Visiting my in-laws in southern Florida, I came across a magazine story from the Westside Regional Medical Center with a story entitled "Dr. Robot is IN", extolling the virtues of their new $1.5 million da Vinci Robot Surgical System. It is also featured on their website.
The da Vinci system combines computer and robotic technologies and takes surgical treatment to the next level. Here's how it works.
As a surgeon prepares to perform a procedure using da Vinci, he or she sits at a console in the operating room that is often several feet away from the patient....
Because da Vinci magnifies images and its robotic arms follow the slightest movement of the surgeon's hands and feet (sometimes used to refocus the camera or adjust a robotic arm), da Vinci enhances dexterity, precision, and control during surgical procedures. da Vince can also scale down hand movements when the tiniest cuts are needed and eliminates hand tremors, which further enhances the technology;s precision.
A doctor at Westside says, "It offers excellent outcomes and a quick recovery, as well as many other advantages for today's on-the-go citizens -- all in the comfort of their community."
da Vinci is being set forth as the state-of-the-art approach to urological surgery, particularly prostatectomy (removal of the prostate.)
In a posting below, I set forth the current knowledge about the relative benefits of laparoscopic versus open prostate surgery. Suffice it to say that there is not a clear winner. Just so, too, in the case of regular laparoscopic surgery versus robot-assisted laparoscopic surgery.
So, in the absence of clinical evidence that the robot is better, what is going on here? Here's the answer, as set forth so clearly by Nancy Schlichting, President and CEO of the Henry Ford Health system in Detroit:
We've seen double-digit increases in the number of prostate cases performed since we introduced the da Vinci Surgical System.
And by the manufacturer:
The following are three examples of hospitals that have captured market share with the da Vinci Surgical System. These organizations have established a leadership position within their communities and have achieved a significant return on investment.
In short, what we have here is a new technology, with no proven advantage in terms of clinical results, that is rapidly moving forward in hospitals because urologists and their hospital administrators have become convinced that their market position depends on owning this robot. It apparently has worked as a marketing plan.
Since its first da Vinci System shipment, Intuitive Surgical has expanded its installed base to more than 300 academic and community hospital sites, while sustaining growth in excess of 25% annually.
Boston has not been immune from this land rush. Boston Medical Center recently bought this machine. The verdict from their surgeon: "Dr. Richard Babayan, chairman of urology at Boston Medical Center, said he's found no difference in continence rates in the 30 robotic cases he's done, compared with traditional surgery."
Notwithstanding the lack of evidence of enhanced clinical efficacy, I have been advised the following by one of our leading doctors:
Due to market forces beyond any of our control, the unfortunate reality is that without a DaVinci robot, BIDMC prostatectomy volume would likely plummet by 2010 and BIDMC would consequently quickly become a non-entity in regional prostate cancer care. This would have dire consequences for BIDMC clinical urology, radiology, radiation oncology, medical oncology, as well as for research in translational oncology. It is unlikely that [we can] fully gauge the breadth and depth of collateral damage that absence of a daVinci robot would bring to our medical center.
Why do I feel like the American Congress several years after President Bush promised them that Iraq had weapons of mass destruction?
Here you have it folks -- the problem facing every hospital, and especially every academic medical center. Do I spend over $1 million on a machine that has no proven incremental value for patients, so that our doctors can become adept at using it and stay up-to-date with the "state of the art", so that I can then spend more money marketing it, and so that I can protect profitable market share against similar moves by my competitors?
I welcome advice from those of you out there who care about the cost and quality of health care, but also from those of you in other business sectors who make choices like this all the time.
Showing posts sorted by relevance for query da vinci evidence. Sort by date Show all posts
Showing posts sorted by relevance for query da vinci evidence. Sort by date Show all posts
Tuesday, February 20, 2007
Monday, April 21, 2014
Look, you can watch this happen in real time!
Those of you who had any doubt at all about the points I raised in my recent post about how the daVinci robot system has extracted funds from the health care system, check out this story by Jaimy Lee and Harris Meyer on Modern Healthcare, "Surgical Robot Costs put Small Hospitals in a Bind." Excerpts:
Memorial Hospital of Converse County last year purchased a $2 million da Vinci Surgical System, the second hospital in Wyoming to do so. Memorial executives said they expect their facility to perform about 100 robotic surgeries a year. That's far below the estimated volume experts say is needed to produce a viable financial return within six years on the robotic system, whose average cost ranges from $1.5 million to $2 million.
Memorial, which reported an operating loss of $2.2 million in the first half of fiscal 2014, used cash reserves to buy the da Vinci system, manufactured by Sunnyvale, Calif.-based Intuitive Surgical. Memorial said 40% of its cost will be reimbursed by Medicare as a capital expense because it is a critical-access hospital.
Ryan Smith, the hospital's CEO, said he doesn't mind if it takes awhile for the pricey new piece of equipment to pay off because it's already attracting patients who previously would have traveled to other hospitals in Colorado or Utah to get robotic surgery. Also, it helps his hospital recruit and retain surgeons, and is expected to reduce surgical complications and lengths of stay. “We did not buy the da Vinci system to get a very high return on investment,” Smith said. “It was the right thing to do for our patients.”
While overall sales of da Vinci systems are on the decline, a number of small and rural hospitals are considering following in Memorial Hospital's footsteps, believing it will help them attract and retain surgeons and appeal to patients. The government system for financing critical-access hospitals helps underwrite some of the costs.
