Comparison of Results of Transcatheter Aortic Valve Implantation in Patients With Versus Without Active Cancer




The aim of this study was to evaluate postprocedural and midterm outcomes of transcatheter aortic valve implantation (TAVI) in patients with aortic stenosis and active cancer. From October 2013 to August 2015, a total of 749 patients undergoing TAVI using the Edwards Sapien XT prosthesis (Edwards Lifesciences, Irvine, California) were prospectively included in the OCEAN-TAVI registry from 8 Japanese centers. A total of 47 patients (44.7% men; median age 83 years) had active cancer. The transfemoral approach was implemented in 85.1% of patients in the cancer group and 78.1% in the noncancer group (p = 0.22). The occurrence of major vascular complication (4.3% vs 7.5%, p = 0.24), life-threatening bleeding (2.1% vs 7.1%, p = 0.15), and major bleeding (8.5% vs 13%, p = 0.38) was similar between the cancer and noncancer groups. No significant differences were observed regarding device success (100% vs 96.2%, p = 0.17) or 30-day survival (95.7% vs 97.3%, p = 0.38). No difference in midterm survival was found between the patients with cancer and without cancer (log-rank, p = 0.42), regardless of advanced or limited cancer (log-rank, p = 0.68). In a multivariable Cox proportional hazard regression analysis, cancer metastasis was one of the most significant predictors of late mortality (hazard ratio 4.73, 95% CI 1.12 to 20.0; p = 0.035). In conclusion, patients with cancer with severe aortic stenosis who underwent TAVI had similar acute outcomes and midterm survival rates compared with patients without cancer. Cancer metastasis was associated with increased mortality after TAVI.


In clinical practice, the presence of active cancer in patients with severe aortic stenosis (AS) is often considered to be a contraindication to surgical aortic valve replacement (SAVR). With the recent progress in transcatheter aortic valve implantation (TAVI) results, TAVI has provided for patients with active cancer an overall life expectancy after TAVI that would exceed 1 year. No data are available on the comparative feasibility and efficacy of TAVI in patients with active cancer compared with those with noncancer. This study evaluates the midterm efficacy and safety of TAVI in patients with active cancer.


Methods


The optimized transcatheter valvular intervention (OCEAN-TAVI) registry is a Japanese multicenter prospective registry. This registry was initiated to observe and document procedural results and postprocedural outcomes of TAVI. The OCEAN-TAVI registry is independent of any industry influence.


From October 2013 to August 2015, a total of 749 consecutive high-risk Japanese patients with symptomatic, severe AS undergoing TAVI using the Edwards Sapien XT prosthesis (Edwards Lifesciences) were prospectively included in the OCEAN-TAVI registry. The patients were located at the Teikyo University School of Medicine (Tokyo, Japan, n = 78), Kokura Memorial Hospital (Fukuoka, Japan, n = 121), Sendai Kousei Hospital (Miyagi, Japan, n = 123), Saiseikai Yokohama-City Eastern Hospital (Kanagawa, Japan, n = 63), New Tokyo Hospital (Chiba, Japan, n = 61), Shonan Kamakura General Hospital (Kanagawa, Japan, n = 83), Toyohashi Heart Center (Aichi, Japan, n = 65), Nagoya Heart Center (Aichi, Japan, n = 13), and Keio University School of Medicine (Tokyo, Japan, n = 142). Inclusion criteria were the presence of symptomatic, degenerative AS with a New York Heart Association Class II or greater, a mean gradient >40 mm Hg or a jet velocity >4.0 m/s, or an aortic valve area <1.0 cm 2 (or an effective orifice area index <0.6 cm 2 /m 2 ). Patients for whom TAVI was deemed the best treatment option were selected based on the clinical consensus of a multidisciplinary team consisting of cardiac surgeons, interventional cardiologists, anesthetists, and imaging specialists. Primary exclusion criteria were the following: bicuspid or noncalcified aortic valve, failed surgical bioprosthesis implantation, severe aortic regurgitation, or dialysis dependence. The prosthesis size (20, 23, 26, and 29 mm) was determined on the basis of preprocedural echocardiographic and multidetector computed tomographic findings. The devices were delivered through the transfemoral, transiliac, or transapical approach. Criteria for selection of either the femoral, iliac, or apical approach were based on the iliofemoral artery diameters, calcifications, and tortuosity. Procedure success and other procedural complications during TAVI were evaluated according to the Valve Academic Research Consortium-2 criteria. Late mortality was defined as any cause of death from 30-day to long-term death. After the procedure, follow-up outpatient visits or telephone interviews were conducted at 30 days, 6 months, and then yearly. The medical ethics committees at all hospitals approved this study protocol, and written informed consent was obtained from all patients before TAVI. This trial is registered with University Hospital Medical Information Network as number UMIN000020423.


