Abdelfattah, Omar

Ahuja, Keerat R

Bansal, Agam

Farwati, Medhat

Gad, Mohamed M

Jain, Vardhmaan

Kapadia, Samir R

Krishnaswamy, Amar

Saad, Anas M

Yun, James

English

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Tower Health Scholar Commons @ Tower Health Reading Hospital Cardiovascular Medicine Fellowship Cardiology Fellowship 9-1-2020 Outcomes of Cancer Patients Undergoing Transcatheter Aortic Valve Replacement. Vardhmaan Jain Anas M Saad Mohamed M Gad Agam Bansal Omar Abdelfattah See next page for additional authors Follow this and additional works at: https://scholarcommons.towerhealth.org/card_fellow_read  Part of the Cardiology Commons Authors Vardhmaan Jain, Anas M Saad, Mohamed M Gad, Agam Bansal, Omar Abdelfattah, Medhat Farwati, Keerat R. Ahuja, James Yun, Amar Krishnaswamy, and Samir R Kapadia RESEARCH LETTEROutcomes of CancerPatients UndergoingTranscatheter AorticValve ReplacementTranscatheter aortic valve replacement (TAVR) hasevolved as a first-line treatment modality for patientswith symptomatic aortic stenosis (AS). The propor-tion of patients with cancer who require TAVR hasgradually increased, with a prevalence close to 4% (1).Although surgical aortic valve replacement (SAVR)has been a long-standing treatment option for ASpatients, cardiac surgery in cancer patients carries anincreased risk of infection, conduction abnormalities,bleeding, and post-procedural intensive carerequirement (2). As a less-invasive option, TAVR istherefore promising. Limited data have assessed theshort- and long-term outcomes of cancer patients,and there are no data regarding readmissions in thispopulation. We investigated a large, representative,nationwide cohort to evaluate the feasibility andshort-term outcomes of TAVR in this group.The Nationwide Readmission Database (NRD) is adatabase created by the Agency for HealthcareResearch and Quality for the Healthcare Cost andUtilization Project that encompasses weighted esti-mates of one-half of the total hospitalizations in theUnited States (3). We used this registry to retrospec-tively select patients who were admitted betweenJanuary 2012 and September 2015 and underwentTAVR using the appropriate International Classifica-tion of Diseases-9th Revision procedure codes (35.05and 35.06). Among included patients, we assessedfor the presence of a malignancy using theInternational Classification of Diseases-9th Revisiondiagnoses codes (140.X to 209.X). We performed chi-square tests for categorical variables and Mann-Whitney U tests for continuous variables to evaluatecomorbidities and outcomes, as well as multivariablelogistic regression analyses to assess mortality pre-dictors after adjusting for age, sex, and all comor-bidities (Table 1). All regression models weremultivariable, and results were presented as oddsratio (OR) with 95% confidence interval (CI). Allstatistical analyses were performed using SPSSversion 26 (IBM, Armonk, New York) for the weightedvalues of observations as provided by the NRD tomeasure national estimates. A 2-sided value of p <0.05 was set for statistical significance. NRD data areanonymized and considered nonhuman subjectresearch; thus, institutional review board approvalwas not required.A total of 63,352 patients underwent TAVR andwere included, of which 2,850 (4.5%) had a malig-nancy. Cancer patients were more likely to havean underlying cardiomyopathy (10.8% vs. 8.8%;p < 0.001), and heart failure (11.2% vs. 8.9%;p < 0.001), but less likely to have hypertension, atrialfibrillation, diabetes mellitus, dyslipidemia, chroniclung disease, and other comorbidities (Table 1).Post-procedural outcomes, including all-cause in-hospital mortality, stroke, bleeding, and permanentpacemaker implantation, did not differ in patientswith and without cancer (Table 1). However, cancerpatients were more likely to develop acute kidneyinjury (17.9% vs. 16.2%; p ¼ 0.023), and to bereadmitted within 30 days of discharge (20.2% vs.17.4%; p < 0.001). After adjusting for age, sex, andall comorbidities mentioned in Table 1, thereremained no difference in all-cause in-hospitalmortality (OR: 0.873 [95% CI: 0.715 to 1.066];p ¼ 0.183), but there was a higher likelihood of30-day readmission (OR: 1.21 [95% CI: 1.09 to 1.34];p < 0.001). Mortality rates were similar irrespectiveof stage or site of cancer. When analyzed specif-ically by site, only patients with colorectal (OR: 3.66[95% CI: 2.30 to 5.82]; p < 0.001), urinary/bladder(OR: 1.87 [95% CI: 1.17 to 2.98]; p ¼ 0.009), anduterine (OR: 5.03 [95% CI: 2.33 to 10.89]; p < 0.001)cancers were associated with the increased risk of30-day readmission, when compared with patientswithout cancer. The most common cause for read-mission in both groups was heart failure, followedby infections and sepsis.Current guidelines recommend TAVR to be per-formed in patients with a life expectancy >12 months(4). However, it is seldom possible to predict the lifeexpectancy of cancer patients, and successful treat-ment of AS may allow for more intensive cancertreatment modalities, which in turn could affect sur-vival. In many cases, symptomatic AS may be theJ A C C : C A R D I O O N C O L O G Y V O L . 2 , N O . 3 , 2 0 2 0ª 2 0 2 0 T H E A U T H O R S . P U B L I S H E D B Y E L S E V I E R O N B E H A L F O F T H E AM E R I C A NC O L L E G E O F C A R D I O L O G Y F O U N DA T I O N . T H I S I S A N O P E N A C C E S S A R T I C L E U N D E RT H E C C B Y - N C - N D L I C E N S E ( h t t p : / / c r e a t i v e c o mm o n s . o r g / l i c e n s e s / b y - n c - n d / 4 . 0 / ) .I S S N 2 6 6 6 - 0 8 7 3rate-limiting step in cancer management. Thus, amultidisciplinary decision-making team of inter-ventionalists and oncologists is warranted. A recentmulticenter study comparing 222 cancer patients with2,522 “no-cancer” patients undergoing TAVR showedthat the 2 groups had similar 30-day outcomes, and1-year mortality was higher in individuals withadvanced cancer (5). The novelty of our study lies inthe reporting of higher readmission rates in such pa-tients, as well as the observation that certain types ofcancers were more commonly associated with earlyreadmission, most notably from heart failure andinfection. These summative findings support thatTAVR in cancer patients is appropriate on a case-by-case basis, and that optimal post-procedural cardio-vascular rehabilitation as well as careful observationfor post-procedural infections may result in overallbetter outcomes.Our study is not without limitations. There is apaucity of information with respect to patient-leveldata regarding cancer treatments, as well as otherunaccounted comorbidities and causes of death. Be-ing an administrative database, it relies on physician/hospital reporting of outcomes. In addition, becauseof the retrospective nature of the analysis, it is notpossible to differentiate active malignancies fromhistory of malignancy. Information on dates of in-hospital outcomes and post-discharge out-of-hospi-tal mortality are not recorded in NRD, which prohibitsconducting a competing risk analysis for in-hospitaloutcomes or readmission. It is noteworthy that ourcomparator arm represents a high-surgical risk pop-ulation, as TAVR in intermediate- and low-risk pa-tients obtained approval in 2016 and 2019,respectively. It would be interesting to see how thisaffects the findings of future trials, especially thosethat also address the question of quality of life, whichis an important consideration in decision-making inadvanced cancer patients undergoing palliativetherapy.Vardhmaan Jain, MDAnas M. Saad, MDMohamed M. Gad, MDAgam Bansal, MDOmar Abdelfattah, MDMedhat Farwati, MDKeerat Rai Ahuja, MDJames Yun, MDAmar Krishnaswamy, MD*Samir R. Kapadia, MD*Department of Cardiovascular MedicineHeart and Vascular InstituteCleveland Clinic9500 Euclid Avenue, J2-3Cleveland, Ohio 44195E-mail: kapadis@ccf.orgTwitter: @tavrkapadiahttps://dx.doi.org/10.1016/j.jaccao.2020.05.023Please