiologists experienced with TFA. Modifications to survey questions and format were made to help clarify the meaning of each question and ensure that the survey was easy to understand. This methodology was previously examined and validated in a prior study (7). The survey was officially launched on March 18, 2016, and closed on December 7, 2016.
To maximize outreach, we approached international societies of cardiovascular interventions including SCAI, European Association of Percutaneous Cardiovascular Interventions (EAPCI), Canadian Association of Interventional Cardiology, and Sociedad Latinoamericana de Cardiología Intervencionista (SOLACI). We also used e-mail lists from well-attended educational courses focused on cardiovascular interventions in the United States, India, and Mexico. Finally, 2 authors (A.A.D. and D.W.N.) performed independent searches on PubMed to send personalized e-mails to academic interventional cardiologists worldwide. E-mails were sent out to more than 12,000 interventional cardiologists to ensure the highest number of participants. Operators from all countries were included if their electronic mail address was available within the server of the societies or educational courses. No exclusions based on region, operator characteristics, or practice were made. The invitation to participate in this academic survey was sent via the Internet multiple times to increase engagement and completion of the survey questions. To maximize privacy, the identity of the respondents remained unknown, and each respondent could answer the questionnaire only once. After survey completion, the data were downloaded from the server, and all analyses were performed using Stata 13.0 software (Stata Corporation, College Station, Texas). Categorical variables were reported as frequencies with their respective percentages. Comparisons were made using the Pearson chi-square test as appropriate. We considered a p value of <0.05 as significant, and all tests were 2-sided.
Of all the interventional cardiologists invited via e-mail, 987 operators from 88 countries completed the electronic survey (Figure 1). Most respondents were from the United States (n = 149, 20%), India (n = 67, 9%), Argentina (n = 62, 8%), Italy (n = 50, 7%), and Mexico (n = 34, 4%). The continent of origin of respondents were Europe (n = 257, 26%), North America (n = 211, 21%), Asia (n = 147, 15%), South America (n = 119, 12%), and Africa (n = 22, 2%). A total of 231 (23%) respondents chose not to disclose their practice location. Most operators were older than 40 years of age and were predominantly men. Most women respondents were from Europe (Table 1). Although the majority of operators in Europe identified themselves as “radialists,” most operators around the world identified themselves as “femoralists and radialists,” with the highest proportion in North America at 50%. The annual procedural volume was >100 PCIs for most respondents, with the highest-volume operators located in Europe. For both diagnostic angiography and PCI, TFA was used <25% of the time in the entire cohort, with lowest rates of use in Europe and Asia (<5%). The data for TFA usage during PCI was similar to diagnostic angiography (Table 1).
Technical aspects of TFA puncture
Pulse palpation only was the preferred TFA technique by 60% of operators. However, TFA access practice was starkly different in North America, where approximately one-third of operators prefer a combination of ultrasound, fluoroscopy, and pulse palpation (Figure 2, Table 2). In case of failure of the initial access attempt, the preferential crossover site was contralateral femoral among 81% of respondents. However, over one-quarter of operators in Asia preferred the radial artery as crossover site for angiography or PCI. Routine femoral angiography after femoral access was performed by 22% of the operators, mostly when a closure device was used, and usually at the end of the procedure. Operators who identified themselves as “femoralists” were more likely to prefer palpation of pulse alone without imaging guidance by fluoroscopy or ultrasound to obtain vascular access. Furthermore, these operators preferred to use a larger sheath size during diagnostic and interventional procedures (Online Table 1).
Technical aspect of diagnostic and interventional TFA procedures
Most operators used either 5-F or 6-F catheters for diagnostic procedures and mainly 6-F guide catheters for PCI. If iliofemoral tortuosity was encountered, most operators used a 0.035-inch Wholey wire to enter the abdominal aorta (Table 2).
For diagnostic procedures, most operators preferred Judkins left catheters to engage the left coronary artery and Judkins right catheters for the right coronary artery (RCA), left, and right saphenous vein grafts (Table 3). For interventional procedures, most operators preferred extra back-up guide catheters (XB or EBU) for PCI of the left anterior descending coronary artery and circumflex coronary arteries. For the RCA, most operators preferred the Judkins right guide catheter. The JR4 catheter was also the preferred for left and right saphenous vein grafts. However, in North America, operators preferred the Amplatz left and multipurpose catheters for left and right saphenous vein grafts, respectively (Table 4).
