Ultrasound-Guided Access Improves Rate of Access-Related Complications for Totally Percutaneous Aortic Aneurysm Repair

Article Outline

• Abstract
• Introduction
• Methods
• Results
• Discussion
• Conclusions
• References
• Copyright

Previous experience with totally percutaneous aortic aneurysm repair has identified morbid obesity and larger sheath sizes (≥20F) as complicating factors for percutaneous access closure. We sought to evaluate the impact of ultrasound-guided femoral access on rates of technical success, conversion to open femoral repair, and access-related complications. A retrospective review of a prospectively maintained database was performed. All consecutive patients undergoing totally percutaneous closure of large-bore-sheath (>12F) access sites with a suture-mediated closure device were included. The cohort was stratified into two groups by access technique, standard percutaneous femoral access, and ultrasound-guided femoral access. Patient variables were evaluated, and outcome measures included technical success, requirement for conversion to open repair, and access-related complications. Recorded conversions only included those related to access closure technique. During the study period, 88 consecutive patients underwent percutaneous closure of 152 large-bore access sites after endovascular aneurysm repair. There was no difference in the proportion of morbidly obese patients (body mass index >35kg/m²) between the two cohorts. Access-related complications were significantly reduced in the group undergoing ultrasound-guided access. Despite the lower complication profile with ultrasound guidance, 24 sites (41%) had sheath sizes ≥20F compared to only 21 sites (24%) in the standard access group (p<0.05). Evaluating conversions and technical success of percutaneous closure, a significant benefit was identified for sheath sizes ≥20F (p<0.05). Upon comparing the two cohorts, operative time continued to decrease from 154 (±64) to 101 (±56) min after the addition of ultrasound guidance for access (p<0.05). The addition of ultrasound-guided femoral access to totally percutaneous aortic aneurysm repair continues to increase the technical success rate for vessel closure and has a clinically profound impact on access-related complications. This technical adjunct appears to have the largest impact on patients requiring larger sheath sizes.

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Introduction 

The extensive use of endovascular therapy has produced a concomitant increase in percutaneous arterial closure techniques; however, only suture-mediated closure devices (SMCDs) have been utilized for closure of large-bore access sites. Haas et al.¹ initially described the “preclose technique” for closing large percutaneous arteriotomy sites (16-22F) after endovascular aneurysm repair (EVAR). This technique has been adopted by several authors, and they have demonstrated that percutaneous closure can be performed with very low morbidity and with technical success rates ranging 66-100%.¹, ², ³, ⁴, ⁵

The Prostar XL (Abbott, Menlo Park, CA) is an SMCD that relies on the delivery of four needles and two sutures through the arterial wall for subsequent closure at the conclusion of EVAR. There are few contraindications to utilizing this device. Several patient factors have raised concern for percutaneous closure, but few are absolute contraindications for use. This device has been evaluated in patients with atherosclerotic disease, and the presence of calcified plaque does not impact time to hemostasis or technical success rates.⁶ In addition, morbid obesity (body mass index [BMI] ≥35) has been found to increase the complication profile of percutaneous closure (odds ratio=14.8).⁷ A redundant pannus can obscure traditional landmarks for access, and deploying the SMCD through dense subcutaneous tissue can be challenging. Involvement of the inguinal ligament in the deployment of the SMCD has been identified as a factor associated with failed closure. Sheath size is the most consistent factor impacting technical success rates for percutaneous closure. Larger sheath sizes (≥20F) dramatically reduce the likelihood of technical success from 98% for ≤18F to 78% for ≥20F.⁷ In an effort to improve the technical success of totally percutaneous EVAR, our institution began using ultrasound (US)-guided access empirically for all access sites utilizing the preclose technique.

We sought to evaluate our own experience utilizing US-guided access, to compare it to our previous experience with percutaneous vessel closure and to identify any potential impact on technical success and access-related complications.

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Methods 

This is an institutional review board-approved study evaluating the experience of US-guided access on percutaneous EVAR outcomes. A prospectively maintained single-institution EVAR database was queried for all consecutive percutaneous EVARs performed from January 2003 to April 2007. All patients underwent percutaneous closure of large-bore sheath (>12F) access sites with off-label use of an SMCD (Prostar XL). Demographic data, intraoperative variables, and follow-up outcomes were recorded. Outcome measures included rates of technical success, conversion to open femoral arterial repair, and access-related complications. The following definitions were utilized for the study:

The majority of patients underwent preoperative and follow-up computed tomographic angiography (CTA) with axial slice intervals at 0.625mm. Patients with renal insufficiency (>2.0mg/dL) were followed with duplex ultrasonography. CTA extended below the femoral heads in order to preoperatively assess the common femoral arteries (CFAs). All EVARs were performed in an operating room. Both general and regional anesthetic techniques were utilized.

