SVR Yields No Additional Benefit With Bypass

ORLANDO — Coupling surgical ventricular reconstruction with coronary artery bypass grafting in patients with severe ischemic heart failure provided no survival or quality of life benefits over surgery alone in the largest randomized trial in cardiac surgery.

“These are definitive findings, and we have to conclude from them that there is no justification to offer [surgical ventricular reconstruction] to these patients, Dr. Robert H. Jones said in presenting the Surgical Treatment for Ischemic Heart Failure (STICH) trial results at the annual meeting of the American College of Cardiology.

STICH, funded by the National Heart, Lung, and Blood Institute, randomized 1,000 patients with left ventricular heart failure, an ejection fraction of 35% or less, and coronary artery disease suitable for coronary artery bypass grafting to CABG alone or CABG plus surgical ventricular reconstruction (SVR), an operation designed to reduce the size of the dilated ventricle and normalize the damaged heart's shape.

During the past decade, SVR has generated excitement among cardiac surgeons, based on the fact that beta-blockers, ACE inhibitors, and other highly effective medications for heart failure make the hypertrophic heart smaller and more normal-shaped. Surgeons reasoned that mechanically reshaping and downsizing the hypertrophic heart might similarly improve clinical outcomes.

“Now we know that it does not,” said Dr. Jones, professor of surgery at Duke University, Durham, N.C. Dr. Jones was the principal investigator for the STICH trial (N. Engl. J. Med. 2009;360:1705-16).

During a median follow-up of 48 months, the primary study end point of all-cause mortality or cardiac hospitalization occurred in 58% of the CABG-plus- SVR group and 59% of those who underwent CABG alone.

The STICH trial included an in-depth quality of life assessment led by Dr. Daniel Mark, director of outcomes research at the Duke Clinical Research Institute.

“We looked at a variety of different ways of assessing quality of life, including heart failure-specific quality of life, and found no evidence that the patients who received SVR on top of their bypass operation did any better or were in any way different in their long-term outcome out to 3 years compared to patients who got bypass surgery alone,” he said.

Hospital costs averaged more than $14,500 higher in the SVR-plus-bypass group, mostly because they spent more time in intensive care, Dr. Mark added.

STICH is a milestone study not only because of its size and clarity, but also because it's the first major comparative effectiveness study examining two different cardiac surgical strategies, he said.

” The tendency of cardiac surgery and, I think, other forms of surgery has been to evolve in an anecdotal fashion,” Dr. Mark said.

Discussant Marvin A. Konstam said that the amount of reduction in end systolic volume achieved in the SVR recipients clearly indicates the STICH surgeons did an effective job of decreasing ventricular wall stress. It is noteworthy that this did not translate into improved outcomes, considering the abundant evidence that doing so pharmacologically does, he said.

This suggests that pharmacologic reduction of end systolic volume by reducing the amount of pathologic myocyte hypertrophy is a very good thing, but when a reduction in end systolic volume is achieved simply structurally it might not have the same benefit, said Dr. Konstam, chief of cardiology at Tufts Medical Center, Boston.

The STICH trial continues, with another 1,212 ischemic heart failure patients who have been randomized to intensive medical therapy alone or in conjunction with CABG. They will be followed for another 2 years. This study has potentially far-reaching impact for all of cardiovascular medicine, Dr. Jones stressed.

“If we find in another 2 years that intensive medical therapy has gotten so good that there's not much room for surgery to further improve outcomes, it's going to change a whole lot of cardiology,” from noninvasive testing to how many cardiac caths get done, he said.

Surgical ventricular reconstruction methods shown here are Dor (A), Jatene (B), McCarthy (C), and Mickleborough (D). ©Elsevier; Reprinted from J. Thorac. Cardiovasc. Surg.; Semin. Thorac. Cardiovasc. Surg.; Ann. Thorac. Surg.

ORLANDO — Coupling surgical ventricular reconstruction with coronary artery bypass grafting in patients with severe ischemic heart failure provided no survival or quality of life benefits over surgery alone in the largest randomized trial in cardiac surgery.

“These are definitive findings, and we have to conclude from them that there is no justification to offer [surgical ventricular reconstruction] to these patients, Dr. Robert H. Jones said in presenting the Surgical Treatment for Ischemic Heart Failure (STICH) trial results at the annual meeting of the American College of Cardiology.

STICH, funded by the National Heart, Lung, and Blood Institute, randomized 1,000 patients with left ventricular heart failure, an ejection fraction of 35% or less, and coronary artery disease suitable for coronary artery bypass grafting to CABG alone or CABG plus surgical ventricular reconstruction (SVR), an operation designed to reduce the size of the dilated ventricle and normalize the damaged heart's shape.

During the past decade, SVR has generated excitement among cardiac surgeons, based on the fact that beta-blockers, ACE inhibitors, and other highly effective medications for heart failure make the hypertrophic heart smaller and more normal-shaped. Surgeons reasoned that mechanically reshaping and downsizing the hypertrophic heart might similarly improve clinical outcomes.

“Now we know that it does not,” said Dr. Jones, professor of surgery at Duke University, Durham, N.C. Dr. Jones was the principal investigator for the STICH trial (N. Engl. J. Med. 2009;360:1705-16).

During a median follow-up of 48 months, the primary study end point of all-cause mortality or cardiac hospitalization occurred in 58% of the CABG-plus- SVR group and 59% of those who underwent CABG alone.

The STICH trial included an in-depth quality of life assessment led by Dr. Daniel Mark, director of outcomes research at the Duke Clinical Research Institute.

