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TRIAGE HF STUDY: SYMPTOMS AND DEVICE PARAMETERS ASSOCIATED WITH HIGH HEART FAILURE RISK STATUS
Abstracts
S177
METHOD:
Multicenter non-blinded prospective study involving 6 heart function clinics. Patients who had an indication for an ACEi and were on ARB were enrolled. The inclusion criteria were HFrEF < 35%, NYHA I-IV and patients optimized with beta-blockers and stable for 3 month prior to enrollment. Patients were excluded if there was a history of documented ACEi related angioedema, worsening renal function or hyperkalemia. The primary end-point was tolerance to an ACEi documented at 3-6 months post-switch. The secondary end-point was continued tolerance of ACEi at 1-year follow up. RESULTS: Total of 64 patients were enrolled in 6 heart function clinics. Baseline data included: mean EF of 23%; NYHA class I 12(20%), II 37(57.8%), III 12(15.8%); mean creatinine 116 mmol/L, K 4.2mmol/L. Prior ACEi intolerance was reported due to cough in 26 patients (40.6%). In 43% of patients there was no documented prior use of ACEi. At 3-6 month follow-up, 65% of patients who were re-challenged with ACEi tolerated the drug. At 1 year, 56% were still on the ACEi. The major reason to discontinue the ACEi was cough 18 (28%). Of those who had cough as a reason for not being on ACEi at the time of enrollment in the study, at 3-6 month follow up 16/26 (61%) were tolerant of ACEi. CONCLUSION: In patients with HFrEF followed in HF clinics who were on ARBs, more than 50% tolerated being switched to or re-challenged with an ACEi. Servier 192 WITHDRAWN
193 TRIAGE HF STUDY: SYMPTOMS AND DEVICE PARAMETERS ASSOCIATED WITH HIGH HEART FAILURE RISK STATUS SA Virani, V Sharma, M McCann, J Koehler, B Tsang, S Zieroth Vancouver, British Columbia BACKGROUND:
TRIAGE-HF was a Canadian multicenter prospective observational post-market study to evaluate the performance and clinical utility of the heart failure risk status (HFRS) feature on CareLink. HFRS is based on commercially available device diagnostic parameters and reports a dynamically updated individualized patient risk (low, medium or high) of having a heart failure (HF) hospitalization in the next 30 days. The purpose of the current TRIAGE-HF sub-study was to describe the clinical signs and symptoms of worsening HF and non-compliance with medications/lifestyle leading to abnormal device parameters associated with high HFRS. METHODS: TRIAGE-HF enrolled 100 patients with HF and a wireless CRT-D/ICD device followed for 8 months at 3 Canadian HF centers. The HFRS score reported the patient’s overall risk status in addition to specific device parameters contributing to that risk for each transmission. Patients with a high HFRS were contacted by telephone to assess symptoms, and compliance with prescribed therapies and lifestyle management. RESULTS: Twenty four high HFRS occurrences were observed among 100 patients during the study period. Device parameters contributing to high risk are shown in the Table 1. OptiVol was the most common contributing factor, followed by low patient activity and elevated night heart rate. High risk status was associated with worsening HF symptoms in 63% of high HFRS occurrences, and this increased to 83% when non-compliance with pharmacological or lifestyle therapies
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Canadian Journal of Cardiology Volume 32 2016
was also considered. Dyspnea (54%) and peripheral edema (25%) were the most common symptoms reported. CONCLUSION: TRIAGE-HF is the first ever study to provide prospective data on the distribution of abnormal device parameters contributing to high HFRS. Furthermore, high HFRS had good predictive accuracy for worsening HF symptoms and behaviors associated with worsening HF. Whether guided therapy specifically directed at normalizing device parameters can improve patient risk and HF symptoms remains an area of further research. Table 1: Abnormal Device Parameters Contributing to High HFRS Number of Participants (%) with High HFRS
Abnormal Device Parameter OptiVol Index Exceeded
20 (83%)
Low Activity
18 (75%)
Elevated Night Heart Rate
12 (50%)
Low Heart Rate Variability
8 (33%)
Low % V-Pacing (CRT-Only)
6 (25%)
