Outcomes of Radial Versus Femoral Access in Patients With Severe Aortic Stenosis Undergoing Percutaneous Coronary Intervention Prior to Transcatheter Aortic Valve Replacement

Abstract

Background. The safety and feasibility of radial access in patients undergoing percutaneous coronary intervention (PCI) prior to transcatheter aortic valve replacement (TAVR) has not been studied. Methods. This study included consecutive patients who underwent PCI within 30 days before TAVR at Mayo Clinic. Vascular access was left to the discretion of the operator. Baseline demographics, procedural data, PCI outcomes, and subsequent transfemoral TAVR outcomes were extracted from patient charts. Results. A total of 331 patients were included in this study, with 107 patients undergoing PCI via radial access (rPCI), and 224 via femoral access (fPCI). Mean age was 80.6 years and 35.6% were females (35.5% rPCI vs 35.3% fPCI). More patients in the fPCI group had previous coronary artery bypass graft surgery (13.1% rPCI vs 34.4% fPCI; P<.001). Fluoroscopy time (13.36 minutes vs 18.86 minutes; P<.001) and contrast use (115 mL vs 140 mL; P<.01) were lower in the rPCI group than in the fPCI group. Crossover rate from radial to femoral was 6.5%. There were more access-site hematomas in the fPCI group (2.8% rPCI vs 14.3% fPCI; P<.001), with no statistically significant rate of other access-related complications. There was no difference in stroke, myocardial infarction, cardiac arrest, or unplanned surgery. There was no difference in bleeding or stroke between both groups during subsequent transfemoral TAVR. Conclusion. Radial access for pre-TAVR PCI is feasible and safe and is associated with a lower rate of access-site hematoma. This study supports the increased use of transradial access for pre-TAVR PCI.

J INVASIVE CARDIOL 2022;34(5):E356-E362.

Key words: percutaneous coronary intervention, radial access, transcatheter aortic valve replacement

Management of coronary artery disease (CAD) in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) has become increasingly important, particularly after expansion to lower-risk populations.^1-4 While coronary artery revascularization strategies in the TAVR population remain an area of active investigation, percutaneous coronary intervention (PCI) continues to be performed frequently.^5,6

Lower risk of bleeding and vascular complications associated with transradial access have been well established for coronary interventions, especially in patients with acute coronary syndromes.^6-17 However, transradial access for pre-TAVR PCI has not been specifically studied. Patients undergoing transfemoral TAVR have distinctive clinical characteristics with special technical considerations, particularly the need for preservation of femoral access for large-bore sheath insertion during TAVR and concern for the risk of hemodynamic collapse with the use of vasodilators to prevent radial artery spasm.^18,19 This underscores the importance of studying the feasibility and safety of radial access compared with femoral access for PCI and its impact on subsequent TAVR outcomes in this particular patient population.

The aim of this study was to examine the outcomes of patients who underwent radial-access PCI (rPCI) vs femoral-access PCI (fPCI) within 30 days before transfemoral TAVR. We hypothesized that radial access for pre-TAVR PCI was safe and associated with fewer vascular-related complications as compared with femoral access.

Methods

This was a retrospective analysis of consecutive patients undergoing PCI within 30 days prior to TAVR at Mayo Clinic in Rochester, Minnesota. A total of 331 patients undergoing pretransfemoral TAVR PCI from January 2016 to December 2019 were included. Selection of vascular access for PCI was left to the discretion of the operator.

Baseline demographics, procedural data, PCI outcomes, and subsequent TAVR outcomes were extracted from the patients’ electronic health records. The primary outcome was bleeding or access-site complications. Bleeding complications were classified according to the Bleeding Academic Research Consortium (BARC) criteria.²⁰ Access-site hematomas, irrespective of size, were extracted. Radial artery occlusion was defined as the absence of a radial artery pulse immediately post procedure. Details regarding access sheath size, vascular hemostasis, access-site crossover, complexity of PCI (including number of vessels treated), and presence of bypass grafts were also recorded. The study was approved by the Mayo Clinic institutional review board.

