American dialysis outcomes are the worst within the High Income Countries (HIC) as shown with international studies by the Dialysis Outcomes and Practice Patterns Study (DOPPS). The findings show that it is the practice of dialysis in America with short (2.5-3.5 hours/session in the 1980's), Rapid Ultrafiltration and reliance mainly on in-center treatment has brought America to this embarrassing low point in medical practice that has not significantly improved in the last 40 years. Other countries in the 1990's published opinion/editorials in medical journals begging their practitioners to not kill their patients like America. (here).
America started their dialysis legacy under the altruistic care of Belding Scribner and Willem Kolff who performed the first successful Hemodialysis session in 1943 in Nazi occupied Holland. The machine was made from parts scavenged from a washing machine and a sowing machine motor. The patient woke up from a uremic coma, but succumbed when Kolff ran out of usable vascular access sites. Instead of selling the rights to this miracle machine, Kolff freely gave it to the world. Kolff is known for many things, but one of his quotes sums up his whole mission in medicine: "The exciting thing is to see somebody who is doomed to die, live and be happy."
Although Kolff came to America and collaborated with other dialysis researchers such as John Merrill at Peter Bent Brigham Hospital helping to develop the Brigham/Kolff dialysis machine, no one over the next 17 years was able to manage a patient on hemodialysis for more than a few months due to lack of chronic vascular access. It was not until Belding Scribner, MD, motivated by the death of a patient from Spokane, WA came up with a solution when he woke from sleep that changed the trajectory of this miracle of modern medicine.
Belding Scribner, BMJ. 2003 Jul 19; 327(7407): 167
Scribner came upon his idea in 1960 after he saw a young man recover briefly following dialysis, only to die a few weeks later. At the time, haemodialysis could only be performed for a few cycles. In a painful procedure, glass tubes were inserted into a patient's blood vessels, permanently destroying them for further access.
The patient weighed on Scribner's mind until one night when he suddenly awoke with an idea of how to save patients with end stage kidney disease. He would fashion a loop between an artery and vein, allowing the device—rather than the patient's own vessels—to be opened and closed with each cycle of dialysis.
He enlisted instrument designer Wayne Quinton to work on his idea. They fashioned the U shaped device made of Teflon that would become known as the “Scribner shunt.” Teflon proved to have a special advantage over glass: its non-stick surface did not trigger blood clotting.
Both Kolff and Scribner shared the same altruistic motivation to simply save lives as Scribner likewise gave his lifesaving invention away freely and thus the era of chronic hemodialysis saving patients otherwise doomed to a painful and difficult death by uremia. This era continued unabated with improving, life sparing treatments until, the advent of 1972 when the ESRD program was sponsored by CMS. This gave patients with ESRD in the US under 65 access to Medicare benefits. Even though Belding Scribner lobbied congress and other officials throughout the 1960's for Federal funding, no one could imagine that this needed program designed to save lives would lead to the destruction of the legacy Scribner and Kolff had left for the world to follow and emulate.
The irony of the 1972 ESRD program is that the quality of dialysis began to fail in America when the program started. Belding Scribner came to this conclusion in his historical account of dialysis in America written in 1999:
Dialysis Therapy in the United States: A Historical Perspective
In my view, the quality of hemodialysis care in the United States began to deteriorate when renal patients became eligible for Medicare coverage in 1972. The questions I pose herein are twofold: What went wrong with the quality of hemodialysis in the United States, and can that quality be improved?
There are two basic ways that hemodialysis affects the health and longevity of the patient with end-stage renal disease. The first is by the removal of uremic toxins; the second is by using the powerful tool, ultrafiltration, to normalize blood pressure (BP).
The history of toxin removal
During the 1960's and early 1970s, prescribing the correct dose of dialysis was pure guesswork. Criteria for adequate dialysis were based on clinical grounds: eradication of uremic manifestations and adequate rehabilitation {2,3}. Any uremic manifestation, including elevated blood pressure was considered inadequate dialysis in the early 1970's {4}.
How had this modern medical miracle, freely given to us through Kolff and Scribner end in death, misery and morbid conditions in US dialysis centers across this nation? The answer became abundantly clear to investigative journalists in the decades to follow at such institutions as the New York Times :
Death and Deficiency in Kidney Treatment
Dec. 4, 1995
Over the last decade, National Medical Care, a division of W. R. Grace & Company, has been accused in legal proceedings and by patients, medical experts and some Government investigators of a variety of shortcomings. These are among the actions by the company, critics say, that have led to deficiencies in care:
*Shifting the duties of doctors and registered nurses to lesser-trained and poorly supervised technicians and medical staff.
*Allowing the use of outdated, poorly maintained equipment.
*Manufacturing equipment that has not met Federal standards.
*Keeping patients on dialysis for too little time.
*Re-using disposable equipment that manufacturers -- including, for many years, a division of National Medical itself -- recommended be used only once.
*Diverting Federal money that could be spent on patient care to enrich its doctors for little work and to finance other businesses.
