- Email: [email protected]
The impact of a strategy of image-guided left ventricular lead placement during cardiac resynchronization therapy on health care utilization
International Journal of Cardiology 187 (2015) 311–312
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
The impact of a strategy of image-guided left ventricular lead placement during cardiac resynchronization therapy on health care utilization Yasser Rodriguez a,⁎, John Nan b, Omar Yasin c, John Gorcsan III a, Samir Saba a a b c
Cardiovascular Electrophysiology, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, United States Department of Medicine, University of Wisconsin, Madison, WI, United States University of Michigan School of Medicine, University of Michigan, Ann Arbor, MI, United States
a r t i c l e
i n f o
Article history: Received 21 March 2015 Accepted 24 March 2015 Available online 25 March 2015 Keywords: Cardiac resynchronization therapy Health care utilization LV lead position Heart failure hospitalization
Chronic heart failure presents a significant economic burden on the health care system [1]. In approximately one-third of all affected patients, heart failure (HF) causes electrical disturbances in the conduction pathways, leading to prolonged AV nodal conduction times, delay in the onset of right or left ventricular systole, or both [2]. The finding of intraventricular conduction delay has been associated with significant increase in HF hospitalizations and an increased risk of death [2]. In addition to pharmacologic intervention, cardiac resynchronization therapy (CRT) implantable cardioverter defibrillators (ICDs) and pacemakers (PMs) have emerged as an effective therapy, conferring symptomatic relief, functional improvement and survival benefit to a large proportion of affected HF patients [3,4]. Despite the demonstrated benefits of CRT-ICD therapy, approximately one-third of patients do not respond [2]. Of all the possible reasons why some patients are refractory to CRT, the choice of site of left ventricular pacing has emerged as a promising modifiable explanation as demonstrated in single-center randomized trials [5,6]. Echocardiography-guided (EG) transvenous LV lead placement for CRT has been shown to reduce the combined risk of death and hospitalization associated with HF [5,6]. Extrapolating from this finding, EG
⁎ Corresponding author at: University of Pittsburgh Cardiovascular Institute, Department of Cardiac Electrophysiology, PUH B535, 200 Lothrop Street, Pittsburgh, PA 15213, United States. E-mail address: [email protected] (Y. Rodriguez).
http://dx.doi.org/10.1016/j.ijcard.2015.03.357 0167-5273/© 2015 Published by Elsevier Ireland Ltd.
transvenous LV lead placement may have a positive economic impact. Our objective was to characterize the economic impact of this lead placement strategy by examining health care utilization. This study is a prospective, single-center, observational analysis. From the STARTER population (n = 187), patients who underwent CRT implantation using either EG LV lead positioning (n = 110) or routine approach without image guidance (n = 77), and who were followed-up in the outpatient clinics of the University of Pittsburgh Medical Center (UPMC) between June 2005 to March 2011 were included. Patients' demographic and clinical data were extracted from the electronic medical record. Outpatient and inpatient health care utilization data were collected using the billing databases of UPMC. All echocardiographic studies were analyzed at UPMC before the implantation procedure. As previously described [5], the site of latest mechanical activation was determined by speckle tracking echocardiography using the 8-segment free wall LV model at the basal and mid-LV levels. CRT was performed using a transvenous approach with the right ventricular (RV) lead placed in or near the RV apex. Coronary venography was performed in left anterior oblique projection in all patients. Patients randomized to the EG study group had their LV lead placement attempted in the latest LV mechanical activation site. Patients who were randomized to the control arm had their LV leads placed in the routine manner, targeting posterior or lateral LV regions. The primary endpoint of this analysis was total health care utilization after the CRT device implantation, which was used as a surrogate for healthcare cost. This endpoint was divided between outpatient and inpatient visits. An inpatient encounter was defined as admission to the hospital overnight either in observation or in-hospital status. An outpatient encounter was defined as an encounter in the outpatient clinics with a physician or physician extender. All patients enrolled in the STARTER trial [5] were included in this analysis. Baseline characteristics were similar between the two groups (Table 1) and they had comparable follow-up periods after CRT device implantation (49.6 and 46.7 months, p = 0.68). During follow-up, patients in the routine EG lead placement group had significantly lower total (p = 0.02), inpatient (p = 0.006), and outpatient (p = 0.056) healthcare encounters (Table 2). Total cost of health care during the follow-up period was available on 131 of 187 (70%) patients (78 in the EG and 53 in the routine group). There was a strong trend towards lower total cost of care in the EG compared to the routine group ($0.55 ± 1.08 million versus $1.02 ± 2.06 million, p = 0.093).
