ADVANCE: TAVI survival remains high with CoreValve

At 1 year, overall survival after implantation with the transcatheter aortic CoreValve in the postmarket ADVANCE study was 82.1% and cardiovascular survival 88.2%. This compares with survival rates of 87.4% and 91.7% at 6 months and 95.5% and 96.6% at 30 days, principal investigator Dr. Axel Linke said at Transcatheter Cardiovascular Therapeutics 2012.

"If you put it into the perspective of the PARTNER A and B cohorts [in the pivotal trial in the Sapien transcatheter valve system], our mortality rate is, in absolute values, 8% to 13% lower," he said in an interview.

One explanation is that the 1,015-patient, postmarket ADVANCE study sought out centers experienced with transcatheter aortic valve implantation (TAVI). The 44 centers in Western Europe, Asia, and South America had to have performed at least 40 TAVI procedures, with some German centers having done as many as 500, to be certified by a TAVI proctor and to have a heart team in place. In comparison, some centers in the PARTNER trial of the Edwards Lifesciences Sapien valve contributed just six or seven patients and were selected based on their experience with general cardiologic intervention, he observed.

The 1-year survival rates in ADVANCE also surpass those from early registries, notably the French Aortic National CoreValve and Edwards Registry, where the initial experience with TAVI was associated with interventional mistakes, which were linked to early mortality, Dr. Linke said. The CoreValve System has been implanted in more than 30,000 patients since approval in the European Union in 2007, but is limited to investigational use in the United States.

No details were presented regarding mortality in various subgroups or complications such as stroke, paravalvular leaks or left bundle branch block (LBBB). A recent analysis raised concerns about LBBB, showing that one-third of 202 consecutive patients with no prior conduction disturbances developed new-onset LBBB after TAVI with a balloon-expandable valve (Sapien or Sapien XT). Although it resolved in 37.7% by hospital discharge and 57.3% at 6- to 12-month follow-up, patients with persistent LBBB had a significantly higher incidence of syncope and complete atrioventricular block requiring a permanent pacemaker (J. Am. Coll. Cardiol. 2012;60:1743-52 [doi:10.1016/j.jacc.2012.035].

The researchers will look at LBBB in detailed analyses expected from ADVANCE, but there’s been no evidence of a problem with LBBB in earlier follow-up in ADVANCE or from other CoreValve users.

Quality of life data from ADVANCE, reported in a separate poster session at the meeting, showed significant benefits with CoreValve, even in higher-risk patients. The access route used during TAVI had no impact on quality of life improvement at 6 months.

Dr. Linke has served as a consultant for Medtronic, the study sponsor.

[email protected]

At 1 year, overall survival after implantation with the transcatheter aortic CoreValve in the postmarket ADVANCE study was 82.1% and cardiovascular survival 88.2%. This compares with survival rates of 87.4% and 91.7% at 6 months and 95.5% and 96.6% at 30 days, principal investigator Dr. Axel Linke said at Transcatheter Cardiovascular Therapeutics 2012.

"If you put it into the perspective of the PARTNER A and B cohorts [in the pivotal trial in the Sapien transcatheter valve system], our mortality rate is, in absolute values, 8% to 13% lower," he said in an interview.

One explanation is that the 1,015-patient, postmarket ADVANCE study sought out centers experienced with transcatheter aortic valve implantation (TAVI). The 44 centers in Western Europe, Asia, and South America had to have performed at least 40 TAVI procedures, with some German centers having done as many as 500, to be certified by a TAVI proctor and to have a heart team in place. In comparison, some centers in the PARTNER trial of the Edwards Lifesciences Sapien valve contributed just six or seven patients and were selected based on their experience with general cardiologic intervention, he observed.

The 1-year survival rates in ADVANCE also surpass those from early registries, notably the French Aortic National CoreValve and Edwards Registry, where the initial experience with TAVI was associated with interventional mistakes, which were linked to early mortality, Dr. Linke said. The CoreValve System has been implanted in more than 30,000 patients since approval in the European Union in 2007, but is limited to investigational use in the United States.