Early in our experience, the contralateral access site (smaller sheath size) was closed utilizing the preclose technique; but as our experience matured, we began to approach both ipsilateral and contralateral access sites with the preclose technique. Totally percutaneous aneurysm repair is offered to all elective EVAR patients in the absence of severe CFA occlusive disease or aneurysmal disease that would require simultaneous groin exposure and direct femoral arterial repair.

The preclose technique has been previously described by several authors with slight modifications in technique.¹, ², ³, ⁵, ⁸ Our technique has previously been described in detail.⁷ Prior to the addition of US guidance, percutaneous access was made based on landmarks, palpation of the pulse, and fluoroscopic identification of the vessel over the medial one-third of the femoral head. Once access was obtained utilizing a single-wall micropuncture technique, a 6F short sheath was placed over a wire. Then, contrast arteriography was performed at an oblique projection to confirm access in the CFA just above the profunda femoris artery. The 6F sheath was then replaced with the 10F Prostar XL SMCD (one device technique); the device was deployed, placing four needles and two sutures through the arteriotomy site. The arteriotomy site was then sequentially dilated up to in some instances 24F inner diameter in order to accommodate EVAR.

With the addition of US guidance, a US probe (Sonosite, Bothell, WA) was placed in a sterile probe cover and utilized to map the CFA with both axial and sagittal views. Marking the profunda femoris artery and scanning the anterior wall of the vessel for calcification typically takes a few minutes. US-guided access is then performed such that the arteriotomy is made just proximal to the profunda femoris artery; this ensures that the CFA has been punctured at the most distal aspect without accessing the superficial femoral artery. The wire is then placed, and the arteriotomy is dilated to accept the 10F Prostar XL. All patients are initially accessed with a micropuncture needle and then dilated to a 6F sheath after access. In addition, all patients were administered heparin during the procedure (80-100 U/kg). The remainder of the EVARs and vessel closures were performed in a standard fashion.

We learned that access too proximal in the CFA can lead to penetration of the redundant inguinal ligament in an obese patient. When the sutures were tied, the inguinal ligament was buttressed to the arteriotomy repair much like a pledgeted suture. When the patient stood, the abdominal wall pulled the sutures through the vessel wall, resulting in a hemorrhagic complication. Access too low in the groin can result in superficial artery or profunda artery punctures. Both can result in vessel thrombosis or arteriovenous fistula formation if unrecognized.

Because more complications are likely to occur with the larger sheath site, we removed the larger sheath site first while maintaining access from the smaller sheath site should angiographic evaluation of the larger sheath closure or proximal arterial control of the aorta be required. At the time of sheath removal, an assistant applied proximal pressure to the CFA. The sutures and subcutaneous tract were generously soaked with heparinized saline solution. The sheath was removed over a hydrophilic wire, and the first white suture was secured over the wire. The second green suture was then secured. Manual compression was then slowly withdrawn, and an assessment of hemostasis was made. Both knots were tightened again utilizing a “knot pusher.” If adequate hemostasis was achieved, the hydrophilic wire was removed and the knots were tightened one last time.

Patient variables were compared utilizing univariate statistics. Data are expressed as proportions for dichotomous variables and mean ± standard deviation for continuous variables. Differences between the two groups were determined by the Student t-test for parametric data and the Mann-Whitney U-test for nonparametric data. The chi-squared test was utilized for comparisons of nominal data, and the Fischer exact test was utilized when appropriate. Statistical significance was set at p<0.05. All analyses were performed utilizing SPSS 15.0 (SPSS, Inc., Chicago, IL).

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Results 

During the study period, 88 consecutive patients underwent percutaneous closure of 152 large-bore access sites after EVAR. All procedures were performed in an operative suite utilizing both general and regional anesthesia. Seven patients underwent percutaneous thoracic endovascular aneurysm repair. The predominant endograft utilized in this cohort was the Zenith stent graft (Cook, Bloomington, IN). Only 5.4% of patients experienced an access-related groin complication. Technical success was achieved in 95% of all patients, with a respective 5% conversion rate to femoral cutdown.

