National Surgical, Obstetric, and Anesthesia Plans: Bridging the Cardiac Surgery Gap.

Six billion people worldwide lack access to safe, timely, and affordable cardiac surgical care when needed, despite cardiovascular diseases remaining the world's leading cause of mortality. The large surgical backlog of rheumatic heart disease, stable and high incidence of congenital heart disease, and growing burden of ischemic heart disease around the world calls for urgent scaling of cardiovascular services beyond mere prevention. National Surgical, Obstetric, and Anesthesia Plans are being developed by countries as holistic health systems interventions to increase access to surgical care, but to date, limited to no attention has been given to the inclusion of cardiovascular care.

Malpractice litigation in cardiac surgery: Alleged injury mechanisms and outcomes.

BACKGROUND AND AIM: The feared prospect of involvement in malpractice litigation ultimately becomes a reality for many physicians in high-risk specialties such as cardiothoracic surgery. This study systematically analyzes malpractice claims by procedure type and alleged injury mechanism. METHODS: An extensive nation-wide database of medical malpractice claims was searched, and 140 involving cardiac procedures were identified. The primary reason for the lawsuit was classified as a periprocedural injury, postoperative mismanagement, failure to operate in a timely manner or at all, performing an unnecessary procedure, performing a procedure too soon, lack of informed consent, or patient abandonment. RESULTS: Cardiac surgeons were defendants in 47.8% of cases and cardiologists in 56.4%. Forty percent of cases involved coronary artery bypass grafting, valvular surgery, or both; 50% of these received defendant verdicts. The most common reason for the lawsuit was periprocedural injury, most frequently due to poor prosthetic valve fit/securement (23.1%) or surgical site infection (15.4%). For congenital cases, most lawsuits alleged periprocedural injury, with perfusion-related issues (cooling during circulatory arrest, failure to inform surgeon about poor oxygenation) cited in 37.5%. Cardiologists and cardiothoracic or vascular surgeons were codefendants in 14.3% of cases, most commonly coronary artery bypass grafting (40%) or cardiac catheterizations (25%). In all catheterization cases, the allegation against the surgeon was a failure to diagnose/treat the complication in a proper or timely manner. In postoperative mismanagement cases, bleeding/tamponade was the most common allegation category (31.8%). CONCLUSIONS: A careful review of cardiac surgical malpractice litigation can identify common contributory factors to adverse patient outcomes and catalyze practice improvement.

Malpractice litigation in the endovascular era.

OBJECTIVE: The standard of care in the treatment of vascular disease continues to evolve as endovascular therapies develop. Currently, it is unclear how medical malpractice litigation has adapted to the "endovascular era." This retrospective case review is the most comprehensive analysis to date of malpractice actions involving endovascular procedures performed by vascular surgeons (VSs), interventional radiologists (IRs), interventional cardiologists (ICs), and cardiothoracic surgeons (CTSs). METHODS: The legal databases LexisNexis and Westlaw were searched for all published legal cases in the United States involving endovascular procedures. The search was limited to state and federal cases up to and including the year 2016. Keywords included "malpractice," "vascular," "endovascular," "catheter," "catheterization," "stent," "angiogram," "angiography," and "surgery." Cases involving tax revenue, insurance disputes, Social Security Disability, and hospital employment contract disputes were excluded. Data were analyzed using χ2 test. RESULTS: There were 2115 initial search results identified, and 369 cases were included in final analysis. The rate of endovascular procedure-related lawsuits (per 1000 active physicians in the specialty) was highest for ICs (105.56), whereas rates for VSs and IRs were comparable (18.47 and 16.85, respectively); 93% of the IC cases were related to coronary interventions. Overall, 55% (148/271 classifiable cases) of actions were related to elective procedures. For VSs specifically, 46% (25/54) of cases arose from diagnostic angiography and inferior vena cava filter placement, two relatively minor procedure types. Overall, 83% (176/211 finalized cases) of verdicts favored defendants, with no significant differences across the specialties; 43% (157/368) of total cases involved death of the patient. Among the four specialties, there was a significant (P = .0004) difference in the primary allegation (informed consent, preprocedure negligence, intraprocedure complications, or postprocedure complications) underlying the litigation. For CTSs and VSs, there was a predominance of informed consent and preprocedure negligence allegations (70% [7/10] and 52% [28/54], respectively). Intraprocedure negligence was the most common allegation for IRs (59% [23/39]), whereas allegations were more evenly distributed among ICs. CONCLUSIONS: Key issues were identified regarding malpractice litigation involving the specialties that commonly perform endovascular procedures. Despite the increasing number of ICs doing peripheral interventions, a large majority of IC cases were related to coronary treatments. A surprisingly large percentage of VS cases were related to seemingly minor cases. There were significant interspecialty differences in the primary underlying allegations. As the scope of endovascular procedures broadens and deepens, it is important for clinicians to be aware of legal considerations relevant to their practice.

