Zhong-han, NI; Jian-fang, LUO; Wen-hui, HUANG; Yuan, LIU; Ling, XUE; Rui-xin, FAN; Ji-yan, CHEN

Section Editor(s): CHEN, Li-min

With early and intermediate outcomes showing reduced operative morbidity, mortality and shorter hospital stays, endovascular repair of aortic pathology has become more commonplace.^1,2 The conventional thoracic endovascular aortic repair (TEVAR) routinely requires surgical cutdown to expose the common femoral artery (CFA). Surgical cutdown increases invasiveness and the risk of complications.^3-6 Additionally, CFA exposure usually requires general or regional anesthesia.

Owing to the increasing number of TEVAR procedures and the introduction of suture-mediated closure devices, more safe and efficient as well as convenient vascular access management techniques are desirable. The use of suture-mediated closure devices was initially reported in 1999 by Haas and colleagues, who had achieved percutaneous access with up to a 22-F sheath using the 10-F Perclose Prostar XL device (Abbott Vascular, USA).⁷ The feasibility and safety of a Preclosing technique with two 6 F closure devices (Perclose Proglide, Abbott Vascular, USA) has been reported.⁸

We carried out a case-control study in 236 Chinese patients with type B aortic dissection (AD) or thoracic aortic aneurysms who underwent TEVAR since January 2008 in our cardiac center. The safety and efficacy of the Preclosing technique using a 6 F Perclose Proglide has been investigated.

METHODS

Patient selection

Group A includes consecutive patients who underwent TEVAR using the Preclosing technique between December 2009 and November 2010. Group B includes consecutive patients who underwent TEVAR with surgical femoral cut down from January 2008 to November 2009. The endovascular procedures consisted of percutaneous access requiring 20-25 F (outer diameter) sheaths. The common femoral arteries (CFA) were evaluated by preprocedural planning computed tomography angiography (CTA).

Patients who had other procedures or surgeries in addition to TEVAR were excluded. Other exclusion criteria includes small-caliber ilio-femoral vessels (<7 mm diameter), and the presence of a CFA aneurysm or dissection. Informed consent was obtained for endovascular treatment from all the patients and their closest relatives. Institutional review board approval was granted. All endovascular procedures were performed in the catheterization room under fluoroscopy by a team of cardiac interventionalists with/or without cardiovascular surgeons. All data from patients were rendered anonymous.

Procedure

Group A (totally percutaneous closure group)

An 18 gauge needle was used to puncture the CFAs under fluoroscopy along its anterior aspect at the mid-level of the femoral head. After over-the-wire introduction into the vessel, then two 6 F Perclose Proglide devices were placed. The first device was rotated laterally in a 30°-45° angle and then deployed in the standard manner, except that the Perclose suture strands were carefully extracted from the device and tagged extracorporeally with a hemostatic forceps under a piece of wet gauze. Before complete removal of the first carrier device, a 0.035 inch hydrophilic guide wire was reinserted into the femoral artery via a marked monorail wire tube in the first device in situ. A second Perclose device was then introduced and rotated 30°-45° medially, and activated. The sutures were again secured extracorporeally. The guide wire is reinserted followed by temporary insertion of a 9 F vascular sheath to maintain hemostasis. All endovascular aortic repair procedures were routinely performed. Upon completion of the endovascular procedure, anticoagulation is fully-reversed with an adequate amount of protamine and 5 mg dexamethasone to prevent allergic reaction. With aid of the knot pusher, the preformed knots are tightened according to the recommendations provided by the Perclose Proglide's manufacturer and manual compression was then released. After verification of hemostasis, the guidewire was removed. In case of persistent bleeding, a third or even a fourth Perclose device may be deployed before removal of the guide wire. Distal perfusion is checked and manual compression is maintained for a further 5-10 minutes following banding with elastic adhesive tape or a bandage, and patients are confined to bed for 4-6 hours. All these procedure could be accomplished either under general anesthesia or under local anesthesia with sedation. After the procedure, patients were sent to the CCU. CFA puncture sites were assessed by physical examination, Duplex ultrasono-graphy was performed if needed. Patients were allowed to leave the CCU when there was no need for mechanical ventilation and sedation, based on steady vital signs.

