Pulmonary Artery Denervation Significantly Increases 6-Min Walk Distance for Patients With Combined Pre- and Post-Capillary Pulmonary Hypertension Associated With Left Heart Failure: The PADN-5 Study
The authors sought to assess the benefits of pulmonary artery denervation (PADN) among combined pre- and post-capillary pulmonary hypertension (CpcPH) patients in a prospective, randomized, sham-controlled trial. PADN has been shown to improve hemodynamics of pulmonary arterial hypertension in a ser...
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Veröffentlicht in: | JACC. Cardiovascular interventions 2019-02, Vol.12 (3), p.274-284 |
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creator | Zhang, Hang Zhang, Juan Chen, Mengxuan Xie, Du-Jiang Kan, Jing Yu, Wande Li, Xiao-Bo Xu, Tian Gu, Yue Dong, Jianzeng Gu, Hong Han, Yaling Chen, Shao-Liang |
description | The authors sought to assess the benefits of pulmonary artery denervation (PADN) among combined pre- and post-capillary pulmonary hypertension (CpcPH) patients in a prospective, randomized, sham-controlled trial.
PADN has been shown to improve hemodynamics of pulmonary arterial hypertension in a series of patients. Additionally, benefits of targeted medical therapy for patients with CpcPH secondary to left-sided heart failure are unknown.
Ninety-eight CpcPH patients, defined as mean pulmonary arterial pressure ≥25 mm Hg, pulmonary capillary wedge pressure >15 mm Hg, and pulmonary vascular resistance (PVR) >3.0 Wood units (WU), were randomly assigned to PADN or sildenafil plus sham PADN. Standard medical therapy for heart failure was administered to all patients in both groups. The primary endpoint was the increase in the 6-min walk distance at the 6-month follow-up. The secondary endpoint was change in PVR. Clinical worsening was assessed in a post hoc analysis. The main safety endpoint was occurrence of pulmonary embolism.
At 6 months, the mean increases in the 6-min walk distance were 83 m in the PADN group and 15 m in the sildenafil group (least square mean difference 66 m, 95% confidence interval: 38.2 to 98.8 m; p < 0.001). PADN treatment was associated with a significantly lower PVR than in the sildenafil group (4.2 ± 1.5 WU vs. 6.1 ± 2.9 WU; p = 0.001). Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014). At the end of the study, there were 7 all-cause deaths and 2 cases of pulmonary embolism.
PADN is associated with significant improvements in hemodynamic and clinical outcomes in patients with CpcPH. Further studies are warranted to define its precise role in the treatment of this patient population. (Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure [PADN-5]; NCT02220335). |
doi_str_mv | 10.1016/j.jcin.2018.09.021 |
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PADN has been shown to improve hemodynamics of pulmonary arterial hypertension in a series of patients. Additionally, benefits of targeted medical therapy for patients with CpcPH secondary to left-sided heart failure are unknown.
Ninety-eight CpcPH patients, defined as mean pulmonary arterial pressure ≥25 mm Hg, pulmonary capillary wedge pressure >15 mm Hg, and pulmonary vascular resistance (PVR) >3.0 Wood units (WU), were randomly assigned to PADN or sildenafil plus sham PADN. Standard medical therapy for heart failure was administered to all patients in both groups. The primary endpoint was the increase in the 6-min walk distance at the 6-month follow-up. The secondary endpoint was change in PVR. Clinical worsening was assessed in a post hoc analysis. The main safety endpoint was occurrence of pulmonary embolism.
At 6 months, the mean increases in the 6-min walk distance were 83 m in the PADN group and 15 m in the sildenafil group (least square mean difference 66 m, 95% confidence interval: 38.2 to 98.8 m; p < 0.001). PADN treatment was associated with a significantly lower PVR than in the sildenafil group (4.2 ± 1.5 WU vs. 6.1 ± 2.9 WU; p = 0.001). Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014). At the end of the study, there were 7 all-cause deaths and 2 cases of pulmonary embolism.
