MitraClip: Outcomes Not Tied to Specialty

NEW YORK – Outcomes for the MitraClip procedure were similar for cardiologists and cardiac surgeons in an ongoing study of "real-world" use of the percutaneous mitral valve repair system.

The EVEREST II Continued Access Study, known as REALISM, is a prospective, multicenter data analysis of outcomes with the investigational MitraClip System (Abbott), said Dr. Gorav Allawadi, a CT surgeon at the University of Virginia, Charlottesville.

A total of 433 patients were included in the 30-day follow-up analysis; 47 were treated by 6 cardiothoracic surgeons and 386 by interventional cardiologists. Both patient groups had a mean age over 70 years, two-thirds had NYHA Class III or IV, and over half had functional mitral regurgitation. More than half had coronary artery disease, and nearly two-thirds had atrial fibrillation.

MitraClip procedural results were similar for cardiothoracic surgeons and interventional cardiologists, although there was a trend for the surgeons to use more clips. A single clip was implanted in 49% of the surgeon-treated cohort and in 58% of those treated by interventional cardiologists. Two clips were used in 51% of patients treated by surgeons and in 36% of patients treated by interventional cardiologists. (Clips could not be deployed in 6% of the patients treated by interventional cardiologists.) Mean procedural times were similar, 135 minutes for the surgeons versus 145 minutes for the interventional cardiologists. Post-procedure hospital stays averaged 2.5 days in both groups; 90% of patients were discharged home without the need for home health care, Dr. Allawadi reported.

In-hospital complication rates were low and did not differ significantly between the groups. Deaths occurred in 2.1% of the surgeon-treated patients and in 3.4% of the interventional cardiologist-treated patients. Major stroke occurred in 1.3% in patients treated by interventional cardiologists and in none of the surgeon-treated patients.

Outcomes at 30 days were similar, with more than half of both groups achieving 1-plus mitral regurgitation status or better and 90% at 2-plus or below. Similarly, 85% of both groups had improved to NYHA class I or II by 30 days post-procedure.

Dr. Allawadi said that the similarity in outcomes should not discourage a multidisciplinary approach to the treatment of these patients. When the CT surgeon performs the MitraClip procedure at his institution, the cardiologist scrubs as well. And if the interventional cardiologist is doing the procedure, the surgeon is still closely involved.

In response to a question about why the surgeons tended to use more clips, he speculated that it might be because surgeons don’t have as much experience with the device as yet. "We’re still very much on the learning curve."

In May, Abbott undertook a voluntary global recall of MitraClip after receiving three reports of incidents where the radiopaque ring at the tip of the steerable guide catheter detached in the heart following implant. Abbott emphasized that the concern only involves delivery of the device and that patients with previously implanted MitraClip devices are not affected.

Abbott officials expect it will take several months to resume shipments of the system, which is marketed in Europe but is investigational in the U.S. The firm says the recall is not likely to impact anticipated U.S. approval of the device later this year, according to a report in "The Gray Sheet."

Dr. Allawadi disclosed consulting fees and honoraria from Abbott. ☐

Rebecca Kern of "The Gray Sheet" added to this article. "The Gray Sheet" and this publication are both owned by Elsevier.

NEW YORK – Outcomes for the MitraClip procedure were similar for cardiologists and cardiac surgeons in an ongoing study of "real-world" use of the percutaneous mitral valve repair system.

The EVEREST II Continued Access Study, known as REALISM, is a prospective, multicenter data analysis of outcomes with the investigational MitraClip System (Abbott), said Dr. Gorav Allawadi, a CT surgeon at the University of Virginia, Charlottesville.

A total of 433 patients were included in the 30-day follow-up analysis; 47 were treated by 6 cardiothoracic surgeons and 386 by interventional cardiologists. Both patient groups had a mean age over 70 years, two-thirds had NYHA Class III or IV, and over half had functional mitral regurgitation. More than half had coronary artery disease, and nearly two-thirds had atrial fibrillation.

MitraClip procedural results were similar for cardiothoracic surgeons and interventional cardiologists, although there was a trend for the surgeons to use more clips. A single clip was implanted in 49% of the surgeon-treated cohort and in 58% of those treated by interventional cardiologists. Two clips were used in 51% of patients treated by surgeons and in 36% of patients treated by interventional cardiologists. (Clips could not be deployed in 6% of the patients treated by interventional cardiologists.) Mean procedural times were similar, 135 minutes for the surgeons versus 145 minutes for the interventional cardiologists. Post-procedure hospital stays averaged 2.5 days in both groups; 90% of patients were discharged home without the need for home health care, Dr. Allawadi reported.

