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
Hauptverfasser: 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
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container_issue 3
container_start_page 274
container_title JACC. Cardiovascular interventions
container_volume 12
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 &gt;15 mm Hg, and pulmonary vascular resistance (PVR) &gt;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 &lt; 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. 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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 &gt;15 mm Hg, and pulmonary vascular resistance (PVR) &gt;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 &lt; 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 &gt;15 mm Hg, and pulmonary vascular resistance (PVR) &gt;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 &lt; 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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source MEDLINE; ScienceDirect Journals (5 years ago - present); EZB-FREE-00999 freely available EZB journals
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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