SafeCare Magazine 3rd Quarter 2017
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EDITORIAL BRIEF
Mending Broken Hearts
- Nearly 1 Million CABG Surgeries Performed Worldwide Annually
Sarju Bharucha, JD, Editor-in-Chief
- Nearly 1 Million CABG Surgeries Performed Worldwide Annually
Sarju Bharucha, JD, Editor-in-Chief
As we explore the various facets of medicine, there are surgeries that defy what men ever thought they could accomplish. One of these surgeries include Coronary Artery Bypass and Grafting (“CABG”). Surprisingly, each year nearly one million CABG surgeries are performed worldwide. Initially, this heart-stopping and electrifying procedure of intricately grafting to coronary arteries involved only saws, forceps, sutures, and human hands. It has now progressed to include novel technologies, including robots.
In this issue, we are bringing you an exclusive interview with Dr. Peter McKeown, MD, MBA, MPA, MPH, a Harvard educated physician leader, internationally renowned heart surgeon, and The SafeCare Group advisor to delve into the questions that probe the pros and cons of these new technologies across all facets of medicine. For example, questions such as “how big a role should technology play? How do we assess new procedures and technologies?”
In this issue, we are bringing you an exclusive interview with Dr. Peter McKeown, MD, MBA, MPA, MPH, a Harvard educated physician leader, internationally renowned heart surgeon, and The SafeCare Group advisor to delve into the questions that probe the pros and cons of these new technologies across all facets of medicine. For example, questions such as “how big a role should technology play? How do we assess new procedures and technologies?”
COVER STORY TRANSCRIPT
Mending Broken Hearts
Nearly one million CABG surgeries are performed worldwide annually - what is the future of heart surgery?
Full, in-depth interview by The SafeCare Group CEO & Chairman Yisrael M. Safeek, MD, MBA with Harvard-trained heart surgeon and The SafeCare Group advisor Peter McKeown, MD, MBA, MPA, MPH.
Yisrael Safeek: Welcome Dr. McKeown. You are a Harvard educated physician leader and internationally renowned heart surgeon. Since 2015, you have served as a patient safety advisor for The SafeCare Group, and I thank you for serving. Before that, you served as Deputy Chief Medical Officer for the VA Mid-South Healthcare Network and Executive Director of Asheville Medical Research and Education Corporation (AMREC), as well as Cardiothoracic Surgery Program Director of a Cleveland Clinic Affiliated program. Your faculty appointments included Professor of Surgery, Division of Cardiovascular and Thoracic Surgery, University of South Florida, Professor of Surgery and Head of School, University of New England, Australia, serving as Deputy Dean of Joint Medical Program, and Conjoint Professor School of Medicine and Public Health, University of Newcastle. You are the author of over 100 publications and several book chapters and a former Board Member of the American Heart Association and American College of Chest Physicians. You are a fellow of the American College of Healthcare Executives, the American Board of Thoracic Surgery, and the American College of Surgeons. How about you telling our readers about your education and training?
Peter McKeown: I went to medical school in Australia at the University of Queensland and did an internship at the Royal Brisbane Hospital, before moving to San Francisco to do a general surgery residency at St. Mary’s Hospital. This was followed by a vascular surgery fellowship at Stanford University and then cardiothoracic surgery residency at Emory University in Atlanta. In 1988, I did a sabbatical year in London with Dr. Marc de Laval and Professor Sir Magdi Yacoub in congenital cardiac surgery and heart and heart lung transplantation. During that year I also had the opportunity to visit major cardiac surgery centers in Paris, Rome, Melbourne and Rotterdam. In 1998 to 1999, with support from the Society of Thoracic Surgeons (STS) with an Alley Sheridan Scholarship I was able to do a sabbatical year at Harvard University, doing a Masters in Public Health in clinical effectiveness and a Masters in Public Administration from the Kennedy School of Government in Healthcare policy and Healthcare leadership. I consider myself very fortunate to have had all these many wonderful opportunities.
YS: I thank you for your service as a Colonel in United States Army Reserve. You have done some interesting humanitarian missions in the US Army to Bolivia, Vietnam, Indonesia and Mongolia. Have these had any impact on your perspective on patient care in this country?
PM: These humanitarian missions were so rewarding and certainly altered my perspective on the delivery of care to underserved areas and the role of technology. The patients would come from miles around to be seen arriving in their “Sunday best” walking or riding on camels, horses, motor bikes, carts and cars. In Mongolia I did an appendectomy under local anesthesia in an 11 year old boy in a hospital with no CT scan, no running water and no permanent electricity, but with help and support from a Mongolian army health team. It was a humbling experience, and fortunately the patient did well.
In each of these humanitarian missions there was a language barrier and so we worked with translators and a host military medical team. You learnt to enhance your communication skills. I did find that there is something universal about a doctor–patient relationship and an appropriate smile and a nod go a long way. In some cases, I am sure they came out of curiosity, but at other times we saw very rare and complex conditions, like Hanson’s disease (leprosy), advance Leishmaniasis and complex congenital heart conditions. There were times when we and/or the family did not have the resources to treat conditions in a way we take for granted day to day in this country.
In far western Mongolia, I saw patients with obvious congenital cardiac lesions that we might have been able to diagnose with a portable echocardiography machine and we decided that should be part of future missions. Unfortunately many families could not even afford or find a way to send their child to the capital, Ulaanbaatar, let alone programs overseas and we had to accept this, but I think being able to make a diagnosis with an echo and at least give the family a prognosis would help. Every day was a lesson in trying to maximize the resources available. It was really a matter of trying to deliver the best, safest and most compassionate care you could given the resources available.
