Early Adoption of Transcatheter Aortic Valve Replacement (TAVR) at an Academic Community Hospital

Publication/Presentation Date

7-26-2013

Abstract

Background

Transcatheter Aortic Valve Replacement (TAVR) is a cutting edge heart procedure that allows replacement of the aortic valve without conventional open-heart surgery. TAVR represents an alternative without the need for sternotomy or cardiopulmonary bypass. Instead, a catheter is used to deploy the valve by leading a delivery sheath through an incision in either the groin (transfemoral) or chest (transapical) directly to the aorta. Patients must meet several requirements in order to be considered for TAVR. Eligible patients suffer from severe Aortic Stenosis (AS) and must be deemed inoperable or high risk for conventional open-heart surgery by a cardiologist and a cardiac surgeon.

Objective

This project was conducted to evaluate the success of TAVR procedures over the first year of utilization in an academic community hospital. Areas of focus were patient demographics including age, sex, and significant comorbidities. Other data gathered reflected distribution of surgical approaches, length of hospital and open-heart unit stay, infection, readmission rate, and fatalities. In addition to the raw statistical aspect of this study, the importance of collaborative medicine must be recognized.

Methods

Transcatheter implantation of an Edwards SAPIEN transcatheter heart valve (THV) was attempted in 52 symptomatic patients with severe aortic stenosis who were deemed inoperable or high risk for conventional surgical aortic valve replacement. All data was obtained via retrospective analysis of the first 52 patients who underwent the TAVR procedure at an academic community hospital over a one year period.

Results

52 patients were taken to the operating room for planned TAVR. 3 patients in early experience ewere aborted due to femoral arterial inadequacy. It should be noted that the transapical approach was not FDA-approved at that time. Indeed one of these patients went on to have successful transapical implantation. There were no perioperative deaths. There were 7 early deaths in the first year: 2 within thirty days of surgery, 3 within three months of surgery, 1 within six months of surgery, and 1 within twelve months of surgery. 65% of TAVRs were completed using the transapical approach. Mean frailty score of patients was 4.45. Mean STS score was 6.13. 20 patients were female and 32 were male. The mean patient age was 73. The mean length of hospital stay was 5 days, with the mean open-heart unit stay being 2 days. 17 patients (33%) were readmitted post-operatively, totaling 46 readmissions. Only 2 patients were readmitted with infection of the surgical wound, both transfemoral patients.

96% of patients had hypertension as a comorbidity. Out of 52 patients, 23 (42%) had previous open-heart surgery (22 CABG, 1 MVR). 63% suffered from coronary artery disease. Post-operatively, 6 patients (13%) required a permanent pacemaker implanted. 65% of patients did not experience any aortic insufficiency post-operatively.

Conclusions

Transcatheter Aortic Valve Replacement (TAVR) is a new “hybrid” procedure offering treatment for high risk patients who have aortic stenosis, and are deemed not candidates for conventional open-heart surgery. The procedure is technically demanding and requires an experienced, collaborative team of interventional cardiologists and cardiothoracic surgeons. The procedure is typically performed in a Hybrid OR, combining high-tech radiographic instrumentation of a cardiac catheterization lab with the size, equipment, and safety of an operating room.

Lehigh Valley Health Network (LVHN), a large academic community hospital, was an early adopter of the technology, having performed their first TAVR procedure within six months of FDA approval. The first year outcomes were excellent and consistent with the results of the original PARTNERS Trial. These outcomes further underscore the importance of collaboration between specialties, such as interventional cardiology and cardiac surgery. It also confirms the importance of having new technology first adopted in high volume programs.

Aortic Stenosis

The aortic valve lies between the left ventricle and the aorta, which is the main artery carrying blood out of the heart. Aortic stenosis (AS) results from the hardening of the aortic valve leaflets. Calcium deposits on the leaflets, narrowing the valve area and preventing blood from flowing through the valve properly. Due to the narrowing of the valve, the left ventricle must work harder to pump blood to the aorta. The left ventricle becomes hypertrophied, typically causing diastolic heart failure and symptoms of shortness of breath. In extreme cases, symptoms can include chest pain and even syncope. AS is determined to be severe through echocardiograms or cardiac catheterizations, which analyze valve area, mean gradient, and jet velocity of the aortic valve.

The Procedure

There are currently two TAVR approaches utilized: transfemoral and transapical. During the transfemoral approach, an incision is made in the groin area and the delivery sheath is placed in the femoral artery. Alternatively, the transapical incision is a small incision in the chest under the left breast, allowing access to the apex of the heart. It is important to note that the transfemoral approach was approved by the U.S. Food and Drug Administration (FDA) first in November 2011 for inoperable candidates only. About a year later, the transapical approach was approved, expanding the patient eligibility to those who are at high risk for conventional open-heart surgery.

The procedure is performed under general anesthesia. In either approach, the first step is to gain access to the heart. A sheath is placed either into the femoral artery (TF) or into the apex of the heart (TA). A catheter wire is placed across the valve, followed by a balloon aortic valvuloplasty (BAV). This procedure initially opens the valve to allow easier introduction of transcatheter valve. Transcatheter calve is then introduced and deployed over a second balloon. During these inflations, rapid temporary pacing is performed at heart rates as high as 200 beats per minute. This is done is to ensure there is no cardiac output during the time the balloon is inflated, preventing the heart from touching or ejecting the valve. All wires are then removed, and the incision is closed.

Comments

Mentor: Raymond Singer, MD

Disciplines

Nursing

Department(s)

Research Scholars, Research Scholars - Posters

Document Type

Poster

Rights Information

COPYRIGHT INFORMATION ~ When using this image, the credit information should be in the following format: Image courtesy of Lehigh Valley Health Network

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