Catheterization and Cardiovascular Interventions 00:00–00 (2014)
Original Studies Outcomes Using a Clinical Practice Pathway for the Management of Pulse Loss Following Pediatric Cardiac Catheterization Andrew C. Glatz,1,2,3* MD, MSCE, Rachel Keashen,1 MSN, CPNP-AC, Julie Chang,1 CRNP, Lisa-Ann Balsama,1 CVT, Yoav Dori,1,2 MD, PhD, Matthew J. Gillespie,1,2 MD, Therese M. Giglia,1,2 MD, Leslie Raffini,2,4 MD, and Jonathan J. Rome,1,2 MD Objective: Objectives To describe the results of a clinical practice pathway (CPP) for the management of postcatheterization pulse loss in a children’s hospital. Background: Standardized approaches to the diagnosis and management of postcatheterization arterial thrombus are lacking. As a result, substantial practice variation exists. Methods: Data collected prospectively for quality improvement purposes were retrospectively reviewed. Results: Since initiation of the CPP, 93/1,672 (5.4%) catheterizations resulted in pulse loss at a median patient age and weight of 73 days (1 day– 5.8 years) and 4.8 kg (2–14.1 kg). Arterial thrombus was documented by ultrasound (US) in 85. Of these, 66 resolved by 12 weeks of therapy, seven patients died, and four were lost to follow-up before completing treatment. Eight patients had persistent thrombus despite a full treatment course (89% success rate in those able to complete treatment). Of patients treated with unfractionated heparin as initial therapy, 46% (17/ 37) achieved a therapeutic partial thromboplastin time within 12 hr with 19% (67/343) of all levels therapeutic. As a result, the CPP was modified to use enoxaparin as first line agent, of which 57% (41/72) had a therapeutic anti-Xa level after the 2nd dose and 88% by the 4th dose. No bleeding complications were observed. A priori established process metrics were achieved. Conclusions: A CPP utilizing early initiation of anticoagulation and US to aid diagnosis of postcatheterization arterial thrombus and response to therapy is feasible and effective. In those able to complete up to 12 weeks of treatment, resolution occurs in nearly 90%. VC 2014 Wiley Periodicals, Inc. Key words: congenital heart disease/pediatrics; anticoagulants; complications–pediatric catheterization; complications; vascular access
INTRODUCTION
Pulse loss is a well-recognized complication after pediatric cardiac catheterization with previously
reported prevalence rates ranging from 0.6 to 9.6% [1–12], with differences in rates largely explained by differences in case mix and methods of ascertainment.
Division of Cardiology, Children’s Hospital of Philadelphia Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania 3 Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania 4 Division of Hematology, Children’s Hospital of Philadelphia.
*Correspondence to: Andrew C. Glatz, Division of Cardiology, 6th Floor, Main Building, Children’s Hospital of Philadelphia, 34th Street and Civic Center Blvd, Philadelphia, PA 19104. E-mail: [email protected]
Disclosures: Drs. Glatz and Rome are consultants for Bristol-Myers Squibb, Inc.
DOI: 10.1002/ccd.25686 Published online 00 Month 2014 in Wiley Online Library (wileyonlinelibrary.com)
1 2
Conflict of interest: Nothing to report. C 2014 Wiley Periodicals, Inc. V
Received 30 June 2014; Revision accepted 22 September 2014
2
Glatz et al.
Fig. 1. Flowchart depicting the steps of the CPP to manage postcatheterization pulse loss (tPA, tissue plasminogen activator; US, ultrasound).
