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Abstract

Objectives:

We sought to perform transcatheter aortic valve replacement (TAVR) via the transfemoral approach in patients with peripheral arterial disease (PAD), small caliber ileofemoral vessels and vascular tortuosity.

Background:

For patients with increased surgical risk, TAVR is associated with a higher 1-year survival rate than surgical aortic valve replacement (SAVR). Transfemoral vascular access for TAVR results in superior outcomes versus procedures performed via other routes in terms of mortality, morbidity and healthcare economics. In many patients, the ability to safely perform the procedure via the transfemoral approach is limited by narrow, diseased and tortuous ileofemoral vasculature.

Methods:

We employed the SoloPath Balloon Expandable TransFemoral Access System (Terumo Med. Corp., Tokyo, Japan) to perform transfemoral TAVR in five patients with PAD, small caliber ileofemoral vessels and vascular tortuosity.

Results:

We report our experience using this balloon-expandable sheath during 5 cases of transfemoral TAVR in patients with inhospitable ileofemoral vasculature of mean diameter ⩽5.8 mm. The unexpanded sheath’s malleable structure and hydrophilic coating permitted deployment despite severe stenoses and tortuosity. Subsequent inflation to 18 Fr facilitated successful TAVR. Postprocedural angiography demonstrated no significant vascular access complications. In one case, the entire procedure was performed percutaneously, without common femoral artery surgical cutdown.

Conclusions:

The SoloPath sheath system permits transfemoral TAVR in patients with PAD small caliber ileofemoral vessels and vascular tortuosity. The transfemoral balloon-expandable sheath allowed these patients to avoid the increased morbidity and mortality risks associated with direct aortic or transapical access.

Keywords

balloon-expandable PAD SoloPath TAVR transfemoral

Introduction

Since Cribier and colleagues first reported performing transcatheter aortic valve replacement (TAVR) in 2002 [Cribier et al. 2002], numerous data registries [Piazza et al. 2008; Rodés-Cabau et al. 2010; Biondi-Zoccai et al. 2011; Bosmans et al. 2011; Eltchaninoff et al. 2011; Zahn et al. 2011, Di Mario et al. 2013] and several trials [Grube et al. 2007; Leon et al. 2010; Smith et al. 2011] have established TAVR as a practical therapeutic option for patients at high risk for surgical aortic valve replacement (SAVR). In March 2014, the US CoreValve High Risk Study (Medtronic Inc., Minneapolis, MN) showed a superior 1-year survival benefit of TAVR over SAVR (14.2% versus 19.1%, p = 0.04) without an increased risk of stroke (8.8% versus 12.6%, p = 0.10) in patients with increased surgical risk [Popma et al. 2014].

Vascular access for TAVR is most commonly obtained via a transfemoral [Webb et al. 2006], subclavian [Modine et al. 2011], direct aortic [Latsios et al. 2010] or transapical [Lichtenstein et al. 2006] approach. In certain patients, the ability to safely perform the procedure via the transfemoral approach is limited by peripheral arterial disease (PAD) and small caliber vessels. The sheath size required to delivery transcatheter valves has decreased with successive generations of TAVR devices from 24 Fr initially to 18 Fr or less at present. However, even 18 Fr delivery sheaths require a minimum internal vessel diameter of approximately 6.0 mm across the entire course from the site of vascular access to the aortic valve.

The SoloPath Balloon Expandable TransFemoral Access System (Terumo Med. Corp., Tokyo, Japan) was designed to provide transfemoral access for TAVR or endovascular aneurysm repair (EVAR) in patients with PAD and tortuous vessels by opening and straightening 25–35 cm of vasculature proximal to the arterial insertion site [Sedaghat et al. 2013]. Available in several sizes, the sheath measures 11.5–15 Fr in external circumference during insertion. Navigation of tortuous vasculature is facilitated by the sheath’s malleable structure and hydrophilic coating. Subsequently, the sheath expands to 17.5–24 Fr externally (14–21 Fr internally) by inflation of an integrated balloon. We report our experience using this balloon-expandable sheath during 5 cases of transfemoral TAVR in patients with small (mean diameter ⩽ 5.8 mm) iliofemoral vessels.

