{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T00:54:56Z","timestamp":1773104096821,"version":"3.50.1"},"reference-count":23,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2017,11,20]],"date-time":"2017-11-20T00:00:00Z","timestamp":1511136000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2018,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>There are sparse clinical data on the procedural trends, outcomes and readmission rates following FDA approval and expansion of Transcatheter mitral valve repair\/MitraClip<jats:sup>\u00ae<\/jats:sup>. Whether a complex new technology can be disseminated safely and quickly is controversial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The study cohort was derived from the National Readmission Data (NRD) 2013\u201314. MitraClip<jats:sup>\u00ae<\/jats:sup> was identified using appropriate International Classification of Diseases, 9th Revision, Clinical Modification (ICD\u20109\u2010CM) codes. The primary outcome was a composite of in\u2010hospital mortality\u2009+\u2009procedural complications. Secondary outcome included 30\u2010day readmissions. Hierarchical two level logistic models were used to evaluate study outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Our analysis included 2003 MitraClip<jats:sup>\u00ae<\/jats:sup> procedures. Overall in\u2010hospital mortality was 3.9%. As expected, there was a significant increase in procedural volume post\u2010FDA approval. Importantly, a corresponding downward trend in mortality and procedural complications was observed. Significant predictors of in\u2010hospital mortality and procedural complications included the use of vasopressors (<jats:italic>P<\/jats:italic> &lt;0.001) and hemodynamic support (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001). Higher hospital volume (\u226510 MitraClips\/year) was associated with lower in\u2010hospital mortality and complications (<jats:italic>P<\/jats:italic>\u2009=\u20090.02). There were 304 (15.1%) 30\u2010day readmissions, with heart failure being the most common cause of readmission. Elective procedures had lower in\u2010hospital mortality (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001) and lower readmission rates (<jats:italic>P<\/jats:italic>\u2009=\u20090.011) compared with nonelective procedures.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>A significant increase in MitraClip<jats:sup>\u00ae<\/jats:sup> procedural volumes occurred post\u2010FDA approval. Overall morbidity and mortality were low and trended downwards. Hospital procedure volume \u226510 cases were associated with lower mortality and overall complication rates. These data suggest a successful roll out of a very complex novel structural heart procedure.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.27366","type":"journal-article","created":{"date-parts":[[2017,11,20]],"date-time":"2017-11-20T06:14:39Z","timestamp":1511158479000},"page":"1171-1181","source":"Crossref","is-referenced-by-count":16,"title":["Procedural trends, outcomes, and readmission rates pre\u2010and post\u2010FDA approval for <scp>M<\/scp>itra<scp>C<\/scp>lip from the <scp>N<\/scp>ational <scp>R<\/scp>eadmission <scp>D<\/scp>atabase (2013\u201314)"],"prefix":"10.1002","volume":"91","author":[{"given":"Sidakpal S.","family":"Panaich","sequence":"first","affiliation":[{"name":"Department of Cardiovascular Diseases Mayo Clinic Rochester Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shilpkumar","family":"Arora","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Mount Sinai St Luke's Roosevelt Hospital Center New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Apurva","family":"Badheka","sequence":"additional","affiliation":[{"name":"Department of Cardiology, The Everett Clinic Everett Washington"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5481-7601","authenticated-orcid":false,"given":"Varun","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Mount Sinai St Luke's Roosevelt Hospital Center New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5087-0464","authenticated-orcid":false,"given":"Elad","family":"Maor","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Diseases Mayo Clinic Rochester Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2206-0413","authenticated-orcid":false,"given":"Claire","family":"Raphael","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Diseases Mayo Clinic Rochester Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abhishek","family":"Deshmukh","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Diseases Mayo Clinic Rochester Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guy","family":"Reeder","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Diseases Mayo Clinic Rochester Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6082-5379","authenticated-orcid":false,"given":"Mackram","family":"Eleid","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Diseases Mayo Clinic Rochester Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charanjit S.","family":"Rihal","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Diseases Mayo Clinic Rochester Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,11,20]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)60692-9"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(06)69208-8"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)00558-4"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehm001"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.08.723"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009355"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.12.054"},{"key":"e_1_2_9_9_1","unstructured":"Project HCaU.NRD Description of Data Elements.2016.https:\/\/www.hcup-us.ahrq.gov\/db\/nation\/nrd\/nrddde.jsp."},{"key":"e_1_2_9_10_1","unstructured":"Project HCaU.NRD Overview.2017.https:\/\/www.hcup-us.ahrq.gov\/nrdoverview.jsp."},{"key":"e_1_2_9_11_1","unstructured":"KM McDonald PS Romano J Geppert SM Davies BW Duncan KG Shojania A. 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