Statistical analysis. ​Continuous variables were presented as mean ± standard deviation or median (25th-75th percentiles). Discrete variables are summarized as frequency (percentage). Comparisons of baseline, procedural, and angiographic characteristics between groups were made using the Pearson’s Chi-squared test for categorical variables and the Student’s t test or rank-sum test for continuous variables. Statistical significance is defined as a 2-tailed P-value of <.05. Statistical analyses were completed utilizing SAS statistical software, version 9.4 (SAS Institute).

Results

Baseline characteristics. A total of ​331 patients were included in this study, with 107 patients undergoing rPCI and 224 undergoing fPCI. Mean age in the overall cohort was 80.6 ± 7.8 years and 35.6% were female (35.5% in the rPCI group vs 35.3% in the fPCI group). Diabetes was present in 43.5% and hypertension was present in 91.5% of the total cohort. More patients in the fPCI group had history of coronary artery bypass grafting (13.1% in  the rPCI group vs 34.4% in the fPCI group; P<.001). Baseline demographics are summarized in Table 1.

Echocardiographic characteristics. ​ Left ventricular ejection fraction was lower in the fPCI group compared with the rPCI group (58 ± 12% rPCI vs 54 ± 15% fPCI; P=.02). Mean aortic valve gradient (43.7 ± 12.2 mm Hg rPCI vs 41.4 ± 13.2 mm Hg fPCI), aortic valve areas (0.9 ± 0.5 cm² rPCI vs 0.9 ± 0.4 cm² fPCI), and peak velocities (4.1 ± 0.6 cm/s rPCI vs 4.1 ± 0.6 cm/s fPCI) were similar in both groups. Echocardiographic characteristics are summarized in Table 1.

Procedural characteristics. ​ Ultrasound-guided access was performed in 14.2% of cases (4.7% in the rPCI group and 19.2% in the fPCI group; P<.001). Left main PCI was performed in 2.8% of rPCI and 9.8% of fPCI cases; however, the difference did not reach statistical significance. Coronary artery bifurcation PCI (10.3% in the rPCI group vs 22.3% in the fPCI group; P<.01) and saphenous vein graft PCI (4.7% in the rPCI group vs 17.4% in the fPCI group; P<.001) were more frequent in the fPCI group. Intravascular ultrasound (IVUS) guidance was utilized in 14.2% of procedures, with more frequent utilization in the fPCI group (7.5% in the rPCI group vs 17.4% in the fPCI group; P=.01). Total radiation skin dose (601.64 mGy in the rPCI group vs 767.81 mGy in the fPCI group; P=.047), dose-area product (34.95 mGY•cm² in the rPCI group vs 48.48 mGY•cm² in the fPCI group; P<.01), and fluoroscopy times (13.36 minutes in the rPCI group vs 18.86 minutes in the fPCI group; P<.001) were lower in the rPCI group compared with the fPCI group. Total procedure time was longer in the fPCI group (64 minutes in the rPCI group vs 90 minutes in the fPCI group; P<.001), with more volume of contrast used (115 mL in the rPCI group vs 140 mL in the fPCI group). Intra-arterial nitroglycerin was administered in 18.7% and intra-arterial ­verapamil in 44.9% of the rPCI group. Procedural characteristics are summarized in Table 2.

Procedural complications. There was no difference in the BARC bleeding types 2 and 3-5 between both groups. One patient in the fPCI group developed retroperitoneal bleeding. Access-site hematomas were more frequent in the fPCI group vs the rPCI group (2.8% in the rPCI group vs 14.3% in the fPCI group; P<.001). Pseudoaneurysms were reported 0.9% of the rPCI group and 2.7% of the fPCI group. In the fPCI group, 1 patient developed an arteriovenous fistula. Access-site crossover was required in 6.5% of rPCI cases. Radial artery occlusion immediately post procedure occurred in 2.8% of rPCI cases. There was no difference in other complications including transient ischemic attack or stroke (0.9% in the rPCI group vs 0.4% in the fPCI group), cardiac arrests, or unplanned cardiovascular surgeries (Figure 1).

