- Email: [email protected]
Trends and Outcomes With Transcatheter Versus Surgical Mitral Valve Repair in Patients ≥80 Years of Age
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Trends and Outcomes with Transcatheter versus Surgical Mitral Valve Repair in Patients e80 Years of Age Aaqib H. Malik MD, MPH , Syed Zaid MD , Srikanth Yandrapalli MD , Suchith Shetty MD, MPH , Wilbert S. Aronow MD , Hasan Ahmad MD , Gilbert H.L. Tang MD, MSc, MBA PII: DOI: Reference:
S0002-9149(20)30018-7 https://doi.org/10.1016/j.amjcard.2019.12.050 AJC 24383
To appear in:
The American Journal of Cardiology
Received date: Revised date: Accepted date:
12 November 2019 23 December 2019 30 December 2019
Please cite this article as: Aaqib H. Malik MD, MPH , Syed Zaid MD , Srikanth Yandrapalli MD , Suchith Shetty MD, MPH , Wilbert S. Aronow MD , Hasan Ahmad MD , Gilbert H.L. Tang MD, MSc, MBA , Trends and Outcomes with Transcatheter versus Surgical Mitral Valve Repair in Patients e80 Years of Age, The American Journal of Cardiology (2020), doi: https://doi.org/10.1016/j.amjcard.2019.12.050
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Published by Elsevier Inc.
Trends and Outcomes with Transcatheter versus Surgical Mitral Valve Repair in Patients ≥80 Years of Age Aaqib H. Malika, MD, MPH; Syed Zaidb, MD; Srikanth Yandrapallib, MD; Suchith Shettyc, MD, MPH; Wilbert S. Aronowb, MD; Hasan Ahmadb, MD; Gilbert H. L. Tangd, MD, MSc, MBA
Total word count: (text without references): 688 Running title: Transcatheter versus surgical mitral repair in elderly a
Department of Medicine, Westchester Medical Center and New York Medical College, Valhalla, NY, USA b
Department of Cardiology, Westchester Medical Center and New York Medical College, Valhalla, NY, USA c
Department of Medicine, University of Iowa Health Care, Carver College of Medicine, Iowa, USA d
Department of Cardiovascular Surgery, Mount Sinai Hospital, New York, NY USA
Total word count: Conflicts of interest: All authors have no conflicts of interest to declare Address for correspondence: Aaqib H Malik MD MPH Department of Medicine, Westchester Medical Center and New York Medical College, Valhalla, NY, USA Tel: 914-610-6458 Fax: 877-208-5496 E-mail: [email protected] *A preliminary analysis of this study was presented as a moderated poster at TCT 2019 in San Francisco.
Conceptualization Methodology Software
AM AM AM
Validation
AM, SZ
Formal analysis
AM
Investigation
AM
Resources
All authors
Data Curation
AM
Writing - Original Draft Writing - Review & Editing
All authors
Visualization
All authors
Supervision
GT
Project administration Funding acquisition
GT
All authors
NA
Ideas; formulation or evolution of overarching research goals and aims Development or design of methodology; creation of models Programming, software development; designing computer programs; implementation of the computer code and supporting algorithms; testing of existing code components Verification, whether as a part of the activity or separate, of the overall replication/ reproducibility of results/experiments and other research outputs Application of statistical, mathematical, computational, or other formal techniques to analyze or synthesize study data Conducting a research and investigation process, specifically performing the experiments, or data/evidence collection Provision of study materials, reagents, materials, patients, laboratory samples, animals, instrumentation, computing resources, or other analysis tools Management activities to annotate (produce metadata), scrub data and maintain research data (including software code, where it is necessary for interpreting the data itself) for initial use and later reuse Preparation, creation and/or presentation of the published work, specifically writing the initial draft (including substantive translation) Preparation, creation and/or presentation of the published work by those from the original research group, specifically critical review, commentary or revision – including pre-or postpublication stages Preparation, creation and/or presentation of the published work, specifically visualization/ data presentation Oversight and leadership responsibility for the research activity planning and execution, including mentorship external to the core team Management and coordination responsibility for the research activity planning and execution Acquisition of the financial support for the project leading to this publication CRediT author statement