Group B (surgical cut down group)

In the control group we employed a cutdown procedure, a vascular surgeon was necessarily required and general anesthesia was used in most cases. CFA was exposed and repaired by the same surgeon with standard techniques. These patients and sites were monitored as was group A.

Data collection

A prospectively maintained interventional database at our institution was used. Patient demographics, comorbidities, procedural details, complications, costs and follow-up information were all recorded in a computerized database.

The primary endpoint of the study for both groups was technical success rate; which was defined as percutaneous closure without the necessity of surgery or endovascular site-related adjunctive procedures for hemorrhagic, infectious, or ischemic complications (in-hospital). The secondary endpoint included early access site-related complications (e.g., access site hemorrhage, pseudo-anurysm, infection, wound dehiscence, and hematoma), anesthesia method, procedure time in minutes (which was defined as the period from the patient lying on the catheterization table to the final dressing application), CCU stay in hours, time from procedure to discharge in days, hospital stay in days, procedure expense (RMB Yuan), hospital cost (RMB Yuan).

Statistical analysis

Continuous variables were expressed as mean±standard deviation (SD), and discrete data are given as counts and percentages. Comparisons of continuous variables were performed with two-sided Student's t tests. Differences in categorical variables were analyzed by the chi-square test or Fisher's exact test and Mann-Whitney test was used for cost calculation. Each access site was used as its own independent binomial categorical variable relating to the success or failure of closure. Significance was set at P <0.05 and reflected two tailed distributions in all cases. Statistical analyses were performed using the SPSS software (version 11.0, SPSS, Chicago, IL, USA).

RESULTS

Patients' characteristics

The 85 patients who underwent total percutaneous endograft placement using the Preclosing technique between December 2009 and November 2010 were enrolled in group A, while 151 patients treated using a traditional surgical cut down approach from January 2008 to November 2009 were included in group B. Table 1 shows the demographic and comorbidity data for both groups. About 90% of the patients were diagnosed with type B aortic dissections. The most common comorbidity of patients was hypertension. There were no significant differences between the two groups regarding their demographic and clinical characteristics. Table 2 lists the sizes of and models of endograft systems in each group.

Table 1

Table 2

Some technical details and the anesthesia methods are presented in Table 3. In group A, local anesthesia with conscious sedation was used for 58 of the 85 patients, 68.2% vs. 51.7% in group B (P <0.01). The overall technical success rate was 100% in group A vs. 97.4% in group B. Early complications were observed in 9.4% patients in group A vs. 22.5% of group B. There were two infectious sites, one dehiscence and one pseudoanurysm treated by surgical methods in the group B. In group A, 91.8% of arteries (78/85) required only two devices for closure. Three or four devices were required for hemostasis in 4.7% (4/85) and 2.4% (2/85) of cases.

Table 3

The procedure time and cost are compared in Table 3. The mean procedure time was 96 minutes in group A, 127 minutes in group B (P <0.01). The mean length of stay was 7.5 days after total percutaneous endovascular repair, as compared with 10.5 days after conventional endovascular repair (P <0.01). The differences in procedure costs and hospital costs were not significant between the two groups.

DISCUSSION

Although the traditional surgical cut down approach for TEVAR repair has obvious advantages, such as secure hemostasis and optimal arterial repair, the associated complications cannot be ignored.⁹ In an analysis of 186 patients, Morasch et al³ demonstrated a 22.8% incidence of complications in the open repair group vs. none in the percutaneous group in a 30-day follow-up. This result resembles the finding of our study, with early complications affected more than 20% patients in the traditional surgical cut down group. These procedures were performed in our catheterization suite instead of an operating room and the patients were monitored and cared by physicians after the procedures, which might partially result in more complications. While blood loss is more usual in the surgical cut down group than in the percutaneous group, as other authors reported,⁸ no blood transfusion was necessary in either group.

