COPD Common in TAVR Patients, Associated with Increased CV Mortality

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Almost a quarter of patients undergoing transcatheter aortic valve replacement (TAVR) have concomitant chronic obstructive pulmonary disease (COPD), which puts them at increased risk of mortality at 1 year, mainly from cardiovascular causes, according to a large French TAVR registry study published online February 14, 2014, ahead of print in the American Journal of Cardiology. The study also found the increased risk conferred by COPD is consistent across multiple subgroups.

Researchers led by Romain Chopard, MD, of University Hospital Besançon (Besançon, France), assessed the impact of COPD on Valve Academic Research Consortium (VARC)-defined outcomes in 3,933 consecutive patients with severe symptomatic aortic stenosis from the FRANCE 2 national TAVR registry. The patients were treated between January 2010 and December 2011 at 34 centers (33 in France, 1 in Monaco). All were considered unsuitable for surgical valve replacement because of coexisting illness. Overall, 22.7% had concomitant COPD (n = 895).

Thirty-Day Trends Worsen at 1 Year for COPD

Device success was high and equivalent in both groups, though COPD patients showed trends toward higher all-cause mortality and acute kidney injury at 30 days. Similarly, at 1 year patients with COPD experienced higher mortality, mainly from cardiovascular causes, as well as higher rates of NYHA class III or IV and the VARC combined efficacy endpoint (table 1).

Table 1. VARC Outcomes According to Presence of COPD

 

COPD
(n = 895)

No COPD
(n = 3,033)

P Value

TAVR Success

96.6%

96.5%

0.43

30-Day All-Cause Death

10.8%

8.7%

0.065

30-Day Acute Kidney Injury

2.2%

1.3%

0.06

1-Year All-Cause Death

21.8%

18.4%

0.03

1-Year CV Death

10.3%

8.3%

0.056

1-Year NYHA III or IV

13.6%

7.3%

< 0.001

1-Year VARC Combined Efficacy Endpoint

44.3%

34.9%

< 0.001


Other VARC-defined outcomes at 1 year including stroke, rehospitalization for valve-related symptoms or worsening congestive heart failure, and valve-related dysfunction were similar between groups.

On multivariate regression analysis, COPD was found to be an independent predictor of 1-year all-cause mortality (HR 1.19; 95% CI 1.005-1.41; P = 0.03) and of the combined efficacy endpoint (HR 1.59; 95% CI 1.29-2.79; P < 0.001) after adjustment for comorbidities. Conversely, COPD did not predict 30-day mortality (HR 1.27; 95% CI 0.99-1.61; P = 0.051) or the combined VARC safety endpoint (HR 1.03; 95% CI 0.88-1.21; P = 0.63).

In a propensity-matched cohort of 710 pairs, the rate of major adverse events (stroke, life-threatening bleeding, acute kidney injury stage 2 or 3, MI, and major vascular complications) was similar in patients with and without COPD. Higher 30-day, 1-year, and CV mortality, as well as poorer VARC efficacy remained consistent in the matched population.

Results were also consistent across multiple subgroups defined by type of vascular access and anesthesia. For instance, among patients receiving transfemoral TAVR, those with COPD were not at higher risk of mortality than those without COPD (RR 1.37; 95% CI 1.10-1.71; P = 0.14).

COPD Direct Impacts Prognosis

“The prevalence of concomitant COPD observed in our study, with almost one-quarter of patients referred for TAVI, is consistent with previous reports,” the authors observe. “This is somewhat higher than the rate of COPD observed among patients undergoing surgical aortic valve replacement, suggesting that since the advent of TAVI, patients with severe aortic stenosis and concomitant COPD are preferentially treated with this technique rather than being referred for surgery.”

In the current study, they note, mortality was higher in patients with concomitant COPD, “even though TAVI should be considered as an interventional procedure, which would be expected to be less invasive and safer in terms of pulmonary function than conventional cardiac surgery.” Taken together, the authors say, the findings “suggest that the COPD process itself directly impacts on prognosis after TAVI, regardless of the type and results of the procedure.”

Less Invasive Option Best

According to Philippe Généreux, MD, of Columbia University Medical Center (New York, NY), a weakness of the paper is that COPD was not quantified by definitive criteria. “Clearly, the definition they use and the lack of characterization of COPD is a problem,” he told TCTMD in an interview. “If the authors had better identified COPD and classified patients according to [their COPD] severity—meaning mild, moderate, severe, and oxygen dependent, for instance—their findings would have been stronger. Sometimes TAVR patients have [an incorrect] diagnosis of COPD because they come in with shortness of breath, which is a symptom of aortic stenosis.”

Still, Dr. Généreux expressed surprise at the high rate of COPD in the study, although “it may be a referral bias,” he said, “because PARTNER B showed that a lot of these patients are nonoperable, so they go for TAVR up front.”

And in the end, that may be for the best, he said. “Despite the limitations, the message is true and has been validated in PARTNER,” Dr. Généreux concluded. “These patients with COPD are indeed at high risk. They have higher mortality. For clinicians, when we see a COPD patient, we all have the same reaction: this patient will be high risk whatever we do, so the less invasive the better, and we know they do worse with surgery.”

Study Details

Patients with COPD were more often male (56% vs 49%; P < 0.001), younger (81.4 years vs 82.8 years; P < 0.001), NYHA class III or IV (84% vs 72%; P < 0.001), and diabetic (28% vs 25%; P = 0.03), and they were more likely to have higher logistic EuroScore (24.5 vs 21.0; P = 0.001) and PAD (31% vs 27%; P = 0.006). The transfemoral access route was the most commonly used approach, both in patients with and without COPD.

Combined efficacy was defined as all-cause mortality between 30 days and 1 year; failure of current therapy for aortic stenosis requiring hospitalization for symptoms of valve-related or cardiac decompensation; and prosthetic heart valve dysfunction (aortic valve area < 1.2 cm2 and mean aortic valve gradient > 20 mm Hg or peak velocity > 3 m/s or moderate or severe prosthetic valve aortic regurgitation).

 


Source:
Chopard R, Meneveau N, Chocron S, et al. Impact of chronic obstructive pulmonary disease on VARC-defined outcomes after transcatheter aortic valve implantation (from the FRANCE 2 Registry). Am J Cardiol. 2014;Epub ahead of print.

 

Disclosures:

  • Dr. Chopard reports no relevant conflicts of interest.
  • Dr. Généreux reports serving as a speaker for Edwards Lifesciences.

 

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