Balloon valvuloplasty and transcatheter aortic valve replacement via aortofemoral bypass grafts: A case report and review of literature

Abstract

BACKGROUND

Transcatheter aortic valve replacement (TAVR) can be performed through multiple access sites with the preferred approach being transfemoral. In patients with severe peripheral arterial disease and previous grafts, the safety of transfemoral access via direct graft puncture, especially when performed twice within a short period, remains unclear compared to alternative access methods. We present a case demonstrating the safety and efficacy of direct graft puncture for transfemoral access during balloon aortic valvuloplasty (BAV) and TAVR.

CASE SUMMARY

An 82-year-old man presented with dyspnea on exertion. Echocardiogram was significant for severe aortic stenosis. Following a heart team discussion, the patient was scheduled for a balloon valvuloplasty followed by staged TAVR. Based on pre-TAVR computed tomography angiogram, the aortobifemoral graft was deemed as an appropriate access site. Micropuncture needle was used to access the right femoral artery graft, and the sheath was upscaled to 10 Fr. He underwent successful intervention to ostial left anterior descending and left circumflex arteries, and BAV with 22 mm Vida BAV balloon. Hemostasis was achieved using Perclose. For TAVR, an 8 Fr sheath was inserted via the right femoral bypass graft. The arteriotomy was pre-closed with two Perclose ProGlides and access was upsized to 18F Gore DrySeal. A 5Fr sheath was used for left femoral bypass graft access. Patient underwent successful TAVR with 29 mm CoreValve. Hemostasis was successfully achieved using 2 Perclose for right access site and one Perclose for left side with no postoperative bleeding complications.

CONCLUSION

BAV and TAVR are feasible and safe through a direct puncture of the aortofemoral bypass graft with successful hemostasis using Perclose.

Key Words: Balloon aortic valvuloplasty; Aortic valve replacement; Aortic stenosis; Aortofemoral bypass grafts; Case report

Core Tip: This case report focuses on the safety and efficacy of a direct puncture of an aortofemoral graft for transfemoral access to perform balloon aortic valvuloplasty and a staged transcatheter aortic valve replacement (TAVR) within a short time frame in a patient with severe peripheral arterial disease. While alternative non-femoral access approaches are reasonable, we chose direct graft puncture as the ideal access based on multi-detector computed tomography imaging. This demonstrates the safety of obtaining large-bore catheter access twice through an aortofemoral graft. Our case adds to the literature by exploring the short-term outcomes of puncturing an avascular structure during TAVR in a complex patient. This transfemoral approach may be considered in patients with aortofemoral grafts when general anesthesia or alternative access methods are less desirable.

INTRODUCTION

Transcatheter aortic valve replacement (TAVR) is a widely recognized procedure used to treat severe aortic stenosis for high surgical risk patients and can be performed through multiple access sites with the preferred approach being transfemoral. In patients with prior lower limb bypass, few case reports have reported the usefulness and safety of direct graft puncture for transfemoral access[1]. The concerns associated with direct graft puncture include challenges in achieving post-procedural hemostasis leading to hematoma formation, disruption of the anastomosis with subsequent development of pseudoaneurysm, and the risk of graft site infection requiring surgical intervention. However, when performed diligently with proper imaging guidance, accessing a vascular graft for intervention can be achieved with minimal complications. Additionally, femoral hemostasis in patients with femoral grafts using vascular closure devices have been reported to be safe and effective[2,3]. There are several types of vascular closure devices- clip-based, suture-based, disc-based, and plug-based[4]. The use of certain plug-based devices such as Angio-Seal and Mantra, and suture based devices has been published in the literature. Herein, we report a case of successful balloon aortic valvuloplasty (BAV), followed by staged TAVR, both performed via an aortobifemoral bypass graft.

CASE PRESENTATION

Chief complaints

An 82-year-old man presented to ambulatory clinic for dyspnea with exertion for past 5-6 months.