Grundvoraussetzungen herzchirurgischer Einheiten zur Behandlung von Patienten mit angeborenen Herzfehlern.

This document defines fundamental structures of congenital cardiac surgery departments in Germany. It has been developed by the executive boards of the German Society for Thoracic and Cardiovascular Surgery (GSTCVS) and the German Society of Pediatric Cardiology (GSPC) in collaboration with the working group for Congenital and Pediatric Heart Surgery of the GSTCVS.This updated consensus paper is based on a previous publication of the European Association for Cardiothoracic Surgery (EACTS) and is a refinement and adaptation of its initial version published by the GSTCVS in 2005. In Germany, pediatric cardiology and cardiac surgery facilities caring for patients with congenital cardiac defects are subject to certain regulations. For example, in 2010 the Federal Joint Committee implemented the resolution on Quality Assurance Measures in the Provision of Cardiac Surgical Care for Children and Adolescents (directive congenital cardiac surgery) which regulates structural and process quality compulsorily. To date, fundamental and considerable differences of the respective departments persist.Congenital cardiac surgery departments have to provide the whole spectrum of the cardiac surgical therapy from the neonate to the adult with congenital cardiac defects (with the exception of heart transplantation) continuously and with the appropriate experience. Furthermore, the departments have to prove their constant scientific activity and ensure that they facilitate education and training for the specialty certification in cardiac surgery. The responsible surgeons of all congenital cardiac surgery departments commit to participate in the currently voluntary national quality assurance for congenital cardiac defects of the GSTCVS and the GSPC and perform an individual surgical outcome assessment and risk stratification. This is supplemented by the willingness for external certification specific to the individual and the facilitation of peer review procedures for quality assurance purposes. Additional measures, such as collaboration in clinical research and ongoing interdisciplinary education and training, are preferable.

[Medico-legal implications of infections during interventionnal cardiology procedure]. / Conséquences médico-légales des infections en cardiologie interventionnelle.

Nosocomial infections in interventional cardiology are rare, but their extreme severity is responsible for medico-legal issues. By the will of the legislator, it should be understood that, as soon as the nosocomial nature of an infection has been recognized, the victims will almost systematically obtain compensation. The payer will be determined by the level of seriousness of the infection and the existence or not of a possible fault. To avoid a conviction, the care teams must compel themselves to respect the recommendations of the professional societies, but also to ensure a perfect traceability of the prophylactic measures. Particular attention must be paid to the management of the vascular approach. Finally, it is essential to inform patients and all those involved in the healthcare chain of the need to get in touch with the intervention team if suspicious signs of an infection appear, to allow for specialized cares.

Advancing the Culture of Patient Safety and Quality Improvement.

The American health care system has many great successes, but there continue to be opportunities for improving quality, access, and cost. The fee-for-service health care paradigm is shifting toward value-based care and will require accountability around quality assurance and cost reduction. As a result, many health care entities are rallying health care providers, administrators, regulators, and patients around a national imperative to create a culture of safety and develop systems of care to improve health care quality. However, the culture of patient safety and quality requires rigorous assessment of outcomes, and while numerous data collection and decision support tools are available to assist in quality assessment and performance improvement, the public reporting of this data can be confusing to patients and physicians alike and result in unintended negative consequences. This review explores the aims of health care reform, the national efforts to create a culture of quality and safety, the principles of quality improvement, and how these principles can be applied to patient care and medical practice.

Cardiac surgeons and the quality movement: the Michigan experience.

The Michigan Society of Thoracic and Cardiovascular Surgeons created a voluntary quality collaborative with all the cardiac surgeons in the state and all hospitals doing adult cardiac surgery. Utilizing this collaborative over the last 3 years and creating a unique relationship with a payor, an approach to processes and outcomes has produced improvements in the quality of care for cardiac patients in the state of Michigan.

