Case Study

A Matched Analysis of Vascular Complications Following Transfemoral Aortic Valve Implantation Using Either the 19 French Re-Collapsible SoloPath Sheath or a Regular 18 French Sheath: The SOLOTAVI Registry

Didier Tchétché, MD, Quentin Labarre, MD, Nicolas Dumonteil, MD, Pamela Gatto, MD, Andrea Mangiameli, MD, Thomas Thimon, MD, Farid Nedjari, MD, Bruno Farah, MD, Atul Pathak, MD, PhD, Jean Fajadet, MD
Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France

Didier Tchétché, MD, Quentin Labarre, MD, Nicolas Dumonteil, MD, Pamela Gatto, MD, Andrea Mangiameli, MD, Thomas Thimon, MD, Farid Nedjari, MD, Bruno Farah, MD, Atul Pathak, MD, PhD, Jean Fajadet, MD
Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France

Abstract
Aims: Vascular complications remain associated with transfemoral aortic valve implantation (TF-TAVI). We sought to explore the effect of the 19 Fr SoloPath Re-Collapsible sheath on the occurrence of major vascular complications in contemporary TF-TAVI practice when used as a routine introducer. Methods: We statistically matched 106 pairs of TF-TAVI patients by the use of a propensity score. Patients in both groups received a Medtronic CoreValve prosthesis via either the new 19 Fr SoloPath Re-Collapsible sheath or a standard 18 Fr sheath (Cook Check-Flo Performer). Valve Academic Research Consortium 2 outcomes were assessed at 30 days. Results: Vascular complications occurred in 14.1% of the patient from the SoloPath Re-Collapsible group vs. 22.6% in the Cook Check-Flo Performer group (P=0.11). Only 0.9% of the patients in the SoloPath Re-Collapsible group and 1.9% in the comparative group (P =0.32) had a major vascular complication. Bleeding occurred in 5.7% of the patients; minor bleeding in 3.8% of the cases. At 30-day follow-up, death occurred in 2.8% of the overall population without any difference between groups. Conclusion: The 19 Fr SoloPath Re-Collapsible introducer is comparable to a regular 18 Fr sheath with low rates of major vascular complications and bleeding. Apart from being efficient for challenging and complex arterial anatomies, it can be used as a safe alternative sheath for 18 Fr-compatible TAVI devices, with excellent outcomes.

Over the past decade, transcatheter aortic valve implantation (TAVI) has emerged as a robust treatment for inoperable or high-risk patients presenting with symptomatic aortic stenosis.1-3 Even in experienced centers, several issues remain inevitably associated with transfemoral (TF) TAVI, including vascular complications.4 Major vascular complications have been reported to increase all-cause and cardiovascular mortality.5 The impact of the introducer sheath utilized for TF-TAVI remains difficult to analyze. However, the sheath outer diameter to femoral artery ratio (SFAR) has been proposed as a determinant of vascular complications; a SFAR greater than 1.05 being related to higher rates of complications.6 Despite improvement in sheath size, some of the commercially available TAVI devices require an 18-20 French (Fr) introducer for femoral access. Several technological refinements aim at minimizing the sheath-induced trauma to the vessels, as, for example, an expandable sheath. The Terumo SoloPath Re-Collapsible sheath (Onset Medical, Terumo) is a 19 Fr balloon-expandable sheath with an insertion profile of 14 Fr. In its latter iteration, it can be re-collapsed, if needed, at the end of the procedure, by an integrated external balloon7 (Online Video 1). It is designed to decrease constraints to the Iliac and femoral arteries during insertion and withdrawal. A few reports with small cohorts have been published, highlighting a potential benefit of this type of introducer in challenging iliac and femoral arteries, particularly vessels smaller than usually recommended. No data exist on its performance when used for regular TF-TAVI cases. We sought to analyze the impact of the SoloPath Re-Collapsible sheath on the occurrence of major vascular complications in contemporary TF-TAVI practice when used as a routine introducer. 
 
