The Brazilian Society for Cardiovascular Surgery (SBCCV) and Brazilian Society for Extracorporeal Circulation (SBCEC) Standards and Guidelines for Perfusion Practice.

A primary role for clinical medicine societies is to develop standards and guidelines for practice as an instrument to promote safe and effective patient care. The Brazilian Society for Cardiovascular Surgery (SBCCV) represented by its Department for Mechanical Circulatory Assistance (DECAM) and the the Brazilian Society for Extracorporeal Circulation (SBCEC) conducted a careful critical review of current clinical perfusion practices in Brazil. In addition, a literature review focused on patient safety and surgical outcomes in cardiac surgery was performed. This is the first joint initiative of these two societies (SBCCV/SBCEC) to provide a framework for safe and effective clinical perfusion practice for our cardiac surgery patients. The purpose of this pioneering work was to develop guidelines for the perfusion profession and for those involved in cardiopulmonary bypass (CPB) technology in our country. Both the SBCCV and the SBCEC recommend that institutions and clinical teams adopt the standards and guidelines outlined in this text. The standards and guidelines we recommend are based on those published by the published American Society for Extracorporeal Technology (AmSECT) with a phased adoption recommendation set as an achievable goal. Further, we recommend that cardiac surgery programs develop institution-specific protocols to support the clinical use of these guidelines.

The Pioneering Era of Cardiac Surgery

Open heart surgery has developed considerably over the past several decades including numerous pioneering efforts in Brazil regarding biomedical engineering and circulatory support[. Pioneer surgeons, such as John Kirklin, Francis Fontan, Euryclides Zerbini, Adib Jatene, and Denton Cooley were part of our lives and we were able to study their papers, witness their presentations and participate in professional discussions. They are passing away one after another but their work, techniques, experience and wisdom stays with us as their legacy. The impact of their methods profoundly changed the lives of our patients with congenital heart defects, giving them the chance of enjoying a better quality of life. Now, the pioneering era of cardiac surgery has essentially ended in Brazil.

Congenital cardiac surgery is markedly changing and surgeon-centered outcomes are being replaced by team-based efforts with new paradigms requiring an adaptive work environment in institutions where cardiac surgery is performed.

As William Norwood aptly put in his paper, Our Roots, Our Future [, "Institutions are not what they are by historical prerogative: the people walking the halls are responsible for maintaining the legacy and creating new vistas." That being said, we need to continue the initial work of our pioneers and press on upgrading their achievements to ever higher standards. The era we have now entered is no longer about quantity, it is about achieving excellent whole-patient quality outcomes including optimized neurologic outcomes. We must dig deep into issues that impact the quality of outcomes, teamwork and overall transparency in our respective professions.

Reviewing Perfusion Practice: Time to Stop Living in the Past

Brazil has a strong history of innovation that extends back to the earliest days of cardiac surgery when our centers pioneered advances in heart-lung machines (HLMs), cardiac valves, conduit implants, and surgical techniques. Brazil started to produce their own HLMs in 1959 and indeed used one of them to perform the first heart transplantation in South America. These innovations highlighted the teamwork primarily of surgeons and biomedical engineers. This was natural since surgeons and other physicians were the first 'perfusionists'. Additionally, perfusion products, including a series of oxygenators, were developed and manufactured domestically. While we fondly remember these great achievements, we also need to focus on the future. Unfortunately, there are still people living in the past and not adapting to evolving cardiac surgery and perfusion practices. We continue to blame our economic burden for the stagnation of our practice while paying little to no attention to the need for cultural change in the operating room.

Furthermore, clinical perfusion has not been recognized by the government as a distinctive profession until quite recently. Currently, only five professional councils recognize Perfusion as a specialty for their undergraduates: Biology, Biomedicine, Nursing, Pharmacy, and Physiotherapy. These professions do not have a standardized perfusion-specific curriculum. Consequently, perfusionist education and training is heterogenous. Furthermore, it is still the case in Brazil that perfusionists must follow the instructions of surgeons and anesthesiologists. In fact, the conduct of perfusion is only considered a medical act once the perfusion record is signed by the surgeon. This practice risks perfusionists not taking full ownership for the conduct of CPB and that raises serious safety concerns since the surgeon and anesthesiologist have much to attend to during cardiac surgery and the perfusionist is the individual who can best manage extracorporeal support with all of its nuances. These facts support the outdated paradigm whereby perfusionists are essentially asked to follow the instructions of surgeons and anesthesiologists during CPB instead of working collaboratively within a famework of well-developed perfusion practice guidelines. Currently, the SBCEC and the SBCCV are in discussion with the Federal Councils regarding ways for this activity to be uniformly recognized by the Professions and subsequently legalized with a federal law regulating perfusion activities. Brazilian perfusionists must have the education, tools and authority to perform their job and to become active and respected members of the multidisciplinary cardiac surgery team. Several limitations currently exist which impair the advancement of perfusion practice, including educational gaps, a lack of case ownership, and a lack of tools to assess the adequacy of perfusion in real time during surgery. This is a vicious cycle which impacts outcomes and patient safety.