High AF Burden or Rapid Rate During AF
5(21%)
Shock
0 (0%)
Medtronic 194 ECONOMIC EVALUATION OF ENTRESTO FOR THE TREATMENT OF HEART FAILURE WITH REDUCED EJECTION FRACTION IN ADULT PATIENTS WITH NYHA CLASS II OR III IN CANADA N Zaour, A Lee, D Becker, C Deschaseaux, M Barbeau Dorval, Québec BACKGROUND:
An economic evaluation was completed to assess the value of ENTRESTO for the treatment of HFrEF Class II-III adult patients. The value of ENTRESTO (in addition to background therapy) as compared to the current standard of care, acei (in addition to background therapy) was assessed within the framework of a cost-effectiveness analysis (CEA). METHODS: The base case analysis considered the perspective of the Canadian healthcare system. A Markov model was used to follow HFrEF patients over a 20-year horizon. Patients were allowed to transition between five health states based on the four New York Heart Association (NYHA) classifications and death. All-cause hospitalization was considered for all NYHA health states. Results from PARADIGM-HF, were used to inform the transitions of patients among NYHA classes for each fourmonth cycle until year three. From year three onward, it was assumed that the distribution of patients by NYHA class did not change. Utility data were obtained from EuroQol-5 dimensions (EQ-5D) from PARADIGM-HF by NYHA class. Resource use and costs were collected from clinical trials, published literature, expert opinion, and standard Canadian sources. RESULTS: Consistent with the findings from the pivotal clinical trial, the model predicted a mortality benefit with ENTRESTO. CV and all-cause mortality at different time points (2, 5, 10 years) were higher with ACEi vs ENTRESTO leading to a gain in survival of 1.22 years over the 20 year time horizon of the
model. The model also predicted that patients on ACEi would have more hospitalizations, for all categories examined (heart failure (HF), CV related, and non-CV related). In addition, ACEi treated patients spent more time in more severe NYHA classes. In the base-case, ENTRESTO was associated with incremental costs and quality-adjusted life years (QALYs) compared with ACEi of $18,946 and 0.63, respectively, resulting in an incremental cost-effectiveness ratio (ICER) of $29,999 per QALY gained. At an ICER threshold of $50,000, ENTRESTO had a 99.5% probability of being cost-effective. CONCLUSIONS: ENTRESTO was associated with increased expected years of survival, and decreased hospitalizations compared to ACEi. ENTRESTO is cost-effective and thus it is reasonable to assume that the reimbursement of ENTRESTO for HFrEF Class II-III by public drug plans provides good value for money compared to the ACE is already reimbursed by the plans.
Canadian Cardiovascular Society (CCS) Highlighted ePoster CORONARY AND STRUCTURAL INTERVENTION POTPOURRI Sunday, October 23, 2016 195 CATHETER ANGIOGRAPHY VERSUS COMPUTED TOMOGRAPHY ANGIOGRAPHY FOR THE DIAGNOSIS OF EXTRACARDIAC FIBROMUSCULAR DYSPLASIA IN PATIENTS WITH SPONTANEOUS CORONARY ARTERY DISSECTION E Rayner-Hartley, T Verma, A Starovoytov, M Heydari, J Saw Vancouver, British Columbia BACKGROUND:
Spontaneous coronary artery dissection (SCAD) is an infrequent condition predominantly affecting young women, and has a strong association with fibromuscular dysplasia (FMD). Screening for incidental FMD in extracardiac arteries (renal, iliac, and cerebrovascular arteries) is routinely done in patients with SCAD. Comparison of noninvasive CT angiography to the gold-standard catheter angiography for diagnosing extracardiac FMD has not been performed. METHODS: We reviewed our cohort of non-atherosclerotic SCAD patients who were consented in our Vancouver General Hospital SCAD registries. For this study, we included patients who had undergone both CT angiography and catheter angiography for diagnosis of extracardiac FMD in the renal and/or iliac arteries. We retrospectively reviewed for the presence of FMD in both imaging modalities. The diagnosis of extracardiac FMD required multifocal (string-of-beads) appearance of the affected arteries. We compared the sensitivity, specificity, and predictive values of CT angiography versus the gold-standard catheter angiography for FMD diagnosis. RESULTS: We included 27 patients who underwent extracardiac FMD evaluation with both CT angiography and catheter