Case descriptions

Case 1

The patient was an 88-year-old woman with severe aortic stenosis and a history of coronary artery bypass surgery with a left internal mammary artery that crossed the midline, making SAVR high risk with a Society of Thoracic Surgeons (STS) 30-day mortality risk score of 10.4%. Computerized tomography (CT) angiography demonstrated significant tortuosity of the right common femoral artery (RCFA) and calcific disease of the right common iliac artery (RCIA) with a diameter of 5.2 mm by 6.1 mm (mean 5.7 mm; Figure 1). Given more severe disease on the left, the patient’s RCFA was exposed by surgical cutdown and a SoloPath 18 Fr 35 cm sheath was placed over a 0.035 inch (0.889 mm) Amplatz super stiff guidewire. The sheath was gradually expanded with inflation to 20 atm. (2 MPa), dilating the RCFA and RCIA. A 26 mm CoreValve was then delivered via the 18F sheath and deployed successfully. Subsequent RCFA angiography demonstrated a good result with only a small, non flow-limiting dissection of the RCFA at the surgical cutdown site that did not require any intervention.

Figure 1.

(A) CT angiography of the focal RCIA stenosis measuring 5.2 mm by 6.1 mm. (B) Fluoroscopy of the SoloPath sheath inserted past the stenosis. (C) Fluoroscopy of the SoloPath sheath inflated, dilating the stenosis. (D) Digital subtraction fluoroscopy of the RCIA after completion of TAVR and removal of the sheath. The previously seen stenosis appears significantly improved following dilation with the SoloPath sheath.

Case 2

The patient was a frail 89-year-old woman with severe aortic stenosis who was 4 feet 7 inches (1.39 m) tall, weighed 92 lbs (41.7 kg) and had a heavily calcified aortic valve, making SAVR high risk with an STS 30-day mortality risk score of 9.0%. CT angiography demonstrated left external iliac artery (LEIA) tortuosity with a minimum luminal diameter of 5.3 by 5.3 mm (mean 5.3 mm; Figure 2). Given smaller caliber vessels on the right side, the patient’s left common femoral artery (LCFA) was exposed by surgical cutdown and a SoloPath 18 Fr 35 cm sheath was placed over a 0.035 inch (0.889 mm) Amplatz super stiff guidewire. The sheath was gradually expanded with inflation to 20 atm. (2 Mpa). A 26 mm CoreValve was deployed successfully. Subsequent LEIA and LCFA angiography demonstrated no vascular complications.

Figure 2.

(A) Three-dimensional reconstruction of CT angiogram showing tortuosity and diminutive ileofemoral vessels. (B) CT angiogram showing LEIA minimal luminal diameter of 5.3 by 5.3 mm. (C) Fluoroscopic angiogram showing left ileofemoral system prior to procedure. (D) Fluoroscopy showing left ileofemoral system straightened and dilated by SoloPath sheath.

Case 3

The patient was an 84-year-old woman with severe aortic stenosis and a left ventricular ejection fraction of 15%, making SAVR high risk with an STS 30-day mortality risk score of 12.1%. CT angiography demonstrated moderate RCFA calcification and a right external iliac artery (REIA) with minimum luminal diameter of 5.2 mm by 6.1 mm (mean 5.7 mm). The patient’s RCFA was exposed by surgical cutdown and a SoloPath 18 Fr 35 cm sheath was placed over a 0.035 inch (0.889 mm) Amplatz super stiff guidewire. The sheath was gradually expanded with inflation to 20 atm. (2 MPa), dilating the REIA stenosis. A 29 mm CoreValve was deployed successfully. Subsequent REIA and RCFA angiography demonstrated no vascular complications.

Case 4

The patient was a 90-year-old woman with severe aortic stenosis, severe pulmonary hypertension, and prior stroke, making SAVR high risk with an STS 30-day mortality risk score of 8.7%. CT angiography demonstrated moderate LCFA calcification with minimal luminal diameter of 5.5 mm by 6.1 mm (mean 5.8 mm) and LEIA tortuosity with a minimal luminal diameter of 4.4 mm by 6.4 mm (mean 5.4 mm). There was more severe disease of the RCFA, and thus the patient’s LCFA was exposed by surgical cutdown and a SoloPath 18 Fr 35 cm sheath was placed over a 0.035 inch (0.889 mm) Amplatz super stiff guidewire. The sheath was gradually expanded with inflation to 20 atm. (2 MPa), dilating the LCFA and LEIA stenosis. A 29 mm CoreValve was deployed successfully. Subsequent LCFA and LEIA angiography demonstrated no vascular complications.