Abstract Transcatheter mitral valve repair (TMVR) has shown comparable outcomes to surgical mitral valve replacement or repair (SMVR) in patients who are at a higher risk of surgical complications and therefore are not amenable to surgery. Elderly patients are considered poor surgical candidates due to their advanced age, and presence of comorbidities. A sub-analysis of EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) trial identified patients of >70 years of age appear to have a similar risk-benefit profile for either approach of surgery or transcatheter. This finding does have some caveats considering the trial included surgical cohort with both repair and replacement. Utilizing the National Inpatient Sample, we identified a surgical cohort of ≥80 years of age that underwent mitral valve repair and used propensity matching to compare it with a similar cohort that underwent TMVR. In a well-balanced cohort, TMVR was associated with significantly lower in-patient mortality (0.7% vs 3.1%). TMVR was also associated with significantly decreased in-hospital complications such as acute kidney injury, cardiogenic shock, postoperative hemorrhage, transfusion, permanent pacemaker, and respiratory and vascular complications. Owing to this, the duration of hospital stay is approximately 6 days less with TMVR. Trend analysis has shown a paradigm shift in these elderly patients with 85% of all repairs in 2012 were performed surgically, whereas in 2016 almost 94% of all the repairs being performed via a transcatheter approach. In conclusion, in patients ≥80 years of age, the surgical MVR had 4-fold higher mortality compared to TMVR with higher cardiac, vascular, hemorrhagic and respiratory complications. Despite the limitations of being observational in nature, this data strongly supports the preferential use of the transcatheter approach for mitral valve repair in patients ≥80 years of age. Key words: Mitral valve repair; Transcatheter; Mortality
Introduction Elderly patients are at increased risk of complications from surgical procedures. 1 However, with an aging population, a higher number of elderly patients are undergoing complex and high-risk surgeries. EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) trial found comparable mortality risk of 6% at 1-year between transcatheter mitral valve repair (TMVR) and surgical MVR (SMVR) or replacement but a much-reduced incidence of immediate 30-day hemorrhagic complications (15% vs 48%) with TMVR. 2,3 This came at the cost of higher reoperations for valve dysfunction in the TMVR group. An exploratory subgroup analysis of the EVEREST II study also identified 70 years as the cutoff age where the benefit of TMVR and SMVR or replacement reached equivalence. However, the surgical cohort in the EVEREST II included patients who underwent replacement as well. The current study was, therefore, designed to compare the efficacy and safety of TMVR with isolated SMVR without any valvular replacement in patients ≥80 years of age. Methods The National Inpatient Sample (NIS) 2012-2016 was used from the Agency for Healthcare Research and Quality’s (AHRQ) Healthcare Cost and Utilization Project (HCUP). Details are provided elsewhere.4 Briefly, the NIS is the largest publicly available all-payer inpatient healthcare database in the United States (US). It includes all discharge records of patients treated in the US community hospitals, excluding rehabilitation and long-term acute care facilities. Discharge weights are provided in the form of a variable ‘DISCWT’ to obtain national estimates. The year 2016 is the first full year since the adoption of newer International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). Prior to that ICD-9-CM was used to identify study cohort and other characteristics. We retrospectively
analyzed the data ICD-9 and ICD-10 procedural codes to identify all hospitalizations in patients who underwent mitral valve repair. We excluded patients who underwent concomitant cardiac surgery, or other valvular procedures including aortic, pulmonary or tricuspid. Our cohort was further divided into patients who underwent TMVR and SMVR and we excluded patients who had undergoing mitral valve replacement. Propensity matching was performed by using ‘nearest neighbor matching’. Logistic regression was employed to estimate the distance measure. Matching was performed with caliper set at 0.1 and cases were matched with controls without replacement and with common support. (see supplementary Figures 1-3). Patient characteristics were identified from the variables created by using STATA software macro for Elixhauser comorbidity index. In a matched cohort the patient characteristics, in-hospital complications and outcomes were compared via the Rao and Scott χ2 statistic to account for survey design of the NIS. Continuous variables were compared between groups using a t-test. Statistical analyses were performed using Stata 16.0 (StataCorp. 2019. Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC.) and R (R Development Core Team, Vienna, Austria).
Results Over a period of 5 years, 7415 patients underwent repeat MVR with either surgical-MVR (n=2655, 36%) or TMVR (n=4760, 64%) in patients ≥80 years of age. Figure 1 shows a flowchart for the final cohort selection. Yearly trend analysis showed a continuous increasing utilization of TMVR compared to surgical MVR from 15.4% in 2012 to 94.4% in 2016 (p-fortrend <0.01) (Figure 2). About 85% of total procedures were performed surgically in 2012, whereas in 2016 almost 94% of the procedures were performed via a transcatheter approach in 2016.
