Portal de Periódicos da CAPES

Incorporating Innovation and New Technology Into Cardiothoracic Surgery

2018; Elsevier BV; Volume: 107; Issue: 4 Linguagem: Inglês

10.1016/j.athoracsur.2018.10.022

1552-6259

Joseph A. Dearani, Todd K. Rosengart, M. Blair Marshall, Michael J. Mack, David R. Jones, Richard L. Prager, Robert J. Cerfolio,

Aortic aneurysm repair treatments

The appropriate implementation of new technology, root cause analysis of “imperfect” outcomes, and the continuous reappraisal of postgraduate training are needed to improve the care of tomorrow’s patients. Healthcare delivery remains one of the most expensive sectors in the United States, and the application of new and expensive technology that is necessary for the advancement of this complex specialty must be aligned with providing the best care for our patients. There are a several pathways to innovation: One is partnering with industry and the other is the investigational laboratory. Innovation and the funding thereof come from both the public and private sector. Most new trials that are likely to impact cardiothoracic surgery are industry-sponsored trials to meet the requirements necessary for regulatory approval. Cost considerations are paramount when considering integration of innovative technology and treatments into a clinical cardiothoracic surgical practice. The value of any new innovation is determined by the quality divided by the cost, and lean initiatives maximize this equation. The importance and implications of conflict of interest have been a concern for physicians, particularly when new technology or procedures are incorporated into clinical practice, and full disclosures by medical professionals and others involved are essential. Our societies and associations provide a platform for presentation and peer-reviewed discussion of new procedures, innovations, and trials and provide a venue for the sharing of knowledge on the highest quality patient care through education and research. The appropriate implementation of new technology, root cause analysis of “imperfect” outcomes, and the continuous reappraisal of postgraduate training are needed to improve the care of tomorrow’s patients. Healthcare delivery remains one of the most expensive sectors in the United States, and the application of new and expensive technology that is necessary for the advancement of this complex specialty must be aligned with providing the best care for our patients. There are a several pathways to innovation: One is partnering with industry and the other is the investigational laboratory. Innovation and the funding thereof come from both the public and private sector. Most new trials that are likely to impact cardiothoracic surgery are industry-sponsored trials to meet the requirements necessary for regulatory approval. Cost considerations are paramount when considering integration of innovative technology and treatments into a clinical cardiothoracic surgical practice. The value of any new innovation is determined by the quality divided by the cost, and lean initiatives maximize this equation. The importance and implications of conflict of interest have been a concern for physicians, particularly when new technology or procedures are incorporated into clinical practice, and full disclosures by medical professionals and others involved are essential. Our societies and associations provide a platform for presentation and peer-reviewed discussion of new procedures, innovations, and trials and provide a venue for the sharing of knowledge on the highest quality patient care through education and research. The specialty of Cardiothoracic Surgery has been associated with innovation and advanced technology since the earliest days of the specialty when cardiopulmonary bypass, the “heart-lung” machine, was successfully applied to the repair of intracardiac defects in the mid 1950s. The first 50 years of heart surgery was characterized by the development of new operations, particularly in the arena of congenital heart surgery, with progressive improvement in outcomes. The next 50 years will be marked by our ability to perform both standard and complex operations with greater precision and near perfect outcomes with smaller and smaller incisions and unique vascular and targeted organ approaches. Patients increasingly expect a perfect operation without complications and a quick return to a (near) normal quality of life after surgery. The appropriate implementation of new technology, root cause analysis of “imperfect” outcomes, and the continuous reappraisal of postgraduate training are needed to improve the care of tomorrow’s patients [1Cerfolio R.J. Minnich D.J. Wei B. Watson C. DeCamp M.M. Achieving a 3-star society of thoracic surgery lobectomy ranking by using continuing process improvement, lean methodology, and root cause analysis.Semin Thorac Cardiovasc Surg. 2017; 29: 550-557Abstract Full Text Full Text PDF Scopus (12) Google Scholar]. Healthcare delivery