Room For Improvement in Quality of Life After TAVR
While most patients who undergo transcatheter aortic valve replacement (TAVR) experience favorable results, approximately one in three patients have poor outcomes one year after the procedure, demonstrating a need to improve patient selection and care, according to a study published April 1 in JAMA: Cardiology.
Using data from the STS/ACC TVT Registry, Suzanne V. Arnold, MD, MHA, and colleagues observed patients with severe aortic stenosis who underwent TAVR. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), which includes a summary score from zero to 100 points, with higher scores indicating less symptom burden and better quality of life (QOL). The KCCQ assesses four domains related to valvular heart disease: physical limitation, symptom frequency, QOL and social limitation. Disease-specific health status was assessed in 45,564 patients at baseline, 31,636 surviving patients at 30-days and 7,014 surviving patients at one year.
The mean baseline KCCQ score in the 30-day cohort was 42.3 and the QOL domain was the most impaired at a mean score of 33.2. This rating indicates that patients reported their valve disease severely limited QOL and that they would be dissatisfied if they continued to feel this way. The social limitation domain was also severely impaired at a mean score of 39.8. The physical limitation domain showed slightly less impairment with a mean score of 43.2 and the symptom frequency domain was the least impaired with a mean score of 51.8.
The 30-day follow-up KCCQ score improved to a mean of 69.9 points. On average, each domain increased more than 20 points during the first 30 days after TAVR, indicating large improvements, with the largest improvement observed in the QOL domain. The physical limitation domain was least affected by TAVR.
One year after TAVR, surviving patients demonstrated substantial improvements in health status with a mean KCCQ score of 75.9. The researchers integrated survival and QOL to determine that 62.3 percent of patients had favorable outcomes at one year. A poor outcome was attributable to death in 19.4 percent of patients, persistently poor QOL in 17.4 percent and a decline in QOL in 4.9 percent.
Older age, no prior coronary artery bypass graft, chronic lung disease, low mean aortic gradient and worse baseline health status were each associated with worse health status after TAVR and lower rates of favorable outcome. The lowest rates of favorable outcomes were among patients with severe lung disease, those who required dialysis and those with very poor baseline health status.
“We found that most patients had substantial impairment in health status before TAVR and demonstrated considerable improvement after the procedure,” the authors write. They add these findings are encouraging and demonstrate that results that have been observed in previous clinical trials can be extended to the commercial TAVR population.
They conclude that while these findings show positive outcomes for many patients, one in three still had poor outcomes one year after TAVR, half of which were attributable to death and poor QOL. Continued efforts to improve patient selection as well as procedural and postprocedural care are needed to maximize health status recovery and improve outcomes in these patients.
In an accompanying editorial, Karen P. Alexander, MD, FACC, writes, “Hindsight is 20/20, but higher rates for symptomatic improvement with TAVR seem attainable. The ability to anticipate symptom and quality of life outcomes from TAVR with more informed selection is central to achieving goals of care. This process will necessitate commitment to routine assessment of patient-reported outcomes as a starting point, understanding that competing risks are in play for symptoms as well as survival, and embracing palliation when treatment is unlikely to achieve goals of care. Restating the obvious, TAVR only treats symptoms due to aortic stenosis.”
Additionally, in an editor’s note published with the paper, Robert O. Bonow, MD, MS, MACC, and Patrick T. O’Gara, MD, MACC, write that the study is a “welcome analysis” of the quality of life data within the STS/ACC TVT Registry, but they are cautious due to the amount of missing data. “The editors believe these data are insightful, but we urge the TVT Registry to intensify its efforts for more comprehensive quality of life outcome data collection so that the cardiology community has a fuller comprehension of the benefits of this expensive and resource-intensive technology,” they write.
Arnold SV, Spertus JA, Vemulapalli S, et al. JAMA Cardiol 2017;2:409-16.
After Endovascular or Surgical Therapy For CLI
Approximately one in five patients hospitalized for critical limb ischemia (CLI) and undergoing revascularization is readmitted within 30 days, according to a study published May 2 in Circulation. Further, risk of readmission is influenced by CLI presentation, patient demographics, comorbidities and in-hospital complications, but not by the mode of revascularization.
