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Keywords:

  • TAVI;
  • aortic stenosis;
  • vascular closure devices

Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONCLUSIONS
  8. REFERENCES
  9. Supporting Information

Objectives

To describe results from our “modified crossover technique” for vascular access management during transcatheter aortic valve implantation (TAVI).

Background

Vascular access management remains a major cause of complications following TAVI due to the large bore sheaths required.

Methods

All suitable patients undergoing TAVI in our center, between June and August 2011, underwent our “modified crossover technique,” which enables the passage of a balloon through left radial access and inflation in the proximal iliac to allow percutaneous closure in a clean field.

Results

In total, 15 patients were included: the logistic EuroSCORE was 19.7 ± 12.1% and STS score 5.7 ± 5.6%. The mean therapeutic femoral access site diameter was 8.1 ± 1.0 mm. Ten (66.7%) patients received Edwards SAPIEN™ XT (two using the new E-sheath) and five (33.3%) patients a Medtronic CoreValve ReValving System® device. The “modified crossover technique” was used successfully in all patients. There were three vascular complications occurring at the therapeutic access site: one rupture of the external iliac artery, one Prostar failure, and one pseudoaneurysm of the right common femoral artery. All complications were successfully treated percutaneously with covered stent implantation via access from the contralateral femoral artery. In view of the balloon inflation from the left radial artery, the complications could be treated in a clean field with minimal blood loss.

Conclusions

Our “modified crossover technique” using the left radial artery as the diagnostic site for balloon inflation appears a helpful adjunct in managing TAVI vascular access sites. © 2012 Wiley Periodicals, Inc.


INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONCLUSIONS
  8. REFERENCES
  9. Supporting Information

Transcatheter aortic valve implantation (TAVI) is a feasible treatment strategy in high-risk patients with severe symptomatic aortic stenosis (AS) [1-4]. Currently, there are two devices commercially available in Europe: Edwards SAPIEN XT™ (Edwards Lifesciences, Irvine, CA) and Medtronic CoreValve ReValving System® (Medtronic, Minneapolis, MN). Both of these can be delivered through the common femoral artery.

Single- and multi-center TAVI registries have reported a variable rate of major vascular complications, likely a consequence of the large caliber sheaths and the general frailty of the patients [5-7]. Our group previously described a technique for percutaneous vascular access management in TAVI patients, entitled the “Crossover Technique” [8]. In this report, we describe our new technique in a cohort of patients undergoing transfemoral TAVI with both currently available devices, where the primary means of closure was percutaneous.

METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONCLUSIONS
  8. REFERENCES
  9. Supporting Information

All patients referred to our center (San Raffaele Scientific Institute, Milan, Italy) for consideration of TAVI were assessed by a multidisciplinary team (two interventional cardiologists, one cardiothoracic surgeon, and one anesthesiologist). The transfemoral approach was our first choice access if the vessel size was greater than 6 mm. Percutaneous closure was chosen in all transfemoral cases with the Prostar preclosure device. All subjects gave full informed consent for the procedure and subsequent data collection as per our hospital policy.

The “Modified Crossover Technique”

A flowchart of the revised technique is shown in Fig. 1 with a schematic diagram in Fig. 2. Firstly, the left radial artery is cannulated with a 6 French introducer sheath (Terumo Medical Corporation, Somerset, NJ). A diagnostic exchange length wire (Kimal plc, Worcestershire, UK) or a Storq wire (Cordis/Johnson & Johnson, Miami Lakes, FL) is then used through a 120-cm multipurpose diagnostic catheter (Cordis/Johnson & Johnson, Miami Lakes, FL) to gain access to the therapeutic femoral access site. A 0.018″ guidewire (V18, Boston Scientific, Natick, MA) is then advanced to the distal femoral artery. Contrast is injected through this catheter to identify the therapeutic access site anatomy. This is cannulated under direct fluoroscopic guidance, utilizing the guidewire as a landmark, avoiding areas of tortuosity and calcification. A Prostar (Abbott Vascular, IL) device is then advanced into the common femoral artery and secured.

image

Figure 1. A flowchart of our “modified crossover technique.”