Antithrombotic regimen for TFA in elective PCI and acute coronary syndrome and hemostasis
Most operators in this survey preferred weight-based unfractionated heparin (UFH) for elective PCI and acute coronary syndrome (ACS). The highest preference for bivalirudin was in North America (17%). Only 2% of all respondents routinely use low molecular weight heparin (Figure 3). Manual compression was the most commonly preferred hemostasis method. Collagen plug and suture-based vascular closure devices (VCD) were commonly preferred in Europe (54%) and North America (70%) (Figure 4). Although 84% of respondents believed that their complication rate after TFA for elective or ACS PCI was <5%, femoral operators rarely discharged patients on the same day after an uncomplicated TFA PCI (Table 5).
Most operators stated that their rate of TFA use has decreased during the past 5 years. Whereas one-half of operators in Europe and North America believe that their TFA use will remain unchanged in the future (Figure 5).
In this large international study based on a collaboration of cardiovascular societies, we found that: 1) TFA is still a commonly used access site by interventional cardiologists around the world; 2) even though most operators in North America prefer to combine ultrasound and/or fluoroscopy with palpation for TFA puncture, the majority of interventional cardiologists in the rest of the world use pulse palpation alone to gain arterial access; 3) most TFA operators use the contralateral femoral arterial access as primary crossover site; 4) weight-based UFH remains the most commonly preferred anticoagulant agent around the world for transfemoral PCI; 5) most operators use manual compression to achieve hemostasis, however, VCDs seem to be widely popular in North America and Europe; and 6) most interventional cardiologists believe that their future TFA practice will not change over time.
Even though most diagnostic and interventional procedures in the United States are performed using femoral approach, there are few randomized studies that would guide TFA best practices for the avoidance of vascular and bleeding complications (8–11). Although routine real-time U.S. guidance for femoral arterial access did not improve the rate of common femoral artery cannulation, FAUST (Femoral Arterial Access with Ultrasound Trial) showed that ultrasound guidance reduced the risks of vascular access complications, decreased the time needed for vascular access, improved the first-pass success rate, and eliminated accidental venous punctures (11). Despite the encouraging results of this trial, a recent survey showed that most operators believed that ultrasound-guided femoral access resulted in prolonged procedural times and only one-half believed that ultrasound carried improved safety as compared with fluoroscopy and pulse palpation (12). Understanding the reasons behind the lack of adoption of evidence-based practices remains critical for improving cardiovascular outcomes.
Vascular access remains a critical component of procedures performed in the catheterization laboratory. Suboptimal access techniques may predispose to vascular and bleeding complications, which are in turn associated with increased mortality (13,14). Obesity, variation in anatomy, chronic conditions, and coagulopathy may also increase the risk for vascular access and bleeding complications (15). In 2010, a panel of experts recommended the use of ultrasound guidance for vascular access (venous and arterial) to improve safety and avoid complications (16). Even though the SCAI best practices in the cardiac catheterization laboratory do not address whether ultrasound- or fluoroscopy-guided access is necessary (6), less than one-half of operators in North America use a combination of ultrasound or fluoroscopy with pulse palpation to gain femoral access. The use of ultrasound-guided access was exceedingly low, and most operators around the world only use pulse palpation to gain vascular access (∼60%), suggesting important opportunities to improve clinical practice in the cardiac catheterization laboratory. Education in the use of ultrasound and fluoroscopic guidance is key, although limited availability of ultrasound devices in countries outside North America and Western Europe may in part explain their low use rates.
Even though the use of micropuncture needles is theoretically attractive because of their smaller profile (21 ga vs. 18 ga for standard needles), they have never been shown to be beneficial. In a retrospective single-center study, use of micropuncture needles was associated with higher risk for retroperitoneal hematomas, possibly due to inadvertent guidewire entry into small branches, such as the inferior epigastric and the lateral circumflex iliac artery (17). A randomized clinical trial testing micropuncture was terminated early due to low vascular complication rates (18). Similarly, another clinical randomized trial was terminated prematurely for low event rates (Micropuncture vs. Standard Common Femoral Artery Access; NCT02026180). Only 11% of participants in our survey used a micropuncture needle consistently (>90% of the time).