On a positive note, it is important to highlight the progress made by the Brazilian Society of Extracorporeal Circulation. Supported and stimulated by their society, a significant number of Brazilian perfusionists have had the opportunity to attend symposium-based perfusion related courses, exchange experiences with more advanced international programs and to discuss current techniques of extracorporeal circulation with local perfusionists and those from abroad.

In more developed countries, perfusionists have the freedom to choose perfusion products according their performance, their patient population's needs, and the information available in the literature. Each component is selected via an independent decision with the ideal components used to build the circuit. Alternatively, in Brazilian perfusion practice, it is difficult to be objective since product decisions are almost exclusively based on price and subjective preferences due to the lack of scientific publications comparing Brazilian perfusion products with those available in other markets. In our country, oxygenator manufacturers typically provide complimentary HLMs with an agreement that their oxygenator can only be guaranteed on their HLM. There is an obvious conflict of interest with such an agreement. This implied agreement has no scientific basis and, to our knowledge, is not practiced elsewhere which speaks to the need for change in Brazilian cardiac surgery. Again, our culture needs to adapt to end such practices for the benefit of our patients. This is even more of a concern when one notes that the majority of HLMs made and used in Brazil do not have servoregulating safety devices incorporated for arterial flow, cardioplegia delivery, level sensing, and bubble detectors. Servoregulation for HLM functions is not enough. Perfusionists must also be trained to operate the devices. Standards for perfusion practice, including the use of safety devices, must be established and adhered to.

Why are Clinical Perfusion Standards so Important?

The Gritten Report[ published by the University Hospitals of Bristol National Health Service (NHS) Foundation Trust of Great Britain described the death of a five-month-old infant undergoing complex cardiac surgery and was released May 25, 2005. The Root Cause Analysis (RCA) report was led by Mark Gritten, an independent and nationally known NHS senior professional. A police investigation and coroner's inquest labeled the case 'unlawful killing'. In English law, unlawful killing means that the killing was made without lawful excuse and in violation of criminal law including murder, manslaughter, and infanticide. The finding of unlawful killing must be beyond reasonable doubt; that is, the evidence must be overwhelmingly obvious that death would result from the act when all factors are taken into account. Otherwise, a verdict of accidental death or death by misadventure would apply. The death was the result of a calcium overdose by a perfusionist that caused irreversible brain damage and subsequent death the day after surgery. The hospital put safeguards into place immediately to minimize any similar incidents happening again. Also, the National Society of Perfusionists perhaps carried some responsibility for this incident because it does not appear to have disseminated other perfusion incidents between its members.

The report concluded that this was a unique but avoidable incident that resulted in an indictment not just to the perfusionist involved in the accident, but to all perfusionists and the perfusion profession as a whole in Great Britain. Had a similar incident happened in São Paulo or Rio or elsewhere in Brazil, would the SBCEC or SBCCV also be held responsible?

Perfusion practice during cardiovascular surgery is recognized in the international literature as a critical component to successful patient outcomes. Therefore, as medical societies, we have the responsibility to change our culture, our commercial practices, legislation, regulations and whatever else which involves our specialty which can improve patient outcomes[. The intent of our proposed standards and guidelines document is to provide a modern framework for the practice of cardiopulmonary bypass in Brazil that can maximize patient safety and outcomes.