YS: With robotic arms and video cameras, video games surgery is here. With any innovation, there often emerges an equation between innovation and cost effectiveness. And what about the risks for patients?
PM: So we have to ask ourselves how big a role should technology play? How do we assess new procedures and new technologies? Technology certainly has a significant role to play in improving the quality and safety of health care if appropriately applied. Think of advanced monitoring devices, the heart-lung machine, ventricular assist devices and computers, electronic health records and bar-coded medication delivery. On the other hand, we have also seen new technologies and procedures applied before they were adequately assessed. The Angelchick prosthesis for gastroesophageal reflux is one. The Lonescu-Shiley and the convexo-concave Bjork-Shiley valves are other examples where new devices ultimately proved to be disastrous for patients.
The robot is another device that has seen wide spread application without adequate scrutiny. While there may be some data to support its use in prostatectomies and perhaps gynecology procedures the benefits are marginal. In cardiac surgery there are a few programs with large experience reporting good or even excellent results, but that has not been universal and there are also programs that have abandoned its use. In programs successfully using the robot, it is uncertain whether those same results could not have been obtained with standard minimally invasive approaches without the robot.
A recent paper showed that there was little difference in thoracic lobectomies for lung cancer between a traditional non-robotic minimally invasive technique like Video Assisted Thoracoscopy (VATS) and robotic procedures. In fact, if anything the VATS cases tended to have less blood loss and shorter stays. If non-robotic minimally invasive procedures worked just as well as robotic cases then using non-robotic techniques would be preferable. It would decrease the operating time, the cross clamp times, and the added expense associated with the robot. Robotic procedures generally increase both the operating time and the cost by 30 -50%. In the recent study utilizing the STS database it was found that only a limited number of programs were using robotic-assisted CABG and most of these only did between one and five procedures a year and some of these I suspect were just for the take down of the mammary artery. While the outcomes were ok, there were fewer grafts in the robotic groups raising the question of incomplete revascularization.
The fact that the use of the robot in cardiac surgery is now used routinely in only a few select programs should raise some questions about its overall efficacy and even safety. There is a steep learning curve with these procedures and it is hard to estimate how many patients have been harmed in smaller programs where the push to do robotics procedures was based more on marketing than improving safety or outcomes. There are many hospitals now using the robot for simple hernia and gallbladder which are normally straight forward laparoscopic procedures. I can see no justification for the use of the robot in these procedures and I believe it unnecessarily increases the risk to the patient and significantly increases cost and operating times. It seems that around the country there are a lot of $1-2million robots cluttering the corridors or no longer employed as originally intended.
I do think there is a role for robotic surgery, and there are several centers with truly outstanding results. If properly applied in a limited number of institutions it can play a significant role and it will be a lead in to nanotechnology in the future, but is it ready for prime time in the average cardiac surgery program? This raises the question of is there an adequate review process to assess for the implementation of new procedures and new technologies. What role should the FDA play? There seems to be a dichotomy where on the one hand medicine in the US is becoming over regulated and on the other hand there is an inadequate assessment process for new technologies and new procedures and perhaps more importantly ongoing assessments. What may succeed in a few centers with outstanding talented teams may not be appropriate for general consumption.
YS: Heart surgery is risky business. To cut is a chance to cure, and it’s also a chance to fail. Can you tell our readers about “Off Pump” CABG?
PM: Over the last 15 years or so there was some enthusiasm for doing coronary artery bypass procedures without the heart lung machine, so called “Off Pump” to reduce the complications of the heart lung machine. There were certainly some centers, including Emory University with excellent results with Off-Pump procedures. But there was a suspicion that in some centers it might not be better and that the number of grafts being performed on each patient was less and that the quality of the anastomoses was not as good when the heart is beating. The VA again to their credit did a landmark prospective randomized trial (ROOBY trial) published in the New England Journal of Medicine in 2009 that showed that the off pump cases at one year had worse composite outcomes and poorer graft patency than did patients in the on pump group. It was expected that the on pump group would have worse neurological outcomes but the study showed no significant difference.
These large trial are expensive and time consuming but essential in some situations to get accurate data and to see if new procedures and techniques are suitable for all programs. Off-Pump procedures definitely require a special skill to use on a routine basis. Programs, like Emory having great results with Off-Pump procedures should continue to do what works for them. You can’t play soccer on a tennis court and you have to do what is the best for your patients in your environment. This story is not dissimilar to the robotic heart surgery story. It just means we can’t always extrapolate from one surgeon or one program to another and before there widespread adoption of a new technique or device there needs to be an extensive evaluation. Enthusiasm needs to be tempered with a measured reality.
In response to this sort of challenge of assessing new procedures, the Royal Australasian College of Surgeons set up the Australian Safety and Efficacy Register of New Interventional Procedures ASERNIP. It was established to assess new procedures and devices and appears to be an effective mechanism of review without overburdening with regulation. One of the goals is to change the asymptote, that is flattening of the learning curve, and see where and how new technologies should be introduced. It has an ongoing review element which is important.
YS: What have been the biggest advances in Cardiothoracic Surgery in the last 10 years?
PM: I think the increasing use of minimally invasive techniques (using smaller incisions) has been amongst the biggest advances in cardiothoracic surgery over the last 10 years. We are now seeing widespread application of minimally invasive approaches in many aspects of cardiac surgery including valve surgery, endoscopic vein harvest (using one or two small incisions to harvest the leg vein for bypass surgery), and endovascular (femoral artery) approaches for thoracic aortic aneurysms and traumatic transections of the aorta. There has also been an increase in attempts to repair rather than replace the mitral valve.
