- Email: [email protected]
Cardiac venous injuries: Procedural profiles and outcomes during left ventricular lead placement for cardiac resynchronization therapy
Cardiac venous injuries: Procedural profiles and outcomes during left ventricular lead placement for cardiac resynchronization therapy Johnny Chahine, MD,* Bryan Baranowski, MD, FHRS,† Khaldoun Tarakji, MD, FHRS,† Mohamed M. Gad, MD,* Walid Saliba, MD, FHRS,† John Rickard, MD, FHRS,† Daniel J. Cantillon, MD, FHRS,† Mohamed Diab, MD,† Mohamed Kanj, MD, FHRS,† Thomas Callahan, MD, FHRS,† Thomas Dresing, MD,† Mandeep Bhargava, MBBS, FHRS,† Mina Chung, MD, FHRS,† Mark J. Niebauer, MD, FHRS,† Niraj Varma, MD, FHRS,† Patrick Tchou, MD, FHRS,† Bruce L. Wilkoff, MD, FHRS,† Oussama Wazni, MD, FHRS,† Ayman A. Hussein, MD, FHRS† From the *Department of Medicine, Cleveland Clinic, Cleveland, Ohio, and †Section of Cardiac Pacing and Electrophysiology, Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. BACKGROUND Injury to the cardiac venous structures can complicate left ventricular lead placement for cardiac resynchronization therapy (CRT). Little is known about the outcomes of coronary sinus (CS) dissection with or without perforation. OBJECTIVE The purpose of this study was to determine the outcomes in patients who had a CS injury during CRT implantation. METHODS All patients undergoing procedures for CRT implantation at the Cleveland Clinic (2001–2018) were enrolled in a prospectively maintained registry for procedural profiles and complications. All patients with cardiac venous injuries during the procedures were included. RESULTS CS injury occurred in 35 of 5011 patients (0.7%; 6 perforations (17.1%), 29 dissections without perforation (82.9%)). In patients with dissection in the absence of perforation, attempts at CS lead placement after dissection were successful in 21 of 29 patients (72.4%). In those with perforation (n56, 17.1%), CS lead placement was successful in one of them (16.7%). Cardiac tamponade occurred in 2 patients (5.7%), and the procedure was
Introduction Cardiac resynchronization therapy (CRT) has been proven to improve left ventricular (LV) function and clinical outcomes in select patients with severe systolic dysfunction and wide QRS interval.1 Procedure-related complications have been reported to occur in w7%–10% of patients and include lead dislodgment, infection, and acute heart failure.2,3 Address reprint requests and correspondence: Dr Ayman A. Hussein, Section of Cardiac Pacing and Electrophysiology, Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Mail Code J2-2, 9500 Euclid Avenue, Cleveland, OH 44195. E-mail address: [email protected].
aborted in both of them. Overall, CS lead placement failed in 13 patients (37%) but 9 (25.7%) underwent subsequent CRT with CS lead placement (n56, 17.1%; median 58 days later) or epicardial leads (n53, 8.6%). Three of the remaining 4 patients (8.6%) refused to undergo further procedures, and the fourth (2.9%) died of a complicated course. CONCLUSION CS injury is not common during CRT implantation procedures and did not preclude successful lead placement in 23 of 35 patients (65.7%) during the index procedure and 6 of 6 (100%) during the subsequent attempted procedures. A low rate of mortality was observed in such patients, but CS injury was associated with increased morbidity. KEYWORDS Cardiac resynchronization therapy; Coronary sinus dissection; Coronary sinus perforation; Coronary venous injury; Outcomes; Mortality; Morbidity (Heart Rhythm 2020;-:1–6) © 2020 Published by Elsevier Inc. on behalf of Heart Rhythm Society.
Coronary sinus (CS) injuries can occur during CRT implantation procedures.4 Multiple factors may increase the risk of CS injury, including challenging coronary anatomy, presence of CS valves, and forceful manipulation of catheters.5 Little is known about the procedural profiles and clinical outcomes in patients who develop CS injury during an attempt at CS lead placement. More specifically, the procedural outcomes such as successful placement of the CS lead during the index or subsequent procedures have not been systematically addressed. In the present study, we report procedural profiles and outcomes in patients with coronary venous injuries during
1547-5271/$-see front matter © 2020 Published by Elsevier Inc. on behalf of Heart Rhythm Society.
https://doi.org/10.1016/j.hrthm.2020.03.011
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2 CRT device implantation in a large prospectively maintained cohort spanning the course of 18 years at a tertiary care center.
Electronic Data Capture (REDCap) tools hosted at the Cleveland Clinic.6
Methods
Results
Study population
Baseline characteristics
All consecutive patients undergoing cardiac implantable electronic device placement at the Cleveland Clinic (2001– 2018) were enrolled in a prospectively maintained registry for procedural profiles and complications. All procedural complications were identified in monthly morbidity and mortality meetings. The study was approved by Cleveland Clinic’s Institutional Review Board. Patients with a reported CS injury during CRT implantation procedure were included in the present analysis and included both CS dissections and perforations. CS dissection was defined as a tear of the CS wall and identified by the presence of a true and a false lumen or contrast staining upon contrast angiography. CS perforation was diagnosed by contrast extravasation outside the coronary venous system into the pericardial space.