History of present illness

His dyspnea was progressively worsening without any relieving factors and had begun to significantly impair his daily functioning. His symptoms were consistent with New York Heart Association Class III.

History of past illness

His past medical history included hypertension, diabetes mellitus, chronic diastolic heart failure, hyperlipidemia, chronic kidney disease stage 3, coronary artery disease with a drug eluting stent (DES) placed in the proximal left anterior descending (LAD) artery nine years ago, and peripheral arterial disease. His past surgical history includes an aortobifemoral bypass for peripheral arterial disease with polytetrafluoroethylene graft in 1985.

Personal and family history

For medications, the patient was taking metoprolol tartrate 50 mg twice daily, aspirin 81 mg daily, amlodipine 5 mg daily, spironolactone 25 mg daily, atorvastatin 40 mg once daily, and 1.5 mg of Soliqua 100/33 subcutaneous injection daily. He was not taking any herbal medication and was adherent to his medications. He had no known allergies. He had no significant family history. He was a former tobacco smoker. He reported smoking three packs of cigarettes daily for five years before quitting 40 years ago. He was a retired engineer and lived with his son and grandchildren. He reported being consistent with a low-salt and low-fat diet.

Physical examination

Physical examination was unremarkable with the exception of 1+ lower extremity edema and grade 3/5 systolic murmur.

Laboratory examinations

His hepatic function was normal (aspartate aminotransferase/alanine aminotransferase were 17 U/L and 18 U/L respectively). His renal function was decreased with a baseline creatinine level of 1.5 mg/dL. Besides the laboratory values listed above, he also had an elevated pro-BNP level of 3093 pg/mL.

Imaging examinations

An echocardiogram was performed which showed severe aortic stenosis with a peak velocity of 4.0 m/s, mean aortic gradient of 44 mmHg and an aortic valve area of 0.96 cm². Other findings included a normal ejection fraction of 65%, trace aortic regurgitation, trace mitral regurgitation, and trace tricuspid regurgitation.

FINAL DIAGNOSIS

Based on the patient’s medical historyand and imaging findings, a diagnosis of severe aortic stenosis was confirmed.

TREATMENT

Following a heart team discussion, it was recommended that the patient would need his aortic valve replaced. Subsequently, the patient underwent left heart catheterization (LHC) as part of a TAVR workup. LHC showed 2-vessel coronary artery disease with a 70% ostial LAD lesion, hemodynamically significant by instantaneous wave-free ratio with a value of 0.88. He also had 95% distal left circumflex (LCx) lesion. His society of thoracic surgeons score was 4.361%, and he had Frailty Index of 1. The case was discussed with the cardiothoracic surgery team and considering multiple comorbidities he was deemed a suitable candidate for TAVR.

Computed tomography angiography (CTA) TAVR protocol was performed which showed patency of the aortobifemoral graft. There were occlusions in both native common iliac arteries and native right external iliac artery. There was severe narrowing in the right common femoral artery proximal to the distal anastomosis of the graft. The left external iliac artery, left internal iliac artery, and left common femoral artery were patent.

He was scheduled for a complex high-risk and indicated percutaneous coronary intervention (PCI) with intra-aortic balloon pump for mechanical circulatory support and BAV. Based on the pre-TAVR CTA, the aortobifemoral graft was deemed an appropriate access site (Figure 1A and B). Micro puncture needle was used to access the right femoral artery graft at the level of the femoral head using ultrasound and fluoroscopic guidance, and a femoral angiogram was performed (Figure 1C). Using serial dilators, the access site was upscaled to 10 Fr Pinnacle sheath. Heparin was administered to maintain an activated clotting time (ACT) greater than 250 seconds. Initially, PCI was performed on the LCx with balloon angioplasty and a DES was placed. Then, ostial LAD intervention was performed with cutting balloon and a DES was placed (Figure 2A and B). The patient subsequently underwent BAV with 22 mm Vida BAV balloon valvuloplasty catheter (Figure 2C). Hemostasis was achieved using Perclose without any postoperative access complications. At the end of the procedure, a final ACT was assessed to ensure that it is greater than 250 seconds. The patient was transferred to the coronary care unit for further monitoring. Patient was monitored in the coronary care unit (CCU) as per standard institutional protocol and remained without any postoperative complications. He was discharged on postoperative day 1.

