Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device

Background Right ventricular failure (RVF) increases morbidity and mortality. The RECOVER RIGHT study evaluated the safety and efficacy of a novel percutaneous right ventricular assist device, the Impella RP (Abiomed, Danvers, MA), in a prospective, multicenter trial. Methods Thirty patients with RV...

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Veröffentlicht in:The Journal of heart and lung transplantation 2015-12, Vol.34 (12), p.1549-1560
Hauptverfasser: Anderson, Mark B., MD, Goldstein, James, MD, Milano, Carmelo, MD, Morris, Lynn D., MD, Kormos, Robert L., MD, Bhama, Jay, MD, Kapur, Navin K., MD, Bansal, Aditya, MD, Garcia, Jose, MD, Baker, Joshua N., MD, Silvestry, Scott, MD, Holman, William L., MD, Douglas, Pamela S., MD, O’Neill, William, MD
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container_end_page 1560
container_issue 12
container_start_page 1549
container_title The Journal of heart and lung transplantation
container_volume 34
creator Anderson, Mark B., MD
Goldstein, James, MD
Milano, Carmelo, MD
Morris, Lynn D., MD
Kormos, Robert L., MD
Bhama, Jay, MD
Kapur, Navin K., MD
Bansal, Aditya, MD
Garcia, Jose, MD
Baker, Joshua N., MD
Silvestry, Scott, MD
Holman, William L., MD
Douglas, Pamela S., MD
O’Neill, William, MD
description Background Right ventricular failure (RVF) increases morbidity and mortality. The RECOVER RIGHT study evaluated the safety and efficacy of a novel percutaneous right ventricular assist device, the Impella RP (Abiomed, Danvers, MA), in a prospective, multicenter trial. Methods Thirty patients with RVF refractory to medical treatment received the Impella RP device at 15 United States institutions. The study population included 2 cohorts: 18 patients with RVF after left ventricular assist device (LVAD) implantation (Cohort A) and 12 patients with RVF after cardiotomy or myocardial infarction (Cohort B). The primary end point was survival to 30 days or hospital discharge (whichever was longer). Major secondary end points included indices of safety and efficacy. Results The patients (77% male) were a mean age of 59 ± 15 years, 53% had diabetes, 88.5% had a history of congestive heart failure, and 37.5% had renal dysfunction. Patients were on an average of 3.2 inotropes/pressors. Device delivery was achieved in all but 1 patient. Hemodynamics improved immediately after initiation of Impella RP support, with an increase in cardiac index from 1.8 ± 0.2 to 3.3 ± 0.23 liters/min/m2 ( p < 0.001) and a decrease in central venous pressure from 19.2 ± 4 to 12.6 ± 1 mm Hg ( p < 0.001). Patients were supported for an average of 3.0 ± 1.5 days (range, 0.5–7.8 days). The overall survival at 30 days was 73.3%. All patients discharged were alive at 180 days. Conclusions In patients with life-threatening RVF, the novel percutaneous Impella RP device was safe, easy to deploy, and reliably resulted in immediate hemodynamic benefit. These data support its probable benefit in this gravely ill patient population.
