Access the full text.
Sign up today, get DeepDyve free for 14 days.
B. Sieniewicz, J. Gould, B. Porter, B. Sidhu, J. Behar, S. Claridge, S. Niederer, C. Rinaldi (2018)
Optimal site selection and image fusion guidance technology to facilitate cardiac resynchronization therapyExpert Review of Medical Devices, 15
M. Bogaard, P. Doevendans, G. Leenders, P. Loh, R. Hauer, Harry Wessel, M. Meine (2010)
Can optimization of pacing settings compensate for a non-optimal left ventricular pacing site?Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 12 9
J. Nielsen, H. Petersen, F. Karlsen, Lene Chri, J. Haarbo (2014)
ESC Guidelines on cardiac pacing and cardiac resynchronization therapy
C. Stephansen, A. Sommer, M. Kronborg, J. Jensen, B. Nørgaard, C. Gerdes, J. Kristensen, H. Jensen, D. Fyenbo, K. Bouchelouche, J. Nielsen (2019)
Electrically vs. imaging-guided left ventricular lead placement in cardiac resynchronization therapy: a randomized controlled trial.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
R. Dersimonian, R. Dersimonian, N. Laird, N. Laird (1986)
Meta-analysis in clinical trials.Controlled clinical trials, 7 3
(2021)
Abstract 9509: is left ventricular lead placement at site of latest mechanical activation associated with cardiac resynchronization therapy outcomes? Results of a meta-analysis
A. Sommer, M. Kronborg, B. Nørgaard, S. Poulsen, K. Bouchelouche, M. Böttcher, H. Jensen, J. Jensen, J. Kristensen, C. Gerdes, P. Mortensen, J. Nielsen (2016)
Multimodality imaging‐guided left ventricular lead placement in cardiac resynchronization therapy: a randomized controlled trialEuropean Journal of Heart Failure, 18
Cheuk-Man Yu, G. Bleeker, J. Fung, M. Schalij, Qing Zhang, E. Wall, Y. Chan, S. Kong, Jeroen Bax (2005)
Left Ventricular Reverse Remodeling but Not Clinical Improvement Predicts Long-Term Survival After Cardiac Resynchronization TherapyCirculation, 112
F. Khan, M. Virdee, C. Palmer, P. Pugh, D. O’Halloran, M. Elsik, P. Read, D. Begley, S. Fynn, D. Dutka (2012)
Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial.Journal of the American College of Cardiology, 59 17
C. Yancy, M. Jessup, B. Bozkurt, J. Butler, D. Casey, M. Drazner, G. Fonarow, S. Geraci, T. Horwich, J. Januzzi, Maryl Johnson, E. Kasper, W. Levy, F. Masoudi, P. Mcbride, J. McMurray, J. Mitchell, Pamela Peterson, B. Riegel, F. Sam, L. Stevenson, W. Tang, E. Tsai, B. Wilkoff (2013)
2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines.Circulation, 128 16
Jagmeet Singh, H. Klein, David Huang, S. Reek, M. Kuniss, A. Quesada, A. Barsheshet, D. Cannom, I. Goldenberg, S. McNitt, J. Daubert, W. Zareba, A. Moss (2011)
Left Ventricular Lead Position and Clinical Outcome in the Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy (MADIT-CRT) TrialCirculation, 123
Hidekazu Tanaka, H. Nesser, T. Buck, O. Oyenuga, R. Jánosi, S. Winter, S. Saba, J. Gorcsan (2010)
Dyssynchrony by speckle-tracking echocardiography and response to cardiac resynchronization therapy: results of the Speckle Tracking and Resynchronization (STAR) studyEuropean Heart Journal, 31
David Calvo, Marta Pombo (2022)
Comments on the 2021 ESC guidelines on cardiac pacing and cardiac resynchronization therapy.Revista espanola de cardiologia
R. Bai, L. Biase, P. Mohanty, A. Hesselson, E. Ruvo, Peter Gallagher, C. Elayi, S. Mohanty, Javier Sanchez, J. Burkhardt, R. Horton, G. Gallinghouse, S. Bailey, J. Zagrodzky, R. Canby, M. Minati, Larry Price, C. Hutchins, Melody Muir, L. Calò, A. Natale, G. Tomassoni (2011)
Positioning of Left Ventricular Pacing Lead Guided by Intracardiac Echocardiography with Vector Velocity Imaging During Cardiac Resynchronization Therapy ProcedureJournal of Cardiovascular Electrophysiology, 22
V. Delgado, R. Bommel, M. Bertini, C. Borleffs, N. Marsan, A. Ng, G. Nucifora, N. Veire, C. Ypenburg, E. Boersma, E. Holman, M. Schalij, J. Bax (2011)
Relative Merits of Left Ventricular Dyssynchrony, Left Ventricular Lead Position, and Myocardial Scar to Predict Long-Term Survival of Ischemic Heart Failure Patients Undergoing Cardiac Resynchronization TherapyCirculation, 123
P. Wouters, C. Lieshout, V. Dijk, P. Delnoy, P. Doevendans, M. Cramer, G. Frederix, F. Slochteren, M. Meine (2021)
Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluationBMJ Open, 11
J. Sterne, J. Savović, M. Page, R. Elbers, N. Blencowe, I. Boutron, C. Cates, Hung-Yuan Cheng, M. Corbett, S. Eldridge, J. Emberson, M. Hernán, S. Hopewell, A. Hrõbjartsson, D. Junqueira, P. Jüni, J. Kirkham, T. Lasserson, Tianjing Li, A. McAleenan, B. Reeves, S. Shepperd, I. Shrier, L. Stewart, K. Tilling, I. White, P. Whiting, J. Higgins (2019)
RoB 2: a revised tool for assessing risk of bias in randomised trialsBMJ, 366
Yan Jin, Qi Zhang, Jia-liang Mao, B. He (2015)
Image-guided left ventricular lead placement in cardiac resynchronization therapy for patients with heart failure: a meta-analysisBMC Cardiovascular Disorders, 15
S. Saba, J. Marek, D. Schwartzman, Sandeep Jain, Evan Adelstein, Pamela White, O. Oyenuga, T. Onishi, P. Soman, J. Gorcsan (2013)
Echocardiography-Guided Left Ventricular Lead Placement for Cardiac Resynchronization Therapy: Results of the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region TrialCirculation: Heart Failure, 6
M. Page, J. McKenzie, P. Bossuyt, I. Boutron, T. Hoffmann, C. Mulrow, Larissa Shamseer, J. Tetzlaff, E. Akl, S. Brennan, R. Chou, Julie Glanville, J. Grimshaw, A. Hrõbjartsson, M. Lalu, Tianjing Li, E. Loder, E. Mayo-Wilson, Steve McDonald, L. McGuinness, L. Stewart, James Thomas, A. Tricco, V. Welch, P. Whiting, D. Moher (2020)
The PRISMA 2020 statement: an updated guideline for reporting systematic reviewsSystematic Reviews, 10
R. Borgquist, M. Carlsson, H. Markstad, A. Werther-Evaldsson, E. Ostenfeld, A. Roijer, Z. Bakos (2020)