PADN is associated with significant improvements in hemodynamic and clinical outcomes in patients with CpcPH. Further studies are warranted to define its precise role in the treatment of this patient population. (Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure [PADN-5]; NCT02220335).</description><identifier>EISSN: 1876-7605</identifier><identifier>DOI: 10.1016/j.jcin.2018.09.021</identifier><identifier>PMID: 30732732</identifier><language>eng</language><publisher>United States</publisher><subject>Aged ; Arterial Pressure ; Autonomic Denervation - adverse effects ; Autonomic Denervation - mortality ; China ; Exercise Tolerance ; Female ; Heart Failure - diagnosis ; Heart Failure - mortality ; Heart Failure - physiopathology ; Humans ; Hypertension, Pulmonary - etiology ; Hypertension, Pulmonary - mortality ; Hypertension, Pulmonary - physiopathology ; Hypertension, Pulmonary - surgery ; Male ; Middle Aged ; Predictive Value of Tests ; Prospective Studies ; Pulmonary Artery - innervation ; Pulmonary Embolism - mortality ; Pulmonary Embolism - physiopathology ; Recovery of Function ; Risk Factors ; Time Factors ; Treatment Outcome ; Walk Test</subject><ispartof>JACC. Cardiovascular interventions, 2019-02, Vol.12 (3), p.274-284</ispartof><rights>Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30732732$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhang, Hang</creatorcontrib><creatorcontrib>Zhang, Juan</creatorcontrib><creatorcontrib>Chen, Mengxuan</creatorcontrib><creatorcontrib>Xie, Du-Jiang</creatorcontrib><creatorcontrib>Kan, Jing</creatorcontrib><creatorcontrib>Yu, Wande</creatorcontrib><creatorcontrib>Li, Xiao-Bo</creatorcontrib><creatorcontrib>Xu, Tian</creatorcontrib><creatorcontrib>Gu, Yue</creatorcontrib><creatorcontrib>Dong, Jianzeng</creatorcontrib><creatorcontrib>Gu, Hong</creatorcontrib><creatorcontrib>Han, Yaling</creatorcontrib><creatorcontrib>Chen, Shao-Liang</creatorcontrib><title>Pulmonary Artery Denervation Significantly Increases 6-Min Walk Distance for Patients With Combined Pre- and Post-Capillary Pulmonary Hypertension Associated With Left Heart Failure: The PADN-5 Study</title><title>JACC. Cardiovascular interventions</title><addtitle>JACC Cardiovasc Interv</addtitle><description>The authors sought to assess the benefits of pulmonary artery denervation (PADN) among combined pre- and post-capillary pulmonary hypertension (CpcPH) patients in a prospective, randomized, sham-controlled trial.
PADN has been shown to improve hemodynamics of pulmonary arterial hypertension in a series of patients. Additionally, benefits of targeted medical therapy for patients with CpcPH secondary to left-sided heart failure are unknown.
Ninety-eight CpcPH patients, defined as mean pulmonary arterial pressure ≥25 mm Hg, pulmonary capillary wedge pressure >15 mm Hg, and pulmonary vascular resistance (PVR) >3.0 Wood units (WU), were randomly assigned to PADN or sildenafil plus sham PADN. Standard medical therapy for heart failure was administered to all patients in both groups. The primary endpoint was the increase in the 6-min walk distance at the 6-month follow-up. The secondary endpoint was change in PVR. Clinical worsening was assessed in a post hoc analysis. The main safety endpoint was occurrence of pulmonary embolism.
At 6 months, the mean increases in the 6-min walk distance were 83 m in the PADN group and 15 m in the sildenafil group (least square mean difference 66 m, 95% confidence interval: 38.2 to 98.8 m; p < 0.001). PADN treatment was associated with a significantly lower PVR than in the sildenafil group (4.2 ± 1.5 WU vs. 6.1 ± 2.9 WU; p = 0.001). Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014). At the end of the study, there were 7 all-cause deaths and 2 cases of pulmonary embolism.
