A Case with Severe and Symptomatic Aortic Stenosis and Severe Calcification: Implantation of a TRINITY Heart Valve Prosthesis — A Novel, Truly Repositionable and Retrievable Transapical Transcatheter Aortic Valve System

Disclosure: Dr. Hengstenberg reports no financial interest, arrangement or affiliation with Transcatheter Technologies.

Dr. Christian Hengstenberg can be contacted at christian.hengstenberg@gmail.com.

Transcatheter aortic valve implantation (TAVI) has become an option for selected, high-risk patients with severe and symptomatic aortic stenosis. TAVI devices are either self- or balloon-expandable. In some cases, positioning of the valve may be difficult and result in suboptimal clinical result, including paravalvular regurgitation, atrioventricular (AV) conduction delay, or compromise of coronary perfusion. A truly repositionable and retrievable TAVI system, the Trinity heart valve system (Transcatheter Technologies) (Figure 1) was developed to achieve optimal clinical results. 

In the current case, the Trinity heart valve system was implanted in a 74-year-old patient with severe and symptomatic aortic valve stenosis and severe calcification. The patient had a body mass index of 35.1 kg/m², suffered from dyspnea according to the New York Heart Association (NYHA) class III, had a history of arterial hypertension and was free of coronary artery disease. The patient had normal kidney function with a creatinine of 0.9 mg/dL. 

The diagnostic procedures consisted of transthoracic and transesophageal echocardiographies, where ejection fraction was 59%, the peak and mean pressure gradients were 120 and 58 mmHg, respectively, and the aortic valve area was 0.6 cm². There was minimal aortic regurgitation with a pressure half-time (PHT) of 4400 ms. Pulmonary artery pressure was 17 mmHg above central venous pressure, with minimal mitral regurgitation. In computer tomography, the annulus size was 20 mm and the descending aorta showed severe calcifications at the height of the bifurcation; thus, a transfemoral approach was not possible. Coronary angiography was normal. The risk scores were calculated to 4.5% and 2.95% for the logistic EuroSCORE I and Society of Thoracic Surgeons (STS) score, respectively. 

The implantation of the Trinity heart valve was done after surgical standard preparation of the left ventricular apex (using an approximately 4 cm submammary incision). Balloon aortic valvuloplasty was performed, and the folded Trinity valve prosthesis was advanced through a 31 French (F) sheath into the left ventricle and further into the aortic root (Figure 2). The sheath protected the crimped valve during insertion and was retracted with the prosthesis still folded. The position was controlled via fluoroscopy. During beating heart without rapid left ventricular pacing, the delivery wheel on the handle was turned by one quarter, expanding the valve (Figure 3). The prosthesis was fully anchored and subsequently, its position checked. Valvular function was evaluated by injection of contrast medium into the ascending aorta and by transesophageal echocardiography. In our case, the first position showed the valve was not optimally positioned, so the TAVI prosthesis was repositioned until it reached a satisfying position. Once the final position was achieved, the attached strings were released and retracted. It is of note that during final valve release, the geometry of the prosthesis does not change further (Figures 3 and 4). After repositioning, re-evaluation of the device performance revealed an improved result with no paravalvular leakage. The intra procedural invasive peak-to-peak gradient was excellent with 5-8 mmHg.

A video animation of Trinity valve implantation can be seen on the company’s website at transcatheter-technologies.com. 

On 30-day follow-up, the patient markedly improved clinically to NYHA functional class I. The effective orifice area increased from 0.3 cm² to 1.4 cm², and the mean transvalvular gradient was significantly reduced from 135 to 20 mmHg. There was no paravalvular leakage and no AV block requiring pacemaker implantation. 

Conclusions 

The novel, self-expandable Trinity valve prosthesis is a repositionable valve system. In this case, the combination and severity of calcification made both an optimal position and optimal clinical result very difficult to achieve. Here, repositioning of the Trinity valve resulted in optimal position and perfect function (no paravalvular leakage, no conduction defects). Both the implantation result and short-term clinical and hemodynamic outcome were excellent.