We are also witnessing the expansion of the indications for Transcatheter Aortic Valve Replacement (TAVR); a percutaneous way to replace the aortic valve also using a femoral artery approach. New instruments and new devices have made these approaches possible. Perhaps less obvious, but still important has been the improvements in preventative care and looking for ways minimizing the complications of using the heart lung machine by reducing the inflammatory response (cytokine mitigation). Ablation techniques for atrial fibrillation, both by cardiologist and surgeons are improving the lives of many patients with this condition. There have been steady improvements in ventricular assist devices, artificial hearts and transplants.
In congenital cardiac surgery we are also seeing steady improvements in outcomes and safety. The use of the robot in heart surgery has seen a slight growth in the last 10 years with attempts to expand its use from valves to coronary artery bypass and lung resections. Researchers are working on a substitute conduit for the saphenous vein and the mammary artery for coronary bypass grafting. Mechanical coronary anastomotic staplers are still in the experimental stages. And as in many fields of medicine, there has been expanded interest in stem cell use for repairing damaged hearts. The cardiologists’ use of percutaneous coronary interventions with drug eluding stents (PCI) has helped to decrease some of the complications we used to see from myocardial infarctions, and has definitely improved the outcome for selected patients, although many studies still show that surgical revascularization (CABG) remains superior to PCI in a lot of cases.
The medical treatment for heart disease has also improved with newer anti-cholesterol medications and the wider use of beta blockers and along with that reduction in one of the biggest risk factors-smoking. Unfortunately, at the same time we are seeing almost an epidemic rise in obesity and diabetes and this does not bode well in the long run. Sadly many of the great leaders and pioneers in cardiac surgery including Drs. Shumway, Barnard, Sabiston, Cooley, Kirklin, DeBakey and others have passed away during the last 5 to 10 years. I had the chance to meet many of them, albeit briefly, over the years and it is sad to lose such a legacy.
YS: From your perspective as a cardiothoracic surgeon, what are the most impressive innovations in heart surgery?
PM: There have been numerous advances in heart surgery over the last 50 years that includes things like the development of the Heart lung machine by Gibbon, heart and heart-lung transplants that we now almost take for granted, major advances in vascular surgery including endovascular stent repair of thoracic and abdominal aneurysms , development of heart valves both mechanical and tissue valves, the use of pacemakers and implantable cardioverter defibrillators , the introduction of minimally invasive approaches including endoscopic vein harvesting and mini thoracotomy approaches, the recent interventional aortic and mitral valve techniques ( TAVR and Mitral Clip) and of course robotic surgery.
Coronary angioplasty, stents and other percutaneous interventions (PCI) by cardiologists have also had a significant impact. I was a general surgery resident at St. Mary’s hospital in San Francisco in the late 1970s when Dr Richard Myler and Dr Andreas Gruentzig did the first coronary angioplasty in the country. Coincidentally, Dr. Gruentzig had moved to Emory from Zurich by the time I was doing my cardiac surgery training at Emory. Now PCI is taken for granted and there is a standard time for patient presenting with an acute myocardial infarct (STEMI) to be rushed to the cath lab to open a blocked coronary artery, called the “door to balloon time”. This has saved a tremendous number of lives and certainly prevented irreparable damage to heart muscle. There have been other more subtle and perhaps less emphasized advances in heart surgery and these include things like preventative disease interventions ( smoking cessation and diet), the use of beta blockers, statins for cholesterol and better control of hypertension.
The increasing use of large data bases like the VA CICSP (Continuous Improvement in Cardiac Surgery Program) and the STS databases to measure outcomes and reflectively address adverse events, has had a significant impact. The VA deserves a large amount of credit for the contribution it has made to cardiac surgery in this regard. In the 1980s it became obvious that heart surgery results in the VA were less than ideal. In response to this in 1987 the VA introduced the CICSP in which all VA cardiac surgery cases are recorded and analyzed. In 1989 the STS established a similar database which now contains over 6 million cumulative operative records and accounts for over 90% to 95% of adult cardiac surgery performed in the United States. Both of these databases have been enormously helpful in assessing risk and outcome. Results are risk adjusted so program managers get frequent reports listing the observed to expected (O/E) results. The ideal O/E is 1 or less than 1. By using a risk adjusted model we can now compare different programs and their outcomes. These results have been used to benchmark good programs in an effort to help some of the less effective programs. Because these database programs were largely internally generated within the organization they have been strongly supported by members of the organization.
We also have to give credit to the incorporation of highly trained professionals within the team including perfusionists that run the heart lung machine, physician assistants and nurse practitioners that do endoscopic vein harvesting and provide a continuity of care, the cardiac trained anesthesiologists and the experienced and very talented ICU nurses. It is very clear that successful, safe heart surgery is a “team sport”.
YS: Are heart operations safer as compared to 10 years ago?
PM: Yes. Absolutely! I think there is no doubt from the data that cardiac surgery is much safer than it used to be. While the patients nowadays are more likely to be sicker, have multivessel disease, poor ventricular function and more comorbidities, we find from the data that not only are the risk adjusted mortalities less but the unadjusted mortality is also lower. Overall mortality for coronary bypass is now around 1 -2% which is a remarkable achievement.
YS: How important are checklists in cardiac surgery.
PM: Checklists are something else that we have adopted from the airline industry. I have been doing “Time Outs” at the beginning of each case for over 20 years after a near miss with a wrong side VATS lung biopsy. A near miss that was a great learning opportunity. To some extent we have abrogated this responsibility to the nursing staff…. And that is wrong. If the surgeon wants to be the conductor then they need to conduct. We now have outside entities telling us what should be in the “Time Out” and it is becoming so extensive as to be impractical. It is also useless if not everyone is paying attention.
If you want to quickly assess the safety culture of an OR watch how the “time out “is performed.