Of 5011 consecutive patients undergoing a procedure for CRT implantation, 35 patients (0.7%) had coronary venous injuries. These included CS perforation in 6 patients (17.1%) and CS dissection without perforation in the remaining 29 patients (82.9%). Twenty-eight of 35 patients (80%) had their injury in the body of the CS, and the rest had it in the tributaries. The mean age of patients with CS injuries was 67.2 6 11.8 years, and 21 of them (60%) were men. The mean LV ejection fraction before the procedures was 24.9% 6 9.5%, and 12 (32.3%) had a history of cardiac surgery. Regarding anticoagulation and antiplatelet therapy before the procedure, 22 (62.9%) were on aspirin, 8 were on warfarin (22.9%), 7 were on clopidogrel (20%), and 2 were on direct oral anticoagulants (5.7%). Only 6 of 35 patients (17.1%) were not receiving any anticoagulation or antiplatelet drugs. While antiplatelet agents were continued uninterrupted periprocedurally, warfarin was held for 4–5 days before the procedures and direct oral anticoagulants were held at least 2 days prior. The mean preoperative international normalized ratio for patients on warfarin was 1.4 6 0.4. The indications for CRT device placement were symptomatic heart failure (New York Heart Association functional class II–IV) with severely reduced LV ejection fraction (35%) and wide QRS interval in 31 patients (88.6%). The remaining 4 patients (11.4%) were undergoing procedures for CRT implantation procedures because of atrioventricular block requiring pacing with LV ejection fraction ,50% (2 of them had undergone atrioventricular junction ablation for atrial fibrillation). The patients’ baseline characteristics and CRT indications are summarized in Table 1.
Primary and secondary clinical outcomes The primary clinical outcome of interest was the acute and subacute successful placement of the CS or LV leads after CS injury. The secondary clinical outcomes were the rate of major complications, in-hospital death, and hospital length of stay. Major complications were a priori defined as the occurrence of procedure-related tamponade, cardiac arrest, or myocardial infarction within a week of the procedure. In addition to the prospectively maintained registry, a further chart review was performed to characterize the clinical course in patients with CS injuries.
Variables and statistical analyses Collected baseline variables included age, sex, underlying comorbidities, body mass index, preprocedural LV ejection fraction, New York Heart Association functional class, QRS width, baseline rhythm, presence of atrioventricular block, and type of intraventricular block before the procedure. Procedural data comprised the type of device implanted (CRT-defibrillator vs CRT-pacemaker), type of procedure (new implantation vs upgrade), site of CS injury, form of CS injury (dissection alone vs perforation), and probable cause of the injury. Other outcome variables collected were acute and subacute complications and New York Heart Association functional class up to 6 months after the index procedures as well as hospitalizations within 6 months. All statistical analyses were performed using the statistical software JMP Pro version 10.0 (SAS Institute Inc., Cary, NC). Descriptive statistics are presented as mean 6 SD or median (interquartile range [IQR]) for continuous variables and as frequency (percentage) for categorical variables. Study data were collected and managed using Research
Procedural profiles The procedures that were associated with CS injuries were de novo implantation procedures in 20 patients (57.1%) and device upgrades in 13 patients (37.1%) and were performed for a replacement of preexisting CS leads in the remaining 2 patients (5.7%). Most patients were undergoing procedures for the implantation of CRT-defibrillators (n531 [88.6%]) and the remaining 4 were for the implantation of CRTpacemakers (11.4%). The profiles of procedures with coronary venous injuries are summarized in Table 2. The site of coronary venous injury was the main body of the CS in 28 patients (80%) and a branch of the coronary venous system in the remaining 7 patients (20%). The underlying factors in coronary venous injuries included difficult CS anatomy in 17 patients (48.6%), including small caliber or tortuosity of the CS or branches in 12 patients (34.3%); presence of CS valves, which interfered with the sheath or lead advancement in 3 patients (8.6%); and posterior or steep takeoff of the CS in 2 patients (5.7%). Direct injury by the
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Chahine et al Table 1
Outcomes of Coronary Injuries After CRT
Baseline characteristics of the patients
3 Table 2
Procedural profiles
Variable
Value
Variable
Age (y) Male sex White race Other Underlying comorbidities Hyperlipidemia Coronary artery disease Prior percutaneous coronary intervention Prior bypass graft Hypertension Nicotine use disorder (current or former) Diabetes mellitus History of transient ischemic attack/stroke Prior valve surgery Alcohol use disorder Body mass index (kg/m2) Left ventricular ejection fraction (%) Baseline NYHA FC Class II Class III Class IV QRS width (ms) Baseline rhythm Sinus rhythm Atrial fibrillation Atrioventricular block First degree Second-degree Mobitz II Complete heart block Type of intraventricular conduction delay Left bundle branch block Right bundle branch block Left anterior fascicular block Paced rhythm Indication for CRT EF ,35%, QRS 150 ms with LBBB and NYHA FC II–IV EF ,35%, QRS 120–149 ms with LBBB and NYHA FC II–IV EF ,35%, QRS 150 ms with non-LBBB and NYHA FC II–IV EF ,35%, QRS 120–149 ms with non-LBBB pattern, NYHA FC III or IV EF ,50%, need for a pacemaker for atrioventricular block, NYHA FC I–IV
67.2 6 11.8 21 (60) 27 (77.1) 8 (22.9)
Planned CRT device CRT-defibrillator CRT-pacemaker Procedure New implantation Upgrade LV lead replacement Site of CS injury The main body of the CS Lateral branch Middle cardiac vein Anterolateral branch Posterolateral branch Mid-lateral branch Type of CS injury Dissection without perforation Perforation Underlying factors in CS injury Difficult coronary venous system anatomy, frequently needing multiple attempts Small caliber of the CS or branches Tortuosity of the CS or branches Presence of CS valves Posterior or steep takeoff of the CS Direct injury by the balloon Inability to maintain sheath stability needing multiple attempts at engaging the CS Difficulty engaging CS due to right atrial dilation Unclear cause of injury
26 (74.3) 25 (71.4) 8 (22.9) 10 (28.6) 24 (68.6) 18 (51.4) 11 (31.4) 10 (28.6) 4 (11.4) 1 (2.9) 27.1 6 5.8 24.9 6 9.5 7 (20) 27 (77.1) 1 (2.9) 157 6 30 28 (80) 7 (20) 19 (54.3) 10 (28.6) 2 (5.7) 7 (20) 24 (68.6) 2 (5.7) 2 (5.7) 7 (20) 14 (40) 7 (20) 5 (14.3) 5 (14.3) 4 (11.4)
Values are presented as mean 6 SD or as n (%). CRT 5 cardiac resynchronization therapy; EF 5 ejection fraction; LBBB 5 left bundle branch block; NYHA FC 5 New York Heart Association functional class.