The Preclosing technique has predominantly been studied with Prostar systems (Abbott Perclose, USA). But as pointed out by Lee et al,¹⁰ the Prostar system features a cumbersome deployment mechanism. Off-label use of two 6-F Perclose Proglide devices for a Preclosing technique shows a potentially higher rate of successful closure. Therefore, in order to overcome the inherent shortcoming of the open exposure method, we switched to this recently described and convenient totally percutaneous technique.

In the present study, the Preclosing technique with two or more 6F Perclose Proglide devices followed by 20-25 F catheter introductions was evaluated in 85 femoral arteries. Technical success was achieved more often than surgical incision. The study indicates that this totally percutaneous endovascular stent-graft repair using the Preclosing technique is very safe and effective, which exceeds the results of other previous studies.¹⁰

We attribute this excellent success rate to several factors: First, we have sufficient experience with the 6 F Perclose Proglide devices; therefore we experienced a technique-specific learning curve without requiring a device-specific learning. Without this previous experience, it might require some practice before achieving a low failure rate.¹¹ Second, meticulous patient selection minimized complications. Especially, obtaining a contrast-enhanced CT scan down to the femoral bifurcation before the procedure is of paramount importance to optimal results. For percutaneous TEVAR, a CFA diameter that exceeds the diameter of the endograft outer diameter by at least 1.0 mm is required. Contraindications include morbid obesity (BMI >35 kg/m²), anterior or circumferential femoral wall calcification, or high suprainguinal femoral bifurcations,⁸ and must be respected. However, in our series no patient was excluded on the basis of these criteria, so we believe the high technical success rate may indicate favorable femoral anatomy in our cohort. Third, fluoroscopy is used to guide puncture of the anterior wall of the CFA directly overlying the midpoint of the femoral head. Accurate access accounts for the effective hemostasis in the end, and effective compression of the CFA against the femoral head is easy to do at this location if necessary. Proper assessment of femoral angiography has been beneficial in reducing vascular access site complications.^11,12 Serial dilatation of the arteriotomy site prior to stent-graft delivery reduces the risk of arterial dissection and intimal injury during the introduction of large-caliber delivery sheaths. The importance of maintaining a guide-wire in the CFA until confirmation of adequate hemostasis is a key to the high success rates. When a Perclose Proglide device fails, the guide-wire allows insertion of an additional Perclose device. Brown and colleagues once reported successful deployment of six suture-mediated closure devices in the same vessel access.¹³ The guide-wire also serves as a rail for the introduction of a balloon catheter to block the artery in case of vessel rupture. Fourth, the average age of patients in our series is less than 57 years old. Such a relatively young patient population may account for the absence of serious atherosclerotic disease at the CFA. It is inevitable that a few patients in a group undergoing Preclosing technique will require conversion to an open surgical operation, so surgeons, if not required on the spot, should be available in case of serious complications.¹⁴

With regard to the anesthesia technique, we employed general anesthesia due to the possibility of CFA spasm or patient motion in the initial phase, but case by case we can perform percutaneous TEVAR under local anesthesia with sedation in most situations. This is one of the major attractive aspects of the Preclosing technique, and could reduce the dependency on general anesthesia,¹⁵ as well as morbidity and decreased CCU stay. TEVAR by femoral surgical cut down can also be performed under local anesthesia and sedation. However, it seems that general anesthesia provides more comfort and security to both patients and surgeons than local anesthesia.

