Rigid Plating Speeds Sternal Healing

COLORADO SPRINGS – Rigid fixation with sternal plates resulted in superior sternal bone healing post sternotomy, compared with conventional wire cerclage in a randomized trial.

This was the first-ever randomized study to utilize CT scans to objectively assess sternal union. The results at 6 months of follow-up showed a striking advantage for rigid plate fixation using the proprietary SternaLock system, Dr. Jaishankar Raman said at the annual meeting of the Western Thoracic Surgical Association.

Most cardiac surgeons will be surprised, as was he, at how low the sternal union rates were 3 months poststernotomy. In fact, the sternal union rate then with conventional wire closure was zero, while for sternal plating it was 17%, added Dr. Raman of the University of Chicago.

He reported on 141 randomized cardiac surgery patients at six centers in the United States and Germany. All were at high risk for sternal wound complications, mostly due to multiple comorbid diseases. Their multilevel CT scans obtained at 3 or 6 months post surgery were independently scored in structured fashion by two independent radiologists at a core imaging center.

At 6 months, sternal union, or osteosynthesis – as defined by a CT score of 3 or more – was achieved in 70% of the rigid plate fixation group, compared with 20% of those with conventional wire cerclage.

There were no significant differences between the two study arms in rates of wound dehiscence or other adverse events.

Asked about the cost of SternaLock fixation, Dr. Raman replied, "That’s the biggest stumbling block in developing this technology."

The wire for conventional cerclage costs less than $50 per patient. In contrast, the SternaLock system costs about $1,000 per patient. It could be argued that if rigid plate fixation reduces the incidence of sternal wound complications in high-risk patients, the advanced technology would be cost effective. However, the randomized trial wasn’t powered to show a significant difference in such complications.

Dr. Raman observed that wire cerclage has been accepted as the time-honored and most widely employed means of sternal closure ever since the modern era of cardiac surgery began back in the 1950s, even though it is a crude method.

"Even though we may not like it, we in cardiac surgery do more bone approximation and bone fixation than most other bone-handling surgeons. Yet all other bone-handling surgeons have moved on to plate and screw fixation. Biomechanical studies show that plate fixation is significantly better than wire closure," according to the surgeon.

Discussant Dr. Matthew S. Slater, clinical director of adult cardiac surgery at Oregon Health & Sciences Center, Portland, said that based on the assumption that rigid plate fixation is a better method than conventional wire cerclage, what he’d really like to see next is a comparative study pitting the SternaLock system against other novel fixation technologies on the market, such as KLS Martin’s Sternal Talon and ACUTE Innovations’ AcuTie.

Dr. Raman agreed that would be a logical next step, adding that it’s his strong impression the industry is not interested in funding comparative trials.

He declared that he received a research grant from Biomet Microfixation, which markets the SternaLock and funded the randomized trial.

COLORADO SPRINGS – Rigid fixation with sternal plates resulted in superior sternal bone healing post sternotomy, compared with conventional wire cerclage in a randomized trial.

This was the first-ever randomized study to utilize CT scans to objectively assess sternal union. The results at 6 months of follow-up showed a striking advantage for rigid plate fixation using the proprietary SternaLock system, Dr. Jaishankar Raman said at the annual meeting of the Western Thoracic Surgical Association.

Most cardiac surgeons will be surprised, as was he, at how low the sternal union rates were 3 months poststernotomy. In fact, the sternal union rate then with conventional wire closure was zero, while for sternal plating it was 17%, added Dr. Raman of the University of Chicago.

He reported on 141 randomized cardiac surgery patients at six centers in the United States and Germany. All were at high risk for sternal wound complications, mostly due to multiple comorbid diseases. Their multilevel CT scans obtained at 3 or 6 months post surgery were independently scored in structured fashion by two independent radiologists at a core imaging center.

At 6 months, sternal union, or osteosynthesis – as defined by a CT score of 3 or more – was achieved in 70% of the rigid plate fixation group, compared with 20% of those with conventional wire cerclage.

There were no significant differences between the two study arms in rates of wound dehiscence or other adverse events.

Asked about the cost of SternaLock fixation, Dr. Raman replied, "That’s the biggest stumbling block in developing this technology."

