Leaflet perforation or tear late after transcatheter aortic valve implantation.

Leaflet perforation (left) and tear (right) of self-expandable transcatheter bioprostheses.

Leaflet perforation or tear in 2 patients after remote chest irradiation with a calcified aortic root are reported. This could be an underrecognized complication after transcatheter aortic valve replacement.

See Commentaries on pages 95, 97, and 99.

Case 1

A 70-year-old woman had a medical history notable for breast cancer with chest irradiation after 23-mm Freestyle (Medtronic Inc, Minneapolis, Minn) inclusion root replacement in 2008 for radiation-associated aortic stenosis, followed by valve-in-valve transcatheter aortic valve replacement (TAVR) in 2014 with a 23-mm CoreValve (Medtronic Inc) because of structural valve degeneration. Completion aortography showed a mild paravalvular leak for which postimplant balloon valvuloplasty using a 20-mm noncompliant balloon was performed. Subsequent minimal paravalvular leak was confirmed by transesophageal echocardiography. Serial follow-up transthoracic echocardiography demonstrated mild aortic insufficiency, thought to be a paravalvular leak, which had been stable. Now she presented with New York Heart Association class III symptoms. A repeat transthoracic echocardiogram again showed the same appearance, and a transesophageal echocardiogram showed moderate-to-severe aortic insufficiency of unclear origin (Figure 1, A and B). She subsequently underwent surgical TAVR valve explantation with aortic root replacement with a mechanical composite conduit. The CoreValve was 5.8 years old. The intraoperative findings were notable for diffuse calcification of the aortic root, endothelialization of the TAVR valve into the aortic wall, and a 7- to 8-mm perforation at the middle of the leaflet, corresponding to the right coronary cusp (Video 1 and Figure 1, C). Significant calcifications were present where the perforated leaflet was abutting; however, no calcified material was sticking through the CoreValve stent cage (Figure 1, D). Her postoperative course was uneventful.

Figure 1

Echocardiographic and intraoperative imaging studies for patient 1. A, Parasternal long-axis view of the transthoracic echocardiogram showing mild-to-moderate aortic insufficiency. B, Midesophageal long-axis view of the transesophageal echocardiogram showing moderate-to-severe aortic insufficiency of unclear origin. C, Intraoperative photograph of the CoreValve with a 7- to 8-mm hole (yellow arrow) at the middle of the leaflet corresponding to the original right coronary cusp location. D, View of the aortic root and annulus after CoreValve explantation. No obvious sharp calcification was seen at the area corresponding to the leaflet perforation (yellow arrow).

Case 2

A 60-year-old man had a medical history notable for remote chest irradiation for malignant lymphoma and coronary artery disease after quadruple coronary artery bypass grafting in 1998 and TAVR in 2017 for severe stenosis using a 34-mm Evolut R (Medtronic). Now he presented with congestive heart failure with mixed severe mitral stenosis and regurgitation with mild central aortic insufficiency through the TAVR valve (Figure 2, A). Although his aortic valve was still fairly competent, he requested TAVR valve explantation with double mechanical valve replacement in the hope of potentially avoiding future repeat sternotomy. He underwent reoperative CarboMedics mechanical (LivaNova, London, United Kingdom) aortic (25 mm) and mitral valve (27 mm) replacement after Evolut R explantation. The Evolut R was 3 years old. Diffuse calcification of the entire aorta and TAVR valve erosion into the aortic root was evident. In addition, a tear was noted at the middle edge of the leaflet, corresponding to the right coronary cusp (Video 1 and Figure 2, D). A piece of calcification was protruding through the stent cage of the Evolut R and was thought to be the cause of the leaflet damage (Figure 2, B and C). His postoperative course was also uneventful. Both patients provided informed consent for the publication of the study data.

Figure 2

Echocardiographic, computed tomography scan, and intraoperative imaging studies of patient 2. A, Intraoperative midesophageal short-axis view of the transesophageal echocardiogram showing mild central aortic insufficiency of the Evolut R. B, Preoperative computed tomography scan of the chest showing calcification through the fenestration of the Evolut R stent cage (yellow arrow). C, Intraoperative imaging study showing the calcification through the Evolut R stent cage (yellow arrow) and leaflet tear (white arrow). D, Another view showing the leaflet tear (white arrow).

Discussion

With the exponential growth in the use of TAVR during the past decade owing to the expansion of indications for lower risk and younger patients, the need for device explantation for various clinical reasons has been increasing. Unrecognized issues during the early TAVR era, such as aortic endothelialization and the unclear feasibility of repeat TAVR procedures, have been gradually unmasked. Leaflet perforation or damage can be significantly underreported. A paucity of cases with findings similar to ours has been reported, because these can be frequently unrecognized, as shown in the present report. As illustrated, these TAVR valve findings were completely intraoperative incidental findings. The aortic insufficiency was thought to be a paravalvular leak for years in patient 1 despite multiple transthoracic echocardiograms. The origin of the aortic insufficiency remained unclear even after transesophageal echocardiography. Tissue damage due to crimping, postimplant balloon valvuloplasty, or a combination of both, was a possibility. Alavi et al demonstrated postcrimping structural leaflet changes, especially in smaller delivery profiles, although the characteristics of the perforation in this patient were inconsistent with previously reported leaflet trauma.

The leaflet damage in patient 2 was also an incidental finding, although it was causing only mild aortic insufficiency. However, compromised valve longevity in our second patient could have been a possible scenario if the damage had not been recognized or the TAVR valve had not been explanted. Both patients had remarkable clinical characteristics, with remote chest radiation therapy and severe aortic root calcifications. Performing TAVR and leaving the native aortic valve and calcifications in this subset of patients might be detrimental to long-term TAVR durability, because repetitive trauma of the leaflets can result in microscopic or macroscopic damage. Theoretically, this complication could also occur with balloon-expandable devices. Ironically, both patients ended up receiving a mechanical prosthesis after multiple follow-up visits. As TAVR usage continues to increase, judicious clinical judgment with consideration of a “lifetime management strategy” is crucial for TAVR candidate selection.