Feasibility of Transfemoral Aortic Valve Implantation in Patients With Aortic Disease and Simultaneous or Sequential Endovascular Aortic Repair

Abstract: Objectives. The transfemoral approach for transcatheter aortic valve implantation (TF-TAVI) is associated with a significant survival benefit for intermediate and high-risk patients. Due to the increased procedural risk, many operators avoid TF-TAVI in patients with aortic disease. Moreover, significant peri-interventional device interaction may occur in patients with previous endovascular aortic repair (EVAR). We evaluated the feasibility of TF–TAVI in patients with aortic disease in combination with simultaneous or sequential EVAR. Methods. Data from 15 TF-TAVI patients with concomitant aortic disease treated between 2009 and 2019 in three German heart centers representing 4410 TAVI procedures were analyzed. Results. Two patients with progressive penetrating atherosclerotic ulcers (PAUs) in the descending thoracic aorta underwent sequential and simultaneous thoracic EVAR (TEVAR), respectively. One patient with stable PAU and 4 patients with not yet relevant abdominal aortic aneurysm (AAA) underwent isolated TF-TAVI. One patient with relevant AAA underwent TF-TAVI and sequential EVAR. Seven patients with previous EVAR due to an AAA underwent TF-TAVI (5 with a bifurcated graft and 2 with a straight graft). TF-TAVI and sequential or simultaneous TEVAR were technically successful in all patients. Vascular complications occurred in 1 patient. One patient died within 30 days and 2 patients died within 12 months. Conclusion. TF-TAVI can be performed successfully in patients with aortic disease or previous endovascular aortoiliac intervention. Simultaneous and sequential (T)EVAR is feasible.

J INVASIVE CARDIOL 2019;31(10):289-295. (Epub 2019 August 15).

Key words: aortic disease, aortic valve stenosis, percutaneous intervention

Transcatheter aortic valve implantation (TAVI) is currently the standard of care for patients with severe, symptomatic aortic stenosis (AS) who are deemed inoperable or at high surgical risk, and current data show promising results in the intermediate-risk population.^1-5 If suitable, the transfemoral approach (TF-TAVI) is recommended due to various advantages (better outcomes, faster patient recovery, shorter procedural time) in comparison with the transthoracic approach.^1-6 The significant benefits of TAVI become increasingly evident in studies focusing on the less-invasive TF approach and excluding transapical procedures.^1-6

The presence of aortic disease in patients undergoing TF-TAVI increases the procedural risk.^6-8 Therefore, many operators avoid the TF approach in such patients, taking the exclusion criteria of the PARTNER trial under consideration.⁷ Moreover, significant device interaction may occur during the TF-TAVI procedure in patients with previous endovascular aortic repair (EVAR).^8-10 Subsequently, the TAVI operator is faced with the problem of whether or not the transthoracic approach should be preferred and if thoracic EVAR ([T]EVAR) should be performed simultaneously or sequentially in cases of relevant aortic disease (eg, abdominal aortic aneurysm [AAA] and complicated type-B penetrating atherosclerotic ulcer [PAU]). The data regarding feasibility of TF-TAVI in patients without treated aortic lesions or previous EVAR are sparse.^8-10 The purpose of the present study was therefore to systematically evaluate the feasibility of TF-TAVI in patients with aortic disease or previous endovascular aorto- bi-iliacal stenting and to assess the safety of simultaneous or sequential (T)EVAR in order to facilitate optimal procedural planning in such complicated cases.

Methods

Patient population. Between January 2009 and January 2019, a total of 15 consecutive high-risk patients with symptomatic aortic valve stenosis and concomitant aortic disease underwent TF-TAVI using the following bioprosthetic valves: the CoreValve (MCV; n = 4), Evolut R (MER; n = 1), or Evolut Pro (MEP; n = 1) (Medtronic); the Sapien XT (ESXT; n = 3) or Sapien 3 (ES3; n = 4) (Edwards Lifesciences); the Symetis Acurate neo (SAN; n = 1) (Boston Scientific Corporation); and the Direct Flow (DF; n = 1) (Direct Flow Medical). The decision for TF-TAVI was made by an interdisciplinary heart team and was based on current recommendations.^1-4,7,11,12 Mortality and vascular complication rates were used as endpoints according to Valve Academic Research Consortium (VARC) recommendations.¹³ Indication for sequential and simultaneous TEVAR was based on the guidelines for the diagnosis and treatment of aortic diseases.¹⁴ Three patients underwent TEVAR, with 1 receiving the Gore stent-graft system (W. L. Gore & Associates) and 2 receiving the Endurant stent-graft system (Medtronic). TF-TAVI and (T)EVAR procedures were performed according to previously reported standard techniques.^2,7-17 Data from three German heart centers representing 4410 TAVI procedures were retrospectively analyzed.