The wire for conventional cerclage costs less than $50 per patient. In contrast, the SternaLock system costs about $1,000 per patient. It could be argued that if rigid plate fixation reduces the incidence of sternal wound complications in high-risk patients, the advanced technology would be cost effective. However, the randomized trial wasn’t powered to show a significant difference in such complications.

Dr. Raman observed that wire cerclage has been accepted as the time-honored and most widely employed means of sternal closure ever since the modern era of cardiac surgery began back in the 1950s, even though it is a crude method.

"Even though we may not like it, we in cardiac surgery do more bone approximation and bone fixation than most other bone-handling surgeons. Yet all other bone-handling surgeons have moved on to plate and screw fixation. Biomechanical studies show that plate fixation is significantly better than wire closure," according to the surgeon.

Discussant Dr. Matthew S. Slater, clinical director of adult cardiac surgery at Oregon Health & Sciences Center, Portland, said that based on the assumption that rigid plate fixation is a better method than conventional wire cerclage, what he’d really like to see next is a comparative study pitting the SternaLock system against other novel fixation technologies on the market, such as KLS Martin’s Sternal Talon and ACUTE Innovations’ AcuTie.

Dr. Raman agreed that would be a logical next step, adding that it’s his strong impression the industry is not interested in funding comparative trials.

He declared that he received a research grant from Biomet Microfixation, which markets the SternaLock and funded the randomized trial.

COLORADO SPRINGS – Rigid fixation with sternal plates resulted in superior sternal bone healing post sternotomy, compared with conventional wire cerclage in a randomized trial.

This was the first-ever randomized study to utilize CT scans to objectively assess sternal union. The results at 6 months of follow-up showed a striking advantage for rigid plate fixation using the proprietary SternaLock system, Dr. Jaishankar Raman said at the annual meeting of the Western Thoracic Surgical Association.

Most cardiac surgeons will be surprised, as was he, at how low the sternal union rates were 3 months poststernotomy. In fact, the sternal union rate then with conventional wire closure was zero, while for sternal plating it was 17%, added Dr. Raman of the University of Chicago.

He reported on 141 randomized cardiac surgery patients at six centers in the United States and Germany. All were at high risk for sternal wound complications, mostly due to multiple comorbid diseases. Their multilevel CT scans obtained at 3 or 6 months post surgery were independently scored in structured fashion by two independent radiologists at a core imaging center.

At 6 months, sternal union, or osteosynthesis – as defined by a CT score of 3 or more – was achieved in 70% of the rigid plate fixation group, compared with 20% of those with conventional wire cerclage.

There were no significant differences between the two study arms in rates of wound dehiscence or other adverse events.

Asked about the cost of SternaLock fixation, Dr. Raman replied, "That’s the biggest stumbling block in developing this technology."

The wire for conventional cerclage costs less than $50 per patient. In contrast, the SternaLock system costs about $1,000 per patient. It could be argued that if rigid plate fixation reduces the incidence of sternal wound complications in high-risk patients, the advanced technology would be cost effective. However, the randomized trial wasn’t powered to show a significant difference in such complications.

Dr. Raman observed that wire cerclage has been accepted as the time-honored and most widely employed means of sternal closure ever since the modern era of cardiac surgery began back in the 1950s, even though it is a crude method.

"Even though we may not like it, we in cardiac surgery do more bone approximation and bone fixation than most other bone-handling surgeons. Yet all other bone-handling surgeons have moved on to plate and screw fixation. Biomechanical studies show that plate fixation is significantly better than wire closure," according to the surgeon.

Discussant Dr. Matthew S. Slater, clinical director of adult cardiac surgery at Oregon Health & Sciences Center, Portland, said that based on the assumption that rigid plate fixation is a better method than conventional wire cerclage, what he’d really like to see next is a comparative study pitting the SternaLock system against other novel fixation technologies on the market, such as KLS Martin’s Sternal Talon and ACUTE Innovations’ AcuTie.

Dr. Raman agreed that would be a logical next step, adding that it’s his strong impression the industry is not interested in funding comparative trials.

He declared that he received a research grant from Biomet Microfixation, which markets the SternaLock and funded the randomized trial.