remains one of the most expensive sectors in the United States, and the application of new and expensive technology that is necessary for the advancement of this complex specialty must be aligned with providing the best care for our patients and be carefully weighed against its ultimate true value and additional costs. There are a several pathways to innovation. One is partnering ideas with industry, whereas the other is taking ideas to the investigational laboratory. When a surgeon is interested in implementing a new procedure or bringing a new technology into his or her practice, it is essential to maintain a proper balance between “what is best” versus “what is new” for the entire practice. The patient will be interested in what is “best” for her or him, and most often “what is best” for the practice is what is “best for the patient.” Usually an operation or procedure that has an established track record (years and decades) with documented early and late mortality rates and associated complication rates is the gold standard by which the new approach must be compared. The applied technology (eg, heart-lung machine) has been established over decades and has gone through many updates and modifications that include the addition of alarms and monitors to improve safety. In addition, methods that reduce volume primes result in the decreased need for transfusion, and during these evolutions the profession of perfusion technology evolved, creating a new field of expertise. Additional examples of “what is best” could be the choice of which prosthetic heart valve provides a long track record of durability and hemodynamic performance or which chemotherapeutic drug provides the best targeted therapy and long-term survival. The patient community relies on, assumes, and trusts that the medical community will steer them in the “best” direction. Because “new” technology or “new” procedures have not yet stood the test of time, it is reasonable to assume that what is new may or may not ultimately turn into what is best. New procedures, new drugs, and new technology will be uniformly embraced by both patient and medical communities when current options have demonstrated mediocre or poor results. Although new technologies and treatment options can be a powerful marketing strategy to draw patients to a practice, it is the essential ethical construct of the medical profession that the surgical and medical teams, relevant departments, and hospital (institution) have the patient's best interest as the priority. In addition, there must be a thorough understanding of the implications and consequences (quality outcomes and financial) in the event that what is new turns out to be worse than what was the “standard.” It is easy to be wowed and/or swayed by new technologies, gadgets, and procedures. However, it is of paramount importance to stay objective about the potential benefits, understand the cost drawbacks and learning curves associated with the change, and avoid potential conflicts of interest (COIs). The value (quality divided by the cost times appropriateness) of the change must remain patient-centric in our decision-making, that is, keep straight “what’s in it for us versus what’s in it for the patient.” Transitioning scientific ideas to clinical practice—from “bench to bedside”—is perhaps the most exciting and rewarding exercise in medical science. At the center of this process is the physician or surgeon scientist, uniquely positioned and armed both with an awareness of the clinical problem and a potential roadmap for the application of its solution and an understanding of basic science sufficient to help guide and focus activities in the laboratory. The pathway from bench to bedside is perhaps the longest of any clinical innovation but often the most rewarding. It often requires both innovation and refinement in the laboratory followed by accrual of probative data gathering in the real world of healthcare delivery to patients. This road is mined with an inordinate number of obstacles, false passageways, and red herrings, so a thorough awareness of the obstacles to progression and an ideal algorithm to circumnavigate these obstacles is critical if potential clinical breakthrough from the laboratory can ever have a place in clinical practice. Perhaps the first and foremost foundational premise of driving from bench to bedside is pragmatism. Translational innovation needs to be applicable to the clinical world in realistic terms and its effects provable in a realistic time frame and/or effect size. For example, if administration of a new drug requires a delivery route that is prohibitively risky, invasive, or costly (eg, requires a craniotomy) relative to its potential benefit, it is unlikely to be supported. Likewise, if the effect size of a new drug, device, or technique is not significantly large enough to yield change in a large enough number of patients over a short enough time period to yield provable benefit, it will be relatively