During subsequent transfemoral TAVR, there was no difference in vascular bleeding complications between both groups (14.0% in the rPCI group vs 8.5% in the fPCI group). There was also no difference in stroke post TAVR between both groups (0.9% in the rPCI group vs 3.1% in the fPCI group). Procedural complications are summarized in Table 3.

Discussion

The current study evaluated the outcomes of radial vs femoral access for pre-TAVR PCI (Figure 2) and demonstrated the following: (1) radial access was safe and associated with less access-site hematomas when compared with the femoral group; (2) femoral access was used in more complex interventions including bifurcation stenting and saphenous vein graft stenting, and was associated with higher radiation and procedure time; and (3) there was no difference in stroke or bleeding outcomes between both groups during subsequent transfemoral TAVR.

Transradial access has become the preferred route for coronary angiography and PCI worldwide.¹⁵ Prior studies showed that transradial access was associated with decreased mortality in ST-segment elevation myocardial infarction patients, along with less risk of vascular complications and improved patient satisfaction.^8,17 In patients with severe aortic stenosis, radial access was shown to be feasible and safe in complex PCI.²¹ However, in patients with severe aortic stenosis undergoing TAVR, there are further considerations that pertain to the choice of access in pre-TAVR PCI. Such considerations include efforts to preserve adequate femoral access for valve delivery site as well as the use of the radial artery as the secondary access site for pigtail insertion during TAVR. The latter approach was shown to reduce vascular and bleeding complications compared with femoral secondary access.^22,23 Outcomes of radial compared with femoral access in pre-TAVR PCI and its impact on subsequent TAVR has not been systematically studied. With the expansion of TAVR to the lower-risk population with longer life expectancy, the burden of coronary artery disease in this patient population is expected to grow. Therefore, aspects of pre-TAVR PCI, including choice of access, are gaining importance.

In the current study, rPCI access was used in 32.4% of patients undergoing pre-TAVR PCI. Radial-access PCI was successful in the majority of patients, with a rate of crossover to femoral artery of 6.5%. Prior radial access studies showed crossover rates ranging from 1.8%-4.7%.¹⁶ The crossover rate in the current study population may be higher for several reasons. Pre-TAVR patients are generally older and have a higher prevalence of radial and subclavian tortuosity.²⁴ Moreover, the use of vasodilators in patients with severe aortic stenosis is controversial given the risk of hemodynamic collapse, which can potentially predispose to more radial artery vasospasm. In the current study, intra-arterial nitroglycerin was used in 15% and verapamil in 44.9% of rPCIs, with no cases of shock after its administration. The decision to defer the use of vasodilator administration in 40% of patients was most likely based on operator concern over hemodynamic collapse in the setting of aortic stenosis and was not associated with the severity of the aortic stenosis. The latter is supported by the study finding that the aortic valve mean gradient in patients who received intra-arterial vasodilators was comparable in patients who did not receive intra-arterial vasodilators. More studies are needed to demonstrate the safety of vasodilator use in patients with severe aortic stenosis. In prior radial access studies, the frequency of BARC type 2 bleeding was 0.4%, while BARC type 3-5 ranged from 0.1%-1.7%.¹⁶ In these studies, large access-site hematomas ranged from 0.6%-1.2%.¹⁶ In the current study, BARC type 2 bleeding occurred in 0.93% of rPCI patients with no BARC type 3-5 bleeding, and 2.8% had access-site hematomas. The greater frequency of radial access-site hematomas in the current study compared with prior studies can be explained by the inclusion of all access-site hematomas irrespective of size, use of 6-Fr sheaths in 99.1% of cases, as well as the study cohort of elderly patients with higher-risk bleeding profiles. The rates of pseudoaneurysms, fistulas, and radial artery occlusions are low and similar to previously reported rates.¹⁶