Christopher Blagg, MD, commented on an early post on HemoDoc about what happened to the excellent dialysis outcomes prior to the ESRD program and where it went wrong:
Thanks Peter.It was a different world in the 1960s. In 1962 the Seattle Artifical Kidney Center was developed as the world's first out-of-hospital dialysis unit because the University of Washington Hospital would not allow Dr. Scribner further expansion for the dialysis program beyond the first 4 patients. Scrib and the King County Medical Society never thought of making their new center anything other than a community supported non-profit operation.
In similar circumstances a few years later the Brigham group developed an out-of-hospital unit that became for-profit and led to National Medical Care. When the Medicare progam began the potential profit margin was large and so dialysis flourished and led to what we see in the US today. As Dr. Scribner commented to a Congressional hearing and on 60 minutes, what began as a noble experiment degenerated into a a multi-million dollar money-making enterprise. Opposition by NMC to home hemodialysis - it was unsafe and the cost savings were exagerated - was one of the main reasons home hemodialysis withered throughout the 70s and 80s.
Posted by: Christopher Blagg | Tuesday, December 28, 2010 at 06:18 AM
Instead of health and restoration Scribner and Kolff brought forth from a 100% fatal disease prior to 1960, hemodialysis in America became a source of death, misery and pain as patients were dialyzed for as little as 2.5 hours thrice weekly. Belding Scribner with his first patient established 8 hours thrice weekly as what was needed to restore a patient and relieve their uremic symptoms and hypertension. Subsequent studies decades later by Sunny Eloot in Ghent Belgium performing exquisite solute studies showed why long, slow and frequent dialysis is the only physiologic approach that cleanse the body of uremic toxins in ESRD.
Impact of increasing haemodialysis frequency versus haemodialysis duration on removal of urea and guanidino compounds: a kinetic analysis
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https://doi.org/10.1093/ndt/gfp059
Background. Patients with renal failure retain a large variety of uraemic solutes, characterized by different kinetic behaviour. It is not entirely clear what the impact is of increasing dialysis frequency and/or duration on removal efficiency, nor whether this impact is the same for all types of solutes.
Methods. This study was based on two-compartmental kinetic data obtained in stable haemodialysis patients ( n = 7) for urea, creatinine (CREA), guanidinosuccinic acid (GSA) and methylguanidine (MG). For each individual patient, mathematical simulations were performed for different dialysis schedules, varying in frequency, duration and intensity. For each dialysis schedule, plasmatic and extraplasmatic weekly time-averaged concentrations (TAC) were calculated, as well as their %difference to weekly TAC of the reference dialysis schedule (three times weekly 4 h).
Results. Increasing dialysis duration was most beneficial for CREA and MG, which are distributed in a larger volume (54.0 ± 5.9 L and 102.6 ± 33.9 L) than urea (42.7 ± 6.0 L) [plasmatic weekly TAC decrease of 31.5 ± 3.2% and 31.8 ± 3.8% for CREA and MG with Q B of 200 mL/min, compared to 25.7 ± 3.2% for urea ( P = 0.001 and P < 0.001)]. Increasing dialysis frequency resulted only in a limited increase in efficiency, most pronounced for solutes distributed in a small volume like GSA (30.6 ± 4.2 L). Increasing both duration and frequency results in weekly TAC decreases of >65% for all solutes. Comparable results were found in the extraplasmatic compartment.
Conclusion. Prolonged dialysis significantly reduces solute concentration levels, especially for those solutes that are distributed in a larger volume. Increasing both dialysis frequency and duration is the superior dialysis schedule.
Instead, even today, America dialysis patients are dialyzed for the shortest period of any HIC nation with rapid removal of fluids that leads to cramping or vomiting and passing out during almost every session for many patients. This leads to further serious health consequences giving American dialysis patients the shortest expected lifetimes and survival. Home Hemodialysis has never regained its place in America as it was in the early 1970's at 40% of the renal dialysis population.
The story of how America destroyed the legacy of Scriber's and Kolff's falls at the feet, mainly in my opinion, of National Medical Care Inc (NMC) and three individuals: Constance Hampers, MD, Eugene Shupack, MD and Edmond G. Lowrie. All three were involved with NMC as either founders or leaders of this for-profit dialysis corporation. However, there is a more fundamental connection between all of them: they all trained at Peter Bent Brigham Hospital Nephrology. Thus began a long chain of undue influence, in my opinion, from Peter Bent Brigham Hospital that remains today and stands, in my opinion, in opposition to optimal dialysis that Scribner defined as that which relieves all uremic symptoms and hypertension. Todays, American style, short, fast and violent dialysis sessions are noted for patients who become disabled and often hypertensive with excessive fluid gains between sessions. The saga of what, in my opinion, is the undue influence of the Peter Bent Brigham Nephrology program as seen in a simple chart of their program leaders and graduates who are some of the leading researchers in dialysis today as well as leaders of the for profit dialysis industry that perpetuates America's failed dialysis practices.
https://www.brighamandwomens.org/assets/BWH/medicine/pdfs/lazarus-early-dialysis-part3.pdf
It is my opinion that the works of Gus Hampers and Edmund G. Lowrie are continued in their students legacy of pervasive studies that ask the wrong clinical questions and perpetuate short, fast and violent dialysis sessions. In my next post in this series, I will review how this one nephrology program has dominated the entire American dialysis practice patterns and the academic dialysis studies over the last 50 years through for profit medicine and academic studies protecting their for-profit practice patterns.