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The Effect of a Transcatheter Mitral Valve Repair Program on the Outcomes of Mitral Valve Surgery: a Retrospective Multicenter Study

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The Effect of a Transcatheter Mitral Valve Repair Program on the Outcomes of Mitral Valve Surgery: a Retrospective Multicenter Study Research Article Annals of Cardiology and Cardiovascular Medicine Published: 16 Apr, 2018 The Effect of a Transcatheter Mitral Valve Repair Program on the Outcomes of Mitral Valve Surgery: A Retrospective Multicenter Study Samir V Patel1*, Nileshkumar J Patel2, Rajesh Sonani3, Sunny Jhamnani4, Palak Patel5, Sidakpal S Panaich6, Abhishek Deshmukh7 and Apurva O Badheka8 1Sparks Health Systems, USA 2University of Miami Miler School of Medicine, USA 3Brandon Regional Medical center, USA 4Yale School of Medicine, USA 5Massachusetts College of Pharmacy and Health Sciences, USA 6University of Iowa, USA 7Mayo Clinic, USA 8Everett Clinic, USA Abstract Background: After approval by CMS, the use of Transcatheter Mitral Valve Repair (TMVR) is being adopted by many centers. The present study was conducted to compare the outcomes of surgical mitral valve repair and/or replacement among centers with and without the TMVR program. Methods: The subjects were derived from the Nationwide Inpatient Sample (NIS) using the ICD-9- CM procedure code of 35.12, 35.23 and 35.24 in the year 2011. If any center had performed at least one TMVR procedure in the year 2011 identified by ICD-9 code 35.97 (introduced in Oct 2010), OPEN ACCESS the center was considered as TMVR capable. Propensity score was used to compare outcomes of mortality, complications, complications plus mortality, length of stay (LOS), cost of hospitalization *Correspondence: and disposition. Samir V Patel, Sparks Health Systems, University of Arkansas Medical Science Results: A total of 1,598 surgical mitral valve repair/replacements were performed in 2011 with West, 1120 Lexington Avenue, Fort 59.82% (956) in TMVR non-capable and 40.18% (642) in TMVR capable centers. After propensity matching, TMVR capable centers had significantly lower mortality compared to TMVR non-capable Smith, Arkansas, 72901, USA, Tel: centers (1.7% vs. 3.2%, p=0.0034). TMVR capable centers were also noted to have lower incidence 1-479-709-7260; Fax: 1-479-573-2560; of post-procedural complications (34.7% vs. 38.3%, p=0.019) along with higher direct disposition to E-mail: [email protected] home and home health care facilities (86.1% vs. 79.9%, p<0.001) but a higher hospitalization costs Received Date: 31 Jan 2018 ($48603 vs. $42883, p<0.0001). Accepted Date: 29 Mar 2018 Published Date: 16 Apr 2018 Conclusion: Surgical mitral valve operations have better outcomes in terms of lower in-hospital mortality, lower post-procedural complications and better discharge disposition in centers with Citation: TMVR programs. Patel SV, Patel NJ, Sonani R, Jhamnani S, Patel P, Panaich SS, et al. The Keywords: Mitral valve surgery; TMVR; Mortality Effect of a Transcatheter Mitral Valve Repair Program on the Outcomes of Introduction Mitral Valve Surgery: A Retrospective Surgical mitral valve repair and replacement are the two major treatment options for patients Multicenter Study. Ann Cardiol with mitral regurgitation [1]. It is estimated, that 69% of patients undergoing a procedure for Cardiovasc Med. 2018; 2(1): 1015. mitral regurgitation, undergo mitral valve repair. The operative mortality of mitral valve repair and Copyright © 2018 Samir V Patel. This replacement are thought to be about 1.4% and 3.7% respectively [2]. However, in selected patients is an open access article distributed who are at high operative risk with favorable anatomical characteristics, Transcatheter Mitral Valve under the Creative Commons Attribution Repair (TMVR) is a viable option. Following the Endovascular Valve Edge-to-Edge Repair Study License, which permits unrestricted (EVEREST) Trials, TMVR was approved by the Food and Drug Administration in October 2013 use, distribution, and reproduction in and subsequently the Centers for Medicare and Medicaid coverage in May 2014. This has led to any medium, provided the original work gradual increase in its utilization by many centers across the nation. However, there is no data on is properly cited. the effect of TMVR, a relatively novel procedure on mitral valve surgical outcomes being performed Remedy Publications LLC. 1 2018 | Volume 2 | Issue 1 | Article 1015 Samir V Patel, et al., Annals of Cardiology and Cardiovascular Medicine Table 1: Baseline table with outcomes in unmatched dataset. Mitral valve surgeries in TMVR capable vs. non-capable Unmatched Group