Management of large bore access complications in the era of trans-catheter aortic valve replacement

Abstract

Objectives

Trans-catheter aortic valve replacement is a commonplace procedure for patients with aortic valvular stenosis who are at a high risk for surgery, evidenced by the 34,892 trans-catheter aortic valve replacements performed in 2016. Trans-catheter aortic valve replacement’s rate of major vascular complications with second-generation closure devices is 4.5% according to a meta-analysis of 10,822 patients. To manage those complications, percutaneous approaches to arterial repairs show shorter length of stay, higher rate of direct to home discharge and equivalent outcomes at long-term follow-up. This study’s goal is to show that one center’s vascular access strategy can decrease open repairs and improve patient outcomes.

Methods

Our team began accessing the mid-common femoral artery at least 1–2 cm proximal to the takeoff of the profunda femoris. This allowed an endovascular stent to be deployed if necessary via contralateral femoral access. We performed a completion angiogram following every trans-catheter aortic valve replacement to ensure no arterial complications. We conducted a retrospective review of a prospectively maintained database for all trans-catheter aortic valve replacement cases at a tertiary care center from 1 January 2016 to 30 June 2018.

Results

A total of 699 trans-catheter aortic valve replacement procedures were performed with 25/31 (80.6%) cases met inclusion criteria. An increase was noted in the number of stent procedures versus cutdown procedures over time (P < 0.001). A decrease was noted in the number of vascular surgery team activations following trans-catheter aortic valve replacement (P = 0.004). A non-significant trend was noted toward a shorter median length of stay for the stent group (P = 0.149). There was no increase in 30-day mortality rate (0.0% for both groups) or 30-day readmissions (4/15 (26.7%) for stents vs. 2/10 (20.0%) for open repairs; P > 0.999).

Conclusions

This strategy is safe and feasible to implement and reduces the number of open repairs following trans-catheter aortic valve replacement, activation of surgical resources, and possibly the length of stay.

Keywords

Vascular access complications trans-catheter aortic valve replacement femoral access stents vascular surgical procedures

Introduction

Trans-catheter aortic valve replacement (TAVR) is a commonplace procedure for patients with aortic stenosis who are at a high risk for surgery, evidenced by the 34,892 TAVRs performed in 2016.¹ TAVR’s rate of major vascular complications with second-generation closure devices is 4.5% according to a meta-analysis of 10,822 patients. This is an improvement from the 15.3% of major vascular complications reported after use of first-generation closure devices in a 419 patient series by Genereux et al. during the PARTNER (Placement of AoRTic TraNscathetER Valve Trial) trial.² It is important to note that the number of patients requiring interventions to repair these complications was not reported in either series thus we cannot compare intervention rates.

Percutaneous approaches to arterial repairs following access complications show shorter length of stay and a higher rate of direct “to home” discharge. Drafts et al. found equivalent or improved rates of vascular event for percutaneous (18.8%) and surgical cutdown (21.3%).³ Regarding longevity, in a 56 patient report percutaneous repair showed no incidence of vascular complications or claudication symptoms at a mean follow-up of 676 days.⁴ The major limitation to routinely performing endovascular repairs for access site complications is proximity of the TAVR access site to the profunda femoris artery and the risk of devascularization of the profunda femoris artery with the placement of a stent (the word “stent” is used to signify an endovascular covered stent throughout the paper).

Most patients undergoing TAVR are prohibitive risk patients for surgical intervention. With this in mind, our team thought it appropriate to adjust our procedural techniques to facilitate minimally invasive salvage of access complications given the lower perioperative morbidity of endovascular techniques. To facilitate endovascular repairs following TAVR, the Cardiac Surgery team in coordination with the Vascular Surgery team changed their TAVR access strategy in a transition process that began early in 2016.

