Double Transseptal Guide Sheath to Prevent Dock Drop During SAPIEN M3 Transcatheter Mitral Valve Replacement

This study looks at a heart procedure called transcatheter mitral valve replacement. Doctors use a device called SAPIEN M3 to replace a damaged heart valve. The valve is replaced without open-heart surgery, through thin tubes guided to the heart. One step of the procedure can be harder in some patients. The new valve must be guided into place by a part called a "dock." In certain patients, the dock can land too low. This is called a "dock drop." It can make the procedure less successful. Doctors developed a new technique to prevent this problem. It is called the double transseptal guide sheath (DGS) technique. It uses two thin tubes during the procedure, instead of one. The two tubes lift the dock into a better position before the new valve is placed. Researchers reviewed medical records from 77 patients. These patients were treated at 16 hospitals across Europe. Some patients had heart anatomy that put them at higher risk for a low dock. These patients received the double-tube technique. Other patients received the standard, single-tube technique. The double-tube technique raised the dock to a safer position. This position was similar to patients with naturally lower-risk heart anatomy. The technique did not cause more complications than the standard technique. These findings suggest the double-tube technique may help prevent a low dock. This may benefit patients with higher-risk heart anatomy during this procedure.

Inclusion Criteria: * Adult patients with severe mitral regurgitation deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair * Underwent transcatheter mitral valve replacement with the Edwards SAPIEN M3 system at one of the 16 participating centers of the European SAPIEN M3 Double Guide Sheath Consortium * Treated using either the double transseptal guide sheath (DGS) technique or the standard single guide sheath (SGS) technique, with technique selection made at operator discretion based on pre-procedural computed tomography assessment of papillary muscle anatomy * Consecutive patients undergoing the index SAPIEN M3 procedure at a participating center during the study period (December 2024 to August 2026) Exclusion Criteria: \- None beyond the inclusion criteria above