But small hospitals going down that path will face the same issues now confronting major systems that have installed surgical robots. Some studies have raised doubts about whether robotic surgery offers better outcomes than standard laparoscopic procedures. And Intuitive Surgical faces dozens of product liability lawsuits across the country filed by patients who claim injuries from the device.
[By the way, notice how the hospital's website above, promises: "reducing outpatient recovery times, blood loss, and pain." See my earlier post for documentation of how these claims are unsupported by the evidence.]
For critical-access hospitals, Medicare helps subsidize the purchase as a capital expenditure on a depreciated basis, calculated by what percentage of patients are Medicare beneficiaries. But “it's a big question in terms of priorities and where your scarce resources are best used,” said Brock Slabach, senior vice president of the National Rural Health Association. “Patients perceive it to be better. But is the cost worth the benefit?”
More small hospitals view the da Vinci system “as a tool they need to recruit and retain surgeons and to stay viable,” said Liz Tiernan, a consultant in the Advisory Board Co.'s research and insights groups. “It is considered a standard of care .… but it's rarely financially viable for them.”
[W]hen surgeons at a smaller hospital don't reach the estimated proficiency threshold, that raises questions about the adequacy of their experience. “It becomes even more difficult to justify this decision,” Tiernan said.
Memorial Hospital of Converse County last year purchased a $2 million da Vinci Surgical System, the second hospital in Wyoming to do so. Memorial executives said they expect their facility to perform about 100 robotic surgeries a year. That's far below the estimated volume experts say is needed to produce a viable financial return within six years on the robotic system, whose average cost ranges from $1.5 million to $2 million.
Memorial, which reported an operating loss of $2.2 million in the first half of fiscal 2014, used cash reserves to buy the da Vinci system, manufactured by Sunnyvale, Calif.-based Intuitive Surgical. Memorial said 40% of its cost will be reimbursed by Medicare as a capital expense because it is a critical-access hospital.
Ryan Smith, the hospital's CEO, said he doesn't mind if it takes awhile for the pricey new piece of equipment to pay off because it's already attracting patients who previously would have traveled to other hospitals in Colorado or Utah to get robotic surgery. Also, it helps his hospital recruit and retain surgeons, and is expected to reduce surgical complications and lengths of stay. “We did not buy the da Vinci system to get a very high return on investment,” Smith said. “It was the right thing to do for our patients.”
While overall sales of da Vinci systems are on the decline, a number of small and rural hospitals are considering following in Memorial Hospital's footsteps, believing it will help them attract and retain surgeons and appeal to patients. The government system for financing critical-access hospitals helps underwrite some of the costs.
But small hospitals going down that path will face the same issues now confronting major systems that have installed surgical robots. Some studies have raised doubts about whether robotic surgery offers better outcomes than standard laparoscopic procedures. And Intuitive Surgical faces dozens of product liability lawsuits across the country filed by patients who claim injuries from the device.
[By the way, notice how the hospital's website above, promises: "reducing outpatient recovery times, blood loss, and pain." See my earlier post for documentation of how these claims are unsupported by the evidence.]
For critical-access hospitals, Medicare helps subsidize the purchase as a capital expenditure on a depreciated basis, calculated by what percentage of patients are Medicare beneficiaries. But “it's a big question in terms of priorities and where your scarce resources are best used,” said Brock Slabach, senior vice president of the National Rural Health Association. “Patients perceive it to be better. But is the cost worth the benefit?”
More small hospitals view the da Vinci system “as a tool they need to recruit and retain surgeons and to stay viable,” said Liz Tiernan, a consultant in the Advisory Board Co.'s research and insights groups. “It is considered a standard of care .… but it's rarely financially viable for them.”
[W]hen surgeons at a smaller hospital don't reach the estimated proficiency threshold, that raises questions about the adequacy of their experience. “It becomes even more difficult to justify this decision,” Tiernan said.
Sunday, June 14, 2015
Protecting the public trust--a robotically assisted liver donation case
One common theme of the Lewis Blackman and Michael Skolnik stories is that of a surgeon who neglects to engage in a proper informed consent with a patient about the relative risks and benefits of a new surgical procedure. That both cases end in tragedy is immensely sad, but it would be a mistake to view the cases as isolated examples. Indeed, they are representative of a broader violation of the public trust. As I have noted with regard to the Blackman case:
[These are] cases in which an ambitious surgeon with a new technique or using new equipment takes on a case without providing full disclosure to the patient or family about the potential for increased risk compared to proven methods. Some hospitals are complicit in promoting such "experiments" by not requiring IRB approval (i.e., human subjects review) or approval by some peer ethics committee. They (surgeon and hospital) do this for business reasons, to offer themselves in a competitive marketplace as having "the latest and the best." The surgeon then writes an article proclaiming the success of the new procedure, but that article seldom or ever looks at the long-term consequences, and it never indicates why--in terms of risk to the patient--the new procedure went forth in the first place.
Today, I summarize another case that, to me, raises similar concerns. I offer it so that you can make your own judgment, and I welcome your comments below.
The surgery occurred several years ago. Of course, I have no access to the detailed patient records. I only have materials that are in the public domain, but they offer a story worth telling.
There is perhaps no procedure more compelling than a living related liver donation, and I count the surgeons who carry out these procedures as nothing short of heroic. USCF notes:
In living donor liver transplantation, a piece of liver is removed from a living donor and transplanted into a recipient. The procedure, performed after the diseased liver has been removed, is possible because the liver regenerates or grows. The liver's unique ability to regenerate itself — combined with technological advances — allows more people to be donors.
