title: Conventional surgery and transcatheter closure via surgical transapical approach for paravalvular leak repair in high-risk patients: results from a single-centre experience.
abstract: OBJECTIVE
  Paravalvular leaks (PVL) occur in up to 17% of all surgically implanted prosthetic valves. Re-operation is associated with high morbidity and mortality. Transcatheter closure via a surgical transapical approach (TAp) is an emerging alternative for selected high-risk patients with PVL. The aim of this study was to compare the in-hospital outcomes of patients who underwent surgery and TA-closure for PVL in our single-centre experience.
  
  
  METHODS
  From October 2000 to June 2013, 139 patients with PVL were treated in our Institution. All the TA procedures were performed under general anaesthesia in a hybrid operative room: in all but one case an Amplatzer Vascular Plug III device was utilized.
  
  
  RESULTS
  Hundred and thirty-nine patients with PVL were treated: 122 patients (87.3%) underwent surgical treatment (68% mitral PVL; 32% aortic PVL) and 17 patients (12.2%) underwent a transcatheter closure via a surgical TAp approach (all the patients had mitral PVL; one case had combined mitral and aortic PVLs); in 35% of surgical patients and in 47% of TAp patients, multiple PVLs were present. The mean age was 62.5 ± 11 years; the Logistic EuroScore was 15.4 ± 3. Most of the patients were in New York Heart Association (NYHA) functional class III-IV (57%). Symptomatic haemolysis was present in 35% of the patients, and it was particularly frequent in the TAp (70%). Many patients had >1 previous cardiac operation (46% overall and 82% of TAp patients were at their second of re-operation). Acute procedural success was 98%. In-hospital mortality was 9.3%; no in-hospital deaths occurred in patients treated through a TAp approach. All the patients had less than moderate residual valve regurgitation after the procedure. Surgical treatment was identified as a risk factor for in-hospital death at univariate analysis (OR: 8, 95% CI: 1.8-13; P = 0.05). Overall actuarial survival at follow-up was 39.8 ± 7% at 12 years and it was reduced in patients who had >1 cardiac re-operation (42 ± 8 vs. 63 ± 6% at 9 years; P = 0.009).
  
  
  CONCLUSIONS
  A transcatheter closure via a surgical TAp approach appears to be a safe and effective therapeutic option in selected high-risk patients with PVL and is associated with a lower hospital mortality than surgical treatment, in spite of higher predicted risk. Long-term survival remains suboptimal in these challenging patients.
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy taramasso.maurizio@hsr.it.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Taramasso
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Denti
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Guidotti
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Sticchi
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Vasileios
authors.initials: V
authors.lastname: Panoulas
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Giustino
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Pozzoli
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Buzzatti
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Linda
authors.initials: L
authors.lastname: Cota
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: De Bonis
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Montorfano
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Castiglioni
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Blasio
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: La Canna
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Cardiac Surgery Department, San Raffaele Scientific Institute, San Raffaele University Hospital, Milan, Italy.
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
mesh_terms: D000368:Aged; D006328:Cardiac Catheterization; D006348:Cardiac Surgical Procedures; D017023:Coronary Angiography; D015150:Echocardiography, Doppler; D019560:Echocardiography, Three-Dimensional; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000601:surgery*; D011475:Prosthesis Failure; D012189:Retrospective Studies; D055989:Septal Occluder Device; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
keywords: High risk; Percutaneous paravalvular leaks closure; Re-operative surgery