Antonio Di Monaco1, Gemma Pelargonio1, Maria Lucia Narducci2, Lamberto Manzoli3, Stefania Boccia4, Maria Elena Flacco3, Lorenzo Capasso3, Lucy Barone1, Francesco Perna1, Gianluigi Bencardino1, Teresa Rio1, Milena Leo1, Luigi Di Biase5, Pasquale Santangeli6, Andrea Natale7, Antonio Giuseppe Rebuzzi1, Filippo Crea1. 1. Department of Cardiovascular Sciences, Cardiology Institute, Catholic University of Sacred Heart, Rome, Italy. 2. Department of Cardiovascular Sciences, Cardiology Institute, Catholic University of Sacred Heart, Rome, Italy lianarducci@yahoo.it. 3. Department of Medicine and Aging Sciences, University 'G D'Annunzio' Chieti, Chieti, Italy. 4. Institute of Hygiene, Catholic University of Sacred Heart, Rome, Italy. 5. Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX, USA Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA Department of Cardiology, University of Foggia, Foggia, Italy. 6. Department of Cardiology, University of Foggia, Foggia, Italy Cardiovascular Division, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. 7. Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX, USA.
Abstract
BACKGROUND: Transvenous lead extraction (TLE) is a complex invasive procedure and the experience of the operator and the team is a major determinant of procedural outcomes. AIM: Because of very limited data available on minimum procedural volumes to enable training and ongoing competency for TLEs, we performed a meta-analysis aimed at assessing the outcomes of TLE in the centres with low, medium, and high volume of procedures. METHODS: Of the 280 papers initially retrieved until February 2013, 66 observational studies met inclusion criteria and were included in at least one stratified meta-analysis: 17 were prospective studies; 47 had a retrospective design; and 2 were defined 'experience studies'. We included only articles published after the introduction of laser technique (year 1999). We divided the studies in low, medium, and high volume centres utilizing either the European Heart Rhythm Association (EHRA) or Lexicon classification criteria. RESULTS: When meta-analyses were carried out separately for the studies with larger and smaller sample sizes, either using EHRA or Lexicon classification criteria, no clear differences emerged in the combined rate of major complications or intraoperative deaths. In contrast, both minor complications and mortality at 30 days decreased as centre volume increased. CONCLUSIONS: In our meta-analysis of observational studies, patients who have been treated in higher volume centres have a lower probability of minor complications and death at 30 days regardless of the infection rate, length of lead duration, type of device, and type of extraction. Published on behalf of the European Society of Cardiology. All rights reserved.
BACKGROUND: Transvenous lead extraction (TLE) is a complex invasive procedure and the experience of the operator and the team is a major determinant of procedural outcomes. AIM: Because of very limited data available on minimum procedural volumes to enable training and ongoing competency for TLEs, we performed a meta-analysis aimed at assessing the outcomes of TLE in the centres with low, medium, and high volume of procedures. METHODS: Of the 280 papers initially retrieved until February 2013, 66 observational studies met inclusion criteria and were included in at least one stratified meta-analysis: 17 were prospective studies; 47 had a retrospective design; and 2 were defined 'experience studies'. We included only articles published after the introduction of laser technique (year 1999). We divided the studies in low, medium, and high volume centres utilizing either the European Heart Rhythm Association (EHRA) or Lexicon classification criteria. RESULTS: When meta-analyses were carried out separately for the studies with larger and smaller sample sizes, either using EHRA or Lexicon classification criteria, no clear differences emerged in the combined rate of major complications or intraoperative deaths. In contrast, both minor complications and mortality at 30 days decreased as centre volume increased. CONCLUSIONS: In our meta-analysis of observational studies, patients who have been treated in higher volume centres have a lower probability of minor complications and death at 30 days regardless of the infection rate, length of lead duration, type of device, and type of extraction. Published on behalf of the European Society of Cardiology. All rights reserved.
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