The WHO has come up with a guideline but I have tried to keep the “Time Out” simple and relevant with a list of “P”s and “Qs”. 1. Is it the right Patient? 2. Are they in the right position and is it the right site/side? 3. Is it the right Procedure, confirming the consent? 4. Are Prophylactic Antibiotics given? 5. Are the Pictures (X-rays or Cath films up and confirm site and procedure)? 6. Are blood Products available? 7. Are all the right prostheses and equipment available and functioning? Q’s > are there any questions or concerns? Before coming off bypass I think it helps to have another checklist: 1. Blood gases including Ph, Po2, Hct (> 20); 2. Core temperature 36C; 3. Rhythm > if not adequate consider pacing wires; 4. Ventilation; 5. TEE assessment of function and or/repair etc.; 6. Surgical sites - no major bleeding.
YS: When you perform open-heart surgery, you are literally taking someone's life in your hands. What advice would you give a doctor preparing for surgery?
PM: My father used to always say “Check and recheck”. I guess it is a bit like the carpenter’s “Measure twice – cut once”. But that simple edict has kept me out of trouble many times. In 2007 Yisrael, you and Pam May published a paper “Protocols, Prompters, Bundles, Checklists and Triggers: Synopsis of a Preventable Mortality Reduction Strategy”, which was finally published in the Journal of Physician Executives and eventually given the recognition it deserved, but it is interesting that the very journals that should have snapped it up initially , the Joint Commission Journal on Quality and Patient Safety and Patient Safety & Quality Healthcare failed to even acknowledge it.
YS: How large is the problem of patient safety in the US healthcare system?
PM: Everybody quotes the 1999 Institute of Medicine report “To Err is Human: Building a Safer Health System”. It suggested that at “least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented…. With costs (including the expense of additional care necessitated by the errors, lost income and household productivity) of between $17 billion and $29 billion per year in hospitals nationwide”. But even before that a 1991 Harvard study published in the New England Journal of Medicine found in a review of more than 30,000 hospital admissions “that nearly 4% of hospital patients suffered complications from treatment which either prolonged their hospital stay or resulted in disability or death, and that two-thirds of such complications were due to errors in care… one percent of admissions, involved actual negligence”.
As a fellow surgeon it is hard to reconcile these facts and come up with a meaningful explanation. Even more challenging is deciding what actions can and should be taken to improve patient safety. Our first response is to try to find who is culpable and who is responsible and punish accordingly. Unfortunately this is usually counterproductive. In 2005 the Australian Council for Safety and Quality in Health Care published their “National Patient Safety Education Framework” with a goal to “provide a simple, flexible and accessible Framework that identifies the knowledge, skills, behaviors, attitudes and performance required by all health care workers in relation to patient safety.” The Chair of the Council Professor Bruce Barraclough, a surgeon went on to say “the Framework is patient-centered. It recognizes that safety is everybody’s business and is relevant for all health care workers at all levels.” That document remains a great resource on patient safety. It addresses some of the issues in developing a patient safety culture.
YS: What are some of the critical factors in developing a high quality culture organization?
PM: Firstly, the leadership is critical and I believe it is impossible to have sustainable high quality patient safety programs without significant physician involvement and physician leadership. So physicians have to get involved and administrators have to find ways to engage the physicians and get them involved in the process. In addition to this, every single member of the staff has to be made to feel that they are a patient advocate. Secondly the patient safety culture has to be hard wired into the organization. That is to say it becomes embedded within the culture of the organization and is not just the flavor of the month. Thirdly, there is a need for consistency and perseverance with clearly defined expectations and effective monitoring and surveillance and appropriate data collection and data sharing. Fourthly, while there has to be some consequences and culpability there also has to be a no fault, blame-free reporting system. Staff have to be able to report concerns about unsafe practices and personnel without fear of reprisal. This involves an effective open and transparent communication strategy. Staff have to know what is the proper reporting system and process.
YS: It can be argued that transparency is a good thing as more information people have, the better. Are there any problems of publication of surgeons’ outcomes?
PM: This has been a real challenge. The STS and NSQIP data have suggested that the program is more important than the individual and this has led to a reluctance to divulge individual surgeon specific data. In fact, I think at the moment releasing individual data is counterproductive. High functioning organizations are highly dependent on a team approach. Surgeons need to be educated and trained as to how to build integrated highly functioning team. The CT surgeon today, particularly if they are employed are much less likely to have much say in which positions are part of the team and more importantly who those team members are.
Again the RVU based compensation has a tendency to develop internal competition both between surgeons within a program and between surgeons and cardiologists. This is not conducive if you are trying to build a high quality patient focused program. Theoretically a salary based non RVU compensation could be helpful in team building.
YS: How do we get physicians to take leadership positions?
PM: We have to ask them and support them and train them for these positions, although we have to be careful we don’t skew the workforce towards non clinical care. The administrative burden in medicine is already way disproportional to what it should be. Recently several for profit and some not for profit hospital chains have been struggling to keep financially solvent. It is interesting that some of these have instituted cost saving measures by cutting out CMO (Chief Medical Officer) positions. HCA seems to be the exception and they are constantly recruiting but having trouble filling CMO positions with good candidates. Interestingly they are doing better than some of the organizations that have minimized physician leadership. There may or may not be a relationship here.
I had the honor of being an associate of the Cleveland Clinic and attended one of their executive programs. Two things about the leadership model at the Cleveland Clinic really impressed me .Firstly the Clinic is physician led and secondly, perhaps even more important than that - they have inculcated a servant leadership model. We are seeing more physicians in CEO positions and I think generally that is a good thing but there is also the danger that they may forget who their real constituents are and become what has facetiously been called “the dark side”. Also remember that every doctor and/or nurse that takes on an administrative role is one clinician delivering patient care.
