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Restrictive Filling Pattern and Mortality: Comparison of Individual Patient Versus Literature Based Meta-Analyses
Abstracts
patients had NIHSS <1, 1/5 NIHSS = 15, 1/5 NIHSS = 18. In conclusion, standard 24 h Holter monitoring only detects 4.9% of patients with new or paroxysmal AF admitted with AIS in sinus rhythm. Increasing the period of monitoring to 48 h will detect 7.3% more cases of significant AF. There is no correlation between stroke site, severity and the incidence of new onset or paroxysmal AF. doi:10.1016/j.hlc.2008.05.205 205 Restrictive Filling Pattern and Mortality: Comparison of Individual Patient Versus Literature Based Meta-Analyses Katrina Poppe 1,2,3,4,5,6,∗ , Rob Doughty 1,2,3,4,5,6 , C.M. Yu 1,2,3,4,5,6 , Miguel Quintana 1,2,3,4,5,6 , Jacob Moller 1,2,3,4,5,6 , Allan Klein 1,2,3,4,5,6 , Greg Gamble 1,2,3,4,5,6 , Frank Dini 1,2,3,4,5,6 , Gillian 1,2,3,4,5,6 Whalley 2 The
1 The
University of Auckland, Auckland, New Zealand; Prince of Wales Hospital, Hong Kong, China; 3 The Karolinska Institute, Stockholm, Sweden; 4 HS Rigshospitalet, Copenhagen, Denmark; 5 The Cleveland Clinic, Cleveland, United States; 6 Santa Chiara Hospital, Pisa, Italy Purpose: The restrictive mitral filling pattern (RFP) is the most severe form of diastolic dysfunction. We have performed standard literature-based meta-analyses (LMA) and individual patient meta-analyses (IPMA, MeRGE collaboration) to investigate the relationship between RFP and mortality in patients with heart failure (HF) and postacute myocardial infarction (AMI). We aimed to compare the effects of each analytical approach. Methods: The LMA included 16 AMI and 27 HF prospective observational studies. A weighted fixed effects odds ratio (OR) was calculated using RevMan. The IPMA included 12 AMI and 18 HF databases that were checked, then merged and a univariate hazard ratio (HR) calculated using SAS. Median length of follow-up (FU) and absolute survival difference were calculated for LMA and IPMA. Results: Both LMA and IPMA analyses demonstrated that the RFP was associated with increased mortality, although the size of the effect (AMI: OR 4.1 vs. HR 2.7; HF: OR 4.4 vs. HR 2.4), length of FU (AMI: 2.6 years vs. 3.7 years; HF: 1.5 years vs. 4.0 years) and difference in absolute survival differed between these methods. Literature MA
Individual patient MA
AMI, n
3855
3386
Effect
OR = 4.10 (3.38, 4.99)
HR = 2.67 (2.23, 3.20)
Median length of FU (years)
2.6
3.7
Absolute survival diff (%)
22.6
15.7
HF, n
3077
3113
Effect
OR = 4.36 (3.60, 5.04)
HR = 2.42 (2.06, 2.83)
Median length of FU (years)
1.5
4.0
Absolute survival diff (%)
26.4
16.6
Conclusion: Restrictive mitral filling was associated with significantly worse outcome but the size of the risk was lower in the IPMA in both groups. The reasons for these differences include longer FU in the IPMA, fewer analyt-
S87
ical assumptions, and use of a HR in the IPMA allowing quantification of the average survival over time rather than at a single point in time. These factors should be considered when conducting meta-analyses of observational data. doi:10.1016/j.hlc.2008.05.206 206 Implantable Defibrillators for Primary Prevention: Validation of Randomised Clinical Trials Manoj Obeyesekere 1,∗ , Sandeep Prabhu 1 , Eliza P. Teo 1 , Eli Kotler 1 , Archer Broughton 1 , Geoff Toogood 2 , Peter Kistler 1 1 Alfred
Hospital, Melbourne, Australia; Victoria, Australia
2 Frankston
Hospital,
Introduction: Randomised clinical trials (RCT) demonstrate reduction of sudden cardiac death (SCD) with defibrillators (ICDs) for primary prevention in patients with left ventricular dysfunction. However whether benefit shown in clinical trials translate to clinical practice remains to be determined. Objective: To determine if “real world” outcomes are comparable to RCTs. Method: Seventy-eighty patients (mean age 57 ± 13 years, 82% M) with LVEF < 35% underwent implantation of an ICD for a primary prevention indication. Device selection & programming were at the discretion of the implanting physician. Patients were followed up day 1, week 4, 6 monthly & post-device therapy. Results: 32 VR, 8 DR & 38 BiV ICDs were implanted. During a mean follow up of 343 ± 222 days, 12 (15%) received appropriate and 3 (4%) patients received inappropriate device therapy. Device activation was associated with lower LV EF & non-sustained VT. There was no difference in NYHA class, aetiology, co-morbidities or QRS duration between these groups. Fifteen patients required hospitalisation (12 cardiac failure, 2 cardiac transplantation, 1 angina). There were 8 deaths (2 cardiac failure, 1 lead infection, 5 non-cardiac). There were 4 device related complications (3 lead repositions, 1 lead infection). Conclusion: Appropriate device activation occurred in 15% of patients during a mean follow up of nearly one year consistent with outcomes demonstrated in MADIT II & ScD-HeFT. These findings support the use of ICD therapy for primary prevention of SCD in LV dysfunction. doi:10.1016/j.hlc.2008.05.207