The mean procedure time and hospital stay was longer in the control group than in the group treated percutaneously. Total procedure time was significantly longer with surgical groin management, due to a time-consuming preparations and inefficient cooperation with surgeons; none of them take pleasure in participating in this plain cut down and closure work, while a lot of complicated operations require their attention. Although our catheterization room occupancy expense is not calculated according to procedure duration, the shorter procedure time and hospital stay was a definite advantage in favor of the total percutaneous TEVAR group.

The shorter hospital stay resulted mainly from the small wound and rapid healing. The patients who underwent femoral cut down might also be able to be discharged the day following the procedure, just like in the western countries, but they usually refused as they were worryied about infection and dehiscence of their large wounds. In our daily practice as well as in the current study, wound-healing complications are a real issue, percutaneous TEVAR does offer an advantage in this regard.

As doctors and patients point out, the cost incured by the Perclose devices must be regarded as a significant factor, but even we performed more CAG (for more patients were older than 50 years), along with using more temporary rapid right ventricular pacing technique which can ensure more accurately thoracic endograft deployment than controlled blood pressure lowering methods, we found it surprising that consumption of these devices did not significantly increase the costs as compared to femoral surgical cut down. We concluded that, when factoring in the decreased anesthesia/surgery/CCU stay/hospital stay expenses, these savings counterbalanced the extra cost of the devices. Abdominal aortic aneurysm patients were excluded, and to repair this kind of pathology will cost more than RMB 6000 Yuan for contralateral access closure with two additional Perclose Proglide devices.

Other studies have also shown these advantages of percutaneous methods.^14,16 In addition, it was shown that surgical exposure is followed by significant scar development, whereas virtually no scar tissue is formed with a percutaneous approach.¹⁷ The high immediate success of the Preclosing technique appears to be maintained on midterm follow-up.^18,19 There is an increasing frequency of performing additional endoluminal procedures for endoleaks, additional aortic pathology, or recurrent or persistent enlarging aneurysm formation. This Preclosing technique for initial endograft placement might also facilitate these secondary procedures.^19,20

In the light of such a high success rate of arterial closure after TEVAR, surgeon's input is no longer compulsory to our team. We are expecting, with the next generation of closure devices improving overall safety and ease of use, with further developments of the endograft delivery catheters downsizing to 16 F, total percutaneous TEVAR will be even safer and easier.

According to our daily practice, our patients referred from far distances were allowed to be followed up locally. We contacted them via telephone to obtain information including symptoms and CTA scan results. Only when disease progression was suspected were they advised to receive a check-up at our institution. Most of the Guangzhou patients had follow-up appointments clinically. Since the study is retrospective, we did not intend to evaluate femoral artery patency with imaging, and only assessed local complications by the patients' symptoms such as claudication. Based on this kind of follow-up method, no hematomas, pseudoaneurysms, fistulas, infections were observed in affected limbs. Of those patients in Preclosing group, 31/85 (36.5%) had an adequate postoperative CT scan for the assessment of femoral artery patency at 6 months, there was no any new occlusive lesions at the site of the arteriotomy. The patients accrued in the recent 6 months of the study did not yet have their 6- month CTA scans. For the small size of subjects and short term follow-up, we have not yet analyze and summarize these relevant data. However, our preliminary observation has exhibited a promising future like those reported studies.

The current study is retrospective and investigated only the early outcomes of the Preclosing technique with the Perclose Proglide devices in TEVAR. With the increasing volume of endovascular procedures, randomized, controlled trials emphasizing the midterm and long-term effects of the technique on the femoral artery will be conducted. All the experts involved in the TEVAR landscape are expecting more rigorous analysis of these closure devices and techniques.

In summary, totally percutaneous aortic repair with the 6 F Perclose Proglide Preclosing technique is safe and effective with an inspiring technical success rates. Complications can be minimized with adequate preoperative imaging, technical expertise, and good patient selection. As there is still considerable room for down regulation of the price of devices. Preclosing technique may facilitate TEVAR and decrease hospital cost for the patients and healthcare providers at the same time.

REFERENCES