We describe transcatheter aortic valve implantation in a patient who had severe peripheral artery disease. The patient's vascular condition required additional preliminary peripheral intervention to enable adequate vascular access.
A 78-year-old man with severe aortic stenosis, substantial comorbidities, and severe heart failure symptoms was referred for aortic valve replacement. The patient's 20-mm aortic annulus necessitated the use of a 23-mm Edwards Sapien valve inserted through a 22F sheath, which itself needed a vessel diameter of at least 7 mm for percutaneous delivery. The left common femoral artery was selected for valve delivery. The left iliac artery and infrarenal aorta underwent extensive intervention to achieve an intraluminal diameter larger than 7 mm. After aortic valvuloplasty, valve deployment was successful, and the transaortic gradient decreased from 40 mmHg to less than 5 mmHg. The patient was discharged from the hospital 4 days postoperatively. We conclude that transcatheter aortic valve implantation can be successfully performed in patients with obstructed vascular access, including stenosis of the infrarenal aorta and the subclavian and coronary arteries.
Transcatheter aortic valve implantation (TAVI) has emerged as a mainstream therapeutic option for valve replacement in patients who are at extreme surgical risk.1 Cardiologists and cardiac surgeons now consider TAVI in patients who have been deemed poor candidates for aortic valve replacement because of their substantial comorbidities.2–,4 Careful preoperative planning is crucial in selecting the proper strategy, avoiding intraoperative pitfalls in patients with marginal overall reserve, and minimizing surgical intervention for aortic valve stenosis.5 The TAVI procedure requires expertise in peripheral and coronary interventional techniques, including large-bore intravenous access.6 Until recently, lower-profile delivery systems for TAVI were not available in the United States.
We describe a case of TAVI that was complicated by severe peripheral artery disease. The elderly patient had contraindications to vascular access that initially made him ineligible for TAVI, so we also describe the additional interventions that were necessary to enable TAVI.
In May 2012, a 78-year-old man with critical limb ischemia, recurrent angina, prior aortocoronary bypass, severe aortic stenosis, and New York Heart Association functional class IV symptoms of heart failure was referred for possible aortic valve replacement. His estimated Society of Thoracic Surgeons risk score for TAVI was 21%.2 His aortic valve area was 0.6 cm2/cm2, which resulted in secondary pulmonary hypertension, a systolic pulmonary artery pressure of approximately 70 mmHg, a moderately depressed left ventricular ejection fraction (0.45), and chronic atrial fibrillation. The patient had substantial additional comorbidities, including end-stage renal disease and tissues weakened by previous mediastinal radiation therapy for a lymphoma.
Transesophageal echocardiograms revealed a 20-mm annular diameter. This annular size necessitated the use of a 23-mm Edwards Sapien® valve (Edwards Lifesciences LLC; Irvine, Calif), delivered through a 22F RetroFlex® delivery system (Edwards Lifesciences) in accordance with the manufacturer's recommendation. A 7-mm vessel diameter was necessary for percutaneous valve delivery. In addition to transesophageal echocardiography (in accordance with our institution's protocol for TAVI), we performed computed tomographic (CT) angiography, right and left cardiac catheterization, and aortoiliac angiography.
The CT angiogram showed extensive and diffuse disease in multiple areas. In particular, the infrarenal aorta was severely calcific, with multiple stenoses that reduced the aortic diameter to less than 2.7 mm (Fig. 1). We decided to perform TAVI through the left common femoral artery, because it had a diameter of 8 mm and only mild disease in its distal portion.
Because of the severely calcific stenosis of the infrarenal abdominal aorta, we performed a staged procedure 2 months before TAVI. Two overlapping iCAST™ stent-grafts—a 9 × 59-mm proximal stent and a 10 × 38-mm distal stent (Atrium Medical Corporation; Hudson, NH)—were deployed in the abdominal aorta distal to the takeoff of the superior mesenteric artery. Intravascular ultrasonography was used to guide real-time stent sizing and to evaluate the endoluminal results after stenting (Fig. 2). A CT reconstruction image of the abdominal aorta after the staged intervention showed that the distal aorta had acquired sufficient caliber to accommodate the 22F delivery system. However, the image also showed some remaining critical stenoses at the aortoiliac junction that would have to be dealt with periprocedurally (Fig. 3).
