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"Petzer, Ed"
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52 Suitability for subcutaneous implantable cardioverter-defibrillator therapy – the impact of different selection policies
2017
BackgroundWith subcutaneous ICDs (S-ICD) not offering the same range of pacing therapies as transvenous systems (T-ICD), it is unclear how many ICD recipients may be suitable for a S-ICD. In addition, the benefit from ICD therapy is dependent on non-sudden cardiac death (SCD) risk. The study aims were to [1] establish how many ICD recipients may be suitable for S-ICD implantation based on a range of selection policies, and [2] determine the impact of S-ICD use on the risk of non-SCD.MethodsWe performed a retrospective study of all ICD implants over 5 years (2009–2013). We evaluated how widely the S-ICD could be utilised using the following indications: (a) Least liberal use – S-ICD used only in patients with inherited channelopathies and idiopathic ventricular fibrillation; (b) Intermediate use – S-ICD also used for SCD primary prevention in hypertrophic cardiomyopathy; (c) Most liberal use – S-ICD also used for SCD primary prevention in coronary artery disease (CAD) and non-ischaemic dilated cardiomyopathy (DCM) who have a narrow QRS complex (120msec). Given the potential impact of age on the benefit from S-ICDs, we stratified our results by implant age (70, 60 and 50 years). Non-SCD risk was quantified using the MADIT-II risk score (score 0–5, 5 (highest risk)). Mann-Whitney U testing was used to compare risk scores.ResultsOver the 5 years, there were 402 implants (79% male, age 70±13 years). After exclusion of patients implanted with a CRT-D device or with a pacing indication, 219 remained for consideration of a S-ICD. Using our definition of least liberal use, intermediate use, and most liberal use, the number of patients considered suitable for a S-ICD was 18 (4.5%), 30 (7.5%) and 77 (19.2%), respectively. Age as a discriminator had a significant impact on the proportion of patients considered suitable for a S-ICD. This was predominantly due to a reduction in the number of patients with CAD and DCM being considered for a prophylactic device. Using the most liberal definition, the number of potential S-ICD candidates dropped from 52 (12.9%) in those 70 years old at implant, to 34 (8.5%) for 60 years, to 20 (5%) using 50 years as the cut-off.The MADIT-II score was 0.22±0.1, 0.47±0.1 and 0.96±0.1, in the least liberal, intermediate and most liberal use S-ICD groups, respectively. The score was 2.07±0.1, 2.11±0.1 and 2.24±0.1 in the respective T-ICD groups. The mean MADIT-II score in the S-ICD group was significantly lower than that in the respective T-ICD group (p<0.0001, for all three selection policies).ConclusionsWhile up to one-fifth of patients currently receiving ICDs may be suitable for a S-ICD, this result is dependent on both which patient groups the S-ICD is used in and whether an age cut-off is applied. The cohort of patients suitable for a S-ICD also have a lower risk of non-SCD compared to those receiving conventional T-ICDs.
Journal Article
51 Impact of the Introduction of a Standardised ICD Programming Protocol: Real-world Data from a Single Centre
2016
AimsRandomised trials have shown that empiric ICD programming, using long detection times and high detection zones, reduces device therapy in ICD recipients. However, there is less data on its effectiveness in a “real-world” setting, especially secondary prevention patients. Our aim was to evaluate the introduction of a standardised programming protocol in a “real-world” setting of unselected ICD recipients.MethodsWe analysed 270 consecutive ICD recipients implanted in a single centre – 135 implanted prior to protocol implementation (Physician-Led group) and 135 after (Standardised group). The protocol included long arrhythmia detection times (30/40 or equivalent) and high rate detection zones (primary prevention lower treatment zone 200 bpm). Programming in the Physician-Led group was at the discretion of the implanter. The primary endpoint was time-to-any therapy (ATP or shocks). Secondary endpoints were time-to-inappropriate therapy and time-to-appropriate therapy. The safety endpoints were syncopal episodes, hospital admissions, and death.ResultsAt 12 months follow-up, 47 patients had received any ICD therapy (Physician-Led group, n = 31 vs. Standardised group, n = 16). There was a 47% risk reduction in any device therapy (p = 0.04) and an 86% risk reduction in inappropriate therapy (p = 0.009) in the Standardised compared to the Physician-led group. Results were consistent across primary and secondary prevention patients. There were no significant differences in the rates of syncope, hospitalization and death.ConclusionsIn unselected patients in a “real-world” setting introduction of a standardised programming protocol, using long detection times and high detection zones, significantly reduces the burden of ICD therapy without an increase in adverse outcomes.Abstract 51 Figure 1Kaplan-Meier curves for survival from any-therapy. Physician-Led (dotted) vs. Standardised (black)Abstract 51 Figure 2Kaplan-Meier curves for survival from inappropriate therapy. Physician-led (dotted) vs. Standardised (black)
Journal Article
Impact of the introduction of a standardised ICD programming protocol: real-world data from a single centre
2016
Purpose
Randomised trials have shown that empiric ICD programming, using long detection times and high detection zones, reduces device therapy in ICD recipients. However, there is less data on its effectiveness in a “real-world” setting, especially secondary prevention patients. Our aim was to evaluate the introduction of a standardised programming protocol in a real-world setting of unselected ICD recipients.
Methods
We analysed 270 consecutive ICD recipients implanted in a single centre—135 implanted prior to protocol implementation (physician-led group) and 135 after (standardised group). The protocol included long arrhythmia detection times (30/40 or equivalent) and high rate detection zones (primary prevention lower treatment zone 200 bpm). Programming in the physician-led group was at the discretion of the implanter. The primary endpoint was time-to-any therapy (ATP or shocks). Secondary endpoints were time-to-inappropriate therapy and time-to-appropriate therapy. The safety endpoints were syncopal episodes, hospital admissions and death.
Results
At 12 months follow-up, 47 patients had received any ICD therapy (physician-led group,
n
= 31 vs. standardised group,
n
= 16). There was a 47 % risk reduction in any device therapy (
p
= 0.04) and an 86 % risk reduction in inappropriate therapy (
p
= 0.009) in the standardised compared to the physician-led group. There was a non-significant 30 % risk reduction in appropriate therapy (
p
= 0.32). Results were consistent across primary and secondary prevention patients. There were no significant differences in the rates of syncope, hospitalisation, and death.
Conclusions
In unselected patients in a real-world setting, introduction of a standardised programming protocol, using long detection times and high detection zones, significantly reduces the burden of ICD therapy without an increase in adverse outcomes.
Journal Article