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Bleeding events are common after transcatheter aortic valve replacement (TAVR), driven mainly by vascular complications. Moreover, transfusion is linked to increased mortality at 1 year, according to a retrospective study published online August 13, 2012, ahead of print in the American Heart Journal.

Investigators led by Didier Tchetche, MD, of the Clinique Pasteur (Toulouse, France), evaluated the clinical impact of bleeding and transfusion in 943 consecutive patients who underwent TAVR between November 2005 and August 2011 using pooled data from the PRAGMATIC Plus initiative, a collaboration of 4 experienced European centers. The study cohort was divided into those who did (n = 367) or did not (n = 576) require transfusion, which consisted of either 4 or more units of packed red blood cells (n = 111) or 1 to 4 units of red blood cells (n = 256).

The great majority of cases (84.1%) were performed via the transfemoral route, predominantly with a percutaneous access and closure strategy. Device success, achieved in 92.3% of patients, was lower in the transfusion group compared with the no-transfusion group (89.9% vs. 93.8%; P = 0.03).

Vascular Complications Behind About a Quarter of Bleeds

Life-threatening bleeding and major bleeding occurred in 13.9% and 20.9% of the cohort, respectively, and were more common in patients who received transfusions than in those who did not (29.2% vs. 4.2% and 28.3% vs. 16.1%; both P < 0.001). Over one-third of patients (38.9%) required red blood cell transfusion; vascular complications, seen in 23.2%, were more common in those who were transfused than in those who were not.

Overall, 30-day mortality was 7.2%. In multivariate analysis, transfusion was associated with increased 30-day and 1-year mortality compared with no transfusion (table 1).

Table 1. Effect of Transfusion vs. No Transfusion on Mortality

In addition, patients who received at least 4 units of red blood cells were at increased risk of 30-day and 1-year mortality compared with those who received lesser amounts or no transfusion (table 2).

Table 2. Effect on Mortality by Level of Transfusion

Abbreviation: RBC, red blood cells.

One-year survival was lower in the transfusion group compared with those who did not receive transfusions (75.2% vs. 84.9%; P < 0.001). The same was true for those who received at least 4 units of red blood cells compared with those who received 1 to 4 units or no transfusion (65.5% vs. 79.6% vs. 84.8%; P < 0.01).

Moreover, in a landmark analysis excluding patients who died before 30 days post TAVR, there was a 1-year survival advantage for untransfused and less-transfused patients compared with heavily transfused patients (91% vs. 85% vs. 77%; log rank P = 0.03 for no transfusion vs. 1 to 4 units of red blood cells and log rank P = 0.07 for 1 to 4 units vs. 4 or more units).

In addition, major vascular complications, acute kidney injury, and major stroke occurred more often in those who had any transfusion compared with those who had none.

Multivariate predictors of need for transfusion with at least 4 units of red blood cells included:

• Age (adjusted OR 0.94; P < 0.001)
• Female gender (adjusted OR 2.11; P = 0.002)
• Previous cerebrovascular accident (adjusted OR 1.95; P = 0.016)
• Severe anemia (adjusted OR 3.47; P < 0.01)
• Major stroke (adjusted OR 9.85; P < 0.001)
• Major vascular complication (adjusted OR 12.40; P < 0.01)

Bleeding No Less Common with Surgery

In an interview with TCTMD, Philippe Généreux, MD, of Columbia University Medical Center (New York, NY), urged comparison of TAVR with surgery for better perspective on the findings. “When you look at TAVR data [in isolation], it looks like [there are] a lot of vascular complications like bleeding,” he acknowledged. But surgery also is associated with multiple complications including significant bleeding, he noted. Moreover, the data reported in the study, which began in 2005, largely represent the operators’ early experience using first-generation devices. With smaller-sheath devices, bleeding may well be reduced by half, he predicted.

However, Dr. Généreux observed, the population currently being treated with TAVR tends to be old and frail and have multiple comorbidities, often including anemia, so bleeding and transfusion can occur for a host of reasons. “You start with a very sick population for whom the incidence of bleeding is varied and then do an invasive procedure, and of course they’re going to bleed,” he said. “The good news is that TAVR is a less invasive procedure than surgery and so they will probably bleed less than with surgery.

“There is a lot of room for improvement in the TAVR field,” he added, “but compared with surgical [aortic valve replacement], which is already a very mature procedure, TAVR is going to reduce its bleeding rate; surgery will not.”

Currently, the best antithrombotic regimen to minimize bleeding after TAVR while still protecting patients from ischemic events is unknown, Dr. Généreux observed, adding that the issue is complicated by the fact that perhaps 20% of older patients have atrial fibrillation and are already on warfarin. But data on the newer anticoagulants [such as dabigatran and rivaroxaban] should be helpful in this regard, he said. In addition, some data suggest that use of bivalirudin instead of heparin may reduce periprocedural bleeding, he added.

Each Approach Has Its Own Type of Bleeding

As for a differential bleeding risk with different TAVR approaches, “we may think that the transapical or transaortic approaches have less bleeding [than transfemoral access], but we don’t have direct comparisons so far,” Dr. Généreux said. “I think they all have different types of bleeding.” For this reason, it is important for the heart team to discuss and reach a consensus about the best option for a given patient, he added.

“It is also interesting that in the study a lot of bleeding was caused by closure device failure,” Dr. Généreux noted, suggesting that such situations may be improved with better closure devices, better technique, or surgical cutdown.

Dr. Généreux was lukewarm toward the authors’ suggestion of developing a TAVR-specific bleeding score, saying that to be helpful, such a risk score would have to be fine-tuned to identify preventable and nonpreventable bleeding, and procedural and postprocedural bleeding. “The good part about this publication is that we identify the drawbacks of TAVR,” Dr. Généreux concluded. “But there is a lot of hope because the devices are getting smaller and patient selection is getting better. We need to stick to the conclusion of PARTNER, which is that TAVR is noninferior to surgery no matter what the complication.”

 

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Source:
Tchetche D, Van der Boon RMA, Dumonteil N, et al. Adverse impact of bleeding and transfusion on the outcome post-transcatheter aortic valve implantation: Insights from the Pooled-RotterdAm-Milano-Toulouse In Collaboration Plus (PRAGMATIC Plus) initiative. Am Heart J. 2012;Epub ahead of print.

 

 

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• PARTNER Analysis: Vascular Complications Common in Transfemoral TAVR
• Fewer Vascular Complications as TAVR Evolves
• Access Site Complications Often Related to Closure Failure in TAVR Procedures