The standards and guidelines document we developed for perfusion practice in Brazil is based on publications from AmSECT[. It focuses on the role of written institutional protocols to dictate clinical practice. We worked on four main subjects:

empowerment of perfusion as profession with a focus on professional qualification and education standards

standardization of perfusion practices

mandatory safety devices

importance of non-technical skills and patient centered team work

Professional Constraints:

Although perfusion is considered a medical act, Perfusion as a profession is still not fully regulated in Brazil. Consequently, the legal responsibility for what happens at the pump is unclear. The surgeon's knowledge of what is actually happening on the pump at all times during an operation depends upon their communications with the perfusionist. The surgeon's signature on the perfusion record is a formality which does not ensure proper care during CPB. This practice jeopardizes the development of a new generation of perfusionists who should be taking ownership for their individual perfusion cases and, of course, introducing the necessary changes to modernize existing clinical practices. The Perfusionist must be responsible for the whole procedure of extracorporeal circulation and be an active member of the cardiac surgery team, as is the case with most enters abroad.

According to the SBCEC, perfusionists are expected to have:

Dedication to the patient

Full integration with the team in which they work

Professional competence

Personal ethical and professional conduct, as well as being zealous, affable, aware and observant.

Considering our context, the effort of publishing this document by the societies SBCCV and SBCEC should be considered as one of most important steps for the future of cardiopulmonary bypass practice in Brazil.

The "holy trinity" for the cardiac surgey patient- perfusionist, surgeon and anesthesist- is a critical issue for optimal outcomes in cardiac surgery. Therefore, publication in Brazil of the Standards and Guidelines for Perfusion Practice aims not only to improve CPB but also to improve overall surgical outcomes as an important quality improvment initiative.

Perfusion and the Pediatric Cardiac Surgery:

In the early 1950s, the pioneers of congenital cardiac surgery, among them- Bigelow, Lewis, Kirklin, Gibbon and others- realized that the time available with hypothermia and inflow occlusion would not be sufficient to safely perform lenghty intracardiac operations and that an extracorporeal support system would be needed. In 1954, Lillehei introduced the technique of controlled cross-circulation, in which a patient's parent functioned as the extracorporeal pump and oxygenator- a system that put both the parent and the child at risk. Therefore, the development of mechanical cardiopulmonary bypass circuits in the late 1950s was an important step for the progress of congenital cardiac surgery. Since then, extracorporeal perfusion circuits have come a long way to the current low prime membrane oxygenators, the use of centrifugal pumps, vacuum-assisted venous drainage, electronic gas blenders, in-line oxygen analyzers and other important devices.

The array and complexity of the equipment, the perfusion techniques to manage a wide variety of patient's age and size along with the broad spectrum of surgical procedures are real challenges that require properly trained and knowledgeable perfusionists.

Because one size does not fit all, the need for a standalone Standards and Guidelines document to perform perfusion for congenital heart surgery is unquestionable and it will in many ways be unique as compared to the one used for the correction of acquired heart disease in adults.

Providing cardiopulmonary support for repair of congenital heart lesions has become a specialty standing on its own. This context should determine the strategies and processes to address these issues; the professionals, administrators, and professional societies should be engaged in planning, setting and articulating the goals of robust pediatric perfusion standards and guidelines to improve the outcomes in pediatric cardiac surgery.

The Brazilian Society for Cardiovascular Surgery (SBCCV) and the Brazilian Society for Extracorporeal Circulation (SBCEC) Standards and Guidelines for Perfusion Practice address perfusion in general. We believe that developing a specific Brazilian Pediatric Perfusion Standards and Guidelines document is essential and that it should be published in the near future to complement this document.

Development of this Document

The Standards and Guidelines for Perfusion Practice will serve as a useful guide for Brazilian cardiac surgical teams to develop institution-specific protocols aimed at improving the reliability, safety, and effectiveness of cardiopulmonary bypass. We are aware that the development of a Standards and Guidelines for Perfusion document alone will not change patient care or outcomes. Safe, reliable, and effective care will be best served through the implementation of institutional protocols based on these standards. SBCCV/SBCEC's Standards and Guidelines for Perfusion Practice reflect the changing landscape for perfusion leading to the safe and optimal provision of cardiopulmonary bypass for our patients as well as a working team-based environment that is supportive of these policies.

We preferred to name this document "Standards and Guidelines for Perfusion Practice" because this terminology is contemporary and coincides with the language used by other professional medical societies, including AmSECT [.