Ninety-Day Readmissions of Bundled Valve Patients: Implications for Healthcare Policy.

Medicare's Bundle Payment for Care Improvement (BPCI) Model 2 groups reimbursement for valve surgery into 90-day episodes of care, which include operative costs, inpatient stay, physician fees, postacute care, and readmissions up to 90 days postprocedure. We analyzed our BPCI patients' 90-day outcomes to understand the late financial risks and implications of the bundle payment system for valve patients. All BPCI valve patients from October 2013 (start of risk-sharing phase) to December 2015 were included. Readmissions were categorized as early (≤30 days) or late (31-90 days). Data were collected from institutional databases as well as Medicare claims. Analysis included 376 BPCI valve patients: 202 open and 174 transcatheter aortic valves (TAVR). TAVR patients were older (83.6 vs 73.8 years; P = 0.001) and had higher Society of Thoracic Surgery predicted risk (7.1% vs 2.8%; P = 0.001). Overall, 18.6% of patients (70/376) had one-or-more 90-day readmission, and total claim was on average 51% greater for these patients. Overall readmissions were more common among TAVR patients (22.4% (39/174) vs 15.3% (31/202), P = 0.052) as was late readmission. TAVR patients had significantly higher late readmission claims, and early readmission was predictive of late readmission for TAVR patients only (P = 0.04). Bundled claims for a 90-day episode of care are significantly increased in patients with readmissions. TAVR patients represent a high-risk group for late readmission, possibly a reflection of their chronic disease processes. Being able to identify patients at highest risk for 90-day readmission and the associated claims will be valuable as we enter into risk-bearing episodes of care agreements with Medicare.

Neurologic Injury Predicts Plaintiff Award in Federal Cardiac Surgery Trials.

BACKGROUND: Cardiothoracic surgery is one of the more highly litigated medical specialties. The incidence and outcomes of federal cases related to cardiac surgery have not been previously explored. METHODS: A legal research service was queried for cardiac surgery-related terms. Citations and related documents were reviewed for relevance and case details. Inclusion criteria were federal district court cases involving cardiac operations. Exclusion criteria were rulings on solely procedural matters. Associations were explored using the Fisher exact test. RESULTS: Of 354 unique citations from 1956 to 2017, 19.2% (n = 68) met criteria. The highest number of cases (25% [n = 17]) were litigated in the Third Circuit. Operations involved coronary artery bypass grafting in 33.8% (n = 23), valves in 32.4% (n = 22), and congenital operations in 19.1% (n = 13). Litigation was prompted by media reporting in 10.3% (n = 7) and involved neurologic injury in 17.6% (n = 12), death in 33.8% (n = 23), and informed consent issues in 29.4% (n = 20). Findings were summary judgment for the defendant in 45.6% (n = 31), partial summary judgment in 17.6% (n = 12), dismissal in 27.9% (n = 19), and ruling for the plaintiff in 7.4% (n = 5). Of the rulings for the plaintiffs, damages had a median dollar amount of $591,300 (interquartile range, $214,2673.50 to $5,807,687.00]. In Fisher's exact test analysis, neurologic injury was significantly associated with ruling for the plaintiff (p < 0.01); death, surgeon defendant, surgical decision-making/conduct, and adult cardiac case type were not associated. CONCLUSIONS: Federal cardiac malpractice court cases are rare. Rulings in favor of the plaintiff, although also rare, are associated with neurologic injury. A comprehensive picture of cardiac surgery-related litigation will require advances in data abstraction techniques and codification.

National Survey of UK Consultant Surgeons' Opinions on Surgeon-Specific Mortality Data in Cardiothoracic Surgery.