ABSTRACTS
Heart, Lung and Circulation 2008;17S:S1–S209
patients had NIHSS <1, 1/5 NIHSS = 15, 1/5 NIHSS = 18. In conclusion, standard 24 h Holter monitoring only detects 4.9% of patients with new or paroxysmal AF admitted with AIS in sinus rhythm. Increasing the period of monitoring to 48 h will detect 7.3% more cases of significant AF. There is no correlation between stroke site, severity and the incidence of new onset or paroxysmal AF. doi:10.1016/j.hlc.2008.05.205 205 Restrictive Filling Pattern and Mortality: Comparison of Individual Patient Versus Literature Based Meta-Analyses Katrina Poppe 1,2,3,4,5,6,∗ , Rob Doughty 1,2,3,4,5,6 , C.M. Yu 1,2,3,4,5,6 , Miguel Quintana 1,2,3,4,5,6 , Jacob Moller 1,2,3,4,5,6 , Allan Klein 1,2,3,4,5,6 , Greg Gamble 1,2,3,4,5,6 , Frank Dini 1,2,3,4,5,6 , Gillian 1,2,3,4,5,6 Whalley 2 The
1 The
University of Auckland, Auckland, New Zealand; Prince of Wales Hospital, Hong Kong, China; 3 The Karolinska Institute, Stockholm, Sweden; 4 HS Rigshospitalet, Copenhagen, Denmark; 5 The Cleveland Clinic, Cleveland, United States; 6 Santa Chiara Hospital, Pisa, Italy Purpose: The restrictive mitral filling pattern (RFP) is the most severe form of diastolic dysfunction. We have performed standard literature-based meta-analyses (LMA) and individual patient meta-analyses (IPMA, MeRGE collaboration) to investigate the relationship between RFP and mortality in patients with heart failure (HF) and postacute myocardial infarction (AMI). We aimed to compare the effects of each analytical approach. Methods: The LMA included 16 AMI and 27 HF prospective observational studies. A weighted fixed effects odds ratio (OR) was calculated using RevMan. The IPMA included 12 AMI and 18 HF databases that were checked, then merged and a univariate hazard ratio (HR) calculated using SAS. Median length of follow-up (FU) and absolute survival difference were calculated for LMA and IPMA. Results: Both LMA and IPMA analyses demonstrated that the RFP was associated with increased mortality, although the size of the effect (AMI: OR 4.1 vs. HR 2.7; HF: OR 4.4 vs. HR 2.4), length of FU (AMI: 2.6 years vs. 3.7 years; HF: 1.5 years vs. 4.0 years) and difference in absolute survival differed between these methods. Literature MA
Individual patient MA
AMI, n
3855
3386
Effect
OR = 4.10 (3.38, 4.99)
HR = 2.67 (2.23, 3.20)
Median length of FU (years)
2.6
3.7
Absolute survival diff (%)
22.6
15.7
HF, n
3077
3113
Effect
OR = 4.36 (3.60, 5.04)
HR = 2.42 (2.06, 2.83)
Median length of FU (years)
1.5
4.0
Absolute survival diff (%)
26.4
16.6
Conclusion: Restrictive mitral filling was associated with significantly worse outcome but the size of the risk was lower in the IPMA in both groups. The reasons for these differences include longer FU in the IPMA, fewer analyt-
S87
ical assumptions, and use of a HR in the IPMA allowing quantification of the average survival over time rather than at a single point in time. These factors should be considered when conducting meta-analyses of observational data. doi:10.1016/j.hlc.2008.05.206 206 Implantable Defibrillators for Primary Prevention: Validation of Randomised Clinical Trials Manoj Obeyesekere 1,∗ , Sandeep Prabhu 1 , Eliza P. Teo 1 , Eli Kotler 1 , Archer Broughton 1 , Geoff Toogood 2 , Peter Kistler 1 1 Alfred
Hospital, Melbourne, Australia; Victoria, Australia
2 Frankston
Hospital,
Introduction: Randomised clinical trials (RCT) demonstrate reduction of sudden cardiac death (SCD) with defibrillators (ICDs) for primary prevention in patients with left ventricular dysfunction. However whether benefit shown in clinical trials translate to clinical practice remains to be determined. Objective: To determine if “real world” outcomes are comparable to RCTs. Method: Seventy-eighty patients (mean age 57 ± 13 years, 82% M) with LVEF < 35% underwent implantation of an ICD for a primary prevention indication. Device selection & programming were at the discretion of the implanting physician. Patients were followed up day 1, week 4, 6 monthly & post-device therapy. Results: 32 VR, 8 DR & 38 BiV ICDs were implanted. During a mean follow up of 343 ± 222 days, 12 (15%) received appropriate and 3 (4%) patients received inappropriate device therapy. Device activation was associated with lower LV EF & non-sustained VT. There was no difference in NYHA class, aetiology, co-morbidities or QRS duration between these groups. Fifteen patients required hospitalisation (12 cardiac failure, 2 cardiac transplantation, 1 angina). There were 8 deaths (2 cardiac failure, 1 lead infection, 5 non-cardiac). There were 4 device related complications (3 lead repositions, 1 lead infection). Conclusion: Appropriate device activation occurred in 15% of patients during a mean follow up of nearly one year consistent with outcomes demonstrated in MADIT II & ScD-HeFT. These findings support the use of ICD therapy for primary prevention of SCD in LV dysfunction. doi:10.1016/j.hlc.2008.05.207
ABSTRACTS
Heart, Lung and Circulation 2008;17S:S1–S209