Supplementary Table 4 | Clinical trials of device therapy for chronic heart failure Trial (years) Total n (n with QOL Treatments QOL instruments Notes measurements) and results Multicentre Insync 453 (453) CRT versus MLHF — Randomization Clinical control (CRT Evaluation (MIRACLE)1 deferred for Median (1998–2002) 6 months) improvement at 6 months was 9 points for control and 19 points for the CRT group Cardiac 813 (813) CRT versus MLHF — medical therapy Heart Failure Mean difference (CAREHF)2,3 in MLHF at (2001–2003) 18 months was 10.7 points in favour of CRT Comparison of Medical 1,520 (405) CRT versus MLHF Follow-up QOL Therapy, Pacing, and medical therapy questionnaires Defibrillation in Mean difference were completed Failure in MLHF at in 85% of (COMPANION)4,5 6 months was patients at (2000–2002) 15 points in 6 months favour of CRT Multicentre Automatic 1,820 (1,699) CRT plus ICD KCCQ — Defibrillator versus ICD alone Implantation Trial with Mean difference Cardiac of between 1 and Resychronization 3 points on the Therapy (MADITCRT)6 KCCQ Overall (2004–2008) Summary Scale Randomized Evaluation 129 (129) HeartMate® I MLHF Complete QOL of Mechanical (Thoratec SF-36 data collection Assistance for the Corporation, USA) Beck Depression was Treatment of (pulsatile flow Inventory considerably Congestive Heart LVAD) versus lower in the Failure (REMATCH)7 medical therapy Mean difference medical therapy (1998–2001) of 17 points in the group than in MLHF, 5 points in the LVAD group the Beck Depression Inventory, 25 points in the SF36 physical function, and 47 points in the SF36 emotional role at 1 year, all favouring LVAD
Supplementary Table 4 | Clinical trials of device therapy for chronic heart failure Trial (years) Total n (n with QOL measurements) Treatments QOL instruments and results Notes Multicentre Insync Randomization Clinical Evaluation (MIRACLE)1 (1998–2002) 453 (453) CRT versus control (CRT deferred for 6 months) MLHF Median improvement at 6 months was 9 points for control and 19 points for the CRT group — Cardiac Failure (CAREHF)2,3 (2001–2003) 813 (813) CRT versus medical therapy MLHF Mean difference in MLHF at 18 months was 10.7 points in favour of CRT — Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION)4,5 (2000–2002) 1,520 (405) CRT versus medical therapy MLHF Mean difference in MLHF at 6 months was 15 points in favour of CRT Follow-up QOL questionnaires were completed in 85% of patients at 6 months Multicentre Automatic Defibrillator Implantation Trial with Cardiac Resychronization Therapy (MADITCRT)6 (2004–2008) 1,820 (1,699) CRT plus ICD versus ICD alone KCCQ Mean difference of between 1 and 3 points on the KCCQ Overall Summary Scale — Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH)7 (1998–2001) 129 (129) HeartMate® I (Thoratec Corporation, USA) (pulsatile flow LVAD) versus medical therapy MLHF SF-36 Beck Depression Inventory Mean difference of 17 points in the MLHF, 5 points in the Beck Depression Inventory, 25 points in the SF36 physical function, and 47 points in the SF36 emotional role at 1 year, all favouring LVAD Complete QOL data collection was considerably lower in the medical therapy group than in the LVAD group
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