Transplant-Free Survival and Interventions at 6 Years in the SVR Trial
BACKGROUND:In the SVR trial (Single Ventricle Reconstruction), 1-year transplant-free survival was better for the Norwood procedure with right ventricle-to-pulmonary artery shunt (RVPAS) compared with a modified Blalock–Taussig shunt in patients with hypoplastic left heart and related syndromes. At...
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| Veröffentlicht in: | Circulation (New York, N.Y.) N.Y.), 2018-05, Vol.137 (21), p.2246-2253 |
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| creator | Newburger, Jane W Sleeper, Lynn A Gaynor, J William Hollenbeck-Pringle, Danielle Frommelt, Peter C Li, Jennifer S Mahle, William T Williams, Ismee A Atz, Andrew M Burns, Kristin M Chen, Shan Cnota, James Dunbar-Masterson, Carolyn Ghanayem, Nancy S Goldberg, Caren S Jacobs, Jeffrey P Lewis, Alan B Mital, Seema Pizarro, Christian Eckhauser, Aaron Stark, Paul Ohye, Richard G |
| description | BACKGROUND:In the SVR trial (Single Ventricle Reconstruction), 1-year transplant-free survival was better for the Norwood procedure with right ventricle-to-pulmonary artery shunt (RVPAS) compared with a modified Blalock–Taussig shunt in patients with hypoplastic left heart and related syndromes. At 6 years, we compared transplant-free survival and other outcomes between the groups.
METHODS:Medical history was collected annually using medical record review, telephone interviews, and the death index. The cohort included 549 patients randomized and treated in the SVR trial.
RESULTS:Transplant-free survival for the RVPAS versus modified Blalock–Taussig shunt groups did not differ at 6 years (64% versus 59%, P=0.25) or with all available follow-up of 7.1±1.6 years (log-rank P=0.13). The RVPAS versus modified Blalock–Taussig shunt treatment effect had nonproportional hazards (P=0.009); the hazard ratio (HR) for death or transplant favored the RVPAS before stage II surgery (HR, 0.66; 95% confidence interval, 0.48–0.92). The effect of shunt type on death or transplant was not statistically significant between stage II to Fontan surgery (HR, 1.36; 95% confidence interval, 0.86–2.17; P=0.17) or after the Fontan procedure (HR, 0.76; 95% confidence interval, 0.33–1.74; P=0.52). By 6 years, patients with RVPAS had a higher incidence of catheter interventions (0.38 versus 0.23/patient-year, P |
| doi_str_mv | 10.1161/CIRCULATIONAHA.117.029375 |
| format | Article |
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METHODS:Medical history was collected annually using medical record review, telephone interviews, and the death index. The cohort included 549 patients randomized and treated in the SVR trial.
RESULTS:Transplant-free survival for the RVPAS versus modified Blalock–Taussig shunt groups did not differ at 6 years (64% versus 59%, P=0.25) or with all available follow-up of 7.1±1.6 years (log-rank P=0.13). The RVPAS versus modified Blalock–Taussig shunt treatment effect had nonproportional hazards (P=0.009); the hazard ratio (HR) for death or transplant favored the RVPAS before stage II surgery (HR, 0.66; 95% confidence interval, 0.48–0.92). The effect of shunt type on death or transplant was not statistically significant between stage II to Fontan surgery (HR, 1.36; 95% confidence interval, 0.86–2.17; P=0.17) or after the Fontan procedure (HR, 0.76; 95% confidence interval, 0.33–1.74; P=0.52). By 6 years, patients with RVPAS had a higher incidence of catheter interventions (0.38 versus 0.23/patient-year, P<0.001), primarily because of more interventions between the stage II and Fontan procedures (HR, 1.72; 95% confidence interval, 1.00–3.03). Complications did not differ by shunt type; by 6 years, 1 in 5 patients had had a thrombotic event, and 1 in 6 had had seizures.
CONCLUSIONS:By 6 years, the hazards of death or transplant and catheter interventions were not different between the RVPAS versus modified Blalock–Taussig shunt groups. Children assigned to the RVPAS group had 5% higher transplant-free survival, but the difference did not reach statistical significance, and they required more catheter interventions. Both treatment groups have accrued important complications.
CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique identifierNCT00115934.</description><identifier>ISSN: 0009-7322</identifier><identifier>EISSN: 1524-4539</identifier><identifier>DOI: 10.1161/CIRCULATIONAHA.117.029375</identifier><identifier>PMID: 29437119</identifier><language>eng</language><publisher>United States: by the American College of Cardiology Foundation and the American Heart Association, Inc</publisher><subject>Blalock-Taussig Procedure - adverse effects ; Cardiac Catheterization - statistics & numerical data ; Child, Preschool ; Disease-Free Survival ; Follow-Up Studies ; Fontan Procedure ; Heart Transplantation ; Heart Ventricles - surgery ; Humans ; Hypoplastic Left Heart Syndrome - mortality ; Hypoplastic Left Heart Syndrome - surgery ; Infant ; Interviews as Topic ; Kaplan-Meier Estimate ; Norwood Procedures ; Proportional Hazards Models ; Pulmonary Artery - surgery ; Seizures - etiology ; Thrombosis - etiology</subject><ispartof>Circulation (New York, N.Y.), 2018-05, Vol.137 (21), p.2246-2253</ispartof><rights>2018 by the American College of Cardiology Foundation and the American Heart Association, Inc.</rights><rights>2018 American Heart Association, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4797-2c08d9df26ff1b1e1330830f204ed3664cd5241eb77f74c2abe8a98189f2ba2d3</citedby><cites>FETCH-LOGICAL-c4797-2c08d9df26ff1b1e1330830f204ed3664cd5241eb77f74c2abe8a98189f2ba2d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3674,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29437119$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Newburger, Jane W</creatorcontrib><creatorcontrib>Sleeper, Lynn A</creatorcontrib><creatorcontrib>Gaynor, J William</creatorcontrib><creatorcontrib>Hollenbeck-Pringle, Danielle</creatorcontrib><creatorcontrib>Frommelt, Peter C</creatorcontrib><creatorcontrib>Li, Jennifer S</creatorcontrib><creatorcontrib>Mahle, William T</creatorcontrib><creatorcontrib>Williams, Ismee A</creatorcontrib><creatorcontrib>Atz, Andrew M</creatorcontrib><creatorcontrib>Burns, Kristin M</creatorcontrib><creatorcontrib>Chen, Shan</creatorcontrib><creatorcontrib>Cnota, James</creatorcontrib><creatorcontrib>Dunbar-Masterson, Carolyn</creatorcontrib><creatorcontrib>Ghanayem, Nancy S</creatorcontrib><creatorcontrib>Goldberg, Caren S</creatorcontrib><creatorcontrib>Jacobs, Jeffrey P</creatorcontrib><creatorcontrib>Lewis, Alan B</creatorcontrib><creatorcontrib>Mital, Seema</creatorcontrib><creatorcontrib>Pizarro, Christian</creatorcontrib><creatorcontrib>Eckhauser, Aaron</creatorcontrib><creatorcontrib>Stark, Paul</creatorcontrib><creatorcontrib>Ohye, Richard G</creatorcontrib><creatorcontrib>Pediatric Heart Network Investigators</creatorcontrib><creatorcontrib>On behalf of the Pediatric Heart Network Investigators</creatorcontrib><title>Transplant-Free Survival and Interventions at 6 Years in the SVR Trial</title><title>Circulation (New York, N.Y.)</title><addtitle>Circulation</addtitle><description>BACKGROUND:In the SVR trial (Single Ventricle Reconstruction), 1-year transplant-free survival was better for the Norwood procedure with right ventricle-to-pulmonary artery shunt (RVPAS) compared with a modified Blalock–Taussig shunt in patients with hypoplastic left heart and related syndromes. At 6 years, we compared transplant-free survival and other outcomes between the groups.
METHODS:Medical history was collected annually using medical record review, telephone interviews, and the death index. The cohort included 549 patients randomized and treated in the SVR trial.
