Catheter Cardiovasc Interv. 2012 Oct 1;80(4):663-72.
Safety and efficacy of balloon pulmonary valvuloplasty: A Multicenter Experience.
Holzer RJ, Gauvreau K, Kreutzer J, Trucco SM, Torres A, Shahanavaz S, Bergersen L.
METHODS: Prospective data collection. C3PO Registry. Cases performed between 02/07 and 06/10 at eight institutions. The registry was queried for cases of isolated BPV.
RESULTS:
211 cases were included (45%, Less than 1 month old).
Procedural success was achieved in 91% procedures, being defined as one of the following:
(i) post-BPV peak systolic valvar gradient to < 25 mm Hg (88%),
(ii) decrease in gradient by 50% (79%), or
(iii) reduction of RV/systemic pressure ratio by 50% (45%).
Procedural success was more common in neonates, when compared to older patients (96% vs. 87%, P = 0.03).
Procedure failure - Risk factors included (i) moderate or severe pulmonary valve thickening (OR 2.9, CI 1-8.3), and (ii) presence of supravalve PS (OR 9.6, CI 2.7-33.8).
Adverse events:
Low severity AEs (levels 1-2) occurred in 9% of patients.
Higher severity AEs (levels 3-5) occurred in 3% of patient.
No deaths.
Risk factors for any AE (levels 1-5) were (i) age below 1 month (OR 3.5, CI 1.3-8.9) and (ii) operator experience of less than 10 years (OR 3.8, CI 1.5-9.9).
CONCLUSIONS: Procedural success is common and AEs, especially higher severity AEs, are rare for BPV in patients with isolated PS. Results have improved considerably when compared to historical data.
© 2012 Wiley Periodicals Inc.
Showing posts with label Adverse reaction. Show all posts
Showing posts with label Adverse reaction. Show all posts
Sunday, October 14, 2012
Wednesday, April 27, 2011
Balloon Pulmonary Angioplasty - Adverse reactions (C3PO group)
Balloon Angioplasty and Stenting of Branch Pulmonary Arteries
Adverse Events and Procedural Characteristics: Results of a Multi-Institutional Registry
Ralf J. Holzer, et al.
Circ Cardiovasc Interv Apr 26, 2011 (Pub ahead of print)
Background—Pulmonary artery (PA) balloon angioplasty and/or stenting (PA rehabilitation) is one of the most common procedures performed in the cardiac catheterization laboratory, but comprehensive and consistently reported data on procedure-related adverse events (AE) are scarce.
Methods and Results—Data were prospectively collected using a multicenter registry (Congenital Cardiac Catheterization Project on Outcomes). All cases that included balloon angioplasty and/or stent implantation in a proximal or lobar PA position were included. Multivariate analysis was used to evaluate for independent predictors of AE and need for early reintervention. Between February 2007 and December 2009, 8 institutions submitted details on 1315 procedures with a PA intervention. An AE was documented in 22% with a high severity (level 3 to 5) AE in 10% of cases. Types of AE included vascular/cardiac trauma (19%), technical AE (15%), arrhythmias (15%), hemodynamic AE (14%), bleeding via endotracheal tube/reperfusion injury (12%), and other AE (24%). AE were classified as not preventable in 50%, possibly preventable in 41%, and preventable in 9%. By multivariate analysis, independent risk factors for level 3 to 5 AE were presence of ≥2 indicators of hemodynamic vulnerability, age below 1 month, use of cutting balloons, and operator experience of <10 years. Reintervention during the study period occurred in 22% of patients undergoing PA rehabilitation.
Conclusions—PA rehabilitation is associated with a 10% incidence of high-level severity AE. Hemodynamic vulnerability, young age, use of cutting balloons, and lower operator experience were significant independent risk factors for procedure-related AE.
Link to article
Adverse Events and Procedural Characteristics: Results of a Multi-Institutional Registry
Ralf J. Holzer, et al.
Circ Cardiovasc Interv Apr 26, 2011 (Pub ahead of print)
Background—Pulmonary artery (PA) balloon angioplasty and/or stenting (PA rehabilitation) is one of the most common procedures performed in the cardiac catheterization laboratory, but comprehensive and consistently reported data on procedure-related adverse events (AE) are scarce.
Methods and Results—Data were prospectively collected using a multicenter registry (Congenital Cardiac Catheterization Project on Outcomes). All cases that included balloon angioplasty and/or stent implantation in a proximal or lobar PA position were included. Multivariate analysis was used to evaluate for independent predictors of AE and need for early reintervention. Between February 2007 and December 2009, 8 institutions submitted details on 1315 procedures with a PA intervention. An AE was documented in 22% with a high severity (level 3 to 5) AE in 10% of cases. Types of AE included vascular/cardiac trauma (19%), technical AE (15%), arrhythmias (15%), hemodynamic AE (14%), bleeding via endotracheal tube/reperfusion injury (12%), and other AE (24%). AE were classified as not preventable in 50%, possibly preventable in 41%, and preventable in 9%. By multivariate analysis, independent risk factors for level 3 to 5 AE were presence of ≥2 indicators of hemodynamic vulnerability, age below 1 month, use of cutting balloons, and operator experience of <10 years. Reintervention during the study period occurred in 22% of patients undergoing PA rehabilitation.