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Y. Rodriguez et al. / International Journal of Cardiology 187 (2015) 311–312
Table 1 Baseline characteristics of patient population. Characteristic
Echocardiographic guided CRT (n = 110)
Routine control CRT (n = 77)
P value
Age, y Men, % NYHA HF classes II/III/IV, % Ischemic heart disease, % Diabetes mellitus, % LVEF, % QRS duration, ms Serum creatinine, mg/dL.
66 ± 11 70% 16/64/20 58% 37% 26 ± 6 157 ± 27 1.2 ± 0.4
67 ± 13 78% 8/71/21 67% 36% 26 ± 7 162 ± 27 1.3 ± 0.6
0.61 0.29 0.21 0.27 0.98 0.80 0.27 0.20
CRT indicated cardiac resynchronization therapy; LVEF, left ventricular ejection fraction; NYHA HF, New York Heart Association class of heart failure.
The impact of EG LV lead placement on several cardiac parameters has been recently assessed by two randomized control trials [5,6]. Khan et al. demonstrated in the TARGET study a 33.3% decrease in HF hospitalizations during a two-year follow up period [6]. Similarly, Saba et al. demonstrated in the STARTER study a 23.8% decrease in hospitalizations over a nearly two-year period [5]. In our present analysis, we demonstrated an overall 35% decrease in total hospitalizations. Extrapolating from the improvement in hemodynamic parameters seen in these studies along with the overall reduction in HF hospitalizations, we can infer that the patients that underwent EG LV lead placement may have had an improvement in overall clinical stability. This assertion is further reflected in the 33% decrease in outpatient healthcare utilization. Heart failure currently poses a significant economic burden on the American health care system [1]. An estimated five million patients are living with the condition, with 550,000 new cases being diagnosed yearly [1]. One-third of these patients will develop electrical conduction disturbances, and within that subpopulation, many patients could possibly benefit from CRT [2]. Cardiac arrhythmia and conduction disorders rank as one of the top areas of Medicare expenditure, costing an estimated $509,251,000 in 2009 [7,8]. EG approach does not increase the duration of implantation, radiation exposure or procedural complications [5] and yet seems to confer a significant decrease in healthcare utilization, and therefore cost. The importance of the site of LV pacing has been demonstrated by several studies [9,10]. The focus has progressed from comparisons between the LV free versus anterior wall to the site of latest mechanical activation. More recently, the TARGET trial demonstrated that an EG LV approach led to a significant LVESV reduction and HF related hospitalizations [6]. The STARTER trial found a reduction in the primary end points of death and HF hospitalizations, with a secondary end point of LVESV reduction as well [5]. These recent studies both demonstrated a mechanistic improvement with EG LV placement, in the form of an improvement in echocardiographic parameters, which are in turn reflected in the decrease in HF hospitalizations. Our finding results demonstrate that, compared to routine LV lead placement, a strategy of EG LV lead placement for CRT is associated with less healthcare utilization in the form of outpatient and inpatient encounters. EG approach does not increase the duration of implantation, radiation exposure or procedural complications yet it can potentially confer a significant positive economic impact. These findings have important implications to the cost of management of heart failure.