Methods
Study Population
 
Between January 2, 2014 and December 22, 2015, 695 patients underwent TF-TAVI at our institution and were prospectively included into a local database. Indication for TAVI was decided during a multidisciplinary heart team meeting, based on comorbidities, as previously described.8 All patients underwent TF-TAVI under conscious sedation with a fluoroscopy-guided puncture and double Proglide (Abbott Vascular) preclosure technique for the femoral access. Unfractionated heparin was administered at a dose of 50 UI/kg, with a target activated clotting time (ACT) of 200-250 seconds. No protamine was administrated at the end of the procedure. Patients were treated with aspirin and a loading dose of clopidogrel (300 mg) at least a day before TF-TAVI. Aspirin, 75-160 mg daily, was maintained lifelong post TAVI. Clopidogrel, 75 mg daily, was combined with aspirin for 6 months post TF-TAVI, unless there was a need for a concomitant anticoagulant treatment. In order to account for differences related to prosthesis type, we only considered patients receiving a Medtronic 18 Fr CoreValve system (Medtronic) (Figure 1).
 
Up to February 2015, the standard introducer for TF-TAVI with the CoreValve was the Cook Check-Flo Performer (Cook Medical). It is a regular sheath with an inner diameter of 18 Fr (5.94 mm), an outer diameter of 21.8 Fr (7.19 mm), and a working length of 30 cm. From February to December 2015, the Terumo SoloPath Re-Collapsible sheath was used in all consecutive patients undergoing TF-TAVI with the CoreValve. This sheath is able to expand and actively collapse (Figure 2). It is balloon-expandable with an external diameter before expansion of 14 Fr (4.62 mm) in its proximal portion and 5.3 Fr (1.75 mm) at the tip. An inner expander balloon is inflated at 20 atm for one minute, then deflated and removed, leaving a large central lumen extending from the proximal end to the distal end of the sheath. Expanded, the external diameter becomes 21.25 Fr (7 mm) while the lumen becomes 19.5 Fr (6.43 mm). The working length is 35 mm. At the end of the procedure, this latter iteration of the SoloPath sheath can be collapsed if needed, by the mean of an integrated external balloon, to reduce frictions with the vessels during its withdrawal. The use of the re-collapsible property was left at the discretion of the operator.
 
Suitability for TF-TAVI was assessed in all patients by multisclice computed tomography (MSCT) at baseline, based on the minimal luminal diameter. The degrees of calcifications and tortuosity were also assessed and qualitatively classified in four grades: none, mild, moderate, and severe. Only patients with iliac and femoral artery inner diameters greater or equal to 6 mm and successful deployment of preclosure stiches were included in this analysis. All patients had serial blood testing from hospital admission to discharge. A transthoracic echocardiography was obtained at discharge. An iliac and femoral duplex ultrasonography was systematically performed 24 hours post TF-TAVI.
 
Among the initial 695 TF-TAVI patients, we retrospectively identified and matched 106 pairs of patients receiving either type of introducer for CoreValve implantation. Matching was based on relevant clinical, biological, and MSCT parameters obtained at baseline, such as gender, age, body mass index, anticoagulation therapy, peripheral vascular disease, cerebrovascular events, hemoglobin and platelet counts, or femoral artery size. All patients provided written, informed consent for data collection and anonymized analysis. 
 
Definitions
 
The SFAR was obtained by dividing the outer diameter of the sheath (the expanded diameter for the Terumo SoloPath Re-Collapsible sheath) by the diameter of the common femoral artery.
The Valve Academic Research Consortium (VARC) 2 definitions were used to assess outcomes.9 For the purpose of our study, the focus was on vascular complications. 
 