Technical approach. The TF-TAVI procedure was performed in standard manner under conscious sedation.^2-7,11 The balloon-expandable bioprosthesis was delivered using a 14 or 16 Fr eSheath introducer set (Edwards Lifesciences). The self-expandable bioprosthesis was delivered using an 18 or 20 Fr Cook sheath (Cook Medical) or an EnVeo Pro delivery catheter system (Medtronic).

The 0.035˝ extra-stiff wire (Amplatz Extra-Stiff [Boston Scientific]; Confida guidewire [Medtronic]; or Lunderquist Extra-Stiff [Cook Medical]) was gently advanced to the ascending aorta over a pigtail catheter not touching the aortic pathologies at any time. If necessary, guidewire kinking was successfully managed with a Judkins right (JR) 4.0 guiding catheter. Using standard catheter-exchange techniques, TF-TAVI was performed while avoiding any significant contact with the aortic pathologies or previous implanted endovascular stent-graft (the “no-touch” technique). (T)EVAR was performed sequentially or simultaneously depending on the patient’s comorbidities and frailty. Decisions were based on the individual heart-team approaches of the participating centers.

Results

Patient and procedural characteristics. Between January 2009 and January 2019, data from 15 TF-TAVI patients with combined aortic disease were analyzed. Our study cohort represents a typical TAVI patient population of elderly patients with symptomatic AS and at very high operative risk (Tables 1 and 2). Ten patients had coronary artery disease, 4 patients had prior heart surgery, 7 patients had prior percutaneous intervention, and 10 patients had peripheral vascular disease. TF-TAVI and sequential or simultaneous TEVAR were technically successful in all patients. Vascular complications occurred in only 1 patient (access related). One patient died within 30 days and 2 patients died within 12 months (patients #10 and #12).

TF-TAVI and (T)EVAR due to complicated type-B PAU. Due to advanced age, comorbidities, and frailty, TF-TAVI and simultaneous EVAR were performed in patient #1 with complicated type-B PAU in the descending infrarenal aorta detected during the routine multislice computed tomography (MSCT) performed before the procedure. TF-TAVI was completed successfully without vascular complications using a 29 mm ES3 bioprosthesis. The mean gradient was 7 mm Hg, and mild paravalvular leakage (PVL) was observed. Hemodynamics did not show an approximation of the diastolic aortic pressure and the left ventricular end-diastolic pressure, confirming lack of hemodynamic relevance of the PVL.¹⁶

After surgical cutdown to the iliofemoral vessels, a 23 x 70 mm Endurant stent-graft was advanced over the 0.035˝ Lunderquist Extra-Stiff wire initially used for the TF-TAVI procedure, with its shaped tip now placed in the ascending aorta. The process was finalized successfully without endoleak. This system does not require an additional delivery sheath.

MSCT of patient #2 revealed a complicated type-B PAU in the descending thoracic aorta just after the left subclavian artery (Figure 1). TF-TAVI was successfully performed with a 29 mm ES3 bioprosthesis with the no-touch technique regarding the aortic pathology without vascular complications. The mean gradient after implantation was 12 mm Hg and PVL was not observed. Sequential percutaneous TEVAR was performed 6 weeks later with a 30 x 150 mm Gore stent-graft, with a pigtail catheter placed in the left subclavian artery over the left radial artery as a safety marker due to the short proximal landing zone. The stent-graft was advanced percutaneously over the 0.035˝ Amplatz Super-Stiff wire using a 24 Fr Gore sheath and a Perclose ProGlide (Abbott Vascular). Angiography and CT showed an excellent result after stent-graft deployment, with no endoleak (Figures 1 and 2).

Patient #3 had an uncomplicated, asymptomatic (non-progressive) PAU in the descending infrarenal aorta and underwent successful TF-TAVI using the Symetis Acurate neo L bioprosthesis, with a mean gradient of 14 mm Hg after implantation without PVL. Under fluoroscopic guidance, wire positioning with the same catheter-exchange technique and gentle passing of the delivery system without touching the aortic pathology the valve was safely deployed in the usual manner without vascular complications. The uncomplicated type-B PAU was treated conservatively under careful surveillance according to the guidelines.¹⁴

TF-TAVI and AAA. A relevant 57 mm infrarenal AAA was detected in the MSCT of patient #4. TF-TAVI was carefully performed using the no-touch technique with the 29 mm Evolut R bioprosthesis, with a mean gradient of 9 mm Hg after implantation. PVL was not observed. The patient was discharged without vascular complications and sequential EVAR with the Endurant stent-graft system (bifurcated 3616C166 mm; contralateral limb 1616C124 mm and 1616C82 mm) was successfully performed after surgical cutdown. The Endurant stent-graft system was advanced over the 0.035˝ Lunderquist wire. This system does not require an additional delivery sheath.