S177
METHOD:
Multicenter non-blinded prospective study involving 6 heart function clinics. Patients who had an indication for an ACEi and were on ARB were enrolled. The inclusion criteria were HFrEF < 35%, NYHA I-IV and patients optimized with beta-blockers and stable for 3 month prior to enrollment. Patients were excluded if there was a history of documented ACEi related angioedema, worsening renal function or hyperkalemia. The primary end-point was tolerance to an ACEi documented at 3-6 months post-switch. The secondary end-point was continued tolerance of ACEi at 1-year follow up. RESULTS: Total of 64 patients were enrolled in 6 heart function clinics. Baseline data included: mean EF of 23%; NYHA class I 12(20%), II 37(57.8%), III 12(15.8%); mean creatinine 116 mmol/L, K 4.2mmol/L. Prior ACEi intolerance was reported due to cough in 26 patients (40.6%). In 43% of patients there was no documented prior use of ACEi. At 3-6 month follow-up, 65% of patients who were re-challenged with ACEi tolerated the drug. At 1 year, 56% were still on the ACEi. The major reason to discontinue the ACEi was cough 18 (28%). Of those who had cough as a reason for not being on ACEi at the time of enrollment in the study, at 3-6 month follow up 16/26 (61%) were tolerant of ACEi. CONCLUSION: In patients with HFrEF followed in HF clinics who were on ARBs, more than 50% tolerated being switched to or re-challenged with an ACEi. Servier 192 WITHDRAWN
193 TRIAGE HF STUDY: SYMPTOMS AND DEVICE PARAMETERS ASSOCIATED WITH HIGH HEART FAILURE RISK STATUS SA Virani, V Sharma, M McCann, J Koehler, B Tsang, S Zieroth Vancouver, British Columbia BACKGROUND:
TRIAGE-HF was a Canadian multicenter prospective observational post-market study to evaluate the performance and clinical utility of the heart failure risk status (HFRS) feature on CareLink. HFRS is based on commercially available device diagnostic parameters and reports a dynamically updated individualized patient risk (low, medium or high) of having a heart failure (HF) hospitalization in the next 30 days. The purpose of the current TRIAGE-HF sub-study was to describe the clinical signs and symptoms of worsening HF and non-compliance with medications/lifestyle leading to abnormal device parameters associated with high HFRS. METHODS: TRIAGE-HF enrolled 100 patients with HF and a wireless CRT-D/ICD device followed for 8 months at 3 Canadian HF centers. The HFRS score reported the patient’s overall risk status in addition to specific device parameters contributing to that risk for each transmission. Patients with a high HFRS were contacted by telephone to assess symptoms, and compliance with prescribed therapies and lifestyle management. RESULTS: Twenty four high HFRS occurrences were observed among 100 patients during the study period. Device parameters contributing to high risk are shown in the Table 1. OptiVol was the most common contributing factor, followed by low patient activity and elevated night heart rate. High risk status was associated with worsening HF symptoms in 63% of high HFRS occurrences, and this increased to 83% when non-compliance with pharmacological or lifestyle therapies
S178
Canadian Journal of Cardiology Volume 32 2016
was also considered. Dyspnea (54%) and peripheral edema (25%) were the most common symptoms reported. CONCLUSION: TRIAGE-HF is the first ever study to provide prospective data on the distribution of abnormal device parameters contributing to high HFRS. Furthermore, high HFRS had good predictive accuracy for worsening HF symptoms and behaviors associated with worsening HF. Whether guided therapy specifically directed at normalizing device parameters can improve patient risk and HF symptoms remains an area of further research. Table 1: Abnormal Device Parameters Contributing to High HFRS Number of Participants (%) with High HFRS
Abnormal Device Parameter OptiVol Index Exceeded
20 (83%)
Low Activity
18 (75%)
Elevated Night Heart Rate
12 (50%)
Low Heart Rate Variability
8 (33%)
Low % V-Pacing (CRT-Only)
6 (25%)
High AF Burden or Rapid Rate During AF
5(21%)
Shock
0 (0%)
