Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk

Arnold, Suzanne V.; Reynolds, Matthew R.; Wang, Kaijun; Magnuson, Elizabeth A.; Baron, Suzanne J.; Chinnakondepalli, Khaja; Reardon, Michael J.; Tadros, Peter; Zorn, George L.; Maini, Brij; Mumtaz, Mubashir; Brown, John; Kipperman, Robert; Adams, David H.; Popma, Jeffrey J.; Cohen, David J.; Investigators, CoreValve Us Pivotal Trial

doi:10.1016/j.jcin.2015.04.018

Cited by 104 publications

(66 citation statements)

References 18 publications

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“…2,3,6,7 Nonetheless, there are several subtle differences in outcomes between the pivotal trials and the TVT registry. For example, the changes in the KCCQ-OS at 30 days and 1 year in TVT of 27 and 32 points, respectively, are ~5–10 points greater than those seen in the PARTNER A and B and CoreValve clinical trials.…”

Section: Discussionmentioning

confidence: 99%

“…Although the pivotal trials demonstrated both survival and quality of life (QOL) benefits of TAVR within select cohorts of patients and hospital centers, 1–7 it is critical to understand how this novel technology performs as it moves beyond experienced centers and operators and outside of the strict inclusion and exclusion criteria of the clinical trials. In order to understand these outcomes more fully, the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) developed the STS/ACC Transcatheter Valve Therapy (TVT) Registry.…”

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Quality-of-Life Outcomes After Transcatheter Aortic Valve Replacement in an Unselected Population

et al. 2017

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Importance In clinical trials, transcatheter aortic valve replacement (TAVR) has been shown to improve symptoms and quality of life. As this technology moves into general clinical practice, it is critical to evaluate the health status outcomes among unselected patients treated with TAVR. Design/Participants Observational study of patients with severe aortic stenosis treated with TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry. Main Outcomes Disease-specific health status was assessed at baseline and at 30 days (n=31,636) and 1 year after TAVR (n=7,014) with the Kansas City Cardiomyopathy Questionnaire-overall summary score (KCCQ-OS; range 0–100 points). We examined factors associated with health status at 1 year after TAVR using multivariable linear regression, with adjustment for baseline health status and accounting for clustering of patients within sites. Results Mean baseline KCCQ-OS was 42.3±23.7, indicating substantial health status impairment. Surviving patients had, on average, large improvements in health status at 30 days that persisted to 1 year, with a mean improvement in the KCCQ-OS of 27.6 points at 30 days and 31.9 points at 1 year. Worse baseline health status, older age, higher ejection fraction, lung disease, home oxygen, lower mean aortic valve gradient, prior stroke, diabetes, pacemaker, atrial fibrillation, slower gait speed, and non-femoral access were associated with worse health status at 1 year. Overall, 62.3% of patients had a favorable outcome at 1 year (alive with reasonable quality of life [KCCQ-OS ≥60] and no significant decline [≥10 points] from baseline) with the lowest rates seen among patients with severe lung disease (51.4%), on dialysis (47.7%), or with very poor baseline health status (49.2%). Conclusion In a national, contemporary clinical practice cohort of unselected patients, we found that improvement in health status following TAVR was similar to that seen in the pivotal clinical trials. While the health status results were favorable for the majority of patients, ~1 in 3 patients still had a poor outcome 1 year after TAVR. Continued efforts are needed to improve patient selection and procedural/post-procedural care in order to maximize health status outcomes of this evolving therapy.

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Quality-of-Life Outcomes After Transcatheter Aortic Valve Replacement in an Unselected Population

et al. 2017

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“…Nonetheless, some patients do not improve functionally or live long following TAVR, with approximately 1 in 4 patients treated with TAVR dying within 1 year (4). Moreover, despite substantial improvement in QOL for many patients, a sizeable minority continues to experience significant heart failure symptoms, with associated functional limitation and poor QOL (5–9). …”

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Prediction of Poor Outcome After Transcatheter Aortic Valve Replacement