balloon was thought by the implanting physicians to be the mechanism in 2 patients (5.7%). Other contributing factors to CS injury were the inability to maintain sheath stability needing multiple attempts at engaging the CS in 2 patients (5.7%) and difficulty engaging the CS due to right atrial dilatation in 1 patient (2.9%). In the remaining 13 patients (37%), the mechanism of injury could not be ascertained.
Primary outcome The primary clinical outcome, which was the acute and subacute successful placement of the CS leads after CS
Value 31 (88.6) 4 (11.4) 20 (57.1) 13 (37.1) 2 (5.7) 28 (80) 2 (5.7) 2 (5.7) 1 (2.9) 1 (2.9) 1 (2.9) 29 (82.9) 6 (17.1) 17 (48.6) 8 (22.9) 4 (11.4) 3 (8.6) 2 (5.7) 2 (5.7) 2 (5.7) 1 (2.9) 13 (37.1)
Values are presented as n (%). CRT 5 cardiac resynchronization therapy; CS 5 coronary sinus; LV 5 left ventricular.
injury, was achieved in 28 of 35 patients (80%). Among 29 patients with dissection and no perforation, CS lead placement after dissection was acutely successful in 21 patients (72.4%). Among the remaining 6 patients with CS perforation, CS lead placement was acutely successful in only 1 patient (16.7%). Of the remaining 13 patients (37.1%) with failed initial procedures, 6 (17.1%) underwent subsequent CS lead attempts (9 days to 10 months later, all successful), and none of them had recurrent dissection with reattempted CS lead placement. Three patients (8.6%) had epicardial leads placed within 2 weeks of index procedures (one of them needed urgent surgical repair of the CS for a severe pericardial bleed due to CS perforation, and an epicardial lead was placed at the time of surgery). Overall, CRT implantation was achieved in 31 patients (88.6%) with either CS leads (n528, 80%) or LV epicardial leads (n53, 8.6%). Three of the remaining 4 patients (8.6%) declined further procedures. The fourth one was an 84-yearold woman with multiple comorbidities (nonischemic cardiomyopathy, low flow, low gradient severe aortic stenosis, left bundle branch block, and sarcoidosis) whose procedure was complicated by pericardial tamponade due to CS perforation
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4 treated with pressors and pericardiocentesis, which itself was complicated by liver laceration and hemorrhagic ascites. This patient had a complicated course with progressive shock. The goals of care were discussed with the family who decided not to escalate care, and the patient died the next day.
Major procedure-related complications occurred in 2 patients (5.7%), both of them had cardiac tamponade due to CS perforation, and the procedures were aborted in both of them. The first one was the above-mentioned patient, and this was the only in-hospital death in this cohort. The second patient had 1600 cm3 drained from the pericardial space in the electrophysiology laboratory and eventually required emergent surgical repair of the CS with concomitant LV epicardial lead placement. The median length of stay in the study population was 1 day (IQR 1–3 days) and noted to be longer in patients with CS perforation (median 3 days; IQR 3–7 days) than in those with CS dissection alone (median 1 day; IQR 1–3 days). Overall, only 7 patients (20%) had a hospital stay longer than 3 days after the procedures. The secondary outcomes are summarized in Table 3.
Case scenarios Cases 1–4 (Figures 1–4) illustrate examples of outcomes of CS dissection and perforation during CS lead placement. Cases 1 and 2 provide examples of distal injuries of the CS (coronary dissection alone and perforation, respectively) and successful placement of the CS lead in a branch proximal to the injury site (in the high lateral and the posterolateral branch, respectively). Case 3 was the patient Table 3
Procedural outcomes
Variable
Value
Successful CS lead implantation Acute In CS dissection alone In CS perforation Acute and subacute In CS dissection alone In CS perforation Length of stay (d) In CS dissection alone In CS perforation Intraoperative complications Cardiac tamponade Hypotension requiring pressors without any pericardial effusion Small pericardial effusion Postoperative complications (within 6 mo) Upper extremity deep venous thrombosis Lead and generator infection Hospitalization within 6 mo Provide a breakdown of reason for hospitalization
22 (62.9) 21 (72.4) 1 (16.7) 28 (80) 24 (82.8) 4 (66.7) 1 (1–3) 1 (1–3) 3 (3–7) 2 (5.7) 1 (2.9) 1 (2.9) 2 (5.7) 1 (2.9) 8 (22.9)
Values are presented as median (interquartile range) or as n (%). CS 5 coronary sinus.
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Secondary outcomes
Figure 1 Case 1: A 66-year-old man with ischemic cardiomyopathy (left ventricular ejection fraction of 18%), history of coronary artery bypass graft, left bundle branch block, QRS duration of 178 ms, and New York Heart Association functional class II despite optimal medical therapy who presented for the implantation of a biventricular implantable cardioverterdefibrillator. The procedure was complicated by coronary sinus dissection (orange arrow). The operator was able to engage the true lumen and successfully implant the coronary sinus lead in a high lateral branch (blue arrow). The patient was stable on discharge the next day.
with CS perforation requiring emergent surgical repair and the implantation of an epicardial lead. Case 4 provides an example of CS dissection, which was complicated by perforation during the injection of contrast into the dissection plane with extravasation into the pericardial space (Online Supplemental Video 1). The procedure was aborted, and the postoperative course was uneventful. Eventually, this patient had a successful CS lead placement 8 months later.