Regeneration happens over a short period, possibly days to weeks and certainly within eight weeks. When surgeons remove a piece of the donor's liver, the part that remains grows back quickly to its original size.
That simple description belies the complexity and risks of this procedure, not only for the recipient, but also for the donor. Back in 2010, Dr. William F. Balistreri, Medical Director, Liver Transplantation Program, Cincinnati Children's Hospital Medical Center, noted (cites omitted):
Live donor liver transplantation, specifically, performance of a major hepatectomy on a healthy individual who has no medical indication other than offering an allograft liver for the recipient, has long been viewed with caution and skepticism. Therefore, substantial efforts are expended to ensure the safety and long-term well being of the donor. The best outcomes for both donors and recipients have been maximized via technical refinements, innovative pre- and postoperative management strategies, and careful follow-up.
The estimated risk of mortality is 0.5 to 1%. Overall donor morbidity is high, estimated to be roughly 35%. This is usually related to the surgical incision and the possibility of blood clots; other reported problems include bleeding, infection, bile leaks, damage to the bile tree, or risks from anesthesia. Donors have reported chronic problems, including bile strictures, reoperations, and chronic pain.
In summary, the risk of dying from living liver donor surgery may be as high as 0.5% when donating the right lobe. If all complications are included, 1 of every 3 donors will experience a complication; most are considered minor or have no permanent sequelae. Thus, centers must carefully weigh the risks against the benefits. Likewise, potential living liver donors should balance the decision to donate with the advice of family, friends, an independent donor advocate, and the medical/surgical team. As stated by Marsh and colleagues, "no matter how carefully right lobar living donor transplantation is applied, the historical verdict on the ethics of this procedure may be harsh."
Dr. Balisteri's remarks relate to the general case. Adding the use of robotic surgery techniques increases that risk, as noted in the textbook Transplantation of the Liver, by Ronald W. Busuttil, Goran B. Klintmalm (page 734):
So, now let's go back to 2008. What more compelling story can we imagine than a brother donating a portion of his liver to his sibling? Titled "True Example of Brotherly Love," Channel 13 reported:
Finding the perfect match means accepting that the right person may never come along. But for one Rockford area family the right donor is not only a perfect match, but a testament of brotherly love. The two underwent a first in the medical world. It's called the da Vinci Robotic Surgical System and now the University of Illinois Medical Center in Chicago completed the world's first minimally invasive liver resection.
This is basically bonding two brothers in a very unique way. Gary Tongue needed a living donor. Gary tells 13 News, "One day he showed up and wanted to know about the live donor transplant thing." "He" is Charles Tongue, Gary Tongue's half-brother. Gary had liver cancer which to him was a death sentence until both families started exploring. Charles says, "You have to be pretty much a perfect match. Weight, height, everything has to be about right."
With the most important match being blood-type. Dr. Enrico Benedetti completed the procedure by taking 60% of Charles' liver to replace the diseased liver in Gary. Doctors ended up finding five tumors saying it was worse then they thought. Gary states, "It was rough for awhile. It's one heck of a surgery to go through, but I think it's all going to worth it." Both came home last week and continue to recover together. Charles states, "It's a big weight off his shoulders that you know he's got it and things are working good and I know he's going to live now."
Gary continues on by saying "You really have to love someone to do what he did. By giving me a piece of that. It saved my life is what he did."
The publicity continued on a liver failure support group site, with the following headlines:
Surgeons used the Da Vinci System to perform the first ever robotic liver transplant, done at the UIC Medical Center.
Team performs world's first robotic liver transplant
The story continues (emphasis not added):
Gary Tongue, a Rockford area man, was the first to receive this
transplantation performed by robotic surgical techniques. Charles
Tongue, his half-brother, was the donor of the liver. When Charles
realized how high his half-brother's risks were, Gary decided he could
donate a portion of his liver to him and potentially save his life.
UIC's chief of general surgery, Dr. Pier Cristoforo Giulianotti and his colleague Dr. Fabio Sbrana, used the da Vinci Robotic Surgical System to remove 60 percent of Charles Tongue's liver. Surgeons then placed Charles' liver into his half-brother, Gary. The process would have included a long incision covering the entire upper abdomen that is required to remove the right lobe of the liver. UIC's surgical team, aided by the da Vinci Robotic System, used a different approach. They completed the procedure through four small incisions. They then removed the lobe through a three-inch incision in the lower abdomen to minimize any postoperative pain that patients might experience.
According to Giulianotti, "this transplant could be a turning point event heralding a new era in living-donor liver transplantation. The possibility of offering the donor a perfect minimally-invasive operation, increasing the accuracy of the resection while minimizing operative risk and blood loss, is a major step forward."
Benedetti further explained transplantations by clarifying the risks involved. "We discuss openly the risk of the donor procedure with prospective donors and we routinely involve an ethical committee representative to ensure that the potential donor has fully understood the risks," said Benedetti. "We quote a risk of mortality of 0.2-0.5 percent, according to the current Literature data. We also quote a risk of about 30 percent of complications, including potential for bleeding, leak of bile, infection etc. Usually after resection the liver will regenerate to full size within five to seven weeks."