Cardiac Resynchronization Therapy Guided by Echocardiography, MRI, and CT Imaging: A Randomized Controlled Study.JACC. Clinical electrophysiology, 6 10
G. Knapp, J. Hartung (2003)
Improved tests for a random effects meta‐regression with a single covariateStatistics in Medicine, 22
J. Yepes-Nuñez, G. Úrrutia, M. Romero-García, S. Alonso-Fernández (2021)
The PRISMA 2020 statement: an updated guideline for reporting systematic reviews.Revista espanola de cardiologia, 74 9
M. Fudim, F. Dalgaard, S. Al‐Khatib, D. Friedman, Kathryn Lallinger, W. Abraham, J. Cleland, A. Curtis, M. Gold, V. Kutyifa, C. Linde, D. Schaber, A. Tang, Fatima Ali-Ahmed, S. Goldstein, B. Kaufman, Robyn Fortman, J. Davis, Lurdes Inoue, G. Sanders (2020)
Future research prioritization in cardiac resynchronization therapy.American heart journal, 223
M. Spartalis, E. Tzatzaki, E. Spartalis, C. Damaskos, A. Athanasiou, E. Livanis, V. Voudris (2017)
The Role of Echocardiography in the Optimization of Cardiac Resynchronization Therapy: Current Evidence and Future PerspectivesThe Open Cardiovascular Medicine Journal, 11
J. Gorcsan, O. Oyenuga, P. Habib, Hidekazu Tanaka, Evan Adelstein, Hideyuki Hara, D. McNamara, S. Saba (2010)
Relationship of Echocardiographic Dyssynchrony to Long-Term Survival After Cardiac Resynchronization TherapyCirculation, 122
Hindawi Journal of Interventional Cardiology Volume 2022, Article ID 6285894, 10 pages https://doi.org/10.1155/2022/6285894 Review Article Outcomes of Cardiac Resynchronization Therapy with Image-GuidedLeftVentricularLeadPlacementattheSiteofLatest Mechanical Activation: A Systematic Review and Meta-Analysis 1,2 3 4 Nancy M. Allen LaPointe , Fatima Ali-Ahmed , Frederik Dalgaard , 5,6 2,7 1,6,8 Andrzej S. Kosinski , Gillian Sanders Schmidler , and Sana M. Al-Khatib Department of Medicine, Duke University School of Medicine, Durham, NC 27710, USA Duke-Margolis Center for Health Policy, Duke University, Durham, NC 27708, USA Department of Cardiology, Mayo Clinic, Rochester, MN 55902, USA Department of Cardiology, Herlev and Gentofte Hospital, Hellerup, Denmark Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC 27710, USA Duke Clinical Research Institute, Durham, NC 27710, USA Department of Population Health Sciences, Duke University School of Medicine, Durham, NC 27710, USA Division of Cardiology, Duke University Medical Center, Durham, NC 27710, USA Correspondence should be addressed to Nancy M. Allen LaPointe; nancy.allenlapointe@duke.edu Received 8 March 2022; Accepted 22 April 2022; Published 20 May 2022 Academic Editor: Yuichiro Maekawa Copyright © 2022 Nancy M. Allen LaPointe et al. 'is is an open access article distributed under the Creative Commons AttributionLicense,whichpermitsunrestricteduse,distribution,andreproductioninanymedium,providedtheoriginalworkis properly cited. Aim. To assess evidence for an image-guided approach for cardiac resynchronization therapy (CRT) that targets left ventricular (LV) lead placement at the segment of latest mechanical activation. Methods. A systematic review of EMBASE and PubMed was performed for randomized controlled trials (RCTs) and prospective observational studies from October 2008 through October 2020 that compared an image-guided CRTapproach with a non-image-guided approach for LV lead placement. Meta-analyses were performed to assess the association between the image-guided approach and NYHA class improvement or changes in end- systolic volume (LVESV), end-diastolic volume (LVEDV), and ejection fraction (LVEF). Results. From 5897 citations, 5 RCTs including 818 patients (426 image-guided and 392 non-image-guided) were identified. 'e mean age ranged from 66 to 71 years, 76% were male, and 53% had ischemic cardiomyopathy. Speckle tracking echocardiography was the primary image-guided method in all studies. LV lead placement within the segment of the latest mechanical activation (concordant) was achieved in the image-guided arm in 45% of the evaluable patients. 'ere was a statistically significant improvement in the NYHA class at 6 months (oddsratio1.66;95%confidenceinterval(CI) [1.02,2.69])withtheimage-guidedapproach,but nostatisticallysignificant change inLVESV(MD −7.1%;95%CI[−16.0,1.8]),LVEDV(MD −5.2%;95% CI[−15.8,5.4]),orLVEF(MD0.68;95%CI[−4.36, 5.73]) versus the non-image-guided approach. Conclusion. 'e image-guided CRTapproach was associated with improvement in the NYHA class but not echocardiographic measures, possibly due to the small sample size and a low rate of concordant LV lead placement despite using the image-guided approach. 'erefore, our meta-analysis was not able to identify consistent im- provement in CRT outcomes with an image-guided approach. the use of CRT, not all patients realize the full benefits of this 1.Introduction therapy [1–3]. 'e left ventricular (LV) lead placement has CRT has been shown to improve outcomes in heart failure been identified as an important factor for CRT response patients;however,evenamongthecarefullyselectedpatients [4–7]. In addition to avoiding placement in an apical seg- for whom clinical trials and subsequent guidelines support ment, placing the LV lead in the LV segment with the latest 2 Journal of Interventional Cardiology mechanical activation that is free from transmural scarring ejection fraction, end-systolic volume or diameter, end-dia- has been suggested [5, 8, 9]. Previous studies using speckle stolic volume or diameter), NYHA class improvement, 6- minute walk test (6 MWT), ICD shocks, quality of life, device- tracking echocardiography (STE) to identify and target the LV segment of latest mechanical activation showed prom- related adverse events, and any composite of the outcomes. isingresultsbutwererelativelysmallstudies,including1to2 Tworeviewersthenindependentlyreviewedthefulltextofeach centers with unclear generalizability [10, 11]. 