Advanced cancer was defined as cancers with a stage greater than T2, and/or N1, and/or M1 as well as any malignancy considered refractory, relapsing, or recurrent. All cancer information including the type of cancer, advanced cancer, or cancer metastasis was obtained by outpatient visits or telephone interviews from all patients.


Quantitative variables were assessed for normal distribution with the Shapiro–Wilk test and are expressed as mean ± SD or as median and interquartile range (25% to 75%), as appropriate. Qualitative variables are expressed as numeric values and percentages. Comparison of quantitative variables was performed using the unpaired Student t test or the Wilcoxon rank-sum test, depending on the variable distribution. The chi-square test or Fisher’s exact test was used to compare qualitative variables. Kaplan–Meier analysis was performed using the log-rank test to compare survival rates between the active cancer group and noncancer groups, active cancer group and limited cancer group, and cancer metastasis group and nonmetastasis group. A univariate logistic regression analysis was performed to obtain the odds ratio for late mortality. Thereafter, a Cox logistic regression analysis was performed using variables with p values <0.10 in the univariate analysis, examining their independent associations with late mortality. The data were analyzed with the PASW statistics 22.0 software (SPSS Inc., Chicago, Illinois).




Results


Forty-seven patients (6.3%) had active cancer. The baseline characteristics of patients with and without cancer are presented in Table 1 . The cancer group was younger than the noncancer group. Body surface area and body mass index were significantly larger in patients with cancer than those in the noncancer group. The value of the Society of Thoracic Surgeons (STS) score and EuroSCORE II was lower in patients with cancer than in the noncancer group. The estimated glomerular filtration rate was higher in patients with cancer than in the noncancer group. A larger annulus area was observed in patients with cancer than in those without cancer. Other baseline co-morbidities were similar between the 2 groups.



Table 1

Study population

























































































































































































Variable Cancer P
Yes
n = 47
No
n = 702
Age (years) 83 [80-87] 85 [82-88] <0.01
Men 21 (45%) 232 (33%) 0.10
Height (cm) 153 [147-159] 149 [143-155] <0.01
Weight (kg) 57 [49-65] 48 [41-55] <0.01
BSA (m 2 ) 1.51 [1.40-1.62] 1.40 [1.28-1.52] <0.01
BMI (kg/m 2 ) 23.6 [21.0-26.2] 21.7 [19.2-24.1] 0.03
Diabetes mellitus 14 (30%) 175 (25%) 0.57
Hyperlipidemia 20 (43%) 300 (43%) 0.98
Smoker 15 (32%) 135 (19%) 0.06
Hypertension 35 (75%) 531 (75.6%) 0.86
New York Heart Association class III / IV 19 (40%) 339 (48%) 0.30
Coronary artery disease 12 (26%) 170 (24%) 0.91
Previous myocardial infarction 5 (11%) 59 (8%) 0.37
Previous coronary bypass 3 (6%) 56 (8%) 0.48
Previous percutaneous coronary intervention 15 (33%) 190 (27%) 0.41
Atrial fibrillation 8 (17%) 134 (19%) 0.84
Peripheral artery disease 11 (23%) 108 (15%) 0.15
Cerebrovascular disease 5 (11%) 101 (14%) 0.48
Chronic obstructive pulmonary disease 15 (32%) 138 (20%) 0.04
Logistic EuroSCORE (%) 11.4 [5.3-17.5] 12.9 [6.2-19.5] 0.13
The Society of Thoracic Surgeons (STS score) (%) 5.4 [3.4-7.5] 7.0 [4.6-9.4] <0.01
EuroSCORE II (%) 3.1 [1.5-4.7] 3.9 [2.0-5.8] 0.04
Aortic valve area (cm 2 ) 0.65 [0.56-0.74] 0.62 [0.50-0.74] 0.10
Aortic valve area index (cm 2 /m 2 ) 0.43 [0.38-0.48] 0.43 [0.35-0.51] 0.99
Mean pressure gradient (mmHg) 50.4 [38.8-62.1] 48.0 [36.2-59.9] 0.74
Left ventricular ejection fraction (%) 65.9 [54.0-66.4] 65.0 [59.9-70.5] 0.90
Annulus area by computed tomography (mm 2 ) 442 [376-507] 379 [336-422] <0.01
Medication
Aspirin 35 (75%) 520 (74%) 0.95
Thienopyridine 28 (60%) 359 (51%) 0.27
Warfarin 7 (15%) 109 (16%) 0.91
Laboratory tests
Hemoglobin (g/dL) 11.1 [9.6-12.6] 11.1[10.1-12.1] 0.96
Platelet count (x10000/uL) 16.3 [12.9-19.8] 17.4 [13.8-21.0] 0.17
Serum albumin, g/dL 3.9 [3.5-4.3] 3.8 [3.5-4.1] 0.68
estimated glomerular filtration rate (mL/min/1.73m2) 55.5 [48.0-63.1] 48.3 [35.8-60.8] <0.01