For diagnostic angiography, operators use either 5-F and 6-F sheaths whereas for PCI most operators prefer 6-F sheaths. Despite the development of many newer catheters, Judkins left 4.0 remain the most used catheter for left coronary artery angiography and the Judkins right is most commonly used for angiography of the RCA and left and right saphenous vein grafts. It is plausible that the higher use of vascular imaging devices and smaller size sheaths and catheters used by operators self-identified as radialists may explain why radialists have the lower rate of femoral complications.
For left anterior descending coronary artery and circumflex PCI, most operators prefer extra back-up systems. In a prior survey, the choice of guide catheters was similar for transfemoral and transradial PCI (7). Judkins right guide catheters are most commonly used for PCI of the RCA and left and right saphenous vein grafts. To a lesser extent, Amplatz left and multipurpose catheters are used for left and right vein graft PCI, mainly in North America and Europe. These findings may be related to the lower cost of conventional Judkins catheters compared with other catheters (19).
Despite the results of multiple clinical trials testing newer anticoagulant agents for elective and ACS PCI (20), recent data showed a decline in the use of bivalirudin monotherapy in the United States (21). A possible explanation for this change in trend include the results of the HEAT-PPCI (Unfractionated Heparin versus Bivalirudin in Primary Percutaneous Coronary Intervention) trial, which showed no difference in bleeding events between bivalirudin and UFH monotherapy, and improved ischemic endpoints and health care cost associated with UFH. Since the publication of this trial, the decline in the use of bivalirudin monotherapy was associated with an increase in the use of UFH monotherapy, likely due to a combination of convenient administration, point-of-care monitoring, reversibility, and low cost (20).
Although most interventional cardiologists in North America and Europe use VCD (suture- or collagen plug-based), most operators in the rest of the world prefer manual compression. The SCAI best practice recommendations lists manual compression, compression devices, and VCDs as options for femoral access site management (6). The document also recommends femoral angiography after vascular access to identify and/or prevent immediate complications.(6) Nearly one-third of respondents felt that femoral angiography was not needed. The lowest preference was in Asia and South America. Further, more than one-half of operators in Europe and North America perform femoral angiography at the end of the diagnostic or interventional procedures. These important findings highlight areas for improvement in access technique that can be achieved with education (6).
Same-day discharge after uncomplicated PCI has been shown to be safe and noninferior to standard overnight hospitalization (22,23). However, most operators prefer to keep their patients overnight after uncomplicated TFA PCI. Physicians in North and South America favored same-day discharge in comparison to other regions. In a recent review, a total of 1,339 patients (of 107,018) were discharged on the same day of PCI (same-day PCI rate 1.25%). The vast majority of these procedures were performed via TFA (∼96%), and bleeding complication rates were similar between same-day discharge and overnight stay. Further, there were no differences in death or rehospitalization rates (24). According to SCAI best practices, same-day discharge can be considered if appropriate monitoring has been completed, and the discharge is in line with patient’s and physician’s preferences (6).
Implication of the findings
This study found significant variability in preferences for TFA techniques. Much of the variability may reflect underlying limited education, engrained practices, scarcity of resources to obtain ultrasound devices, or strong perceptions regarding the lack of benefit for imaging guidance in vascular access. The diffusion of new practice techniques and innovative technologies depends on certain “drivers” and “barriers” from the social/behavioral perspective (25). Important parameters that play a critical role include the contextual factors necessary to promote the use of new techniques and devices. Wilson (25) showed that patients’ demand, lower costs of learning and performing the procedure, aggressive promotion of technology, and the magnitude of benefit perceived by the operators are important parameters that result in a “change of culture” to adopt new techniques and innovative devices. Although some of the variability in TFA techniques can be explained by the perception in lack of benefit by operators, evidence-based practices that result in lower vascular and bleeding complications in the cardiac catheterization laboratory should be encouraged by international cardiovascular societies.
Study strengths and limitations
This is the largest study that focused on femoral access techniques with an international scope. The results are contemporary and reflect current global practice of femoral access in the United States and around the world. Finally, it attempts to examine femoral access techniques using survey methodology that would not otherwise be possible.