No details were presented regarding mortality in various subgroups or complications such as stroke, paravalvular leaks or left bundle branch block (LBBB). A recent analysis raised concerns about LBBB, showing that one-third of 202 consecutive patients with no prior conduction disturbances developed new-onset LBBB after TAVI with a balloon-expandable valve (Sapien or Sapien XT). Although it resolved in 37.7% by hospital discharge and 57.3% at 6- to 12-month follow-up, patients with persistent LBBB had a significantly higher incidence of syncope and complete atrioventricular block requiring a permanent pacemaker (J. Am. Coll. Cardiol. 2012;60:1743-52 [doi:10.1016/j.jacc.2012.035].

The researchers will look at LBBB in detailed analyses expected from ADVANCE, but there’s been no evidence of a problem with LBBB in earlier follow-up in ADVANCE or from other CoreValve users.

Quality of life data from ADVANCE, reported in a separate poster session at the meeting, showed significant benefits with CoreValve, even in higher-risk patients. The access route used during TAVI had no impact on quality of life improvement at 6 months.

Dr. Linke has served as a consultant for Medtronic, the study sponsor.

[email protected]

At 1 year, overall survival after implantation with the transcatheter aortic CoreValve in the postmarket ADVANCE study was 82.1% and cardiovascular survival 88.2%. This compares with survival rates of 87.4% and 91.7% at 6 months and 95.5% and 96.6% at 30 days, principal investigator Dr. Axel Linke said at Transcatheter Cardiovascular Therapeutics 2012.

"If you put it into the perspective of the PARTNER A and B cohorts [in the pivotal trial in the Sapien transcatheter valve system], our mortality rate is, in absolute values, 8% to 13% lower," he said in an interview.

One explanation is that the 1,015-patient, postmarket ADVANCE study sought out centers experienced with transcatheter aortic valve implantation (TAVI). The 44 centers in Western Europe, Asia, and South America had to have performed at least 40 TAVI procedures, with some German centers having done as many as 500, to be certified by a TAVI proctor and to have a heart team in place. In comparison, some centers in the PARTNER trial of the Edwards Lifesciences Sapien valve contributed just six or seven patients and were selected based on their experience with general cardiologic intervention, he observed.

The 1-year survival rates in ADVANCE also surpass those from early registries, notably the French Aortic National CoreValve and Edwards Registry, where the initial experience with TAVI was associated with interventional mistakes, which were linked to early mortality, Dr. Linke said. The CoreValve System has been implanted in more than 30,000 patients since approval in the European Union in 2007, but is limited to investigational use in the United States.

No details were presented regarding mortality in various subgroups or complications such as stroke, paravalvular leaks or left bundle branch block (LBBB). A recent analysis raised concerns about LBBB, showing that one-third of 202 consecutive patients with no prior conduction disturbances developed new-onset LBBB after TAVI with a balloon-expandable valve (Sapien or Sapien XT). Although it resolved in 37.7% by hospital discharge and 57.3% at 6- to 12-month follow-up, patients with persistent LBBB had a significantly higher incidence of syncope and complete atrioventricular block requiring a permanent pacemaker (J. Am. Coll. Cardiol. 2012;60:1743-52 [doi:10.1016/j.jacc.2012.035].

The researchers will look at LBBB in detailed analyses expected from ADVANCE, but there’s been no evidence of a problem with LBBB in earlier follow-up in ADVANCE or from other CoreValve users.

Quality of life data from ADVANCE, reported in a separate poster session at the meeting, showed significant benefits with CoreValve, even in higher-risk patients. The access route used during TAVI had no impact on quality of life improvement at 6 months.

Dr. Linke has served as a consultant for Medtronic, the study sponsor.

[email protected]