Comparison of Resource Utilization of Pulmonary Vein Isolation
Comparison of Resource Utilization of Pulmonary Vein Isolation
The Value PVI study, which was sponsored by Medtronic, Inc, was conducted as a retrospective chart collection for PAF patients undergoing PVI ablation. The study was undertaken at seven geographically diverse US centers, including university teaching hospitals and regional specialized cardiac facilities. The institutional review board (IRB) at each hospital approved the study using their own policies and staff. Patient chart abstraction and data collections were conducted by using an independent contract research organization (CRO) and clinical hospital staff. Medtronic employees were not permitted to collect patient charts or data by rule of several participating hospital IRBs due to patient privacy and study data integrity.
The initial collection design was to attempt to collect 25 cryoballoon patient charts and 25 focal RF patient charts at each of the seven participating hospitals (350 patient charts total). All data were extracted from patient charts and recorded onto a clinical report form (CRF). Data elements recorded were a mix of hospital resource allocation and procedural efficiency. Hospital resources evaluated included medical equipment usage, anesthesia selection, pharmaceutical testing agents, and imaging equipment. Procedural efficiency measures were denoted as room occupancy, procedural times, and length of hospitalization.
Inclusion criteria were: a PAF diagnosis; a first AF ablation procedure; and PVI ablation by either cryoballoon or focal RF catheter. Exclusion criteria were: previous left atrial (LA) ablation; procedure dates older than January 1, 2011; procedures occurring during a physician's learning curve (procedures 1–25 with each catheter); and LA substrate ablations beyond PVI. As a retrospective collection, patients were already treated by either cryoballoon or RF catheter based on physician discretion and patient consultation.
All chart collections encompassed only those procedures that occurred between January 1, 2011 and May 31, 2013, and collections were made in reverse chronological order at each site. Of note, patient charts older than January 1, 2011 were not included in this study so that catheter performance evaluations could be made on the most currently available technology and practices. Also, the first 25 procedures of either cryoballoon or RF catheter usage were excluded in order to avoid learning-curve influence on the data set. Data points were only recorded from clinical hospital charts and left blank when not present. No extrapolation of data was allowed when recording information onto the CRF, and all CRFs were transferred into an electronic database by a CRO for statistical analyses.
All descriptive statistics are recorded as means with reported standard error of the mean, and all means are reported with the number of individual patient charts calculated for that statistic in parentheses. For comparisons of continuous variables, a two-sample Student's t-test was used to determine statistically significant interactions. Discrete variables were analyzed using the Fisher exact test. Statistical significance was set at P<.05. This study did not test a prospective hypothesis and no adjustments were made for the multiplicity of testing.
Methods
The Value PVI study, which was sponsored by Medtronic, Inc, was conducted as a retrospective chart collection for PAF patients undergoing PVI ablation. The study was undertaken at seven geographically diverse US centers, including university teaching hospitals and regional specialized cardiac facilities. The institutional review board (IRB) at each hospital approved the study using their own policies and staff. Patient chart abstraction and data collections were conducted by using an independent contract research organization (CRO) and clinical hospital staff. Medtronic employees were not permitted to collect patient charts or data by rule of several participating hospital IRBs due to patient privacy and study data integrity.
The initial collection design was to attempt to collect 25 cryoballoon patient charts and 25 focal RF patient charts at each of the seven participating hospitals (350 patient charts total). All data were extracted from patient charts and recorded onto a clinical report form (CRF). Data elements recorded were a mix of hospital resource allocation and procedural efficiency. Hospital resources evaluated included medical equipment usage, anesthesia selection, pharmaceutical testing agents, and imaging equipment. Procedural efficiency measures were denoted as room occupancy, procedural times, and length of hospitalization.
Inclusion criteria were: a PAF diagnosis; a first AF ablation procedure; and PVI ablation by either cryoballoon or focal RF catheter. Exclusion criteria were: previous left atrial (LA) ablation; procedure dates older than January 1, 2011; procedures occurring during a physician's learning curve (procedures 1–25 with each catheter); and LA substrate ablations beyond PVI. As a retrospective collection, patients were already treated by either cryoballoon or RF catheter based on physician discretion and patient consultation.
All chart collections encompassed only those procedures that occurred between January 1, 2011 and May 31, 2013, and collections were made in reverse chronological order at each site. Of note, patient charts older than January 1, 2011 were not included in this study so that catheter performance evaluations could be made on the most currently available technology and practices. Also, the first 25 procedures of either cryoballoon or RF catheter usage were excluded in order to avoid learning-curve influence on the data set. Data points were only recorded from clinical hospital charts and left blank when not present. No extrapolation of data was allowed when recording information onto the CRF, and all CRFs were transferred into an electronic database by a CRO for statistical analyses.
Statistical Analyses
All descriptive statistics are recorded as means with reported standard error of the mean, and all means are reported with the number of individual patient charts calculated for that statistic in parentheses. For comparisons of continuous variables, a two-sample Student's t-test was used to determine statistically significant interactions. Discrete variables were analyzed using the Fisher exact test. Statistical significance was set at P<.05. This study did not test a prospective hypothesis and no adjustments were made for the multiplicity of testing.
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