"Living donor liver transplantation is a life-saving option, especially for a patient with liver cancer," Benedetti said, "but it's very important that the donor understands the risks and be healthy enough to be a good candidate." He pointed out that in order to do this surgery doctors must operate on a healthy man to remove much of his liver. In the Tongues' case, Charles didn't hesitate to offer his liver to his half-brother, Gary. "I couldn't ask Charles to do this, but he insisted," said Gary.
The same story showed up on this investor website.
In 2011, the case was summarized by the surgeons and others in an article in Transplant International. Of relevance to us here, the article stated:
The possibility of using minimally invasive robotic technique for RLDH was discussed during the process of informed consent. All technical aspects and safety issues were explained, emphasizing the fact that the robotic approach had never been used before for RLDH. Subsequently, the ethics committee of the hospital evaluated the donor in accordance with the previously published standard protocol [6]. The donor agreed to proceed with the planned RLDH using robotic technique.
The "previously published standard protocol" is dated 2005. Its focus is on the general ethical standards that apply to liver transplants, well before any application of robotic surgery to this kind of procedure. And we are left with no information as to how the surgeon explained the risk of the robotic technique to the patient, or how the surgeon explained why use of the robotic technique would be superior to standard procedures.
Of particular note, the authors acknoweldge that "the length of surgery was longer than that normally required for open right donor hepatectomy," but then state that "it must be considered that the complicated venous anatomy prolonged the total operating time."
I can't evaluate the latter clause, but my understanding from experts in the field is that the 8-hour duration of this case was considerably longer than a standard open donor hepatectomy, which is usually 5 to 6 hours.
Years later, the April 2015 Annals of Surgery "Recommendations for Laparoscopic Liver Resection" (Volume 261, Number 4, at page 623) notes that the quality of evidence--which presumably includes the above article--that the outcomes of robotic liver resections "are superior or not inferior to other techniques" is "low" and that the procedure should still be considered in the stage of development that requires institutional ethical approval and detailed reporting of results and maintenance of a registry:
It is hard to go back to 2008 and imagine what was in the mind of the surgical team for this case. The issue is complicated by the intense desire of this hospital to be known as a center for robotically assisted surgery and the surgical team's long-term relationship with the company manufacturing this equipment. (Interpretations today are also complicated by their financial relationships with the company.)
[These are] cases in which an ambitious surgeon with a new technique or using new equipment takes on a case without providing full disclosure to the patient or family about the potential for increased risk compared to proven methods. Some hospitals are complicit in promoting such "experiments" by not requiring IRB approval (i.e., human subjects review) or approval by some peer ethics committee. They (surgeon and hospital) do this for business reasons, to offer themselves in a competitive marketplace as having "the latest and the best." The surgeon then writes an article proclaiming the success of the new procedure, but that article seldom or ever looks at the long-term consequences, and it never indicates why--in terms of risk to the patient--the new procedure went forth in the first place.
Today, I summarize another case that, to me, raises similar concerns. I offer it so that you can make your own judgment, and I welcome your comments below.
The surgery occurred several years ago. Of course, I have no access to the detailed patient records. I only have materials that are in the public domain, but they offer a story worth telling.
There is perhaps no procedure more compelling than a living related liver donation, and I count the surgeons who carry out these procedures as nothing short of heroic. USCF notes:
In living donor liver transplantation, a piece of liver is removed from a living donor and transplanted into a recipient. The procedure, performed after the diseased liver has been removed, is possible because the liver regenerates or grows. The liver's unique ability to regenerate itself — combined with technological advances — allows more people to be donors.
Regeneration happens over a short period, possibly days to weeks and certainly within eight weeks. When surgeons remove a piece of the donor's liver, the part that remains grows back quickly to its original size.
That simple description belies the complexity and risks of this procedure, not only for the recipient, but also for the donor. Back in 2010, Dr. William F. Balistreri, Medical Director, Liver Transplantation Program, Cincinnati Children's Hospital Medical Center, noted (cites omitted):
Live donor liver transplantation, specifically, performance of a major hepatectomy on a healthy individual who has no medical indication other than offering an allograft liver for the recipient, has long been viewed with caution and skepticism. Therefore, substantial efforts are expended to ensure the safety and long-term well being of the donor. The best outcomes for both donors and recipients have been maximized via technical refinements, innovative pre- and postoperative management strategies, and careful follow-up.
The estimated risk of mortality is 0.5 to 1%. Overall donor morbidity is high, estimated to be roughly 35%. This is usually related to the surgical incision and the possibility of blood clots; other reported problems include bleeding, infection, bile leaks, damage to the bile tree, or risks from anesthesia. Donors have reported chronic problems, including bile strictures, reoperations, and chronic pain.
In summary, the risk of dying from living liver donor surgery may be as high as 0.5% when donating the right lobe. If all complications are included, 1 of every 3 donors will experience a complication; most are considered minor or have no permanent sequelae. Thus, centers must carefully weigh the risks against the benefits. Likewise, potential living liver donors should balance the decision to donate with the advice of family, friends, an independent donor advocate, and the medical/surgical team. As stated by Marsh and colleagues, "no matter how carefully right lobar living donor transplantation is applied, the historical verdict on the ethics of this procedure may be harsh."
Dr. Balisteri's remarks relate to the general case. Adding the use of robotic surgery techniques increases that risk, as noted in the textbook Transplantation of the Liver, by Ronald W. Busuttil, Goran B. Klintmalm (page 734):
So, now let's go back to 2008. What more compelling story can we imagine than a brother donating a portion of his liver to his sibling? Titled "True Example of Brotherly Love," Channel 13 reported:
Finding the perfect match means accepting that the right person may never come along. But for one Rockford area family the right donor is not only a perfect match, but a testament of brotherly love. The two underwent a first in the medical world. It's called the da Vinci Robotic Surgical System and now the University of Illinois Medical Center in Chicago completed the world's first minimally invasive liver resection.
