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Patients with Severe Pulmonary Hypertension Benefit from TAVR Despite Increased Mortality

Author profile picture By L.A. McKeown

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While the presence of pulmonary hypertension increases all-cause mortality at 1 year after transcatheter aortic valve replacement (TAVR), even patients with the most severe form of the condition reap functional benefits that render the therapy a reasonable option, according to a registry study published online February 25, 2014, ahead of print in Circulation: Cardiovascular Interventions.

Investigators led by Adrien Luçon, MD, of Centre Hospitalier Privé Saint Martin (Caen, France), assessed the prognostic value of pulmonary hypertension in 2,435 patients enrolled in the FRANCE 2 registry with severe aortic stenosis who underwent TAVR at 34 centers in 2010 and 2011. Patients were divided into 3 groups depending on systolic pulmonary artery pressure:

  • No pulmonary hypertension (< 40 mm Hg; 34.7%)
  • Mild-to-moderate (40-59 mm Hg; 45.7%)
  • Severe (≥ 60 mm Hg; 19.6%)

The 2 devices used to perform TAVR—Sapien XT (Edwards Lifesciences, Irvine, CA) and CoreValve (Medtronic, Minneapolis, MN)—were implanted with similar frequency across groups.

Universal Functional Improvement Seen

Procedural success and early complications were similar across groups (P = 0.6 for both comparisons). There also were no differences in valve prosthesis complications such as valve migration, aortic rupture, or acute coronary occlusion.

At 1 year, all-cause mortality (primary endpoint) was higher in the 2 groups with pulmonary hypertension compared with the group without the condition. However, 30-day all-cause mortality and 1-year cardiovascular mortality were similar across the groups (table 1).

Table 1. Mortality by Degree of Pulmonary Hypertension

 

None

Mild-to-Moderate

Severe

P Value

All-Cause Death at 30 Days

10%

10%

11%

0.5

All-Cause Death at
1 Year

22%

28%

28%

0.032

CV Death at 1 Year

11.1%

13.2%

11%

0.7


At 1 year, all-cause death, MI, or stroke occurred in 28% of patients with no pulmonary hypertension compared with 33% in the mild-to-moderate group (P = 0.2) and 33% in the severe group (P = 0.1).

On multivariate analysis, independent predictors of all-cause mortality were mild-to-moderate (HR 1.22; 95% CI 0.96-1.54) and severe pulmonary hypertension (HR 1.33; 95% CI 1.01-1.75).

At last follow-up (median 237 days), each of the 3 groups showed clear improvement in NYHA functional class (P < 0.0001).

“Our results suggest that a pulmonary hypertension, even severe, associated with symptomatic [aortic stenosis] should not lead to [exclusion of] patients from TAVI,” Dr. Luçon and colleagues write.

Pulmonary Hypertension Not Sole Mortality Culprit

Noting that the current findings are “mainly confirmatory” of data from the Canadian TAVR registry, Josep Rodés-Cabau, MD, of the Heart and Lung Institute of Laval University (Quebec City, Canada), agreed that there is no justification for denying TAVR to patients with severe pulmonary hypertension as long as they have been carefully evaluated and the expected benefits outweigh the risk. However, he told TCTMD in a telephone interview, unlike the current study, the Canadian registry also observed a correlation between pulmonary hypertension and increased risk of cardiovascular death.

Dr. Rodés-Cabau noted that pulmonary hypertension may not be the sole contributor to increased all-cause mortality in these patients since they often have concomitant moderate to severe mitral regurgitation and/or low ejection fraction.

“What is still uncertain… is who among them will improve [with TAVR],” he said. “The registries help to give us some additional information on these patients, but I think we need to look at another endpoint such as rehospitalization [and not just] functional class to get the true picture,” he said.

“The main thing is that the hemodynamic result has to be very good,” Dr. Rodés-Cabau continued.  “You don’t want to take these patients in for TAVR and end up with moderate-to-severe aortic regurgitation that is going to cause them more problems, more rehospitalization. I would not be surprised if these patients do have more rehospitalizations, but that is something we need to look at in future studies.”

Study Details

Mean age in all groups was 83 years. In patients with severe pulmonary hypertension, mean systolic pulmonary pressure was 65 mm Hg; they were more symptomatic (84.9% NYHA functional class III or IV), had higher logistic EuroScore (mean, 28.3%), and more frequently had histories of aortic valve replacement surgery and balloon valvuloplasty. LVEF in the severe group was 49 ± 15 mm Hg, lower than in the other groups (P < 0.0001).

 

Source:
Luçon A, Oger E, Bedossa M, et al. Prognostic implications of pulmonary hypertension in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: study from the FRANCE 2 registry. Circ Cardiovasc Interv. 2014;Epub ahead of print.

 

 

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Disclosures
  • The FRANCE 2 registry was supported by Edwards Lifesciences and Medtronic.
  • Dr. Luçon reports no relevant conflicts of interest.
  • Dr. Rodés-Cabau reports serving as a consultant to Edwards Lifesciences and St. Jude Medical.

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