In the Journals

Risk score may predict need for pacemaker after TAVR

Researchers have developed and validated the Emory risk score as a tool for predicting patients’ need for pacemaker implantation after transcatheter aortic valve replacement, according to findings published in JACC: Cardiovascular Intervention.

In a derivation cohort, independent predictors of pacemaker implantation included a history of syncope (OR = 2.48; 95% CI, 1.11-5.54), baseline right bundle branch block (OR = 4.33; 95% CI, 2.1-8.95), QRS duration of at least 138 milliseconds (OR = 2.487; 95% CI, 1.17-5.27) and valve oversizing greater than 15.6% (OR = 1.93; 95% CI, 1.03-3.62) were included in the Emory risk score.

After analysis in a validation cohort, researchers created a risk score of pre-TAVR characteristics including:

  • a clinical history of syncope (1 point);
  • baseline right bundle branch block configuration on baseline electrocardiography (2 points);
  • QRS duration greater at least 140 milliseconds (1 point); and
  • valve oversizing at least 16% (1 point).

According to the study, the Emory risk score was associated with pacemaker implantation (per point increase OR = 2.2; P < .001) with an area under the receiver-operating characteristic curve of 0.78 (95% CI, 0.69-0.87), similar to its performance in the derivation cohort or 0.73 AUC (95% CI, 0.65-0.81).

“The Emory risk score was highly correlated to and performed well for prediction of need for pacemaker implantation in the validation cohort. Notably, our risk score performed as well in the validation cohort as it did in the derivation cohort despite notable differences in baseline comorbidities,” Soroosh Kiani, MD, a CV fellow at Emory University, and colleagues wrote. “To our knowledge, this is the first proposed risk score for the need for pacemaker implantation after TAVR.”

Researchers analyzed patients who underwent first-time TAVR (Sapien 3, Edwards Lifesciences) at Emory University (n = 1,266). A total of 778 patients were included in the derivation cohort, and using a multivariate analysis, researchers identified predictors for pacemaker implantation, which were later confirmed in a 367-patient validation cohort.

“Our study focused exclusively on the Sapien 3 valve, which may limit the generalizability of these findings,” the researchers wrote. “It may be reasonable to expand these findings to other comparable balloon-expandable valves, though this is purely speculative and remains to be vigorously tested. However, this limitation is likely to be minor, as the Sapien 3 valve represents the most current generation of commercially available balloon-expandable valve, and prior generations are less commonly used.”

“Certainly, using the Emory risk score for permanent pacemaker implantation allows for a better preprocedural conversation with the patient,” Stefan Toggweiler, MD, and Miriam Brinkert, MD, of the Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland, wrote in a related editorial. “However, the question remains how this risk estimation may change clinical practice. Let’s assume you have two patients scheduled for TAVR, one has a risk for permanent pacemaker implantation of 10%, the other one has a risk of 40%. How would clinical management of these patients differ in your hospital? Even with a high risk of 40%, preemptive implantation of a permanent pacemaker appears not justified and may not be reimbursed in most countries.” – by Scott Buzby

Disclosures: Kiani and Brinkert report no relevant financial disclosures. Toggweiler reports he is a consultant and proctor for Boston Scientific and New Valve Technology; and has received unrestricted institutional research grants from Boston Scientific and Fumedica AG. Please see the study for all other authors’ relevant financial disclosures.

Researchers have developed and validated the Emory risk score as a tool for predicting patients’ need for pacemaker implantation after transcatheter aortic valve replacement, according to findings published in JACC: Cardiovascular Intervention.

In a derivation cohort, independent predictors of pacemaker implantation included a history of syncope (OR = 2.48; 95% CI, 1.11-5.54), baseline right bundle branch block (OR = 4.33; 95% CI, 2.1-8.95), QRS duration of at least 138 milliseconds (OR = 2.487; 95% CI, 1.17-5.27) and valve oversizing greater than 15.6% (OR = 1.93; 95% CI, 1.03-3.62) were included in the Emory risk score.

After analysis in a validation cohort, researchers created a risk score of pre-TAVR characteristics including:

  • a clinical history of syncope (1 point);
  • baseline right bundle branch block configuration on baseline electrocardiography (2 points);
  • QRS duration greater at least 140 milliseconds (1 point); and
  • valve oversizing at least 16% (1 point).

According to the study, the Emory risk score was associated with pacemaker implantation (per point increase OR = 2.2; P < .001) with an area under the receiver-operating characteristic curve of 0.78 (95% CI, 0.69-0.87), similar to its performance in the derivation cohort or 0.73 AUC (95% CI, 0.65-0.81).

“The Emory risk score was highly correlated to and performed well for prediction of need for pacemaker implantation in the validation cohort. Notably, our risk score performed as well in the validation cohort as it did in the derivation cohort despite notable differences in baseline comorbidities,” Soroosh Kiani, MD, a CV fellow at Emory University, and colleagues wrote. “To our knowledge, this is the first proposed risk score for the need for pacemaker implantation after TAVR.”

Researchers analyzed patients who underwent first-time TAVR (Sapien 3, Edwards Lifesciences) at Emory University (n = 1,266). A total of 778 patients were included in the derivation cohort, and using a multivariate analysis, researchers identified predictors for pacemaker implantation, which were later confirmed in a 367-patient validation cohort.

“Our study focused exclusively on the Sapien 3 valve, which may limit the generalizability of these findings,” the researchers wrote. “It may be reasonable to expand these findings to other comparable balloon-expandable valves, though this is purely speculative and remains to be vigorously tested. However, this limitation is likely to be minor, as the Sapien 3 valve represents the most current generation of commercially available balloon-expandable valve, and prior generations are less commonly used.”

“Certainly, using the Emory risk score for permanent pacemaker implantation allows for a better preprocedural conversation with the patient,” Stefan Toggweiler, MD, and Miriam Brinkert, MD, of the Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland, wrote in a related editorial. “However, the question remains how this risk estimation may change clinical practice. Let’s assume you have two patients scheduled for TAVR, one has a risk for permanent pacemaker implantation of 10%, the other one has a risk of 40%. How would clinical management of these patients differ in your hospital? Even with a high risk of 40%, preemptive implantation of a permanent pacemaker appears not justified and may not be reimbursed in most countries.” – by Scott Buzby

Disclosures: Kiani and Brinkert report no relevant financial disclosures. Toggweiler reports he is a consultant and proctor for Boston Scientific and New Valve Technology; and has received unrestricted institutional research grants from Boston Scientific and Fumedica AG. Please see the study for all other authors’ relevant financial disclosures.