Major vascular complications were defined as access-related vascular injury leading to:
  • Death;
  • Life-threatening or major bleeding;
  • Visceral ischemia, neurological impairment or distal embolization (non-cerebral) from a vascular source:
    • Requiring surgery; 
    • Resulting in amputation or irreversible end-organ damage; or
    • Requiring the use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischemia or neurological impairment; or
    • Any new ipsilateral lower extremity ischemia. 
Minor vascular complications were defined as:
  • Access site or access-related vascular injury not leading to death, life-threatening or major bleeding; 
  • Visceral ischemia, neurological impairment or distal embolization treated with embolectomy and/or thrombectomy, and not resulting in:
    • Amputation;
    • Irreversible end-organ damage;
    • Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication or vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent-graft). 
Percutaneous closure device failure was defined as:
  • Failure of a closure device to achieve hemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning). 
 
Correlation analysis was performed between vascular complication or bleeding complication, and risk factors such as hypertension, diabetes, and triple antiplatelet-oral anticoagulant association.
Events were assessed during hospital stay and up to thirty days.
 
Statistical Analysis
 
Propensity score matching was performed with the use of a logistic regression model in a 1:1 ratio. Matching was performed without replacement and with a caliper of 0.2 of the standard deviation of the logit of the propensity score. Matching of the patients was based on relevant clinical, biological, and MSCT parameters: age, sex, body mass index, hemoglobin level and platelet count at baseline, surgical risk scores, antiplatelet and anticoagulant treatment at baseline, iliac and femoral artery characteristics (minimal diameter, calcification and tortuosity). After identification of 106 pairs of patients, a Wilcoxon test was applied to confirm the absence of statistical difference between patients. A t-test for paired samples was performed when there were less than five events in both groups. Correlation was assessed by Spearman’s rho. Normality of the distributions was assessed using the Shapiro-Wilks test. Continuous variables are presented as means with standard deviation (SD). Categorical variables are presented as frequencies and percentages and, compared using Pearson Chi Square Test or Fisher’s exact test, as appropriate. One-way analysis-of-variance was used to compare means across multiple categories. A P-value <0.05 was considered significant. All statistical analyses were performed using MedCalc version 16.2.1. (MedCalc Software, Ostend, Belgium).
 
Results
Baseline Characteristics
 
Table 1 summarizes the baseline characteristics of our study population. Two hundred and twelve patients were identified, equally distributed among SoloPath Re-Collapsible and Cook Check-Flo Performer groups. The patients had a high surgical risk profile since the mean Logistic EuroScores were respectively 19.62 ± 11.30% and 20.66 ± 11.49% (P=0.75). Femoral artery diameter was equivalent between groups. The only significant differences were smaller iliac arteries (8.1 ± 1.4 vs 8.6 ± 1.4 mm, P=0.01) and, as a consequence, a greater SFAR (0.98 ± 0.16 vs 0.76 ± 0.12, P<0.01) in patients treated with the SoloPath Re-Collapsible sheath. Calcifications and tortuosity were equivalent between groups. The incidence of peripheral artery disease was 7% in both groups.
 
Procedural Outcome. Table 2 outlines the main procedural details. Procedural success was similar between groups. The only reason for failure to achieve procedural success was moderate to severe paravalvular regurgitation, not statistically different between groups: 6.6 vs 5.6%, P=0.75. No procedural death was observed.
 
Failure to achieve hemostasis with closure devices occurred in a similar proportion between groups (9 vs 12%, P=0.58), leading to the implantation of a covered stent in the same proportion of patients (9 vs 10%, P=0.85). Only one patient in the SoloPath Re-Collapsible cohort had to undergo a bailout vascular surgery after failure of covered stents.
 
The use of the re-collapsible property of the SoloPath sheath was left at the discretion of the operators and applied in only 22/106 (20.7%) patients because of moderate to severe calcifications and/or tortuosity. No patient experienced any failure to recapture a CoreValve, when needed, or to withdraw the sheath from the vasculature at the end of the procedure.
 
