Older patients’ knowledge improved by multidisciplinary care

Chronic kidney disease (CKD) patients who are older or more vulnerable can achieve similar outcomes with their treatment, particularly on understanding of it and their condition, compared to those with less advanced disease through a combined “teambased approach” including “physicians, advanced practitioners, social workers, pharmacists and dietitians”. That is one conclusion of a recentlypublished study in Kidney Medicine

THOUGH MULTIDISCIPLINARY APPROACHES to CKD may require “more resources and potentially increase costs”, says first author Surekha Annadanam (University of Michigan, Ann Arbor, USA) and colleagues, previous studies have suggested that they may have a beneficial effect on patient outcomes. For their study, Annadanam et al focused on patient-centred outcomes, which they define as “outcomes that are individualised to the patient and their experiences”. They point to reports such as the one led by Hannah Tiu (Henderson Hospital, Henderson, USA) in Clinical Nephrology that suggest trial, fistulas that had not been used for dialysis were included. It seems unlikely that these factors accounted for the differing results of the trials. Another possible explanation is that the two negative trials used the Lutonix balloon, whereas the Lookstein study used the IN.PACT AV balloon, which delivers a higher dose of paclitaxel. In summary, despite extensive study, experts in the field are uncertain about the benefit of paclitaxel-coated balloons for AVFs.

Sirolimus is another anti-proliferative drug that may be of benefit in this setting. Several strands of evidence suggest that sirolimus may be effective in preventing the neointimal hyperplasia that causes AVF restenosis. Firstly, sirolimus is an anti-proliferative drug and has been shown to inhibit both proliferation and migration in vascular smooth muscle cells in vitro and there is also supportive evidence from preclinical models of AVFs suggesting a benefit for sirolimus. Sirolimus-coated balloons have now been developed and are therefore an alternative to paclitaxel-coated balloons.

The MagicTouch (Concept Medical) balloon has been assessed in the single arm MATILDA study. 4 Target lesion primary patency rates at three, six and 12 months were encouraging at 98, 83 and 58%. Selution (MedAlliance) is another sirolimus-coated balloon that has been reported in the ISABELLA study5, which was also uncontrolled. Patency rates of 95, 72 and 44% were found. Although these results are promising, proper assessment requires an RCT. The MagicTouch balloon is being assessed in the IMPRESSION industry-sponsored trial of 170 patients at three sites in Singapore.6

The investigator-led Paclitaxel or sirolimus coated balloons for ArterioVEnous fistulas (PAVE-2) trial has been funded by NIHR. This will be a three-armed trial including over 600 patients from around the UK. Both the IN.PACT AV and MagicTouch balloons will be compared to a control group, with a primary endpoint of time to end of treatment segment primary patency. Inclusion criteria will allow either one or two treatment segments, in contrast to PAVE where only one was allowed. The trial is currently in set-up, and we hope it will significantly advance our understanding of the efficacy of both paclitaxel and sirolimus coated balloons for AVFs.

Narayan Karunanithy is an honorary senior lecturer at the School of Biomedical Engineering and Imaging Sciences, King’s College London (London, UK).

Michael Robson is a reader in Nephrology in the Faculty of Life Sciences and Medicine, King’s College London.

Disclosures: Robson was the chief investigator for the PAVE trial. Karunanithy consults for BD, Medtronic, Boston Scientific and Penumbra.

References:

1. Trerotola, SO, Lawson J, Roy-Chaudhury P, Saad TF, Trial LAC. Drug Coated Balloon Angioplasty in Failing AV Fistulas: A Randomized Controlled Trial. Clin J Am Soc Nephro 2018;13(8):1215-24

2. Lookstein, RA, Haruguchi H, Ouriel K, Weinberg I, Lei L, Cihlar S et al. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J Med 2020;383(8):733-42

3. Karunanithy, N, Robinson EJ, Ahmad F, Burton JO, Calder F, Coles S et al. A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit during angioplasty of arteriovenous fistulas. Kidney Int 2021;

4. Tang, TY, Soon SXY, Yap CJQ, Chan SL, Choke ETC, Chong TT. Utility of Sirolimus Coated Balloons for Salvaging Dysfunctional Arteriovenous Fistulae: One Year Results From the MATILDA trial. Eur J Vasc Endovasc 2021;62(2):316-17

5. Tang, TY, Yap CJ, Soon SX, Tan RY, Pang SC, Patel A et al. Utility of the selution SLR sirolimus eluting balloon to rescue failing arterio-venous fistulas12 month results of the ISABELLA Registry from Singapore. Cvir Endovasc 2022;5(1):8

6. Pang, SC, Tan RY, Choke E, Ho J, Tay KH, Gogna A et al. SlroliMus coated angioplasty versus plain balloon angioplasty in the tREatment of dialySis access dysfunctION (IMPRESSION): study protocol for a randomized controlled trial. Trials 2021;22(1) patients with kidney disease do not usually understand their treatment, nor do they get the best possible communication to help them understand it. Both studies were led overall by Julie Wright Nunes (University of Michigan Department of Internal Medicine, Ann Arbor, USA) and her research team and funded through the US National Institutes of Health (NIH)-affiliated National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

The authors designed a study with several patient-centred outcomes, including “CKD-specific knowledge, kidney disease-related stress, overall health, and health status compared to one year ago”. Knowledge, measured through the kidney disease knowledge survey (KiKS), was the primary outcome.

In total, the study enrolled 245 patients with a mean age of 60 years. Of these, 168 (69%) received general nephrology care while 77 (31%) received multidisciplinary care. “Given the nature of the multidisciplinary care clinic,” the authors state, those in the latter group were on average older (64 years vs. 58 in the nephrology care group) and had more advanced CKD (66% with stage 4–5 vs. 36%).

The overall mean score for knowledge measured with KiKS was not significantly different between the multidisciplinary group and the general care group (66.7% and 67.0% respectively [p=0.89]). However, a greater percentage of those in the former group could correctly identify their own CKD stage versus those in the latter (48% vs. 34%).

The study authors note that patients seen in the multidisciplinary clinics specifically saw older patients with more advanced CKD. They argue that, given there is “a trend for older age […] to be associated with lower knowledge” (-0.1 confidence interval [CI], p=0.06), it is notable that this is levelled out after patients received multidisciplinary care—suggesting it helps older patients to match their younger counterparts in knowledge of their disease. The study also found levels of disease-specific stress varied not only across level of progression but also along lines of race, with African American patients found to have a higher level of stress (0.4 CI, p<0.01) compared to white patients.

Though multidisciplinary care was not found in this study to make significant improvements to stress level or knowledge generally, it can achieve outcomes on these metrics for more vulnerable patients that are comparable to those with less advanced CKD. “Focused, repetitive education”, they state, “may result in sustainable differences in specific areas of knowledge related to individual patients.”