A not-yet-relevant 52 mm infrarenal AAA was detected in patient #5. Initial guidewire kinking due to the aneurysm was successfully managed with a JR 4.0 guiding catheter. Using standard catheter-exchange techniques (and after safely passing by the aortic pathology), a 23 mm ES3 bioprosthesis was implanted, with a mean gradient of 10 mm Hg and no PVL after implantation. A surveillance strategy was chosen regarding the AAA. Vascular complications did not occur. A not-yet-relevant infrarenal AAA was detected in patients #6-#8 (53.5 mm, 42 mm, and 45 mm, respectively). TF-TAVI was performed successfully with the no-touch technique by use of the 29 mm MCV, the 26 mm ES3, and the 27 mm DF bioprosthesis, respectively, with good postprocedural valve function and absence of relevant PVL.

TF-TAVI after EVAR. Patient #9 had a history of aorto-bi-iliacal EVAR with the Endurant stent-graft system (bifurcated 2516C170 mm; contralateral limb 1613C120 mm) due to an infrarenal AAA and was evaluated for TF-TAVI due to previous heart surgery and multiple comorbidities. MSCT indicated safe passage of the delivery system via TF approach (Figure 3). However, due to a higher risk for the balloon-expandable uncovered valve frame to “stick” to the aortic stents, we chose the self-expandable bioprosthesis as we considered the covered valve frame to be a safer option. The pigtail catheter was placed in the non-coronary cusp via the right radial artery. After surgical cutdown to the right iliofemoral vessels, the valve-delivery system was advanced. Very gentle traction of the stiff wire was necessary in order to achieve a continuously central position of the guidewire in the endovascular stent-graft during advancement in order to minimize the risk of the TAVI delivery system sticking to the stent struts. Intermittent pulling of the stiff wire while passing the distal part of the endovascular stent-graft was important in order to achieve a continuous coaxial position in the vessel and thus avoid collision of the stent-graft struts with the delivery system of the aortic valve bioprosthesis. After this critical part, TF-TAVI with the 29 mm Evolut Pro bioprosthesis was performed in standard manner^1-6 with no PVL. The mean gradient was 8 mm Hg after deployment.

Patients #10-#15 had similar histories of previous EVAR due to AAA (4 patients with a bifurcated graft and 2 patients with a straight graft). TF-TAVI was likewise performed successfully with the no-touch technique (26 mm MCV, 29 mm ESXT, 29 mm ESXT, 29 mm ESXT, 29 mm MCV, and 26 mm MCV bioprostheses, respectively), with good postprocedural valve function and absence of relevant PVL.

Discussion

The combination of aortic disease and symptomatic aortic valve stenosis in high-risk patients is challenging and data are sparse. TF-TAVI is therefore frequently withheld from patients with aortoiliacal disease or previous EVAR despite the significant benefits of the TF approach in high-risk patients and the very promising results in the intermediate-risk population.

Our study cohort includes the most important constellation of challenging patients with combined aortic disease and symptomatic aortic valve stenosis that the TAVI operator can encounter in everyday practice. Our data prove the feasibility of TF-TAVI in patients with aortic disease or previous EVAR. If necessary (according to the guidelines),¹⁴ simultaneous or sequential (T)EVAR was successfully performed.

This manuscript suggests a complete TF approach in patients with combined aortic and aortic valve disease, taking into consideration the advantages of retrograde access and the possible extension to low-risk patients in the future. Experience with both TAVI and (T)EVAR procedures is a prerequisite, and a heart-team approach is necessary for decision making.

Aortic disease and TAVI. Surgical aortic valve replacement (SAVR) remains the first-line therapy for symptomatic aortic valve stenosis. The less-invasive way of replacing the aortic valve is TF-TAVI.^1-3 Therefore, the TF approach is the gold standard for high-risk patients, and current data show promising results in the intermediate-risk population as well.^1-5 Nevertheless, for some patients with aortic or aortoiliacal disease, the TF approach is complicated. Therefore, many interventionists avoid TF-TAVI in such patients, taking the exclusion criteria of the PARTNER trial under consideration.⁶ In these circumstances, alternative approaches for TAVI (transapical, subclavian, transaortic) or even SAVR are preferred by operators.