In-Hospital and 30-Day Outcomes
 
Patients were followed post TF-TAVI, up to 30 days for the purpose of this study (Table 3). In-hospital outcomes were identical between groups. Vascular complications were similar: 14.1% in the SoloPath Re-Collapsible group vs 22.6% in the Check-Flo Performer group (P=0.11). More than 90% of the vascular complications observed in both groups were minor ones. Only 0.9% of the patients in the SoloPath Re-Collapsible group and 1.9% in the comparative group (P=0.32) had a major vascular complication. In SoloPath Re-Collapsible group, 35 patients had SFAR >1.05, among them, five had a vascular complication (14%) and 71 patients had SFAR <1.05, with the same level of vascular complication (14%). No SFAR >1.05 was found in the control group. 
 
Bleeding occurred in 9.4% (10 patients) of our total study population, with minor bleeding in 60% of the cases. A limited number of patients had life-threatening or major bleeding: 4 in total (1.8%), without differences between the groups. Indeed, very few patients required more than 4 units of red blood cells: 2.8% in the SoloPath Re-Collapsible group and 3.7% in the Check-Flo Performer group (P=0.56).
 
Table 4 lists the life-threatening, major and minor vascular complications or bleeding complications. The higher number of bleeding at puncture site in SoloPath Re-Collapsible group is due to closure device failure. 
Antiplatelet and oral anticoagulant treatments at discharge were similarly prescribed in both groups.
 
No correlation was found between diabetes (rho = -0.05; P=0.23), hypertension (rho = -0.01; P=0.44) and triple antiplatelet-oral anticoagulant association (rho = 0.04; P=0.27), and vascular or bleeding complications in our cohort. In-hospital death occurred in 5 patients (2.3%): 2 in the SoloPath Re-Collapsible group and 3 in the Check-Flo Performer group; P=0.81. Three patients had cardiogenic shock, 2 severe sepsis, and 1 patient had hemorrhagic shock with gastric origin. In our SOLOPATH cohort, no correlation between high SFAR and vascular complication was found (r = 0.03; P=0.98). 
 
At 30-day follow-up, death occurred in 2.8% of the overall population: 2 patients in the SoloPath Re-Collapsible group and three in the Check-Flo Performer group; P=0.81. No additional death was observed between discharge and 30 days. Lastly, 3 patients had a stroke, all in the SoloPath Re-Collapsible group, without any statistically significant difference: P=0.25.
 
Discussion
 
Our study is one of the first to assess the safety and the efficacy of the 19 Fr SoloPath Re-Collapsible sheath when routinely utilized for TF-TAVI, in regular patients. We did not observe, in a propensity-matched analysis, any difference regarding rates of vascular complications in patients undergoing TF-TAVI with either this 19 Fr introducer or a regular 18 Fr sheath. 
 
Whether it is the original SoloPath or the newer, re-collapsible iteration, this sheath has been mainly used in small series, for challenging iliac and femoral anatomies with encouraging results.10,11 Sedaghat et al recently reported a series of 43 patients with extensive and complex peripheral vascular disease treated with the SoloPath Re-Collapsible sheath. The mean SFAR was 1.2 and major vascular complications occurred in 9.3% of this cohort.7 We observed lower rates of major vascular complications in our cohort when treating standard and less complex patients with a SFAR below 1. This difference underscores the impact of the peripheral vasculature anatomy (diameter, tortuosity and calcification) on the outcome post TF-TAVI. However, including in our analysis only patients with successful closure device deployment may, in a mild proportion, underestimate the final rate of vascular complications in an unselected population. Incorporating in our analysis patients in whom closure devices were not successfully deployed at first attempt may have led to higher bleeding rates and the need for the implantation of covered stent or bailout vascular surgery.
 
Van Mieghem et al demonstrated that sheath size had a negative impact on vascular complication occurrence, while Hayashida et al first introduced the SFAR as a determinant of this type of complications.4,6 The SFAR was higher in the SoloPath Re-Collapsible cohort, theoretically putting the patients from this group at higher likelihood of major vascular complications. We did not observe this pattern, underscoring the performance of this type of sheath in more challenging, but still regular, anatomies. In a recent series of 60 patients treated with a 14 Fr equivalent iteration of the CoreValve (EVOLUT R), major vascular complications occurred in 8.3%.12 Most of the operators had limited experience with the new delivery system of this device and learning curve may partly explain the higher-than-expected rate of major vascular complications. It expresses the challenges of sheathless procedures, with multiple sheath insertions and withdrawals, and probably, the value of having a sheath constantly protecting the iliac and femoral arteries during catheter manipulation.
 
