Initial experience of a large,self‐expanding,and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters’ registry

Objectives : The UK & Ireland Implanters’ registry is a multicenter registry which reports on real‐world experience with novel transcatheter heart valves. Background : The 34 mm Evolut R transcatheter aortic valve is a self‐expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. Methods : Between January 2017 and April 2018, clinical, procedural and 30‐day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium‐2(VARC‐2)‐defined endpoint of device success. The primary safety outcome was the VARC‐2‐defined composite endpoint of early safety at 30 days. Results : A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm². Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all‐cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%. Conclusions : Real‐world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.     

Contemporary transcatheter aortic valve replacement with third‐generation balloon‐expandable versus self‐expanding devices

Objectives

To evaluate balloon‐expandable and self‐expanding third‐generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes.

Background

Two competing third‐generation TAVR technologies are currently commercially available in the US. There are no published head‐to‐head comparisons of the relative performance of these two devices.

Methods

257 consecutive patients undergoing TAVR with a third‐generation balloon‐expandable (Edwards Sapien 3) or self‐expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30‐day outcomes were prospectively collected.

Results

74 patients received a self‐expanding valve (SEV) and 183 received a balloon‐expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30‐day mortality was comparable (1.4% vs 1.6%, P = 1.00).

Conclusions

Short‐term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay.

     

Coronary obstruction following transcatheter aortic valve‐in‐valve implantation for failed surgical bioprostheses

Transcatheter aortic valve implantation (TAVI) for failed surgical bioprostheses, or “valve‐in‐valve” implantation, is a therapeutic option for high‐risk patients. While coronary occlusion during TAVI for native aortic stenosis has been described, in the setting of valve‐in‐valve implantation the bioprsthetic posts may be protective against this complication. We describe the first two cases of coronary occlusion following valve‐in‐valve therapy, both occurring during treatment of degenerated Mitroflow bioprostheses. Aortic root anatomy, coronary ostial position, and the specifics of the bioprosthetic valve type need to be considered in assessing and preventing this rare complication. © 2011 Wiley‐Liss, Inc.     

Transcatheter aortic valve implantation 10 years after valve‐in‐valve transcatheter aortic valve implantation for failing aortic valve homograft root replacement

Valve‐in‐valve transcatheter aortic valve implantation (ViV‐TAVI) is an established therapy for a degenerated surgical bioprosthesis. TAVI‐in‐TAVI following ViV‐TAVI has not been previously performed. We report a high‐risk patient presenting with severe left ventricular failure secondary to undiagnosed critical aortic stenosis due to degeneration of the implanted transcatheter heart valve more than a decade after initial ViV‐TAVI for a failing stentless aortic valve homograft. Successful TAVI‐in‐TAVI reversed the clinical and echocardiographic changes of decompensated heart failure with no evidence of coronary obstruction.     

Balloon valuloplasty prior to transcatheter valve‐in‐valve implantation in a degenerated mitroflow aortic bioprosthesis

Transcatheter valve‐in‐valve implantation is an emerging treatment option for high‐risk patients with failing aortic bioprostheses. The presence of the prosthesis stents is thought to prevent coronary artery obstruction, a known complication of transcatheter aortic valve implantation in the native aortic valve. The Sorin Mitroflow aortic bioprosthesis (Sorin Group, Saluggia, Italy) has a particular design in that the pericardial leaflets are mounted outside the valve stent. As a consequence, the pericardial leaflets of this prosthesis may be displaced well away from the stents during the deployment of transcatheter valves. This might explain why both the cases of coronary occlusion following valve‐in‐valve implantation reported to date occurred in patients with a malfunctioning Mitroflow bioprosthesis. We describe a patient with a malfunctioning 25 mm Mitroflow bioprosthesis successfully treated by percutaneous transcatheter valve‐in‐valve implantation, and discuss the role that balloon aortic valvuloplasty plays in the performance of this delicate procedure. © 2012 Wiley Periodicals, Inc.     

Bioprosthetic aortic valve leaflet disruption with high energy electrocautery to prevent coronary artery obstruction during valve‐in‐valve transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) is well‐established for the treatment of bioprosthetic aortic valve stenosis (AS) in high surgical risk patients. Coronary artery obstruction from displacement of the bioprosthetic valve leaflets during valve‐in‐valve (VIV) TAVR is a rare, but potentially fatal, complication. Recently, the bioprosthetic aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) procedure was developed as a method for disrupting bioprosthetic leaflets in patients undergoing VIV TAVR at high risk for coronary obstruction. This case describes a successful VIV TAVR utilizing a simplified concept of the BASILICA technique in a patient where the full procedure could not be completed.     

Procedural and clinical outcomes of the valve‐in‐valve technique for severe aortic insufficiency after balloon‐expandable transcatheter aortic valve replacement

Objective : To describe the clinical and procedural outcomes of patients treated with the valve‐in‐valve technique for severe aortic insufficiency (AI) after balloon‐expandable transcatheter aortic valve replacement (TAVR). Background : Severe AI immediately after valve implantation is a notable complication of TAVR. It can be treated with a valve‐in‐valve technique which involves deploying a second valve within the first one to crush the leaflets of the first implant leaving a new functional valve. Methods : We analyzed data on 142 consecutive patients at our institution undergoing TAVR with the Sapien valve between November of 2007 and April of 2011. Etiologies of acute AI, procedural and intermediate term clinical outcomes were reported for those in whom a valve‐in‐valve procedure was necessary. Post‐hoc analysis of these cases with C‐THV imaging (Paieon Medical Ltd.) was performed to elucidate the mechanism for successful AI treatment. Results : A total of 5 of 142 (3.5%) patients were treated with the valve‐in‐valve technique. Etiologies of the aortic valve insufficiency included bioprosthesis malposition (n = 3), valve dysfunction (n = 1), and valve undersizing (n = 1). With placement of the second valve, the first valve dimensions increased to approach the nominal valve size while the second valve size remained less than nominal. Conclusions : The valve‐in‐valve technique is an appropriate bailout measure for patients with acute valvular AI after balloon‐expandable TAVR. © 2012 Wiley Periodicals Inc.