Transcatheter closure of paravalvular leaks using a paravalvular leak device - a prospective Polish registry.
BACKGROUND
Transcatheter paravalvular leak closure (TPVLC) has become an established treatment option but is mostly performed with off-label use of different non-dedicated occluders. The first one specifically designed for TPVLC is the paravalvular leak device (PLD - Occlutech).


OBJECTIVE
We present initial short-term results of a prospective registry intended to assess the safety and efficacy of TPVLC with PLD.


METHODS
We screened patients with paravalvular leak (PVL) after surgical valve replacement (SVR). Heart failure symptoms and/or hemolytic anemia were indications for TPVLC. Patients were selected according to PVL anatomy by RT 3D TEE. Only those considered appropriate for closure with a single PLD were enrolled. The procedures were performed via transvascular or transapical access using type W (waist) PLDs only.


RESULTS
Thirty patients with 34 PVLs (18 aortic, 16 mitral) were included. We implanted 35 PLDs with a total device success rate of 94.3% (100% for aortic, 88.2% for mitral). The procedural success rate, encompassing device success without in-hospital complications, was 94.1% (100% for aortic, 93.8% for mitral). During the follow-up period we recorded an increase of hemoglobin concentration (3.9 to 4.1 g/dl), red blood count (11.6 to 12.2 M/mm(3)) and functional improvement by NYHA class.


CONCLUSIONS
Paravalvular leak device type W is a promising TPVLC device, but meticulous preselection of patients based on imaging of PVL anatomy is a prerequisite. A PLD should only be chosen for channels shorter than 5 mm. Size of the device should match the PVL cross-sectional area without any oversizing. Such an approach facilitates high device and procedural success rates.
3 Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Grzegorz
G
Smolka
2 Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Piotr
P
Pysz
3 Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Michał
M
Kozłowski
Division of Cardiac Surgery, Medical University of Silesia, Katowice, Poland.
Marek
M
Jasiński
Division of Cardiac Surgery, Medical University of Silesia, Katowice, Poland.
Radosław
R
Gocoł
2 Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Tomasz
T
Roleder
2 Department of Physiological and Medical Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.
Agnieszka
A
Kargul
3 Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Andrzej
A
Ochała
3 Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Wojciech
W
Wojakowski
occluder; paravalvular leak; percutaneous closure; prosthetic heart valve