RESULTS:Transplant-free survival for the RVPAS versus modified Blalock–Taussig shunt groups did not differ at 6 years (64% versus 59%, P=0.25) or with all available follow-up of 7.1±1.6 years (log-rank P=0.13). The RVPAS versus modified Blalock–Taussig shunt treatment effect had nonproportional hazards (P=0.009); the hazard ratio (HR) for death or transplant favored the RVPAS before stage II surgery (HR, 0.66; 95% confidence interval, 0.48–0.92). The effect of shunt type on death or transplant was not statistically significant between stage II to Fontan surgery (HR, 1.36; 95% confidence interval, 0.86–2.17; P=0.17) or after the Fontan procedure (HR, 0.76; 95% confidence interval, 0.33–1.74; P=0.52). By 6 years, patients with RVPAS had a higher incidence of catheter interventions (0.38 versus 0.23/patient-year, P<0.001), primarily because of more interventions between the stage II and Fontan procedures (HR, 1.72; 95% confidence interval, 1.00–3.03). Complications did not differ by shunt type; by 6 years, 1 in 5 patients had had a thrombotic event, and 1 in 6 had had seizures.
CONCLUSIONS:By 6 years, the hazards of death or transplant and catheter interventions were not different between the RVPAS versus modified Blalock–Taussig shunt groups. Children assigned to the RVPAS group had 5% higher transplant-free survival, but the difference did not reach statistical significance, and they required more catheter interventions. Both treatment groups have accrued important complications.
CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique identifierNCT00115934.</description><subject>Blalock-Taussig Procedure - adverse effects</subject><subject>Cardiac Catheterization - statistics & numerical data</subject><subject>Child, Preschool</subject><subject>Disease-Free Survival</subject><subject>Follow-Up Studies</subject><subject>Fontan Procedure</subject><subject>Heart Transplantation</subject><subject>Heart Ventricles - surgery</subject><subject>Humans</subject><subject>Hypoplastic Left Heart Syndrome - mortality</subject><subject>Hypoplastic Left Heart Syndrome - surgery</subject><subject>Infant</subject><subject>Interviews as Topic</subject><subject>Kaplan-Meier Estimate</subject><subject>Norwood Procedures</subject><subject>Proportional Hazards Models</subject><subject>Pulmonary Artery - surgery</subject><subject>Seizures - etiology</subject><subject>Thrombosis - etiology</subject><issn>0009-7322</issn><issn>1524-4539</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkN9LwzAQx4MoOn_8CxLffOm8S7qmeRzD6WA40Cn4FNL2yqpdO5N2w__eyFTwKdyXz13uPoxdIQwRE7yZzB4nz_PxcrZ4GN-PQ6aGILRUowM2wJGIo3gk9SEbAICOlBTihJ16_xbKJEDH7EToWCpEPWDTpbON39S26aKpI-JPvdtWW1tz2xR81nTkttR0Vdt4bjue8FeyzvOq4d0qwC-PfOkqW5-zo9LWni5-3jP2PL1dTu6j-eJuNhnPozxWWkUih7TQRSmSssQMCaWEVEIpIKZCJkmcF2F9pEypUsW5sBmlVqeY6lJkVhTyjF3v525c-9GT78y68jnVYX9qe28EAGqEFFVA9R7NXeu9o9JsXLW27tMgmG-N5r_GkCmz1xh6L3--6bM1FX-dv94CEO-BXVsHRf697nfkzIps3a1MEA0SMNwLmMJICIi-IyW_AA4cffQ</recordid><startdate>20180522</startdate><enddate>20180522</enddate><creator>Newburger, Jane W</creator><creator>Sleeper, Lynn A</creator><creator>Gaynor, J William</creator><creator>Hollenbeck-Pringle, Danielle</creator><creator>Frommelt, Peter C</creator><creator>Li, Jennifer S</creator><creator>Mahle, William T</creator><creator>Williams, Ismee A</creator><creator>Atz, Andrew M</creator><creator>Burns, Kristin M</creator><creator>Chen, Shan</creator><creator>Cnota, James</creator><creator>Dunbar-Masterson, Carolyn</creator><creator>Ghanayem, Nancy S</creator><creator>Goldberg, Caren S</creator><creator>Jacobs, Jeffrey P</creator><creator>Lewis, Alan B</creator><creator>Mital, Seema</creator><creator>Pizarro, Christian</creator><creator>Eckhauser, Aaron</creator><creator>Stark, Paul</creator><creator>Ohye, Richard G</creator><general>by the American College of Cardiology Foundation and the American Heart Association, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20180522</creationdate><title>Transplant-Free Survival and Interventions at 6 Years in the SVR Trial</title><author>Newburger, Jane W ; Sleeper, Lynn