'us, the selectedpublicationtoconfirmthatthestudymettheinclusion question remains as to whether a personalized approach to criteria. Finally, one investigator reviewed the full text of the LV lead placement that uses cardiac imaging to identify and selected studies to identify those that compared CRToutcomes target the LV site of the latest mechanical activation can in patients with an image-guided approach for LV lead improve CRT outcomes. To address this question, we placement at the site of the latest LV mechanical activation to conducted a systematic literature review to identify ran- those without an image-guided approach for LV lead placement. domized controlled studies or prospective observational studies of image-guided approaches for LV lead placement One investigator abstracted study characteristics, pa- tient characteristics, and results, and a second investigator and performed meta-analyses to assess the association be- tween the image-guided approach and CRT outcomes. confirmed study applicability and the accuracy of the ab- stracted data. Abstracted study characteristics included study design, number of study sites, location of study site 2.Methods (s), funding source, publication year, study arms, number 'is review was conducted as part of a National Heart, Lung, of subjects, method of assessing LV mechanical dyssyn- and Blood Institute-funded project to synthesize evidence chrony, imaging method, follow-up period, and outcomes. related to CRTand to identify and prioritize clinical and policy Patient characteristics included age, sex, ischemic cardio- evidence gaps [12]. To address one component of the evidence myopathy versus non-ischemic cardiomyopathy, LBBB, gap regarding the extent and/or location of LV mechanical QRS duration, sinus rhythm, LV ejection fraction, NYHA dyssynchrony predicting CRT outcomes, we conducted a class, and location of LV lead. In addition, if reported, the systematic literature review for studies evaluating CRT out- number of patients whose LV lead was confirmed to have comes in patients with an image-guided approach for LV lead been placed within the LV segment of latest mechanical placement within the LV segment with the latest mechanical activation (concordant LV lead placement) or next to the activation versus a non-image-guided approach. 'e Preferred segment of latest mechanical activation (adjacent LV lead Reporting Items for Systematic Reviews and Meta-Analyses placement) in each study arm was also captured. 'e (PRISMA) statement was followed [13]. abstracting investigator and the over-reading investigator independently assessed risk of bias using the revised Cochrane risk-of-bias tool for randomized trials [14]. 2.1. Literature Search Strategy. A literature search was Discrepancies were resolved through discussion. conducted using PubMed and Embase for randomized controlled trials (RCT) or prospective studies of CRT. 'e MeSH and Emtree terms “cardiac resynchronization ther- 2.3. Statistical Analysis. Categorical outcomes (≥1 class apy” and “cardiac resynchronization therapy device” were improvement in the NYHA class) were reported as fre- used in addition to title and abstract searches for “cardiac quencies with percentages. Continuousvalues were reported resynchronization therapy,” “cardiac resynchronization as means with standard deviations (SDs). For LVEF, the therapy,” “atrio biventricular pacing,” “atrio-biventricular mean(SD)oftheabsolutechangefrombaselinetofollow-up pacing,” “biventricular pacing,” or “biventricular pace- was reported. For LVEDV and LVESV, themean (SD)of the maker.”ResultswerelimitedtoEnglishlanguagearticlesand relative change,expressedas apercentage, frombaseline was human studies with publication dates between October 2008 reported. For one study, the mean relative change and and October 2020. standard deviation in LVEDV and LVESV were estimated using the reported mean and standard deviation at baseline and the absolute change from baseline since the relative 2.2. Study Selection, Abstraction, and Bias Assessment. change was not reported [10]. Two reviewers independently screened all identified titles and Meta-analyses were conducted for all outcomes of in- abstracts. Publications that met the selection criteria as de- termined by either reviewer were moved on to full-text review. terest that were reported in three or more included studies. Meta-analyses were performed using a DerSimonian–Laird InadditiontobeingeitheranRCTorprospectiveobservational study in humans and published in English, all studies had to random-effects model, and we conservatively used the Knapp–Hartung approach to adjust the standard errors of include the following: the use of CRT in eligible inpatient or outpatient heart failure patients; an assessment of the location the estimated model coefficients [15, 16]. Categorical out- comeswere pooledandpresentedasanoddsratio(OR)with and/or extent of LV mechanical dyssynchrony by any imaging 95% confidence intervals (CIs). Continuous outcomes were method; a report of CRToutcomes of interest in relation to the pooledandpresentedasthemean difference(MD)with 95% LV mechanical dyssynchrony. CRT outcomes of interest in- CI. Heterogeneity was assessed with Cochrane’s Q and I cluded all-cause mortality, heart failure mortality, heart failure indexesandthecorresponding pvalue. I valuesgreaterthan hospitalization, ventricular arrhythmias, change in LV dys- synchrony, change in echocardiographic parameters (LV 75% indicate large heterogeneity. Journal of Interventional Cardiology 3 5,897 citations identified by literature search: MEDLINE: 2,267 Embase: 3,630 3,084 total unique citations screened 2,999 abstracts excluded • Not RCT or Prospective Observational Study • No assessment of LVMD • No CRT outcomes of interest 85 passed