YS: How do you see the future of heart surgery?
PM: The new catheter interventions for coronary disease and valves will, I think, lead in the future to hybridization between interventional cardiology and cardiac surgery. We have already seen this in vascular surgery, where the vascular surgery residency programs produce graduate surgeons who can now manage vascular disease across the whole spectrum. They do the diagnostic work up, the interventional procedures and the open surgical procedures, and the long term follow up. Being able to integrate a longitudinal care path within one specialty has significant advantages. The cardiac surgery residency programs are now starting to incorporate the catheter based skills in to the training. It remains to be seen whether all the training required catheter skills plus traditional cardiothoracic surgery, can be accomplished in the abbreviated six year programs. These new skills may require additional fellowship training. What I can say is that the future following from the past will be even more exciting and interesting.
Nearly one million CABG surgeries are performed worldwide annually - what is the future of heart surgery?
Full, in-depth interview by The SafeCare Group CEO & Chairman Yisrael M. Safeek, MD, MBA with Harvard-trained heart surgeon and The SafeCare Group advisor Peter McKeown, MD, MBA, MPA, MPH.
Yisrael Safeek: Welcome Dr. McKeown. You are a Harvard educated physician leader and internationally renowned heart surgeon. Since 2015, you have served as a patient safety advisor for The SafeCare Group, and I thank you for serving. Before that, you served as Deputy Chief Medical Officer for the VA Mid-South Healthcare Network and Executive Director of Asheville Medical Research and Education Corporation (AMREC), as well as Cardiothoracic Surgery Program Director of a Cleveland Clinic Affiliated program. Your faculty appointments included Professor of Surgery, Division of Cardiovascular and Thoracic Surgery, University of South Florida, Professor of Surgery and Head of School, University of New England, Australia, serving as Deputy Dean of Joint Medical Program, and Conjoint Professor School of Medicine and Public Health, University of Newcastle. You are the author of over 100 publications and several book chapters and a former Board Member of the American Heart Association and American College of Chest Physicians. You are a fellow of the American College of Healthcare Executives, the American Board of Thoracic Surgery, and the American College of Surgeons. How about you telling our readers about your education and training?
Peter McKeown: I went to medical school in Australia at the University of Queensland and did an internship at the Royal Brisbane Hospital, before moving to San Francisco to do a general surgery residency at St. Mary’s Hospital. This was followed by a vascular surgery fellowship at Stanford University and then cardiothoracic surgery residency at Emory University in Atlanta. In 1988, I did a sabbatical year in London with Dr. Marc de Laval and Professor Sir Magdi Yacoub in congenital cardiac surgery and heart and heart lung transplantation. During that year I also had the opportunity to visit major cardiac surgery centers in Paris, Rome, Melbourne and Rotterdam. In 1998 to 1999, with support from the Society of Thoracic Surgeons (STS) with an Alley Sheridan Scholarship I was able to do a sabbatical year at Harvard University, doing a Masters in Public Health in clinical effectiveness and a Masters in Public Administration from the Kennedy School of Government in Healthcare policy and Healthcare leadership. I consider myself very fortunate to have had all these many wonderful opportunities.
YS: I thank you for your service as a Colonel in United States Army Reserve. You have done some interesting humanitarian missions in the US Army to Bolivia, Vietnam, Indonesia and Mongolia. Have these had any impact on your perspective on patient care in this country?
PM: These humanitarian missions were so rewarding and certainly altered my perspective on the delivery of care to underserved areas and the role of technology. The patients would come from miles around to be seen arriving in their “Sunday best” walking or riding on camels, horses, motor bikes, carts and cars. In Mongolia I did an appendectomy under local anesthesia in an 11 year old boy in a hospital with no CT scan, no running water and no permanent electricity, but with help and support from a Mongolian army health team. It was a humbling experience, and fortunately the patient did well.
In each of these humanitarian missions there was a language barrier and so we worked with translators and a host military medical team. You learnt to enhance your communication skills. I did find that there is something universal about a doctor–patient relationship and an appropriate smile and a nod go a long way. In some cases, I am sure they came out of curiosity, but at other times we saw very rare and complex conditions, like Hanson’s disease (leprosy), advance Leishmaniasis and complex congenital heart conditions. There were times when we and/or the family did not have the resources to treat conditions in a way we take for granted day to day in this country.
In far western Mongolia, I saw patients with obvious congenital cardiac lesions that we might have been able to diagnose with a portable echocardiography machine and we decided that should be part of future missions. Unfortunately many families could not even afford or find a way to send their child to the capital, Ulaanbaatar, let alone programs overseas and we had to accept this, but I think being able to make a diagnosis with an echo and at least give the family a prognosis would help. Every day was a lesson in trying to maximize the resources available. It was really a matter of trying to deliver the best, safest and most compassionate care you could given the resources available.
YS: With robotic arms and video cameras, video games surgery is here. With any innovation, there often emerges an equation between innovation and cost effectiveness. And what about the risks for patients?
PM: So we have to ask ourselves how big a role should technology play? How do we assess new procedures and new technologies? Technology certainly has a significant role to play in improving the quality and safety of health care if appropriately applied. Think of advanced monitoring devices, the heart-lung machine, ventricular assist devices and computers, electronic health records and bar-coded medication delivery. On the other hand, we have also seen new technologies and procedures applied before they were adequately assessed. The Angelchick prosthesis for gastroesophageal reflux is one. The Lonescu-Shiley and the convexo-concave Bjork-Shiley valves are other examples where new devices ultimately proved to be disastrous for patients.
