Surgical and Catheter-Based Reinterventions Are Common in Long-Term Survivors of the Fontan Operation.

2017

2017 Sep

1941-7632

<p><strong>BACKGROUND: </strong>There are limited follow-up studies examining surgical and catheter-based reinterventions in long-term survivors of the Fontan operation.</p>

<p><strong>METHODS AND RESULTS: </strong>All 773 patients who underwent Fontan at our institution between 1992 and 2009 were retrospectively reviewed. Current information regarding post-Fontan intervention was available for 70%. By 20 years after Fontan, 65% of patients had experienced either surgical or transcatheter intervention. The median time to first reintervention was 9.8 years. Freedom from reoperation was 69% at 15 years and 63% at 20 years. The most common operations were pacemaker placement and Fontan revision. Risk factors for pacemaker placement included systemic left ventricle (hazard ratio [HR], 2.2; P=0.006) and lateral tunnel Fontan (HR, 4.3; P=0.001). Freedom from interventional catheterization was 53% at 15 years and 50% at 20 years. The most common procedures performed were fenestration closure and pulmonary artery intervention. Catheter intervention for anatomic indications was associated with Fontan after 2002 (HR, 2.1; P=0.007), Norwood operation (HR, 2.3; P=0.001), and longer cardiopulmonary bypass time (HR, 1.1 per 10 minutes; P=0.001). Catheter intervention for physiological indications was associated with prolonged post-Fontan pleural drainage (HR, 4.0; P&lt;0.001) and hypoplastic left heart syndrome (HR, 2.0; P=0.01).</p>

<p><strong>CONCLUSIONS: </strong>In this study of Fontan survivors, two thirds of patients required surgical or catheter-based reintervention by 20 years. Families should be counseled that the Fontan is typically not the final stage of single-ventricle palliation.</p>

10.1161/CIRCINTERVENTIONS.116.004924

Circ Cardiovasc Interv

28851719

Parents' Preferences Regarding Public Reporting of Outcomes in Congenital Heart Surgery.

2018

606-11

2018 Feb

1552-6259

<p><strong>BACKGROUND: </strong>Calls for public reporting of outcomes in congenital heart surgery have led to several different reporting schemes, including a star rating system and benchmark procedure-specific mortality data tables. Important unanswered questions remain about the optimal format and content of public reporting of congenital heart surgery outcomes.</p>

<p><strong>METHODS: </strong>In conjunction with three parent advocacy groups, we developed a questionnaire to gauge parents' attitudes regarding the format and content of an "optimal" public reporting scheme. Parents were solicited for participation through email lists of members of parent advocacy groups and from a cohort of parents whose children had undergone an STS benchmark procedure of the Society of Thoracic Surgeons at the Children's Hospital of Philadelphia after January 1,&nbsp;2007.</p>

<p><strong>RESULTS: </strong>The 1,297 responses received provided complete data for analysis. Nearly all the participants were mothers of children with congenital heart disease, and most were white. About half of the children were diagnosed prenatally, and 63% underwent initial repair of the defect in the neonatal period. Parents identified survival statistics, surgeon-specific experience, and complication rates as most important. Presented with three display formats for mortality rates, most parents (89%) identified a numeric procedure-based approach as the best format, and more than half identified the hospital star rating system as the worst format.</p>

<p><strong>CONCLUSIONS: </strong>Parents of children with congenital heart disease identify survival statistics, surgeon-specific experience, and complication rates as the most important outcome measures to report publicly. Additionally, parents preferred mortality data to be presented in a&nbsp;procedure-specific format using a numeric procedure-based approach, as opposed to the star rating system.</p>

10.1016/j.athoracsur.2017.05.043

Ann. Thorac. Surg.

28826991

Value of a flow cytometry crossmatch in the setting of a negative complement-dependent cytotoxicity crossmatch in heart transplant recipients.