Discussion In this series, we report procedural profiles and outcomes in patients with coronary venous injuries during CRT device implantation in a large prospectively maintained cohort spanning the course of 18 years at a tertiary care center. The incidence of CS injury was 0.7%, occurring in 35 of 5011 consecutive patients undergoing procedures for CRT implantation, and this was associated with increased morbidity and prolonged hospital stay, primarily in patients with CS perforation. Nonetheless, CS lead placement was successful in most patients during the index procedures, especially in the absence of associated perforation. Many patients with CS injury during the index procedures were brought back for subsequent attempts at CS lead placement, and this was successful in all of them. In addition, a few patients received surgical LV epicardial leads. The findings suggest that in the absence of perforation, finding the true lumen might allow successful lead placement.
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Outcomes of Coronary Injuries After CRT
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Figure 2 Case 2: A 65-year-old woman with nonischemic cardiomyopathy (left ventricular ejection fraction of 32%), left bundle branch block, QRS duration of 172 ms, and New York Heart Association functional class II despite optimal medical therapy who presented for the implantation of a biventricular implantable cardioverter-defibrillator. The procedure was complicated by coronary sinus perforation (orange arrow). The procedure was successful by implanting the lead proximal to the injury site in the posterolateral branch (blue arrow). The patient was stable on discharge 3 days later.
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Alternatively, targeting a more proximal branch than the injury site is reasonable as long as the patient is hemodynamically stable. Furthermore, considering a subsequent endovascular approach for CS lead placement rather than referral to a surgical
Figure 3 Case 3: A 67-year-old man with end-stage renal disease on hemodialysis, severe chronic obstructive pulmonary disease, nonischemic cardiomyopathy (left ventricular ejection fraction of 28%), right bundle branch block, left anterior fascicular block, QRS duration of 146 ms, and New York Heart Association functional class IV despite optimal medical therapy who presented for the implantation of a new biventricular implantable cardioverter-defibrillator. The procedure was complicated by coronary sinus perforation (orange arrow) and a pericardial effusion. An urgent pericardiocentesis initially drained 1200 cm3 of blood. Because of continued drainage (a total of 1600 cm3 of blood drained), the patient underwent urgent surgical repair of the coronary sinus. An epicardial left ventricular lead was also implanted during surgery. The patient was discharged 1 week later.
LV epicardial lead would be reasonable in those with failure due to CS injury during the index procedures. The following measures during CS cannulation and CS lead placement might help to decrease the risk of CS injury: recognizing an unusual catheter and wire course or behavior and confirming with venography, as applicable; advancing sheaths, leads, and balloons over wires; and gentle manipulation of catheters and sheaths while avoiding forward pressure in areas of resistance. In such scenarios, angiography can help identify valves, strictures, and spasms of the CS. In the case of valves that could preclude sheath advancement, using subselective sheaths over wires could help in many scenarios. That said, despite such precautions, CS injuries can still happen, and when they do, maintaining access when possible beyond the dissection site may still allow successful lead implantation. Targeting a more proximal branch to the dissection location may also allow a successful lead implantation procedure. When operators choose to proceed further with CS lead implantation after dissection, careful advancement of sheath and wire while watching wire course and behavior is also important to avoid cannulating the false lumen and further worsening dissection or eventually leading to perforation. Importantly, the early recognition of perforations is essential for both hemodynamic monitoring and early intervention in the case of tamponade physiology. In the literature, the incidence of CS dissection (with and without associated perforation) from the National Cardiovascular Data Registry (NCDR) Implantable CardioverterDefibrillator Registry has been reported to be w0.28%.7 While this could represent an underestimate of the actual incidence because of underreporting, both the NCDR data and our report confirm low incidence rates. The strength of the present report’s incidence estimate is being derived from a prospectively maintained cohort at a tertiary center. Nonetheless, the associated major complication rate and in-
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Figure 4 Case 4: A 77-year-old man with nonischemic cardiomyopathy (left ventricular ejection fraction of 15%), right bundle branch block, QRS duration of 186 ms, and New York Heart Association functional class III who presented for the implantation of a biventricular implantable cardioverter-defibrillator. The procedure was complicated by coronary sinus dissection (orange arrow). With contrast injection into the dissection plane, coronary sinus perforation occurred with extravasation into the pericardial space (green arrow) (Online Supplemental Video 1). The procedure was then aborted. A dual-chamber device was placed. The postoperative course was uneventful. The patient underwent a repeat attempt at coronary sinus lead placement (8 months later) without evidence of coronary injury (blue arrow), which was successful at the posterolateral branch after full recovery of the proximal CS. Note: Atrial lead was repositioned during the first procedure.
hospital deaths in patients with CS dissection from the NCDR Implantable Cardioverter-Defibrillator Registry were 5.9% and 3%, respectively, which are comparable to those reported in the present cohort.7 The observation of successful subsequent implantation without the recurrence of dissection suggests healing of injury or thrombosis/fibrosis of the false lumen preferentially directing wires and tools toward the true lumen. In a study by de Cock et al5 including 11 patients with CS dissection, the vast majority of patients had no evidence of CS injury on angiography 2 to 3 months after the index procedures. In another report on failed CS lead placement, reattempting CS lead placement was successful in 6 of 6 selected patients and one of them was a patient with dissection during the index procedure.8 A potential limitation of this study is that the experience from the present report may not be generalizable to lowervolume centers. Minor dissections might have been underreported by proceduralists; hence, the true incidence of CS injury might be underestimated. Small branch dissection or perforation related to the advancement of the leads into target branches might have been underreported as well.
