Transcatheter aortic valve implantation equivalent to surgical replacement

Transcatheter aortic valve implantation shows reductions in early and mid-term all-cause mortality similar to those with surgical aortic valve replacement, even in patients with low to intermediate surgical risk, a meta-analysis and systematic review has shown.

Dr. Giuseppe Gargiulo of Federico II University in Naples, Italy, and coauthors analyzed data from five randomized trials and 31 observational matched studies comparing mortality outcomes in 16,638 patients undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR).

Their analysis found no statistically significant difference between the two procedures in terms of early or midterm all-cause mortality, even among patients judged as being at low to intermediate surgical risk (Ann Intern Med. 2016 Jun 7. doi: 10.7326/M16-0060).

In terms of 2- to 5-year mortality, overall there was a statistically nonsignificant increase in the risk of all-cause mortality with TAVI (odds ratio, 1.28; 95% confidence interval, 0.97-1.69), although the long-term mortality outcomes in patients in the low to intermediate surgical risk subgroup were inconclusive.

However, the authors did note significantly reduced early all-cause mortality in individuals who underwent transfemoral TAVI compared to those who underwent SAVR (OR 0.68, 95%CI, 0.53 to 0.87).

The analysis also showed that individuals who underwent TAVI had a higher incidence of permanent pacemaker implantation, vascular complications, and moderate to severe paravalvular leak, while those who underwent SAVR had more frequent incidence of major bleeding, acute kidney injury, and new-onset atrial fibrillation.

“These findings, which apply to adults with severe aortic stenosis, consolidate the role of TAVI as an alternative to SAVR,” the authors wrote. “Indeed, TAVI techniques continue to improve, newer valves address the issue of paravalvular leak, the percentage of pacemakers is decreasing, and the rate of vascular complications is expected to be lowered as the result of smaller sheaths and improved procedural techniques.”

The researchers noted that elderly patients and those with coronary artery disease showed a greater benefit from TAVI than from SAVR, suggesting that this may be because these groups have a heightened risk that favors less invasive surgical approaches.

They also found greater reductions in early mortality with TAVI when a Sapien valve was implanted, compared to a CoreValve. They noted that this was due mostly to a single large study and the effect did not persist through to the midterm follow-up.

One author reported grants from the CardioPath PhD Program, Federico II University of Naples, and from the European Association of Percutaneous Coronary Interventions, outside the submitted work. Another author declared a consultancy for Edwards Lifesciences. There were no other conflicts of interest declared.

Transcatheter aortic valve implantation shows reductions in early and mid-term all-cause mortality similar to those with surgical aortic valve replacement, even in patients with low to intermediate surgical risk, a meta-analysis and systematic review has shown.

Dr. Giuseppe Gargiulo of Federico II University in Naples, Italy, and coauthors analyzed data from five randomized trials and 31 observational matched studies comparing mortality outcomes in 16,638 patients undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR).

Their analysis found no statistically significant difference between the two procedures in terms of early or midterm all-cause mortality, even among patients judged as being at low to intermediate surgical risk (Ann Intern Med. 2016 Jun 7. doi: 10.7326/M16-0060).

In terms of 2- to 5-year mortality, overall there was a statistically nonsignificant increase in the risk of all-cause mortality with TAVI (odds ratio, 1.28; 95% confidence interval, 0.97-1.69), although the long-term mortality outcomes in patients in the low to intermediate surgical risk subgroup were inconclusive.

However, the authors did note significantly reduced early all-cause mortality in individuals who underwent transfemoral TAVI compared to those who underwent SAVR (OR 0.68, 95%CI, 0.53 to 0.87).

The analysis also showed that individuals who underwent TAVI had a higher incidence of permanent pacemaker implantation, vascular complications, and moderate to severe paravalvular leak, while those who underwent SAVR had more frequent incidence of major bleeding, acute kidney injury, and new-onset atrial fibrillation.

“These findings, which apply to adults with severe aortic stenosis, consolidate the role of TAVI as an alternative to SAVR,” the authors wrote. “Indeed, TAVI techniques continue to improve, newer valves address the issue of paravalvular leak, the percentage of pacemakers is decreasing, and the rate of vascular complications is expected to be lowered as the result of smaller sheaths and improved procedural techniques.”

The researchers noted that elderly patients and those with coronary artery disease showed a greater benefit from TAVI than from SAVR, suggesting that this may be because these groups have a heightened risk that favors less invasive surgical approaches.

They also found greater reductions in early mortality with TAVI when a Sapien valve was implanted, compared to a CoreValve. They noted that this was due mostly to a single large study and the effect did not persist through to the midterm follow-up.

One author reported grants from the CardioPath PhD Program, Federico II University of Naples, and from the European Association of Percutaneous Coronary Interventions, outside the submitted work. Another author declared a consultancy for Edwards Lifesciences. There were no other conflicts of interest declared.

Transcatheter aortic valve implantation shows reductions in early and mid-term all-cause mortality similar to those with surgical aortic valve replacement, even in patients with low to intermediate surgical risk, a meta-analysis and systematic review has shown.

Dr. Giuseppe Gargiulo of Federico II University in Naples, Italy, and coauthors analyzed data from five randomized trials and 31 observational matched studies comparing mortality outcomes in 16,638 patients undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR).

Their analysis found no statistically significant difference between the two procedures in terms of early or midterm all-cause mortality, even among patients judged as being at low to intermediate surgical risk (Ann Intern Med. 2016 Jun 7. doi: 10.7326/M16-0060).

In terms of 2- to 5-year mortality, overall there was a statistically nonsignificant increase in the risk of all-cause mortality with TAVI (odds ratio, 1.28; 95% confidence interval, 0.97-1.69), although the long-term mortality outcomes in patients in the low to intermediate surgical risk subgroup were inconclusive.

However, the authors did note significantly reduced early all-cause mortality in individuals who underwent transfemoral TAVI compared to those who underwent SAVR (OR 0.68, 95%CI, 0.53 to 0.87).

The analysis also showed that individuals who underwent TAVI had a higher incidence of permanent pacemaker implantation, vascular complications, and moderate to severe paravalvular leak, while those who underwent SAVR had more frequent incidence of major bleeding, acute kidney injury, and new-onset atrial fibrillation.

“These findings, which apply to adults with severe aortic stenosis, consolidate the role of TAVI as an alternative to SAVR,” the authors wrote. “Indeed, TAVI techniques continue to improve, newer valves address the issue of paravalvular leak, the percentage of pacemakers is decreasing, and the rate of vascular complications is expected to be lowered as the result of smaller sheaths and improved procedural techniques.”

The researchers noted that elderly patients and those with coronary artery disease showed a greater benefit from TAVI than from SAVR, suggesting that this may be because these groups have a heightened risk that favors less invasive surgical approaches.

They also found greater reductions in early mortality with TAVI when a Sapien valve was implanted, compared to a CoreValve. They noted that this was due mostly to a single large study and the effect did not persist through to the midterm follow-up.

One author reported grants from the CardioPath PhD Program, Federico II University of Naples, and from the European Association of Percutaneous Coronary Interventions, outside the submitted work. Another author declared a consultancy for Edwards Lifesciences. There were no other conflicts of interest declared.