2017

2017 Oct

1399-0012

<p>Complement-dependent cytotoxicity crossmatch (CDCXM) is used for evaluation of preformed HLA-specific antibodies in patients undergoing heart transplantation. Flow cytometry crossmatch (FCXM) is a more sensitive assay and used with increasing frequency. To determine the clinical relevance of a positive FCXM in the context of negative CDCXM in heart transplantation, the United Network for Organ Sharing (UNOS) database was analyzed. Kaplan-Meier analysis and Cox proportional hazard modeling were used to assess graft survival for three different patient cohorts defined by crossmatch results: T-cell and B-cell CDCXM+ ("CDCXM +" cohort), CDCXM- but T-cell and/or B-cell FCXM+ ("FCXM+" cohort), and T-cell/B-cell CDCXM- and FCXM- ("XM-" cohort). During the study period, 2,558 patients met inclusion criteria (10.7% CDCXM+, 18.8% FCXM+, 65.5% XM-). CDCXM+ patients had significantly decreased graft survival compared to FCXM+ and XM- cohorts (p=0.003 and &lt;0.001 respectively). CDCXM- and FCXM+ patients did not have decreased graft survival compared to XM- patients (p=0.09). In multivariate analysis, only CDCXM+ was associated with decreased graft survival (HR 1.22, 95% CI 1.01-1.49). In conclusion, positive FCXM in the context of negative CDCXM does not confer increased risk of graft failure. Further study is needed to understand implications of CDCXM and FCXM testing in heart transplant recipients. This article is protected by copyright. All rights reserved.</p>

10.1111/ctr.13064

Clin Transplant

28766759

Effect of Fontan-Associated Morbidities on Survival With Intact Fontan Circulation.

2017

2017 Mar 16

1879-1913

<p>Although survival after the Fontan operation has improved, little is known about the burden of major medical morbidities associated with the modern total cavopulmonary connection (TCPC). A total of 773 consecutive patients who underwent a first Fontan operation at our institution between 1992 and 2009 were retrospectively reviewed. All subjects underwent TCPC (53% lateral tunnel, 47% extracardiac conduit). Median length of follow-up was 5.3&nbsp;years (interquartile range 1.4 to 11.2), and 30% had follow-up &gt;10&nbsp;years. Freedom from a composite medical morbidity outcome (protein-losing enteropathy, plastic bronchitis, serious thromboembolic event, or tachyarrhythmia) was 47% at 20&nbsp;years (95% confidence interval [CI] 38 to 55). Independent risk factors for morbidity included pre-Fontan atrioventricular valve regurgitation (hazard ratio [HR] 1.7, 95% CI 1.2 to 2.4, p&nbsp;= 0.001), pleural drainage &gt;14&nbsp;days (HR 1.5, 95% CI 1.01 to 2.2, p&nbsp;= 0.04), and longer cross-clamp time (HR 1.2 per 10&nbsp;minutes, 95% CI 1.06 to 1.3, p&nbsp;= 0.004) at the time of TCPC. Surgical era, Fontan type, and ventricular morphology were not associated with the composite outcome. Presence of Fontan-associated morbidity was associated with a 36-fold increase in the risk of subsequent Fontan takedown, heart transplantation, or death (95% CI 17 to 76, p &lt;0.001). For patients without any component of the composite outcome, freedom from Fontan failure was 98% at 20&nbsp;years (95% CI 96 to 99). Medical morbidities after TCPC are common and significantly reduce the longevity of the Fontan circulation. However, for those patients who remain free from the composite morbidity outcome, 20-year survival with intact Fontan circulation is encouraging.</p>

10.1016/j.amjcard.2017.03.004

Am. J. Cardiol.

28385177

Long-term survival after the Fontan operation: Twenty years of experience at a single center.