Table 1 shows a well-matched cohort of 2,910 elderly patients undergoing TMVR and SMVR. Despite being well-matched, the surgical approach is associated with 4 times the mortality of TMVR (3.1% vs 0.7%), and it incurs a more expensive and longer length of hospital stay. Additionally, TMVR was consistently associated with a lower rate of acute kidney injury, cardiogenic shock, postoperative hemorrhage, transfusion, permanent pacemaker, and respiratory and vascular complications (p<0.05). (see TABLE 1) Discussion The main findings of this analysis can be summarized as follows: 1) there has been a consistent and significant trend towards increased utilization of TMVR in comparison to surgical MVR for degenerative mitral valve disease; 2) TMVR is associated with significantly lower inhospital mortality; 3) the risk of in-hospital complications (including cardiac, vascular, respiratory, and hemorrhagic) and resource utilization (length of hospital stay) is in favor of transcatheter approach. This large real-world registry analysis suggests a paradigm shift towards transcatheter therapy for the isolated repair of mitral valve especially in elderly patients. This is partly supported in the trend analysis as we see a sudden increase in the TMVR procedures from 760 in 2014 to 1445 in 2015. This also could be partly explained by the change in ICD coding with newer more sensitive ICD-10 codes that became effective in 2015, but it could also represent the fact that mitral valve repair is now more routinely performed in the elderly population. In outcome analysis, TMVR appears to be was associated with lower in-hospital complications and in-hospital mortality compared to the surgical approach. However, due to the administrative nature of our data, we were unable to adequately assess the anatomical and long-
term efficacy of TMVR. We also lack the information on medication usage and ejection fraction in our data. Finally, we were unable to differentiate the etiology and type of mitral regurgitation. Nevertheless, our results confirm the chronological age to be an important parameter for risk assessment of these patients who undergo MVR. In patients ≥80 years of age, TMVR is safer and is associated with lower procedural morbidity and mortality suggesting that patients ≥80 years of age may not be the best surgical candidates for the mitral valve repair. TMVR in elderly may also be preferred due to a lower cost, lower risk of morbidity, decreased mortality, and also because it may result in similar symptom relief, as was shown in EVEREST II trial, however a comparably suboptimal MR reduction.
References
1. Khan-Kheil AM, Khan HN. Surgical mortality in patients more than 80 years of age. Ann R Coll Surg Engl 2016;98:177-180. 2. Mauri L, Foster E, Glower DD, Apruzzese P, Massaro JM, Herrmann HC, Hermiller J, Gray W, Wang A, Pedersen WR, Bajwa T, Lasala J, Low R, Grayburn P, Feldman T, Investigators EI. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol 2013;62:317-328. 3. Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L, Investigators EI. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med 2011;364:1395-1406. 4. HCUP National Inpatient Sample (NIS). Healthcare Cost and Utilization Project (HCUP). 2012-2016. Agency for Healthcare Research and Quality R, MD. www.hcupus.ahrq.gov/nisoverview.jsp
Figure legend
Figure 1. Flowchart to identify the cohort of surgical and transcatheter mitral valve repair.
Figure 2. The trend of mitral valve repair according to transcatheter or surgical approach from 2012 to 2016.