note: The authors have reported that they have no relationships relevantto the contents of this paper to disclose. This study was made possible by agenerous gift from Jennifer and Robert McNeil.The authors attest they are in compliance with human studies committees andanimal welfare regulations of the authors’ institutions and Food and DrugAdministration guidelines, including patient consent where appropriate. Formore information, visit the JACC: CardioOncology author instructions page.TABLE 1 Baseline Characteristics and Outcomes of TAVR Patients With andWithout Cancer (n ¼ 63,352)Cancer(n ¼ 2,849)No Cancer(n ¼ 60,503) p ValueAge, yrs 83 (76–87) 83 (77–88)Sex <0.001Male 1,748 (61.4) 31,549 (52.1)Female 1,101 (38.6) 28,954 (47.9)Cancer stageLocalized/regional 2,675 (93.9)Metastatic 175 (6.1)Cancer siteProstate cancer 388 (13.6)Breast cancer 147 (5.1)Leukemia/lymphoma 1,476 (51.8)Lung cancer 206 (7.2)Colorectal cancer 92 (3.2)Urinary bladder cancer 102 (3.6)Uterine corpus cancer 27 (0.9)Other cancers 413 (14.5)ComorbiditiesHypertension 2,098 (73.6) 48,489 (80.1) <0.001Atrial fibrillation 1,139 (40) 26,706 (44.1) <0.001Cardiomyopathy 309 (10.8) 5,317 (8.8) <0.001Diabetes mellitus 849 (29.8) 21,324 (35.2) <0.001Heart failure 320 (11.2) 5,413 (8.9) <0.001Previous MI 326 (11.4) 6,830 (11.3) 0.811Carotid artery disease 157 (5.5) 4,150 (6.9) 0.005Dyslipidemia 1,472 (51.7) 35,906 (59.3) <0.001Chronic lung disease 868 (30.5) 20,261 (33.5) 0.001Renal failure 1,010 (35.5) 21,758 (36) 0.589Obesity 308 (10.8) 9,720 (16.1) <0.001Smoking 760 (26.7) 16,239 (26.8) 0.845Alcohol abuse 47 (1.6) 638 (1.1) 0.004OutcomesLength of stay, days 6 (4–11) 6 (3–9) <0.001In-hospital mortality 107 (3.8) 2,300 (3.8) 0.954In-hospital stroke 58 (2) 1,438 (2.4) 0.257Post-procedural blood transfusion 709 (24.9) 12,830 (21.2) <0.001In-hospital acute kidney injury 509 (17.9) 9,826 (16.2) 0.023Permanent pacemaker implantation 291 (10.2) 6,380 (10.5) 0.59430-day readmission* 494 (20.2) 9,018 (17.4) <0.00130-day in-hospital mortality* 27 (1.1) 585 (1.1) 0.988Values are median (interquartile range) or n (%). *For 30-day readmission rates, we excluded patients who diedwithin index hospitalization and patients who were discharged in December each year (and September 2015) toallow for at least 30 days of follow-up for all patients.MI ¼ myocardial infarction; TAVR ¼ transcatheter aortic valve replacement.J A C C : C A R D I O O N C O L O G Y , V O L . 2 , N O . 3 , 2 0 2 0 Research LetterS E P T E M B E R , 2 0 2 0 : 5 0 6 – 8507RE F E RENCE S1. Stachon P, Kaier K, Milde S, et al. Two-year survival of patients screened fortranscatheter aortic valve replacement with potentially malignant incidentalfindings in initial body computed tomography. Eur Heart J Cardiovasc Imaging2015;16:731–7.2. Yusuf SW, Sarfaraz A, Durand JB, Swafford J, Daher IN. Management andoutcomes of severe aortic stenosis in cancer patients. Am Heart J 2011;161:1125–32.3. Healthcare Cost and Utilization Project (HCUP). HCUP NIS DatabaseDocumentation. Rockville, MD: Agency for Healthcare Research and Quality,2012.4. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update ofthe 2014 AHA/ACC Guideline for the Management of Patients With ValvularHeart Disease: a report of the American College of Cardiology/American HeartAssociation Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2017;70:252–89.5. Landes U, Iakobishvili Z, Vronsky D, et al. Transcatheter aortic valvereplacement in oncology patients with severe aortic stenosis. J Am Coll Car-diol Intv 2019;12:78–86.Research Letter J A C C : C A R D I O O N C O L O G Y , V O L . 2 , N O . 3 , 2 0 2 0S E P T E M B E R , 2 0 2 0 : 5 0 6 – 8508

Outcomes of Cancer Patients Undergoing Transcatheter Aortic Valve Replacement.

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Outcomes of Cancer Patients Undergoing Transcatheter Aortic Valve Replacement.

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