The transfemoral approach was implemented in 85% of patients in the cancer group and 78% in the noncancer group. A larger valve size was selected in the cancer group compared with noncancer group ( Table 2 ).



Table 2

Procedural characteristics























































Cancer P
Yes
n = 47
No
n = 702
Variable
Transfemoral 40 (85%) 548 (78%) 0.22
Transapical 5 (11%) 136 (19%)
Transiliac 2 (4%) 18 (3%)
Valve size (mm)
SapienXT 20 1 (2%) 8 (1%) <0.01
SapienXT 23 20 (43%) 472 (67%)
SapienXT 26 22 (47%) 207 (30%)
SapienXT 29 4 (9%) 15 (2%)
Post dilatation 12 (26%) 166 (24%) 0.45


Procedural outcomes are presented in Table 3 . The occurrence between the cancer and noncancer groups of major and minor vascular complication, life-threatening bleeding, major bleeding, and minor bleeding was similar. No cancer-related bleeding and thrombosis events were observed. The incidence of cardiac tamponade, valve migration, conversion to open heart surgery, cerebrovascular accidents, transfusion, acute kidney injury stage 3, and new pacemaker implantation was similar in both groups. Between the cancer and noncancer groups, no significant differences were observed in terms of device success, and 30-day survival. The rate of early safety end point (30 days) was significantly higher in the noncancer group than the cancer group. The incidence of postprocedural aortic regurgitation ≥ mild, postprocedural mean pressure gradient and left ventricular ejection fraction were similar in both groups.



Table 3

Postprocedural outcomes of the study population

















































































































Variable Cancer P
Yes No
Patient number n = 47 n = 702
Major vascular complication 2 (4%) 49 (7%) 0.47
Minor vascular complication 2 (4%) 35 (5%) 0.82
Life threatening bleeding 1 (2%) 50 (7%) 0.15
Major bleeding 4 (9%) 91 (13%) 0.38
Minor bleeding 8 (17%) 115 (16%) 0.91
Cardiac tamponade 0 (0%) 12 (2%) 0.46
Valve migration 0 (0%) 8 (1%) 0.59
Conversion to open heart surgery 0 (0%) 10 (1%) 0.52
Cerebrovascular accidents 1 (2%) 21 (3%) 1.0
Stroke 0 (0%) 18 (3%) 0.24
Transfusion 12 (26%) 240 (34%) 0.22
Acute kidney injury stage 3 0 (0%) 17 (2%) 0.28
Device success 45 (96%) 625 (89%) 0.15
Post implantation
Mean pressure gradient, mmHg 10.1 ± 4.2 10.8 ± 4.5 0.28
Left ventricular ejection fraction, % 64.1 ± 9.6 65.5 ± 10.4 0.45
Aortic regurgitation ≥ mild 19 (42%) 267 (39%) 0.75
New Pacemaker 1 (2%) 38 (5%) 0.50
Early safety endpoint (30 days) 4 (9%) 134 (19%) 0.05
30 day survival 45 (96%) 683 (97%) 0.38


Table 4 illustrates the types of cancer. The most commonly seen cancers were lung (19%), prostate (15%), female breasts (11%), and colon and rectum (11%) cancers.


Nov 25, 2016 | Posted by in CARDIOLOGY | Comments Off on Comparison of Results of Transcatheter Aortic Valve Implantation in Patients With Versus Without Active Cancer

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