Figure 1 Computed tomography angiography and cardiac catheterization images of aortobifemoral grafts. A: Computed tomography (CT) showing bilateral aortofemoral grafts; B: CT assessment of graft sizing/caliber; C: Right aortofemoral graft access for balloon valvuloplasty; D: Bilateral aortofemoral graft access for transcatheter aortic valve replacement.

Figure 2 Fluoroscopy images. A: Coronary angiogram showing ostial left anterior descending artery and distal left circumflex lesion; B: Coronary angiogram after percutaneous coronary intervention on ostial left anterior descending artery and distal left circumflex lesion; C: Balloon aortic valvuloplasty with 22 mm vida balloon aortic valvuloplasty balloon; D: Deployment of 29 mm Evolut-R CoreValve.

Three weeks later, the patient was scheduled for TAVR. Graft patency was assessed using color Doppler on the ultrasound. Ultrasound and fluoroscopic-guided access of the graft was obtained using a micro puncture needle at the level of the femoral head. A femoral angiogram was performed using a micro puncture sheath and an 8 Fr sheath was advanced over the wire. Over Supra Core wire, the arteriotomy was pre-closed with two Perclose ProGlides and access was upsized to 18 Fr Gore Dry Seal after passing serial dilators. A 5Fr sheath was used for left femoral arterial access (Figure 1D). Heparin was administered during the procedure for anticoagulation. The patient underwent a successful TAVR with 29 mm Core Valve (Figure 2D) with post-deployment echocardiogram demonstrating no significant paravalvular leak and low peak and mean gradients across the aortic valve. Hemostasis was successfully achieved using 2 Perclose for right access site and one Perclose for left side with no postoperative bleeding complications. Protamine was administered for heparin reversal and cefazolin 2 g was administered as antibiotic prophylaxis[5]. The patient was transferred to the cardiothoracic unit for closer monitoring. Postoperative course in the cardiothoracic care unit (CTU) was uneventful with no signs of access site-related complications.

OUTCOME AND FOLLOW-UP

Following high-risk PCI and BAV, the patient was monitored in the CCU as per standard institutional protocol and remained without any postoperative complications. He was discharged on postoperative day 1. Following TAVR, the post-deployment echocardiogram demonstrated no significant paravalvular leak and low peak and mean gradients across the aortic valve. Postoperative course in the CTU was uneventful with no signs of access site-related complications. On outpatient follow-up, the patient reported significant improvement in symptoms, and no complications were noted at the access site. Follow-up echocardiogram demonstrated findings consistent with the postoperative study, with no significant paravalvular leak and low peak and mean gradients across the aortic valve.

DISCUSSION

We present a case of high-risk PCI with BAV and staged TAVR being successfully performed using transfemoral access through a direct puncture of an aortobifemoral bypass graft in both procedures. Hemostasis was successfully achieved using Perclose without having postoperative bleeding complications.

In cases with previous aortofemoral grafts, careful pre-TAVR planning is of paramount importance[6]. Multi-detector computed tomography (MDCT) imaging is considered the standard of care and helps with evaluating graft diameter, degree of vessel calcification, and tortuosity[7]. In patients with history of aortofemoral grafts, MDCT can help in determining patency and dimensions of the graft. The minimal graft dimension in our case did not limit the delivery of the sheaths[1]. Furthermore, ultrasound-guided access is the standard of care at our institution and should be used especially in cases with aortofemoral grafts to reduce complications[8].

