Data Transparency and Congenital Heart Disease
Gerard R. Martin, MD, FACC; Jeffrey P. Jacobs, MD, FACC

On June 1, 2015, CNN published an article about transparency of reporting of cardiac surgical outcomes. The story made some important points about the need for transparency with families. We believe that it is important to state that the majority of our colleagues provide excellent pediatric cardiac care, and we are advocates of transparency. We agree with CNN that patients and their families have the right to know the expected outcomes of medical and surgical treatment.

Congenital Heart Disease (CHD) is the most common birth defect and impacts between eight and 12 infants of every 1,000 live births. Many of these infants will require treatment by surgery or catheter based intervention. Over the past 3 decades much progress has been made in team based care (cardiologists, cardiac surgeons, anesthesiologists, intensivists, nurses and all allied health professionals) and survival for the most severely impacted infants has dramatically improved. As a result of these improvements there are now more adults living with CHD than children.

CHD is not one condition, it has several major categories of defects with hundreds if not thousands of variations. This variation makes measuring results difficult but not impossible. Databases to track and benchmark outcomes have been created for the subspecialties of pediatric cardiac surgery, pediatric cardiology, pediatric cardiac anesthesia, and pediatric cardiac critical care:

• Surgeons have led the way with The Society of Thoracic Surgeons Congenital Heart Surgery Database, which is now 21 years old and includes 331,672 records.
• Interventional Cardiologists now have the NCDR’s IMPACT Registry, which is only 5 years old but already has more than 60,000 records.
• Pediatric cardiac anesthesia now uses the Joint Congenital Cardiac Anesthesia Society-Society of Thoracic Surgeons Congenital Cardiac Anesthesia Database.
• Cardiac ICU’s now have both the Pediatric Cardiac Critical Care Consortium (PC4) and the Virtual Pediatric Intensive Care Unit System (VPS).

Comparison of results between centers is now possible as there are now risk adjustment models that allow comparison of apples to apples. Making this data interpretable to families is the next logical step.

As a result of this, we believe it’s important to advise families to ask their doctors to see the data and ask questions. To our CHD colleagues, thank you for your commitment to excellent care to this incredibly important community.

Dr. Martin of the Children’s National Health System, is Senior Vice President of HLK, and Medical Director of Global Services.

Dr. Jacobs is a Professor Surgery at Johns Hopkins University, Director the Andrews/Daicoff Cardiovascular Program, and Surgical Director of Heart Transplantation and Extracorporeal Life Support Programs at Johns Hopkins All Children’s Heart Institute.

---

An Algorithm for Cardiac Arrest
A Review of the Recent Publication in JACC: Tanveer Rab, MD; Michael C. McDaniel, MD

A state-of-the-art review on the management of out-of-hospital cardiac arrest (OHCA) in the resuscitated comatose patient was published in the July 7th, 2015 issue of the Journal of the American College of Cardiology by Rab et al.¹ This important topic was undertaken on behalf of the Interventional Council of the American College of Cardiology (ACC) as currently there are no universal guidelines or consensus documents for the optimal management of these patients who have high mortality, heterogeneous presentations, and few randomized trials to guide management. Furthermore, this topic is timely due to increasing focus on quality initiatives such as pay-for-performance and public reporting of percutaneous coronary intervention (PCI) mortality, which have the potential to create conflicting incentives if clinicians have to select between their patient’s best interest and their own quality metrics.

The highlight of the manuscript is a simplified management algorithm (Figure). First, most comatose patients with OHCA without unfavorable resuscitation features should undergo urgent targeted temperature management (TTM), invasive angiography, and culprit lesion revascularization despite the findings on the initial ECG or neurologic status. Second, given the heterogeneity of comatose patients with OHCA without ST-elevations, emergent consultation with an interventional cardiologist should be undertaken prior to activation of the cardiac catheterization lab to discuss the patient, evaluate for unfavorable resuscitation features, and exclude other causes for the cardiac arrest that are unlikely to benefit from angiography. While there are no absolute predictors of futility, the algorithm lists multiple unfavorable resuscitation features which would predict lower likelihood of meaningful survival and where care should be individualized.