This is basically bonding two brothers in a very unique way. Gary Tongue needed a living donor. Gary tells 13 News, "One day he showed up and wanted to know about the live donor transplant thing." "He" is Charles Tongue, Gary Tongue's half-brother. Gary had liver cancer which to him was a death sentence until both families started exploring. Charles says, "You have to be pretty much a perfect match. Weight, height, everything has to be about right."
With the most important match being blood-type. Dr. Enrico Benedetti completed the procedure by taking 60% of Charles' liver to replace the diseased liver in Gary. Doctors ended up finding five tumors saying it was worse then they thought. Gary states, "It was rough for awhile. It's one heck of a surgery to go through, but I think it's all going to worth it." Both came home last week and continue to recover together. Charles states, "It's a big weight off his shoulders that you know he's got it and things are working good and I know he's going to live now."
Gary continues on by saying "You really have to love someone to do what he did. By giving me a piece of that. It saved my life is what he did."
The publicity continued on a liver failure support group site, with the following headlines:
Surgeons used the Da Vinci System to perform the first ever robotic liver transplant, done at the UIC Medical Center.
Team performs world's first robotic liver transplant
The story continues (emphasis not added):
Transplant surgeons performed the world's first minimally-invasive
liver resection for living-donor transplantation last week at the University of Illinois Medical Center.
UIC's chief of general surgery, Dr. Pier Cristoforo Giulianotti and his colleague Dr. Fabio Sbrana, used the da Vinci Robotic Surgical System to remove 60 percent of Charles Tongue's liver. Surgeons then placed Charles' liver into his half-brother, Gary. The process would have included a long incision covering the entire upper abdomen that is required to remove the right lobe of the liver. UIC's surgical team, aided by the da Vinci Robotic System, used a different approach. They completed the procedure through four small incisions. They then removed the lobe through a three-inch incision in the lower abdomen to minimize any postoperative pain that patients might experience.
According to Giulianotti, "this transplant could be a turning point event heralding a new era in living-donor liver transplantation. The possibility of offering the donor a perfect minimally-invasive operation, increasing the accuracy of the resection while minimizing operative risk and blood loss, is a major step forward."
Benedetti further explained transplantations by clarifying the risks involved. "We discuss openly the risk of the donor procedure with prospective donors and we routinely involve an ethical committee representative to ensure that the potential donor has fully understood the risks," said Benedetti. "We quote a risk of mortality of 0.2-0.5 percent, according to the current Literature data. We also quote a risk of about 30 percent of complications, including potential for bleeding, leak of bile, infection etc. Usually after resection the liver will regenerate to full size within five to seven weeks."
"Living donor liver transplantation is a life-saving option, especially for a patient with liver cancer," Benedetti said, "but it's very important that the donor understands the risks and be healthy enough to be a good candidate." He pointed out that in order to do this surgery doctors must operate on a healthy man to remove much of his liver. In the Tongues' case, Charles didn't hesitate to offer his liver to his half-brother, Gary. "I couldn't ask Charles to do this, but he insisted," said Gary.
The same story showed up on this investor website.
In 2011, the case was summarized by the surgeons and others in an article in Transplant International. Of relevance to us here, the article stated:
The possibility of using minimally invasive robotic technique for RLDH was discussed during the process of informed consent. All technical aspects and safety issues were explained, emphasizing the fact that the robotic approach had never been used before for RLDH. Subsequently, the ethics committee of the hospital evaluated the donor in accordance with the previously published standard protocol [6]. The donor agreed to proceed with the planned RLDH using robotic technique.
The "previously published standard protocol" is dated 2005. Its focus is on the general ethical standards that apply to liver transplants, well before any application of robotic surgery to this kind of procedure. And we are left with no information as to how the surgeon explained the risk of the robotic technique to the patient, or how the surgeon explained why use of the robotic technique would be superior to standard procedures.
Of particular note, the authors acknoweldge that "the length of surgery was longer than that normally required for open right donor hepatectomy," but then state that "it must be considered that the complicated venous anatomy prolonged the total operating time."
I can't evaluate the latter clause, but my understanding from experts in the field is that the 8-hour duration of this case was considerably longer than a standard open donor hepatectomy, which is usually 5 to 6 hours.
Years later, the April 2015 Annals of Surgery "Recommendations for Laparoscopic Liver Resection" (Volume 261, Number 4, at page 623) notes that the quality of evidence--which presumably includes the above article--that the outcomes of robotic liver resections "are superior or not inferior to other techniques" is "low" and that the procedure should still be considered in the stage of development that requires institutional ethical approval and detailed reporting of results and maintenance of a registry:
It is hard to go back to 2008 and imagine what was in the mind of the surgical team for this case. The issue is complicated by the intense desire of this hospital to be known as a center for robotically assisted surgery and the surgical team's long-term relationship with the company manufacturing this equipment. (Interpretations today are also complicated by their financial relationships with the company.)