abstract screening 79 articles excluded: • No CRT outcomes reported for extent or location of LVMD • No comparison of image-guided versus non-image- guided approaches 6 included articles (6 unique studies) 1 study excluded because outcome of interest was not reported in an analyzable format 5 included in meta-analyses (5 unique studies) Figure 1: Literature flow diagram. CRT �cardiac resynchronization therapy; LVMD �left ventricular mechanical dyssynchrony; RCT �randomized controlled trial. p values≤0.05 were considered statistically significant. studies [10, 11, 17] and was electrically guided in two studies Analyses were performed using R (version 4.0.2), including [18, 19]. However, in one study with the standard-of-care the R package “metafor” (version 2.4-0). CRT placement, results from the CT and CMR were also made available to physicians [17]. Four of the studies were rated as having a low overall risk of bias [10, 17–19], and one 3.Results was rated as having some overall risk of bias [11]. Study characteristics are summarized in Table 1. From 3084 unique citations identified, a total of 5 studies A total of 818 patients were enrolled in the 5 identified met the selection criteria for this analysis (Figure 1) RCTs,with426(52%)intheinterventionarmand392(48%) [10, 11, 17–19]. All studies were randomized controlled in the comparator arm. Patient characteristics are presented trials, and all but one were single-center studies [10]. While in Table 2. Characteristics were similar between the control the selected imaging methodology in each study to identify and intervention arms of each study. 'e mean patient age the site of latest mechanical activation was performed on all was greater than 65 years in all studies, and most patients patients enrolled in the study, the results were provided to were male (range of 73% to 79%). 'e proportion of patients theimplanting physician only for those patients randomized with ischemic cardiomyopathy in each study ranged from to the imaging arm. Speckle tracking echocardiogram (STE) 46%to62%,themeanormedianQRSdurationwasover150 was the primary imaging method used in all studies to msec in all studies, and all but one study enrolled patients identify the LV segment of latest mechanical activation and with NYHA classes II, III, and IV. Regardless of the study thus the targeted LV segment for LV lead placement. arm,mostLVleadswere ultimatelyplacedwithinalateral or However, three of the studies use multimodal imaging to posterior segment (Table 2). Among 390 evaluable patients further refine the targeted segment [17–19]. All three used intheimage-guidedarm,176(45%)hadconcordantLVlead computed tomography (CT) to visualize coronary sinus placement and 172 (44%) had the LV lead placed in an branches. In addition, one study used cardiac magnetic adjacent segment. In the non-image-guided arm, 117 of 366 resonance (CMR) [17], one used rubidium positron emis- (32%) patients had a concordant lead placement and 174 sion tomography [18], and one used single-photon emission (48%) had an adjacent lead placement. computed tomography [19] to identify areas of transmural All outcomes of interest reported in each study are listed myocardial scar to avoid LV lead placement. In the control in Table 1; however, only four outcomes of interest were arms,CRTplacementwasasperthestandardofcareinthree 4 Journal of Interventional Cardiology Table 1: Summary of study characteristics. First author Study design, Image-guided Risk of bias (year) study sites, and Study arms (N) Outcomes of interest method A B C D E F G Study name locations Image-guided:110 enrolled; Primary: ≥ 15% reduction in LVESV at 6 months Khan [10] RCT (1:1) 103 completed Other: ≥1 improvement in the NYHA class, change in the NYHA +++ ?? ++ (2012) 2 sites 2D Echo/STE SOC: 110 enrolled; 104 class, relative change in LVESV, absolute change in LVEF, absolute TARGET United Kingdom completed change in LVEDV—all at 6 months Primary: all-cause mortality or HF hospitalization (mean follow-up Image-guided:110 enrolled; Saba [11] RCT (3:2) 1.8 years (±1.3 years)) 73 completed +++ – + + (2013) 1 site 2D Echo/STE Other: all-cause mortality (mean 1.8 years follow-up), HF SOC: 77 enrolled; 48 STARTER United States hospitalization(mean1.8yearsfollow-up),relativechangeinLVESV completed (at 6 months), and absolute change in LVEF (at 6 months) Primary: all-cause mortality, HF hospitalization, or improvement Image-guided: 89 enrolled; Sommer [19] RCT (1:1) (NYHA class and QOL) 2D Echo/ 88 completed +++ ? +++ (2016) 1 site Other: HF hospitalization or death at 1.8 years, relative change in STE+SPECT+CT Electrically guided: 93 Imaging CRT Denmark LVESV, absolutechange inLVEF,relative changein LVEDV,and≥1 enrolled; 91 completed improvement in NYHA class—all at 6 months Image-guided: 62 enrolled; Primary: absolute change in LVEF at 6 months Stephansen RCT (1:1) 2D Echo/ 59 completed Other: ≥ 1 improvement in the NYHA class, change in LVESV, +++ ? +++ [18] (2019) 1 site STE+PET+CT Electrically guided+CT: 60 change in LVEDV, clinical response (death, HF hospitalization, or Electro-CRT Denmark enrolled; 54 completed improvement (NYHA class and QOL))—all at 6 months Image-guided: 55 Primary: ≥15% reduction in LVESV at 6 months RCT (1:1) randomized; 53 completed Borgquist [17] 2D Echo/ Other: all-cause mortality (within 2 years), all-cause mortality or HF +++ ? +++ 1 site SOC+CT/CMR if (2020) STE+CMR+CT hospitalization (within 2 years), HF hospitalization (within 2 years), Sweden available: 52 randomized; ≥1 improvement in NYHA class 49 completed CMR �cardiac magnetic resonance; CT �computed tomography; Echo �echocardiogram; HF �heart failure; LV �left ventricular; LVEDV �left ventricular end-diastolic volume; LVEF �left ventricular ejection fraction; LVESV �left ventricular