2017

2017 Mar 06

1097-685X

<p><strong>OBJECTIVE: </strong>Existing studies of patients palliated with the Fontan operation are limited by heterogeneous patient populations and incomplete follow-up. This study aimed to describe long-term post-Fontan survival in a modern patient cohort.</p>

<p><strong>METHODS: </strong>All 773 patients who underwent a first Fontan operation at our institution between 1992 and 2009 were reviewed. The primary outcome was the composite endpoint of Fontan takedown, heart transplantation, or death before 2013.</p>

<p><strong>RESULTS: </strong>Follow-up rate was 99.2%. Survival with intact Fontan circulation was 94% at 1&nbsp;year (95% confidence interval [95% CI], 92%-95%), 90% at 10&nbsp;years (95% CI, 88%-92%), 85% at 15&nbsp;years (95% CI, 82%-88%), and 74% at 20&nbsp;years (95% CI, 67%-80%). Distinct risk factors were identified for early (≤1&nbsp;year) and late composite outcomes. Independent risk factors for early outcome included prolonged pleural drainage (hazard ratio [HR], 4.4; P&nbsp;&lt;&nbsp;.001), intensive care unit stay&nbsp;&gt;1&nbsp;week (HR, 2.4; P&nbsp;&lt;&nbsp;.001), Fontan before 1997 (HR, 3.3; P&nbsp;&lt;&nbsp;.001), preoperative atrioventricular valve regurgitation (HR, 2.0; P&nbsp;&lt;&nbsp;.001), and longer crossclamp time (HR, 1.3 per 10&nbsp;minutes; P&nbsp;&lt;&nbsp;.001). Late outcome was predicted by atrioventricular valve regurgitation prior to Fontan (HR, 2.0; P&nbsp;≤&nbsp;.001), and post-Fontan ICU stay&nbsp;&gt;1&nbsp;week (HR, 2.4; P&nbsp;&lt;&nbsp;.001).</p>

<p><strong>CONCLUSIONS: </strong>Long-term mortality after Fontan operation remains substantial. Risk factors for death or loss of Fontan circulation differ between the early and late postoperative periods. Long-term survival has not improved appreciably over the last decade, suggesting that alternatives to the Fontan are warranted.</p>

10.1016/j.jtcvs.2017.01.056

J. Thorac. Cardiovasc. Surg.

28341469

Design and initial results of a programme for routine standardised longitudinal follow-up after congenital heart surgery.

2016

1590-1596

2016 Dec

1467-1107

<p><strong>BACKGROUND: </strong>With improvements in early survival following congenital heart surgery, it has become increasingly important to understand longer-term outcomes; however, routine collection of these data is challenging and remains very limited. We describe the development and initial results of a collaborative programme incorporating standardised longitudinal follow-up into usual care at the Children's Hospital of Philadelphia (CHOP) and University of Michigan (UM).</p>

<p><strong>METHODS: </strong>We included children undergoing benchmark operations of the Society of Thoracic Surgeons. Considerations regarding personnel, patient/parent engagement, funding, regulatory issues, and annual data collection are described, and initial follow-up rates are reported.</p>

<p><strong>RESULTS: </strong>The present analysis included 1737 eligible patients undergoing surgery at CHOP from January 2007 to December 2014 and 887 UM patients from January 2010 to December 2014. Overall, follow-up data, of any type, were obtained from 90.8% of patients at CHOP (median follow-up 4.3 years, 92.2% survival) and 98.3% at UM (median follow-up 2.8 years, 92.7% survival), with similar rates across operations and institutions. Most patients lost to follow-up at CHOP had undergone surgery before 2010. Standardised questionnaires assessing burden of disease/quality of life were completed by 80.2% (CHOP) and 78.4% (UM) via phone follow-up. In subsequent pilot testing of an automated e-mail system, 53.4% of eligible patients completed the follow-up questionnaire through this system.</p>

<p><strong>CONCLUSIONS: </strong>Standardised follow-up data can be obtained on the majority of children undergoing benchmark operations. Ongoing efforts to support automated electronic systems and integration with registry data may reduce resource needs, facilitate expansion across centres, and support multi-centre efforts to understand and improve long-term outcomes in this population.</p>

10.1017/S1047951116001669

Cardiol Young

28148316

Improving Cardiac Surgical Site Infection Reporting and Prevention By Using Registry Data for Case Ascertainment.