Conflict of interest Yasser Rodriguez: None. John Nan: None. Omar Yasin: None. John Gorcsan: Dr. Gorcsan disclosed receiving research grant support from Biotronik, GE, Toshiba, Medtronic, and St. Jude Medical. Samir Saba: Dr. Saba disclosed receiving research support and consultation fees from Boston Scientific, Medtronic, and St. Jude Medical.
References [1] M.J. Calvert, N. Freemantle, G. Yao, J.G.F. Cleland, L. Billingham, J.C. Daubert, S. Bryan, Cost-effectiveness of cardiac resynchronization therapy: results from the CARE-HF trial, Eur. Heart J. 26 (2005) 2681–2688. [2] W.T. Abraham, W.G. Fisher, A.L. Smith, D.B. Delurgio, A.R. Leon, E. Loh, D.Z. Kocovic, M. Packer, A.L. Clavell, D.L. Hayes, M. Ellestad, J. Messenger, MIRACLE Study Group, Cardiac resynchronization in chronic heart failure, N. Engl. J. Med. 346 (2002) 1845–1853. [3] M.R. Bristow, L.A. Saxon, J. Boehmer, S. Krueger, D.A. Kass, T. De Marco, P. Carson, L. DiCarlo, D. DeMets, B.G. White, D.W. DeVries, A.M. Feldman, Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators, Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure, N. Engl. J. Med. 350 (2004) 2140–2150. [4] J.G.F. Cleland, J.-C. Daubert, E. Erdmann, et al., The Cardiac Resynchronization — Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure, N. Engl. J. Med. 352 (2005) 1539–1549. [5] S. Saba, J. Marek, D. Schwartzman, S. Jain, E. Adelstein, P. White, O.A. Oyenuga, T. Onishi, P. Soman, J. Gorcsan III, Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy; Results of the speckle tracking assisted resynchronization therapy for electrode region trial, Circ. Heart Fail. 6 (2013) 427–434. [6] F.Z. Khan, M.S. Virdee, C.R. Palmer, P.H. Pugh, D. O'Halloran, M. Elsik, P.A. Read, D. Begley, S.P. Fynn, D.P. Dutka, Targeted left ventricular lead placement to guide cardiac resynchronization therapy; the TARGET study: a randomized, controlled trial, J. Am. Coll. Cardiol. 59 (2012) 1509–1518. [7] CMS, Medicare Ranking for All Short-stay Hospitals: Fiscal Year, https://www.cms.gov/ DataCompendium/15_2009_Data_Compendium.asp2009 (Accessed April 10, 2011). [8] CMS, Medicare Short-stay Hospital MS-DRGs Ranked by Discharges: Fiscal Year, https://www.cms.gov/DataCompendium/15_2009_Data_Compendium.asp2009 (Accessed April 10, 2011). [9] P.W. Foley, S. Chalil, K. Ratib, R. Smith, F. Prinzen, A. Auricchio, F. Leyva, Fluoroscopic left ventricular lead position and the long-term clinical outcome of cardiac resynchronization therapy, Pacing Clin. Electrophysiol. 34 (2011) 785–797. [10] C. Butter, A. Auriccho, C. Stellbrink, E. Fleck, J. Ding, Y. Yu, E. Huvelle, J. Spinelli, Pacing Therapy for Chronic Heart Failure II Study Group, Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients, Circulation 104 (2001) 3026–3029.
Table 2 Health care utilization comparison between echo-guided transvenous LV lead placement versus the routine fluoroscopic approach. Characteristic
Echocardiographic guided CRT (n = 110)
Routine control CRT (n = 77)
P value
Total healthcare visits, n Total inpatient visits, n Total outpatient visits, n Total follow up time, months
22.8 ± 22.1 2.7 ± 2.8 20.2 ± 21.0 49.6 ± 20.4
34.4 ± 39.6 4.2 ± 4.2 30.2 ± 38.1 46.7 ± 24.1
0.02 0.006 0.056 0.68
CRT indicated cardiac resynchronization therapy.