Our team began accessing the mid-common femoral artery at least 1–2 cm proximal to the takeoff of the profunda femoris. This allowed an endovascular stent to be deployed if necessary via contralateral femoral access. In addition, a completion angiogram was performed via contralateral femoral access following every TAVR implantation to ensure no extravasation, pseudoaneurysm, severe stenosis or arterial damage from the closure device. This allowed any abnormalities to be immediately corrected by stent graft placement via contralateral femoral access without open repair or return to the operating room (OR).

Methods

Access strategy

Prior to the present institution’s change of access strategy, the operative team accessed the femoral artery via 4 Fr micropuncture access kit at the level which appeared most conducive to needle puncture on ultrasound. Femoral access prior to the change of access strategy could be immediately adjacent to the profunda femoris artery or within the external femoral artery. During the procedure, a 14 Fr or 16 Fr sheath was utilized as the Edwards Sapien III heart valve which was most commonly used required a 14 Fr sheath for 20 mm, 23 mm and 26 mm valves and a 16 Fr sheath for 29 mm valves. Following the procedure, the second-generation closure device was deployed, manual pressure applied for several minutes and the patient was sent to the post-anesthesia care unit. When bleeding or other access complications developed, the patient would return to the OR with the vascular surgery service for a salvage operation where the majority of cases were surgical cutdowns.

The current strategy consists of three parts:

Access of the common femoral artery via 4 Fr micropuncture hollow-bore Seldinger technique with a 0.018 wire at least 1–2 cm proximal to the takeoff of the profunda femoris artery and below the inguinal ligament via ultrasound guidance.

Completion angiogram via 6 Fr contralateral femoral access following the deployment of two second-generation closure devices (6 Fr ProGlide) in preclose fashion.

Immediate wire advancement and stent graft deployment of a Gore Viabahn VBX Balloon Expandable Endoprosthesis via 7 Fr or 8 Fr “up and over” sheath to repair active extravasation or complete or near complete occlusion prior to leaving the OR.

Within the described access strategy, only ultrasound guidance was utilized to localize the access site and two second-generation closure devices were used in preclose fashion during every case. Manual pressure was held following sheath removal for 15 min. The above access strategy was implemented gradually beginning in 2016 as an idea for quality improvement between RL, the Cardiac Surgeon who performs the most TAVRs at the institution and DM, a Vascular Surgeon closely involved with the cardiac surgery team. The strategy was initially performed on selected patients deemed high risk for vascular access complications. As the strategy met the desired aims (decreased open repairs), the strategy was moved to be used in all procedures at some point during the 2017 calendar year.

Retrospective review

A retrospective medical chart review was performed to include all patients undergoing TAVR at a single tertiary care institution from 1 January 2016 until 31 December 2018. Utilizing the cardiac surgery’s internal quality database, all patients undergoing TAVR during that time period were identified. All patients indicated with any complication consecutively underwent individual chart review.

The review assessed for date of procedure, vascular complications, need for any type of additional procedures, 30-day readmission, 30-day mortality and length of stay. Exclusion criteria included: patients whose sheaths were not removed or were upgraded for Extracorporeal Membrane Oxygenation or Impella access; patients undergoing non-femoral TAVR; patients receiving stenting for non-access site bleeding; and patients under 18 years old. Summary statistics were calculated for outcomes of interest and compared using Wilcoxon rank-sum test and Fisher’s exact test. Significance of trend over time was assessed using Cochran–Armitage test. All tests were two-sided and P-values of less than 0.05 were considered statistically significant. All analyses were conducted using the program, R 3.5.1.⁵

Results

From 1 January 2016 until 31 December 2018, 699 TAVR procedures were performed at the institution. Of these procedures, 6/699 (0.9%) were reported to have major vascular complications and 28 (4.0%) were reported to have minor vascular complications as defined by the Valve Academic Research Consortium recommendations. Of the total study sample, 153 (21.9%) charts were flagged for complications, which included a wide array of clinical issues from subclinical hematomas to major complications not related to vascular access. A total of 153 flagged medical charts were analyzed with 31/699 (4.4%) of cases requiring additional procedures for access complications.