Table 1. A propensity-matched comparison of transcatheter versus isolated surgical mitral valve repair (National Inpatient Sample 2012-2016) All patients
TMVR in ≥80 years
SMVR in ≥80 years
(n=2910)
(n=1455)
(n=1455)
Age, mean (SD,) (years)
83.7 (2.8)
83.7 (2.5)
0.9140
Women
53.3%
50.9%
0.5351
White
80.1%
79.7%
0.5878
Black
2.1%
3.8%
Others
9.3%
7.2%
Missing
8.6%
9.3%
Hypertension
76.0%
75.6%
0.9225
Diabetes mellitus
15.5%
15.8%
0.9038
Heart failure
72.2%
71.5%
0.8485
Atrial fibrillation
68.7%
69.1%
0.9277
Arrhythmias
78.0%
78.7%
0.8356
Peripheral vascular
8.9%
10.0%
0.6792
Neurological disorders
5.8%
6.5%
0.7003
Chronic pulmonary
31.6%
37.1%
0.1697
Hypothyroidism
20.3%
17.2%
0.3011
Chronic kidney disease
27.5%
23.4%
0.2614
Characteristics
P values
disease
disease
Liver disease
1.7%
1.4%
0.7383
Obesity*
6.2%
5.8%
0.8694
Weight loss**
5.5%
6.2%
0.7417
Elixhauser score mean
5.5 (2.0)
5.6 (2.0)
0.7760
Acute kidney injury
10.7%
25.1%
<0.001
Cardiogenic shock
2.1%
7.9%
<0.001
Post-operative
9.3%
39.5%
<0.001
Transfusion
6.2%
36.1%
<0.001
Respiratory
1.7%
4.1%
0.0807
Permanent pacemaker
0.7%
5.8%
<0.001
Vascular complications
<0.3%
2.1%
0.0551
(SD) In-hospital complications
hemorrhage
complications
Discharge disposition
<0.01
Routine
63.9%
16.8%
SNF/NH/IC
15.8%
47.4%
Home healthcare
18.2%
32.3%
4.7 (6.1)
10.4 (7.6)
<0.01
0.7%
3.1%
0.0262
Length of stay, mean days (SD) In-hospital death
Teaching hospital
82.1%
83.9%
0.9814
Hospital region Northwest
21.0%
22.3%
Midwest
27.5%
27.8%
South
32.0%
30.9%
West
19.6%
18.9% 0.1836
Hospital bed size Small
9.3%
5.5%
Medium
15.5%
19.6%
Large
75.3%
74.9% 0.7924
Primary payer Medicare/Medicaid
94.9%
93.8%
Private
3.8%
4.1% 0.2877
Median household income (percentile) 0-25th
17.9%
16.2%
26-50th
18.9%
23.7%
51-75th
32.7%
26.8%
76-100th
30.6%
33.3%
45,194 (23,605)
51,022 (30,762)
Total cost ($)
0.1532
0.01
Abbreviations: TMVR=Transcatheter mitral valve repair; SMVR=Surgical mitral valve repair; SD=Standard deviation; SNF=Short-term nursing facility; NH=Nursing home; IC=Intermediate care *Obesity is defined as patients with a diagnostic code of overweight and obesity with body mass index of ≥25
*Weight loss defined as patients with diagnostic code of nutritional deficiencies including kwashiorkor, marasmus, and other protein-calorie malnutrition.
Trends and Outcomes with Transcatheter versus Surgical Mitral Valve Repair in Patients e80 Years of Age Aaqib H. Malik MD, MPH , Syed Zaid MD , Srikanth Yandrapalli MD , Suchith Shetty MD, MPH , Wilbert S. Aronow MD , Hasan Ahmad MD , Gilbert H.L. Tang MD, MSc, MBA PII: DOI: Reference:
S0002-9149(20)30018-7 https://doi.org/10.1016/j.amjcard.2019.12.050 AJC 24383
To appear in:
The American Journal of Cardiology
Received date: Revised date: Accepted date:
12 November 2019 23 December 2019 30 December 2019
Please cite this article as: Aaqib H. Malik MD, MPH , Syed Zaid MD , Srikanth Yandrapalli MD , Suchith Shetty MD, MPH , Wilbert S. Aronow MD , Hasan Ahmad MD , Gilbert H.L. Tang MD, MSc, MBA , Trends and Outcomes with Transcatheter versus Surgical Mitral Valve Repair in Patients e80 Years of Age, The American Journal of Cardiology (2020), doi: https://doi.org/10.1016/j.amjcard.2019.12.050
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Published by Elsevier Inc.
Trends and Outcomes with Transcatheter versus Surgical Mitral Valve Repair in Patients ≥80 Years of Age Aaqib H. Malika, MD, MPH; Syed Zaidb, MD; Srikanth Yandrapallib, MD; Suchith Shettyc, MD, MPH; Wilbert S. Aronowb, MD; Hasan Ahmadb, MD; Gilbert H. L. Tangd, MD, MSc, MBA
Total word count: (text without references): 688 Running title: Transcatheter versus surgical mitral repair in elderly a
Department of Medicine, Westchester Medical Center and New York Medical College, Valhalla, NY, USA b
Department of Cardiology, Westchester Medical Center and New York Medical College, Valhalla, NY, USA c
Department of Medicine, University of Iowa Health Care, Carver College of Medicine, Iowa, USA d
Department of Cardiovascular Surgery, Mount Sinai Hospital, New York, NY USA
Total word count: Conflicts of interest: All authors have no conflicts of interest to declare Address for correspondence: Aaqib H Malik MD MPH Department of Medicine, Westchester Medical Center and New York Medical College, Valhalla, NY, USA Tel: 914-610-6458 Fax: 877-208-5496 E-mail: [email protected] *A preliminary analysis of this study was presented as a moderated poster at TCT 2019 in San Francisco.