end-systolic volume; NYHA �New York Heart Association class; Obs �observational; PET �positron emission tomography; QOL �quality of life; SD �standard deviation; SOC �standard of care; STE �speckle tracking echocardiogram; risk of bias: A �randomization process, B �assignment to intervention, C �adhering to intervention, D �missing outcome data, E �measurement of outcome, F �selection of reported results, and G �overall (green indicates “low”, yellow indicates “some”, and red indicates “high” risk of bias). Journal of Interventional Cardiology 5 Table 2: Summary of patient characteristics. Khan et al. [10] Saba et al. [11] Sommer et al. [19] Stephansen et al. [18] Borgquist et al. [17] Age Median (IQR) Image-guided 66 (11) 71 (9) 70 (10) 67 (8) 72 (65, 76) Non-image-guided 72 (64, 80) 67 (13) 71 (9) 72 (8) 70 (8) All patients NR NR NR NR 68 (8) Sex, male Image-guided 77% 60% 78% 73% 74% Non-image-guided 80% 78% 80% 77% 73% All patients 79% 73% 79% 75% 74% Ischemic cardiomyopathy Image-guided 56% 58% 52% 47% 42% Non-image-guided 56% 67% 47% 53% 51% All patients 56% 62% 49% 49% 46% Sinus rhythm Image-guided 100% 75% NR NR 89% Non-image-guided 100% 73% NR NR 92% All patients 100% 74% NR NR 90% QRS duration (ms) Median (IQR) Image-guided 157 (27) 167 (22) 169 (23) 171 (16) 157 (148, 170) Non-image-guided 159 (146, 170) 162 (27) 165 (22) 170 (17) 169 (22) All patients NR NR NR NR 170 (19) LBBB ∗ ∗ Image-guided NR NR 84% 84% 74% ∗ ∗ Non-image-guided NR NR 88% 93% 74% ∗ ∗ All patients NR NR 86% 89% 74% NYHA class Image-guided II 0 16% 49% 66% 26% III 86% 64% 49% 31% 68% IV 14% 20% 1% 3% 6% Non-image-guided II 0 8% 43% 58% 25% III 85% 71% 52% 40% 57% IV 15% 21% 5% 2% 18% All patients II 0 13% 46% 62% 26% III 85% 67% 51% 35% 63% IV 15% 20% 3% 2% 12% LVEF (%) Median (IQR) Image-guided 26 (6) 25 (6) 31 (8) 23 (10) 23 (19, 28) Non-image-guided 24 (18, 29) 26 (7) 24 (6) 29 (8) 23 (12) All patients NR NR NR NR 23 (11) LV lead placement Image-guided Anterior 3% 5% 22% Anterolateral 0 Lateral 46% 47% NR 45% Posterolateral 0 0 4% Posterior 35% 44% 25% Inferior 12% NR 5% 4% Non-image-guided Anterior 6% 2% 22% Anterolateral 0 Lateral 47% 42% NR 43% Posterolateral 0 0 4% Posterior 38% 56% 28% Inferior 6% NR 0 4% 6 Journal of Interventional Cardiology Table 2: Continued. Khan et al. [10] Saba et al. [11] Sommer et al. [19] Stephansen et al. [18] Borgquist et al. [17] All patients Anterior 5% 0% 3% 22% Anterolateral 0 16% 0 0 Lateral 46% 42% 44% NR 44% Posterolateral 0 34% 0 4% Posterior 37% 8% 50% 26% Inferior 9% 0% 2% 4% Values are mean (standard deviation), unless otherwise speci…c. 100% when including patients with chronic right ventricular pacing and QRS ≥180 ms per entry criteria at baseline. A anterior; AL anterolateral; I inferior; IQR interquartile range; LBBB left bundle branch block; LV left ventricle; LVEF left ventricular ejection fraction; NYHA New York Heart Association; NR not reported. Non-image OR [95% CI] Weight Guided Image Guided Study (Image Guided over (%) Non-image Guided) Events N Events N Khan 2012 85 103 68 104 28.5 2.50 [1.31, 4.79] 53 88 46 91 Sommer 2016 34.3 1.48 [0.82, 2.68] Stephansen 2019 36 59 27 50 20.7 1.33 [0.62, 2.86] Borgquist 2020 39 53 33 49 16.5 1.35 [0.57, 3.17] Summary (I = 0.0%, Q = 2.2, P=0.53) 100 1.66 [1.02, 2.69] Favors Favors Non-image Guided Image Guided 0.50 1.00 2.00 3.00 5.00 OR (Image Guided over Non-image Guided) Figure 2: > 1 NYHA class improvement at 6 months. reported in three or more studies and therefore analyzed in approach as compared to the non-image-guided approach; this study. In all studies, patients and the physicians however, no statistically signi…cant di‘erences in any of the assessing outcomes were blinded to the assigned treatment echocardiographic measures were found between the ap- arm. Four studies assessed the number of patients with ≥1 proaches. Mortality and heart failure hospitalization out- class improvement in the NYHA class, 6 months after CRT comes were reported in four of the …ve included studies; placement [10, 17–19]. ƒe meta-analysis showed a statis- however, because the reported outcome measures were tically signi…cant greater odds of improvement in NYHA inconsistent across studies and/or the number of events in class in those with an image-guided approach (pooled OR each study arm could not be ascertained from the publi- 1.66, 95% CI 1.02 to 2.69; I 0.0%, p 0.53) (Figure 2). cation, meta-analyses for these outcomes were not feasible. Figures 3–5 present the results from the three other meta- ƒe results of our meta-analysis are not consistent with a analyses. ƒere were no statistically signi…cant di‘erences prior meta-analysis; however, as described in the following, between image-guided and non-image-guided approaches our study provides an expanded and more contemporary in terms of relative reduction in LVESV (mean di‘erence perspective [20]. In addition, the …ve RCTs included in our 7.10%, 95% CI −16.00 to 1.80; I 64.0%, p 0.039), relative study had di‘erences in study enrollment criteria and components of the intervention and/or comparator arms, reduction in LVEDV (mean di‘erence −5.20%, 95% CI −15.80 to 5.40; I 60.9%, p 0.077), or absolute increase in leading to some heterogeneity; however, these trials mirror LVEF (mean di‘erence 0.68, 95% CI −4.36 to 5.73; the evolution of technology and guideline recommendations I 74.2%, p 0.009) at 6 months after CRT implant. for CRT. Lastly, the proportion of patients in each study who achieved LV lead placement in the targeted segment varied, as did the rate of patients in the comparator arms who 4. Discussion fortuitously had the LV lead placed in the LV segment of In our meta-analysis, we found a statistically signi…cant latest activation without a scar. ƒis may have resulted in a improvement in the NYHA