There are several reasons to consider targeted temperature management, invasive angiography, and culprit lesion revascularization in most patients with OHCA. The 2013 ACCF/AHA Guidelines for the Management of ST-segment Elevation Myocardial Infarction (STEMI) endorse these therapies in STEMI after OHCA as class I recommendations, but do not address their role in OHCA with no ST-elevations on ECG.² However, many studies support a similar approach in this population as approximately one fourth of patients with OHCA without ST-elevations have an acute occlusion^3-6 and nearly 60% have significant obstructive lesions at angiography.^6-10 Angiography provides an opportunity to define the coronary anatomy, perform culprit lesion revascularization, as well as hemodynamic assessment and support. Importantly, observational studies have demonstrated that patients resuscitated after OHCA who are referred for early coronary angiography and revascularization have improved outcomes as compared with those patients who are conservatively managed post arrest, and the combination of early coronary angiography and early targeted temperature management might produce the best outcomes.

However, these are observational reports which are frequently confounded, and difficult to adequately control for all factors impacting a physicians’ decision regarding management. While randomized controlled trials of early coronary angiography versus no or late coronary angiography in patients with no ST-elevation on ECG following cardiac arrest are required to make more definite conclusions, the current data suggests proceeding with TTM and invasive coronary angiography in most of these patients.

While emergent angiography and culprit lesion PCI can offer important benefits to comatose patients resuscitated from OHCA, there are concerns that quality improvement initiatives could create conflicting incentives for hospitals and physicians. The National Quality Forum (NQF) has endorsed risk-adjusted total in-hospital PCI mortality and 30-day all-cause risk-standardized PCI mortality with STEMI and/or cardiogenic shock for public reporting.¹¹ Furthermore, some insurance programs offer hospitals financial rewards for low risk-adjusted PCI mortality. While paved with noble intentions, these pay-for-performance and public reporting of mortality can have unintended consequences, potentially promoting risk-adverse behavior that negatively impact the patients who have the most to gain from the procedure. It was noted the adjusted total mortality for patients presenting with STEMI is significantly higher in states with public reporting compared to those without public reporting.¹² This may be in part related to lower utilization of angiography and PCI in patients these patients with STEMI (61.8% vs 68%, OR 0.73; 95% CI 0.59-0.89, p = 0.002) and cardiogenic shock or cardiac arrest (41.5% vs 46.7%; OR 0.79; 95% CI 0.64-0.98, p = 0.03) compared to states that do not publicly report mortality outcomes. Interestingly, in Massachusetts, the rates of PCI were similar to other non-reporting states prior to public reporting, and began to diverge with the start of public reporting.

Given these concerns, the authors endorsed the recommendations set forth in the scientific statement from the American Heart Association: “OHCA cases should be tracked but not publicly reported or used for overall PCI performance ranking, which would allow accountability for their management but would not penalize high-volume cardiac resuscitation centers (CRCs) for following the 2010 AHA Guidelines for CPR and ECC. Until an adequate risk adjustment model is created to account for the numerous out-of-hospital and in-hospital variables that impact survival more than the performance of PCI, we believe that categorizing OHCA STEMI-PCI cases separately from other STEMI-PCI cases should occur. These patients should not be included in public reporting.”¹³

References

1. Rab T, Kern K, Tamis-Holland J, et al. J Am Coll Cardiol. 2015;66:62–73.
2. O’Gara PT, Kushner FG, Ascheim DD, et al. J Am Coll Cardiol. 2013;61:e78-e140.
3. Hollenbeck RD, McPherson JA, Mooney MR, et al. Resuscitation. 2014;85:88-95.
4. Radsel P, Knafelj R, Kocjancic S, et al. JACC. 2011;108:634-8.
5. Strote JA, Maynard C, Olsufka M, et al. JACC. 2012;109:451-4.
6. Merchant RM, Abella BS, Khan M, et al. Resuscitation. 2008;79:398-403.
7. Dumas F, Cariou A, Manzo-Silberman S, et al. Circulation: Cardio Interv. 2010;3:200-7.
8. Reynolds JC, Callaway CW, El Khoudary SR, et al. J Intensive Care Med. 2009;24:179-86.
9. Bro-Jeppesen J, Kjaergaard J, Wanscher M, et al. Eur Heart J: Acute Card Care. 2012;1:291-301.
10. Anyfantakis ZA, Baron G, Aubry P, et al. Am Heart J. 2009;157:312-8.
11. Dehmer GJ, Drozda JP, Brindis RG, et al. J Am Coll Cardiol. 2014;63:1239-45.
12. Joynt KE, Blumenthal DM, Orav E, et al. JAMA. 2012;308:1460-8.
13. Peberdy MA, Donnino MW, Callaway CW, et al. Circulation. 2013;128:762-773.

Keywords: Cardiac Surgical Procedures, Heart Defects, Congenital, Out-of-Hospital Cardiac Arrest, CardioSource WorldNews Interventions

< Back to Listings