Conceptualization Methodology Software
AM AM AM
Validation
AM, SZ
Formal analysis
AM
Investigation
AM
Resources
All authors
Data Curation
AM
Writing - Original Draft Writing - Review & Editing
All authors
Visualization
All authors
Supervision
GT
Project administration Funding acquisition
GT
All authors
NA
Ideas; formulation or evolution of overarching research goals and aims Development or design of methodology; creation of models Programming, software development; designing computer programs; implementation of the computer code and supporting algorithms; testing of existing code components Verification, whether as a part of the activity or separate, of the overall replication/ reproducibility of results/experiments and other research outputs Application of statistical, mathematical, computational, or other formal techniques to analyze or synthesize study data Conducting a research and investigation process, specifically performing the experiments, or data/evidence collection Provision of study materials, reagents, materials, patients, laboratory samples, animals, instrumentation, computing resources, or other analysis tools Management activities to annotate (produce metadata), scrub data and maintain research data (including software code, where it is necessary for interpreting the data itself) for initial use and later reuse Preparation, creation and/or presentation of the published work, specifically writing the initial draft (including substantive translation) Preparation, creation and/or presentation of the published work by those from the original research group, specifically critical review, commentary or revision – including pre-or postpublication stages Preparation, creation and/or presentation of the published work, specifically visualization/ data presentation Oversight and leadership responsibility for the research activity planning and execution, including mentorship external to the core team Management and coordination responsibility for the research activity planning and execution Acquisition of the financial support for the project leading to this publication CRediT author statement
Abstract Transcatheter mitral valve repair (TMVR) has shown comparable outcomes to surgical mitral valve replacement or repair (SMVR) in patients who are at a higher risk of surgical complications and therefore are not amenable to surgery. Elderly patients are considered poor surgical candidates due to their advanced age, and presence of comorbidities. A sub-analysis of EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) trial identified patients of >70 years of age appear to have a similar risk-benefit profile for either approach of surgery or transcatheter. This finding does have some caveats considering the trial included surgical cohort with both repair and replacement. Utilizing the National Inpatient Sample, we identified a surgical cohort of ≥80 years of age that underwent mitral valve repair and used propensity matching to compare it with a similar cohort that underwent TMVR. In a well-balanced cohort, TMVR was associated with significantly lower in-patient mortality (0.7% vs 3.1%). TMVR was also associated with significantly decreased in-hospital complications such as acute kidney injury, cardiogenic shock, postoperative hemorrhage, transfusion, permanent pacemaker, and respiratory and vascular complications. Owing to this, the duration of hospital stay is approximately 6 days less with TMVR. Trend analysis has shown a paradigm shift in these elderly patients with 85% of all repairs in 2012 were performed surgically, whereas in 2016 almost 94% of all the repairs being performed via a transcatheter approach. In conclusion, in patients ≥80 years of age, the surgical MVR had 4-fold higher mortality compared to TMVR with higher cardiac, vascular, hemorrhagic and respiratory complications. Despite the limitations of being observational in nature, this data strongly supports the preferential use of the transcatheter approach for mitral valve repair in patients ≥80 years of age. Key words: Mitral valve repair; Transcatheter; Mortality
Introduction Elderly patients are at increased risk of complications from surgical procedures. 1 However, with an aging population, a higher number of elderly patients are undergoing complex and high-risk surgeries. EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) trial found comparable mortality risk of 6% at 1-year between transcatheter mitral valve repair (TMVR) and surgical MVR (SMVR) or replacement but a much-reduced incidence of immediate 30-day hemorrhagic complications (15% vs 48%) with TMVR. 2,3 This came at the cost of higher reoperations for valve dysfunction in the TMVR group. An exploratory subgroup analysis of the EVEREST II study also identified 70 years as the cutoff age where the benefit of TMVR and SMVR or replacement reached equivalence. However, the surgical cohort in the EVEREST II included patients who underwent replacement as well. The current study was, therefore, designed to compare the efficacy and safety of TMVR with isolated SMVR without any valvular replacement in patients ≥80 years of age. Methods The National Inpatient Sample (NIS) 2012-2016 was used from the Agency for Healthcare Research and Quality’s (AHRQ) Healthcare Cost and Utilization Project (HCUP). Details are provided elsewhere.4 Briefly, the NIS is the largest publicly available all-payer inpatient healthcare database in the United States (US). It includes all discharge records of patients treated in the US community hospitals, excluding rehabilitation and long-term acute care facilities. Discharge weights are provided in the form of a variable ‘DISCWT’ to obtain national estimates. The year 2016 is the first full year since the adoption of newer International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). Prior to that ICD-9-CM was used to identify study cohort and other characteristics. We retrospectively
