Outcomes and predictors of success and complications for paravalvular leak closure: an analysis of the SpanisH real-wOrld paravalvular LEaks closure (HOLE) registry
Eulogio García (1), MD; Dabit Arzamendi (2), MD, PhD; Pilar Jimenez-Quevedo (3), MD, PhD; Fernando Sarnago (4), MD; Gerard Martí (5), MD; Angel Sanchez-Recalde (6), MD; Garikoit Lasa-Larraya (7), MD; Manuel Sancho (8), MD, PhD; Andres Iñiguez (9), MD, PhD; Javier Goicolea (10), MD; Koldobika Garcia-San Roman (11), MD; Juan Horacio Alonso-Briales (12), MD; Eduardo Molina (13), MD; Jose Calabuig (14), MD; Xavier Freixa (15), MD; Alberto Berenguer (16), MD, FESC; Mariano Valdes-Chavarri (17), MD, PhD; Nicolas Vazquez (18), MD; Jose Francisco Diaz (19), MD; Ignacio Cruz-Gonzalez (20)*, MD, PhD 1. Hospitales Universitarios Montepríncipe and Moncloa, Madrid, Spain;
2. Hospital Santa Creu y San Pau, Barcelona, Spain;
3. Hospital Clínico San Carlos, Madrid, Spain;
4. Hospital Gregorio Marañón, Madrid, Spain;
5. Hospital Vall D’Hebron, Barcelona, Spain;
6. Hospital la Paz, Madrid, Spain;
7. Hospital Universitario Donostia, San Sebastian, Spain;
8. Hospital Puerta del Mar, Cadiz, Spain;
9. Hospital Meixoeiro, Vigo, Spain;
10. Hospital Puerta de Hierro, Madrid, Spain;
11. Hospital Universitario de Cruces, Baracaldo, Spain;
12. Hospital Virgen de la Victoria, Malaga, Spain;
13. Complejo Hospitalario Universitario de Granada, Granada, Spain;
14. Clínica Universitaria de Navarra, Pamplona, Spain;
15. Hospital Clinic de Barcelona, Barcelona, Spain;
16. Hospital General Universitario Valencia, Valencia, Spain;
17. Hospital Virgen de la Arrixaca, Murcia, Spain;
18. Hospital Universitario da A Coruña, A Coruña, Spain;
19. Hospital Juan Ramón Jiménez, Huelva, Spain;
20. Hospital Universitario de Salamanca, IBSAL, Salamanca, Spain
The aim of the study was to assess the safety and efficacy of percutaneous closure of paravalvular prosthetic leak (PVL) and to identify the predictors of procedural success and early complications.
METHODS AND RESULTS:
A total of 514 first-attempt percutaneous PVL closure in 469 patients were included at 19 centres. Technical and procedural success was achieved in 86.6% and 73.2% of the patients, respectively.
In multivariate analysis, the independent predictors for procedural success in mitral lesions were the type of device used (AMPLATZER AVP III vs. others, HR 2.68 [1.29-5.54], p=0.008) and the number of procedures performed at the centre (top quartile vs. others, HR 1.93 [1.051-3.53], p=0.03). For aortic leaks the only predictor of procedural success was the leak size (≥10 mm vs. <10 mm, HR 3.077 [1.13-8.33], p=0.027).
The overall major adverse events rate (death or emergency surgery or stroke) at 30 days was 5.6%; the only predictor for combined adverse events was New York Heart Association functional Class IV (HR 4.2 [1.42-12.34], p=0.009).
Percutaneous closure of PVL can be performed with a reasonable rate of procedural success and a low rate of major complications. The type of device used, the accumulated experience and the leak size are predictors of procedural success.
CITATION EuroIntervention. 2017 Mar 20;12(16):1962-1968. doi: 10.4244/EIJ-D-16-00581