class with the image-guided diminished added value with the imaging-guided approach. Journal of Interventional Cardiology 7 MD [95% CI] Weight Image Guided Non-image Guided Study (Image Guided minus (%) Mean SD N Mean SD N Non-image Guided) Khan 2012 −29 16 103 −17 14 104 35.4 −12.0 [−16.1, −7.9] Saba 2013 −30 29 73 −20 25 48 21.0 −10.0 [−19.7, −0.3] Sommer 2016 −34 23 88 −33 23 91 28.2 −1.0 [ −7.7, 5.7] Stephansen 2019 −25 36 59 −22 33 54 15.5 −3.0 [−15.7, 9.7] Summary (I = 64.0%, Q = 8.3, P=0.039) 100 −7.1 [−16.0, 1.8] Favors Favors Image Guided Non-image Guided −20.0 −15.0 −10.0 −5.0 0.0 5.0 10.0 MD (Image Guided minus Non-image Guided) Figure 3: Mean relative reduction in LVESV at 6 months. MD [95% CI] Weight Image Guided Non-image Guided Study (Image Guided minus (%) Mean SD N Mean SD N Non-image Guided) Khan 2012 −21 13 103 −12 11 104 45.9 −9.0 [−12.3, −5.7] Sommer 2016 −24 20 88 −22 23 91 31.4 −2.0 [ −8.3, 4.3] Stephansen 2019 −18 25 59 −16 22 54 22.7 −2.0 [−10.7, 6.7] Summary (I = 60.9%, Q = 5.1, P=0.077) 100 −5.2 [−15.8, 5.4] Favors Favors Image Guided Non-image Guided −15.0 −10.0 −5.0 0.0 5.0 10.0 MD (Image Guided minus Non−image Guided) Figure 4: Mean relative reduction in LVEDV at 6 months. ƒerefore, our meta-analysis was not able to identify con- CI 1.91 to 5.01), and reduction of LVESV (MD −20.36; 95% sistent improvement in CRT outcomes with an image- CI −27.82 to −12.90) at 6 months [10, 11, 20, 21]. CRT guided approach. response was de…ned di‘erently in the three included ƒe systematic review and meta-analysis conducted by studies, and therefore, this endpoint was not included in our Jin et al. included two studies using speckle tracking analysis. In addition, we excluded the study using ICE be- echocardiography to identify the target for optimal LV lead cause it did not meet our inclusion criteria for an image- guided approach that identi…ed a speci…c target for LV lead placement (Targeted Left Ventricular Lead Placement to Guide CRT (TARGET) and Speckle Tracking Assisted placement [21]. However, our analysis included three ad- Resynchronization ƒerapy for Electrode Region ditional studies that were published after the meta-analysis (STARTER) studies) and one study using intracardiac by Jin et al. [17–19]. ƒese newer studies included multi- echocardiography (ICE) during LV lead implantation to modal imaging approaches in the intervention arm, and two select the best placement option [10, 11, 20, 21]. Jin et al. of them included an electrically guided approach as the concluded that the image-guided approach was associated comparator. ƒe results from these three studies, in contrast with a statistically signi…cant greater CRTresponse (OR 2.10; to TARGET and STARTER, largely showed no di‘erence in 95% CI 1.43 to 3.07), improvement in LVEF (MD 3.46; 95% CRT outcomes between the image-guided and non-imaged 8 Journal of Interventional Cardiology MD [95% CI] Weight Image Guided Non−image Guided Study (Image Guided minus (%) Mean SD N Mean SD N Non−image Guided) Khan 2012 8 7 103 5 8 104 29.5 3.00 [ 0.95, 5.05] Saba 2013 12 11 73 9 10 48 21.7 3.00 [−0.79, 6.79] Sommer 2016 12 9 88 12 8 91 27.5 0.00 [−2.50, 2.50] Stephansen 2019 7 11 59 11 10 54 21.3 −4.00 [−7.87, −0.13] Summary (I2 = 74.2%, Q = 11.6, P=0.009) 100 0.68 [−4.36, 5.73] Favors Favors Non−image Guided Image Guided −10.00 −5.00 0.00 5.00 10.00 MD (Image Guided minus Non−image Guided) Figure 5: Mean absolute increase in LVEF at 6 months. arms. ƒerefore, the results of our study were inconsistent mechanical activation that is free of scar. While electrical with that conducted by Jin et al. but may provide a more guidance and programming are important components for CRT outcomes, those alone are not likely able to overcome contemporary perspective. ƒe …ve RCTs in our study were published over an issues associated with a less-than-optimally placed LV lead [22, 23]. Imaging to identify the site of latest mechanical approximately 8-year time span, and thus, patient selection criteria and components of the image-guided or comparator activation was conducted in all patients in all of the included arms evolved with technology and guidelines during this studies; however, the imaging data were only provided to the time. TARGETand STARTER were the …rst RCTs to address implanting physician for those patients in each study who whether an image-guided approach for LV lead placement were randomized to the image-guided study arm. ƒerefore, can improve CRT outcomes [10, 11]. Patients with a QRS post hoc, the number of patients who ultimately had their duration of ≥120 milliseconds (ms) without considering the LV lead placed at the site of latest mechanical activation presence of LBBB were enrolled. In fact, neither study (concordant), in the segment adjacent to the segment with presents the number of patients with LBBB. However, the latest mechanical activation (adjacent), and distant from the segment of the latest mechanical activation (discordant) subsequent studies, following the evolution of clinical practice guidelines, enrolled a high proportion of patients in both study groups was ascertainable and was reported in having LBBB, for whom a standard approach targeting the all of the included studies. ƒe proportion of patients who posterior or posterolateral LV segment may be more likely to achieved a concordant LV lead varied among studies with be the segment of latest mechanical activation [17–19]. In the highest proportion at 61% in TARGET and the lowest addition, TARGET and STARTER used STE as the sole proportion at 21% in the study by Borgquist et al. In ad- imaging method. Subsequent studies incorporated multi- dition, the proportion of patients with the fortuitous modal imaging into the intervention arm to better identify placement of the LV lead within the