Conclusion In this series, the incidence of CS injury was 0.7% in patients undergoing procedures for CRT implantation and this was associated with increased morbidity and prolonged hospital stay. The vast majority of patients were able to receive CS leads for CRT either during the index procedures or during subsequent endovascular attempts.
Appendix Supplementary data Supplementary data associated with this article can be found in the online version at https://doi.org/10.1016/j.hrthm.2020. 03.011.
References 1. Bristow MR, Saxon LA, Boehmer J, et al. 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 2004;350:2140–2150. 2. Niu H, Hua W, Wang F, Zhang S, Chen K, Chen X. Complications of cardiac resynchronization therapy in patients with congestive heart failure. Chin Med J (Engl) 2006;119:449–453. 3. Gras D, B€ocker D, Lunati M, et al. CARE-HF Study Steering Committee and Investigators. Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety. Europace 2007;9:516–522. 4. Yoda M, Hansky B, Koerfer R, Minami K. Coronary sinus dissection during left ventricular pacing electrode implantation. Ann Thorac Cardiovasc Surg 2007; 13:275–277. 5. de Cock CC, van Campen CMC, Visser CA. Major dissection of the coronary sinus and its tributaries during lead implantation for biventricular stimulation: angiographic follow-up. Europace 2004;6:43–47. 6. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research Electronic Data Capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–381. 7. Hsu JC, Varosy PD, Bao H, Dewland TA, Curtis JP, Marcus GM. Coronary venous dissection from left ventricular lead placement during cardiac resynchronization therapy with defibrillator implantation and associated in-hospital adverse events (from the NCDR ICD Registry). Am J Cardiol 2018;121:55–61. 8. Fatemi M, Etienne Y, Castellant P, Blanc J-J. Primary failure of cardiac resynchronization therapy: what are the causes and is it worth considering a second attempt? A single-centre experience. Europace 2008;10:1308–1312.
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Introduction Cardiac resynchronization therapy (CRT) has been proven to improve left ventricular (LV) function and clinical outcomes in select patients with severe systolic dysfunction and wide QRS interval.1 Procedure-related complications have been reported to occur in w7%–10% of patients and include lead dislodgment, infection, and acute heart failure.2,3 Address reprint requests and correspondence: Dr Ayman A. Hussein, Section of Cardiac Pacing and Electrophysiology, Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Mail Code J2-2, 9500 Euclid Avenue, Cleveland, OH 44195. E-mail address: [email protected].
aborted in both of them. Overall, CS lead placement failed in 13 patients (37%) but 9 (25.7%) underwent subsequent CRT with CS lead placement (n56, 17.1%; median 58 days later) or epicardial leads (n53, 8.6%). Three of the remaining 4 patients (8.6%) refused to undergo further procedures, and the fourth (2.9%) died of a complicated course. CONCLUSION CS injury is not common during CRT implantation procedures and did not preclude successful lead placement in 23 of 35 patients (65.7%) during the index procedure and 6 of 6 (100%) during the subsequent attempted procedures. A low rate of mortality was observed in such patients, but CS injury was associated with increased morbidity. KEYWORDS Cardiac resynchronization therapy; Coronary sinus dissection; Coronary sinus perforation; Coronary venous injury; Outcomes; Mortality; Morbidity (Heart Rhythm 2020;-:1–6) © 2020 Published by Elsevier Inc. on behalf of Heart Rhythm Society.
Coronary sinus (CS) injuries can occur during CRT implantation procedures.4 Multiple factors may increase the risk of CS injury, including challenging coronary anatomy, presence of CS valves, and forceful manipulation of catheters.5 Little is known about the procedural profiles and clinical outcomes in patients who develop CS injury during an attempt at CS lead placement. More specifically, the procedural outcomes such as successful placement of the CS lead during the index or subsequent procedures have not been systematically addressed. In the present study, we report procedural profiles and outcomes in patients with coronary venous injuries during
1547-5271/$-see front matter © 2020 Published by Elsevier Inc. on behalf of Heart Rhythm Society.
https://doi.org/10.1016/j.hrthm.2020.03.011
FLA 5.6.0 DTD HRTHM8319_proof 21 May 2020 5:38 am ce
Heart Rhythm, Vol -, No -, - 2020
2 CRT device implantation in a large prospectively maintained cohort spanning the course of 18 years at a tertiary care center.
Electronic Data Capture (REDCap) tools hosted at the Cleveland Clinic.6
Methods
Results
Study population
Baseline characteristics
All consecutive patients undergoing cardiac implantable electronic device placement at the Cleveland Clinic (2001– 2018) were enrolled in a prospectively maintained registry for procedural profiles and complications. All procedural complications were identified in monthly morbidity and mortality meetings. The study was approved by Cleveland Clinic’s Institutional Review Board. Patients with a reported CS injury during CRT implantation procedure were included in the present analysis and included both CS dissections and perforations. CS dissection was defined as a tear of the CS wall and identified by the presence of a true and a false lumen or contrast staining upon contrast angiography. CS perforation was diagnosed by contrast extravasation outside the coronary venous system into the pericardial space.