2016

190-9

2016 Jan

1552-6259

<p><strong>BACKGROUND: </strong>The use of administrative data for surgical site infection (SSI) surveillance leads to inaccurate reporting of SSI rates [1]. A quality improvement (QI) initiative was conducted linking clinical registry and administrative databases to improve reporting and reduce the incidence of SSI [2].</p>

<p><strong>METHODS: </strong>At our institution, The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) and infection surveillance database (ISD) were linked to the enterprise data warehouse containing electronic health record (EHR) billing data. A data visualization tool was created to (1) use the STS-CHSD for case ascertainment, (2) resolve discrepancies between the databases, and (3) assess impact of QI initiatives, including wound alert reports, bedside reviews, prevention bundles, and billing coder education.</p>

<p><strong>RESULTS: </strong>Over the 24-month study period, 1,715 surgical cases were ascertained according to the STS-CHSD clinical criteria, with 23 SSIs identified through the STS-CHSD, 20 SSIs identified through the ISD, and 32&nbsp;SSIs identified through the billing database. The rolling 12-month STS-CHSD SSI rate decreased from 2.73% (21 of 769 as of January 2013) to 1.11% (9 of 813 as of December 2014). Thirty reporting discrepancies were reviewed to ensure accuracy. Workflow changes facilitated communication and improved adjudication of suspected SSIs. Billing coder education increased coding accuracy and narrowed variation between the 3 SSI sources. The data visualization tool demonstrated temporal relationships between QI initiatives and SSI rate reductions.</p>

<p><strong>CONCLUSIONS: </strong>Linkage of registry and infection control surveillance data with the EHR improves SSI surveillance. The visualization tool and workflow changes facilitated communication, SSI adjudication, and assessment of the QI initiatives. Implementation of these initiatives was associated with decreased SSI rates.</p>

10.1016/j.athoracsur.2015.07.042

Ann. Thorac. Surg.

26410159

Use of administrative data for surgical site infection surveillance after congenital cardiac surgery results in inaccurate reporting of surgical site infection rates.

2014

651-7; discussion 657-8

2014 Feb

1552-6259

<p><strong>BACKGROUND: </strong>The National Healthcare Safety Network (NHSN) is a safety surveillance system managed by the Centers for Disease Control and Prevention that monitors procedure specific rates of surgical site infections (SSIs). At our institution, SSI data is collected and reported by three different methods: (1) the NHSN database with reporting to the Centers for Disease Control and Prevention; (2) the hospital billing database with reporting to payers; and (3) The Society of Thoracic Surgeons Congenital Heart Surgery Database. A quality improvement initiative was undertaken to better understand issues with SSI reporting and to evaluate the effect of different data sources on annual SSI rates.</p>

<p><strong>METHODS: </strong>Annual cardiac surgery procedure volumes for all three data sources were compared. All episodes of SSI identified in any data source were reviewed and adjudicated using NHSN SSI criteria, and the effect on SSI rates was evaluated.</p>

<p><strong>RESULTS: </strong>From January 1, 2008, to December 31, 2011, 2,474 cardiac procedures were performed and reported to The Society of Thoracic Surgeons Congenital Heart Surgery Database. Billing data identified 1,865 cardiac surgery procedures using the 63 CARD International Classification of Diseases-Ninth Revision codes from the NHSN inclusion criteria. Only 1,425 procedures were targeted for NHSN surveillance using the NHSN's CARD operative procedure group in the same period. Procedures identified for NHSN surveillance annually underestimated the number of cardiac operations performed by 17% to 71%. As a result, annual SSI rates potentially differed by 12% to 270%.</p>

<p><strong>CONCLUSIONS: </strong>The NHSN CARD surveillance guidelines for SSI fail to identify all pediatric cardiac surgical procedures. Failure to target&nbsp;all at-risk procedures leads to inaccurate reporting of SSI rates largely based on identifying the denominator. Inaccurate recording of SSI data has implications for public reporting, benchmarking of outcomes, and denial of payment. Use of The Society of Thoracic Surgeons Congenital Heart Surgery Database as the gold standard to identify procedures for surveillance will lead to more accurate reporting of SSI rates.</p>

10.1016/j.athoracsur.2013.08.076

Ann. Thorac. Surg.

24365216