In my mind, the team should have been required to get IRB approval (a standard for objective review of human subjects experiments) for this case. It was a new technology being applied to a live donor who had little to gain
and well documented risks of morbidity and mortality. Approval of the
usual ethics committee for live donors was likely inadequate when adding on the unknown risk of robotic surgery. The biggest risk of
doing these cases in a minimally invasive way is that if you get into
serious (and often sudden) massive bleeding you won't be able to
open and control the bleeding quickly enough. The patient could die or have severe hemorrhage before it is controlled. There is also the additional risk of a longer time under anaesthesia. An IRB review by uninvolved individuals with a variety of backgrounds would have balanced those potential risks against the additional scientific and clinical knowledge that could result from the experiment.
In summary, new surgical approaches like this--where there will not likely be randomized trials but where the risk is high--suggest that IRB approval should be part of the development of the new technology. Absent that, the patient is held hostage to the possibility that the surgeon's personal judgment--no matter how well intentioned--might be colored by commercial strategies of that doctor, the hospital, and the equipment supplier.
In summary, new surgical approaches like this--where there will not likely be randomized trials but where the risk is high--suggest that IRB approval should be part of the development of the new technology. Absent that, the patient is held hostage to the possibility that the surgeon's personal judgment--no matter how well intentioned--might be colored by commercial strategies of that doctor, the hospital, and the equipment supplier.
Wednesday, September 10, 2014
Robots around Le Monde
I present this view from France courtesy of patient safety and quality expert Michael Millenson, who saw a copy of Le Monde while in Europe. Rough translation: Robotic Surgeons: Stop the Fraud! The article is by Professor Abdel Rahmène Azzouzi, Chief of Urology of the University Hospital of Angers.
Here are Google-assisted translations of some key excerpts:
For over ten years now, proponents of robotic surgery bombard shameless untruths about the value of surgical robots in their field. As Ezekiel J. Emanuel said, a former adviser on health to the White House and a columnist for the New York Times, this pseudo-innovation increases costs without improving quality of care (New York Times, May 27, 2012 ).
Given the lack of evidence of the superiority of robotic techniques in the prostate removal surgery, how can we not question the inertia of regional health agencies (ARS), the Council of the College of Physicians and the French Association of Urology, who prefer not to offend, for reasons that escape us, the holders of an innovation with questionable benefit to the patient.
The overly commercial strategy of Intuitive Surgical - the monopoly on this robotic technology with its model Da Vinci - is shocking in health care and particularly affecting patients with cancer.
In its approach to its surgeon customers, it is only a question of increasing the number of cases for surgery by attracting psychologically fragile patients at the announcement of their disease and touting their results they do not have scientific proof. In other words, if the Da Vinci robot was a drug, it would never have obtained authorization to market.
For their part, supporters of the robot, having invested in the order of 2 to 2.5 million euros to acquire this surgical tool, betting on a return on investment by increasing the number of procedures, which in the case cancer localized prostate would increase the stock of patients operated incorrectly or prematurely. This irresponsible move strengthens the opponents of screening for prostate cancer, and delay the quality of the management of the disease.
A Republican practice of medicine as expected in France must ensure that patients' interests and those of the community are always higher than the activity of so-called "expert" centers, in terms of fame and financial benefits .
Given the lack of rigorous evaluation today and to better protect patients from a natural attraction to new technologies, our advice to all patients who are diagnosed with prostate cancer . . . is to be vigilant before a proposal to remove the prostate, especially in centers with a robot, and to ensure that all available treatment options has been offered to them.
In other words and as stipulated in Article 35 of the Code of Public Health, the physician must provide clear and honest information, and provide proper care to his patients.
Therapeutic innovation, when it is real, is essential to the evolution of medical practice, but it is only if it is dedicated to the patient, and not to those who support it or to manufacturers who are at the origin.
Sunday, April 14, 2013
Robotic surgery: New medical malpractice underwriting risk
If I am a medical malpractice insurance company, should I be concerned about a new underwriting risk?
The question is prompted by a recent story in the Denver Post. The lede:
The Colorado medical board has charged Dr. Warren Kortz with 14 counts of unprofessional conduct after a series of failed procedures with Porter Adventist Hospital's robotic surgery arm, as federal officials launch a wider review of the highly touted procedures.
The state alleges that from 2008 to 2010, Kortz cut and tore blood vessels, left sponges and other instruments inside patients after closing, injured patients through improper padding and positioning, subjected some to overly long surgeries, and had to abort kidney donations because of mistakes.
Now, one surgeon does not an actuarial trend make. The article notes:
Apparently not many, if these ads from a simple Google search on "medical malpratice robotic surgery" are any indication.
The question is prompted by a recent story in the Denver Post. The lede:
The Colorado medical board has charged Dr. Warren Kortz with 14 counts of unprofessional conduct after a series of failed procedures with Porter Adventist Hospital's robotic surgery arm, as federal officials launch a wider review of the highly touted procedures.
The state alleges that from 2008 to 2010, Kortz cut and tore blood vessels, left sponges and other instruments inside patients after closing, injured patients through improper padding and positioning, subjected some to overly long surgeries, and had to abort kidney donations because of mistakes.
Now, one surgeon does not an actuarial trend make. The article notes:
The U.S. Food and Drug Administration said
it is stepping up interviews of surgeons about the devices after a new
series of mishap reports, although the agency said it has not yet
identified a trend. Hospitals spend more than $1 million on each of the
da Vinci-brand surgery units and are under pressure to keep them busy.