Baseline patient demographics are listed in Table I. There were no significant differences in baseline demographics after the initiation of US-guided groin access for all patients. In addition, there were no identifiable differences in BMI. Eighteen percent of patients had BMI <25kg/m², 66% had BMI of 25-35kg/m², and 16% had BMI >35kg/m². Comparing intraoperative variables between percutaneous femoral arteriotomy (PFA) and US-guided arteriotomy, no difference existed in transfusion rates, blood loss, or length of stay (Table II). There was a significant reduction in operative time after the initiation of US guidance, which we attribute to an increased surgeon and institutional learning curve and not directly to access technique. In addition, a significantly higher proportion of larger bore sheath sizes (≥20F) were treated in the US-guided cohort (41% vs. 24%, p<0.05).

Table I. Demographics of 88 patients undergoing percutaneous EVAR

Table II. Intraoperative characteristics and outcomes stratified by access technique

Seven patients required conversion to open femoral cutdown: six in the PFA group and one in the US-guided group. Five conversions in the PFA group were secondary to inadequate hemostasis (technical failures), and one patient was converted to open cutdown and retroperitoneal exposure secondary to external iliac artery transection. This complication was not related to access technique. The one conversion in the US-guided group was due to a device failure, and at the surgeon's discretion, a femoral cutdown procedure was performed. There were no conversions to open repair for thrombotic or embolic complications. The respective technical success for PFA was 94% compared to 98% for US-guided access. The complication profile for US guidance was markedly improved to 0% compared to the six patients (7%) undergoing PFA. Four of the six patients experienced hematomas, while two patients developed pseudoaneurysms.

The impacts of access technique and sheath size on outcomes are listed in Table III. The US-guided cohort did not experience a complication in 59 sites over a mean follow-up period of 9 (±5) months. US-guided access did have an overall reduction in the conversion rate for sheath sizes >20F, whereas the difference for smaller sheath sizes was negligible. Utilizing US guidance, the technical success for larger bore sheaths improved from 82% to 100%, p<0.05. The impact of BMI and outcome was also evaluated, but no significant differences were identified based on access technique. The one patient who required conversion in the US-guided cohort secondary to device failure had a BMI <35kg/m². Only seven patients in the US-guided cohort had a BMI >35kg/m² with a 100% technical success rate compared to 13 patients in the PFA group with a technical success rate of 87%, p=0.31. There were no thrombotic complications and no surgical site infections in this series.

Table III. Univariate comparison of access-related outcomes stratified by access technique and sheath size

	Access technique
Variable	PFA (n=93 sites)	US-guided (n=59 sites)	p
Access-specific complications
<20F	3 (4%)	0	0.314
>20F	3 (14%)	0	0.110
Conversionsa
<20F	3 (4%)	1 (3%)	0.598
>20F	3 (14%)	0	<0.05
Technical success
<20F	69 (97%)	34 (97%)	1.0
>20F	18 (82%)	24 (100%)	<0.05

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Discussion 

Totally percutaneous aneurysm repair can be performed with a high technical success rate and access-related complication profile that is extremely low. In this report, the overall technical success rate was 95% and the groin complication rate was 5%. Compared to a surgical site infection rate of 8%, a wound dehiscence and necrosis rate of 6.5%, and a lymphocele rate of 4% for femoral cutdown during EVAR,⁹ the benefit of percutaneous closure is profound. Patients who undergo femoral artery cutdown also have long-term morbidity that may present with delayed lymphoceles, chronic pain, and scrotal edema, whereas it is extremely rare for patients to experience delayed complications from percutaneous closure.⁴

The majority of data published on this technique represent case series from single institutions; however, several authors have reported risk factors for technical failures and for increased risk of groin complications. Both obesity and larger bore sheath sizes have been implicated as having a higher complication profile and a lower rate of technical success.⁷ Utilizing US-guided access, we report a negligible improvement in the outcomes for morbidly obese patients, but this technical adjunct does improve overall morbidity of the procedure and technical success rate for larger sheath sizes.

Obesity has uniformly been associated with groin complications and has been cited by several authors as a potential cause of SMCD failure.⁵, ⁷, ¹⁰, ¹¹ The redundant pannus and groin folds make percutaneous access a challenge. Often, an assistant is required to retract the pannus while classical groin landmarks are identified. While morbid obesity is a complicating factor for performing successful percutaneous closure, these patients are also at extremely high risk for wound complications following CFA cutdown and probably have the most to benefit from successful percutaneous closure.