“We looked at a variety of different ways of assessing quality of life, including heart failure-specific quality of life, and found no evidence that the patients who received SVR on top of their bypass operation did any better or were in any way different in their long-term outcome out to 3 years compared to patients who got bypass surgery alone,” he said.

Hospital costs averaged more than $14,500 higher in the SVR-plus-bypass group, mostly because they spent more time in intensive care, Dr. Mark added.

STICH is a milestone study not only because of its size and clarity, but also because it's the first major comparative effectiveness study examining two different cardiac surgical strategies, he said.

” The tendency of cardiac surgery and, I think, other forms of surgery has been to evolve in an anecdotal fashion,” Dr. Mark said.

Discussant Marvin A. Konstam said that the amount of reduction in end systolic volume achieved in the SVR recipients clearly indicates the STICH surgeons did an effective job of decreasing ventricular wall stress. It is noteworthy that this did not translate into improved outcomes, considering the abundant evidence that doing so pharmacologically does, he said.

This suggests that pharmacologic reduction of end systolic volume by reducing the amount of pathologic myocyte hypertrophy is a very good thing, but when a reduction in end systolic volume is achieved simply structurally it might not have the same benefit, said Dr. Konstam, chief of cardiology at Tufts Medical Center, Boston.

The STICH trial continues, with another 1,212 ischemic heart failure patients who have been randomized to intensive medical therapy alone or in conjunction with CABG. They will be followed for another 2 years. This study has potentially far-reaching impact for all of cardiovascular medicine, Dr. Jones stressed.

“If we find in another 2 years that intensive medical therapy has gotten so good that there's not much room for surgery to further improve outcomes, it's going to change a whole lot of cardiology,” from noninvasive testing to how many cardiac caths get done, he said.

Surgical ventricular reconstruction methods shown here are Dor (A), Jatene (B), McCarthy (C), and Mickleborough (D). ©Elsevier; Reprinted from J. Thorac. Cardiovasc. Surg.; Semin. Thorac. Cardiovasc. Surg.; Ann. Thorac. Surg.

ORLANDO — Coupling surgical ventricular reconstruction with coronary artery bypass grafting in patients with severe ischemic heart failure provided no survival or quality of life benefits over surgery alone in the largest randomized trial in cardiac surgery.

“These are definitive findings, and we have to conclude from them that there is no justification to offer [surgical ventricular reconstruction] to these patients, Dr. Robert H. Jones said in presenting the Surgical Treatment for Ischemic Heart Failure (STICH) trial results at the annual meeting of the American College of Cardiology.

STICH, funded by the National Heart, Lung, and Blood Institute, randomized 1,000 patients with left ventricular heart failure, an ejection fraction of 35% or less, and coronary artery disease suitable for coronary artery bypass grafting to CABG alone or CABG plus surgical ventricular reconstruction (SVR), an operation designed to reduce the size of the dilated ventricle and normalize the damaged heart's shape.

During the past decade, SVR has generated excitement among cardiac surgeons, based on the fact that beta-blockers, ACE inhibitors, and other highly effective medications for heart failure make the hypertrophic heart smaller and more normal-shaped. Surgeons reasoned that mechanically reshaping and downsizing the hypertrophic heart might similarly improve clinical outcomes.

“Now we know that it does not,” said Dr. Jones, professor of surgery at Duke University, Durham, N.C. Dr. Jones was the principal investigator for the STICH trial (N. Engl. J. Med. 2009;360:1705-16).

During a median follow-up of 48 months, the primary study end point of all-cause mortality or cardiac hospitalization occurred in 58% of the CABG-plus- SVR group and 59% of those who underwent CABG alone.

The STICH trial included an in-depth quality of life assessment led by Dr. Daniel Mark, director of outcomes research at the Duke Clinical Research Institute.

“We looked at a variety of different ways of assessing quality of life, including heart failure-specific quality of life, and found no evidence that the patients who received SVR on top of their bypass operation did any better or were in any way different in their long-term outcome out to 3 years compared to patients who got bypass surgery alone,” he said.

Hospital costs averaged more than $14,500 higher in the SVR-plus-bypass group, mostly because they spent more time in intensive care, Dr. Mark added.

STICH is a milestone study not only because of its size and clarity, but also because it's the first major comparative effectiveness study examining two different cardiac surgical strategies, he said.

” The tendency of cardiac surgery and, I think, other forms of surgery has been to evolve in an anecdotal fashion,” Dr. Mark said.

Discussant Marvin A. Konstam said that the amount of reduction in end systolic volume achieved in the SVR recipients clearly indicates the STICH surgeons did an effective job of decreasing ventricular wall stress. It is noteworthy that this did not translate into improved outcomes, considering the abundant evidence that doing so pharmacologically does, he said.

This suggests that pharmacologic reduction of end systolic volume by reducing the amount of pathologic myocyte hypertrophy is a very good thing, but when a reduction in end systolic volume is achieved simply structurally it might not have the same benefit, said Dr. Konstam, chief of cardiology at Tufts Medical Center, Boston.

The STICH trial continues, with another 1,212 ischemic heart failure patients who have been randomized to intensive medical therapy alone or in conjunction with CABG. They will be followed for another 2 years. This study has potentially far-reaching impact for all of cardiovascular medicine, Dr. Jones stressed.

“If we find in another 2 years that intensive medical therapy has gotten so good that there's not much room for surgery to further improve outcomes, it's going to change a whole lot of cardiology,” from noninvasive testing to how many cardiac caths get done, he said.

Surgical ventricular reconstruction methods shown here are Dor (A), Jatene (B), McCarthy (C), and Mickleborough (D). ©Elsevier; Reprinted from J. Thorac. Cardiovasc. Surg.; Semin. Thorac. Cardiovasc. Surg.; Ann. Thorac. Surg.