More patients in the fPCI group had history of prior coronary artery bypass grafting, as well as more bifurcation and saphenous vein graft interventions. This was consistent with prior studies showing that the TAVR population had high prevalence of complex multivessel coronary artery disease and prior coronary artery bypass grafting with a higher mean SYNTAX score of 14.⁴ Calcific coronary artery disease was also shown to be common in the pre-TAVR evaluation.⁶ Such coronary anatomy often requires complex interventions, such as rotational atherectomy and bifurcation stenting, and the latter often requires larger sheath placement for larger guiding catheters. This may explain operator selection for femoral access in more complex coronary anatomy, despite the feasibility of the use of larger guiding catheters via radial approach, such as contemporary sheathless guiding catheters. Findings of this study along with the availability of contemporary larger radial guiding catheters may encourage the radial approach rather than defaulting to femoral access during complex PCI. Moreover, in our study, fPCI was associated with increased fluoroscopy time, radiation dose, and PCI duration. This could also be explained by the more frequent use of femoral access in complex coronary interventions, as well as the high frequency of ad hoc procedures in that patient group.

As for access-related complications, there were similar rates of BARC 2 and BARC 3-5 bleeding in the rPCI group compared with the fPCI group. One patient in the fPCI group had a retroperitoneal bleed. The rate of femoral pseudoaneurysms was 2.7% and arteriovenous fistula rate was 0.4% in the fPCI group. There was a higher rate of all sizes of access-site hematoma with fPCI compared with rPCI. These complications can preclude the use of the same femoral site for subsequent TAVR, and this is particularly important for patients who have that same side as their only amenable TAVR access site. One caveat in the current study was the relative underutilization of ultrasound guidance for femoral access. The use of ultrasound-guided femoral access was shown in the FAUST trial to reduce vascular complications driven by a decrease in large hematomas >5 cm (2.2%-0.6%).¹⁵ Increased use of ultrasound-guided access might impact the safety of femoral access in pre-TAVR PCI in these patients, and subsequent studies are needed to evaluate that option.

The current study did not find any difference in bleeding outcomes between rPCI and fPCI during subsequent transfemoral TAVR. This can be due to the use of the contralateral femoral side for valve delivery, ubiquitous use of ultrasound-guided femoral access (which is the standard of care during TAVR), and the growing use of the radial artery as a secondary access during TAVR.²⁵ The event rates were low, which could also be an explanation for the lack of difference in the bleeding rates between both groups. Larger studies are warranted to evaluate the impact of rPCI vs fPCI on subsequent TAVR-related outcomes.

Study limitations. ​This was a retrospective study, which is prone to selection bias. The choice of access site was not randomized, which can confound the results. Femoral-access PCI may have been used more often in more complex anatomy, such as bifurcation stenting, which could have impacted the outcomes. Hematoma size was not measured, and the impact of the hematoma size is unknown. Finally, ultrasound-guided access was uncommon and could have impacted the vascular complication rate.

Conclusion

Radial PCI in the setting of severe aortic stenosis in patients undergoing TAVR evaluation was safe and feasible and associated with acceptable crossover rates. Femoral access was used more frequently in more complex PCIs and was associated with more access-site hematomas. There was no difference in bleeding rates between both groups during subsequent transfemoral TAVR. Larger, prospective studies with greater utilization of ultrasound-guided access are needed to evaluate the impact of radial vs femoral access choice for pre-TAVR PCI.

Affiliations and Disclosures

From the ¹Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, Florida; and ²the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. D. Guerrero reports research grant support from Abbott Vascular and Edwards Lifesciences. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript accepted July 30, 2021.

Address for correspondence: Abdallah El Sabbagh, MD, Mayo Clinic, Department of Cardiovascular Medicine, 4500 San Pablo Road, Jacksonville, FL 32224. Email: elsabagh.abdallah@mayo.edu

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