A number of potential risk factors have been identified from single-center studies [3,5,6,8,9,11,12], including: younger or smaller patient, the use of larger catheters, the need to perform an intervention via the artery, the need for repeat catheterization, various technique factors, and longer procedural time. We recently reported our institutional experience with postcatheterization pulse loss over a 5.5-year period [13], during which time we retrospectively observed an overall prevalence of pulse loss of 3.0%; and 4.3% among only those procedures which utilized femoral arterial cannulation. We identified smaller patient size, the use of larger diameter arterial catheters, the need for arterial catheter exchange, and a procedure-ending activated clotting time less than 250 sec as independent risk factors for pulse loss. Despite these well-recognized rates and risks, standardized approaches to diagnosis and treatment of postcatheterization pulse loss are lacking. There is a brief set of recommendations published as part of a larger consensus statement on antithrombotic therapy in children [14], but these are based on little more than single-center case series data without comparison groups and address only the treatment of the acute arterial injury. As such, they are not systematically applied and a great deal of both center- and practitioner-wide variability exists in the field regarding this issue. To better standardize the diagnosis and management of postcatheterization pulse loss within our own institution, we implemented a clinical practice pathway (CPP) in May of 2010 devised by a multidisciplinary committee of clinicians. The purpose of the current
report is to evaluate our experience with the initial use of the CPP, focusing on process metrics and clinical outcomes. MATERIALS AND METHODS
As part of a continuing quality improvement (CQI) initiative, a CPP was developed by a multidisciplinary committee with the objective of standardizing the diagnosis and management of postcatheterization pulse loss within our institution. Members of the committee included physician representatives from cardiology, interventional cardiology, and hematology; advanced practice nurses from interventional cardiology; and staff members from our catheterization laboratory and postcatheterization recovery unit. The CPP was initially devised and refined over a number of monthly meetings and ultimately implemented and posted to our hospital intranet site in May of 2010. After implementation, process metrics and clinical outcomes were tracked and reviewed at monthly meetings with refinements to the CPP made as deemed necessary. This study is a retrospective analysis of the data collected prospectively as part of this CQI initiative between May, 2010 and September, 2012. The study was approved by the institutional review board with waiver of the need for informed consent. Clinical Practice Pathway The flow of a patient through the CPP is illustrated in Fig. 1. In brief, the pathway is initiated when a
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Pulse Loss Clinical Pathway
3
TABLE I. Dose Adjustment Guidelines for uFH and Enoxaparin Unfractionated heparin PTT (seconds) 120
Enoxaparin
Dose change
Anti-Xa (units/ml)
Dose change
50 units/kg bolus, increase rate by 10% Increase rate by 10% No change Decrease rate by 10% Hold for 30 min, decrease rate by 10% Hold for 60 min, decrease rate by 15%
2
Increase dose by 25% Increase dose by 10% No change Decrease dose by 20% Decrease dose by 30% Hold dose until anti-Xa
Original Studies Outcomes Using a Clinical Practice Pathway for the Management of Pulse Loss Following Pediatric Cardiac Catheterization Andrew C. Glatz,1,2,3* MD, MSCE, Rachel Keashen,1 MSN, CPNP-AC, Julie Chang,1 CRNP, Lisa-Ann Balsama,1 CVT, Yoav Dori,1,2 MD, PhD, Matthew J. Gillespie,1,2 MD, Therese M. Giglia,1,2 MD, Leslie Raffini,2,4 MD, and Jonathan J. Rome,1,2 MD Objective: Objectives To describe the results of a clinical practice pathway (CPP) for the management of postcatheterization pulse loss in a children’s hospital. Background: Standardized approaches to the diagnosis and management of postcatheterization arterial thrombus are lacking. As a result, substantial practice variation exists. Methods: Data collected prospectively for quality improvement purposes were retrospectively reviewed. Results: Since initiation of the CPP, 93/1,672 (5.4%) catheterizations resulted in pulse loss at a median patient age and weight of 73 days (1 day– 5.8 years) and 4.8 kg (2–14.1 kg). Arterial thrombus was documented by ultrasound (US) in 85. Of these, 66 resolved by 12 weeks of therapy, seven patients died, and four were lost to follow-up before completing treatment. Eight patients had persistent thrombus despite a full treatment course (89% success rate in those able to complete treatment). Of patients treated with unfractionated heparin as initial therapy, 46% (17/ 37) achieved a therapeutic partial thromboplastin time within 12 hr with 19% (67/343) of all levels therapeutic. As a result, the CPP was modified to use enoxaparin as first line agent, of which 57% (41/72) had a therapeutic anti-Xa level after the 2nd dose and 88% by the 4th dose. No bleeding complications were observed. A priori established process metrics were achieved. Conclusions: A CPP utilizing early initiation of anticoagulation and US to aid diagnosis of postcatheterization arterial thrombus and response to therapy is feasible and effective. In those able to complete up to 12 weeks of treatment, resolution occurs in nearly 90%. VC 2014 Wiley Periodicals, Inc. Key words: congenital heart disease/pediatrics; anticoagulants; complications–pediatric catheterization; complications; vascular access
INTRODUCTION
Pulse loss is a well-recognized complication after pediatric cardiac catheterization with previously
reported prevalence rates ranging from 0.6 to 9.6% [1–12], with differences in rates largely explained by differences in case mix and methods of ascertainment.