In our contemporary cohort, most of the vascular complications were minor, mainly related to a failure of the closure device, with a liberal use of covered stents. The double ProGlide technique for preclosure, routinely utilized in our institution, seems to generate lower rates of major vascular complication as compared to the ProStar technique.13 Apart from sheath insertion and removal, a proper handling of closure devices is crucial to avoid vascular complications. The experience of our team with closure devices may partly explain this low rate of complications. Moreover, we included patients with iliac and femoral vessels of 8 mm on average, spontaneously decreasing the risk of vascular complications with 18 Fr-compatible TAVI devices. 
 
The insertion and withdrawal profiles of the SoloPath Re-Collapsible sheath could be protective features. However, we used the re-collapsible property in very few patients, mainly those with smaller and more calcified arteries. It seems to offer additional safety, but could be associated with greater rates of minor bleeding when routinely used. Indeed, some bleeding may occur at the arteriotomy site, around the collapsed sheath, even with complementary manual compression during removal. That was one of the reasons for re-collapsing SoloPath only in patients for whom a higher force was required to remove the sheath at the end of the procedure, because of calcium and/or tortuosities.
 
Thirty-day all-cause and cardiovascular mortality were low in our cohort, likely related to lower rates of vascular complications and bleeding. We had observed in the past that bleeding post TF-TAVI was predominantly due to vascular complications and associated to greater cardiovascular mortality.5 Vascular complications are multifactorial, including the quality of the arterial puncture, the efficiency of closure device deployment, and sheath insertion and withdrawal profile. Numerous commercially available TAVI devices remain 18 Fr-compatible. The SoloPath Re-Collapsible sheath may help to prevent vascular complications in regular and more challenging peripheral vasculature encountered when using these 18 Fr TAVI devices. So far, the main obstacle to a liberal use of the SoloPath Re-Collapsible sheath is an economic issue, this sheath being more expensive than standard introducers such as the Cook Check-Flo Performer. Efforts have to be made by the company to decrease the costs inherent to this promising sheath in order to broaden its utilization in daily practice.
 
Our study has several limitations. It is a non-randomized, retrospective analysis of prospectively gathered data. A larger cohort of patients and a longer follow-up could strengthen our findings. As TAVI has evolved quickly, it is true that most of TAVI procedures are now performed with a 14 Fr access sheath with new devices such as the CoreValve Evolut R. Nevertheless, several commercially available TAVI devices remain 18 Fr-compatible and could therefore benefit from the 19 French SoloPath Re-Collapsible sheath.
 
Conclusion
 
The 19 Fr SoloPath Re-Collapsible introducer is comparable to a regular 18 Fr sheath with low rates of major vascular complications and bleeding. Apart from being efficient for challenging and complex arterial anatomies, it can be used as a safe alternative sheath for 18 Fr-compatible TAVI devices, with excellent outcomes.
 
Impact on Daily Practice
 
The SoloPath Re-Collapsible sheath may widen the number of patients treatable via transfemoral access for TAVI and achieve low rates of vascular complications. 
 
References
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  4. Van Mieghem NM, Tchetche D, Chieffo A, et al. Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation. Am J Cardiol. 2012; 110: 1361-1367.
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  11. Abu Saleh WK, Tang GH, Ahmad H, et al. Vascular complication can be minimized with a balloon-expandable, re-collapsible sheath in TAVR with a self-expanding bioprosthesis. Catheter Cardiovasc Interv. 2016 Jul; 88(1): 135-143.
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Disclosure: SOLOTAVI is an investigator-initiated and driven registry. The investigators received research grants from Terumo. Terumo had no access to patient data or results prior to publication.

The authors can be contacted via Didier Tchétché, MD, at d.tchetche@clinique-pasteur.com.