segment with the latest transmural scar and coronary anatomy [17–19]. Likewise, mechanical activation, free of scar, in the comparator arms the components of the comparator arm evolved over time to also varied, with the highest proportion at 45% in TARGET include electrically guided approaches and/or some imaging and the lowest proportion at 12% in STARTER. In a separate meta-analysis, we also found a statistically signi…cant as- results to inform on coronary anatomy [17, 18]. ƒis evo- lution in methodology may have resulted in greater het- sociation between CRT outcomes and concordant or adja- erogeneity among studies and diminishment of the value- cent LV lead placement versus discordant LV lead placement added response with an image-guided approach. However, [24]. ƒerefore, the potential lack of di‘erentiation in these newer studies more closely represent contemporary concordant LV lead placement between study arms may capabilities and the importance of this issue, as further have also diminished the e‘ect from the intervention and reinforced by the recent initiation of a small RCT in the merit further study. Netherlands comparing CRT outcomes in those with real- ƒere are several limitations to this study, including the time image-guided LV lead placement using CMR feature relatively small number of studies eligible for inclusion and the small number of total patients. All but one study was a tracking versus those with the standard-of-care LV lead placement with electrical guidance [22]. single-center study; however, the included multicenter study only included 2 sites. ƒerefore, performance of the inter- Lastly, the primary goal of an image-guided approach is to place the LV lead within the LV segment with latest vention and the results may not be generalizable. ƒere was Journal of Interventional Cardiology 9 also considerable heterogeneity identified in the analyses for Authors’ Contributions LVEF and LVESV. As described above, changes in guideline Concept and design and acquisition, analysis, and inter- recommendations and technology over time resulted in pretation of data were carried out by all authors. 'e potentially significant differences in study populations and/ manuscript was drafted by N. Allen LaPointe. Critical re- or LV lead implantation techniques, resulting in heteroge- vision of the manuscript for important intellectual content neity across studies and/or within studies. Lastly, the study wasdonebyallauthors.Statisticalanalysiswasperformedby by Borgquest et al. was terminated early due to equivocal A. Kosinski. Supervision was conducted by G. Sanders resultsbetweenstudyarms,potentiallyintroducingbias[17]. Schmidler and S. Al-Khatib. In conclusion, our meta-analysis found that an image- guided CRTapproach was associated with improvement in the Acknowledgments NYHA class but not echocardiographic measures. 'erefore, our meta-analysis was not able to identify consistent im- 'e authors thank Kathryn Lallinger and Kamaria Kaalund provement in CRToutcomes with an image-guided approach. for project coordination support. 'e authors also thank Whilethesmallsamplesizeandpotentiallackofdifferentiation Brystana Kaufman, PhD, Marat Fudim, MD, Vanessa between study arms in the achievement of concordant LV lead Blumer, MD, and Sarah Goldstein, MD, for their help with placementmaypartiallyexplaintheequivocalfindings,itisalso the initial literature screening. 'is study was funded by an important to note that optimal LV lead placement alone may NHLBI grant (1R01HL131754-01A1) on the Power of not fully address the complexity of heart failure management Bayesian Methods, RCTs, and Decision Models to Inform with CRT. Other factors such as device optimization, per- CRT Uncertainties (PI: GSS). centage of biventricular pacing, and arrhythmia burden may also need to be considered and integrated into any future References strategic approach for CRT. [1] M. Glikson, J. C. Nielsen, M. B. Kronborg et al., “2021 ESC Data Availability Guidelines on cardiac pacing and cardiac resynchronization therapy,” European Heart Journal, vol. 42, no. 35, pp. 3427– 'e data underlying the findings are included in the article. 3520, 2021. [2] C. W. Yancy, M. Jessup, B. Bozkurt et al., “2013 ACCF/AHA guideline for the management of heart failure: a report of the Additional Points American college of cardiology foundation/American heart association task force on practice guidelines,” Journal of the Summary and Highlights. Five randomized controlled trials American College of Cardiology, vol. 62, no.16, pp. e147–239, wereidentifiedthatcomparedCRToutcomeswithanimage- guided approach versus a non-image-guided approach; [3] C. M. Yu, G. B. Bleeker, J. W. H. Fung et al., “Left ventricular however,thecomponentsoftheimage-guidedapproachand reverse remodeling but not clinical improvement predicts non-image-guidedapproachwerenotidenticalinallstudies. long-term survival after cardiac resynchronization therapy,” Achievementofaleftventricular(LV)leadplacementwithin Circulation, vol. 112, no. 11, pp. 1580–1586, 2005. the LV segment with the latest mechanical activation [4] V. Delgado, R. J. van Bommel, M. Bertini et al., “Relative (concordant) occurred in 45% of evaluated patients with the merits of left ventricular dyssynchrony, left ventricular lead image-guided approach but also fortuitously occurred in position, and myocardial scar to predict long-term survival of ischemic heart failure patients undergoing cardiac resynch- 32% of evaluated patients with the non-image-guided ap- ronization therapy,” Circulation, vol. 123, no. 1, pp. 70–78, proach.'e image-guided approachfor placementof theLV lead for CRT within the LV segment with the latest me- [5] B. J. Sieniewicz, J. Gould, B. Porter et al., “Optimal site se- chanical activation was associated with a