The SBCCV/SBCEC Standards and Guidelines for Perfusion Practice: 2018 is primarily based on a previous document developed by AmSECT, through its Perfusion Quality Committee. Initially, AmSECT developed a draft standard for perfusion entitled the "Essentials for Perfusion Practice, Clinical Function: Conduct of Extracorporeal Circulation," which was originally endorsed by the membership in 1993[, and then reviewed and revised on a number of occasions[. In 2011, the AmSECT Board of Directors (BOD) asked the International Consortium for Evidence-Based Perfusion (ICEBP) subcommittee to review and update the "Essentials and Guidelines" document. The ICEBP conducted a careful review and critique of the document as well as its relevance and purpose, given the focus on patient safety and surgical outcomes. This initiative resulted in a revised joint document entitled, the Report from AmSECT's, International Consortium for Evidence-Based Perfusion American Society of ExtraCorporeal Technology Standards and Guidelines for Perfusion Practice: 2013[. It was developed as an outgrowth of marrying evidence-based practices from the literature with an understanding of the context in which care is currently provided. Quite notably at the same time, the Minimum Standards for Perfusion Practice in Brazil document was developed as an outgrowth of ongoing collaboration with the International Quality Improvement Collaborative for Congenital Heart Surgery (IQIC) which is managed from Boston Children's Hospital and overseen by an international steering committee. Adoption of the Minimum Standards for Perfusion Practice in Brazil document will empower perfusionists to effect change at their institution by working towards practice standards endorsed by their national organizations including minimum safety devices for all cardiopulmonary bypass cases, monitoring devices to help assess the adequacy of perfusion, and promotion of a team-based appoach for the care of cardiac surgical patients. Our vision to improve perfusion practice, and thus patient outcomes, is for the minimum standards to be adopted as soon as possible by Brazilian cardiac surgery teams with the comprehensive list of AmSECT standards phased in as soon as practial given the constraints discussed previously.

Following translation to Portuguese and critical review by colleagues, this final document was presented to the SBCCV and SBCEC for their steering commitiee aproval. A majority of the members of the steering commities of both societies voted to accept this document as an official position for the Standards and Guidelines for Perfusion Practice in Brazil. Both documents are included in this manuscript. The SBCCV and SBCEC endorse this comprehensive report and strongly recommend implementation.

Minimum Standards for Perfusion Practice in Brazil:

Seven standards were identified as the minimum recomendation for perfusion practice. The SBCCV and SBCEC considers these seven standards as mandatory for all cardiac surgical centers (Appendix 1).

SBCCV/SBCEC Comprehensive Standards and Guidelines for Perfusion Practice in Brazil:

The Perfusion Standards listed in Appendix 2 have been modified and adapted to the Brazilian regulatoy agencies' policies and recommendations, by taking The American Society of ExtraCorporeal Technology (AmSECT) Standards and Guidelines as a model[ and translated to Portuguese. The final document consists of 15 areas of practice including 50 Standards and 38 Guidelines (Appendix 1) with the first standard focusing on the development of institutional protocols to support their implementation and use. Each institution must commit to working towards implementing all standards for patients undergoing cardiovascular surgery.

Terminology

The SBCCV and SBCEC would like to point out that cardiac surgery clinicians must understand the terminology used in this report. The meanings of these words, as described in the AmSECT publications, are listed below in order to facilitate understanding and adoption of the Standards and Guidelines[:

Standards: practices, technology, and/or conduct of care that institutions shall meet to fulfill the minimum requirements for cardiopulmonary bypass

Guidelines: recommendation that should be considered and may assist in the development and implementation of protocols

Protocols: an institution-specific written document, derived from professional standards and guidelines, which contains decision and treatment algorithms

In this document, the word shall is used to indicate a mandatory requirement

In this document, the word should is used to indicate a recommendation

In this document, the term surgical care team is used to indicate the components of the system: surgeon, anesthesiologist, perfusionist, nurse, and technicians

CONCLUSION

The SBCCV and SBCEC both recognize the vital need for cultural and clinical changes in the application of cardiopulmonary bypass in Brazil. Cardiac surgery centers must adopt the Minimum Standards For Perfusion Practice in Brazil as soon as possible and work towards adopting the Comprehensive Standards and Guidelines for Perfusion Practice in Brazil moving forward. Ultimately, a team-based approach utilizing nationally endorsed standards will help ensure safe and optimal cardiopulmonary bypass for all our patients and improve outcomes for the complex population we serve.