Of 5011 consecutive patients undergoing a procedure for CRT implantation, 35 patients (0.7%) had coronary venous injuries. These included CS perforation in 6 patients (17.1%) and CS dissection without perforation in the remaining 29 patients (82.9%). Twenty-eight of 35 patients (80%) had their injury in the body of the CS, and the rest had it in the tributaries. The mean age of patients with CS injuries was 67.2 6 11.8 years, and 21 of them (60%) were men. The mean LV ejection fraction before the procedures was 24.9% 6 9.5%, and 12 (32.3%) had a history of cardiac surgery. Regarding anticoagulation and antiplatelet therapy before the procedure, 22 (62.9%) were on aspirin, 8 were on warfarin (22.9%), 7 were on clopidogrel (20%), and 2 were on direct oral anticoagulants (5.7%). Only 6 of 35 patients (17.1%) were not receiving any anticoagulation or antiplatelet drugs. While antiplatelet agents were continued uninterrupted periprocedurally, warfarin was held for 4–5 days before the procedures and direct oral anticoagulants were held at least 2 days prior. The mean preoperative international normalized ratio for patients on warfarin was 1.4 6 0.4. The indications for CRT device placement were symptomatic heart failure (New York Heart Association functional class II–IV) with severely reduced LV ejection fraction (35%) and wide QRS interval in 31 patients (88.6%). The remaining 4 patients (11.4%) were undergoing procedures for CRT implantation procedures because of atrioventricular block requiring pacing with LV ejection fraction ,50% (2 of them had undergone atrioventricular junction ablation for atrial fibrillation). The patients’ baseline characteristics and CRT indications are summarized in Table 1.
Primary and secondary clinical outcomes The primary clinical outcome of interest was the acute and subacute successful placement of the CS or LV leads after CS injury. The secondary clinical outcomes were the rate of major complications, in-hospital death, and hospital length of stay. Major complications were a priori defined as the occurrence of procedure-related tamponade, cardiac arrest, or myocardial infarction within a week of the procedure. In addition to the prospectively maintained registry, a further chart review was performed to characterize the clinical course in patients with CS injuries.
Variables and statistical analyses Collected baseline variables included age, sex, underlying comorbidities, body mass index, preprocedural LV ejection fraction, New York Heart Association functional class, QRS width, baseline rhythm, presence of atrioventricular block, and type of intraventricular block before the procedure. Procedural data comprised the type of device implanted (CRT-defibrillator vs CRT-pacemaker), type of procedure (new implantation vs upgrade), site of CS injury, form of CS injury (dissection alone vs perforation), and probable cause of the injury. Other outcome variables collected were acute and subacute complications and New York Heart Association functional class up to 6 months after the index procedures as well as hospitalizations within 6 months. All statistical analyses were performed using the statistical software JMP Pro version 10.0 (SAS Institute Inc., Cary, NC). Descriptive statistics are presented as mean 6 SD or median (interquartile range [IQR]) for continuous variables and as frequency (percentage) for categorical variables. Study data were collected and managed using Research
Procedural profiles The procedures that were associated with CS injuries were de novo implantation procedures in 20 patients (57.1%) and device upgrades in 13 patients (37.1%) and were performed for a replacement of preexisting CS leads in the remaining 2 patients (5.7%). Most patients were undergoing procedures for the implantation of CRT-defibrillators (n531 [88.6%]) and the remaining 4 were for the implantation of CRTpacemakers (11.4%). The profiles of procedures with coronary venous injuries are summarized in Table 2. The site of coronary venous injury was the main body of the CS in 28 patients (80%) and a branch of the coronary venous system in the remaining 7 patients (20%). The underlying factors in coronary venous injuries included difficult CS anatomy in 17 patients (48.6%), including small caliber or tortuosity of the CS or branches in 12 patients (34.3%); presence of CS valves, which interfered with the sheath or lead advancement in 3 patients (8.6%); and posterior or steep takeoff of the CS in 2 patients (5.7%). Direct injury by the
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Chahine et al Table 1
Outcomes of Coronary Injuries After CRT
Baseline characteristics of the patients
3 Table 2
Procedural profiles
Variable
Value
Variable
Age (y) Male sex White race Other Underlying comorbidities Hyperlipidemia Coronary artery disease Prior percutaneous coronary intervention Prior bypass graft Hypertension Nicotine use disorder (current or former) Diabetes mellitus History of transient ischemic attack/stroke Prior valve surgery Alcohol use disorder Body mass index (kg/m2) Left ventricular ejection fraction (%) Baseline NYHA FC Class II Class III Class IV QRS width (ms) Baseline rhythm Sinus rhythm Atrial fibrillation Atrioventricular block First degree Second-degree Mobitz II Complete heart block Type of intraventricular conduction delay Left bundle branch block Right bundle branch block Left anterior fascicular block Paced rhythm Indication for CRT EF ,35%, QRS 150 ms with LBBB and NYHA FC II–IV EF ,35%, QRS 120–149 ms with LBBB and NYHA FC II–IV EF ,35%, QRS 150 ms with non-LBBB and NYHA FC II–IV EF ,35%, QRS 120–149 ms with non-LBBB pattern, NYHA FC III or IV EF ,50%, need for a pacemaker for atrioventricular block, NYHA FC I–IV
67.2 6 11.8 21 (60) 27 (77.1) 8 (22.9)
Planned CRT device CRT-defibrillator CRT-pacemaker Procedure New implantation Upgrade LV lead replacement Site of CS injury The main body of the CS Lateral branch Middle cardiac vein Anterolateral branch Posterolateral branch Mid-lateral branch Type of CS injury Dissection without perforation Perforation Underlying factors in CS injury Difficult coronary venous system anatomy, frequently needing multiple attempts Small caliber of the CS or branches Tortuosity of the CS or branches Presence of CS valves Posterior or steep takeoff of the CS Direct injury by the balloon Inability to maintain sheath stability needing multiple attempts at engaging the CS Difficulty engaging CS due to right atrial dilation Unclear cause of injury
26 (74.3) 25 (71.4) 8 (22.9) 10 (28.6) 24 (68.6) 18 (51.4) 11 (31.4) 10 (28.6) 4 (11.4) 1 (2.9) 27.1 6 5.8 24.9 6 9.5 7 (20) 27 (77.1) 1 (2.9) 157 6 30 28 (80) 7 (20) 19 (54.3) 10 (28.6) 2 (5.7) 7 (20) 24 (68.6) 2 (5.7) 2 (5.7) 7 (20) 14 (40) 7 (20) 5 (14.3) 5 (14.3) 4 (11.4)
Values are presented as mean 6 SD or as n (%). CRT 5 cardiac resynchronization therapy; EF 5 ejection fraction; LBBB 5 left bundle branch block; NYHA FC 5 New York Heart Association functional class.
balloon was thought by the implanting physicians to be the mechanism in 2 patients (5.7%). Other contributing factors to CS injury were the inability to maintain sheath stability needing multiple attempts at engaging the CS in 2 patients (5.7%) and difficulty engaging the CS due to right atrial dilatation in 1 patient (2.9%). In the remaining 13 patients (37%), the mechanism of injury could not be ascertained.