On the day of TAVI, we gained access to the left radial artery with use of a 5F Glidesheath® (Terumo Medical Corporation; Somerset, NJ). This second access enabled us to advance a pigtail catheter from the radial artery to the aortic root for imaging throughout the procedure, whereas a 22F RetroFlex delivery system would have been occlusive and precluded the use of a second femoral access. As expected from the pre-TAVI computed tomogram, we had to perform several percutaneous transluminal angioplasty procedures to expand the left aortoiliac junction to a diameter of 7 mm. We deployed a 10 × 40-mm Atlas® PTA Dilatation Catheter (Bard Peripheral Vascular Systems, Inc.; Tempe, Ariz) over a 0.035-in Amplatz Super Stiff Guidewire (Boston Scientific Corporation; Natick, Mass). After the 7-mm vessel was secured, access was obtained by means of a cutdown of the left common femoral artery, and a 22F RetroFlex delivery system was advanced into the abdominal aorta. The stenotic aortic valve was crossed with a 5F multipurpose catheter (Cordis, a Johnson & Johnson company; Miami Lakes, Fla) over a 0.035-in straight wire. When the catheter was in the left ventricle, it was exchanged for a 0.035-in LunderquistTM wire (Cook Medical, Inc.; Bloomington, Ind). We performed the aortic valvuloplasty with use of rapid right ventricular pacing and a 20 × 40-mm balloon (Edwards Lifesciences), which yielded minimal aortic regurgitation. Finally, we advanced the 22F RetroFlex delivery system—with the Sapien valve crimped over the delivery balloon—into the aortic annulus. Deployment was successful (Fig. 4). The transaortic gradient decreased from 40 mmHg to less than 5 mmHg. The left femoral artery was surgically repaired. The entire procedure took 3 hours 33 minutes. The patient was given 150 mL of angiographic contrast medium, and his total fluoroscopic exposure was 18 minutes. He was transferred to the postoperative intensive care unit, had an uneventful stay, and was discharged from the hospital 4 days postoperatively. He was then lost to direct follow-up but was known to be alive several months afterwards.
This report illustrates the use of TAVI in a patient who was not eligible for aortic valve replacement and who lacked suitable arterial access. Such patients traditionally have been excluded from surgical intervention because of the predicted high mortality rate.4 Cardiologists and cardiac surgeons have to overcome several challenges to perform TAVI in these “extreme-risk” patients, and vascular access is frequently the primary problem. In the Partner Trial,4 the prevalence of vascular sequelae was 20% because of the large profile of the delivery system that was used.
To date, 5 different vascular access methods for TAVI have been described: transfemoral, transapical, subclavian, direct aortic, and left carotid. At the time of this patient's procedure, transapical access was not available in the United States, and the evidence supporting transcarotid delivery is anecdotal and controversial.7 We considered using the transaortic approach8 via a limited mini-sternotomy; however, this route was less appealing because of the patient's 3 venous grafts (only 2 of which were still patent), a patent left internal mammary artery (LIMA)-to-left anterior descending coronary artery graft proximal to the sternum, and tissues weakened by the patient's previous radiation therapy.
Subclavian and axillary artery access has become increasingly popular.9–,11 In our patient, vessel dimension and tortuosity made this option suboptimal. In addition to having small-caliber vessels, our patient was undergoing hemodialysis through a left brachial fistula, and even a limited dissection might have simultaneously jeopardized the LIMA and the fistula.
With only the transfemoral route available, we opted for the left axis because of its larger iliac vessel (as determined by means of CT angiography). We proceeded through the calcific and stenotic infrarenal aortic and iliac vessels by extensively covering them with 2 overlapping iCAST covered stents. In case of rupture, these stents would prevent the dreadful situation of retroperitoneal bleeding after stent deployment.
We also performed focal iliac percutaneous transluminal angioplasty with use of noncompliant balloons (8 × 40 and 10 × 40 mm). This route offered the largest possible access through a highly diseased vessel and, accordingly, the greatest chance of success. Our use of intravascular ultrasonography assisted in the real-time evaluation of vessel dimensions to guide intervention in specific vascular areas.
Arterial access can be a substantial challenge in patients in whom there are few options for treatment. Using current 22F–24F delivery systems to perform TAVI necessitates meticulous preoperative evaluation and planning, and possibly also staged interventions by cardiologists and surgeons.1 Lower-profile devices will soon be available to meet the challenges presented by the newly treatable population of formerly “no-option” patients.7
We thank St. Luke's Episcopal Hospital for providing logistic support and for its ongoing support of and commitment to graduate educational programs. Stephen N. Palmer, PhD, ELS, and Katherine Jenson, BA, contributed to the editing of the manuscript. James Philpot, ACE, prepared the figures.
Presented at the Adriatic Vascular Summit, Siena, Italy, 5–8 September 2012.
From: Departments of Cardiology (Drs. Azpurua, Fish, Krajcer, and Nascimbene) and Cardiothoracic Surgery (Dr. Livesay), Texas Heart Institute, Houston, Texas 77030