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image

Figure 2. A schematic illustration of our “modified crossover technique.” Panel A shows insertion of a standard short radial sheath into the left femoral artery. Panel B illustrates the use of the 120 cm diagnostic multi-purpose catheter to position the 0.018″ guide wire in the superficial femoral artery. Panel C demonstrates the insertion of the pigtail catheter adjacent to the 0.018″ guide wire to facilitate valve positioning. Panel D illustrates the use of the over-the-wire balloon inflated at low pressure in the proximal iliac artery to allow percutaneous closure in a clean field. Panel E shows contrast injection via the over-the-wire balloon central lumen to visualize the peripheral vessels.

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A pathway to the femoral artery is then created utilizing blunt dissection. The transcatheter valve is implanted as described elsewhere [9]. After deployment, the delivery system is removed with the introducer sheath remaining at the junction of distal aorta and common iliac. This can be retracted gradually and contrast injected if any concern regarding iliac rupture. An appropriately sized semi-compliant peripheral angioplasty over-the-wire (OTW) balloon, e.g., Fox Plus (Abbott Vascular) is then passed over the 0.018″ wire via the left radial artery into the common iliac of the therapeutic site, proximal to the introducer sheath.

The contrast injection can be repeated to identify any rupture of the common or external iliac. If there is no evidence of damage, the OTW balloon is advanced into the external iliac. The Prostar sutures are prepared. The OTW balloon is then inflated at low pressure to stop blood flow to the puncture site allowing the introducer sheath to be removed and full Prostar closure. As the OTW balloon is inflated this occurs in a clean field. This is then deflated and an angiographic image of the closure site can be visualized with contrast injection through the balloon by adding a Y-connector (Fig. 2), taking advantage of the residual central lumen (0.035″ compatible) which is occupied by a 0.018″ wire.

If extravasation is visible, the OTW balloon can be advanced and inflated at low pressure (2 atm) for 5–10 minutes. This puts a gentle stretch on the vessel and ensures Prostar sutures close the puncture site satisfactorily. Another image is taken and if extravasation persists, the balloon inflation should be repeated for a further 5 minutes. If there still remains extravasation, further inflations with coinciding manual compression is the treatment of choice. Occasionally, it may be necessary to consider covered stent implantation, but generally these measures are adequate.

If the access site image appears satisfactory, the OTW balloon and wire can be removed from the left radial artery and the sheath removed with standard compression mechanisms.

In the case of evidence of severe bleeding and/or iliac rupture or persistent pseudoaneurysm, the OTW balloon passed via the left radial artery can be promptly inflated to prevent catastrophic blood flow. This should secure hemostasis and give necessary time to gain femoral access from the contralateral side and then crossing over to deploy a covered stent (Viabahn®, Gore & Associates, Newark, DE). As the OTW balloon is in situ, time is available to perform these procedures in a calm manner, minimizing blood loss.

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONCLUSIONS
  8. REFERENCES
  9. Supporting Information

Between June and August 2011, 15 consecutive patients underwent TAVI using our “modified crossover technique” with diagnostic access via the left radial artery in our institution. The mean age was 79.5 ± 5.1 years, with a logistic EuroSCORE of 19.7 ± 12.1% and STS score 5.7 ± 5.6%. The mean therapeutic femoral access size was 8.1 ± 1.0 mm and all patients had evidence of mild to moderate calcification of the access vessel.

Ten patients received an Edwards SAPIEN XT™ valve: four patients a 23 mm valve (via standard 18 French sheaths) and six patients a 26 mm valve (4 with standard 19 French sheaths and 2 with 18 French E-sheaths). Medtronic CoreValve® 29 mm valves (using 18 French introducers) were implanted in the remaining five patients. Procedural success as defined by the Valve Academic Research Consortium (VARC) was achieved in all subjects [10]. There were no in-hospital deaths, myocardial infarctions, or stroke.

Vascular complications occurred in three patients at the femoral therapeutic access site. One patient had evidence of rupture of the right external iliac on final control angiography, following implantation of an Edwards SAPIEN XT™ 23 mm. The OTW was inflated from the left radial artery, which allowed time to position an 8 French sheath in the left femoral artery to allow implantation of a Viabahn 8 × 10 mm. Final control angiography confirmed a good result. A second patient had evidence of Prostar failure at the therapeutic left femoral access site following Edwards SAPIEN XT™ 26 mm. A Viabahn 8 × 50 mm was implanted via 8 French access in the right femoral artery with no evidence of contrast extravasation on control angiography. Again, this occurred while an OTW balloon was inflated from the left radial artery. Finally, a patient had evidence of a pseudoaneurysm of the right common femoral artery, after Edwards SAPIEN XT™ 26 mm valve implantation using the 18 French E-sheath. Following prolonged inflation with an OTW balloon, access in the left femoral artery was secured with an 8 French sheath and subsequently a Viabahn 8 mm × 50 mm was implanted with good result (Fig. 3).

image

Figure 3. Angiographic images of the pseudoaneurysm of the femoral therapeutic site. Panel A: Prior to percutaneous intervention. Panel B: The result following covered stent implantation.

