Cath Lab Digest

Oklahoma Heart Institute recently performed the first transcatheter aortic valve replacement procedures in Tulsa, Oklahoma. We present the details of one of the cases.

Clinical presentation

J.S. is an 87-year-old female with severe calcific aortic stenosis and New York Heart Association (NYHA) class III-IV congestive heart failure symptoms who is referred for transfemoral transcatheter aortic valve replacement (TAVR).  Her past medical history is remarkable for coronary artery disease for which she underwent three-vessel coronary artery bypass grafting in 1996. In addition, she has severe oxygen-dependent chronic obstructive pulmonary disease (FEV1 0.65 L, 40% predicted) with severe pulmonary hypertension, stage III chronic kidney disease, hypertension, and type II diabetes mellitus on insulin therapy. The predicted operative mortality for surgical aortic valve replacement based on the Society for Thoracic Surgeons database (STS score) was calculated to be 24.3%. She was evaluated by two cardiothoracic surgeons for surgical aortic valve replacement and was deemed inoperable in light of her history and predicted surgical risks. 

The patient had worsening congestive heart failure symptoms to the point that she was short of breath at rest and with minimal activity (NYHA class III-IV). Because of her advanced age and multiple co-morbidities, there was concern as to whether TAVR would significantly impact her symptoms, quality of life and survival. Therefore, balloon aortic valvuloplasty (BAV) was performed on January 18, 2012 at Oklahoma Heart Institute Hospital to assess for symptomatic and functional improvement, and therefore help gauge the relative contribution of severe aortic stenosis to her overall condition (Figure 1). Following BAV, the patient had a marked and dramatic improvement of her congestive heart failure symptoms to NYHA class II as well as improvement in her functional capacity, indicating that she would likely respond very well to TAVR. In addition, despite her multiple co-morbidities, she remained an active and independent individual who greatly wished to continue to enjoy her hobbies, and many children and grandchildren.

Given these considerations, she was felt to be an appropriate candidate for transfemoral TAVR and comprehensive pre-procedural testing was performed at Oklahoma Heart Institute, including transthoracic and transesophageal echocardiography, cardiac catheterization with coronary and bypass graft angiography, as well as computed tomographic (CT) evaluation of the aortic valve/annulus, aorta and iliofemoral vessels (Figures 2-5). These studies were performed, interpreted and reviewed by the multidisciplinary Heart Team at Oklahoma Heart Institute, and the patient was felt to be an appropriate candidate for transfemoral TAVR utilizing a 23 mm Edwards Sapien transcatheter heart valve.

Procedural details

The patient was admitted electively to the Oklahoma Heart Institute Hospital on May 16, 2012, in preparation for scheduled transfemoral TAVR on the following day. On May 17, she underwent successful transfemoral TAVR with a 23 mm Edwards Sapien transcatheter heart valve utilizing the RetroFlex 3 delivery system. The procedure was performed in the newly-constructed, dedicated, hybrid cardiac catheterization laboratory at Oklahoma Heart Institute Hospital. 

General endotracheal anesthesia was utilized, as was intra-procedural transesophageal echocardiography (TEE). The procedure was performed completely percutaneously, without the need for surgical vascular access. The native aortic valve was crossed, and the Edwards Sapien valve was deployed with rapid pacing after careful positioning under fluoroscopic and TEE guidance (Figure 6; video available at www.cathlabdigest.com). Following deployment of the valve, TEE demonstrated a well-positioned valve with trivial central aortic regurgitation and no paravalvular regurgitation. Clinically, the patient tolerated the procedure very well and was extubated without difficulty at the conclusion of the procedure while still in the hybrid catheterization laboratory.

Post-procedural course

The patient was admitted to the cardiovascular intensive care unit (CVICU) immediately following successful TAVR as per institutional protocol. Clopidogrel was administered on arrival to the CVICU. She did very well immediately following the procedure and ambulated without difficulty on post-procedure day #1, at which time she was transferred out of the CVICU to a cardiac telemetry floor. The patient underwent follow-up transthoracic echocardiography on post-procedure day #1 that demonstrated that the Edwards Sapien aortic valve prosthesis was functioning well, with a mean gradient of 13mmHg and trivial-mild central aortic regurgitation. She continued to do very well and was discharged home on post-procedure day #2 in good condition. The only new medication added to her regimen on discharge was clopidogrel 75 mg PO daily which she was instructed to continue for six months. Outpatient follow-up in the Oklahoma Heart Institute TAVR clinic was scheduled for one week after discharge.

The patient was seen in the Oklahoma Heart Institute outpatient TAVR clinic one week following her procedure. She reported significant improvement in her congestive heart failure symptoms at that visit (NYHA class II) as compared to her baseline prior to the procedure (NYHA class III-IV). In addition, her total walk distance had improved significantly. She also reported that she was no longer using her home oxygen on a regular basis. The femoral artery vascular access site for TAVR was examined carefully and noted to be unremarkable. She was advised to continue her aspirin and clopidogrel therapy as previously instructed and six-month outpatient follow-up was scheduled.

Discussion

Transfemoral transcatheter aortic valve replacement using the Edwards Sapien transcatheter heart valve system is indicated for patients with severe symptomatic native aortic valve stenosis who have been deemed inoperable for open surgical aortic valve replacement by a cardiothoracic surgeon and in whom existing co-morbidities would not preclude expected benefit from correction of aortic stenosis. The landmark PARTNER trial demonstrated significant and marked improvements in survival, symptoms and quality of life in patients treated with this device, as compared with standard medical therapy.  In addition, current two-year follow-up data from this trial indicate continued excellent performance of this valve prosthesis.

As described herein, our patient J.S. met the criteria for transfemoral TAVR and underwent this procedure successfully at Oklahoma Heart Institute with an excellent result.

The author can be contacted at Kamran.Muhammad@oklahomaheart.com. 

For more information on Oklahoma Heart Institute’s TAVR program, including videos of the first TAVR procedure in Tulsa, as well as our newly-constructed hybrid cardiac catheterization laboratory, please visit: http://www.oklahomaheart.com/tavr 

References

1. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363(17):1597-607.
2. Makkar RR, Fontana GP, Jilaihawi H, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med 2012;366(18):1696-704.

The Hybrid Lab at Oklahoma Heart Institute

Cath Lab Digest talks with Kamran I. Muhammad, MD, FACC, FSCAI, Interventional Cardiology, Oklahoma Heart Institute, Tulsa, Oklahoma

Can you tell us about the new hybrid lab?

Oklahoma Heart Institute recently built a brand-new, dedicated hybrid cardiac cath lab, the only such lab in Tulsa and in the region. This lab was planned, custom designed, and constructed from the ground up over the past year to bring advanced technologies and capabilities to our city and region for the benefit of our patients. This type of advanced lab is an important requirement for hybrid cases such as transcatheter aortic valve replacement (TAVR). Our hybrid lab is located in the cardiac catheterization lab. It is a Philips hybrid lab and officially opened in April 2012. As you know, hybrid labs combine the capabilities of an operating room and a cardiac cath lab in order to provide this type of advanced care.