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
The impact of a strategy of image-guided left ventricular lead placement during cardiac resynchronization therapy on health care utilization Yasser Rodriguez a,⁎, John Nan b, Omar Yasin c, John Gorcsan III a, Samir Saba a a b c
Cardiovascular Electrophysiology, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, United States Department of Medicine, University of Wisconsin, Madison, WI, United States University of Michigan School of Medicine, University of Michigan, Ann Arbor, MI, United States
a r t i c l e
i n f o
Article history: Received 21 March 2015 Accepted 24 March 2015 Available online 25 March 2015 Keywords: Cardiac resynchronization therapy Health care utilization LV lead position Heart failure hospitalization
Chronic heart failure presents a significant economic burden on the health care system [1]. In approximately one-third of all affected patients, heart failure (HF) causes electrical disturbances in the conduction pathways, leading to prolonged AV nodal conduction times, delay in the onset of right or left ventricular systole, or both [2]. The finding of intraventricular conduction delay has been associated with significant increase in HF hospitalizations and an increased risk of death [2]. In addition to pharmacologic intervention, cardiac resynchronization therapy (CRT) implantable cardioverter defibrillators (ICDs) and pacemakers (PMs) have emerged as an effective therapy, conferring symptomatic relief, functional improvement and survival benefit to a large proportion of affected HF patients [3,4]. Despite the demonstrated benefits of CRT-ICD therapy, approximately one-third of patients do not respond [2]. Of all the possible reasons why some patients are refractory to CRT, the choice of site of left ventricular pacing has emerged as a promising modifiable explanation as demonstrated in single-center randomized trials [5,6]. Echocardiography-guided (EG) transvenous LV lead placement for CRT has been shown to reduce the combined risk of death and hospitalization associated with HF [5,6]. Extrapolating from this finding, EG
⁎ Corresponding author at: University of Pittsburgh Cardiovascular Institute, Department of Cardiac Electrophysiology, PUH B535, 200 Lothrop Street, Pittsburgh, PA 15213, United States. E-mail address: [email protected] (Y. Rodriguez).
http://dx.doi.org/10.1016/j.ijcard.2015.03.357 0167-5273/© 2015 Published by Elsevier Ireland Ltd.
transvenous LV lead placement may have a positive economic impact. Our objective was to characterize the economic impact of this lead placement strategy by examining health care utilization. This study is a prospective, single-center, observational analysis. From the STARTER population (n = 187), patients who underwent CRT implantation using either EG LV lead positioning (n = 110) or routine approach without image guidance (n = 77), and who were followed-up in the outpatient clinics of the University of Pittsburgh Medical Center (UPMC) between June 2005 to March 2011 were included. Patients' demographic and clinical data were extracted from the electronic medical record. Outpatient and inpatient health care utilization data were collected using the billing databases of UPMC. All echocardiographic studies were analyzed at UPMC before the implantation procedure. As previously described [5], the site of latest mechanical activation was determined by speckle tracking echocardiography using the 8-segment free wall LV model at the basal and mid-LV levels. CRT was performed using a transvenous approach with the right ventricular (RV) lead placed in or near the RV apex. Coronary venography was performed in left anterior oblique projection in all patients. Patients randomized to the EG study group had their LV lead placement attempted in the latest LV mechanical activation site. Patients who were randomized to the control arm had their LV leads placed in the routine manner, targeting posterior or lateral LV regions. The primary endpoint of this analysis was total health care utilization after the CRT device implantation, which was used as a surrogate for healthcare cost. This endpoint was divided between outpatient and inpatient visits. An inpatient encounter was defined as admission to the hospital overnight either in observation or in-hospital status. An outpatient encounter was defined as an encounter in the outpatient clinics with a physician or physician extender. All patients enrolled in the STARTER trial [5] were included in this analysis. Baseline characteristics were similar between the two groups (Table 1) and they had comparable follow-up periods after CRT device implantation (49.6 and 46.7 months, p = 0.68). During follow-up, patients in the routine EG lead placement group had significantly lower total (p = 0.02), inpatient (p = 0.006), and outpatient (p = 0.056) healthcare encounters (Table 2). Total cost of health care during the follow-up period was available on 131 of 187 (70%) patients (78 in the EG and 53 in the routine group). There was a strong trend towards lower total cost of care in the EG compared to the routine group ($0.55 ± 1.08 million versus $1.02 ± 2.06 million, p = 0.093).