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These three vascular complications were all able to be repaired on the table in a bloodless field, largely due to the vascular closure method our team utilizes. This allows for a controlled environment and minimal blood loss. Repair was performed using endovascular intervention alone without requirement for surgery. All patients were independently mobile upon discharge and no further peripheral intervention was required in the following 30-days.

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONCLUSIONS
  8. REFERENCES
  9. Supporting Information

Our center experience shows that our modified “crossover technique” for vascular access closure is a safe strategy in patients undergoing TAVI for severe symptomatic AS. Our three vascular complications, throughout the very early experience, were able to be repaired rapidly by the interventionalist. In these cases, the use of this technique was instrumental in preventing severe bleeding.

Complications of vascular access are a major cause of morbidity and indeed mortality following TAVI. Additionally, blood loss at the time of vascular injury can contribute to the incidence of major/life-threatening bleeding as defined by VARC [10]. The acquisition and maintenance of vascular access is therefore of prime importance during valvular intervention using large bore vascular access and the skills for adequate management must be available in the catheterization laboratory from the outset. Our method allows direct visualization of the puncture site, thereby avoiding tortuosity, calcification, and bifurcations. The method described also allows control of the artery, as if there is any evidence of bleeding the OTW balloon can be immediately advanced to obstruct iliac blood flow, allowing time to develop a strategy for repair of the artery.

This technique utilizing the left radial artery rather than the contralateral femoral artery evolved in view of our seemingly high rate of vascular complications amongst our transfemoral TAVI patients [9, 11]. Even though we have not yet attempted, we believe that the right radial artery could be alternatively utilized. As has been demonstrated in coronary studies, there are less bleeding risks with intervention performed radially. It was therefore considered that with only one femoral arterial access site, potentially our risk of complications (both vascular and bleeding) would reduce, as it was not uncommon to have a pseudoaneurysm from the femoral diagnostic site.

The use of our “modified crossover technique” means that iliac or femoral rupture can be effectively managed without immediate hemodynamic collapse. As when we described the initial method, we feel other interventional teams performing TAVI should try to adopt this technique.

Experience in TAVI and peripheral access management will inevitably lead to a reduction in major vascular complications. Moreover, advances in technology allowing smaller delivery systems and lower profile devices will increase the safety of the procedure further. It is essential to be meticulous in patient selection and managing vascular access to prevent these potentially catastrophic complications.

Clearly, these are early results from our “modified cross over technique” and a large number of patient is necessary in order to confirm these preliminary findings.

CONCLUSIONS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONCLUSIONS
  8. REFERENCES
  9. Supporting Information

In this preliminary experience, our “modified crossover technique” appears a viable strategy in the percutaneous management of high-risk patients undergoing transfemoral TAVI. Further experience is necessary and to ensure long-term outcomes remain respectable.

REFERENCES

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONCLUSIONS
  8. REFERENCES
  9. Supporting Information
  • 1
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  • 2
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Supporting Information

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. METHODS
  5. RESULTS
  6. DISCUSSION
  7. CONCLUSIONS
  8. REFERENCES
  9. Supporting Information

Additional Supporting Information may be found in the online version of this article.

FilenameFormatSizeDescription
ccd24380-sup-0001-SuppFig1.tif2305KSupporting Fig. 1. An illustration of the ‘modified crossover technique’ for vascular access management. Panel A demonstrates the position of the 0.018″ guidewire advanced from the left radial artery to the distal therapeutic femoral artery. An angiographic image is made injecting contrast through a multi-purpose catheter to identify the therapeutic access site anatomy. In Panel B following valve delivery, the large bore sheath is retracted and an over-the-wire balloon is positioned via the left radial artery to the common iliac of the therapeutic site. This can then be inflated at low pressure (Panel C) to allow sheath removal and full Prostar closure in a bloodless field. Panel D shows the final angiographic image of the closure site by injecting contrast through the central lumen of the over-the-wire balloon, to ensure no vascular complications.

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