The combination of aortic disease and symptomatic aortic valve stenosis in high-risk patients remains challenging and data are sparse. Until today, only a few isolated case reports have been published regarding combined TF-TAVI and TEVAR in patients with AS and thoracic aortic aneurysm.^9,10,18,19 In the present study, we proved the feasibility of TF–TAVI in high-risk patients with various aortic diseases. Our data show that with standard catheter-exchange techniques, TF-TAVI can be performed while avoiding any contact with the aortic pathologies using the no-touch technique. The ability to perform (T)EVAR at any time is a precondition for treating such patients through the retrograde TF approach. Depending on the aortic pathology and based on the current guidelines,^14,17 (T)EVAR can be performed sequentially or simultaneously, taking the patient’s comorbidities and frailty under consideration. The present article suggests the Perclose ProGlide technique for (T)EVAR when possible (eg, acceptable iliofemoral anatomy, use of a delivery sheath up to 24 Fr). A surgical cutdown should be considered for stent-graft systems that do not require an additional delivery sheath and for patients with complicated peripheral vasculature. A non-femoral access should be considered in patients with combined aortic and severe peripheral vascular disease, and also in cases of chronic, stable, type-B aortic dissection without signs of malperfusion and therefore no necessity to perform (T)EVAR.

The present case series includes a frail patient with dynamic, unstable, symptomatic type-B PAU who underwent simultaneous TF-TAVI and TEVAR in order to elude consecutive aortic complications. On the other hand, another patient with a relevant AAA and impaired renal function underwent isolated TF-TAVI in order to avoid a prolonged intervention with additional contrast media injection due to a double treatment. After rehabilitation, this patient underwent sequential, elective EVAR in a much more stable condition. Therefore, regarding the dilemma of simultaneous versus sequential (T)EVAR after TF-TAVI, we recommend an individualized heart-team approach for each patient.

TF-TAVI after previous EVAR. Exact MSCT evaluation of the stent-graft system is necessary before performing TF-TAVI after previous EVAR. In this study, the critical part of the delivery system passing through the metal scaffold of the aorto-bi-iliacal stents was managed with the use of a self-expandable bioprosthesis that had the stent-frame of the valve covered. Use of the balloon-expandable bioprosthesis for a partial inflation of the distal section of the balloon can also minimize the contact between the uncovered Edwards valve frame and the endovascular stent and allow safe passage of the valve.⁸ Achieving a continuous coaxial position of the wire in the vessel during advancement of the delivery system through the endovascular stent-graft is of great importance in order to avoid collision with the stent struts. In this regard, very gentle traction of the stiff wire is necessary in order to achieve a continuously central position.

Study limitations and strengths. The small number of patients is a limitation of this study. Nevertheless, the advantage of the TF approach for TAVI is frequently withheld from high-risk patients with severe symptomatic aortic valve stenosis and combined aortic disease or previous EVAR due to the sparse data regarding the interventional treatment of such patients. To our knowledge, this is the largest analysis of patients under these special conditions. The present analysis includes the most important constellation of aortic diseases that can challenge the TAVI operator, and thus its purpose was to provide rare data in an exemplary way regarding the feasibility of TF-TAVI in such patients. In addition, this study shows that the ability to perform simultaneous or sequential (T)EVAR is a precondition for treating these patients through the retrograde TF route.

Conclusion

TF-TAVI can be performed successfully in patients with aortic disease or previous endovascular aortoiliacal intervention. Simultaneous and sequential (T)EVAR are feasible, depending on the patient’s aortic pathology and frailty. An individual heart-team approach is necessary for decision making.

Acknowledgments. We thank Antonios Katsounas from the Division of Infectious Diseases, Department for Gastroenterology, Hepatology, and Infectious Diseases at Otto-von-Guericke University, Magdeburg, for his support.

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From ¹the Department of Cardiology and Angiology, University Hospital Bergmannsheil, Ruhr University Bochum, Bochum, Germany; ²the Department of Cardiology and Angiology, Contilia Heart and Vascular Center, Elisabeth Hospital Essen, Essen, Germany; ³the Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum, NRW, Ruhr University Bochum, Bochum, Germany; ⁴the Department of Cardiothoracic Surgery, University Hospital Bergmannsheil, Ruhr University Bochum, Bochum, Germany; ⁵the Department of Cardiology, Klinikum Westfalen, Heart Center Westfalen, Dortmund, Germany; ⁶the Department of Radiology, University Hospital Bergmannsheil, Ruhr University Bochum, Bochum, Germany; and ⁷the Department of Cardiology, Heart Center Stadtspital Triemli, Zurich, Switzerland.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Plicht reports lecture honoraria from Abbott Vascular and Philips Medical. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript submitted March 29, 2019, provisional acceptance given April 18, 2019, final version accepted April 24, 2019.

Address for correspondence: Polykarpos C. Patsalis, MD, Heart Center Bergmannsheil, Department of Cardiology and Angiology, Ruhr University Bochum, Bürkle-de-la-Camp-Platz 1, 44789 Bochum, Germany. Email: polykarpos.patsalis@bergmannsheil.de