Similar to prior surveys performed in the field of cardiovascular interventions, the present survey was created to understand current perceptions and preferences on TFA practice around the world and does not reflect actual use, complications, or temporal trends (7). Because we used Internet-based tools to reach out to interventional cardiologists worldwide, areas with limited internet access may be underrepresented. The number of respondents from Africa was low, and practice patterns reported in this survey may not be a true representation of interventional cardiology practices in that region of the world. Further, the survey may not have been sent to operators in countries who are not enrolled in international societies of cardiovascular interventions. Likewise, the practice profile may have missed operators who are less Internet connected such as those in developing countries. To maximize the response rate, we sent more than 12,000 e-mails via electronic servers of professional societies and well-attended educational courses focused on cardiovascular interventions. These e-mails were sent out multiple times to ensure that the highest number of operators respond to this survey. Although we acknowledge that the response rate of this study is 8%, this is the largest cohort of interventional cardiologists responding to a survey that help inform current femoral practices and techniques in the United States and around the world. Furthermore, the radial survey that has been previously performed by Bertrand et al. (7) has widely been cited as a benchmark to examine radial practices at large. This study highlights the fact that femoral techniques and practices are variable with persistence of techniques known to compromise safety. As such, our study serves the purpose of raising awareness on best practices for femoral access techniques in the catheterization laboratory. Approximately, 23% (n = 231) of respondents did not reveal the location of their practice. In order to present a clear picture of their practice and avoid bias, we presented them as a separate category titled “undisclosed location.” Finally, the Fisher exact test is intended for situations when expected values in cells are small (e.g., Africa), but the Pearson chi-square test was used to generate p values instead, given the large number of rows and columns used for cross-tabulation.
This international study provides evidence that femoral access remains an important technique in coronary angiography and intervention, but there are important gaps between best practices advocated by interventional societies and current practice. Contrary to some expectations, these significant variations in practice pose educational and quality improvement opportunities. Increasing use of fluoroscopic and ultrasound guidance for vascular access, performing femoral angiography immediately after obtaining access, and considering same-day discharge in selected patients are potential targets for improving quality of care and preventing TFA-related complications.
WHAT IS KNOWN? Transfemoral access remains the predominant access site for coronary angiography and PCI in the United States. In 2016, the Society of Coronary Angiography and Intervention published a consensus statement on best practices in the cardiac catheterization laboratory, which was endorsed by multiple international societies of cardiovascular intervention.
WHAT IS NEW? Significant variation exists in techniques and practices of transfemoral access for coronary angiography and PCI, which highlights important gaps between best practices advocated by societies of interventional cardiology and current clinical practice in the United States and around the world.
WHAT IS NEXT? Increasing use of fluoroscopic and ultrasound guidance for vascular access, performing femoral angiography immediately after obtaining access, and considering same day discharge in selected patients are potential targets for improving quality of care and preventing transfemoral access-related complications.
The authors would like to acknowledge Dr. Ivan Chevere for his help in the design and conduct of this study.
Dr. Windecker has received research grants to his institution from Bracco, Boston Scientific, and Terumo. Dr. Byrne has received speakers fees from B. Braun Melsungen AG, Biotronik, and Boston Scientific; and has received research grants to his institution from HeartFlow and Boston Scientific. Dr. Brilakis has received consulting/speaker honoraria from Abbott Vascular, Asahi, Cardinal Health, Elsevier, GE Healthcare, Medicure, and St. Jude Medical; has received research support from InfraRedx, Osprey, and Boston Scientific; and his spouse is an employee of Medtronic. Dr. Banerjee has received speaker honoraria from Medtronic, AstraZeneca, and Gore; and has received research grants to his institution from Boston Scientific and Merck. Dr. Rao has received consultant honoraria from Medtronic. Dr. Moscucci has received book royalties from Wolters Kluwer Lippincott Williams & Wilkins; and has stock ownership in Gilead Sciences, Inc. Dr. Cohen is a consultant for AstraZeneca, Merit Medical, Abiomed, Medtronic, and Terumo Medical; and is on the speakers bureau of Medtronic and Abiomed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- acute coronary syndrome(s)
- percutaneous coronary intervention
- right coronary artery
- Society for Coronary Angiography and Interventions
- transfemoral approach
- unfractionated heparin
- vascular closure devices
- Received July 5, 2017.
- Revision received August 3, 2017.
- Accepted August 22, 2017.
- 2017 American College of Cardiology Foundation
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