A ; Gaynor, J William ; Hollenbeck-Pringle, Danielle ; Frommelt, Peter C ; Li, Jennifer S ; Mahle, William T ; Williams, Ismee A ; Atz, Andrew M ; Burns, Kristin M ; Chen, Shan ; Cnota, James ; Dunbar-Masterson, Carolyn ; Ghanayem, Nancy S ; Goldberg, Caren S ; Jacobs, Jeffrey P ; Lewis, Alan B ; Mital, Seema ; Pizarro, Christian ; Eckhauser, Aaron ; Stark, Paul ; Ohye, Richard G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4797-2c08d9df26ff1b1e1330830f204ed3664cd5241eb77f74c2abe8a98189f2ba2d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Blalock-Taussig Procedure - adverse effects</topic><topic>Cardiac Catheterization - statistics & numerical data</topic><topic>Child, Preschool</topic><topic>Disease-Free Survival</topic><topic>Follow-Up Studies</topic><topic>Fontan Procedure</topic><topic>Heart Transplantation</topic><topic>Heart Ventricles - surgery</topic><topic>Humans</topic><topic>Hypoplastic Left Heart Syndrome - mortality</topic><topic>Hypoplastic Left Heart Syndrome - surgery</topic><topic>Infant</topic><topic>Interviews as Topic</topic><topic>Kaplan-Meier Estimate</topic><topic>Norwood Procedures</topic><topic>Proportional Hazards Models</topic><topic>Pulmonary Artery - surgery</topic><topic>Seizures - etiology</topic><topic>Thrombosis - etiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Newburger, Jane W</creatorcontrib><creatorcontrib>Sleeper, Lynn A</creatorcontrib><creatorcontrib>Gaynor, J William</creatorcontrib><creatorcontrib>Hollenbeck-Pringle, Danielle</creatorcontrib><creatorcontrib>Frommelt, Peter C</creatorcontrib><creatorcontrib>Li, Jennifer S</creatorcontrib><creatorcontrib>Mahle, William T</creatorcontrib><creatorcontrib>Williams, Ismee A</creatorcontrib><creatorcontrib>Atz, Andrew M</creatorcontrib><creatorcontrib>Burns, Kristin M</creatorcontrib><creatorcontrib>Chen, Shan</creatorcontrib><creatorcontrib>Cnota, James</creatorcontrib><creatorcontrib>Dunbar-Masterson, Carolyn</creatorcontrib><creatorcontrib>Ghanayem, Nancy S</creatorcontrib><creatorcontrib>Goldberg, Caren S</creatorcontrib><creatorcontrib>Jacobs, Jeffrey P</creatorcontrib><creatorcontrib>Lewis, Alan B</creatorcontrib><creatorcontrib>Mital, Seema</creatorcontrib><creatorcontrib>Pizarro, Christian</creatorcontrib><creatorcontrib>Eckhauser, Aaron</creatorcontrib><creatorcontrib>Stark, Paul</creatorcontrib><creatorcontrib>Ohye, Richard G</creatorcontrib><creatorcontrib>Pediatric Heart Network Investigators</creatorcontrib><creatorcontrib>On behalf of the Pediatric Heart Network Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Circulation (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Newburger, Jane W</au><au>Sleeper, Lynn A</au><au>Gaynor, J William</au><au>Hollenbeck-Pringle, Danielle</au><au>Frommelt, Peter C</au><au>Li, Jennifer S</au><au>Mahle, William T</au><au>Williams, Ismee A</au><au>Atz, Andrew M</au><au>Burns, Kristin M</au><au>Chen, Shan</au><au>Cnota, James</au><au>Dunbar-Masterson, Carolyn</au><au>Ghanayem, Nancy S</au><au>Goldberg, Caren S</au><au>Jacobs, Jeffrey P</au><au>Lewis, Alan B</au><au>Mital, Seema</au><au>Pizarro, Christian</au><au>Eckhauser, Aaron</au><au>Stark, Paul</au><au>Ohye, Richard G</au><aucorp>Pediatric Heart Network Investigators</aucorp><aucorp>On behalf of the Pediatric Heart Network Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transplant-Free Survival and Interventions at 6 Years in the SVR Trial</atitle><jtitle>Circulation (New York, N.Y.)</jtitle><addtitle>Circulation</addtitle><date>2018-05-22</date><risdate>2018</risdate><volume>137</volume><issue>21</issue><spage>2246</spage><epage>2253</epage><pages>2246-2253</pages><issn>0009-7322</issn><eissn>1524-4539</eissn><abstract>BACKGROUND:In the SVR trial (Single Ventricle Reconstruction), 1-year transplant-free survival was better for the Norwood procedure with right ventricle-to-pulmonary artery shunt (RVPAS) compared with a modified Blalock–Taussig shunt in patients with hypoplastic left heart and related syndromes. At 6 years, we compared transplant-free survival and other outcomes between the groups.