The lack of a trend, however, does not protect doctors and hospitals from malpractice cases. If I were a plaintiff's attorney, here's the way I would frame the medical malpractice argument to a judge and jury:
Each of these opportunities to enhance the plaintiff's case can be offset by an appropriate risk management approach. But how many medical malpractice insurance companies have recognized this new vulnerability and taken steps among their insured entities to ameliorate the risks?The lack of a trend, however, does not protect doctors and hospitals from malpractice cases. If I were a plaintiff's attorney, here's the way I would frame the medical malpractice argument to a judge and jury:
A hospital and its doctors decide to purchase and employ a surgical robot, notwithstanding a lack of peer-reviewed evidence as to its clinical efficacy vis-à-vis other forms of laparoscopic or open surgery.
There is evidence that the hospital has spent significant sums of money in marketing the availability of the robotic surgery in its service territory. There is evidence, too, that ties the marketing campaign to a change in that hospital's market share for the particular procedures advertised. The profit-and-loss statements of doctors in the hospital show the income gained from this change in market share.
There is evidence that the hospital has spent significant sums of money in marketing the availability of the robotic surgery in its service territory. There is evidence, too, that ties the marketing campaign to a change in that hospital's market share for the particular procedures advertised. The profit-and-loss statements of doctors in the hospital show the income gained from this change in market share.
The doctors in that hospital present poor documentation as to why they chose to employ the robot on particular patients, failing to show in the medical records--or in the patient consent forms--a clear demonstration of relative risks and benefits vis-à-vis other forms of laparoscopic or open surgery. At the hospital governance level, the medical executive committee of the hospital has failed to adopt specific rules and regulations concerning such documentation in the medical records or patient consent forms.
Even if there is a record of simulation or other training by the doctor using the machine, the evaluation of his or her performance in that training session is not carried out by an objective observer. Maybe the extent and type of training are not even documented. Perhaps, too, the general pedagogical efficacy of the training has not been subjected to peer review by experts in clinical process education. At the hospital governance level, the medical executive committee of the hospital has failed to address the issue of granting privileges for use of the robot that sufficiently address these pedagogical and documentation concerns.
(In some cases,) the doctor has employed the robot in novel settings, beyond those used by the preponderance of physicians. At the hospital governance level, the medical executive committee of the
hospital has failed to systematically address the issue of granting privileges for use
of the robot for these purposes.
Apparently not many, if these ads from a simple Google search on "medical malpratice robotic surgery" are any indication.
Friday, November 21, 2008
Uncle!
Many months ago, I wrote about the da Vinci Robot Surgical System and expressed doubts about whether there was evidence to support the clinical efficacy of this equipment, as opposed to the marketing efficacy of the company selling it. Well, the time has come to graciously say, "Uncle!"
Without making any representations about the relative clinical value of this robotic system versus manual laparoscopic surgery, I am writing to let you know we have decided to buy one for our hospital. Why? Well, in simple terms, because virtually all the academic medical centers and many community hospitals in the Boston area have bought one. Patients who are otherwise loyal to our hospital and our doctors are transferring their surgical treatments to other places. Prospective residents who are trying to decide where to have their surgical training look upon our lack of the robot as a deficit in our education program. Prospective physician recruits feel likewise. And, these factors are now spreading beyond urology into the field of gynecological surgery. So as a matter of good business planning, concern for the quality of our training program, and to continue to attract and retain the best possible doctors, the decision was made for us.
So there you have it. It is an illustrative story of the health care system in which we operate.
Without making any representations about the relative clinical value of this robotic system versus manual laparoscopic surgery, I am writing to let you know we have decided to buy one for our hospital. Why? Well, in simple terms, because virtually all the academic medical centers and many community hospitals in the Boston area have bought one. Patients who are otherwise loyal to our hospital and our doctors are transferring their surgical treatments to other places. Prospective residents who are trying to decide where to have their surgical training look upon our lack of the robot as a deficit in our education program. Prospective physician recruits feel likewise. And, these factors are now spreading beyond urology into the field of gynecological surgery. So as a matter of good business planning, concern for the quality of our training program, and to continue to attract and retain the best possible doctors, the decision was made for us.
So there you have it. It is an illustrative story of the health care system in which we operate.
Friday, June 20, 2014
Peel me a grape!
Whenever I promise myself not to write another post about robotic surgery, I see an ad or an interview doubling as an ad so full of misrepresentations that I have to reach out for an antiemetic.
Here's the latest, a June 18 piece on Bloomberg TV. It is shocking because Bloomberg is so careful about accuracy in its news reports. Of course, the video starts with a short ad, which is clearly labeled as such. But they really should have kept that label in place for the duration of the video.
Did Intuitive Surgical pay for this piece or just provide the visuals? For surely they did provide the visuals, as is clearly disclosed.
It appears that they also provided some answers. When the interviewer asks at, 3:56, "What about the costs?" Dr. Michael Stifelman from NYU's Langone Robotic Surgery Center responds, "There is a perception that robotics is going to be more costly. What we're finding is that, when put into experienced hands . . . those increased cost are somewhat nominal if anything. The benefit for the patient is they're going to get out of the hospital earlier . . . less risk of blood loss, less pain, and most importantly . . . the costs to society. Each patient will be able to get back to work more quickly than they would using a more traditional technique for these procedures."