difficult to execute a clinical trial sufficient to validate that innovation. This premise extends to measurable phenotype or therapeutic signal. Work in cardiac angiogenesis, for example, has been hampered over the years because of the lack of an imaging test sufficiently sensitive to demonstrate increased myocardial perfusion corroborating symptomatic improvements seen with treatment interventions—even though exercise tolerance testing provided such evidence. On the other hand these studies have been facilitated by the relatively small “N” and relatively short period of time in which therapeutic effects were produced by such interventions. A related paradigm of the bench to bedside journey is the need for laboratory effects that must also be meaningfully translatable to the clinical scenario. For example in our original exploration of options in the field of therapeutic angiogenesis, we chose to study the heart rather than the peripheral vasculature. This was because although we knew angiogenic mediators could be administered to create collateral vessels to bypass an arterial lesion, it seemed implausible that such therapy could be delivered across a large enough territory to bypass all peripheral atherosclerotic obstructions across a diffuse anatomy that might play a role in peripheral vascular disease. Studies in this field have tended to substantiate this premise. Likewise not only must a proposed strategy be scientifically sound, it must also be a clinically sound therapy. The gene that can be used to “cure” Friedrich’s ataxia has been known for some time, and knockout animals with the disease can be cured of some of its physical stigmata. However in the clinic even though the cardiac manifestations of Friedrich’s ataxia are potentially treatable, there is no pragmatic way to administer the Friedrich’s ataxia gene to the brain of patients to address its most devastating neurologic sequelae. As a clinical cure the sound science of treating Friedrich’s ataxia is severely challenged. As with many endeavors funding is also the key to achieving success of translational research. Competition for such funding is fierce, whether it be from granting agencies, venture capital firms, or private, “angel,” investors so it is imperative that support for any translational innovations is as strong as it can possibly be. This starts with the potential impact of the product. Small ideas are laudable, but it is best to start with big ideas—those that will help many individuals in a significant way or a more limited number of individuals in an even more significant, life-changing way. Often these ideas fall under the US Food and Drug Administration (FDA) approval headings of “breakthrough” or orphan drug status, both of which carry advantages in the regulatory approval process. In this context smaller ideas impacting fewer patients in less significant ways are far less likely to command the interest needed to attract funding that is critical to product development. In the landscape of these many considerations, the final potential obstacle and key leg of the bench to bedside journey is execution, and this largely depends on personnel. In the laboratory this may depend on working with strong collaborators with critical scientific expertise. In the clinical/translational phase this may depend significantly on the innovations team, including a highly competent chief executive officer and leadership team, without whom nearly any translational endeavor is likely to fail. Among the many of this team’s decision points, one of the most important is their choice between single and multisite phase I and II trials, which must balance issues of efficiency, consistency in execution, and standardization of results versus cost and time delay. Errors on one side or the other may doom an otherwise highly successful implementation strategy just as it nears the finish line. All told, however, few endeavors are as stimulating and rewarding as managing the journey from bench to bedside. None is better suited to the task than the surgeon, who frequently command and oversee the clinical challenges of greatest need and exhibiting the greatest opportunity for “delta” including impactful clinical improvement over a short duration. Innovation and the funding thereof come from both the public and private sector. Basic science investigation and some later stage comparative effectiveness trials emanate largely from federally funded sources. However, innovation and funding in the medical device arena, especially as it relates to cardiovascular and thoracic surgery comes mainly from the private sector. Most new medical devices and drugs require regulatory approval before use in human subjects, and therefore regulatory approval trials are necessary. In addition, label expansion of previously approved devices and drugs, which is necessary for medical training and education in the use of those products, also requires sponsor-generated clinical trials. Thus