Case 5

The patient was a 90-year-old man with severe aortic stenosis and a history of coronary artery bypass surgery, making SAVR high risk with an STS 30-day mortality risk score of 7.0%. CT angiography demonstrated RCIA tortuosity and moderate calcification with a minimum luminal diameter of 4.9 mm by 6.7 mm (mean 5.8 mm), proximal to a 23 mm RCIA aneurysm. The patient’s more severely diseased LCFA was accessed percutaneously to permit angiography and intravascular ultrasound (IVUS) of the RCIA (Figure 3). Subsequently, the patient’s RCFA was accessed percutaneously and two Perclose ProGlide devices (Abbott Labs, Abbott Park, IL) were deployed but not tightened in the manner of the ‘Preclose technique’ [Michaels and Ports, 2001; Griese et al. 2013]. A SoloPath 18 Fr 35 cm sheath was placed over a 0.035 inch (0.889 mm) Amplatz super stiff guidewire. The sheath was gradually expanded with inflation to 20 atm. (2 MPa), dilating the RCIA stenosis. A 31 mm CoreValve was deployed successfully. Subsequent RCIA angiography demonstrated no vascular complications.

Figure 3.

(A) CT angiography of the focal RCIA stenosis measuring 4.9 mm by 6.7 mm. (B) Fluoroscopic angiography of the RCIA stenosis. (C) IVUS of the RCIA stenosis. (D) Fluoroscopic angiography following CoreValve deployment demonstrating no RCIA vascular complications after withdrawal of the SoloPath sheath.

Discussion

Transfemoral access

Transfemoral vascular access for TAVR is preferred whenever possible because a growing body of evidence suggests superior outcomes from transfemoral procedures versus procedures performed via other routes in terms of mortality, morbidity and economics. A 2011 single-center Canadian registry analysis of procedures performed since 2009 reported 30-day mortality rates of 3.8% for transfemoral access and 9.4% for transapical access [Gurvitch et al. 2011]. The PARTNER A trial as-treated analysis demonstrated mortality differences between transfemoral and transapical approaches both at 30 days (3.7% versus 8.7%) and at 1 year (21.3% versus 29.1%) [Smith et al. 2011]. In a 2012 single-center Canadian study, new-onset atrial fibrillation occurred more frequently following transapical TAVR than following transfemoral TAVR [odds ratio (OR) 4.08, 95% confidence interval (CI) 1.35-12.31] [Amat-Santos et al. 2012], increasing postprocedural morbidity and hospital length of stay. Despite initial reports of higher stroke rates resulting from transfemoral catheters traversing the aortic arch, studies have demonstrated equivalent rates of magnetic resonance imaging (MRI) detectible cerebral emboli [Rodés-Cabau et al. 2011] and overt stroke [Eggebrecht et al. 2012] between transfemoral and transapical approaches.

A medical economic reanalysis of the PARTNER A data demonstrated both decreased cost and increased quality-adjusted life years associated with transfemoral as opposed to transapical TAVR [Reynolds et al. 2012a]. Further PARTNER A data revealed significantly greater quality of life for transfemoral TAVR patients as opposed to SAVR patients, whereas no quality of life difference was noted between transapical TAVR and SAVR patients [Reynolds et al. 2012b]. A 2013 single-center American study of 18 transfemoral and 26 nontransfemoral procedures demonstrated a mean hospital admission of 4.3 ± 2.9 days for transfemoral TAVR versus 7.3 ± 5.4 days for transapical and transcarotid TAVR (p = 0.022) [Thourani et al. 2013]. Also, only transfemoral TAVR may be performed without general anesthesia and entirely percutaneously, without a surgical cutdown to expose the vascular access site [Motloch et al. 2012].

To date, trials and registries comparing TAVR access approaches are all subject to the limitation that patients have not been randomized by access approach, and access approach is selected by operators as a result of differences in patients’ baseline disease characteristics. Stortecky and colleagues [Stortecky et al. 2013] cite a 2013 EuroPCR presentation by Windecker who reported that, after adjustment for these confounding variables in the SOURCE XT registry, 1-year survival was higher following transfemoral procedures (85.0%) than transapical procedures (72.8%, p < 0.0001).

Confirming the general preference of operators for the transfemoral approach, analysis of a 137-center European registry of 4571 patients treated from January 2011 to May 2012 reported a transfemoral approach in 74.2% of patients [Di Mario et al. 2013].