statistically sig- lection and image fusion guidance technology to facilitate nificant greater odds of the NYHA class improvement at 6 cardiac resynchronization therapy,” Expert Review of Medical months than the use of a non-image-guided approach. No Devices, vol. 15, no. 8, pp. 555–570, 2018. differences in echocardiographic measures at 6 months [6] M. Spartalis, E. Tzatzaki, E. Spartalis et al., “'e role of following the CRT implant were found with the image- echocardiography in the optimization of cardiac resynchro- guided approach as compared to a non-image-guided ap- nization therapy: current evidence and future perspectives,” proach.'erefore,thismeta-analysiswasnotabletoidentify 7e Open Cardiovascular Medicine Journal, vol. 11, no. 1, pp. 133–145, 2017. consistent improvement in CRT outcomes with an image- [7] J. P. Singh, H. U. Klein, D. T. Huang et al., “Left ventricular guided approach. lead position and clinical outcome in the multicenter auto- matic defibrillator implantation trial-cardiac resynchroniza- Disclosure tion therapy (MADIT-CRT) trial,” Circulation, vol. 123, no. 11, pp. 1159–1166, 2011. Dr. Al-Khatib receives research funding from Medtronic, [8] J. Gorcsan 3rd, O. Oyenuga, P. J. Habib et al., “Relationship of Abbott, and Boston Scientific. echocardiographic dyssynchrony to long-term survival after cardiac resynchronization therapy,” Circulation, vol. 122, no. 19, pp. 1910–1918, 2010. Conflicts of Interest [9] H. Tanaka, H.-J. Nesser, T. Buck et al., “Dyssynchrony by 'e authors declare that they have no conflicts of interest. speckle-tracking echocardiography and response to cardiac 10 Journal of Interventional Cardiology resynchronizationtherapy:resultsoftheSpeckleTrackingand Resynchronization (STAR) study,” European Heart Journal, vol. 31, no. 14, pp. 1690–1700, 2010. [10] F. Z. Khan, M. S. Virdee, C. R. Palmer et al., “Targeted left ventricular lead placement to Guide cardiac resynchroniza- tion therapy,” Journal of the American College of Cardiology, vol. 59, no. 17, pp. 1509–1518, 2012. [11] S. Saba, J. Marek, D. Schwartzman et al., “Echocardiography- guided left ventricular lead placement for cardiac resynch- ronization therapy,” Circulation: Heart Failure, vol. 6, no. 3, pp. 427–434, 2013. [12] M. Fudim, F. Dalgaard, S. M. Al-Khatib et al., “Future re- search prioritization in cardiac resynchronization therapy,” American Heart Journal, vol. 223, pp. 48–58, 2020. [13] M. J. Page, J. E. McKenzie, P. M. Bossuyt et al., “'e PRISMA 2020 statement:an updatedguideline for reporting systematic reviews,” Systematic Reviews, vol. 10, no. 1, p. 89, 2021. [14] J. A. C. Sterne, J. Savovic,´ M. J. Page et al., “RoB 2: a revised tool for assessing risk of bias in randomised trials,” BMJ, vol. 366, Article ID l4898, 2019. [15] R. DerSimonian and N. Laird, “Meta-analysis in clinical trials,” Controlled Clinical Trials, vol. 7, no. 3, pp. 177–188, 1986. [16] G. Knapp and J. Hartung, “Improved tests for a random effects meta-regression with a single covariate,” Statistics in Medicine, vol. 22, no. 17, pp. 2693–2710, 2003. [17] R. Borgquist, M. Carlsson, H. Markstad et al., “Cardiac resynchronizationtherapyguidedbyechocardiography,MRI,and CT imaging,” Journal of the American College of Cardiology: Clinical Electrophysiology, vol. 6, no. 10, pp. 1300–1309, 2020. [18] C.Stephansen,A.Sommer,M.B.Kronborgetal.,“Electrically vs. imaging-guided left ventricular lead placement in cardiac resynchronization therapy: a randomized controlled trial,” EP Europace, vol. 21, no. 9, pp. 1369–1377, 2019. [19] A. Sommer, M. B. Kronborg, B. L. Nørgaard et al., “Multi- modality imaging-guided left ventricular lead placement in cardiac resynchronization therapy: a randomized controlled trial,” European Journal of Heart Failure, vol. 18, no. 11, pp. 1365–1374, 2016. [20] Y. Jin, Q. Zhang, J.-l. Mao, and B. He, “Image-guided left ventricular lead placement in cardiac resynchronization therapy for patients with heart failure: a meta-analysis,” BMC Cardiovascular Disorders, vol. 15, no. 1, p. 36, 2015. [21] R. Bae, L. Di Biase, P. Mohanty, A. B. Hesselson, E. De Ruvo, andP.L.Gallagher,“Positioningofleftventricularpacinglead guided by intracardiac echocardiography with vector velocity imaging during cardiac resynchronization therapy proce- dure,” Journal of Cardiovascular Electrophysiology, vol. 22, no. 9, pp. 1034–1041, 2011. [22] P. C. Wouters, C. van Lieshout, V. F. van Dijk et al., “Ad- vanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation,” BMJ Open, vol. 11, no. 10, Article ID e054115, [23] M. D. Bogaard, P. A. Doevendans, G. E. Leenders et al., “Can optimization of pacing settings compensate for a non-optimal left ventricular pacing site?” Europace, vol. 12, no. 9, pp. 1262–1269, 2010. [24] N. M. Allen Lapointe, F. Ali-Ahmed, F. Dalgaard, A. S. Kosinski, G. D. Sanders, and S. M. Al-Khatib, “Abstract 9509: is left ventricular lead placement at site of latest me- chanical activation associated with cardiac resynchronization therapy outcomes? Results of a meta-analysis,” Circulation, vol. 144, no. 1, Article ID A9509, 2021.
Journal of Interventional Cardiology – Hindawi Publishing Corporation
Published: May 20, 2022
You can share this free article with as many people as you like with the url below! We hope you enjoy this feature!
Read and print from thousands of top scholarly journals.
Already have an account? Log in
Bookmark this article. You can see your Bookmarks on your DeepDyve Library.
To save an article, log in first, or sign up for a DeepDyve account if you don’t already have one.
Copy and paste the desired citation format or use the link below to download a file formatted for EndNote
Access the full text.
Sign up today, get DeepDyve free for 14 days.
All DeepDyve websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.