analyzed the data ICD-9 and ICD-10 procedural codes to identify all hospitalizations in patients who underwent mitral valve repair. We excluded patients who underwent concomitant cardiac surgery, or other valvular procedures including aortic, pulmonary or tricuspid. Our cohort was further divided into patients who underwent TMVR and SMVR and we excluded patients who had undergoing mitral valve replacement. Propensity matching was performed by using ‘nearest neighbor matching’. Logistic regression was employed to estimate the distance measure. Matching was performed with caliper set at 0.1 and cases were matched with controls without replacement and with common support. (see supplementary Figures 1-3). Patient characteristics were identified from the variables created by using STATA software macro for Elixhauser comorbidity index. In a matched cohort the patient characteristics, in-hospital complications and outcomes were compared via the Rao and Scott χ2 statistic to account for survey design of the NIS. Continuous variables were compared between groups using a t-test. Statistical analyses were performed using Stata 16.0 (StataCorp. 2019. Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC.) and R (R Development Core Team, Vienna, Austria).
Results Over a period of 5 years, 7415 patients underwent repeat MVR with either surgical-MVR (n=2655, 36%) or TMVR (n=4760, 64%) in patients ≥80 years of age. Figure 1 shows a flowchart for the final cohort selection. Yearly trend analysis showed a continuous increasing utilization of TMVR compared to surgical MVR from 15.4% in 2012 to 94.4% in 2016 (p-fortrend <0.01) (Figure 2). About 85% of total procedures were performed surgically in 2012, whereas in 2016 almost 94% of the procedures were performed via a transcatheter approach in 2016.
Table 1 shows a well-matched cohort of 2,910 elderly patients undergoing TMVR and SMVR. Despite being well-matched, the surgical approach is associated with 4 times the mortality of TMVR (3.1% vs 0.7%), and it incurs a more expensive and longer length of hospital stay. Additionally, TMVR was consistently associated with a lower rate of acute kidney injury, cardiogenic shock, postoperative hemorrhage, transfusion, permanent pacemaker, and respiratory and vascular complications (p<0.05). (see TABLE 1) Discussion The main findings of this analysis can be summarized as follows: 1) there has been a consistent and significant trend towards increased utilization of TMVR in comparison to surgical MVR for degenerative mitral valve disease; 2) TMVR is associated with significantly lower inhospital mortality; 3) the risk of in-hospital complications (including cardiac, vascular, respiratory, and hemorrhagic) and resource utilization (length of hospital stay) is in favor of transcatheter approach. This large real-world registry analysis suggests a paradigm shift towards transcatheter therapy for the isolated repair of mitral valve especially in elderly patients. This is partly supported in the trend analysis as we see a sudden increase in the TMVR procedures from 760 in 2014 to 1445 in 2015. This also could be partly explained by the change in ICD coding with newer more sensitive ICD-10 codes that became effective in 2015, but it could also represent the fact that mitral valve repair is now more routinely performed in the elderly population. In outcome analysis, TMVR appears to be was associated with lower in-hospital complications and in-hospital mortality compared to the surgical approach. However, due to the administrative nature of our data, we were unable to adequately assess the anatomical and long-
term efficacy of TMVR. We also lack the information on medication usage and ejection fraction in our data. Finally, we were unable to differentiate the etiology and type of mitral regurgitation. Nevertheless, our results confirm the chronological age to be an important parameter for risk assessment of these patients who undergo MVR. In patients ≥80 years of age, TMVR is safer and is associated with lower procedural morbidity and mortality suggesting that patients ≥80 years of age may not be the best surgical candidates for the mitral valve repair. TMVR in elderly may also be preferred due to a lower cost, lower risk of morbidity, decreased mortality, and also because it may result in similar symptom relief, as was shown in EVEREST II trial, however a comparably suboptimal MR reduction.