Vascular complications

Vascular access complications are the most frequent procedural complications of TAVR, with rates reported as high as 17.0% in the high-risk PARTNER trial cohort A patients randomized to TAVR [Smith et al. 2011] (244/348 transfemoral) and 30.7% in the extreme risk PARTNER trial cohort B inoperable patients [Leon et al. 2010] (all transfemoral). Using the Valve Academic Research Consortium definitions [Leon et al. 2011a, 2011b], Van Mieghem and colleagues reported rates of major vascular complications, life-threatening bleeding and major bleeding of 14.2%, 11.0% and 17.8%, respectively, in a 5 -center registry of 986 patients undergoing transfemoral TAVR [Van Mieghem et al. 2012]. Hayashida and colleagues documented significant risk factors for major vascular complications during TAVR including sheath-to-femoral-artery diameter ratio, femoral calcification and institutional experience [Hayashida et al. 2011]. Larger sheath diameter has been previously implicated as a risk factor for vascular complications during transfemoral coronary interventions [Büchler et al. 2008; Doyle et al. 2008].

Ileofemoral CT angiography is performed routinely before transfemoral TAVR to assess potential access sites for inadequate vessel size, PAD, tortuosity and calcification [Eltchaninoff et al. 2009], all of which may prevent the passage of the TAVR delivery system. Kurra and colleagues reviewed CT angiograms of 100 consecutive patients referred for TAVR at a single American site and reported ileofemoral arterial stenoses to less than 8 mm, greater than 60% circumferential calcification of the iliac bifurcation and/or common external iliac angulation less than 90 degrees in 35% of patients [Kurra et al. 2009]. Kpodonu and colleagues even report a strategy of ‘cracking and paving’, performing balloon angioplasty and deploying a covered stent in a diseased iliac artery prior to performing an EVAR [Kpodonu et al. 2009].

Balloon-expandable sheath

A balloon-expandable sheath is a novel device that permits transfemoral TAVR in many patients with inhospitable vasculature. Inserted with a profile of 13 Fr, the SoloPath system may be placed in vessels that would not otherwise accommodate a sheath of 21 Fr external circumference. Flexibility and hydrophilic coating allow navigation of tortuous vessels with minimal endothelial trauma or plaque scraping. Once the sheath is inserted, the inner dilator balloon is gradually inflated to 20 atm. (2 MPa), allowing for uniform sheath expansion to an 18 Fr internal diameter and a 21 Fr external diameter, which facilitates the smooth passage of the TAVR delivery system. Furthermore, we believe that traumatic injury to arteries during sheath placement is reduced by employing gradual balloon dilation instead of the traditional Dotter method because balloon dilation, like angioplasty, utilizes vessel elasticity as opposed to longitudinal scraping with dilator insertion. To date, no trial data support this contention, and only two other case series have addressed the issue [Fusari et al. 2012; Dimitriadis et al. 2013].

The cases we report here demonstrate that transfemoral TAVR may be performed safely in select patients with ileofemoral vessels measuring less than 6 mm in luminal diameter. The transfemoral balloon-expandable sheath allowed these patients to avoid the increased morbidity and mortality risks associated with direct aortic or transapical access. As in case 5, the entire procedure may be performed percutanously, without common femoral artery surgical cutdown, using two Perclose ProGlide devices and the ‘Preclose technique’. Compared with surgical vascular access, this entirely percutaneous approach allows for ambulation within 8 hours of the procedure and shorter hospitalization without increased vascular access complications [Nakamura et al. 2014].

Theoretical contraindications to a balloon-expandable sheath include extremely diminutive or heavily calcified vessels, which may rupture under the stress of balloon dilation. In case 1, vessel calcification may have resulted in the observed small RCFA dissection.

Conclusion

In our experience, the SoloPath Balloon Expandable Transfemoral Access System permits transfemoral TAVR in patients with PAD and arterial tortuosity. This device makes transfemoral TAVR a reasonable option in patients with arterial diameters less than 6 mm, although caution is warranted in cases of highly calcified vessels. By facilitating otherwise inhospitable transfemoral vascular access, this balloon-expandable sheath shields patients from the increased morbidity and mortality associated with nontransfemoral access routes and makes possible an entirely percutaneous TAVR procedure, associated with more rapid recovery than procedures involving surgical vascular access.

Footnotes

Conflict of interest statement

Dr. Forrest reports receiving physician proctoring and consulting fees from Medtronic Inc and Edwards Lifesceinces.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

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A balloon-expandable sheath facilitates transfemoral TAVR in patients with peripheral vascular disease and tortuosity

Abstract

Objectives:

Background:

Methods:

Results:

Conclusions:

Keywords

Introduction

Case descriptions

Case 1

Case 2

Case 3

Case 4

Case 5

Discussion

Transfemoral access

Vascular complications

Balloon-expandable sheath

Conclusion

Footnotes

Conflict of interest statement

Funding

References