St Jude Medical announced on 15 January 2010 it will sponsor the SCD-HeFT 10-year Follow-up Study, along with the US National Heart, Lung, and Blood Institute (NHLBI). The study will revisit 1,855 patients who participated in the original SCD-HeFT (Sudden cardiac death in heart failure trial) to determine long-term outcomes 10 years after their last recorded follow-up. The study will be led by Gust H Bardy at the Seattle Institute for Cardiac Research (SICR), who was also the principal investigator in the original SCD-HeFT.
The original SCD-HeFT study proved the effectiveness of implantable cardioverter defibrillator (ICD) therapy over placebo or amiodarone for a specific population of patients, and was instrumental in changing the US reimbursement policy for ICD therapy. The SCD-HeFT outcome findings remain a key reference point for all other ICD evaluations for patients with congestive heart failure. The trial was conducted from 1997–2003 and studied 2,521 patients with heart failure for an average follow-up period of 45.5 months. It was and remains the largest, longest and only placebo-controlled, randomised, multicentre trial of ICD therapy.
At the time of the presentation of the SCD-HeFT findings in March 2004, the patients who had not yet received an ICD were given the option to receive one. It is estimated, however, that few of the patients in the placebo or amiodarone groups ultimately received an ICD, essentially maintaining the original study groups of heart failure patients treated either with ICD or non-ICD therapies. As a result, long-term results of these two patient groups can likely still provide significant findings regarding the long-term efficacy of ICD therapy.
The 15 January marked the median 10-year anniversary of follow-up for the SCD-HeFT population. The SCD-HeFT 10-Year Follow-up Study will attempt to investigate all surviving patients and those who have succumbed since the end of the original trial by recontacting the 148 institutions participating in the trial (136 in the US, 11 in Canada and one in New Zealand). The follow-up data obtained in this project will be merged with the original SCD-HeFT database collected during the original trial, thus providing a long-term follow-up profile on all patients that were enrolled.
“The outcome of SCD-HeFT changed medical practice, but despite the virtues of the trial, many key questions remain regarding long-term efficacy, complications and cost of ICD therapy,” said Bardy. “We believe the results of this study have the potential to help direct long-term ICD management for the foreseeable future.”
The primary goals of the SCD-HeFT 10-Year Follow-up Study are:
- To compare 10-year mortality data of the remaining 1,855 SCD-HeFT patients in the three arms of the trial (ICD, placebo and amiodarone) since the close of the follow-up on 31 October 2003.
- To obtain outcome data in the major subgroups of SCD-HeFT: ischaemic versus non-ischaemic; New York Heart Association (NYHA) class II vs. class III heart failure; and in women and minorities.
- To obtain 10-year ICD use rates, complication rates, lead failure rates and replacement rates.
- To validate or refute the observation that amiodarone increases mortality in NYHA class III patients.
- To obtain 10-year hospitalisation and major procedure data.
- To obtain 10-year quality of life data.
“We believe the patient groups examined in SCD-HeFT can provide additional insights regarding the long-term benefits of ICD therapies,” said Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St Jude Medical Cardiac Rhythm Management Division. “Our sponsorship of this study demonstrates our commitment to advancing the practice of medicine by providing physicians with clinically relevant information that has an impact the decisions they make about treating patients with heart failure.”
The original SCD-HeFT, also sponsored by the NHLBI, with supplementary sponsorship by Medtronic and Wyeth Ayerst, provided solid data to the Centers for Medicare and Medicaid Services who approved payment of ICD therapy in ischaemic and non-ischaemic systolic dysfunction patients with left ventricular ejection fractions less-than or equal to 35% and with NYHA class II and class III congestive heart failure. Other studies, such as the Multicenter Automatic Defibrillator Implantation Trial 2 (MADIT-II) eight-year study, sponsored by Boston Scientific, have also demonstrated the long-term mortality benefits of ICD therapy – that study found unadjusted mortality figures at eight years in patients with prior myocardial infarction were 45% for the ICD recipients and 61% for those in the control group.