Arnold

Afilalo

Spertus

et al. 2016

Journal of the American College of Cardiology

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BACKGROUND A series of models have been developed to identify patients at high risk for poor outcomes after transcatheter aortic valve replacement (TAVR) to help guide treatment choices, offer patients realistic expectations of long-term outcomes, and support decision making. OBJECTIVES We examined the performance of the previously developed TAVR Poor Outcome risk models in an external dataset and explored the incremental contribution of geriatric domains to model performance. METHODS Poor outcome after TAVR was defined as death, poor quality of life (QOL), or decline in QOL, as assessed using the Kansas City Cardiomyopathy Questionnaire. We tested 4 TAVR Poor Outcome risk models: 6-month and 1-year full and clinical (reduced) models. We examined each model’s discrimination and calibration in the CoreValve trial dataset, then tested the incremental contribution of frailty and disability markers to the model’s discrimination using the incremental discrimination index (IDI). RESULTS Among 2,830 patients who underwent TAVR in the CoreValve US Pivotal Extreme and High Risk trials and associated continued access registries, 31.2% experienced a poor outcome at 6 months following TAVR (death: 17.6%; very poor QOL: 11.6%; QOL decline: 2.0%) and 50.8% experienced a poor outcome at 1 year (death: 30.2%; poor QOL: 19.6%; QOL: decline 1.0%). The models demonstrated similar discrimination as in the Placement of Aortic Transcatheter Valves Trial cohorts (c-indexes: 0.637 to 0.665) and excellent calibration. Adding frailty as a syndrome increased the c-indexes by 0.000 to 0.004 (IDI p < 0.01 for all except the 1-year clinical model), with the most important individual components being disability and unintentional weight loss. CONCLUSIONS Although discrimination of the TAVR Poor Outcome risk models was generally moderate, calibration was excellent among patients with different risk profiles and treated with a different TAVR device. These findings demonstrated the value of these models for individualizing outcome predictions in high-risk patients undergoing TAVR.

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“…[1][2][3][4][5] In fact, recent analyses from 2 separate randomized controlled trials have reported that healthrelated quality of life improves earlier and faster among highrisk patients assigned to transfemoral TAVR, as compared with surgical aortic valve replacement. 6,7 Nevertheless, it is becoming increasingly clear that not all patients assigned to TAVR benefit from the procedure. For example, in the CoreValve US Pivotal trial, extreme risk cohort (mean Society of Thoracic Surgeons [STS] score 10.4±5.6%), 39% of patients were deemed to have had a poor outcome after TAVR (22% death, 16% poor quality of life, and 1.4% quality of life decline).…”

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“…Therefore, health-related quality of life may serve as a useful surrogate marker for the combined effect of a patient's age, AS severity, comorbidities, and frailty parameters. Although there have been several studies quantifying improvements in health-related quality of life as compared with baseline following TAVR, [4][5][6][7][8] it remains unclear whether the status of baseline health-related quality of life per se may serve as a useful parameter for further risk stratification of patients before the procedure.…”

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Can We Predict Quality of Life and Survival After Transcatheter Aortic Valve Replacement?

O’Sullivan

Wenaweser

2015

Circ: Cardiovascular Interventions

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Included patients were stratified into KCCQ overall summary score quartiles depending on whether the reported health status was deemed very poor (28%), poor (38%), fair (24%), or good (10%). The key finding was that as compared with patients with good baseline health status, those with the poorest baseline health status had the worst in-hospital (prolonged hospital stay, increased requirement for dialysis, higher inhospital mortality rates, lower likelihood to be discharged home) and 1-year (2-fold increased hazard of death) clinical outcomes, even after adjustment for relevant baseline clinical and demographic characteristics. 17 Reassuringly, 70% of patients in the lowest KCCQ overall summary score quartile were still alive at 1 year, suggesting that very poor baseline health status per se should not be considered a contraindication for TAVR. Nevertheless, this figure was probably an overestimation because excluded patients were sicker and had significantly worse 1-year clinical outcomes as compared with the included patient population. Furthermore, no data were provided on quality of life improvement after TAVR, which is a major limitation because it is unclear from the present study what proportion of patients with very poor health status at baseline had a clinically meaningful improvement in quality of life after TAVR.In conclusion, the study by Arnold et al confirms in a large population of real-world patients that quantifying baseline health status using the KCCQ questionnaire serves as a useful parameter to help further risk-stratify patients being considered for TAVR. After almost 14 years of TAVR in clinical use, the discussion of utility versus futility remains an ongoing issue. It appears obvious that a patient with multiple comorbidities and a high frailty score would ultimately have a poor functional status. Needless to say, advanced age and female sex may contribute substantially to this. To attempt an anatomically difficult TAVR intervention in this setting is most probably futile; on the other hand, a patient with no frailty and good functional status will overcome a procedural complication much faster and will most likely profit from the minimal-invasive approach. Risk assessment should include comorbidities, frailty status, and the age and sex of the patient. A straightforward, standard TAVR procedure may be indicated and utile in patients with poor functional status at baseline and good anatomic features. Conversely, anatomically complex interventions represent too high a risk in this setting and should be avoided. On the contrary, more intermediate risk patients will likely profit from TAVR in the future because of refined technological features and growing experience of the operators. A high level of clinical experience and detailed analysis of the anatomic factors of the aortic valvular complex will remain crucial. DisclosuresDr Wenaweser has received proctoring and lecture fees from Medtronic and Edwards Lifesciences, Boston Scientific. The other author reports no conflicts. References

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Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk

Cited by 104 publications

References 18 publications

Quality-of-Life Outcomes After Transcatheter Aortic Valve Replacement in an Unselected Population

Quality-of-Life Outcomes After Transcatheter Aortic Valve Replacement in an Unselected Population

Prediction of Poor Outcome After Transcatheter Aortic Valve Replacement

Can We Predict Quality of Life and Survival After Transcatheter Aortic Valve Replacement?

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