doi_str_mv 10.1016/j.healun.2015.08.018
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The RECOVER RIGHT study evaluated the safety and efficacy of a novel percutaneous right ventricular assist device, the Impella RP (Abiomed, Danvers, MA), in a prospective, multicenter trial. Methods Thirty patients with RVF refractory to medical treatment received the Impella RP device at 15 United States institutions. The study population included 2 cohorts: 18 patients with RVF after left ventricular assist device (LVAD) implantation (Cohort A) and 12 patients with RVF after cardiotomy or myocardial infarction (Cohort B). The primary end point was survival to 30 days or hospital discharge (whichever was longer). Major secondary end points included indices of safety and efficacy. Results The patients (77% male) were a mean age of 59 ± 15 years, 53% had diabetes, 88.5% had a history of congestive heart failure, and 37.5% had renal dysfunction. Patients were on an average of 3.2 inotropes/pressors. Device delivery was achieved in all but 1 patient. Hemodynamics improved immediately after initiation of Impella RP support, with an increase in cardiac index from 1.8 ± 0.2 to 3.3 ± 0.23 liters/min/m2 ( p &lt; 0.001) and a decrease in central venous pressure from 19.2 ± 4 to 12.6 ± 1 mm Hg ( p &lt; 0.001). Patients were supported for an average of 3.0 ± 1.5 days (range, 0.5–7.8 days). The overall survival at 30 days was 73.3%. All patients discharged were alive at 180 days. Conclusions In patients with life-threatening RVF, the novel percutaneous Impella RP device was safe, easy to deploy, and reliably resulted in immediate hemodynamic benefit. These data support its probable benefit in this gravely ill patient population.</description><identifier>ISSN: 1053-2498</identifier><identifier>EISSN: 1557-3117</identifier><identifier>DOI: 10.1016/j.healun.2015.08.018</identifier><identifier>PMID: 26681124</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>cardiogenic shock ; Female ; heart failure ; Heart Failure - surgery ; Heart-Assist Devices ; hemodynamics ; Humans ; Male ; Middle Aged ; Prospective Studies ; Prosthesis Design ; right ventricular assist device ; right ventricular failure ; Surgery</subject><ispartof>The Journal of heart and lung transplantation, 2015-12, Vol.34 (12), p.1549-1560</ispartof><rights>International Society for Heart and Lung Transplantation</rights><rights>2015 International Society for Heart and Lung Transplantation</rights><rights>Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c398t-77328383ad23651c50ac60e7ac2e8c4a5b5a2f0988601ebd0c7b6f345f7111e63</citedby><cites>FETCH-LOGICAL-c398t-77328383ad23651c50ac60e7ac2e8c4a5b5a2f0988601ebd0c7b6f345f7111e63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1053249815013935$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26681124$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Anderson, Mark B., MD</creatorcontrib><creatorcontrib>Goldstein, James, MD</creatorcontrib><creatorcontrib>Milano, Carmelo, MD</creatorcontrib><creatorcontrib>Morris, Lynn D., MD</creatorcontrib><creatorcontrib>Kormos, Robert L., MD</creatorcontrib><creatorcontrib>Bhama, Jay, MD</creatorcontrib><creatorcontrib>Kapur, Navin K., MD</creatorcontrib><creatorcontrib>Bansal, Aditya, MD</creatorcontrib><creatorcontrib>Garcia, Jose, MD</creatorcontrib><creatorcontrib>Baker, Joshua N., MD</creatorcontrib><creatorcontrib>Silvestry, Scott, MD</creatorcontrib><creatorcontrib>Holman, William L., MD</creatorcontrib><creatorcontrib>Douglas, Pamela S., MD</creatorcontrib><creatorcontrib>O’Neill, William, MD</creatorcontrib><title>Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device</title><title>The Journal of heart and lung transplantation</title><addtitle>J Heart Lung Transplant</addtitle><description>Background Right ventricular failure (RVF) increases morbidity and mortality. The RECOVER RIGHT study evaluated the safety and efficacy of a novel percutaneous right ventricular assist device, the Impella RP (Abiomed, Danvers, MA), in a prospective, multicenter trial. Methods Thirty patients with RVF refractory to medical treatment received the Impella RP device at 15 United States institutions. The study population included 2 cohorts: 18 patients with RVF after left ventricular assist device (LVAD) implantation (Cohort A) and 12 patients with RVF after cardiotomy or myocardial infarction (Cohort B). The primary end point was survival to 30 days or hospital discharge (whichever was longer). Major secondary end points included indices of safety and efficacy. Results The patients (77% male) were a mean age of 59 ± 15 years, 53% had diabetes, 88.5% had a history of congestive heart failure, and 37.5% had renal dysfunction. Patients were on an average of 3.2 inotropes/pressors. Device delivery was achieved in all but 1 patient. Hemodynamics improved immediately after initiation of Impella RP support, with an increase in cardiac index from 1.8 ± 0.2 to 3.3 ± 0.23 liters/min/m2 ( p &lt; 0.001) and a decrease in central venous pressure from 19.2 ± 4 to 12.6 ± 1 mm Hg ( p &lt; 0.001). Patients were supported for an average of 3.0 ± 1.5 days (range, 0.5–7.8 days). The overall survival at 30 days was 73.3%. All patients discharged were alive at 180 days. Conclusions In patients with life-threatening RVF, the novel percutaneous Impella RP device was safe, easy to deploy, and reliably resulted in immediate hemodynamic benefit. These data support its probable benefit in this gravely ill patient population.</description><subject>cardiogenic shock</subject><subject>Female</subject><subject>heart failure</subject><subject>Heart Failure - surgery</subject><subject>Heart-Assist Devices</subject><subject>hemodynamics</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>right ventricular assist device</subject><subject>right ventricular failure</subject><subject>Surgery</subject><issn>1053-2498</issn><issn>1557-3117</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFUk2P0zAUjBCIXRb-AUI-cknws-PE5YAEVdmttNKiUrharvNCXdIk-CNS_wU_GYcWDlw42Yd5M29mXpa9BFoAherNodij7mJfMAqioLKgIB9l1yBEnXOA-nH6U8FzVi7kVfbM-wOllHHBnmZXrKokACuvs58fsMfWBk-GlmjSDxN2ZERnYtA9DtGTCfvgrImddkR7b30gDU7WIGkHR5z9tg8kbeICabXtosO3ZLtHMrrBj2iCnZBsVsuHr6sN2axv77bEh9icZrmQYOvjiF2nyebThfV59qTVnccXl_cm-_JxtV3e5fcPt-vl-_vc8IUMeV1zJrnkumG8EmAE1aaiWGvDUJpSi53QrKULKSsKuGuoqXdVy0vR1gCAFb_JXp9506I_IvqgjtabeZffthXUgpZMguAJWp6hJnnyDls1OnvU7qSAqrkLdVDnLtTchaJSpS7S2KuLQtwdsfk79Cf8BHh3BmDyOVl0yhuLvcHGupScagb7P4V_CUxne2t09x1P6A9DdH3KUIHyTFH1eb6H-RxAUOALLvgvNU6x3Q</recordid><startdate>20151201</startdate><enddate>20151201</enddate><creator>Anderson, Mark B., MD</creator><creator>Goldstein, James, MD</creator><creator>Milano, Carmelo, MD</creator><creator>Morris, Lynn D., MD</creator><creator>Kormos, Robert L., MD</creator><creator>Bhama, Jay, MD</creator><creator>Kapur, Navin K., MD</creator><creator>Bansal, Aditya, MD</creator><creator>Garcia, Jose, MD</creator><creator>Baker, Joshua N., MD</creator><creator>Silvestry, Scott, MD</creator><creator>Holman, William L., MD</creator><creator>Douglas, Pamela S., MD</creator><creator>O’Neill, William, MD</creator><general>Elsevier 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>20151201</creationdate><title>Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device</title><author>Anderson, Mark B., MD ; Goldstein, James, MD ; Milano, Carmelo, MD ; Morris, Lynn D., MD ; Kormos, Robert L., MD ; Bhama, Jay, MD ; Kapur, Navin K., MD ; Bansal, Aditya, MD ; Garcia, Jose, MD ; Baker, Joshua N., MD ; Silvestry, Scott, MD ; Holman, William L., MD ; Douglas, Pamela S., MD ; O’Neill, William, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c398t-77328383ad23651c50ac60e7ac2e8c4a5b5a2f0988601ebd0c7b6f345f7111e63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>cardiogenic shock</topic><topic>Female</topic><topic>heart failure</topic><topic>Heart Failure - surgery</topic><topic>Heart-Assist Devices</topic><topic>hemodynamics</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>right