most new trials that are likely to impact cardiothoracic surgery are industry-sponsored trials to meet the requirements necessary for regulatory approval. These trials are generally developed by the trial sponsor and the trial leadership team composed of expert, experienced clinicians in the field in close consultation with the FDA. Trials fall into two main categories: 510K studies in which a new medical device is “substantially equivalent” to an already approved one, termed a “predicate device,” and investigational device exemption (IDE) studies in which there is no predicate device. Devices in the 510K regulatory path require a minimum of data, usually nonrandomized early safety data. IDE studies are usually randomized trials of the new device compared with a control, which is usually the current standard of care for a particular condition. A more recent category of IDE trials is early feasibility studies, which were defined in the FDA guidance document in 2013 [2U.S. Food & Drug Administration. Early Feasibility Studies (EFS) Program. Available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm572934.htm. Accessed December 31, 2017.Google Scholar]. In response to outmigration of medical device innovation from the United States the FDA initiated a new program that allows earlier access to innovative medical devices to investigators and patients in the United States [3Makower J. FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies. Available at https://www.medtecheurope.org/wp-content/uploads/2015/07/01112010_FDA-impact-on-US-medical-technology-innovation_Backgrounder.pdf. Accessed March 7, 2019.Google Scholar]. As of the end of 2017 there were 97 early feasibility or first in human studies approved in the United States of which 39 were in the cardiovascular field. This opportunity to develop and study new medical devices requires close collaboration between device trial sponsors and the clinicians who are leading the clinical trials and performing the studies in patients. Ethical standards exist for disclosure of real or perceived COI between the trial sponsor and clinicians leading and performing the studies. Transparency of relationships to all parties, especially patients, is mandatory. Recently, collaborative approaches between the National Institutes of Health (NIH)-sponsored Cardiothoracic Surgery Trials Network and industry have allowed industry-sponsored trials to be performed within the NIH-supported research trial infrastructure. Currently over 50 sites in the United States, Canada, and Germany participate in NIH- and industry-sponsored trials within the network. The Cardiothoracic Surgery Trials Network has recently received an additional 7 years of funding from the NIH, allowing ample opportunity for future innovation with both industry and the NIH. Cost considerations are paramount when considering integration of innovative technology and treatments into a clinical cardiothoracic surgical practice. The cost of new medical devices and procedures is usually significantly greater, often by multiples, than earlier generation “commoditized” devices and procedures. A recent example includes transcatheter aortic valve replacement in which the new device cost is six to eight times that of a surgically implanted valve and robotic thoracic procedures wherein there are thousands of dollars of “disposables” per case not used in an open thoracic procedure. How can a practice and/or institution justify and implement these additional expenditures? There are a number of ways that innovative technology and procedures can be integrated in a cost-effective manner into clinical practice. The first is by participating in clinical research trials. Trial budgets are negotiated between the trial sponsor and the research organization at a clinical site. A fair budget can usually be negotiated to ensure that a clinical practice or institution does not lose money by participating in the research trials. The Center for Medicare & Medicaid Services (CMS) is required by law to allow full access to clinical research trials to Medicare beneficiaries. Private insurance usually, but not always, follows Medicare’s lead. Any research trial approved by the FDA is covered for reimbursement by Medicare. An important aspect of this coverage is the categoric designation of a medical device by the FDA. If a research trial is designated a Category A, then the trial costs but not the study device are covered, placing a significant burden on the trial site [4Centers for Medicare & Medicaid Services. Medicare Coverage Related to Investigational Device Exemption (IDE) Studies. Available at https://www.cms.gov/Medicare/Coverage/IDE. Accessed December 31, 2017.Google Scholar]. A Category B designation covers the cost of the device in addition to procedure reimbursement. One key factor in individual institutions is whether the research organization is integrated within the hospital cost structure or is separate from administrative and financial