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End-stage renal disease increases risk for mortality, bleeding after TAVR
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Patients with end-stage renal disease, or ESRD, who underwent transcatheter aortic valve replacement had an increased risk for in-hospital mortality and bleeding compared with those who were not dialysis dependent, according to a study published in the Journal of the American College of Cardiology.
Both groups of patients had similar rates of vascular complications, according to the study.
“Patients with ESRD who have severe [aortic stenosis] still remain a high-risk group for TAVR,” Molly Szerlip, MD, interventional cardiologist at Baylor Scott and White The Heart Hospital – Plano in Texas, and colleagues wrote. “Even though patients with ESRD survive the procedure and initial hospitalization after TAVR, they remain at high risk for early mortality and rehospitalization.”
Transcatheter Valve Therapies registry
Researchers analyzed data from 72,631 patients (mean age, 83 years; 52% men) with aortic stenosis from the Society of Thoracic Surgeons/ACC Transcatheter Valve Therapies registry who underwent TAVR between November 2011 and June 2016. Data assessed in this study included comorbidities, patient demographics, quality of life, functional status, procedural details, hemodynamics and outcomes at 30 days and 1 year.
Of the patients in the study, 4.3% had ESRD. Compared with patients without ESRD, those with the disease were more likely to be younger (83 years vs. 76 years; P < .01) and had a higher STS Predicted Risk of Mortality score based on higher rates of comorbidities including previous MI, hypertension, peripheral artery disease and worsened HF symptoms (14.4% vs. 6.8%; P < .01).
Patients with ESRD had a higher rate of in-hospital mortality vs. those without the disease (5.1% vs. 3.4%; P < .01) despite having a lower observed-to-expected mortality ratio (0.32 vs. 0.44; P < .01).
The rate of major vascular complications was similar in patients with and without ESRD (4.5% vs. 4.6%, respectively; P = .86). The ESRD group had a higher rate of major bleeding (1.4% vs. 1%; P = .03).
Patients who required dialysis had a higher rate of mortality at 1 year compared with those who did not require dialysis (36.8% vs. 18.7%; P < .01).
“If ESRD patients are treated with TAVR, realistic expectations in survival and rehospitalization should be identified prior to the procedure,” Szerlip and colleagues wrote. “Although procedural outcomes appear acceptable, a 1-year survival in only one-half of the treated patients raises concerns regarding the benefit of treatment in this patient population.”
Further research
“Although ESRD may not be an absolute contraindication to TAVR, just because we can replace the valve does not mean we should in every dialysis patient with severe [aortic stenosis],” George Bayliss, MD, associate professor of medicine at Brown University, wrote in a related editorial. “More data is needed to identify a probably small subset of ESRD patients with [aortic stenosis] who are too sick to undergo surgical repair, yet who would benefit from a TAVR. Even then, those patients and their families need to know that the procedure carries high risk and may, at best, only buy a little more time.” – by Darlene Dobkowski
Disclosures: Szerlip reports she served as a speaker for Edwards Lifesciences and Medtronic. Bayliss reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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B. Hadley Wilson, MD, FACC
The major takeaways are that TAVR has been a great procedure for those who are at high risk for surgical AVR. We all now know that even in intermediate and low risk, it’s also a very good, viable option vs. surgery.
The quest of this study was to determine in some of the highest-risk patients — those with renal disease who undergo dialysis — if TAVR would also be very helpful in reducing morbidity and mortality in this group.
The interesting findings were that although there was a reduction in some of the morbidities and mortality compared to what has been projected or seen in the past on dialysis patients that had surgical AVR, it was not as much as we would have hoped. In other words, the mortality was still high.
One has to be a little bit wiser in the selection of patients with renal failure with or without dialysis going to TAVR, and not presume that it’s going to be safe and low risk. It just means that we need a heart team approach and to incorporate the patient in the shared decision-making process, and to realize that yes, it may be less risky than surgery, but it’s still going to be a significant risk.
To be specific, we saw that the in-hospital mortality was certainly higher than those who didn’t have dialysis, and the 1-year mortality was quite significant at 37%. Studies in the past have suggested that patients on dialysis that have surgical AVR may have an even higher mortality; even as much as 50%. But still, a mortality rate of 37% is quite high. That gives us pause before we think that TAVR is going to be the answer for renal patients. It still has to be done very judiciously in this group.
The other factors were that patients on dialysis had higher rates of major bleeding, as is usual with most procedures and surgeries in that population. That’s one of the morbidities that we can expect as well. Despite TAVR being relatively less invasive than surgical AVR, there were still significant rates of bleeding and also some major vascular complications.
It just has to be put into context that it needs to be a sanguine decision made by a heart team involving the family before one uses this procedure, albeit TAVR still may be safer and less risky than surgical AVR.
Some of the specifics are that the patients that were on dialysis were younger and more commonly diabetic and hypertensive, which are comorbid conditions that might lead to higher risk. The young age didn’t protect them from these other comorbid conditions or from having higher rates of complications.
The major thing is that patients with renal disease or dialysis that undergo TAVR do have higher risk than the non-dialysis patients in terms of their bleeding and their mortality. TAVR is not an easy answer for dialysis patients either.
This study was done with the TVT registry, and more than 70,000 patients were reviewed to garner about 2,000 renal patients that were evaluated. These ACC/STS/TVT/NCDR registries are fantastic for being able to look at specific groups and see if we can find types and subtypes that might benefit from procedures.
In this case, if we looked at further research, we might try to explore if any sungroups of patients on dialysis might be safer with TAVR, especially if they don’t have any significant other comorbidities like diabetes and hypertension. We can continue to use these vast registries to search for particular subgroups that actually may benefit from TAVR even in the chronic kidney disease population.
This study is a great example of the power of these registries in being able to answer questions. As was put in the prologue, there have been studies in the past that had showed that maybe dialysis patients do better with TAVR. In fact, those studies did not provide a definitive answer because of the sample size. This study points out the power of the registries for answering questions vs. isolated smaller studies.
Perspective
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R. David Anderson, MD, MS, FACC, FSCAI
The major takeaway from the paper by Szerlip and colleagues is that among patients undergoing TAVR who have concomitant end-stage renal disease, there is clearly higher risk for 1-year mortality than perhaps was previously recognized. Given the outcomes of end-stage renal disease patients who undergo surgical AVR, this may have been an expected finding. Despite being younger on average, end-stage renal disease patients being considered for TAVR have a higher burden of comorbidities and a higher vascular complication rate. They also experience statistically higher in-hospital mortality, but a doubling of 1-year mortality.
As the custodians of this technology, surgeons and cardiologists have tried to select patients who have at least a 1-year horizon to justify the risks and costs of this therapy. This puts a wrench into that analysis among this higher-risk population and makes patient selection among end-stage renal disease patients more challenging. Selection of end-stage renal disease patients for TAVR will require even more consideration of other factors such as the presence of arrhythmias, mitral or tricuspid insufficiency, frailty and a patient’s functional status to maximize the chance of offering therapy to those patients who might most benefit from the technology.
Patients with severe aortic stenosis who are being considered for treatment with TAVR are a higher risk group of patients who even after the procedure will be at higher risk of mortality. What is needed is more research designed to help clinicians better select those patients who will benefit from a TAVR procedure compared with those who may not.
The authors should be congratulated for a very important study from a well-established national database.
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