TAVR Use Triples in France, With Docs Treating Lower-Risk Patients

In-hospital and 30-day mortality rates are declining, but pacemaker rates are on the rise, a complication that researchers say needs correcting.

TAVR Use Triples in France, With Docs Treating Lower-Risk Patients

Transcatheter aortic valve replacement to treat severe aortic stenosis continues to expand in France, with TAVR rates nearly tripling from one earlier registry period to the next, according to the results of a new analysis.

With the growth of TAVR, operators are also achieving better outcomes compared with earlier experiences. In an assessment of 12,804 patients participating in the FRANCE TAVI registry, which included patients treated at 48 centers between 2013 and 2015, the in-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively.

Comparatively, in the FRANCE 2 registry, which included 4,165 patients undergoing TAVR at 34 centers between 2010 and 2012, the in-hospital and 30-day mortality rates were 8.2% and 10.1%, respectively.

Lead investigator Vincent Auffret, MD (Pontchaillou University Hospital Center, Rennes, France), told TCTMD the improved clinical outcomes were expected given the evolution in the types of patients treated and improved operator experience. Overall, patients treated between 2013 and 2015 had a lower surgical risk compared with those treated between 2010 and 2012 (logistic EuroSCORE of 21.7% in FRANCE 2 vs 17.9% in FRANCE TAVI).

Additionally, “among experienced centers, patients deemed at high surgical risk (those with a logistic EuroSCORE greater than 20%) accounted for only 25% of TAVR recipients,” in the more recent cohort, said Auffret.

Increased operator experience, better postoperative care, and technological gains, such as smaller sheaths that allow femoral access in a higher percentage of patients and device features to reduce to reduce paravalvular leak, all contributed to the reduction in mortality, said Auffret.

In a second study previously reported by TCTMD when it was presented at TVT 2017 in Chicago, IL, John Carroll, MD (University of Colorado, Aurora), and colleagues also highlighted the value of operator experience. In their analysis of the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) TVT Registry, there was a clear volume-outcome relationship in TAVR, with greater operator experience linked to reductions in mortality as well as vascular and bleeding complications.

Both studies were published online today ahead of the July 4, 2017, issue of the Journal of the American College of Cardiology.

Shifts in Practice

The latest FRANCE TAVI registry data highlight how TAVR has evolved over time, with hospitals shifting toward a more “minimalist” approach.

For example, in 2010, more than 70% of patients received general anesthesia and transesophageal echocardiography (TEE) guidance was used in 64% of procedures. In contrast, just 47% of patients treated in 2015 in FRANCE TAVI received general anesthesia and TEE was used in only one quarter of cases. Additionally, 83% of TAVR cases were performed with transfemoral access in 2015. Since 2010, transapical access has been declining, down from 19.2% that year to 3.9% in 2015.  

The changes in practice are also reflected in the earlier discharge rates in the latest registry. In FRANCE TAVI, 25% of patients were discharged within the first 5 days while just 12% of TAVR patients went home this early in 2010-2012. Patients in FRANCE TAVI were discharged a full day earlier compared with patients in FRANCE 2 (median time to discharge 8 vs 9 days; P < 0.001).

In 2010, 1.3% of patients were converted to surgery. In 2015, this number was down to 0.4%.

Notably, the need for a permanent pacemaker following TAVR is up, with 12.6% of patients receiving a device in FRANCE 2 and 17.5% implanted with a permanent pacemaker in FRANCE TAVI (P < 0.001).

“Obviously, when treating lower-risk patients, achieving a low rate of complications is one of your main goals,” said Auffret. “Bearing that in mind, conduction disturbances remain the main shortcoming of TAVR and the increased risk observed from FRANCE 2 to FRANCE TAVI is a significant concern which should be further evaluated.”

The trend, he noted, might be related to the introduction of Sapien 3 (Edwards Lifesciences), which has been associated with higher rates of pacemaker implantation compared with Sapien XT (Edwards Lifesciences) and CoreValve (Medtronic). Changes in how Sapien 3 is implanted, with an emphasis on a more “aortic implantation,” may reduce the pacemaker rates, Auffret said, but this still needs to be determined.

Are Docs Concerned About Durability?

Interestingly, despite the shift toward lower-risk patients, the average age of those undergoing TAVR was slightly higher in the FRANCE TAVI registry—mean 83.4 years versus 82.8 years in FRANCE 2.

“Although risk profile decreased, patients’ age increased, which might be related to the unanswered question of valve durability in the TAVR field,” said Auffret. “To date, we have robust data from the randomized PARTNER program showing no evidence of increased valve deterioration at 5 years compared with surgery, but data beyond 5 years are exceedingly scarce, which probably explains why TAVR has mainly been performed among lower-risk octogenarians for whom the durability may be less problematic.”

In an editorial accompanying the study, Alain Cribier, MD, Eric Durand, MD, and Helene Eltchaninoff, MD (University Hospital Charles Nicolle, Rouen, France), write that TAVR’s “odyssey” is far from complete and say more disruption is likely afoot, particularly as operators expand into lower-risk or younger patients.

“However, long-term durability of the valves is the unanswered question that remains to be addressed before extension of indication to patients with long life expectancy,” state the editorialists.

Sources
Disclosures
  • Edwards Lifesciences and Medtronic partly funded the FRANCE TAVI Registry.
  • Auffret has received fellowship support from the French Cardiology Federation and has received research grants from Abbott, Edwards Lifesciences, Medtronic, Biosensors, Terumo, and Boston Scientific.
  • Carroll reports serving as a site investigator studies sponsored by Edwards Lifesciences and Medtronic.
  • Cribier has served as a proctor and consultant for Edwards Lifesciences.
  • Eltchaninoff has received lecture fees and served as a proctor for Edwards Lifesciences. Durand has received lecture fees for Edwards Lifesciences.

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