METHODS:Medical history was collected annually using medical record review, telephone interviews, and the death index. The cohort included 549 patients randomized and treated in the SVR trial.
RESULTS:Transplant-free survival for the RVPAS versus modified Blalock–Taussig shunt groups did not differ at 6 years (64% versus 59%, P=0.25) or with all available follow-up of 7.1±1.6 years (log-rank P=0.13). The RVPAS versus modified Blalock–Taussig shunt treatment effect had nonproportional hazards (P=0.009); the hazard ratio (HR) for death or transplant favored the RVPAS before stage II surgery (HR, 0.66; 95% confidence interval, 0.48–0.92). The effect of shunt type on death or transplant was not statistically significant between stage II to Fontan surgery (HR, 1.36; 95% confidence interval, 0.86–2.17; P=0.17) or after the Fontan procedure (HR, 0.76; 95% confidence interval, 0.33–1.74; P=0.52). By 6 years, patients with RVPAS had a higher incidence of catheter interventions (0.38 versus 0.23/patient-year, P<0.001), primarily because of more interventions between the stage II and Fontan procedures (HR, 1.72; 95% confidence interval, 1.00–3.03). Complications did not differ by shunt type; by 6 years, 1 in 5 patients had had a thrombotic event, and 1 in 6 had had seizures.
CONCLUSIONS:By 6 years, the hazards of death or transplant and catheter interventions were not different between the RVPAS versus modified Blalock–Taussig shunt groups. Children assigned to the RVPAS group had 5% higher transplant-free survival, but the difference did not reach statistical significance, and they required more catheter interventions. Both treatment groups have accrued important complications.
CLINICAL TRIAL REGISTRATION:URLhttps://www.clinicaltrials.gov. Unique identifierNCT00115934.</abstract><cop>United States</cop><pub>by the American College of Cardiology Foundation and the American Heart Association, Inc</pub><pmid>29437119</pmid><doi>10.1161/CIRCULATIONAHA.117.029375</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Circulation (New York, N.Y.), 2018-05, Vol.137 (21), p.2246-2253 |
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| language | eng |
| recordid | cdi_proquest_miscellaneous_2001910817 |
| source | MEDLINE; American Heart Association Journals; EZB-FREE-00999 freely available EZB journals; Journals@Ovid Complete |
| subjects | Blalock-Taussig Procedure - adverse effects Cardiac Catheterization - statistics & numerical data Child, Preschool Disease-Free Survival Follow-Up Studies Fontan Procedure Heart Transplantation Heart Ventricles - surgery Humans Hypoplastic Left Heart Syndrome - mortality Hypoplastic Left Heart Syndrome - surgery Infant Interviews as Topic Kaplan-Meier Estimate Norwood Procedures Proportional Hazards Models Pulmonary Artery - surgery Seizures - etiology Thrombosis - etiology |
| title | Transplant-Free Survival and Interventions at 6 Years in the SVR Trial |
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