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Propensity Score Matched Analysis of Mechanical Vs. Bioprosthetic Valve Replacement in Patients with Previous Stroke

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Propensity Score Matched Analysis of Mechanical Vs. Bioprosthetic Valve Replacement in Patients with Previous Stroke Circ J 2018; 82: 2041 – 2048 ORIGINAL ARTICLE doi: 10.1253/circj.CJ-18-0003 Cardiovascular Surgery Propensity Score Matched Analysis of Mechanical vs. Bioprosthetic Valve Replacement in Patients With Previous Stroke Shao-Wei Chen, MD; Victor Chien-Chia Wu, MD; Yu-Sheng Lin, MD; Ching-Chang Chen, MD; Dong-Yi Chen, MD; Chih-Hsiang Chang, MD; Pao-Hsien Chu, MD; Pei-Chi Ting, MD; An-Hsun Chou, MD, PhD; Tien-Hsing Chen, MD Background: This study compared the long-term outcomes of prosthetic heart valve replacement with mechanical or bioprosthetic valves in patients with prior stroke. Methods and Results: In total, 1,984 patients with previous stroke who had received valve replacement between 2000 and 2011 were identified using the Taiwan National Health Insurance Research Database. Propensity score matching analysis was used. Ultimately, 547 patients were extracted from each group and were eligible for analysis. On survival analysis, the risks of all-cause mortality and recurrence of stroke were similar. The incidence of major bleeding was greater in the mechanical valve group than in the bioprosthetic valve group (P=0.040), whereas no difference was observed in re-do valve surgery. On subgroup analysis, the bioprosthetic valve was favored for older age (≥60 years) and previous gastrointestinal (GI) bleeding patients. The mechanical valve, however, was favored for younger patients (<60 years). Conclusions: In patients with previous stroke, bioprosthetic valves had a lower incidence of complications connected to major bleeding than did the mechanical valves. Survival and stroke recurrence rates, however, did not differ between the 2 groups. We recommend bioprosthetic valves for patients >60 years or who have a history of GI bleeding. Key Words: Long-term prognosis; Old stroke; Valve replacement ioprosthetic valves have been increasingly used in age of the patient at the time of the valve replacement.2,3 valve replacement surgery in the recent 20 years. In The Veterans Affairs randomized trial, however, deter- B a recent paper, however, titled “Mechanical or bio- mined that 50% of deaths were not related to prosthetic logic prostheses for aortic-valve and mitral-valve replace- valve complications and emphasized that comorbidity was ment” in New England Journal of Medicine, Goldstone et key in determining patient outcomes.4 Furthermore, the al, using data from an administration database in California, indications for valves in patients with a specific comorbid- reported that mechanical prosthetic valve replacement was ity are still controversial, similar to the previous debate associated with significantly better survival than biopros- concerning dialysis patients.5 thetic valve replacement.1 This landmark study raised the Patients who have previously had a stroke when under- concern that there is in fact limited evidence supporting the going valve surgery are not uncommon. Cardiac surgery in implantation of bioprosthetic valves in diseased or elderly patients with previous stroke is associated with increased patients. The choice of prosthetic heart valve during valve mortality and an increased risk of postoperative stroke.6–9 replacement surgery is between the bioprosthetic valve A history of stroke may affect long-term outcome after and the mechanical valve for the majority of patients. valve replacement, and influences the decision making for Determining which to use is primarily dependent on the the type of valve selection. Few studies, however, have Received January 5, 2018; revised manuscript received March 23, 2018; accepted April 11, 2018; released online May 24, 2018 Time for primary review: 31 days Division of Thoracic and Cardiovascular Surgery, Department of Surgery (S.-W.C.), Department of Neurosurgery (C.-C.C.), Department of Anesthesiology (P.-C.T., A.-H.C.), Chang Gung Memorial Hospital, Linkou Medical Center, Chang Gung University, Taoyuan City; Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taoyuan City (S.-W.C., C.-H.C.); Department of Cardiology (V.C.-C.W., D.-Y.C., P.-H.C.), Kidney Research Center, Department of Nephrology (C.-H.C.), Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan City; Department of Cardiology, Chang Gung Memorial Hospital, Chiayi Branch, Chiayi City (Y.-S.L.); and Department of Cardiology, Chang Gung Memorial Hospital, Keelung Branch, Keelung (T.