312
Y. Rodriguez et al. / International Journal of Cardiology 187 (2015) 311–312
Table 1 Baseline characteristics of patient population. Characteristic
Echocardiographic guided CRT (n = 110)
Routine control CRT (n = 77)
P value
Age, y Men, % NYHA HF classes II/III/IV, % Ischemic heart disease, % Diabetes mellitus, % LVEF, % QRS duration, ms Serum creatinine, mg/dL.
66 ± 11 70% 16/64/20 58% 37% 26 ± 6 157 ± 27 1.2 ± 0.4
67 ± 13 78% 8/71/21 67% 36% 26 ± 7 162 ± 27 1.3 ± 0.6
0.61 0.29 0.21 0.27 0.98 0.80 0.27 0.20
CRT indicated cardiac resynchronization therapy; LVEF, left ventricular ejection fraction; NYHA HF, New York Heart Association class of heart failure.
The impact of EG LV lead placement on several cardiac parameters has been recently assessed by two randomized control trials [5,6]. Khan et al. demonstrated in the TARGET study a 33.3% decrease in HF hospitalizations during a two-year follow up period [6]. Similarly, Saba et al. demonstrated in the STARTER study a 23.8% decrease in hospitalizations over a nearly two-year period [5]. In our present analysis, we demonstrated an overall 35% decrease in total hospitalizations. Extrapolating from the improvement in hemodynamic parameters seen in these studies along with the overall reduction in HF hospitalizations, we can infer that the patients that underwent EG LV lead placement may have had an improvement in overall clinical stability. This assertion is further reflected in the 33% decrease in outpatient healthcare utilization. Heart failure currently poses a significant economic burden on the American health care system [1]. An estimated five million patients are living with the condition, with 550,000 new cases being diagnosed yearly [1]. One-third of these patients will develop electrical conduction disturbances, and within that subpopulation, many patients could possibly benefit from CRT [2]. Cardiac arrhythmia and conduction disorders rank as one of the top areas of Medicare expenditure, costing an estimated $509,251,000 in 2009 [7,8]. EG approach does not increase the duration of implantation, radiation exposure or procedural complications [5] and yet seems to confer a significant decrease in healthcare utilization, and therefore cost. The importance of the site of LV pacing has been demonstrated by several studies [9,10]. The focus has progressed from comparisons between the LV free versus anterior wall to the site of latest mechanical activation. More recently, the TARGET trial demonstrated that an EG LV approach led to a significant LVESV reduction and HF related hospitalizations [6]. The STARTER trial found a reduction in the primary end points of death and HF hospitalizations, with a secondary end point of LVESV reduction as well [5]. These recent studies both demonstrated a mechanistic improvement with EG LV placement, in the form of an improvement in echocardiographic parameters, which are in turn reflected in the decrease in HF hospitalizations. Our finding results demonstrate that, compared to routine LV lead placement, a strategy of EG LV lead placement for CRT is associated with less healthcare utilization in the form of outpatient and inpatient encounters. EG approach does not increase the duration of implantation, radiation exposure or procedural complications yet it can potentially confer a significant positive economic impact. These findings have important implications to the cost of management of heart failure.