Primary outcome The primary clinical outcome, which was the acute and subacute successful placement of the CS leads after CS
Value 31 (88.6) 4 (11.4) 20 (57.1) 13 (37.1) 2 (5.7) 28 (80) 2 (5.7) 2 (5.7) 1 (2.9) 1 (2.9) 1 (2.9) 29 (82.9) 6 (17.1) 17 (48.6) 8 (22.9) 4 (11.4) 3 (8.6) 2 (5.7) 2 (5.7) 2 (5.7) 1 (2.9) 13 (37.1)
Values are presented as n (%). CRT 5 cardiac resynchronization therapy; CS 5 coronary sinus; LV 5 left ventricular.
injury, was achieved in 28 of 35 patients (80%). Among 29 patients with dissection and no perforation, CS lead placement after dissection was acutely successful in 21 patients (72.4%). Among the remaining 6 patients with CS perforation, CS lead placement was acutely successful in only 1 patient (16.7%). Of the remaining 13 patients (37.1%) with failed initial procedures, 6 (17.1%) underwent subsequent CS lead attempts (9 days to 10 months later, all successful), and none of them had recurrent dissection with reattempted CS lead placement. Three patients (8.6%) had epicardial leads placed within 2 weeks of index procedures (one of them needed urgent surgical repair of the CS for a severe pericardial bleed due to CS perforation, and an epicardial lead was placed at the time of surgery). Overall, CRT implantation was achieved in 31 patients (88.6%) with either CS leads (n528, 80%) or LV epicardial leads (n53, 8.6%). Three of the remaining 4 patients (8.6%) declined further procedures. The fourth one was an 84-yearold woman with multiple comorbidities (nonischemic cardiomyopathy, low flow, low gradient severe aortic stenosis, left bundle branch block, and sarcoidosis) whose procedure was complicated by pericardial tamponade due to CS perforation
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4 treated with pressors and pericardiocentesis, which itself was complicated by liver laceration and hemorrhagic ascites. This patient had a complicated course with progressive shock. The goals of care were discussed with the family who decided not to escalate care, and the patient died the next day.
Major procedure-related complications occurred in 2 patients (5.7%), both of them had cardiac tamponade due to CS perforation, and the procedures were aborted in both of them. The first one was the above-mentioned patient, and this was the only in-hospital death in this cohort. The second patient had 1600 cm3 drained from the pericardial space in the electrophysiology laboratory and eventually required emergent surgical repair of the CS with concomitant LV epicardial lead placement. The median length of stay in the study population was 1 day (IQR 1–3 days) and noted to be longer in patients with CS perforation (median 3 days; IQR 3–7 days) than in those with CS dissection alone (median 1 day; IQR 1–3 days). Overall, only 7 patients (20%) had a hospital stay longer than 3 days after the procedures. The secondary outcomes are summarized in Table 3.
Case scenarios Cases 1–4 (Figures 1–4) illustrate examples of outcomes of CS dissection and perforation during CS lead placement. Cases 1 and 2 provide examples of distal injuries of the CS (coronary dissection alone and perforation, respectively) and successful placement of the CS lead in a branch proximal to the injury site (in the high lateral and the posterolateral branch, respectively). Case 3 was the patient Table 3
Procedural outcomes
Variable
Value
Successful CS lead implantation Acute In CS dissection alone In CS perforation Acute and subacute In CS dissection alone In CS perforation Length of stay (d) In CS dissection alone In CS perforation Intraoperative complications Cardiac tamponade Hypotension requiring pressors without any pericardial effusion Small pericardial effusion Postoperative complications (within 6 mo) Upper extremity deep venous thrombosis Lead and generator infection Hospitalization within 6 mo Provide a breakdown of reason for hospitalization
22 (62.9) 21 (72.4) 1 (16.7) 28 (80) 24 (82.8) 4 (66.7) 1 (1–3) 1 (1–3) 3 (3–7) 2 (5.7) 1 (2.9) 1 (2.9) 2 (5.7) 1 (2.9) 8 (22.9)
Values are presented as median (interquartile range) or as n (%). CS 5 coronary sinus.
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Secondary outcomes
Figure 1 Case 1: A 66-year-old man with ischemic cardiomyopathy (left ventricular ejection fraction of 18%), history of coronary artery bypass graft, left bundle branch block, QRS duration of 178 ms, and New York Heart Association functional class II despite optimal medical therapy who presented for the implantation of a biventricular implantable cardioverterdefibrillator. The procedure was complicated by coronary sinus dissection (orange arrow). The operator was able to engage the true lumen and successfully implant the coronary sinus lead in a high lateral branch (blue arrow). The patient was stable on discharge the next day.
with CS perforation requiring emergent surgical repair and the implantation of an epicardial lead. Case 4 provides an example of CS dissection, which was complicated by perforation during the injection of contrast into the dissection plane with extravasation into the pericardial space (Online Supplemental Video 1). The procedure was aborted, and the postoperative course was uneventful. Eventually, this patient had a successful CS lead placement 8 months later.