Procedures performed

Further review revealed 25/31 (80.6%) of cases met study inclusion criteria. Excluded cases are detailed below in Table 1. Of the 25 included cases, 14/25 (56.0%) received stents only, 10/25 (40.0%) patients received surgical cutdowns only and one patient required a surgical cutdown following stent placement 1/25 (4.0%). This patient required both interventions as endovascular stent placement did not control access site bleeding. This patient was included in the surgical cutdown group for post-operative outcome analysis. Of the 14 patients who received stents, there were no instances of coverage of the profunda or complications at the access site.

Table 1.

Excluded cases and rationale.

Case	Reason for exclusion
1	Bleeding managed with thrombin injection
2	Bleeding managed with thrombin injections ×2
3	Sheaths removed via cutdown per attending preference on postoperative day 1, no active bleeding at time of procedure
4	Sheaths removed via cutdown per attending preference intra-operatively, no active bleeding at time of procedure
5	Patient placed on ECMO at end of procedure, sheaths upsized
6	Ruptured aorta during case requiring open chest and abdomen, received stent to access site in addition to a multitude of other procedures but bleed later found to be coming from extravasating branch of internal iliac artery

ECMO: Extracorporeal Membrane Oxygenation.

Patient outcomes

Between cutdown and stent cohorts, no differences for both cohorts were noted in 30-day mortality rate (0.0%) and wound complications (0%). There were six 30-day readmissions, 4/15 (26.7%) for stents and 2/10 (20.0%) for open repairs (P > 0.999). A non-significant trend was observed toward shorter median LOS for the stent group (P = 0.149). These comparisons are detailed in Table 2. Long-term post-procedure patency data are not available at this time for the studied cohort of patients, but this is an area for further investigation in the future.

Table 2.

Comparison of stent versus surgical cutdown.

Outcome	All interventions (n = 25)	Stent (n = 15)	Cutdown (n = 10)	P value
Length of stay, median [IQR]	4 [3–6]	3 [3–8]	5 [4–5.75]	0.149
Readmission (%)	5/25 (20%)	3/15 (20%)	2/10 (20%)	>0.999
Team performing intervention
Cardiac	13/25 (52%)	13/15 (87%)	0/10 (0%)	<0.001
Vascular	12/25 (48%)	2/15 (13%)	10/10 (100%)	<0.001

IQR: interquartile range.

As pictured in Figure 1, a statistically significant trend was demonstrated in the number of stent procedures versus cutdown procedures during the study period (P < 0.001). An increasing trend may be noted in the number of salvage operations over time; however, this increase corresponds to an increase in the total number of TAVR procedures performed at our institution over that time, the total overall intervention rate stayed relatively stable at 3.93% in 2018 from 4.12% in 2016.

Figure 1.

Stent and cutdown usage for arterial repairs over time.

In 2016, all salvage procedures were surgical cutdowns but in 2018 only one surgical cutdown was performed for an occluded common femoral artery due to malfunction of a second-generation closure device. Similarly, as seen in Figure 2, a statistically significant trend was noted in whether the salvage procedure was performed by the cardiac surgery team performing the index TAVR or a separate vascular surgery team (P = 0.004).

Figure 2.

Surgical service performing salvage procedures over time.

Resource utilization

In 2016, all salvage operations were being performed by the vascular surgery team. These were all separate operations requiring the patient to return to the OR as well as a second surgical team to be assembled for the operation. In 2018, 75.0% of salvage procedures were performed by the cardiac team who performed the index TAVR operation.

Discussion

The investigators of the present study chose to change the institution’s access strategy in an effort to decrease the number of surgical cutdowns. By reducing the amount of surgical cutdowns following TAVR, the team aimed to decrease patient morbidity and mortality. This change was the product of discussion regarding the nature of a minimally invasive procedure, TAVR, with an open surgical salvage technique, surgical cutdown. TAVR is a procedure with an almost complete saturation in the high risk and prohibitive risk for surgery population. The majority of patients undergoing TAVR are high risk, thus the authors find it counter-intuitive to utilize strategies which favor an open repair in the era of available and arguably equivocal, endovascular techniques.