In-hospital complication rates were low and did not differ significantly between the groups. Deaths occurred in 2.1% of the surgeon-treated patients and in 3.4% of the interventional cardiologist-treated patients. Major stroke occurred in 1.3% in patients treated by interventional cardiologists and in none of the surgeon-treated patients.

Outcomes at 30 days were similar, with more than half of both groups achieving 1-plus mitral regurgitation status or better and 90% at 2-plus or below. Similarly, 85% of both groups had improved to NYHA class I or II by 30 days post-procedure.

Dr. Allawadi said that the similarity in outcomes should not discourage a multidisciplinary approach to the treatment of these patients. When the CT surgeon performs the MitraClip procedure at his institution, the cardiologist scrubs as well. And if the interventional cardiologist is doing the procedure, the surgeon is still closely involved.

In response to a question about why the surgeons tended to use more clips, he speculated that it might be because surgeons don’t have as much experience with the device as yet. "We’re still very much on the learning curve."

In May, Abbott undertook a voluntary global recall of MitraClip after receiving three reports of incidents where the radiopaque ring at the tip of the steerable guide catheter detached in the heart following implant. Abbott emphasized that the concern only involves delivery of the device and that patients with previously implanted MitraClip devices are not affected.

Abbott officials expect it will take several months to resume shipments of the system, which is marketed in Europe but is investigational in the U.S. The firm says the recall is not likely to impact anticipated U.S. approval of the device later this year, according to a report in "The Gray Sheet."

Dr. Allawadi disclosed consulting fees and honoraria from Abbott. ☐

Rebecca Kern of "The Gray Sheet" added to this article. "The Gray Sheet" and this publication are both owned by Elsevier.

NEW YORK – Outcomes for the MitraClip procedure were similar for cardiologists and cardiac surgeons in an ongoing study of "real-world" use of the percutaneous mitral valve repair system.

The EVEREST II Continued Access Study, known as REALISM, is a prospective, multicenter data analysis of outcomes with the investigational MitraClip System (Abbott), said Dr. Gorav Allawadi, a CT surgeon at the University of Virginia, Charlottesville.

A total of 433 patients were included in the 30-day follow-up analysis; 47 were treated by 6 cardiothoracic surgeons and 386 by interventional cardiologists. Both patient groups had a mean age over 70 years, two-thirds had NYHA Class III or IV, and over half had functional mitral regurgitation. More than half had coronary artery disease, and nearly two-thirds had atrial fibrillation.

MitraClip procedural results were similar for cardiothoracic surgeons and interventional cardiologists, although there was a trend for the surgeons to use more clips. A single clip was implanted in 49% of the surgeon-treated cohort and in 58% of those treated by interventional cardiologists. Two clips were used in 51% of patients treated by surgeons and in 36% of patients treated by interventional cardiologists. (Clips could not be deployed in 6% of the patients treated by interventional cardiologists.) Mean procedural times were similar, 135 minutes for the surgeons versus 145 minutes for the interventional cardiologists. Post-procedure hospital stays averaged 2.5 days in both groups; 90% of patients were discharged home without the need for home health care, Dr. Allawadi reported.

In-hospital complication rates were low and did not differ significantly between the groups. Deaths occurred in 2.1% of the surgeon-treated patients and in 3.4% of the interventional cardiologist-treated patients. Major stroke occurred in 1.3% in patients treated by interventional cardiologists and in none of the surgeon-treated patients.

Outcomes at 30 days were similar, with more than half of both groups achieving 1-plus mitral regurgitation status or better and 90% at 2-plus or below. Similarly, 85% of both groups had improved to NYHA class I or II by 30 days post-procedure.

Dr. Allawadi said that the similarity in outcomes should not discourage a multidisciplinary approach to the treatment of these patients. When the CT surgeon performs the MitraClip procedure at his institution, the cardiologist scrubs as well. And if the interventional cardiologist is doing the procedure, the surgeon is still closely involved.

In response to a question about why the surgeons tended to use more clips, he speculated that it might be because surgeons don’t have as much experience with the device as yet. "We’re still very much on the learning curve."

In May, Abbott undertook a voluntary global recall of MitraClip after receiving three reports of incidents where the radiopaque ring at the tip of the steerable guide catheter detached in the heart following implant. Abbott emphasized that the concern only involves delivery of the device and that patients with previously implanted MitraClip devices are not affected.

Abbott officials expect it will take several months to resume shipments of the system, which is marketed in Europe but is investigational in the U.S. The firm says the recall is not likely to impact anticipated U.S. approval of the device later this year, according to a report in "The Gray Sheet."

Dr. Allawadi disclosed consulting fees and honoraria from Abbott. ☐

Rebecca Kern of "The Gray Sheet" added to this article. "The Gray Sheet" and this publication are both owned by Elsevier.