Division of Cardiology, Children’s Hospital of Philadelphia Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania 3 Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania 4 Division of Hematology, Children’s Hospital of Philadelphia.
*Correspondence to: Andrew C. Glatz, Division of Cardiology, 6th Floor, Main Building, Children’s Hospital of Philadelphia, 34th Street and Civic Center Blvd, Philadelphia, PA 19104. E-mail: [email protected]
Disclosures: Drs. Glatz and Rome are consultants for Bristol-Myers Squibb, Inc.
DOI: 10.1002/ccd.25686 Published online 00 Month 2014 in Wiley Online Library (wileyonlinelibrary.com)
1 2
Conflict of interest: Nothing to report. C 2014 Wiley Periodicals, Inc. V
Received 30 June 2014; Revision accepted 22 September 2014
2
Glatz et al.
Fig. 1. Flowchart depicting the steps of the CPP to manage postcatheterization pulse loss (tPA, tissue plasminogen activator; US, ultrasound).
A number of potential risk factors have been identified from single-center studies [3,5,6,8,9,11,12], including: younger or smaller patient, the use of larger catheters, the need to perform an intervention via the artery, the need for repeat catheterization, various technique factors, and longer procedural time. We recently reported our institutional experience with postcatheterization pulse loss over a 5.5-year period [13], during which time we retrospectively observed an overall prevalence of pulse loss of 3.0%; and 4.3% among only those procedures which utilized femoral arterial cannulation. We identified smaller patient size, the use of larger diameter arterial catheters, the need for arterial catheter exchange, and a procedure-ending activated clotting time less than 250 sec as independent risk factors for pulse loss. Despite these well-recognized rates and risks, standardized approaches to diagnosis and treatment of postcatheterization pulse loss are lacking. There is a brief set of recommendations published as part of a larger consensus statement on antithrombotic therapy in children [14], but these are based on little more than single-center case series data without comparison groups and address only the treatment of the acute arterial injury. As such, they are not systematically applied and a great deal of both center- and practitioner-wide variability exists in the field regarding this issue. To better standardize the diagnosis and management of postcatheterization pulse loss within our own institution, we implemented a clinical practice pathway (CPP) in May of 2010 devised by a multidisciplinary committee of clinicians. The purpose of the current
report is to evaluate our experience with the initial use of the CPP, focusing on process metrics and clinical outcomes. MATERIALS AND METHODS
As part of a continuing quality improvement (CQI) initiative, a CPP was developed by a multidisciplinary committee with the objective of standardizing the diagnosis and management of postcatheterization pulse loss within our institution. Members of the committee included physician representatives from cardiology, interventional cardiology, and hematology; advanced practice nurses from interventional cardiology; and staff members from our catheterization laboratory and postcatheterization recovery unit. The CPP was initially devised and refined over a number of monthly meetings and ultimately implemented and posted to our hospital intranet site in May of 2010. After implementation, process metrics and clinical outcomes were tracked and reviewed at monthly meetings with refinements to the CPP made as deemed necessary. This study is a retrospective analysis of the data collected prospectively as part of this CQI initiative between May, 2010 and September, 2012. The study was approved by the institutional review board with waiver of the need for informed consent. Clinical Practice Pathway The flow of a patient through the CPP is illustrated in Fig. 1. In brief, the pathway is initiated when a
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Pulse Loss Clinical Pathway
3
TABLE I. Dose Adjustment Guidelines for uFH and Enoxaparin Unfractionated heparin PTT (seconds) 120
Enoxaparin
Dose change
Anti-Xa (units/ml)
Dose change
50 units/kg bolus, increase rate by 10% Increase rate by 10% No change Decrease rate by 10% Hold for 30 min, decrease rate by 10% Hold for 60 min, decrease rate by 15%
2
Increase dose by 25% Increase dose by 10% No change Decrease dose by 20% Decrease dose by 30% Hold dose until anti-Xa