The robot is another device that has seen wide spread application without adequate scrutiny. While there may be some data to support its use in prostatectomies and perhaps gynecology procedures the benefits are marginal. In cardiac surgery there are a few programs with large experience reporting good or even excellent results, but that has not been universal and there are also programs that have abandoned its use. In programs successfully using the robot, it is uncertain whether those same results could not have been obtained with standard minimally invasive approaches without the robot.
A recent paper showed that there was little difference in thoracic lobectomies for lung cancer between a traditional non-robotic minimally invasive technique like Video Assisted Thoracoscopy (VATS) and robotic procedures. In fact, if anything the VATS cases tended to have less blood loss and shorter stays. If non-robotic minimally invasive procedures worked just as well as robotic cases then using non-robotic techniques would be preferable. It would decrease the operating time, the cross clamp times, and the added expense associated with the robot. Robotic procedures generally increase both the operating time and the cost by 30 -50%. In the recent study utilizing the STS database it was found that only a limited number of programs were using robotic-assisted CABG and most of these only did between one and five procedures a year and some of these I suspect were just for the take down of the mammary artery. While the outcomes were ok, there were fewer grafts in the robotic groups raising the question of incomplete revascularization.
The fact that the use of the robot in cardiac surgery is now used routinely in only a few select programs should raise some questions about its overall efficacy and even safety. There is a steep learning curve with these procedures and it is hard to estimate how many patients have been harmed in smaller programs where the push to do robotics procedures was based more on marketing than improving safety or outcomes. There are many hospitals now using the robot for simple hernia and gallbladder which are normally straight forward laparoscopic procedures. I can see no justification for the use of the robot in these procedures and I believe it unnecessarily increases the risk to the patient and significantly increases cost and operating times. It seems that around the country there are a lot of $1-2million robots cluttering the corridors or no longer employed as originally intended.
I do think there is a role for robotic surgery, and there are several centers with truly outstanding results. If properly applied in a limited number of institutions it can play a significant role and it will be a lead in to nanotechnology in the future, but is it ready for prime time in the average cardiac surgery program? This raises the question of is there an adequate review process to assess for the implementation of new procedures and new technologies. What role should the FDA play? There seems to be a dichotomy where on the one hand medicine in the US is becoming over regulated and on the other hand there is an inadequate assessment process for new technologies and new procedures and perhaps more importantly ongoing assessments. What may succeed in a few centers with outstanding talented teams may not be appropriate for general consumption.
YS: Heart surgery is risky business. To cut is a chance to cure, and it’s also a chance to fail. Can you tell our readers about “Off Pump” CABG?
PM: Over the last 15 years or so there was some enthusiasm for doing coronary artery bypass procedures without the heart lung machine, so called “Off Pump” to reduce the complications of the heart lung machine. There were certainly some centers, including Emory University with excellent results with Off-Pump procedures. But there was a suspicion that in some centers it might not be better and that the number of grafts being performed on each patient was less and that the quality of the anastomoses was not as good when the heart is beating. The VA again to their credit did a landmark prospective randomized trial (ROOBY trial) published in the New England Journal of Medicine in 2009 that showed that the off pump cases at one year had worse composite outcomes and poorer graft patency than did patients in the on pump group. It was expected that the on pump group would have worse neurological outcomes but the study showed no significant difference.
These large trial are expensive and time consuming but essential in some situations to get accurate data and to see if new procedures and techniques are suitable for all programs. Off-Pump procedures definitely require a special skill to use on a routine basis. Programs, like Emory having great results with Off-Pump procedures should continue to do what works for them. You can’t play soccer on a tennis court and you have to do what is the best for your patients in your environment. This story is not dissimilar to the robotic heart surgery story. It just means we can’t always extrapolate from one surgeon or one program to another and before there widespread adoption of a new technique or device there needs to be an extensive evaluation. Enthusiasm needs to be tempered with a measured reality.
In response to this sort of challenge of assessing new procedures, the Royal Australasian College of Surgeons set up the Australian Safety and Efficacy Register of New Interventional Procedures ASERNIP. It was established to assess new procedures and devices and appears to be an effective mechanism of review without overburdening with regulation. One of the goals is to change the asymptote, that is flattening of the learning curve, and see where and how new technologies should be introduced. It has an ongoing review element which is important.
YS: What have been the biggest advances in Cardiothoracic Surgery in the last 10 years?
PM: I think the increasing use of minimally invasive techniques (using smaller incisions) has been amongst the biggest advances in cardiothoracic surgery over the last 10 years. We are now seeing widespread application of minimally invasive approaches in many aspects of cardiac surgery including valve surgery, endoscopic vein harvest (using one or two small incisions to harvest the leg vein for bypass surgery), and endovascular (femoral artery) approaches for thoracic aortic aneurysms and traumatic transections of the aorta. There has also been an increase in attempts to repair rather than replace the mitral valve.
We are also witnessing the expansion of the indications for Transcatheter Aortic Valve Replacement (TAVR); a percutaneous way to replace the aortic valve also using a femoral artery approach. New instruments and new devices have made these approaches possible. Perhaps less obvious, but still important has been the improvements in preventative care and looking for ways minimizing the complications of using the heart lung machine by reducing the inflammatory response (cytokine mitigation). Ablation techniques for atrial fibrillation, both by cardiologist and surgeons are improving the lives of many patients with this condition. There have been steady improvements in ventricular assist devices, artificial hearts and transplants.
In congenital cardiac surgery we are also seeing steady improvements in outcomes and safety. The use of the robot in heart surgery has seen a slight growth in the last 10 years with attempts to expand its use from valves to coronary artery bypass and lung resections. Researchers are working on a substitute conduit for the saphenous vein and the mammary artery for coronary bypass grafting. Mechanical coronary anastomotic staplers are still in the experimental stages. And as in many fields of medicine, there has been expanded interest in stem cell use for repairing damaged hearts. The cardiologists’ use of percutaneous coronary interventions with drug eluding stents (PCI) has helped to decrease some of the complications we used to see from myocardial infarctions, and has definitely improved the outcome for selected patients, although many studies still show that surgical revascularization (CABG) remains superior to PCI in a lot of cases.