centers in 2011 Demographic Variables TMVR non-capable centers TMVR capable centers Overall P-value Total No. of Observations (un weighted) (%) 956 (59.82%) 642 (40.18%) 1598 Total No. of Hospitals (%) 160 (82%) 35 (18%) 195 No. Mitral valve surgeries per hospital (Hospital Volume) Median (q1, q3) 10 (5, 19) 41 (20, 63) 15 (7, 41) <0.001 Age (%) mean (standard err) 60.03 (0.45) 59.27 (0.58) 59.72 (0.36) 0.41 Sex (%) Male 49.04 55.03 51.46 <0.001 Female 50.96 44.97 48.54 Race (%) Whites 74.41 62.66 69.66 Blacks 10.28 6.8 8.88 Hispanics 3.91 7.98 5.55 <0.001 Others 4.79 8.68 6.36 Missing 6.62 13.88 9.55 Charlson Score (%) 0 40.67 40.31 40.52 1 30.11 32.93 31.25 0.01 More than or equal to 2 29.22 26.76 28.23 Co-morbidities (%) Obesity 9.48 7.81 8.81 0.01 Hypertension 56.69 51.71 54.68 <0.001 Diabetes Mellitus 14.91 13.02 14.15 0.02 Congestive Heart Failure 36.34 39.45 37.6 0.01 History of Chronic Pulmonary Disease 19.4 16.36 18.17 0.001 Peripheral Vascular Disease 6.59 9.1 7.6 <0.001 Fluid-electrolyte abnormalities & Renal Failure 38.71 35.3 37.33 0.002 Neurological disorder or paralysis 6.53 5.88 6.27 0.25 Anemia or coagulopathy 43.09 41.14 42.3 0.08 Solid Tumors or Metastatic Cancers or Lymphoma 0.68 0.8 0.73 0.53 Depression, Psychosis, or Substance Abuse 12.8 12.15 12.54 0.39 Liver disorders 1.97 2.99 2.38 0.01 Rheumatoid Arthritis/ Collagen Vascular diseases 2.18 3.02 2.52 0.02 Chronic blood loss anemia 1.73 1.65 1.7 0.77 Pulmonary circulation disorders 0.62 1.02 0.78 0.05 Hypothyroidism 11.24 9.65 10.6 0.03 Acute myocardial infarction 0.91 0.59 0.78 0.11 Median Household Income Category for patient's Zip code (%) 0-25th percentile 24.3 15.07 20.58 26-50th percentile 21.44 18.5 20.25 <0.001 51-75th percentile 27.51 26.29 27.02 76-100th percentile 25.32 38.66 30.7 Primary Payer (%) Medicare 40.36 41.42 40.79 Medicaid 9.21 4.87 7.46 <0.001 Private including HMOs & PPOs 45.7 50.38 47.59 Other/Self-pay/No charge 4.51 3.19 3.97 Remedy Publications LLC. 2 2018 | Volume 2 | Issue 1 | Article 1015 Samir V Patel, et al., Annals of Cardiology and Cardiovascular Medicine Hospital Characteristics Bed size of Hospital depending on Location & Teaching Status (%) Small 7.5 3.78 6 Medium 29.24 5.17 19.53 <0.001 Large 62.96 91.05 74.3 Hospital Location & Teaching Status¥ (%) Rural 1.76 0.65 1.31 Urban Non-teaching 38.15 6.36 25.32 <0.001 Urban Teaching 59.79 92.99 73.19 Hospital Region (%) Northeast 24.06 20.99 22.82 Midwest 15.3 27.87 20.37 South 32.37 25.18 29.46 <0.001 West 25.32 24.97 25.18 Missing 2.95 0.99 2.16 Type of Admission (%) Non-elective 18.91 15.28 17.44 <0.001 Elective 80.68 84.72 82.31 Admission Day (%) Weekdays 95.84 96.86 96.25 0.02 Weekends 4.16 3.14 3.75 Disposition (%) Home 45.17 40.59 43.32 Home Health Care 36.21 44.99 39.75 <0.001 Transfer to Short-term Hospital/other facilities 16.26 12.87 14.89 In-hospital Mortality (%) 2.16 1.55 1.91 0.05 Length of hospital-stay-Median (Quartile 1 , 3), days 6 (5, 9) 6 (5, 9) 6 (5, 9) Cost (Mean, SE) ($) 44056 (1157) 46006 (1338) 44854 (876) 0.01 HMO: Health Maintenance Organization; PPO: Preferred Provider Organization *= This represents a quartile classification of the estimated median household income of residents in the patient's ZIP Code. These values are derived from ZIP Code- demographic data obtained from Claritas. The quartiles are identified by values of 1 to 4, indicating the poorest to wealthiest populations. Because these estimates are updated annually, the value ranges vary by year. http://www.hcupus.ahrq.gov/db/vars/zipinc_qrtl/nisnote.jsp. ¥=The inclusion criteria for the hospitals as teaching hospitals includes presence of an American Medical Association approved residency program, membership of the Council of Teaching Hospitals, or having a fulltime equivalent interns and residents to patient’s ratio of 0.25 or higher. in the same institutions. The present study was conducted to compare The NIS data is also used to study trends in other acute medical and the post-procedural outcomes of surgical mitral valve repair and/or surgical conditions [6]. replacement between centers, which have adopted TMVR and those From NIS database of year 2011, we identified mitral surgery that did not. procedures by using the International Classification of Diseases, 9th Methods Revision, Clinical Modification (ICD-9-CM) procedure codes, 35.12 (Open heart valvuloplasty of mitral valve without replacement), 35.23 The study subjects were obtained from the National Inpatient (Open and other replacement of mitral valve with tissue graft) and Sample (NIS) database, a subset of the Healthcare Cost and Utilization 35.24 (Open and other replacement of mitral valve).
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