ventricular assist device</topic><topic>right ventricular failure</topic><topic>Surgery</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Anderson, Mark B., MD</creatorcontrib><creatorcontrib>Goldstein, James, MD</creatorcontrib><creatorcontrib>Milano, Carmelo, MD</creatorcontrib><creatorcontrib>Morris, Lynn D., MD</creatorcontrib><creatorcontrib>Kormos, Robert L., MD</creatorcontrib><creatorcontrib>Bhama, Jay, MD</creatorcontrib><creatorcontrib>Kapur, Navin K., MD</creatorcontrib><creatorcontrib>Bansal, Aditya, MD</creatorcontrib><creatorcontrib>Garcia, Jose, MD</creatorcontrib><creatorcontrib>Baker, Joshua N., MD</creatorcontrib><creatorcontrib>Silvestry, Scott, MD</creatorcontrib><creatorcontrib>Holman, William L., MD</creatorcontrib><creatorcontrib>Douglas, Pamela S., MD</creatorcontrib><creatorcontrib>O’Neill, William, MD</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>The Journal of heart and lung transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Anderson, Mark B., MD</au><au>Goldstein, James, MD</au><au>Milano, Carmelo, MD</au><au>Morris, Lynn D., MD</au><au>Kormos, Robert L., MD</au><au>Bhama, Jay, MD</au><au>Kapur, Navin K., MD</au><au>Bansal, Aditya, MD</au><au>Garcia, Jose, MD</au><au>Baker, Joshua N., MD</au><au>Silvestry, Scott, MD</au><au>Holman, William L., MD</au><au>Douglas, Pamela S., MD</au><au>O’Neill, William, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device</atitle><jtitle>The Journal of heart and lung transplantation</jtitle><addtitle>J Heart Lung Transplant</addtitle><date>2015-12-01</date><risdate>2015</risdate><volume>34</volume><issue>12</issue><spage>1549</spage><epage>1560</epage><pages>1549-1560</pages><issn>1053-2498</issn><eissn>1557-3117</eissn><abstract>Background Right ventricular failure (RVF) increases morbidity and mortality. The RECOVER RIGHT study evaluated the safety and efficacy of a novel percutaneous right ventricular assist device, the Impella RP (Abiomed, Danvers, MA), in a prospective, multicenter trial. Methods Thirty patients with RVF refractory to medical treatment received the Impella RP device at 15 United States institutions. The study population included 2 cohorts: 18 patients with RVF after left ventricular assist device (LVAD) implantation (Cohort A) and 12 patients with RVF after cardiotomy or myocardial infarction (Cohort B). The primary end point was survival to 30 days or hospital discharge (whichever was longer). Major secondary end points included indices of safety and efficacy. Results The patients (77% male) were a mean age of 59 ± 15 years, 53% had diabetes, 88.5% had a history of congestive heart failure, and 37.5% had renal dysfunction. Patients were on an average of 3.2 inotropes/pressors. Device delivery was achieved in all but 1 patient. Hemodynamics improved immediately after initiation of Impella RP support, with an increase in cardiac index from 1.8 ± 0.2 to 3.3 ± 0.23 liters/min/m2 ( p &lt; 0.001) and a decrease in central venous pressure from 19.2 ± 4 to 12.6 ± 1 mm Hg ( p &lt; 0.001). Patients were supported for an average of 3.0 ± 1.5 days (range, 0.5–7.8 days). The overall survival at 30 days was 73.3%. All patients discharged were alive at 180 days. Conclusions In patients with life-threatening RVF, the novel percutaneous Impella RP device was safe, easy to deploy, and reliably resulted in immediate hemodynamic benefit. These data support its probable benefit in this gravely ill patient population.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26681124</pmid><doi>10.1016/j.healun.2015.08.018</doi><tpages>12</tpages></addata></record>
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subjects cardiogenic shock
Female
heart failure
Heart Failure - surgery
Heart-Assist Devices
hemodynamics
Humans
Male
Middle Aged
Prospective Studies
Prosthesis Design
right ventricular assist device
right ventricular failure
Surgery
title Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device
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