The medical treatment for heart disease has also improved with newer anti-cholesterol medications and the wider use of beta blockers and along with that reduction in one of the biggest risk factors-smoking. Unfortunately, at the same time we are seeing almost an epidemic rise in obesity and diabetes and this does not bode well in the long run. Sadly many of the great leaders and pioneers in cardiac surgery including Drs. Shumway, Barnard, Sabiston, Cooley, Kirklin, DeBakey and others have passed away during the last 5 to 10 years. I had the chance to meet many of them, albeit briefly, over the years and it is sad to lose such a legacy.
YS: From your perspective as a cardiothoracic surgeon, what are the most impressive innovations in heart surgery?
PM: There have been numerous advances in heart surgery over the last 50 years that includes things like the development of the Heart lung machine by Gibbon, heart and heart-lung transplants that we now almost take for granted, major advances in vascular surgery including endovascular stent repair of thoracic and abdominal aneurysms , development of heart valves both mechanical and tissue valves, the use of pacemakers and implantable cardioverter defibrillators , the introduction of minimally invasive approaches including endoscopic vein harvesting and mini thoracotomy approaches, the recent interventional aortic and mitral valve techniques ( TAVR and Mitral Clip) and of course robotic surgery.
Coronary angioplasty, stents and other percutaneous interventions (PCI) by cardiologists have also had a significant impact. I was a general surgery resident at St. Mary’s hospital in San Francisco in the late 1970s when Dr Richard Myler and Dr Andreas Gruentzig did the first coronary angioplasty in the country. Coincidentally, Dr. Gruentzig had moved to Emory from Zurich by the time I was doing my cardiac surgery training at Emory. Now PCI is taken for granted and there is a standard time for patient presenting with an acute myocardial infarct (STEMI) to be rushed to the cath lab to open a blocked coronary artery, called the “door to balloon time”. This has saved a tremendous number of lives and certainly prevented irreparable damage to heart muscle. There have been other more subtle and perhaps less emphasized advances in heart surgery and these include things like preventative disease interventions ( smoking cessation and diet), the use of beta blockers, statins for cholesterol and better control of hypertension.
The increasing use of large data bases like the VA CICSP (Continuous Improvement in Cardiac Surgery Program) and the STS databases to measure outcomes and reflectively address adverse events, has had a significant impact. The VA deserves a large amount of credit for the contribution it has made to cardiac surgery in this regard. In the 1980s it became obvious that heart surgery results in the VA were less than ideal. In response to this in 1987 the VA introduced the CICSP in which all VA cardiac surgery cases are recorded and analyzed. In 1989 the STS established a similar database which now contains over 6 million cumulative operative records and accounts for over 90% to 95% of adult cardiac surgery performed in the United States. Both of these databases have been enormously helpful in assessing risk and outcome. Results are risk adjusted so program managers get frequent reports listing the observed to expected (O/E) results. The ideal O/E is 1 or less than 1. By using a risk adjusted model we can now compare different programs and their outcomes. These results have been used to benchmark good programs in an effort to help some of the less effective programs. Because these database programs were largely internally generated within the organization they have been strongly supported by members of the organization.
We also have to give credit to the incorporation of highly trained professionals within the team including perfusionists that run the heart lung machine, physician assistants and nurse practitioners that do endoscopic vein harvesting and provide a continuity of care, the cardiac trained anesthesiologists and the experienced and very talented ICU nurses. It is very clear that successful, safe heart surgery is a “team sport”.
YS: Are heart operations safer as compared to 10 years ago?
PM: Yes. Absolutely! I think there is no doubt from the data that cardiac surgery is much safer than it used to be. While the patients nowadays are more likely to be sicker, have multivessel disease, poor ventricular function and more comorbidities, we find from the data that not only are the risk adjusted mortalities less but the unadjusted mortality is also lower. Overall mortality for coronary bypass is now around 1 -2% which is a remarkable achievement.
YS: How important are checklists in cardiac surgery.
PM: Checklists are something else that we have adopted from the airline industry. I have been doing “Time Outs” at the beginning of each case for over 20 years after a near miss with a wrong side VATS lung biopsy. A near miss that was a great learning opportunity. To some extent we have abrogated this responsibility to the nursing staff…. And that is wrong. If the surgeon wants to be the conductor then they need to conduct. We now have outside entities telling us what should be in the “Time Out” and it is becoming so extensive as to be impractical. It is also useless if not everyone is paying attention.
If you want to quickly assess the safety culture of an OR watch how the “time out “is performed.
The WHO has come up with a guideline but I have tried to keep the “Time Out” simple and relevant with a list of “P”s and “Qs”. 1. Is it the right Patient? 2. Are they in the right position and is it the right site/side? 3. Is it the right Procedure, confirming the consent? 4. Are Prophylactic Antibiotics given? 5. Are the Pictures (X-rays or Cath films up and confirm site and procedure)? 6. Are blood Products available? 7. Are all the right prostheses and equipment available and functioning? Q’s > are there any questions or concerns? Before coming off bypass I think it helps to have another checklist: 1. Blood gases including Ph, Po2, Hct (> 20); 2. Core temperature 36C; 3. Rhythm > if not adequate consider pacing wires; 4. Ventilation; 5. TEE assessment of function and or/repair etc.; 6. Surgical sites - no major bleeding.