Following the strategy change, the institution was able to meet our goal of demonstrating a statistically significant decrease in surgical cutdowns as illustrated in Figure 1 (P < 0.001). Additionally, we observed a significant decrease in the utilization of vascular surgery resources to complete the required salvage operations as seen in Figure 2 (P < 0.004). Aforementioned, the decreased use of vascular surgery resources corresponds to a decreased utilization of OR resources as 75.0% of cases in 2018 did not require a separate operative team assembly or additional OR time. Our goal was to show a difference in outcome measures; unfortunately, we were unable to show a significant difference in outcome measures such as length of stay or mortality. While we assume that percutaneous salvage procedures, similar to an independent procedure on the groin, would have an improved safely profile our study was underpowered to prove that assumption.

In discussing our access strategy with other providers, concerns were raised regarding contrast use, radiation exposure and complications regarding stent patency. We felt the additional step of the procedure was appropriate given the relatively low amount of additional contrast and radiation required to do a focused angiogram in light of the quote 4.5% risk of access site complications. Regarding stent complications, it is the authors’ opinion that given the high-risk nature of this patient population, the morbidity of an open cutdown and the excellent safety and patency profile of stent grafts within the common iliac artery this is the most appropriate strategy for these patients. The increased use of stent grafts may also affect the overall cost effectiveness of our access strategy as stent placement is generally more costly than prophylactic surgical cutdown done at the time of the initial operation. Prophylactic surgical cutdowns are not routinely performed at our institution for TAVR procedures.

Choice of stent

A VBX stent was chosen as it is able to gain immediate bleeding control and has an anecdotal improved precision of deployment over a self-expanding stent. As the VBX is a balloon-mounted stent, the step of removing the stent delivery device and inserting a balloon is removed. A self-expanding stent would be preferable in such proximity to the inguinal ligament as the increased rigidity of a VBX across the groin is a concern. However, given the elderly and frail nature of our patient population, limited life span and limited activity, the advantages of the VBX during the procedure were weighed as more valuable than the aforementioned detractions. Our patients are followed with ultrasound and CTA and no reinterventions have yet been required for stenosis or stent thrombosis.

Retroperitoneal hematoma

Retroperitoneal hematomas are a commonly cited concern with more proximal access of the common femoral artery. Of our 669 cases only 4 (0.57%) retroperitoneal hematomas were observed, one of which required endovascular stent placement. The authors were unable to find a published rate of retroperitoneal hematomas following TAVR; however, the retroperitoneal hematoma rates for cardiac catheterizations which are a much smaller sheath are between 0.15% and 0.5%.⁶,⁷ We evaluated for access site complications from the second contralateral femoral access site, but no complications or issues were found including instances where stents were deployed. Other clinical concerns were more difficult to ascertain from the database and chart review due to the subjective nature of evaluation of hematomas and bleeding not requiring intervention.

Crossover balloon occlusion technique

During the PARTNER trial, in a 58 patient series, an access strategy including routine angiography and crossover balloon occlusion technique (CBOT) was described by Genereux et al.⁸ This strategy uses an angioplasty balloon inflated proximal to first-generation closure device during sheath removal and knot advancement.⁸ This technique required further intervention in 10.8% of patients, stenting in 5.4% (3/58) and surgical repair in 5.4% (3/58). Our team was aware of CBOT, but CBOT was not utilized because of the high re-intervention rate in comparison to endovascular stenting.

Future considerations

Further investigations are indicated with regards to access strategies, access complications and the mechanism of access complications as endovascular interventions continue to rise in utilization. A multi-center cohort study comparing the access strategy of the present study and differing strategies at similar institutions would be the next best step to help confirm our findings and assess for any other impacts these strategies may have on patient outcomes. For instance, prophylactic surgical cutdowns are generally not performed for TAVR at the author’s institution; however, in a well-selected patient with high potential to fail percutaneous closure strategies (calcified arteries and femoral stenosis) this could be appropriate and may warrant further investigation. In addition, as there is minimal follow-up data regarding stents in common femoral artery following TAVR, further assessment of long-term patency and their effect on future femoral procedures between stents and surgical cutdowns is indicated.