standpoints. It is common for reimbursement for FDA IDE trials to go to the research organization rather than the hospital. Unless financial reconciliation between the two organizations within an institution occurs, a hospital may be resistant to research trial participation because of unreimbursed costs. Another method by which the CMS facilitates adoption of innovation of new, novel technology into clinical practice is an additional payment to institutions called “new technology add-on payment” [5Centers for Medicare & Medicaid Services. Acute Inpatient PPS. Available at https://www.cms.gov/medicare/medicare-fee-for-service-payment/AcuteInpatientPPS/index.html. Accessed December 31, 2017.Google Scholar]. Trial sponsors apply to the CMS for this additional payment once a device receives FDA approval for commercial sale. This additional payment allows new technology to be cost competitive or cost neutral with current standard of care devices and procedures, thereby facilitating adoption of the technology. Recent examples of this in the cardiovascular device field include the two recently approved sutureless surgical aortic valves and a transcatheter mitral valve repair device. These additional payments are temporary but mitigate the additional cost of new technology adoption until a new diagnosis-related group is determined by the CMS based on calculated costs. Other “soft” benefits of participation in new technology innovations need to be factored into the calculation of a fiscally responsible research enterprise. This is generically termed a “halo effect,” which can be manifest in a number of ways. Participation in innovative research trials often results in incremental clinical patient and procedure volume as a result of patients being recruited and “screening out” of a particular trial. Other aspects of the halo effect include additional diagnostic testing and procedures performed to determine trial eligibility as well as an increase in posttrial resource utilization such as rehabilitation. Although these are considered soft benefits, they can and should be carefully tracked to judge the cost-effectiveness of the research enterprise to an institution. Other less tangible benefits include raising the profile of an institution, which provides stature in the local market, and helping to improve a hospital rating in national rankings such as the US News and World Report. Ultimately however investment in research and development is a key component of any successful business within or outside of healthcare. The most successful organizations are those who view investment in research and innovation as a core business principle that is necessary to maintain leadership in a particular field. The value of any new innovation is determined by the quality divided by the cost. Lean initiatives maximize this equation. Because of the high cost of healthcare delivery and the wastefulness that has occurred in the past, many healthcare systems have applied the “lean process,” which is the elimination of all wasteful steps in a process. This occurs via value stream mapping of the process and eliminating the nonvalued added steps and streamlining the valued, added ones [6Cerfolio R.J. Steenwyk B.L. Watson C. et al.Decreasing the pre-incision time for pulmonary lobectomy: the process of lean and value stream mapping.Ann Thorac Surg. 2016; 101: 1110-1115Abstract Full Text Full Text PDF PubMed Scopus (26) Google Scholar, 7Cichos K.H. Linsky P.L. Wei B. Minnich D.J. Cerfolio R.J. Cost savings of standardization of thoracic surgical instruments: the process of lean.Ann Thorac Surg. 2017; 104: 1889-1895Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar]. It has been successfully applied in many fields of medicine, particularly to the field of cardiothoracic surgery, and it increasingly will be applied in the future. Standardization is an essential process that reduces variability and has been shown to reduce cost and at the same time improve quality. This by definition will increase the value of healthcare since because is defined as quality divided by cost. For these reasons many specialties in healthcare have developed postoperative “care pathways,” or algorithms that “fast track” patients postoperatively after straightforward operations such as robotic mitral valve repair (Fig 1), coronary artery bypass grafting, or lobectomy [8Cerfolio R.J. Pickens A. Bass C. Katholi C. Fast-tracking pulmonary resections.J Thorac Cardiovasc Surg. 2001; 122: 318-324Abstract Full Text Full Text PDF PubMed Scopus (141) Google Scholar, 9Cerfolio R.J. Bryant A.S. Bass C.S. Alexander J.R. Bartolucci A.A. Fast tracking after Ivor Lewis esophagogastrectomy.Chest. 2004; 126: 1187-1194Abstract Full Text Full Text PDF PubMed Scopus (131) Google Scholar, 10Cook D. Thompson J.E. Habermann E.B. et al.From “solution shop” model to “focused factory: in hospital surgery: increasing care value and predictability.Health Aff (Millwood). 