CRRT Business Switching Hands

Baxter to acquire Edward's CRRT business:

"Baxter International Inc announced a definitive agreement with Edwards Lifesciences Corporation under which Baxter will acquire certain assets related to Edwards’ hemofiltration product line, also known as Continuous Renal Replacement Therapy (CRRT). The transaction is expected to close in the third quarter of 2009, pending regulatory approvals.

Under the terms of the agreement, Baxter will provide Edwards an initial cash payment of approximately $56 million upon the close of the transaction. Additionally, Baxter will receive transition services from Edwards and is expected to pay Edwards up to an additional $9 million based on revenue objectives expected to be achieved over the next two years. The impact of this transaction is immaterial to Baxter’s financial results for 2009."

This makes sense, it fits in with Baxter's renal products, CRRT is a small market and the hardware and disposables are probably barely profitable especially with the low volumes Edwards was doing. Edwards never really gave it much attention. Presumably Baxter's solution operation is more profitable and soon they will work exclusively on what were previously Edward's Aquarius and other CRRT machines (Aquarius shown, image from the Aquarius Website).

Uremic Frost: "Fresenius and Prisma...it's your move."

Bedtime reading

The abstracts from the 2005 10th International Conference on Continuous Renal Replacement Therapies (CRRT), hosted by Dr. Mehta, are available online here.

Renal replacement therapy in the intensive care unit

Indian Journal of Critical Care Medicine has a great review article titled Renal replacement therapy in the intensive care unit by Jose Chacko. The article covers all the big hitters: IHD, CVVHD, CVVH, SCUF, and SLEDD. The most interesting part to me:

Continuous Vs Intermittent therapies - what's the evidence?

The physiological superiority of CRRT over conventional IHD is unquestioned. Does this result in improved clinical outcomes? Many trials that compare these modalities involve patients with different severity of illness at baseline; crossover from one arm to the other was also allowed in many studies, making it difficult to interpret the results. Besides, the majority of trials do not include patients with significant haemodynamic instability - precisely the subgroup of patients who are likely to have a survival advantage with continuous therapies. Kellum et al did a meta-analysis of 13 clinical trials involving 1400 patients. Out of this, only 3 were randomised. On unadjusted analysis, there was no difference survival between CRRT and IHD. However, when adjusted for study quality or baseline severity of illness, or both, CRRT was associated with improved survival. Under no conditions, either of inclusion criteria or adjustment method did CRRT fare worse. Mehta et al, in their study, randomised 166 patients to receive either IHD or CRRT. CRRT was associated with increased ICU and hospital mortality. However, patients in the CRRT group had a higher baseline severity of illness by APACHE II and III scores, more hepatic failure and more organ failures. There was strong bias in favour of IHD by all these counts, thus obviating meaningful analysis. In a more recent trial, Vinsonneau et al, for the haemodiafe group compared alternate day IHD with CRRT and reported no survival benefit at 60 days. However, the trial did not standardise the time of initiation of therapy or the dose of delivered dialysis. The actual CRRT dose delivered was only 25 ml/kg/hr, significantly less than the optimal 35 ml/kg/hr that has been associated with improved outcomes.

Chacko J. Renal replacement therapy in the intensive care unit. Indian J Crit Care Med 2008;12:174-80

Lins, et. al, Nephrology Dialysis Transplantation 2009 Study

Lins, et al, has a new study titled: Intermittent versus continuous renal replacement therapy for acute kidney injury patients admitted to the intensive care unit: results of a randomized clinical trial in Nephrology Dialysis Transplant.

The Nephrosphere criticizes it:

This study by Lins, et al. published in Nephrology Dialysis Transplanation addresses the age old question of whether continuous renal replacement therapy (CRRT) is superior to hemodialysis (HD) in acute kidney injury. The authors stratified by severity of illness and conclude that there’s no difference between the groups. In my mind, however, the fatal flaw is the people who were left out of the study. Out of the 650 subjects eligible and in need of RRT, over half (n=344) were excluded, 37% of them for clinical reasons (including coagulation distubrances and hemodynamic instability). In other words, the most unstable patietns, the ones most likely to benefit from CRRT, were excluded from the study! It’s hard to conclude much from this other than CRRT probably isn’t advantageous in more stable patients.

That comment gets right to the heart of the matter, CRRT is for the most unstable patients, ones where the regular hemodialysis is judged to be too much of a strain on the system. As noted above, a number of subjects were excluded for hemodynamic instability, but then the study says: "The main reason for conversion from IRRT to CRRT was haemodynamic instability" (and the other way for coagulation disturbances).

I highlight this point: "An overall mortality of 60.1% was observed." just so people with family members on CRRT in this condition are aware of the most likely outcome.

Looking closer at the outcomes, even though it didn't reach the 10% difference (or patient sample size for that matter) CRRT does coming out slightly "ahead": "Intention-to-treat analysis revealed a mortality of 62.5% in patients treated with IRRT compared to 58.1% in patients treated with CCRT (P = 0.430)." Along with this informative graphic:This is why we keep doing these studies, however, none of them can quite get to the definitive proof needed to claim that CRRT is better in certain patients. Lins, et al. does get closer than other recent attempts, and provides insight into the next steps he feels should be taken. There is certainly opportunity here for a researcher who finds the correct patient group to make a bit of a name for themselves.

The full study is currently available for free at the link.