Discussion In this series, we report procedural profiles and outcomes in patients with coronary venous injuries during CRT device implantation in a large prospectively maintained cohort spanning the course of 18 years at a tertiary care center. The incidence of CS injury was 0.7%, occurring in 35 of 5011 consecutive patients undergoing procedures for CRT implantation, and this was associated with increased morbidity and prolonged hospital stay, primarily in patients with CS perforation. Nonetheless, CS lead placement was successful in most patients during the index procedures, especially in the absence of associated perforation. Many patients with CS injury during the index procedures were brought back for subsequent attempts at CS lead placement, and this was successful in all of them. In addition, a few patients received surgical LV epicardial leads. The findings suggest that in the absence of perforation, finding the true lumen might allow successful lead placement.
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Chahine et al
Figure 2 Case 2: A 65-year-old woman with nonischemic cardiomyopathy (left ventricular ejection fraction of 32%), left bundle branch block, QRS duration of 172 ms, and New York Heart Association functional class II despite optimal medical therapy who presented for the implantation of a biventricular implantable cardioverter-defibrillator. The procedure was complicated by coronary sinus perforation (orange arrow). The procedure was successful by implanting the lead proximal to the injury site in the posterolateral branch (blue arrow). The patient was stable on discharge 3 days later.
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Alternatively, targeting a more proximal branch than the injury site is reasonable as long as the patient is hemodynamically stable. Furthermore, considering a subsequent endovascular approach for CS lead placement rather than referral to a surgical
Figure 3 Case 3: A 67-year-old man with end-stage renal disease on hemodialysis, severe chronic obstructive pulmonary disease, nonischemic cardiomyopathy (left ventricular ejection fraction of 28%), right bundle branch block, left anterior fascicular block, QRS duration of 146 ms, and New York Heart Association functional class IV despite optimal medical therapy who presented for the implantation of a new biventricular implantable cardioverter-defibrillator. The procedure was complicated by coronary sinus perforation (orange arrow) and a pericardial effusion. An urgent pericardiocentesis initially drained 1200 cm3 of blood. Because of continued drainage (a total of 1600 cm3 of blood drained), the patient underwent urgent surgical repair of the coronary sinus. An epicardial left ventricular lead was also implanted during surgery. The patient was discharged 1 week later.
LV epicardial lead would be reasonable in those with failure due to CS injury during the index procedures. The following measures during CS cannulation and CS lead placement might help to decrease the risk of CS injury: recognizing an unusual catheter and wire course or behavior and confirming with venography, as applicable; advancing sheaths, leads, and balloons over wires; and gentle manipulation of catheters and sheaths while avoiding forward pressure in areas of resistance. In such scenarios, angiography can help identify valves, strictures, and spasms of the CS. In the case of valves that could preclude sheath advancement, using subselective sheaths over wires could help in many scenarios. That said, despite such precautions, CS injuries can still happen, and when they do, maintaining access when possible beyond the dissection site may still allow successful lead implantation. Targeting a more proximal branch to the dissection location may also allow a successful lead implantation procedure. When operators choose to proceed further with CS lead implantation after dissection, careful advancement of sheath and wire while watching wire course and behavior is also important to avoid cannulating the false lumen and further worsening dissection or eventually leading to perforation. Importantly, the early recognition of perforations is essential for both hemodynamic monitoring and early intervention in the case of tamponade physiology. In the literature, the incidence of CS dissection (with and without associated perforation) from the National Cardiovascular Data Registry (NCDR) Implantable CardioverterDefibrillator Registry has been reported to be w0.28%.7 While this could represent an underestimate of the actual incidence because of underreporting, both the NCDR data and our report confirm low incidence rates. The strength of the present report’s incidence estimate is being derived from a prospectively maintained cohort at a tertiary center. Nonetheless, the associated major complication rate and in-
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Figure 4 Case 4: A 77-year-old man with nonischemic cardiomyopathy (left ventricular ejection fraction of 15%), right bundle branch block, QRS duration of 186 ms, and New York Heart Association functional class III who presented for the implantation of a biventricular implantable cardioverter-defibrillator. The procedure was complicated by coronary sinus dissection (orange arrow). With contrast injection into the dissection plane, coronary sinus perforation occurred with extravasation into the pericardial space (green arrow) (Online Supplemental Video 1). The procedure was then aborted. A dual-chamber device was placed. The postoperative course was uneventful. The patient underwent a repeat attempt at coronary sinus lead placement (8 months later) without evidence of coronary injury (blue arrow), which was successful at the posterolateral branch after full recovery of the proximal CS. Note: Atrial lead was repositioned during the first procedure.
hospital deaths in patients with CS dissection from the NCDR Implantable Cardioverter-Defibrillator Registry were 5.9% and 3%, respectively, which are comparable to those reported in the present cohort.7 The observation of successful subsequent implantation without the recurrence of dissection suggests healing of injury or thrombosis/fibrosis of the false lumen preferentially directing wires and tools toward the true lumen. In a study by de Cock et al5 including 11 patients with CS dissection, the vast majority of patients had no evidence of CS injury on angiography 2 to 3 months after the index procedures. In another report on failed CS lead placement, reattempting CS lead placement was successful in 6 of 6 selected patients and one of them was a patient with dissection during the index procedure.8 A potential limitation of this study is that the experience from the present report may not be generalizable to lowervolume centers. Minor dissections might have been underreported by proceduralists; hence, the true incidence of CS injury might be underestimated. Small branch dissection or perforation related to the advancement of the leads into target branches might have been underreported as well.
Conclusion In this series, the incidence of CS injury was 0.7% in patients undergoing procedures for CRT implantation and this was associated with increased morbidity and prolonged hospital stay. The vast majority of patients were able to receive CS leads for CRT either during the index procedures or during subsequent endovascular attempts.
Appendix Supplementary data Supplementary data associated with this article can be found in the online version at https://doi.org/10.1016/j.hrthm.2020. 03.011.
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