Conclusions—PA rehabilitation is associated with a 10% incidence of high-level severity AE. Hemodynamic vulnerability, young age, use of cutting balloons, and lower operator experience were significant independent risk factors for procedure-related AE.
Link to article
Tuesday, April 19, 2011
Risk Categories in Cath Procedures
Circulation: Cardiovascular Interventions.
2011; 4: 188-194
Procedure-Type Risk Categories for Pediatric and Congenital Cardiac Catheterization
Lisa Bergersen, MD, MPH, Kimberlee Gauvreau, ScD, Audrey Marshall, MD, Jacqueline Kreutzer, MD, Robert Beekman, MD, Russel Hirsch, MD, Susan Foerster, MD, David Balzer, MD, Julie Vincent, MD, William Hellenbrand, MD, Ralf Holzer, MD, John Cheatham, MD, John Moore, MD, James Lock, MD and Kathy Jenkins, MD, MPH
Abstract
Background— The Congenital Cardiac Catheterization Project on Outcomes (C3PO) was established to develop outcome assessment methods for pediatric catheterization.
Methods and Results— Six sites have been recording demographic, procedural and immediate outcome data on all cases, using a web-based system since February 2007. A sample of data was independently audited for validity and data completeness. In 2006, participants categorized 84 procedure types into 6 categories by anticipated risk of an adverse event (AE). Consensus and empirical methods were used to determine final procedure risk categories, based on the outcomes: any AE (level 1 to 5); AE level 3, 4, or 5; and death or life-threatening event (level 4 or 5). The final models were then evaluated for validity in a prospectively collected data set between May 2008 and December 31, 2009. Between February 2007 and April 2008, 3756 cases were recorded, 558 (14.9%) with any AE; 226 (6.0%) level 3, 4, or 5; and 73 (1.9%) level 4 or 5. General estimating equations models using 6 consensus-based risk categories were moderately predictive of AE occurrence (c-statistics: 0.644, 0.664, and 0.707). The participant panel made adjustments based on the collected empirical data supported by clinical judgment. These decisions yielded 4 procedure risk categories; the final models had improved discrimination, with c-statistics of 0.699, 0.725, and 0.765. Similar discrimination was observed in the performance data set (n=7043), with c-statistics of 0.672, 0.708, and 0.721.
Conclusions— Procedure-type risk categories are associated with different complication rates in our data set and could be an important variable in risk adjustment models for pediatric catheterization.
2011; 4: 188-194
Procedure-Type Risk Categories for Pediatric and Congenital Cardiac Catheterization
Lisa Bergersen, MD, MPH, Kimberlee Gauvreau, ScD, Audrey Marshall, MD, Jacqueline Kreutzer, MD, Robert Beekman, MD, Russel Hirsch, MD, Susan Foerster, MD, David Balzer, MD, Julie Vincent, MD, William Hellenbrand, MD, Ralf Holzer, MD, John Cheatham, MD, John Moore, MD, James Lock, MD and Kathy Jenkins, MD, MPH
Abstract
Background— The Congenital Cardiac Catheterization Project on Outcomes (C3PO) was established to develop outcome assessment methods for pediatric catheterization.
Methods and Results— Six sites have been recording demographic, procedural and immediate outcome data on all cases, using a web-based system since February 2007. A sample of data was independently audited for validity and data completeness. In 2006, participants categorized 84 procedure types into 6 categories by anticipated risk of an adverse event (AE). Consensus and empirical methods were used to determine final procedure risk categories, based on the outcomes: any AE (level 1 to 5); AE level 3, 4, or 5; and death or life-threatening event (level 4 or 5). The final models were then evaluated for validity in a prospectively collected data set between May 2008 and December 31, 2009. Between February 2007 and April 2008, 3756 cases were recorded, 558 (14.9%) with any AE; 226 (6.0%) level 3, 4, or 5; and 73 (1.9%) level 4 or 5. General estimating equations models using 6 consensus-based risk categories were moderately predictive of AE occurrence (c-statistics: 0.644, 0.664, and 0.707). The participant panel made adjustments based on the collected empirical data supported by clinical judgment. These decisions yielded 4 procedure risk categories; the final models had improved discrimination, with c-statistics of 0.699, 0.725, and 0.765. Similar discrimination was observed in the performance data set (n=7043), with c-statistics of 0.672, 0.708, and 0.721.
Conclusions— Procedure-type risk categories are associated with different complication rates in our data set and could be an important variable in risk adjustment models for pediatric catheterization.
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