PARTNER: Lung Disease No Barrier to TAVR But Increases Mortality Risk

Download this article's Factoid (PDF & PPT for Gold Subscribers


While patients with chronic lung disease receiving transcatheter aortic valve replacement (TAVR) show higher long-term mortality rates than those without such comorbidity, the percutaneous treatment still matches surgical replacement in high-risk patients and surpasses standard therapy in inoperable patients. The findings, from a new subanalysis of the PARTNER trial, were published online October 16, 2013, ahead of print in the Journal of the American College of Cardiology.

Ron Waksman, MD, of the MedStar Washington Hospital Center (Washington, DC), and colleagues included all 2,553 patients who underwent TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve) study including both the randomized trial (Cohorts A and B) and the continued access registry. Among them, 1,108 had chronic lung disease.

Non-Cardiovascular Deaths a Major Driver of Overall Mortality

At 1 year, TAVR patients had higher all-cause mortality in conjunction with chronic lung disease (23.4% vs. 19.6%; P = 0.02). Yet rates of death from cardiovascular causes were similar with and without lung disease (10.2% vs. 9.0%; P = 0.26). In the lung disease group, oxygen dependence again increased the risk of all-cause (29.7% vs. 21.4%; P = 0.004) but not cardiovascular death (12.4% vs. 9.4%; P = 0.12).

Patients in PARTNER Cohort A, considered at high surgical risk, had similar rates of death (all-cause and cardiovascular) and repeat hospitalization at 1 and 2 years with either TAVR or surgical replacement (table 1).

Table 1. Cohort A: Chronic Lung Disease Patients at High Surgical Risk

 

TAVR
(n = 149)

Surgery
(n = 138)

P Value

All-Cause Death
1 Year
2 Years

 
25.0%
35.2%


 26.9%
33.6%


 0.60
0.92

Cardiovascular Death
1 Year
2 Years


 10.6%
11.6%


 8.6%
10.0%


 0.61
0.63

Repeat Hospitalization
1 Year
2 Years

 17.5%
24.2%

 18.5%
21.6%

 0.81
0.87


Among patients in PARTNER Cohort B, which enrolled those considered inoperable, TAVR showed trends toward lower all-cause and cardiovascular death at 1 year compared with standard therapy. By 2 years, the difference in all-cause death became significant. At both time points, TAVR held the advantage in terms of repeat hospitalization (table 2).

Table 2. Cohort B: Inoperable Chronic Lung Disease Patients

 

TAVR
(n = 72)

Standard Therapy
(n = 95)

P Value

All-Cause Death
1 Year
2 Years

 
37.5%
52.0%

 
52.2%
69.6%

 
0.12
0.04

Cardiovascular Death
1 Year
2 Years

 
20.3%
25.5%

 
31.4%
44.9%

 
0.27
0.06

Repeat Hospitalization
1 Year
2 Years

 
24.6%
26.8%

 
52.3%
67.5%

 
0.004
< 0.001

 

On multivariate Cox regression analysis, independent predictors of higher all-cause death risk in chronic lung disease patients after TAVR were poor patient mobility (HR 1.67; 95% CI 1.23-2.22; P = 0.009), oxygen dependency (HR 1.44; 95% CI 1.05-1.97; P = 0.02), and mean pulmonary artery pressure (per 10 mm Hg increase; HR 1.26; 95% CI 1.10-1.45; P = 0.008).

Results Speak to Patient Selection

While the analysis echoes the overall PARTNER findings, with no statistical difference in mortality for TAVR vs. surgery and lower mortality for TAVR vs. standard therapy, and confirms that patients with lung disease have worse outcomes, “the main purpose of this study,” Dr. Waksman told TCTMD in a telephone interview, “was to see which patients with COPD can benefit from TAVR and for whom it may be futile.”

Dr. Waksman emphasized that patient selection in this population must be improved.

In a telephone interview with TCTMD, Josep Rodés-Cabau, MD, of the Quebec Heart and Lung Institute (Quebec City, Canada), agreed that uncertainty over patient selection “has been one of the major limitations of the procedure to date. . . . We need these kinds of tools and studies. We need objective data.”

In Canada, Dr. Rodés-Cabau continued, “these [non-cardiovascular] factors became a major factor in the later period.” High rates of death from non-cardiovascular causes, he said, mean that there are patients for whom TAVR may be futile.

Both physicians emphasized the difficulty in determining symptom etiology for a patient with lung disease and severe aortic stenosis who presents with shortness of breath. These cases require the guidance of a heart team that includes a pulmonologist. The paper also suggests that patients with unclear etiology might first undergo aortic valvuloplasty to help determine whether valve stenosis is the main culprit.

Markers of Mortality Clinically Relevant

"You have to be very careful about patients who are either oxygen-dependent or have very limited mobility," Dr. Waksman noted, "because those patients will have poorer outcomes and then you can ask what would be the utility of TAVR in this population."

One asset of TAVR is that it can be performed with conscious sedation rather than the general anesthesia required by surgery, Dr. Waksman pointed out. This potential benefit for lung disease patients remains to be tested, however, since most TAVR patients in PARTNER received general anesthesia.

Study Details

Among TAVR patients, those with chronic lung disease tended to be younger, have higher Society of Thoracic Surgeons risk score, be in New York Heart Association class IV, and have cerebral vascular disease, peripheral vascular disease, or a permanent pacemaker than those without the comorbidity. They also had higher mean values for pulmonary artery pressure, aortic valve area, and LVEF.

Note: Study coauthors Martin B. Leon, MD, and Susheel K. Kodali, MD, are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.

 


Source:
Dvir D, Waksman R, Barbash, IM, et al. Outcomes of patients with chronic lung disease and severe aortic stenosis treated with transcatheter versus surgical aortic valve replacement or standard therapy: Insights from the PARTNER trial. J Am Coll Cardiol. 2013;Epub ahead of print.

 

 

Related Stories:

PARTNER: Lung Disease No Barrier to TAVR But Increases Mortality Risk

While patients with chronic lung disease receiving transcatheter aortic valve replacement (TAVR) show higher long term mortality rates than those without such comorbidity, the percutaneous treatment still matches surgical replacement in high risk patients and surpasses standard therapy in inoperable
Disclosures
  • Drs. Waksman and Rodés-Cabau report no relevant conflicts of interest.

Comments