Dhaval Kolte, MD, PHD, et al., reviewed hospitalizations for a primary diagnosis of CLI during which patients underwent endovascular or surgical therapy (revascularization and/or amputation) and were discharged alive and were within the 2013-2014 Nationwide Readmissions Databases. Incidence, reasons and costs of 30-day unplanned readmissions were determined. Hierarchical logistic regression models were used to identify independent predictors of 30-day readmissions.
Results showed that there were 60,998 index CLI hospitalizations (mean age, 68.9 years; 40.8 percent women; 24.6 percent for rest pain, 37.2 percent for ulcer and 38.2 percent for gangrene).
Thirty-day readmission rate was 20.4 percent. Presentation with ulcer or gangrene, age ≥65 years, female sex, large hospital size, teaching hospital status, known coronary artery disease, heart failure, diabetes, chronic kidney disease, anemia, coagulopathy, obesity, major bleeding, acute myocardial infarction, vascular complications and sepsis were identified as independent predictors of 30-day readmission.
The mode of revascularization was not independently associated with readmissions. Infections (23.5 percent), persistent or recurrent manifestations of peripheral arterial disease (PAD) (22.2 percent), cardiac conditions (11.4 percent), procedural complications (11.0 percent) and endocrine issues (5.7 percent) were the most common reasons for readmission. The inflation-adjusted aggregate costs of 30-day readmissions for CLI were $624 million.
In a Journal Scan article on ACC.org, Melvyn Rubenfire, MD, FACC, explains that “CLI was defined as chronic (≥2 weeks) ischemic rest pain, nonhealing wound/ulcers or gangrene in one or both legs attributable to objectively proven occlusive PAD. The cost of all-cause 30-day re-hospitalization following treatment for CLI was over $10,000 per patient. The authors suggested that implementation of multidisciplinary CLI teams and wound teams, remote monitoring of wound healing and limb perfusion and measures aimed at reducing procedural complications, and infections may represent potential strategies to decrease readmissions and lower health care costs.”
Kolte D, Kennedy KF, Shishehbor MH, et al. Circulation 2017;May 2:[Epub ahead of print].
Late Thrombotic Events After Bioresorbable Scaffold Implantation
PCI patients treated with a bioresorbable vascular scaffold (BVS) may have a significantly higher risk of definite/probable device thrombosis than those treated with an everolimus-eluting stent (EES), according to a study published April 18 in the European Heart Journal. Further, there is a higher risk of ischemia-driven target lesion failure associated with BVS compared with EES and a trend toward a higher risk of target vessel myocardial infarction and target lesion failure in those treated with BVS.
Carlos Collet, MD, et al., conducted a systematic review and meta-analysis that included randomized trials that compared the clinical outcomes (safety and efficacy) of BVS with EES. Patients treated with either BVS or EES had at least a 24-month follow-up. A total of five randomized trials that evaluated a total of 1,730 patients was included.
The primary safety endpoint of definite/probable device thrombosis was significantly higher in the BVS-treated than the EES-treated patients (2.4 percent vs. 0.9 percent; p = 0.01). There was also a higher rate of very late device thrombosis in those treated with BVS (1.4 percent vs. 0.5 percent with EES; odds ratio [OR], 3.04; p = 0.03). Patients who received BVS were also at a higher risk of definite/probable device thrombosis compared with those receiving EES (OR 2.93; p = 0.01).
The primary efficacy endpoint was the risk of target lesion failure, defined as cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization. This occurred in 9.3 percent of patients in the BVS group compared with 6.6 percent in the EES group. There was also a trend toward a higher risk of target lesion failure with BVS compared with EES (OR, 1.48, p = 0.09), primarily driven by a higher risk of target vessel myocardial infarction and ischemia-driven target lesion revascularization. Of note, 92 percent of target vessel myocardial infarctions that occurred with BVS was in the absence of dual antiplatelet therapy (DAPT). However, there was no difference in the risk of cardiac death between the two groups.
In a Journal Scan article on ACC.org, Barbara S. Wiggins, PharmD, AACC, comments that “This is a meta-analysis and certainly warrants further investigation. The risk of device thrombosis that occurred in the absence of DAPT may indicate that early discontinuation may not be an option in patients with BVS. Shorter durations of treatment with DAPT in the new generation drug-eluting stents are being adopted.”
Collet C, Asano T, Miyazaki Y, et al. Eur Heart J 2017;Apr 18:[Epub ahead of print].