2014; 33: 746-755Crossref PubMed Scopus (51) Google Scholar, 11Suri R.M. Thompson J.E. Burkhart H.M. et al.Improving affordability through innovation in the surgical treatment of mitral valve disease.Mayo Clinic Proc. 2013; 88: 1075-1084Abstract Full Text Full Text PDF PubMed Scopus (34) Google Scholar]. These algorithms are derived from evidenced-based outcomes. The postoperative course can be divided into subparts, and each one can have a protocol for management, for example, an algorithm for postoperative atrial fibrillation or chest tube management. These pre- and postoperative care pathways or algorithms improve the quality of care and at the same time reduce cost [11Suri R.M. Thompson J.E. Burkhart H.M. et al.Improving affordability through innovation in the surgical treatment of mitral valve disease.Mayo Clinic Proc. 2013; 88: 1075-1084Abstract Full Text Full Text PDF PubMed Scopus (34) Google Scholar], reduce errors, reduce variability in the multiple ways of managing a particular problem, and prevent new team members from adding unnecessary tests or steps. The missing link to complete standardization is the intraoperative part of the process, not just the pre- and postoperative pathways. Although it is not feasible or appropriate to standardize every aspect or step of every operation between surgeons, there should be a concerted effort to standardize as much as possible. For example, operations can be categorized on a spectrum of procedures that are highly structured and reproducible (coronary artery bypass grafting, mitral repair, lobectomy, etc), and the setup and orchestration could be identical from one operation to the next (Fig 2) [12Dearani J.A. Gold M. Leibovich B.C. et al.The role of imaging, deliberate practice, structure, and improvisation in approaching surgical perfection.J Thorac Cardiovasc Surg. 2017; 154: 1329-1336Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar]. This allows new team members to be incorporated seamlessly. In contrast some operations require a fair amount of improvisation because they are encountered infrequently or the anatomy is different from case to case (eg, prosthetic valve endocarditis, heart transplant in heterotaxy, etc). These procedures are inherently more difficult to standardize [12Dearani J.A. Gold M. Leibovich B.C. et al.The role of imaging, deliberate practice, structure, and improvisation in approaching surgical perfection.J Thorac Cardiovasc Surg. 2017; 154: 1329-1336Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar], but at a minimum steps in various sections of the procedure (eg, the opening, cannulation, closure, etc) can be nearly identical from case to case. Any system, no matter how complex, can be standardized or mapped to some degree; however the number of variations and/or perturbations all need to be assessed. This facilitates and optimizes efficiency for all team members and limits the number of improvised steps to shorter durations in the middle of the procedure.Fig 2Gold standard–innovation continuum for specific procedures. (CABG = coronary artery bypass grafting; MV = mitral valve; MVR = mitral valve replacement; TAVR = transcatheter aortic valve replacement.)View Large Image Figure ViewerDownload Hi-res image Download (PPT) In our experience these “reproducible” portions of the operation can be taught to a trainee in a predictable manner [13Cerfolio R.J. Cichos K.H. Wei B. Minnich D.J. Robotic lobectomy can be taught while maintaining quality patient outcomes.J Thorac Cardiovasc Surg. 2016; 152: 991-997Abstract Full Text Full Text PDF PubMed Scopus (30) Google Scholar]. In contrast, the more complex sections (ie, the improvised sections) of an operation should be reserved for faculty surgeons or senior trainees so the effectiveness and efficiency of the procedure is not compromised in a way that would be potentially detrimental to patient care. However over time these skills can be taught as well. The role of simulation and the ability to prepare for an operation with the availability of advanced 3-dimensional printed or virtual models cannot be overemphasized [12Dearani J.A. Gold M. Leibovich B.C. et al.The role of imaging, deliberate practice, structure, and improvisation in approaching surgical perfection.J Thorac Cardiovasc Surg. 2017; 154: 1329-1336Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar]. Advances in anatomic imaging, specifically 3-dimensional printed models, can facilitate preoperative practice of the planned surgical procedure. Expert performance, particularly in surgical procedures, requires both deliberate and independent practice. The orchestration of an operation involves “structured” steps (ie, predictable and reproducible) and “improvised” steps (ie, requires spontaneous adaptation because of complexity or unexpected findings). Although every operation involves a combination of both structured and improvised steps, the more structure that can be applied to a procedure, the greater the likelihood of a predictably good outc