-H.C.), Taiwan Mailing address: Tien-Hsing Chen, MD, Department of Cardiology, Chang Gung Memorial Hospital, Keelung, No. 5 Fuxing Street, Guishan District, Taoyuan City 33305, Taiwan. E-mail: [email protected] ISSN-1346-9843 All rights are reserved to the Japanese Circulation Society. For permissions, please e-mail: [email protected] Circulation Journal Vol.82, August 2018 2042 CHEN SW et al. Figure 1. (A) Subject enrollment between 2000 and 2011, extracted from the Taiwan National Health Insurance Research Database; and (B) no. bioprosthetic valve and mechanical valve replacements. reported the long-term outcomes of cardiac surgery all medical services for all Taiwanese people. The NHIRD according to valve replacement type in patients with previ- is derived from the NHI program; thus, NHI claims data ous stroke. Furthermore, valve selection in this high-risk accurately represent the Taiwan population, with only patient group has not been previously addressed. Evaluating minimal data omitted and a small participation bias pres- the balance of risk and benefits between bleeding because ent. The claim data for each patient can be linked using a of anticoagulant therapy and prosthetic valve structure consistent data encryption process, which allows for con- deterioration is complex and multifactorial in this specific tinual tracking of all of the claims of any individual within population. Therefore, the aim of this nationwide popula- the NHI program. All personal information in the NHIRD tion-based cohort study was to compare mortality, recur- is anonymized and de-identified to protect privacy; thus, rence of stroke, major bleeding, and re-do valve surgery this study was exempt from a full review by the Ethics between bioprosthetic and mechanical valves using pro- Institutional Review Board of Chang Gung Memorial pensity score matching analysis. Hospital. Subjects Methods We examined the NHIRD inpatient records of all patients Data Source admitted for valve replacement between January 2000 and The data were obtained from the Taiwan National Health December 2011. Both Taiwan NHI procedure codes Insurance Research Database (NHIRD). Taiwan has a (68016, 68017, and 68018), which are used for claims for mandatory government-operated universal health insur- reimbursement, and International Classification of Diseases, ance program, the National Health Insurance (NHI) pro- Ninth Revision, Clinical Modification (ICD-9-CM) pro- gram, which was launched in 1995 and covers almost all cedure codes (35.21, 35.22, 35.23, 35.24), were used to (99%) of the approximately 23 million residents of Taiwan extract data for patients who received a valve replacement as of December 2015,10 providing comprehensive medical (Figure 1A). In total, 21,547 patients who underwent valve care coverage and reimbursing the medical expenditure of replacement in any position during the study period in Circulation Journal Vol.82, August 2018 Valve Replacement in Old Stroke 2043 Table 1. Clinical and Surgical Subject Characteristics vs. PSM Status Before PSM After PSM Variable Bioprosthetic Mechanical Bioprosthetic Mechanical Total P-value P-value valve valve valve valve n 1,984 606 1,378 – 547 547 – Age (years) 63.7±13.2 67.4±11.6 62.0±13.6 <0.001 66.7±11.7 66.3±12.6 0.532 Male gender 1,120 (56.5) 349 (57.6) 771 (56.0) 0.497 316 (57.8) 309 (56.5) 0.669 Stroke type 0.645 0.633 Ischemic 1,729 (87.1) 534 (88.1) 1,195 (86.7) 481 (87.9) 476 (87.0) Hemorrhagic 185 (9.3) 51 (8.4) 134 (9.7) 48 (8.8) 56 (10.2) Both 70 (3.5) 21 (3.5) 49 (3.6) 18 (3.3) 15 (2.7) Time from last stroke (years) 2.7±3.0 3.3±3.4 2.4±2.9 <0.001 3.1±3.3 3.0±3.3 0.606 Valve disease etiology 0.012 0.743 Rheumatic heart 667 (33.6) 180 (29.7) 487 (35.3) 164 (30.0) 167 (30.5) Infective endocarditis 335 (16.9) 96 (15.8) 239 (17.3) 85 (15.5) 93 (17.0) Degeneration and others 982 (49.5) 330 (54.5) 652 (47.3) 298 (54.5) 287 (52.5) Comorbidity Diabetes mellitus 545 (27.5) 178 (29.4) 367 (26.6) 0.208 158 (28.9) 160 (29.3) 0.894 Hypertension 1,208 (60.9) 422 (69.6) 786 (57.0) <0.001 368 (67.3) 370 (67.6) 0.897 CHF 898 (45.3) 302 (49.8) 596 (43.3) 0.007 272 (49.7) 264 (48.3) 0.629 CAD 1,069 (53.9) 357 (58.9) 712 (51.7) 0.003 324 (59.2) 311 (56.9) 0.426 PAD 129 (6.5) 46 (7.6) 83 (6.0) 0.192 43 (7.9) 41 (7.5) 0.820 Atrial fibrillation 951 (47.9) 314 (51.8) 637 (46.2) 0.022 280 (51.2) 267 (48.8) 0.432 Dialysis 86 (4.3) 34 (5.6) 52 (3.8) 0.064 30 (5.5) 29 (5.3) 0.894 COPD 246 (12.4) 86 (14.2) 160 (11.6) 0.108 79 (14.4) 75 (13.7) 0.728 Liver cirrhosis 54 (2.7) 20 (3.3) 34 (2.5) 0.294 17 (3.1) 18 (3.3) 0.864 GI bleeding history 494 (24.9) 178 (29.4) 316 (22.9) 0.002 151 (27.6) 162 (29.6) 0.462 Charlson score 3.4±2.1 3.5±2.0 3.3±2.1 0.037 3.5±2.0 3.5±2.2 0.965 Hospital level <0.001 0.102 Medical center (teaching 1,336 (67.3) 373 (61.6) 963 (69.9) 361 (66.0) 335 (61.2) hospital) Regional/district hospital 648 (32.7) 233 (38.4) 415 (30.1) 186 (34.0) 212 (38.8) Valve type 0.054 0.744 AVR alone 772 (38.9) 260 (42.9) 512 (37.2) 237 (43.3) 225 (41.1) MVR alone 984 (49.6) 281 (46.4) 703 (51.0) 251 (45.9) 263 (48.1) AVR+MVR 228 (11.5) 65 (10.7) 163 (11.8) 59 (10.8) 59 (10.8) Additional surgery CABG 481 (24.2) 164 (27.1) 317 (23.0) 0.052 143 (26.1) 138 (25.2) 0.729 Aortic surgery 111 (5.6) 38 (6.3) 73 (5.3) 0.385 34 (6.2) 32 (5.9) 0.800 TV repair or replacement 193 (9.7) 56 (9.2) 137 (9.9) 0.627 54 (9.9) 57 (10.4) 0.764 Data given as mean ± SD or n (%).
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