During manual chart review, our team noticed a large discrepancy regarding which patients were flagged for minor and major vascular complications and which patients met criteria for minor and major vascular complications. As major and minor vascular complications are a commonly used metric for vascular procedures, our team wondered if this discrepancy could exist for other research groups databases and if complications rates are in fact different than reported.

In terms of database use, national databases do not collect information regarding access techniques such as the methods and equipment utilized for access. Inclusion of more accurate access related information would improve the ability to study different access strategies across a larger patient population.

Limitations

Our study was a retrospective cohort study which inherently has limitations regarding claims of causality. As a result, the present findings do not fully confirm an increased number of surgical cutdowns would lead to shorter length of stay as analysis produced a non-significant trend toward shorter median LOS (P = 0.149).

Study scope was limited from reporting outcomes of a single center’s experience of access complications following TAVR. Although our study cohort was robust, including 699 cases, of these cases only 25 patients received surgical cutdown or stent interventions. There were 6/31 (19.4%) exclusions which were discussed above which highlights the heterogeneity of the patients within the study and is one of the difficulties in studying access complications which happen to a small proportion of patients (∼4.5%).

Conclusions

We were able to implement a change in access strategy in less than three years which proved effective in decreasing the number of surgical cutdowns and vascular surgery activations without any increase in intervention rate (3.93% in 2018 from 4.12% in 2016) or any noted negative effects on patient outcomes. This led to 75% of access complications being repaired during the index operation without return to the OR in comparison to 0% at the beginning of the study. Additional studies are indicated to further evaluate the ideal large-bore access strategy; however, the previously described approach appears safe and effective in decreasing the number of surgical cutdowns and utilization of surgical resources following TAVR.

Footnotes

Acknowledgements

Thank you to Chang Liu, PhD, MA, Devon T. Collins, MPH, CPH, CHES, and Neul Ha, BS of the Inova Fairfax Department of Surgery Research Team for their assistance. This study was presented in Scientific Session II at the 33rd Annual Meeting of the Eastern Vascular Society, Pittsburg, PA, USA, 5–7 September 2019.

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.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Institutional Review Board

Approved by Inova IRB as an exempted study, number U19-04–3513.

ORCID iD

Michael H Parker

References

Messenger

JC.

Trends in United States TAVR Practice. Cardiac Interv Today 2017; 69: 1215–1230.

Généreux

Webb

Svensson

, et al. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial. J Am Coll Cardiol 2012; 60: 1043–1052.

Drafts

Choi

Sangal

, et al. Comparison of outcomes with surgical cut‐down versus percutaneous transfemoral transcatheter aortic valve replacement: TAVR transfemoral access comparisons between surgical cut‐down and percutaneous approach. Catheter Cardiovasc Interv 2018; 91: 1354–1362.

Grossman

Siverberg

Berkovitch

, et al. Long-term outcomes of iliofemoral artery stents after transfemoral aortic valve replacement. J Vasc Interv Radiol 2018; 29: 1733–1740.

Team

RC.

R: a language and environment for statistical computing. 2013. R Foundation for Statistical Computing, Vienna, Austria. http://www.R-project.org

Sreeram

SUHA

Lumsden

Miller

, et al. Retroperitoneal hematoma following femoral arterial catheterization: a serious and often fatal complication. Am Surgeon 1993; 59: 94–98.

Kent

Moscucci

Mansour

, et al. Retroperitoneal hematoma after cardiac catheterization: prevalence, risk factors, and optimal management. J Vasc Surg 1994; 20: 905–913.

Genereux

Kodali

Leon

, et al. Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation. Jacc Cardiovasc Interv 2011; 4: 861–867.