Medtronic 194 ECONOMIC EVALUATION OF ENTRESTO FOR THE TREATMENT OF HEART FAILURE WITH REDUCED EJECTION FRACTION IN ADULT PATIENTS WITH NYHA CLASS II OR III IN CANADA N Zaour, A Lee, D Becker, C Deschaseaux, M Barbeau Dorval, Québec BACKGROUND:
An economic evaluation was completed to assess the value of ENTRESTO for the treatment of HFrEF Class II-III adult patients. The value of ENTRESTO (in addition to background therapy) as compared to the current standard of care, acei (in addition to background therapy) was assessed within the framework of a cost-effectiveness analysis (CEA). METHODS: The base case analysis considered the perspective of the Canadian healthcare system. A Markov model was used to follow HFrEF patients over a 20-year horizon. Patients were allowed to transition between five health states based on the four New York Heart Association (NYHA) classifications and death. All-cause hospitalization was considered for all NYHA health states. Results from PARADIGM-HF, were used to inform the transitions of patients among NYHA classes for each fourmonth cycle until year three. From year three onward, it was assumed that the distribution of patients by NYHA class did not change. Utility data were obtained from EuroQol-5 dimensions (EQ-5D) from PARADIGM-HF by NYHA class. Resource use and costs were collected from clinical trials, published literature, expert opinion, and standard Canadian sources. RESULTS: Consistent with the findings from the pivotal clinical trial, the model predicted a mortality benefit with ENTRESTO. CV and all-cause mortality at different time points (2, 5, 10 years) were higher with ACEi vs ENTRESTO leading to a gain in survival of 1.22 years over the 20 year time horizon of the
model. The model also predicted that patients on ACEi would have more hospitalizations, for all categories examined (heart failure (HF), CV related, and non-CV related). In addition, ACEi treated patients spent more time in more severe NYHA classes. In the base-case, ENTRESTO was associated with incremental costs and quality-adjusted life years (QALYs) compared with ACEi of $18,946 and 0.63, respectively, resulting in an incremental cost-effectiveness ratio (ICER) of $29,999 per QALY gained. At an ICER threshold of $50,000, ENTRESTO had a 99.5% probability of being cost-effective. CONCLUSIONS: ENTRESTO was associated with increased expected years of survival, and decreased hospitalizations compared to ACEi. ENTRESTO is cost-effective and thus it is reasonable to assume that the reimbursement of ENTRESTO for HFrEF Class II-III by public drug plans provides good value for money compared to the ACE is already reimbursed by the plans.
Canadian Cardiovascular Society (CCS) Highlighted ePoster CORONARY AND STRUCTURAL INTERVENTION POTPOURRI Sunday, October 23, 2016 195 CATHETER ANGIOGRAPHY VERSUS COMPUTED TOMOGRAPHY ANGIOGRAPHY FOR THE DIAGNOSIS OF EXTRACARDIAC FIBROMUSCULAR DYSPLASIA IN PATIENTS WITH SPONTANEOUS CORONARY ARTERY DISSECTION E Rayner-Hartley, T Verma, A Starovoytov, M Heydari, J Saw Vancouver, British Columbia BACKGROUND:
Spontaneous coronary artery dissection (SCAD) is an infrequent condition predominantly affecting young women, and has a strong association with fibromuscular dysplasia (FMD). Screening for incidental FMD in extracardiac arteries (renal, iliac, and cerebrovascular arteries) is routinely done in patients with SCAD. Comparison of noninvasive CT angiography to the gold-standard catheter angiography for diagnosing extracardiac FMD has not been performed. METHODS: We reviewed our cohort of non-atherosclerotic SCAD patients who were consented in our Vancouver General Hospital SCAD registries. For this study, we included patients who had undergone both CT angiography and catheter angiography for diagnosis of extracardiac FMD in the renal and/or iliac arteries. We retrospectively reviewed for the presence of FMD in both imaging modalities. The diagnosis of extracardiac FMD required multifocal (string-of-beads) appearance of the affected arteries. We compared the sensitivity, specificity, and predictive values of CT angiography versus the gold-standard catheter angiography for FMD diagnosis. RESULTS: We included 27 patients who underwent extracardiac FMD evaluation with both CT angiography and catheter