YS: When you perform open-heart surgery, you are literally taking someone's life in your hands. What advice would you give a doctor preparing for surgery?
PM: My father used to always say “Check and recheck”. I guess it is a bit like the carpenter’s “Measure twice – cut once”. But that simple edict has kept me out of trouble many times. In 2007 Yisrael, you and Pam May published a paper “Protocols, Prompters, Bundles, Checklists and Triggers: Synopsis of a Preventable Mortality Reduction Strategy”, which was finally published in the Journal of Physician Executives and eventually given the recognition it deserved, but it is interesting that the very journals that should have snapped it up initially , the Joint Commission Journal on Quality and Patient Safety and Patient Safety & Quality Healthcare failed to even acknowledge it.
YS: How large is the problem of patient safety in the US healthcare system?
PM: Everybody quotes the 1999 Institute of Medicine report “To Err is Human: Building a Safer Health System”. It suggested that at “least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented…. With costs (including the expense of additional care necessitated by the errors, lost income and household productivity) of between $17 billion and $29 billion per year in hospitals nationwide”. But even before that a 1991 Harvard study published in the New England Journal of Medicine found in a review of more than 30,000 hospital admissions “that nearly 4% of hospital patients suffered complications from treatment which either prolonged their hospital stay or resulted in disability or death, and that two-thirds of such complications were due to errors in care… one percent of admissions, involved actual negligence”.
As a fellow surgeon it is hard to reconcile these facts and come up with a meaningful explanation. Even more challenging is deciding what actions can and should be taken to improve patient safety. Our first response is to try to find who is culpable and who is responsible and punish accordingly. Unfortunately this is usually counterproductive. In 2005 the Australian Council for Safety and Quality in Health Care published their “National Patient Safety Education Framework” with a goal to “provide a simple, flexible and accessible Framework that identifies the knowledge, skills, behaviors, attitudes and performance required by all health care workers in relation to patient safety.” The Chair of the Council Professor Bruce Barraclough, a surgeon went on to say “the Framework is patient-centered. It recognizes that safety is everybody’s business and is relevant for all health care workers at all levels.” That document remains a great resource on patient safety. It addresses some of the issues in developing a patient safety culture.
YS: What are some of the critical factors in developing a high quality culture organization?
PM: Firstly, the leadership is critical and I believe it is impossible to have sustainable high quality patient safety programs without significant physician involvement and physician leadership. So physicians have to get involved and administrators have to find ways to engage the physicians and get them involved in the process. In addition to this, every single member of the staff has to be made to feel that they are a patient advocate. Secondly the patient safety culture has to be hard wired into the organization. That is to say it becomes embedded within the culture of the organization and is not just the flavor of the month. Thirdly, there is a need for consistency and perseverance with clearly defined expectations and effective monitoring and surveillance and appropriate data collection and data sharing. Fourthly, while there has to be some consequences and culpability there also has to be a no fault, blame-free reporting system. Staff have to be able to report concerns about unsafe practices and personnel without fear of reprisal. This involves an effective open and transparent communication strategy. Staff have to know what is the proper reporting system and process.
YS: It can be argued that transparency is a good thing as more information people have, the better. Are there any problems of publication of surgeons’ outcomes?
PM: This has been a real challenge. The STS and NSQIP data have suggested that the program is more important than the individual and this has led to a reluctance to divulge individual surgeon specific data. In fact, I think at the moment releasing individual data is counterproductive. High functioning organizations are highly dependent on a team approach. Surgeons need to be educated and trained as to how to build integrated highly functioning team. The CT surgeon today, particularly if they are employed are much less likely to have much say in which positions are part of the team and more importantly who those team members are.
Again the RVU based compensation has a tendency to develop internal competition both between surgeons within a program and between surgeons and cardiologists. This is not conducive if you are trying to build a high quality patient focused program. Theoretically a salary based non RVU compensation could be helpful in team building.
YS: How do we get physicians to take leadership positions?
PM: We have to ask them and support them and train them for these positions, although we have to be careful we don’t skew the workforce towards non clinical care. The administrative burden in medicine is already way disproportional to what it should be. Recently several for profit and some not for profit hospital chains have been struggling to keep financially solvent. It is interesting that some of these have instituted cost saving measures by cutting out CMO (Chief Medical Officer) positions. HCA seems to be the exception and they are constantly recruiting but having trouble filling CMO positions with good candidates. Interestingly they are doing better than some of the organizations that have minimized physician leadership. There may or may not be a relationship here.
I had the honor of being an associate of the Cleveland Clinic and attended one of their executive programs. Two things about the leadership model at the Cleveland Clinic really impressed me .Firstly the Clinic is physician led and secondly, perhaps even more important than that - they have inculcated a servant leadership model. We are seeing more physicians in CEO positions and I think generally that is a good thing but there is also the danger that they may forget who their real constituents are and become what has facetiously been called “the dark side”. Also remember that every doctor and/or nurse that takes on an administrative role is one clinician delivering patient care.
YS: How do you see the future of heart surgery?
PM: The new catheter interventions for coronary disease and valves will, I think, lead in the future to hybridization between interventional cardiology and cardiac surgery. We have already seen this in vascular surgery, where the vascular surgery residency programs produce graduate surgeons who can now manage vascular disease across the whole spectrum. They do the diagnostic work up, the interventional procedures and the open surgical procedures, and the long term follow up. Being able to integrate a longitudinal care path within one specialty has significant advantages. The cardiac surgery residency programs are now starting to incorporate the catheter based skills in to the training. It remains to be seen whether all the training required catheter skills plus traditional cardiothoracic surgery, can be accomplished in the abbreviated six year programs. These new skills may require additional fellowship training. What I can say is that the future following from the past will be even more exciting and interesting.
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