PADN is associated with significant improvements in hemodynamic and clinical outcomes in patients with CpcPH. Further studies are warranted to define its precise role in the treatment of this patient population. (Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure [PADN-5]; NCT02220335).</description><subject>Aged</subject><subject>Arterial Pressure</subject><subject>Autonomic Denervation - adverse effects</subject><subject>Autonomic Denervation - mortality</subject><subject>China</subject><subject>Exercise Tolerance</subject><subject>Female</subject><subject>Heart Failure - diagnosis</subject><subject>Heart Failure - mortality</subject><subject>Heart Failure - physiopathology</subject><subject>Humans</subject><subject>Hypertension, Pulmonary - etiology</subject><subject>Hypertension, Pulmonary - mortality</subject><subject>Hypertension, Pulmonary - physiopathology</subject><subject>Hypertension, Pulmonary - surgery</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Predictive Value of Tests</subject><subject>Prospective Studies</subject><subject>Pulmonary Artery - innervation</subject><subject>Pulmonary Embolism - mortality</subject><subject>Pulmonary Embolism - physiopathology</subject><subject>Recovery of Function</subject><subject>Risk Factors</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Walk Test</subject><issn>1876-7605</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkM1Kw0AUhQdB_H8BFzJLN4nz00wSd6VVK1QttOKy3Ca3OjWZxJmJ0Lfps3TpUzlFRbhw7uLc83EuIeecxZxxdbWKV4U2sWA8i1keM8H3yBHPUhWliiWH5Ni5FWOK5ak4IIeSpVKEOSJfk66qGwN2TfvWY5AhGrSf4HVj6FS_Gr3UBRhfrem9KSyCQ0dV9KANfYHqnQ6182AKpMvG0kk4Q-MdfdH-jQ6aeqENlnRiMaJgwtI4Hw2g1VW1I_6zR-sWA964HbXvXFNo8FhuN7ug7WaMS09HCNZvN7egq87iNZ29IZ30h49RQqe-K9enZH8JlcOzXz0hz7c3s8EoGj_d3Q_646gVnPsIsyTjLIUezxaiBzkXhVRpnrO87AGgSITkPSmVVACQpAUwlMgzVfKMLaRg8oRc_uS2tvno0Pl5rV2BoZLBpnNzIUQIY0KlwXrxa-0WNZbz1uo61J3__V9-A6Huiv0</recordid><startdate>20190211</startdate><enddate>20190211</enddate><creator>Zhang, Hang</creator><creator>Zhang, Juan</creator><creator>Chen, Mengxuan</creator><creator>Xie, Du-Jiang</creator><creator>Kan, Jing</creator><creator>Yu, Wande</creator><creator>Li, Xiao-Bo</creator><creator>Xu, Tian</creator><creator>Gu, Yue</creator><creator>Dong, Jianzeng</creator><creator>Gu, Hong</creator><creator>Han, Yaling</creator><creator>Chen, Shao-Liang</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20190211</creationdate><title>Pulmonary Artery Denervation Significantly Increases 6-Min Walk Distance for Patients With Combined Pre- and Post-Capillary Pulmonary Hypertension Associated With Left Heart Failure: The PADN-5 Study</title><author>Zhang, Hang ; Zhang, Juan ; Chen, Mengxuan ; Xie, Du-Jiang ; Kan, Jing ; Yu, Wande ; Li, Xiao-Bo ; Xu, Tian ; Gu, Yue ; Dong, Jianzeng ; Gu, Hong ; Han, Yaling ; Chen, Shao-Liang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p211t-e858107a418b24a912c3679909d4aae25231433636aaa57ca0e3e186d180b3203</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Aged</topic><topic>Arterial Pressure</topic><topic>Autonomic Denervation - adverse effects</topic><topic>Autonomic Denervation - mortality</topic><topic>China</topic><topic>Exercise Tolerance</topic><topic>Female</topic><topic>Heart Failure - diagnosis</topic><topic>Heart Failure - mortality</topic><topic>Heart Failure - physiopathology</topic><topic>Humans</topic><topic>Hypertension, Pulmonary - etiology</topic><topic>Hypertension, Pulmonary - mortality</topic><topic>Hypertension, Pulmonary - physiopathology</topic><topic>Hypertension, Pulmonary - surgery</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Predictive Value of Tests</topic><topic>Prospective Studies</topic><topic>Pulmonary Artery - innervation</topic><topic>Pulmonary Embolism - mortality</topic><topic>Pulmonary Embolism - physiopathology</topic><topic>Recovery of Function</topic><topic>Risk Factors</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Walk