References
1. Khan-Kheil AM, Khan HN. Surgical mortality in patients more than 80 years of age. Ann R Coll Surg Engl 2016;98:177-180. 2. Mauri L, Foster E, Glower DD, Apruzzese P, Massaro JM, Herrmann HC, Hermiller J, Gray W, Wang A, Pedersen WR, Bajwa T, Lasala J, Low R, Grayburn P, Feldman T, Investigators EI. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol 2013;62:317-328. 3. Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L, Investigators EI. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med 2011;364:1395-1406. 4. HCUP National Inpatient Sample (NIS). Healthcare Cost and Utilization Project (HCUP). 2012-2016. Agency for Healthcare Research and Quality R, MD. www.hcupus.ahrq.gov/nisoverview.jsp
Figure legend
Figure 1. Flowchart to identify the cohort of surgical and transcatheter mitral valve repair.
Figure 2. The trend of mitral valve repair according to transcatheter or surgical approach from 2012 to 2016.
Table 1. A propensity-matched comparison of transcatheter versus isolated surgical mitral valve repair (National Inpatient Sample 2012-2016) All patients
TMVR in ≥80 years
SMVR in ≥80 years
(n=2910)
(n=1455)
(n=1455)
Age, mean (SD,) (years)
83.7 (2.8)
83.7 (2.5)
0.9140
Women
53.3%
50.9%
0.5351
White
80.1%
79.7%
0.5878
Black
2.1%
3.8%
Others
9.3%
7.2%
Missing
8.6%
9.3%
Hypertension
76.0%
75.6%
0.9225
Diabetes mellitus
15.5%
15.8%
0.9038
Heart failure
72.2%
71.5%
0.8485
Atrial fibrillation
68.7%
69.1%
0.9277
Arrhythmias
78.0%
78.7%
0.8356
Peripheral vascular
8.9%
10.0%
0.6792
Neurological disorders
5.8%
6.5%
0.7003
Chronic pulmonary
31.6%
37.1%
0.1697
Hypothyroidism
20.3%
17.2%
0.3011
Chronic kidney disease
27.5%
23.4%
0.2614
Characteristics
P values
disease
disease
Liver disease
1.7%
1.4%
0.7383
Obesity*
6.2%
5.8%
0.8694
Weight loss**
5.5%
6.2%
0.7417
Elixhauser score mean
5.5 (2.0)
5.6 (2.0)
0.7760
Acute kidney injury
10.7%
25.1%
<0.001
Cardiogenic shock
2.1%
7.9%
<0.001
Post-operative
9.3%
39.5%
<0.001
Transfusion
6.2%
36.1%
<0.001
Respiratory
1.7%
4.1%
0.0807
Permanent pacemaker
0.7%
5.8%
<0.001
Vascular complications
<0.3%
2.1%
0.0551
(SD) In-hospital complications
hemorrhage
complications
Discharge disposition
<0.01
Routine
63.9%
16.8%
SNF/NH/IC
15.8%
47.4%
Home healthcare
18.2%
32.3%
4.7 (6.1)
10.4 (7.6)
<0.01
0.7%
3.1%
0.0262
Length of stay, mean days (SD) In-hospital death
Teaching hospital
82.1%
83.9%
0.9814
Hospital region Northwest
21.0%
22.3%
Midwest
27.5%
27.8%
South
32.0%
30.9%
West
19.6%
18.9% 0.1836
Hospital bed size Small
9.3%
5.5%
Medium
15.5%
19.6%
Large
75.3%
74.9% 0.7924
Primary payer Medicare/Medicaid
94.9%
93.8%
Private
3.8%
4.1% 0.2877
Median household income (percentile) 0-25th
17.9%
16.2%
26-50th
18.9%
23.7%
51-75th
32.7%
26.8%
76-100th
30.6%
33.3%
45,194 (23,605)
51,022 (30,762)
Total cost ($)
0.1532
0.01
Abbreviations: TMVR=Transcatheter mitral valve repair; SMVR=Surgical mitral valve repair; SD=Standard deviation; SNF=Short-term nursing facility; NH=Nursing home; IC=Intermediate care *Obesity is defined as patients with a diagnostic code of overweight and obesity with body mass index of ≥25
*Weight loss defined as patients with diagnostic code of nutritional deficiencies including kwashiorkor, marasmus, and other protein-calorie malnutrition.