Obese patients challenge the success of this procedure by distorting traditional groin landmarks and placing the surgeon at risk of cannulating too high or too low in the groin. If access is obtained too high through the shelving edge of the inguinal ligament and the SMCD buttresses the fascia to the arteriotomy site, the outcome can be devastating and potentially fatal when the patient ambulates. We have experienced this complication once, and it was the impetus for utilizing US guidance to ensure access as low as possible on the CFA without puncturing the superficial femoral artery. Utilizing US-guided access, no patient with a BMI >35kg/m² experienced a groin complication and all morbidly obese patients were successfully closed. The only conversion to an open femoral cutdown procedure occurred in a patient with BMI <35kg/m².

Larger bore sheath sizes ranging 18-20F also contribute to the risk of conversion to open repair and to procedural morbidity. While most series report a success rate of 90-95% for sheath sizes ≤18F, the success rate for sizes ≥20F approaches 50-85%.⁴, ⁵, ¹², ¹³ The majority of these failures are technical problems that may be limited with more experience utilizing the Prostar XL device.¹² Proper access is integral to the success of this technique when utilizing larger sheath sizes that have little margin for error. “Perfect” access equates with perfect closure. US-guided access has several clear advantages. It is inexpensive and readily available to vascular surgeons, and a surveillance exam can be performed within minutes. This allows the surgeon to identify appropriate location and a portion of the vessel with reduced calcification. Obtaining access just above the profunda artery, the surgeon ensures that the 10F Prostar device is not deployed in the superficial femoral artery or profunda artery, and this marks the lowest access point to avoid a “high puncture” through the patient's inguinal ligament and soft tissues.

We did not observe a single case of vessel thrombosis in our series, although this complication has been reported in other series.⁴ All patients in this series were anticoagulated with 80-100 U/kg heparin during the procedure, whereas some authors reduce the volume of heparin to 1,000-3,000 units for percutaneous EVAR. Another reason for the lack of thrombotic complications in our cohort may be attributed to ensuring access in the CFA as opposed to small-caliber vessels (superficial femoral artery or profunda femoris artery). In addition, we did not observe any cases of surgical site infection at the percutaneous groin site. This entity is a rarely reported event (0.2%) but can be associated with significant morbidity.⁴ It is our practice to utilize sterile adhesive drapes, preoperative antibiotics, and strict adherence to sterile techniques in all cases.

The off-label use of this SMCD is not without risk of conversion (5% in this series) to open femoral cutdown, and there is a clear learning curve utilizing the device. All cases requiring conversion were the result of inadequate hemostasis. We recommend that all procedures be performed in an operative suite and that the surgeon be familiar with interrogating the device and addressing malfunctions. When a technical failure occurs, a dilator can be advanced into the arteriotomy site over the hydrophilic wire that remains in place. Then, we will either deploy a second device or perform a controlled femoral cutdown on the CFA. Early in the learning curve it is prudent to utilize the SMCD just on the contralateral limb in thin patients and then progress to more difficult groins and larger sheath sizes after a comfort level is achieved.

Some authors utilize the 6F Proglide (Abbott) device for percutaneous EVAR. We routinely use this device for smaller sheath sizes. For larger sheath sizes, we prefer the 10F Prostar XL device for the following reasons: the device allows a single deployment, the suture needles are deployed from inside the artery, and it is less expensive. In our experience, the Proglide device requires two devices and two deployments. The second deployment is rotated such that the sutures cross, which can be an inexact process. In addition, the footplate that is deployed in the vessel allows very little rotation to separate the two sutures. While there are good outcomes with both devices, we prefer the deployment method of the Prostar XL (from inside to outside the vessel) for larger sheath size vessels. Lastly, the cost of a single Prostar XL device is approximately $200 less than the cost of two Proglide devices.

There are limitations of this study that deserve mention. The retrospective design of this report tends to inherent bias within the data. This series does represent a consecutive series of percutaneous EVARs both before and after a modification in access technique; however, there is still potential for selection bias. In addition, the data set is a small single-institution population, which increases the possibility of a Type II error. While a prospective, randomized controlled trial would be needed to validate our results, we feel that this is not warranted. The ease of use and other benefits of US-guided access have clear advantages in obese patients with large sheaths.

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Conclusions 

Percutaneous treatment of aortic aneurysmal disease offers several advantages over open femoral access, but this technique is not without risk of conversion to standard open femoral cutdown. The addition of US-guided femoral access to totally percutaneous aortic aneurysm repair continues to increase the technical success rate and has a clinically profound impact on access-related complications. Use of this adjunct adds little time or cost to the procedure, but obtaining guided access improves the technical success rate, especially in patients requiring larger bore sheath sizes.

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