BACKGROUND: In the United Kingdom, cardiothoracic surgeons have led the outcome reporting revolution seen over the last 20 years. The objective of this survey was to assess cardiothoracic surgeons' opinions on the topic, with the aim of guiding future debate and policy making for all subspecialties. METHODS AND RESULTS: A questionnaire was developed using interviews with experts in the field. In January 2015, the survey was sent out to all consultant cardiothoracic surgeons in the United Kingdom (n=361). Logistic regression, bivariate correlation, and the χ(2) test were used to assess whether there was a relationship between answers and demographic variables. Free-text responses were analyzed using the grounded theory approach. The response rate was 73% (n=264). The majority of respondents (58.1% oppose, 34.1% favor, and 7.8% neither) oppose the public release of surgeon-specific mortality data and associate it with several adverse consequences. These include risk-averse behavior, gaming of data, and misinterpretation of data by the public. Despite this, the majority overwhelmingly supports publication of team-based measures of outcome. The free-text responses suggest that this is because most believe that quality of care is multifactorial and not represented by an individual's mortality rate. CONCLUSIONS: There is evident opposition to surgeon-specific mortality data among UK cardiothoracic surgeons who associate this with several unintended consequences. Policy makers should refine their strategy behind publication of surgeon-specific mortality data and possibly consider shift toward team-based results for which there will be the required support. Stakeholder feedback and inclusive strategy should be completed before introducing major initiatives to avoid unforeseen consequences and disagreements.

Nursing, knowledge and power: a case analysis.

This paper is concerned with events that were the subject of an inquest (The report of the Manitoba pediatric cardiac surgery inquest: an inquiry into twelve deaths at the Winnipeg Health Sciences Centre in 1994, Provincial Court of Manitoba, Winnipeg) into the deaths of 12 children who died while undergoing or shortly after having undergone cardiac surgery at the Winnipeg Health Sciences Centre, Man., Canada, during 1994. A notable finding of this inquest was that nurses involved with the pediatric cardiac surgery program were concerned about the competence of the surgeon and made sustained efforts throughout 1994 to have these concerns addressed. That the nurses' concerns were not taken seriously is the central problem of this paper. The work of Foucault is used to set out a ground for thinking about this problem. In this case, knowledge practices, specifically those concerning who can claim status as a credible knower, produced limits for nurses. Such limits are neither good nor bad in themselves, but rather have effects with which we must be concerned. In this case, the limits produced by certain knowledge practices had the effect of rendering the nurses' concerns irrelevant and this is significant in itself and also because it was an important part of how patient care was allowed to be compromised.

[Is heart surgery in the Netherlands sufficiently safe?]. / Is hartchirurgie in Nederland veilig genoeg?

Recently the media, including this journal, paid attention to some cases of true or alleged failure of open heart surgery, i.e. mortality due to heart valve replacement, poor outcome in paediatric heart surgery (the so-called Bristol affair), and a series of failed Björk-Shiley mechanical heart valves, thereby questioning the safety of heart surgery. Viewed from a safety perspective, there is a need for criteria for safety assessment of health care services, initiatives aiming at staff exchange and transparency of performance data, and the role of safety committees and safety management plans. Medicolegal developments illustrate the increasing relevance of risk information for patients based on physician experience and hospital performance with respect to maintaining safety standards.

A technical review of the United Kingdom National Adult Cardiac Surgery Governance Analysis 2008-11.

The Society for Cardiothoracic Surgery in Great Britain and Ireland (SCTS) has published named mortality data since 2001. The importance of accurate and robust clinical outcome reporting has been emphasized by a number of high-profile cases in England. In this article, we give a technical review of the United Kingdom National Adult Cardiac Surgery Governance Analysis 2008-11. The statistical and analytical assumptions and methods are discussed in order to add an additional layer of transparency to the clinical governance process and precipitate scrutiny with the aim of optimizing future analyses.

The Affordable Care Act: implications for cardiothoracic surgery.

The Affordable Care Act legislation that was passed by the US Congress and signed into law by President Obama on March 23, 2010 is having a substantial effect throughout all of health care in the United States. Cardiothoracic surgeons, as hospital-based procedural specialists, bring unique assets and certain important liabilities into this massive restructuring of our health care delivery system. This article highlights how each of the 10 titles in the Obamacare legislation might affect our specialty; its collaborative relationship with our cardiovascular, medical specialty, and primary care colleagues; and our clinical practice roles and responsibilities in accountable care organizations and primary care medical homes. This article also addresses the unique assets in clinical data in medicine and quality improvement demonstrated by our specialty that have been used to help shape the current and future landscape. Finally, key resources are identified to allow the cardiothoracic community to monitor the ongoing progress of Obamacare as implementation begins. Keeping abreast of these rapidly changing developments will be an important role for our specialty societies and for practitioners alike going forward.