Test</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhang, Hang</creatorcontrib><creatorcontrib>Zhang, Juan</creatorcontrib><creatorcontrib>Chen, Mengxuan</creatorcontrib><creatorcontrib>Xie, Du-Jiang</creatorcontrib><creatorcontrib>Kan, Jing</creatorcontrib><creatorcontrib>Yu, Wande</creatorcontrib><creatorcontrib>Li, Xiao-Bo</creatorcontrib><creatorcontrib>Xu, Tian</creatorcontrib><creatorcontrib>Gu, Yue</creatorcontrib><creatorcontrib>Dong, Jianzeng</creatorcontrib><creatorcontrib>Gu, Hong</creatorcontrib><creatorcontrib>Han, Yaling</creatorcontrib><creatorcontrib>Chen, Shao-Liang</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>JACC. Cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhang, Hang</au><au>Zhang, Juan</au><au>Chen, Mengxuan</au><au>Xie, Du-Jiang</au><au>Kan, Jing</au><au>Yu, Wande</au><au>Li, Xiao-Bo</au><au>Xu, Tian</au><au>Gu, Yue</au><au>Dong, Jianzeng</au><au>Gu, Hong</au><au>Han, Yaling</au><au>Chen, Shao-Liang</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pulmonary Artery Denervation Significantly Increases 6-Min Walk Distance for Patients With Combined Pre- and Post-Capillary Pulmonary Hypertension Associated With Left Heart Failure: The PADN-5 Study</atitle><jtitle>JACC. Cardiovascular interventions</jtitle><addtitle>JACC Cardiovasc Interv</addtitle><date>2019-02-11</date><risdate>2019</risdate><volume>12</volume><issue>3</issue><spage>274</spage><epage>284</epage><pages>274-284</pages><eissn>1876-7605</eissn><abstract>The authors sought to assess the benefits of pulmonary artery denervation (PADN) among combined pre- and post-capillary pulmonary hypertension (CpcPH) patients in a prospective, randomized, sham-controlled trial.
PADN has been shown to improve hemodynamics of pulmonary arterial hypertension in a series of patients. Additionally, benefits of targeted medical therapy for patients with CpcPH secondary to left-sided heart failure are unknown.
Ninety-eight CpcPH patients, defined as mean pulmonary arterial pressure ≥25 mm Hg, pulmonary capillary wedge pressure >15 mm Hg, and pulmonary vascular resistance (PVR) >3.0 Wood units (WU), were randomly assigned to PADN or sildenafil plus sham PADN. Standard medical therapy for heart failure was administered to all patients in both groups. The primary endpoint was the increase in the 6-min walk distance at the 6-month follow-up. The secondary endpoint was change in PVR. Clinical worsening was assessed in a post hoc analysis. The main safety endpoint was occurrence of pulmonary embolism.
At 6 months, the mean increases in the 6-min walk distance were 83 m in the PADN group and 15 m in the sildenafil group (least square mean difference 66 m, 95% confidence interval: 38.2 to 98.8 m; p < 0.001). PADN treatment was associated with a significantly lower PVR than in the sildenafil group (4.2 ± 1.5 WU vs. 6.1 ± 2.9 WU; p = 0.001). Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014). At the end of the study, there were 7 all-cause deaths and 2 cases of pulmonary embolism.
PADN is associated with significant improvements in hemodynamic and clinical outcomes in patients with CpcPH. Further studies are warranted to define its precise role in the treatment of this patient population. (Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure [PADN-5]; NCT02220335).</abstract><cop>United States</cop><pmid>30732732</pmid><doi>10.1016/j.jcin.2018.09.021</doi><tpages>11</tpages></addata></record> |
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subjects | Aged Arterial Pressure Autonomic Denervation - adverse effects Autonomic Denervation - mortality China Exercise Tolerance Female Heart Failure - diagnosis Heart Failure - mortality Heart Failure - physiopathology Humans Hypertension, Pulmonary - etiology Hypertension, Pulmonary - mortality Hypertension, Pulmonary - physiopathology Hypertension, Pulmonary - surgery Male Middle Aged Predictive Value of Tests Prospective Studies Pulmonary Artery - innervation Pulmonary Embolism - mortality Pulmonary Embolism - physiopathology Recovery of Function Risk Factors Time Factors Treatment Outcome Walk Test |
title | Pulmonary Artery Denervation Significantly Increases 6-Min Walk Distance for Patients With Combined Pre- and Post-Capillary Pulmonary Hypertension Associated With Left Heart Failure: The PADN-5 Study |
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