Battle of Dual- Versus Single-Chamber ICDs
Compare outcomes of single and dual chamber ICDs for primary prevention single vs dual chamber icd sudden cardiac death. Patients were included if they received an ICD single vs dual chamber icd primary prevention and did not have a documented indication for pacing. Adjusted risks of 1-year mortality, all-cause readmission, HF readmission and device-related complications within 90 days were estimated with propensity-score matching based on patient, clinician and hospital factors. In a propensity-matched cohort, rates of complications were lower for single chamber devices 3.
Among patients receiving an ICD for primary prevention without indications for pacing, the use of a dual chamber device compared with a single chamber device was associated with a higher risk of device-related complications but not with different risks for mortality or hospitalization. Further studies should be performed to determine if other benefits of dual chamber devices exist, such as reduced device therapy or improved quality of life, to justify their use in this context. A central decision regarding implantable cardioverter defibrillator ICD therapy is whether to implant a single or dual chamber device.
This question was not addressed by the randomized trials establishing the benefit of ICDs for primary prevention of sudden cardiac death, as the majority of patients enrolled in these efficacy trials received single chamber devices. More complex dual chamber devices may offer theoretical benefits beyond single chamber devices for patients without an indication for pacing, including clearer interpretability of electrograms for clinicians, enhanced device arrhythmia discrimination algorithms, possible reductions in inappropriate therapies, and the potential for a reduced risk for hospitalization and death.
Yet, in addition to possible benefits, dual chamber devices may have greater risks. Because the implantation of a dual chamber ICD is a more complex and time-consuming procedure than implantation of a single chamber device, the possibility of device-related complications such as infection and lead displacement requiring reoperation is likely higher. However, the risk of longer-term complications, including mechanical complications requiring re-operation, is unknown.
Thus, the aims of this study are to identify patients without an indication for pacing and compare outcomes, including mortality, hospitalizations and longer term implantation-related complications between single and dual chamber devices. The ICD registry was established in through a partnership of the Heart Rhythm Society and the American College of Cardiology Foundation, and on April 1, it became the sole repository of ICD implantation data for Medicare beneficiaries. With the January Coverage with Evidence Decision, CMS mandated that hospitals enter Medicare patients receiving primary prevention ICDs into the database.
Data are submitted by participating hospitals using certified software. Data quality is examined using a formal Data Quality Reporting and audit process. Pacing indications were ascertained from the NCDR data collection form and included second or third degree heart block, previous bradycardic arrest, abnormal sinus node function, or a documented paced rhythm. Atrio-ventricular conduction is determined by ECG findings at the time of the decision to implant an ICD single vs dual chamber icd is recorded in the registry as normal, first degree heart block, second or third degree heart block without pacing and paced.
Sinus node function is recorded in the registry as normal or abnormal prior to the date of implant. Outcomes were ascertained from the time of implant through December from CMS claims data and included all-cause mortality, all-cause readmission and readmission for HF at one year based upon a primary discharge diagnosis of HF.
Complications were evaluated using the single vs dual chamber icd employed for a performance measure developed for CMS in partnership with the American College of Cardiology and endorsed by the National Quality Forum. Based upon input from a technical expert single vs dual chamber icd convened as part of the metric development, the time frames used for the assessment of each individual complication varies depending upon the extent to which the panel deemed it was likely to be attributable to the ICD implantation.
These measures have standard definitions and include: It was felt by the technical expert panel that developed the CMS measure that a subsequent ICD implanted within 90 days of the index procedure would be an unplanned event. Independent patient-level variables were obtained from the NCDR ICD Registry and included: Physician characteristics included annual volume of ICD implants and level of training.
In order to avoid case-wise deletion of those observations with missing data points, missing values were imputed. For categorical variables, the missing variables were imputed as the most common single vs dual chamber icd among those with the data present. For continuous variables, the missing values were imputed as the median. Baseline characteristics were compared between patients who received a single chamber device and patients who received single vs dual chamber icd dual chamber device using t-tests for continuous variables and chi-square tests for categorical variables.
Unadjusted outcome rates were compared between patients who received a single chamber device and patients who received a dual chamber device using t tests. Because patients were not randomly assigned to receive single or dual chamber devices, we attempted to create more comparable treatment groups using propensity score matching to adjust for differences in observed characteristics.
The log odds of the probability that single sucht frau gilda laske patient received a dual chamber ICD was modeled as a function of all of the available data about the patients, clinicians and hospitals at the time of implant.