Multiple studies have highlighted the pros and cons of alternative access for TAVR when transfemoral access is not permissible. Transfemoral access is utilized in at least 85% of TAVRs, as it is the preferred approach because the femoral artery typically provides an adequate diameter for the insertion of the required equipment[9-11]. In both the PARTNER Trial using the Edwards SAPIEN valve and the United States CoreValve Trial using CoreValve, the devices require large bore access, either through transfemoral or the transapical access[12-14]. In addition to transfemoral access, other accesses include transaxillary, transcaval, trans-subclavian, or transcarotid[9,10,15-20]. Each alternative access has their advantages and disadvantages and is limited by the vessel diameter requirement of each device. Transaxillary access was first introduced in 2011 and has become the most frequent alternative access route, alongside transcarotid access[16,21]. In a network meta-analysis, trans-subclavian approaches had more risk for stroke and life-threatening bleeds compared to transfemoral access and transcaval access had the highest rate of major vascular complications compared to transfemoral access[20].

Few case reports describe the usefulness and safety of direct graft puncture of an aortobifemoral grafts (Table 1)[1,22]. Direct graft puncture used to be unpopular due to multiple concerns including inability to achieve hemostasis post-procedure with subsequent hematoma, disruption of the anastomosis and subsequent pseudoaneurysm, and graft site infection necessitating surgical intervention because of the avascular nature of the graft[22]. However, studies have reported complication rates ranging from 0-20% with direct endovascular graft puncture[23,24]. Hence direct graft puncture for arterial access is now presumed to be safe and feasible[22]. In a case study describing two patients with aortofemoral graft undergoing TAVR, no postoperative complications were observed after direct puncture of the graft[1]. Our case is unique for demonstrating that direct graft puncture remains a safe and viable approach even after accessing the same site with a large-bore catheter twice within a short interval between the BAV and the staged TAVR.

Table 1 Review of literature on complications following transfemoral access of graft.

Ref.	Type of graft	Closure devices	Complications
Rosseel et al[1]	Two patients had aortobifemoral bypass grafts	Both patients used the same technique- 2. Perclose devices and 1 additional 6Fr Angioseal (Terumo, Shibuya, Tokyo, Japan)	None
Wu et al[3]	Aortobifemoral bypass graft	14F MANTA vascular closure device (Teleflex, Wayne, United States) and 4 Perclose devices	None
Ezeh et al[26]	Aortobifemoral bypass graft	2 Perclose devices	None
Geyer et al[27]	Aortobifemoral bypass graft	18F MANTA vascular closure device (Teleflex, Wayne, United States)	None

Repeat imaging of the vascular access after a BAV and before TAVR can be reasonable in certain situations. If there is suspicion of pseudoaneurysm or hematoma at the vascular access site, ultrasound imaging would be useful as an initial test. CT imaging is particularly useful in cases where bleeding is suspected, especially if the patient has hemodynamic compromise after the procedure[25]. Without any obvious signs of complication, a repeat imaging is unlikely to have clinical significance.

Multiple steps can be taken to prevent post-operative complications from direct graft puncture for arterial access. The use of ultrasound guidance for access has been shown to help minimize trauma to the graft and ensure graft patency prior to access[24]. After the procedure was finished, a vascular closure device was used to suture the arteriotomy. Vascular closure devices, such as Perclose, have been deemed to be not only as effective as manual compression but also safer with slightly fewer complications. They have proven to be safe alternatives for closing femoral artery puncture sites and prosthetic grafts after TAVR[1,3,26-29].

In case of uncontrolled bleeding, certain bail-out options are available. Similar to routine transfemoral access, an additional Perclose or a collagen-plug vascular closure device such as AngioSeal or Manta can be used[3,27,29-32]. If hemostasis is still unsuccessful, a covered stent or a surgical cutdown can be considered[29,33].

CONCLUSION

BAV and TAVR are feasible and safe through a direct puncture of the aortobifemoral bypass graft with successful hemostasis using Perclose.