title: Submammary device implantation. Good long-term performance and better patients' satisfaction. A single-center experience.
abstract: BACKGROUND
  Device related distress negatively affects the quality of life of cardiac device recipients mostly of women. A submammary approach has been proposed to reduce the physical impact of the implantation. Our aim was to assess the safety of this approach and to evaluate the patients' acceptance of the device.
  
  
  METHODS
  We enrolled 42 patients who underwent a submammary device. The primary endpoint was the need for implant revision that was assessed in the study group compared with the overall control group of 72 standard cardiac device recipients (29 females and 43 males)and with the female group (29 females of controls). In the female population (42 women of the submammary group and 29 of controls) patients' acceptance was calculated with the Florida Patient Acceptance Survey (FPAS).
  
  
  RESULTS
  The rate of implant revision was similar in the two groups and the revision-free survival was comparable with a median follow-up of about six years (Log rank test p=0.949). Similar results were found when considering only the female population. Patients' acceptance was greater in the submammary group [total FPAS 85 (95%CI 83-86) vs 74.5 (95%CI 70.2-77.3) p<0,001] and a strongly significant superiority of the submammary group was found regarding body image concerns [10 (95%CI 10-10) vs 8 (95%CI 8-8) p<0.001) and device related distress [23 (95%CI 22-23) vs 1 (95%CI 1-1) p<0.001].
  
  
  CONCLUSIONS
  Submammary device implantation is safe and more accepted than standard approach. Our results should encourage cardiologists to suggest this approach to their patients for a better acceptance of the therapy.
authors.affiliation: Department of Cardiology, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy. Electronic address: s.savastano@smatteo.pv.it.
authors.forename: Simone
authors.initials: S
authors.lastname: Savastano
authors.affiliation: Department of Cardiology, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Rordorf
authors.affiliation: Plastic Surgery, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Scotti Foglieni
authors.affiliation: Biometry and Statistics, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Catherine
authors.initials: C
authors.lastname: Klersy
authors.affiliation: Department of Cardiology, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Vicentini
authors.affiliation: Department of Cardiology, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Petracci
authors.affiliation: Department of Cardiology, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Sanzo
authors.affiliation: Department of Cardiology, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Marino
authors.affiliation: Department of Cardiology, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Erika
authors.initials: E
authors.lastname: Taravelli
authors.affiliation: Department of Cardiology, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: De Regibus
authors.affiliation: Department of Cardiology, Ospedale Maggiore di Crema, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Landolina
authors.affiliation: Department of Cardiology, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: De Servi
mesh_terms: D000328:Adult; D017147:Defibrillators, Implantable / Q000592:standards / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D042361:Mammary Glands, Human / Q000000981:diagnostic imaging; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000523:psychology; D017060:Patient Satisfaction; D011788:Quality of Life / Q000523:psychology; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Device; Submammary; Women