Sorry, Dr. Stifelman, but all of those assertions are not supported by objective, peer-reviewed studies. Your point about cost also ignores the purchase cost, disposables, and maintenance contracts associated with this equipment. You also appear to be subtly offering a comparison of robotic surgery with open surgery, as opposed to manual laparoscopic surgery. Here's a more objective recent portrayal of the issue in a recent New Yorker article. An excerpt:
Many hospitals, faced with the pressure to compete with high-tech programs, are advertising robots aggressively—on billboards, on YouTube, even at baseball games. Some may be overselling the benefits of the technology. Researchers at Johns Hopkins University analyzed the Web sites of four hundred U.S. hospitals and, in a study published in the Journal for Healthcare Quality, reported that the majority of sites claimed that robotic surgery offered an “overall better outcome,” and a third of the sites touted “improved cancer control.” (None of the Web sites mentioned risks.) A study by researchers at Columbia University investigated the marketing of robotic gynecological procedures and found that many hospital Web sites described robotic surgery as the “most effective treatment.”
Jason Wright, who worked on the Columbia University study and is the chief of gynecologic oncology at the university, told me that many claims made about robotic surgery aren’t based on clinical evidence. “When you see an ad for a drug on television, the claims that are made have to be backed up by scientific data,” he said. “There’s not the same level of scrutiny for devices.”
Intuitive Surgical loves Dr. Stifelman:
Dr. Michael Stifelman, Associate Professor of Urology and Director of Robotic Surgery at NYU Langone Medical Center, has been named the 2011 recipient of the Crystal Award, given by Intuitive Surgical, Inc., to surgeons who have contributed significantly to the advancement of clinical knowledge in the field of robot-assisted surgery. The company, which manufactures the da Vinci Si robotic surgical system, gave the award to Dr. Stifelman in a ceremony at its annual meeting in Boca Raton, Florida.
And the company also promoted his interview with Diane Sawyer as well as numerous entries on its DaVinci Surgery Community site.
But here's the great part. While Dr. Stifelman talks, the video meticulously presents the visual story of a grape being peeled. I wondered if a surgeon might tell us how relevant that is to prostatectomies, hysterectomies, and the like, so I did a Google search on the question, "Is surgery like peeling a grape?"
I was overwhelmed by the response. What good fortune. Here's a portion of that page from my browser, with videos going all the way back to 2010. Surgery is like peeling a grape, and how lucky we are to be able to do that robotically.
Here's the latest, a June 18 piece on Bloomberg TV. It is shocking because Bloomberg is so careful about accuracy in its news reports. Of course, the video starts with a short ad, which is clearly labeled as such. But they really should have kept that label in place for the duration of the video.
Did Intuitive Surgical pay for this piece or just provide the visuals? For surely they did provide the visuals, as is clearly disclosed.
It appears that they also provided some answers. When the interviewer asks at, 3:56, "What about the costs?" Dr. Michael Stifelman from NYU's Langone Robotic Surgery Center responds, "There is a perception that robotics is going to be more costly. What we're finding is that, when put into experienced hands . . . those increased cost are somewhat nominal if anything. The benefit for the patient is they're going to get out of the hospital earlier . . . less risk of blood loss, less pain, and most importantly . . . the costs to society. Each patient will be able to get back to work more quickly than they would using a more traditional technique for these procedures."
Sorry, Dr. Stifelman, but all of those assertions are not supported by objective, peer-reviewed studies. Your point about cost also ignores the purchase cost, disposables, and maintenance contracts associated with this equipment. You also appear to be subtly offering a comparison of robotic surgery with open surgery, as opposed to manual laparoscopic surgery. Here's a more objective recent portrayal of the issue in a recent New Yorker article. An excerpt:
Many hospitals, faced with the pressure to compete with high-tech programs, are advertising robots aggressively—on billboards, on YouTube, even at baseball games. Some may be overselling the benefits of the technology. Researchers at Johns Hopkins University analyzed the Web sites of four hundred U.S. hospitals and, in a study published in the Journal for Healthcare Quality, reported that the majority of sites claimed that robotic surgery offered an “overall better outcome,” and a third of the sites touted “improved cancer control.” (None of the Web sites mentioned risks.) A study by researchers at Columbia University investigated the marketing of robotic gynecological procedures and found that many hospital Web sites described robotic surgery as the “most effective treatment.”
Jason Wright, who worked on the Columbia University study and is the chief of gynecologic oncology at the university, told me that many claims made about robotic surgery aren’t based on clinical evidence. “When you see an ad for a drug on television, the claims that are made have to be backed up by scientific data,” he said. “There’s not the same level of scrutiny for devices.”
Intuitive Surgical loves Dr. Stifelman:
Dr. Michael Stifelman, Associate Professor of Urology and Director of Robotic Surgery at NYU Langone Medical Center, has been named the 2011 recipient of the Crystal Award, given by Intuitive Surgical, Inc., to surgeons who have contributed significantly to the advancement of clinical knowledge in the field of robot-assisted surgery. The company, which manufactures the da Vinci Si robotic surgical system, gave the award to Dr. Stifelman in a ceremony at its annual meeting in Boca Raton, Florida.
And the company also promoted his interview with Diane Sawyer as well as numerous entries on its DaVinci Surgery Community site.
But here's the great part. While Dr. Stifelman talks, the video meticulously presents the visual story of a grape being peeled. I wondered if a surgeon might tell us how relevant that is to prostatectomies, hysterectomies, and the like, so I did a Google search on the question, "Is surgery like peeling a grape?"
I was overwhelmed by the response. What good fortune. Here's a portion of that page from my browser, with videos going all the way back to 2010. Surgery is like peeling a grape, and how lucky we are to be able to do that robotically.
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