Conflict of interest Yasser Rodriguez: None. John Nan: None. Omar Yasin: None. John Gorcsan: Dr. Gorcsan disclosed receiving research grant support from Biotronik, GE, Toshiba, Medtronic, and St. Jude Medical. Samir Saba: Dr. Saba disclosed receiving research support and consultation fees from Boston Scientific, Medtronic, and St. Jude Medical.
References [1] M.J. Calvert, N. Freemantle, G. Yao, J.G.F. Cleland, L. Billingham, J.C. Daubert, S. Bryan, Cost-effectiveness of cardiac resynchronization therapy: results from the CARE-HF trial, Eur. Heart J. 26 (2005) 2681–2688. [2] W.T. Abraham, W.G. Fisher, A.L. Smith, D.B. Delurgio, A.R. Leon, E. Loh, D.Z. Kocovic, M. Packer, A.L. Clavell, D.L. Hayes, M. Ellestad, J. Messenger, MIRACLE Study Group, Cardiac resynchronization in chronic heart failure, N. Engl. J. Med. 346 (2002) 1845–1853. [3] M.R. Bristow, L.A. Saxon, J. Boehmer, S. Krueger, D.A. Kass, T. De Marco, P. Carson, L. DiCarlo, D. DeMets, B.G. White, D.W. DeVries, A.M. Feldman, Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators, Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure, N. Engl. J. Med. 350 (2004) 2140–2150. [4] J.G.F. Cleland, J.-C. Daubert, E. Erdmann, et al., The Cardiac Resynchronization — Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure, N. Engl. J. Med. 352 (2005) 1539–1549. [5] S. Saba, J. Marek, D. Schwartzman, S. Jain, E. Adelstein, P. White, O.A. Oyenuga, T. Onishi, P. Soman, J. Gorcsan III, Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy; Results of the speckle tracking assisted resynchronization therapy for electrode region trial, Circ. Heart Fail. 6 (2013) 427–434. [6] F.Z. Khan, M.S. Virdee, C.R. Palmer, P.H. Pugh, D. O'Halloran, M. Elsik, P.A. Read, D. Begley, S.P. Fynn, D.P. Dutka, Targeted left ventricular lead placement to guide cardiac resynchronization therapy; the TARGET study: a randomized, controlled trial, J. Am. Coll. Cardiol. 59 (2012) 1509–1518. [7] CMS, Medicare Ranking for All Short-stay Hospitals: Fiscal Year, https://www.cms.gov/ DataCompendium/15_2009_Data_Compendium.asp2009 (Accessed April 10, 2011). [8] CMS, Medicare Short-stay Hospital MS-DRGs Ranked by Discharges: Fiscal Year, https://www.cms.gov/DataCompendium/15_2009_Data_Compendium.asp2009 (Accessed April 10, 2011). [9] P.W. Foley, S. Chalil, K. Ratib, R. Smith, F. Prinzen, A. Auricchio, F. Leyva, Fluoroscopic left ventricular lead position and the long-term clinical outcome of cardiac resynchronization therapy, Pacing Clin. Electrophysiol. 34 (2011) 785–797. [10] C. Butter, A. Auriccho, C. Stellbrink, E. Fleck, J. Ding, Y. Yu, E. Huvelle, J. Spinelli, Pacing Therapy for Chronic Heart Failure II Study Group, Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients, Circulation 104 (2001) 3026–3029.
Table 2 Health care utilization comparison between echo-guided transvenous LV lead placement versus the routine fluoroscopic approach. Characteristic
Echocardiographic guided CRT (n = 110)
Routine control CRT (n = 77)
P value
Total healthcare visits, n Total inpatient visits, n Total outpatient visits, n Total follow up time, months
22.8 ± 22.1 2.7 ± 2.8 20.2 ± 21.0 49.6 ± 20.4
34.4 ± 39.6 4.2 ± 4.2 30.2 ± 38.1 46.7 ± 24.1
0.02 0.006 0.056 0.68
CRT indicated cardiac resynchronization therapy.