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Multicenter Study
. 2024 Sep 1;45(33):3031-3041.
doi: 10.1093/eurheartj/ehae303.

Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study

Danny Dvir  1 , Didier Tchétché  2 , Martin B Leon  3 , Philippe Généreux  4 , Benjamin Seguy  5 , Raj Makkar  6 , Philippe Pibarot  7 , Hemal Gada  8 , Tamim Nazif  9 , David Hildick-Smith  10 , Jörg Kempfert  11 , Nicolas Dumonteil  2 , Axel Unbehaun  11 , Thomas Modine  5 , Brian Whisenant  12 , Christophe Caussin  13 , Lenard Conradi  14 , Thomas Waggoner  15 , Jacob M Mishell  16 , Stanley J Chetcuti  17 , Saibal Kar  18 , Michael J Rinaldi  19 , Molly Szerlip  20 , Ravi K Ramana  21 , Daniel J Blackman  22 , Itsik Ben-Dor  23 , Ran Kornowski  24 , Ron Waksman  23 , Ulrich Gerckens  25 , Paolo Denti  26 , Marian Kukucka  11 , Julien Ternacle  5 , Sabah Skaf  6 , Jan Kovac  27 , Hasan Jilaihawi  6 , Vivek Patel  6 , Rami Jubeh  1 , Mohamed Abdel-Wahab  28 , Susheel Kodali  9
Affiliations
Multicenter Study

Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study

Danny Dvir et al. Eur Heart J. .

Abstract

Background and aims: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction.

Methods: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board.

Results: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all [100%; 95% confidence interval (CI) 94%-100.0%, P < .001] patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 [98.3%; 95% CI (91.1%-100%)] patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1%-99.0%). Within 90 days, freedom from mortality was 95% [95% CI (86.1%-99.0%)], without any cardiovascular deaths.

Conclusions: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

Keywords: Transcatheter aortic valve implantation; Valve Academic Research Consortium; Valve in valve; Virtual transcatheter heart valve to coronary artery; Virtual transcatheter heart valve to sinotubular junction.

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Figures

Structured Graphical Abstract
Structured Graphical Abstract
This pivotal prospective, multicentre study presents favourable clinical outcomes of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients scheduled to undergo TAVI and at risk for coronary artery obstruction.
Figure 1
Figure 1
The ShortCut device. (A) The ShortCut device positioned at the bottom of the cusp with the splitting element activated. (B) Post-ShortCut split of the failed surgical valve
Figure 2
Figure 2
A ShortCut procedure in a patient with a failed bioprosthetic surgical valve. A 76-year-old female with a failed Magna Ease 21 mm surgical bioprosthetic aortic valve (Edwards Lifesciences) at high risk for double coronary obstruction that was treated with ShortCut and Evolut R 23 mm (Medtronic). (A–C) Computed tomography measurements showing predicted risk of coronary obstruction. (D) Baseline aortogram demonstrating risk for coronary obstruction (side view of left and right coronary cusps). (E and F) The ShortCut is positioned. Activated splitting element punctures the leaflet from the ventricular side just above the annulus. The leaflet is split by gently retracting the catheter while feeding the guidewire. (G and H) Echocardiography verifies left and right leaflet split (annotated arrows). (I) Post-TAVI implantation and ring fracture with a 23 mm True balloon (Bard) demonstrating normal coronary flow (annotated arrows). Echocardiography post-TAVI (not shown) showed aortic valve gradients of 15/6 mmHg. The patient had an uneventful hospital stay
Figure 3
Figure 3
A ShortCut procedure in a patient with a failed transcatheter heart valve. A 79-year-old female with a failed Evolut R 29 mm transcatheter aortic valve (Medtronic) at high risk for double coronary obstruction due to leaflets extending well above the sinotubular junction with effaced sinuses and narrow sinotubular junction, that was treated with ShortCut and was implanted with a 23 mm SAPIEN 3 valve (Edwards Lifesciences). (A) Computed tomography measurements showing predicted risk of coronary obstruction. (B–D) Baseline aortogram, right and left coronary angiographic demonstrating of the risk for coronary obstruction (side view of left and right coronary cusps). (E and F) The ShortCut is positioned. Activated splitting element punctures the leaflet from the ventricular side just above the annulus. The leaflet is split by gently retracting the catheter while feeding the guidewire. (G and H) Echocardiography verifies left and right leaflet split (annotated arrows). (I) Post-TAVI demonstration of normal coronary flow (annotated arrows). Echocardiography post-TAVI (not shown) showed aortic valve gradients of 11/5 mmHg. The patient had an uneventful hospital stay
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References

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